chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from other health care professional, regarding to a 1-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 20-JAN-2023, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number W008711 which has been verified to be valid, expiration date reported and validated as 14-MAR-2024) (strength, dose, vaccination scheme frequency, route of administration, and anatomical sites of injection were not reported) Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)  and Hepatitis A Vaccine, Inactivated (VAQTA) (strengths, doses, vaccination scheme frequencies, routes of administration, anatomical sites of injection, lot numbers, and expiration dates were not reported). All of the vaccines were administered as prophylaxis.   Administered doses were stored at a temperature of -10.5 degrees Celsius (C) during a time frame of 1 hour and 34 minutes. There was no previous temperature excursion.  No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from other health care professional, regarding to a 4-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 23-JAN-2023, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number W008711 which has been verified to be valid, expiration date reported and validated as 14-MAR-2024) (strength, dose, vaccination scheme frequency, route of administration, and anatomical sites of injection were not reported) Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)  and diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL) (strengths, doses, vaccination scheme frequencies, routes of administration, anatomical sites of injection, lot numbers, and expiration dates were not reported). All of the vaccines were administered as prophylaxis.   Administered doses were stored at a temperature of -10.5 degrees Celsius (C) during a time frame of 1 hour and 34 minutes. There was no previous temperature excursion.  No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from other health care professional, regarding to a 4-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 23-JAN-2023, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number W008711 which has been verified to be valid, expiration date reported and validated as 14-MAR-2024) (strength, dose, vaccination scheme frequency, route of administration, and anatomical sites of injection were not reported) Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)  and diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL) (strengths, doses, vaccination scheme frequencies, routes of administration, anatomical sites of injection, lot numbers, and expiration dates were not reported). All of the vaccines were administered as prophylaxis.   Administered doses were stored at a temperature of -10.5 degrees Celsius (C) during a time frame of 1 hour and 34 minutes. There was no previous temperature excursion.  No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a nurse and refers to a 6-year-old female patient.  The patient's medical history, concurrent conditions , concomitant therapies and previous drugs reactions or allergies were not reported.  On 23-JAN-2023, the patient was vaccinated with an improperly stored  varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, unk, lot #W008711, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided); measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided); and  pneumococcal vaccine conj 7v (crm197) (PREVENAR), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided) following a temperature excursion of -10.5 degrees Celsius for 1hour 34 minutes (product storage error). It was stated that a data logger was involved and no previous temperature excursion occurred. No adverse reaction reported.  This is one from several cases from the same reporter.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from other health care professional, regarding to 12 months female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 25-JAN-2023, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number W008711 which has been verified to be valid, expiration date reported and validated as 14-MAR-2024) (strength, dose, vaccination scheme frequency, route of administration, and anatomical sites of injection were not reported) Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)  and Hepatitis A Vaccine, Inactivated (VAQTA) (strengths, doses, vaccination scheme frequencies, routes of administration, anatomical sites of injection, lot numbers, and expiration dates were not reported). All of the vaccines were administered as prophylaxis.   Administered doses were stored at a temperature of -10.5 degrees Celsius (C) during a time frame of 1 hour and 34 minutes. There was no previous temperature excursion.  No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from other health care professional, regarding to a 5-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 26-JAN-2023, the patient was vaccinated with improperly stored doses of VARIVAX injection (lot number W008711 which has been verified to be valid, expiration date reported and validated as 14-MAR-2024) (strength, dose, vaccination scheme frequency, route of administration, and anatomical sites of injection were not reported) QUADRACEL (strengths, doses, vaccination scheme frequencies, routes of administration, anatomical sites of injection, lot numbers, and expiration dates were not reported). All of the vaccines were administered as prophylaxis. Administered doses were stored at a temperature of -10.5 degrees Celsius (C) during a time frame of 1 hour and 34 minutes. There was no previous temperature excursion. No additional adverse events were reported in the patient. This is one of several reports received from the same reporter.
Age: 7.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reported VARIVAX,MMR, and IPV  was administered after a temperature excursion.; This spontaneous report was received from a nurse and refers to a 7-year-old male patient.  The patient's medical history, concurrent conditions , concomitant therapies and previous drugs reactions or allergies were not reported.  On 26-JAN-2023, the patient was vaccinated with an improperly stored  varicella virus vaccine live (oka/merck) (VARIVAX)  lot #W008711, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided); measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and  polio vaccine inact (IPV), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided) ) following a temperature excursion of -10.5 degrees Celsius for 1hour 34 minutes (product storage error). It was stated that a data logger was involved and no previous temperature excursion occurred. No adverse reaction reported.  This is one from several cases from the same reporter.
Age: 6.0
Sex: F
Vaccine: DTAP, HEP, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; vaccine was given after temperature excursion; This spontaneous report was received from a nurse and refers to a 6-year-old female patient.  The patient's medical history, concurrent conditions , concomitant therapies and previous drugs reactions or allergies were not reported.  On 16-JAN-2023, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)  lot #W008711, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided); diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided); and  hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided)following a temperature excursion of -10.5 degrees Celsius for 1hour 34 minutes (product storage error). It was stated that a data logger was involved and no previous temperature excursion occurred. No adverse reaction reported.  This is one from several cases from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD was administered after a temperature excursion; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 03-FEB-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #W032150, expiration date: 07-APR-2024, (strength, vaccination scheme, anatomical location and route of administration were not provided) administered for prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion of -3.6 degrees Celsius (C). Time frame was unknown. There was previous temperature excursion. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; Nurse reported that a patient received an expired VARVIVAX.; This spontaneous report was received from a nurse referring to a unknown age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 22-FEB-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #u004714, expiration date: 10-FEB-2023 (who had been verified to be a valid number and assessed as the same date reported) administered for prophylaxis (strength, dose, and route of administration were not provided) (expired product administered). No additional adverse event reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the Vx and nowshingles / Suspected vaccination Failure; suffering with 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 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 Shingles vaccine.     Additional Information: GSK Receipt Date: 18-FEB-2023 Reporter's Comment: This case was reported by a patient's friend via interactive digital media. The reporter stated that the patient had the vaccine and was suffering with shingles right now. The reporter stated so sounds about like the covid vaccine, did not keep you from getting it. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Get the shot,  got shingles, horrible/ Suspected vaccination Failure; Shingles in eye, almost lost it, every week in eye hospital, i almost lost my eye; 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 ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     Additional Information: GSK receipt date: 19-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got the shot and still got shingles inside on one of his/her eye. The patient almost lost eye and for three month every week patient was in the eye hospital and was horrible. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had shingles shots, still fighting them/Suspected vaccination Failure; Still fighting them, worse then you can imagine; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown 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 and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-FEB-2023 Reporter's Comment: This case was reported by a patient's sibling via interactive digital media. The reporter stated that how about them lasting over a year. The reporter stated that it happened to patient and had the singles shots and still fighting them. The reporter further stated that there worse then you could imagine and very painful. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: took the shot and got it/Suspected vaccination Failure; Got it anyways; itches off and on; Hurt at times; 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, pruritus and pain. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 19-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient took the Shingles shot and got shingles anyways and it was itches off and on and it hurt at times. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles after the shot/Suspected vaccination failure; Shingles/ got shingles after the shot; 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.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-Feb-2023 Reporter's Comments: The case was received from the consumer via interactive digital media. The reporter reported that his/her brother had the patient (neighbor) got the shot and got shingles after the shot. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding primary schedule, time to onset for event and laboratory confirmation of shingles were not provided. The follow-up could not be possible as no contact details were available. This 1 of 4 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GSK-US2023AMR028532:Same reporter US-GSK-US2023AMR028533:Same reporter US-GSK-US2023AMR028534:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles after the shot/Suspected vaccination failure; Shingles/got shingles after the shot; 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.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-Feb-2023 Reporter's Comments: The case was received from the consumer via interactive digital media. The reporter reported that his/her brother had the patient (neighbor) got the shot and got shingles after the shot. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding primary schedule, time to onset for event and laboratory confirmation of shingles were not provided. The follow-up could not be possible as no contact details were available. This 1 of 4 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GSK-US2023AMR028529:Same reporter US-GSK-US2023AMR028533:Same reporter US-GSK-US2023AMR028534:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles after the shot/Suspected vaccination failure; Got shingles after the shot; 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.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-Feb-2023 Reporter's Comments: The case was received from the consumer via interactive digital media. The reporter reported that his/her brother had the patient (neighbor) got the shot and got shingles after the shot. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding primary schedule, time to onset for event and laboratory confirmation of shingles were not provided. The follow-up could not be possible as no contact details were available. This 1 of 4 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GSK-US2023AMR028529:Same reporter US-GSK-US2023AMR028532:Same reporter US-GSK-US2023AMR028534:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles/Suspected vaccination failure; 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.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 18-Feb-2023 Reporter's comment: This case was reported via interactive digital media. The reporter's brother had neighbor (patient) who got the Shingles shot and developed the shingles after the shot. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case was one of 4 cases, reported by same reporter. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR028529:Same reporter US-GSK-US2023AMR028532:Same reporter US-GSK-US2023AMR028533:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathic pruritus, Pruritus
