Open Source Medicine Foundation
Are there lots with unusually many adverse events, or a distinct adverse-event identity? — the COVID lot analysis, repeated for every other vaccine
| Vaccine | Lots (≥30 reports) | Hopkins | best k | silhouette | Density | Cluster verdict |
|---|---|---|---|---|---|---|
| Influenza | 333 | 0.81 | 6 | 0.224 | knot | continuum |
| Varicella / Zoster | 337 | 0.829 | 2 | 0.234 | knot | continuum |
| Pneumococcal (PCV) | 377 | 0.819 | 4 | 0.123 | knot | continuum |
| HPV | 258 | 0.71 | 2 | 0.288 | knot | weak/modest |
| DTaP | 148 | 0.771 | 3 | 0.361 | knot | weak/modest |
| Hepatitis A | 73 | 0.825 | 2 | 0.657 | knot | high silhouette* |
| MMR | 38 | 0.779 | 8 | 0.536 | continuum | high silhouette* |
| Rotavirus | 23 | — | — | — | — | too few lots |
| Meningococcal | 10 | — | — | — | — | too few lots |
| Hib | 9 | — | — | — | — | too few lots |
| Hepatitis B | 7 | — | — | — | — | too few lots |
| Polio (IPV) | 10 | — | — | — | — | too few lots |
Verdict scale: continuum silhouette <0.25 · weak/modest 0.25–0.5 · high silhouette* >0.5 (see caveat — check the cluster profiles below; on few lots this is usually a reporting-completeness split). Clustering uses per-lot symptom-category fractions (denominator-free); it needs no dose data.
Hopkins 0.81 · best k=6 · silhouette 0.224 · Calinski-H k=2 · Davies-B k=2 · median start year 2014 · density scan: tight knot found
=== category-fraction mix (PCA) === n=333 (median pairwise dist 4.70)
eps(p15)=0.87: CLUSTER n=34 tightness=0.21x median | mfr={'Influenza (trivalent) — Csl Limited': 7, 'Influenza nasal (quadrivalent) — Medimmune Vaccines, Inc.': 6, 'Influenza (trivalent) — Novartis Vaccines And Diagnostics': 5, 'Influenza (quadrivalent) — Glaxosmithkline Biologicals': 5, 'Influenza (quadrivalent) — Sanofi Pasteur': 5, 'Influenza nasal (trivalent) — Medimmune Vaccines, Inc.': 3, 'Influenza (trivalent) — Seqirus, Inc.': 1, 'Influenza (trivalent) — Glaxosmithkline Biologicals': 1, 'Influenza (quadrivalent) — Seqirus, Inc.': 1} | yr 2007-2024
lots: 03149111A, 11049221A, 14511P, 145205, 145701, 14649211A, 1514501, 1515701, 388459, 500501P ...
defining PTs: Thromboembolic (+-0pt), Menstrual / Reproductive (+-0pt), Cognitive (+-0pt), Tinnitus / Hearing (+-1pt)
eps(p30)=1.07: CLUSTER n=39 tightness=0.25x median | mfr={'Influenza (trivalent) — Csl Limited': 7, 'Influenza nasal (quadrivalent) — Medimmune Vaccines, Inc.': 7, 'Influenza nasal (trivalent) — Medimmune Vaccines, Inc.': 6, 'Influenza (quadrivalent) — Sanofi Pasteur': 6, 'Influenza (trivalent) — Novartis Vaccines And Diagnostics': 5, 'Influenza (quadrivalent) — Glaxosmithkline Biologicals': 5, 'Influenza (trivalent) — Seqirus, Inc.': 1, 'Influenza (trivalent) — Glaxosmithkline Biologicals': 1, 'Influenza (quadrivalent) — Seqirus, Inc.': 1} | yr 2007-2024
lots: 03149111A, 11049221A, 14511P, 145205, 145701, 14649211A, 1514501, 1515701, 388459, 500501P ...
