chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: got first dose on April 13, 2021 /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 46-year-old 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 of Twinrix received on 13th April 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 the 2nd dose of Twinrix, which led to incomplete course of vaccination. The reporter was wondering if ok to give and if so, how long between 2nd and 3rd dose. The health care professional stated that, when asked for patient information he or she do not have that information at the time of reporting. The reporter consented to follow via email.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number c5jl7, expiry date 28th November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th July 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix 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 physician reported that a patient was administrated with Boostrix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case is one of the 28 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number cm7cm, expiry date 29th July 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th July 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix 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 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 reporter stated that, the patient was administrated with Boostrix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 26 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Product storage error
Clinical narrative: after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9x3t5, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th July 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix 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 physician reported that, the patient was administrated with Pediarix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 29 linked cases,reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164800:
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Product storage error
Clinical narrative: after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9x3t5, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th July 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix 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 physician reported that, the patient was administrated with Pediarix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 29 linked cases,reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 12-month-old male patient who received HAV (Havrix) (batch number yl532, expiry date 9th September 2022) for prophylaxis.   On 16th July 2021, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The physician reported that, the patient was administrated with Havrix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported . The reporter consented to follow up. This case is linked with one of 28 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 15-year-old male patient who received HAV (Havrix) (batch number yl532, expiry date 9th September 2022) for prophylaxis.   On 16th July 2021, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The physician reported that a patient was administrated with Havrix after a belowfreezing temperature excursion, which led to  incorrect storage of drug No adverse event was reported. The reporter consented to follow up. This case is linked with one of the many cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164795:Same reporter.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Administrated / after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect product storage in a 17-year-old male patient who received HAV (Havrix) (batch number yl532, expiry date 9th September 2022) for prophylaxis.   On 21st July 2021, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.  Additional details provided were as follows: Physician reported that, the patient was administrated with Havrix after a below freezing temperature excursion, which led to incorrect product storage. No adverse event was reported. Reporter consented to follow-up. This case is 1 of 28 case linked by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164789: US-GLAXOSMITHKLINE-US2021164795:Same reporter. US-GLAXOSMITHKLINE-US2021164801: US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779: US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164784: US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164800: US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164786:Same reporter. US-GLAXOSMITHKLINE-US2021164794:Same reporter. US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164799:Same reporter. US-GLAXOSMITHKLINE-US2021164804:Same reporter. US-GLAXOSMITHKLINE-US2021164805:Same reporter. US-GLAXOSMITHKLINE-US2021164806:Same reporter. US-GLAXOSMITHKLINE-US2021164808:Same reporter.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 12-month-old male patient who received HAV (Havrix) (batch number yl532, expiry date 9th September 2022) for prophylaxis.   On 25th July 2021, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The physician reported that a patient was administrated with Havrix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case is one of 28 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter
Sex: U
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: received a Bexsero /while it was receiving the Trumenba schedule; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine 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 age at vaccination was not reported. The patient received a Bexsero dose while it was receiving the Trumenba schedule, which led to wrong vaccine administered. The reporter stated that she was not the one who inadvertently administered the Bexsero dose, but a nurse from the facility did it as she did not know that the correct schedule was for Trumenba.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Vertigo
