chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other issues or concerns noted; a patient was given expired dose of MMRII; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 15-NOV-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) expiration date 14-NOV-2021, for prophylaxis (dose, lot #, route and site of administration were not reported). No additional adverse event was provided.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A PATIENT WHO HAD RECEIVED FLUMIST QUADRIVALENT BECAME POSITIVE FOR (FLU A) A WEEK AFTER FLU MIST WAS ADMINISTERED TO THE PATIENT; LACK OF EFFECT; A spontaneous report has been received from a health professional. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT.    The report described lack of effect for Flumist Quadrivalent. The reported term was "lack of effect" (Preferred term: Drug ineffective).     On an unknown date, the patient experienced a patient who had received flumist quadrivalent became positive for (flu a) a week after flu mist was administered to the patient (preferred term: Influenza).     The outcome of the event(s) of a patient who had received flumist quadrivalent became positive for (flu a) a week after flu mist was administered to the patient and lack of effect was unknown.     The events were considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Documented Lack of Immunity After Hepatitis B Series; Initial Report Received on 08-Nov-2021. In a case series by patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and with results of post-vaccination tests were collected from existing health records within the military health system.    Patient received an initial hepatitis B series at 57-years-old and a second hepatitis B series at 58-years-old.   A total of 7 doses of the standard hepatitis B vaccine were administered.    At 59-years-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).   On an unspecified date, the hepatitis B surface antibody after the Heplisav-B series was negative.    No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Blood HIV RNA, HIV test, Hepatitis B surface antigen, Hepatitis C virus test
Clinical narrative: Non-Responders to Heplisav-B Vaccination; Initial Report Received on 02-Nov-2021. In a retrospective chart review that was conducted in 2 HIV primary care clinics. Patient is an HIV positive patient, at least 18 years of age, with documented history of HBV vaccination administration prior to November 2017, and negative for both HBsAg and anti-HBs after previous HBV-vaccination.    Baseline laboratories included HIV RNA 89 copies/mL, CD 4 count 260 cells/uL, CD 4 19%, negative for anti-HBc and HCV co-infection.    On an unspecified date, the patient received and completed both doses of HEPLISAV-B vaccine.    On an unspecified date, the patient was noted as not having achieved seroprotection.     Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Blood HIV RNA below assay limit, CD4 lymphocytes decreased, Hepatitis B, Hepatitis C test negative
Clinical narrative: In a retrospective chart review that was conducted in 2 HIV primary care clinics, Patient 2, is an HIV positive patient, at least 18 years of age, with documented history of HBV vaccination administration prior to November 2017, and negative for both HBsAg and anti-HBs after previous HBV-vaccination. Baseline laboratories included HIV RNA undetectable, CD 4 count 318 cells/uL, CD 4 35%, negative for anti-HBc and HCV co-infection. On an unspecified date, the patient received and completed both doses of HEPLISAV-B vaccine. On an unspecified date, the patient was noted as not having achieved seroprotection. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Blood HIV RNA below assay limit, CD4 lymphocytes, Hepatitis B core antibody positive, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative
Clinical narrative: In a retrospective chart review that was conducted in 2 HIV primary care clinics, Patient 3, is an HIV positive patient, at least 18 years of age, with documented history of HBV vaccination administration prior to November 2017, and negative for both HBsAg and anti-HBs after previous HBV-vaccination. Baseline laboratories included HIV RNA undetectable, CD 4 count 107 cells/uL, CD 4 3%, positive for anti-HBc and negative HCV co-infection. On an unspecified date, the patient received and completed both doses of HEPLISAV-B vaccine. On an unspecified date, the patient was noted as not having achieved seroprotection. Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis C test negative, Therapy non-responder
Clinical narrative: In a retrospective chart review that was conducted in 2 HIV primary care clinics, Patient 3, is an HIV positive patient, at least 18 years of age, with documented history of HBV vaccination administration prior to November 2017, and negative for both HBsAg and anti-HBs after previous HBV-vaccination. Baseline laboratories included HIV RNA undetectable, CD 4 count 107 cells/uL, CD 4 3%, positive for anti-HBc and negative HCV co-infection. On an unspecified date, the patient received and completed both doses of HEPLISAV-B vaccine. On an unspecified date, the patient was noted as not having achieved seroprotection. Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Blood HIV RNA, CD4 lymphocytes increased, Hepatitis B core antibody negative, Hepatitis C
Clinical narrative: Non-Responders to Heplisav-B Vaccination; Initial Report Received on 02-Nov-2021. In a retrospective chart review that was conducted in 2 HIV primary care clinics, Patient is an HIV positive patient, at least 18 years of age, with documented history of HBV vaccination administration prior to November 2017, and negative for both HBsAg and anti-HBs after previous HBV-vaccination.    Baseline laboratories included HIV RNA 55,492, CD 4 count 97 cells/uL, CD 4 17%, negative for anti-HBc and negative HCV co-infection.    On an unspecified date, the patient received and completed both doses of HEPLISAV-B vaccine.    On an unspecified date, the patient was noted as not having achieved seroprotection.  Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Blood HIV RNA below assay limit, CD4 lymphocytes decreased, Hepatitis B, Hepatitis viral test negative
Clinical narrative: In a retrospective chart review that was conducted in 2 HIV primary care clinics, Patient 5, is an HIV positive patient, at least 18 years of age, with documented history of HBV vaccination administration prior to November 2017, and negative for both HBsAg and anti-HBs after previous HBV-vaccination. Baseline laboratories included HIV RNA undetectable, CD 4 count 95 cells/uL, CD 4 8%, negative for anti-HBc and negative HCV co-infection. On an unspecified date, the patient received and completed both doses of HEPLISAV-B vaccine. On an unspecified date, the patient was noted as not having achieved seroprotection. Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Therapy non-responder
Clinical narrative: Non-Responders to Heplisav-B Vaccination; Initial Report Received on 02-Nov-2021  In a retrospective chart review that was conducted in 2 HIV primary care clinics. Patient, is an HIV positive patient, at least 18 years of age, with documented history of HBV vaccination administration prior to November 2017, and negative for both HBsAg and anti-HBs after previous HBV-vaccination.    Baseline laboratories included HIV RNA undetectable, CD 4 count 214 cells/uL, CD 4 14%, positive for anti-HBc and negative HCV co-infection.    On an unspecified date, the patient received and completed both doses of HEPLISAV-B vaccine.    On an unspecified date, the patient was noted as not having achieved seroprotection.  Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Blood HIV RNA, CD4 lymphocytes increased, Hepatitis B core antibody positive, Hepatitis C
Clinical narrative: In a retrospective chart review that was conducted in 2 HIV primary care clinics, Patient 7, is an HIV positive patient, at least 18 years of age, with documented history of HBV vaccination administration prior to November 2017, and negative for both HBsAg and anti-HBs after previous HBV-vaccination. Baseline laboratories included HIV RNA 504 copies/mL, CD 4 count 241 cells/uL, CD 4 15%, negative for anti-HBc and negative HCV co-infection. On an unspecified date, the patient received and completed both doses of HEPLISAV-B vaccine. On an unspecified date, the patient was noted as not having achieved seroprotection. Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Blood HIV RNA below assay limit, CD4 lymphocytes, Hepatitis B core antibody positive, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative
Clinical narrative: Non-Responders to Heplisav-B Vaccination; Initial Report Received on 02-Nov-2021   In a retrospective chart review that was conducted, Patient 8, is an HIV positive patient, at least 18 years of age, with documented history of HBV vaccination administration prior to November 2017, and negative for both HBsAg and anti-HBs after previous HBV-vaccination.    Baseline laboratories included HIV RNA undetectable, CD 4 count 663 cells/uL, CD 4 35%, positive for anti-HBc and negative HCV co-infection.    On an unspecified date, the patient received and completed both doses of HEPLISAV-B vaccine.    On an unspecified date, the patient was noted as not having achieved seroprotection.  Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis C test negative, Therapy non-responder
Clinical narrative: Non-Responders to Heplisav-B Vaccination; Initial Report Received on 02-Nov-2021   In a retrospective chart review that was conducted, Patient 8, is an HIV positive patient, at least 18 years of age, with documented history of HBV vaccination administration prior to November 2017, and negative for both HBsAg and anti-HBs after previous HBV-vaccination.    Baseline laboratories included HIV RNA undetectable, CD 4 count 663 cells/uL, CD 4 35%, positive for anti-HBc and negative HCV co-infection.    On an unspecified date, the patient received and completed both doses of HEPLISAV-B vaccine.    On an unspecified date, the patient was noted as not having achieved seroprotection.  Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Blood HIV RNA below assay limit, CD4 lymphocytes decreased, Hepatitis B, Hepatitis viral test negative
Clinical narrative: In a retrospective chart review that was conducted in 2 HIV primary care clinics, Patient 9, is an HIV positive patient, at least 18 years of age, with documented history of HBV vaccination administration prior to November 2017, and negative for both HBsAg and anti-HBs after previous HBV-vaccination. Baseline laboratories included HIV RNA undetectable, CD 4 count 228 cells/uL, CD 4 24%, positive for anti-HBc and positive for HCV co-infection. On an unspecified date, the patient received and completed both doses of HEPLISAV-B vaccine. On an unspecified date, the patient was noted as not having achieved seroprotection. Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: got shingles; 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 Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's neighbor. The age at vaccination was not reported. The patient got the Shingles shot and immediately got the shingles. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash macular, Vaccination failure
Clinical narrative: had the Shingles vacc but still got Shingles/ Suspected vaccination failure; shingles; spots; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, spot-like rash and pain. The patient was treated with origanum vulgare oil (Oregano Oil). On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the spot-like rash and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, spot-like rash and pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter stated that, the patient had the Shingles vaccine but still got Shingles. Oregano oil was put on the spots and it took the pain away and dried up the spots. Follow up was not possible as no contact details were provided. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via Regulatory Authority and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had the 2 shots Shingles vaccine and had shingles. The reporter said shingles could happen even if you have had the vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Consciousness fluctuating, Herpes zoster, Loss of consciousness, Seizure, Vaccination failure
Clinical narrative: shots that don't prevent you from getting shingles/Suspected vaccination failure; severe shingles, was hospitalized, from esophagus to stomach; seizures; going in and out of consciousness.; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), seizure (serious criteria GSK medically significant and life threatening), loss of consciousness (serious criteria GSK medically significant and life threatening) and shingles (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure, seizure, loss of consciousness and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, seizure, loss of consciousness and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's child. The age at vaccination was not reported. The patient received shingles vaccine and the shot almost killed the patient. he ended up in emergency room had seizures and was going in and out of consciousness. The patient also had severe cases of shingles and he was hospitalized four times. The shingles went down to his esophagus into his stomach. The reporter stated that stop pushing the poison shots that did not even prevent from shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms for 48 hours; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in high school was not a fun time).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient said beware the 2nd shot, he/she had flu like symptoms for 48 hours. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shingle shot, still got shingles/ Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she got the shingle shot and still got shingles. The reporter also stated that you could still get shingles with the shot. Emergency room doctor told him/her that it was like getting the vaccine not getting Covid which you could still get with the shot. Follow up was not possible as no contact details were provided. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, FLU3, HEP, HEPA, MENB, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: were exposed to 30.2F for about 1h; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2021, the patient received FluLaval Tetra 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix, Menveo, Bexsero, Bexsero Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Havrix, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix, Menveo, Bexsero, Bexsero Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Havrix, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, had a freezing temperature excursion that affected their vaccines. The vaccines were exposed to 30.2 Fahrenheit for about 1hour and the reporter did not know if the vaccines were administered after that excursion. The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: received Flulaval incorrectly stored at -0.1C.; This case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage 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 reported as follows: Age at vaccination was not applicable for this report. The reporter stated that about 44 patients were administered with Flulaval which was incorrectly stored at minus 0.1c. No symptoms reported. The reporter did not have any patient/vaccination details at the time of report. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only adjuvant portion; received only adjuvant portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number D4PA4, expiry date 10th February 2023) for prophylaxis.   On 18th November 2021, the patient received Shingrix. On 18th November 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The registered nurse reported that a patient received only adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not specify if it was 1st dose or 2nd dose of Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Oct2020, never received second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 95-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on October 2020, at a clinic).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient's daughter. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter wished to know if the patient needed to restart the series or just get the second dose.  The patient would schedule an appointment for a second dose now. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 12 months ago, failed to receive the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 12 months ago on an unknown date, via unknown route in unknown injection site).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient failed to return within the recommended time frame to receive the second dose, which led to incomplete course of vaccination. This case was linked with case US2021239191, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021239191:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 18-24 months ago. Second not yet received.; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose between 18 to 24 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 provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: TDAP
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 patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th November 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 19th November 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received expired dose of Boostrix vaccine, which led to expired vaccine used. The reporter did not provide more details. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only given the liquid portion of Menveo; only given the liquid portion of Menveo; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA466A, expiry date 31st March 2022) for prophylaxis.   On 18th November 2021, the patient received Menveo. On 18th November 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received only the liquid portion of Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, a correct reconstituted Menveo vaccines was given on the day of reporting. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 52R7X, expiry date 10th October 2021) for prophylaxis.   On 19th November 2021, the patient received Shingrix. On 19th November 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received expired dose of Shingrix on the day of reporting, which led to expired vaccine used. No other symptoms noted by patient. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report was received from literature: This report concerned a female of an unspecified age, race and ethnic origin. The objective of this study was to describe people with diseases or treatments that suppressed their immune system cannot count on the same protection most vaccinated people had. The patient's height, and weight were not reported. The patient had a rare concurrent condition, mucous membrane pemphigoid, which causes blistering of the gums and other areas. The patient was previously treated with the the steroid prednisone (drug used for unknown indication) in the past. She initially received two doses of the Pfizer vaccine (BNT 162) for prophylactic vaccination, but an antibody test revealed she had no response.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and expiry: unknown) dose, start therapy date were not reported, 1 total was administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included mycophenolate mofetil, an immunosuppressant drug often prescribed for organ transplant recipients. On an unspecified date, the patient again underwent antibody test which was negative. So, later she got three Moderna doses, after which she finally achieved a response similar to healthy people who have had two doses. The whole process lasted for six months. She quoted that "Her ordeal had contributed to approval of boosters for everyone but especially for immunocompromised people, boosters work and are needed!" The author emphasized on the awareness that must be created on how immunocompromised people without strong vaccine protection, are coping with Covid. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211124463-Covid-19 vaccine ad26.cov2.s-Suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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: U
