chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: shingles on the right side; internal pain still awful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 25-JAN-2023 Reporter comment: This case was reported by a patient via interactive digital media. The patient had 1st Shingles vaccine but got Shingles before getting the 2nd. The reporter reported that, the second week and internal pain was still awful. The patient stated that shingles happened on the right side. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Fatigue, Inappropriate schedule of product administration
Clinical narrative: 1st dose 4 years ago, 2nd dose last year; 3rd dose last year; tiredness after 2nd; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (received 1st dose 4 years ago).   On an unknown date, the patient received the 3rd dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced tiredness, drug dose administration interval too long and extra dose administered. On an unknown date, the outcome of the tiredness was recovered/resolved and the outcome of the drug dose administration interval too long and extra dose administered were unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comments: The reporter was the husband of the patient. The patient received second dose and third dose of Shingrix last year in 2022, after her second dose, the patient experienced tiredness for one day which was resolved. The reporter consented to follow up. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. The patient received 3rd dose of Shingrix, which led to extra dose administered. The case was linked with case US2023008729, reported by same reporter.; Sender's Comments:  US-GSK-US2023008729:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2021, has to get the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 23rd November 2021, received 1st dose).   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: 20-Jan-2023. Reporter's Comments: The reporter reported patient received 1st dose of Shingrix at a different pharmacy/provider's office thus he does not have the lot number, confirmation of which arm it was given in, or if it was given intramuscularly. The patient had yet to get dose 2 and it was beyond the six month window. Consented to follow up. Additional Supportive Information: Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Received Vx after temp excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 1-day-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   In January 2023, the patient received Engerix B pediatric (intramuscular) and Engerix B Pre-Filled Syringe Device. In January 2023, unknown after receiving Engerix B pediatric 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 Information: GSK receipt date : 20 Jan 2023 Reporters comment: The physician reported that 5 patients received Engerix B after a temperature excursion of too cold. All patients were one day old. Two patients were boys, and three were girls. Reporter consented to follow up. Additional supportive information: As patient received Engerix B after a temperature excursion of too cold, which led to incorrect storage of drug. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR009387:Same reporter US-GSK-US2023AMR009449:same reporter - female patient US-GSK-US2023AMR009450:same reporter -  female patient US-GSK-US2023008733:same reporter -  female patient
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: received Engerix after a cold temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 1-day-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   In January 2023, the patient received Engerix B pediatric (intramuscular) and Engerix B Pre-Filled Syringe Device. In January 2023, unknown after receiving Engerix B pediatric 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 Information: GSK Receipt Date: 20-JAN-2023 Reporter's comments:  The physician reported that 5 patients received Engerix B after a temperature excursion of too cold. Reporter consented to follow up. Additional supportive information: Received Engerix B after a temperature excursion of too cold, which led to incorrect storage of drug. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR009449:same reporter - female case US-GSK-US2023AMR009450:same reporter - female case US-GSK-US2023008735:same reporter - male patient US-GSK-US2023AMR009387:same reporter - male patient
Age: 54.0
Sex: M
Vaccine: HEPA
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: Pediatric dose administered to adult; Pediatric dose administered to adult; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 54-year-old male patient who received HAV (Havrix 720) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   On 19th January 2023, the patient received the 1st dose of Havrix 720. On 19th January 2023, unknown after receiving Havrix 720, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.  Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comment: The reporter reported that the adult patient inadvertently received the pediatric dose of the Havrix vaccine in the right arm. The reporter did consent to follow up. Additional supportive information: The adult patient was administered a pediatric dose of Havrix, which had led to accidental underdose and adult use of a child product.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Incorrect route of product administration, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Nodule at injection site, size is half an orange, slightly increased in size; Fatigue; Vx administered subcutaneously; Injection site nodule is warm; Injection site nodule is red; Injection site noduleTender to touch; Injection site raised; This case was reported by a nurse via call center representative and described the occurrence of injection site nodule in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 19th October 2022 received 1st dose).   On 19th January 2023, the patient received the 2nd dose of Shingrix (subcutaneous). In January 2023, unknown after receiving Shingrix, the patient experienced injection site warmth, injection site erythema, injection site tenderness and injection site swelling. On 19th January 2023, the patient experienced injection site nodule, fatigue and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site nodule, injection site warmth, injection site erythema, injection site tenderness, injection site swelling and fatigue were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site nodule, injection site warmth, injection site erythema, injection site tenderness, injection site swelling and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comment: The reporter was the patient.  The reporter reported that patient received Shingrix at a local pharmacy.  