chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: lost her twin nephews due to a severe side effect; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "lost her twin nephews due to a severe side effect". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The reporter specified that she lost her twin nephews due to a severe side effect and a heart attack after getting the vaccine and her niece got a severe illness from taking bad shots of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300039512 same reporter, drug and different patient, event;US-PFIZER INC-PV202300017123 same reporter, drug and different patient, event;; Reported Cause(s) of Death: lost her twin nephews due to a severe side effect
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: inadvertently administered a 3-year-old patient who was supposed to receiving the first dose in the primary series, with a dose of the booster vaccine; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID:   A 3-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1 (maroon cap; booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "inadvertently administered a 3-year old patient who was supposed to bereceiving the first dose in the primary series, with a dose of the booster vaccine".  Additional information: The reporter (nurse), called regarding the COVID-19 booster; stated that they inadvertently administered a 3-year-old patient who was supposed to be receiving the first dose in the primary series, with a dose of the booster vaccine. The nurse wanted to know if the patient would still need a second dose or if the patient is considered fully vaccinated.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: pulmonary embolisms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "pulmonary embolisms".  Clinical course: covid vaccine almost killed myself, reporter's son and daughter. All 3 of them developed blood clots (pulmonary embolisms) in the same time frame after getting the vaccine. They have all suffered life changing effects and have ongoing medical issues as well as of medical bills. And they were not old and fat and out of shape. In fact, if it hadn't been for being somewhat in shape none of them would have lived through it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia, Pain
Clinical narrative: Arrhythmia; pain and suffering; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ARRHYTHMIA (hospitalization, medically significant), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "pain and suffering". The event "arrhythmia" required physician office visit. Therapeutic measures were taken as a result of arrhythmia.  Clinical course: It was reported that after Sep2022 Pfizer Booster, without company making any public awareness about adverse heart results, in 24Nov the patient was hospitalized at (Hospital Name and Address withheld) with severe Arrhythmia. The patient had been receiving medical care at physician cardiologist clinic (City and State withheld). The patient received legal advice to try to settle that matter directly with the physician. The patient also had suffering and having a life-long consequences, pain and suffering, to name some problems, and might face stroke and/or death: At that point as long as physician treat the patient fairly and with respect the patient would continue dealing with the physician.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria (hives); This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the parent.  An 18-month-old female patient received BNT162b2 (BNT162B2), in 2022 as dose 1 (maroon cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset 2022, 2 weeks after the suspect product(s) administration, outcome "recovered", described as "Urticaria (hives)". The event "urticaria (hives)" required physician office visit. Therapeutic measures were taken as a result of urticaria. Additional information: the reporter said that her 18 month old daughter received the Pfizer-BioNTech covid vaccine (maroon cap) last year and experienced Urticaria (hives) 2 weeks after receiving the 1st dose of the covid vaccine. The reporter took the child to an Allergist that gave to the patient Zyrtec as therapeutic measures to help with the hives but they lasted for 5 months.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Metastatic neoplasm
Clinical narrative: My Uncle was cancer free in Jul, developed stage 4 cancer in most of his organs in Sep and died in Oct.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: METASTATIC NEOPLASM (death, medically significant), outcome "fatal", described as "My Uncle was cancer free in Jul, developed stage 4 cancer in most of his organs in Sep and died in Oct.". The patient date of death was unknown. Reported cause of death: "My Uncle was cancer free in Jul, developed stage 4 cancer in most of his organs in Sep and died in Oct.". It was not reported if an autopsy was performed.  Clinical course: My healthy 45 year old sister-in-law just died a few days before Christmas. She just got your new multi variant booster shot. Cause of death: Unknown. My Uncle was cancer free in Jul, developed stage 4 cancer in most of his organs in Sep and died in Oct. Are you mutating the COVID virus. Really I want to know. What have you people unleashed. This is criminal. We will not take this anymore. You will no longer be able to hide from us. You Are Killing Innocent People.  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.; Reported Cause(s) of Death: My Uncle was cancer free in Jul, developed stage 4 cancer in most of his organs in Sep and died in Oct.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Age 36, pass away on Friday 27Jan2023; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 36-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; manufacturer unknown), for Covid-19 Immunization. The following information was reported: DEATH (death, medically significant) with onset 27Jan2023, outcome "fatal", described as "Age 36, pass away on Friday 27Jan2023". The patient date of death was 27Jan2023. The reported cause of death was unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Age 36, pass away on Friday 27Jan2023
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 26-Jan-2023 regarding an unsolicited valid Social-Media Non-serious case received from a consumer/non-health care professional.  This case involves an unknown age and unknown gender patient who experienced flu  after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In 1984, the patient received a  last dose of suspect Influenza vaccine produced by unknown manufacturer (strength ,dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event Flu (influenza) (unknown latency) following the administration of Influenza vaccine.  It was reported Had 3 Flu shots in my 24 year career 1971/95. Got the flue 3 times once 24 hour once 3 weeks on my back and once put me in the hospital for several days. Last flu shot 1984 last case of flu 1984. Keep your shot, i will stay healthy.  Action taken : Not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 28-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who experienced flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, strength, formulation, expiry date and lot number not reported) via unknown route in unknown administration site for flu.  On an unknown date the patient developed flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered, Medication error, No adverse event, Wrong product administered
Clinical narrative: received an extra dose DTap in error with no reported adverse event; prescribed IPV but instead were given the combo vaccine QUADRACEL with no reported adverse event; Initial information received on 26-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case US-SA-2023SA033514.  This case involves a 4 years old female patient who received an extra dose DTAP in error with no reported adverse event and was prescribed IPV but instead were given the combo vaccine diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar RA 27/3), varicella zoster vaccine live (oka/merck) (Proquad) for Immunisation.  On 24-Jan-2023, the patient received a dose of 0.5 ml suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (Suspension for injection) (lot: U7526AA; expiry date: 07-Sep-2024; strength: standard) via intramuscular route in the left thigh for immunization.  On 24-Jan-2023 the patient received an extra dose of DTAP in error with no reported adverse event (extra dose administered) and was prescribed IPV but instead were given the combo vaccine diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (Quadracel) with no reported adverse event (wrong product administered) (latency: same day).   Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: received an extra dose DTap in error with no reported adverse event; twins were prescribed IPV but instead were given the combo vaccine QUADRACEL with no reported adverse event; Initial information received on 26-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient who received an extra dose dtap in error with no reported adverse event and twins were prescribed IPV but instead were given the combo diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (PROQUAD) for Immunisation.  On 24-Jan-2023, the patient received 0.5 dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, Suspension for injection, at 1X (once), (lot number: U7526AA: expiry date: 07-Sep-2024) via intramuscular route in the left thigh for immunisation.  On 24-Jan-2023 the patient received an extra dose dtap in error with no reported adverse event (extra dose administered) and twins were prescribed ipv but instead were given the combo vaccine quadracel with no reported adverse event (wrong product administered) (latency: same day) following the administration of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for all events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 80.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Tenivac was administered with no reported adverse event; Initial information received on 27-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 80 years old female patient who was administered with expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Jan-2023, the patient received 0.5 ml total dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult suspension for injection (Strength: Standard; lot number: U6922AA, expiry date: 22-Jan-2023, frequency: once) via intramuscular route in the right deltoid for immunization.  On 26-Jan-2023, the patient was administered with expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  It was reported Caller reported an expired dose of TENIVAC was administered and is requesting validity and safety information.  At time of reporting, the outcome was Unknown for the event expired dose of tenivac was administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: a vaccine expired on 22-Jan-2023 was administered to patient on 26-Jan-2023 with no reported AE; Initial information received on 27-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of unknown age and gender who was administered expired vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] on 26-jan-2023 with expiry date 22-jan-2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Jan-2023, the patient received an unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (expiry date: 22-jan-2023) (Suspension for injection) (lot number; strength not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 26-Jan-2023 the patient was administered expired vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with expiry date 22-jan-2023 with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 40.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of TENIVAC was administered with no reported adverse event; Initial information received on 27-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 40 years old male patient who was administered expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Jan-2023, the patient received a 0.5 ml dose of expired suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT with no adverse event (frequency: once, strength: standard, expiry date: 22-Jan-2023 and lot U6922AA) via intramuscular route in the left deltoid as Immunization (expired product administered).  Action taken: not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Hypersensitivity, Rash, Urticaria
Clinical narrative: allergic reaction; rash on knee and up, in upper arms/ getting worse in legs and arms; went to hospital/ Hives as a reaction to vaccine; feel bad; body was hot; I felt cold,; I could not sleep well; This case was reported by a consumer and described the occurrence of allergic reaction in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number T5X9N, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included fexofenadine hydrochloride (Allegra) for feeling hot.   On 20th January 2023, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In January 2023, the patient started Allegra at an unknown dose and frequency. In January 2023, less than a day after receiving Shingrix, the patient experienced sleep disturbance. On 20th January 2023, the patient experienced feeling bad, feeling hot and feeling cold. On 21st January 2023, the patient experienced allergic reaction, rash and hives. On an unknown date, the outcome of the allergic reaction, feeling hot, rash and hives were not recovered/not resolved and the outcome of the feeling bad, feeling cold and sleep disturbance were unknown.   It was unknown if the reporter considered the allergic reaction, feeling bad, feeling hot, feeling cold, sleep disturbance and rash to be related to Shingrix. The reporter considered the hives to be related to Shingrix.     Additional Information: GSK Receipt date: 22-JAN-2023, 23-JAN-2023 Reporter comment: The reporter reported that, the patient received 1st shingrix vaccine it was done on the morning and approximately after 5 to 6 hours later she started to feel bad, her body was kind hot, but she felt cold, she did not have a fever. she could not sleep well that night. The patient took Allegra midnight, but it did not help her to reduce the heat in body.  On the next morning she had a rash around her right knee and up, also in both upper arms. The patient took Benadryl , but the rash was getting worse in both her legs and arms.  Looks like it was a Hives, sometimes patient have Hives and know how it looks, Benadryl usually helps her but not in this time, so she decided to go to the Hospital in case it is something else and she will become worse at night.  It was a Hives as a reaction on this vaccine.  The patient need to know what kind of medicine is in vaccine gave her allergic reaction, so please send her the list of ingredients patient received with this first shot of vaccine.  The patient stated that, this is very important for her to know. may be you can give me some idea why she had a Hives, what caused it. The reporter consented to follow up. Note: Co-suspect products included Benadryl was not coded as suspect in product tab because it contain NOS hence only mention in narrative.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin test negative
Clinical narrative: Painful rash on her face; This case was reported by a consumer via call center representative and described the occurrence of painful rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received the 2nd dose of Shingrix (intramuscular). In April 2022, 3 days after receiving Shingrix, the patient experienced painful rash. The patient was treated with prednisone. On an unknown date, the outcome of the painful rash was not recovered/not resolved.   It was unknown if the reporter considered the painful rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-JAN-2023 Reporter's comments: The reporter was the patient. She had received her second Shingrix dose via intramuscular route in April 2022. Three days later, she had developed a painful rash on the right side of her face. She had seen three physician, but the cause of rash was unknown.  She had skin scrapings done but they were negative. Three days earlier before the time of reporting, she had completed a three week course of prednisone and the rash improved but was now back again. Nothing else was reported. The reporter did not consent to follow-up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Itch a little bit; Rash of 8 inches in left arm toward  elbow; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number HE4P7, expiry date 25th January 2024) for prophylaxis.   On 4th November 2022, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pruritus and rash. On an unknown date, the outcome of the pruritus and rash were recovered/resolved.   It was unknown if the reporter considered the pruritus and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-JAN-2023 Reporter's comments: The Healthcare Professional (HCP) had called up to report that a patient received the 1st dose of Shingrix vaccine in her left arm, and got a rash that was about 8 inches long that went down her arm toward her elbow, and itched a little bit. The rash went away a week later. The reporter did not consent to follow-up.
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Patient fainted after Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of faint in a female patient who received Men B NVS (Bexsero) (batch number TP294, expiry date 31st October 2024) 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 faint (serious criteria GSK medically significant). On an unknown date, the outcome of the faint was unknown.   It was unknown if the reporter considered the faint to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's comments: A medical assistant had reported that the patient fainted after a Bexsero vaccine administration. The reporter had consented to follow-up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever, nausea, chills, sore arm
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Healthcare provider reports the administration of an expired dose of VAQTA to a patient on 27-JAN-2023.; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. Patient's pertinent medical history, drug reactions and allergies and concomitant medication were unknown by reporter.  On 27-JAN-2023, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA), intramuscular injection, administered as prophylaxis, (dose, strength, route of administration, and anatomical location were not provided; lot number U021561 had been verified to be a valid number; expiration date was reported and established as 14-JAN-2023) (expired vaccine used).  No additional adverse event reported.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Influenza like illness
Clinical narrative: flu like side effects; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid with an associated reaction of influenza like illness.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   The reporter considered the influenza-like symptoms to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-Jan-2023 and 25-Jan-2023 Reporter's Comments: The patient received the first shot 3 years ago. The patient experienced flu like side effects from the vaccine. She also she stated that she had flu-like symptoms with her first dose in 2020. The patient experienced same side effects from all the Covid shots and boosters. So, the patient kept putting off getting second dose of Shingrix shot. Now, the patient had like to get it, but wonder if it could just get the second dose, or if it could start the series over again and get the 2 shots several months apart. The patient was concerned that the vaccine would not be effective with shots space of 3 years apart. This case had been linked with US2023011253 same reporter.; Sender's Comments:  US-GSK-US2023011253:Same reporter
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness at the injection site.; Swelling at the injection site.; Pain at the injection site.; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th January 2023, the patient received Shingrix (intramuscular). On 20th January 2023, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to Shingrix.     Additional Information: GSK receipt date: 23 Jan 2023 Reporters comment: The reporter stated that the patient received the Shingrix vaccine on 19th January 2023 the following day she started feeling redness, swelling and pain at the injection site that is going away with ice pack.  Education provided on side effects. Patient refused to provide consent to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Headache, Impaired work ability
Clinical narrative: due to symptoms was not able to work, too weak; headache; shoulder pain, shoulder pain in the shoulder; arm where he got the shot; chills; body pain; weakness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2023, the patient received the 1st dose of Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced headache, shoulder pain, pain in arm, chills, general body pain and weakness. On 25th January 2023, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the headache, shoulder pain, pain in arm, chills, general body pain, weakness and activities of daily living impaired were not recovered/not resolved.   The reporter considered the headache, shoulder pain, pain in arm, chills, general body pain, weakness and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comments: The reporter was the wife of patient. She reported that her husband received shot of Shingrix and was not able to go to work on the day of reporting due to his symptoms.  The patient experienced headache, shoulder pain in the shoulder or arm where he got the shot, chills, body pain, weakness (too weak to go to work). These events were not resolved.  No further questions asked such as lot number, route of administration or contact information due to the difficulty of accuracy of using a translator.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: due to symptoms was not able to work, too weak; headache; shoulder pain, shoulder pain in the shoulder; arm where he got the shot; chills; body pain; weakness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2023, the patient received the 1st dose of Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced headache, shoulder pain, pain in arm, chills, general body pain and weakness. On 25th January 2023, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the headache, shoulder pain, pain in arm, chills, general body pain, weakness and activities of daily living impaired were not recovered/not resolved.   The reporter considered the headache, shoulder pain, pain in arm, chills, general body pain, weakness and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comments: The reporter was the wife of patient. She reported that her husband received shot of Shingrix and was not able to go to work on the day of reporting due to his symptoms.  The patient experienced headache, shoulder pain in the shoulder or arm where he got the shot, chills, body pain, weakness (too weak to go to work). These events were not resolved.  No further questions asked such as lot number, route of administration or contact information due to the difficulty of accuracy of using a translator.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: active case of Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2022, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt date: 25-Jan-2023. Reporter's Comment: The patient self-reported this case. The patient received Shingrix on left arm. The patient stated that she had an active case of Shingles (lack of effect). The reporter consented to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Adrenal insufficiency, Haemorrhage, Narcolepsy, Parkinson's disease, Sleep apnoea syndrome
Clinical narrative: PARKINSON'S DISEASE; BLEEDING; NARCOLEPSY; ADRENAL INSUFFICIENCY; BLOOD CLOTS; SLEEP APNEA; This spontaneous report received from a patient via a company representative concerned a 50 year old of unspecified sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total for covid-19 prophylaxis. 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 was severely vaccine injured and experienced Parkinson's disease, bleeding, narcolepsy, adrenal insufficiency, blood clots, sleep apnea, and dysautonomia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bleeding, narcolepsy, sleep apnea, adrenal insufficiency, blood clots and Parkinson's disease was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20230160590- Parkinson's disease, bleeding, narcolepsy, adrenal insufficiency.  The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  V0:20230160590- Blood Clots. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: PARKINSON'S DISEASE; BLEEDING; NARCOLEPSY; ADRENAL INSUFFICIENCY; BLOOD CLOTS; SLEEP APNEA; This spontaneous report received from a patient via a company representative concerned a 50 year old of unspecified sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total for covid-19 prophylaxis. 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 was severely vaccine injured and experienced Parkinson's disease, bleeding, narcolepsy, adrenal insufficiency, blood clots, sleep apnea, and dysautonomia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bleeding, narcolepsy, sleep apnea, adrenal insufficiency, blood clots and Parkinson's disease was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20230160590- Parkinson's disease, bleeding, narcolepsy, adrenal insufficiency.  The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  V0:20230160590- Blood Clots. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medications details were reported.  Patient received vaccine at Pharmacy.  Beyond use date of the vaccine was 01-Jul-2021.  No treatment medications details were reported.  NDC number was reported as 80777-273-10.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received wherein patient and vaccination details added. Case narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medications details were reported.  Patient received vaccine at Pharmacy.  Beyond use date of the vaccine was 01-Jul-2021.  No treatment medications details were reported.  NDC number was reported as 80777-273-10.    This case was linked to MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received wherein patient and vaccination details added. Case narrative updated.; Sender's Comments:  MODERNATX, INC.-MOD-2023-704416:Master case
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: just administered the diluent portion of the ACTHIB without reconstituting it with the lyophilized vaccine component with no reported adverse event; Initial information received on 27-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 months old female patient who was just administered the diluent portion of the HIB (PRP/T) Vaccine [ACT-HIB] without reconstituting it with the lyophilized vaccine component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Jan-2023, the patient received a 0.6 ml dose of suspect diluent portion of the HIB (PRP/T) Vaccine without reconstituting it with the lyophilized vaccine component with no reported adverse event (product preparation issue) (Powder and solvent for solution for injection) (lot UJ677AAB, Expiry date: 07-Apr-2023 with strength unknown) via intramuscular route in the left thigh for immunization.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.