defining PTs: Thromboembolic (+-0pt), Menstrual / Reproductive (+-0pt), Cognitive (+-0pt), Tinnitus / Hearing (+-1pt)
eps(p30)=1.07: CLUSTER n=5 tightness=0.25x median | mfr={'Influenza (trivalent) — Sanofi Pasteur': 4, 'Influenza (quadrivalent) — Glaxosmithkline Biologicals': 1} | yr 2012-2017
lots: 4373E, U4762BA, UH716AA, UI666AB, UI882AA
defining PTs: Dermatological (+11pt), Fever / Chills (+4pt), Fatigue / Malaise (+4pt), Injection site (+3pt)
eps(p30)=1.07: CLUSTER n=5 tightness=0.28x median | mfr={'Influenza (trivalent) — Sanofi Pasteur': 3, 'Influenza (trivalent) — Novartis Vaccines And Diagnostics': 1, 'Influenza (quadrivalent) — Sanofi Pasteur': 1} | yr 2010-2018
lots: 111784P1, U5015AA, UI422AB, UI664AA, UJ004AB
If one cluster’s top deviations are all near 0pt, the split is separating lots by reporting completeness (how many symptom categories per report), not by a distinct adverse-event identity — the same pattern seen for COVID.
| Lot | Event | Cases | PRR |
|---|---|---|---|
YK2207 | Palmar-plantar erythrodysaesthesia syndrome | 3 | 33664.4 |
252664 | Foetal non-stress test normal | 3 | 24048.7 |
1104…1A | HIV antigen negative | 50 | 19675.6 |
AFLL…AA | Heat rash | 6 | 10305.7 |
1104…1A | Hepatitis B surface antigen negative | 51 | 9120.6 |
252664 | Complication of pregnancy | 3 | 8016.2 |
4 administrative/handling terms (product/dispensing/storage errors) removed from this list — they are data-entry artifacts, not clinical events.
| Lot | Reports | Serious% | Deaths | Volume z |
|---|---|---|---|---|
NOBA…ER | 259 | 10.4% | 2 | 22.6 |
145701 | 230 | 0.4% | 0 | 20.0 |
1514…01 | 137 | 5.1% | 0 | 11.5 |
1515…01 | 128 | 1.6% | 0 | 10.7 |
Z7275 | 122 | 0.0% | 0 | 10.1 |
5005…8P | 113 | 1.8% | 0 | 9.3 |
Hopkins 0.829 · best k=2 · silhouette 0.234 · Calinski-H k=2 · Davies-B k=5 · median start year 2018 · density scan: tight knot found
=== category-fraction mix (PCA) === n=333 (median pairwise dist 4.77)
eps(p15)=0.67: CLUSTER n=21 tightness=0.07x median | mfr={'Varivax — Merck': 21} | yr 2013-2020
lots: H018451, J006358, K005180, K007979, K026385, L006383, L008270, L024256, M000996, M027885 ...
defining PTs: Menstrual / Reproductive (+-0pt), Thromboembolic (+-0pt), Cognitive (+-0pt), Mental Health (+-0pt)
eps(p30)=0.99: CLUSTER n=11 tightness=0.24x median | mfr={'Shingrix / varicella-zoster — Merck': 11} | yr 2012-2017
lots: 1605AA, H019999, J000443, J001700, L012475, L036823, L037790, L046295, M001746, M014310 ...
defining PTs: Dermatological (+3pt), Injection site (+2pt), Menstrual / Reproductive (+-0pt), Thromboembolic (+-0pt)
eps(p30)=0.99: CLUSTER n=31 tightness=0.22x median | mfr={'Varivax — Merck': 23, 'Shingrix / varicella-zoster — Merck': 5, 'Shingrix / varicella-zoster — Glaxosmithkline Biologicals': 3} | yr 2012-2023
lots: 274YD, 5NC4N, 7KG39, H016765, H018451, J004268, J006358, K005180, K007979, K026385 ...
defining PTs: Menstrual / Reproductive (+-0pt), Thromboembolic (+-0pt), Cognitive (+-0pt), Mental Health (+-0pt)
eps(p30)=0.99: CLUSTER n=5 tightness=0.23x median | mfr={'Shingrix / varicella-zoster — Glaxosmithkline Biologicals': 5} | yr 2017-2019
lots: 454S2, 9XC39, GZ29L, KB99G, XJ57B
If one cluster’s top deviations are all near 0pt, the split is separating lots by reporting completeness (how many symptom categories per report), not by a distinct adverse-event identity — the same pattern seen for COVID.
