| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2824729 | 20 | M | CA | 02/05/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y000134 Y011017 |
Extra dose administered, Product administered to patient of inappropriate age; E...
Extra dose administered, Product administered to patient of inappropriate age; Extra dose administered, Product administered to patient of inappropriate age
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Reported to Dr. no concerns, monitoring for possible fever
Reported to Dr. no concerns, monitoring for possible fever
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| 2824730 | 59 | M | TN | 02/05/2025 |
COVID19 |
MODERNA |
3043030 |
Blister rupture, Vaccination site vesicles
Blister rupture, Vaccination site vesicles
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A blister formed within 24 hrs at his vaccination site. Ruptured on it's own and is now healin...
A blister formed within 24 hrs at his vaccination site. Ruptured on it's own and is now healing
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| 2824731 | 87 | F | SC | 02/05/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered
Extra dose administered
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patient received the arexvy vaccine twice, once on 10/27/23 and once on 2/4/25
patient received the arexvy vaccine twice, once on 10/27/23 and once on 2/4/25
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| 2824732 | 66 | F | OH | 02/05/2025 |
MENB |
PFIZER\WYETH |
IF5308 |
Pain
Pain
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Patient stated that she has burning pain in her arm
Patient stated that she has burning pain in her arm
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| 2824733 | 2 | F | OR | 02/05/2025 |
MNQ |
SANOFI PASTEUR |
U8194AA |
Rash
Rash
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Rash
Rash
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| 2824757 | 1.33 | M | AK | 02/05/2025 |
HIBV HIBV HIBV HIBV MMR MMR VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
X020942 X020942 X020942 X020942 X011431 X011431 Y013350 Y013350 |
No adverse event, Product storage error; Product storage error; No adverse event...
No adverse event, Product storage error; Product storage error; No adverse event, Product storage error; Product storage error; No adverse event, Product storage error; Product storage error; No adverse event, Product storage error; Product storage error
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No additional AE; HCP called to report TE where PEDVAXHIB was administered to one patient. No signs ...
No additional AE; HCP called to report TE where PEDVAXHIB was administered to one patient. No signs or symptoms reported. No additional AE/No PQC. PEDVAX HIB: X020942 EXP: 03/07/2026 35.2F for 0 HOURS 50 MINUTES 0 SECONDS - CURRENT 35.8f for 0 HOURS 37 MINUTES 30 SE; This spontaneous report was received from an other healthcare professional referring to a 16-month-old male patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported. On an unknown date in 2025, the patient was vaccinated with haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection (0.5 ml, lot#: X020942, expiration date: 07-MAR-2026; strength and route of administration were not reported) for prophylaxis. The administered vaccine experienced temperature excursion (TE) on 31-JAN-2025: 35.2F for 50 minutes (product storage error). The vaccine experienced TE at 35.8 F for 37 minutes previously. No additional adverse event occurred.
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| 2824758 | F | CA | 02/05/2025 |
HPV9 |
MERCK & CO. INC. |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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received the second dose of GARDASIL-9 a month late; No additional AE; This spontaneous report was r...
received the second dose of GARDASIL-9 a month late; No additional AE; This spontaneous report was received from an adult patient female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided), which was month late (inappropriate schedule of product administration) and wanted to know whether she should restart the dose or continue with the schedule. No additional adverse event (AE) was reported.
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| 2824759 | 24 | F | GA | 02/05/2025 |
HPV9 |
MERCK & CO. INC. |
W014513 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No side effects or symptoms reported; HCP called to report a patient received an expired dose of GAR...
No side effects or symptoms reported; HCP called to report a patient received an expired dose of GARDASIL 9. It is unknown what dose in the series this vaccination is. no side effects or symptoms reported. Product has not undergone any temperature excursions, potency supported. No additi; This spontaneous report was received from a medical assistant referring to a currently non-pregnant 24-year-old female patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported. On 04-FEB-2025, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, 0.5 milliliter (mL), lot number W014513, expiration date 26-JAN-20225, as prophylaxis (expired product administered). Product did not undergo any temperature excursions, potency supported. No adverse event was reported.
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| 2824760 | U | 02/05/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Cough
Cough
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lingering cough; This non-serious case was reported by a consumer via interactive digital media and ...
lingering cough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cough (Verbatim: lingering cough). The outcome of the cough was unknown. Additional Information: GSK Receipt Date: 10-JAN-2025 The case was received from the patient via interactive digital media. The reporter reported was there a lingering cough.
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| 2824761 | U | 02/05/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Neuralgia, Sensitive skin, Vaccination failure; Herpes zoster, Ne...
Herpes zoster, Neuralgia, Sensitive skin, Vaccination failure; Herpes zoster, Neuralgia, Sensitive skin, Vaccination failure
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suspected vaccination failure; Got shingles; This serious case was reported by a consumer via intera...
suspected vaccination failure; Got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included chickenpox (had as a kid). Previously administered products included Varicella zoster vaccine (had a Shingles shot over 5 years ago). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In AUG-2024, more than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got 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 and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 21-JAN-2025 and 24-JAN-2025 This case was reported by a patient via interactive digital media. Patient had a Shingles shot over 5 years ago. He/she also had the new 2 shots Shingles shot 2 years ago (from the date of reporting). Patient got shingles at the end of August 2024. The patient wanted to know would he/she has sensitive skin in that area forever, would he/she have to deal with nerve pain from this shingles. The patient said that the shot did not guarantee you and, how many after-affects you have to deal with. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine 1 and Shingles vaccine 2.
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| 2824762 | U | 02/05/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv...
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 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 was not reported and the outcome of the shingles was not resolved. 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: 24-JAN-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she got the vaccine over four years ago and he/she had shingles right now and they suck. 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: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
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| 2824764 | M | 02/05/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; husband vaccinated and has had shingles; This serious case was report...
Suspected vaccination failure; husband vaccinated and has had 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: husband vaccinated and has had 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: 29-JAN-2025 The case was received from the consumer via interactive digital media. Reporter reported that husband vaccinated and had shingles. Reporter believed the vaccine lessened the pain though. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. This is 1 of 3 linked cases reported by the same reporter for different patients.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025AMR013185:same reporter different patient US-GSK-US2025AMR013181:same reporter different patient
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| 2824765 | F | MA | 02/05/2025 |
VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK UNK UNK UNK |
Abdominal pain, Dermatitis bullous, Diarrhoea haemorrhagic, Faecal calprotectin ...
