chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE's reported; PNEUMOVAX 23 that underwent a temperature excursion was administered to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions or concomitant therapies provided.  On 02-NOV-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T009744, expiration date 28-JAN-2022 (exact dose, route of administration and anatomical location were not provided) to prevent pneumococcal infection (product storage error). The administered dose of the vaccine underwent a temperature excursion. No adverse events (AEs) were reported.
Sex: M
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer referring  to  himself, the patient age was not provided.  Information regarding the patient's medical history, concomitant medications, drug allergies or reactions was not provided. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, frequency, administration route, lot number and expiry were not provided). On 22-SEP-2020, the patient was vaccinated with Varicella zoster vaccine rge (cho)(SHINGRIX) and Influenza vaccine(FLU) (strength, dose, frequency, administration route, lot number and indication were not provided). On 28-JUL-2020 the patient experienced shingles (herpes zoster). The outcome of herpes zoster was unknown, and the reporter did not assess the causal relatedness between the event and the suspect therapies.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Herpes zoster, Incorrect route of product administration, Scab
Clinical narrative: herpes zoster; VARIVAX administered IM; This spontaneous report was received from a physician concerning a 1-year-old female patient. Pertinent medical ystory, drug reactions/allergies and concomitant medications were reported as none.    On 02-NOV-2021, the patient was vaccinated with 0.5 mL of varicella virus vaccine live (oka/merck) (VARIVAX) administered intramuscularly (Incorrect route of product administration) for prophylaxis with lot # U010395 and expiration date on 01-APR-2023 (dose number and anatomical location were not reported).         On 16-NOV-2021, the patient was diagnosed with Herpes zoster. No laboratory diagnostics/studier were performed, and the patient did not receive any treatment. At the moment of this report, the patient was recovering from the event, the blisters were healing, however, the physician was unable to collect a sample this time since lesions were crusted over and were "all dried up"  No causality assessment was provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE,; Medical assistant calling to report pediatric dose of V AQT A that was administered to an adult patient; This spontaneous report was received from a medical assistant and refers to an adult patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, past drug reaction or allergies were not provided.  On 08-DEC-2021, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (dose and vaccination scheme frequency were unknown by the reporter, route of administration and anatomical site of vaccination were not reported; lot number T037788 that was verified to be a valid lot number for syringe formulation with and expiration date reported and established as 30-APR-2022) (product administered to patient of inappropriate age) for prophylaxis.  No additional adverse event was reported (AE) (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; Caller stated the vaccine was administered after expiration; This spontaneous report was received from a register nurse and refers to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 14-DEC-2021, 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 (ml) (vaccination scheme frequency, route of administration and anatomical site of application were not reporter; lot number S004578 that was verified to be a valid lot number for syringe formulation with an expiration date reported and established as 29-SEP-2021) (expired product administered) for prophylaxis.  No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unreported age and gender. The patient's pertinent medical history, concomitant therapies, and previous drug reactions or allergies were not reported.  On 15-DEC-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), subcutaneous (SQ), 0.5 ml (milliliter) for prophylaxis (expired product administered) (lot number S039309 has been verified to be a valid lot number, the expiration date was reported and established as 31-MAR-2018; dose number, vaccination scheme and anatomical site of vaccination were not reported).   No additional AE was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE; MMRII was administered to a patient that expired on 04DEC2021; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.  On 13-DEC-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 ml (milliliter) (Expired product administered) (lot # S039319 has been verified to be a valid lot number, expiration date was reported and established as 04-DEC-2021; , dose number, vaccination scheme, route of administration and anatomical site of vaccination were not reported) for prophylaxis. The measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) has not had any temperature excursions.   No additional AE was reported.
Sex: M
Vaccine: RV5
Symptoms: Gastroenteritis, No adverse event, Product administered to patient of inappropriate age, Product prescribing error, Product use in unapproved indication
Clinical narrative: Patient had gastroenteritis and has ingested one dose of ROTATEQ vaccine; Patient had gastroenteritis and has ingested one dose of ROTATEQ vaccine whcih was prescribed.; Product use in unapproved indication gastroenteritis; No adverse event; This spontaneous report was received from a 52-year-old male patient (reporting on himself). The patient's concurrent condition included gastroenteritis. No information regarding patient's pertinent medical history, previous drug reactions, or allergies were reported.   On 15-DEC-2021 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, lot#, expiration date, frequency and vaccination site were not provided) for prophylaxis. The vaccine was used for gastroenteritis (Product use in unapproved indication).   On 15-DEC-2021, patient had gastroenteritis and had ingested one dose of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccine (Product administered to patient of inappropriate age). Patient stated that this vaccine was prescribed to him (product prescribing error) and could not recall the name of the prescriber. He stated he felt great and was working good and stated that he had ingested 2 additional medications. No product quality complaint (PQC) and no additional adverse event (AE) was reported.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other AE; The patient received her first dose of GARDASIL 9 and age 12 and didn't receive the second dose until the age of 25.; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age.  The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date, when the patient was 12 years old, she was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, lot #, expiration date, route of administration, anatomical location not provided). On 17-DEC-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 mL, one time, lot # U007667, expiration date: 23-MAY-2023 (route of administration, anatomical location not provided), when she was 25 years old, as prophylaxis (inappropriate schedule of product administration).  No other adverse event (AE) was reported.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received a second dose of VAQTA earlier than recommended; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 15-JUL-2021, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (strength, lot #, expiration date, route of administration, anatomical location not provided); and on 17-DEC-2021, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 mL, lot # T035721, expiration date: 15-APR-2022 (route of administration, anatomical location not provided), earlier than recommended, as prophylaxis (inappropriate schedule of product administration).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to patient; No additional adverse events reported; This spontaneous report as received from a physician refers to a patient of unknown age ro gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.    On 17-DEC-2021 the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)  (dose details not provided) with lot # S035355 and expiration date of 05-NOV-2021, for prophylaxis (expired product administered. The dose was properly stored up through the time of the administration. No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of varicella-like rash 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 varicella-like rash. On an unknown date, the outcome of the varicella-like rash was unknown. It was unknown if the reporter considered the varicella-like rash to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced a very chicken pox like rash. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: 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.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date refer case US2021AMR256463).   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 details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that getting shingles shot was no big deal. The patient's arm was sore for one night after 2nd dose of Shingles. The follow-up would not possible, as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR256463:same reporter - 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This case was reported by a other health professional via sales rep and described the occurrence of fever in an unspecified number of patients 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 fever and chills. On an unknown date, the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were reported as follows: The reporter was a physician assistant. The age at vaccination was not applicable as this report. The patients had experienced fever and chills following a dose of Shingrix. The reporter did not consent to follow up.
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months 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 details were provided as follows: The patient self-reported this case. The patient got the shingles shot and 3 months later got shingles. The patient had them (shingles) twice now. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the fatigue to be related to Shingrix. Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was not reported. The reporter wanted to know how long does fatigue last after Shingrix shot. The follow-up would not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the general body pain to be related to Shingrix. Additional details were provided as follows: The case was reported by patient's husband. The age at vaccination was not reported. The patient received her Shingrix dose and had body aches that felt like she had been hit by a train.  The body ache resolved after about 3 days. The reporter had nothing else to report. Patient was not available to provide consent for medical doctor follow up. For tolerance to 2nd dose, refer case US2021258611; Sender's Comments: US-GLAXOSMITHKLINE-US2021258611:same reporter, same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: had the shot / still got the shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in 2009).   On an unknown date, the patient received Shingles vaccine. On 17th December 2021, 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 details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had the Shingles shot several years later and on the day of reporting in December 2021, the patient had still got the shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding the shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine. Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had the Shingles shot and the shingles and still had the nerve endings pain daily. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; fever; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and fever. On an unknown date, the outcome of the pain in arm and fever were unknown.  It was unknown if the reporter considered the pain in arm and fever to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the shingles shot and ended up with a fever and very sore arm. And what upset the patient was the price 190 dollar. And there was a need of another shot.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak; This case was reported by a consumer via sales rep and described the occurrence of shingles in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 20th October 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months 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 details were provided as follows: The patient self reported this case. The patient received their first dose of Shingrix at pharmacy and had an outbreak of shingles. Till the time of reporting, the patient had not received second dose of Shingrix. Upon following up with the patient, the patient stated the shingles outbreak was less severe than before she received her first dose of the Shingrix vaccine. The reporter provided permission to contact healthcare professional (primary care physician). The reporter consented to follow up. No additional details were provided by the reporter.
Sex: U
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: dose 1 of Twinrix for 2nd dose was administered Engerix-B instead of Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX VACCINE).   On 14th December 2021, the patient received Engerix B. On 14th December 2021, unknown after receiving Engerix B, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received an Engerix-B instead of 2nd dose of Twinrix which led to wrong vaccine administered.  Reporter stated that the date of the Twinrix administration would had been at least a month ago and did not received 2nd dose of Twinrix till the date of reporting.  Reporter called on behalf of another pharmacist and did not had patient information, date of the Twinrix administration, or lot number /expiration date.  The pharmacist did not have lot number/expiration date of Engerix-B. The reporter consented to follow up. Note: Incomplete course of vaccination was not coded for twinrix 2nd dose as it could be given after 7-day post 1 months as per deviation.
Sex: F
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/got the shingrix series, months later was put on cellcept. Broke out with shingles; horrible case of shingles; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and mycophenolic acid (Cellcept) for product used for unknown indication.   On an unknown date, the patient received the 1st dose of Shingrix, the 2nd dose of Shingrix and Cellcept at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Cellcept was discontinued. 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 details provided were as follows: The age at vaccination was not reported. The patient got the Shingrix series and then was put on Cellcept a few months later.  She broke out in a horrible case of shingles and her doctor recommended getting the shots again now that she was off the Cellcept. The reporter asked could they repeat. It was unknown if the reporter considered the shingles to be related to Cellcept. The health care professional stopped responding when asked for credentials and disconnected the chat. The reporter did not consent to follow-up. No additional information was available. 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.
Age: 1.0
Sex: U
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, Peripheral swelling, Product administered to patient of inappropriate age
Clinical narrative: had a large local reaction, Upper leg swollen from the hip to the knee; dtap on 1/22/09 and 4/23/09; dtap on 1/22/09 and 4/23/09; This case was reported by a physician via sales rep and described the occurrence of swelling of legs in a 18-month-old patient who received DTPa (DTaP vaccine) for prophylaxis.   Previously administered products included DTaP (received 1st dose on 22nd January 2009).   On 23rd April 2009, the patient received the 2nd dose of DTaP vaccine. On 23rd April 2009, unknown after receiving DTaP vaccine, the patient experienced drug dose administration interval too short and inappropriate age at vaccine administration. On an unknown date, the patient experienced swelling of legs. On an unknown date, the outcome of the swelling of legs, drug dose administration interval too short and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the swelling of legs to be related to DTaP vaccine.  Additional details were provided as follows:  The reporter stated that the patient received DTaP vaccine on 22nd Jan 2009 and 23rd April 2009, which led to drug dose administration interval too short and inappropriate age at vaccine administration. The patient reportedly had a large local reaction after the 2nd dose in the thigh, the patients upper leg was swollen from the hip to the knee. No additional information was available regarding product, patient, event, etc. The reporter consented to follow up.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, MENB, TDAP
Symptoms: Product storage error
Clinical narrative: above temperature excursion, the highest being 52F; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Havrix, Kinrix, Kinrix Pre-Filled Syringe Device and Boostrix. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Havrix, Kinrix, Kinrix Pre-Filled Syringe Device and Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details were provided as follows: The age at vaccination was not applicable to this report. The nurse reported that the patients had received doses of Bexsero, Engerix B, Infanrix, Pediarix, Havrix, Kinrix and Boostrix after temperature excursion, which led to incorrect storage of drug. The nurse reported that above temperature excursion, with the highest being 52F for a total of an undetermined length of time starting from 22th November 2021. The nurse did not have exact excursion information and was unsure if vaccinations were far enough out of range to qualify. The nurse was referred to CDC regarding revaccination, if required after she completed more research on total time of excursion. The health care professional wished to remain anonymous. The reporter did not consent to follow-up.
Age: 0.33
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 373J9, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 25th October 2021, the patient received the 1st dose of FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 25th October 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient received 1st dose of FluLaval Quadrivalent, which led to inappropriate age at vaccine administration. The patient received 2nd dose of FluLaval Quadrivalent on 16th December 2021, when the patient was over 6 months old. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st and 2nd dose on an unknown date). On 3rd December 2021, the patient received the 3rd dose of Shingrix. On 3rd December 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional details were provided as follows: The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up. This case was linked with case US2021257810, reported by same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021257810:same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2018, has not received their 2nd dose; This case was reported by a physician 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 in October 2018).   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 details were 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 Shingrix, which led to incomplete course of vaccination. The reporter was requesting guidance regarding the second dose or if the patient should restart the series. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose on 2020, has not received her 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th September 2020, intramuscular, in unknown arm).   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 details were 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 Shingrix, which led to incomplete course of vaccination. The reporter stated that, for unknown reason the patient had not yet received her second dose . The reporter did not consent to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: vaccinated with an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number GB429, expiry date 5th December 2021) for prophylaxis.   On 9th December 2021, the patient received Shingrix. On 9th December 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received an expired dose of Shingrix, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 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 Herpes zoster (Shingrix) (batch number K7T79, expiry date 14th April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. 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 details were provided as follows: The age at vaccination was not reported. The patient received only adjuvant portion of shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that did not know, if the Shingrix adjuvant was administered to a patient or if it went missing. The reporter unable to provide patient details.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number K9R97, expiry date 15th November 2021) for prophylaxis. On 16th December 2021, the patient received Shingrix. On 16th December 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follows: The patient received expired dose of Shingrix, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Adverse reaction
Clinical narrative: REACTION FROM MODERNA BOOSTER; This spontaneous report received from a patient with unknown age, gender, race and ethnicity. 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 expiration date were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. It was unspecified whether patient had any adverse reaction on covid-19 vaccine ad26.cov2.s. The patient received non-company suspect mrna 1273 ( form of admin, route of admin, and batch number and expiration date were not reported) dose was not reported, every 1 total, therapy dates were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced reaction from moderna booster. Patient reported that they gave Moderna Booster and on the paper work it said JNJ Covid booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of reaction from moderna booster was not reported. This report was non-serious. This report was associated with a product quality complaint:90000205636 and 90000205637. The suspected product quality complaint has been confirmed to be voided (did not meet product quality complaint criteria as reported complaints were adverse events) based on the PQC evaluation/investigation performed.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: PAIN IN MY BACK CRAWLING TO MY LOWER  BACK; PAIN IN MY SHOULDER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s  (dose number in series 2) (suspension for injection, route of admin and batch number were not reported) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination. 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, after receiving booster vaccine the patient had too much pain in shoulder and in back crawling to lower back (dose number in series 2 adverse event). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in shoulder and pain in back was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Pain in extremity, Paralysis, Pneumonia
Clinical narrative: THE LEFT SIDE OF HER BODY WAS PARALYZED FROM THE ARM, TORSO AND LEG ON THE LEFT SIDE.; BLOOD CLOT IN THE LEG; PNEUMONIA; CHEST PAIN; PAIN IN BOTH LEGS; BLOOD CLOT IN THE LUNG; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 182811, and expiry: UNKNOWN) dose was not reported, 1 total (dose number in series: 1) administered on 19-OCT-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 23-NOV-2021, the patient experienced blood clot in the leg, pneumonia, blood clot in the lung, chest pain and pain in both legs, and was hospitalized. The patient went to the emergency room for the chest pain and was diagnosed with pneumonia  and 2 blood clots, one in her lung and one in her leg but. She was unsure that which side of the lung and leg in which had the blood clot. Laboratory data included: CAT (computerized tomography) (NR: not provided) Blood clot in the lung, blood clot in one of the legs. The patient was admitted in the hospital 23-Nov-2021 and was discharged on 27-Nov-2021. On 05-DEC-2021, the patient admitted in hospital due to the left side of her body was paralyzed from the arm, torso and leg on the left side and chest pain, which she described as the same chest pain as before that never went away and was currently admitted in hospital. They gave antibiotics for the pneumonia and something else for the blood clots. The patient recieved physical therapy in order to treat the paralysis and to regain strength in the left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pneumonia, and had not recovered from blood clot in the leg, blood clot in the lung, chest pain, pain in both legs, and the left side of her body was paralyzed from the arm, torso and leg on the left side. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:20211225184-COVID-19 VACCINE AD26.COV2.S-Blood clot in the leg,Pneumonia,The left side of her body was paralyzed from the arm,torso and leg on the left side,Blood clot in the lung,Chest pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211225184-COVID-19 VACCINE AD26.COV2.S-Pain in both legs. This event(s) is labeled per RA and is therefore considered potentially related.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Thrombosis
Clinical narrative: THE LEFT SIDE OF HER BODY WAS PARALYZED FROM THE ARM, TORSO AND LEG ON THE LEFT SIDE.; BLOOD CLOT IN THE LEG; PNEUMONIA; CHEST PAIN; PAIN IN BOTH LEGS; BLOOD CLOT IN THE LUNG; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 182811, and expiry: UNKNOWN) dose was not reported, 1 total (dose number in series: 1) administered on 19-OCT-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 23-NOV-2021, the patient experienced blood clot in the leg, pneumonia, blood clot in the lung, chest pain and pain in both legs, and was hospitalized. The patient went to the emergency room for the chest pain and was diagnosed with pneumonia  and 2 blood clots, one in her lung and one in her leg but. She was unsure that which side of the lung and leg in which had the blood clot. Laboratory data included: CAT (computerized tomography) (NR: not provided) Blood clot in the lung, blood clot in one of the legs. The patient was admitted in the hospital 23-Nov-2021 and was discharged on 27-Nov-2021. On 05-DEC-2021, the patient admitted in hospital due to the left side of her body was paralyzed from the arm, torso and leg on the left side and chest pain, which she described as the same chest pain as before that never went away and was currently admitted in hospital. They gave antibiotics for the pneumonia and something else for the blood clots. The patient recieved physical therapy in order to treat the paralysis and to regain strength in the left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pneumonia, and had not recovered from blood clot in the leg, blood clot in the lung, chest pain, pain in both legs, and the left side of her body was paralyzed from the arm, torso and leg on the left side. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:20211225184-COVID-19 VACCINE AD26.COV2.S-Blood clot in the leg,Pneumonia,The left side of her body was paralyzed from the arm,torso and leg on the left side,Blood clot in the lung,Chest pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211225184-COVID-19 VACCINE AD26.COV2.S-Pain in both legs. This event(s) is labeled per RA and is therefore considered potentially related.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021, and dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-SEP-2021, the patient experienced inappropriate schedule of vaccine administration, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate schedule of vaccine administration and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Off label use, Product administered to patient of inappropriate age, SARS-CoV-2 test
Clinical narrative: POSITIVE FOR COVID-19 INFECTION; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a consumer concerned a 17 year old female. Initial information was processed with the additional information received on 14-DEC-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) .5 ml, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced product administered to patient of inappropriate age, and off label use. On 07-DEC-2021, the patient experienced positive for covid-19 infection. Laboratory data included: Body temperature (NR: not provided) 103 F. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from positive for covid-19 infection, and the outcome of product administered to patient of inappropriate age and off label use was not reported. This report was non-serious. This case is associated with product quality complaint number 90000206738. This case, from the same reporter is linked to 20211230837 and 20211232501.; Sender's Comments: V0- Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.