chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Atrial fibrillation, Biopsy, Blood test, Eczema nummular
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 76 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Mar2021 14:15 (Lot number: EN6206, Expiration Date: Jun2021) at the age of 75 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Mild heart attack stent" (unspecified if ongoing); "Mild heart attack stent" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot Number: EN6198, Expiration date: 30Jun2021 intramuscularly in left arm at 14:15 as dose 1, single), administration date: 25Feb2021, when the patient was 75 years old, for COVID-19 Immunisation, reaction: "AFIB", "Atopic dermatitis / rash on leg then entire body". The patient had no prior vaccinations. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "not recovered", described as "some AFib"; ECZEMA NUMMULAR (non-serious) with onset 08Sep2021, outcome "not recovered", described as "nummular eczema / rash on entire body". On 08Nov2021, rash on entire body was still experienced and was still ongoing. It was reported that the patient had no previous skin related rashes until his vaccination on 25Feb2021, patient had been to dermatologist 8 times with no real solution. The rash goes away with prednisolone but returns within a week or so. Patient experienced some health issues with the continued use of prednisone. AFib occurred only after vaccination and was possibly linked to use of prednisone 20 mg. The patient underwent the following laboratory tests and procedures: allergy test: (08Nov2021) no allergies except balsam of peru; biopsy: (08Jul2021) no lupus, no cancer, no fungus; blood test: (08Jul2021) atopic dermatitis. Therapeutic measures were taken as a result of atrial fibrillation, eczema nummular which included prednisone 20 mg (also reported as taking for allergic skin break out) from 27Apr2021 to 06May2021. It was reported that  patient had cardioversion on 25May2021, but still had some AFib. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202101169206 same patient and drug; similar events, different dose.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Anaemia, Blood test, Fatigue, Nausea
Clinical narrative: Anemia; He has been complaining about nausea; Fatigue; Abdominal pain started after the 2nd dose and he did not have it after the first; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 23Feb2022 (Lot number: fm0698) at the age of 13 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 1, Dose brand: Pfizer, Batch/Lot No: 33036bd), administration date: 02Feb2022, when the patient was 13 years old, for COVID-19 Immunization, reaction(s): "Nausea", "Fatigue". The following information was reported: NAUSEA (non-serious) with onset 23Feb2022, outcome "not recovered", described as "He has been complaining about nausea"; FATIGUE (non-serious) with onset 23Feb2022, outcome "not recovered", described as "Fatigue"; ABDOMINAL PAIN (non-serious) with onset 23Feb2022, outcome "not recovered", described as "Abdominal pain started after the 2nd dose and he did not have it after the first"; ANAEMIA (non-serious) with onset 03Mar2022, outcome "not recovered", described as "Anemia". The events "he has been complaining about nausea", "fatigue", "abdominal pain started after the 2nd dose and he did not have it after the first" and "anemia" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea, fatigue, abdominal pain, anaemia.  Additional Information: The patient had no known allergies. Prior vaccination within 4 weeks was reported as none. Treatment received for adverse event was reported as antacid. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient was not tested for COVID-19. The reporter stated that after each dose the patient had expected immune response. The patient has been complaining about nausea, abdominal pain and fatigue that still persists. That abdominal pain seemed to be getting better but we took him to see his Doctor on 03Mar that is when he stated that the abdominal pain started after the 2nd dose and he did not have it after the first. The doctor had to press on his abdomen that day for him to notice the pain. That was the case for the next several days with him stating it was getting better. On 10Mar when he got home from school he said he had a sharp pain in his abdomen during one of his classes and the pain remained after that. The doctor suggested taking a blood sample and it came back with indications of anemia. Also took a specimen to check for blood in feces to check for an ulcer. That came back negative, but she wants one more before ruling a ulcer out. The patient has been referred to a GI specialist.  No follow-up attempts are possible. No further information is expected
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Stool analysis
