| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2861566 | 1 | M | 09/25/2025 |
VARCEL |
MERCK & CO. INC. |
|
Herpes zoster
Herpes zoster
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Shingles after receiving varicella vaccine. No history of chickenpox.
Shingles after receiving varicella vaccine. No history of chickenpox.
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| 2861567 | 4 | M | VA | 09/25/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
|
Abnormal behaviour, Mood swings; Abnormal behaviour, Mood swings
Abnormal behaviour, Mood swings; Abnormal behaviour, Mood swings
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Extreme mood swings, behavior challenges started within a week of vaccination. Currently working to ...
Extreme mood swings, behavior challenges started within a week of vaccination. Currently working to try to remedy the problems
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| 2861568 | 79 | M | VA | 09/25/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Cardiac monitoring, Central nervous system function test, Cerebrovascular accide...
Cardiac monitoring, Central nervous system function test, Cerebrovascular accident, Death, Guillain-Barre syndrome; Hypoaesthesia, Lumbar puncture
More
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Became sick, stroke, began losing feeling in hands and feet, diagnosed with Guillian Barre Syndrome,...
Became sick, stroke, began losing feeling in hands and feet, diagnosed with Guillian Barre Syndrome, multiple strokes, death
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โ | โ | โ | โ | ||
| 2861569 | 80 | F | CA | 09/25/2025 |
COVID19 |
MODERNA |
3052549 |
Facial paralysis, Swelling face
Facial paralysis, Swelling face
|
Patient speaking another language-so her Brother in-law (patient caretaker) called on her behalf 9/2...
Patient speaking another language-so her Brother in-law (patient caretaker) called on her behalf 9/25/25 at 9:15am. He stated after the Spikevax Covid vaccine yesterday, patient got adverse reactions where the left side of her face was swollen and her lips were drooping. I asked if there is any pain and shortness of breath or other symptoms. He said no pain, fever, or shortness of breath. I advised him to have patient apply ice over the swollen area on the face and taking benadryl and keep hydrating herself.I also advised patient to call her primary care doctor for a follow up and double check to make sure everything is fine. I also advise patient to watch out for any sign of breathing problem or adverse reaction getting worse to reach out to us or go to the doctor for help. I called patient back at 3:27pm, spoke to patient care taker, he said patient went to ER to get it checked out with the doctor there. Doctor test her lips and said there was no nerve damage. They advised her to take benadryl same as my recommendations. They told patient everything is fine. Patient already already have a regular doctor appointment with her doctor on upcoming Saturday 9/27/25. Patient said don't want me to contact her doctor, she will follow up with her doctor then. Patient and care taker was very satisfied with the care and advise they received from us. He also mentioned her face swelling was 80% improved and the lip no longer drooping. Things are improving as getting back to normal.
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| 2861570 | 9 | M | KY | 09/25/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
273h3 |
Dizziness, Loss of consciousness
Dizziness, Loss of consciousness
|
Patient received vaccine, walked out of shot room, reported dizziness, sat down, then passed out in ...
Patient received vaccine, walked out of shot room, reported dizziness, sat down, then passed out in chair. Parents were on the scene to monitor. Gave patient water, patient was good to go after 15 minutes. Parents reported history of syncope with shots and refused ambulance assistance.
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| 2861572 | 78 | F | TN | 09/25/2025 |
FLU3 |
SEQIRUS, INC. |
407245 |
Dizziness, Feeling abnormal
Dizziness, Feeling abnormal
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The patient received her Fluad vaccine at around 4:00pm on 9/23/2025 and started noticed adverse eff...
The patient received her Fluad vaccine at around 4:00pm on 9/23/2025 and started noticed adverse effects about an hour later. She described feeling extremely dizzy and light-headed, as if she was going to faint or fall down. When trying to sleep at night, she laid on her right side and felt like her "world was ending." Nothing was controlling her dizziness, and she called her physician to report the symptoms. They attributed them to getting the flu shot and advised her to rest and drink plenty of fluids. The patient's husband has a home health nurse that visits regularly, and the nurse checked the patient's blood pressure and heart rate on Wednesday 9/24/2025, and both were found to be normal. She still felt dizzy up through Thursday morning, 9/25/2025, but was almost entirely better by the time she called and spoke with me in the afternoon. She did not describe any other side effects or symptoms, and as of now is back to feeling normal.
