chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Hypertension, Inflammation, Muscular weakness, Myalgia
Clinical narrative: heart "attack" episode; pain into my jaw and down my arm; pain into my jaw and down my arm; couldn't breath /Shortness of breath; muscle pain; weakness; inflammation; high BP; muscle weakness; pain; This is a spontaneous report form a contactable consumer reporting for herself. A 51-year-old (Non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Formulation: Solution for injection, Lot Number: unknown) via unspecified route of administration in right arm on 31Mar2021 13:00 (at age of 51-years old) as single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. Patient had no other allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. Patient received other medications in two weeks Birth Control. Patient had reported that, had her first shot on Wednesday, 31Mar2021. By Thursday, 1Apr2021 09:30 AM she was experiencing muscle weakness and pain. Tuesday morning at 5:30 am 6Apr2021 she woke up experiencing what now known to have been a heart attack episode. She felt like abs elephant was sitting on her chest while left side she had pain into her jaw and down her arm as well as could not breath. Shortness of breath. This lasted 15-20 min. She has since for the past 2 months been in and out of doctors trying to figure out the source of her muscle pain and weakness. The Adverse events resulted in visit of Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability, or permanent damage. She went from only seeing her doctor every couple of years only when not well to she has now seen a cardiologist, rheumatologist, orthopedic. She has had EKGs, Computed tomography (CT) Scan of her heart, stress test, been put on BP meds, anti-inflammatory, antidepressants. To try and regulate her inflammation and to help keep the inflammation from causing stress on her heart aka. high BP. She went from a healthy active self-employed 51-year-old woman to her body literally giving out since shot. Treatment received for adverse events through Medication. Patient underwent lab test and procedure include Electrocardiogram, CT Scan of her heart, stress test on unspecified date result was unknown. The outcome of all events recovered with sequel (Recovered with lasting effects).   Information on batch/Lot number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Pain, Pain in extremity, Pain in jaw
Clinical narrative: heart "attack" episode; pain into my jaw and down my arm; pain into my jaw and down my arm; couldn't breath /Shortness of breath; muscle pain; weakness; inflammation; high BP; muscle weakness; pain; This is a spontaneous report form a contactable consumer reporting for herself. A 51-year-old (Non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Formulation: Solution for injection, Lot Number: unknown) via unspecified route of administration in right arm on 31Mar2021 13:00 (at age of 51-years old) as single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. Patient had no other allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. Patient received other medications in two weeks Birth Control. Patient had reported that, had her first shot on Wednesday, 31Mar2021. By Thursday, 1Apr2021 09:30 AM she was experiencing muscle weakness and pain. Tuesday morning at 5:30 am 6Apr2021 she woke up experiencing what now known to have been a heart attack episode. She felt like abs elephant was sitting on her chest while left side she had pain into her jaw and down her arm as well as could not breath. Shortness of breath. This lasted 15-20 min. She has since for the past 2 months been in and out of doctors trying to figure out the source of her muscle pain and weakness. The Adverse events resulted in visit of Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability, or permanent damage. She went from only seeing her doctor every couple of years only when not well to she has now seen a cardiologist, rheumatologist, orthopedic. She has had EKGs, Computed tomography (CT) Scan of her heart, stress test, been put on BP meds, anti-inflammatory, antidepressants. To try and regulate her inflammation and to help keep the inflammation from causing stress on her heart aka. high BP. She went from a healthy active self-employed 51-year-old woman to her body literally giving out since shot. Treatment received for adverse events through Medication. Patient underwent lab test and procedure include Electrocardiogram, CT Scan of her heart, stress test on unspecified date result was unknown. The outcome of all events recovered with sequel (Recovered with lasting effects).   Information on batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase increased, C-reactive protein increased, Hepatic enzyme increased, Inflammation
