| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
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| 2865829 | 83 | F | FL | 10/14/2025 |
COVID19 |
PFIZER\BIONTECH |
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Arrhythmia, COVID-19, SARS-CoV-2 test
Arrhythmia, COVID-19, SARS-CoV-2 test
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She got Covid; an arrythmia from her heart; This is a spontaneous report received from a Consumer or...
She got Covid; an arrythmia from her heart; This is a spontaneous report received from a Consumer or other non HCP. An 84-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 83 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: pfizer COVID shot (DOSE 1, SINGLE, Lot: EN6199), administration date: 06Mar2021, when the patient was 80-year-old, for Covid-19 Immunization; pfizer COVID shot (DOSE 2, SINGLE, Lot: EP7534), administration date: 27Mar2021, when the patient was 80-year-old, for Covid-19 Immunization; pfizer COVID shot (DOSE 3 (BOOSTER), SINGLE, Lot: FF2593), administration date: 28Oct2021, when the patient was 80-year-old, for Covid-19 Immunization; pfizer COVID shot (DOSE 4 (BOOSTER), SINGLE, Lot: GH9702, got Omicron 3 weeks after receiving that dose), administration date: 22Dec2021, when the patient was 80-year-old, for Covid-19 Immunization; pfizer COVID shot (DOSE 5 (BOOSTER), SINGLE, Lot: FJ4991), administration date: 02Jul2022, when the patient was 81-year-old, for Covid-19 Immunization; pfizer COVID shot (DOSE 1, SINGLE, Lot: HG4671), administration date: 24Oct2023, when the patient was 82-year-old, for Covid-19 Immunization. The following information was reported: ARRHYTHMIA (medically significant) with onset 2025, outcome "unknown", described as "an arrythmia from her heart"; COVID-19 (medically significant) with onset 13Sep2025, outcome "unknown", described as "She got Covid". The events "she got covid" and "an arrythmia from her heart" required physician office visit. Therapeutic measures were taken as a result of covid-19. Clinical course: Patient got Covid on 13Sep2025, woke up with it. Took a test that someone gave her and it registered positive. Felt ok to go to a urgent care. Got Paxlovid out of fear. She took Paxlovid on 15Sep2025. She has an arrythmia from her heart now and it has to be from Covid. Just went and found this out. She also had big time covid fog. Thinks it was gone now. She was up to date with her shots except for this last spring of 2025. Clarified to be Covid shots. Found out in May or Jun of this year that there was a another covid vaccine and debated whether she should get it. She decided she was going to get it in the fall. It was the only one she missed. Clarified that she missed another spring dose and told her doctor about it as well, but her doctor told her just to wait until the fall. The patient had to go to a cardiologist, which was new for her, because of the arrhythmia. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500200875 same patient/reporter, different dose/AE;US-PFIZER INC-202500202062 same patient/reporter, different dose/AE;
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| 2865830 | 10/14/2025 |
COVID19 COVID19 FLUX FLUX |
PFIZER\BIONTECH PFIZER\BIONTECH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Implant site erythema, Implant site pain, Nausea, Pyrexia, Tremor; Vomiting; Imp...
Implant site erythema, Implant site pain, Nausea, Pyrexia, Tremor; Vomiting; Implant site erythema, Implant site pain, Nausea, Pyrexia, Tremor; Vomiting
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shakes; n/v (nausea and vomiting); n/v (nausea and vomiting); fever; sudden redness pain of one impl...
shakes; n/v (nausea and vomiting); n/v (nausea and vomiting); fever; sudden redness pain of one implant; sudden redness pain of one implant; This is a spontaneous report received from a Consumer or other non HCP from medical information team, 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; influenza vaccine (FLU VACCINE VII), in 2025 as dose number unknown, single for immunisation. The patient's relevant medical history included: "Breast CA survivor" (unspecified if ongoing); "implants", start date: Mar2025, stop date: Mar2025, notes: 7 months ago. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 2025, 24 hrs after the suspect product(s) administration, outcome "unknown", described as "fever"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 2025, latency 24 hrs after the suspect product(s) administration, outcome "unknown" and all described as "n/v (nausea and vomiting)"; TREMOR (non-serious) with onset 2025, 24 hrs after the suspect product(s) administration, outcome "unknown", described as "shakes"; IMPLANT SITE PAIN (non-serious), IMPLANT SITE ERYTHEMA (non-serious) all with onset 2025, latency 24 hrs after the suspect product(s) administration, outcome "unknown" and all described as "sudden redness pain of one implant". The events "shakes", "n/v (nausea and vomiting)", "fever" and "sudden redness pain of one implant" required physician office visit. Therapeutic measures were taken as a result of tremor, nausea, vomiting, pyrexia, implant site pain, implant site erythema. Additional information: Breast CA survivor- implants 7 months ago. Received covid shot- with flu shot- severe reaction 24 hours later- n/v (nausea and vomiting), shakes, fever. Followed by sudden redness pain of one implant. Followed up with plastic surgeon- on cipro and NSAID, Acetaminophen. The patient asked if there were cases resolving in the research without implant removal. 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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| 2865831 | 18 | F | 10/14/2025 |
COVID19 |
PFIZER\BIONTECH |
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Vaccination site pain
Vaccination site pain
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mild soreness at the injection site; This is a spontaneous report received from a Consumer or other ...
mild soreness at the injection site; This is a spontaneous report received from a Consumer or other non HCP. An 18-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 12Oct2025 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 18 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Oct2025 at 22:00, outcome "unknown", described as "mild soreness at the injection site".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500121455 same reporter/drug/AE, Different patient;
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| 2865832 | F | 10/14/2025 |
COVID19 RSV |
MODERNA PFIZER\WYETH |
8146367 MF2162 |
Chills, Myalgia, Pregnancy test; Chills, Myalgia, Pregnancy test
Chills, Myalgia, Pregnancy test; Chills, Myalgia, Pregnancy test
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chills; muscle aches; This is a spontaneous report received from a Consumer or other non HCP. Other ...
chills; muscle aches; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789796 (Moderna). A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 27Sep2025 as dose 1, single (Lot number: MF2162) intramuscular for maternal immunisation; elasomeran (SPIKEVAX), on 27Sep2025 as dose number unknown, single (Lot number: 8146367) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: 1994 (ongoing); "Eczema" (ongoing); "COVID-19", start date: 15Aug2024 (not ongoing); "caesarean section", start date: 28Aug2019, stop date: 28Aug2019, notes: Breech delivery, C-section; "Pregnancy", stop date: 30Oct2021, notes: Live full-term birth; "Alcohol use", stop date: 20Feb2021, notes: 2 drinks per week prior to pregnancy; "Pregnancy", stop date: 28Aug2019, notes: Breech delivery, C-section, Live full-term birth. Date of last menstrual period: 21Jan2025. The patient was 35 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v, elasomeran. The patient was 35 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 28Oct2025. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 27Sep2025, outcome "recovered" (28Sep2025); MYALGIA (non-serious) with onset 27Sep2025, outcome "recovered" (28Sep2025), described as "muscle aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, myalgia. Additional information: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (muscle aches) and MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) in a patient (gravida 3, para 2) who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 8146367) for COVID-19 prophylaxis. Co-suspect product included non-company product RSV vaccine prot. subunit PreF 2v (Abrysvo) for an unknown indication. asthma, eczema Patient was diagnosed with Covid 19. The patient's past medical history included COVID-19 on 15Aug2024, Pregnancy (Breech delivery, C-section, Live full-term birth) on 28Aug2019, Pregnancy (Live full-term birth) on 30Oct2021, Alcohol use (2 drinks per week prior to pregnancy) on 20Feb2021 and C-section (Breech delivery, c section) on 28Aug2019. Concurrent medical conditions included Asthma since 1994 and Eczema. On 27Sep2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of RSV vaccine prot. subunit PreF 2v (Abrysvo) (Intramuscular use) 1 dosage form. The patient's last menstrual period was on 21Jan2025 and the estimated date of delivery was 28Oct2025. On 27Sep2025, the patient experienced CHILLS (chills), MYALGIA (muscle aches) and MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy). The patient received mRNA-1273.251 (Spikevax LP.8.1 PFS) beginning around the thirty-fifth week of the pregnancy and RSV vaccine prot. subunit PreF 2v (Abrysvo) beginning around the thirty-fifth week of the pregnancy. The patient was treated with Paracetamol (Tylenol) on 27Sep2025 at an unspecified dose and frequency. On 27Sep2025, MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) had resolved. On 28Sep2025, CHILLS (chills) and MYALGIA (muscle aches) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2025, Pregnancy test: Positive. No concomitant medications were provided. It was reported that there was no maternal history of infertility. The patient had no allergies to medications, food, and other products. The night of vaccination, patient had chills and muscle aches and took tylenol. Case Comment/Sender Comment: Company comment: The benefit-risk relationship of product is not affected by this report. No follow-up attempts are possible. No further information is expected.
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| 2865833 | 54 | 10/14/2025 |
COVID19 |
PFIZER\BIONTECH |
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Vaccination site pain
Vaccination site pain
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began experiencing mild soreness at the injection site around 10 PM; This is a spontaneous report re...
began experiencing mild soreness at the injection site around 10 PM; This is a spontaneous report received from a Consumer or other non HCP. A 54-year-old patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 12Oct2025 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Oct2025 at 22:00, outcome "unknown", described as "began experiencing mild soreness at the injection site around 10 PM". The information on the batch/lot number for BNT162b2 omicron (lp.8.1) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500202323 same reporter/drug/AE, Different patient;
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| 2865844 | F | 10/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pain
Pain
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Soreness; This non-serious case was reported by a consumer via interactive digital media and describ...
Soreness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: Soreness). The outcome of the pain was unknown. The reporter considered the pain to be related to Shingrix. The company considered the pain to be related to Shingrix. Additional Information: GSK Receipt Date: 05-OCT-2025 This case was reported by a patient via interactive digital media. The patient self-reported the case for herself. She mentioned that she had received two shots and it was not that bad, just soreness. The patient's daughter had gotten shingles at the young age of 32 years. It had been horrible for her (patient's daughter) but did not last a long time. The patient had requested people to get vaccines, as it was worth it. The batch number was not provided, and we are unable to contact the reporter.
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| 2865845 | M | MO | 10/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Product preparation issue
Product preparation issue
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patient received only the diluent portion of Shingrix; patient received only the diluent portion of ...
patient received only the diluent portion of Shingrix; patient received only the diluent portion of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 07-JUL-2025, the patient received the 1st dose of Shingrix. On 07-JUL-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the diluent portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: patient received only the diluent portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 06-OCT-2025 The pharmacist asked for recommendations on this situation. The batch number was not provided upon follow- up with the reporter.
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| 2865846 | 60 | F | VA | 10/14/2025 |
COVID19 |
PFIZER\BIONTECH |
HJ7224 |
Blood glucose, Glycosylated haemoglobin, Limb mass, SARS-CoV-2 test, Vaccination...
Blood glucose, Glycosylated haemoglobin, Limb mass, SARS-CoV-2 test, Vaccination site mass
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Each time she would get Covid shots, lump would go back and forth/every time she got a shot she woul...
