chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Hepatic enzyme increased, Hypertension, Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis break outs on front of hand/sides of fingers/knuckles/Psoriatic arthritis aggravated; Elevated liver enzyme levels; Sleep impacted/changed sleep pattern /Sleep disturbed; Blood pressure high; 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-163-4308595-00.  A 69 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "Psoriatic arthritis breakouts on front of hand/sides of fingers/knuckles/Psoriatic arthritis aggravated"; HEPATIC ENZYME INCREASED (non-serious), outcome "unknown", described as "Elevated liver enzyme levels"; SLEEP DISORDER (non-serious), outcome "unknown", described as "Sleep impacted/changed sleep pattern /Sleep disturbed"; HYPERTENSION (non-serious), outcome "unknown", described as "Blood pressure high". The patient underwent the following laboratory tests and procedures: blood pressure measurement: high; blood test: elevated liver enzymes. The action taken for adalimumab was unknown. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Psoriatic arthritis break outs on front of hand/sides of fingers/knuckles, elevated liver enzyme levels, sleep impacted/changed sleep pattern and high blood pressure was not provided.   Causality for Pfizer BioNTech COVID-19 Vaccine: The reporter's causality for the event(s) of Psoriatic arthritis break outs on front of hand/sides of fingers/knuckles, elevated liver enzyme levels, sleep impacted/changed sleep pattern and high blood pressure was possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: Sleep disorder
Clinical narrative: Psoriatic arthritis break outs on front of hand/sides of fingers/knuckles/Psoriatic arthritis aggravated; Elevated liver enzyme levels; Sleep impacted/changed sleep pattern /Sleep disturbed; Blood pressure high; 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-163-4308595-00.  A 69 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "Psoriatic arthritis breakouts on front of hand/sides of fingers/knuckles/Psoriatic arthritis aggravated"; HEPATIC ENZYME INCREASED (non-serious), outcome "unknown", described as "Elevated liver enzyme levels"; SLEEP DISORDER (non-serious), outcome "unknown", described as "Sleep impacted/changed sleep pattern /Sleep disturbed"; HYPERTENSION (non-serious), outcome "unknown", described as "Blood pressure high". The patient underwent the following laboratory tests and procedures: blood pressure measurement: high; blood test: elevated liver enzymes. The action taken for adalimumab was unknown. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Psoriatic arthritis break outs on front of hand/sides of fingers/knuckles, elevated liver enzyme levels, sleep impacted/changed sleep pattern and high blood pressure was not provided.   Causality for Pfizer BioNTech COVID-19 Vaccine: The reporter's causality for the event(s) of Psoriatic arthritis break outs on front of hand/sides of fingers/knuckles, elevated liver enzyme levels, sleep impacted/changed sleep pattern and high blood pressure was possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19, Tooth infection
Clinical narrative: Teeth infection; COVID-19; COVID-19; 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-163-4310130-00.  A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Dec2021 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single, intramuscular, administration date 02May2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 11Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1150237) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "recovered" (2022) and all described as "COVID-19"; TOOTH INFECTION (non-serious), outcome "not recovered", described as "Teeth infection". The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of Teeth infection and COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of Teeth infection was not reported and for COVID-19 was possible with PFIZER BIONTECH COVID-19 VACCINE.  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 events Drug ineffective, Suspected COVID-19 and Tooth infection and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: 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-163-4296882-00 (RA). A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First Dose, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Second Dose, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "moderate to severe rheumatoid arthritis flare up". The action taken for adalimumab was unknown. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of moderate to severe rheumatoid arthritis flare up was not provided. The reporter's assessment of the causal relationship of the event moderate to severe rheumatoid arthritis flare up with the suspect product bnt162b2 was Possible at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Clinical course: Solicited report by a consumer of an adult female with an event of non-serious moderate to severe rheumatoid arthritis flare up with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced moderate to severe rheumatoid arthritis flare up. On an unknown date, moderate to severe rheumatoid arthritis flare up resolved. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event. 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.
