| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2872530 | 11 | M | NC | 11/13/2025 |
COVID19 |
MODERNA |
8146670 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
|
Received the adult dose 0.5 ML of Spikevax instead of the 0.25mL dose that an 11yr old should have r...
Received the adult dose 0.5 ML of Spikevax instead of the 0.25mL dose that an 11yr old should have received. Mother contacted and stated no reaction and patient is fine with no adverse reaction.
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| 2872531 | 11 | M | NC | 11/13/2025 |
COVID19 |
MODERNA |
8146670 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
|
Patient received the adult dose of 0.5 mL of vaccine instead of the pediatric dose of 0.25mL. These...
Patient received the adult dose of 0.5 mL of vaccine instead of the pediatric dose of 0.25mL. These was no adverse reaction and mother reports child is fine. No side effects noted. Mother was made aware and contacted
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| 2872532 | 35 | M | IL | 11/13/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EWO 176 EWO 176 EWO 177 EWO 177 |
Biopsy kidney abnormal, Focal segmental glomerulosclerosis, Haematochezia, Joint...
Biopsy kidney abnormal, Focal segmental glomerulosclerosis, Haematochezia, Joint swelling, Nephrotic syndrome; Oedema peripheral, Tubulointerstitial nephritis, Urine abnormality, Urine odour abnormal; Biopsy kidney abnormal, Focal segmental glomerulosclerosis, Haematochezia, Joint swelling, Nephrotic syndrome; Oedema peripheral, Tubulointerstitial nephritis, Urine abnormality, Urine odour abnormal
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In July of 2021 I began experiencing blood in my stools. A little while later I began to notice some...
In July of 2021 I began experiencing blood in my stools. A little while later I began to notice some chances to my body and health. I am not certain of the date, but a month or 2 after receiving my second vaccine, I noticed my urine was becoming more foamy and smelt off. A few months later, I experienced swelling in my ankles. The swelling continued and I experienced significant pitting in my legs. I saught medial attention, and was diagnosed with nephrotic syndrome, and after a biopsy was completed of my kidney tissue I was diagnosed with Focal Segmental Glumerial Sclerosis. I have been managing this disease since diagnosis in August of 2022.
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| 2872533 | 16 | M | VA | 11/13/2025 |
COVID19 COVID19 HEP HEP HPV9 HPV9 IPV IPV MMR MMR TD TD VARCEL VARCEL |
MODERNA MODERNA GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
3052668 3052668 7993Z 7993Z Y019751 Y019751 Y1D03P1 Y1D03P1 Y019931 Y019931 U8492BA U8492BA Z010437 Z010437 |
Dyspnoea, Pain, Pruritus, Rash macular, Urticaria; Wheezing; Dyspnoea, Pain, Pru...
Dyspnoea, Pain, Pruritus, Rash macular, Urticaria; Wheezing; Dyspnoea, Pain, Pruritus, Rash macular, Urticaria; Wheezing; Dyspnoea, Pain, Pruritus, Rash macular, Urticaria; Wheezing; Dyspnoea, Pain, Pruritus, Rash macular, Urticaria; Wheezing; Dyspnoea, Pain, Pruritus, Rash macular, Urticaria; Wheezing; Dyspnoea, Pain, Pruritus, Rash macular, Urticaria; Wheezing; Dyspnoea, Pain, Pruritus, Rash macular, Urticaria; Wheezing
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1 hour after vaccines administered he had hives developing on his neck and upper torso and itchy red...
1 hour after vaccines administered he had hives developing on his neck and upper torso and itchy red skin. He was given benadryl 50mg and after another hour of monitoring symptoms worsening. He started to have difficulty breathing, and wheezing. Epi pen administered and he was transported to ER. He had follow up appointment the next day with NP and was stable. He felt sore from the vaccines and subsequent reaction.
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| 2872535 | 38 | F | TX | 11/13/2025 |
FLU3 TDAP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
U8832DA 5N9L9 |
Circumstance or information capable of leading to medication error, Exposure dur...
