| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2867461 | 29 | F | WI | 10/21/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
my9547 409415 |
Aphasia, Erythema; Aphasia, Erythema
Aphasia, Erythema; Aphasia, Erythema
|
Patient stepped out of vaccination room stating to our technician she is having an allergic reaction...
Patient stepped out of vaccination room stating to our technician she is having an allergic reaction. Tech informed pharmacist and called EMS right away. Patient looked red and was having some trouble speaking. Pharmacist administered an epipen while on phone with ems services. EMS arrived in 5 minutes. By this time patient was not read and was speaking without much trouble. EMS observed her for about 20 more minutes per patient's choice and at that time she was picked up by a friend. No allergies reported per patient and has had both vaccines in the past. (not same season of course) The pharmacist called patient about 3 hours later and she said she was feeling well and unaware of why she had had those effects.
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| 2867463 | 35 | F | NV | 10/21/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EW0173 301308A |
Cardiac valve disease, Echocardiogram abnormal, Palpitations; Cardiac valve dise...
Cardiac valve disease, Echocardiogram abnormal, Palpitations; Cardiac valve disease, Echocardiogram abnormal, Palpitations
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HEART PALPITATIONS
HEART PALPITATIONS
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| 2867464 | 85 | F | MA | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
|
Extra dose administered, Wrong product administered
Extra dose administered, Wrong product administered
|
High does flu vaccine given instead of Covid vaccine. Last dose of high dose flue was on 10/082025
High does flu vaccine given instead of Covid vaccine. Last dose of high dose flue was on 10/082025
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| 2867465 | 55 | F | CA | 10/21/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Chest discomfort, Dyspnoea, Pruritus, Throat irritation
Chest discomfort, Dyspnoea, Pruritus, Throat irritation
|
generalized pruritis, throat itching, scalp itching, shortness of breath and chest tightness.
generalized pruritis, throat itching, scalp itching, shortness of breath and chest tightness.
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| 2867466 | 35 | F | MO | 10/21/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
P327D |
Discomfort, Injection site pain, Pain in jaw
Discomfort, Injection site pain, Pain in jaw
|
Left sided jaw pain15 minutes after injection. Feels like when she had her wisdom tooth pulled. Pain...
Left sided jaw pain15 minutes after injection. Feels like when she had her wisdom tooth pulled. Pain and pressure. Left deltoid pain , non-radiating. Laid down when she went home and pain went away but returned when sitting or standing up. Advised by provider to seek care in the Emergency room. Contacted patient on 10/16/2025 and she did not seek care in the Emergency room or urgent care and has no symptoms on 10/16/2025, she did take two Tylenol on 10/15/2025.
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| 2867469 | 61 | F | NM | 10/21/2025 |
COVID19 |
MODERNA |
|
Angina pectoris, Pericarditis
Angina pectoris, Pericarditis
|
Suspected pericarditis/inflammation based on experience with identical pain symptoms that occurred a...
Suspected pericarditis/inflammation based on experience with identical pain symptoms that occurred a week after cardiac ablation. Mild but persistent chest pain around heart with an ebb and flow nature. No other symptoms. After phone review with cardiology office, beginning two week course of .6mg colchicine today, October 21, 2025.
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| 2867471 | 73 | F | AK | 10/21/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052154 UT8794CA |
Arthralgia, Joint stiffness; Arthralgia, Joint stiffness
Arthralgia, Joint stiffness; Arthralgia, Joint stiffness
|
per patient she received the vaccine on Thursday and then on friday she woke up with extreme joint p...
per patient she received the vaccine on Thursday and then on friday she woke up with extreme joint pain in her left knee. it was very stiff and later in the day she could barely even bend it. It was bad enough she made an appointment with her prescriber for the following week. Once she woke up on saturday the pain was basically gone and has since completely disappeared.
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| 2867472 | 79 | M | CA | 10/21/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
NA0738 NA0738 |
Asthenia, Blood pressure increased, Dizziness, Hypogeusia, Hyposmia; Immediate p...
Asthenia, Blood pressure increased, Dizziness, Hypogeusia, Hyposmia; Immediate post-injection reaction, Respiratory disorder, Vertigo
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Patient reported adverse events to pharmacy on 10/21/2025. Immediately after the vaccination, patie...
Patient reported adverse events to pharmacy on 10/21/2025. Immediately after the vaccination, patient reported vertigo. Later that day patient noticed lack of strength and dizziness. One week after shot, patient noticed breathing problems and increased in blood pressure. About 2 weeks after, patient noticed decrease in taste and smell. Patient has not seen his PCP regarding the adverse events and has not taken anything to treat the symptoms. Patient was advised to seek medical help regarding his symptoms.
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| 2867473 | 7 | M | IL | 10/21/2025 |
COVID19 FLUN3 |
MODERNA MEDIMMUNE VACCINES, INC. |
3053238 3053238 |
Erythema, Skin warm; Erythema, Skin warm
Erythema, Skin warm; Erythema, Skin warm
|
Redness and hot to the touch. Occurred within a day of giving the vaccine.
Redness and hot to the touch. Occurred within a day of giving the vaccine.
|
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| 2867474 | 63 | M | FL | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
UT8781DA |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
Set up a flu shot clinic at a senior living facility. A 63-year-old male received a high dose (65 an...
Set up a flu shot clinic at a senior living facility. A 63-year-old male received a high dose (65 and older Flu-Zone HD) flu shot instead of the regular dose (FluBlok). Patient had no reactions at all.
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| 2867476 | 18 | F | KY | 10/21/2025 |
FLU3 HPV9 MENB |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS |
2CA5M Y008843 CD44A |
Extra dose administered, No adverse event, Wrong patient received product; Extra...
Extra dose administered, No adverse event, Wrong patient received product; Extra dose administered, No adverse event, Wrong patient received product; Extra dose administered, No adverse event, Wrong patient received product
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RN accidentally administered unneeded HPV9 shot intended for the pt's sister; the pt had alread...
RN accidentally administered unneeded HPV9 shot intended for the pt's sister; the pt had already completed her HPV series. No adverse effects noted, staff encouraged this RN to submit to VAERS. Pt and family aware of administration error and provided with HPV9 VIS. Supervising MD made aware.
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| 2867477 | 4 | M | CA | 10/21/2025 |
COVID19 DTAPIPV FLU3 MMRV |
MODERNA GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
|
Febrile convulsion; Febrile convulsion; Febrile convulsion; Febrile convulsion
Febrile convulsion; Febrile convulsion; Febrile convulsion; Febrile convulsion
|
febrile seizure lasting about 1.5 minutes, temperature measures after seizure 104F
febrile seizure lasting about 1.5 minutes, temperature measures after seizure 104F
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| 2867479 | 10/21/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Drug interaction
Drug interaction
|
it triggered an immune response to my Dysport (neurotoxin quit working overnight).; it triggered an ...
it triggered an immune response to my Dysport (neurotoxin quit working overnight).; it triggered an immune response to my Dysport (neurotoxin quit working overnight).; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in 2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; botulinum toxin type a HAemagglutinin complex (DYSPORT [BOTULINUM TOXIN TYPE A HAEMAGGLUTININ COMPLEX]). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INTERACTION (non-serious), IMMUNE SYSTEM DISORDER (non-serious) all with onset 2025, outcome "unknown" and all described as "it triggered an immune response to my Dysport (neurotoxin quit working overnight).". The action taken for botulinum toxin type a HAemagglutinin complex was unknown. Additional information: Patient got COVID booster but it triggered an immune response to Dysport (neurotoxin quit working overnight). This effect's been reported (n๏ฟฝ45). The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2867480 | 10 | M | TX | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
UT8858NA |
Urticaria
Urticaria
|
Patient started developing hives on injected arm after vaccine. Dr. was notified and evaluated. Ben...
Patient started developing hives on injected arm after vaccine. Dr. was notified and evaluated. Benadryl 5 ml was given to patient and patient was monitored for an additional 20 minutes. Patient did not show any respiratory symptoms.
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| 2867482 | 84 | F | KS | 10/21/2025 |
COVID19 |
MODERNA |
3052581 (Privat |
Death
Death
|
Death reported 2 days after vaccination
Death reported 2 days after vaccination
|
โ | |||||
| 2867483 | 33 | F | LA | 10/21/2025 |
FLU3 |
SEQIRUS, INC. |
409413 |
Arthralgia, Injection site pain, Tenderness
Arthralgia, Injection site pain, Tenderness
|
Pain right deltoid/shoulder region. tender to palpation. no bruising, swelling, or reddening. not...
Pain right deltoid/shoulder region. tender to palpation. no bruising, swelling, or reddening. not hot to touch. treating with Ibuprofen, heating pad, and rest.
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| 2867484 | 78 | M | PA | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
|
Erythema, Swelling, Tenderness
Erythema, Swelling, Tenderness
|
tenderness, redness, and swelling. Had about a 5" ring of redness and swelling
tenderness, redness, and swelling. Had about a 5" ring of redness and swelling
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| 2867485 | 72 | F | FL | 10/21/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Blood pressure increased, Hypoaesthesia, Respiratory acidosis, Swollen tongue, T...
Blood pressure increased, Hypoaesthesia, Respiratory acidosis, Swollen tongue, Throat tightness
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tongue swelling, numbness, respiratory, increased blood pressure, throat closure
tongue swelling, numbness, respiratory, increased blood pressure, throat closure
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| 2867488 | 0.5 | F | WI | 10/21/2025 |
DTAPHEPBIP FLU3 RSV RV5 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
z9s4d f4a7r 3m9ds 2142142 |
No adverse event, Product administered to patient of inappropriate age, Wrong pr...
No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered
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Patient was mistakenly given Arexvy (adult dose of RSV vaccine). Clinic staff informed mother of in...
Patient was mistakenly given Arexvy (adult dose of RSV vaccine). Clinic staff informed mother of incident and called CDC, agency, and Hospital Infection disease on-call number to get information on next steps. Beyforus was suggested by CDC and Hospital ID to counteract Arexvy. Clinic staff gave Beyforus to patient. Between the time of the Arexvy 1400 to Beyforus around 1500, no adverse reactions were noted.
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| 2867489 | 49 | M | NY | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
U881DA |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
administration of 2 doses of fluzone np/received second administration by mistake with no reported a...
administration of 2 doses of fluzone np/received second administration by mistake with no reported adverse event; Initial information received on 15-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 49 years old male patient who was administered with 2 doses of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] and second administration was by mistake with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Oct-2025, the patient was administered with 2 doses of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection, lot U881DA, Strength: standard, Frequency: once, expiry date:30-Jun-2026, via intramuscular route in the left deltoid for Influenza [Immunisation], and second administration was by mistake with no reported adverse event (extra dose administered) (latency: same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2867491 | 13 | F | WA | 10/21/2025 |
COVID19 |
PFIZER\BIONTECH |
409415 |
Dizziness
Dizziness
|
The patient had a small dizzy episode after getting the shot. She recovered in couple minutes and wa...
The patient had a small dizzy episode after getting the shot. She recovered in couple minutes and was fine. I called her again in the night and mother said she was doing fine.
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| 2867492 | 62 | F | CA | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
u8823da |
Dizziness, Vomiting
Dizziness, Vomiting
|
Patient complains of dizziness and throwing up that lasted approximately 7 days. This reaction occur...
Patient complains of dizziness and throwing up that lasted approximately 7 days. This reaction occurred approximately 2 hours post immunization.
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| 2867493 | 10 | F | PA | 10/21/2025 |
COVID19 |
MODERNA |
3052671 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
10 year old patient received 12+ Moderna COVID Booster Vaccine. No negative reaction reported.
10 year old patient received 12+ Moderna COVID Booster Vaccine. No negative reaction reported.
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| 2867494 | 78 | M | NY | 10/21/2025 |
FLU3 FLU3 RSV RSV |
SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
U8874BA U8874BA E75E5 E75E5 |
Depressed level of consciousness, Dizziness, Feeling hot, Nausea, Pallor; Unresp...
Depressed level of consciousness, Dizziness, Feeling hot, Nausea, Pallor; Unresponsive to stimuli; Depressed level of consciousness, Dizziness, Feeling hot, Nausea, Pallor; Unresponsive to stimuli
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Patient presented to pharmacy with his wife for a flu and rsv vaccine. Patient reported a history of...