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal scarring, Pain
Clinical narrative: the patient experienced scar tissue in colon and pain after took covid 19 booster shot; the patient experienced scar tissue in colon and pain after took covid 19 booster shot; 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-163-4308065-00.  A 70 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization completed., Unknown manufacturer., Route : Intramuscular), for COVID-19 Vaccination. The following information was reported: GASTROINTESTINAL SCARRING (medically significant), PAIN (medically significant), outcome "recovered" and all described as "the patient experienced scar tissue in colon and pain after took covid 19 booster shot". The action taken for adalimumab was unknown.The patient had scar tissue removed in his colon in 2021.   The reporter's assessment of the causal relationship of the gastrointestinal scarring and pain with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter's assessment of the causal relationship of gastrointestinal scarring and pain with the suspect product Humira was reported as no reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events gastrointestinal scarring and pain and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Smear cervix, Smear cervix abnormal
Clinical narrative: COVID-19; COVID-19; Pap smear abnormal; 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-163-4309910-00.  A 42 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19"; SMEAR CERVIX ABNORMAL (non-serious), outcome "recovered", described as "Pap smear abnormal". The patient underwent the following laboratory tests and procedures: smear cervix: unknown results. The action taken for adalimumab was unknown.  Clinical course: Solicited report by a consumer of an adult female with events of non-serious Covid and Abnormal pap smear but it was not cancerous with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced COVID and Abnormal pap smear but it was not cancerous. On unknown dates, Covid and Abnormal pap smear but it was not cancerous resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Covid and Abnormal pap smear but it was not cancerous with Humira (Adalimumab) was a reasonable possibility.  Causality for Pfizer biontech covid-19 vaccine(tozinameran): The reporter's causality for the events of Covid was related and Abnormal pap smear was not reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, the reported event of pap smear abnormal is assessed as unrelated to vaccine ,due to known pathophysiology on the medical condition. 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: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Antibody test, Chest pain, Fatigue, Heart rate
Clinical narrative: chest pain; Resting HR increase from my normal low 50s to 67 according to my watch the day after second dose; kidney pain bilaterally; GI distress; extreme fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: FEXOFENADINE. Past drug history included: Prednisone, reaction(s): "Known allergies: Prednisone", notes: prednisone. And to expand on above., I have had over 70 negative rapid, tests and 1 negative antibody. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Oct2021, for Covid-19 immunization, reaction(s): "Extreme fatigue". The following information was reported: CHEST PAIN (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "chest pain"; HEART RATE INCREASED (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "Resting HR increase from my normal low 50s to 67 according to my watch the day after second dose"; RENAL PAIN (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "kidney pain bilaterally"; ABDOMINAL DISCOMFORT (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "GI distress"; FATIGUE (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "extreme fatigue". The events "chest pain", "resting hr increase from my normal low 50s to 67 according to my watch the day after second dose", "kidney pain bilaterally", "gi distress" and "extreme fatigue" 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 chest pain, heart rate increased, abdominal discomfort, fatigue.  Additional Information: Patient took other medications in two weeks: Multivitamin. Patient received treatment for AEs was probiotics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Renal pain, SARS-CoV-2 test
Clinical narrative: chest pain; Resting HR increase from my normal low 50s to 67 according to my watch the day after second dose; kidney pain bilaterally; GI distress; extreme fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: FEXOFENADINE. Past drug history included: Prednisone, reaction(s): "Known allergies: Prednisone", notes: prednisone. And to expand on above., I have had over 70 negative rapid, tests and 1 negative antibody. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Oct2021, for Covid-19 immunization, reaction(s): "Extreme fatigue". The following information was reported: CHEST PAIN (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "chest pain"; HEART RATE INCREASED (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "Resting HR increase from my normal low 50s to 67 according to my watch the day after second dose"; RENAL PAIN (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "kidney pain bilaterally"; ABDOMINAL DISCOMFORT (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "GI distress"; FATIGUE (non-serious) with onset Nov2021, outcome "recovered with sequelae", described as "extreme fatigue". The events "chest pain", "resting hr increase from my normal low 50s to 67 according to my watch the day after second dose", "kidney pain bilaterally", "gi distress" and "extreme fatigue" 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 chest pain, heart rate increased, abdominal discomfort, fatigue.  Additional Information: Patient took other medications in two weeks: Multivitamin. Patient received treatment for AEs was probiotics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Haematochezia, Mucous stools
