chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: MMR, MMR, UNK, MMR
Symptoms: Enterovirus infection, Herpangina, Morbillivirus test positive, Pyrexia, Rash morbilliform
Clinical narrative: severe measleslike symptoms following vaccination; This spontaneous report was received from a non-health care professional and refers to a Child patient of unknown gender (exact age unknown).   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 15-Apr-2025, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), reported lot #4015995 was confirmed as invalid lot # for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live; expiration date: 24-Sep-2026 (formulation, site of administration not provided), 0.5ML administered intramuscularly (IM) with sterile diluent (MERCK STERILE DILUENT) for prophylaxis.  On 21-Apr-2025, the patient experienced severe measles like symptoms following vaccination, high fever for 4 days, cough, conjunctivitis, runny nose, and koplik spots (Measles). On 24-APR-2025, another symptom rash (reported as rash for 6 days) started. On 26-Apr-2025, a polymerase chain reaction (PCR) test and Measles virus assay (MeVA) test (MeVA testing determines if a case was caused by measles vaccine strain or wild-type measles virus) were both positive. On an unknown day in April 2025, respiratory viral test (RVP) was negative.    At the reporting time, the outcome of severe measles was unknown.   The reporter considered the events of severe measles and measles virus test positive to be related to the suspect vaccine and sterile diluent (reported as MMR vaccine reactions). This is one of the 3 reports received from the same reporter. Follow up information from FDA (agency #US-009507513-2283670) on 19-May-2025.  Patient information was updated, it was confirmed that concerned to a 1-year-old patient. The lot # Y015995 was reported and has been verified to be valid for this product, expiration date confirmed as 24-Sep-2026.
Vaccine: MMR, MMR, UNK, MMR
Symptoms: Respiratory disorder
Clinical narrative: severe measleslike symptoms following vaccination; This spontaneous report was received from a non-health care professional and refers to a Child patient of unknown gender (exact age unknown).   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 15-Apr-2025, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), reported lot #4015995 was confirmed as invalid lot # for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live; expiration date: 24-Sep-2026 (formulation, site of administration not provided), 0.5ML administered intramuscularly (IM) with sterile diluent (MERCK STERILE DILUENT) for prophylaxis.  On 21-Apr-2025, the patient experienced severe measles like symptoms following vaccination, high fever for 4 days, cough, conjunctivitis, runny nose, and koplik spots (Measles). On 24-APR-2025, another symptom rash (reported as rash for 6 days) started. On 26-Apr-2025, a polymerase chain reaction (PCR) test and Measles virus assay (MeVA) test (MeVA testing determines if a case was caused by measles vaccine strain or wild-type measles virus) were both positive. On an unknown day in April 2025, respiratory viral test (RVP) was negative.    At the reporting time, the outcome of severe measles was unknown.   The reporter considered the events of severe measles and measles virus test positive to be related to the suspect vaccine and sterile diluent (reported as MMR vaccine reactions). This is one of the 3 reports received from the same reporter. Follow up information from FDA (agency #US-009507513-2283670) on 19-May-2025.  Patient information was updated, it was confirmed that concerned to a 1-year-old patient. The lot # Y015995 was reported and has been verified to be valid for this product, expiration date confirmed as 24-Sep-2026.
Vaccine: MMR, MMR, UNK, MMR
Symptoms: Conjunctivitis, Cough, Morbillivirus test positive, Pyrexia, Rash
Clinical narrative: severe measleslike symptoms following vaccination; This spontaneous report was received from a non-health care professional and refers to a Child patient of unknown gender (exact age unknown).   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 15-Apr-2025, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), reported lot #4015995 was confirmed as invalid lot # for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live; expiration date: 24-Sep-2026 (formulation, site of administration not provided), 0.5ML administered intramuscularly (IM) with sterile diluent (MERCK STERILE DILUENT) for prophylaxis.  On 21-Apr-2025, the patient experienced severe measles like symptoms following vaccination, high fever for 4 days, cough, conjunctivitis, runny nose, and koplik spots (Measles). On 24-APR-2025, another symptom rash (reported as rash for 6 days) started. On 26-Apr-2025, a polymerase chain reaction (PCR) test and Measles virus assay (MeVA) test (MeVA testing determines if a case was caused by measles vaccine strain or wild-type measles virus) were both positive. On an unknown day in April 2025, respiratory viral test (RVP) was negative.    At the reporting time, the outcome of severe measles was unknown.   The reporter considered the events of severe measles and measles virus test positive to be related to the suspect vaccine and sterile diluent (reported as MMR vaccine reactions). This is one of the 3 reports received from the same reporter. Follow up information from FDA (agency #US-009507513-2283670) on 19-May-2025.  Patient information was updated, it was confirmed that concerned to a 1-year-old patient. The lot # Y015995 was reported and has been verified to be valid for this product, expiration date confirmed as 24-Sep-2026.