Clinical narrative: Anemia; He has been complaining about nausea; Fatigue; Abdominal pain started after the 2nd dose and he did not have it after the first; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 23Feb2022 (Lot number: fm0698) at the age of 13 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 1, Dose brand: Pfizer, Batch/Lot No: 33036bd), administration date: 02Feb2022, when the patient was 13 years old, for COVID-19 Immunization, reaction(s): "Nausea", "Fatigue". The following information was reported: NAUSEA (non-serious) with onset 23Feb2022, outcome "not recovered", described as "He has been complaining about nausea"; FATIGUE (non-serious) with onset 23Feb2022, outcome "not recovered", described as "Fatigue"; ABDOMINAL PAIN (non-serious) with onset 23Feb2022, outcome "not recovered", described as "Abdominal pain started after the 2nd dose and he did not have it after the first"; ANAEMIA (non-serious) with onset 03Mar2022, outcome "not recovered", described as "Anemia". The events "he has been complaining about nausea", "fatigue", "abdominal pain started after the 2nd dose and he did not have it after the first" and "anemia" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea, fatigue, abdominal pain, anaemia.  Additional Information: The patient had no known allergies. Prior vaccination within 4 weeks was reported as none. Treatment received for adverse event was reported as antacid. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient was not tested for COVID-19. The reporter stated that after each dose the patient had expected immune response. The patient has been complaining about nausea, abdominal pain and fatigue that still persists. That abdominal pain seemed to be getting better but we took him to see his Doctor on 03Mar that is when he stated that the abdominal pain started after the 2nd dose and he did not have it after the first. The doctor had to press on his abdomen that day for him to notice the pain. That was the case for the next several days with him stating it was getting better. On 10Mar when he got home from school he said he had a sharp pain in his abdomen during one of his classes and the pain remained after that. The doctor suggested taking a blood sample and it came back with indications of anemia. Also took a specimen to check for blood in feces to check for an ulcer. That came back negative, but she wants one more before ruling a ulcer out. The patient has been referred to a GI specialist.  No follow-up attempts are possible. No further information is expected
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chromaturia, Dehydration, Dyspnoea, Lymphadenopathy
Clinical narrative: Experienced fever of 102F for a period of greater than 24hours, fever of 101 for 3 days which started about 30 hours after injection.; lymphadenopathy under armpit same side of injection site (right bicep); Severe dehydration (dark brown/reddish urine) even after consuming over 1.5 gallons of water; Nausea; Difficulty breathing at times.; Severe dehydration (dark brown/reddish urine) even after consuming over 1.5 gallons of water and adding electrolytes daily for over 96 hours now.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administration date 07Mar2022 (Lot number: FK9895) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allerges: Gluten" (unspecified if ongoing), notes: known allergies: Gluten; "known allergies: dairy" (unspecified if ongoing), notes: known allergies: dairy. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0173), administration date: 04May2021, when the patient was 34 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730), administration date: 13Apr2021, when the patient was 34 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 08Mar2022, outcome "not recovered", described as "Experienced fever of 102F for a period of greater than 24hours, fever of 101 for 3 days which started about 30 hours after injection."; LYMPHADENOPATHY (non-serious) with onset 08Mar2022, outcome "not recovered", described as "lymphadenopathy under armpit same side of injection site (right bicep)"; DEHYDRATION (non-serious) with onset 08Mar2022, outcome "not recovered", described as "Severe dehydration (dark brown/reddish urine) even after consuming over 1.5 gallons of water"; NAUSEA (non-serious) with onset 08Mar2022, outcome "not recovered", described as "Nausea"; DYSPNOEA (non-serious) with onset 08Mar2022, outcome "not recovered", described as "Difficulty breathing at times."; CHROMATURIA (non-serious) with onset 08Mar2022, outcome "not recovered", described as "Severe dehydration (dark brown/reddish urine) even after consuming over 1.5 gallons of water and adding electrolytes daily for over 96 hours now.". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Experienced fever of 102F for a period of greater than 24hours, fever of 101 for 3 days which started about 30 hours after injection.; lymphadenopathy under armpit same side of injection site (right bicep); Severe dehydration (dark brown/reddish urine) even after consuming over 1.5 gallons of water; Nausea; Difficulty breathing at times.; Severe dehydration (dark brown/reddish urine) even after consuming over 1.5 gallons of water and adding electrolytes daily for over 96 hours now.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administration date 07Mar2022 (Lot number: FK9895) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allerges: Gluten" (unspecified if ongoing), notes: known allergies: Gluten; "known allergies: dairy" (unspecified if ongoing), notes: known allergies: dairy. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0173), administration date: 04May2021, when the patient was 34 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730), administration date: 13Apr2021, when the patient was 34 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 08Mar2022, outcome "not recovered", described as "Experienced fever of 102F for a period of greater than 24hours, fever of 101 for 3 days which started about 30 hours after injection."; LYMPHADENOPATHY (non-serious) with onset 08Mar2022, outcome "not recovered", described as "lymphadenopathy under armpit same side of injection site (right bicep)"; DEHYDRATION (non-serious) with onset 08Mar2022, outcome "not recovered", described as "Severe dehydration (dark brown/reddish urine) even after consuming over 1.5 gallons of water"; NAUSEA (non-serious) with onset 08Mar2022, outcome "not recovered", described as "Nausea"; DYSPNOEA (non-serious) with onset 08Mar2022, outcome "not recovered", described as "Difficulty breathing at times."; CHROMATURIA (non-serious) with onset 08Mar2022, outcome "not recovered", described as "Severe dehydration (dark brown/reddish urine) even after consuming over 1.5 gallons of water and adding electrolytes daily for over 96 hours now.". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, SARS-CoV-2 test
Clinical narrative: The patient even had anaphylaxis to the COVID (Corona Virus Disease 2019) vaccine; This is a spontaneous report received from contactable reporter (Consumer or other non HCP).  A 62 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication included: ENBREL taken for rheumatoid arthritis. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "The patient even had anaphylaxis to the COVID (Corona Virus Disease 2019) vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2020) positive, notes: the patient contracted COVID-19 (Corona Virus Disease 2019). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood culture, Blood thyroid stimulating hormone, Cardiogenic shock, Coxsackie virus test negative, Coxsackie virus test positive
Clinical narrative: Cardiogenic shock temporally associated with COVID-19 vaccination; This is a literature report.  A 21 year-old male patient received bnt162b2 (BNT162B2), administration date 05Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID-19 infection" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CARDIOGENIC SHOCK (medically significant), outcome "unknown", described as "Cardiogenic shock temporally associated with COVID-19 vaccination". The patient underwent the following laboratory tests and procedures: blood culture: no growth, notes: No growth; blood thyroid stimulating hormone: 1.95, notes: 1.95 µIU/mL; coxsackie virus test negative: negative; coxsackie virus test positive: positive; cytomegalovirus test: negative; gastrointestinal pathogen panel: positive, notes: Positive for Campylobacter species; hepatitis c antibody negative: negative; hiv antibody negative: negative; legionella test: negative; sars-cov-2 antibody test: positive; sars-cov-2 test: negative, notes: Day 1 of admission Negative Day 7 of admission Negative.  The lot number for [bnt162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Cytomegalovirus test, Gastrointestinal pathogen panel, HIV antibody negative, Hepatitis C antibody negative, Legionella test
Clinical narrative: Cardiogenic shock temporally associated with COVID-19 vaccination; This is a literature report.  A 21 year-old male patient received bnt162b2 (BNT162B2), administration date 05Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID-19 infection" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CARDIOGENIC SHOCK (medically significant), outcome "unknown", described as "Cardiogenic shock temporally associated with COVID-19 vaccination". The patient underwent the following laboratory tests and procedures: blood culture: no growth, notes: No growth; blood thyroid stimulating hormone: 1.95, notes: 1.95 µIU/mL; coxsackie virus test negative: negative; coxsackie virus test positive: positive; cytomegalovirus test: negative; gastrointestinal pathogen panel: positive, notes: Positive for Campylobacter species; hepatitis c antibody negative: negative; hiv antibody negative: negative; legionella test: negative; sars-cov-2 antibody test: positive; sars-cov-2 test: negative, notes: Day 1 of admission Negative Day 7 of admission Negative.  