chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 05-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 06-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 07-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 11-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 11-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 19-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Age: 18.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient has had no reported side effects.; Nurse reported that a dose of PROQUAD was administered to an 18 year old male on Tuesday, 7/28/2022 instead of the individual MMR-II and VARIVAX.; Nurse reported that a dose of PROQUAD was administered to an 18 year old male on Tuesday, 7/28/2022 instead of the individual MMR-II and VARIVAX.; This spontaneous report was received from a certified medical assistant other health referring to an 18-year-old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 26-JUL-2022 (also reported as on Tuesday), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), at a dose of 0.5 milliliter, subcutaneously, lot number W006583 and expiration date of 23-AUG-2023 for prophylaxis. (anatomical location was not reported), instead of the individual Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX). The patient had no reported side effects (wrong product administered and product administered to patient of inappropriate age).
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: COVID-19, SARS-CoV-2 test negative
Clinical narrative: had first vaccine, contacted Covid; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2022, the patient received the 1st dose of Shingrix. On 15th June 2022, 31 days after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was recovering/resolving.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-JUL-2022 Reporter's Comments: The case was reported via interactive digital media. The patient received his first Shingrix vaccine on 15th May of this year. The patient was contacted Covid on 15th June and tested negative on 27th June. The patient asked when he could have 2nd Shingrix shot after recovering from Covid.
Sex: U
Vaccine: TDAP
Symptoms: Illness
Clinical narrative: Was Sick for a week; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   Previously administered products included tetanus vaccine with an associated reaction of no adverse event.   On an unknown date, the patient received dTpa vaccine. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to dTpa vaccine.     Additional Information: GSK receipt date: 24-JUL-2022 Reporter's comments: The case was reported by a consumer via interactive digital media Patient self-reported the case. Patient got a DTaP shot and was sick for a week.  Patient had went in for tetanus but was told this was better. Patient had tetanus before with no reaction never again.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: What helps the pain; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 25-JUL-2022 Reporter's comment: The case was reported by the consumer via interactive digital media. The reporter wanted to know what helps to pain. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm hurt like hell; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-JUL-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient got first dose last week from date of reporting. The patient's arm hurt like hell, but as per patient shingles hurt much more. The patient would get 2nd dose in mid of the September. Additional Supportive Information: The follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Illness
Clinical narrative: I was sick for 3 months; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 22-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient was sick for 3 months from that BS, two shots.  The reporter stated that don't do it. Additional Supportive Information:  The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Drug eruption
Clinical narrative: Drug erruption of shingrix was worst/8 months suffering flare ups; This case was reported by a consumer via interactive digital media and described the occurrence of drug eruption in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug eruption. On an unknown date, the outcome of the drug eruption was not recovered/not resolved.   It was unknown if the reporter considered the drug eruption to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-JUL-2022 Reporter's Comments: This case was received from patient via interactive digital media The reporter reported that, the drug eruption of shingrix was worst.  The patient was suffering flare ups from 8 months, every other month for 8 months now with no visible improvement.  The reporter suggested that to not get this vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: temperature of 100; body aches; This case was reported by a other health professional and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever and general body pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022104395, US2022107809   Additional Information: GSK receipt date: 26-JUL-2022 Reporter's comment: The reporter reported that the patient experienced temperature of 100 and some body ache after 1st dose. The reporter consent to follow up. For tolerance to the 2nd dose refer case US2022107809. This case is linked to the case US2019110512, US2020173746, US2021AMR153878 and US2022AMR056349, reported by the same reporter.; Sender's Comments:  US-GSK-US2022107809:Same patient, second dose US-GSK-US2022104395:Same patient, third dose US-GSK-US2019110512:Same reporter US-GSK-US2020173746:Same reporter US-GLAXOSMITHKLINE-US2021AMR153878:Same reporter US-GLAXOSMITHKLINE-US2022AMR056349:Same reporter
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Arm was in pain; 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 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, less than a month after receiving Bexsero and Bexsero Pre-Filled Syringe Device, 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 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-JUL-2022 Reporter's Comments:  This case was reported by patient's parent via interactive digital media. The patient received the Bexsero injection before going to college. The reporter knew the second dose could be given 1 month after the first dose but how far past one month could it be given.  The patient's arm was in pain for about 3 weeks afterwards.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: It sucks/feel like been punched; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 25th July 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was not recovered/not resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got the shingles shot on the day before the date of reporting.  The patient stated that it sucked and it felt like he/she had been punched but it was better than having all the nerves on fire. Follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: pain in arm; Headache; body aches; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm, headache and general body pain. On an unknown date, the outcome of the pain in arm, headache and general body pain were unknown.   It was unknown if the reporter considered the pain in arm, headache and general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-July-2022 Reporter's comment: This case was reported by consumer via interactive digital media. The patient just had his/her shingles shot two days before date of reporting. The side effects were pain in arm, headache and body ache but that certainly was better than the alternative. The patient's insurance paid 100 percent. The follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: arm still hurts; It wasn't the stick/felt like toad tar going in; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm and arm discomfort. On an unknown date, the outcome of the pain in arm and arm discomfort were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and arm discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-JUL-2022 Reporter's Comments: This case reported by the patient via interactive digital media. The patient got first shingles vaccine about a week ago.  His/her arm still hurts at the time of reporting.  It was not the stick. It felt like toad tar going in.  His/her second shot would be in two months.  The patient felt sorry for all who were suffering from that. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Hypersensitivity