Clinical narrative: Vertigo; Felt not herself; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2021, several hours after receiving Shingrix, the patient experienced feeling abnormal. On an unknown date, the patient experienced vertigo. On an unknown date, the outcome of the vertigo and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the vertigo and feeling abnormal to be related to Shingrix.  Additional details were reported as follows: The patient received her first dose of Shingrix and after few hours experienced felt not herself that night until 3rd day then had vertigo both recovered. The patient declined follow up with her medical doctor. The reporter did not consent to follow-up.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Blood pressure fluctuation, Heart rate increased, Lethargy, Oxygen saturation abnormal, Pyrexia
Clinical narrative: motor tic in foot; lethargy; oxygen saturation varied between 88 to 98; low grade fever; blood pressure both increased and decreased; increased heart rate; vomiting; This case was reported by a consumer via call center representative and described the occurrence of lethargy in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 19th August 2020, the patient received the 1st dose of Menveo (intramuscular) .5 ml. On 19th August 2020, less than a day after receiving Menveo, the patient experienced lethargy, oxygen saturation abnormal, low grade fever, blood pressure fluctuation, heart rate increased and vomiting. On an unknown date, the patient experienced motor tic. On an unknown date, the outcome of the lethargy, oxygen saturation abnormal, low grade fever, blood pressure fluctuation, heart rate increased and vomiting were recovered/resolved and the outcome of the motor tic was not recovered/not resolved.   It was unknown if the reporter considered the lethargy, oxygen saturation abnormal, low grade fever, blood pressure fluctuation, heart rate increased, vomiting and motor tic to be related to Menveo.  Additional details were provided as follows: The reporter was the mother of the patient.  The patient had received the Menveo vaccine and within 24 hours he had lethargy, vomiting, increased heart rate, blood pressure both increased and decreased, low grade fever, oxygen saturation varied between 88 to 98.  These symptoms lasted for approximately 4 days then resolved.  She took her son to a pediatric cardiologist on the 5th day and he had no symptoms.  Three to six months later the patient had developed a motor tic in his foot, he had not been to the doctor about the motor tic, it was not resolved. The reporter consented to follow up.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Tic, Vomiting
Clinical narrative: motor tic in foot; lethargy; oxygen saturation varied between 88 to 98; low grade fever; blood pressure both increased and decreased; increased heart rate; vomiting; This case was reported by a consumer via call center representative and described the occurrence of lethargy in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 19th August 2020, the patient received the 1st dose of Menveo (intramuscular) .5 ml. On 19th August 2020, less than a day after receiving Menveo, the patient experienced lethargy, oxygen saturation abnormal, low grade fever, blood pressure fluctuation, heart rate increased and vomiting. On an unknown date, the patient experienced motor tic. On an unknown date, the outcome of the lethargy, oxygen saturation abnormal, low grade fever, blood pressure fluctuation, heart rate increased and vomiting were recovered/resolved and the outcome of the motor tic was not recovered/not resolved.   It was unknown if the reporter considered the lethargy, oxygen saturation abnormal, low grade fever, blood pressure fluctuation, heart rate increased, vomiting and motor tic to be related to Menveo.  Additional details were provided as follows: The reporter was the mother of the patient.  The patient had received the Menveo vaccine and within 24 hours he had lethargy, vomiting, increased heart rate, blood pressure both increased and decreased, low grade fever, oxygen saturation varied between 88 to 98.  These symptoms lasted for approximately 4 days then resolved.  She took her son to a pediatric cardiologist on the 5th day and he had no symptoms.  Three to six months later the patient had developed a motor tic in his foot, he had not been to the doctor about the motor tic, it was not resolved. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient was administered with an expired dose of Engerix B; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number unknown, expiry date April 2021) for prophylaxis.   On 2nd August 2021, the patient received Engerix B. On 2nd August 2021, unknown after receiving Engerix B, 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 age at vaccination was not reported. The patient was administered with an expired dose of Engerix B. The pharmacy technician explained that there were 9 doses of Engerix B with expiration date January 2022 and 1 dose that expired in April 2021 (all in the same box) and that expired dose was given to the patient. As per the reporter they received the product from another one of their pharmacies, and the box was not sealed, so they could not be sure how this occurred. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / 22 months before this report / has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 22 months 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 details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. No more information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose/on 07/11/2019 never received the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 11th July 2019, batch Number XC972 expiry date 29th August 2021).   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 case details were provided as follows: The age at vaccination was not applicable for this report. The patient never received the 2nd dose after 1st dose till the time of reporting which led to incomplete course of vaccination. Vaccine administration Facility was reported for the 1st dose. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose / before the 2 months recommended in / schedule; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 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 the second dose of shingrix before the 2 months recommended in the shingrix schedule, which led to shortening of vaccine schedule. The reporter consented to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Acute haemorrhagic leukoencephalitis, Magnetic resonance imaging head abnormal, Plasmapheresis, Vasogenic cerebral oedema
Clinical narrative: Acute Hemorrhagic Leukoencephalitis; Vasogenic edema; This case was reported in a literature article and described the occurrence of acute hemorrhagic leukoencephalitis in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.  On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced acute hemorrhagic leukoencephalitis (serious criteria GSK medically significant) and vasogenic cerebral edema (serious criteria GSK medically significant). The patient was treated with operations and procedures (Plasma Exchange) and corticosteroid nos (Corticosteroids (Drug Name Unknown)). On an unknown date, the outcome of the acute hemorrhagic leukoencephalitis and vasogenic cerebral edema were recovered/resolved.   The reporter considered the acute hemorrhagic leukoencephalitis and vasogenic cerebral edema to be related to Influenza vaccine.  Additional details were reported as follows: This case was reported in a literature article and described the occurrence of acute hemorrhagic leukoencephalitis in a patient of unspecified age and gender, who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown) for prophylaxis. No information on patient's medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified seasonal influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after the vaccination, the patient presented to acute hemorrhagic leukoencephalitis (AHLE) that was promptly diagnosed with magnetic resonance imaging (MRI) brain, which showed significant areas of hemorrhage with vasogenic edema including involvement of the pons. The patient was aggressively treated with plasma exchange and corticosteroids and had a favorable outcome. The authors stated, "Acute Hemorrhagic Leukoencephalitis (AHLE) is a rare but devastating and fatal form of Acute Disseminated Encephalomyelitis. Very rarely, this can be a complication of vaccination. There is currently no consensus on the optimal treatment strategy of AHLE." This article corresponding to this case is not available for regulatory submission due to copyright restriction.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure, Vision blurred
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; BLURRED VISION; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight was 290 pounds, and height was 71 inches. The patient's concurrent conditions included non-smoker, and no alcohol use, and other pre-existing medical conditions included no known medical history. The patient experienced drug allergy when treated with morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total administered on 13-MAR-2021 on Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the patient experienced blurred vision (both eyes) one week after receiving vaccine. His vision is getting worse. On 30-JUL-2021, the patient was diagnosed with with COVID-19 (suspected COVID-19 infection, suspected clinical vaccination failure). On 30-JUL-2021, Antigen test was performed that was positive. Symptoms of COVID-19 also getting worse.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid 19 infection, and blurred vision, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187995.; Sender's Comments: V0: 20210801741- 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
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; VIAL OF THE VACCINE WAS PUNCTURED AND WAS LATER ON STORED IN THE REFRIGERATOR FOR 25 HOURS (UNDER 40-41 DEGREES F) AND WAS GIVEN TO 1 PATIENT; OFF LABEL USE; This spontaneous report received from a consumer concerned a female of 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 admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced product storage error. On JUL-2021, the subject experienced vial of the vaccine was punctured and was later on stored in the refrigerator for 25 hours (under 40-41 degrees f) and was given to 1 subject. On JUL-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error, vial of the vaccine was punctured and was later on stored in the refrigerator for 25 hours (under 40-41 degrees f) and was given to 1 patient and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Musculoskeletal stiffness