The lot number for [bnt162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Cardiogenic shock temporally associated with COVID-19 vaccination; This is a literature report.  A 21 year-old male patient received bnt162b2 (BNT162B2), administration date 05Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID-19 infection" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CARDIOGENIC SHOCK (medically significant), outcome "unknown", described as "Cardiogenic shock temporally associated with COVID-19 vaccination". The patient underwent the following laboratory tests and procedures: blood culture: no growth, notes: No growth; blood thyroid stimulating hormone: 1.95, notes: 1.95 µIU/mL; coxsackie virus test negative: negative; coxsackie virus test positive: positive; cytomegalovirus test: negative; gastrointestinal pathogen panel: positive, notes: Positive for Campylobacter species; hepatitis c antibody negative: negative; hiv antibody negative: negative; legionella test: negative; sars-cov-2 antibody test: positive; sars-cov-2 test: negative, notes: Day 1 of admission Negative Day 7 of admission Negative.  The lot number for [bnt162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort, Arthralgia, Drug ineffective, Dysphagia, Suspected COVID-19
Clinical narrative: Joint pain; trouble swallowing; Upset stomach; Suspected COVID-19; drug ineffective; 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-163-4258612-00.  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 03Nov2021 (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single, intramuscular, administration date 18Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 28Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown", described as "drug ineffective"; SUSPECTED COVID-19 (medically significant) with onset Dec2021, outcome "recovered", described as "Suspected COVID-19"; ARTHRALGIA (non-serious), outcome "recovering", described as "Joint pain"; DYSPHAGIA (non-serious), outcome "unknown", described as "trouble swallowing"; ABDOMINAL DISCOMFORT (non-serious) with onset Dec2021, outcome "unknown", described as "Upset stomach". The action taken for upadacitinib was unknown.  Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of joint pain, covid, trouble swallowing and upset stomach with Rinvoq (Upadacitinib) was no reasonable possibility. Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran): The reporter's causality for the event(s) of joint pain, covid, trouble swallowing and upset stomach with Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was Possible.The reporter considered "drug ineffective", "suspected covid-19", "joint pain", "trouble swallowing" and "upset stomach" related to bnt162b2.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 75.0
Sex: M
Vaccine: COVID19, FLUX, UNK
Symptoms: Cough, Dizziness, Movement disorder, Oedema, Throat irritation
Clinical narrative: cough; throat irritation; dizzy; edema (oedema); was not moving around well; Initial information received on 09-Mar-2022 regarding an unsolicited valid non-serious case received from the health professional.  This case involves a 75-year-old male patient who experienced cough, throat irritation, dizzy, edema and was not moving around well, while receiving vaccine influenza vaccine, covid-19 vaccine and treprostinil sodium [Tyvaso].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.  At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  On 29-Jan-2022, the patient started taking treprostinil sodium at dose of 36 microgram (ug) (6 breaths), every 6 hours (QID), via inhalational (IH) route (strength, formulation, batch number, expiry date and indication was not provided).    On an unknown date in Feb-2022, the patient got her third covid-19 vaccine (produced by unknown manufacturer) (strength, formulation, dosage, lot number and expiry date not reported) via unknown route in unknown administration site for covid-19 immunization and influenza vaccine (produced by unknown manufacturer) (strength, formulation, dosage, lot number and expiry date not reported) via unknown route in unknown administration site for Flu prophylaxis (Antiviral prophylaxis). Information on batch number was requested.  On an unknown date, the patient developed cough, throat irritation, was getting dizzy (dizziness) and edema (oedema) and was not moving around well (unknown latency) following the first dose intake of influenza vaccine, covid-19 vaccine and treprostinil sodium. Her blood pressure and weight remained stable. She was overall feeling better after that day with the vaccination. It was unknown if the physician was aware.  Action taken with influenza vaccine and covid-19 vaccine was not applicable  Action taken with treprostinil sodium: No action was taken for the events of cough, throat irritation, and oedema; unknown for dizzy and was not moving around well.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event of cough, was Unknown for rest of the events.