Abdominal pain, Dermatitis bullous, Diarrhoea haemorrhagic, Faecal calprotectin increased, Herpes zoster disseminated; Perioral dermatitis, Pyrexia, Rash, Scab, Skin lesion; Vaccination failure, Varicella virus test positive; Abdominal pain, Dermatitis bullous, Diarrhoea haemorrhagic, Faecal calprotectin increased, Herpes zoster disseminated; Perioral dermatitis, Pyrexia, Rash, Scab, Skin lesion; Vaccination failure, Varicella virus test positive
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Vaccination failure; diagnosed with disseminated herpes zoster/ severe HZ; This serious case was rep...
Vaccination failure; diagnosed with disseminated herpes zoster/ severe HZ; This serious case was reported in a literature article and described the occurrence of vaccination failure in a 60-year-old female patient who received Herpes zoster (Zoster vaccine) for prophylaxis. Literature Reference. Co-suspect products included Herpes zoster (Zoster vaccine) for prophylaxis, prednisolone for crohn's disease, vedolizumab for crohn's disease and upadacitinib for crohn's disease. The patient's past medical history included stricturoplasty. Previously administered products included MERCAPTOPURINE with an associated reaction of drug ineffective, infliximab with an associated reaction of drug ineffective and ustekinumab with an associated reaction of drug ineffective. Concurrent medical conditions included crohn's disease (30-year history), ileal resection, crohn's disease aggravated, bloody diarrhea, abdominal pain, bloody diarrhea and inflammatory bowel disease. On an unknown date, the patient received Zoster vaccine and Zoster vaccine. In JUL-2023, the patient started prednisolone. On an unknown date, the patient started vedolizumab. In SEP-2023, the patient started upadacitinib (oral) 45 mg once a day (45 mg daily). The dose was changed to 30 mg once a day (30 mg daily). The dose was changed to 45 mg once a day (45 mg daily). On an unknown date, an unknown time after receiving Zoster vaccine and Zoster vaccine, the patient experienced vaccination failure (Verbatim: Vaccination failure) (serious criteria hospitalization and GSK medically significant) and herpes zoster disseminated (Verbatim: diagnosed with disseminated herpes zoster/ severe HZ) (serious criteria hospitalization and GSK medically significant). The patient was treated with aciclovir (Acyclovir), valaciclovir (Valacyclovir) and risankizumab. Prednisolone was discontinued. Vedolizumab was discontinued. Upadacitinib was discontinued. The outcome of the vaccination failure was not reported and the outcome of the herpes zoster disseminated was resolving. The reporter considered the vaccination failure and herpes zoster disseminated to be related to Zoster vaccine and Zoster vaccine. The company considered the vaccination failure and herpes zoster disseminated to be unrelated to Zoster vaccine and Zoster vaccine. Additional Information: GSK receipt date: 03-FEB-2025 Author reported a 60-year-old female patient with a 30-year history of refractory Crohn's disease (CD) requiring ileocolic resection, multiple stricturoplasties, and failed medical treatment with mercaptopurine (6-MP), infliximab, ustekinumab, and vedolizumab who presented with disseminated Herpes zoster (HZ) while on upadacitinib. For context, the patient began having worsening CD symptoms while on vedolizumab in July of 2023 and was initiated on a prednisolone course with a slow taper. patient received first dose of the Recombinant Zoster Vaccine (RZV) while on prednisolone and vedolizumab. Two months later, patient developed frequent, bloody diarrhea and was transitioned from vedolizumab to upadacitinib. During the 12- week upadacitinib induction (45 mg/d) period and ongoing taper of prednisolone, patient received second dose of the RZV. patient was tapered to 30 mg/d of upadacitinib, but after 3 months had recurrence of abdominal pain, bloody diarrhea, and an elevated fecal calprotectin concerning for a CD flare. Upadacitinib was increased back to 45 mg/d, and, after 3 weeks, patient had symptomatic remission. patient completed prednisolone taper in March of 2024. In July of 2024, the patient presented to the emergency department and was found to be febrile and have a diffuse vesicular/bullous facial rash that crossed the midline with oral involvement and lesions of the right medial thigh, bilateral arms, bilateral groin, and across patient back. At the time of presentation, patients CD therapy was 45 mg/day of upadacitinib monotherapy. patient was diagnosed with disseminated HZ by Varicella zoster virus (VZV) polymerase chain reaction of the lesions and blood. patient was admitted to the hospital and ultimately treated with intravenous acyclovir for 8 days until all lesions had crusted over before transitioning to a 1-week course of high-dose oral valacyclovir, followed by an indefinite course of suppressive valacyclovir. Upadacitinib was held during hospitalization and on discharge. patient was discharged after 11 days. As an outpatient, after remaining off all immunosuppressive therapy for CD for a month and a half, patient was initiated on risankizumab and has remained in clinical remission. The lifetime risk of developing HZ increases with age (due to a decline in cell-mediated immunity), in female gender, in adults with IBD, and with exposure to immunosuppressive therapy. Completion of the two-dose RZV has been shown to have between 76 percent and 97 percent vaccine effectiveness in large cohort studies and is known to lower long-term risk of HZ in older patients with inflammatory bowel disease (IBD). However, despite RZV, this patient still developed severe HZ, in part due to patients multiple risk factors as detailed above, in addition to the fact that patient was on immunosuppressive therapy at the time of RZV (first dose on prednisolone and vedolizumab and second dose on prednisolone and upadacitinib). Although some of these studies examined non-IBD populations and non-RZV vaccines, the concept of decreased immunogenic response due to immunosuppressive therapy at the time of vaccination likely applies to this patient. The data suggest that patient may have had a blunted immune response to the RZV, given patient was on immunosuppressive therapy at the times of both vaccine administrations. This likely made patient more susceptible to HZ infection. presented a rare case of severe HZ in a patient with refractory CD on upadacitinib requiring inpatient management and transition of CD therapy. Notably, patient had completed the RZV and was on immunosuppressive agents at the time of vaccination In conclusion, the RZV has demonstrated clear benefit in reducing the risk of developing HZ in patients with IBD; however, this case demonstrates that consideration of individual risk factors of HZ, including immunosuppressive therapy at times of RZV, should be considered before initiation of a JAKi. This article corresponding to this case is not available for regulatory submission due to copyright restriction.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about time to onset) is considered unrelated to GSK Zoster vaccine. Herpes zoster disseminated is an unlisted event which is considered unrelated to GSK Zoster vaccine.
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| 2824766 | 78 | F | FL | 02/05/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
4DS4N |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and...
Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 78-year-old female patient who received HAB (Twinrix) (batch number 4DS4N, expiry date 25-SEP-2026) for prophylaxis. Previously administered products included Twinrix (received 1st dose of vaccine in May 2023). In JAN-2025, the patient received the 2nd dose of Twinrix. In JAN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). The outcome of the drug dose administration interval too long 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 : 06-JAN-2025 Pharmacist called to verify the interval in between 2nd and 3rd dose of Twinrix in a patient that had received the first dose on May 2023 and the 2nd dose on January 2025. Reporter also enquiring when the 3rd dose should administered. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule.
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| 2824767 | F | MN | 02/05/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Cold sweat, Diarrhoea, Dizziness, Headache, Nausea; Pyrexia, Syncope
Cold sweat, Diarrhoea, Dizziness, Headache, Nausea; Pyrexia, Syncope
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Faint; Low grade fever; headache; nausea; diarrhea; cold sweat; Lightheadedness; This serious case w...
Faint; Low grade fever; headache; nausea; diarrhea; cold sweat; Lightheadedness; This serious case was reported by a consumer via call center representative and described the occurrence of faint in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had shingles in left inner thigh in the past, years ago). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced faint (Verbatim: Faint) (serious criteria GSK medically significant), low grade fever (Verbatim: Low grade fever), headache (Verbatim: headache), nausea (Verbatim: nausea), diarrhea (Verbatim: diarrhea), cold sweat (Verbatim: cold sweat) and light headedness (Verbatim: Lightheadedness). The outcome of the faint and light headedness were not reported and the outcome of the low grade fever, headache, nausea, diarrhea and cold sweat were resolved. It was unknown if the reporter considered the faint, low grade fever, headache, nausea, diarrhea, cold sweat and light headedness to be related to Shingrix. The company considered the faint to be unrelated to Shingrix. It was unknown if the company considered the low grade fever, headache, nausea, diarrhea, cold sweat and light headedness to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR014324 Additional Information: GSK Receipt Date: 06-JAN-2025 The patient self-reported this case for herself. The patient stated she was over 70 years old and received Shingrix 5 months ago from the date of reporting in 2024. She stated she was due to take dose 2 on 20-FEB-2025. She was afraid she would have symptoms like with dose 1. She said hours after receiving dose 1, she experienced low grade fever, headache, nausea, diarrhea, cold sweats, faint and lightheaded in 2024. Referred her to HCP (health care professional). CDC (centers for disease control and prevention) phone number provided.; Sender's Comments: Syncope is an unlisted event which, due to the following criteria (insufficient information provided about the clinical description) is considered unrelated to GSK vaccine Shingrix. US-GSK-US2025AMR014324:same patient
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| 2824768 | 0.33 | F | FL | 02/05/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
AE2J7 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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administered Flulaval when the patient was 4 months; This non-serious case was reported by a other h...
administered Flulaval when the patient was 4 months; 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 4-month-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number AE2J7, expiry date 16-JUN-2025) for prophylaxis. On an unknown date, the patient received the 1st dose of FluLaval 2024-2025 season (right thigh). On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced inappropriate age at vaccine administration (Verbatim: administered Flulaval when the patient was 4 months). 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: 07-JAN-2025 The reporter was informed that a female patient was administered Flulaval in the right thigh when the patient was 4 months of age which led to inappropriate age at vaccine administration.
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| 2824769 | U | AZ | 02/05/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Product preparation issue
Product preparation issue
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vial of antigen of Shingrix had been reconstituted using the Arexvy's diluent and potentially a...
vial of antigen of Shingrix had been reconstituted using the Arexvy's diluent and potentially administered to a patient; vial of antigen of Shingrix had been reconstituted using the Arexvy's diluent and potentially administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 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 wrong solution used in drug reconstitution (Verbatim: vial of antigen of Shingrix had been reconstituted using the Arexvy's diluent and potentially administered to a patient) and inappropriate dose of vaccine administered (Verbatim: vial of antigen of Shingrix had been reconstituted using the Arexvy's diluent and potentially administered to a patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 08-JAN-2025 Pharmacist called to inform that he suspected that a vial of antigen of Shingrix had been reconstituted using the Arexvy's diluent and potentially administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
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| 2824770 | 80 | M | FL | 02/05/2025 |
RSV VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Asthenia, Pyrexia, Tremor; Asthenia, Pyrexia, Tremor
Asthenia, Pyrexia, Tremor; Asthenia, Pyrexia, Tremor
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weakness; fever; trembling; This non-serious case was reported by a consumer via call center represe...
weakness; fever; trembling; This non-serious case was reported by a consumer via call center representative and described the occurrence of weakness in a 80-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included overweight. On 08-JAN-2025, the patient received Arexvy (unknown arm) and the 1st dose of Shingrix (unknown arm). On 09-JAN-2025, 1 days after receiving Arexvy and Shingrix, the patient experienced weakness (Verbatim: weakness), fever (Verbatim: fever) and tremor (Verbatim: trembling). The patient was treated with ibuprofen. The outcome of the weakness, fever and tremor were not resolved. It was unknown if the reporter considered the weakness, fever and tremor to be related to Arexvy and Shingrix. It was unknown if the company considered the weakness, fever and tremor to be related to Arexvy and Shingrix. Additional Information: GSK Receipt Date: 09-JAN-2025 The reporter was the wife of the patient. The patient received the first dose of Shingrix and the Arexvy vaccine day before reporting. The vaccines were injected into different arms. Around noontime on the day of reporting, the patient began to experience weakness, fever (100.1 degrees Fahrenheit) and trembling. The patient took Ibuprofen to treat the fever.
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| 2824771 | F | CO | 02/05/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center ...
Inappropriate schedule of 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 elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Patient received first dose in April 2024). 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: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 10-JAN-2025 Patient thought she received her first dose of Shingrix in April 2024 she was not sure about the date, no specific date was provided, and reported that she never went back to receive the second dose. The patient did not have Lot, Expiry, NDC, Route or location of Administration to provide. The patient also reported that she did receive another vaccine that same day in the opposite arm, but cannot remember the name of the other vaccine. Till the time of reporting the patient did not received the second dose of Shingrix. This case is linked with the case US2025003283 by the same reporter.; Sender's Comments: US-GSK-US2025003283:Same reporter/Different patient
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| 2824772 | 68 | M | CA | 02/05/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
xm42T |
Extra dose administered
Extra dose administered
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patient received 2 doses of Arexvy; This non-serious case was reported by a pharmacist via call cent...
patient received 2 doses of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 68-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number xm42T) for prophylaxis. Previously administered products included Arexvy (patient received 1st dose of Arexvy on 08th December, 2023 of batch number ar442). On 15-JAN-2025, the patient received the 2nd dose of Arexvy. On 15-JAN-2025, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: patient received 2 doses of Arexvy). The outcome of the extra dose administered was unknown. Additional Information: GSK receipt date: 16-JAN-2025 Other HCP reported that a male patient received the Arexvy shot on 08th December, 2023 and then received another dose on 15th January, 2025. Patient received 2 doses of Arexvy which led to extra dose administered. The vaccine administration facility was the same as primary reporter.