The reporter reported HCP admitted to administering dose subcutaneously, instead of intramuscularly.  The patient experiencing fatigue and a nodule at the injection site which was warm, red, raised, and tender to touch.  The reporter reported nodule was approximately the size of half an orange.  The reporter reported fatigue and nodule began last night, between 11pm and 12am. The nodule had slightly increased in size since onset. The reporter wanted to knew would the dose need to be repeated or any efficacy on subcutaneous versus intramuscular injections. The patient unable to provide lot number and expiration details of vaccine. The reporter consent to follow up. Additional supportive information: The patient received Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The case US2023008745 is identified as duplicate of case US2023008742.  All future correspondence would be added in case US2023008742, which stands as case of record for this patient and the case US2023008745 would be deleted.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Nodule at injection site, size is half an orange, slightly increased in size; Fatigue; Vx administered subcutaneously; Injection site nodule is warm; Injection site nodule is red; Injection site noduleTender to touch; Injection site raised; This case was reported by a nurse via call center representative and described the occurrence of injection site nodule in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 19th October 2022 received 1st dose).   On 19th January 2023, the patient received the 2nd dose of Shingrix (subcutaneous). In January 2023, unknown after receiving Shingrix, the patient experienced injection site warmth, injection site erythema, injection site tenderness and injection site swelling. On 19th January 2023, the patient experienced injection site nodule, fatigue and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site nodule, injection site warmth, injection site erythema, injection site tenderness, injection site swelling and fatigue were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site nodule, injection site warmth, injection site erythema, injection site tenderness, injection site swelling and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comment: The reporter was the patient.  The reporter reported that patient received Shingrix at a local pharmacy.  The reporter reported HCP admitted to administering dose subcutaneously, instead of intramuscularly.  The patient experiencing fatigue and a nodule at the injection site which was warm, red, raised, and tender to touch.  The reporter reported nodule was approximately the size of half an orange.  The reporter reported fatigue and nodule began last night, between 11pm and 12am. The nodule had slightly increased in size since onset. The reporter wanted to knew would the dose need to be repeated or any efficacy on subcutaneous versus intramuscular injections. The patient unable to provide lot number and expiration details of vaccine. The reporter consent to follow up. Additional supportive information: The patient received Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The case US2023008745 is identified as duplicate of case US2023008742.  All future correspondence would be added in case US2023008742, which stands as case of record for this patient and the case US2023008745 would be deleted.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose given to an adult; Pediatric dose given to an adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 32-year-old female patient who received HBV (Engerix B pediatric) (batch number A9349, expiry date 19th April 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th January 2023, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 18th January 2023, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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: 20-JAN-2023 Reporter's Comment: The nurse called to report a pediatric Engerix-B dose was administered to a adult patient. The reporter consent to follow up via email. Additional supportive information: The patient was given Engerix-B pediatric instead of Engerix-B adult as per the patient's age at time of vaccination, which led to underdose and adult use of a child product.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired Pediarix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 2AJ32, expiry date 2nd September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th January 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 19th January 2023, unknown after receiving Pediarix and Pediarix 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-JAN-2023 Reporter's comments: The office manager had reported that, a patient had received an expired dose (2 September 2022) of the Pediarix vaccine at Left thigh on 19 January 2023. The reporter had consented to follow-up. Additional supportive information: At the time of reporting, the patient had received an expired dose of Pediarix vaccine, which had led to expired vaccine used.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted with sterile diluent; patient was given a dose of improperly reconstituted Menveo on 20Jan2023; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA902A, expiry date 31st January 2024) for prophylaxis.   On 20th January 2023, the patient received Menveo. On 20th January 2023, 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 Information: GSK Receipt Date: 20-JAN-2023 Reporter's comments: A medical assistant had reported that, a female patient was given a dose of improperly reconstituted Menveo vaccine. The vaccine was reconstituted with sterile diluent.  No other symptoms were reported. The reporter had consented to follow-up via email. Additional supportive information: At the time of reporting, the patient had received Menveo vaccine which was reconstituted with sterile diluent, which had led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) 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.   On 20th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 20th January 2023, unknown after receiving Twinrix and Twinrix 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-JAN-2023 Reporter's comments: The pharmacist had reported that, an expired dose of Twinrix which was expired on  01 January 2023 was administered at the time of reporting.  The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up. Additional supportive information: At the time of reporting, the patient had received an expired dose of Twinrix vaccine, which had led to expired vaccine used.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose years ago, series not completed; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 28-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine (1st dose received years ago.).   On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, 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: 20-JAN-2023 Reporter comment: The pharmacist reported that, the information about the possibility of administrating Engerix-B to a patient whom received the first dose years ago, not giving s a specific date or information about the vaccine.  The patient's details were collected.  Not giving s a specific date or information about the vaccine. The pharmacist wanted to administer Engerix-B this time around but the previous dose was a unknown brand of Hepatitis B vaccine and the patient had not received the second dose yet. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Hepatitis B, which led to incomplete course of vaccination.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Gait disturbance, Hypoaesthesia
Clinical narrative: numbness in the shin area on right leg; pain in right knee; difficulty walking up and down stairs; This case was reported by a consumer via call center representative and described the occurrence of numbness in leg in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th January 2023, the patient received the 1st dose of Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced walking difficulty. On 21st January 2023, the patient experienced numbness in leg and knee pain. On an unknown date, the outcome of the numbness in leg, knee pain and walking difficulty were not recovered/not resolved.   It was unknown if the reporter considered the numbness in leg, knee pain and walking difficulty to be related to Shingrix.     Additional Information: GSK Receipt date: 23-Jan-2023 Reporter's Comment: The patient self-reported this case. The patient received Shingrix on left arm. The patient stated that he felt pain in his right knee and numbness in the shin area on his right leg. He now had difficulty walking up and down stairs. Symptoms had not yet resolved. The patient requested, if possible, that Safety contact him to let him know if other patients had experienced knee pain with Shingrix. The reporter consented to follow-up.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 49-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th 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 20th January 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 20th January 2023, unknown after receiving Havrix and Havrix 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: 23-Jan-2023. Reporter's Comment: The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional Supportive Information: The patient received expired Havrix vaccine, which led to expired vaccine used. The case is linked with case US2023009573, reported by same reporter.; Sender's Comments:  US-GSK-US2023009573:same reporter - wife´s case
Sex: F
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old female 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.   Previously administered products included Havrix (1st dose received in 2011 with batch number AHAVB472AA).   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix 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 Information: GSK Receipt date: The pharmacist reported that, the patient got first dose of Havrix and hasnt had booster administered. Vaccination date and expiration date were asked but not available. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive booster of Havrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 5 years ago, never got 2 doses; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose probably received 5 year ago.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt date: 23-JAN-2023 Reporter comment: The pharmacist stated that immunocompetent patient who probably received 5 year ago a Shingrix first dose. The patient never got 2 doses. however, patient was not sure about that first dose 5 year ago. The reporter did not consent to follow up Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 2 doses by the end of 2021, shingles in summer 2022/suspected vaccination failure; Shingles/ then patient had shingles in summer 2022; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had been having shingles outbreaks every year since 2013).   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: 23-Jan-2023 Reporter's comment: The patient reported that she received Shingrix vaccine 2 dose series by the end of 2021 and then had shingles in summer 2022. The patient denied to provide any other information or follow up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 01OCT2021, 2nd dose was not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 1st October 2021 received 1st dose batch number 9435L and expiry date 8th April 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comment: The pharmacist had a immunocompetent patient who received Shingrix first dose. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dyspnoea, Fatigue, Headache
Clinical narrative: Headache; Tiredness; Weakness; Shortness of breath; This case was reported by a consumer via call center representative and described the occurrence of headache in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th January 2023, the patient received the 1st dose of Shingrix. On 11th January 2023, less than a day after receiving Shingrix, the patient experienced headache, tiredness and weakness. On 13th January 2023, the patient experienced shortness of breath. Shingrix was discontinued. On an unknown date, the outcome of the headache, tiredness, weakness and shortness of breath were recovered/resolved.   It was unknown if the reporter considered the headache, tiredness, weakness and shortness of breath to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comments: The patient reported case for herself. The patient stated that she received her first dose of Shingrix and experienced headache, tiredness, weakness that was resolved.  The patient stated that two days after the dose she began to experience periods of shortness of breath that would come and go but resolved after about a week.  She would not be getting the second dose based on the recommendation of the pharmacy. The reporter consented to follow up.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 30-year-old female patient who received HBV (Engerix B) (batch number 74EM4, expiry date 20th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th January 2023, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 25th January 2023, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's Comment: The reporter reported that a patient received an expired dose of Engerix-B. The reporter consented to follow up. Additional Supportive information: The reporter reported that a patient received an expired dose of Engerix-B, which led to expired vaccine used.
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received HAVRIX (batch number 7YA99, expiry date 30th September 2022) for prophylaxis. On 25th January 2023, the patient received HAVRIX. On 25th January 2023, unknown after receiving HAVRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional Information: GSK Receipt Date: 26-JAN-2023. Reporter's Comment: The reporter reported the administration of an expired dose of HAVRIX. The reporter stated that HAVRIX was administered. The reporter consented to follow up. Additional Supportive Information: The reporter reported the administration of an expired dose of HAVRIX, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received one dose of Shingrix vs 2 doses; This case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on an unknown date).   On an unknown date, the patients did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 26-JAN-2023 Reporter Comment: Submitted via sales rep on behalf of HCP. The reporter reported that, the unknown number of patients may have received one dose of Shingrix versus 2 doses. No other adverse event information available. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patients did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RECEIVED EXPIRED VACCINE/PRODUCTS HAD REACHED THEIR LISTED EXPIRATION DATES; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 08-SEP-2022) dose was not reported, administered on 20-SEP-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported. On 20-SEP-2022, the patient experienced received expired vaccine/products had reached their listed expiration dates. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received expired vaccine/products had reached their listed expiration dates was not reported. This report was non-serious. This case, from the same reporter is linked to 20230149982, 20230150340, 20230150255, 20230150600, 20230150423, 20230150716, 20230150777 and 20230150588.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: WAS GIVEN EXPIRED VACCINE/PRODUCTS (HAD REACHED THEIR LISTED EXPIRATION DATES); This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 08-SEP-2022) dose was not reported, administered on 22-SEP-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported. On 22-SEP-2022, the patient experienced was given expired vaccine/products (had reached their listed expiration dates). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of was given expired vaccine/products (had reached their listed expiration dates) was not reported. This report was non-serious. This case, from the same reporter is linked to 20230149982, 20230150157, 20230150423, 20230150600, 20230150588, 20230150716, 20230150777 and 20230150340.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED / PRODUCTS HAD REACHED THEIR LISTED EXPIRATION DATES; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 08-SEP-2022) dose was not reported, administered on 06-OCT-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported.  On 06-OCT-2022, the patient experienced expired vaccine used / products had reached their listed expiration dates. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used / products had reached their listed expiration dates was not reported. This report was non-serious. This case, from the same reporter is linked to 20230149982, 20230150157, 20230150423, 20230150588, 20230150600, 20230150716, 20230150777 and 20230150255.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: WAS GIVEN EXPIRED VACCINE/PRODUCTS HAD REACHED THEIR LISTED EXPIRATION DATES; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 08-SEP-2022) dose was not reported, administered on 24-OCT-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. On 24-OCT-2022, the patient experienced was given expired vaccine/products had reached their listed expiration dates. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of was given expired vaccine/products had reached their listed expiration dates was not reported. This report was non-serious. This case, from the same reporter is linked to 20230149982, 20230150340, 20230150255, 20230150600, 20230150157, 20230150588, 20230150716 and 20230150777.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RECEIVED EXPIRED VACCINE/PRODUCTS HAD REACHED THEIR LISTED EXPIRATION DATES; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 08-SEP-2022) dose was not reported, administered on 18-NOV-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported. On 18-NOV-2022, the patient experienced received expired vaccine/products had reached their listed expiration dates. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received expired vaccine/products had reached their listed expiration dates was not reported. This report was non-serious. This case, from the same reporter is linked to 20230150340, 20230150255, 20230150600, 20230150423, 20230150157, 20230150777, 20230150716 and 20230149982.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: GIVEN EXPIRED VACCINE/PRODUCTS (HAD REACHED THEIR LISTED EXPIRATION DATES); This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 08-SEP-2022) dose was not reported, administered on 10-NOV-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported. On 10-NOV-2022, the patient experienced given expired vaccine/products (had reached their listed expiration dates). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of given expired vaccine/products (had reached their listed expiration dates) was not reported. This report was non-serious. This case, from the same reporter is linked to 20230150340, 20230150255, 20230150157, 20230150423, 20230149982, 20230150588, 20230150716 and 20230150777.
Age: 50.0
Sex: U
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Vaccine storage temperature issue, health department advised to repeat.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR, PNC15
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Our 15 month old daughter was given 3 vaccines on 1/26/23. We were told she was getting DTaP, Chicken Pox and PVC13. We received a call the next morning 1/27/23 from the nurse that administered the shots telling us that she gave our daughter the wrong vaccine. She gave her a second dose of MMR instead of the chicken pox vaccine. She was not supposed to receive this second dose of MMR until the age of 4. She is now having redness on both legs at both injection sites. We are very concerned that she can continue to have reactions from this second MMR shot as she just had her first dose 3 months prior. The doctor and nurse showed no concern and said everything will be fine.
Age: 25.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Vaccine storage temperature issue, health department advised to repeat.
Age: 63.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Cough, Headache, Malaise, SARS-CoV-2 test positive
Clinical narrative: On 01/05/2023, I woke up with a slight headache. I went to work and around noon had a coughing fit. I then tested myself for COVID-19 and it was positive. I came home and called my doctor. They scheduled a video visit. I spoke with her and she said that since I have high blood pressure and my age qualified me to get PAXLOVID. I started taking that Thursday night. I took it for five days. I didn't test myself again until the following Wednesday. I was negative. My symptoms were very slight to begin with. I had a headache off and on for a week after even finishing the PAXLOVID and was testing negative.
Age: 56.0
Sex: M
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Vaccine storage temperature issue, health department advised to repeat.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Myalgia
Clinical narrative: Test positive for COVID 3 months prior to dose 4 COVID-19 vaccination; Since testing positive have been having Myalgia, that's progressively getting worse, and shortness of breath; Have started taking Celebrex, Tramadol and Advair.
Age: 28.0
Sex: F
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Vaccine storage temperature issue, health department advised to repeat.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging abnormal, Mobility decreased, Pain in extremity, Tendonitis, X-ray limb abnormal
Clinical narrative: The same day after the vaccination my arm started hurting. The pain got worse and within a month both arms started hurting. The left arm hurts worse than the right. I went to the doctor in June, and they recommended me to do physical therapy. The physical therapy was working but I had to stop because I did not have time. I went to the doctor again by that time I couldn't lift my left arm up. I had an MRI and X-ray of my shoulder. I was diagnosed with calcific tendonitis.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Provider Dr ordered Covid Pfizer ages 6 months to 4 years old, Pt was given wrong vaccine. . Pt was injected with Pfizer for 5-11 years old 0.2 ml were given, pt left the clinic with no signs or symptoms it was not until later that we realized wrong dose was given. Dr.  was Notified. . Nursing Director Advised,
Age: 38.0
Sex: F
Vaccine: UNK, UNK, VARCEL
Symptoms: Fatigue, Headache, Injection site discharge, Injection site reaction, Pyrexia
Clinical narrative: Patient said she started having symptoms 2 days after getting the vaccines. The injection site opened up and started leaking a clear fluid. She is having headaches, fever, fatigue and red spots on her skin.
Age: 38.0
Sex: F
Vaccine: UNK, UNK, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Patient said she started having symptoms 2 days after getting the vaccines. The injection site opened up and started leaking a clear fluid. She is having headaches, fever, fatigue and red spots on her skin.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injury, Pain in extremity
Clinical narrative: arm pain and injury after injection
Age: 72.0
Sex: U
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Vaccine storage temperature issue, health department advised to repeat.
Age: 45.0
Sex: U
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Vaccine storage temperature issue, health department advised to repeat.
Age: 65.0
Sex: U
Vaccine: FLUA4
Symptoms: Product storage error
Clinical narrative: Vaccine storage temperature issue, health department advised to repeat.
Age: 42.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Hypertension, Migraine, Vomiting
Clinical narrative: I just had a migraine and high blood pressure. I was throwing up from the headache as well.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pain of skin
Clinical narrative: Skin hurts to touch, back, legs, neck, arms
Age: 0.17
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Wrong vaccine administered -- should have been Prevnar 13 - PCV 13 no side effect noted so far by parents on 1-3-2023
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient present to clinic for an appointment, he did not think he had received any covid-19 vaccines. Vaccines were reconciled in his chart this morning and showed no covid vaccines received either. upon completion of vaccine patient mentioned he did have on done before. It was then found that the patients name was spelt different in the State Immunization System then in local chart. Patient in fact did receive three monovalent Pfizer Vaccines.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Electric shock sensation, Fall
Clinical narrative: Body shaking, electricity (tingling), leg weakness, diagnosed with GBS (Guillian Barré Syndrome), left leg thrombosis blot clot, I've been suffering from this for 18 plus months.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Guillain-Barre syndrome, Headache, Impaired work ability, Laboratory test
Clinical narrative: Body shaking, electricity (tingling), leg weakness, diagnosed with GBS (Guillian Barré Syndrome), left leg thrombosis blot clot, I've been suffering from this for 18 plus months.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Multiple fractures, Muscular weakness, Paraesthesia, Thrombosis
Clinical narrative: Body shaking, electricity (tingling), leg weakness, diagnosed with GBS (Guillian Barré Syndrome), left leg thrombosis blot clot, I've been suffering from this for 18 plus months.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Body shaking, electricity (tingling), leg weakness, diagnosed with GBS (Guillian Barré Syndrome), left leg thrombosis blot clot, I've been suffering from this for 18 plus months.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Myalgia
Clinical narrative: Very High very, muscle and joint pain. Chest pains for 2 years now.