chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HBP calling reporting that a patient received an improperly stored PROQUAD.  Reference TE case #02780764. HBP reported that the PROQUAD underwent a TE on 03/06/2025. HBP reported that the date of the administration was 03/27/2025. No symptoms or side; Information has been received from Business Partner/CRO on 01-Apr-2025.  This spontaneous report was received from a 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 therapies were not reported.   On 27-Mar-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y009589, expiration date: 17-Nov-2025) 0.5 mL for prophylaxis. On 27-Mar-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported) for prophylaxis. This vaccination underwent temperature excursion in 39.44 Fahrenheit for 1 hour 35 minutes (Product storage error). No additional adverse event was reported.
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptomatic adverse events were reported. No additional information is available. No additional AE; HCP called to report that the patient inadvertently received an extra dose of PROQUAD.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-APR-2025, the patient was inadvertently vaccinated with an extra dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, 0.5 milliliters (mL), lot #Y019465; which has been verified to be valid for of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, with an expiration date reported and establish as 24-MAY-2026, administered for prophylaxis (strength, route and anatomical site of administration were not provided), with the sterile diluent (BAXTER STERILE DILUENT), lot #1973306; which has been verified to be valid, with an expiration date reported and establish as 30-OCT-2026 (Extra dose  administered). No symptomatic adverse events were reported (No adverse event).
Sex: F
Vaccine: PNC21
Symptoms: Pain, Swelling
Clinical narrative: some swelling; Pain; This spontaneous report was received from field-based employee (FBE) and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (strength, dose, dose number, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced some swelling and pain.  The primary reporter could not confirm if swelling and pain started before or after patient was administered Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE). The patient went to a hospital to seek treatment for pain and swelling about one week ago and unknown if patient was admitted.  At the reporting time, the outcome of some swelling and Pain was unknown.   The causal relationship between both events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No side effects or symptoms have been reported.; 41-year-old female received a dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a 41-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 04-APR-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) Injection (lot #Y019464, expiration date: 24-MAY-2026) 0.5 mL as prophylaxis. The vaccine was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot # and expiration date was not provided) (inappropriate age at vaccine administration). No adverse event was reported.
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant 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 was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event).   Follow-up information has been received from reporter on 01-APR-2025. On 08-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # Y018156, expiration date 29-Apr-2026). The temperature excursion was 5.7 degree Fahrenheit for 30 hours 30 minutes.   This previous invalid report become valid since patient information was reported.  This is one of several reports received from the same reporter.
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant 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 was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event).   Follow-up information has been received from reporter on 01-APR-2025. On 10-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # Y018156, expiration date 29-Apr-2026). The temperature excursion was 5.7 degree Fahrenheit for 30 hours 30 minutes.   This previous invalid report become valid since patient information was reported.  This is one of several reports received from the same reporter.
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant 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 was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event).   Follow-up information has been received from reporter on 01-APR-2025. On 18-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # Y018156, expiration date 29-Apr-2026). The temperature excursion was 6.6 degree Fahrenheit for 81 hours.   This previous invalid report become valid since patient information was reported.  This is one of several reports received from the same reporter.
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant 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 was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event).   Follow-up information has been received from reporter on 01-APR-2025. On 19-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # Y018156, expiration date 29-Apr-2026). The temperature excursion was 6.6 degree Fahrenheit for 90 hours.   This previous invalid report become valid since patient information was reported.  This is one of several reports received from the same reporter.
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant 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 was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event).   Follow-up information has been received from reporter on 01-APR-2025. On 20-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # Y018156, expiration date 29-Apr-2026). The temperature excursion was 6.6 degree Fahrenheit for 90 hours.   This previous invalid report become valid since patient information was reported.  This is one of several reports received from the same reporter.