Clinical narrative: SPINE WAS IN PAIN; HER BACK FELT EXTREMELY STIFF; CHILLS; HIGH FEVER; EXTREME FATIGUE; BODY FEELS WEAK; LOW GRADE FEVER ON AND OFF; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-JUL-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 08-JUL-2021, the subject experienced extreme fatigue. On 08-JUL-2021, the subject experienced body feels weak. On 08-JUL-2021, the subject experienced low grade fever on and off. Laboratory data included: Body temperature (NR: not provided) 99.7-101.5 Fahrenheit. On an unspecified date, the subject experienced spine was in pain, her back felt extremely stiff, chills, and high fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spine was in pain, her back felt extremely stiff, chills, and high fever, and had not recovered from extreme fatigue, body feels weak, and low grade fever on and off. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Spinal pain
Clinical narrative: SPINE WAS IN PAIN; HER BACK FELT EXTREMELY STIFF; CHILLS; HIGH FEVER; EXTREME FATIGUE; BODY FEELS WEAK; LOW GRADE FEVER ON AND OFF; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-JUL-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 08-JUL-2021, the subject experienced extreme fatigue. On 08-JUL-2021, the subject experienced body feels weak. On 08-JUL-2021, the subject experienced low grade fever on and off. Laboratory data included: Body temperature (NR: not provided) 99.7-101.5 Fahrenheit. On an unspecified date, the subject experienced spine was in pain, her back felt extremely stiff, chills, and high fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spine was in pain, her back felt extremely stiff, chills, and high fever, and had not recovered from extreme fatigue, body feels weak, and low grade fever on and off. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, SARS-CoV-2 test positive, Sinus disorder, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; BACK PAIN; SUSPECTED COVID-19 INFECTION; SINUS; This spontaneous report received from a patient concerned a 61 year old female. Initial information was processed along with additional information received on 03-AUG-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies, drug abuse or illicit drug usage. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, the patient started feeling or having sinus, sore throat, chills and fever. The patient also had a headache that was really bad and was having body aches. The patient stated that the symptoms are like waves they come and go and also back hurts really bad. The patient had Tylenol and Advil for symptoms. The patient had contacted the physician and planned to receive infusion as patient was asthmatic. The patient was tested positive for covid-19 and test type was nasal instant test. The patient believed that it was the delta one. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sinus, suspected covid-19 infection, suspected clinical vaccination failure and back pain was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000188105.; Sender's Comments: V0:20210803371-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
Sex: M
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Asthenia, Diarrhoea, Eye pain, Fatigue
Clinical narrative: FEELS LIKE EYES ARE BULGING; EYE PAIN FROM THE HEADACHE; WAS DRIFTING OFF; CALF PAIN/CALVES ARE ACHING A BIT BUT THAT MIGHT BE FROM LOW ENERGY; A FEW EPISODES DIARRHEA; FATIGUE/FEELING PRETTY DRAINED; LOW ENERGY/DOES NOT HAVE ENOUGH ENERGY TO GET OUT OF BED; HEADACHE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, no alcohol, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-AUG-2021, the subject experienced feels like eyes are bulging. On 03-AUG-2021, the subject experienced eye pain from the headache. On 03-AUG-2021, the subject experienced was drifting off. On 03-AUG-2021, the subject experienced calf pain/calves are aching a bit but that might be from low energy. On 03-AUG-2021, the subject experienced a few episodes diarrhea. On 03-AUG-2021, the subject experienced headache. On 03-AUG-2021, the subject experienced fatigue/feeling pretty drained. On 03-AUG-2021, the subject experienced low energy/does not have enough energy to get out of bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue/feeling pretty drained, had not recovered from a few episodes diarrhea, headache, low energy/does not have enough energy to get out of bed, eye pain from the headache, calf pain/calves are aching a bit but that might be from low energy, and feels like eyes are bulging, and the outcome of was drifting off was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Pain in extremity
Clinical narrative: FEELS LIKE EYES ARE BULGING; EYE PAIN FROM THE HEADACHE; WAS DRIFTING OFF; CALF PAIN/CALVES ARE ACHING A BIT BUT THAT MIGHT BE FROM LOW ENERGY; A FEW EPISODES DIARRHEA; FATIGUE/FEELING PRETTY DRAINED; LOW ENERGY/DOES NOT HAVE ENOUGH ENERGY TO GET OUT OF BED; HEADACHE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, no alcohol, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-AUG-2021, the subject experienced feels like eyes are bulging. On 03-AUG-2021, the subject experienced eye pain from the headache. On 03-AUG-2021, the subject experienced was drifting off. On 03-AUG-2021, the subject experienced calf pain/calves are aching a bit but that might be from low energy. On 03-AUG-2021, the subject experienced a few episodes diarrhea. On 03-AUG-2021, the subject experienced headache. On 03-AUG-2021, the subject experienced fatigue/feeling pretty drained. On 03-AUG-2021, the subject experienced low energy/does not have enough energy to get out of bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue/feeling pretty drained, had not recovered from a few episodes diarrhea, headache, low energy/does not have enough energy to get out of bed, eye pain from the headache, calf pain/calves are aching a bit but that might be from low energy, and feels like eyes are bulging, and the outcome of was drifting off was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious