chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's and no PQC's were reported.; A medical assistant reported that an improperly stored vaccine was administered to a patient.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On 11-APR-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot number U008181 has been determined to be valid for varicella virus vaccine live (oka/merck), expiration date reported and established as 08-FEB-2023) (strength, dose, frequency, route of administration and anatomical location were not provided).         No adverse event reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No additional AEs; MMR II was mixed with lidocaine and administered; This spontaneous report was received from a physician referring to a patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.     On 13-APR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # T018892, expiration date 02-JUN-2022, at a dose of 0.5 milliliter, subcutaneous for prophylaxis. The vaccine had been mixed with lidocaine previous to administration (product preparation issue).  No other information provided. No additional adverse events or product quality complaints (PQC) reported.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No further adverse events.; MMR and VARIVAX were administered to 2 patients in the deltoid area; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.     On 21-APR-2022, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX), both intramuscular in the deltoid area (incorrect route of product administration) for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). No additional details available. No further adverse events. No product quality complaint.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 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 injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-Apr-2022 Reporter's comments: This case was reported by the patient's husband. The patient had injection site pain after her first dose of Shingrix. The reporter did not consent to follow-up. The reporter did not know lot number or expiration date. The patient was not available to give consent for follow up. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022AMR067953.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR067953:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pruritus, Vaccine positive rechallenge
Clinical narrative: Itching; Paining; 2nd shot knocked me off my feet; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles twice on back). Previously administered products included Shingles vaccine with an associated reaction of pruritus (received 1st dose on an unknown date and experienced itching and pain, refer case US2022AMR066755).   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 feeling unwell, pruritus and pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling unwell was recovered/resolved and the outcome of the pruritus and pain were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, pruritus and pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR066755   Additional Information: GSK Receipt Date: 18-APR-2022  Reporter's Comments: This case was received from the patient via interactive digital media. The patient got Shingles shots and still had itching and paining years after. The patient mentioned that the second shot knocked him/her off feet for three days, but well worth it if it worked. Additional Supportive Information: The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR066755:Same reporter
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody, Therapy non-responder
Clinical narrative: 3 doses given as a child and is not immunized; This case was reported by a physician and described the occurrence of therapy non-responder in a 23-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis and HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B pediatric, the 2nd dose of Engerix B pediatric and the 3rd dose of Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, Engerix B pediatric and Engerix B pediatric, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   Additional Information: GSK Receipt Date: 19-Apr-2022 Reporter's comments: The patient received three doses of Engerix-B, pediatric doses given as a child. But the patient was not immunized. No further details were provided to the first line specialist. Second line specialist attempted callback but physician was not available at the time of call, so no further details were obtained. As event was not noted by first line during the call, it was not asked of the physician whether safety had permission to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Pain in arm; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2022AMR025409).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix 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 Shingrix.     Linked case(s) involving the same patient:  US2022AMR025409   Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced a sore arm for 4 days. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR025409:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Illness, Rash, Rash papular
Clinical narrative: Had the shot but it keeps coming back/Suspected vaccination failure; Could this be shingles?/had the shot but it keeps coming back; Bumpy rash on my butt; Tired; Sick; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, papular rash, tiredness and sickness. On an unknown date, the outcome of the vaccination failure, papular rash, tiredness and sickness were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, papular rash, tiredness and sickness to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's Comment: This case was patient by a consumer via interactive digital media. The patient got a bumpy rash on his/her butt sometimes, specially if he/she was tired or sick. It took a week to go away. The reporter wanted to know if this could be shingles. The patient had the shot but shingles was coming back. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Had the shot but it keeps coming back/Suspected vaccination failure; Could this be shingles?/had the shot but it keeps coming back; Bumpy rash on my butt; Tired; Sick; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, papular rash, tiredness and sickness. On an unknown date, the outcome of the vaccination failure, papular rash, tiredness and sickness were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, papular rash, tiredness and sickness to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's Comment: This case was patient by a consumer via interactive digital media. The patient got a bumpy rash on his/her butt sometimes, specially if he/she was tired or sick. It took a week to go away. The reporter wanted to know if this could be shingles. The patient had the shot but shingles was coming back. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product dispensing error, Recalled product administered
Clinical narrative: administrated with engerix-b batch recall; administrated with engerix-b batch recall; This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's comments: No patient's identifiers were provided.  The nurse reported that a patient was administrated with Engerix B batch recall for October.  The reporter had been on maternity leave and had just found out about it. No vaccination date was provided. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The nurse reported that a patient was administered with Engerix B batch recall, which led to recalled drug administered and drug dispensing error. The Vaccine Administration Facility is the same as primary reporter. This is 1 of the 8 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR068024:Same reporter US-GLAXOSMITHKLINE-US2022066344:Same reporter US-GLAXOSMITHKLINE-US2022AMR068022:Same reporter US-GLAXOSMITHKLINE-US2022AMR068023:Same reporter US-GLAXOSMITHKLINE-US2022AMR068021:Same reporter US-GLAXOSMITHKLINE-US2022AMR068026:Same reporter US-GLAXOSMITHKLINE-US2022AMR068027:Same reporter
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Recalled product administered
Clinical narrative: administrated with engerix-b batch recall; administrated with engerix-b batch recall; This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's comments: No patient's identifiers were provided.  The nurse reported that a patient was administrated with Engerix B batch recall for October.  The reporter had been on maternity leave and had just found out about it. No vaccination date was provided. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The nurse reported that a patient was administered with Engerix B batch recall, which led to recalled drug administered and drug dispensing error. The Vaccine Administration Facility is the same as primary reporter. This is 1 of the 8 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR068024:Same reporter US-GLAXOSMITHKLINE-US2022066344:Same reporter US-GLAXOSMITHKLINE-US2022AMR068021:Same reporter US-GLAXOSMITHKLINE-US2022AMR068023:Same reporter US-GLAXOSMITHKLINE-US2022AMR068022:Same reporter US-GLAXOSMITHKLINE-US2022AMR068025:Same reporter US-GLAXOSMITHKLINE-US2022AMR068027:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles, got them anyway, horrible; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the shingles shot and got shingles anyway.  The patient stated shingles were horrible.  Additional supportive information: 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. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the first shot but got shingles before I got the booster/suspected Vaccination failure; I have shingles right now.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 19-APR-2022  Reporter's Comments: This case was received from the patient via interactive digital media. The patient got the first shot but got shingles before he/she got the booster. The patient had shingles right now. The patient advised to definitely get the booster as soon as recommended. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise
Clinical narrative: broke out in Shingles; ill all day; 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 14th April 2022, the patient received Shingrix. On 15th April 2022, 1 days after receiving Shingrix, the patient experienced unwell. On 18th April 2022, the patient experienced shingles. On an unknown date, the outcome of the shingles and unwell were unknown.   It was unknown if the reporter considered the shingles and unwell to be related to Shingrix.  Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient received Shingrix on a Thursday night. The patient was ill all day Friday and then broke out in Shingles Monday. The patient had never had Shingles before.  The patient's doctor said that, she had never had this happen.  The reporter wanted to know that how rare was this. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had bad case of shingles 2 years after he got the vaccine/suspected vaccination failure; had a bad case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years 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: 20-APR-2022  Reporter's Comments: This case was received from the patient's wife via interactive digital media. The patient had bad case of shingles 2 years after he got the Shingle vaccine.  The reporter stated that vaccine did not always work Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Oral herpes
Clinical narrative: Shingles 2 days after 1st shot; I get cold sores; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 50-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 3 times).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles and cold sores. On an unknown date, the outcome of the shingles was unknown and the outcome of the cold sores was not recovered/not resolved.   It was unknown if the reporter considered the shingles and cold sores to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced shingles 2 days later the vaccination. The patient stated that needless to say he/she didn't get the 2nd dose, So he/she had them 4 times. The patient also stated that now he/she got cold sores, which he/she hadn't had until that 1st shot. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got both shots, have still had breakouts of shingles/Suspected vaccination failure; Have still had breakouts of shingles, very mild; 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.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (the patient had the first ever shingles vaccine many years ago from reporting and got a mild case of 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: 21-APR-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient got both the shots of Shingrix vaccine. The patient still had breakouts of shingles, but very mild. The patient hated to think that, what it would had been like with no shots. 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. The follow up would not possible as no contact details were available.
Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Gave a BOOSTRIX vaccine IV instead of IM; Dose was given in the right antecubital; This case was reported by a pharmacist via sales rep and described the occurrence of intramuscular formulation administered by other route in a 69-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   On 17th April 2022, the patient received Boostrix (intravenous). On 17th April 2022, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. On an unknown date, the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown.   Additional Information: GSK Receipt Date: 17-Apr-2022 and 18-APR-2022 Reporter's comments: This case was identified as duplicate of US2022066299. The case US2022066299 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient. The duplicate case received included additional following information: Pharmacist reported that the nurse administered a dose of Boostrix to the patient in the Emergency Department, but the dose was given intravenously instead of intramuscularly. The dose was given in the right antecubital. He already spoke to Poison Control, who did not issue any immediate safety concerns. The reporter gave consent to follow up. Additional Supportive Information: The patient received Boostrix via intravenous route in right antecubital which led to, intramuscular formulation administered by other route and vaccine administered at inappropriate site.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066299:Same reporter. FU1 deleted.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Nurse administered only the liquid component of Menveo in January 2022.; Nurse administered only the liquid component of Menveo in January 2022.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA569A, expiry date 30th June 2022) for prophylaxis.   In January 2022, the patient received Menveo. In January 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: 19-Apr-2022 Reporter's comment: The nurse administered only the liquid component of Menveo in January 2022. The reporter did not have relevant information regarding the patient.  The reporter stated that it could be one of 5 patients. The reporter was doing an ongoing investigation. The reporter gave consent for safety team follow up. Additional Supportive Information: The nurse administered only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Rash vesicular
Clinical narrative: rash, same "shingles rash" he had in the same place 40 years earlier; This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 40 years earlier).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was recovered/resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: The patient was given 1st dose of Shingrix and two weeks later, the patient developed a rash.  The reporter stated that the patient told it was the same shingles rash he had in the same place 40 years earlier. The reporter refused to answer any further questions and she was too busy.  The reporter did not consent to follow-up.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Infanrix was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received DTPa (Infanrix) (batch number KG4M7, expiry date 6th February 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th April 2022, the patient received the 4th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 20th April 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: Registered nurse (RN) stated that an expired dose of Infanrix was administered to a patient on the day of reporting. The reporter consented to follow-up via mail. Additional Supportive Information: On 20th April 2022, patient received dose of Infanrix that was already got expired on 6th February 2022, which led to expired vaccine used. Note: As per the structure field, dose no 4 was captured.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Acarodermatitis, Pruritus
Clinical narrative: scabies; Itching, both hands, legs, thighs, back and head; This case was reported by a consumer via call center representative and described the occurrence of scabies in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unspecified date).   In January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than a month after receiving Shingrix, the patient experienced scabies and pruritus. On an unknown date, the outcome of the scabies and pruritus were recovering/resolving.   It was unknown if the reporter considered the scabies and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-Apr-2022 Reporter's comments: This case was reported by the patient. She received her second dose of Shingrix early in the year. Exact date was unknown. After receiving Shingrix, starting in the last 2 weeks of January, she experienced itching in both hands. The patient also experienced itching on her legs, thighs, back and back of her head. The patient had gone to her doctor where she was diagnosed with scabies. She was also referred to a dermatologist. The patient reported that by 8th April 2022 itching has gotten better but has not fully resolved. The consent to follow up was given.
Sex: F
Vaccine: VARZOS
Symptoms: Off label use
Clinical narrative: prescription was written for Shingrix for a 34 y/o immunocompetent patient with history of shingles; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a 34-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.   Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's comment: The pharmacist reported that prescription was written for Shingrix of 34 year old patient who was immunocompetent. Shingrix had not been administered till the time of reporting. The reporter consented to follow up. Additional Supportive Information: The patient who was immunocompetent was prescribed with Shingrix, which led to off label use.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Boostrix administered intravenously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 22-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   On 21st April 2022, the patient received Boostrix (intravenous). On 21st April 2022, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 21-APR-2022  Reporter's Comments: Pharmacist reporting Boostrix administered intravenously. Reported information was all that health care professional (HCP) provided at this time. HCP gave permission for safety team to follow up. The reporter consented to follow up. Additional Supportive Information: the patient got Boostrix dose via IV route, which led to intramuscular formulation administered by other route.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number abxA87az, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 15th April 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's Comment: The patient received an expired dose of Bexsero. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Bexsero which was already expired, which led to expired vaccine used. This was one of 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022068144:Same reporter. US-GLAXOSMITHKLINE-US2022068148:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2018, is late for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received the 1st dose of Shingrix on unknown date in 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 Information: GSK Receipt Date: 21-APR-2022 Reporter's Comment: The reporter did not have the exact date of administration or the lot/expiry in their records. The reporter consented to follow up.  Additional Supportive Information: The patient did not receive the second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Foetal exposure during pregnancy
Clinical narrative: This spontaneous report received from a health care professional concerned a 3 month oldmale. The patient's height, and weight were not reported. No concurrent conditions were reported. The mother had medical history of COVID infection in April 2021, and was vaccinated in August the same year. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number: 1808982, expiry: unknown) dose was not reported, 1 total, administered on AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced fetal exposure during pregnancy. The patient was born in NOV-2021. On 12-FEB-2022 the patient's parent noticed there was swelling in the leg situation that prompted them to take patient to the hospital. On 15-FEB-2022, the patient was diagnosed with deep venous thrombosis and was hospitalized on the same day and on 22-FEB-2022 the patient was discharged. The number of days of hospitalization were 8 days. Doctors had been wondering whether there might had been a relationship between the vaccine administration while in utero and the subsequent development of DVT (Deep vein thrombosis) in an infant born to a vaccinated mother. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from deep venous thrombosis in infant, and the outcome of fetal exposure during pregnancy was not reported. This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20220449140. Sender's Comments: V0- 20220440088- Covid-19 vaccine ad26.cov2.s- Deep venous thrombosis in infant- 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). Therefore, this event(s) is considered unassessable. 20220440088-COVID-19 VACCINE Ad26.COV2.S- Fetal exposure in pregnancy. The event(s) has a compatible/suggestive 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: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anxiety, Dyspnoea, Headache, Musculoskeletal pain
Clinical narrative: STOMACH ACHES; SHORTNESS OF BREATH/TROUBLE BREATHING/RESPITORY PROBLEMS; TREMENDOUS MENTAL AND PHYSICAL PAIN; WORRY; MUSCLE AND JOINT SORENESS; HEADACHES; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: venous deficiency in legs (At the time of vaccination). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. 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 stomach aches, shortness of breath/trouble breathing/respitory problems, tremendous mental and physical pain, worry, muscle and joint soreness, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach aches, headaches, muscle and joint soreness, and shortness of breath/trouble breathing/respitory problems, and the outcome of tremendous mental and physical pain and worry was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: STOMACH ACHES; SHORTNESS OF BREATH/TROUBLE BREATHING/RESPITORY PROBLEMS; TREMENDOUS MENTAL AND PHYSICAL PAIN; WORRY; MUSCLE AND JOINT SORENESS; HEADACHES; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: venous deficiency in legs (At the time of vaccination). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. 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 stomach aches, shortness of breath/trouble breathing/respitory problems, tremendous mental and physical pain, worry, muscle and joint soreness, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach aches, headaches, muscle and joint soreness, and shortness of breath/trouble breathing/respitory problems, and the outcome of tremendous mental and physical pain and worry was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple sclerosis (treated with Ocrevus (ocrelizumab) infusions which wipe out B cells). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: 20-JAN-2022) dose was not reported, 1 total administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included ocrelizumab for multiple sclerosis. On an unspecified date, the patient did quantitative antibody test which showed no antibodies and no B cells specifically (confirmed immunological vaccination failure). The patient had antibodies checked after vaccination due to concomitant use of ocrelizumab and it was found that did not acquire any antibodies. The patient reported 9 months after vaccination, had a repeat quantitative antibody check and still does not had any antibodies. The patient did not attribute the lack of antibodies to the vaccine, but rather the treatment with ocrelizumab and said ocrelizumab did not allow to generate B cells after the vaccine. The patient experienced wicked bone pain with subsequent Ocrevus infusions after receiving the vaccine. The patient's physician told that the bone pain was probably due to the body trying to make new B cells after vaccination. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccination failure and wicked bone pain was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000227475. Sender's Comments: V0-20220442907-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccination failure. The event(s) has a compatible/suggestive 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: CONMEDS-OTHER SUSPECT DRUGS, SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hypersensitivity
Clinical narrative: ALLERGIC REACTION (RED RASH ON FACE AND TINY BUMPS AND WAS BLOTCHY); This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included: insomnia, and ibs, and concurrent conditions included: seasonal allergies, allergy to dogs, allergy to penicillin, marijuana abuse (approx 4 times per month), alcoholic (1 drink per day average), and smoking (approx 5 cigarettes per month). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. Age at time of vaccination 40 years old. No concomitant medications were reported. On 30-APR-2021, the patient experienced allergic reaction (red rash on face and tiny bumps and was blotchy). Laboratory data (dates unspecified) included: Blood test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from allergic reaction (red rash on face and tiny bumps and was blotchy). This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received one dose Moderna covid-19 vaccine (spikevax, elasomeran) (Dose number in series 1) (forms of admin, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered on an unspecified date for prophylactic vaccination. The patient had an allergic reaction with first dose of moderna covid-19 vaccine (spikevax, elasomeran) and did not complete the series due that (Dose number in series 1).  The patient received first covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on 09-MAY-2021 for prophylactic vaccination because patient was unable to take Moderna, which was an off label use as inappropriate schedule of vaccine administered (Dose number in series 2). The batch number was not reported and has been requested. Age at time of vaccination 67 years old. No concomitant medications were reported. The patient also received additional second covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin not reported, batch number:1882809, expiry: Unknown) dose was not reported, 1 total administered on 12-NOV-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with second covid-19 vaccine ad26. cov2.s (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.