Circumstance or information capable of leading to medication error, Exposure during pregnancy, Wrong product administered; Circumstance or information capable of leading to medication error, Exposure during pregnancy, Wrong product administered
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PT CAME IN TO GET TDAP, TECHNICIAN TYPED UP FLUBLOK, UPON IDENTIFYING PATIENT AND CONFIRMING, HER 3 ...
PT CAME IN TO GET TDAP, TECHNICIAN TYPED UP FLUBLOK, UPON IDENTIFYING PATIENT AND CONFIRMING, HER 3 KIDS WERE CRYING, CLIMBING ON TOP OF FURNITURE/RISK FOR FALL, RUNNING IN SHOT ROOM, PT WAS PREGNANT AND COULD NOT ANSWER QUESTIONS DUE TO KIDS DISTRACTING, TOLD HER I WAS GIVING THE VACCINE THAT WAS NOT MADE FROM EGGS, SAFE TO GIVE FOR HIVES, MADE FOR THOSE WHO HAVE SENSITIVIES FROM REGULAR SHOT, GAVE FLUBLOK. AFTER LEAVING THE SHOT ROOM, SHE NOTICED HER RECEIPT AND SAW FLUBLOK THEN SAID SHE ACTUALLY WANTED TETANUS. TECH NOTICED HIS ERROR AND WHEN I SAID WHEN I COUNSELED HER ABOUT FLUBLOK, SHE SAID SHE DIDN'T HEAR DUE TO HER KIDS THAT I WAS GIVING THAT TO HER. I APOLOGIZED AND GAVE HER BOOSTRIX IN HER OTHER ARM AND TOLD HER I'D REPORT BUT TO STILL CALL ME IF SHE DOES BREAK OUT INTO HIVES OR ANY OTHER REACTION TO CALL ME SO I CAN REPORT AGAIN.
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| 2872536 | 69 | F | 11/13/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Urticaria
Urticaria
|
Patient presented to urgent care with complaints of full body hives that began Monday night followin...
Patient presented to urgent care with complaints of full body hives that began Monday night following receiving the flu vaccine. No relief with OTC benadryl.
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| 2872538 | 11 | F | AZ | 11/13/2025 |
FLU3 HPV9 PNC20 TDAP |
SANOFI PASTEUR MERCK & CO. INC. PFIZER\WYETH SANOFI PASTEUR |
UT8861NA Y015760 MG7416 U8669AA |
No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
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Prevnar 20 was given to pediatric patient. Per Provider no concerns, only for monitoring. Patients g...
Prevnar 20 was given to pediatric patient. Per Provider no concerns, only for monitoring. Patients guardian was contacted and patient has been fine.
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| 2872543 | 32 | M | WA | 11/13/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
041L20A 013M20A |
Angina pectoris, Cardiac stress test normal, Chest X-ray normal, Echocardiogram ...
Angina pectoris, Cardiac stress test normal, Chest X-ray normal, Echocardiogram normal, Electrocardiogram normal; Angina pectoris, Cardiac stress test normal, Chest X-ray normal, Echocardiogram normal, Electrocardiogram normal
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Chronic pain in my heart. I have been to urgent care, hospital emergency rooms, and a cardiologist. ...
Chronic pain in my heart. I have been to urgent care, hospital emergency rooms, and a cardiologist. Each time they tell me there are no abnormal findings. Especially when I bring up that it started after receiving my second COVID shot. They immediately seem skeptical. I went to the cardiologist, and they were unable to find an immediate cause for the pain and especially after I brought up the COVID shot the Dr finally stated that I likely have some level of myocarditis but told me to take IBUPROFEN and offered no follow up or additional help.
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| 2872547 | 57 | M | NJ | 11/13/2025 |
FLU3 |
SANOFI PASTEUR |
UT8852NA |
Liquid product physical issue
Liquid product physical issue
|
Reporting vaccination administration error: The vaccine appeared to be transparent; however, upon sh...