Clinical narrative: I had so much inflammation; the inflammation this thing has gone so high; my condition got worse; I was in emergency and hospital for, I went there on Thursday and I came back on Sunday; My CRC level were the C reaction for protein for inflammation was so high; my liver enzyme were high you know ATL, AST, GBT.; my body became so stiff that I could not even move; stiffened my hands; my pain was so high; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported, expiration date not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunization and also methylprednisolone sodium succinate (SOLU MEDROL), via an unspecified route of administration from an unspecified date (Lot number was not reported) to an unspecified date, at 40 mg for an unspecified indication. Medical history included Heart surgery. The patient's concomitant medications were not reported. The patient reported that she had so much inflammation, the inflammation this thing has gone so high that her condition got worse. She was in emergency and hospital for she went there on thursday and came back on Sunday for 4 days, her CRC level were the c reaction for protein for inflammation was so high, her liver enzyme were high you know ALT, AST, GBT, her body became so stiff that she could not even move; stiffened her hands, her pain was so high. Patient went to the rheumatologist. In the hospital patient got worst because patient cannot take any medication. Patient heard some other people that they have the CRC gone the high and the inflammation also is getting high in their body. Patient never had this problem. when patient came back from the hospital, went to clinic doctor because her pain was so high that she being a heart patient and had open heart surgery (intent: history) and then clinic doctor gave her solumedrol 40 mg injection, even that didn't help for few days. Reported that her hands stiffened and she never had this kind of stiffness in her life. The patient underwent lab tests and procedures which included alanine aminotransferase: high, aspartate aminotransferase increased: high, C-reactive protein increased: increased and Hepatic enzyme increased: increased. Outcome for all the events was unknown.  Follow up needed, further information was requested.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: I had so much inflammation; the inflammation this thing has gone so high; my condition got worse; I was in emergency and hospital for, I went there on Thursday and I came back on Sunday; My CRC level were the C reaction for protein for inflammation was so high; my liver enzyme were high you know ATL, AST, GBT.; my body became so stiff that I could not even move; stiffened my hands; my pain was so high; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported, expiration date not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunization and also methylprednisolone sodium succinate (SOLU MEDROL), via an unspecified route of administration from an unspecified date (Lot number was not reported) to an unspecified date, at 40 mg for an unspecified indication. Medical history included Heart surgery. The patient's concomitant medications were not reported. The patient reported that she had so much inflammation, the inflammation this thing has gone so high that her condition got worse. She was in emergency and hospital for she went there on thursday and came back on Sunday for 4 days, her CRC level were the c reaction for protein for inflammation was so high, her liver enzyme were high you know ALT, AST, GBT, her body became so stiff that she could not even move; stiffened her hands, her pain was so high. Patient went to the rheumatologist. In the hospital patient got worst because patient cannot take any medication. Patient heard some other people that they have the CRC gone the high and the inflammation also is getting high in their body. Patient never had this problem. when patient came back from the hospital, went to clinic doctor because her pain was so high that she being a heart patient and had open heart surgery (intent: history) and then clinic doctor gave her solumedrol 40 mg injection, even that didn't help for few days. Reported that her hands stiffened and she never had this kind of stiffness in her life. The patient underwent lab tests and procedures which included alanine aminotransferase: high, aspartate aminotransferase increased: high, C-reactive protein increased: increased and Hepatic enzyme increased: increased. Outcome for all the events was unknown.  Follow up needed, further information was requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Headaches/Headache; Body aches; Soreness at the injection site; Fever; This is a spontaneous report from a Pfizer sponsored program support.  A contactable 38-year-old Nurse (patient) reported for herself. A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0178; Expiration Date: unspecified date in 2022), via an unspecified route of administration, administered in arm left on 09Jun2021 at 11:15 as 2nd dose, single for COVID-19 immunization. The patient did not had any medical history. Family medical history were none. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0186; Expiration Date: Unknown), via an unspecified route of administration, administered in arm left on 19May2021 as 1st dose, single for COVID-19 immunization. The patient did not receive any other vaccine prior to COVID-19 Vaccine. On 10Jun2021, the patient experience soreness at the injection site, headaches, fever, and body aches. It was reported that soreness has worsened but the other symptoms have improved. The patient would like to know if these symptoms are normal, and will they go away and like to know if there is anything else, she can take for her symptoms. It was reported that she missed work yesterday and today and she was supposed to return to work tomorrow, but she was not sure if she will be able to. The patient stated she has been taking Tylenol and Ibuprofen and they have not been working. The reporter seriousness of the events Headache and body aches are reported as serious. The patient had not yet recovered from the events   Information about lot/batch number cannot be obtained. Additional information has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available