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| 2824773 | 76 | F | FL | 02/05/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
LN4P2 |
Arthralgia, Mobility decreased, Pyrexia, Sleep disorder
Arthralgia, Mobility decreased, Pyrexia, Sleep disorder
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fever; joint pain in knees/knees started to ache in the joints; I could not move legs because joints...
fever; joint pain in knees/knees started to ache in the joints; I could not move legs because joints hurt; kicked in; Sleep disturbance; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number LN4P2, expiry date 01-NOV-2025) for prophylaxis. Concomitant products included naproxen sodium (Aleve). On 16-JAN-2025 08:30, the patient received Arexvy (intramuscular, left deltoid). In JAN-2025, less than a day after receiving Arexvy, the patient experienced sleep disturbance (Verbatim: Sleep disturbance). On 16-JAN-2025, the patient experienced knee pain (Verbatim: joint pain in knees/knees started to ache in the joints), mobility decreased (Verbatim: I could not move legs because joints hurt) and feeling unwell (Verbatim: kicked in). On 17-JAN-2025, the patient experienced fever (Verbatim: fever). The action taken with Arexvy was unknown. The outcome of the fever and knee pain were not resolved and the outcome of the mobility decreased was resolved and the outcome of the feeling unwell and sleep disturbance were not reported. It was unknown if the reporter considered the fever and feeling unwell to be related to Arexvy. The reporter considered the knee pain, mobility decreased and sleep disturbance to be related to Arexvy. It was unknown if the company considered the fever and feeling unwell to be related to Arexvy. The company considered the knee pain, mobility decreased and sleep disturbance to be related to Arexvy. Additional Information: GSK Receipt Date: 17-JAN-2025 The reporter was the patient. The patient received Arexvy vaccine on 16th January 2025, intramuscularly in the left arm. The reporter said, a day before day of reporting the patient took the RSV vaccine, and patient wanted to report some of the symptoms that patient had because patient thought they were kind of unusual. Throughout the day her knees started to ache in the joints and by 1 am she could not move her legs because her joints hurt so much. The patient had never had a reaction to a vaccine before ever. The patient managed to get some Aleve and just kind of sat for about 2 hours while it kicked in. The patient was able to go back to sleep but she still had the pain when she got up this morning at 6:00 she could move but her joints still hurt. The patient was mobile, she was moving. Her right leg was fine. Her left knee still had some aching, and she had also developed a fever this afternoon. The patient mentioned it was only her knees that were bothering her (no other part of her body, no other joints). The patient was not sure if the fever was due to Arexvy or not because she indicated that there were cold or flu bugs going around in her area.
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| 2824774 | U | MO | 02/05/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
|
Incorrect dose administered, Product preparation issue
Incorrect dose administered, Product preparation issue
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pharmacist might have forget to do a reconstitution; have forget to do a reconstitution; This non-se...
pharmacist might have forget to do a reconstitution; have forget to do a reconstitution; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: pharmacist might have forget to do a reconstitution) and inappropriate dose of vaccine administered (Verbatim: have forget to do a reconstitution). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 17-JAN-2025 The Healthcare professional reported that he/she might had forgot to do a reconstitution of Arexvy, He/she had 9 powder Arexvy vials in stock and 8 sterile diluents in stock, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
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| 2824775 | F | NC | 02/05/2025 |
VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Arthralgia, Complex regional pain syndrome, Guillain-Barre syndrome, Hypoaesthes...
Arthralgia, Complex regional pain syndrome, Guillain-Barre syndrome, Hypoaesthesia, Magnetic resonance imaging abnormal; Muscle spasms, Muscle tightness, Muscular weakness, Paraesthesia, Sensory disturbance; Synovitis, Temperature intolerance
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maybe GBS-type symptoms; CRPS-like symptoms/CRPS; synovitis/synovitis in distal radius of the domina...
maybe GBS-type symptoms; CRPS-like symptoms/CRPS; synovitis/synovitis in distal radius of the dominant (clarified to be right) hand/ It was in left toe, in right arm especially, the left anterior groin, back, thorax; This serious case was reported by a physician via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On 14-SEP-2024, the patient received the 2nd dose of Shingrix (right arm). On an unknown date, 2 weeks after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: maybe GBS-type symptoms) (serious criteria GSK medically significant), complex regional pain syndrome (Verbatim: CRPS-like symptoms/CRPS) and synovitis (Verbatim: synovitis/synovitis in distal radius of the dominant (clarified to be right) hand/ It was in left toe, in right arm especially, the left anterior groin, back, thorax). The outcome of the guillain barre syndrome and complex regional pain syndrome were unknown and the outcome of the synovitis was not reported. It was unknown if the reporter considered the guillain barre syndrome, complex regional pain syndrome and synovitis to be related to Shingrix. The company considered the guillain barre syndrome to be unrelated to Shingrix. It was unknown if the company considered the complex regional pain syndrome and synovitis to be related to Shingrix. Additional Information: GSK Receipt Date: 21-JAN-2025, 22-JAN-2025 & 23-JAN-2025 The patient is the reporter. Called about Shingrix and personally, as a patient, was experiencing CRPS-like symptoms, maybe GBS-type symptoms in the right arm, which is the arm it was injected into. When she received the first injection she did not have any issues. After receiving the second injection on 14th September 2024 she started having problems two weeks later. She stated it started as synovitis in distal radius of the dominant (clarified to be right) hand. Then she consulted her hand sub-specialist colleagues (clarified outside of her own practice), and she got a magnetic resonance imaging etc, and it was confirmed there was synovitis that happened concurrently to CRPS and GBS. It was in her left toe, in her right arm especially, the left anterior groin, her back, her thorax. It popped up in random places ever since the second injection. It started two weeks after the injection, then she noticed the growth was getting bigger, she had numbness and tingling in the first two digits, palmar and radial side, and the growth is on the central radial nerve. She have had shoulder aching, cold sensitivity or temp sensitivity, when she pick up her water bottle or her coffee. She had weakness of range of motion with a blank spot when she was lowering a weight, all of a sudden there was a give-way. She dropped something yesterday on her knee. She was an extremely healthy person, a pillar of health, her specialty was physical medicine and rehab, with interventional spine subspecialty, there was a lot of sensory symptoms, and it felt like she was cramping and she had gotten massages and they say she was really tight, had chiro adjustment and they agreed it was tight. It was a problem both personally, and for the community she serve. She was a subspecialist and she need to inject and need to be able to feel if she was in the subdural space. This was a community of 75,000 people potentially impacted by this. She granted permission for safety to follow up at the address above, which is her personal address. She did not give safety permission to follow up at her professional address, as she was concerned for her privacy. She had to end this conversation to see patients, but may provide further details via follow up call or email to the Medical Information team.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
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| 2824776 | 79 | F | PA | 02/05/2025 |
FLUX FLUX RSV RSV |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Injection site discharge, Injection site discolouration, Injection site erythema...
