| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2855365 | 08/25/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Fatigue, Pain in extremity
Fatigue, Pain in extremity
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Had a little fatigue; my arm sore; This non-serious case was reported by a consumer via interactive ...
Had a little fatigue; my arm sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 07-AUG-2025, the patient received the 1st dose of Shingles vaccine. On 07-AUG-2025, less than a day after receiving Shingles vaccine, the patient experienced fatigue (Verbatim: Had a little fatigue) and pain in arm (Verbatim: my arm sore). The outcome of the fatigue and pain in arm were not reported. It was unknown if the reporter considered the fatigue and pain in arm to be related to Shingles vaccine. It was unknown if the company considered the fatigue and pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 07-AUG-2025 This case was reported by a patient via interactive digital media. The patient Just got her/his first shot of Shingles vaccine The patient had a little fatigue and arm sore.
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| 2855366 | F | 08/25/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Oral herpes
Oral herpes
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woke up to a mouthful of fever blisters; This non-serious case was reported by a consumer via inter...
woke up to a mouthful of fever blisters; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever blister in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced fever blister (Verbatim: woke up to a mouthful of fever blisters). The outcome of the fever blister was not reported. It was unknown if the reporter considered the fever blister to be related to Shingles vaccine. It was unknown if the company considered the fever blister to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 17-AUG-2025 This case was reported by a patient via interactive digital media. The reporter said to stay out of the sun after you get the shot. She and her husband got the first shot at same time. Two weeks to the day they both woke up to a mouthful of fever blisters. She never get fever blisters. They had spent a day on the beach. She believed the blisters were because they got the shot and went out in the sun. No reaction after the second shot. This case is linked with case US2025AMR106849 from the same reporter for husband.; Sender's Comments: US-GSK-US2025AMR106849:Case for husband
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| 2855367 | F | 08/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Hypersensitivity
Hypersensitivity
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allergic reaction; This non-serious case was reported by a consumer via interactive digital media an...
allergic reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: allergic reaction). The outcome of the allergic reaction was not reported. It was unknown if the reporter considered the allergic reaction to be related to Shingrix. It was unknown if the company considered the allergic reaction to be related to Shingrix. Additional Information: GSK Receipt Date: 19-AUG-2025 The reporter reported that he completed it, took two vaccines, but his wife got all allergic reaction so she's not taking the second dose of Shingrix vaccine.
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| 2855368 | 0.92 | F | MO | 08/25/2025 |
DTAPIPV DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
42Y93 42Y93 |
Inappropriate schedule of product administration, Product administered to patien...
Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered; Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
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Kinrix was administered at 2 months old and another dose at 4 months old instead of Pediarix.; Kinri...
Kinrix was administered at 2 months old and another dose at 4 months old instead of Pediarix.; Kinrix was administered at 2 months old and another dose at 4 months old instead of Pediarix; Kinrix was administered at 2 months old and another dose at 4 months old instead of Pediarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-month-old female patient who received DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis. Co-suspect products included DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis. On an unknown date, the patient received Kinrix, Kinrix. On an unknown date, an unknown time after receiving Kinrix and Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered at 2 months old and another dose at 4 months old instead of Pediarix.), inappropriate schedule of vaccine administered (Verbatim: Kinrix was administered at 2 months old and another dose at 4 months old instead of Pediarix) and wrong vaccine administered (Verbatim: Kinrix was administered at 2 months old and another dose at 4 months old instead of Pediarix). The outcome of the inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and wrong vaccine administered were 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: 28-JUL-2025 LPN called to report that they administered a dose of Kinrix to a female patient at 2 and 4 months old instead of Pediarix, 2nd line MIS confirmed that Kinrix was the 1st and 2nd dose of DTaP and IPV which led to inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and wrong vaccine administered.
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| 2855369 | 4 | F | MI | 08/25/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5J23D |
Circumstance or information capable of leading to medication error, Incorrect do...
Circumstance or information capable of leading to medication error, Incorrect dose administered
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Administration on deltoid and vastus lateralis; This non-serious case was reported by a other health...
Administration on deltoid and vastus lateralis; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 5J23D) for prophylaxis. On 11-JUL-2025, the patient received Kinrix. On 11-JUL-2025, an unknown time after receiving Kinrix, the patient experienced incomplete dose administered (Verbatim: Administration on deltoid and vastus lateralis). The outcome of the incomplete dose administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 30-JUL-2025 On 30-Jul-2025 a Clinical manager called and reported the following: Th reporter had an incident in our office, were a partial dose of Kinrix was administered in the deltoid, child was moving around which led to Incomplete dose administered. They remove and change the needle, and the rest of the vaccine, in the vastus lateralis. Along with the needle being change and the injection site, reporter was just wondering if some of that vaccine have been lost. The reporter need to know if the child received enough of the vaccination or if they need to be revaccinate.
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| 2855370 | 54 | F | WI | 08/25/2025 |
HEPAB HEPAB |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration, Incomplete course of vaccinati...
Inappropriate schedule of product administration, Incomplete course of vaccination; Inappropriate schedule of product administration, Incomplete course of vaccination
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Missing third dose; Late second dose; This non-serious case was reported by a pharmacist via call ce...
Missing third dose; Late second 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 54-year-old female patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On 24-NOV-2024, the patient received the 2nd dose of Twinrix. The patient did not receive the 3rd dose of Twinrix. On 24-NOV-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Missing third dose). The outcome of the drug dose administration interval too long and incomplete course of vaccination were 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: 07-AUG-2025 Pharmacist explained that he has a patient come in for vaccine, but she was off schedule and caller was wondering if they should repeat the series. According to Glaxo Smith Kline documentation, it supposed to be at 0, 1 month, 6 months. The patient received second dose at longer interval than recommended which led drug dose administration interval too long. They were requesting to come in and get their third dose today on 07-August-2025, what should been actually back in May, which led incomplete course of vaccination. It was unknown by the Pharmacist if the patient got any prior Hepatitis A or Hepatitis B vaccines. The reporter did not consent to follow-up.