Sex: U
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: severe eczema flare up; This is a spontaneous report from a contactable consumer. This consumer reported for a patient.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173), via an unspecified route administered in Arm Left on 04Jun2021 as unknown, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since, vaccination, the patient was not tested for Covid-19. On an unspecified date, severe eczema flare up requiring steroid shot. prescribing doctor said that, the patient was the second patient to have this reaction to the vaccine that he had seen just that day. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021691179 same reporter/drug/AE with different patient
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Medication error, Product preparation error
Clinical narrative: Pentacel was administered without ActHIB component with no AE; Initial information received on 10-Jun-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 month old female patient administered pentacel without acthib component DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 10-Jun-2021, the patient received a 0.5mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE once [lot UJ413AA,UJ389AB, expiry date: 09-Oct-2021 via an intramuscular route at right thigh for prophylactic vaccination.  It was a case of actual medication error due to product preparation issue [Latency: on the same day].  It was reported that, Acthib was not reconstituted . Pentacel was administered without ActHIB component. Patient asks if it should be 0.5 ml NaCl saline solution used. Also, it necessary to wait to administer the ActHIB component. Nurse reported patient was given Pentacel without the HIB component  At the time of report no adverse event was reported.  It was not reported if the patient received a corrective treatment 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: 1.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Medication error, Product preparation error, Product preparation issue
Clinical narrative: ActHib vial was inadvertently mixed with a Merck vaccine diluent, rather than the diluent that is supplied with the ActHib vaccine and administered to the patient with no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via physician via regulatory authority (GMI) (reference number- 00636420 and 00636271) and transmitted to Sanofi on 10-Jun-2021.  This case involves a 15 month old male patient who received 0.5 mL fourth dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] [lot number: UJ437ABB, expiry date: 03-May-2022, total, drug interval dosage: once] via intramuscular route at the right thigh, on 09-Jun-2021, for prophylactic vaccination which was inadvertently mixed with a Merck vaccine diluent, rather than the diluent that is supplied with the HIB (PRP/T) VACCINE [ACT-HIB] (product preparation error).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was a case of actual medication error due to wrong diluent used. (Latency: on the same day)  At the time of report, reporter wanted to know the recommendations on what to do will be upon that ACT-HIB was reconstituted with the wrong diluent, that for a Merck vaccine, rather than the supplied diluent, and then administered to the patient and additionally asked how to proceed.   At the time of report, reporter wanted to the protocol/side effect of giving Hib reconstituted with Merck diluent and wanted to know if patient need to revaccinated.  At the time of report, no adverse event reported.  At the time of report, event outcome was not applicable.   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.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, Medication error
Clinical narrative: A patient (12 years old) received a double dose of MENACTRA, no AE; Initial information received on 08-Jun-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 year old and unknown gender patient who received double doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] [extra dose administered].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   The patient received a double doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, One dose was given on 29-Jan-2021 and second dose was accidentally repeated on 02-Jun-2021, (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered.  It was also reported that recent medication error that occurred in one of our clinics last week. A patient (12 years old) received a double dose of meningococcal MCV4P. One dose was given on 1/29/21 and a second dose was accidentally repeated on 6/2/21. Can you we give any insight or education that the patient should be monitored for. They appreciate any guidance or insight we can give.   At the time of report, no adverse event was reported.  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.
Sex: U
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: Patient was potential anaphylaxis from PEG (polyethylene glycol) and Polysorbate 80; Initial information regarding an unsolicited valid serious case was received from the other health professional via Agency (Reference number- 00638599) and transmitted to Sanofi on 13-Jun-2021.  This case involves an 80 year old patient (gender unspecified) who experienced potential anaphylaxis from PEG (polyethylene glycol) and polysorbate 80 (anaphylactic reaction), after patient received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, in September 2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number, expiry date and other dosing details] for prophylactic vaccination.  On an unknown date, the patient developed a serious potential anaphylaxis from PEG (polyethylene glycol) and Polysorbate 80 (anaphylactic reaction), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.  At the time of report, the patient was more than 80 year old and was on-hold for a corona virus disease (COVID) vaccine due to potential anaphylaxis from PEG (polyethylene glycol) and Polysorbate 80 and wanted to know if either of these ingredients is in FLUZONE HIGH-DOSE and additionally, if PEG is an ingredient then wanted to know the molecular weight.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the event outcome was unknown for the anaphylactic reaction.  Information on the batch number was requested.; Sender's Comments: This case involves an 80 year old patient who presented with anaphylactic reaction after the administration of HIGH-DOSE QUADRIVALENT. Time of onset is unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Expired product administered, Medication error
Clinical narrative: expired dose of ActHib was administered with no adverse event; Initial and additional information received on 14-Jun-2021 regarding an unsolicited valid non-serious case received from other health professional via physician via Regulatory authority (Reference number- 00639997 and 00640595).  This case involves a 4 months old male patient who administered 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ316AA and expiry date: 08-Jun-2021) via intramuscular route in right thigh for prophylactic vaccination on 14-Jun-2021 for prophylactic vaccination (expired product administered).  Relevant medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  This was an actual medication error case due to expired vaccine used (latency was same day).  It was reported that nurse administered Acthib to a patient and noticed that the dilute and vaccine has two completely different expiration dates. The powder/vaccine portion expired 6 days ago on June 8 2021 and the dilute expires Jan 2022. A caller calling back in to get an answer to how to proceed after an expired dose of ActHib was administered. The caller reported that it was unknown to the clinic that the two components of the ActHib have different expiration dates. The clinic would have administered Pentacel but the family wanted individual vaccines; that the clinic does not usually administer ActHib alone; and that the family were very cautious of vaccines for their children. Diluent: LOT: U6849AB and expiry date:22-Jan-2022 Hib Portion: LOT: UJ316AA and expiry date: 08-Jun-2021.  At the time of reporting, no adverse event reported.  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 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: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient got an extra dose of the MENACTRA with no adverse event; Patient recieved Menactra instead of the intended Bexsero with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00640413) and transmitted to Sanofi on 14-Jun-2021.  This case involves a 17 years old female patient who received 0.5 mL third dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6877BA and expiry date: 29-Feb-2022) via unknown route in right deltoid (extra dose administered) for prophylactic vaccination on 02-Jun-2021 instead of MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV [BEXSERO] (wrong product administered).  The patient's past vaccination(s) included Menactra on 08-AUG-2017 and 13-AUG-2020. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  The reporter asked when would be best to give a meningococcal B vaccine. Should they be looking for anything.  It was reported that the patient received Menactra on 08Aug2017 and 13Aug2020. She then received a third dose of Menactra in the right deltoid by mistake on 02Jun2021. The intended vaccine on 02Jun2021 was a meningococcal B vaccine, Bexsero. They told a medical assistant (MA) to give a "meningitis vaccine" and the MA chose Menactra instead of the intended Bexsero.  It was an actual medication error case due to extra dose administered and wrong vaccine administered (latency: same day).  