chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, FLU4, MENB, MNQ, RV1, TDAP
Symptoms: Product storage error
Clinical narrative: went below freezing point; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) 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, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Menveo, Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Menveo, Bexsero and Bexsero Pre-Filled Syringe Device, 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 several vaccines Bexsro, Menveo, Flulaval, Kinrix, Pediarix, Boostrix, Infanrix, Rotarix that went below freezing point was inadvertently administered to patient over a period of time, which led to incorrect storage of drug. The reporter consented to follow up. No details of patient or other vaccine details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hasn't gotten the second dose yet.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2017). Concurrent medical conditions included als.   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 reporter was the patient.  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 vaccination schedule. The patient spoke per personal information and referred to healthcare professional. No healthcare professional information was provided. The reporter did not consent to follow up.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: half the dose was administered.; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 12-month-old male patient who received HAV (Havrix pediatric) (batch number 2k57N, expiry date 11th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2021, the patient received Havrix pediatric (intramuscular) .25 ml and Havrix Pre-Filled Syringe Device. On 11th October 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose 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 reported. The HCP reported that the patient did not get complete dose of Havrix, the patient was moving and the syringe came out when administering the dose, which led to accidental underdose. The HCP stated that approximately half the dose was administered. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: 2 "flu shots" within a week; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 50-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number E9R44, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA SHOT.   On 11th October 2021, the patient received the 2nd dose of FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 11th October 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device and an unknown time after receiving INFLUENZA SHOT, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that, the patient had received 2 flu shots within a week, which led to an extra dose administered. It was reported that 1st dose was given on 4th October 2021 on pharmacy and they were not sure of the brand name of the vaccine The lot number for the 1st dose was 30847 with expiry date 30th June 2022 and 2nd dose was given today at the time of reporting at their facility.  The health care professional reported that, the vaccine administered was Flulaval QIV The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Insomnia
Clinical narrative: red dot near injection site; trouble sleeping; fatigued; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingrix (intramuscular). In September 2021, less than a day after receiving Shingrix, the patient experienced difficulty sleeping and fatigue. On an unknown date, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the difficulty sleeping and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, difficulty sleeping and fatigue to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient had received the first dose of Shingrix vaccine a few weeks ago (end of September 2021) could not remember exact date, on the left upper arm. The reporter stated that the same night his wife had trouble sleeping and was fatigued the next day. The reporter stated that he had  noticed a red dot near Shingrix injection site on the patient's left arm.. The reporter consented to follow up. This case was linked with US2021210526, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021210526:same reporter
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose couple of days after first dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   In October 2021, the patient received the 2nd dose of Shingrix. In October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 1st dose on 4th October 2021. The patient received 2nd dose of Shingrix vaccine a couple of days after being administered the first dose, which led to shortening of vaccination schedule. At the time of the report, the patient has had no symptoms. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose 2 years apart form first; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th October 2019).   On 27th September 2021, the patient received the 2nd dose of Shingrix. On 27th September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix later than the recommended dosing interval, which led to lengthening of vaccination schedule. The patient was not immunocompromised. No lot numbers available at the moment of the call. The patient did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shot 1 on Dec-2020, has not had shot #2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 02nd December 2020, did not remember if the 1st dose was in right or left arm, but the patient thought it was probably in right 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 reporter was the patient.  The age at vaccination was not applicable for this report. The patient was unable to locate the lot number for the shot given but did provide contact information for the primary care office where the shot was given.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 18Jul2021 / not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 39-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 18th July 2021).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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. Till the time of reporting, the patient did not receive 2nd dose of Twinrix , which led to incomplete course of vaccination. The pharmacist states the first dose was given at another location, so the lot and expiration of dose 1 are not available. The reporter consent to follow up.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose given to adult patient; Pediatric dose given to adult patient; This case was reported by a pharmacist and described the occurrence of adult use of a child product in a 23-year-old male patient who received HBV (Engerix B) (batch number p7294, expiry date 3rd January 2022) for prophylaxis.   On 6th October 2021, the patient received the 1st dose of Engerix B 10 mcg. On 6th October 2021, unknown after receiving Engerix B, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   Additional details were reported as follows: This case was reported by the pharmacist. The pharmacist reported that engerix-b was given to a patient, which led to adult use of a child product and underdose. The pharmacist consented to follow-up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a third dose; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1 st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On 11th October 2021, the patient received the 3rd dose of Shingrix. On 11th October 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 reporter was the patient. The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter did not consent to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: rash is approximately 10 inches; Warmth; redness and erythema; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number F29KK, expiry date 22nd October 2022) for prophylaxis.   On 6th October 2021, the patient received Shingrix. On 6th October 2021, less than a day after receiving Shingrix, the patient experienced injection site rash, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site rash, injection site warmth and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, injection site warmth and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The pharmacist reported that the patient received Shingrix and experienced warmth, redness and erythema on left arm and rash approximately 10 inches by 4 and half, were she received the vaccine. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in June of 2018; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 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 reporter was the patient.  The age at vaccination was not applicable for this report. The patient stated after receiving 1st dose of Shingrix he was not told that he needed a second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not consent to follow up. The patient did not provide any additional details.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, 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 age at vccination was not reported. The patient received 3rd dose of Shingrix at the pharmacy, which led to extra dose administered. The reporter wanted to know what to tell her patient. The pharmacist was unable to provide any of the patient demographic information or the answers to the content questions for the Shingrix vaccine adverse event at the time of the call due to the fact that the vaccine was given to the patient at a different chain pharmacy. The consent to follow up was unknown as the reporter did not asked for consent to follow up with patient's health care professional.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Product supply issue, Social problem
Clinical narrative: unable to receive second dose, lack of availability; unable to receive second dose, Covid pandemic; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date, intramuscularly about 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue and social problem. On an unknown date, the outcome of the product supply issue and social problem were unknown.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not applicable for this report. The reporter was not able to provide information regarding the lot number and expiration date. She was unable to receive the second dose due to lack of availability, which led to product supply issue. And then later was not able to get the second dose due to the Covid pandemic, which led to social problem. The reporter did not consent to follow-up. This case was linked with US2021210630, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021210630:Same reporter
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: received today a dose of Boostrix expired; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9L39Z, expiry date 8th October 2021) for prophylaxis.   On 12th October 2021, the patient received Boostrix. On 12th October 2021, unknown after receiving Boostrix, 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 physician reported that, the patient received a dose of Boostrix which was already expired on 8th October 2021. The reporter did not consent to follow-up.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 52S9R, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 12th October 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired dose of Fluarix QIV, which led to expired vaccine used. The reporter consented to follow up. The case has been linked with the case US2020093493 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020093493:same reporter
Age: 50.0
Sex: M
Vaccine: UNK
Symptoms: Exposure via skin contact, Incorrect dose administered
Clinical narrative: Unsure if complete dose was given; Vaccine squirted out from  patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 50-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number BM9ZY, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season (intramuscular) .5 ml and Fluarix Tetra Pre-Filled Syringe Device. On 12th October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered and exposure via skin contact 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 details were provided as follows: The pharmacist reported that while administration of Fluarix vaccine some of the vaccine squirted out of patient's arm and pharmacist was unsure if complete dose was received, which led to incomplete dose administered and exposure via skin contact. The pharmacist enquired if patient needed another dose. The pharmacist was warm transferred to medical information for guidance. The pharmacist stated that this patient was to get another dose of the vaccine.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: maladministration after expiration date; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 5D4H4, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received expired dose of Fluarix QV, which led to expired vaccine used.  The reporter consented to follow up by email.  No details from patients involved were available. This is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021211495:same reporter US-GLAXOSMITHKLINE-US2021211493:same reporter US-GLAXOSMITHKLINE-US2021211492:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received Fluarix after expiration date; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 5D4H4, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received expired dose of Fluarix QV, which led to expired vaccine used.  The reporter consented to follow up by email.  No details from patients involved were available. This is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021211489:same reporter US-GLAXOSMITHKLINE-US2021211493:same reporter US-GLAXOSMITHKLINE-US2021211495:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received Fluarix after expiration date; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 5D4H4, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received expired dose of Fluarix QV, which led to expired vaccine used.  The reporter consented to follow up by email.  No details from patients involved were available. This is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021211492:same reporter US-GLAXOSMITHKLINE-US2021211489:same reporter US-GLAXOSMITHKLINE-US2021211495:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received Fluarix after expiration date; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 5D4H4, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received expired dose of Fluarix QV, which led to expired vaccine used.  The reporter consented to follow up by email.  No details from patients involved were available. This is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021211492:same reporter US-GLAXOSMITHKLINE-US2021211493:same reporter US-GLAXOSMITHKLINE-US2021211489:same reporter
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Rash, Rash vesicular
Clinical narrative: were almost like shingles; rashes on lower back and torso/ almost like shingles; Headache; Chills; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2021, the patient received the 1st dose of Shingrix. On 1st July 2021, less than a day after receiving Shingrix, the patient experienced vesicular rash, rash, headache and chills. On an unknown date, the outcome of the vesicular rash and rash were not recovered/not resolved and the outcome of the headache and chills were recovered/resolved.   It was unknown if the reporter considered the vesicular rash, rash, headache and chills to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received the shingrix shot and on the same day  The patient had chills, headache, and rashes on lower back and torso.  She elaborated that rashes were almost like shingles, but the rashes did not had blisters.  She also mentioned that those rashes were no longer there, but they reappeared on the same spot when under stress. The reporter did not give a consent to follow-up with health care professional. Rather, she wanted safety to follow-up with herself.  She provided her email address. The reporter did not have lot/expiry date, dose, route of administration, and if the dose administered on the right or left deltoid. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: flu-like symptoms; Fever; headache; muscle aches; Chills; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2021, 12 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, fever, headache, muscle pain and chills. On an unknown date, the outcome of the influenza-like symptoms, fever, headache, muscle pain and chills were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, headache, muscle pain and chills to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The age at vaccination was not reported. The patient received Shingrix vaccine about 6 weeks ago and reported that 12 hours after receiving the vaccine, began to experience flu-like symptoms, fever, headache, muscle aches and chills.. The reporter asked if a second vaccine was needed or if one dose would be sufficient. Referred to health care professional and consented to follow-up. The reporter gave permission to contact health care professional.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only diluent part; received only diluent part; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a child patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA584A, expiry date 31st August 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, the pediatric patient received only diluent part of Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient details were under investigation by the clinic.  The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles after first dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis.   On 27th August 2021, the patient received the 1st dose of Shingrix. On 30th August 2021, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: Pharmacist reported that a patient got 1st dose of Shingrix and presented an active episode of shingles. The reporter consented to follow up.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received Menveo reconstituted with sterile water; received Menveo reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 14-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 11th October 2021, the patient received Menveo. On 11th October 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details provided were as follows: The nurse reported that a patient received a dose of Menveo reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Infanrix to a 11 year old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number 52m39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th September 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 29th September 2021, unknown after receiving Infanrix and Infanrix 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 was administered Infanrix at 11 year of age, which led to  inappropriate age at vaccine administration. No further events were reported.  The reporter agreed to be contacted for follow-up.
Sex: U
Vaccine: DTAP, HEP, HEPA
Symptoms: Product storage error
Clinical narrative: were stored below temperature and not viable but administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix, Havrix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix, Havrix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, 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 medical assistant reported that Havrix, Engerix, and Infanrix were stored below temperature and administered to unknown number of patients, which led to  incorrect storage of drug. The vaccines were deemed not viable. The reporter consented to follow up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Drug ineffective
Clinical narrative: LACK OF EFFECT/ NO EVIDENT OF THE PATIENT  HAVING HAD THE JANSSEN COVID-19  VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned a 55 year old male. Initial information was processed along with additional information received from a department on 04-OCT-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: Unknown and Expiry: Unknown) dose was not reported,1 total, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in SEP-2021, the patient went to the doctor for routine blood work and was told that there was no evidence of the Janssen Covid-19 vaccine in his system (Lack of effect/ no evident of the patient having had the Janssen Covid-19 vaccine administered). The doctor specify that he should receive another vaccine, possibly Pfizer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lack of effect/ no evident of the patient having had the Janssen covid-19 vaccine administered was not reported. This report was serious (Other Medically Important Condition). This report was associated with a REGULATORY AUTHORITY: 90000195676.; Sender's Comments: V0:20211004100-covid-19 vaccine ad26.cov2.s-lack of effect/ no evident of the patient having had the Janssen covid-19 vaccine administered. This event(s) is considered not related. 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
Sex: F
Vaccine: COVID19
Symptoms: Thinking abnormal, Tremor
Clinical narrative: DEAFNESS FOR ABOUT 2 DAYS; PSYCHOTIC EPISODES; COULD NOT WALK; KICKING LEGS AND HANDS; MUMBLING; CARRYING ON; SHAKING; GOT REAL HOT, DIDN'T WANT FAN ON; THOUGHT HUSBAND WAS STILL ALIVE; COULD NOT GET UP; GONE BACK IN TIME ONE MINUTE AND IN RIGHT MIND THE NEXT; NO STRENGTH; This spontaneous report received from a consumer concerned an unspecified age. 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 administration not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on SEP-2021 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 in SEP-2021, about 2 weeks after vaccination, patient experienced ringing in ears and deafness for about 2 days.  According to the reporter, it was an epileptic seizure but this was not diagnosed. The patient did not know what she was doing: kicking legs and hands, mumbling, carrying on, shaking, she got real hot and did not want the fan on. Then she had psychotic episodes that lasted about 2 days after the ringing in ears and hearing/ deafness stopped. She did not have a fever. After that patient did not have any more episodes. She thought her husband was still alive. On an unspecified date, patient was hospitalised for about 5-6 days and then she was sent to a behavioral center for 8-9 days. As per the reporter, patient was still in the hospital. Patient had been having effects like back in time one minute and in right mind the next. Patient stayed in bed 4 days after she got the shot. She could not get up and walk and did not have the strength. Reporter advised the patient to contact her HCP for advise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deafness for about 2 days, psychotic episodes, kicking legs and hands, mumbling, carrying on, shaking, and got real hot, didn't want fan on, and the outcome of could not get up, could not walk, thought husband was still alive, gone back in time one minute and in right mind the next and no strength was not reported This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211006204-covid-19 vaccine ad26.cov2.s -Deafness for about 2 days, psychotic episodes, could not walk,  kicking legs and hands, mumbling, carrying on, shaking, got real hot, didn't want fan on, thought husband was still alive, could not get up, gone back in time one minute and in right mind the next. 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).  20211006204-covid-19 vaccine ad26.cov2.s -No strength. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: PAIN; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, 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. Concomitant medications included upadacitinib for moderate to severe rheumatoid arthritis. On an unspecified date, the patient experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory distress syndrome, Dependence on respirator, Suspected COVID-19, Vaccination failure
Clinical narrative: LUNGS ARE STIFFENING (ACUTE RESPIRATORY DISTRESS SYNDROME); PATIENT PLACED ON VENTILATOR; SUSPECTED COVID-19 INFECTION/BREAKTHROUGH INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a 62 year old male. 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: Unknown, Expiry: Unknown) 1 total, dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection (breakthrough infection, dying in intensive care unit) (ICU). On unspecified date, the patient experienced lungs are stiffening (Acute respiratory distress syndrome) from the ventilator. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, lungs are stiffening (Acute respiratory distress syndrome) from the ventilator and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000196340.; Sender's Comments: V0: 20211011489-covid-19 vaccine ad26.cov2.s-lungs are stiffening (Acute respiratory distress syndrome), Patient placed on ventilator, suspected covid-19 infection/ breakthrough infection. 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).  20211011489-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event(s) is considered not related. 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