chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; both VARIVAX and PROQUAD were involved in a temperature excursion on 9JUN2022.; This spontaneous report has been received from a certified medical assistant, regarding an unknown number of patients of unknown ages and genders.  The patient's pertinent medical history, previous drug reactions or allergies, and  concomitant medications were unknown.   On 09-JUN-2022, the following vaccines were involved in a temperature excursion: varicella virus vaccine live (oka/merck) (VARIVAX) as prophylaxis (lot number U008180 had been verified to be a valid number; expiration date reported and established as: 12-DEC-2023; (scheme, dosage and anatomical site of injection were not provided) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA)(PROQUAD) as prophylaxis (lot number W007744 had been verified to be a valid number; expiration date reported and established as 04-SEP-2023.  The vaccines were exposed to a temperature of 8.6 Fahrenheit degrees for a time frame of 13 minutes. No previous temperatures excursion were reported. On an unknown dates in 2022, the vaccines were administered to the patients (product storage error). No adverse events reported.   This was a non-valid case due to lack of patient's identifiers.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pharmacist reports interruption of schedule pertaining to GARDASIL 9. Pharmacist reports that Patient received GARDASIL 9 at the age of 11 and is now 16 and requesting to finish series.; No additional AEs reported. No PQCs reported. No further details provided.; This spontaneous report has been received from a registered pharmacist concerning a currently 16-year-old patient of unknown gender. The patient's concomitant therapies, pertinent medical history, and drug reactions/allergies were not reported.  In approximately 2017 (at the age of 11 years old), the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not provided) for prophylaxis.  On an unspecified date in July 2022 (reported as "now 16 years old"), the patient was requesting to finish series, which indicated an interruption of schedule (inappropriate schedule of product administration). The report stated that the patient did not receive first dose at his facility and refused to provide any additional information at this time. There was no additional adverse event (AE) reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Physician calling in to request a vaccine temperature excursion evaluation for GARDASIL 9 (see TE case number 02215650 for details) that had been administered to a patient.; This spontaneous report was received from a physician referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On 29-JUL-2022, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection dose 0.5 ml, lot #U028825, expiration date: 02-NOV-2023, administered intramuscularly (strength, vaccination scheme frequency, and anatomical location were not reported) for prophylaxis after the excursion occurred (product storage error). Temperature excursion information: on 25-JUL-2022 46.5 degree Fahrenheit for 15 min and on 29-JUL-2022 48.2 degree Fahrenheit for 15 minutes. There was no additional adverse event reported (no adverse event).  This was one of two cases from the same reporter. ; Sender's Comments:  US-009507513-2208USA000140:
Age: 43.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse events.; Caller is HCP reporting that patient received third dose of GARDASIL 9 earlier than recommended. Dates of administrations are 27AUG2021, 02NOV2021, 28JAN2022.; This spontaneous report was received from a medical assistant referring to a 43-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 27-AUG-2021, the patient was vaccinated with the first dose of HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, subsequently on 02-NOV-2021, she received the second dose and on 28-JAN-2022, the patient was vaccinated with the third dose (inappropriate schedule of product administration); all administered as one dose for prophylaxis (exact doses, strengths, anatomical injection sites, lot numbers, expiration dates, and routes of administration were not provided). No additional adverse events were reported.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; patient received the 3rd dose of GARDASIL 9 too close to the 2nd dose; This spontaneous report was received from a nurse referring to a 12-year-old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 07-FEB-2021 and 02-APR-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (doses, routes of administration, lot numbers and expiration dates not reported) and on 27-JUL-2022, the patient received the third dose of the vaccine,1 dosage form, lot number 1780876, expiration date 09-NOV-2023 for prophylaxis (route of administration not reported), that was administered too close to the second dose (inappropriate schedule of product administration). No adverse event was reported.