At the time of reporting, the patient experienced no adverse event and feels fine.   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: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: A patient received and expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from nurse via Regulatory authority (Reference number- 00640469) and transmitted to Sanofi on 14-Jun-2021.  This case involves a one-year-old female patient who received and expired 0.5 mL dose of 1st dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ320AAB and expiry date: 13-Jun-2021) via an intramuscular route in the left thigh for prophylactic vaccination on 14-Jun-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) for prophylactic vaccination.  The nurse wanted to know that the vaccine it still viable or not and another shot should be given or not to the patient.  This was a case of actual medication error due to Expired vaccine used (latency same day).  At the time of reporting, no adverse events were reported.  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: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, Medication error
Clinical narrative: an expired Adacel vaccine was administered, with no reported adverse event; Initial information was received on 15-Jun-2021 regarding an unsolicited valid non-serious case from other health professional (GMI Inquiry number: 00642258).  It was reported that an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6321AA, expiry date: 07-Jun-2021) was administered to a 11-year old female patient on 14-Jun-2021 via an intramuscular route at left arm for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event reported.  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 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy  VALACYCLOVIR, PREDNISONE, EYE DROPS
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: Unknown exact date of immunization, unknown lot number.  Patient was not vaccinated in clinic and he forgot his COVID vaccination card at work.  Patient reports having completed second COVID shot (Pfizer) around mid-March.  He was diagnosed with COVID today (6/21/2021) after experiencing nasal congestion and loss of taste/smell.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: She felt dizziness immediately and passed out as we were leaving the store.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Exposure to SARS-CoV-2, Nasal congestion, Oropharyngeal pain
Clinical narrative: PATIENT FULLY VACCINATED FOR COVID, RECEIVED SECOND SHOT IN MARCH, INFECTED WITH COVID IN JUNE.  COUGH, SORE THROAT, AND NASAL CONGESTION STARTED 6/17/21.  POSITIVE HOUSEHOLD CONTACT WITH COVID.  PATIENT HAD POSITIVE COVID TEST ON 6/21/21.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: PATIENT FULLY VACCINATED FOR COVID, RECEIVED SECOND SHOT IN MARCH, INFECTED WITH COVID IN JUNE.  COUGH, SORE THROAT, AND NASAL CONGESTION STARTED 6/17/21.  POSITIVE HOUSEHOLD CONTACT WITH COVID.  PATIENT HAD POSITIVE COVID TEST ON 6/21/21.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus both ears started a few days after 2d Pfizer covid dose on March 31. Consulted Doctor April 15. Had ear wax removed from 1 ear April 20.  Tinnitus has continued.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Ear pain, Hyperacusis, Tinnitus
Clinical narrative: Tinnitus (severe). Hearing loud pounding noises 24/7. Can't sleep. ENT doctor > Ear exam was normal, hearing test was normal, brain catscan was normal. Tinnitus began on March 30, 2021 and continued with no end in sight. Been suffering for 3 months.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein, Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram ST segment elevation
Clinical narrative: Patient presented with chest pain that started 3 days after second dose of Pfizer vaccine. He had chest pain, shortness of breath. EKG did show some borderline ST elevations in the anterolateral leads. Troponin was performed which was elevated at 5 initially. Plan is for admission for further workup and management.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Metabolic function test, Troponin I increased
Clinical narrative: Patient presented with chest pain that started 3 days after second dose of Pfizer vaccine. He had chest pain, shortness of breath. EKG did show some borderline ST elevations in the anterolateral leads. Troponin was performed which was elevated at 5 initially. Plan is for admission for further workup and management.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram abnormal, Myocarditis, Troponin increased
Clinical narrative: Patient presented with chest pain that started 3 days after second dose of Pfizer vaccine. He had chest pain, shortness of breath. EKG did show some borderline ST elevations in the anterolateral leads. Troponin was performed which was elevated at 5 initially. Plan is for admission for further workup and management.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein, Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram ST segment elevation
Clinical narrative: Myocarditis
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Metabolic function test, Troponin I increased
Clinical narrative: Myocarditis
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram abnormal, Myocarditis, Troponin increased
Clinical narrative: Myocarditis
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Autoimmune disorder, Fatigue, Headache, Hot flush
Clinical narrative: AFTER THE FIRST DOSE, I BEGAN TO HAVE HOT FLASHES 4-5 TIMES DAILY.  JOINT PAIN, HEADACHES, FATIGUE, HOT FLASHES CONTINUE TO THE DATE OF THIS REPORT.  AFTER THE SECOND SHOT, IT TOOK NEARLY 2 WEEKS TO RECOVER TO A POINT WHERE I FELT AS THOUGH I COULD FUNCTION.  AS A RESULT OF THE ABOVE-DESCRIBED SIDE EFFECTS, I SOUGHT MEDICAL ATTENTION.  BLOOD WORK RETURNED HYPOTHYROID, AND AUTO IMMUNE DISEASE (NEITHER HAD EVER BEFORE BEEN DIAGNOSED OR SEEN IN BLOODWORK).  I AM STILL EASILY FATIGUED, EXTREMELY SENSITIVE TO HEAT, AND CONTINUE TO GET HOT FLASHES, FATIGUES, JOINT PAIN, AND SWEAT PROFUSELY.  HOT FLASHES/HEAT SENSITIVITY ARE AFFECTING DAILY LIFE AND AT POINTS I AM UNABLE TO FUNCTION AS A RESULT OF THEM.  FAMILY MEDICAL PROFESSIONAL REFERRED ME TO A RHEUMATOLOGIST TO BETTER PINPOINT THE CAUSE FOR THE POSITIVE BLOOD TESTS SHOWING AUTO IMMUNE DISEASE.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Hypothyroidism, Temperature intolerance
Clinical narrative: AFTER THE FIRST DOSE, I BEGAN TO HAVE HOT FLASHES 4-5 TIMES DAILY.  JOINT PAIN, HEADACHES, FATIGUE, HOT FLASHES CONTINUE TO THE DATE OF THIS REPORT.  AFTER THE SECOND SHOT, IT TOOK NEARLY 2 WEEKS TO RECOVER TO A POINT WHERE I FELT AS THOUGH I COULD FUNCTION.  AS A RESULT OF THE ABOVE-DESCRIBED SIDE EFFECTS, I SOUGHT MEDICAL ATTENTION.  BLOOD WORK RETURNED HYPOTHYROID, AND AUTO IMMUNE DISEASE (NEITHER HAD EVER BEFORE BEEN DIAGNOSED OR SEEN IN BLOODWORK).  I AM STILL EASILY FATIGUED, EXTREMELY SENSITIVE TO HEAT, AND CONTINUE TO GET HOT FLASHES, FATIGUES, JOINT PAIN, AND SWEAT PROFUSELY.  HOT FLASHES/HEAT SENSITIVITY ARE AFFECTING DAILY LIFE AND AT POINTS I AM UNABLE TO FUNCTION AS A RESULT OF THEM.  FAMILY MEDICAL PROFESSIONAL REFERRED ME TO A RHEUMATOLOGIST TO BETTER PINPOINT THE CAUSE FOR THE POSITIVE BLOOD TESTS SHOWING AUTO IMMUNE DISEASE.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: The subject, I,  experienced sudden loss of consciousness --with no warning--for a few minutes a day following her first dose.  Although she is now well, it could had been poentially life threatening to self and others if the incident occured while behind the wheels as there were no physical warning signs prior to the incident.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Intermittent tingling in hands, feet, and legs.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AEs; we had a delivery of GARDASIL 9 that did not arrive for more than 5 days, when the product was received it was supposed to be returned to the wholesaler, instead they were placed in the refrigerator; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On an unknown date in April 2021, there was a delivery of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) that did not arrive for more than 5 days, when the product was received it was supposed to be returned instead of placing in the refrigerator (temperature was unknown by reporter).   On 13-MAY-2021, the patient was vaccinated with the improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (1 time dose, lot# T026168, expiration date 04-DEC-2022; route was not reported) for prophylaxis (product storage error). It was reported that 5 bad doses were given and six potential patients were involved, one of the six patients involved was administered a valid dose. It could not be confirmed which patient received the valid dose. There was no previous temperature excursion. No data logger was involved. No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Dyspnoea, Vaccine positive rechallenge
Clinical narrative: hospitalized after receiving her flu shot / within hours she could not breath / admitted to the hospital for approximately 24 hours; hospitalized after receiving her flu shot / within hours she could not breath / admitted to the hospital for approximately 24 hours; This case was reported by a consumer via call center representative and described the occurrence of asthmatic attack in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of dyspnoea (received on an unknown date 7 or 8 years prior to reporting date and also experienced asthma attack, refer case US2021129095). Concomitant products included budesonide + formoterol fumarate (Symbicort) and ipratropium + salbutamol (Albuterol And Ipratropium Nebule).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced asthmatic attack (serious criteria hospitalization) and difficulty breathing (serious criteria hospitalization). The patient was treated with steroids nos (Steroids). Rechallenge with Influenza vaccine Quadrivalent unspecified season was positive. On an unknown date, the outcome of the asthmatic attack and difficulty breathing were recovered/resolved.   It was unknown if the reporter considered the asthmatic attack and difficulty breathing to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: This case was reported by patient herself via an outbound call for the Program. The age at vaccination was not reported but could be 58 or 59 years. Concomitant products included rescue inhaler and oral steroids (unspecified). 3 years prior the reporting date, the patient received flu vaccine and within hours she could not breath and was admitted to the hospital for approximately 24 hours and given steroids. The patient stated that the hospitalization was for asthma attack. The patient's symptoms resolved by the time she was discharged from the hospital. The patient had elected not to take Nucala due to the cost and stated she did not trust injections in general as she had twice been hospitalized after receiving her flu shot.  The patient consented to follow up with her physician The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021129095:same reporter
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Headache
Clinical narrative: never stopped having a headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a 17-year-old female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by patient's parents. Patient experienced headache and never stopped since she got the shot, it had been 4 years.  No other information was reported.
Sex: U
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: GIVEN DILUTENT ONLY; GIVEN DILUTENT ONLY; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only diluent of Rotarix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No other information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Incomplete course of vaccination, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: My arm was so sore for days; arm swelled; My arm  / became red; My arm  /  was hot to touch; didn't get the second shot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced pain in arm, swelling arm, erythema of extremities, skin warm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the swelling arm, erythema of extremities, skin warm and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain in arm, swelling arm, erythema of extremities and skin warm to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient for herself/himself. The age at vaccination was not reported for 1st dose and it was not applicable for 2nd dose. The patient received the first dose of Shingles vaccine years ago and arm was so sore for days, arm  was swelled and became red and was hot to touch. Till the time of reporting patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Immobile, Product administered to patient of inappropriate age
Clinical narrative: they were immobile from around 5 pm to 12 am; Inappropriate age at vaccine administration; This case was reported by a consumer via other manufacturer and described the occurrence of immobile in a 49-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced immobile (serious criteria GSK medically significant) and inappropriate age at vaccine administration. On an unknown date, the outcome of the immobile was recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the immobile to be related to Shingles vaccine.  Additional details were provided as follows:  This case was reported by patient himself.  The age at vaccination was not reported.  The patient (less than 50 years age) received Shingles vaccine, which led to inappropriate age at vaccine administration and experienced immobile from around 5 pm to 12 am. The patient stated that the symptoms mimicked the Shingles shot and was hoping each shot dose would be less and less impactful. This case had been linked with US2021AMR134304, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR134304:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the vaccine and got the Shingles right after / I'm leary of the Coronavirus vaccine / suspected vaccination failure; got the Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter. The age at vaccination was not reported. The patient received Shingles vaccine and experienced shingles right after and because of that patient was leary of the coronavirus vaccine. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.