Clinical narrative: Blood in stool; Loose stools; Mucus stools; 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-163-4308149-00 (Same patient).  A 70 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at cf for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMATOCHEZIA (medically significant), outcome "unknown", described as "Blood in stool"; DIARRHOEA (non-serious), outcome "unknown", described as "Loose stools"; MUCOUS STOOLS (non-serious), outcome "unknown", described as "Mucus stools". The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab) : The reporter's causality for the event(s) of loose stool, blood in stool and mucus in stool was not provided.  Causality for Pfizer BioNTech COVID-19 Vaccine (Tozinameran) (Tozinameran) Unknown : The reporter's causality for the event(s) of loose stool, blood in stool and mucus in stool was Possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Condition aggravated, Feeling abnormal, Gait disturbance, Limb discomfort
Clinical narrative: her foot got stuck so she fell and broke three ribs; last night and started feeling tight and tight; she couldn't walk; has arthritis and it has gotten worse; her foot got stuck so she fell and broke three ribs; Yesterday it was strong- pain in the caller's arm, legs, and hands; caller got worse but the doctor said she would get better; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19), administration date 26Nov2021 (Lot number: EL9266) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "heart surgery" (unspecified if ongoing), notes: Verbatim: heart surgery she had three bypasses; "Arthritis" (unspecified if ongoing); "Diabetes mellitus" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "Blood cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiac disorder; METFORMIN taken for diabetes mellitus; ATORVASTATIN taken for blood cholesterol; GLIPIZIDE XL taken for diabetes mellitus; GABAPENTIN taken for arthritis. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE, lot EL9266), administration date: 23Feb2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "headache", "pain in her arm"; Bnt162b2 (DOSE 2,SINGLE, lot EN6207, Second dose: its like a rash where the balls are like 25 cent or 10 cent currency and its like a rash and it is inside her skin.), administration date: 16Mar2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "its like a rash", "Shingles", "feel more pressure and is starting to get scared". The following information was reported: RIB FRACTURE (medically significant), LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "her foot got stuck so she fell and broke three ribs"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "last night and started feeling tight and tight"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "she couldn't walk"; ARTHRITIS (non-serious), outcome "unknown", described as "has arthritis and it has gotten worse"; PAIN (non-serious), outcome "unknown", described as "Yesterday it was strong- pain in the caller's arm, legs, and hands"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "caller got worse but the doctor said she would get better". Clinical details: Patient sat down last night and started feeling tight and tight and she couldn't walk. The caller has arthritis and it has gotten worse. The caller called because her foot got stuck so she fell and broke three ribs. Yesterday it was strong- pain in the caller's arm, legs, and hands. The patient saw her new doctor but she didn't pay too much attention.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rib fracture
Clinical narrative: her foot got stuck so she fell and broke three ribs; last night and started feeling tight and tight; she couldn't walk; has arthritis and it has gotten worse; her foot got stuck so she fell and broke three ribs; Yesterday it was strong- pain in the caller's arm, legs, and hands; caller got worse but the doctor said she would get better; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19), administration date 26Nov2021 (Lot number: EL9266) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "heart surgery" (unspecified if ongoing), notes: Verbatim: heart surgery she had three bypasses; "Arthritis" (unspecified if ongoing); "Diabetes mellitus" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "Blood cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiac disorder; METFORMIN taken for diabetes mellitus; ATORVASTATIN taken for blood cholesterol; GLIPIZIDE XL taken for diabetes mellitus; GABAPENTIN taken for arthritis. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE, lot EL9266), administration date: 23Feb2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "headache", "pain in her arm"; Bnt162b2 (DOSE 2,SINGLE, lot EN6207, Second dose: its like a rash where the balls are like 25 cent or 10 cent currency and its like a rash and it is inside her skin.), administration date: 16Mar2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "its like a rash", "Shingles", "feel more pressure and is starting to get scared". The following information was reported: RIB FRACTURE (medically significant), LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "her foot got stuck so she fell and broke three ribs"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "last night and started feeling tight and tight"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "she couldn't walk"; ARTHRITIS (non-serious), outcome "unknown", described as "has arthritis and it has gotten worse"; PAIN (non-serious), outcome "unknown", described as "Yesterday it was strong- pain in the caller's arm, legs, and hands"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "caller got worse but the doctor said she would get better". Clinical details: Patient sat down last night and started feeling tight and tight and she couldn't walk. The caller has arthritis and it has gotten worse. The caller called because her foot got stuck so she fell and broke three ribs. Yesterday it was strong- pain in the caller's arm, legs, and hands. The patient saw her new doctor but she didn't pay too much attention.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hyperthyroidism
Clinical narrative: She had like hyperthyroid in the hospital; her body incredibly weak she couldn't get up; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 16Apr2021 (Lot number: ER8731) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: HYPERTHYROIDISM (hospitalization, medically significant), outcome "unknown", described as "She had like hyperthyroid in the hospital"; ASTHENIA (non-serious), outcome "unknown", described as "her body incredibly weak she couldn't get up".; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect vaccine BNT162B2 to reported event of  HYPERTHYROIDISM  cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-202200404920 same reporter/drug/event, different patients
Sex: F
Vaccine: COVID19
Symptoms: Hypothyroidism
Clinical narrative: her mom after receive the second dose of adult purple cap Pfizer she got hypothyroid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HYPOTHYROIDISM (medically significant), outcome "unknown", described as "her mom after receive the second dose of adult purple cap Pfizer she got hypothyroid".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event hypothyroidism cannot be excluded.   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.,Linked Report(s) : US-PFIZER INC-202200404844 same reporter/drug/event, different patients
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: hives disappeared after he took Pfizer Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown Manufacturer), for COVID-19 immunization; Bnt162b2 (Dose 2, before he is taking Zyrtec and Allegra for his hives), for COVID-19 immunization, reaction(s): "he experience turbel case of hives" The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "hives disappeared after he took Pfizer Booster". Additional Information: Verbatim and Event Description Describe the adverse experience (AE)/beneficial effect/at risk including all pertinent information: Caller (name withheld), Consumer mentioned he had something important to report, he took Pfizer injection and on the second dose he experience turbel case of hives and suffered 6 months but after he took Pfizer Booster his hives disappeared. It helps him to clear his skin and stop itching, before he is taking Zyrtec and Allegra for his hives. Caller wants to report it so if others have the same disease they can use it as a suggestion. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, COVID-19, Papule, Pruritus, Rash
Clinical narrative: Rash that covered whole left arm from injection site to the left hand that was extremely itchy and lasted for 3 weeks; papules; vesicles; Rash that covered whole left arm from injection site to the left hand that was extremely itchy and lasted for 3 weeks; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Mar2021 (Lot number: EN6208) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "positive epstein barr virus", start date: Sep1987 (ongoing), notes: positive epstein barr virus, Pertinent details: Secondary to mononucleosis Sep1987; "Splenectomy", start date: 19Dec1999 (unspecified if ongoing), notes: Car Accident 19Dec1999. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EN6200), administration date: 19Feb2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset 27Mar2021, outcome "recovered" (27Apr2021), PRURITUS (non-serious), outcome "unknown" and all described as "Rash that covered whole left arm from injection site to the left hand that was extremely itchy and lasted for 3 weeks"; PAPULE (non-serious), outcome "unknown", described as "papules"; BLISTER (non-serious), outcome "unknown", described as "vesicles". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash.  Additional information: The patient has provide information regarding the reported adverse event (s) with the use of the product. The patient has considered the Pfizer product had a causal effect to the adverse event.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Chest X-ray, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Test: Covid, Result: Yes (positive); Test: Covid, Result: Yes (positive); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 19Nov2021 (Lot number: FJ8757) at the age of 65 years as dose 3 (booster), single, intramuscular, administered in arm right, administration date 31Mar2021 (Lot number: ER8734) as dose 2, single and intramuscular, administered in arm right, administration date 08Mar2021 12:00 (Lot number: EN6199) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Shingles" (unspecified if ongoing), notes: Shingles once; "Lyme disease" (unspecified if ongoing), notes: had a prescription for an antibiotic for Lyme disease once from 1956 to date that is it. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Test: Covid, Result: Yes (positive)". The patient underwent the following laboratory tests and procedures: blood test: unknown results, notes: let me know what my levels were. I believe he said 380; chest x-ray: no pneumonia; COVID test: yes, notes: Covid Result: Yes Positive; no, notes: Covid Result: No Negative.
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, Medication error
Clinical narrative: Menactra on day 1 and then received a second dose 4 weeks later, instead of the recommended 8 weeks; Initial information was received on 08-MAR-2022 regarding an unsolicited valid non-serious case received from a pharmacist via call center.  This case involves an adult unknown gender patient who experienced menactra on day 1 and then received a second dose 4 weeks later, instead of the recommended 8 weeks while receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) vaccine [MENACTRA].  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.     On an unknown date, the patient received one dosage of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine (strength, dose, route, batch number and expiry date) in unknown administered site for prophylactic vaccination. Information on batch number is requested.   On an unknown date the patient developed a non-serious menactra on day 1 and then received a second dose 4 weeks later, instead of the recommended 8 weeks (inappropriate schedule of product administration) 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 menactra on day 1 and then received a second dose 4 weeks later, instead of the recommended 8 weeks.  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: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered an expired Tenivac with no reported adverse event; Initial information received on 09-Mar-2022 regarding an unsolicited valid non-serious case received from an other health professional via call center.  This case involves an unknown age and unknown gender patient who was administered an expired tenivac with no reported adverse event while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult suspension for injection (lot U6603AA; expiry date: 05-Mar-2022; strength, frequency: unknown) at an unknown dose via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was administered an expired tenivac with no reported adverse event (expired product administered) (unknown latency) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 4.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, Product storage error
Clinical narrative: IPOL due to completing inventory; temperature excursion was 1.8C to 0.8C; total time of excursion was 35 minutes; IPOL was administered to 1 patient post-excursion with no reported adverse event; the patient received 4 doses previously, and the dose she received on 02Mar2022 would have been her 5th with no reported adverse eveent; Initial information received on 11-Mar-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 4 years old female patient in whom ipol was administered post-excursion with no reported adverse event, the patient received 4 doses previously; the dose she received on 02-Mar-2022 would have been her 5th with no reported adverse event and the temperature excursion of IPOL was 1.8c to 0.8c; total time of excursion was 35 minutes due to completing inventory while receiving vaccine IPV (Vero) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Dtap); Measles, Mumps, Rubella Vaccine (MMR) and Varicella Zoster Vaccine (Varicella Vaccine) for Prophylactic immunization.  On 02-Mar-2022, the patient received 0.5ml dose of suspect IPV (VERO) vaccine suspension for injection (lot: T1E871M, expiry date: 10-Oct-2022) via intramuscular route in left vastus lateralis for immunization.  On 02-MAR-2022, the ipol was administered to patient post-excursion with no reported adverse event (poor quality product administered), received 4 doses previously and the dose she received on 02-Mar-2022 would have been her 5th with no reported adverse event (inappropriate schedule of product administration) (latency: same day) following the administration of IPV (VERO). On an unknown date the temperature excursion of IPOL was 1.8c to 0.8c; total time of excursion was 35 minutes due to completing inventory (product storage error) (unknown latency) following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event (poor quality product administered, product storage error and inappropriate schedule of product administration).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient was accidentally given expired Menactra with no reported adverse event; Initial information received on 11-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 years old male patient who experienced a patient was accidentally given expired menactra with no reported adverse event 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 09-Mar-2022, the patient received a 0.5 ml dosage of meningococcal a-c-y-w135 (d conj) vaccine via intramuscular route in left arm  (with unknown strength and formulation) (batch number :U6827BA and expiry date :18 Feb 2022) for immunization.   On 09-Mar-2022 (latency: same day)the patient developed a non-serious patient was accidentally given expired menactra 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 (a patient was accidentally given expired Menactra with no reported adverse event).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error
Clinical narrative: consumer received an expired dose of Pentacel  with no adverse event; Initial information received on 14-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  Country:  This case involves a 4 months old male patient who had received an expired dose of pentacel  with no adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj (pneumococcal conjugate vaccine) and rotavirus vaccine (rotavirus vaccine) for immunisation.  On 19-Jul-2021, the patient received a dose 0.5 ml once a day of suspect Pentacel (lot UJ214AAA, expiry date: 02-May-2021) via intramuscular route in the right leg for immunization On 19-Jul-2021 the patient received an expired dose of pentacel  with no adverse event (expired product administered) (latency: same day).  Action taken: not applicable  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.