Each time she would get Covid shots, lump would go back and forth/every time she got a shot she would get a lump and has multiple lumps in both arms; Each time she would get Covid shots, lump would go back and forth/every time she got a shot she would get a lump and has multiple lumps in both arms; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP from product quality group, Program ID:. A 62-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Dec2023 as dose 1 (toppac), single (Lot number: HJ7224) at the age of 60 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: Second time she had covid; "high blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing); "Water retention" (unspecified if ongoing); "for stomach" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "arthritic" (unspecified if ongoing); "Allergies: penicillin" (unspecified if ongoing); "heart issues" (unspecified if ongoing); "she seasonal has terrible allergies/allergies" (unspecified if ongoing); "bronchitis" (unspecified if ongoing), notes: would end up getting exacerbated and go into bronchitis and gets that once a year, almost faithfully, in the fall; "afterwards did get Covid, more than once" (unspecified if ongoing), notes: first or second year of the pandemic in 2021 or 2022. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; AMLODIPINE taken for hypertension; LOSARTAN taken for hypertension; SIMVASTATIN taken for blood cholesterol increased; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity; FUROSEMIDE taken for fluid retention; OMEPRAZOLE/SODIUM BICARBONATE taken for abdominal discomfort. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; LOT: EP7534, in left arm), administration date: 13Mar2021, when the patient was 57-year-old, for Covid-19 immunization, reaction(s): "The terrible muscle aches and you know the soreness, the shot spot you know which I can still feel, I still feel a knot under my skin in several spots of my arms spots", "The terrible muscle aches and you know the soreness, the shot spot you know which I can still feel, I still feel a knot under my skin in several spots of my arms spots", "The terrible muscle aches and you know the soreness, the shot spot you know which I can still feel, I still feel a knot under my skin in several spots of my arms spots", "lump an injection injury"; BNT162b2 (DOSE 2, SINGLE; LOT: EW0151, in right arm), administration date: 03Apr2021, when the patient was 57-year-old, for Covid-19 immunization, reaction(s): "hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot/would get Covid shots, lump would go back and forth between her two arms", "hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot/would get Covid shots, lump would go back and forth between her two arms"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; LOT: FH8020, in left arm), administration date: 14Oct2021, when the patient was 58-year-old, for Covid-19 immunization, reaction(s): "lump an injection injury", "hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot/would get Covid shots, lump would go back and forth between her two arms"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE; LOT: FJ4991, in left arm), administration date: 09Apr2022, when the patient was 58-year-old, for Covid-19 immunization, reaction(s): "Each time she would get Covid shots, lump would go back and forth/every time she got a shot she would get a lump and has multiple lumps in both arms", "Each time she would get Covid shots, lump would go back and forth/every time she got a shot she would get a lump and has multiple lumps in both arms"; BNT162b2 (DOSE 5 (BOOSTER), SINGLE; LOT: FP7138, Arm), administration date: 12Aug2022, when the patient was 59-year-old, for Covid-19 immunization, reaction(s): "Almost every time she got a shot she would get a lump", "Muscle aches", "headaches", "it just took down her overall energy and stamina", "if there is a terrible humid day she can be in so much discomfort", "it just took down her overall energy and stamina", "where she got shots can be very tender"; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 7 (BOOSTER), SINGLE; LOT: AK0928, in Arm), administration date: 04Aug2023, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "gotten a shot she would get a lump and has multiple lumps in both arms/over time lump seems to have traveled; same arm and then again later; a shot in her right arm; has multiple lumps, in both arms", "gotten a shot she would get a lump and has multiple lumps in both arms/over time lump seems to have traveled; same arm and then again later; a shot in her right arm; has multiple lumps, in both arms"; Bnt162b2 (DOSE 6 (BOOSTER), SINGLE; in Arm Left), for Covid-19 immunization, reaction(s): "lump". The following information was reported: VACCINATION SITE MASS (non-serious), LIMB MASS (non-serious), outcome "not recovered" and all described as "Each time she would get Covid shots, lump would go back and forth/every time she got a shot she would get a lump and has multiple lumps in both arms". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site mass, limb mass. Additional information: Additional information: It was reported that, patient got Covid after being vaccinated, patient thinks, more than once. Thinks patient had the vaccine a couple of times by then. Takes as precaution because patient has autoimmune disease and her son suffers from autoimmune disease. Son had chemo over 10 years, his autoimmunity was dangerously low right now. He goes through these treatments and caller has to be careful as well as she can be on a regular basis. Has had some lingering, guesses they might even call it long Covid. Patient had studied up on it, trying to decipher if its one thing or another. Believes patient only had covid twice, if that second time was in fact Covid, it was very similar. Had been well otherwise, all though patient had diabetes, has heart issues. Is not a sickly person that was always sick with something. Because of her practices in handwashing and wearing masks out, which she still does, thinks was actually with all things she would normally get like she seasonal has terrible allergies, that would end up getting exacerbated and go into bronchitis and gets that once a year, almost faithfully, in the fall. Thankful to Pfizer because, between of her practices and having had the vaccines, has been more well overall as far as colds, flu, bronchitis. Had literally never had bronchitis since getting the first Covid shot. And she has learned to be more careful in public. Muscle aches and headaches: Clarified, she had the muscle aches and headaches both times having Covid. The very first shot was very painful thereafter, it really bothered her. There was hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot. Each time she would get Covid shots, lump would go back and forth between her two arms. Clarified, she experienced in lumps in both arms, had shots in both arms. Treatment: Really not able to take any NSAIDS so patient would only rely on Tylenol and because she is diabetic, worries about kidneys so she does not take very much Tylenol. Patient would do more CBD, which was a derivative of hemp, she would rub that on there and it would sometimes be effective. Has tried another natural thing called Arnica. Results of those seem to be hit or miss. Lump started in arm where she initially had shot was in left arm. Then over time lump seems to have travelled a little bit in the same arm and then again later when patient had a shot in her right arm. Now, has multiple lumps, in both arms. Specific date this started, unknown. Was when she got first shot, within a few days after that the lump was still there. Was told by pharmacist that it is a significant lump that the pharmacist would call the lump an injection injury. Clarified, she now has multiple lumps. Almost every time she has gotten a shot, patient would get a lump and has multiple lumps in both arms. Treatment: There was not really treatment because, when she asked if she should use hot or cold compress was told no. Said it would work itself out over time and told her to just take Tylenol, or Aspirin. Was afraid to massage too much and did not really rub it but would check to see if still there and if still as big and if it was moving. It did move some, patient thinks, from where it was initially. Patient thinks that was the lot number Eighth Dose: Pfizer thinks it says 23-24. Administered on16Dec2023 LOT: Can't tell since writing was messed up and states the first character was either a H or # and then J7324 or J7224. Patient cannot tell what it states for lot number due to writing. When clarifying that, caller had total of 8 Covid vaccines, Patient stated, she was not sure if that was all of them. That was all patient has documented, not sure if she had more. patient does not have any further details to provide for any other covid vaccine or any further lot numbers. Patient only had what was on her three vaccine cards as provided above.