Age: 0.83
Sex: M
Vaccine: HIBV, PNC, RV5, TDAP, UNK, VARCEL
Symptoms: Crying, Diarrhoea, Discomfort, Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: diarrhea; bad rash; crying excessively; He got two VARIVAX vaccines on 08-AUG-2022.; 10 months old; he only got two vaccines; fever; This spontaneous report was received from a consumer and refers to her 10-month-old son. The patient's medical history included umbilical cord around neck, neonatal asphyxia, resuscitation and intensive care. (reported as his umbilical cord choked him, but he was resuscitated, he had to spend a couple of days in intensive care). The patient's concurrent conditions and concomitant medications were not reported.  On 08-AUG-2022, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (inappropriate age at vaccine administration)(reported as he got two VARIVAX vaccines in each leg - extra dose administered).  On 08-AUG-2022, the patient experienced fever (reported as very high). The reporter stated that she had certain situations where he could not take certain medications (names of medications were not specified by caller). On 09-AUG-2022, he got diarrhea (reported as five times) and bad rash. The patient went to the bathroom so many times that he could not sit down comfortably. He was crying excessively. The mother tried to call a nurse at the emergency room (ER) to get help and was advised to let him sit in a cold tube, which did not work. The mother was given the paper with vaccine report which listed diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (reported as TDAP), varicella virus vaccine live (oka/merck) (VARIVAX), pneumococcal vaccine conj 7v (crm197) (PREVNAR) (also reported as PREVNAR 13), hib vaccine conj (crm197) (HIBTITER) (also reported as HIB), polio vaccine inact 3v (reported as OPV/IV3) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ). According to the consumer, the patient was given only two vaccines on 08-AUG-2022. According to the consumer, the patient was given only two vaccines on 08-AUG-2022. The reporter was confused about what vaccines were administered, because of the vaccines listed on the paper and she only saw 2 shots given. They rushed her to sign the forms without giving time to consent and she thought her son would be getting the vaccines like normal. The reporter also mentioned she wanted to report the doctor.  At the time of reporting, the patient had not recovered from the events. Action taken with varicella virus vaccine live (oka/merck) (VARIVAX) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided. The causal relationship between the events and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.   The causal relationship between the events and the suspect therapies was not provided.
Age: 0.83
Sex: M
Vaccine: HIBV, PNC, RV5, TDAP, UNK, VARCEL
Symptoms: Pyrexia, Rash, Sitting disability
Clinical narrative: diarrhea; bad rash; crying excessively; He got two VARIVAX vaccines on 08-AUG-2022.; 10 months old; he only got two vaccines; fever; This spontaneous report was received from a consumer and refers to her 10-month-old son. The patient's medical history included umbilical cord around neck, neonatal asphyxia, resuscitation and intensive care. (reported as his umbilical cord choked him, but he was resuscitated, he had to spend a couple of days in intensive care). The patient's concurrent conditions and concomitant medications were not reported.  On 08-AUG-2022, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (inappropriate age at vaccine administration)(reported as he got two VARIVAX vaccines in each leg - extra dose administered).  On 08-AUG-2022, the patient experienced fever (reported as very high). The reporter stated that she had certain situations where he could not take certain medications (names of medications were not specified by caller). On 09-AUG-2022, he got diarrhea (reported as five times) and bad rash. The patient went to the bathroom so many times that he could not sit down comfortably. He was crying excessively. The mother tried to call a nurse at the emergency room (ER) to get help and was advised to let him sit in a cold tube, which did not work. The mother was given the paper with vaccine report which listed diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (reported as TDAP), varicella virus vaccine live (oka/merck) (VARIVAX), pneumococcal vaccine conj 7v (crm197) (PREVNAR) (also reported as PREVNAR 13), hib vaccine conj (crm197) (HIBTITER) (also reported as HIB), polio vaccine inact 3v (reported as OPV/IV3) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ). According to the consumer, the patient was given only two vaccines on 08-AUG-2022. According to the consumer, the patient was given only two vaccines on 08-AUG-2022. The reporter was confused about what vaccines were administered, because of the vaccines listed on the paper and she only saw 2 shots given. They rushed her to sign the forms without giving time to consent and she thought her son would be getting the vaccines like normal. The reporter also mentioned she wanted to report the doctor.  At the time of reporting, the patient had not recovered from the events. Action taken with varicella virus vaccine live (oka/merck) (VARIVAX) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided. The causal relationship between the events and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.   The causal relationship between the events and the suspect therapies was not provided.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PNEUVMOAX 23 were administered after a supported temp excursion occurred; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medication were not provided.   On 10-AUG-2022, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), lot # U026796, expiration date 28-JAN-2023 for prophylaxis after a temperature excursion of 48 minutes at 9.2 degrees Celsius (Product storage error) (dose, route of administration, and injection anatomical location were not provided). No additional adverse events were reported (No adverse event).   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2208USA005566: US-009507513-2208USA005605:
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; reported that a dose of PROQUAD was administered to a 15 year old consumer.; This spontaneous report was received from a medical assistant and refers to a 15-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 29-JUL-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) 0.5ml, lot #W006587 (lot number has been verified to be valid),expiration date: 23-AUG-2023 (strength, anatomical location, and route of administration were not provided)as prophylaxis (Inappropriate age at vaccine administration). No adverse event was reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; HCP called in and reported that improperly stored vaccines, PEDVAX HIB and ROTATEQ were administered. No further information was provided. See additional AEs reported in cases #02229849, #022; This spontaneous report was received from a registered nurse and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 18-AUG-2022, the patient was vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #U031543 was determined to be valid, expiration date: 23-JUN-2024 (dose, vaccination schedule, site and route of administration were not provided), and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1879873 was determined to be valid, expiration date: 12-NOV-2023, administered orally (dose and vaccination schedule were not provided), both for prophylaxis. No additional adverse events were reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: The shot didnt work for me/Suspected vaccination failure; The shot didnt work for me; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient stated that the shot does not work for him/her so the patient was taking Valcyclovir one tablet everyday and was doing very well. The patient stated about other person that it might as their doctor about that. He/she was sorry to hear about those issues experienced by other person. Additional Supportive Information: This case was conservatively considered for the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming the targeted event were unknown at the time of reporting. The follow-up would not be possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Shingles/Suspected vaccination failure; Shingles; Painful; This 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, less than 9 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient received vaccine earlier in 2022. The patient developed shingles twice this year in the same place. The patient was not sure as it was severe but, it was painful. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vaccinated three years ago, got shingles now/Suspected vaccination failure; shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male 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, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's comment: The case was reported by patient. The reporter stated that he/she was vaccinated three years ago with both the doses of Shingrix. The patient had shingles at the time of reporting. The reporter had also asked that if they need to get vaccinated again. Additional supportive information: This case was considered as suspected vaccination failure since details regarding laboratory confirmation of shingles was not reported at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: That vaccine gave me the shingles/ Suspected vaccination failure; gave me the shingles; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022.  Reporter's Comments: This case was reported by patient via interactive digital media. The vaccine gave shingles to the patient. Additional Supportive Information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for herpes zoster were unknown. The follow up would not be possible as contact details were not provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Immune system disorder, Stress, Vaccination failure
Clinical narrative: still got shingles on my scalp/ Suspected vaccination failure; still got shingles on my scalp; so stress has compromised my immune system; so stress has compromised my immune system; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, stress and immune system disorder. On an unknown date, the outcome of the vaccination failure, shingles, stress and immune system disorder were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, stress and immune system disorder to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had received both doses of Shingles vaccine and still had got shingles on her scalp. She had a disabled husband, so stress had compromised her immune system. The first dermatologist she saw told her that she had folliculitis, so she was put on wrong prescription (Rx). She had got second opinion after the symptoms were getting worsen. The patient stated that did not wait.  Additional supportive information: This case was considered as suspected vaccination failure since details regarding time to onset and laboratory confirmation of shingles was reported at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Took the vaccine...had shingles again/Suspected vaccination failure; Had shingles again; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comments: This case was received from the patient via interactive digital media. The patient had shingles and then later took the Shingles vaccine. The patient had shingles again. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Shingles rash/suspected vaccination failure; Shingles rash; shingles rash; my pain; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and pain. The patient was treated with tea tree oil. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022.  Reporter's Comments: This case was reported by the patient via interactive digital media. The patient put water on a wet washcloth and sprinkled with tea tree oil and put it on shingles rash. It took away patient's pain. Additional Supportive Information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation for shingles were unknown. The follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: second dose of MENVEO administered; This case was reported by a nurse via other manufacturer and described the occurrence of extra dose administered in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (1st dose received on last year.).   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received second dose of Menveo vaccine, the patient received the first dose in last year. The reporter did not provide additional details because this was not a Merck product. No additional adverse events were reported. No product quality complaint was reported. The reporter did not consent to follow up. Additional supportive information: The patient received 2nd dose of Menveo, which led to extra dose administrated.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash at injection site 4 days later; This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 days after receiving Shingles vaccine, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient had rash at injection site 4 days later. Additional supportive information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: made us sick as dogs; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (Patient's Mother and Father) and pain (Family History) (Patient's Mother and Father).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-JUL-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and it made felt sick as dogs but so worth it in the long run. The patient stated that just pray he/she never had to now. Additional supportive information: The follow-up would not possible, as no contact, details were available. This case is linked with case US2022AMR119005, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: made us sick as dogs; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a unspecified number of patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-JUL-2022 Reporter's Comment: This case reported via interactive digital media. Patients received dose of Shingles vaccine, which made them sick as dogs but so worth it in the long run. Additional supportive information: The follow-up would not possible, as no contact, details were available. This case is linked with case US2022AMR118995, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR118995:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: injection site rash; red rash  at the injection site; warm  rash at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2022, the patient received the 1st dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced injection site rash, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site rash, injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, injection site erythema and injection site warmth to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the Shingrix on Monday.  On the day of reporting, he/she still had a warm, red, rash at the injection site.  The reported wanted to know was this normal. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: Genital herpes type 2; This case was reported by a consumer via interactive digital media and described the occurrence of herpes simplex type ii in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th June 2022, the patient received the 1st dose of Shingrix. In August 2022, between 1 and 2 months after receiving Shingrix, the patient experienced herpes simplex type ii. On an unknown date, the outcome of the herpes simplex type ii was unknown.   It was unknown if the reporter considered the herpes simplex type ii to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got the first dose of Shingrix vaccine and this month (reporting month) the patient developed Genital Herpes type 2 for the first time in his/her life. The patient did not had sexual intercourse anymore and was being married for 45 years, no sexually transmitted disease before. The patient was informed about research studies. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: kicked my butt for 48 hrs; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included SHINGLES VACCINE (RECOMBINANT NON-LIVE).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-AUG-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient reported that this vaccine was no joke either.  The patient reported that 1st dose was ok. The 2nd dose kicked his/her butt for 48 hours. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort
Clinical narrative: upset stomach; This case was reported by a consumer via interactive digital media and described the occurrence of upset stomach in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was unknown.   It was unknown if the reporter considered the upset stomach to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced upset stomach.  The patient asked how long did the upset stomach last. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm very sore, hurt several days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-AUG-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and it hurt (arm sore) for several days but better than shingles. The patient stated that if you did like him/her their arm would be very sore tomorrow. He/she advised to take Tylenol tonight. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Influenza like illness, Injection site mass, Injection site swelling
Clinical narrative: Swelled as golf ball size knot at injection site; Swelled as golf ball size knot at injection site; I shivered; felt like I was coming down with the flu; Cold; pain in my arm; I'm exhausted; Trembled for 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of injection site lump in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In August 2022, unknown after receiving Shingles vaccine, the patient experienced exhaustion. On an unknown date, the patient experienced injection site lump, injection site swelling, shivering, influenza-like symptoms, feeling cold, tremor and pain in arm. On an unknown date, the outcome of the injection site lump, shivering, influenza-like symptoms and feeling cold were unknown and the outcome of the injection site swelling and exhaustion were not recovered/not resolved and the outcome of the tremor was recovered/resolved and the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the injection site lump, injection site swelling, shivering, influenza-like symptoms, feeling cold, tremor, exhaustion and pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the first dose. Even though it was 85° outside in the house patient had to turn off all the air conditioning. The patient had to put blankets and quilts on the bed to get warm and could not get warm for 4 hours. The patient was shivered and felt like coming down with the flu. The patient's shoulders swelled up like a golf ball size knot at the injection site. The patient trembled for 2 days and was cold.  This was day 4 the patient was exhausted and the pain in arm was lessened but still swollen.  The pharmacist said the second dose would be even worse. Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Tremor
Clinical narrative: Swelled as golf ball size knot at injection site; Swelled as golf ball size knot at injection site; I shivered; felt like I was coming down with the flu; Cold; pain in my arm; I'm exhausted; Trembled for 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of injection site lump in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In August 2022, unknown after receiving Shingles vaccine, the patient experienced exhaustion. On an unknown date, the patient experienced injection site lump, injection site swelling, shivering, influenza-like symptoms, feeling cold, tremor and pain in arm. On an unknown date, the outcome of the injection site lump, shivering, influenza-like symptoms and feeling cold were unknown and the outcome of the injection site swelling and exhaustion were not recovered/not resolved and the outcome of the tremor was recovered/resolved and the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the injection site lump, injection site swelling, shivering, influenza-like symptoms, feeling cold, tremor, exhaustion and pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the first dose. Even though it was 85° outside in the house patient had to turn off all the air conditioning. The patient had to put blankets and quilts on the bed to get warm and could not get warm for 4 hours. The patient was shivered and felt like coming down with the flu. The patient's shoulders swelled up like a golf ball size knot at the injection site. The patient trembled for 2 days and was cold.  This was day 4 the patient was exhausted and the pain in arm was lessened but still swollen.  The pharmacist said the second dose would be even worse. Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: didn't feel well for 3 days/kicked his/her butt big time; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell 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, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Linked case(s) involving the same patient:US2022AMR121789   Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, shingles vaccine kicked his/her butt big time.  The patient had every side effects you could have and didn't feel well for 3 days.  The side effects were nothing compared to what her husband had endured after having shingles.  The reporter stated that, take care and he/she would hope your second would not as bad. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR121789; Sender's Comments:  US-GSK-US2022AMR121789:Second dose case/Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: had a fever; was tired; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine (On unknown date the patient had received 1st dose of Shingrix, refer case US2022AMR121785.).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and tiredness. On an unknown date, the outcome of the fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the fever and tiredness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR121785   Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comments:  This case was received from patient via interactive digital media. The reporter stated that the second one  had a fever and was tired but only lasted a day. The side effects were nothing compared to what the patient's husband was endured after having shingles. The patient mentioned Take care and  hope your second was not as bad The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR121785:First dose case/Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: all i had was a sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced sore arm. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache
Clinical narrative: a lot of headaches; Felt bad; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced headache and feeling bad. On an unknown date, the outcome of the headache and feeling bad were unknown.   It was unknown if the reporter considered the headache and feeling bad to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-Aug-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got the dose of Shingrix vaccine yesterday and felt really bad, a lot of headaches. The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 10 months late for 2nd shot; This 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 (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comments:  This case was reported by consumer via interactive digital media. The patient was 10 months late for 2nd Shingrix shot and asked was it too late. Additional Supportive Information: Till the time of reporting patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Overdose; 18 years of received Engerix-B adult; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 18-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   In 2022, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.  This report was made by GSK without prejudice and did not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 09-Aug-2022. Reporter's comment: The pharmacy intern stated that a month ago an 18 year old patient received an adult dose of Engerix-B. Not able to confirm whether it was the PFS or vial, so the reporter chosen PFS. Health care professional did not have the lot or exp date of the vaccine as it was administered by another facility and also declined follow up. The reporter did not consent to follow-up. Additional Supportive Information: An 18 year old patient received an adult dose of Engerix-B, which led to overdose and inappropriate age at vaccine administration.