Age: 9.0
Sex: M
Vaccine: DTAPIPV, IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was fully vaccinated in terms of DTAP, he only needed a dose of IPOL,with no reported adverse event; Initial informationreceived on 08-Mar-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional (HCP) via call center.  This case involves a 9 years old male patient who was fully vaccinated in terms of DTAP (Diphtheria Tetanus AC Pertussis), he only needed a dose of IPOL (Poliovirus Vaccine Inactivated), with no reported adverse event while receiving vaccine Diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) Vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Polio vaccine for Immunisation.  On 01-Mar-2022, the patient received a 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 HYBRID AC Pertussis/ipv (MRC5) Vaccine (formulation and Strength: Unknown) (lot C5862BA, expiry date: unknown) via intramuscular route in the left arm.  On 01-MAR-2022 the patient received a dose of quadracel despite being fully vaccinated in terms of DTAP with no reported adverse event,he only needed a dose of IPOL (wrong product administered) (latency: same day) following the administration of Diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) Vaccine.  Action taken: was not applicable.  At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: has been administered on 07MAR2022 to a 16 year-old after it expired on 02MAR2022; Initial information received on 08-Mar-2022 regarding an unsolicited valid non-serious case received via consumer/non-hcp.  This case involves a 16 years old female patient who experienced has been administered on 07mar2022 to a 16 year-old after it expired on 02mar2022 while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Menactra).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Mar-2022, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at a dose of o.5 ml with lot U6878BA via intramuscular route in the right deltoid for prophylactic vaccination.  On an unknown date the patient developed a non-serious "has been administered on 07mar2022 to a 16 year-old after it expired on 02mar2022 (expired product administered)" (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was reported that "Practice manager is calling to ask information about MENACTRA that has been administered on 07MAR2022 to a 16 year-old after it expired on 02MAR2022".   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (has been administered on 07MAR2022 to a 16 year-old after it expired on 02MAR2022).  At time of reporting, the outcome was Unknown for the event has been administered on 07mar2022 to a 16 year-old after it expired on 02mar2022.  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, HPV4, MNQ, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: reporting that an expired dose of MENACTRA was inadvertently given to a patient, with no reported adverse event; Initial information received on 10-MAR-2022 regarding an unsolicited valid non-serious case received from a health care professional via call center.  This case involves an infant patient with unknown demographics who experienced reporting that an expired dose of menactra was inadvertently given to a patient, with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) vaccine [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included -HPV vaccine VLP RL1 4V (YEAST) (GARDASIL), Diphtheria Vaccine toxoid, pertussis vaccine Acellular 3-component, tetanus vaccine toxoid (BOOSTRIX) and Influenza vaccine inact SPLIT 3V (FLUZONE HIGH DOSE) for Prophylactic vaccination.  On 10-Mar-2022, the patient received a dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine (batch- U6827BA, expiry-13-FEB-2022) (dose, strength and frequency-unknown) via intramuscular route in right deltoid for prophylactic vaccination.  On 10-MAR-2022 the patient developed "reporting that an expired dose of menactra was inadvertently given to a patient, with no reported adverse event" (expired product administered) following the administration of  Meningococcal A-C-Y-W135 (D CONJ) vaccine.  Action taken:  not applicable.  At time of reporting, the outcome was Unknown for the event reporting that an expired dose of menactra was inadvertently given to a patient, with no reported adverse event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Pericarditis
Clinical narrative: 3 weeks after 1st vaccine I ended up in the hospital  with heart attack. This was exactly one year after getting covid.  Exactly 3 weeks after 2nd vaccine I was back in the hospital with pericarditis and acute kidney failure.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus. It will be a year with tinnitus with no break :(