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| 2861573 | 67 | M | MI | 09/25/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Dizziness, Heart rate increased, Nausea; Dizziness, Heart rate increased, Nausea
Dizziness, Heart rate increased, Nausea; Dizziness, Heart rate increased, Nausea
|
Nausea dizziness rapid heartbeat
Nausea dizziness rapid heartbeat
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| 2861574 | 54 | F | KS | 09/25/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0587 |
Erythema, Peripheral swelling, Pruritus, Skin warm
Erythema, Peripheral swelling, Pruritus, Skin warm
|
WARM TO TOUCH, RED AND RAISED ABD ITCHY. IT SPREAD ACROSS HER ARM THE NEXT DAY. TOOK IBUPROFEN AND ...
WARM TO TOUCH, RED AND RAISED ABD ITCHY. IT SPREAD ACROSS HER ARM THE NEXT DAY. TOOK IBUPROFEN AND ALLERGY MEDICINE. SHE STATED THAT IT HELPED BY THE THIRD DAY.
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| 2861575 | 2 | F | OH | 09/25/2025 |
MMRV |
MERCK & CO. INC. |
|
Eye swelling, Ocular hyperaemia, Rash morbilliform, Urticaria
Eye swelling, Ocular hyperaemia, Rash morbilliform, Urticaria
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Patient had a bump/redness on her right eye on 9/24/25, the night of 9/25/25 he entire body got cove...
Patient had a bump/redness on her right eye on 9/24/25, the night of 9/25/25 he entire body got covered in hives, eye swelling again. Now she is getting bumps that look scattered like measles all over her body.
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| 2861576 | 52 | F | WA | 09/25/2025 |
FLU3 PNC21 VARZOS |
SANOFI PASTEUR MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
U8790BA Z006076 3EG9B |
Fatigue, Injection site rash, Injection site warmth, Pain, Sluggishness; Fatigue...
Fatigue, Injection site rash, Injection site warmth, Pain, Sluggishness; Fatigue, Injection site rash, Injection site warmth, Pain, Sluggishness; Fatigue, Injection site rash, Injection site warmth, Pain, Sluggishness
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Rash surrounding the injection site which pt described as feeling "hot". Rash was noticed ...
Rash surrounding the injection site which pt described as feeling "hot". Rash was noticed the day following the vaccines. Pt states no shortness of breath. Pt calling the Dr as a precaution. Felt tired/sluggish and had some soreness (potentially normal shingles side effects excluding the rash)
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| 2861577 | 50 | M | OR | 09/25/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
na0590 u8832da |
Dizziness, Pain; Dizziness, Pain
Dizziness, Pain; Dizziness, Pain
|
Patient was given vaccines in the afternoon. By evening he had body aches and pain. These side eff...
Patient was given vaccines in the afternoon. By evening he had body aches and pain. These side effects are resolving, but patient started noticing dizziness on 9/24/25.
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| 2861579 | 2 | F | NY | 09/25/2025 |
FLU3 |
SEQIRUS, INC. |
406995 |
Injection site erythema, Injection site swelling, Injection site urticaria
Injection site erythema, Injection site swelling, Injection site urticaria
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hives/redness and swelling per mom to lef deltoid
hives/redness and swelling per mom to lef deltoid
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| 2861580 | 59 | M | ME | 09/25/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
FF8839 8841 |
Cutaneous vasculitis, Immune system disorder, Ocular hyperaemia, Peripheral veno...
Cutaneous vasculitis, Immune system disorder, Ocular hyperaemia, Peripheral venous disease; Cutaneous vasculitis, Immune system disorder, Ocular hyperaemia, Peripheral venous disease
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Emune system both eyes itlormation red eye treat with eye drops 12/22/22-9/13/25 Vastulitus of the s...
Emune system both eyes itlormation red eye treat with eye drops 12/22/22-9/13/25 Vastulitus of the skin also emun problem 24 & 25 Cronic insufficey of the legs 2023-2025
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โ | |||||
| 2861593 | 74 | F | TN | 09/25/2025 |
RSV |
UNKNOWN MANUFACTURER |
|
Chest pain, Fear, Hot flush, Pain in extremity, Sleep disorder
Chest pain, Fear, Hot flush, Pain in extremity, Sleep disorder
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1st evening Left Arm got sore - Lasted about a week!! (Very Sore :-() Couldn't lay on that side...
1st evening Left Arm got sore - Lasted about a week!! (Very Sore :-() Couldn't lay on that side! That Fri Aug 29th + Sat Aug 30th + Sun Aug 31st - I had 3 rounds of Chest Pain (middle to Left) - 1 time each of these days + a 4th time. I was resting each time. But scared me, mild. it woke me up one morning with Hot Flash, then the same Chest Pain (that following Mon or Tues)
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| 1272136 | F | CO | 09/24/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
ER8731 ER8731 ER8731 unknown unknown unknown |
COVID-19, Drug ineffective; Fatigue, Hypoaesthesia, Paraesthesia; Hypoaesthesia,...