Reporting vaccination administration error: The vaccine appeared to be transparent; however, upon shaking it, I observed some particulates floating within it (the vaccine was administered).
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| 2872548 | 33 | F | NJ | 11/13/2025 |
FLU3 |
SANOFI PASTEUR |
UT8817LA |
Swelling face, Urticaria
Swelling face, Urticaria
|
Swollen Face and Hives
Swollen Face and Hives
|
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| 2872549 | 5 | F | NC | 11/13/2025 |
COVID19 |
MODERNA |
3052581 |
Incorrect dose administered
Incorrect dose administered
|
Wrong dose of COVID vaccine administered to patient. Patient presented to clinic with mother for COV...
Wrong dose of COVID vaccine administered to patient. Patient presented to clinic with mother for COVID vaccine. Mother provided prescription for COVID vaccine from PCP. I went to pull vaccine from freezer from the state side, from the bin that was labeled "6 months through 11 years". I administered vaccination. After patient left clinic. I went to document the immunization. The lot number was not matching. The lot number I wrote down from the vaccine I gave and the lot number from system were different. Initially I thought someone put in wrong lot numbers into system. After further investigation I realized that the vaccine was in the incorrect bin. The bin was labeled "6 month to 11 years old" but the actual box that was in the bin was the over 12 year old vaccines. RN (supervisor) notified of incident. RN (state consultant) informed of incident. Mother of patient informed of incident. Instructed mother to keep eye out for localized or adverse reaction from vaccine and report to ER if occurs or call clinic for any questions. When called patient's mother she did not report having noticed any adverse reactions so far.
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| 2872550 | 31 | M | TX | 11/13/2025 |
COVID19 |
PFIZER\BIONTECH |
FE3592 |
Death
Death
|
Death- 2-1-22
Death- 2-1-22
|
โ | โ | ||||
| 2872554 | 89 | F | FL | 11/13/2025 |
FLU3 |
SEQIRUS, INC. |
8146751 |
Injection site pruritus
Injection site pruritus
|
itching at injection side. Successfully treated with one tablet of Diphenhydramine (25mg). Resident...
itching at injection side. Successfully treated with one tablet of Diphenhydramine (25mg). Resident stated that itching was relieved within a few minutes (about 5 minutes) She was monitored for 30 minutes post injection and was seen by the PA 3 hours later (due to a previously scheduled appointment). The PA was notified of the adverse reaction via phone call.
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| 2872555 | 79 | F | NY | 11/13/2025 |
COVID19 |
MODERNA |
3052735 |
Dyspnoea, Erythema
Dyspnoea, Erythema
|
Patient stated that she felt "red in the face and short of breath" 10 minutes after vaccin...
Patient stated that she felt "red in the face and short of breath" 10 minutes after vaccine administration
More
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| 2872556 | 81 | M | MA | 11/13/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052733 U8764CB |
Influenza like illness, Skin infection; Influenza like illness, Skin infection
Influenza like illness, Skin infection; Influenza like illness, Skin infection
|
PATIENT DEVELOPED A SKIN INFECTION, WAS NOT NOTICED, LEFT BANDAGE ON FOR A WEEK, STARTED TO DEVELOP ...
PATIENT DEVELOPED A SKIN INFECTION, WAS NOT NOTICED, LEFT BANDAGE ON FOR A WEEK, STARTED TO DEVELOP FLU LIKE SYMPTOMS, PATIENT WAS TAKEN TO THE HOSPITAL, AND WAS PUT ON ANTIBIOTICS, PT IS DUE TO BE RELEASED FROM THE HOSPITAL, THIS WAS REPORTED BY THE FACILITY WHERE HE LIVES (WITHHELD)
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โ | |||||
| 2872559 | 52 | F | MA | 11/13/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
U8823Ba U8823Ba |
Chest discomfort, Cough, Dyspnoea, Injection site erythema, Injection site indur...
Chest discomfort, Cough, Dyspnoea, Injection site erythema, Injection site induration; Injection site pruritus, Injection site swelling, Injection site warmth, Malaise
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Patient reported: "not feeling too good", manifested through slightly SOB and chest tightn...