Vaccine: MMR, MMR, UNK, MMR
Symptoms: Rash morbilliform, Respiratory viral panel, Rhinorrhoea
Clinical narrative: severe measleslike symptoms following vaccination; This spontaneous report was received from a non-health care professional and refers to a Child patient of unknown gender (exact age unknown).   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 15-Apr-2025, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), reported lot #4015995 was confirmed as invalid lot # for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live; expiration date: 24-Sep-2026 (formulation, site of administration not provided), 0.5ML administered intramuscularly (IM) with sterile diluent (MERCK STERILE DILUENT) for prophylaxis.  On 21-Apr-2025, the patient experienced severe measles like symptoms following vaccination, high fever for 4 days, cough, conjunctivitis, runny nose, and koplik spots (Measles). On 24-APR-2025, another symptom rash (reported as rash for 6 days) started. On 26-Apr-2025, a polymerase chain reaction (PCR) test and Measles virus assay (MeVA) test (MeVA testing determines if a case was caused by measles vaccine strain or wild-type measles virus) were both positive. On an unknown day in April 2025, respiratory viral test (RVP) was negative.    At the reporting time, the outcome of severe measles was unknown.   The reporter considered the events of severe measles and measles virus test positive to be related to the suspect vaccine and sterile diluent (reported as MMR vaccine reactions). This is one of the 3 reports received from the same reporter. Follow up information from FDA (agency #US-009507513-2283670) on 19-May-2025.  Patient information was updated, it was confirmed that concerned to a 1-year-old patient. The lot # Y015995 was reported and has been verified to be valid for this product, expiration date confirmed as 24-Sep-2026.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye disorder, Eyelash discolouration, Investigation, Menstruation irregular, Topography corneal
Clinical narrative: Got covid after having the covid vaccine/went on Paxlovid; Got covid after having the covid vaccine/went on Paxlovid; This is a spontaneous report received from a Physician.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 24Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 21May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation. The patient did not receive any other vaccines on the same date as the Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The patient was not taking any other medications within 2 weeks prior to the event onset. The patient did not previously receive the Pfizer suspect vaccine. The patient's relevant medical history included: "Lyme disease" (unspecified if ongoing); "joint pain" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu vaccine (Last time had the flu vaccine was 2017; got it every year), administration date: 2017, when the patient was 46 years old, for Immunization; Hep a (sometime had one of the two Hep A), administration date: 2002, when the patient was 31 years old, for Immunization; Hep a (two Hep A), for Immunization; Hep b (2 of the 3 of Hep B), administration date: 2002, when the patient was 31 years old, for Immunization; Hep b (3 of Hep B), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Got covid after having the covid vaccine/went on Paxlovid". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The reporter called in regard to the Covid vaccine, got it way back in 2021. The second covid vaccine was done at a (withheld) on 21May2021 and got it like a prescription. Confirmed both doses were the Pfizer Covid Vaccine. The patient got COVID after having the COVID vaccine and went on Paxlovid.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2  in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-2021499225 same reporter/patient, different dose/event;US-PFIZER INC-202500107364 same reporter/patient, different dose/event;US-PFIZER INC-202500106966 same reporter/patient, different dose/event;
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Got covid after having the covid vaccine/went on Paxlovid; Got covid after having the covid vaccine/went on Paxlovid; This is a spontaneous report received from a Physician.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 24Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 21May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation. The patient did not receive any other vaccines on the same date as the Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The patient was not taking any other medications within 2 weeks prior to the event onset. The patient did not previously receive the Pfizer suspect vaccine. The patient's relevant medical history included: "Lyme disease" (unspecified if ongoing); "joint pain" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu vaccine (Last time had the flu vaccine was 2017; got it every year), administration date: 2017, when the patient was 46 years old, for Immunization; Hep a (sometime had one of the two Hep A), administration date: 2002, when the patient was 31 years old, for Immunization; Hep a (two Hep A), for Immunization; Hep b (2 of the 3 of Hep B), administration date: 2002, when the patient was 31 years old, for Immunization; Hep b (3 of Hep B), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Got covid after having the covid vaccine/went on Paxlovid". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The reporter called in regard to the Covid vaccine, got it way back in 2021. The second covid vaccine was done at a (withheld) on 21May2021 and got it like a prescription. Confirmed both doses were the Pfizer Covid Vaccine. The patient got COVID after having the COVID vaccine and went on Paxlovid.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2  in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-2021499225 same reporter/patient, different dose/event;US-PFIZER INC-202500107364 same reporter/patient, different dose/event;US-PFIZER INC-202500106966 same reporter/patient, different dose/event;
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; A HCP called and reported that an expired dose of VAQTA was administered to patient on 02MAY2025 with expiry date of 18APR2025. The caller confirmed the dose has never been stored outside of the recommended storage range.; This spontaneous report was received from a/an Other health professional and refers to a(n) 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 02-May-2025, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA), (strength, dose, dose number, frequency, vaccination scheme, route, anatomical location, lot #X023974, expiration date: 18-Apr-2025), as prophylaxis (expired vaccine used). No additional adverse event reported.