COVID-19, Drug ineffective; Fatigue, Hypoaesthesia, Paraesthesia; Hypoaesthesia, Miliaria, Paraesthesia; Biopsy skin, Biopsy skin normal, Paraesthesia; Fatigue, Hypoaesthesia, Paraesthesia; Hypoaesthesia, Miliaria, Paraesthesia; Biopsy skin, Biopsy skin normal, Paraesthesia; Fatigue, Hypoaesthesia, Paraesthesia; Hypoaesthesia, Miliaria, Paraesthesia; Biopsy skin, Biopsy skin normal, Paraesthesia
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Caller didn't get COVID until the end of September or early Oct2022, after having one shot in A...
Caller didn't get COVID until the end of September or early Oct2022, after having one shot in Apr2021.; Caller didn't get COVID until the end of September or early Oct2022, after having one shot in Apr2021.; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An adult female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Polyethylene glycol. Vaccination history included: Flu shot (I had a minor flu shot reaction back in 2002 or 2003 with similar nerve damage), for Immunization, reaction(s): "nerve damage".The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (2022) and all described as "Caller Caller didn't get COVID until the end of September or early Oct2022, after having one shot in Apr2021. She was sick for 2.5 days, and then it was over with no bad effects". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021749083 Same patient/vaccine, different event;
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| 2860896 | ID | 09/24/2025 |
MMRV |
MERCK & CO. INC. |
Z008220 |
No adverse event, Product storage error
No adverse event, Product storage error
|
No additional AE/No PQC.; HCP reported administration of improperly stored vaccines. No additional A...
No additional AE/No PQC.; HCP reported administration of improperly stored vaccines. No additional AE/No PQC. ? Names of vaccines involved (including lot/exp) PROQUAD Z008220 10/27/2026 ? Temperature (54.5F) ? Time frame 3 hours 44 minut; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-Sep-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), lot# Z008220, which has been verified to be valid, expiration date: 27-Oct-2026, administered for prophylaxis (dose, route of administration and anatomical site of injection were not provided). The vaccine administered was improperly stored at a temperature of 54.5F for a time frame of 3 hours and 44 minutes (Product storage error). No previews temperature excursions and no additional adverse events were reported (no adverse event).
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| 2860897 | F | 09/24/2025 |
PPV PPV PPV |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Rash; Rash; Rash
Rash; Rash; Rash
|
got a rash and it is the size of a hand and wrapping around her arm; This spontaneous report was rec...
got a rash and it is the size of a hand and wrapping around her arm; This spontaneous report was received from a female Patient and refers to herself of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 19-Sep-2025, the patient was vaccinated with Pneumococcal Vaccine in left upper arm (dose, route, strength, lot # and expiration date were not reported) for prophylaxis. On the evening of same day, the patient got a rash and it is the size of a hand and wrapping around her arm. Instead of receding the rash is growing a couple inches a day. Patient advised she got sick over the weekend. The patient inquired whether she needs to go to the emergency room (ER). At the reporting time, the outcome of rash was unknown. The causal relationship between the event rash and Pneumococcal Vaccine was unknown/.
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| 2860898 | 60 | M | KS | 09/24/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMVB056A |
Expired product administered
Expired product administered
|
Expired drug used; This non-serious case was reported by a pharmacist via call center representative...
Expired drug used; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 60-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB056A, expiry date 31-AUG-2025) for prophylaxis. On 04-SEP-2025, the patient received Menveo. On 04-SEP-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired drug used). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 08-SEP-2025 Pharmacist reported that an expired dose of Menveo (2 vial presentation) was administered to a patient.
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| 2860899 | 90 | M | 09/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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Shingrix - Late second dose; This non-serious case was reported by a pharmacist via call center repr...
Shingrix - Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 92-year-old male patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (First dose was received on 03-OCT-2023). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: Shingrix - Late second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 10-SEP-2025 The pharmacist stated that the patient had received the first dose of Shingrix in 2023 and enquired if it was acceptable to administer the second dose without restarting the series.
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| 2860924 | 1.58 | M | OK | 09/24/2025 |
HEPA HEPA HEPA HEPA HEPA HEPA MMRV MMRV MMRV MMRV MMRV MMRV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Adenoidal hypertrophy, Adenotonsillectomy, Aphasia, Attention deficit hyperactiv...