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; medical assistant who reports temperature excursion products PROQUAD and VARIVAX were administered to patients. Diluent not involved in excursion.; This spontaneous report was received from a physician assistant 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 was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # and expiration date were not reported) as prophylaxis which experienced temperature excursion (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which was not involved in excursion. No additional adverse event (AE) reported (No adverse event).   Follow-up information has been received from reporter on 01-APR-2025. On 21-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # Y018156, expiration date 29-Apr-2026). The temperature excursion was 6.8 degree Fahrenheit for 115 hours.   This previous invalid report become valid since patient information was reported.  This is one of several reports received from the same reporter.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: HCP called to state that she ran titers for a patient and she is showing no immunity for VARIVAX; This spontaneous report was received from a Nurse Practitioner on 07-Apr-2025 and refers to a 61-year-old female patient.   The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT) (reported as DILUENT MRK) used to reconstitute the vaccine.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka-Merck) (VARIVAX) (0.5mL/ series; formulation, route, lot # and expiration date were not reported) for Prophylaxis. The patient's vaccine history was unknown, so this case was serving as a precautionary adverse event (AE).  On an unknown date, the reporter ran titers for the patient, who showed no immunity for the varicella virus vaccine live (Oka-Merck) (VARIVAX) (Immunodeficiency).   The action taken with varicella virus vaccine live (Oka-Merck) (VARIVAX) was reported as Dose not changed.   At the reporting time, the outcome of Immunodeficiency was unknown.   The causal relationship between the event of Immunodeficiency and varicella virus vaccine live (Oka-Merck) (VARIVAX) was not provided.   Upon internal review, the event of Immunodeficiency was determined to be medically significant.
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: so far has not experienced any side effects; patient was accidently administered an expired dose of PNEUMOVAX 23 on Apr 10, 2025; This spontaneous report was received from a licensed practical nurse (LPN) referring 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 therapies were not reported.   On 10-Apr-2025, the patient was accidently administered an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (lot #X014729, expiration date: 22-Nov-2024) 0.5 mL for prophylaxis (strength and route of administration were not reported) (Expired product administered).  At the time of the call, the reporter stated the patent received expired dose within the past thirty minutes, and so far, the patient had not experienced any side effects (No adverse event). At the reporting time, the outcome of the events was unknown. No further information provided. No additional adverse event (AE) or product quality complaint (PQC) was reported.   The action taken with Pneumococcal Vaccine, Polyvalent (23-valent) was reported as not applicable.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No Additional AE; 12-month-old patient received an adult dose of VAQTA for their initial vaccination; This spontaneous report was received from an Other health professional and referred to a 12-month-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 an adult dose of Hepatitis A Vaccine, Inactivated (VAQTA INJ 50/1.0 U/ml) Injection (lot #Y009094, expiration date: 29-Nov-2025), dose number 1, 1 mL for prophylaxis (overdose). No Additional AE.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AE; inadvertent administration of PROQUAD to an adult patient on 11APR2025 who was supposed to receive a dose of MMR-II; This spontaneous report was received from a registered nurse and refers to an adult female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Historical drug included Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) in 1993.  The reporter reported inadvertent administration of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) for prophylaxis to an adult patient on 11-APR-2025 who was supposed to receive a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) for prophylaxis. Both suspect vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT). No additional adverse event. The dose, strength, route, lot number and expiration date were not reported for suspect products.  Lot number is being requested and will be submitted if received.
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: unknown cause of death; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in an unspecified number of patients 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 unknown cause of death (Verbatim: unknown cause of death) (serious criteria death and GSK medically significant). The reported cause of death was unknown.   The reporter considered the unknown cause of death to be related to Shingles vaccine.     The company considered the unknown cause of death to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-APR-2025 This case was reported by a consumer via interactive digital media. The reporter stated that some had passed from shingles shot. This case was linked with case US2025AMR045186,reported by the same reporter.; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR045186:same reporter /different patient; Reported Cause(s) of Death: unknown cause of death
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: got a very painful shingles two weeks later and it's been over three months and they were so painful; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: got a very painful shingles two weeks later and it's been over three months and they were so painful). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date:06-FEB-2024 This case was reported by a patient via interactive digital media The patient took Shingrix vaccine shots and two weeks later had the worse case of shingles and it's been over three months and they were so painful and stated hope he/she never get them again. The patient stated that after his/her close friend developed shingles, the patient saw how painful it could really be and live a full life and didn't want shingles to get in the way and here's the patient's story on why he/she started a conversation with his/her doctor about his/her shingles risk.