Age: 1.08
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no symptomatic, no additional AE; report administrations of VARIVAX and PROQUAD on 05/02/2026 for 13-month-old twin patients.; HCP calling to report administrations of VARIVAX and PROQUAD for 13-month-old twin patients. Patients are not symptomatic; This spontaneous report was received from a Nurse and refers to 13-months old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 02-MAY-2025, the patient was vaccinated with a dose of  Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot # and expiration date were not reported); along with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot # and expiration date were not reported) diluted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported); all vaccines were administered for prophylaxis (inappropriate schedule/ accidental overdose).  The patient was asymptomatic, and no additional adverse event was reported.  This is one of 2 reports from the same reporter.
Age: 1.08
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: not symptomatic, no addtional AE; HCP calling to report administrations of VARIVAX and PROQUAD on 05/02/2026 for 13-month-old twin patients. Patients are not symptomatic. Unable to collect LOT/EXP for the VARIVAX and PROQUAD. No other information at this time. Permission to contact g; This spontaneous report was received from a Nurse and refers to a 13-months-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 02-May-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (Strength, dose, dose number, frequency, vaccination scheme, route, anatomical location, lot #, and expiration date were not reported), as prophylaxis.  On the same date, the patient was also vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (Strength, dose, dose number, frequency, vaccination scheme, route, anatomical location, lot #, and expiration date were not reported), as prophylaxis (inappropriate schedule of vaccina administered). The patient was not symptomatic, and no additional adverse event reported.   This is one of two reports from the same reporter. Lot # is being requested and will be submitted if received.
Age: 38.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects or symptoms reported/No Additional AE; Caller states the product expired 04/23/2025 and was  administered 05/19/2025; This spontaneous report was received from a Nurse 19-MAY-2025 and refers to a 38-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 19-MAY-2025, the patient was vaccinated with an expired dose of Human Papillomavirus 9-valent Vaccine, Recombinant Injection (lot #X019625, expiration date: 23-APR-2025), prefilled syringe, dose: 0.5 mL for prophylaxis (route of administration and dose number was not reported)(Expired product administered).  The reporter confirmed that the vaccine was stored at the appropriate condition. No further information. No side effects or symptoms reported.
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reported that improperly stored VAQTA was administered.; This spontaneous report has been received from an other health professional, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 23-MAY-2025, the patient was vaccinated with an improperly stored dose of with improperly storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) suspension for injection, at a dose of 0.5 milliliter (ml), as prophylaxis, lot number Y013274 which was determined to be valid, with an expiration date on 26-DEC-2025(vaccination scheme, route of administration, and anatomical site of injection were not reported).  Administered doses were stored at a temperature of 35.04 degrees Fahrenheit (F), during a time frame of 2 hours and 14 minutes (product storage error).  No additional adverse events were reported in the patient.