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| 2865848 | M | TX | 10/14/2025 |
COVID19 FLUX |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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COVID-19, SARS-CoV-2 test; COVID-19, SARS-CoV-2 test
COVID-19, SARS-CoV-2 test; COVID-19, SARS-CoV-2 test
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Covid-ish symptoms-positive Covid-19 test; This is a spontaneous report received from a Consumer or ...
Covid-ish symptoms-positive Covid-19 test; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 74-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 06Oct2025 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 06Oct2025 as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Niacin, reaction(s): "flushing", notes: Allergy. Vaccination history included: comirnaty (DOSE NUMBER UNKNOWN, SINGLE), administration date: 09Oct2024; flu vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: 04Oct2024; Moderna (DOSE NUMBER UNKNOWN, SINGLE). The following information was reported: COVID-19 (non-serious) with onset Oct2025, outcome "unknown", described as "Covid-ish symptoms-positive Covid-19 test". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Had Covid-ish, flu-ish symptoms after taking Covid vaccine: Tuesday, began getting those same symptoms, like Covid-ish flu-ish kind of thing going on. Was told that, apparently, the vaccines don't necessarily give virus, is not live virus but, can give those side effects. Just never had problem with Moderna vaccines for Covid. That past week, transitioned into Wednesday, yesterday, today, feeling normal. Tuesday, was not feeling so normal after taking that thing. Clarified, caller took Pfizer Covid vaccine, this past Monday, had the problem Tuesday. Indication: Cancer patient, had Chronic lymphocytic leukemia, is heart patient, has A-fib, tries to stay away from debilitating things, like Covid, flu, and other things. Was the patient taking any other medications within 2 weeks prior to the event onset reported as takes 11 medications, ranging from diuretics for congestive heart failure, blood pressure problems, different things, for different reasons. Takes a plethora of drugs. It was 04Oct2024, he had high dose flu vaccine, not 6Oct2024, was a 5 day gap, between high dose flu vaccine and Covid vaccine. Patient Medical History: Did the patient previously receive the Pfizer suspect vaccine reported as Has had many Covid shots, mainly from Moderna, never had any abnormal response. Felt both companies were very good companies. May be that Pfizer just does not agree with him or, could be the flu shots too, is hard to know. Clarified, the Covid-19 vaccine caller received last year, 2024 and tested positive for Covid-19, and the Covid vaccine he had this past Monday, 6Oct2025, were the only Pfizer Covid vaccines he had. Tested positive for Covid-19, day after receiving Covid-19 vaccine, last year. After most recent Covid-19 vaccine, had Covid-ish, flu-ish symptoms after taking Covid vaccine. Description of Product Complaint: Description of complaint: Took Pfizer Covid-19 vaccine, very next day, tested positive for Covid-19 this year. allergic to any previous vaccination, medications, food or other products reported as yes, Took Niacin, that gave him extreme flushing, is for cholesterol, to raise good cholesterol. Came off that, within 2 days. Was not just flushing but, the heat wave that comes. Batch/lot number is not provided, and it cannot be obtained.
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| 2865849 | 61 | F | NV | 10/14/2025 |
FLU3 |
SANOFI PASTEUR |
U8800BA |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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PATIENT RECEIVED HIGH DOSE FLU VACCINE (65+) INSTEAD OF FLUBLOK FOR 18-64 YEARS OLD. VACCINE WAS TYP...
PATIENT RECEIVED HIGH DOSE FLU VACCINE (65+) INSTEAD OF FLUBLOK FOR 18-64 YEARS OLD. VACCINE WAS TYPED AND PROCESSED FOR CORRECT FLUBLOK, BUT HIGH DOSE WAS GRABBED OUT OF THE FRIDGE AND ADMINISTED INCORRECTLY.
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| 2865850 | 40 | F | TX | 10/14/2025 |
FLU3 |
SANOFI PASTEUR |
u8790aa |
Injection site erythema, Injection site pain, Injection site swelling, Injection...
Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
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Patient reported pain ,redness, swelling at injection site and heat on site
Patient reported pain ,redness, swelling at injection site and heat on site
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| 2865851 | 5 | F | WA | 10/14/2025 |
DTAPIPVHIB PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
UK305AB LX2496 |
Product administered to patient of inappropriate age, Wrong product administered...
Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered
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Patient has reached 5 years of age with no previous vaccine history. Staff administered Pentacel and...
Patient has reached 5 years of age with no previous vaccine history. Staff administered Pentacel and PCV-20, however patient is over 4 years of age (for the Pentacel specifically) and should have had vaccine components administered individually.
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| 2865852 | 43 | F | WA | 10/14/2025 |
FLU3 |
SANOFI PASTEUR |
UT8792JA |
Pain, Product administered at inappropriate site
Pain, Product administered at inappropriate site
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Thurs 10/9 - Called and spoke with the affected caregiver over the phone and interviewed EH team. EH...
Thurs 10/9 - Called and spoke with the affected caregiver over the phone and interviewed EH team. EH caregiver began administering injection by inserting in caregiver arm, but the syringe plunger completely stuck and immobile, so she removed the needle and discarded. When she gave the 2nd injection, she inserted the needle slightly higher, to avoid using the same injection site. Affected caregiver began having symptoms shortly thereafter and a coworker felt the injection site looked high, therefore she reached out to the EH email. Guidance provided on 9/20 to fill out form, but the affected caregiver wanted to monitor it for a bit. She also shared that she had a PCP appointment scheduled prior to this incident, and she did mention her symptoms to the PCP, who prescribed a steroid. Affected caregiver was advised to continue informing EH about her symptom resolution - at the time of the phone call, she still had soreness when raising her arm above shoulder height (ex/ to wash her hair). She was also curious whether she should receive another flu vaccine (whether the injection would be less effective if the injury was due to the injection being given outside of the deltoid), but at this time EH did not recommend repeating her vaccine.
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| 2865853 | 64 | F | SC | 10/14/2025 |
COVID19 PNC20 RSV VARZOS |
MODERNA PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3052087 LG5576 AE435 332L4 |
Injection site cellulitis, Injection site erythema, Injection site pruritus, Inj...
Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling; Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling; Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling; Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling
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Patient said that her left arm was red, swollen, and itchy around the area where she got vaccinated ...
Patient said that her left arm was red, swollen, and itchy around the area where she got vaccinated 4 days earlier. She went to her dr and he said it was probably cellulitis and gave her a prescription for an antibiotic.
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| 2865854 | 75 | M | WI | 10/14/2025 |
COVID19 |
PFIZER\BIONTECH |
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Synovitis
Synovitis
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left wrist sinovitis, lasted 2 days
left wrist sinovitis, lasted 2 days
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| 2865855 | 4 | M | NJ | 10/14/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
9JC49 |
Injection site reaction, Rash, Rash erythematous
Injection site reaction, Rash, Rash erythematous
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Round, red rashes developed roughly 26-27 hours after vaccine. Located on belly, back and at injecti...
Round, red rashes developed roughly 26-27 hours after vaccine. Located on belly, back and at injection site on thigh
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| 2865856 | 81 | F | WI | 10/14/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0587 |
Back pain, Injection site erythema, Injection site warmth
Back pain, Injection site erythema, Injection site warmth
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Patient had pain in lower back the night after getting the injection. Patient took a tylenol and the...
Patient had pain in lower back the night after getting the injection. Patient took a tylenol and the pain imrproved significantly the next day. 2-3 days after the injection, redness and feeling of warmth developed on the injection arm. Patient did not use any treatment for that.
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| 2865857 | 49 | M | CA | 10/14/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
5N79Z |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Patient received RSV vaccine before the recommended age from the CDC.
Patient received RSV vaccine before the recommended age from the CDC.
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| 2865858 | 37 | F | ME | 10/14/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
LT9HP |
Miliaria, Rash, Rash pruritic
Miliaria, Rash, Rash pruritic
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Prickly Rash to face , neck and upper chest, itchy, not draining, which was noted at 09:00pm on 10/1...
Prickly Rash to face , neck and upper chest, itchy, not draining, which was noted at 09:00pm on 10/13/2025. Has had this same type of reaction for the 3rd year in a row. Have used Benerdryl and topical hydrocortisone to recover from incident. Usually have this issue for 2-7 days.
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| 2865859 | 67 | F | GA | 10/14/2025 |
COVID19 |
MODERNA |
3052036 |
Dizziness, Nausea, Vertigo, Vomiting
Dizziness, Nausea, Vertigo, Vomiting
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Patient reports that the day after vaccination she was extremely dizzy, nauseated and vomiting. She ...
Patient reports that the day after vaccination she was extremely dizzy, nauseated and vomiting. She has experienced vertigo in the past, however, she reports this being extreme. These symptoms lasted about 12 hours. She reports that she did not take anything for the symptoms.
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| 2865860 | 74 | F | CA | 10/14/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052586 407253 |
Injected limb mobility decreased, Pain, Pain in extremity; Injected limb mobilit...
Injected limb mobility decreased, Pain, Pain in extremity; Injected limb mobility decreased, Pain, Pain in extremity
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Patient stated she has been experiencing pain in her left arm after vaccination. She has limited mo...
Patient stated she has been experiencing pain in her left arm after vaccination. She has limited mobility with her left arm. Lifting her arm above her shoulder causes pain. Patient did not report any treatment or remedies she has tried as treatment.
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| 2865861 | 65 | M | 10/14/2025 |
FLU3 |
SEQIRUS, INC. |
407267 |
Pain, Pain in extremity
Pain, Pain in extremity
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Sore arm that becomes more sore with lifting and use. Started 10/7/25 and still continuing today.
Sore arm that becomes more sore with lifting and use. Started 10/7/25 and still continuing today.
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| 2865888 | 68 | F | IN | 10/14/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
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Asthenia, Back pain, Chills, Decreased appetite, Dizziness; Dyspnoea, Lethargy, ...
Asthenia, Back pain, Chills, Decreased appetite, Dizziness; Dyspnoea, Lethargy, Mobility decreased, Nausea, Pyrexia
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Wednesday morning vaccine was given in the right arm. Thursday morning experienced debilitating back...
Wednesday morning vaccine was given in the right arm. Thursday morning experienced debilitating back pain where you cannot lift your head up or move. Saturday & Sunday very lethargic. Monday went to work and became nauseous/dizzy in the evening then had severe chills with a fever of 101+ Monday night for 6 hours during which it was difficult to breathe without focusing on breathing. Tuesday morning woke up at 4 am with a fever of 101.8, Could not eat or drink. Tuesday at noon began drinking water. Fever broke Tuesday at 1:30 pm. Was able to drink a protein shake at 6:30 pm.
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| 2865889 | 66 | M | 10/14/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
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Dizziness, Fatigue; Dizziness, Fatigue
Dizziness, Fatigue; Dizziness, Fatigue
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three weeks dizziness and fatigue reported by patient to pharmacy, patient directed to discuss with ...
three weeks dizziness and fatigue reported by patient to pharmacy, patient directed to discuss with primary care
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| 2865890 | 35 | M | IL | 10/14/2025 |
FLU3 |
SEQIRUS, INC. |
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Dyspnoea, Hypopnoea, Laboratory test, Pulmonary function test decreased
Dyspnoea, Hypopnoea, Laboratory test, Pulmonary function test decreased
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Shortness of breath, eventually leading to extremely shallow breathing and an emergency room visit o...
Shortness of breath, eventually leading to extremely shallow breathing and an emergency room visit on 1/22/25. Was pressured to receive vaccine because physician told me that I would not be allowed into the delivery room of my first child scheduled for 1/15/25.
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| 2865891 | 67 | F | 10/14/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
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Dizziness, Fatigue; Dizziness, Fatigue
Dizziness, Fatigue; Dizziness, Fatigue
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three weeks dizziness and fatigue reported by patient to pharmacy, patient directed to discuss with ...
three weeks dizziness and fatigue reported by patient to pharmacy, patient directed to discuss with primary care
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| 2865892 | 70 | F | CO | 10/14/2025 |
FLU3 |
SEQIRUS, INC. |
407257 |
Peripheral swelling
Peripheral swelling
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Pt reported a "silver dollar sized bump" on arm on 9/30/25 to pharmacy staff, but pharmacy...
Pt reported a "silver dollar sized bump" on arm on 9/30/25 to pharmacy staff, but pharmacy staff was unable to contact patient after multiple attempts to confirm information/adverse event.
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| 2865893 | 35 | F | CA | 10/14/2025 |
FLU3 |
SEQIRUS, INC. |
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Product administered at inappropriate site
Product administered at inappropriate site
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I was given my flu shot in my tricep, nowhere near my deltoid.
I was given my flu shot in my tricep, nowhere near my deltoid.
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| 2865894 | 75 | F | CA | 10/14/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052669 407266 |
Pain in extremity; Pain in extremity
Pain in extremity; Pain in extremity
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Patient had both flu and COVID then 3 days later developed significant lower extremity pain. Unsure ...
Patient had both flu and COVID then 3 days later developed significant lower extremity pain. Unsure if related to having both vaccines at once or if related to vaccines at all but patient never has had this pain before.
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| 2865895 | 50 | F | MI | 10/14/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
NDC: 8077701129 NDC: 8077701129 |
Dizziness, Ear discomfort, Hyperacusis, Hypoacusis, Tinnitus; Vertigo
Dizziness, Ear discomfort, Hyperacusis, Hypoacusis, Tinnitus; Vertigo
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Hearing in left ear is muffled, loud or abrupt sounds are painful, tinnitus with varying volume, ver...
Hearing in left ear is muffled, loud or abrupt sounds are painful, tinnitus with varying volume, vertigo or dizziness intermittently, pressure in left ear.
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| 2865897 | 78 | F | GA | 10/14/2025 |
FLU3 FLU3 FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
UT8781DA UT8781DA UT8782DA UT8782DA |
Extra dose administered, No adverse event, Wrong patient received product; Incor...
Extra dose administered, No adverse event, Wrong patient received product; Incorrect dose administered, No adverse event; Extra dose administered, No adverse event, Wrong patient received product; Incorrect dose administered, No adverse event
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Patient had already got a flu shot on 9/20/25 but answered yes when the technician verified another ...
Patient had already got a flu shot on 9/20/25 but answered yes when the technician verified another patient's name and asked the patient if she was receiving the influenza vaccine and she said yes. She had no reaction at the time but will report to us if anything occurs.
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| 2865898 | 64 | F | CA | 10/14/2025 |
FLU3 |
SANOFI PASTEUR |
U8864AA |
Hypersensitivity, Pruritus, Urticaria
Hypersensitivity, Pruritus, Urticaria
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Patient's daughter called around 8pm on 10/10/2025 and informed us that her Mother had allergic...
Patient's daughter called around 8pm on 10/10/2025 and informed us that her Mother had allergic reaction with vaccine. Patient had Pfizer Covid-19 Comirnaty and Flublok at the same time. The daughter stated that her Mom had Pfizer Comirnaty before and had no problem, and it must be new vaccine Flublok. Patient developed hives and felt intense itchy all over body. Patient was advised to take Benadryl and keep monitor the side effects. On 10/11/2025, we contacted patient to follow up and patient said it was getting much better and no longer taking benadryl.
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| 2865899 | 76 | F | 10/14/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered
Extra dose administered
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Received duplicate dose of Arexvy vaccine
Received duplicate dose of Arexvy vaccine
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| 2865900 | 41 | M | FL | 10/14/2025 |
COVID19 |
PFIZER\BIONTECH |
na4452 |
Erythema, Peripheral swelling, Rash macular
Erythema, Peripheral swelling, Rash macular
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Mom called 10/09/25 stated sons arm was red/pinkish and swollen, blotchy. I check with her today and...
Mom called 10/09/25 stated sons arm was red/pinkish and swollen, blotchy. I check with her today and stated was fading , area had grown in size of irritation. Was looing better slightly pink
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| 2865901 | 79 | M | FL | 10/14/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Joint swelling, Mobility decreased, Pain in extremity
Joint swelling, Mobility decreased, Pain in extremity
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patient's arm still sore after four days, unable to move the arm, shoulder swollen
patient's arm still sore after four days, unable to move the arm, shoulder swollen
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| 2865902 | 65 | M | CA | 10/14/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SEQIRUS, INC. |
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Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Second dose of flu shot was given to patient about 1 month after patient got his first flu shot. Pat...
Second dose of flu shot was given to patient about 1 month after patient got his first flu shot. Patient mistakenly thought he hasn't gotten his flu shot for the season. We informed patient to contact us if there is any unusual problem besides common vaccine reaction such as soreness or fatigue, etc. We also left patient a voicemail shortly patient left the pharmacy to see who is his primary care physician that he would like us to notify about the incident.
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| 2865904 | 68 | M | FL | 10/14/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255t2 |
Injection site bruising, Injection site nodule, Injection site pain
Injection site bruising, Injection site nodule, Injection site pain
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Soreness almost immediately after, now site is bruised and a knot has formed, and it's still so...
Soreness almost immediately after, now site is bruised and a knot has formed, and it's still sore and painful to pt.
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| 2865905 | 65 | F | AZ | 10/14/2025 |
COVID19 FLU3 PNC21 |
PFIZER\BIONTECH SANOFI PASTEUR MERCK & CO. INC. |
MY9550 UT8794DA Z007870 |
Injection site erythema, Injection site pruritus, Injection site warmth; Injecti...
Injection site erythema, Injection site pruritus, Injection site warmth; Injection site erythema, Injection site pruritus, Injection site warmth; Injection site erythema, Injection site pruritus, Injection site warmth
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Several hours after receiving the vaccines, patient noticed itching, redness, and warmth on left arm...
Several hours after receiving the vaccines, patient noticed itching, redness, and warmth on left arm. Patient reported it started as about 2 inches across but was about 4 inches across when reported. Patient said effect seemed to originate from lower vaccine (2 given in same arm) and administering technician reports lower vaccine was Fluzone HD. Patient has had several doses of Comirnaty but this was the first time getting Fluzone HD.
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| 2865906 | 83 | F | CA | 10/14/2025 |
FLU3 |
SANOFI PASTEUR |
U8800BA |
Chills, Loss of consciousness, Mobility decreased, Vomiting
Chills, Loss of consciousness, Mobility decreased, Vomiting
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According to the spouse's phone call at 3 pm, she was constantly vomiting, chills, unable to mo...
According to the spouse's phone call at 3 pm, she was constantly vomiting, chills, unable to move and lost consciousness. So he called 911 and was sent to ER.
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| 2865907 | 83 | M | FL | 10/14/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
F4AC3 |
Extra dose administered
Extra dose administered
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Patient received a secondary dose of Arexvy when they had a vaccination on 10/20/2023 at our facilit...
Patient received a secondary dose of Arexvy when they had a vaccination on 10/20/2023 at our facility as well.
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| 2865908 | 14 | M | CT | 10/14/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
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Injection site pain, Nausea, Vomiting; Injection site pain, Nausea, Vomiting
Injection site pain, Nausea, Vomiting; Injection site pain, Nausea, Vomiting
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Nausea began around 8 hours after vaccination and Vomiting began about 9 hours after vaccination and...
Nausea began around 8 hours after vaccination and Vomiting began about 9 hours after vaccination and lasted for about 20 minutes. No other symptoms other than soreness and tenderness at injection sites.
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| 2865909 | 6 | M | NY | 10/14/2025 |
FLU3 |
SEQIRUS, INC. |
406995 |
Erythema, Pruritus, Skin warm, Swelling
Erythema, Pruritus, Skin warm, Swelling
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itching overnight, swelling, redness, warm to touch.
itching overnight, swelling, redness, warm to touch.
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| 2865910 | 80 | F | NC | 10/14/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Abdominal discomfort, Chills, Fatigue, Head discomfort, Headache; Injection site...
Abdominal discomfort, Chills, Fatigue, Head discomfort, Headache; Injection site abscess, Injection site erythema, Pyrexia, Restlessness
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Chills - 3 hrs. Fever 101.9 Several hours. Redness + itch at injection site for 6 days. Extreme head...
Chills - 3 hrs. Fever 101.9 Several hours. Redness + itch at injection site for 6 days. Extreme headache in center of forehead - thought it was going to explode - lasted several hours. Upset stomach + extreme tiredness for for several dats. Restless.
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| 2865212 | 67 | F | FL | 10/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Back pain, Flank pain, Perineal cyst
Back pain, Flank pain, Perineal cyst
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lump in perineum; she developed side pain; lumbar back pain; This serious case was reported by a con...
lump in perineum; she developed side pain; lumbar back pain; This serious case was reported by a consumer via call center representative and described the occurrence of perineal cyst in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 29-SEP-2025, the patient received the 1st dose of Shingrix. On 01-OCT-2025, 2 days after receiving Shingrix, the patient experienced perineal cyst (Verbatim: lump in perineum) (serious criteria GSK medically significant), pain (Verbatim: she developed side pain) and lumbar pain (Verbatim: lumbar back pain). The outcome of the perineal cyst and lumbar pain were not resolved and the outcome of the pain was resolving. It was unknown if the reporter considered the perineal cyst, pain and lumbar pain to be related to Shingrix. The company considered the perineal cyst to be unrelated to Shingrix. It was unknown if the company considered the pain and lumbar pain to be related to Shingrix. Additional Information: GSK Receipt Date: 03-OCT-2025 The patient reported that 2 days after vaccination in the afternoon, she developed side pain which was improved and lumbar back pain which was persisting. The patient also noticed a lump in her perineum. Nothing else was reported. The batch number was not provided and a request for this information had been made.; Sender's Comments: A case of Perineal cyst, 2 days after receiving Shingrix, in a 67-year-old female patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
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| 2865213 | M | CA | 10/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
4M472 |
Onychomycosis, Pneumonia, Rash
Onychomycosis, Pneumonia, Rash
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Pnemonia; nail fungus; underarm rash; This serious case was reported by a consumer and described the...
Pnemonia; nail fungus; underarm rash; This serious case was reported by a consumer and described the occurrence of pneumonia in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 4M472) for prophylaxis. On 16-APR-2025, the patient received Shingrix .5 ml. On 16-APR-2025, less than a day after receiving Shingrix, the patient experienced pneumonia (Verbatim: Pnemonia) (serious criteria GSK medically significant), fungal infection of nail (Verbatim: nail fungus) and rash (Verbatim: underarm rash). The outcome of the pneumonia, fungal infection of nail and rash were not resolved. It was unknown if the reporter considered the pneumonia, fungal infection of nail and rash to be related to Shingrix. The company considered the pneumonia to be unrelated to Shingrix. It was unknown if the company considered the fungal infection of nail and rash to be related to Shingrix. Additional Information: GSK Receipt Date: 03-OCT-2025 Patient needs assistance reversing persistent side effects Pneumonia, nail fungus and underarm rash. Symptoms were treated.; Sender's Comments: A case of Pneumonia, less than a day after receiving Shingrix in a 64-year-old 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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| 2865214 | M | 10/13/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Concussion, Febrile convulsion, Impaired driving ability, Magnetic resonance ima...
Concussion, Febrile convulsion, Impaired driving ability, Magnetic resonance imaging head normal
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My son had a febrile seizure; concussion; This serious case was reported by a consumer via interacti...
My son had a febrile seizure; concussion; This serious case was reported by a consumer via interactive digital media and described the occurrence of seizure in a 19-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero with an associated reaction of febrile convulsion (had a febrile seizure after his 1-year-old shots- had developed a fever and rash, refer case US2025AMR124514). Family history included epilepsy (the patient's sibling had epilepsy), multiple allergies (the patient's sibling was allergic to everything - nuts, soy, environmental, asthma, allergies, ADD, etc), asthma and attention deficit disorder. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced seizure (Verbatim: My son had a febrile seizure) (serious criteria GSK medically significant and other: Serious as per reporter) and concussion (Verbatim: concussion). The outcome of the seizure was resolved and the outcome of the concussion was not reported. The reporter considered the seizure to be related to Bexsero. It was unknown if the reporter considered the concussion to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the reporter considered the seizure to be related to Bexsero Pre-Filled Syringe Device. The company considered the seizure to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the concussion to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Linked case(s) involving the same patient: US2025AMR124514 Additional Information: GSK Receipt Date: 27-SEP-2025 The case was received from patient's parent via interactive digital media. The patient had no more seizures until after they forced him to take the Meningococcal B shot for school when he was 19 years old and had received a concussion from that seizure. The neurologist misdiagnosed him with something terrible, and they believed her even though he had only 1 more seizure 4 months later. The parent followed her instruction for only 2 years when all she wanted to do was increase medication dose and prohibit him from driving despite him being seizure free for 6 months, then 12 month, etc. The physician said his blood levels on the medication needed to be higher or she would not allow him to drive and told her- perhaps he really did not need this medication he was below the blood levels for this medication and was seizure free. The doctor scoffed and dismissed and refused to sign off for him to drive. He drove anyway. The parent changed doctors, had a new MRI and the faint mass that the previous doctor thought she saw as something devastating was not anything- it was not there. So, for 2 years, previous doctor misdiagnosed were led down a path to believe that his seizures would increase and patient's life would be terrible, and they needed more meds, etc and had asked for patient's diagnoses to be corrected in his medical records - this was very important. Provoked vs non provoked seizures were important distinction to life insurance companies. Vaccines provoke seizures. The hospital had refused to change their incorrect diagnoses or acknowledge they were wrong. The reporter told them never to take vaccines again and the reporter stopped taking the Flu shot 14 years ago and had not had the Flu since. No covid shots either. The reporter tried calling the manufacturer of the Meningococcal B vaccine Glaxo Smith Kline to ask how long that vaccine might stay in her son's system, if it were a live or attenuated vaccination, if other issues other than seizures might occur, if it could cause that mass on my son's brain, etc, anything they had seen in trials similar to what happened with her son or if they had an antidote to reverse the vaccine or expel it from her son's body like steroids, etc. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Epilepsy, unknown time after receiving Bexsero and Bexsero Pre-Filled Syringe Device, in a 19-year-old male patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to?onset and absence of biological plausibility and alternative risk factor (Family h/o epilepsy and multiple allergies ) US-GLAXOSMITHKLINE INC-US2025AMR124514:Same patient another dose
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| 2865217 | M | 10/13/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
P2443 |
Incorrect dose administered
Incorrect dose administered
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accidental administration of Twinrix to an 8 year old which is outside the age range of approved pa...
accidental administration of Twinrix to an 8 year old which is outside the age range of approved package labeling; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received HAB (Twinrix) (batch number P2443) for prophylaxis. On 15-SEP-2025, the patient received Twinrix (left deltoid). On an unknown date, an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: accidental administration of Twinrix to an 8 year old which is outside the age range of approved package labeling). The outcome of the inappropriate age at vaccine administration was unknown. 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: 23-SEP-2025, 25-SEP-2025 Customer requests information from medical regarding administration of Twinrix to an 8 year old so they can inform the parent if they need to take additional steps. Patient didn't report any side effects.
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| 2865218 | F | LA | 10/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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does not remember if she received her second Shingrix vaccine; This non-serious case was reported by...
does not remember if she received her second Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (first dose was received on an unknown date). The patient did not receive the 2nd dose of Shingrix, the patient experienced incomplete course of vaccination (Verbatim: does not remember if she received her second Shingrix vaccine). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 23-SEP-2025 The reporter was patient itself. The batch number was not provided, and we are unable to contact the reporter.
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| 2865219 | M | NE | 10/13/2025 |
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 physician via call center repr...
Shingrix - Late second dose; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2018). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving 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 :01-OCT-2025 A patient forgot to get his second dose of Shingrix. He was wondering if he should restart the series since it had been so long. The reporter could not find anything anywhere about ever needing to restart the series, but he saw it recommended that the second dose should be given within a year (and it had been 7). The reporter asked if there ever any reason to restart the series.
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| 2865220 | NJ | 10/13/2025 |
DTAP DTAPHEPBIP DTAPIPV HEP MMR |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Product storage error; Product storage error; Product storage error; Product sto...
Product storage error; Product storage error; Product storage error; Product storage error; Product storage error
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Vaccine stored outside recommended conditions/ HCP did not know if vaccines were administered after ...
Vaccine stored outside recommended conditions/ HCP did not know if vaccines were administered after the temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and MMR (Priorix) for prophylaxis. On an unknown date, the patient received Engerix B, Infanrix, Kinrix, Pediarix and Priorix. On an unknown date, an unknown time after receiving Engerix B, Infanrix, Kinrix, Pediarix and Priorix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions/ HCP did not know if vaccines were administered after the temperature excursion). The outcome of the incorrect storage of drug 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 The reporter stated that they had an excursion with their refrigerator that stored GlaxoSmithKline vaccines, it reached up to 23 degrees Fahrenheit. The reporter asked If they were administered to patients, they had to get them re-done. The patient's information was asked but unknown since HCP (health care professional) did not know if vaccines were administered after the temperature excursion. The batch number was not provided upon follow- up with the reporter.
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