Clinical narrative: Neuropathic itching; Burning itch; This case was reported by a consumer and described the occurrence of itch burning in a 70-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included gastroesophageal reflux disease. Concomitant products included pantoprazole.   On 1st August 2021, the patient received Shingles vaccine. On 1st January 2022, 153 days after receiving Shingles vaccine, the patient experienced itch burning. On an unknown date, the patient experienced neuropathic itching. On an unknown date, the outcome of the itch burning was not recovered/not resolved and the outcome of the neuropathic itching was unknown.   It was unknown if the reporter considered the itch burning and neuropathic itching to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-Feb-2023 Reporter comment: This case was self-reported by the patient. The patient experienced burning itch and it was ongoing. The burning itch symptoms were treated. The patient would appreciate the opportunity to provide much more detail for this very disruptive condition that she was seemed to be stuck with. The reporter gave permission to contact. Additional Supportive Information: Neuropathic itching was reported as indication but conservatively captured as event and product end date was reported as 17th November 2021 in source document it was not captured as information was not clear. Clarification has been raised.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient missed second shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 11 months ago).   On an unknown date, the patient did not receive 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: 14-Feb-2023 Reporter's Comments: The reporter reported that the patient missed the second dose of Shingrix. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury
Clinical narrative: I got the first vaccine and then got Shingles; Nerve damage is incurable, had the Shindrix vaccines but no help; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles and nerve damage. On an unknown date, the outcome of the shingles was unknown and the outcome of the nerve damage was not recovered/not resolved.   It was unknown if the reporter considered the shingles and nerve damage to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-FEB-2023 Reporter's Comments: The case was received from the patient via interactive digital media. The patient got the first vaccine and then got shingles.  The patient stated that the nerve damage was incurable and had the Shingrix vaccines since. No help but possible a preventative against future attack. Additional Supportive Information: The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR025271:Same reporter (Deletion case)
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a pharmacist via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date:15-FEB-2023 Reporter's comment:  The pharmacist reported that the patient had 1st dose of Shingrix. On day 3, the patient developed rash which got better by day 7. The reporter agrees to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and pain (extremely painful sores on butt).   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 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: 14-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that she received her second dose of Shingles vaccine. The patient stated that she know that the vaccine was only 60 to 80 percentage effective due to health, but she took the vaccine on any percentage over having the shingles again. The patient stated that they really need to change the advertising they make it seem like shingles was a minor itchy rash. The patient reported that his/her shingles broke out along her sciatic nerve in her right leg and surrounding areas and hundreds of extremely painful sores on her butt, down the back of her leg and best of all his man parts. The patient stated that she wished for death until her physician prescribed pain killers that kept him/her unconscious for the more than week that it took to heal. Patient could do was wake up, pee, pop a pain killer and pass out. The patient hope she never experience these things again and she gladly dealing with her sore arm for a few days. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 9/28/2021, never went back for the 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine  (received first shot on 28th September 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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: 16-FEB-2023 Reporter's Comments: The patient never went back for the second one.  The patient asked that he/she need to start from the beginning with the first shot again or just get the 2nd one. Additional Supportive Information: The patient did not receive second shot of Shingles vaccine, which led to incomplete course of vaccination
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Allergic to Flu vaccine; This case was reported by a consumer via patient support programs and described the occurrence of allergy in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included breast cancer. Concurrent medical conditions included atrial fibrillation, drug allergy (paxil), penicillin allergy and spice allergy (garlic).   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Flu vaccine.     Linked case(s) involving the same patient:  US2023AMR027301   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: This case was reported by a consumer via (Patient Brochure Fulfillment/Shipment; Nurse Calls to Patients) patient support programs. The patient reported that she received flu vaccine. The patient stated that after received Flu vaccine she experienced allergy. The reporter did not consent to follow up. Additional supportive information: For tolerance to the pharma case refer US2023AMR027301; Sender's Comments:  US-GSK-US2023AMR027301:Pharma case
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Influenza like illness, Lymphadenopathy, Neck pain
Clinical narrative: Severe pain down arm up neck; Pain up neck; Arthralgias; Flu like symptoms; Left arm lymph nodes swollen; Headache; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, 6 hrs after receiving Shingrix, the patient experienced pain in arm, neck pain, arthralgia, influenza-like symptoms, swollen lymph nodes and headache. On an unknown date, the outcome of the pain in arm, neck pain, arthralgia, influenza-like symptoms, swollen lymph nodes and headache were recovered/resolved.   The reporter considered the pain in arm, neck pain, arthralgia, influenza-like symptoms, swollen lymph nodes and headache to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The patient was self-reported this case. The patient received 1st dose of Shingrix vaccine. The reporter stated that 6 hours after received Shingrix vaccine the patient experienced severe pain down arm up neck, arthralgia, flu like symptoms on second day it worse and by day three it was resolved. The patient experienced left arm lymph node swollen and headache. The reporter believed that it was directly tied to immunization. The reporter stated that the patient was fine and did not disuse from second dose. Additional supportive information: According to narrative verbatim the causality was conservatively captured as possible.