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: received vaccine that was stored at -0 with no reported adverse event; Initial information received on 23-May-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age and gender patient who received influenza USP TRIVAL A-B subvirion vaccine [Fluzone] that was stored at -0 with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of influenza USP TRIVAL A-B subvirion vaccine Suspension for injection (strength- unknown, expiry date- 30-Jun-2025 and lot UT843UJA) via unknown route in unknown administration site for Influenza immunization that was stored at -0 with no reported adverse event (poor quality product administered) (same day latency).   Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Blister, Hyperkeratosis, Melanocytic naevus, Rash vesicular
Clinical narrative: Squamous cell carcinoma; developed a blister on my back that evolved into what looked like a chickenpox; This serious case was reported by a consumer via call center representative and described the occurrence of squamous cell carcinoma in a female patient who received Herpes zoster (Shingrix) (batch number 27LR2, expiry date 25-MAR-2027) for prophylaxis.   Previously administered products included Shingrix (The patient received the first dose of Shingrix on 13 September 2024 (Lot number GK2AZ; expiration date 21 April 2026) Intramuscularly, in the left upper arm.The dose given was unknown). Concomitant products included ezetimibe (Zetia) and pitavastatin calcium (Livalo).   On 27-FEB-2025, the patient received the 2nd dose of Shingrix. In MAR-2025, 1 week after receiving Shingrix, the patient experienced chickenpox (Verbatim: developed a blister on my back that evolved into what looked like a chickenpox). On an unknown date, the patient experienced squamous cell carcinoma (Verbatim: Squamous cell carcinoma) (serious criteria GSK medically significant and clinically significant/intervention required). The outcome of the squamous cell carcinoma was unknown and the outcome of the chickenpox was resolved.   It was unknown if the reporter considered the squamous cell carcinoma and chickenpox to be related to Shingrix.     The company considered the squamous cell carcinoma and chickenpox to be unrelated to Shingrix.   Additional Information: GSK receipt date: 22-MAY-2025 Consumer reported that about 1 week after receiving the second dose of Shingrix, the patient developed a blister on her back. Shortly after, a blister developed on her upper thigh. The blister on her back resolved, but the blister on her thigh developed into a mole, which grew very quickly. This mole had a hole in the center and a horn like growth coming from it. The patient had this mole biopsied in April, 2025. By the time the patient had surgery on May 6, 2025, the mole had grown back to 1cm. The mole on her thigh was Squamous Cell Carcinoma.; Sender's Comments: Squamous cell carcinoma and Varicella are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Squamous cell carcinoma, Surgery
Clinical narrative: Squamous cell carcinoma; developed a blister on my back that evolved into what looked like a chickenpox; This serious case was reported by a consumer via call center representative and described the occurrence of squamous cell carcinoma in a female patient who received Herpes zoster (Shingrix) (batch number 27LR2, expiry date 25-MAR-2027) for prophylaxis.   Previously administered products included Shingrix (The patient received the first dose of Shingrix on 13 September 2024 (Lot number GK2AZ; expiration date 21 April 2026) Intramuscularly, in the left upper arm.The dose given was unknown). Concomitant products included ezetimibe (Zetia) and pitavastatin calcium (Livalo).   On 27-FEB-2025, the patient received the 2nd dose of Shingrix. In MAR-2025, 1 week after receiving Shingrix, the patient experienced chickenpox (Verbatim: developed a blister on my back that evolved into what looked like a chickenpox). On an unknown date, the patient experienced squamous cell carcinoma (Verbatim: Squamous cell carcinoma) (serious criteria GSK medically significant and clinically significant/intervention required). The outcome of the squamous cell carcinoma was unknown and the outcome of the chickenpox was resolved.   It was unknown if the reporter considered the squamous cell carcinoma and chickenpox to be related to Shingrix.     The company considered the squamous cell carcinoma and chickenpox to be unrelated to Shingrix.   Additional Information: GSK receipt date: 22-MAY-2025 Consumer reported that about 1 week after receiving the second dose of Shingrix, the patient developed a blister on her back. Shortly after, a blister developed on her upper thigh. The blister on her back resolved, but the blister on her thigh developed into a mole, which grew very quickly. This mole had a hole in the center and a horn like growth coming from it. The patient had this mole biopsied in April, 2025. By the time the patient had surgery on May 6, 2025, the mole had grown back to 1cm. The mole on her thigh was Squamous Cell Carcinoma.; Sender's Comments: Squamous cell carcinoma and Varicella are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This serious case was reported by a consumer via interactive digital media and described the occurrence of stroke in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced stroke (Verbatim: stroke) (serious criteria GSK medically significant). The outcome of the stroke was not reported.   It was unknown if the reporter considered the stroke to be related to Shingrix.     The company considered the stroke to be unrelated to Shingrix.   Additional Information: GSK receipt date: 21-MAY-2025 This case was reported by a patient via interactive digital media. Physician gave the first round of Shingrix vaccine to reporter and patient had horrible scary side effects. Patient stated that he/she would not get the second round. Patient heard that it was worst than the first. Patient thought he/she was having a stroke. Patient's husband was getting ready to call an ambulance.; Sender's Comments: Cerebrovascular accident is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Vaccine: VARZOS