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| 2855371 | 1 | M | CA | 08/25/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
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Incorrect dose administered
Incorrect dose administered
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Maladministration of adult dose to a pediatric patient; Maladministration of adult dose to a pediatr...
Maladministration of adult dose to a pediatric patient; Maladministration of adult dose to a pediatric patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 1-year-old male patient who received HAV (Havrix adult) for prophylaxis. On 18-MAR-2025, the patient received the 1st dose of Havrix adult. On 18-MAR-2025, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: Maladministration of adult dose to a pediatric patient) and overdose (Verbatim: Maladministration of adult dose to a pediatric patient). The outcome of the adult product administered to child and overdose were 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: 13-AUG-2025 Registered nurse called to asked about safety concerns on five patients vaccination schedule (potential first dose) with the maladministration of an adult dose of havrix which led to adult product administered to child and overdose. Vaccination dates and partial patient demographics (only gender and age) were obtained in this call. No vaccine detail was obtained in this call. No further information was obtained in this call.
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| 2855372 | F | NY | 08/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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patient had their 1st dose in 2022; This non-serious case was reported by a nurse via call center re...
patient had their 1st dose in 2022; This non-serious case was reported by a nurse 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 (patient received first dose in 2022). Concurrent medical conditions included immunocompromised and hiv infection. The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: patient had their 1st dose in 2022). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 15-AUG-2025 The nurse wanted to know if she needs to restart a series if an HIV patient had their 1st dose in 2022, or should she finish the series with just one more 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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| 2855373 | OH | 08/25/2025 |
HIBV |
SANOFI PASTEUR |
UK113AB |
No adverse event, Product preparation error
No adverse event, Product preparation error
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an inappropriate use due to the reconstitution of ACTHIB with sterile water instead of the diluent w...
an inappropriate use due to the reconstitution of ACTHIB with sterile water instead of the diluent with no reported adverse event; Initial information received on 20-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received HIB (PRP/T) vaccine [ACT-HIB] reconstituted with sterile water instead of the diluent 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 unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Unknown strength) with lot UK113AB and expiry date 30-Sep-2025 via unknown route in unknown administration site for Immunization reconstituted with sterile water instead of the diluent with no reported adverse event (product preparation error) (Latency same day) Reportedly, reporter noted that during inventory they found a dose of the ACTHIB diluent but not the powder. The nurse noted that this product may have been recently administered to a patient, but they were unable to confirm as the administering HCP was out of the office at the time of the call, and so they could not confirm whether the ACTHIB suspected to have been reconstituted with sterile water was administered to a patient 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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| 2855374 | NY | 08/25/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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3rd PENTACEL dose was not properly spaced from the second dose received Pentacel at 3 months, 5 mont...
3rd PENTACEL dose was not properly spaced from the second dose received Pentacel at 3 months, 5 months, and then at 6 months with no reported adverse event; Initial information received on 21-Aug-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who received 3rd diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] dose was not properly spaced from the second dose received pentacel at 3 months, 5 months, and then at 6 months 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 dose 3 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Immunisation that was not properly spaced from the second dose received pentacel at 3 months, 5 months, and then at 6 months with no reported adverse event (inappropriate schedule of product administration) (Latency same day) Information on the batch number was requested corresponding to the one at time of event occurrence Action 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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| 2855383 | 08/25/2025 |
COVID19 FLU3 MEN UNK |
MODERNA GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
B0005 45546 B4J4B ek7D6 |
Pectus excavatum, Product storage error; Pectus excavatum, Product storage error...
Pectus excavatum, Product storage error; Pectus excavatum, Product storage error; Pectus excavatum, Product storage error; Pectus excavatum, Product storage error
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Liquid vaccine was exposed to temperatures greater than 46 degree Fahrenheit with a maximum temperat...
