| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2847650 | F | CA | 06/27/2025 |
RAB |
NOVARTIS VACCINES AND DIAGNOSTICS |
Unknown |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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The patient received booster of Rabavert after 30 years; Case reference number US-BN-2025-000902 is ...
The patient received booster of Rabavert after 30 years; Case reference number US-BN-2025-000902 is a spontaneous case report initially received from a other health care professional via MedCommunication (reference number: USBAV25-1011) on 02-May-2025 and concerns a female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On an unspecified date, as reported, 30 years ago, the patient had primary series of RabAvert vaccine along with prefilled syringe, needle for injection and injection for reconstitution (batch number: unknown) at an unknown dose, route and site of administration for unknown indication. On 02-May-2025, as reported 30 years after first dose, the patient received first booster dose of RabAvert vaccine along with prefilled syringe, needle for injection and injection for reconstitution (batch number: unknown) at an unknown dose, route and site of administration (explicitly coded as 'Inappropriate schedule of vaccine administration'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to RabAvert vaccine. No further information was provided.; Reporter's Comments: A female patient of unspecified age received first booster dose of RabAvert vaccine for unknown indication, as reported 30 years after first dose, which is considered as inappropriate schedule of vaccine administration. It was unknown if the patient experienced any adverse events due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age received first booster dose of RabAvert vaccine for unknown indication, as reported 30 years after first dose, which is considered as inappropriate schedule of vaccine administration. It was unknown if the patient experienced any adverse events due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2847651 | F | NJ | 06/27/2025 |
RAB |
NOVARTIS VACCINES AND DIAGNOSTICS |
Unknown |
Incomplete course of vaccination
Incomplete course of vaccination
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The patient received only one dose of Rabavert about three months ago; Case reference number US-BN-2...
The patient received only one dose of Rabavert about three months ago; Case reference number US-BN-2025-000910 is a spontaneous case initially received from pharmacist via Med Communication (reference number: USBAV25-1033) on 06-May-2025 and concerns a 42-years-old female patient. The patient's medical history and concomitant medication details were not provided. On unspecified date, reported as three months ago, the patient took first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route or site of administration for indication pre-exposure prophylaxis. As reported, the patient received only one dose of RabAvert about three months ago as the patient was not told about other doses needed (explicitly coded as 'incomplete course of vaccination'). At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert. No further information was provided.; Reporter's Comments: This case concerns a 42-year-old adult female patient. On unspecified date, the patient received the first dose of RabAvert vaccine with an indication of pre-exposure prophylaxis. As reported, the patient received only one dose of RabAvert about three months ago as the patient was not told about other doses needed which is considered as �incomplete course of vaccination'. At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert. Incomplete course of vaccination is considered as listed as per company convention. The patients' medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: This case concerns a 42-year-old adult female patient. On unspecified date, the patient received the first dose of RabAvert vaccine with an indication of pre-exposure prophylaxis. As reported, the patient received only one dose of RabAvert about three months ago as the patient was not told about other doses needed which is considered as �incomplete course of vaccination'. At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert. Incomplete course of vaccination is considered as listed as per company convention. The patients' medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2847652 | M | GA | 06/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Papule, Pruritus
Papule, Pruritus
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Itching on his back, near the lumbar area; bumps are very small red spots the size of a pin head and...
Itching on his back, near the lumbar area; bumps are very small red spots the size of a pin head and are not blistered or open, they are just barely raised; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included atrial fibrillation, blood pressure high and hyperlipidemia. Concomitant products included flecainide, diltiazem (Cardizem), atorvastatin, acetylsalicylic acid (Aspirin) and colecalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, vitamin b1 nos (Multivitamin). In APR-2025, the patient received Shingrix (intramuscular use, unknown deltoid) .5 ml. On 15-MAY-2025, less than 2 months after receiving Shingrix, the patient experienced pruritus (Verbatim: Itching on his back, near the lumbar area) and red papule (Verbatim: bumps are very small red spots the size of a pin head and are not blistered or open, they are just barely raised). The outcome of the pruritus and red papule were not resolved. It was unknown if the reporter considered the pruritus and red papule to be related to Shingrix. It was unknown if the company considered the pruritus and red papule to be related to Shingrix. Additional Information: GSK Receipt Date: 17-JUN-2025 The patient self-reported this case. The patient received 1st dose of Shingrix vaccine in mid-April this year and about 3 or 4 weeks later he noticed itching on his back, near the lumbar area. He reported that it remained confined to that area until one week ago, when it spread around his waist just below the belt line, onto his hip, and up his chest almost to his nipples and the bumps were very small red spots the size of a pin head and were not blistered or open, they were just barely raised. They crossed the midline in both the back and the front of his body, and it seemed to be progressing, getting more widespread and itchy. He started using a new soap about 6 months ago. The information on the medications listed is all that is available. He did not wish to locate his bottles to tell me the dosage. He stated that he has been taking these medicines for a very long time and did not believe they could be impacting his experiences with the bumps or itching.
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| 2847653 | F | AR | 06/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pyrexia
Pyrexia
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Fever; This non-serious case was reported by a consumer via call center representative and described...
Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old 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, less than a year after receiving Shingrix, the patient experienced fever (Verbatim: Fever). The outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to Shingrix. It was unknown if the company considered the fever to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR079662 Additional Information: GSK Receipt Date: 24-JUN-2025 While asking questions about Shingrix, the caller mentioned that her daughter had a reaction to Shingrix. When questioned about this event, she was reluctant to provide any information, only saying that her daughter received both doses of Shingrix vaccine a few months ago in 2024 and that she had a fever in 2024 after the first dose. She did not wish to provide any further information on behalf of her daughter without her daughter's consent.
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| 2847654 | 06/27/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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I received one if the shingles vaccine , but failed to get the second one. Do i have to start all ov...