| Lot | Event | Cases | PRR |
|---|---|---|---|
T022…14 | Vaccination site cellulitis | 5 | 2469.2 |
L008…73 | Neurological examination normal | 3 | 1141.6 |
J2N44 | Facial paresis | 3 | 934.1 |
K009…70 | Hepatic enzyme increased | 3 | 728.4 |
6 administrative/handling terms (product/dispensing/storage errors) removed from this list — they are data-entry artifacts, not clinical events.
| Lot | Reports | Serious% | Deaths | Volume z |
|---|---|---|---|---|
5816…11 | 554 | 2.2% | 1 | 31.7 |
N022…79 | 248 | 0.0% | 0 | 13.8 |
B5EK2 | 173 | 12.1% | 0 | 9.4 |
CH2X7 | 165 | 9.7% | 1 | 8.9 |
539A2 | 147 | 8.8% | 0 | 7.8 |
3Z4KL | 142 | 6.3% | 1 | 7.5 |
Hopkins 0.819 · best k=4 · silhouette 0.123 · Calinski-H k=2 · Davies-B k=4 · median start year 2016 · density scan: tight knot found
=== category-fraction mix (PCA) === n=376 (median pairwise dist 4.43)
eps(p15)=0.97: CLUSTER n=9 tightness=0.24x median | mfr={'Pneumovax 23 — Merck': 9} | yr 2014-2022
lots: K007822, K009106, K009874, K019386, L002310, L007720, L024132, L040178, W019533
defining PTs: Menstrual / Reproductive (+-0pt), Thromboembolic (+-0pt), Cognitive (+-0pt), Tinnitus / Hearing (+-0pt)
eps(p15)=0.97: CLUSTER n=6 tightness=0.22x median | mfr={'Pneumovax 23 — Merck': 6} | yr 2013-2022
lots: J005067, J009827, K007824, N000508, S004548, U034712
defining PTs: Menstrual / Reproductive (+-0pt), Thromboembolic (+-0pt), Cognitive (+-0pt), Tinnitus / Hearing (+-0pt)
eps(p15)=0.97: CLUSTER n=5 tightness=0.23x median | mfr={'Pneumovax 23 — Merck': 5} | yr 2013-2020
lots: J004747, K007773, K009105, R033080, T022294
defining PTs: Musculoskeletal (+4pt), Menstrual / Reproductive (+-0pt), Thromboembolic (+-0pt), Cognitive (+-0pt)
eps(p30)=1.14: CLUSTER n=59 tightness=0.64x median | mfr={'Pneumovax 23 — Merck': 57, 'Prevnar 20 — Pfizer/Wyeth': 1, 'Prevnar 13 — Pfizer/Wyeth': 1} | yr 2010-2023
lots: 0651Z, 0866Z, H009826, H021941, HE6176, J004387, J004747, J005067, J009689, J009827 ...
If one cluster’s top deviations are all near 0pt, the split is separating lots by reporting completeness (how many symptom categories per report), not by a distinct adverse-event identity — the same pattern seen for COVID.
| Lot | Event | Cases | PRR |
|---|---|---|---|
0756AE | Phlebitis | 3 | 3067.6 |
0882F | Overdose | 3 | 2780.3 |
1040P | Nonspecific reaction | 4 | 2735.8 |
N4385 | Adverse reaction | 15 | 501.9 |
0756AE | Abasia | 3 | 469.8 |
HF1068 | Needle issue | 3 | 378.4 |
3 administrative/handling terms (product/dispensing/storage errors) removed from this list — they are data-entry artifacts, not clinical events.
| Lot | Reports | Serious% | Deaths | Volume z |
|---|---|---|---|---|
L040…78 | 125 | 6.4% | 0 | 5.8 |
K007…62 | 123 | 14.6% | 0 | 5.7 |
K007…22 | 120 | 2.5% | 0 | 5.5 |
L002…10 | 112 | 7.1% | 0 | 5.1 |
K009…74 | 109 | 11.9% | 0 | 4.9 |
L007…20 | 103 | 7.8% | 0 | 4.6 |
Hopkins 0.71 · best k=2 · silhouette 0.288 · Calinski-H k=2 · Davies-B k=2 · median start year 2013 · density scan: tight knot found
=== category-fraction mix (PCA) === n=258 (median pairwise dist 5.10)
eps(p15)=0.91: CLUSTER n=26 tightness=0.28x median | mfr={'Gardasil 9 (HPV9) — Merck': 19, 'Gardasil (HPV4) — Merck': 7} | yr 2012-2023
lots: 1687291, 1775811, 1775827, 1780876, 1957405, H011350, K005881, K006191, K011562, L001312 ...
defining PTs: Thromboembolic (+-0pt), Cognitive (+-1pt), Tinnitus / Hearing (+-1pt), Sleep (+-1pt)
eps(p30)=1.36: CLUSTER n=60 tightness=0.41x median | mfr={'Gardasil 9 (HPV9) — Merck': 45, 'Gardasil (HPV4) — Merck': 15} | yr 2007-2023
lots: 0928U, 1602284, 1621931, 1637651, 1687291, 1687292, 1775811, 1775827, 1780876, 1780878 ...
defining PTs: Thromboembolic (+-0pt), Cognitive (+-1pt), Tinnitus / Hearing (+-1pt), Sleep (+-1pt)
eps(p45)=1.74: CLUSTER n=99 tightness=0.49x median | mfr={'Gardasil 9 (HPV9) — Merck': 66, 'Gardasil (HPV4) — Merck': 33} | yr 2007-2024
lots: 0131AE, 0928U, 0963AA, 1397AA, 1427F, 1602284, 1614897, 1621931, 1621934, 1637651 ...
defining PTs: Thromboembolic (+-0pt), Cognitive (+-1pt), Tinnitus / Hearing (+-1pt), Sleep (+-1pt)
eps(p60)=2.09: CLUSTER n=129 tightness=0.61x median | mfr={'Gardasil 9 (HPV9) — Merck': 79, 'Gardasil (HPV4) — Merck': 50} | yr 2006-2024
lots: 0072X, 0131AE, 0525U, 0819Y, 0841AA, 0927U, 0928U, 0929U, 0954F, 0963AA ...
If one cluster’s top deviations are all near 0pt, the split is separating lots by reporting completeness (how many symptom categories per report), not by a distinct adverse-event identity — the same pattern seen for COVID.
| Lot | Event | Cases | PRR |
|---|---|---|---|
T039…67 | Ill-defined disorder | 6 | 1134.4 |
9 administrative/handling terms (product/dispensing/storage errors) removed from this list — they are data-entry artifacts, not clinical events.
| Lot | Reports | Serious% | Deaths | Volume z |
|---|---|---|---|---|
K006…60 | 205 | 8.8% | 0 | 6.4 |
1780…76 | 180 | 0.0% | 0 | 5.5 |
1775…27 | 177 | 0.0% | 0 | 5.4 |
1775…11 | 176 | 0.6% | 1 | 5.4 |
N004…98 | 176 | 1.7% | 0 | 5.4 |
W009…29 | 164 | 0.0% | 0 | 5.0 |
Hopkins 0.771 · best k=3 · silhouette 0.361 · Calinski-H k=2 · Davies-B k=3 · median start year 2014 · density scan: tight knot found
=== category-fraction mix (PCA) === n=147 (median pairwise dist 5.12)
eps(p15)=0.33: CLUSTER n=15 tightness=0.08x median | mfr={'DTAPIPV — Glaxosmithkline Biologicals': 10, 'DTaP — Glaxosmithkline Biologicals': 3, 'DTaP — Sanofi Pasteur': 1, 'DTAPIPV — Sanofi Pasteur': 1} | yr 2019-2023
lots: 2KL4K, 34MF9, 3KS4F, 5AY2J, 7EC55, 7P5J5, C472T, C5366AA, C5970AA, G9N2M ...