Adenoidal hypertrophy, Adenotonsillectomy, Aphasia, Attention deficit hyperactivity disorder, Autism spectrum disorder; Blood aluminium increased, Developmental coordination disorder, Ear tube insertion, Electroencephalogram abnormal, Emotional distress; Epilepsy, Eustachian tube dysfunction, Focal dyscognitive seizures, Gait disturbance, Generalised tonic-clonic seizure; Genetic testing, Intellectual disability, Lethargy, Magnetic resonance imaging head normal, Obstructive sleep apnoea syndrome; Otitis media, Pain, Persistent asymmetrical tonic neck reflex, Petit mal epilepsy, Pyrexia; Rash, Screaming, Somnolence, Tonsillar hypertrophy; Adenoidal hypertrophy, Adenotonsillectomy, Aphasia, Attention deficit hyperactivity disorder, Autism spectrum disorder; Blood aluminium increased, Developmental coordination disorder, Ear tube insertion, Electroencephalogram abnormal, Emotional distress; Epilepsy, Eustachian tube dysfunction, Focal dyscognitive seizures, Gait disturbance, Generalised tonic-clonic seizure; Genetic testing, Intellectual disability, Lethargy, Magnetic resonance imaging head normal, Obstructive sleep apnoea syndrome; Otitis media, Pain, Persistent asymmetrical tonic neck reflex, Petit mal epilepsy, Pyrexia; Rash, Screaming, Somnolence, Tonsillar hypertrophy
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On April 6, 2017, my son received MMR, Varicella, and Hepatitis A (Pediatric/Adolescent 2D) at 1 yea...
On April 6, 2017, my son received MMR, Varicella, and Hepatitis A (Pediatric/Adolescent 2D) at 1 year, 7 months, 20 days old. I wanted to wait but Doc said she would have to call CPS and report I said no to Vaccines. Within hours he became unusually lethargic and was difficult to wake. Over the next 2 days he developed a persistent high fever and screamed in pain inconsolably. His physician told me this was normal and advised Tylenol. His fever and pain continued. Within weeks, he lost all prior speech and developmental skills. He stopped talking entirely for years. He developed severe rashes with bowel movements that looked like chemical burns. On August 23, 2017, he required tonsil/adenoid removal and tubes for recurrent ENT issues and obstructive sleep apnea. In 2018, under care of a new pediatrician, I was told elevated aluminum; a detox regimen was started, and he began regaining speech slowly. On October 18, 2021, patient was evaluated by neuropsychologist who documented: Autism Spectrum Disorder (F84.0), Mild Intellectual Disability (F70), Language Delay (F80.2), Developmental Coordination Disorder (F82), ADHD (F90.2). Report states: Developmental milestones were normal if not advanced before 4/6/2017 vaccines. Patient experienced reaction with prolonged high fever and possible encephalopathy resulting in global delays. Beginning in 2024, patient was diagnosed with epilepsy and seizures (tonic-clonic, focal aware, and absence seizures). EEG and MRI showed no alternative cause. He continues to experience breakthrough seizures despite treatment.
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โ | |||||
| 2860931 | M | 09/24/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
|
Suspected vaccination failure; shingles; This serious case was reported by a consumer via interacti...
Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix and Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported. The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. The company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 18-SEP-2025 This case was reported by a patient via interactive digital media. Patient had gotten the shot. Then he had received the shots and still ended up getting shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix (1st and 2nd dose), in a elderly male patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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| 2860932 | M | 09/24/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
|
Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interacti...
Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-SEP-2025 This case was reported by a consumer via interactive digital media. The reporter stated that his/her dad had the vaccination and still got the shingles. It was a bad case too. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, on an unknown time after receiving Shingles vaccine, in a male patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
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| 2860933 | 51 | F | NJ | 09/24/2025 |
COVID19 COVID19 FLU3 FLU3 |
PFIZER\BIONTECH PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Arthralgia, Coccydynia, Fatigue, Pain, Pelvic pain; Pyrexia; Arthralgia, Coccydy...
Arthralgia, Coccydynia, Fatigue, Pain, Pelvic pain; Pyrexia; Arthralgia, Coccydynia, Fatigue, Pain, Pelvic pain; Pyrexia
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Fever 100.4, Fatigue, body aches, joint pain, pelvic pain, tailbone pain not relieved with Tylenol o...
Fever 100.4, Fatigue, body aches, joint pain, pelvic pain, tailbone pain not relieved with Tylenol or naproxen
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| 2861023 | 3 | M | MI | 09/24/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
PX3P7 |
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 did not have an adverse reaction.
Patient did not have an adverse reaction.
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| 2861024 | 24 | M | ME | 09/24/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
D5YS9 D5YS9 |
Cyanosis, Dizziness, Hyperhidrosis, Pallor, Syncope; Tinnitus
Cyanosis, Dizziness, Hyperhidrosis, Pallor, Syncope; Tinnitus
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Patient experienced a vaccine syncope event. About 3 minutes after receiving the vaccine he became ...
Patient experienced a vaccine syncope event. About 3 minutes after receiving the vaccine he became dizzy and lightheaded. He became very pale and experienced tinnitus. He did not lose consciousness. We had him remain seated, and he took deep breaths. We provided water as well as lifesavers and crackers. His lips became cyanotic. He denied trouble breathing or swelling of the tongue or throat. He remained responsive the entire time. After about 10 minutes his symptoms started to improve. The color returned to his face, and he briefly started sweating profusely. He continued to improve and after about 20-25 minutes his symptoms had completely resolved.
More
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| 2861025 | 30 | F | MI | 09/24/2025 |
COVID19 |
MODERNA |
8146545 |
Incorrect dose administered
Incorrect dose administered
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Safety mechanism of Dropsafe needle was not fully deactivated, leading to a partial dose being deliv...
Safety mechanism of Dropsafe needle was not fully deactivated, leading to a partial dose being delivered IM/SubQ. Full vaccine dose was then readministered in the same arm.
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| 2861026 | 47 | F | CT | 09/24/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
ER8737 ER8737 ER8737 ER8737 5???171 5???171 5???171 5???171 330308D 330308D 330308D 330308D |
Asthenia, Blood test, Brain fog, Drug hypersensitivity, Gait disturbance; Gastro...
Asthenia, Blood test, Brain fog, Drug hypersensitivity, Gait disturbance; Gastrointestinal disorder, Headache, Impaired work ability, Influenza, Magnetic resonance imaging; Migraine, Mobility decreased, Muscle tightness, Neck pain, Sleep disorder; Tension headache, X-ray; Asthenia, Blood test, Brain fog, Drug hypersensitivity, Gait disturbance; Gastrointestinal disorder, Headache, Impaired work ability, Influenza, Magnetic resonance imaging; Migraine, Mobility decreased, Muscle tightness, Neck pain, Sleep disorder; Tension headache, X-ray; Asthenia, Blood test, Brain fog, Drug hypersensitivity, Gait disturbance; Gastrointestinal disorder, Headache, Impaired work ability, Influenza, Magnetic resonance imaging; Migraine, Mobility decreased, Muscle tightness, Neck pain, Sleep disorder; Tension headache, X-ray
More
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Started with migraines, unable to walk upright, extreme pain and tightness at base of skull/into the...
Started with migraines, unable to walk upright, extreme pain and tightness at base of skull/into the neck. My symptoms now are GI issues, sleep issues, zero energy, always feel like I have the flu, brain fog has progressed. Have stopped working and am mostly bedridden now.
More
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โ | |||||
| 2861027 | 0.17 | M | IN | 09/24/2025 |
DTPPVHBHPB DTPPVHBHPB |
MSP VACCINE COMPANY MSP VACCINE COMPANY |
U8313AA U8313AA |
Abdominal discomfort, Abdominal pain, Bowel movement irregularity, Erythema, Pai...
Abdominal discomfort, Abdominal pain, Bowel movement irregularity, Erythema, Pain; Pyrexia, Swelling
More
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Colic since administered, fever the day of, significant swelling for two days following, painful, da...
Colic since administered, fever the day of, significant swelling for two days following, painful, dark red, upset stomach and irregular bowl movements for roughly a week following.
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| 2861028 | 57 | F | FL | 09/24/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
320308d 320308d |
Arthralgia, Gait disturbance, Loss of personal independence in daily activities,...
Arthralgia, Gait disturbance, Loss of personal independence in daily activities, Rash, Rash pruritic; Rheumatoid arthritis
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Itchy skin rash on my shins for 2 years, could not wear shorts. It's almost gone, there is jus...
Itchy skin rash on my shins for 2 years, could not wear shorts. It's almost gone, there is just a little skin irritation on the top of my feet. I now have Rheumatoid arthritis. I can barely walk when I first wake up. My joints hurt all the time, I can barely open my sugar packet for my coffee in the morning. I experience daily pain at work because my job requires constant typing.
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| 2861029 | 61 | F | MA | 09/24/2025 |
COVID19 FLU3 PNC20 RSV TDAP |
PFIZER\BIONTECH SANOFI PASTEUR PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
MY9548 U8832AA MA2505 MF2162 5N9L9 |
Dry skin, Injection site erythema, Injection site rash; Dry skin, Injection site...
Dry skin, Injection site erythema, Injection site rash; Dry skin, Injection site erythema, Injection site rash; Dry skin, Injection site erythema, Injection site rash; Dry skin, Injection site erythema, Injection site rash; Dry skin, Injection site erythema, Injection site rash
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Rash/Redness appearing on left arm below vaccination site. Dry skin
Rash/Redness appearing on left arm below vaccination site. Dry skin
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| 2861030 | 1 | M | WA | 09/24/2025 |
PPV |
MERCK & CO. INC. |
X027348 |
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 here for vaccines. MA prepared vaccines and was checked by provider and shots given. It wa...
Patient here for vaccines. MA prepared vaccines and was checked by provider and shots given. It was after the PneumoVax was given that it was discovered a 1 year old received a vaccine meant for 2 years and up. Mother was informed prior to leaving the clinic. No adverse effects have been reported by the mother at the ariting of this report
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| 2861031 | 69 | M | AR | 09/24/2025 |
FLU3 |
SEQIRUS, INC. |
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Headache, Hyperhidrosis, Injection site pain, Nausea, Pyrexia
Headache, Hyperhidrosis, Injection site pain, Nausea, Pyrexia
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Intense headache, soreness at injection site, nausea, slight fever, sweating. From approximately 4 ...
Intense headache, soreness at injection site, nausea, slight fever, sweating. From approximately 4 pm to 6 pm.
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| 2861032 | 74 | F | KS | 09/24/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
&h &h &h &h 3052087 3052087 3052087 3052087 |
Asthenia, Chest pain, Chills, Electric shock sensation, Headache; Hypoaesthesia,...
Asthenia, Chest pain, Chills, Electric shock sensation, Headache; Hypoaesthesia, Immediate post-injection reaction, Pelvic pain, Pyrexia, Vomiting; Back pain, Blood pressure increased, Chest pain, Hypertension, Hyperventilation; Neuralgia, Paraesthesia; Asthenia, Chest pain, Chills, Electric shock sensation, Headache; Hypoaesthesia, Immediate post-injection reaction, Pelvic pain, Pyrexia, Vomiting; Back pain, Blood pressure increased, Chest pain, Hypertension, Hyperventilation; Neuralgia, Paraesthesia
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Immediate pain like and electrical shock through my pelvic area up to my chest ,later chills ,fever...
Immediate pain like and electrical shock through my pelvic area up to my chest ,later chills ,fever, vomiting, head ache and weakness still having weakness after 2 days whole right side went numb day after
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| 2861033 | 13 | F | MN | 09/24/2025 |
FLU3 |
SANOFI PASTEUR |
UT8779NA |
Extra dose administered
Extra dose administered
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Patient given flu vaccine without realizing that she had already received yearly vaccine the week pr...
Patient given flu vaccine without realizing that she had already received yearly vaccine the week prior (9/18/25) with her primary care clinic.
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| 2861034 | 66 | F | FL | 09/24/2025 |
FLU3 FLU3 FLU3 FLU3 HEP HEP HEP HEP |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION |
U8859CA U8859CA U8859CA U8859CA 946909 946909 946909 946909 |
Asthenia, Burning sensation, Chills, Dizziness, Fatigue; Headache, Impaired work...
Asthenia, Burning sensation, Chills, Dizziness, Fatigue; Headache, Impaired work ability, Nasal congestion, Nausea, Neck pain; Pain, Peripheral swelling, Pruritus, Pyrexia, Rhinorrhoea; Skin warm, Urticaria; Asthenia, Burning sensation, Chills, Dizziness, Fatigue; Headache, Impaired work ability, Nasal congestion, Nausea, Neck pain; Pain, Peripheral swelling, Pruritus, Pyrexia, Rhinorrhoea; Skin warm, Urticaria
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patient felt very tired. As she was driving to work when both hands started severely itching and swe...
patient felt very tired. As she was driving to work when both hands started severely itching and swelling all over. She wiped them a cloth that helped. This lasted for about 30 minutes. After getting home she went to bed. She woke up with a bad headache, dizziness, chills, low grade fever and very nauseated. The back of her neck was burning. Only her right hand and forearm have developed hives. She called out from work, took Tylenol and went back to bed. When she work up her nose was dripping and stuffy. She still has pain in her neck and it is hot to touch, hives on her right hand, she has body aches, nauseous and very weak. She will contact her PCP if symptoms continue.
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| 2861035 | 62 | F | PA | 09/24/2025 |
FLU3 |
SEQIRUS, INC. |
407246 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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No current reaction to vaccine but patient is only 62 with no underlying factors qualifying her for ...
No current reaction to vaccine but patient is only 62 with no underlying factors qualifying her for high dose - should have received flucelvax.
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| 2861036 | 90 | M | GA | 09/24/2025 |
FLU3 |
SEQIRUS, INC. |
407245 |
Joint swelling, Peripheral swelling
Joint swelling, Peripheral swelling
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Patient called on 9/24 to state that he did not have swelling at the injection site but had swelling...
Patient called on 9/24 to state that he did not have swelling at the injection site but had swelling in his wrist and hand. Asked patient if he was going to seek medical attention and he said no, just wanted us to know of the reaction since he has not had previously with flu shots
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| 2861037 | 4 | M | PA | 09/24/2025 |
DTAPIPV |
SANOFI PASTEUR |
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Erythema, Peripheral swelling, Pyrexia
Erythema, Peripheral swelling, Pyrexia
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Entire limb swelling, redness, fever. 20mg prednisone 1x daily for 5 days
Entire limb swelling, redness, fever. 20mg prednisone 1x daily for 5 days
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| 2861038 | 57 | F | IN | 09/24/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
342XP 342XP |
Cold sweat, Headache, Injection site pain, Migraine, Mobility decreased; Nausea,...
Cold sweat, Headache, Injection site pain, Migraine, Mobility decreased; Nausea, Photophobia, Vomiting
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10:23 AM 09/24/2025 Patient called in to advise that she is having a reaction to her shingles inject...
10:23 AM 09/24/2025 Patient called in to advise that she is having a reaction to her shingles injection from yesterday. States she had vomiting over night, unable to raise her arm, severe headache and nausea. Writer reached out to office team who advised patient to go to ER versus coming into office. Patient verbalized understanding and will have a driver to take her. Writer called patient again at 11:45 AM on 9/24/2025 to discuss reaction and advise that a VAERS report will be compelted. Patient reported that she is no longer having vomitting. She has had a headache since yesterday, has taken 3 bayer aspirin with no relief. Headache is located int he frontal region of her head and behind her eyes. She does have some light sensitivity if tries to go outside, headache did not resolve with sleeping lastnight and also reports that since she first called into the office, she has taken a nap and headache/migraine is still present. She is also having claminess to her hands as well. Injection site pain is still present as well, reports it was worse this AM when she woke up but pain has started to resolve some. Patient is at home waiting for husband to take her to the ER for evaluation.
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| 2861039 | 52 | F | FL | 09/24/2025 |
UNK UNK UNK UNK UNK VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
unknown unknown unknown unknown unknown UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK |
Burning sensation, Fatigue, Feeling cold, Fibromyalgia, Neuropathy peripheral; O...
Burning sensation, Fatigue, Feeling cold, Fibromyalgia, Neuropathy peripheral; Oedema, Pain, Paraesthesia, Sleep disorder, Swelling; Tremor; Chills, Condition aggravated, Fatigue, Fibromyalgia, Neuropathy peripheral; Pain, Skin burning sensation, Sleep disorder, Tremor, Vaccination failure; Burning sensation, Fatigue, Feeling cold, Fibromyalgia, Neuropathy peripheral; Oedema, Pain, Paraesthesia, Sleep disorder, Swelling; Tremor; Chills, Condition aggravated, Fatigue, Fibromyalgia, Neuropathy peripheral; Pain, Skin burning sensation, Sleep disorder, Tremor, Vaccination failure; Burning sensation, Fatigue, Feeling cold, Fibromyalgia, Neuropathy peripheral; Oedema, Pain, Paraesthesia, Sleep disorder, Swelling; Tremor; Chills, Condition aggravated, Fatigue, Fibromyalgia, Neuropathy peripheral; Pain, Skin burning sensation, Sleep disorder, Tremor, Vaccination failure
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Initial reaction was common (shaking, coldness, tiredness), but it gradually grew into extreme pain,...