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Contusion, Mobility decreased, Pain in extremity, Skin warm
Clinical narrative: armpit painful; aching; unable to move full range of motion; warm to touch; bruising; This non-serious case was reported by a consumer and described the occurrence of axillary pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included gastroesophageal reflux disease. Concomitant products included pantoprazole sodium sesquihydrate (Protonix).   On 26-MAR-2025 20:00, the patient received Shingrix. On 28-MAR-2025, 2 days after receiving Shingrix, the patient experienced axillary pain (Verbatim: armpit painful), pain (Verbatim: aching), mobility decreased (Verbatim: unable to move full range of motion), skin warm (Verbatim: warm to touch) and contusion (Verbatim: bruising). The outcome of the axillary pain, pain, mobility decreased and skin warm were not resolved and the outcome of the contusion was not reported.   It was unknown if the reporter considered the axillary pain, pain, mobility decreased, skin warm and contusion to be related to Shingrix.     It was unknown if the company considered the axillary pain, pain, mobility decreased, skin warm and contusion to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-MAR-2025 The patient self-reported this case for herself. Consumer reported that she took the Shingrix vaccine on Wednesday at 8pm (from the date of reporting) and experienced armpit painful, aching, unable to move full range of motion, warm to touch, it moved into the above pictures Friday, Saturday and Sunday. The bruising started on Friday evening; she had reached out to her PCP (primary care physician) for Monday morning.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Infection, Injection site erythema, Injection site warmth
Clinical narrative: she had an infection; Redness on left arm; she was having redness at injection site which got worsened; injection site of her left arm was hot to the touch; skin was blotchy at injection site; Fever; Bodyaches; Shivering; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 47n3y) for prophylaxis.   On 30-MAR-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 01-APR-2025, 2 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: she was having redness at injection site which got worsened), injection site warmth (Verbatim: injection site of her left arm was hot to the touch ), injection site reaction (Verbatim: skin was blotchy at injection site), fever (Verbatim: Fever), general body pain (Verbatim: Bodyaches) and shivering (Verbatim: Shivering). On 02-APR-2025, the patient experienced infection (Verbatim: she had an infection) and erythema of extremities (Verbatim: Redness on left arm). The outcome of the injection site erythema, injection site warmth, injection site reaction, general body pain, shivering, infection and erythema of extremities were not resolved and the outcome of the fever was unknown.   The reporter considered the injection site erythema, injection site warmth, injection site reaction, fever, general body pain and shivering to be related to Shingrix. The reporter considered the infection to be unrelated to Shingrix. It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.     The company considered the injection site erythema, injection site warmth, injection site reaction, fever, general body pain and shivering to be related to Shingrix. The company considered the infection to be unrelated to Shingrix. It was unknown if the company considered the erythema of extremities to be related to Shingrix.   Additional Information: GSK receipt date: 03-APR-2025 HCP was the reporter. Reporter stated 48 hours after the vaccine was administered the patient complained the injection site of her left arm was hot to the touch, her skin was blotchy at injection site, she was having redness at injection site, fever (temperature not reported) body aches, and shivering. The reporter stated the consumer went to urgent care 2 APR 2025 and was told that she had an infection. The reporter also stated the redness on the left arm at the injection site has spread to the entire left arm as of 2nd April 2025. The reporter was unable to specify where or what type of infection the consumer was diagnosed with. The reporter stated the consumer scheduled an appointment with her PCP 3rd April 2025 for evaluation and was being examined by the PCP at the time of reporting. No further information was obtained or provided.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash macular
Clinical narrative: she had an infection; Redness on left arm; she was having redness at injection site which got worsened; injection site of her left arm was hot to the touch; skin was blotchy at injection site; Fever; Bodyaches; Shivering; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 47n3y) for prophylaxis.   On 30-MAR-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 01-APR-2025, 2 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: she was having redness at injection site which got worsened), injection site warmth (Verbatim: injection site of her left arm was hot to the touch ), injection site reaction (Verbatim: skin was blotchy at injection site), fever (Verbatim: Fever), general body pain (Verbatim: Bodyaches) and shivering (Verbatim: Shivering). On 02-APR-2025, the patient experienced infection (Verbatim: she had an infection) and erythema of extremities (Verbatim: Redness on left arm). The outcome of the injection site erythema, injection site warmth, injection site reaction, general body pain, shivering, infection and erythema of extremities were not resolved and the outcome of the fever was unknown.   The reporter considered the injection site erythema, injection site warmth, injection site reaction, fever, general body pain and shivering to be related to Shingrix. The reporter considered the infection to be unrelated to Shingrix. It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.     The company considered the injection site erythema, injection site warmth, injection site reaction, fever, general body pain and shivering to be related to Shingrix. The company considered the infection to be unrelated to Shingrix. It was unknown if the company considered the erythema of extremities to be related to Shingrix.   Additional Information: GSK receipt date: 03-APR-2025 HCP was the reporter. Reporter stated 48 hours after the vaccine was administered the patient complained the injection site of her left arm was hot to the touch, her skin was blotchy at injection site, she was having redness at injection site, fever (temperature not reported) body aches, and shivering. The reporter stated the consumer went to urgent care 2 APR 2025 and was told that she had an infection. The reporter also stated the redness on the left arm at the injection site has spread to the entire left arm as of 2nd April 2025. The reporter was unable to specify where or what type of infection the consumer was diagnosed with. The reporter stated the consumer scheduled an appointment with her PCP 3rd April 2025 for evaluation and was being examined by the PCP at the time of reporting. No further information was obtained or provided.
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: trouble withdrawing the Priorix out of the vial after reconstitution; changed the needle from 25 g to 21g and still could not withdraw the vaccine out of antigen vial; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) (batch number 955E2, expiry date 13-SEP-2026) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: trouble withdrawing the Priorix out of the vial after reconstitution) and wrong technique in drug usage process (Verbatim: changed the needle from 25 g to 21g and still could not withdraw the vaccine out of antigen vial). The outcome of the inappropriate preparation of medication and wrong technique in drug usage process 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: 03-APR-2025 The registered pharmacist reported that he had trouble withdrawing the Priorix out of the vial after reconstitution and he changed the needle from 25G to 21G and still could not withdraw the vaccine out of antigen vial and was not sure if the correct syringe was used the first time, which led to wrong technique in drug usage process and inappropriate preparation of medication. The reporter tried again and was able to withdraw the vaccine from the antigen vial and was able to administer the suspect product
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Diarrhoea, Headache, Myalgia, Nausea
Clinical narrative: Muscle ache; Chills; Fever; Diarrhea NOS; Headache; Nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 05-APR-2025, the patient received Arexvy (intramuscular, left deltoid). On 05-APR-2025, several minutes after receiving Arexvy, the patient experienced headache (Verbatim: Headache) and nausea (Verbatim: Nausea). On 06-APR-2025, the patient experienced muscle pain (Verbatim: Muscle ache), chills (Verbatim: Chills), fever (Verbatim: Fever) and diarrhea (Verbatim: Diarrhea NOS). The outcome of the headache, nausea, muscle pain, chills, fever and diarrhea were resolving.   It was unknown if the reporter considered the headache, nausea, muscle pain, chills, fever and diarrhea to be related to Arexvy.     It was unknown if the company considered the headache, nausea, muscle pain, chills, fever and diarrhea to be related to Arexvy.   Additional Information: GSK Receipt Date: 07-APR-2025 The patient self-reported this case. The patient received Arexvy vaccine and within a few minutes she had headache and nausea.  On the next day of vaccination she started having chills, fever, muscle aches and diarrhea and stated that the symptoms have all improved, however they are all ongoing.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: Muscle ache; Chills; Fever; Diarrhea NOS; Headache; Nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 05-APR-2025, the patient received Arexvy (intramuscular, left deltoid). On 05-APR-2025, several minutes after receiving Arexvy, the patient experienced headache (Verbatim: Headache) and nausea (Verbatim: Nausea). On 06-APR-2025, the patient experienced muscle pain (Verbatim: Muscle ache), chills (Verbatim: Chills), fever (Verbatim: Fever) and diarrhea (Verbatim: Diarrhea NOS). The outcome of the headache, nausea, muscle pain, chills, fever and diarrhea were resolving.   It was unknown if the reporter considered the headache, nausea, muscle pain, chills, fever and diarrhea to be related to Arexvy.     It was unknown if the company considered the headache, nausea, muscle pain, chills, fever and diarrhea to be related to Arexvy.   Additional Information: GSK Receipt Date: 07-APR-2025 The patient self-reported this case. The patient received Arexvy vaccine and within a few minutes she had headache and nausea.  On the next day of vaccination she started having chills, fever, muscle aches and diarrhea and stated that the symptoms have all improved, however they are all ongoing.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Completed shingles immunization series in 2022, was diagnosed with shingles last week/ suspected vaccination failure; Completed shingles immunization series in 2022, was diagnosed with shingles last week; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 65-year-old male 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: Completed shingles immunization series in 2022, was diagnosed with shingles last week/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Completed shingles immunization series in 2022, was diagnosed with shingles last week). The patient was treated with prednisone and valaciclovir (Valacyclovir). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   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. The company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 07-APR-2025 The patient completed shingles immunization series in 2022, was diagnosed with shingles last week. Male patient 65 years old showed up with rash on left arm, blisters and pain. The patient was treated with prednisone and valacyclovir due to suspected case of 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 provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2).