Injection site discharge, Injection site discolouration, Injection site erythema, Injection site pain, Injection site scab; Pain in extremity, Skin discolouration; Injection site discharge, Injection site discolouration, Injection site erythema, Injection site pain, Injection site scab; Pain in extremity, Skin discolouration
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Infection; a scab on her right arm at the injection site; Fluid came out from scab; a dark spot on h...
Infection; a scab on her right arm at the injection site; Fluid came out from scab; a dark spot on her right arm at the injection site; area around the injection site of her right arm was tender; terrible pain in her right arm; her right arm was a little black and blue at this point; area around the scab was was red; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site scab in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Co-suspect products included Influenza vaccine for prophylaxis. On 05-DEC-2024, the patient received Arexvy (intramuscular, right arm) and Influenza vaccine (left arm). In DEC-2024, less than a month after receiving Arexvy and less than 2 weeks after receiving Influenza vaccine, the patient experienced injection site scab (Verbatim: a scab on her right arm at the injection site), injection site discharge (Verbatim: Fluid came out from scab), injection site discoloration (Verbatim: a dark spot on her right arm at the injection site), injection site tenderness (Verbatim: area around the injection site of her right arm was tender), pain in arm (Verbatim: terrible pain in her right arm), skin discoloration (Verbatim: her right arm was a little black and blue at this point) and erythema (Verbatim: area around the scab was was red). On an unknown date, the patient experienced infection (Verbatim: Infection). The patient was treated with amoxicillin;clavulanic acid and paracetamol (Tylenol). The outcome of the injection site scab, injection site discoloration, injection site tenderness and pain in arm were resolved and the outcome of the injection site discharge, skin discoloration and erythema were not reported and the outcome of the infection was not resolved. It was unknown if the reporter considered the injection site scab, injection site discharge, injection site discoloration, injection site tenderness, pain in arm, skin discoloration, erythema and infection to be related to Arexvy. It was unknown if the company considered the injection site scab, injection site discharge, injection site discoloration, injection site tenderness, pain in arm, skin discoloration, erythema and infection to be related to Arexvy. Linked case(s) involving the same patient: US2020202279 Additional Information: GSK Receipt Date: 28-JAN-2025 The patient received Arexvy in her right arm and a high dose Flu Vaccine (Unknown Product Information) in her left arm, both on 5 December 2024. The patient reported that the nurse administrator did swab both arms before administering the injections. The area around the injection site of her right arm was tender for the first day or two (no specific dates provided). A week after receiving Arexvy, she experienced terrible pain in her right arm. Her right arm was a little black and blue at this point, and her physician told her to take Tylenol, and to ice the area. The patient had no more pain the day after icing the area, and has had no pain since that time. Two weeks after, she noticed a dark spot, the size of a quarter, like a scab on her right arm at the injection site, the area around the scab was red. The patient did call her physician at this point, but was not seen. The patient reported that a week later, when she pressed on the scab, it felt odd, there was a ridge around the scab, and some sort of fluid came out, her physician prescribed Augmentin 500/125 MG tablets to take one twice a day for seven days, along with a probiotic. The patient reported that on the fifth day of the Augmentin medication, on 27 January 2025, the scab fell off the area, and the area looked like a piece of raw meat on her arm. The patient seen her physician on 27 January 2025, and the physician added three more days to her Augmentin duration of therapy, to make a total of ten days and, referred the patient to see a wound specialist. It was unknown if the reporter considered the injection site scab, injection site discharge, injection site discoloration, injection site tenderness, pain in arm, skin discoloration, erythema and infection to be related to Flu Vaccine. The consent to follow-up was not provided. The case is linked with US2020202279 for same patient.; Sender's Comments: US-GSK-US2020202279:same patient
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| 2824778 | F | KS | 02/05/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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never received her second dose; This non-serious case was reported by a consumer via call center rep...
never received her second dose; 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 received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 11-SEP-2023). 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: never received her second dose). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 03-FEB-2025 The patient self-reported this case The patient received her first dose of Shingrix and she never received her second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2824779 | 31 | F | MA | 02/05/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
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Nausea, Pain, Pain in extremity; Nausea, Pain, Pain in extremity
Nausea, Pain, Pain in extremity; Nausea, Pain, Pain in extremity
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Sore arm radiating to other parts of the body, sore thighs; Sore arm radiating to other parts of the...
Sore arm radiating to other parts of the body, sore thighs; Sore arm radiating to other parts of the body, sore thighs; Sore arm radiating to other parts of the body, sore thighs; nausea; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN IN EXTREMITY (Sore arm radiating to other parts of the body, sore thighs), the second episode of PAIN IN EXTREMITY (Sore arm radiating to other parts of the body, sore thighs), PAIN (Sore arm radiating to other parts of the body, sore thighs) and NAUSEA (nausea) in a 31-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication. Obesity Patient was diagnosed with Covid 19. The patient's past medical history included COVID-19 in 2024. Concurrent medical conditions included Obesity. On 02-Feb-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On an unknown date, the patient experienced the first episode of PAIN IN EXTREMITY (Sore arm radiating to other parts of the body, sore thighs), the second episode of PAIN IN EXTREMITY (Sore arm radiating to other parts of the body, sore thighs), PAIN (Sore arm radiating to other parts of the body, sore thighs) and NAUSEA (nausea). At the time of the report, last episode of PAIN IN EXTREMITY (Sore arm radiating to other parts of the body, sore thighs), PAIN (Sore arm radiating to other parts of the body, sore thighs) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. The patient did not have any additional medical history, concomitant disease or risk factor. Concomitant product use was not provided by the reporter. Patient had sore arm radiating to other parts of the body, sore thighs and had nausea. It was unknown if the patient experienced any additional symptoms or events. There were no lab data or results available. Treatment information was not provided.
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| 2824780 | U | 02/05/2025 |
RSV |
PFIZER\WYETH |
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Device breakage
Device breakage
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the tip automatically snap; This is a spontaneous report received from an Other HCP from product qua...
the tip automatically snap; This is a spontaneous report received from an Other HCP from product quality group. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "the tip automatically snap". Additional information: The reporter mentioned that he was calling from pharmacy and they have one of our products Abrysvo which was defective. He mentioned that they're trying to draw the medication out and the tip automatically snap. The reporter considered "the tip automatically snap" not related to rsv vaccine prot.subunit pref 2v. Causality for "the tip automatically snap" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2824781 | 6 | F | TX | 02/05/2025 |
IPV |
SANOFI PASTEUR |
W1C831M |
No adverse event, Product storage error
No adverse event, Product storage error
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IPOL max/low temperature reached: 46.7F/duration out of labelled range: 8 days/ Human error: Yes wit...
IPOL max/low temperature reached: 46.7F/duration out of labelled range: 8 days/ Human error: Yes with no reported adverse event; vaccine administered after excursion with no reported adverse event; Initial information received on 03-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case- US-SA-2025SA035136, US-SA-2025SA035137, US-SA-2025SA035116, US-SA-2025SA035119, US-SA-2025SA035178 This case involves a 6 years old female patient to whom vaccine ( IPV (VERO) [IPOL]) was administered after excursion and max/low temperature reached: 46.7f/duration out of labelled range: 8 days/ human error: yes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was administered IPV (VERO) Suspension for injection (strength- standard) 1x(once) (dose unknown) lot W1C831M expiry date-21-Nov-2025 via unknown route in unknown administration site for immunization after excursion with no reported adverse event (poor quality product administered) (latency same day). On an unknown date ipol max/low temperature reached: 46.7f/duration out of labelled range: 8 days/ human error: yes with no reported adverse event (product storage error) (unknown latency). Reportedly, Reason: They thought it can be stored up to this maximum temperature. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA035136: US-SA-2025SA035137: US-SA-2025SA035116: US-SA-2025SA035119: US-SA-2025SA035178: US-SA-2025SA035116: US-SA-2025SA035119: US-SA-2025SA035178:Cluster case
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| 2824782 | 15 | M | TX | 02/05/2025 |
MEN |
UNKNOWN MANUFACTURER |
U8370AA |
No adverse event, Product storage error
No adverse event, Product storage error
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temperature excursion of menquadfi; max/low temperature reached: 46.7F Duration out of labelled rang...
temperature excursion of menquadfi; max/low temperature reached: 46.7F Duration out of labelled range: 8 days with no reported adverse event; temperature excursion of menquadfi vaccine administered with no reported adverse event; Initial information received on 03-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked to US-SA-2025SA035119, US-SA-2025SA035116, US-SA-2025SA035136, US-SA-2025SA035137 and US-SA-2025SA035178. This case involves a 15 years old male patient who was administered with Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] after excursion, with no reported adverse event and the vaccine were exposed to temperature excursion of; max/low temperature reached: 46.7f duration out of labelled range: 8 days, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received (0.5 ml, once) dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection (strength: not reported) (lot: U8370AA, Expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization). On an unknown date the vaccine was exposed to temperature excursion of Meningococcal A-C-Y-W135 (T Conj) Vaccine, max/low temperature reached: 46.7 f duration out of labelled range: 8 days with no reported adverse event (product storage error) and was administered to a patient with no reported adverse event (poor quality product administered) (latency: same day) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine. Human error: yes Action taken : not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA035119: US-SA-2025SA035116:
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| 2824783 | 4 | F | TX | 02/05/2025 |
IPV |
SANOFI PASTEUR |
W1C831M |
No adverse event, Product storage error
No adverse event, Product storage error
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Max/low temperature reached 46.7F for 8 days and vaccine was administered to patient with no reporte...
Max/low temperature reached 46.7F for 8 days and vaccine was administered to patient with no reported adverse event; Initial information received on 03-Feb-2025 regarding an unsolicited valid non-serious case received from an other health professional. This case was linked with US-SA-2025SA035137, US-SA-2025SA035116 and US-SA-2025SA035178. This case involves a 4 years old female patient where reporter reported max/low temperature reached 46.7f for 8 days and IPV (VERO) [IPOL] was administered to patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect IPV (VERO) Suspension for injection at a strength (standard) lot W1C831M and expiry date- 21-NOV-2025 via unknown route in unknown administration site (dose, strength: not provided) for Immunization and max/low temperature reached 46.7f for 8 days and vaccine was administered to patient with no reported adverse event (poor quality product administered) (latency- same day). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA035137: US-SA-2025SA035116: US-SA-2025SA035116:
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| 2824784 | 5 | M | TX | 02/05/2025 |
IPV |
SANOFI PASTEUR |
W1C831M |
No adverse event, Product storage error
No adverse event, Product storage error
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temperature excursion for open ipol max/low temperature reached: 46.7F Duration out of labelled rang...
temperature excursion for open ipol max/low temperature reached: 46.7F Duration out of labelled range: 8 days with no reported adverse event; Initial information received on 03-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked to US-SA-2025SA035116 (cluster case). This case involves a 5 years old male patient who received (opened) poliomyelitis vaccine (INACTIVATED) [IPOL] which was exposed to temperature excursion max/low temperature reached: 46.7f duration out of labelled range: 8 days with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of IPV (VERO) Suspension for injection with standard strength (expiry date- 21-NOV-2025 and lot W1C831M) once via unknown route in unknown administration site as Immunization and was exposed to temperature excursion, max/low temperature reached: 46.7f duration out of labelled range: 8 days with no reported adverse event (product storage error) (latency- same day). Action taken was not applicable. Reportedly, they thought vaccines could be stored up to this maximum temperature. There was no previous excursion. Human error was involved. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA035116:Cluster case US-SA-2025SA035116:
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| 2824785 | 0.17 | M | GA | 02/05/2025 |
HIBV |
SANOFI PASTEUR |
UK170A8 |
No adverse event, Product preparation error
No adverse event, Product preparation error
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administered an act-hib vaccine with the wrong diluent with no reported adverse event; Initial infor...
administered an act-hib vaccine with the wrong diluent with no reported adverse event; Initial information received on 03-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 weeks old male patient who received haemophilus type B (HIB) vaccine [ACT-HIB] with the wrong diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 03-Feb-2025, the patient received 0.5 ml of HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength- unknown, expiry date- 31-OCT-2025 and lot UK170A8) once via unknown route in the right vastus lateralis as Immunization with the wrong diluent with no reported adverse event (product preparation error) (latency- same day). Reportedly, 0.7 mL of Merck normal saline. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2824800 | 75 | F | PA | 02/05/2025 |
COVID19 |
PFIZER\BIONTECH |
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Decreased appetite, Fatigue, Malaise, Myalgia, Pain in extremity
Decreased appetite, Fatigue, Malaise, Myalgia, Pain in extremity
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loss of appetite; soreness in arm; tiredness; muscle soreness; feeling generally unwell; This is a s...
loss of appetite; soreness in arm; tiredness; muscle soreness; feeling generally unwell; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Feb2025 at 15:15 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; ATORVASTATIN. The following information was reported: MALAISE (non-serious) with onset 02Feb2025 at 09:00, outcome "not recovered", described as "feeling generally unwell"; DECREASED APPETITE (non-serious) with onset 02Feb2025 at 09:00, outcome "not recovered", described as "loss of appetite"; MYALGIA (non-serious) with onset 02Feb2025 at 09:00, outcome "not recovered", described as "muscle soreness"; PAIN IN EXTREMITY (non-serious) with onset 02Feb2025 at 09:00, outcome "not recovered", described as "soreness in arm"; FATIGUE (non-serious) with onset 02Feb2025 at 09:00, outcome "not recovered", described as "tiredness". Therapeutic measures were not taken as a result of decreased appetite, pain in extremity, fatigue, myalgia, malaise. Additional information: The patient did not receive any vaccines on the same date nor within 4 weeks prior to Comirnaty. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2824801 | 44 | F | 02/05/2025 |
COVID19 FLUX |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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Breast pain, Ultrasound breast; Breast pain, Ultrasound breast
Breast pain, Ultrasound breast; Breast pain, Ultrasound breast
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intermittent sharp pain in left breast/Pain continued for one week, intermittently 4-5 times per day...
intermittent sharp pain in left breast/Pain continued for one week, intermittently 4-5 times per day; This is a spontaneous report received from a Pharmacist from a sales representative. A 44-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 10Jan2025 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 10Jan2025 as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST PAIN (non-serious) with onset 27Jan2025, outcome "recovering", described as "intermittent sharp pain in left breast/Pain continued for one week, intermittently 4-5 times per day". The event "intermittent sharp pain in left breast/pain continued for one week, intermittently 4-5 times per day" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the vaccine. Patient did not taking any other medications within 2 weeks of the event starting. Received comirnaty and flu vaccine in left arm on 10Jan2025. On 27Jan2025 began experiencing intermittent sharp pain in left breast. Pain continued for one week, intermittently 4-5 times per day. Went to breast surgeon for evaluation and ultrasound - nothing identified. Breast surgeon stated that this was likely related to the covid-19 vaccine and she has seen a handful of patients with similar symptoms described as "twingey" pain the breast on the side where vaccine was administered. She has not seen this with other vaccines, only Covid-19. Treatment received for the adverse event was Evaluation by breast surgeon. No drug allergy was reported. On 27Jan2025 when patient started to have symptoms patient did not at all associate them with the vaccine so patient did not report at that time. Only after seeing the surgeon did this association become clear. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2824802 | 12 | M | TX | 02/05/2025 |
MEN |
UNKNOWN MANUFACTURER |
U8370AA |
No adverse event, Product storage error
No adverse event, Product storage error
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temperature excursion of menquadfi; max/low temperature reached: 46.7F Duration out of labelled rang...
temperature excursion of menquadfi; max/low temperature reached: 46.7F Duration out of labelled range: 8 days with no reported adverse event; temperature excursion of menquadfi vaccine administered with no reported adverse event; Initial information received on 03-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked to US-SA-2025SA035119, US-SA-2025SA035116, US-SA-2025SA035137 and US-SA-2025SA035178. This case involves a 12 years old male patient who was administered with Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] after excursion, with no reported adverse event and the vaccine were exposed to temperature excursion of; max/low temperature reached: 46.7f duration out of labelled range: 8 days, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received (0.5 ml, once) dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection (strength: standard, frequency: once) (lot: U8370AA, Expiry date: 30-apr-2028) via unknown route in unknown administration site for prophylactic vaccination (immunization). On an unknown date the Meningococcal A-C-Y-W135 (T Conj) Vaccine was exposed to temperature excursion of max/low temperature reached: 46.7 f duration out of labelled range: 8 days with no reported adverse event (product storage error) and was administered to a patient with no reported adverse event (poor quality product administered) (latency: same day) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine. Human error: yes Action taken : not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA035116: US-SA-2025SA035137: US-SA-2025SA035119: US-SA-2025SA035178:
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| 2824803 | 16 | F | TX | 02/05/2025 |
MENB |
PFIZER\WYETH |
LF5302 (7598 TC |
Erythema, Feeling hot, Peripheral swelling
Erythema, Feeling hot, Peripheral swelling
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arm swelling, redness, warmth started 24 hrs after injection. she also received a flu vaccine in th...
arm swelling, redness, warmth started 24 hrs after injection. she also received a flu vaccine in the same arm
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| 2824804 | 79 | M | CA | 02/05/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Muscular weakness, Pain
Muscular weakness, Pain
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Muscle weakness, pain,
Muscle weakness, pain,
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| 2824805 | 71 | M | NJ | 02/05/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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Died 3 months later 12/28/22
Died 3 months later 12/28/22
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| 2824806 | 28 | M | NV | 02/05/2025 |
COVID19 FLU3 IPV |
PFIZER\BIONTECH SANOFI PASTEUR SANOFI PASTEUR |
LM7786 UT8514JA Y1A201M |
Pallor, Syncope, Unresponsive to stimuli; Pallor, Syncope, Unresponsive to stimu...
Pallor, Syncope, Unresponsive to stimuli; Pallor, Syncope, Unresponsive to stimuli; Pallor, Syncope, Unresponsive to stimuli
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Patient received 3 immunizations (Polio, COVID, Flu). After receiving immunization, patient was leav...
Patient received 3 immunizations (Polio, COVID, Flu). After receiving immunization, patient was leaving with other family member and fainted. Patients parent was able to catch the patient before hitting the ground. Able to take the patient back into the Immunization booth where patient was assessed. Code White was called within pharmacy, followed immediately by EMS as patient was very pale and not responding right away. Patient was sat on the floor with feet elevated. Pharmacist stayed with Patient, as well as management from pharmacy to assist with the event. Upon questioning the patient, patient had just recently given/had blood drawn prior to immunization, suffers from low blood pressure (per mother), as well as only had 1 slice of bread; all of which may have contributed to the adverse event. Paramedics came to pharmacy to assess patient. Patient felt much better by time paramedics came. Denied transport to hospital. Patient left pharmacy on their own free will with no help needed. Patient's parents was the driver.
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| 2824807 | 4 | M | AZ | 02/05/2025 |
DTAPIPV FLU3 MMRV |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. |
U8209C13 u8500BA y004545 |
Injection site erythema, Injection site swelling, Pyrexia; Injection site erythe...
Injection site erythema, Injection site swelling, Pyrexia; Injection site erythema, Injection site swelling, Pyrexia; Injection site erythema, Injection site swelling, Pyrexia
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3-4 hours later developed 103 fever and redness and swelling of L deltoid on 4/3. Examined in office...
3-4 hours later developed 103 fever and redness and swelling of L deltoid on 4/3. Examined in office 4/5, afebrile since the one fever but erythema still present. Non tender. No discharge. Not concerning for cellulitis, supportive care with compress, Motrin/tylenol. Used skin marker to outline border to asses for any worsening.
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| 2824815 | 15 | F | OR | 02/05/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
? ? |
Biopsy cervix abnormal, Cervical dysplasia, Colposcopy abnormal, Human papilloma...
Biopsy cervix abnormal, Cervical dysplasia, Colposcopy abnormal, Human papilloma virus test positive, Papilloma viral infection; Smear cervix abnormal
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In December of 2024 I had an abnormal Pap smear, showing positive for HPV. I then went and had a col...
In December of 2024 I had an abnormal Pap smear, showing positive for HPV. I then went and had a colposcopy where they biopsied three different abnormalities they saw. It came back as pre-cancerous cells, one a CIN-1, and the other two CIN 2-3's. I now will be going in early March for a LEEP procedure to remove the cells, hopefully eradicating the HPV and the "pre-cancer". The LEEP procedure will put me at a higher chance of having a high-risk pregnancy in the future. I also will have more frequent Pap smears in the future to insure the HPV & "pre-cancer" are gone and stay gone.
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| 2824816 | 12 | F | AK | 02/05/2025 |
HPV9 |
MERCK & CO. INC. |
X024727 |
Product storage error
Product storage error
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Patient was given vaccien post temperature excursion prior to vaccine being properly cleared by vacc...
Patient was given vaccien post temperature excursion prior to vaccine being properly cleared by vaccine coordinator with manufactures. Vaccines have successfully been cleared with manufacture and were cleared for patient use.
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| 2824817 | 40 | F | NY | 02/05/2025 |
RSV |
PFIZER\WYETH |
LG9828 |
Exposure during pregnancy, Inappropriate schedule of product administration
Exposure during pregnancy, Inappropriate schedule of product administration
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Patient is currently 34 weeks pregnant which falls under the window for RSV but due to policy change...
Patient is currently 34 weeks pregnant which falls under the window for RSV but due to policy changes, pharmacy was no longer eligible to give the patient the vaccine.
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| 2824818 | 12 | F | AK | 02/05/2025 |
MNQ |
SANOFI PASTEUR |
U8113BA |
Product storage error
Product storage error
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Patient was given vaccien post temperature excursion prior to vaccine being properly cleared by vacc...
Patient was given vaccien post temperature excursion prior to vaccine being properly cleared by vaccine coordinator with manufactures. Vaccines have successfully been cleared with manufacture and were cleared for patient use.
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| 2824819 | 64 | F | DC | 02/05/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
5j989 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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patient came to pharmacy and asked for RSV vaccine because her doctor wanted to receive it since cas...
patient came to pharmacy and asked for RSV vaccine because her doctor wanted to receive it since cases are high , we processed it and insurance covered it . ( she received the vaccine on 12/17/24) , she came to pharmacy today (2/5/25) and asked for immunization history report once I printed out I noticed she received this vaccine two times. I asked her if she experienced any side effects and she mentioned she did not have any . she is aware of this situation fully.
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| 2824820 | 15 | M | AK | 02/05/2025 |
HPV9 TDAP |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
X024727 CX4HL |
Product storage error; Product storage error
Product storage error; Product storage error
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Patient was given vaccien post temperature excursion prior to vaccine being properly cleared by vacc...
Patient was given vaccien post temperature excursion prior to vaccine being properly cleared by vaccine coordinator with manufactures. Vaccines have successfully been cleared with manufacture and were cleared for patient use.
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| 2824821 | 0.75 | F | 02/05/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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9mo was given diluted 5-11 yo dosage of pfizer covid vaccine. Given at approximately 9am. At 6pm no ...
9mo was given diluted 5-11 yo dosage of pfizer covid vaccine. Given at approximately 9am. At 6pm no known adverse events to patient.
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| 2824822 | 16 | M | AK | 02/05/2025 |
HPV9 MNQ |
MERCK & CO. INC. SANOFI PASTEUR |
X024727 U3113BA |
Product storage error; Product storage error
Product storage error; Product storage error
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Patient was given vaccien post temperature excursion prior to vaccine being properly cleared by vacc...
Patient was given vaccien post temperature excursion prior to vaccine being properly cleared by vaccine coordinator with manufactures. Vaccines have successfully been cleared with manufacture and were cleared for patient use.
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| 2824823 | 92 | M | GA | 02/05/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52Z52 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient was vaccinated twice (12/2023 and 2/2025) when there is only one dose in series at this time...
Patient was vaccinated twice (12/2023 and 2/2025) when there is only one dose in series at this time. No adverse reactions to record at time of submission of this report.
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| 2824824 | 33 | F | WA | 02/05/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
027B21A 017C21A |
Condition aggravated, Dyspnoea exertional, Fatigue, Pericarditis; Condition aggr...
Condition aggravated, Dyspnoea exertional, Fatigue, Pericarditis; Condition aggravated, Dyspnoea exertional, Fatigue, Pericarditis; Condition aggravated, Dyspnoea exertional, Fatigue, Pericarditis
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Pericarditis resulting in long-standing chronic fatigue & dyspnea on exertion.
Pericarditis resulting in long-standing chronic fatigue & dyspnea on exertion.
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