chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product use issue
Clinical narrative: No additional AE reported.; An adult dose of VAQTA was administered to a 1-year old patient on 30-SEP-2022.; An adult dose of VAQTA was administered to a 1-year old patient on 30-SEP-2022.; This spontaneous report was received from a pharmacist and refers to an 1-year-old patient.  The patient's medical history, concomitant therapies and previous drugs reactions or allergies were not reported.  On 30-SEP-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) at a dose of 1 milliliter (Inappropriate dose of vaccine administered), lot #U036184, expiration date: 02-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided) (Drug use in unapproved age group). No additional adverse event was reported.
Sex: U
Vaccine: HEP, HEPA, MMRV
Symptoms: Product administered to patient of inappropriate age, Sneezing, Somnolence
Clinical narrative: Pediatric patient was administered PROQUAD and was also administered Hep A and Hep B at 25 days of life.; Patient is having some sleepiness and sneezing.; Patient is having some sleepiness and sneezing.; This spontaneous report was received from a physician and refers to a 25-day-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-SEP-2022 (at the age of 25 days), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) subcutaneous injection, lot number W020548, expiration date: 26-DEC-2023 (dose, strength, and route of administration were not provided) (product administered to patient of inappropriate age), and was also administered hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (reported as "Hep A") (product administered to patient of inappropriate age) and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (reported as "Hep B") (dose, strength, lot number, expiration date, and route of administration were not provided for both). All vaccines were administered for prophylaxis.   On an unknown date in 2022, the patient was having some sleepiness and sneezing. The outcome of the events was not provided.   The causality between the suspects and the events was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Herpes zoster, Post herpetic neuralgia, Visual impairment
Clinical narrative: multiple outbreaks of herpes zoster; PHN; vision problems; balance problems; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (Strength, dose, frequency, route of administration, lot number and expiration date were not reported). On unknown dates, after receiving zoster vaccine live (ZOSTAVAX), the patient sufferedmultiple outbreaks of herpes zoster, postherpetic neuralgia, vision problems and balance problems. As result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition; sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury; and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury
Clinical narrative: shingles; nerve damage; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. In or around 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (Strength, dose, frequency, route of administration, lot number and expiration date were not reported). On unknown dates, shortly after receiving receiving zoster vaccine live (ZOSTAVAX), the patient suffered shingles and nerve damage. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition; sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury; and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. In or around September 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (Strength, dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date, shortly after receiving receiving zoster vaccine live (ZOSTAVAX), the patient suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition; sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury; and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury
Clinical narrative: shingles; nerve damage; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. In or around July 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (Strength, dose, frequency, route of administration, lot number and expiration date were not reported). On unknown dates, shortly after receiving receiving zoster vaccine live (ZOSTAVAX), the patient suffered shingles and nerve damage. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition; sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury; and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reporting an improperly stored vaccine was administered to a patient/ Temperature: -11.8 degree Celsius; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 08-SEP-2022, the patient was vaccinated with improperly stored (product storage error) dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U039726, expiration date: 15-DEC-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: -11.8 degree Celsius for 1 hour 45 minutes, no previous temperature excursion. There was no additional adverse event reported.
Sex: U
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No additional AE; HCP reporting an improperly stored vaccine was administered to a patient/ Temperature: -11.8 degree Celsius; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 08-SEP-2022, the patient was vaccinated with improperly stored (product storage error) dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U039726, expiration date: 15-DEC-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: -11.8 degree Celsius for 1 hour 45 minutes, no previous temperature excursion. There was no additional adverse event reported.
Sex: U
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report was received from a nurse referring to a neonate patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.   On 08-SEP-2022, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) quantity 1, lot #U039726, expiration date: 15-DEC-2023, administered for prophylaxis (strength, route of administration, vaccination scheme frequency, anatomical location, and dose were not reported) after a temperature excursion (temperature: -11.8 degrees Celsius (C); time frame: 1 hour 45 minutes) (product storage error). There was previous temperature excursion (details not reported). No additional adverse event was reported (no adverse event).  This is one of 17 reports received from the same reporter.