defining PTs: Menstrual / Reproductive (+0pt), Thromboembolic (+-0pt), Cognitive (+-0pt), Tinnitus / Hearing (+-0pt)
eps(p30)=0.78: CLUSTER n=33 tightness=0.21x median | mfr={'DTAPIPV — Glaxosmithkline Biologicals': 18, 'DTAPIPV — Sanofi Pasteur': 8, 'DTaP — Glaxosmithkline Biologicals': 4, 'Tdap — Glaxosmithkline Biologicals': 1, 'DTaP — Sanofi Pasteur': 1, 'Td — Sanofi Pasteur': 1} | yr 2018-2023
lots: 24T2N, 2KL4K, 34MF9, 3KS4F, 57GJ2, 5AY2J, 5H95B, 7C9NJ, 7D2Y4, 7EC55 ...
defining PTs: Menstrual / Reproductive (+0pt), Thromboembolic (+-0pt), Cognitive (+-0pt), Tinnitus / Hearing (+-0pt)
eps(p45)=1.43: CLUSTER n=46 tightness=0.31x median | mfr={'DTAPIPV — Glaxosmithkline Biologicals': 21, 'DTAPIPV — Sanofi Pasteur': 10, 'DTaP — Glaxosmithkline Biologicals': 8, 'DTaP — Sanofi Pasteur': 3, 'Tdap — Glaxosmithkline Biologicals': 2, 'Td — Sanofi Pasteur': 2} | yr 2011-2024
lots: 24T2N, 2KL4K, 34MF9, 3KS4F, 3RT93, 49TM3, 57GJ2, 5AY2J, 5H95B, 7C9NJ ...
defining PTs: Menstrual / Reproductive (+0pt), Thromboembolic (+-0pt), Cognitive (+-0pt), Mental Health (+-0pt)
eps(p45)=1.43: CLUSTER n=5 tightness=0.29x median | mfr={'Tdap — Sanofi Pasteur': 5} | yr 2007-2017
lots: C2610AA, C2644AA, C2731AA, C3935AA, U5593AA
If one cluster’s top deviations are all near 0pt, the split is separating lots by reporting completeness (how many symptom categories per report), not by a distinct adverse-event identity — the same pattern seen for COVID.
| Lot | Event | Cases | PRR |
|---|---|---|---|
U685…AA | Ophthalmic migraine | 3 | 16455.7 |
U727…AA | Blood donor | 4 | 5171.0 |
C2456A | Hepatitis B surface antigen negative | 5 | 4515.4 |
U685…AA | Vestibular disorder | 3 | 3291.1 |
C2456A | Rubella immunity confirmed | 3 | 2873.4 |
C2456A | Antibody test negative | 5 | 2107.2 |
1 administrative/handling terms (product/dispensing/storage errors) removed from this list — they are data-entry artifacts, not clinical events.
| Lot | Reports | Serious% | Deaths | Volume z |
|---|---|---|---|---|
34MF9 | 101 | 1.0% | 0 | 9.0 |
2KL4K | 81 | 0.0% | 0 | 7.0 |
G9N2M | 78 | 0.0% | 0 | 6.7 |
7P5J5 | 77 | 0.0% | 0 | 6.6 |
H9FM5 | 74 | 0.0% | 0 | 6.3 |
7KM94 | 64 | 0.0% | 0 | 5.3 |
Hopkins 0.825 · best k=2 · silhouette 0.657 · Calinski-H k=2 · Davies-B k=8 · median start year 2018 · density scan: tight knot found
=== category-fraction mix (PCA) === n=61 (median pairwise dist 2.62)
eps(p15)=0.11: CLUSTER n=7 tightness=0.04x median | mfr={'HEP — Merck': 3, 'HEPA — Merck': 3, 'HEPA — Glaxosmithkline Biologicals': 1} | yr 2012-2021
lots: 0385AE, 3A22R, K020216, L010595, L028666, N019924, R013859
defining PTs: Thromboembolic (+0pt), Cognitive (+-0pt), Menstrual / Reproductive (+-0pt), Tinnitus / Hearing (+-0pt)
eps(p30)=0.21: CLUSTER n=11 tightness=0.06x median | mfr={'HEP — Merck': 4, 'HEPA — Merck': 4, 'HEPA — Glaxosmithkline Biologicals': 3} | yr 2012-2022
lots: 0385AE, 3A22R, H4H53, J95H7, K012457, K020216, L010595, L028666, M000442, N019924 ...
defining PTs: Thromboembolic (+0pt), Cognitive (+-0pt), Menstrual / Reproductive (+-0pt), Tinnitus / Hearing (+-0pt)
eps(p30)=0.21: CLUSTER n=5 tightness=0.08x median | mfr={'HEPA — Glaxosmithkline Biologicals': 2, 'HEPA — Merck': 2, 'HEP — Glaxosmithkline Biologicals': 1} | yr 2015-2022
lots: 2BA99, EP47E, K329E, L002717, N005605
defining PTs: Thromboembolic (+0pt), Cognitive (+-0pt), Menstrual / Reproductive (+-0pt), Tinnitus / Hearing (+-0pt)
eps(p45)=0.36: CLUSTER n=25 tightness=0.17x median | mfr={'HEPA — Merck': 11, 'HEP — Merck': 7, 'HEPA — Glaxosmithkline Biologicals': 5, 'HEP — Glaxosmithkline Biologicals': 2} | yr 2012-2022
lots: 0385AE, 2BA99, 3A22R, EP47E, H4H53, J007946, J95H7, K010535, K012457, K020216 ...
If one cluster’s top deviations are all near 0pt, the split is separating lots by reporting completeness (how many symptom categories per report), not by a distinct adverse-event identity — the same pattern seen for COVID.
| Lot | Event | Cases | PRR |
|---|---|---|---|
R022…22 | Nodule | 7 | 1081.3 |
AHBV…86 | Injection site haemorrhage | 3 | 879.6 |
9H2H2 | Nuclear magnetic resonance imaging brain abnormal | 3 | 789.7 |
AHBV…AA | Hepatitis B antigen positive | 3 | 637.5 |
9H2H2 | Electroencephalogram abnormal | 3 | 571.8 |
1491Y | Apnoea | 3 | 566.3 |
3 administrative/handling terms (product/dispensing/storage errors) removed from this list — they are data-entry artifacts, not clinical events.
| Lot | Reports | Serious% | Deaths | Volume z |
|---|---|---|---|---|
0385AE | 272 | 0.0% | 0 | 19.6 |
L016…27 | 203 | 0.5% | 0 | 14.4 |
L025…38 | 135 | 0.7% | 0 | 9.3 |
CP23D | 121 | 0.0% | 0 | 8.3 |
L018…99 | 89 | 0.0% | 0 | 5.9 |
K020…16 | 85 | 1.2% | 0 | 5.6 |
Hopkins 0.779 · best k=8 · silhouette 0.536 · Calinski-H k=8 · Davies-B k=8 · median start year 2016 · density scan: no tight knot (continuum)
too few lots for density scan
If one cluster’s top deviations are all near 0pt, the split is separating lots by reporting completeness (how many symptom categories per report), not by a distinct adverse-event identity — the same pattern seen for COVID.
| Lot | Event | Cases | PRR |
|---|---|---|---|
0226U | No adverse effect | 3 | 3721.2 |
0776Y | Mumps | 5 | 371.2 |
0776Y | Parotitis | 5 | 298.1 |
0297U | Injection site cellulitis | 3 | 230.9 |
6 administrative/handling terms (product/dispensing/storage errors) removed from this list — they are data-entry artifacts, not clinical events.
| Lot | Reports | Serious% | Deaths | Volume z |
|---|---|---|---|---|
L012…79 | 79 | 0.0% | 0 | 10.8 |
U015…79 | 68 | 0.0% | 0 | 9.1 |
K025…66 | 67 | 0.0% | 0 | 9.0 |
L030…86 | 62 | 0.0% | 0 | 8.2 |
W002…82 | 60 | 0.0% | 0 | 7.9 |
L003…55 | 52 | 0.0% | 0 | 6.7 |
Method mirrors the COVID suite (analysis hub): per-lot 17-category profiles; Hopkins tendency; k-means scored with silhouette, Calinski-Harabasz, and Davies-Bouldin; DBSCAN density scan for tight knots; within-vaccine PRR from vaers_lot_signals.parquet. No per-dose rates (openVAERS dose counts are COVID-only). Reproducible: compute_multivax_lot_clusters.py --vaccine <id> + build_multivax_lot_page.py. Passive surveillance; hypothesis-generating only.
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Decentralized trial for PACVS (post-acute COVID-19 vaccination syndrome).
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