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Anticoagulant therapy, Atrial fibrillation, Bacterial infection, Blood pressure abnormal
Clinical narrative: Patient presented on 11/16/2021 with a chief complaint of  atrial fibrillation maintained on Xarelto and the recent diagnosis of COVID-19 presented to the ED with a history of multiple near syncopal episode associated with lightheadedness and falls.   Patient also reported subjective fevers and chills at home as dry cough.   Upon evaluation in the ED, BP was 87/51 with a heart rate of 58 temperature 99.1° with SpO2 98% in room.  Patient reportedly dehydrated.  Patient received fluid bolus with blood pressure improvement to 125/59.   Covid PCR was positive. Chest x-ray reported acute mild bilateral lower lobe pneumonia.  Subsequently SpO2 noted to drop to 88% when patient is speaking on the phone per ED physician  Patient was subsequently admitted for COVID-19 pneumonia under Hospital Medicine.  Patient was also started on gentle IV fluid for acute kidney injury which subsequently improved.   Procalcitonin was significantly elevated and indicative of significant secondary bacterial infection.  Patient was started on Ceftriaxone and doxycycline. MRSA/MSSA panel was negative.  CRP and procalcitonin are trended down.  Patient was placed on 4 L of oxygen and continued to have SpO2 of 86%.  Increased to 6 L and it persistently low at 86%.  Therefore he was placed on HF N/C 50L 60% and patient required increasing oxygen need up to 100% on HFNC. Started the patient on Remdesivir due to worsening with COVID-19 pneumonia with hypoxia on 11/22/21 since CRP was trending up.  Patient was transferred to moderate care status.  Increase the Decadron to 6 mg twice daily as well.  Patient completed Remdesivir.  He was discharged on 11/29/2021
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Chills
Clinical narrative: Patient presented on 11/16/2021 with a chief complaint of  atrial fibrillation maintained on Xarelto and the recent diagnosis of COVID-19 presented to the ED with a history of multiple near syncopal episode associated with lightheadedness and falls.   Patient also reported subjective fevers and chills at home as dry cough.   Upon evaluation in the ED, BP was 87/51 with a heart rate of 58 temperature 99.1° with SpO2 98% in room.  Patient reportedly dehydrated.  Patient received fluid bolus with blood pressure improvement to 125/59.   Covid PCR was positive. Chest x-ray reported acute mild bilateral lower lobe pneumonia.  Subsequently SpO2 noted to drop to 88% when patient is speaking on the phone per ED physician  Patient was subsequently admitted for COVID-19 pneumonia under Hospital Medicine.  Patient was also started on gentle IV fluid for acute kidney injury which subsequently improved.   Procalcitonin was significantly elevated and indicative of significant secondary bacterial infection.  Patient was started on Ceftriaxone and doxycycline. MRSA/MSSA panel was negative.  CRP and procalcitonin are trended down.  Patient was placed on 4 L of oxygen and continued to have SpO2 of 86%.  Increased to 6 L and it persistently low at 86%.  Therefore he was placed on HF N/C 50L 60% and patient required increasing oxygen need up to 100% on HFNC. Started the patient on Remdesivir due to worsening with COVID-19 pneumonia with hypoxia on 11/22/21 since CRP was trending up.  Patient was transferred to moderate care status.  Increase the Decadron to 6 mg twice daily as well.  Patient completed Remdesivir.  He was discharged on 11/29/2021
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dehydration, Dizziness, Fall, Hypoxia
Clinical narrative: Patient presented on 11/16/2021 with a chief complaint of  atrial fibrillation maintained on Xarelto and the recent diagnosis of COVID-19 presented to the ED with a history of multiple near syncopal episode associated with lightheadedness and falls.   Patient also reported subjective fevers and chills at home as dry cough.   Upon evaluation in the ED, BP was 87/51 with a heart rate of 58 temperature 99.1° with SpO2 98% in room.  Patient reportedly dehydrated.  Patient received fluid bolus with blood pressure improvement to 125/59.   Covid PCR was positive. Chest x-ray reported acute mild bilateral lower lobe pneumonia.  Subsequently SpO2 noted to drop to 88% when patient is speaking on the phone per ED physician  Patient was subsequently admitted for COVID-19 pneumonia under Hospital Medicine.  