Sex: U
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: no adverse event; VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report was received from a nurse referring to a neonate patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.   On 08-SEP-2022, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) quantity 1, lot #U039726, expiration date: 15-DEC-2023, administered for prophylaxis (strength, route of administration, vaccination scheme frequency, anatomical location, and dose were not reported) after a temperature excursion (temperature: -11.8 degrees Celsius (C); time frame: 1 hour 45 minutes) (product storage error). There was previous temperature excursion (details not reported). No additional adverse event was reported (no adverse event).  This is one of 17 reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP reporting an improperly stored vaccine was administered to a patient. No additional details provided. No additional AE. No PQC.   ?    Names of vaccines involved: PROQUAD (Lot: W019623, Expiration Date: 19DEC2023) ?    Temperature: -11.8C ?; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-SEP-2022, the patient was vaccinated with inappropriately stored dose (temperature: -11.8 Celsius degrees, time frame: 1 h 45 min 0 sec), no previous temperature excursion) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) subcutaneous injection, lot number W019623, expiration date: 19-DEC-2023, administered for prophylaxis (dose, strength, and route of administration were not provided) (product storage error). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP reporting an improperly stored vaccine was administered to a patient.; No additional AE.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 27-SEP-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W002601, expiration date: 24-JAN-2024, for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). Administrated vaccine varicella virus vaccine live (oka/merck) (VARIVAX) was stored at -11.8 Celsius degrees for 1 hour and 45 minutes, no previous temperature excursion were reported.  There were no adverse events reported (no adverse event).
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 14  year old was administered a PROQUAD vaccine; No aditional AE details; This spontaneous report was received from a healthcare professional and refers to a 14-year-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, (strength, dose, dose number, route and site of vaccination, lot# and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE) details was provided (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired vaccine dose was administered to a patient; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not provided.  On 04-OCT-2022, the patient was vaccinated with an expired dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot #1687291, expiration date: 11-SEP-2022 (strength, dose, dose number, route and site of vaccination were not provided) for prophylaxis (expired vaccine used). No additional adverse events (AEs) was reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On 03-OCT-2022, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (lot#1879866 with an expiration date on 30-OCT-2023) (strength was not provided).  The nurse reported that the patient received improperly stored vaccine (product storage error).   The dose of vaccine was exposed to a temperature excursion of 55.8 degrees Fahrenheit (°F) during a time frame of 44 hours. There was no prior temperature excursion and no adverse events were reported.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Administration of improperly stored vaccine on 15-SEP-2022.; This spontaneous report has been received from a health care business professional and refers to a 6-month-old patient. The patient's medical history, concomitant therapies and previous drugs reactions or allergies were not reported.  On 15-SEP-2022, the patient was vaccinated with first dose of an improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #T026960, expiration date: 17-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided) following a temperature excursion of  35.2 degree Farenheit for 6 hours 12 minutes, it was stated that no previous temperature excursion occured. No additional adverse event was reported.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; Caller reported expired MMR II was administered.; This spontaneous report was received from a nurse and refers to a 2-year-old male patient.  The patient's medical history, concomitant therapies and previous drugs reactions or allergies were not reported.  On 20-SEP-2022, the patient was vaccinated with an expired  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot #T029549, expiration date: 10-SEP-2022, administered for prophylaxis (strength, vaccination scheme and route of administration were not provided) (Expired vaccine used). No additional adverse event were reported.; Sender's Comments:  US-009507513-2210USA001482:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE; An HBP is calling in to report an AE for a patient that was given an expired dose of VAQTA. Because the HBP also had questions regarding the potency of the dose and possible need for re-vaccination this agent requested to speak with an HCP. A nurse t; This spontaneous report was received from a  health professional referring to a patient of unknown age and gender. Information regarding the patient medical history, concomitant medications, drug allergies or reactions was not provided.       On 04-OCT-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 0.5 milligram, intramuscular for prophylaxis, lot number U004366 has been verified to be valid for hepatitis a vaccine, inactivated expired date 01-OCT-2022 (expired product administered). No additional adverse events were reported. The health care business professional was inquiring about the potency of the dose.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got shingles, less severe; still had sores and pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 shingles were unknown and the outcome of the pain was recovered/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: 29-Sep-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter's husband received the vaccine and still got shingles.  The pharmacist told that like covid, it would be less severe.  The patient experienced still had sores and pain, but lasted only a few months. Additional Supportive Information: The follow up would not possible, as no contact, details were available. 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.
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy after 1st dose; This case was reported by a physician via sales rep and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was recovered/resolved.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-Sep-2022 Reporter's comment: The patient received the first dose of Shingrix. The patient developed Bell 's palsy after 2 weeks of first dose. The conditions was resolved after a month of speech and occupational therapy.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had shot years ago, have shingles now/Suspected vaccination failure; Have shingles now; Very 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, several years 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: 01-Oct-2022 Reporter's comment: The case was received from the patient via  interactive digital media. The patient had shot a number of years ago but he/she have had shingles now. The patient stated was very painful. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule 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, Vaccination failure
Clinical narrative: Got the shot and got shingles/Suspected vaccination failure; Got 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: 01-Oct-2022 Reporter's comment: The case was received from the patient's buddy via interactive digital media. The patient got the shot and got shingles. The reporter's elderly dad had them for third time in 2019 and reporter treated him with 6 essential oil blend which for him was amazing. The reporter's dad was not getting the shots. 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: MENB
Symptoms: Axillary pain, Erythema, Swelling
Clinical narrative: marked swelling; Marked edness; Axillary pain; This case was reported by a nurse via sales rep and described the occurrence of local swelling in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced local swelling, localized erythema and axillary pain. On an unknown date, the outcome of the local swelling, localized erythema and axillary pain were unknown.   It was unknown if the reporter considered the local swelling, localized erythema and axillary pain to be related to Bexsero and Bexsero 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: 26-SEP-2022 Reporter's Comment: The patient received the first dose of Bexsero vaccine recently. The patient had a large local reaction. The patient experienced marked swelling and redness and axillary pain.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: It hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comment: This case was reported by patient via interactive digital media. The patient received a dose of Shingles vaccine (actually 2 shots) this year and it hurt. Additional supportive information: The follow-up would not possible, as no contact, details were available. The case US2022AMR140129 was created in error was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site mass, Muscular weakness, Pain
Clinical narrative: Big lump at injection site; Haven't been right since; Painful for 3 years so far; Weakness in that arm; 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 Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site lump, feeling abnormal, pain and weakness of arms. On an unknown date, the outcome of the injection site lump, feeling abnormal and weakness of arms were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site lump, feeling abnormal, pain and weakness of arms to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Sep-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had got the shot and had not been right since. The patient had a big lump at injection site, painful for 3 years so far and had weakness in that arm. The patient would never get another shot again, including Covid vaccine. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Pain, Pruritus
Clinical narrative: Have had shingles/first shot it didn't work; Itching; Pain are so bad; Is very debilitating; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (The patient had shingles for 42 years, started on feet, the arches of left foot, then moved to spine). Previously administered products included Valtrex. Concurrent medical conditions included scar (patient had scarring from years ago).   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 shingles, pruritus, pain and debility. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles, pruritus, pain and debility were unknown.   It was unknown if the reporter considered the shingles, pruritus, pain and debility to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR139421   Additional Information: GSK Receipt Date: 26-Sep-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had 1st shingles shot and experinced shingles.  The patient stated that shot did not worked.  The doctor finally prescribed acyclovir and the patient took it 2 times a day, if the patient missed taking it, the patient might run out the shingles come back.  The patient was very debilitating and had the itching and pain were so bad, the patient had been scarred from years ago. Additional supportive information: The follow-up would not possible, as no contact details were available. This case has been linked with the case US2022AMR139421 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR139421:
Sex: U
Vaccine: FLUX
Symptoms: Expired product administered
Clinical narrative: On datasheet the vx I was given read as expired; This case was reported by a consumer and described the occurrence of expired vaccine used in a patient who received Flu unspecified (Flu vaccine) (batch number FZ453, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comment: The reporter reported that the patient just received Flu vaccine of NDC 58160-890-41 from lab. The reporter stated that the expiration date on the datasheet was given and read as expired. The provider stated that it was an error from their part, and they were missed to write the expiration date. Additional supportive information: The patient received a Flu vaccine which was already expired, which led to expired vaccine used. Follow-up would not possible as no contact details were available.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site swelling, Nausea, Pain in extremity
Clinical narrative: Arm hurts; headache; fever; nausea; throwing up; hot to touch on arm; itchy; feeling very run down; Swollen arm around area of vaccine administration,; This case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2022, the patient received the 1st dose of Shingrix. On 12th September 2022, less than a day after receiving Shingrix, the patient experienced fever and nausea. In September 2022, the patient experienced injection site swelling, vomiting, skin warm, pruritus and fatigue. On 15th September 2022, the patient experienced pain in arm and headache. On an unknown date, the outcome of the injection site swelling, fever, nausea, vomiting, skin warm, pruritus, fatigue, pain in arm and headache were unknown.   It was unknown if the reporter considered the injection site swelling, fever, nausea, vomiting, skin warm, pruritus, fatigue, pain in arm and headache to be related to Shingrix.     Additional Information: GSK receipt date: 14-Sept-2022 and 15-Sept-2022 Reporter's comment: The patient had received a dose of Shingrix and on the same day of vaccination in the evening, the patient reported fever and nausea. 1 day after vaccination, the patient reported throwing up and fever. 2 days after vaccination, the patient reported swollen arm (around area of vaccine administration), hot to touch, itchy and feeling very run down. 3 days after vaccination, the patient had nausea, arm hurts, headache, hot to touch on arm/itchy and feeling very down. The reporter consented to follow-up. Additional supportive information: Based upon the intake response 'Yes, that is correct the events described on September 15th occurred on the 15th. I assumed I could include that information given I was writing the report on the 15th.', new tracking memo was created considering that on 15th September 2022, events were reported and for arm hurt and headache onset date was considered as 15th September 2022, as per response both events occurred of this date.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Skin warm, Vomiting
Clinical narrative: Arm hurts; headache; fever; nausea; throwing up; hot to touch on arm; itchy; feeling very run down; Swollen arm around area of vaccine administration,; This case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2022, the patient received the 1st dose of Shingrix. On 12th September 2022, less than a day after receiving Shingrix, the patient experienced fever and nausea. In September 2022, the patient experienced injection site swelling, vomiting, skin warm, pruritus and fatigue. On 15th September 2022, the patient experienced pain in arm and headache. On an unknown date, the outcome of the injection site swelling, fever, nausea, vomiting, skin warm, pruritus, fatigue, pain in arm and headache were unknown.   It was unknown if the reporter considered the injection site swelling, fever, nausea, vomiting, skin warm, pruritus, fatigue, pain in arm and headache to be related to Shingrix.     Additional Information: GSK receipt date: 14-Sept-2022 and 15-Sept-2022 Reporter's comment: The patient had received a dose of Shingrix and on the same day of vaccination in the evening, the patient reported fever and nausea. 1 day after vaccination, the patient reported throwing up and fever. 2 days after vaccination, the patient reported swollen arm (around area of vaccine administration), hot to touch, itchy and feeling very run down. 3 days after vaccination, the patient had nausea, arm hurts, headache, hot to touch on arm/itchy and feeling very down. The reporter consented to follow-up. Additional supportive information: Based upon the intake response 'Yes, that is correct the events described on September 15th occurred on the 15th. I assumed I could include that information given I was writing the report on the 15th.', new tracking memo was created considering that on 15th September 2022, events were reported and for arm hurt and headache onset date was considered as 15th September 2022, as per response both events occurred of this date.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: severe muscle pain; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th August 2022, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was unknown.   It was unknown if the reporter considered the myalgia to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comments: The patient had the Shingrix vaccine and had severe muscle pain. The patient said that please advise.