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Severe pain down arm up neck; Pain up neck; Arthralgias; Flu like symptoms; Left arm lymph nodes swollen; Headache; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, 6 hrs after receiving Shingrix, the patient experienced pain in arm, neck pain, arthralgia, influenza-like symptoms, swollen lymph nodes and headache. On an unknown date, the outcome of the pain in arm, neck pain, arthralgia, influenza-like symptoms, swollen lymph nodes and headache were recovered/resolved.   The reporter considered the pain in arm, neck pain, arthralgia, influenza-like symptoms, swollen lymph nodes and headache to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The patient was self-reported this case. The patient received 1st dose of Shingrix vaccine. The reporter stated that 6 hours after received Shingrix vaccine the patient experienced severe pain down arm up neck, arthralgia, flu like symptoms on second day it worse and by day three it was resolved. The patient experienced left arm lymph node swollen and headache. The reporter believed that it was directly tied to immunization. The reporter stated that the patient was fine and did not disuse from second dose. Additional supportive information: According to narrative verbatim the causality was conservatively captured as possible.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: May have received three doses of Shingrix; This case was reported by a physician via sales rep and described the occurrence of extra dose administered in an unspecified number of patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th February 2023, the patient received Shingrix. On 14th February 2023, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 14-Feb-2023 Reporter's comment:  Sales rep submitted report with possible AE related to the case.  An unknown amount of patients might have received three doses of Shingrix. There was no additional AE information available at this time.  See email to safety team regarding contact information for GSK sales rep. Additional supportive information:  The patients might have received three doses of Shingrix, which led to Extra dose administered.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Arm still red at injection site.; Arm still Sensitive at injection site; Hives all over body; Pain at injection site, painful; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 21-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number B4C44, expiry date 10th November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included cetirizine hydrochloride (Zyrtec).   On 20th December 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. In December 2022, 1 hr after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site hypersensitivity and hives. In December 2022, the outcome of the injection site pain and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site hypersensitivity and hives were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, injection site hypersensitivity and hives to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Feb-2023 Reporter's comment:  The patient received Boostrix on left arm.  The patient stated that within minutes experienced pain and swelling in arm that lasted for 3 days.  After one hour of administration, the patient experienced injection site was swollen and painful, hives appear all over body.  The swollen injection site was resolve but hives were still present. Within hours of receiving the vaccine, the patient experienced hives all over body that still have not gone away and was taking Zyrtec twice a day.  The patient also mentioned left arm was still red and sensitive at the injection site.  The medical disclaimer and medical information phone number provided referred to healthcare professional. The reporter consented to follow up. Additional supportive information: From the narrative it was not clear if patient experienced time to onset for pain and swelling in arm was within a minute or 1 hr. Conservatively 1 hour was captured in the case as per follow up.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Arm still red at injection site.; Arm still Sensitive at injection site; Hives all over body; Pain at injection site, painful; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 21-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number B4C44, expiry date 10th November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included cetirizine hydrochloride (Zyrtec).   On 20th December 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. In December 2022, 1 hr after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site hypersensitivity and hives. In December 2022, the outcome of the injection site pain and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site hypersensitivity and hives were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, injection site hypersensitivity and hives to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Feb-2023 Reporter's comment:  The patient received Boostrix on left arm.  The patient stated that within minutes experienced pain and swelling in arm that lasted for 3 days.  After one hour of administration, the patient experienced injection site was swollen and painful, hives appear all over body.  The swollen injection site was resolve but hives were still present. Within hours of receiving the vaccine, the patient experienced hives all over body that still have not gone away and was taking Zyrtec twice a day.  The patient also mentioned left arm was still red and sensitive at the injection site.  The medical disclaimer and medical information phone number provided referred to healthcare professional. The reporter consented to follow up. Additional supportive information: From the narrative it was not clear if patient experienced time to onset for pain and swelling in arm was within a minute or 1 hr. Conservatively 1 hour was captured in the case as per follow up.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 2-year and 8-months-old; Kinrix as third dose of DTap and Polio; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10th June 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd February 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-FEB-2023 Reporter's Comments: The reporter called and informed that a dose of Kinrix was administered to a 2 year and 8 months old patient. The HCP(health care professional) told that was supposed to be the third dose of DTap and third dose of polio. The reporter did not consent to follow up. Additional Supportive Information: The 2 year and 8 months old patient received a dose of kinrix, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Age: 0.83
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 10 months-old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th February 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-FEB-2023 Reporter's comment: The reporter was a nurse. The reporter reported that the10 month old baby patient received Kinrix vaccine. The reporter wanted to know for any expected adverse event or risk associated with the vaccination. The reporter did consent to follow up. Additional supportive information: The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration.