chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; she was unsure if any of these vaccines had been administered since the excursion occurred; This spontaneous report has been received from a medical assistant, concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On unknown dates, patients were vaccinated with improperly stored haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number T030706 has been verified to be valid; expiration date reported and established as 02-APR-2023, and lot number U024489 has been verified to be valid; expiration date reported and established as 02-NOV-2023), rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 1742420 has been verified to be valid; expiration date reported and established as 31-JAN-2023), and hepatitis a vaccine, inactivated (VAQTA) (lot number W007371 has been verified to be valid; expiration date reported and established as 13-JUL-2023, lot number W002894 has been verified to be valid; expiration date reported and established as 06-MAR-2023, and lot number U012007 has been verified to be valid; expiration date reported and established as 18-JAN-2023) as prophylaxis (product storage error) (doses, vaccination schemes, routes of administration, and anatomical locations were not provided). The administered doses of the vaccines were stored at a temperature of 52.2 degrees Fahrenheit (F), during a time frame of 2 hours and 53 minutes, and at a temperature of 33.6 F, during a time frame of 4 hours and 59 minutes. There was no previous temperature excursion reported. There was no adverse effect reported. In addition, the reporter that she was unsure if any of these vaccines had been administered since the excursion occurred.  Follow-up information has been received from the nurse (previously reported as medical assistant) during a phone call on 25-OCT-2022.   The nurse was able to locate 5 patients that were involved in this temperature excursion (product storage error) and had already collected data on the patients (captured in MARRS # 2210USA009377, 2210USA009378, 2210USA009379, and 2210USA009380).   This spontaneous report refers to a 2-year-old female patient.   On 06-SEP-2022, she was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot number W002894 has been verified to be valid; expiration date reported and established as 06-MAR-2023 (strength, dose and route of administration were not provided) as prophylaxis.   This is one of 5 reports received from the same reporter.  This case was previously considered non-valid due to lack of patient's identifiers, but upon receipt of follow-up it was determined that the case is now valid. ; Sender's Comments:  US-009507513-2210USA009379:MSD US-009507513-2210USA009377:MSD US-009507513-2210USA009380:MSD US-009507513-2210USA009378:MSD
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse reported PNEUMOVAX 23 was administered after a temperature excursion; No additional AE reported.; This spontaneous report has been received from a nurse referring an unknown number of patients of unknown age and genders. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unknown date, the patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration, anatomical site of application, lot number and expiration date were not provided) which had a temperature excursion of 47 fahrenheit (F), for 0 hours 55 minutes and 0 seconds (product storage error). No additional adverse event reported.   This case was classified as non-valid due to lack of patient identifiers.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: an expired dose of GARDASIL 9 was administered today; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender.  The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 26-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) 0.5 milliliter, administered as prophylaxis (lot number 1687292 has been verified to be a valid lot number with expiration date on 25-AUG-2022, and upon internal validation established as the same date) (vaccination scheme, frequency, route of administration and anatomical site of injection were not provided) There were no previous temperature excursions. No additional information was provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient received VARIVAX via intramuscular route instead of subcutaneous route.; No additional AEs were reported; This spontaneous report has been received from a nurse referring a patient of unknown age and gender. Concomitant medications included sterile diluent. The patient's pertinent medical history, drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number w017551 with expiration date 01-JUN-2024, administered intramuscularly for prophylaxis (specific dosage, vaccination scheme and anatomical site of application were not provided) (incorrect route of product administration). No additional adverse events were reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had 2 doses and shingles came back /Suspected Vaccination failure; Shingles came back; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that he/she had 2 doses of Shingrix and his/her shingles had come back. It did not helped him/her. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Friends got the shot and caught it/Suspected vaccination failure; Caught it; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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: 27-Oct-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that he/she had friends who got the shot and caught them. 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. The case was linked with case US2021AMR100406, US2021AMR100411 and US2021AMR131359 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR100406:Same reporter. US-GSK-US2021AMR100411:Same reporter. US-GLAXOSMITHKLINE-US2021AMR131359:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness; Swelling; This case was reported by a pharmacist via sales rep and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were recovered/resolved.   It was unknown if the reporter considered the erythema and swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comment: The patient had redness and swelling for approximately one week after having received 1st dose of Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itching/ itching" all over after getting her 1st dose of Shingrix.; This case was reported by a other health professional via sales rep and described the occurrence of generalized pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was unknown.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comment: The reporter was Medical Assistant.  The reporter that another medical assistance in the office experienced itching all over after getting her 1st dose of Shingrix. The reporter did not consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 1st dose on 04Oct2022, shingles appeared on 09Oct2022; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2022, the patient received the 1st dose of Shingrix. On 9th October 2022, 5 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient received first of two shingrix shots on 4th October 2022, shingles appeared on 9th October 2022 PM and diagnosed 13th October 2022 was only on his/her left thigh.  The patient was realised it could have been much, much worse. The patient finished Rx on this morning of day of reporting. The patients second shot approximately on 4th December 2022. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; Slight headache; 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 October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm and headache. On an unknown date, the outcome of the pain in arm and headache were unknown.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got the shot Wednesday.  The patient experienced sore arm and slight headache was all he/she had as far as side effects. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Pain in extremity, Product preparation issue
Clinical narrative: sore arm; administered a dose of Shingrix adjuvant-only; administered a dose of Shingrix adjuvant-only; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number H9LL4, expiry date 24th November 2023) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (first dose received on an unknown date and refer case ID US2022152220).   On 20th October 2022, the patient received the 2nd dose of Shingrix. On 20th October 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 21st October 2022, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022152220   Additional Information: GSK Receipt Date: 21-Oct-2022 Reporter's comment: The pharmacist stated yesterday evening, on 20 Oct 2022, the patient received a second dose of Shingrix adjuvant only. 1 day after vaccination, the patient reported a sore arm on the day of reporting. The patient stated she remembered having a sore arm after first dose, however received two vaccines that day and was not sure which vaccine caused the sore arm. The reporter consent to follow-up. Additional supportive information: The patient received a second dose of Shingrix adjuvant only, which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered.This case had been linked with, US2022152220, reported by same patient.; Sender's Comments:  US-GSK-US2022152220:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only adjuvant administered; Only adjuvant administered; 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 FA95N, expiry date 28th July 2023) and (batch number 052JX, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, 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: 21-OCT-2022 Reporter's Comment: The reporter stated that a 2 antigen (powder) was left in the shingrix box and the reporter believes that 2 patient out of the 10 patients received only the adjuvant portion of the shingrix.  The reporter was planning to revaccinate all 10 of them because she was unsure who got them. The reporter did not had any information to provide on the patients. The Vaccine Administration Facility was the same as Primary Reporter The reporter give consent to follow up. This case was for 2 of 2 linked reports. Additional supportive information: The patient received only the adjuvant portion of the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022152231:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Gait disturbance, Headache, Pain
Clinical narrative: fever; chills; headache; body aches and pain; weakness, too weak to walk; almost too weak to walk; 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 Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced fever, chills, headache, general body pain, weakness and walking difficulty. On an unknown date, the outcome of the fever, chills, headache, general body pain, weakness and walking difficulty were recovered/resolved.   It was unknown if the reporter considered the fever, chills, headache, general body pain, weakness and walking difficulty to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-OCT-2022 Reporter's Comments: This case was received from the patient via interactive digital media. The patient had the Shingles vaccine, the next day patient had fever chills headache, body aches and pain, weakness, almost too weak to walk. These symptoms lasted about 18 hours, but the patient guess it was worth it to avoid getting shingles. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; chills; headache; body aches and pain; weakness, too weak to walk; almost too weak to walk; 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 Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced fever, chills, headache, general body pain, weakness and walking difficulty. On an unknown date, the outcome of the fever, chills, headache, general body pain, weakness and walking difficulty were recovered/resolved.   It was unknown if the reporter considered the fever, chills, headache, general body pain, weakness and walking difficulty to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-OCT-2022 Reporter's Comments: This case was received from the patient via interactive digital media. The patient had the Shingles vaccine, the next day patient had fever chills headache, body aches and pain, weakness, almost too weak to walk. These symptoms lasted about 18 hours, but the patient guess it was worth it to avoid getting shingles. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Alot of soreness and swelling at the shot site; Alot of soreness and swelling at the shot site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain 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 injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-OCT-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient just had the first one and experienced a lot of soreness and swelling at the shot site. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: I just threw up; This case was reported by a consumer via interactive digital media and described the occurrence of vomiting in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 21st October 2022, unknown after receiving Shingles vaccine, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown.   It was unknown if the reporter considered the vomiting to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, he/she just threw up.  The reporter wanted to know if he/she could this still be from the shingles vaccine. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Shingles 3 days after 1st dose; The blisters are dry already; 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.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles was unknown and the outcome of the blister was recovering/resolving.   It was unknown if the reporter considered the shingles and blister to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient developed shingles 3 days after getting the first dose of the vaccine.  The patient also developed blisters that were dry already. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had 2 shots, 7 months apart; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose 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 drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 25-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had 2 shingles vaccinations, 7 months apart. The patient know that 2 to 6 months was recommended and asked that he/she need another shot. Additional supportive information: The patient received 2nd dose of shingles vaccine later than recommended interval, which led to lengthening of vaccine schedule. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st and 2nd dose  were year apart; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st shot 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 drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 25-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had first and second shingles shots were more than a year apart. The patient asked that he/she need a booster. Additional supportive information: The patient received 2nd shot of Shingles vaccine later than recommended interval, which led to lengthening of vaccine schedule. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose over a year ago, has not received a second dose yet.; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received just over a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.  The vaccine administration facility was the same as primary reporter. Consented to follow up was denied.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Incomplete course of vaccination, Neuralgia, Pain in extremity, Pain of skin
Clinical narrative: The patient has not yet received her second dose of SHINGRIX; Felt tired; Sore arm; Severe pain on skin, like a sunburn with someone raking a wire brush against it; Pain may be due to a nerve; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 18th February 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not received the 2nd dose of Shingrix. In February 2022, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced nerve pain and skin pain. On 19th February 2022, the patient experienced tiredness and pain in arm. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the nerve pain and skin pain were not recovered/not resolved and the outcome of the tiredness and pain in arm were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the nerve pain, tiredness, pain in arm and skin pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-Oct-2022 Reporter's comment: This case was self-reported by the patient. The next day of the vaccination, the patient felt tired and a sore arm. A week later the patient experience severe pain on a small area on the skin of back.  The patient described the pain was like a sunburn with someone raking a wire brush against it. The patient went to a dermatologist who did not see anything.  About a week ago from reporting, the patient went to primary care physician who stated that the pain might be due to a nerve that runs under the wing of back.  The patient was prescribed with gabapentin for the pain but had not yet started.  The pain on her back had not resolved.  The patient had not yet received second dose of Shingrix. The details were reported for 1st dose. The reporter consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: arm sore to touch; painful at injection site, 2 days; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th October 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In October 2022, less than a week after receiving Shingrix, the patient experienced pain in arm. On 18th October 2022, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-Oct-2022 Reporter's comment: This case was self-reported by the patient. The patient received first Shingrix on left arm.  The patient reported that arm was very painful at the injection site for 2 days.  The patient reported left arm was still sore to the touch.  The reporter did not consent to follow-up. Less than a day, the patient experienced injection site pain.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administration of only Liquid Component; administration of only Liquid 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 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA748A, expiry date 30th November 2023) for prophylaxis.   On 21st October 2022, the patient received Menveo. On 21st October 2022, 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: 21-OCT-2022 Reporter's comment: The patient care technician asked information about the administration of only the liquid Meningococcal CWY component without using it to reconstitute the lyophilized A component.  The reporter asked if patient had to be revaccinated. The reporter consented to follow up. Additional Supportive Information: The patient received only the liquid Meningococcal CWY component without using it to reconstitute the lyophilized A component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: only received one dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   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: 21-OCT-2022 Reporter's Comment: The reporter was the patient's friend who reported that her friend only received one dose of Shingrix. The reporter did not wish to provide any demographic information for herself or for her friend. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number H9LL4, expiry date 24th November 2023) 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 unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR153021   Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's comment: The patient had stated that, she remembered having a sore arm after first dose, however received two vaccines that day and was not sure which vaccine caused the sore arm. The reporter consent to follow-up. Additional supportive information: For tolerance of second dose, refer case US2022AMR153021, reported by same patient. The batch number and expiry date were conservatively captured, as it was not clear for which dose it was reported. Clarification has been raised.; Sender's Comments:  GSK-US2022AMR153021:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Off label use, Pruritus
Clinical narrative: shingles in private parts; Very itchy; received the Shingrix vaccine as she was healing from a previous case of shingles on her left hip; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (The patient was healing from a previous case of shingles on her left hip.).   In June 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2022, unknown after receiving Shingrix, the patient experienced off label use. On 7th October 2022, the patient experienced shingles and pruritus. On an unknown date, the outcome of the shingles and pruritus were not recovered/not resolved and the outcome of the off label use was unknown.   It was unknown if the reporter considered the shingles and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comment: The reporter stated that the patient received her first Shingrix vaccine in June 2022, in the left arm.   The patient recieved Shingrix vaccine as she was healing from a previous case of shingles on her left hip.   The reporter stated couple weeks ago she experienced another out break of shingles. The reporter stated the shingles was in her private parts and very itchy. The reporter also mentioned when case of shingles was healed to get the second Shingrix vaccine by December 2022 to benefit from the 90% coverage. The reporter did not give consent to follow-up. Additional Supportive Information: The patient received the Shingrix vaccine as she was healing from a previous case of shingles on her left hip which lead to off label use. As per source document time to onset for Shingles and Pruritus were 4months was captured.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only adjuvant administered; Only adjuvant administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Herpes zoster (Shingrix) (batch number FA95N, expiry date 28th July 2023) and (batch number 052JX, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comment: The reporter stated that a 2 antigen ( powder) was left in the Shingrix box and the reporter believes that  2 patient out of the 10 patients received only the adjuvant portion of the Shingrix.  Hcp provided Lot number for both the powders that was left in the box: lot#FA95N, expiration date 28th July 2023 (Same lot# and expiration date for both powder).  Liquid administered was lot number 052JX (same for both liquid no expiration available). The reporter was planning to revaccinate all 10 of them because she was unsure who got them. The reporter did not had any information to provide on the patients. The reporter give consent to follow up. This case is linked to the case US2022AMR153035, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR153035:Original Case : US2022152231
Sex: U
Vaccine: COVID19, UNK
Symptoms: Cerebrovascular accident, Deafness, Thrombosis
Clinical narrative: HEARING LOSS; STROKE; BLOOD CLOTS; This solicited report received from a patient: Janssen for XARELTO concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient was treated with rivaroxaban (form of admin and route of admin was not reported, batch number: Unknown, expiry: Unknown) dose and frequency was not reported, administered on an unspecified date for an unspecified indication.  The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced stroke causing blood clots, and hearing loss. The action taken with covid-19 vaccine ad26.cov2. s was not applicable; and action taken with rivaroxaban was not reported. The outcome of the stroke, blood clots and hearing loss was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2. s, and stroke, hearing loss was not related, and blood clots was related; and between rivaroxaban, and stroke, blood clots, and hearing loss was not related.  This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20221049846-covid-19 vaccine ad26.cov2. s- Hearing loss, Stroke. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered not related. V0: 20221049846-covid-19 vaccine ad26.cov2. s- Blood Clots-The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There are no other factors more likely to be associated with the event(s) than the drug. Therefore, this event(s) is considered related. V0: 20221049846-Xarelto- Hearing loss, Stroke-The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered not related  V0: Xarelto- Blood clots- The event(s) is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse drug reaction, Bone pain, COVID-19 immunisation, Pain, Suspected COVID-19
Clinical narrative: BODY ACHES; BONES HURT FROM INSIDE OUT; SIDE EFFECTS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a 62 year old female of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, the patient ended up with Covid (suspected covid-19 infection). It was reported that, this was almost going on a year now where she was getting horrible month-long sick with covid and suffering all the effects (Dose number in series 1). She called in MAR-2021 (reported as March of this past year) when her symptoms were horrific and was not going away. The patient additionally received non-company suspect vaccine Moderna (elasomeran) (Dose number in series 2) (form of admin and route of admin were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on 19-NOV-2021 for covid-19 prophylaxis, which was Revaccination with different COVID-19 vaccine (Dose number in series 2). It was reported that, the patient had number of side effects with both the vaccines (Dose number in series 2). She had body aches and her bones hurt from inside out (coded to bone pain) (Dose number in series 2). The patient signed herself up for the Pfizer booster but thought she should look into it further before getting it. The patient was not sure if she wants to get another vaccination. She was fearful of putting something in her body that was already goofed up. Patient stated it might not have been from getting vaccinated but she has a multitude of a mess from getting covid. She stated there are theories of long covid that some part of the virus was not recognized by your body. She knows the vaccine was not active but does not know how her body will respond. She was also waiting to get into a covid clinic. Her appointment was not until MAR-2023. She has crazy symptoms. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of body aches, side effects, bones hurt from inside out and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: VACCINE DIDN'T WORK; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, race, ethnicity and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced and reported that vaccine didn't work. It was reported as "that didn't work". The action taken with covid-19 vaccine ad26.cov2. was not applicable. The outcome of vaccine didn't work was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: Sender's Comments: V0:20221057049 -COVID-19 VACCINE Ad26.COV2.S-vaccine didn't work. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: NEUROLOGICAL PROBLEMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced neurological problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neurological problems. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: INFLAMMATION ISSUES; This spontaneous report received from a consumer via other manufacturer (Novavax) concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the patient experienced inflammation issues (Dose number in series 1). The patient also received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on NOV-2021 for covid-19 prophylaxis. It was unknown whether the patient experienced any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inflammation issues was not reported. This report was non-serious.