Liquid vaccine was exposed to temperatures greater than 46 degree Fahrenheit with a maximum temperature of 47.91 degree Fahrenheit and was out of range for 16 minutes; Pectus excavatum; This serious case was reported by a nurse via other manufacturer and described the occurrence of pectus excavatum in a patient who received Men B NVS (Meningococcal B vaccine) (batch number B4J4B) for prophylaxis. Co-suspect products included Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 45546) for prophylaxis, Elasomeran (Spikevax) (batch number B0005, expiry date 28-MAY-2025) for prophylaxis and Meningococcal vaccine A/C/Y/W (Men acwy) (batch number ek7D6) for prophylaxis. Concurrent medical conditions included pseudostrabismus, congenital tracheomalacia, asthma and wheezing. Additional patient notes included The patient was not allergic to medications, food, and other products. Concomitant products included salbutamol (Albuterol Hfa) and salbutamol (Albuterol). On 17-DEC-2024, the patient received Meningococcal B vaccine (intramuscular), FluLaval 2024-2025 season (intramuscular), Spikevax (intramuscular) and Men acwy (intramuscular, left deltoid). On 15-APR-2025, 119 days after receiving Meningococcal B vaccine, FluLaval 2024-2025 season, Spikevax and Men acwy, the patient experienced pectus excavatum (Verbatim: Pectus excavatum) (serious criteria other: Serious as per reporter). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: Liquid vaccine was exposed to temperatures greater than 46 degree Fahrenheit with a maximum temperature of 47.91 degree Fahrenheit and was out of range for 16 minutes). The outcome of the pectus excavatum was not resolved and the outcome of the incorrect storage of drug was not applicable. It was unknown if the reporter considered the pectus excavatum to be related to Meningococcal B vaccine, Meningococcal B Vaccine Pre-Filled Syringe Device, FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. The reporter considered the pectus excavatum and incorrect storage of drug to be not reported if related to Spikevax and Men acwy. The company considered the pectus excavatum to be unrelated to Meningococcal B vaccine, Meningococcal B Vaccine Pre-Filled Syringe Device, FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. The company considered the pectus excavatum and incorrect storage of drug to be not reported if related to Spikevax and Men acwy. 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: 24-JUL-2025 The nurse reported multiple excursions in their refrigerator over a period ranging from 03rd December 2024. The exact highest temperature and total combined excursion time were reported as 47.91 degrees Fahrenheit and 33 minutes, respectively. On 13th December 2024, the highest temperature was reported as 47.91 degrees Fahrenheit, and minutes out of range was reported as 16 minutes and the vaccines were administered after excursion, which led to incorrect storage of drug. The patient had pectus excavatum after receiving vaccinations. No Moderna geriatric vaccine was stored in their refrigerator after 04th February 2025. No adverse events were reported in relation to the vaccination of 17th December 2024. No treatment medication was reported.; Sender's Comments: A case of Pectus excavatum, 119 days after receiving Meningococcal B vaccine, Meningococcal B vaccine PRE-FILLED SYRINGE DEVICE, FluLaval 2024-2025 season and FluLaval PRE-FILLED SYRINGE DEVICE in a patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (concurrent congenial tracheomalacia).
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| 2855384 | M | MD | 08/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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Missed dose; This non-serious case was reported by a consumer via call center representative and des...
Missed 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 male patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose 2 to 3 years ago). The patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: Missed dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 14-AUG-2025 The reporter reported that patient received the first dose of Shingrix 2 to 3 years ago but did not received the second dose. Till the time of reporting, the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
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| 2855385 | 08/25/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
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It does make you sick for one or 2 days at most; This non-serious case was reported by a consumer vi...
It does make you sick for one or 2 days at most; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness (Verbatim: It does make you sick for one or 2 days at most). The outcome of the sickness was resolved. The reporter considered the sickness to be related to Shingles vaccine. The company considered the sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 09-AUG-2025 This case was reported by a patient via interactive digital media. Patient reported that vaccine did make you sick for one or 2 days at most.
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| 2855386 | F | 08/25/2025 |
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 interacti...
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 14-AUG-2025 This case was reported by the patient's relative via interactive digital media. The patient got the shot and get shingles anyway. The reporter stated that this happened to both brothers-in-law and sister-in-law (patient). 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. This case is linked with US2025AMR105315, reported by same reporter; 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-US2025AMR105315:same reporter
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| 2855387 | 12 | M | WA | 08/25/2025 |
DTAP |
SANOFI PASTEUR |
3CA25C1 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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daptacel used in unapproved age of 12 year adolescent pt with no reported adverse event; Initial inf...
daptacel used in unapproved age of 12 year adolescent pt with no reported adverse event; Initial information received on 21-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old male patient who received Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] 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 [Pneumococcal Conjugate Vaccine] for Immunisation. On 20-Aug-2025, the 12 year adolescent patient received 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, (Frequency Once) Suspension for injection, (unknown strength) lot 3CA25C1 and expiry date 30-Apr-2026 via intramuscular route in the left deltoid with no reported adverse event (product administered to patient of inappropriate age) (Latency Same day). Reportedly, Caller stated that when they gave the DTAP, it counted as an appropriate dose in their system also along with the State Registry. It did not mark as like a bad dose. 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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| 2855388 | 0.5 | M | IN | 08/25/2025 |
DTAPIPVHIB PNC20 RV5 |
SANOFI PASTEUR PFIZER\WYETH MERCK & CO. INC. |
UK353AA LP4946 2096004 |
Infant irritability; Infant irritability; Infant irritability
Infant irritability; Infant irritability; Infant irritability
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Patient was extremely fussy, would not nap, only wanted to be held. No fever
Patient was extremely fussy, would not nap, only wanted to be held. No fever
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| 2855389 | 16 | F | MO | 08/25/2025 |
MNP |
PFIZER\WYETH |
LP7146 |
Extremity contracture, Hypoaesthesia
Extremity contracture, Hypoaesthesia
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Pt c/o numbness 3-4 hours later from shoulder to hand. 3 days later c/o wrist & hand & her 3...
Pt c/o numbness 3-4 hours later from shoulder to hand. 3 days later c/o wrist & hand & her 3 fingers (middle, ring & pinky finger) were curled. She couldnt straighten them. Outside of her hand was numb too! 8-20-25 Naproxen 500mg bid - call for f/u 2 days.
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| 2855390 | 79 | F | FL | 08/25/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
FF8839 FF8839 |
Cardiac failure congestive, Hypertension, Immediate post-injection reaction, Inj...
Cardiac failure congestive, Hypertension, Immediate post-injection reaction, Injected limb mobility decreased, Muscular weakness; Pain in extremity
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As a 79 year old female, I received my third COVID19 Pfizer vaccine in my left arm on September (27)...
As a 79 year old female, I received my third COVID19 Pfizer vaccine in my left arm on September (27), 2021. Immediately after the COVID19 Vaccine, I had a LARGE HUMERUS on my left arm. As the years past, I had pain in my LEFT ARM. My LEFT ARM became progressively WEAK that I couldn't USE and/or RAISE my LEFT ARM to pick up an empty cup. I was hospitalized on July 12, 2025 for (congestive heart failure/hypertension). While I was hospitalized, I give TWO BLOOD THINNERS in my stomach. Immediately, shrunk to half the size on my LEFT ARM. 9% of the PAIN on the LEFT ARM has gone. I can USE my LEFT ARM again "I think the COVID19 Pfizer Vaccine that I received in my LEFT ARM gave me a TINY BLOOD CLOT in my LEFT ARM which DIDN'T SHOW UP my MRI RESULTS. When I received the BLOOD THINNER while I was in the hospital, the BLOOD THINNER REMOVED the TINY BLOOD CLOT in my LEFT ARM!" I thought that I would have to live with the PAIN in my LEFT ARM after the COVID19 Vaccine. Please research if BLOOD THINNER is the SOLUTIONS to some of the PATIENTS that received COVID 19 Vaccine, and they are in PAIN.
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| 2855391 | 41 | M | NY | 08/25/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LN4928 LN4928 |
Headache, Injection site pain, Injection site swelling, Nausea, SARS-CoV-2 test;...
Headache, Injection site pain, Injection site swelling, Nausea, SARS-CoV-2 test; Vomiting
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Right arm at site of injection, same day arm swelling & pain. Next day nausea, vomiting, headach...
Right arm at site of injection, same day arm swelling & pain. Next day nausea, vomiting, headache
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| 2855392 | 80 | M | FL | 08/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
E7335 |
Injection site swelling
Injection site swelling
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Reported Symptoms: 10053425:INJECTION SITE SWELLING; Narrative: Other Relevant HX: Other: Injection ...
Reported Symptoms: 10053425:INJECTION SITE SWELLING; Narrative: Other Relevant HX: Other: Injection site swelling
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| 2855393 | M | FL | 08/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Dyskinesia, Muscle spasms
Dyskinesia, Muscle spasms
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Reported Symptoms: 10041408:SPASMS; Narrative: Other Relevant HX: Other: SPASMODIC MOVEMENT
Reported Symptoms: 10041408:SPASMS; Narrative: Other Relevant HX: Other: SPASMODIC MOVEMENT
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| 2855394 | 68 | M | NC | 08/25/2025 |
RSV |
PFIZER\WYETH |
LL8398 |
Arthralgia
Arthralgia
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Reported Symptoms: 10003239:ARTHRALGIA; Narrative: Other Relevant HX: Other:
Reported Symptoms: 10003239:ARTHRALGIA; Narrative: Other Relevant HX: Other:
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| 2855395 | M | TN | 08/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Rash
Rash
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Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other: RASH
Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other: RASH
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| 2855396 | 82 | M | NV | 08/25/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
LM7786 LM7786 |
Asthenia, Confusional state, Cough, Decreased appetite, Lethargy; Malaise
Asthenia, Confusional state, Cough, Decreased appetite, Lethargy; Malaise
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Reported Symptoms: 10011232:COUGHING; 10025482:MALAISE; Narrative: The patients daughter called a co...
Reported Symptoms: 10011232:COUGHING; 10025482:MALAISE; Narrative: The patients daughter called a couple days after the vaccine was administered on 4/11/25 and said the patient was experiencing lethargic, weak, decreased appetite, and confusion after getting the vaccine and the plan was to just monitor over the weekend and a provider would check back in after the weekend and if anything got worse they were advised to seek medical attention. Patient has received several doses previously but all were Moderna, this was the first time the patient received Pfizer. Other Relevant HX: Other: COUGH; MALAISE
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| 2855397 | M | TN | 08/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Asthenia
Asthenia
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Reported Symptoms: 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Other Relevant HX: O...
Reported Symptoms: 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Other Relevant HX: Other: WEAKNESS
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| 2855398 | 72 | M | AZ | 08/25/2025 |
COVID19 |
MODERNA |
8081561 |
Asthenia, Diarrhoea, Headache, Laboratory test normal, Pyrexia
Asthenia, Diarrhoea, Headache, Laboratory test normal, Pyrexia
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Reported Symptoms: 10012727:DIARRHEA; 10016558:FEVER; 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZ...
Reported Symptoms: 10012727:DIARRHEA; 10016558:FEVER; 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: 72 YO male with past medical history significant for cirrhosis from hep C, Parkinson's, HTN, chronic diastolic HF, hypothyroidism, obesity, chronic sacral wounds, and chronic pain on home opioids presented to the ED on 11/23/24 with c/o of weakness and fever. While arriving by EMS patient had a 101.5 F fever with complaints of diarrhea and weakness after getting the Moderna Covid vaccine 1 day prior (11/22/24). Patient was stable upon arrival to the ED with unremarkable labs and afebrile. He was given 1g of acetaminophen for complaints of a headache. Patient was then admitted for observation. Patient underwent full workup while admitted and all testing was found to be unremarkable. Patient remained afebrile throughout hospital stay and was discharged to subacute rehab to help improve weakness on 1/29/24. Other Relevant HX: Other: weakness
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| 2855400 | 72 | F | TX | 08/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Headache, Hypermobility syndrome, Injection site pain
Headache, Hypermobility syndrome, Injection site pain
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30 min after taking my second dose of Shingrix, I had joint looseness in my knees and hips. 5 hrs af...
30 min after taking my second dose of Shingrix, I had joint looseness in my knees and hips. 5 hrs after, I had injection site pain in arm muscle and headache, both of which are still present.
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| 2855401 | F | MI | 08/25/2025 |
HPV4 |
MERCK & CO. INC. |
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Human papilloma virus test positive, Papilloma viral infection
Human papilloma virus test positive, Papilloma viral infection
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I contracted HPV this year even though I was vaccinated as a teen. I got 2 doses of Gardisil. That w...
I contracted HPV this year even though I was vaccinated as a teen. I got 2 doses of Gardisil. That was at least 20 years ago. This information may be useful.
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| 2855402 | M | CA | 08/25/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7829AA |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Describe Event, Problem, or Product Use Error: Vaxelis was given to a 5-year-old, but it is licensed...
Describe Event, Problem, or Product Use Error: Vaxelis was given to a 5-year-old, but it is licensed up to 4 years of age, no harm to pt as result of error
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| 2855403 | F | UT | 08/25/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946062 |
Agitation, Anxiety, Dysphagia, Pruritus, Swelling face
Agitation, Anxiety, Dysphagia, Pruritus, Swelling face
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Described Event, Problem, or Product Use Error: Patient given Heplisav B 4th dose and 30 min later p...
Described Event, Problem, or Product Use Error: Patient given Heplisav B 4th dose and 30 min later pt complain of itchiness, denies SOB or chest pain. Benadryl 50mg IVP given per protocol and cont to monitor pt. Pt started complaining hard to swallow and stated that her face feels swollen and looks agitated and anxious. Solu Medrol given per protocol. MD notified and cont. to monitor patient closely. O2 4L given via NC and sat 96%. 911 initiated and pt sent to ER via ambulance.
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| 2855426 | AZ | 08/25/2025 |
MMRV |
MERCK & CO. INC. |
Z002991 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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No Additional AE; Caller reported PROQUAD was administered to an adult. No other information provid...
No Additional AE; Caller reported PROQUAD was administered to an adult. No other information provided. No Additional AE/PQC reported.; This spontaneous report was received from a Nurse and refers to an adult patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 30-Jul-2025, the (adult) patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), 0.5 mL, lot #Z002991, expiration date: 14-Jul-2026, administered by intramuscular route in the right arm as prophylaxis (Product administered to patient of inappropriate age). The vaccine was reconstituted with sterile diluent (no details provided). No other information provided. No additional adverse events. At the reporting time, the outcome of the events was unknown. The action taken with the suspect products was not reported, but established as not applicable.
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| 2855427 | GA | 08/25/2025 |
MMRV |
MERCK & CO. INC. |
Y013577 |
No adverse event, Product storage error
No adverse event, Product storage error
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Nurse Practitioner calling to report inadvertently administering a PROQUAD vaccine after experiencin...
Nurse Practitioner calling to report inadvertently administering a PROQUAD vaccine after experiencing a temperature excursion. Product was supported. See TE Case# 02848877. Permission to contact HCP was granted. Additional AE Case# 02848880 filed. No; no additional asdverse event eported; Information has been received from Business Partner/CRO on 31-Jul-2025. This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT) . On an unknown date, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y013577, expiration date: 03-Feb-2026) for an unknown indication. This vaccine underwent temperature excursion in 17 degree Fahrenheit for 1 hour 45 minutes and in 15 degree Fahrenheit for 30 minutes (Improper storage of product in use). No additional adverse event was reported.
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| 2855428 | 4 | F | MO | 08/25/2025 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
Y019171 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
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No adverse effects were reported; vaccine involved in temperature excursion; This spontaneous report...
No adverse effects were reported; vaccine involved in temperature excursion; This spontaneous report was received from a nurse and refers to a 4-year-old female patient. The patient had no illness at the time of vaccination and no pre-existing physician-diagnosed medical conditions. Her concomitant therapies were not reported. Historical vaccines included 1st dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). On 01-APR-2025, the patient was vaccinated with 2nd dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection at a dose of 0.5 mL, administered intramuscularly in left thigh, lot #Y019171, expiration date: 18-MAY-2026, administered for prophylaxis. The vaccine was reconstituted with sterile diluent (lot# and expiry date not reported). The vaccine was involved in freezer temperature excursion and not supported for use (Product storage error). The vaccine was discarded after use. No adverse effects were reported. This is one of several reports received from the same reporter.
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| 2855429 | 4 | M | MO | 08/25/2025 |
MMRV |
MERCK & CO. INC. |
Y013582 |
No adverse event, Product storage error
No adverse event, Product storage error
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no adverse event; Improper storage of product in use; This spontaneous report was received from a nu...
no adverse event; Improper storage of product in use; This spontaneous report was received from a nurse and refers to a 5-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 10-Apr-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 mL, lot #Y013582, which was confirmed to be a valid lot#; expiration date: 03-Feb-2026, administered by Intramuscular route in Left Thigh, which was reconstituted with sterile diluent (dose, units, lot# and expiration date were not reported) for prophylaxis. It was reported that there was a temperature excursion of freezer and the vaccine was administered to the patient after (reported as prior, conflicting information) to known temperature excursion (Product storage error). As determined by the manufacturer, vaccine was not supported for use. There was no adverse event. Lot# (regarding sterile diluent) is being requested and will be submitted if received.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user :, Index date : 2025-08-04 , number : , number : , number : , number : AA , Central date : 2025-07-31 , Classification :, Attachment description : Minimal Data Entry , Safety case number :
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| 2855430 | 1 | F | MO | 08/25/2025 |
MMR VARCEL |
MERCK & CO. INC. UNKNOWN MANUFACTURER |
X019102 Y013066 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
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No adverse event; improper storage of product in use; This spontaneous report was received from a nu...