I received one if the shingles vaccine , but failed to get the second one. Do i have to start all over again; This non-serious case was reported by a consumer via call center representative 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 on an unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: I received one if the shingles vaccine , but failed to get the second one. Do i have to start all over again). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 31-MAY-2025 The patient self-reported this case. The patient received one of the Shingles vaccine, but failed to get the second one. The reporter asked do they have to start all over, again. The patient asked was there a test to see if you have had chicken pox as patient was a baby when my brother had chicken pox, and she said she didn't see any signs that I ever had it. 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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| 2847655 | 06/27/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Cough, Fatigue, Malaise
Cough, Fatigue, Malaise
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cough; exhaustion; sick; This non-serious case was reported by a consumer via interactive digital me...
cough; exhaustion; sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: sick), cough (Verbatim: cough) and exhaustion (Verbatim: exhaustion). The outcome of the sickness was resolved (duration 1 week) and the outcome of the cough and exhaustion were not reported. It was unknown if the reporter considered the sickness, cough and exhaustion to be related to RSV vaccine. It was unknown if the company considered the sickness, cough and exhaustion to be related to RSV vaccine. Additional Information: GSK Receipt Date: 18-JUN-2025 This case was reported by a patient via interactive digital media. Patient had gotten the vaccine the previous fall, but the emergency room told him/her he/she had RSV. Patient had been sick for over a week, and he/she finally went to the emergency room because his/her cough and exhaustion had gotten really bad. The vaccine had not completely prevented the illness, just like the COVID vaccine had not been perfect.
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| 2847656 | F | 06/27/2025 |
RVX VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
483-636-765 523-292-473 |
Injection site erythema; Injection site erythema
Injection site erythema; Injection site erythema
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Injection site erythema left arm; This non-serious case was reported by a other health professional ...
Injection site erythema left arm; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number 523-292-473) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) (batch number 483-636-765) for prophylaxis. Previously administered products included Shingles vaccine (Received 1st dose of Shingles vaccine on 04-APR-2025 at 09:46, Lot number 487-083-242, intramuscularly in left deltoid.). On 02-JUN-2025 10:47, the patient received the 2nd dose of Shingles vaccine (intramuscular use, left arm). On 05-MAY-2025 10:10, the patient received the 1st dose of RSV vaccine (intramuscular use). On 04-JUN-2025, 2 days after receiving Shingles vaccine and 30 days after receiving RSV vaccine, the patient experienced injection site erythema (Verbatim: Injection site erythema left arm). The outcome of the injection site erythema was resolving. The reporter considered the injection site erythema to be related to Shingles vaccine. The reporter considered the injection site erythema to be unrelated to RSV vaccine. The company considered the injection site erythema to be related to Shingles vaccine. The company considered the injection site erythema to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 20-JUN-2025 This is a Pfizer sponsored interventional study report. A female patient received varicella zoster vaccine rge (cho), powder for suspension for injection (VARICELLA ZOSTER VACCINE RGE (CHO)), on 02Jun2025 and received rsv vaccine prot.subunit pref 2v, powder for solution for injection (RSV Vaccine Prot.Subunit Pref 2V), on 05May2025. The patient had no relevant medical history. There were no concomitant medications. The patient reported no concomitant vaccine or prior vaccination. The following information was reported: erythema at injection site (medically significant) with onset 04Jun2025, described as erythema at injection site left arm. Clinical course: Site was requesting for this serious adverse event (SAE) report to be retracted. On 04 June 2025, the patient reported a severe reaction of redness reaction via the e-diary measuring 21 cm. The site scheduled patient to come into the site to be assessed by the sub-investigator. The site assessed this as a Grade 3 reaction and, in error, submitted an SAE report. However, as this reaction occurred within the 7 day post-vaccination window, it was classified as a reactogenicity event per protocol and does not meet the criteria for a true SAE. The adverse event was being downgraded to grade 2. The patient had not withdrawn and had not experience any life-threatening events. Inform had already been updated accordingly. The action taken in response to the event was not applicable. The outcome of the event was recovering. The investigator considered there was a reasonable possibility that the event erythema at injection site left arm was related to varicella zoster vaccine rge (cho), powder for suspension for injection. The investigator considered there was not a reasonable possibility that the event erythema at injection site left arm was related to rsv vaccine prot.subunit pref 2v, powder for solution for injection. The event erythema at injection site left arm was reported as unrelated to concomitant medications or to any clinical trial procedures.
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| 2847657 | 06/27/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Eye pain, Influenza like illness, Neck pain, Sleep disorder
Eye pain, Influenza like illness, Neck pain, Sleep disorder
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Flu like symptoms; neck hurting; eyes hurting; could not sleep; This non-serious case was reported b...
Flu like symptoms; neck hurting; eyes hurting; could not sleep; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms), neck pain (Verbatim: neck hurting), eye pain (Verbatim: eyes hurting) and difficulty sleeping (Verbatim: could not sleep). The outcome of the influenza-like symptoms, neck pain, eye pain and difficulty sleeping were resolved. It was unknown if the reporter considered the influenza-like symptoms, neck pain, eye pain and difficulty sleeping to be related to Shingles vaccine. It was unknown if the company considered the influenza-like symptoms, neck pain, eye pain and difficulty sleeping to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-JUN-2025 This case was reported by a patient via interactive digital media. Patient just finished Shingles shot and it was not fun at all. Flu-like symptoms could occur and patient also could not sleep without his/her neck and eyes hurting. Patient was glad that was over.
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| 2847658 | 06/27/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster
Herpes zoster
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I got shingles 3 weeks after the shot; This non-serious case was reported by a consumer via interact...
I got shingles 3 weeks after the shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I got shingles 3 weeks after the shot). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-JUN-2025 This case was reported by a patient via interactive digital media. The patient got shingles 3 weeks after the shot.
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| 2847659 | 06/27/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Rash, Rash erythematous, Rash pruritic
Rash, Rash erythematous, Rash pruritic
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painful rash; red itchy rash; This non-serious case was reported by a consumer via interactive digit...
painful rash; red itchy rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of painful rash 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 painful rash (Verbatim: painful rash) and itchy rash (Verbatim: itchy rash). The outcome of the painful rash and itchy rash were not reported. It was unknown if the reporter considered the painful rash and itchy rash to be related to Shingles vaccine. It was unknown if the company considered the painful rash and itchy rash to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-JUN-2025 This case was reported by a patient via (Shingrix GRC chatbot) interactive digital media. Patient had a red painful itchy rash on his/her tummy and did not know what it was.
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| 2847660 | 06/27/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On 20-JUN-2025, an unknown time after receiving Shingles vaccine and 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 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-JUN-2025 This case was reported by a patient via interactive digital media. Patient got both of the shingles vaccine and was diagnosed with shingles. 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 regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine (Dose 1 & 2).
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| 2847661 | 06/27/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Pain, Vaccination failure
Herpes zoster, Pain, Vaccination failure
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suspected vaccination failure; going through the most painful shingles; This serious case was report...
suspected vaccination failure; going through the most painful 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: going through the most painful 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: 21-JUN-2025 This case was reported by a patient via interactive digital media. The patient got the shots and thought he/she was safe. At the time of reporting the patient was going through the most painful shingles. This case was considered as suspected vaccination failure as details regarding completion of primary 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, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
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| 2847662 | 06/27/2025 |
VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK |
Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administ...
Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administered, Herpes zoster, Vaccination failure
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Suspected vaccination failure; had received 3 shots; two episodes when my body was under stress/mild...
Suspected vaccination failure; had received 3 shots; two episodes when my body was under stress/mild pain-free outbreaks; 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 and Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: two episodes when my body was under stress/mild pain-free outbreaks) and extra dose administered (Verbatim: had received 3 shots). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 3 days) and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 21-JUN-2025 This case was reported by a patient via interactive digital media. Patient had all three shots but two episodes when body was under stress but because of the vaccine patient had mild pain free outbreaks. Took vancyclovir within three days and it is gone. Patient had 3 shots, which led to extra dose administered. 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 vaccine Shingles vaccine (dose 1, 2 and 3)
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| 2847663 | 06/27/2025 |
VARZOS VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK UNK |
Blister, Cerebrovascular accident, Herpes zoster, Laboratory test abnormal, Lumb...
Blister, Cerebrovascular accident, Herpes zoster, Laboratory test abnormal, Lumbar puncture abnormal; Vaccination failure, Walking aid user, Wheelchair user; Blister, Cerebrovascular accident, Herpes zoster, Laboratory test abnormal, Lumbar puncture abnormal; Vaccination failure, Walking aid user, Wheelchair user
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Suspected vaccination failure; Shingles/ Shingles entered the spine; stroke; This serious case was r...
Suspected vaccination failure; Shingles/ Shingles entered the spine; stroke; 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. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles/ Shingles entered the spine) (serious criteria other: serious as per reporter) and stroke (Verbatim: stroke) (serious criteria GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the shingles and stroke were resolving. It was unknown if the reporter considered the vaccination failure, shingles and stroke to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure, shingles and stroke to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 21-JUN-2025 This case was reported by a patient via interactive digital media. After both vaccines that the facility thought the patient needed, Shingles raised its ugly head. The blisters were few some on left elbow and left hand on the palm. The patient never had shingles before. A few days after, the patient couldn't remember driving home. A trip to the emergency room and they diagnosed a stroke after many tests and finally after a lumbar puncture it was seen that the shingles had entered the spine. The doctors said only 0.03% experiences this. The patient spent the next year in a wheelchair, then a walker and cane, today the patient could walk 2 miles a day. There was some progress and maybe 90% recovery. The Shingles was serious. This case was considered as suspected vaccination failure as details regarding time to onset for shingles was 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 vaccine Shingles vaccine (dose 1 and 2) Herpes zoster and Cerebrovascular accident are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2)
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| 2847664 | 06/27/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Inappropriate schedule of product administration, Vaccination fai...
Herpes zoster, Inappropriate schedule of product administration, Vaccination failure; Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
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suspected vaccination failure; developed shingles on the chest and stomach/went away in a couple of ...
suspected vaccination failure; developed shingles on the chest and stomach/went away in a couple of months; received the shingles shot at 60 and then at 62; 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. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: developed shingles on the chest and stomach/went away in a couple of months) and drug dose administration interval too long (Verbatim: received the shingles shot at 60 and then at 62). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved and the outcome of the drug dose administration interval too long was not applicable. 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: 23-JUN-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had received the shingles shot at age 60 and again at 62, but he/she still developed shingles on his/her chest and stomach. Fortunately, it was mild, with no blisters, and the symptoms resolved within a couple of months. The patient received 2nd dose of Shingles vaccine, later than the recommended interval, which led to lengthening of vaccination schedule. This case was considered as suspected vaccination failure since the details regarding, 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 about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2).
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| 2847665 | 06/27/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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suspected vaccination failure; got shingles 3 years after my original shingles shot; This serious ca...
suspected vaccination failure; got shingles 3 years after my original shingles shot; 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, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles 3 years after my original shingles shot). 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: 21-JUN-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got shingles three years after his/her original shingles shot. The patient mentioned that trust him/her not fun at all. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, 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 regarding completion of primary vaccine schedule, and laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine.
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| 2847666 | 06/27/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; I have had shingles twice after having the two shingles vaccines; Thi...
Suspected vaccination failure; I have had shingles twice after having the two shingles vaccines; 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. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have had shingles twice after having the two shingles vaccines). 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: 22-JUN-2025 This case was reported by a patient via interactive digital media. The patient has had shingles twice after having the two shingles vaccines. 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 Shingles vaccine (Dose 1 & 2).
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| 2847667 | M | 06/27/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; My dad got it 3 times received the vaccine; This serious case was rep...
Suspected vaccination failure; My dad got it 3 times received the vaccine; 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. The patient's past medical history included shingles (had shingles times). 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: My dad got it 3 times received the vaccine). 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: 22-JUN-2025 This case was reported by a consumer via interactive digital media. He received the vaccine but still got it again and it was even worse. Stress was the number one culprit for bringing shingles on. 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 Shingles vaccine.
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| 2847668 | F | MT | 06/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
MG5S9 |
Eye irrigation, Occupational exposure to product
Eye irrigation, Occupational exposure to product
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nurse that got the Shingrix vaccine in her eye while handling it; nurse that got the Shingrix vaccin...
nurse that got the Shingrix vaccine in her eye while handling it; nurse that got the Shingrix vaccine in her eye while handling it; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure to product via eye in a female patient who received Herpes zoster (Shingrix) (batch number MG5S9, expiry date 30-MAR-2027) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced occupational exposure to product via eye (Verbatim: nurse that got the Shingrix vaccine in her eye while handling it) and inadvertent exposure to vaccine (Verbatim: nurse that got the Shingrix vaccine in her eye while handling it). The outcome of the occupational exposure to product via eye and inadvertent exposure to vaccine were not applicable. Additional Information: GSK Receipt Date: 16-JUN-2025 and 17-JUN-2025 The Vaccine Administration Facility was the same as Primary Reporter On 16 June 2025, a pharmacist from Healthcare Center called to report the incident of a nurse that got the Shingrix vaccine in her eye while handling it which led to occupational exposure to product via eye and inadvertent exposure to vaccine. According to the health care provider, the nurse had already washed her eye with water, but he wanted to have an updated version of the Safety Data Sheet for Shingrix since they had an old version, and in consequence for knowing how to proceed in case of eye contact. The pharmacist got the information about the nurse and the vaccine and commented that she was feeling better after washing her eye with water.
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| 2847669 | 57 | F | FL | 06/27/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
PE9G5 |
Expired product administered
Expired product administered
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Expire dose; This non-serious case was reported by a pharmacist via call center representative and d...
Expire dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received HBV (Engerix B) (batch number PE9G5, expiry date 19-MAY-2025) for prophylaxis. Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b). On 16-JUN-2025, the patient received the 2nd dose of Engerix B. On 16-JUN-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expire dose). The outcome of the expired vaccine used 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: 17-JUN-2025 A patient was accidentally administered an expired dose of Engerix-B which led to expired vaccine use. So, the reporter contacted the CDC they said that they would have to repeat the dose. The reporter was trying to find out if there was a grey period between the expiration date and the date of administration, that it might still count. Also, this was the 2nd Engerix-B dose, the 1st was administered on 14th May 2025. The lot number that healthcare professional provided (PE9G5) was for the 2nd dose.
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| 2847670 | 06/27/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
|
Herpes zoster, Inappropriate schedule of product administration
Herpes zoster, Inappropriate schedule of product administration
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a shingles vaccine was given in 2019 and one today; This non-serious case was reported by a nurse vi...
a shingles vaccine was given in 2019 and one today; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (received first dose in 2019). On 17-JUN-2025, the patient received the 2nd dose of Shingles vaccine. On 17-JUN-2025, an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too long (Verbatim: a shingles vaccine was given in 2019 and one today). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 17-JUN-2025 The Licensed Practical Nurse contacted and mentioned product, enquired if a Shingles vaccine was given in 2019 and one today which led to lengthening of vaccination schedule. The reporter enquired if they need another one if it was 6 years between. No clarification was obtained in regard to the specific name of the vaccine.
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| 2847671 | F | GA | 06/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
39H2S |
Product preparation issue
Product preparation issue
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received only the adjuvant of Shingrix as a first dose; received only the adjuvant of Shingrix as a ...
received only the adjuvant of Shingrix as a first dose; received only the adjuvant of Shingrix as a first dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 39H2S, expiry date 10-MAR-2027) 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 inappropriate preparation of medication (Verbatim: received only the adjuvant of Shingrix as a first dose) and inappropriate dose of vaccine administered (Verbatim: received only the adjuvant of Shingrix as a first dose). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 18-JUN-2025 The nurse reported that they may have accidentally administered only the adjuvant portion of the Shingrix vaccine to 1 out of 7 patients, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This had been the first dose of Shingrix for all seven patients. At the time, it was unclear whether any form of immunity screening or antibody titers specific to Shingrix were available. It was also uncertain whether all seven patients would need to be revaccinated due to the possible administration of the adjuvant only. This was 1 of the 7 cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025076586:Same reporter/Diffrent patient US-GSK-US2025076589:Same reporter/Diffrent patient US-GSK-US2025076590:Same reporter/Diffrent patient US-GSK-US2025076593:Same reporter/Diffrent patient US-GSK-US2025076594:Same reporter/Diffrent patient US-GSK-US2025076598:Same reporter/Diffrent patient
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| 2847672 | 58 | M | GA | 06/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
39H2S |
Product preparation issue
Product preparation issue
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A patient could have potentially received only the adjuvant of Shingrix a as a first dose; A patient...
A patient could have potentially received only the adjuvant of Shingrix a as a first dose; A patient could have potentially received only the adjuvant of Shingrix a as a first dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 39H2S, expiry date 10-MAR-2027) 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 inappropriate preparation of medication (Verbatim: A patient could have potentially received only the adjuvant of Shingrix a as a first dose) and inappropriate dose of vaccine administered (Verbatim: A patient could have potentially received only the adjuvant of Shingrix a as a first dose). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 18-JUN-2025 On 18th June 2025, an nurse called to report that they may have accidentally administered only the adjuvant portion of the Shingrix vaccine to 1 out of 7 patients, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. This had been the first dose of Shingrix for all seven patients. At the time, it was unclear whether any form of immunity screening or antibody titers specific to Shingrix were available. It was also uncertain whether all seven patients would need to be revaccinated due to the possible administration of the adjuvant only. This was 1 of the 7 cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025076585:Same reporter/Diffrent patient US-GSK-US2025076589:Same reporter/Diffrent patient US-GSK-US2025076590:Same reporter/Diffrent patient US-GSK-US2025076593:Same reporter/Diffrent patient US-GSK-US2025076594:Same reporter/Diffrent patient US-GSK-US2025076598:Same reporter/Diffrent patient
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| 2847673 | 50 | F | GA | 06/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
39H2S |
Product preparation issue
Product preparation issue
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A patient could have potentially received only the adjuvant of Shingrix a as a first dose; A patient...
A patient could have potentially received only the adjuvant of Shingrix a as a first dose; A patient could have potentially received only the adjuvant of Shingrix a as a first dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 39H2S, expiry date 10-MAR-2027) 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 inappropriate dose of vaccine administered (Verbatim: A patient could have potentially received only the adjuvant of Shingrix a as a first dose) and inappropriate preparation of medication (Verbatim: A patient could have potentially received only the adjuvant of Shingrix a as a first dose). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. Additional Information: GSK receipt date: 18-JUN-2025 A nurse called to report that they accidentally could have administered only the adjuvant portion of Shingrix which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. This would be the first dose of Shingrix. Was there any immunity screening? Any titers test for Shingrix? Do we have to revaccinate all the 7 patients involved in this possible administration of the adjuvant only? This is 1 of the 7 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025076586:Same reporter/Diffrent patient US-GSK-US2025076585:Same reporter/Diffrent patient US-GSK-US2025076590:Same reporter/Diffrent patient US-GSK-US2025076593:Same reporter/Diffrent patient US-GSK-US2025076594:Same reporter/Diffrent patient US-GSK-US2025076598:Same reporter/Diffrent patient
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| 2847674 | M | NY | 06/27/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
|
Product storage error
Product storage error
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A patient received a dose of Arexvy after a temperature excursion.; This non-serious case was report...
A patient received a dose of Arexvy after a temperature excursion.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 88-year-old male 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 incorrect storage of drug (Verbatim: A patient received a dose of Arexvy after a temperature excursion.). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 18-JUN-2025 The pharmacist called to request information about the stability of Arexvy vaccines exposed to 70 degree Fahrenheit for 2 hours. No prior excursion reported. The healthcare professional wanted to know the stability information. The healthcare professional would like to know the recommendations after vaccinating two patients with Arexvy after this temperature excursion. The first patient who received the dose of Arexvy after a temperature excursion was an 88 years old male which led to incorrect storage of drug. This US2025076611 case reporter by same reporter.; Sender's Comments: US-GSK-US2025076611:same reporter
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| 2847675 | F | NY | 06/27/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
|
Product storage error
Product storage error
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A patient received a dose of Arexvy after a temperature excursion; This non-serious case was reporte...
A patient received a dose of Arexvy after a temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 87-year-old female 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 incorrect storage of drug (Verbatim: A patient received a dose of Arexvy after a temperature excursion). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 18-JUN-2025 The pharmacist called to request information about the stability of Arexvy vaccines exposed to 70 deg F for 2 hours. No prior excursion reported. The healthcare professional wanted to know the stability information. The healthcare professional would like to know the recommendations after vaccinating patient with Arexvy after this temperature excursion which led to incorrect storage of drug. The second patient who received the dose of Arexvy after a temperature excursion was an 87 year old female.; Sender's Comments: US-GSK-US2025076610:same reporter
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| 2847676 | F | AK | 06/27/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
Y49BZ |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Patient received a dose of Kinrix out of the recommended age.; This non-serious case was reported by...
Patient received a dose of Kinrix out of the recommended age.; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis. On 21-JAN-2025, the patient received Kinrix. On 21-JAN-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient received a dose of Kinrix out of the recommended age.). 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: 18-JUN-2025 The nurse reported that they administered a dose of Kinrix to 6 different patients under the age of 4 years old, which led to inappropriate age at vaccine administration. The reporter said that did they need to continue with the same schedule as recommended in the package insert. This was 1 of 6 linked cases, reported by the same reporter.; Sender's Comments: GSK-US2025076584:Same reporter/Diffrent patient US-GSK-US2025076588:Same reporter/Diffrent patient US-GSK-US2025076587:Same reporter/Diffrent patient
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| 2847677 | M | AK | 06/27/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
Y49BZ |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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administered a dose of Kinrix to 6 different patients under the age of 4 years old; This non-serious...
administered a dose of Kinrix to 6 different patients under the age of 4 years old; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-month-old male patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis. On 21-JAN-2025, the patient received Kinrix. On 21-JAN-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered a dose of Kinrix to 6 different patients under the age of 4 years old). 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: 18-JUN-2025 The nurse reported that they administered a dose of Kinrix to 6 different patients under the age of 4 years old, which led to inappropriate age at vaccine administration. The reporter said that did they need to continue with the same schedule as recommended in the package insert. This was 1 of 6 linked cases, reported by the same reporter.; Sender's Comments: GSK-US2025076583:Same reporter/Diffrent patient US-GSK-US2025076587:Same reporter/Diffrent patient US-GSK-US2025076588:Same reporter/Diffrent patient US-GSK-US2025076592:Same reporter/Diffrent patient US-GSK-US2025076595:Same reporter/Diffrent patient
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| 2847678 | M | AK | 06/27/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
Y49BZ |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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received a dose of Kinrix out of the recommended age (patient is less than 4 years old); This non-se...
received a dose of Kinrix out of the recommended age (patient is less than 4 years old); This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-month-old male patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis. On 21-JAN-2025, the patient received Kinrix. On 21-JAN-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient received a dose of Kinrix out of the recommended age (patient is less than 4 years old).). 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: 18-JUN-2025 The nurse reported that they administered a dose of Kinrix to 6 different patients under the age of 4 years old, which led to inappropriate age at vaccine administration. The reporter said that did they need to continue with the same schedule as recommended in the package insert. This is 3 of 6 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025076584:Same reporter/Diffrent patient US-GSK-US2025076583:Same reporter/Diffrent patient US-GSK-US2025076588:Same reporter/Diffrent patient US-GSK-US2025076592:Same reporter/Diffrent patient US-GSK-US2025076595:Same reporter/Diffrent patient
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| 2847679 | M | AK | 06/27/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5H95B |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Patient received a dose of Kinrix out of the recommended age (patient is less than 4 years old).; Th...
Patient received a dose of Kinrix out of the recommended age (patient is less than 4 years old).; This non-serious case was reported by a nurse 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 16-FEB-2026) for prophylaxis. On 29-JUL-2024, the patient received Kinrix. On 29-JUL-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient received a dose of Kinrix out of the recommended age (patient is less than 4 years old).). 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: 18-JUN-2025 The register nurse called to report that they administered a dose of Kinrix to 6 different patients under the age of 4 years old. The reporter asked that did they need to continue with the same schedule as recommended in the PI. The male patient was 3 years old now, he received Kinrix on 29th July 2024 which led to inappropriate age at vaccine administration.; Sender's Comments: US-GSK-US2025076587:Same reporter/Diffrent patient US-GSK-US2025076584:Same reporter/Diffrent patient US-GSK-US2025076588:Same reporter/Diffrent patient US-GSK-US2025076592:Same reporter/Diffrent patient
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| 2847680 | 0.25 | M | WI | 06/27/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
AC21B163BC |
Expired product administered
Expired product administered
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Pediarix Expired dose administered; This non-serious case was reported by a other health professiona...
Pediarix Expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number AC21B163BC, expiry date 06-OCT-2008) for prophylaxis. On 28-OCT-2008, the patient received Pediarix. On 28-OCT-2008, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Pediarix Expired dose administered). The outcome of the expired vaccine used 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: 18-JUN-2025 A medical assistant reported that the patient received an expired dose of Pediarix in 2008. The expiration date was 6th Oct 2008, and the vaccine was given on 28th Oct 2008 which led to Expired vaccine used. The medical assistant asked if this dose was considered valid.; Sender's Comments: US-GSK-US2025076591:Same reporter/Diffrent patient
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| 2847681 | F | 06/27/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
|
Antibody test negative
Antibody test negative
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no titers after administration/zero immunity; This non-serious case was reported by a consumer via c...
no titers after administration/zero immunity; This non-serious case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a female patient who received MMR (Priorix) for prophylaxis. In APR-2025, the patient received Priorix (subcutaneous use). On an unknown date, an unknown time after receiving Priorix, the patient experienced therapy non-responder (Verbatim: no titers after administration/zero immunity). The outcome of the therapy non-responder 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: 20-JUN-2025 The patient called to request information about Priorix and the development of titers after vaccination. The patient received a dose of the GlaxoSmithKline MMR vaccine (did not confirm it was Priorix but it was from GlaxoSmithKline), and after receiving the dose in late April 2025, no titers were developed (reported: zero immunity). The patient was unsure if any previous doses had been administered. A pharmacist recommended receiving another dose, checking titers again, and, if there was still no response, consulting with an immunologist. The vaccine administration facility was the same as the primary reporter.
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| 2847682 | M | FL | 06/27/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A...
COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 71-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "slightly anemic" (not ongoing); "used to be a smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, start date: 2025. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jun2025, outcome "recovering" and all described as "COVID". Clinical course: The patient had been diagnosed with COVID on 24Jun2025 and stated that about 3 to 5 years ago took the vaccinations with the booster. The patient had gotten better. On 24Jun2025 was probably the worst day, was miserable on 23Jun2025 night and 24Jun2025. He was doing better on 25Jun2025. The patient took within the last couple of days codeine, Tylenol and a nasal spray called fluticasone propionate with no issue. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500129432 Same Pt/Vaccine, Diff Dose/AE;
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| 2847684 | NY | 06/27/2025 |
IPV |
SANOFI PASTEUR |
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Product storage error
Product storage error
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vaccine administered to patient after excursion of max temperature reached: 9.3 degrees celsius for ...
vaccine administered to patient after excursion of max temperature reached: 9.3 degrees celsius for 1 hour 5 minutes, then 8.2 degrees celsius for 3 minutes (1 hour 8 minutes) with no reported ae; Initial information received on 24-Jun-2025 regarding an unsolicited valid non-serious case received from Nurse. This case involves an unknown age and unknown gender patient where IPV (VERO) [IPOL] vaccine was administered to patient after excursion of max temperature reached: 9.3 degrees celsius for 1 hour 5 minutes, then 8.2 degrees celsius for 3 minutes (1 hour 8 minutes) 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, vaccine was administered to patient with 0.5 ml 1x (once) dose of suspect IPV (VERO) Suspension for injection lot number not reported via unknown route in unknown administration site (strength, lot/batch number and expiration date: not provided) for immunization after excursion of max temperature reached: 9.3 degrees celsius for 1 hour 5 minutes, then 8.2 degrees celsius for 3 minutes (1 hour 8 minutes) with no reported ae (poor quality product administered) (latency- same day). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested. 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.
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| 2847685 | 65 | F | AZ | 06/27/2025 |
PNC20 TD VARZOS |
PFIZER\WYETH SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
LK6655 U8384AA L2ZK2 |
Purpura, Rash; Purpura, Rash; Purpura, Rash
Purpura, Rash; Purpura, Rash; Purpura, Rash
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Purpuric rash bilateral LE and abdomen. Diagnosed at ED, no notes available for review at time of th...
Purpuric rash bilateral LE and abdomen. Diagnosed at ED, no notes available for review at time of this submission. Received prednisone and hydroxyzine at ED and symptoms resolved after about 1 week.
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| 2847686 | 58 | M | NJ | 06/27/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
ER8733 ER8733 ER8733 ER8733 ER8733 ER8733 ER8731 ER8731 ER8731 ER8731 ER8731 ER8731 |
Autonomic nervous system imbalance, Blindness transient, Blood test, Bradycardia...
Autonomic nervous system imbalance, Blindness transient, Blood test, Bradycardia, COVID-19; Cardiac stress test, Chest X-ray, Computerised tomogram head, Computerised tomogram thorax, Deep vein thrombosis; Dizziness, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Electrocochleogram; Electroencephalogram, Fatigue, Magnetic resonance imaging head, Meniere's disease, Postural orthostatic tachycardia syndrome; Presyncope, Syncope, Tachycardia, Tilt table test positive, Ultrasound Doppler; Vertigo; Autonomic nervous system imbalance, Blindness transient, Blood test, Bradycardia, COVID-19; Cardiac stress test, Chest X-ray, Computerised tomogram head, Computerised tomogram thorax, Deep vein thrombosis; Dizziness, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Electrocochleogram; Electroencephalogram, Fatigue, Magnetic resonance imaging head, Meniere's disease, Postural orthostatic tachycardia syndrome; Presyncope, Syncope, Tachycardia, Tilt table test positive, Ultrasound Doppler; Vertigo
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4-13-21; Driven home from work with lightheadedness; 6-03-21: DVT's right leg; 8-05-21: Driven ...
4-13-21; Driven home from work with lightheadedness; 6-03-21: DVT's right leg; 8-05-21: Driven home from work with lightheadedness, near syncope; 8-10-21: Driven to hospital from work with lightheadedness, near syncope. Overnight in hospital--tachycardia. Through 2022: Continued issues with lightheadedness, transient visual obscuration (TVO's), and unexplained autonomic dysfunction; 5-25-22 Failed Tilt Table Test- POTS diagnosis; 5-25-22: FIRST COVID DIAGNOSIS; 10-13-22: Ambulance from work--1st Vertigo Attack. After serveral months, diagnosed with Meniere's Disease. Continues to-date with these issues including Bradychardia, fatigue. Latest revised diagnosis related to autonomic dysfunction is, "Veso Depressor Syncope"
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| 2847687 | 11 | M | OH | 06/27/2025 |
MNQ MNQ MNQ MNQ MNQ MNQ MNQ MNQ |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U8259AA-PVT U8259AA-PVT U8259AA-PVT U8259AA-PVT U8259AA U8259AA U8259AA U8259AA |
Hypersensitivity, Injection site erythema, Injection site oedema, Injection site...
Hypersensitivity, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction; Injection site swelling, Rash macular; Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth; Myalgia, Pyrexia, Skin tightness; Hypersensitivity, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction; Injection site swelling, Rash macular; Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth; Myalgia, Pyrexia, Skin tightness
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Patient presents with mother to the facility this date following a vaccine reaction given by Public ...
Patient presents with mother to the facility this date following a vaccine reaction given by Public Health on 06/25/2025. Mother reports onset of symptoms occurred last night, 06/26/2025 to include temperature of 100.1, erythema, and edema to the left upper extremity extending mid upper arm. Examination unremarkable with the exception of a flat, reddened rash and mild- moderate edema localize to the left upper extremity, starting at superior aspect of extremity extending to mid upper extremity. Injection site raised, measuring approximately 10mm x 8mm with erythema, edema, warmth and tenderness to touch. Otherwise, general appearance normal. Patient/mother instructed to continue with children's Tylenol and ibuprofen as directed on packaging. To apply cold compress to affected area five times per day x 10 minutes as needed. May also use children's Benadryl as directed on packaging. Discussed red flag symptoms in which to present to nearest ER. Reassured mother of localized allergic reaction, who stated patient's left upper arm is already getting better, that this is likely a delayed onset reaction, not uncommon, and the fact that it is already improving is a good sign. Informed her vaccinate benefits still outweighs risk. Informed mother reaction site should continue getting better and be resolved within the next week or so. Otherwise, she is to return to either location of administration or the facility.
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| 2847688 | 50 | F | VA | 06/27/2025 |
PNC20 |
PFIZER\WYETH |
LX4482 |
Erythema, Peripheral swelling, Urticaria
Erythema, Peripheral swelling, Urticaria
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Patient had reported that the next day she got hives, swelling and redness in a large area on her ar...
Patient had reported that the next day she got hives, swelling and redness in a large area on her arm for 3 weeks. She went to see MD the first week and her doctor said she is allergic to Prevnar 20. It went away after 3 weeks, she is ok now but she wants to report it.
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| 2847694 | 87 | F | MO | 06/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
35A77 |
Erythema, Peripheral swelling, Skin warm
Erythema, Peripheral swelling, Skin warm
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Pt has a red, swollen, warm arm after her vaccination. I discussed she can use ice, tylenol, and ib...
Pt has a red, swollen, warm arm after her vaccination. I discussed she can use ice, tylenol, and ibuprofen
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| 2847695 | 12 | F | ID | 06/27/2025 |
MNQ |
SANOFI PASTEUR |
U7996BB |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient came in for 12 year well child appointment. She cancelled her 11 year well child and had not...
Patient came in for 12 year well child appointment. She cancelled her 11 year well child and had not been seen since she was 9 years old. I gave her the 11/12 year old immunizations- they did not show previously given in her chart. Parent of child did not express that she had received her immunizations at 11 since she was not seen. I always double check with the parents the immunizations that are needed/given. act(s) contributed to the incident? I checked her chart- which showed she had not had these immunizations. I did not check database because parent did not inform me that she may have had them, she was seen before and she was not from out of state. These are usually the reasons I double check database. Database is not always checked by back office because not all employees have a database log in. Because I informed the parent of the need of immunizations and they did not inform me of previous immunizations given. No adverse reactions have been reported over the past year.
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| 2847696 | 53 | F | CA | 06/27/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
594G2 594G2 |
Abdominal pain, Arthralgia, Asthenia, Clumsiness, Dizziness; Gait disturbance, H...
Abdominal pain, Arthralgia, Asthenia, Clumsiness, Dizziness; Gait disturbance, Headache, Oedema peripheral, Pain, Pain in extremity
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In serious pain on the shoulder all the way down to the wrists with bodyaches, had swelling in the a...
In serious pain on the shoulder all the way down to the wrists with bodyaches, had swelling in the armpit of the left arm where vaccine was given but swelling has gone down. Other things going on are feeling weak, unsteady, almost clumsy, dizziness, abd pain, headaches.
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| 2847697 | 16 | M | AZ | 06/27/2025 |
HPV9 MENB MNQ |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
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Anxiety, Blood pressure abnormal, Nervousness, Pallor, Vomiting; Anxiety, Blood ...
Anxiety, Blood pressure abnormal, Nervousness, Pallor, Vomiting; Anxiety, Blood pressure abnormal, Nervousness, Pallor, Vomiting; Anxiety, Blood pressure abnormal, Nervousness, Pallor, Vomiting
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When into pt room, verified correct pt, Verified with mom she read VIS, Pt mother stated he hadn...
When into pt room, verified correct pt, Verified with mom she read VIS, Pt mother stated he hadn't aten anything. Pt was feeling nervous and anxious. Gave pt vaccines pt was fine. Walked out the room, pt mother asked us for water, gave pt water and popsicle , Pt looked paled and wanted to throw up, grabbed vomiting bag, Pt started throwing up spit, pt looked pale, Other M.A. took blood pressure, we repeated taking blood pressure till normal range, Doctor when in 2 times to check up on patient. Pt left after 30 minuets of observation
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| 2847698 | 18 | M | FL | 06/27/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
y3z9p |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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I did not look at shot database. It has only been 7 years since last shot. Haven't been able to...
I did not look at shot database. It has only been 7 years since last shot. Haven't been able to reach patient as of yet.
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| 2847699 | 74 | F | FL | 06/27/2025 |
HEP RSV |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS |
946889 F4AC3 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Vaccine was administered outside of ACIP guidelines. (Patient received 1st dose 1/14/25)
Vaccine was administered outside of ACIP guidelines. (Patient received 1st dose 1/14/25)
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| 2847700 | 85 | F | FL | 06/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7ZZM55 |
Injected limb mobility decreased
Injected limb mobility decreased
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patient could not move left arm starting about 4:30pm, EMT was called and they stated it was not a r...
patient could not move left arm starting about 4:30pm, EMT was called and they stated it was not a reaction to the vaccine but may have hit a nerve. It is 75% better as stated by patient.
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| 2847701 | 8 | M | UT | 06/27/2025 |
COVID19 |
PFIZER\BIONTECH |
md3414 |
No adverse event
No adverse event
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none reported, spoke with parent at 7:45 pm about 1.5 hours after the vaccine was given and he state...
none reported, spoke with parent at 7:45 pm about 1.5 hours after the vaccine was given and he stated there were no current adverse events
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| 2847702 | 13 | TX | 06/27/2025 |
HPV9 |
MERCK & CO. INC. |
Y014059 |
Dizziness, Syncope
Dizziness, Syncope
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Pt. fainted / dizzy per mother.
Pt. fainted / dizzy per mother.
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| 2847703 | 11 | M | AR | 06/27/2025 |
MNP TDAP |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LP7146 793PT |
Rash, Rash erythematous, Rash macular; Rash, Rash erythematous, Rash macular
Rash, Rash erythematous, Rash macular; Rash, Rash erythematous, Rash macular
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A red, splotchy rash developed on patient's left arm the day after Penbraya was administered in...
A red, splotchy rash developed on patient's left arm the day after Penbraya was administered into left arm.
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| 2855866 | M | DC | 06/27/2025 |
RAB |
NOVARTIS VACCINES AND DIAGNOSTICS |
FDP00447 |
Inappropriate schedule of product administration, Malaise, Pyrexia, Viral infect...
Inappropriate schedule of product administration, Malaise, Pyrexia, Viral infection
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The patient receive the second dose of RabAvert on day 8 due to disease; The patient was sick with f...
The patient receive the second dose of RabAvert on day 8 due to disease; The patient was sick with fever, described as viral illness; The patient was sick with fever, described as viral illness; Case reference number US-BN-2024-002277 is a spontaneous case initially received from nurse via Communication (reference number USBAV24-1827) on 31-Jul-2024 and concerns a 6-year-old child male patient born. The patient's medical history and concomitant medication were not reported. On 24-Jul-2024, reported as week ago, the patient received the first dose of RabAvert (batch number: FDP00447, expiration date: 30-Nov-2025), at a dose of 0.5 cc, administered intramuscular at left deltoid, for pre-exposure vaccination. On 27-Jul-2024, reported as three to four days after first vaccination the patient experienced moderate fever, which patient's mother described as viral illness. As reported, no laboratory test or investigation were performed because fever. On an unspecified date, the patient was sick with fever. On 30-Jul-2024, the patient recovered from moderate fever and *viral infection.* On 01-Aug-2024, eight days after first dose of RabAvert, patient received the second dose of RabAvert (batch number: FDP00555, expiration date: 30-Sep-2027), at a dose of 0.5 cc, administered intramuscular at left deltoid (explicitly coded as 'Inappropriate schedule of vaccine administered'). As reported, the patient did not receive second dose of RabAvert vaccine on scheduled date due do disease and second dose was delayed by one day. As reported, there were no complications during recovery from the events of 'fever' and 'viral infection'. *As reported, none of other medications were reported by patient's parent at the time of the events of viral infection and fever or two weeks before the events started.* The reporter assessed the events 'viral infection' and 'fever' as non-serious and causality assessment for the events 'viral infection' and 'fever' was reported as not related. The case is linked to case ID US-BN-2024-002276 due to same report and family member. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Additional information received from a nurse on 01-Aug-2024: included reference number (US-20240731-20bdca). Follow up information received from the reporter on 13-Aug-2024, new information included: patient's details, RabAvert dosing information for the first and second dose, stop date and outcome for the event of 'fever', clarification that the event of 'sickness' was described as viral illness (event recoded to PT: Viral infection), outcome for the event of 'viral infection', causality assessment for the events of 'fever' and 'viral infection' and confirmation that no laboratory test or investigation were performed due to moderate fever. Follow up information received from the reporter on 28-Aug-2024: New information included start and stop date for event of viral infection and confirmation that none of other medications were reported at the time of the events of viral infection and fever or two weeks before the events started.; Reporter's Comments: A 6-year-old male child experienced fever, three days after the first dose of RabAvert. This was described to be associated with a viral illness. The patient's second dose was delayed by one day, which is considered inappropriate schedule of vaccine administered. Viral infection is unlisted and unexpected, whereas fever is listed and expected per CCDS v4.0 and USPI for RabAvert. Inappropriate schedule of product administration is considered listed per company convention. The patient recovered. The patient's medical history and concomitant medication were not reported. The viral infection and pyrexia are assessed as unrelated to RabAvert, but to an unspecified viral disease in this pediatric patient. Inappropriate schedule of product administration is assessed as not related to suspect product, but to human factors. The case is non-serious.; Sender's Comments: A 6-year-old male child experienced fever, three days after the first dose of RabAvert. This was described to be associated with a viral illness. The patient's second dose was delayed by one day, which is considered inappropriate schedule of vaccine administered. Viral infection is unlisted and unexpected, whereas fever is listed and expected per CCDS v4.0 and USPI for RabAvert. Inappropriate schedule of product administration is considered listed per company convention. The patient recovered. The patient's medical history and concomitant medication were not reported. The viral infection and pyrexia are assessed as unrelated to RabAvert, but to an unspecified viral disease in this pediatric patient. Inappropriate schedule of product administration is assessed as not related to suspect product, but to human factors. The case is non-serious. USBAV24-1827:
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| 2847307 | M | 06/26/2025 |
VARCEL |
MERCK & CO. INC. |
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Antibody test negative
Antibody test negative
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Customer called and reported that her adult son received VARIVAX as a child, but he recently had a t...
Customer called and reported that her adult son received VARIVAX as a child, but he recently had a titer which showed no immunity. The customer reports that he is going to receive a booster dose of VARIVAX. She asks if he should receive 1 or 2 doses; This spontaneous report was received from a consumer or other non health professional and refers to a adult male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date (when patient was a child), he was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) as prophylaxis, reconstituted with a sterile diluent (MERCK STERILE DILUENT) (dose, indication, expiration date, and lot # were not reported). On an unknown date (reported as recently), the patient had a titer which showed no immunity (antibody test negative). In addition, it was informed that he was going to receive a booster dose of the suspect vaccine and asked if he should receive 1 or 2 doses. At the reporting time, the patient had not recovered from the event. The causal relationship between the event and the suspect vaccine was not provided. Additional information is not expected.
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