Patient reported: "not feeling too good", manifested through slightly SOB and chest tightness, "like having phlegm, but hard to cough out". Itchiness, redness, swelling, warm and hard to touch noted at injection site, "just feels different"
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| 2872560 | 63 | F | WA | 11/13/2025 |
FLU3 |
SANOFI PASTEUR |
U8847CA |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
|
During visit on 11/10/25 patient requested flu vaccine. Patient was do for Flublock and this MA gav...
During visit on 11/10/25 patient requested flu vaccine. Patient was do for Flublock and this MA gave her Highdose flu. Patient is aware and stated "oh ok, so i just got a little extra dose. That's fine." Vaccine given 10:10AM.
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| 2872561 | 11/13/2025 |
DTAPHEPBIP FLU3 HEPA |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
9P329 FH4YR 273H3 |
Unevaluable event; Unevaluable event; Unevaluable event
Unevaluable event; Unevaluable event; Unevaluable event
|
NONE
NONE
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| 2872562 | 66 | F | OR | 11/13/2025 |
COVID19 |
MODERNA |
3052732 |
Unevaluable event
Unevaluable event
|
Patient went to the doctor's office and received allergy medication and prednisone
Patient went to the doctor's office and received allergy medication and prednisone
|
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| 2872566 | 38 | M | 11/13/2025 |
FLU3 |
SANOFI PASTEUR |
|
Chest pain
Chest pain
|
Chest pain described as squeezing like gas pain, none radiating, denied increase by breathing or ac...
Chest pain described as squeezing like gas pain, none radiating, denied increase by breathing or activity. Breathing even and none labored at 14 b/m, BP 122/58 Right arm at sitting position, HR 67 at rest, Temperature 97.6F, spO2 98%. Skin warm to touch, mucus membrane moist and pink, no sign of distress.
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| 2872568 | 9 | F | 11/13/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
7345R |
Haematemesis, Imaging procedure, Vomiting
Haematemesis, Imaging procedure, Vomiting
|
Patient began vomiting multiple times within hours of the vaccine. Bloody vomit. No other Sx, no foo...
Patient began vomiting multiple times within hours of the vaccine. Bloody vomit. No other Sx, no food borne cause.
More
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| 2872570 | 18 | M | MI | 11/13/2025 |
FLU3 |
SANOFI PASTEUR |
UT8817NA |
Lip swelling, Rash
Lip swelling, Rash
|
swollen lips within 2 hours after vaccine and then rash over body
swollen lips within 2 hours after vaccine and then rash over body
|
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| 2872573 | 20 | F | 11/13/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
4D255 |
No adverse event, Product substitution issue
No adverse event, Product substitution issue
|
Patient 20yr old female received FluLaval (6mo+) on 9/23/2025 which is a state issued vaccine. Patie...
Patient 20yr old female received FluLaval (6mo+) on 9/23/2025 which is a state issued vaccine. Patient should have received FluBlok on 9/23/2025 which is a private issued vaccine since she is 18+. The order was originally for FluLaval, which was administered, however should have been FluBlok. At this time, I am not aware of any adverse effects the patient might have experienced.
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| 2872574 | 33 | F | MN | 11/13/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
AH2G4 |
Erythema, Induration, Mass, Tenderness
Erythema, Induration, Mass, Tenderness
|
Hard Red Lump about quarter size. Sore to touch
Hard Red Lump about quarter size. Sore to touch
|
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| 2872575 | 77 | F | NE | 11/13/2025 |
FLU3 |
SEQIRUS, INC. |
|
Pain
Pain
|
Soreness
Soreness
|
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| 2872576 | 42 | F | VA | 11/13/2025 |
FLU3 |
SANOFI PASTEUR |
TFAA2544 |
Limb injury
Limb injury
|
shoulder injury, physical therapy
shoulder injury, physical therapy
|
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| 2872577 | 46 | F | IA | 11/13/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
NA4457 9CC9K |
Hypoaesthesia, Injected limb mobility decreased, Monoplegia, Pain in extremity, ...
Hypoaesthesia, Injected limb mobility decreased, Monoplegia, Pain in extremity, X-ray; Hypoaesthesia, Injected limb mobility decreased, Monoplegia, Pain in extremity, X-ray
More
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Patient said she has been experiencing numbness and paralysis in her flu short arm, the left arm. Pe...
Patient said she has been experiencing numbness and paralysis in her flu short arm, the left arm. Per her son she had "normal" pain and soreness from the shot and it kept getting worse. About 2 weeks after the shot she had worsened pain with limited mobility. She is now being seen by Dr. She has had a session of physical therapy, and imaging done. The provider is following the patients care now.
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| 2872578 | 1 | M | ID | 11/13/2025 |
FLU3 HEPA MMR PNC20 VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
7NT95 L4EA4 Y019930 LX2496 Y017915 |
No adverse event, Product storage error; No adverse event, Product storage error...
No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error
More
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No adverse event, such as allergic reaction, to report - instead Varivax (varicella) vaccine was sto...
No adverse event, such as allergic reaction, to report - instead Varivax (varicella) vaccine was stored in a freezer that had a temperature variance. The freezer stopped working and the temperature was out of range, making the vaccine not viable. Vaccine was given prior to this being noticed. Patient received varicella vaccine that was not viable.
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| 2872579 | 0.25 | M | OK | 11/13/2025 |
DTPPVHBHPB FLU3 PNC15 RV5 |
MSP VACCINE COMPANY SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
U8267AA UT8802MA Z005994 Y020513 |
No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
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PATIENT RECEIVE FLU VACCINE TOO EARLY. FLU VACCINE GIVEN AT 3 MONTHS 25 DAYS IN ERROR. NO ADVERSE R...
PATIENT RECEIVE FLU VACCINE TOO EARLY. FLU VACCINE GIVEN AT 3 MONTHS 25 DAYS IN ERROR. NO ADVERSE REACTION TO DATE COMMUNICATED WITH MOTHER REGARDING THIS 11/06/25 11/07/25 11/10/25 11/13/25
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| 2872580 | 46 | F | OH | 11/13/2025 |
FLU3 |
SANOFI PASTEUR |
U8767AA |
Arthralgia, Pain in extremity, Sleep disorder, X-ray limb
Arthralgia, Pain in extremity, Sleep disorder, X-ray limb
|
Received flu shot on 10/31/2025. Shoulder was sore/ achy that day and for the next 3-4 days. Startin...
Received flu shot on 10/31/2025. Shoulder was sore/ achy that day and for the next 3-4 days. Starting day 5 achy pain feeling began going down arm and into hand. Tied using aleve, voltaren and heating pad for relief. It was continuing to get worse. On day 9 the achy pain began waking me up at night and on day 11 I had an appointment with my physicians office. Xray of left shoulder on 11/12/2025
More
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| 2872581 | 96 | M | MN | 11/13/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
NA0590 U8875AA |
Syncope; Syncope
Syncope; Syncope
|
Patient reported fainting after arriving home after receiving vaccines
Patient reported fainting after arriving home after receiving vaccines
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| 2872582 | 30 | F | 11/13/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
J24J4 |
Expired product administered
Expired product administered
|
Patient received 2024/2025 flu vaccine instead of the 2025/2026 flu vaccine.
Patient received 2024/2025 flu vaccine instead of the 2025/2026 flu vaccine.
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| 2872583 | 19 | M | MD | 11/13/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
5r4cy |
Dizziness, Palpitations
Dizziness, Palpitations
|
Patient felt lightheaded and heart was racing after receiving the vaccine
Patient felt lightheaded and heart was racing after receiving the vaccine
|
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| 2872585 | 21 | F | 11/13/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
J24J4 |
Expired product administered
Expired product administered
|
Patient received 2024/2025 flu vaccine instead of 2025/2026 flu vaccine
Patient received 2024/2025 flu vaccine instead of 2025/2026 flu vaccine
|
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| 2872586 | 26 | F | 11/13/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
J24J4 |
Expired product administered
Expired product administered
|
Patient received 2024/2025 flu vaccine instead of 2025/2026 flu vaccine
Patient received 2024/2025 flu vaccine instead of 2025/2026 flu vaccine
|
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| 2872587 | 19 | F | 11/13/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
J24J4 |
Expired product administered
Expired product administered
|
Patient received 2024/2025 flu vaccine instead of 2025/2026 flu vaccine
Patient received 2024/2025 flu vaccine instead of 2025/2026 flu vaccine
|
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| 2872588 | 31 | F | 11/13/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
J24J4 |
Expired product administered
Expired product administered
|
Patient received 2024/2025 flu vaccine instead of 2025/2026 flu vaccine
Patient received 2024/2025 flu vaccine instead of 2025/2026 flu vaccine
|
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| 2872589 | 78 | M | 11/13/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Amnesia, Delirium
Amnesia, Delirium
|
Patient stated he had a delirium event the entire next day, where he essentially blacked out and did...
Patient stated he had a delirium event the entire next day, where he essentially blacked out and did not remember the day. His wife said maybe it was from the vaccine. He woke up the following day and thought it was the day after the vaccine.
More
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| 2872590 | 57 | F | 11/13/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
J24J4 |
Expired product administered
Expired product administered
|
Patient received 2024/2025 flu vaccine instead of 2025/2026 flu vaccine
Patient received 2024/2025 flu vaccine instead of 2025/2026 flu vaccine
|
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| 2872591 | 55 | F | IL | 11/13/2025 |
COVID19 COVID19 FLU3 FLU3 |
MODERNA MODERNA SANOFI PASTEUR SANOFI PASTEUR |
3052835 3052835 U8881CA U8881CA |
Blood glucose, Chest X-ray, Dyspnoea, Full blood count, Generalised oedema; Hypo...
Blood glucose, Chest X-ray, Dyspnoea, Full blood count, Generalised oedema; Hypoaesthesia, Muscle twitching, Rash; Blood glucose, Chest X-ray, Dyspnoea, Full blood count, Generalised oedema; Hypoaesthesia, Muscle twitching, Rash
More
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Patient says she had swelling of her whole body and numbness all over her body with muscle twitching...
Patient says she had swelling of her whole body and numbness all over her body with muscle twitching in her legs, started 12 hours after receipt of her Flu shot. Says she had shortness of breath and few bumps on her face and neck. Denied chest pain or weakness. Says she went to Hospital on 11/11/25 at 1.00AM - received Gabapentin 1 tablet. Says all her symptoms resolved within 24 hours. She admits to taking Benadryl 1 capsule on 11/12/25 night. She had a televisit on 11/12/25 with Dr. and was seen in the clinic on 11/13/25 by Dr. with no symptoms. Her vitals and physical exam were normal on 11/13/25. She was discharged home with no new medications. Advised to call or go to ER if has SOB, chest pain or swelling.
More
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| 2872592 | 78 | M | IL | 11/13/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
MY9548 MY9548 |
Arthralgia; Arthralgia
Arthralgia; Arthralgia
|
Patient has stated that the vaccine was given very high in the arm, in the joint. Patient has had j...
Patient has stated that the vaccine was given very high in the arm, in the joint. Patient has had joint pain since. He has been taking ibu with no relief. He will be seeing his PCP soon.
More
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| 2872593 | 38 | F | 11/13/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
J24J4 |
Expired product administered
Expired product administered
|
Patient received 2024/2025 flu vaccine instead of 2025/2026 flu vaccine
Patient received 2024/2025 flu vaccine instead of 2025/2026 flu vaccine
|
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| 2872597 | 59 | F | LA | 11/13/2025 |
COVID19 |
PFIZER\BIONTECH |
na0587 |
Joint swelling
Joint swelling
|
patient reported swelling in her left knee.
patient reported swelling in her left knee.
|
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| 2872604 | 16 | M | WA | 11/13/2025 |
VARCEL |
MERCK & CO. INC. |
Y002062 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE; report VARIVAX with TE administered; This spontaneous report was received from an ...
No additional AE; report VARIVAX with TE administered; This spontaneous report was received from an office manager and refers to a(n) 16-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 22-Oct-2025, the patient was vaccinated with improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), Solvent for solution for infusion (lot #Y002062, expiration date: 09-Jan-2026), reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), Solution for injection (lot # and expiration date were not reported) as prophylaxis (Incorrect product storage). Caller was unsure if patient was symptomatic. No additional adverse event (no adverse event). Temperature excursion was 6.1F, time frame 5 minutes. No previous excursions.
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| 2872607 | 1 | MI | 11/13/2025 |
MMR |
MERCK & CO. INC. |
Z005719 |
No adverse event, Product storage error
No adverse event, Product storage error
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no adverse event; inadvertent administrations of MMR-II, that have been exposed to temperature exc...
no adverse event; inadvertent administrations of MMR-II, that have been exposed to temperature excursions; This spontaneous report was received from a nurse and refers to a 1-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 03-Sep-2025, the patient received the dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #Z005719, expiration date: 07-Mar-2027) (dose and route was not reported) with reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot # and expiration date were not reported) after temperature excursions at 32.6F for 5 minutes and 53.2 F for 8 hours and 27 minutes (product storage error) which was not viable due to temperature too high. There was no previous temperature excursions. No adverse event was reported. This is one of several reports from the same reporter.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : (withheld)@merck.com , Index date : 2025-11-10 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 72372 , Central date : 2025-11-06 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
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| 2872608 | 1 | MI | 11/13/2025 |
MMR |
MERCK & CO. INC. |
Z005719 |
No adverse event, Product storage error
No adverse event, Product storage error
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no adverse event; inadvertent administrations of MMR-II, that have been exposed to temperature exc...
no adverse event; inadvertent administrations of MMR-II, that have been exposed to temperature excursions; This spontaneous report was received from a nurse and refers to a 1-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 02-Sep-2025, the patient received the dose with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot #Z005719, expiration date: 07-Mar-2027) (dose and route was not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot # and expiration date were not reported) after temperature excursions of 32.6F for 0 hours 5 minutes 0 seconds; (53.2F) for 8 hours 27 minutes 0 seconds (Product storage error). No adverse event was reported. This is one of the several reports from the same reporter.
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| 2872618 | 11/13/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster oticus, Pain, Stress, Vaccination failure
Herpes zoster oticus, Pain, Stress, Vaccination failure
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VACCINATION FAILURE; Mine is on my ears; every time I get stressed about something they start to bre...
VACCINATION FAILURE; Mine is on my ears; every time I get stressed about something they start to break out; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles and stress. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: VACCINATION FAILURE) (serious criteria GSK medically significant), herpes zoster oticus (Verbatim: Mine is on my ears) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: every time I get stressed about something they start to break out). The outcome of the vaccination failure, herpes zoster oticus and facial herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure, herpes zoster oticus and facial herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure and herpes zoster oticus to be unrelated to Shingles vaccine. It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 06-NOV-2025 This case was reported by a patient via interactive digital media. The patient self-reported this case for himself. The patient had received the vaccine, and every time he became stressed about something, the breakouts started. They did not hurt as badly as they had before the shot. He also had medication to take whenever the pain began. The affected areas were on his face, hair, and ears.; Sender's Comments: A case of Vaccination failure and Herpes zoster oticus, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received.
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| 2872633 | 11/13/2025 |
COVID19 |
MODERNA |
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Illness
Illness
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The Moderna vaccine made me extremely sick; This spontaneous case was reported by a non-health profe...
The Moderna vaccine made me extremely sick; This spontaneous case was reported by a non-health professional and describes the occurrence of ILLNESS (The Moderna vaccine made extremely sick) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (The Moderna vaccine made extremely sick). At the time of the report, ILLNESS (The Moderna vaccine made extremely sick) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medications were not reported. It was reported that the Moderna vaccine had made patient extremely sick. Treatment information was not reported.
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| 2872634 | 23 | F | FL | 11/13/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Dizziness, Dyspnoea, Fatigue, Headache, Palpitations; Rash, Thrombosis
Dizziness, Dyspnoea, Fatigue, Headache, Palpitations; Rash, Thrombosis
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Fatigue; Headaches; Skin rash/Skin rashes; Blood clots; extreme shortness of breath/shortness of bre...
Fatigue; Headaches; Skin rash/Skin rashes; Blood clots; extreme shortness of breath/shortness of breath extremely serious; Palpitations; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) and DYSPNOEA (extreme shortness of breath/shortness of breath extremely serious) in a 24-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 24-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 17-Dec-2024, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant), DYSPNOEA (extreme shortness of breath/shortness of breath extremely serious) (seriousness criterion medically significant), PALPITATIONS (Palpitations), DIZZINESS (Dizziness), HEADACHE (Headaches) and RASH (Skin rash/Skin rashes). On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, THROMBOSIS (Blood clots), DYSPNOEA (extreme shortness of breath/shortness of breath extremely serious), PALPITATIONS (Palpitations), DIZZINESS (Dizziness), FATIGUE (Fatigue), HEADACHE (Headaches) and RASH (Skin rash/Skin rashes) had not resolved. No concomitant medications were reported. The patient had no medical history, concomitant disease or risk factor. The patient was vaccinated with Moderna vaccine in September 2024 and ever since then she had symptoms that would not go away, such as palpitations, extreme shortness of breath, fatigue, headaches, blood clots and skin rash. She had been for a whole year trying to figure out what was going on with her until she figured the vaccine caused all that. She had been to all doctors and had probably a thousand medical records of exams performed, everything came back clear, although she struggled every day to do basic daily routine. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2025: Live significant follow-up received contains significant information included reporter details, patient's DOB, age, suspect start date, event onset and new event dizziness added, event verbatims and narrative updated, and reference numbers were added.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
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| 2872635 | 11/13/2025 |
COVID19 |
MODERNA |
8146743 |
Device malfunction, No adverse event, Occupational exposure to product, Syringe ...
Device malfunction, No adverse event, Occupational exposure to product, Syringe issue
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Product malfunction which lead to a leak in the PFS; Product malfunction which lead to a leak in the...
Product malfunction which lead to a leak in the PFS; Product malfunction which lead to a leak in the PFS; Occupational exposure; No adverse effect; This spontaneous case was reported by an other health care professional and describes the occurrence of SYRINGE ISSUE (Product malfunction which lead to a leak in the PFS), DEVICE MALFUNCTION (Product malfunction which lead to a leak in the PFS), OCCUPATIONAL EXPOSURE TO PRODUCT (Occupational exposure) and NO ADVERSE EVENT (No adverse effect) in a patient of an unknown age and gender who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 8146743) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 8146743) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced SYRINGE ISSUE (Product malfunction which lead to a leak in the PFS), DEVICE MALFUNCTION (Product malfunction which lead to a leak in the PFS), OCCUPATIONAL EXPOSURE TO PRODUCT (Occupational exposure) and NO ADVERSE EVENT (No adverse effect). At the time of the report, SYRINGE ISSUE (Product malfunction which lead to a leak in the PFS), DEVICE MALFUNCTION (Product malfunction which lead to a leak in the PFS), OCCUPATIONAL EXPOSURE TO PRODUCT (Occupational exposure) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. No concomitant medications were reported. The reporter reported a product malfunction which led to a leak in the PFS and was filed for occupational exposure. The patient did not experience any additional symptoms or events. The Device problem code for pre-filled syringe include FDA code 1250, IMDRF code A050401 which included Use of Device Problem. Treatment information was not reported.
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