Clinical narrative: allergic reaction to the vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of allergy to vaccine in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included shingles vaccine with an associated reaction of no adverse event (1st dose received on an unknown date).   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 allergy to vaccine. On an unknown date, the outcome of the allergy to vaccine was recovered/resolved.   It was unknown if the reporter considered the allergy to vaccine to be related to Shingles vaccine.     Additional Information: GSK receipt date: 26-JUL-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. Patient self-reported the case. Patient had the shingles once and that was enough to motivate patient to get the vaccine.  After the second shot patient had an allergic reaction to the vaccine.  Patient pulled through that ordeal and it was proved that not everyone had the same biochemistry or outcome with vaccines.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain, Pyrexia
Clinical narrative: fever; body ache; it so bad for me; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, general body pain and feeling bad. On an unknown date, the outcome of the fever, general body pain and feeling bad were unknown.   It was unknown if the reporter considered the fever, general body pain and feeling bad to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-JUL-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The reporter mentioned, he/she got 2nd dose of Shingles but it was so bad for him/her. The patient got a fever and had a body ache. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt terrible; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-JUL-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that they felt terrible on the next day of their 1st dose of vaccination. Additional supportive information: Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: my arm was sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Shingles vaccine was discontinued. 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: 27-JUL-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient had Shingle shot and stated never want the shot ever again his/her arm was sore for 5 days just terrible all of it. Additional supportive information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: shot's after effect is a sore arm for a few days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st 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: 27-JUL-2022 Reporter's comments: This case was reported by consumer via interactive digital media. The patient had the 2-dose vaccine too. It was reported that patient knew that after the shot's after effect was a sore arm a few days. This would go away. The reporter mentioned that there is a need to take second shot to insure the protection. The disease of shingles is not anything that patient would wish on anyone. The follow up would not be possible as contact details were not provided. Additional Supportive Information: For tolerance of 2nd dose refer case US2022AMR112182.; Sender's Comments:  US-GSK-US2022AMR112182:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: shot's after effect was a sore arm for a few days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date, for tolerance refer case US2022AMR112178).   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. Rechallenge with Shingles vaccine was positive. 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: 27-JUL-2022 Reporter's comments: This case was reported by consumer via interactive digital media. The patient had the 2-dose vaccine too. It was reported that patient knew that after the shot's after effect was a sore arm a few days. This would go away. The reporter mentioned that there was a need to take second shot to insure the protection. The disease of shingles was not anything that patient would wish on anyone. The follow up would not be possible as contact details were not provided.; Sender's Comments:  US-GSK-US2022AMR112178:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm was sore for one week; This case was reported by a physician via sales rep and described the occurrence of pain in arm 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, unknown after receiving Shingrix, 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 Shingrix.     Additional Information: GSK Receipt Date: 26-JUL-2022 Reporter's Comments: The health care professional shared his own personal experience following the 1st dose of Shingrix.  He said his arm was sore for one week. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: muscle weakness; This case was reported by a consumer via interactive digital media and described the occurrence of muscle weakness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In July 2022, unknown after receiving Shingles vaccine, the patient experienced muscle weakness. On an unknown date, the outcome of the muscle weakness was unknown.   It was unknown if the reporter considered the muscle weakness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-July-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The follow-up would not possible, as no contact, details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feel so bad for a few days; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had first case when patient was pregnant with second child).   In July 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had her first case of shingles when she was pregnant with her second child. She got her first shingles shot a week ago and it made her feel so bad for a few days.  She will get the next one but she dread it. Follow up was not possible as no contact details were available.
Age: 18.0
Sex: U
Vaccine: MNQ, MNQ
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered (2nd dose); 18 year old administered 3rd dose 22/Jul/22; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 18-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 22nd July 2022, the patient received the 3rd dose of Menveo. On an unknown date, the patient received the 2nd dose of Menveo. On 22nd July 2022, not applicable after receiving Menveo and unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The clinic administrator reported that on the day of reporting the patient received 3rd dose of Menveo. The IT issues were present during and after call, call disconnected. The consented to follow-up was unable to obtain. Additional supportive information: The patient received 2nd and 3rd dose of Menveo, which led to extra dose administrated. As per local schedule, there is a single for Menveo and in narrative it was reported that patient received the 3rd dose, therefore in worst approach 2nd dose of Menveo was also captured along with extra dose administered event.
Age: 1.5
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 18 months old received Boostrix/received Boostrix as Dtap 4th dose; 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 18-month-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included infection (suffered a cut on his feet with a gardening tool that created an infection).   On 21st July 2022, the patient received the 4th dose of Boostrix. On 21st July 2022, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 25-Jul-2022 Reporter's comment: An 18 months old male patient received a Boostrix vaccines as a Dtap 4th dose, due he suffered a cut on his feet with a gardening tool that created an infection.  The permission to storage personal information was not asked.  The email was sent to Safety. The reporter consented to follow up. Additional supportive information: The patient received a Boostrix vaccine at inappropriate age, which led to inappropriate age at vaccine administration.
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 37-year-old female patient who received HAV (Havrix) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   On 25th July 2022, the patient received Havrix. On 25th July 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: 25-Jul-2022 Reporter's Comments: The reporter was an agent from the service center.  The patient was administered Havrix vaccine on 25th July 2022 to a patient, then realized the dose was expired. Additional Supportive Information: The patient was administered with Havrix vaccine, which was already expired, which led to expired vaccine used.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: inadvertently administered Bexsero instead; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28th February 2023) 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 25th July 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 25th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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: 25-JUL-2022 Reporter's Comment: The reporter reported that, administration of Bexsero at the time of reporting for patient accidentally and their office usually administers 1st dose of Bexsero at age 16 years old.  She reported that, they were intending to administered Boostrix and inadvertently administered Bexsero instead of Boostrix.  The reporter reported that, Boostrix was administered at the same visit. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, they were intending to administered Boostrix and inadvertently administered Bexsero instead of Boostrix, which led to wrong vaccine administered.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administrated with expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number d24g7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 25th July 2022, unknown after receiving Kinrix and Kinrix 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-JUL-2022 Reporter's comment: The nurse reported that the patient was administered a dose of Kinrix, which had an expiration date of 4th June 2022. No adverse event was reported. No patient's identifiers provided Permission to follow up was not requested. Additional supportive information: The patient had received an expired dose of Kinrix, which led to expired vaccine used.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only liquid conjugate portion; administered only liquid conjugate portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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-Jul-2022. Reporter's Comments: The medical assistant reported that the patient was administered only the liquid conjugate portion of the Menveo vaccine. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not have details available for call but would provide by follow up preferred email above. The reporter consented to follow up. Additional Supportive Information: The patient was administered only the liquid conjugate portion of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: dose 25Jul2022, had an expiration date of 04Jun2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 25th July 2022, unknown after receiving Kinrix and Kinrix 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-JUL-2022 Reporter's Comments: The patient was administered a dose of Kinrix on 25th July 2022, which had an expiration date of 4th June 2022. At the time of reporting, the dose was not repeated.  The reporter consented to follow up. The vaccine administration facility was the same as primary reporter Additional Supportive Information: The patient received expired dose of Kinrix, which led to expired vaccine used.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Herpes zoster, Pain
Clinical narrative: soar/sore; abdominal pain; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number 7bc47, expiry date 9th June 2023) for prophylaxis.   On 19th July 2022, the patient received the 1st dose of Shingrix. On 22nd July 2022, 3 days after receiving Shingrix, the patient experienced shingles and abdominal pain. On 24th July 2022, the patient experienced pain. On an unknown date, the outcome of the shingles, pain and abdominal pain were unknown.   It was unknown if the reporter considered the shingles, pain and abdominal pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-JUL-2022 Reporter's comments: The pharmacist reported that the a patient was administered with Shingrix and had experienced abdominal pain and 5 days after had soreness and the doctor had confirmed it to be shingles. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix diluent administered alone; Shingrix diluent administered alone; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number FCEFF, expiry date 23rd September 2023) for prophylaxis.   In July 2022, the patient received Shingrix. In July 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-Jul-2022 Reporter's Comments:  Office Administrative knew that from 18th July to 25th July 2022, an unknown patient received Shingrix diluent portion alone without the powder. The reporter gave consent to follow up. Additional supportive Information: The patient received Shingrix diluent portion alone without the powder which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only diluent portion; administered only diluent portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 2-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 22952, expiry date 16th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 22nd July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 22nd July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, 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.     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: 27-Jul-2022 Reporter's Comments: The nurse reported that another nurse accidentally administered on 22nd July 2022 only the diluent portion of Rotarix to 2 patients. The reporter consented to follow up. Additional Supportive Information: The nurse reported that another nurse accidentally administered on 22nd July 2022 only the diluent portion of Rotarix to 2 patients, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022111744:Same reporter
Age: 0.08
Sex: F
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only diluent portion; administered only diluent portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Rota (Rotarix lyophilized formulation) (batch number 22952, expiry date 16th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 22nd July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, 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.     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: 27-Jul-2022 Reporter's Comments: The nurse reported that another nurse accidentally administered on 22nd July 2022 only the diluent portion of Rotarix to 2 patients. The reporter consented to follow up. Additional Supportive Information: The nurse reported that another nurse accidentally administered on 22nd July 2022 only the diluent portion of Rotarix to 2 patients, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022111743:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered just liquid portion; administered just liquid portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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: 27-Jul-2022 Reporter's Comments: The pharmacist reported that a nurse administered just the liquid conjugate portion of the Menveo vaccine. Health are professional (HCP) did not have any details at time of call. The reporter consented to follow up via email. Additional Supportive Information: The pharmacist reported that a nurse administered just the liquid conjugate portion of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.