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: subcutaneous product administered by other route; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in an specified number of patients who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular) .5 ml. On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: subcutaneous product administered by other route). The outcome of the subcutaneous injection formulation administered by other route 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-APR-2025 The reporter stated that 12 patients were given a dose of Priorix intramuscularly instead of subcutaneously.  HCP was asked for initials, gender, DOB, lot number, location of IM injection, and date of administration for all 12 patients.  The reporter did not want to give the information at the time of the call. The patients received Priorix intramuscularly instead of subcutaneously, which led to subcutaneous injection formulation administered by other route.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not yet received his second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not yet received his second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 09-APR-2025 The patient self-reported this case. The patient received his first dose of Shingrix and he had not yet received his second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Malaise, Nausea, Vomiting
Clinical narrative: not feeling well; nauseous; feeling very weak; wanting to throw up; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-MAR-2025, the patient received the 2nd dose of Shingrix. On 27-MAR-2025, 1 days after receiving Shingrix, the patient experienced feeling unwell (Verbatim: not feeling well), nausea (Verbatim: nauseous), weakness (Verbatim: feeling very weak) and vomiting (Verbatim: wanting to throw up). The outcome of the feeling unwell was not resolved and the outcome of the nausea, weakness and vomiting were not reported.   The reporter considered the feeling unwell, nausea, weakness and vomiting to be related to Shingrix.     The company considered the feeling unwell, nausea, weakness and vomiting to be related to Shingrix.   Additional Information: GSK receipt date: 31-MAR-2025 The patient received the 2nd dose of Shingrix on 26 March, but today on March 27 she woke up not feeling well feeling, very weak, very nauseous, wanting to throw up and she felt a little bit better in the middle of the day and then the evening she continued to not feel well. That's how the patient described it to the reporter. So this was from getting Shingrix again and wanted to just report it. Her age was probably close to 80 years and that was all the reporter know.
Age: 56.0
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: dose leaked out of the syringe and down my arm. Less than 50% went in.; dose leaked out of the syringe and down my arm. Less than 50% went in; Less than 50% went in; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of exposure via skin contact in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 31-MAR-2025, the patient received the 2nd dose of Shingrix. On 31-MAR-2025, an unknown time after receiving Shingrix, the patient experienced exposure via skin contact (Verbatim: dose leaked out of the syringe and down my arm. Less than 50% went in.), inadvertent exposure to vaccine (Verbatim: dose leaked out of the syringe and down my arm. Less than 50% went in) and underdose (Verbatim: Less than 50% went in). The outcome of the exposure via skin contact, inadvertent exposure to vaccine and underdose were not applicable.   Additional Information: GSK receipt Date: 31-MAR-2025 The patient received the second dose of Shingrix, but the dose leaked out of the syringe and down on arm, which led to exposure via skin contact and inadvertent exposure to vaccine products. Less than 50 percent went in, which led to underdose.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got I ended up getting the shingles more than before; 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.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got I ended up getting the shingles more than before). The patient was treated with lysine (L-Lysine). 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: 04-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported that wouldn't get another shot for any reason after  the first shot ,he/she got ended up getting the shingles more than before, so consumer was use some royal almond gel to put on it made by and took l-Lysine. The follow-up could not be possible as no contact details were available.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: did have a mild case of shingles after the first vaccine; 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 the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: did have a mild case of shingles after the first vaccine). 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: 04-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had the Shingles vaccine twice and had a mild case of shingles after the first vaccine. The patient family member had it in her eye still being followed by the ophthalmologist. Further, stated that shingles was not a joke. This case is linked with US2025AMR041385, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2025AMR041385:same reporter different patient
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: i only got one shot, I don't remember being told I need another one; 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 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 only got one shot, I don't remember being told I need another one). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 04-APR-2025 This case was reported by a patient via interactive digital media. The patient only got one shot and didn't remember being told that he/she need another one Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Herpes zoster, Nausea, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 64-year-old 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 an unknown date, 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have 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 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 to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 06-APR-2025  The patient reported that not sure if GlaxoSmithKline was keeping track of Shingrix vaccine feedback.  The patient had the vaccine 2 doses.  The patient was one that was nauseous and very tired after.  Now 2 years later the reporter had shingles. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about  completion of primary vaccination schedule and laboratory confirmation regarding shingles ) is considered unrelated to GSK vaccine Shingrix (Dose 1& 2).
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (still got shingles again).   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: still got shingles again). 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: 05-APR-2025 This case was reported by a patient via interactive digital media. The reporter stated that his/her friend had two vaccines and still got shingles again.  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).