Symptoms: Ear pain, Herpes zoster, Herpes zoster oticus, Pain, Rash
Clinical narrative: Suspected vaccination failure; Though I had gotten shingles/ rash on my right ear; Though I had gotten shingles/ rash on my neck; right ear lobe, top to bottom, started paining me with excruciating sharp shooting pains; rash on my right ear and my neck; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 69-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In MAY-2025, more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster oticus (Verbatim: Though I had gotten shingles/ rash on my right ear) (serious criteria GSK medically significant), herpes zoster (Verbatim: Though I had gotten shingles/ rash on my neck), ear pain (Verbatim: right ear lobe, top to bottom, started paining me with excruciating sharp shooting pains) and rash (Verbatim: rash on my right ear and my neck). The outcome of the vaccination failure was not reported and the outcome of the herpes zoster oticus, herpes zoster, ear pain and rash were not resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster oticus, herpes zoster, ear pain and rash to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, herpes zoster oticus, herpes zoster, ear pain and rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAY-2025 This case was reported by a patient via interactive digital media. Patient was 69 and had Shingles vaccines years ago (from the date of reporting). Two days ago (from the date of reporting) patient's right ear lobe, from top to bottom, began paining him/her with excruciating sharp shooting pains.  This morning (on the day of reporting morning), patient saw his/her physician and it seemed as though he/she has got shingles.  There was the start of a rash on his/her right ear and neck and had he/she not been seen today it could have moved to his/her face which they call Ramsay Hunt syndrome which affects the facial nerves.  He/she hoped the antiviral medication would work quickly. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding herpes zoster oticus and herpes zoster 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles  Herpes zoster oticus is an unlisted event which is considered unrelated to GSK vaccine Shingles "
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; Though I had gotten shingles/ rash on my right ear; Though I had gotten shingles/ rash on my neck; right ear lobe, top to bottom, started paining me with excruciating sharp shooting pains; rash on my right ear and my neck; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 69-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In MAY-2025, more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster oticus (Verbatim: Though I had gotten shingles/ rash on my right ear) (serious criteria GSK medically significant), herpes zoster (Verbatim: Though I had gotten shingles/ rash on my neck), ear pain (Verbatim: right ear lobe, top to bottom, started paining me with excruciating sharp shooting pains) and rash (Verbatim: rash on my right ear and my neck). The outcome of the vaccination failure was not reported and the outcome of the herpes zoster oticus, herpes zoster, ear pain and rash were not resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster oticus, herpes zoster, ear pain and rash to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, herpes zoster oticus, herpes zoster, ear pain and rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAY-2025 This case was reported by a patient via interactive digital media. Patient was 69 and had Shingles vaccines years ago (from the date of reporting). Two days ago (from the date of reporting) patient's right ear lobe, from top to bottom, began paining him/her with excruciating sharp shooting pains.  This morning (on the day of reporting morning), patient saw his/her physician and it seemed as though he/she has got shingles.  There was the start of a rash on his/her right ear and neck and had he/she not been seen today it could have moved to his/her face which they call Ramsay Hunt syndrome which affects the facial nerves.  He/she hoped the antiviral medication would work quickly. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding herpes zoster oticus and herpes zoster 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles  Herpes zoster oticus is an unlisted event which is considered unrelated to GSK vaccine Shingles "
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Someone I know very well got shingles and she had 2 shots for it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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: Someone I know very well got shingles and she had 2 shots for it). 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: 24-MAY-2025 This case was reported by a patient via interactive digital media.  Reporter stated that someone he/she know very well got shingles and she had 2 shots for it. This case was considered as suspected vaccination failure as details regarding completion 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) and Shingles vaccine (dose 2).
Age: 56.0
Vaccine: RAB
Symptoms: No adverse event, Off label use
Clinical narrative: Intentional Off Label Prescription by HCP: Imovax prescribed with off label diagnosis Open bite of right ring finger without damage to nail, initial encounter with no reported adverse event; Initial information received on 23-May-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 56 years old and unknown gender patient who had prescribed with IPV (VERO) [IMOVAX] off label with diagnosis open bite of right ring finger without damage to nail, initial encounter with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was prescribed with 2.5 u  dose of suspect IPV (VERO), Suspension for injection,frequency:3 times (lot number, strength and expiry date not reported) for open bite of right ring finger without damage of nail, initial encounter (bite) which was intentional off label diagnosis  with no reported adverse event (off label use).   Information on the batch number cannot be requested corresponding to the one at time of event occurrence   Reportedly, Imovax prescribed with off label diagnosis S61.254A Open bite of right ring finger without damage to nail, initial encounter.  Action taken was not applicable.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia, Autoantibody positive, Autoimmune thyroiditis, Blood iron decreased, Dark circles under eyes
Clinical narrative: Our daughter was well prior to the shot. she had had a minor sniffle cold few weeks prior. She had a nearly immediate reaction to the booster. The site of where the shot was administered became highly inflamed and over a couple days turned into a base ball shaped mass under her skin. Then an onslaught of symptoms followed within a week of the shot, and continued since. First dark circles under her eyes, a sore throat and became very lethargic and almost depressed. Then her hair started shedding in small clumps and strands. We had blood tests done, which showed low vitamin D and iron and more were ordered, showing a rapid onset of an autoimmune response with high levels of antibodies present and Hashimoto's Disease.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site inflammation, Injection site mass, Lethargy, Oropharyngeal pain, Vitamin D decreased
Clinical narrative: Our daughter was well prior to the shot. she had had a minor sniffle cold few weeks prior. She had a nearly immediate reaction to the booster. The site of where the shot was administered became highly inflamed and over a couple days turned into a base ball shaped mass under her skin. Then an onslaught of symptoms followed within a week of the shot, and continued since. First dark circles under her eyes, a sore throat and became very lethargic and almost depressed. Then her hair started shedding in small clumps and strands. We had blood tests done, which showed low vitamin D and iron and more were ordered, showing a rapid onset of an autoimmune response with high levels of antibodies present and Hashimoto's Disease.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; Patient received improperly stored vaccine; This spontaneous report was received from a health care professional referring to a patient, age and gender not reported. Information regarding the patient's pertinent medical history, drug allergies or reactions, or concomitant medications was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (VARIVAX), for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, were not reported, valid lot number Y014868, with an expiration date on 03-SEP-2026) which was reconstituted with sterile diluent solution for injection (BAXTER STERILE DILUENT) (lot number and expiration date not provided).  The administered dose of the vaccine experienced a temperature excursion 5.5°F up to 14.4°F degrees Fahrenheit for 40 minutes, 14.5°F up to 46.4°F and 15. 8 degrees Fahrenheit for 10 minutes. It was not reported if the information was recorded by a data logger or not. There was no adverse effect reported.   Follow-up information was received from an other health care professional on 05-MAY-2025. The patient was a 2-year-old male. He received varicella virus vaccine live (VARIVAX) on 24-APR-2025 in the left upper, outer arm, lot# Y014868, expiration date 03-SEP-2026. The patient also received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine (M-M-R II) on the same day, lot# Y010372, expiration date 05-JUN-2026, given in the left upper, outer arm. No side effects were reported. Patient had no significant past medical history. No illness at time of vaccination. No daily medications. No further information was available.
Age: 45.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; HCP calling to request information regarding GARDASIL 9.  Request case 02800767.    HCP reported a male patient received first dose of GARDASIL 9 on 9/14/2024, a second dose on 10/19/2024, and is currently requesting the 3rd dose.  HCP reported that; HCP calling to request information regarding GARDASIL 9.  Request case 02800767.    HCP reported a male patient received first dose of GARDASIL 9 on 9/14/2024, a second dose on 10/19/2024, and is currently requesting the 3rd dose.  HCP reported that; This spontaneous report was received from a Pharmacist and refers to a 46-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 14-Sep-2024, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), 0.5 mL (lot # and expiration date were not reported)( Inappropriate age at vaccine administration).  On 19-Oct-2024, the patient received second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), 0.5 mL (lot # and expiration date were not reported) (Inappropriate age at vaccine administration). No adverse event was reported.