Initial reaction was common (shaking, coldness, tiredness), but it gradually grew into extreme pain, swelling, edema and neuropathy on my left side, especially in the left leg. I wake up during the night feeling like the flesh is being ripped from the bone. I have a constant tingling/stinging down my thigh that goes from feeling like sunburn at best to stabs, stings and burning at worst and it hurts when my clothing touches me. I tire very easily and frequently take 3-5 hour naps on the weekends. It's incredibly difficult to walk any distance and it's also painful to sit at my desk. I had to add a cushion to my chair as well as a footrest to be able to work at all. The website symptoms were mild and eased over time. These have not.
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| 2861040 | 7 | M | WI | 09/24/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
9r2d7 |
Aggression
Aggression
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Extreme aggression violence
Extreme aggression violence
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| 2861041 | 4 | M | IL | 09/24/2025 |
DTAPIPV HEPA MMRV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
93H32 42DM9 Z009075 |
Injection site erythema, Injection site pain, Injection site swelling, Injection...
Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
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Redness, swelling, heat and tenderness at injection site on R thigh. Small area of redness noticed s...
Redness, swelling, heat and tenderness at injection site on R thigh. Small area of redness noticed several hours after injection and has continued to worsen. Parent advised to give allergy medication and apply ice packs.
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| 2861042 | 64 | F | TX | 09/24/2025 |
COVID19 FLU3 PNC21 |
MODERNA SANOFI PASTEUR MERCK & CO. INC. |
3051997 U8790AA Z006076 |
Blood glucose decreased, Injection site erythema, Skin wound; Blood glucose decr...
Blood glucose decreased, Injection site erythema, Skin wound; Blood glucose decreased, Injection site erythema, Skin wound; Blood glucose decreased, Injection site erythema, Skin wound
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Patient had redness located below injection site of right arm, none on shoulder, but solid redness b...
Patient had redness located below injection site of right arm, none on shoulder, but solid redness below shoulder muscle extending to elbow. Area by elbow looked to have broken skin.
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| 2861043 | 17 | F | ID | 09/24/2025 |
FLUN3 MENB MNQ |
MEDIMMUNE VACCINES, INC. NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
YF3413 49M9N U8508AA |
No adverse event, Vaccination error; No adverse event, Vaccination error; No adv...
No adverse event, Vaccination error; No adverse event, Vaccination error; No adverse event, Vaccination error
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MenQuadfi Vaccine was administer in error. Patient had no immediate adverse side effects. Parent wa...
MenQuadfi Vaccine was administer in error. Patient had no immediate adverse side effects. Parent was in room with patient at the time the vaccine was administered and had no concerns regarding receiving an additional dose. Patient's PCP came in following the administration error and discussed the event with parents, parent and patient had no concerns.
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| 2861044 | 74 | F | WY | 09/24/2025 |
PNC20 |
PFIZER\WYETH |
LX2498 |
Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Vaccination site erythema, Vaccination site mass, Vaccination site warmth
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1 week after vaccination (9/16) pt developed a hard lump at vaccination sight and spreading redness ...
1 week after vaccination (9/16) pt developed a hard lump at vaccination sight and spreading redness and warmth from and around vaccine site spreading down her arm consistent with cellulitis. Pt had complained of this at a blood draw (9/18) , and this nurse had provider assess. She did order some doxycyline for the patient and as of my contact with pt on 9/22/25 pt states this has resolved with antibiotics. RN
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| 2861045 | 1.5 | F | MO | 09/24/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
GP759 |
Urticaria
Urticaria
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Hives began at 5:00 pm
Hives began at 5:00 pm
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| 2861046 | 20 | F | TX | 09/24/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
2L353 |
Dizziness, Rash
Dizziness, Rash
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Patient reported feeling dizzy and developed rash to her face.
Patient reported feeling dizzy and developed rash to her face.
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| 2861047 | 83 | F | TX | 09/24/2025 |
COVID19 |
PFIZER\BIONTECH |
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Condition aggravated, Vertigo
Condition aggravated, Vertigo
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Flare of chronic vertigo
Flare of chronic vertigo
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| 2861048 | 12 | F | MN | 09/24/2025 |
MNQ TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
X7R4Z DD7F7 |
Eye pruritus, Eye swelling; Eye pruritus, Eye swelling
Eye pruritus, Eye swelling; Eye pruritus, Eye swelling
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Patient mom reports swollen and itchy eyes
Patient mom reports swollen and itchy eyes
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| 2861049 | 75 | F | 09/24/2025 |
RSV |
PFIZER\WYETH |
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Extra dose administered
Extra dose administered
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Patient inadvertently received a second dose of Abrysvo. First dose 10/2023
Patient inadvertently received a second dose of Abrysvo. First dose 10/2023
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