chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Poor quality product administered, Product administration error
Clinical narrative: When they filled the needle in the vial, it was left off for four days laying underneath the box; When they filled the needle in the vial, it was left off for four days laying underneath the box; Sore arm; Feeling tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2022 (Lot number: FK9896, Expiration Date: 30Jun2022) at the age of 75 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing), notes: Bronchitis; "High cholesterol" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Pneumonia" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure; "Acid Reflux" (unspecified if ongoing); "Herniated Slipped disk" (unspecified if ongoing), notes: Herniated Slipped disk; "COVID" (unspecified if ongoing), notes: COVID; "Pain" (unspecified if ongoing). Concomitant medication(s) included: ALPRAZOLAM; OXYBUTYNIN; FUROSEMIDE; LISINOPRIL; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; MONTELUKAST; CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN; SIMVASTATIN; TYLENOL taken for pain; METOPROLOL; ESOMEPRAZOLE MAGNESIUM. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2022, outcome "recovered" (Mar2022), described as "Sore arm"; FATIGUE (non-serious) with onset Mar2022, outcome "unknown", described as "Feeling tired"; PRODUCT ADMINISTRATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 04Mar2022, outcome "unknown" and all described as "When they filled the needle in the vial, it was left off for four days laying underneath the box". Therapeutic measures were not taken as a result of pain in extremity.  Follow-Up (29Mar2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug interaction, Weight, Weight increased
Clinical narrative: been taking antidepressants and antipsychotics, but after receiving the vaccine, her medications had stopped working.; gained 10 pounds; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications.  The following information was reported: DRUG INTERACTION (non-serious), outcome "unknown", described as "been taking antidepressants and antipsychotics, but after receiving the vaccine, her medications had stopped working."; WEIGHT INCREASED (non-serious), outcome "unknown", described as "gained 10 pounds". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated that when she received the 2nd dose of the Pfizer-BioNTech Covid 19 Vaccine, her left shoulder got frozen and had a muscle spasm, so she went to the doctor to receive a steroid injection to relief her pain. She wanted to know if this should be reported as an adverse event.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizures after taking a shot from your company; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: SEIZURE (medically significant) with onset 2021, outcome "unknown", described as "seizures after taking a shot from your company".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Drug ineffective, Joint swelling, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; Condition aggravated; Swollen wrists; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4325824-00.  A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 07Sep2021 (Batch/Lot number: unknown) at the age of 56 years as dose 2, single and intramuscular, administration date 27Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Condition aggravated"; JOINT SWELLING (non-serious), outcome "unknown", described as "Swollen wrists". The action taken for upadacitinib was dosage permanently withdrawn. On unknown dates, the patient experienced Flare Up, Swollen Wrist and Covid.  Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of the [Condition aggravated, Joint swelling)with the suspect product was not provided at the time of this report. Since no determination has been received and (Covid-19) with the suspect product was provided at the time of this report. based on the company causality assessment.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid positive; covid positive; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2022 (Batch/Lot number: unknown) as dose 4 (booster), single, (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and administration date Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "heart condition" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Mar2022, outcome "unknown" and all described as "covid positive". The event "covid positive" and "covid positive" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Mar2022) positive. The patient reported that as of this morning (28Mar2022) she is covid positive and is currently in the ER to be examined for potential monoclonal infusion.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Nasopharyngitis
Clinical narrative: he has a cold; This is a spontaneous report received from contactable reporter (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 57 year-old male patient received tofacitinib citrate (XELJANZ XR), oral since 03Nov2021 (ongoing) (Batch/Lot number: unknown) at 11 mg 1x/day for rheumatoid arthritis; COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "he has a cold". The action taken for tofacitinib citrate was dosage not changed. Additional information: The patient reports he has a cold. He had his coronavirus vaccine and booster so he thinks it is just a cold. He called his doctor for appointment regarding cold symptoms. He is scheduled for surgery on Thursday, (unknown-patient stated it is not related to arthritis) no additional information or specific symptoms were provided. MD aware.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Pyrexia
Clinical narrative: fevers; body aches; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 60 year-old female patient received tofacitinib citrate (XELJANZ XR), oral since 2016 (ongoing) (Batch/Lot number: unknown) at 11 mg daily for rheumatoid arthritis; bnt162b2 (BNT162B2), administration date Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster),single for covid-19 immunisation. Relevant medical history included: "discouraged/depressed" (ongoing); "discouraged/depressed" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 2022, outcome "recovered" (2022), described as "fevers"; PAIN (non-serious) with onset 2022, outcome "recovered" (2022), described as "body aches". The action taken for tofacitinib citrate was dosage not changed. The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: Patient reported she was sick following COVID booster Jan2022. symptoms included fevers and body aches that lasted 8 days, md aware. patient previously reported that rheumatoid arthritis symptoms had worsened following a break in therapy from Nov20221 to 12Feb2022. She reports that symptoms have now improved and are "much better". patient responds "generally agree" with statement "generally it's been hard to cope with rheumatoid arthritis and sometimes i feel discouraged/depressed,"- started prior to start of therapy and has not changed. patient reports she missed Xeljanz dose one day in 2021 due to forgetting to refill and running out of medication - unknown if there was an adverse event following this missed dose. advised to update md with new/worse symptoms.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: injection site redness; injection site pain; lump at the site; more redness today and it is still there but was worse on Sunday; Initial information received on 21-Mar-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 50 years old female patient who experienced injection site redness, injection site pain and lump at the site while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Mar-2022, the patient received a dose of 0.5 ml injection of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (batch lot: U7187AA)(expiry date :28-Sep-2023) via intramuscular route in the left arm for immunization.  On 19-MAR-2022 (latency :1 day) the patient developed non-serious events of injection site redness (vaccination site erythema) injection site pain (vaccination site pain),lump at the site (vaccination site mass) more redness today and it is still there but was worse on Sunday (condition aggravated) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken : not applicable.  The patient was treated with Ibuprofen.  At time of reporting, the outcome was Unknown for all the events.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of PENTACEL was inadvertently administered to a patient with no reported adverse event; Initial information received on 21-Mar-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 1 years old female patient had expired dose of pentacel was inadvertently administered to a patient with no reported adverse event while receiving vaccine Diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for Immunisation.  On 21-Mar-2022, the patient received a  dose of 0.5 ml (millilitre) suspect Diphtheria/tetanus/5 hybrid ac pertussis/IPV(mrc5)/HIB(PRP/T) vaccine Suspension for injection (strength: unknown)  lot UJ414AAA via intramuscular route in unknown administration site for prophylactic vaccination.  On 21-MAR-2022 the expired dose of pentacel was inadvertently administered to a patient with no reported adverse event (expired product administered) (latency: same day) following the administration of Diphtheria/tetanus/5 hybrid ac pertussis/IPV(mrc5)/HIB(PRP/T) vaccine.  Action taken was not applicable.  At time of reporting, the outcome was 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: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event, Product preparation issue
Clinical narrative: patient received an ACT-HIB vaccine on 08MAR2022 that contained a diluent which had expired on 07MAR2022, vaccine portion in the single-dose vial was not expired but the diluent with no reported adverse event; patient received an ACT-HIB vaccine on 08MAR2022 that contained a diluent which had expired on 07MAR2022, vaccine portion in the single-dose vial was not expired but the diluent with no reported adverse event; Initial information received on 23-Mar-2022 regarding an Unsolicited valid non-serious case received from a other health professional.  This case involves a 1-year-old female patient received HIB (PRP/T) VACCINE [ACT-HIB] vaccine on 08-Mar-2022 that contained a diluent which had expired on 07-Mar-2022, vaccine portion in the single-dose vial was not expired but the diluent 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) with Lot number UJ423AA with an expiration date 20-May-2022 for Prophylactic vaccination.  On 08-Mar-2022, the patient received a 4th dose of suspect HIB (PRP/T) VACCINE at a dose of 0.5 ml via intramuscular route in the left thigh with Lot number UJ423AAA ,Expiry date: 07-Mar-2022) for Immunization.  On 08-Mar-2022, the patient developed a non-serious event patient received an act-hib vaccine on 08mar2022 that contained a diluent which had expired on 07mar2022, vaccine portion in the single-dose vial was not expired but the diluent with no reported adverse event (product preparation issue)(Expired product administered) following the administration of HIB (PRP/T) VACCINE.  Action taken: Not applicable.  Outcome: Recovered on 08-Mar-2022.  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: 3.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: not able to reconstitute the hib portion to the liquid portion with no reported adverse event; Initial information received on 25-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 36 months old male patient that reported not able to reconstitute the hib portion to the liquid portion with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 25-Mar-2022, the patient received a dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine(formulation and Strength:unknown) a dose of 0.5ml(millilitre) (lot U7054AA and expiry date: 18-dec-2022) via intramuscular route in the left thigh for immunization.  On an unknown date, the patient reported not able to reconstitute the hib portion to the liquid portion with no reported adverse event (product preparation issue) (unknown latency) following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine  It was reported "Pentacel vaccine need to be repeated as the liquid portion (DTAP -IPV) component was the only one administered to a pediatric patient and they were not able to reconstitute the hib portion to the liquid portion".  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event product preparation issue.    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: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered expired daptacel to a patient yesterday, expiration date of the product was 11 MAR 2022, with no adverse event; Initial information received on 25-Mar-2022 regarding an unsolicited valid non-serious case was received from other health professional.  This case involves a 4 month old male patient who was administered expired diphtheria-15/tetanus/5 ac pertussis vaccine (Daptacel) yesterday, expiration date of the product was 11-mar-2022, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Mar-2022, the patient received a 0.5 ml dose once of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (lot C5706BA, expiry date: 11-Mar-2022) via intramuscular route in unknown administration site for immunisation.  It was reported that the patient was administered expired diphtheria-15/tetanus/5 ac pertussis vaccine yesterday, expiration date of the product was 11-mar-2022, with no adverse event (expired product administered, latency: same day).   Action taken with diphtheria, tetanus and acellular pertussis vaccine (Daptacel) was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered expired daptacel to a patient yesterday, expiration date of the product was 11 MAR 2022, with no adverse event).  At time of reporting, the outcome was Unknown for the event administered expired daptacel to a patient yesterday, expiration date of the product was 11 mar 2022, with no 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.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Physician reported that a patient inadvertently received an extra dose of menactra. The patient received the first dose on 15-Nov-2021 and a second dose on 28-Mar-2022 with no reported adverse event; Initial information received on 28-Mar-2022 regarding an unsolicited valid non-serious case received from a physician.   This case involves a 11-year-old male patient who received an extra dose of meningococcal A-C-Y-W135 (D conj) vaccine [Menactra]. The patient received the first dose on 15-nov-2021 and a second dose on 28-mar-2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Nov-2021, the patient received a dose Menactra (strength, route, formulation, lot number, expiry date, administration site: unknown). On 28-Mar-2022 he received a extra dose of 0.5 ml total once a day of the same vaccine (strength, formulation, expiry date, administration site: unknown) lot U7208AB via intramuscular route for prophylactic vaccination.  On 28-Mar-2022 physician reported that  patient inadvertently received an extra dose of menactra (extra dose administered) (Latency: same day) after 4 months 13 days approximately of first dose of Menactra. The caller reported that there have been no adverse effects since it was administered on 15-Nov-2022 and 28-Mar-2022.  Action taken was not applicable  Outcome was 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 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: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Physiotherapy
Clinical narrative: Episode of Guillain-Barre Syndrome; This literature case was received on 21-Mar-2022 and concerned a male patient of an unspecified age. At the time of this report, the patient was 71-year-old.   The aim of this case report was to weight the risks and benefits of SARS-CoV-2 vaccinations in patient with a previous history of Guillain-Barre syndrome (GBS) post-influenza vaccination and to determine the safety of SARS-CoV-2 administration.  The patient's medical history and concomitant medications were not reported.   On an unspecified date, several years ago as reported, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; route of administration, anatomical location, dose and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced an episode of Guillain-Barre syndrome (GBS) and had physiotherapy.   On an unspecified date, the patient recovered from the event of Guillain-Barre syndrome.   The reporter assessed the event as related to influenza virus vaccine polyvalent. The patient had an episode of Guillain-Barre syndrome temporary related to influenza vaccination.  The event of Guillain-Barre syndrome was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.    Company comment: A male patient of unspecified age experienced an episode of Guillain-Barré syndrome (GBS) after receiving influenza virus vaccine polyvalent. Elapsed time between vaccination and the onset of the event is unknown. Due to this lack of information regarding chronology, causality is unassessable. Agency criteria for GBS could not be assessed due to insufficient information.; Reporter's Comments: The patient had an episode of Guillain-Barre syndrome temporary related to influenza vaccination.; Sender's Comments: A male patient of unspecified age experienced an episode of Guillain-Barré syndrome (GBS) after receiving influenza virus vaccine polyvalent. Elapsed time between vaccination and the onset of the event is unknown. Due to this lack of information regarding chronology, causality is unassessable. Agency criteria for GBS could not be assessed due to insufficient information.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles again/Suspected vaccination failure; Shingles again; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 25-Mar-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient received the 2nd dose of Shingrix in mid-January 2022 and on 19th March 2022 got Shingles again. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: STILL GOT THEM/Suspected vaccination failure; STILL GOT THEM; This case was reported by a consumer via interactive digital media and described the occurrence of 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 Information: GSK Receipt Date: 27-Mar-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient stated he/she had the Shingles shots and still got shingles. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. 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. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot and has the shingles/Suspected vaccination failure; She has the shingles just terrible; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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 Information: GSK Receipt Date: 28-Mar-2022 Reporter's Comments:  This case was received from patient's cousin via interactive digital media. The patient got Shingle vaccine and still had shingles and it was just terrible. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Never went back for the second dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-MAR-2022 Reporter's Comment: The patient's daughter/son reported this case via interactive digital media. The patient never went back for the 2nd dose of Shingles vaccine. Additional supportive information:  Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Illness, Pyrexia
Clinical narrative: SICK; FEVER; THROWING UP; MASSIVE HEADACHE; FATIGUE; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sick, fever, throwing up, massive headache, and fatigue. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103, 101.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throwing up, was recovering from fever, had not recovered from massive headache, and fatigue, and the outcome of sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: SICK; FEVER; THROWING UP; MASSIVE HEADACHE; FATIGUE; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sick, fever, throwing up, massive headache, and fatigue. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103, 101.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throwing up, was recovering from fever, had not recovered from massive headache, and fatigue, and the outcome of sick was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain with the previous 3 doses; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain with the previous 3 doses) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain with the previous 3 doses). At the time of the report, PAIN IN EXTREMITY (Arm pain with the previous 3 doses) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No information on concomitant medication was reported. The patient received full dose for 1st two doses. No information on treatment medications was reported.   This case was linked to MOD-2022-525602, MOD-2022-525609, MOD-2022-525616 (Patient Link).   Reporter did not allow further contact
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 16-Mar-2022; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 16-Mar-2022) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 16-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 16-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that date the vial was initially stored in the refrigerator was on 31-Jan-2022. The vial did not undergo any temperature excursions.  No treatment medications were reported.   This case was linked to MOD-2022-525860 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The patient received a dose from the vials which are initially stored in refrigerator on 07-Mar-2022 and administered on 24-Mar-2022; The patient received a dose from the vials which are initially stored in refrigerator on 07-Mar-2022 and administered on 24-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from the vials which are initially stored in refrigerator on 07-Mar-2022 and administered on 24-Mar-2022) and PRODUCT STORAGE ERROR (The patient received a dose from the vials which are initially stored in refrigerator on 07-Mar-2022 and administered on 24-Mar-2022) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from the vials which are initially stored in refrigerator on 07-Mar-2022 and administered on 24-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received a dose from the vials which are initially stored in refrigerator on 07-Mar-2022 and administered on 24-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from the vials which are initially stored in refrigerator on 07-Mar-2022 and administered on 24-Mar-2022) and PRODUCT STORAGE ERROR (The patient received a dose from the vials which are initially stored in refrigerator on 07-Mar-2022 and administered on 24-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was reported as nurse states that they administered 5 doses on 24 Mar 2022 of the Moderna Covid-19 Vaccine to 5 patients after the manufacturer date of expiry (29Jan2022) from a single vial,.  Date the vial initially stored in the refrigerator 07-Mar-2022. The vial had not undergone any temperature excursions.  No concomitant medications were provided by the reporter. No treatment information was provided by the reporter
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error, Vaccination site swelling
Clinical narrative: arm swelling at the injection site (booster dose); possible temperature excursion/no temperature monitoring of vial (booster)/Moderna vial that was stored in a refrigerator without any type of temperature monitoring; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm swelling at the injection site (booster dose)) and PRODUCT STORAGE ERROR (possible temperature excursion/no temperature monitoring of vial (booster)/Moderna vial that was stored in a refrigerator without any type of temperature monitoring) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (arm swelling at the injection site (booster dose)) and PRODUCT STORAGE ERROR (possible temperature excursion/no temperature monitoring of vial (booster)/Moderna vial that was stored in a refrigerator without any type of temperature monitoring). At the time of the report, VACCINATION SITE SWELLING (arm swelling at the injection site (booster dose)) and PRODUCT STORAGE ERROR (possible temperature excursion/no temperature monitoring of vial (booster)/Moderna vial that was stored in a refrigerator without any type of temperature monitoring) outcome was unknown.            No concomitant medication was reported.  It was reported that consumer was contacted by the pharmacy where Moderna booster dose was received, and the pharmacist stated the dose received came from a Moderna vial that was stored in a refrigerator without any type of temperature monitoring.  No treatment medication was reported.   This case was linked to MOD-2022-526005 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Vaccination site pain
Clinical narrative: feeling lnocked out for 3 to 4 days; headache; feeling tire; injection site arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling lnocked out for 3 to 4 days), HEADACHE (headache), FATIGUE (feeling tire) and VACCINATION SITE PAIN (injection site arm hurts) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A, 002B21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-Sep-2021, the patient experienced FEELING ABNORMAL (feeling lnocked out for 3 to 4 days), HEADACHE (headache), FATIGUE (feeling tire) and VACCINATION SITE PAIN (injection site arm hurts). In September 2021, FEELING ABNORMAL (feeling lnocked out for 3 to 4 days) had resolved. At the time of the report, HEADACHE (headache), FATIGUE (feeling tire) and VACCINATION SITE PAIN (injection site arm hurts) outcome was unknown.            Concomitant products were not provided. Patient reported of  feeling knocked out for 3 to 4 days. Treatment medications were not reported.   This case was linked to MOD-2022-526422, MOD-2022-526426, MOD-2022-526395 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Mar-2022: Follow-up received contains non significant information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Patients left injection site arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patients left injection site arm hurts) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 002B21A, 007M20A and 048F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 28-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In March 2022, the patient experienced VACCINATION SITE PAIN (Patients left injection site arm hurts). At the time of the report, VACCINATION SITE PAIN (Patients left injection site arm hurts) outcome was unknown.            No concomitant drug reported. No treatment information was provided by the reporter.  Patient reported her records saying that she received 0.25ml for her booster dose.   This case was linked to MOD-2022-526424, MOD-2022-526395, MOD-2022-526422 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Mar-2022: No newinformation.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: lateralized pain on one side of his body, particularly his leg; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (lateralized pain on one side of his body, particularly his leg) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (lateralized pain on one side of his body, particularly his leg). At the time of the report, PAIN IN EXTREMITY (lateralized pain on one side of his body, particularly his leg) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.   This case was linked to MOD-2022-526524 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Received booster instead of full 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received booster instead of full 3rd dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced ACCIDENTAL UNDERDOSE (Received booster instead of full 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Received booster instead of full 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported patient was immunocompromised and wants a fourth shot.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm). At the time of the report, VACCINATION SITE PAIN (Sore left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication information was provided.  No treatment medication were provided.   This case was linked to MOD-2022-526820, MOD-2022-526822, MOD-2022-526823 (Patient Link).