No adverse event; improper storage of product in use; This spontaneous report was received from a nurse and refers to an 1-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 25-Mar-2025, the patient was vaccinated with an improper stored doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (valid lot #X019102, expiration date reported and confirmed as 16-Jul-2025), dose number 1, administered by subcutaneous route in right thigh as prophylaxis and with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (valid lot #Y013066, expiration date reported and confirmed as 29-Jul-2026), dose number 1, administered by subcutaneous route in right thigh as prophylaxis. The suspect vaccines were reconstituted with a sterile diluent (Hollister-Stier STERILE DILUENT) (lot # and expiration date were not reported) as prophylaxis. Temperature excursion occurred a result of a reading from a Digital Data Logger and both vaccines were given prior to known excursion. No adverse events reported. Lot # is being requested and will be submitted if received The is one of several reports received from the same reporter.
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| 2855431 | 5 | F | MO | 08/25/2025 |
MMRV |
MERCK & CO. INC. |
Y019171 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE/No PQC.; Vaccine was given prior to known temperature excursion.; This spontaneous ...
No additional AE/No PQC.; Vaccine was given prior to known temperature excursion.; This spontaneous report was received from a nurse and refers to a 5-year-old female patient. The patient's medical history and concurrent conditions were none. Concomitant therapies were not reported. On 08-Apr-2025, the patient received the second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y019171, expiration date: 18-May-2026, 1 dosage form, formulation and strength were not reported) administered via intramuscular in right arm for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided). Temperature excursion of freezer, it occurred as a result of a reading from a Digital Data Logger. As determined by manufacturer, vaccine not supported for use. The vaccine was given prior to known temperature excursion (Product storage error). The vaccine purchased with public funds. The patient vaccinated at private doctor's office/hospital. Operator was a trained healthcare professional. The vaccine sharp discarded after giving. No additional adverse event (AE). The is one of several reports from the same reporter.
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| 2855432 | 16 | M | HI | 08/25/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Z007212 Y013350 |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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The patient has not reported any side effects related to receiving both vaccines in his left deltoid...
The patient has not reported any side effects related to receiving both vaccines in his left deltoid today, 07Aug2025.; This medical assistant reports that this 16 year old male patient received both a ProQuad (Measles, Mumps, Rubella, and Varicella Virus Vaccine Live) and Varivax (Varicella Virus Vaccine Live) vaccinations in his left deltoid on 07Aug2025.; This medical assistant reports that this 16 year old male patient received both a ProQuad (Measles, Mumps, Rubella, and Varicella Virus Vaccine Live) and Varivax (Varicella Virus Vaccine Live) vaccinations in his left deltoid on 07Aug2025.; This spontaneous report was received from a Medical assistant on 07-AUG-2025 and refers to 16-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The Medical assistant reported that patient's first visit to the clinic and limited medical history was available. On 07-Aug-2025, the patient was vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y013350, expiration date: 02-Aug-2026) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Z007212, expiration date: 05-Oct-2026) in Left Deltoid for prophylaxis (dose , route, and dose number were unspecified)( Overdose, Product administered to patient of inappropriate age). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (route, lot#, dose, dose number were unspecified) for prophylaxis, on the same date. The patient had not reported any side effects related to receiving both vaccines in his left deltoid, Lot # will be requested and will be submitted if received.
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| 2855433 | TX | 08/25/2025 |
VARCEL |
MERCK & CO. INC. |
Z008195 |
No adverse event, Product storage error
No adverse event, Product storage error
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Caller stated no patient symptoms have been reported; Nurse called and reported VARIVAX was administ...
Caller stated no patient symptoms have been reported; Nurse called and reported VARIVAX was administered to a patient after being involved in a temperature excursion. Caller stated PROQUAD and VARIVAX were also administered to multiple other patients. See AE cases 02856250, 02856303, 02856304, 02856305,; This spontaneous report was received from a Nurse (LVN) 14-Aug-2025 and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improper storage dose of with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z008195, expiration date: 30-Apr-2027) 1 dosage form reported as 1 dose (dose and dose number was unspecified) for Prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) 1 dosage form reported as 1 dose (dose and dose number, lot # and expiration date were not reported was unspecified) for Prophylaxis. No patient symptoms have been reported. The administered doses of the vaccine experienced a temperature excursion -8 degree centigrade for 15 minutes. It was unspecified if the data was recorded by a data logger and no previous temperature excursion reported. There was no adverse effect reported. No product quality complaint was involved. Lot # will be requested and will be submitted if received. This is one of several reports from the same source.
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| 2855434 | F | CA | 08/25/2025 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
|
No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
More
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No additional AE; 24-year-old female patient received PROQUAD; This spontaneous report was received ...
No additional AE; 24-year-old female patient received PROQUAD; This spontaneous report was received from a other health professional and refers to a 24-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 14-AUG-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), 0.5 mL (route of administration, anatomical location, lot number and expiration date was not reported) for prophylaxis, the vaccine was reconstituted with sterile diluent (HOLLISTER STERILE DILUENT), (lot number and expiration date not reported) (Product administered to patient of inappropriate age). There was not adverse event reported (No adverse event).
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| 2855436 | F | AZ | 08/25/2025 |
DTPPVHBHPB PNC15 |
MSP VACCINE COMPANY MERCK & CO. INC. |
U777688 Z008265 |
Incorrect route of product administration, Injection site extravasation, Injecti...
Incorrect route of product administration, Injection site extravasation, Injection site mass; Incorrect route of product administration, Injection site extravasation, Injection site mass
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it infiltrated and there was a lump of fluid under the skin; instead of it being admisstered in the ...
it infiltrated and there was a lump of fluid under the skin; instead of it being admisstered in the muscle it was given subcutaneously; This spontaneous report was received from an office worker and a Nurse Practitioner and refers to a(n) 2-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 28-Jul-2025, the patient was vaccinated with Pneumococcal 15-valent Conjugate Vaccine (lot #Z008265, expiration date: 21-Jul-2027) (VAXNEUVANCE) administered by Subcutaneous route in Right Thigh and with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus (VAXELIS), (lot #U777688, expiration date 10-Jun-2026) administered by Subcutaneous route in Right Thigh (expiration date was not reported) as prophylaxis. Per reporter vaccines were administered incorrectly and instead of it being administered in the muscle it was given subcutaneously (Incorrect route of product administration) so it infiltrated and there was a lump of fluid under the skin where it did not belong and it has not gone away in 3 weeks. Patient now has a "lump on its leg" located "right above the knee, on the side facing away from the body, on the right side". Caller stated the vaccines were "administered lower than it should have" and the HCP believes "as the needle was going in, the medical assistant started pushing in causing the lump to form. At the reporting time, the patient had not recovered from it infiltrated and there was a lump of fluid under the skin. Action taken with suspect vaccines was not reported. Causality was not provided.; Reporter's Comments: Keywords : BP; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02859364-02859338 , CLIC number : , ESTAR number : , IRMS number : 500UW00000jLrkBYAS|21082025230024|1680 , Central date : 2025-08-22 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2321607 , MNSC case number : 02859364 , MNSC interaction number : 02859338 , Integration log UniqueID : 500UW00000jLrkBYAS|21082025230024|1680 , Service cloud CaseID : 500UW00000jLrkBYAS
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| 2855438 | 08/25/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Wrong technique in product usage process
Wrong technique in product usage process
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healthcare professional preparing a dose of Bexsero from administration had an issue with the pre-fi...
healthcare professional preparing a dose of Bexsero from administration had an issue with the pre-filled syringe due to a large air bubble so drew up the medication from the Bexsero syringe in order to salvage the medication and administer the vaccin; healthcare professional preparing a dose of Bexsero from administration had an issue with the pre-filled syringe due to a large air bubble so drew up the medication from the Bexsero syringe in order to salvage the medication and administer the vaccin; Product complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong technique in product usage process in a patient who received Men B NVS (Bexsero) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong technique in product usage process (Verbatim: healthcare professional preparing a dose of Bexsero from administration had an issue with the pre-filled syringe due to a large air bubble so drew up the medication from the Bexsero syringe in order to salvage the medication and administer the vaccin), poor quality vaccine administered (Verbatim: healthcare professional preparing a dose of Bexsero from administration had an issue with the pre-filled syringe due to a large air bubble so drew up the medication from the Bexsero syringe in order to salvage the medication and administer the vaccin) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the wrong technique in product usage process, poor quality vaccine administered and pharmaceutical product complaint were 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: 31-JUL-2025 The reporter stated healthcare professional preparing a dose of Bexsero from administration had an issue with the pre-filled syringe due to a large air bubble. The healthcare professional drew up the medication from the Bexsero syringe in order to salvage the medication and administer the vaccine which led to Wrong technique in product usage process and Poor quality vaccine administered. No further information was provided by GSK field representative. No further information was provided/obtained.
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| 2855439 | 12 | F | VA | 08/25/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
FH443 |
Wrong product administered
Wrong product administered
|
was given Men B at age 12 however patient was supposed to get the Men A; This non-serious case was r...
was given Men B at age 12 however patient was supposed to get the Men A; This non-serious case was reported by a other health professional and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number FH443, expiry date 30-JAN-2027) for vaccination. Co-suspect products included Meningococcal vaccine A for prophylaxis. On 15-JUL-2025, the patient received Bexsero .5 ml, the patient did not receive Meningococcal vaccine A. On 15-JUL-2025, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: was given Men B at age 12 however patient was supposed to get the Men A). The outcome of the wrong vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 06-AUG-2025 Patient was given Men B (Bexsero) at age 12 however patient was supposed to get the Men A, which led to wrong vaccine administered. No other products were received by the patient.
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| 2855440 | 3 | M | AR | 08/25/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5H95B |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Kinrix was given to a three year old child; This non-serious case was reported by a other health pro...
Kinrix was given to a three year old child; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 28-FEB-2026) for prophylaxis. On 16-JUL-2025, the patient received Kinrix. On 16-JUL-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was given to a three year old child). The outcome of the inappropriate age at vaccine administration 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: 07-AUG-2025 The health care professional reported that a dose of Kinrix was given to a three year-old child, which led to inappropriate age at vaccine administration.
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| 2855441 | 08/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Product preparation issue
Product preparation issue
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patient was given only the adjuvant of Shingrix without reconstitution; inappropriate dose of vaccin...
patient was given only the adjuvant of Shingrix without reconstitution; inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication (Verbatim: patient was given only the adjuvant of Shingrix without reconstitution) and inappropriate dose of vaccine administered (Verbatim: inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: HCP reported that a patient was given only the adjuvant of Shingrix without reconstitution. Patient initials, DOB, gender are not available. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
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| 2855442 | 59 | M | 08/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pain in extremity
Pain in extremity
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Pain in the arm was reported as worsened; This non-serious case was reported by a pharmacist via sal...
Pain in the arm was reported as worsened; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included simvastatin, metoprolol, lisinopril and metformin. On 14-AUG-2025, the patient received the 1st dose of Shingrix (left deltoid). On 14-AUG-2025, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Pain in the arm was reported as worsened). The outcome of the pain in arm was not resolved. The reporter considered the pain in arm to be related to Shingrix. The company considered the pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 15-AUG-2025 The patient received a dose of Shingrix vaccine and experienced pain in the arm. It was reported as worsened.