Patient was also started on gentle IV fluid for acute kidney injury which subsequently improved.   Procalcitonin was significantly elevated and indicative of significant secondary bacterial infection.  Patient was started on Ceftriaxone and doxycycline. MRSA/MSSA panel was negative.  CRP and procalcitonin are trended down.  Patient was placed on 4 L of oxygen and continued to have SpO2 of 86%.  Increased to 6 L and it persistently low at 86%.  Therefore he was placed on HF N/C 50L 60% and patient required increasing oxygen need up to 100% on HFNC. Started the patient on Remdesivir due to worsening with COVID-19 pneumonia with hypoxia on 11/22/21 since CRP was trending up.  Patient was transferred to moderate care status.  Increase the Decadron to 6 mg twice daily as well.  Patient completed Remdesivir.  He was discharged on 11/29/2021
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pneumonia, Presyncope, Procalcitonin increased, Pyrexia
Clinical narrative: Patient presented on 11/16/2021 with a chief complaint of  atrial fibrillation maintained on Xarelto and the recent diagnosis of COVID-19 presented to the ED with a history of multiple near syncopal episode associated with lightheadedness and falls.   Patient also reported subjective fevers and chills at home as dry cough.   Upon evaluation in the ED, BP was 87/51 with a heart rate of 58 temperature 99.1° with SpO2 98% in room.  Patient reportedly dehydrated.  Patient received fluid bolus with blood pressure improvement to 125/59.   Covid PCR was positive. Chest x-ray reported acute mild bilateral lower lobe pneumonia.  Subsequently SpO2 noted to drop to 88% when patient is speaking on the phone per ED physician  Patient was subsequently admitted for COVID-19 pneumonia under Hospital Medicine.  Patient was also started on gentle IV fluid for acute kidney injury which subsequently improved.   Procalcitonin was significantly elevated and indicative of significant secondary bacterial infection.  Patient was started on Ceftriaxone and doxycycline. MRSA/MSSA panel was negative.  CRP and procalcitonin are trended down.  Patient was placed on 4 L of oxygen and continued to have SpO2 of 86%.  Increased to 6 L and it persistently low at 86%.  Therefore he was placed on HF N/C 50L 60% and patient required increasing oxygen need up to 100% on HFNC. Started the patient on Remdesivir due to worsening with COVID-19 pneumonia with hypoxia on 11/22/21 since CRP was trending up.  Patient was transferred to moderate care status.  Increase the Decadron to 6 mg twice daily as well.  Patient completed Remdesivir.  He was discharged on 11/29/2021
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Staphylococcus test negative
Clinical narrative: Patient presented on 11/16/2021 with a chief complaint of  atrial fibrillation maintained on Xarelto and the recent diagnosis of COVID-19 presented to the ED with a history of multiple near syncopal episode associated with lightheadedness and falls.   Patient also reported subjective fevers and chills at home as dry cough.   Upon evaluation in the ED, BP was 87/51 with a heart rate of 58 temperature 99.1° with SpO2 98% in room.  Patient reportedly dehydrated.  Patient received fluid bolus with blood pressure improvement to 125/59.   Covid PCR was positive. Chest x-ray reported acute mild bilateral lower lobe pneumonia.  Subsequently SpO2 noted to drop to 88% when patient is speaking on the phone per ED physician  Patient was subsequently admitted for COVID-19 pneumonia under Hospital Medicine.  Patient was also started on gentle IV fluid for acute kidney injury which subsequently improved.   Procalcitonin was significantly elevated and indicative of significant secondary bacterial infection.  Patient was started on Ceftriaxone and doxycycline. MRSA/MSSA panel was negative.  CRP and procalcitonin are trended down.  Patient was placed on 4 L of oxygen and continued to have SpO2 of 86%.  Increased to 6 L and it persistently low at 86%.  Therefore he was placed on HF N/C 50L 60% and patient required increasing oxygen need up to 100% on HFNC. Started the patient on Remdesivir due to worsening with COVID-19 pneumonia with hypoxia on 11/22/21 since CRP was trending up.  Patient was transferred to moderate care status.  Increase the Decadron to 6 mg twice daily as well.  Patient completed Remdesivir.  He was discharged on 11/29/2021
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 Moderna 3/29/21  017B21A dose 2 Moderna 4/26/21  048B21A
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pH decreased, COVID-19, Computerised tomogram head normal, Hypotension, Hypoxia
Clinical narrative: Patient with hx of epilepsy and cognitive delay presenting to ER from home with change of mental status. Evaluation on arrival noting hypotension and fluid boluses initiated. Further work up including negative head CT, venous critical care profile demonstrating a pH of 7.33 with pCO2 of 49 and PO2 of 116. COVID 19 positive with hypoxia. Patient subsequently admitted for further evaluation and management.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Mental status changes, PCO2 increased, PO2 increased, SARS-CoV-2 test positive
Clinical narrative: Patient with hx of epilepsy and cognitive delay presenting to ER from home with change of mental status. Evaluation on arrival noting hypotension and fluid boluses initiated. Further work up including negative head CT, venous critical care profile demonstrating a pH of 7.33 with pCO2 of 49 and PO2 of 116. COVID 19 positive with hypoxia. Patient subsequently admitted for further evaluation and management.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was given wrong vaccine for the patients age.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypertension
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Hypertension-Medium, Additional Details: Patient was taken by ambulance to Hospital.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Alveolar lung disease, Blood lactic acid increased, COVID-19, COVID-19 pneumonia, Chills
Clinical narrative: Patient presented to emergency department on 1/1 with complaints of fever, chills, nausea, vomiting and shortness of breath.   In ER patient was tachycardic, febrile, in respiratory distress, EKG shows sinus tachycardia with heart rate of 129, nonspecific ST T-wave changes, lactic acid was elevated to 2.5, CBC showed WBC of 12.2,, CMP, COVID-19 test positive, sepsis protocol initiated, patient received 2 L fluid bolus, initially on BiPAP and wean down to nasal cannula, with his high risk for pulmonary embolism by CT was done which ruled out PE, mild patchy area of alveolar disease in the left lung base concerning for pneumonia.  Patient was admitted for COVID-19 pneumonia was initially on 4 L of nasal cannula, he was started on azithromycin, ceftriaxone antibiotics, treated with dexamethasone, remdesivir, vitamin supplements, zinc supplements, his symptoms improved, patient weaned off oxygen supply. He was discharged home on home health care.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Dyspnoea, Electrocardiogram ST segment abnormal, Electrocardiogram abnormal, Full blood count abnormal
Clinical narrative: Patient presented to emergency department on 1/1 with complaints of fever, chills, nausea, vomiting and shortness of breath.   In ER patient was tachycardic, febrile, in respiratory distress, EKG shows sinus tachycardia with heart rate of 129, nonspecific ST T-wave changes, lactic acid was elevated to 2.5, CBC showed WBC of 12.2,, CMP, COVID-19 test positive, sepsis protocol initiated, patient received 2 L fluid bolus, initially on BiPAP and wean down to nasal cannula, with his high risk for pulmonary embolism by CT was done which ruled out PE, mild patchy area of alveolar disease in the left lung base concerning for pneumonia.  Patient was admitted for COVID-19 pneumonia was initially on 4 L of nasal cannula, he was started on azithromycin, ceftriaxone antibiotics, treated with dexamethasone, remdesivir, vitamin supplements, zinc supplements, his symptoms improved, patient weaned off oxygen supply. He was discharged home on home health care.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Nausea, Positive airway pressure therapy, Pyrexia, Respiratory distress
Clinical narrative: Patient presented to emergency department on 1/1 with complaints of fever, chills, nausea, vomiting and shortness of breath.   In ER patient was tachycardic, febrile, in respiratory distress, EKG shows sinus tachycardia with heart rate of 129, nonspecific ST T-wave changes, lactic acid was elevated to 2.5, CBC showed WBC of 12.2,, CMP, COVID-19 test positive, sepsis protocol initiated, patient received 2 L fluid bolus, initially on BiPAP and wean down to nasal cannula, with his high risk for pulmonary embolism by CT was done which ruled out PE, mild patchy area of alveolar disease in the left lung base concerning for pneumonia.  Patient was admitted for COVID-19 pneumonia was initially on 4 L of nasal cannula, he was started on azithromycin, ceftriaxone antibiotics, treated with dexamethasone, remdesivir, vitamin supplements, zinc supplements, his symptoms improved, patient weaned off oxygen supply. He was discharged home on home health care.