Patient presented to pharmacy with his wife for a flu and rsv vaccine. Patient reported a history of dizziness/fainting after vaccines in the past, which is why he came with his wife. After vaccination, patient was advised to remain in the waiting area to monitor for adverse reaction. After about 5 minutes, the patient reported starting to feel hot and dizzy. I stayed with him as his wife gave him water to drink and splash on his face. Patient declined an ice pack. After a few minutes, the patient became pale and began to lose consciousness. I called to pharmacy technicians to notify management as his wife and I quickly and carefully moved him to the floor on his back with feet elevated on a chair and head cushioned by his jacket. Patient became unresponsive to firm rubs on the sternum and loudly asking if he could hear me. He was unresponsive for about 30 seconds before regaining consciousness. Patient did not have loss of memory, was aware of his surroundings, and declined an ambulance. Patient remained supine for about 5 minutes before beginning to feel nauseous, at which point we turned him to his side in case he needed to vomit. He remained on the floor on his side for another 10 minutes before assisting him up into a chair, where he sat for an additional 5 minutes before leaving the pharmacy with his wife. His blood pressure obtained before leaving measured 158/96 mmHg.
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| 2867495 | 10 | F | 10/21/2025 |
COVID19 |
MODERNA |
3052671 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
10 year old patient received 12+ Moderna COVID Booster Vaccine. No negative reaction reported.
10 year old patient received 12+ Moderna COVID Booster Vaccine. No negative reaction reported.
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| 2867497 | 62 | M | WV | 10/21/2025 |
FLU3 HEPAB PNC20 RSV TDAP VARZOS |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
tfaa2539 az2a3 ma2488 mm9162 pg3rp 94j5e |
Arthralgia, Chest pain, Chills, Feeling abnormal, Insomnia; Arthralgia, Chest pa...
Arthralgia, Chest pain, Chills, Feeling abnormal, Insomnia; Arthralgia, Chest pain, Chills, Feeling abnormal, Insomnia; Arthralgia, Chest pain, Chills, Feeling abnormal, Insomnia; Arthralgia, Chest pain, Chills, Feeling abnormal, Insomnia; Arthralgia, Chest pain, Chills, Feeling abnormal, Insomnia; Arthralgia, Chest pain, Chills, Feeling abnormal, Insomnia
More
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Patient called the next day and said that he felt bad and was up til 4am. His shoulders were sore, h...
Patient called the next day and said that he felt bad and was up til 4am. His shoulders were sore, he felt chilled, and he had chest pain. He tried acetaminophen for the chills, but said it wasn't helping. He tried ice packs for his shoulders, but he didn't like that since he already felt chilled. We both agreed he should go to the ER to have his chest pain evaluated, and he said he would go. I plan to follow up with him later this evening and possibly my next day at work.
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| 2867498 | 84 | M | CA | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
u8830AA |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Pt presented to the vaccine center at the medical office building requesting season flu vaccine. The...
Pt presented to the vaccine center at the medical office building requesting season flu vaccine. The registry staff, administered the vaccine. After the fact, upon documentation of the vaccine she realized that the member had already received this season's annual vaccine on 08/26/25. No known reaction at this time, out reached to the member twice today with no answer, left voicemail to return call.
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| 2867499 | F | ID | 10/21/2025 |
FLU3 |
SEQIRUS, INC. |
AX5589A |
Injection site reaction, Limb discomfort, Pain in extremity
Injection site reaction, Limb discomfort, Pain in extremity
|
Injection site reaction, patient reports discomfort and nerve-related pain throughout the arm of inj...
Injection site reaction, patient reports discomfort and nerve-related pain throughout the arm of injection.
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| 2867500 | 16 | F | MA | 10/21/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
2T543 |
Arthralgia
Arthralgia
|
Joint pain in shoulder, elbow, and wrist. Treated with ice pack and ibuprofen. Pain lasted 24 hours.
Joint pain in shoulder, elbow, and wrist. Treated with ice pack and ibuprofen. Pain lasted 24 hours.
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| 2867513 | 4 | F | NY | 10/21/2025 |
DTAPIPV DTAPIPV FLU3 FLU3 MMRV MMRV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SEQIRUS, INC. SEQIRUS, INC. MERCK & CO. INC. MERCK & CO. INC. |
E2JX7 E2JX7 407007 407007 Z071678 Z071678 |
Blister, Impetigo, Injection site erythema, Injection site pruritus, Injection s...
Blister, Impetigo, Injection site erythema, Injection site pruritus, Injection site reaction; Injection site swelling, Injection site vesicles; Blister, Impetigo, Injection site erythema, Injection site pruritus, Injection site reaction; Injection site swelling, Injection site vesicles; Blister, Impetigo, Injection site erythema, Injection site pruritus, Injection site reaction; Injection site swelling, Injection site vesicles
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(+) redness + swelling. Localized vaccine reaction -> multiple blisters + bullae. ?Itching from i...
(+) redness + swelling. Localized vaccine reaction -> multiple blisters + bullae. ?Itching from itching at site. Bactrim 80mg bid x7 days & Bactroban ointment. Pt. did have a localized vaccine reaction. The concern is re: blisters + bullae. ?Impetigo vs. part of the vaccine reaction.
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| 2867514 | 70 | M | GA | 10/21/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3048034 UT8829BA |
Death; Death
Death; Death
|
Unknown if associate, but Pt died 10/16/2025.
Unknown if associate, but Pt died 10/16/2025.
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โ | |||||
| 2867515 | 63 | M | PA | 10/21/2025 |
COVID19 |
MODERNA |
|
Retinal vein occlusion, Retinogram
Retinal vein occlusion, Retinogram
|
Central Retina Vein Occlusion
Central Retina Vein Occlusion
|
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| 2867516 | 35 | M | TX | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
3458832 |
Hyperhidrosis, Tremor, Vomiting
Hyperhidrosis, Tremor, Vomiting
|
patient received the vaccine around 3:30pm on 10/19/25 and stated that he started shaking, sweating ...
patient received the vaccine around 3:30pm on 10/19/25 and stated that he started shaking, sweating and throwing up uncontrollably around 6:30pm and ended up in the hospital. Although, he was released from the hospital, he is still throwing up and now on anti-emetics around the clock.
More
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โ | |||||
| 2867517 | 51 | F | CA | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
U8800CA |
Product administered to patient of inappropriate age, Wrong patient received pro...
Product administered to patient of inappropriate age, Wrong patient received product
More
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My Neuro MA, (name withheld), gave high dose to a 51 yo patient mistakenly. When she verified with t...
My Neuro MA, (name withheld), gave high dose to a 51 yo patient mistakenly. When she verified with the LVN on site she verified the wrong patient. Before my MA gave the patient the vaccines, she said that she told the patient it was a high dose and the patient confirmed she wanted high dose. Then my MA gave the vaccine.
More
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| 2867518 | 30 | M | SC | 10/21/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052733 406985 |
Dizziness, Feeling cold, Pallor, Tremor, Vomiting; Dizziness, Feeling cold, Pall...
Dizziness, Feeling cold, Pallor, Tremor, Vomiting; Dizziness, Feeling cold, Pallor, Tremor, Vomiting
More
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After giving the patient a shot, I noticed the patient leaning his head back and then forward over h...
After giving the patient a shot, I noticed the patient leaning his head back and then forward over his lap. I rushed over to him and asked if he was okay and he said no. He couldn't talk much but was coherent enough to answer my questions. I asked if he had eaten before he received the shot, and he said yes. He was very pale, sweating profusely, shaking and told me he was cold. I asked him if he was about to pass out and he said yes. I checked his blood pressure, which was 97/49 and a heart rate of 49. I grabbed him a cold water and asked that he just take a few sips. Then, he quickly said, get me a trash can. I ran to get one and he had already vomited. He continued to vomit after a few minutes, totaling about 3 times. I sat with him the whole time while. I told the mom that he needed electrolytes, like gatorade, and a pack of peanut butter crackers, if not allergic to, and have him nibble on them and drink gatorade slowly to rehydrate and regain his strength. Dad was shopping, but came by and helped his son to the car. I mentioned to the mom that there were 2 urgent cares, 1 very close and described where the other one was, in case he worsened. I mentioned to her that this kind of reaction necessitates medical intervention in future, where his physician's office should vaccinate him in the future, especially for any shots other than flu, which he's had numerous times per mom and no reaction.
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| 2867519 | 80 | M | FL | 10/21/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Chills, Dizziness, Pyrexia
Chills, Dizziness, Pyrexia
|
pt got the vaccine and in 6-7 hrs. woke up with high fever chills and dizziness***wife called 911 an...
pt got the vaccine and in 6-7 hrs. woke up with high fever chills and dizziness***wife called 911 and was transported to hospital. was discharged the next day
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| 2867521 | 72 | F | CO | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
|
Dysstasia, Fall, Urinary incontinence, Vomiting, Walking aid user
Dysstasia, Fall, Urinary incontinence, Vomiting, Walking aid user
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patient called to let us know of a rxn. she received the vaccine at the pharmacy listed in this repo...
patient called to let us know of a rxn. she received the vaccine at the pharmacy listed in this report. pt called and left a message on the nurse line noted she had a "terrible" reaction to the high dose flu shot. She spent 3-4 days with vomiting, loss of bladder control, trouble standing and a noted fall, she had to use her walker to ambulate. she would like this information placed in her chart
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| 2867524 | 49 | M | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
|
Burning sensation, Paraesthesia
Burning sensation, Paraesthesia
|
Intermittent burning and tingling in the hands and feet
Intermittent burning and tingling in the hands and feet
|
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| 2867525 | 69 | F | CA | 10/21/2025 |
COVID19 |
MODERNA |
3052732 |
Dysphonia, Hypoaesthesia oral, Paraesthesia oral
Dysphonia, Hypoaesthesia oral, Paraesthesia oral
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Pt given vaccine and stayed at pharmacy wait area for 15 minutes then went home. Pt called about 2 h...
Pt given vaccine and stayed at pharmacy wait area for 15 minutes then went home. Pt called about 2 hours later, saying her tongue tingling, numbness of lips and inside of mouth and tongue, with hoarse voice. She says she recognize those symptoms as hives because she gets hives in the past for other issues. She had taken Benadryl 50mg. She also has Hydroxyzine 25mg which she will take. She has steroid tapering dose pack and Epipen on hand. RPh got pt info & primary & tell pt to contact her primary and see if she should take steroid, as her reactions appear (to her) standard and not severe (she is able to speak and recognizes symptoms of the past). When follow-up with pt, she says she spoke to office and that they told her not to take the steroid, continue Benadryl and hydroxyzine and also take famotidine 20mg. Pt says she is doing well and stable, symptoms better but will continue with next doses of the trio of meds. Contacted pt primary, but unable to reach office.
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| 2867526 | 59 | F | 10/21/2025 |
COVID19 |
PFIZER\BIONTECH |
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Pruritus
Pruritus
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Itching near neck
Itching near neck
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| 2867527 | 30 | M | OR | 10/21/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chest pain, Costochondritis
Chest pain, Costochondritis
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Chest pain
Chest pain
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| 2867528 | 14 | F | TX | 10/21/2025 |
FLU3 |
SEQIRUS, INC. |
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Eye irritation, Eye pruritus, Lacrimation increased, Periorbital swelling, Swell...
Eye irritation, Eye pruritus, Lacrimation increased, Periorbital swelling, Swelling face
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Eyes started itching, watering and burning and then left side of eyes and cheek started swelling a
Eyes started itching, watering and burning and then left side of eyes and cheek started swelling a
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| 2867530 | 46 | F | WA | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
UT8763HHA |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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None reported
None reported
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| 2867532 | 23 | F | WA | 10/21/2025 |
FLU3 |
SANOFI PASTEUR |
UT8763HA |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Unknown
Unknown
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| 1234782 | 64 | M | AL | 10/20/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
UNKNOWN MANUFACTURER MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
not known 002c21a 002c21a 002c21a 002C21A 002C21A 002C21A |
Bell's palsy, Nervous system disorder; Hypoaesthesia; Bell's palsy, Bl...
Bell's palsy, Nervous system disorder; Hypoaesthesia; Bell's palsy, Blindness unilateral, Facial paralysis, Hypoaesthesia, Nervousness; Neurological symptom, Sinus disorder; Hypoaesthesia; Bell's palsy, Blindness unilateral, Facial paralysis, Hypoaesthesia, Nervousness; Neurological symptom, Sinus disorder
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Systemic: Bell's Palsy-Mild, Additional Details: patient came and was asked about shots. he sa...
Systemic: Bell's Palsy-Mild, Additional Details: patient came and was asked about shots. he said he got the covid shot and would never get another vaccine. developed bells palsy and other nerve conditions. He said he had tried to reach out to some reporting agency, but never heard back.
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| 2866883 | TX | 10/20/2025 |
HPV9 |
MERCK & CO. INC. |
Y015760 |
No adverse event, Product storage error
No adverse event, Product storage error
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This case is for GARDASIL-9 administration after the temperature excursion for lot y015760 02/10/202...
This case is for GARDASIL-9 administration after the temperature excursion for lot y015760 02/10/2027 for the second patient.; No additional AE; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection (valid lot #Y015760, expiration date: 10-Feb-2027), 0.5 mL administered by intramuscular route for prophylaxis, which underwent temperature excursion of 47.7 F for 12 minutes, previous temperature excursion included 46.8 F for 5 minutes; 47.1 F for 9 minutes; 46.6 F for 4 minutes (product storage error). No symptoms reported. No further information was provided during the call. No additional adverse event (AE) was reported. This is one of the 5 reports from the same reporter.
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| 2866885 | F | 10/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Death, Guillain-Barre syndrome
Death, Guillain-Barre syndrome
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Died; Guillain Barre Syndrome; This serious case was reported by a consumer via interactive digital ...
Died; Guillain Barre Syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, several months after receiving Shingrix, the patient experienced unknown cause of death (Verbatim: Died) (serious criteria death and GSK medically significant) and guillain barre syndrome (Verbatim: Guillain Barre Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was resolved. The reported cause of death was unknown. It was unknown if the reporter considered the unknown cause of death to be related to Shingrix. The reporter considered the guillain barre syndrome to be related to Shingrix. The company considered the unknown cause of death and guillain barre syndrome to be unrelated to Shingrix. Additional Information: GSK receipt date: 15-OCT-2025 The case was received from the patient's sibling via interactive digital media. The reporter stated that Shingrix gave guillain barre syndrome to his sister. It was horrible and she ended up passing from a complication few months later. The reporter asked if reaction to the shot could be genetic. The batch number was not provided, and unable to contact the reporter. The case was linked with case US2025AMR135492, reported by the same reporter.; Sender's Comments: A case of Death and Guillain-Barre syndrome, several months after receiving Shingrix, in an unknown aged adult female patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. US-GSK-US2025AMR135492:Same reporter different patient; Reported Cause(s) of Death: Unknown cause of death
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| 2866891 | 10/20/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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did not receive the second dose yet; This non-serious case was reported by a consumer via interactiv...
did not receive the second dose yet; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received HAV (Havrix) for prophylaxis. Previously administered products included Havrix (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: did not receive the second dose yet). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date 29 Sep 2025: This case was reported by a consumer via interactive digital media. The reporter asked if take dose two of Havrix 8 years after dose one.
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| 2866896 | MO | 10/20/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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Incomplete series; This non-serious case was reported by a other health professional via call center...
Incomplete series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (received first dose on unknown date). On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim: Incomplete series). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 30-SEP-2025 The reporter asked what the effectiveness of one dose of Bexsero was. The reporter reported that patient received first dose but never receive second dose. The batch number was not provided upon follow- up with the reporter.
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| 2866897 | 3 | M | 10/20/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
X449Y |
Wrong product administered
Wrong product administered
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was given Boostrix instead of Kinrix; This non-serious case was reported by a nurse via call center ...
was given Boostrix instead of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number X449Y) for prophylaxis. Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis. Previously administered products included DTaP vaccine (received 1st dose of vaccine on an unknown date), DTaP vaccine (received 2nd dose of vaccine on an unknown date), DTaP vaccine (received 3rd dose of vaccine on an unknown date) and DTaP vaccine (received 4th dose of vaccine on an unknown date). On 18-SEP-2025, the patient received Boostrix. On an unknown date, the patient received Kinrix. On 18-SEP-2025, an unknown time after receiving Boostrix and not applicable after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: was given Boostrix instead of Kinrix). The outcome of the wrong vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 01-OCT-2025 A pediatric nurse practitioner called and reported that 4-year-old who was given Boostrix instead of Kinrix. Reporter's coworker noted that the HCP had mentioned the patient had already received four doses of DTaP.
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