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| 2855443 | 74 | M | SC | 08/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pruritus, Urticaria
Pruritus, Urticaria
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he developed hives all over his body; very itchy; This non-serious case was reported by a consumer v...
he developed hives all over his body; very itchy; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included blood pressure high. Concurrent medical conditions included diabetes. Concomitant products included aspirin, cimetidine (Zita), carvedilol, losartan, vitamin c, magnesium oxide and evolocumab (Repatha). In JUN-2025, the patient received Shingrix. In JUN-2025, 1 day after receiving Shingrix, the patient experienced hives (Verbatim: he developed hives all over his body) and pruritus (Verbatim: very itchy). The outcome of the hives and pruritus were resolved. It was unknown if the reporter considered the hives and pruritus to be related to Shingrix. It was unknown if the company considered the hives and pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 15-AUG-2025 The patient received Vitamin d as concomitantly. The patient reported that the next day after he received Shingrix he developed hives all over his body and was very itch.
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| 2855444 | F | 08/25/2025 |
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UNKNOWN MANUFACTURER |
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Pain
Pain
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how she treated her pain; This non-serious case was reported by a consumer via interactive digital ...
how she treated her pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced pain (Verbatim: how she treated her pain). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Herpes Zoster vaccine. It was unknown if the company considered the pain to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 02-AUG-2025 This case was reported by a patient via interactive digital media. It was reported as the reporter wanted more on how she treated her pain.
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| 2855445 | 08/25/2025 |
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UNKNOWN MANUFACTURER |
UNK |
Electric shock sensation, Herpes zoster, Pain in extremity, Vaccination failure
Electric shock sensation, Herpes zoster, Pain in extremity, Vaccination failure
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Suspected Vaccination Failure; Got the vaccine and had them again; shot electric shocks down my legs...
Suspected Vaccination Failure; Got the vaccine and had them again; shot electric shocks down my legs; legs worst pain I've ever had also brought me down; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. 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), shingles (Verbatim: Got the vaccine and had them again), electric shock sensation (Verbatim: shot electric shocks down my legs) and leg pain (Verbatim: legs worst pain I've ever had also brought me down). The outcome of the vaccination failure, shingles, electric shock sensation and leg pain were not reported. It was unknown if the reporter considered the vaccination failure, shingles, electric shock sensation and leg pain 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, electric shock sensation and leg pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 08-AUG-2025 This case was reported by a patient via interactive digital media. The patient had them in the same area, it shot electric shocks down his/her legs worst pain and have ever had also brought the patient down. The patient got the Shingles vaccine and had them again but not as bad. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of 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 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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| 2855446 | 08/25/2025 |
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UNKNOWN MANUFACTURER |
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Incomplete course of vaccination
Incomplete course of vaccination
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1st shingles shot 4 years ago; This non-serious case was reported by a consumer via interactive digi...
1st shingles shot 4 years ago; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (received 1st dose 4 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. The patient had incomplete course of vaccination (Verbatim: 1st shingles shot 4 years ago). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 09-AUG-2025 This case was reported by a consumer via interactive digital media. The reporter reported that the patient received their 1st shingles shot 4 years ago. The reporter asked did they need to restart the series. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine which led to incomplete course of vaccination.
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| 2855447 | 08/25/2025 |
VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK UNK UNK |
Fear of falling, Herpes zoster, Muscular weakness, Nerve injury, Neuralgia; Pain...
Fear of falling, Herpes zoster, Muscular weakness, Nerve injury, Neuralgia; Pain, Skin lesion, Vaccination failure, Walking aid user; Fear of falling, Herpes zoster, Muscular weakness, Nerve injury, Neuralgia; Pain, Skin lesion, Vaccination failure, Walking aid user
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loss of muscle strength; loss of nerve; Fear of falling; shooting nerve pain in my leg where the les...
loss of muscle strength; loss of nerve; Fear of falling; shooting nerve pain in my leg where the lesions were; Suspected vaccination failure; Shingles on right leg from ankle all the way to buttock; 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 (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 15-MAR-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on right leg from ankle all the way to buttock). On an unknown date, the patient experienced muscle weakness lower limb (Verbatim: loss of muscle strength), nerve damage (Verbatim: loss of nerve), fear of falling (Verbatim: Fear of falling) and post herpetic neuralgia (Verbatim: shooting nerve pain in my leg where the lesions were). The outcome of the vaccination failure, shingles, fear of falling and post herpetic neuralgia were not reported and the outcome of the muscle weakness lower limb and nerve damage were not resolved. It was unknown if the reporter considered the vaccination failure, shingles, muscle weakness lower limb, nerve damage, fear of falling and post herpetic neuralgia to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, muscle weakness lower limb, nerve damage, fear of falling and post herpetic neuralgia to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 10-AUG-2025 This case was reported by a patient via interactive digital media. The patient was diagnosed with shingles on my right leg from his/her ankle all the way to my buttocks on 15th March 2025 despite of having both Shingrix shots so was told it would be a mild case. About 5 months later he/she was still suffering from the loss of nerve and muscle strength which caused knee to buckle. The patient didn't dare to walk without a walker due to the fear of falling. His/her neurosurgeon said that the nerve and muscle strength would return but it would take a long time. So, patient happened to be one of the unlucky 10 percent of people who got the shot who still got shingles, and one of the unlucky 1-2 percent of people who got shingles to have nerve and muscle loss. The patient still occasionally got shooting nerve pain in leg where the lesions were. The Shingles were not fun. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingrix vaccine (Dose 1 & 2).
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