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AEs were reported,; a patient supposed to receive PREVNAR 20 but received PNEUMOVAX 23 instead due to a human error.; This spontaneous report was received from an other health professional and refers to a 2-month-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 19-MAY-2025, the patient supposed to receive pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20), but received instead pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), 1 dose, lot# X023561, expiry date 17-NOV-2025, for prophylaxis (route of administration and anatomical location were not reported) due to a human error (Wrong product administered). No additional adverse events were reported.
Vaccine: COVID19, FLUN3
Symptoms: Diarrhoea, Frustration tolerance decreased, Hypotension
Clinical narrative: diarrhea; feel like crap; low blood pressure; A spontaneous report has been received from a consumer. The report concerns a male elderly patient (age 71 years).  No medical history was reported.   No concomitant products were reported.  The patient received Covid-19 Vaccine, via unspecified route, on an unknown date. The patient received 1 dose(s).  The patient started treatment with Lenvima (lenvatinib mesilate) (batch number(s) 36066 09) 10 milligram qd, Oral use, on 11-AUG-2023 for liver cell  carcinoma and with Flumist (flumist, influenza virus vaccine polyvalent, q/laiv), on an unknown date.  A OTHER administered NA.  On an unknown date, the patient experienced diarrhea (preferred term: Diarrhoea), low blood pressure (preferred term: Hypotension) and feel like crap (preferred term: Frustration tolerance decreased).     It is unknown if any action was taken with Covid-19 Vaccine (covid-19 vaccine), Flumist (flumist, influenza virus vaccine polyvalent, q/laiv) and Lenvima (lenvatinib mesilate).  The outcome of the event(s) of diarrhea, feel like crap and low blood pressure was unknown.      The events were considered non-serious.   The reporter considered that there was a reasonable possibility of a causal relationship between Covid-19 Vaccine and the following event(s): diarrhea. The reporter considered that there was a reasonable possibility of a causal relationship between Flumist and the following event(s): diarrhea.  The reporter considered that there was a reasonable possibility of a causal relationship between Luer Pre-Filled Syringe and the following event(s): diarrhea.   Device Information:  Combination Product Report: Yes  Product As Reported: Flumist Brand Name: FLUENZ TETRA, FLUENZ TETRA, FLUMIST Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No  All required follow-up attempts have been completed to obtain the Lot / Batch number for Flumist and Covid-19 Vaccine, however the Lot / Batch number was not received.  Summary of follow-up information received by AstraZeneca on 05-Dec-2024 from Marketing company: Summary of unsuccessful Lot/Batch number attempts added. Narrative updated.
Sex: M
Vaccine: VARZOS
Symptoms: Limb mass, Mobility decreased, Pain in extremity
Clinical narrative: Arm hurts to sleep on it. Lean on it. Starts to feel like I have been punched in the arm. Received pusical therapy discontinued therapist said it wasn't helping; Limited range of motion; This non-serious case was reported by a consumer and described the occurrence of pain in arm in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included loperamide hydrochloride (Lopermide).   On 14-JUN-2024, the patient received Shingrix. On 14-JUN-2024, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm hurts to sleep on it. Lean on it. Starts to feel like I have been punched in the arm. Received pusical therapy discontinued therapist said it wasn't helping) and mobility decreased (Verbatim: Limited range of motion). The outcome of the pain in arm and mobility decreased were not resolved.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.     It was unknown if the company considered the pain in arm and mobility decreased to be related to Shingrix.   Additional Information: GSK receipt date: 26-MAY-2025 The reporter reported that the arm hurts to sleep on it, lean on it. Started to feel like he had been punched in the arm.  Received physical therapy discontinued therapist said it was not helping. Therapist tried several therapist said she felt something lime a knot in my shoulder that did not change.  Several weeks of therapy only yielded temporary relief.  Therapist said she would continue for the temporary relief a couple more weeks he wanted for temporary relief but did not expect any long term benefits from it.  The duration of relief was not worth the trip to the office so it was discontinued.  This had been ongoing for almost a year now.  He could not sleep without being woke up constantly due to pain in his arm from laying in it and he tend to move on it in his sleep.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have had the vaccines and still have them; 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: I have had the vaccines and still have them). 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: 23-MAY-2025 This case was reported by a patient via interactive digital media. The patient had the vaccines and still had them. 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.