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Aug 7th 2022, 2nd on Sep 23rd 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 22-year-old patient who received HAV (Havrix) for prophylaxis.   Concurrent medical conditions included immunocompromised. Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 23rd September 2022, the patient received the 2nd dose of Havrix. On 23rd September 2022, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's comment: Pharmacist reported that the patient received a 1st dose of Havrix on 7th August 2022 and 2nd dose on 23rd September 2022. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Havrix earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only diluent component; received only diluent component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 7XC23, expiry date 12th October 2023) for prophylaxis.   On 21st September 2022, the patient received the 1st dose of Shingrix. On 21st September 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comments: The medical assistant called and reported that a female patient received only the diluent component of Shingrix. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. Additional Supportive Information: The patients received Shingrix vaccines with only the diluent component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 3 days after the first; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 26-Sep-2022 Reporter's comment: A pharmacist reported that according to a facility records, a patient received the 2nd dose of Shingrix, 3 days after the first dose.  The patient denies this information. Reporter consented to follow up. Additional supportive information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to shortening of vaccinations schedule.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test
Clinical narrative: shingles after getting first dose, in throat; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number Y7D4B, expiry date 31st August 2023) for prophylaxis.   On 9th September 2022, the patient received the 1st dose of Shingrix. On 9th September 2022, less than a day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK receipt date: 26-SEP-2022 Reporters comment:  The patient received the first dose of shingrix and experienced shingles. His symptoms started the same day. He had lab work on 21st September 2022 and confirmed shingles in his throat, and his symptoms were improving. The reporter would like to know if patient should have second dose and if so when should it be given. The reporter had not heard since then. The reporter consented to follow-up via postal.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2022-2023 season) (batch number NS775, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2022, the patient received Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2022, unknown after receiving Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 26-SEP-2022 Reporter's comment: The nurse reported that a dose of Fluarix Tetra given to the patient and it was already expired. The reporter consented to follow up. Additional Supportive Information: The use of Fluarix Tetra dose which was already expired on 30th June 2022, which led to expired vaccine used.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Extra dose of Menveo administered; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 14-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA712A, expiry date 31st May 2023) for prophylaxis.   Previously administered products included MENVEO (The patient received first dose of Menveo on 5th February 2019).   On 23rd September 2022, the patient received the 2nd dose of Menveo. On 23rd September 2022, 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: 26-SEP-2022 Reporter's Comments: The reporter stated that a extra dose of Menveo was administered in error to a patient. The reporter did not gave consent to follow-up. Additional Supportive Information: The patient received extra dose of Menveo was administered in error which lead to Extra dose administered.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received HAV (Havrix) for prophylaxis.   On 23rd September 2022, the patient received Havrix. On 23rd September 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 26-September-2022 Reporter's comment: Reporter called to ask for information about the administration of an expired dose of Havrix to an 18 year old patient and asked for information about the wait time in order to repeat the dose. The reporter did not provide information about the lot number and expiration date of the dose of Havrix that was administered. Reporter consented to follow up. Additional supportive information. As patient was administered expired dose, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose March2019, 2nd never; This case was reported by a pharmacist via call center representative 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 the first dose of Shingrix in March 2019).   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: 26-SEP-2022 Reporter's Comment: The reporter reported that, never received the 2nd dose of Shingrix.  The reporter wanted to know if needed to restart the series. The reporter did not consent to follow-up.  Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.