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: TRANSVERSE MYELITIS; This spontaneous report received from a patient via another manufacturer concerned multiple patients. The patient's weight, height, age and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose, start therapy date were not reported for an unspecified indication. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced transverse myelitis (spinal inflammation).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of transverse myelitis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient via another manufacturer concerned a patient who experienced transverse myelitis on an unspecified date after receiving the vaccine. Medical history, concomitant medications, laboratory results, diagnostics, treatment, and outcome were not reported. Information is limited in this case, and the occurrence of transverse myelitis could represent background incidence of such events in the general population. Therefore, the relationship of transverse myelitis to vaccination is considered unclassifiable due to insufficient information.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: PEOPLE HAVE SERIOUS SIDE EFFECTS; This spontaneous report received from a consumer via a company representative via social media concerned a multiple patients of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced people have serious side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of people have serious side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20211143081.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: SEVERE NEUROPATHY IN ALL HER LIMBS / VERY DIFFICULT MOBILITY; This spontaneous report received from a patient via a company representative via concerned a 40 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose, start therapy date- and end date were not reported. Frequency time of 01 total was administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced severe neuropathy in all her limbs and very difficult mobility after injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe neuropathy in all her limbs/ very difficult mobility was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211143298-COVID-19 VACCINE AD26.COV2.S-Severe neuropathy in all her limbs/ very difficult mobility. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: PRETTY BIG HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced pretty big headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pretty big headache and nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient 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, and batch number were not reported) dose was not reported, administered on MAR-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 18-NOV-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000203158.           .; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: TERRIBLE HEADACHE; This spontaneous report received from a patient concerned a 56 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: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the patient experienced terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible headache on 15-APR-2021. This report was non-serious. This case, involving the same patient is linked to 20211145086. This case, from the same reporter is linked to 20211145488, 20211145086 and 20211144980.
Sex: U
Vaccine: COVID19
Symptoms: Feelings of worthlessness, Musculoskeletal pain
Clinical narrative: KICKED MY BUTT BADLY FOR 12 HOURS; FELT LIKE GARBAGE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-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 APR-2021, the patient experienced kicked my butt badly for 12 hours. On APR-2021, the patient experienced felt like garbage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from kicked my butt badly for 12 hours, and felt like garbage. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, COVID-19, Gout
Clinical narrative: PAIN IN LOWER BACK; GOUT IN LEFT KNEE; COVID-19; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. 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 AUG-2021, the patient experienced covid-19. On an unspecified date, the patient experienced pain in lower back, and gout in left knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from covid-19, and had not recovered from pain in lower back, and gout in left knee. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Fatigue, Feeling abnormal, Hypoaesthesia, Laboratory test
Clinical narrative: BRAIN FOG; WEAKNESS IN ARMS AND LEGS; FEELING UNWELL; EXTREME FATIGUE; NUMBNESS IN FACE, HANDS AND LEGS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 14-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-OCT-2021, the patient experienced brain fog. On 19-OCT-2021, the patient experienced weakness in arms and legs. On 19-OCT-2021, the patient experienced feeling unwell. On 19-OCT-2021, the patient experienced extreme fatigue. On 19-OCT-2021, the patient experienced numbness in face, hands and legs. Laboratory data (dates unspecified) included: CT scan (NR: not provided) Not reported, and Laboratory test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain fog, weakness in arms and legs, numbness in face, hands and legs, extreme fatigue, and feeling unwell. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Muscular weakness
Clinical narrative: BRAIN FOG; WEAKNESS IN ARMS AND LEGS; FEELING UNWELL; EXTREME FATIGUE; NUMBNESS IN FACE, HANDS AND LEGS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 14-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-OCT-2021, the patient experienced brain fog. On 19-OCT-2021, the patient experienced weakness in arms and legs. On 19-OCT-2021, the patient experienced feeling unwell. On 19-OCT-2021, the patient experienced extreme fatigue. On 19-OCT-2021, the patient experienced numbness in face, hands and legs. Laboratory data (dates unspecified) included: CT scan (NR: not provided) Not reported, and Laboratory test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain fog, weakness in arms and legs, numbness in face, hands and legs, extreme fatigue, and feeling unwell. This report was non-serious.