chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood bilirubin, Imaging procedure, International normalised ratio, Investigation, Physical examination
Clinical narrative: seronegative AIH or drug induced AIH;   Herein, the authors present a patient with drug-induced AIH with possible relation to Pfizer-BioNTech COVID-19 vaccine. Case Description/Methods: A 38-year-old female with a history of Helicobacter pylori treated with amoxicillin and pantoprazole three months ago and recent COVID-19 vaccination presented with two weeks of right upper quadrant pain and diarrhea. Patient received second dose of vaccination two weeks prior to symptom onset. Five days post-symptom onset, she developed a pruritic rash with vomiting and yellowing of her skin. Physical examination was notable for normal mentation, scleral icterus, jaundice, and a maculopapular rash. Initial blood workup showed international normalized ratio 2.4, alkaline phosphatase 212 U/L, ALT 3769 U/L, AST 1572 U/L and total bilirubin of 23.8 mg/ dL. Viral hepatitis serologies, chronic liver disease workup and autoimmune serologies were normal. Imaging demonstrated no intra- or extra-hepatic biliary ductal dilation. Liver biopsy showed portal inflammation with interface activity, diffuse lobular inflammation, and perivenulitis with abundant lymphocytes and plasma cells consistent with seronegative AIH or drug induced AIH. The patient developed altered mental status meeting the criteria of acute liver failure, she was started on corticosteroids as well as supportive care with resolution of encephalopathy and was discharged home on prednisone. Discussion: Several etiologies of drug-induced AIH are well-established, however cases secondary to COVID-19 vaccination have been minimally reported. Common adverse events for COVID-19 vaccination have been noted such as fever, chills, fatigue, headache, and muscle pain. Several rare side effects have occurred including immune thrombocytopenia and one other suspected case of Pfizer- BioNTech COVID-19 vaccination-induced AIH reported in the literature. In that case the patient developed symptoms within one week of the first dose. This case serves to report a potential association and not necessarily causation between the Pfizer-BioNTech COVID-19 vaccination and AIH.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event autoimmune hepatitis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Serology test
Clinical narrative: seronegative AIH or drug induced AIH;   Herein, the authors present a patient with drug-induced AIH with possible relation to Pfizer-BioNTech COVID-19 vaccine. Case Description/Methods: A 38-year-old female with a history of Helicobacter pylori treated with amoxicillin and pantoprazole three months ago and recent COVID-19 vaccination presented with two weeks of right upper quadrant pain and diarrhea. Patient received second dose of vaccination two weeks prior to symptom onset. Five days post-symptom onset, she developed a pruritic rash with vomiting and yellowing of her skin. Physical examination was notable for normal mentation, scleral icterus, jaundice, and a maculopapular rash. Initial blood workup showed international normalized ratio 2.4, alkaline phosphatase 212 U/L, ALT 3769 U/L, AST 1572 U/L and total bilirubin of 23.8 mg/ dL. Viral hepatitis serologies, chronic liver disease workup and autoimmune serologies were normal. Imaging demonstrated no intra- or extra-hepatic biliary ductal dilation. Liver biopsy showed portal inflammation with interface activity, diffuse lobular inflammation, and perivenulitis with abundant lymphocytes and plasma cells consistent with seronegative AIH or drug induced AIH. The patient developed altered mental status meeting the criteria of acute liver failure, she was started on corticosteroids as well as supportive care with resolution of encephalopathy and was discharged home on prednisone. Discussion: Several etiologies of drug-induced AIH are well-established, however cases secondary to COVID-19 vaccination have been minimally reported. Common adverse events for COVID-19 vaccination have been noted such as fever, chills, fatigue, headache, and muscle pain. Several rare side effects have occurred including immune thrombocytopenia and one other suspected case of Pfizer- BioNTech COVID-19 vaccination-induced AIH reported in the literature. In that case the patient developed symptoms within one week of the first dose. This case serves to report a potential association and not necessarily causation between the Pfizer-BioNTech COVID-19 vaccination and AIH.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event autoimmune hepatitis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Immunisation, Lethargy, Pyrexia
Clinical narrative: Booster; Fever; chills; lethargy; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-HCP).  A patient (no qualifiers provided) 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; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (Dose 2; MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; LETHARGY (non-serious), outcome "unknown", described as "lethargy". Additional information: A non-contactable consumer communicated to a Pfizer sales representative for a patient. Patient had fever, chills, lethargy within 10 hours of Pfizer Covid vaccine third dose. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Diarrhoea, Fatigue, Headache
Clinical narrative: Headache; joint pain; armpit pain; exhaustion; arm pain; diarrhea; every part of my body hurt to touch, extremely achey and muscle pain; every part of my body hurt to touch, extremely achey and muscle pain; Dose received: 3; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 16:45 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYMBALTA; WELLBUTRIN; ADDERALL; CRESTOR. Past drug history included: Prilocaine, reaction(s): "Known allergies: Prilocaine". Vaccination history included: Bnt162b2 (Dose 2, single, Batch/Lot No: Unknown (unable to locate or read the details), administered at left arm), administration date: 13Apr2021, when the patient was 52 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, single, Batch/Lot No: Unknown (unable to locate or read the details), administered at left arm), administration date: 23Mar2021, when the patient was 52 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 16:45, outcome "unknown", described as "Dose received: 3"; HEADACHE (non-serious) with onset 23Nov2021 07:00, outcome "recovering", described as "Headache"; ARTHRALGIA (non-serious) with onset 23Nov2021 07:00, outcome "recovering", described as "joint pain"; AXILLARY PAIN (non-serious) with onset 23Nov2021 07:00, outcome "recovering", described as "armpit pain"; FATIGUE (non-serious) with onset 23Nov2021 07:00, outcome "recovering", described as "exhaustion"; PAIN IN EXTREMITY (non-serious) with onset 23Nov2021 07:00, outcome "recovering", described as "arm pain"; DIARRHOEA (non-serious) with onset 23Nov2021 07:00, outcome "recovering", described as "diarrhea"; MYALGIA (non-serious), PAIN (non-serious) all with onset 23Nov2021 07:00, outcome "recovering" and all described as "every part of my body hurt to touch, extremely achey and muscle pain". Therapeutic measures were not taken as a result of headache, arthralgia, axillary pain, fatigue, pain in extremity, diarrhoea, myalgia, pain. Additional information: Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID, prior to vaccination and had not been tested for COVID-19, post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Myalgia, Pain, Pain in extremity
Clinical narrative: Headache; joint pain; armpit pain; exhaustion; arm pain; diarrhea; every part of my body hurt to touch, extremely achey and muscle pain; every part of my body hurt to touch, extremely achey and muscle pain; Dose received: 3; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 16:45 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYMBALTA; WELLBUTRIN; ADDERALL; CRESTOR. Past drug history included: Prilocaine, reaction(s): "Known allergies: Prilocaine". Vaccination history included: Bnt162b2 (Dose 2, single, Batch/Lot No: Unknown (unable to locate or read the details), administered at left arm), administration date: 13Apr2021, when the patient was 52 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, single, Batch/Lot No: Unknown (unable to locate or read the details), administered at left arm), administration date: 23Mar2021, when the patient was 52 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 16:45, outcome "unknown", described as "Dose received: 3"; HEADACHE (non-serious) with onset 23Nov2021 07:00, outcome "recovering", described as "Headache"; ARTHRALGIA (non-serious) with onset 23Nov2021 07:00, outcome "recovering", described as "joint pain"; AXILLARY PAIN (non-serious) with onset 23Nov2021 07:00, outcome "recovering", described as "armpit pain"; FATIGUE (non-serious) with onset 23Nov2021 07:00, outcome "recovering", described as "exhaustion"; PAIN IN EXTREMITY (non-serious) with onset 23Nov2021 07:00, outcome "recovering", described as "arm pain"; DIARRHOEA (non-serious) with onset 23Nov2021 07:00, outcome "recovering", described as "diarrhea"; MYALGIA (non-serious), PAIN (non-serious) all with onset 23Nov2021 07:00, outcome "recovering" and all described as "every part of my body hurt to touch, extremely achey and muscle pain". Therapeutic measures were not taken as a result of headache, arthralgia, axillary pain, fatigue, pain in extremity, diarrhoea, myalgia, pain. Additional information: Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID, prior to vaccination and had not been tested for COVID-19, post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Diarrhoea, Illness, Immunisation, Influenza like illness
Clinical narrative: booster; was "very sick with flu like symptoms; was "very sick with flu like symptoms; Nausea; Diarrhea; Arm rash; Needed to stay in bed for 2 days; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a sponsored program (060820).  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 67 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization; Bnt162b2 (DOSE: 2), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), INFLUENZA LIKE ILLNESS (non-serious) all with onset Nov2021, outcome "recovered" (Nov2021) and all described as "was "very sick with flu like symptoms"; NAUSEA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Nausea"; DIARRHOEA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Diarrhea"; RASH (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Arm rash"; BEDRIDDEN (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Needed to stay in bed for 2 days"; IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "booster". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: The patient reported delayed start of current cycle by 1 week per MD hold because of lowered white and red blood count/neutrophil count which improved last week and cycle started on 17Nov2021. The patient had covid booster 19Nov2021 and was very sick with flu like symptoms, nausea, diarrhea, arm rash and needed to stay in bed for 2 days but now much better. The events were reported to (Pharmacy name withheld) by Patient/Caregiver.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neutrophil count, Rash, Red blood cell count, White blood cell count
Clinical narrative: booster; was "very sick with flu like symptoms; was "very sick with flu like symptoms; Nausea; Diarrhea; Arm rash; Needed to stay in bed for 2 days; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a sponsored program (060820).  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 67 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization; Bnt162b2 (DOSE: 2), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), INFLUENZA LIKE ILLNESS (non-serious) all with onset Nov2021, outcome "recovered" (Nov2021) and all described as "was "very sick with flu like symptoms"; NAUSEA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Nausea"; DIARRHOEA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Diarrhea"; RASH (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Arm rash"; BEDRIDDEN (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Needed to stay in bed for 2 days"; IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "booster". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: The patient reported delayed start of current cycle by 1 week per MD hold because of lowered white and red blood count/neutrophil count which improved last week and cycle started on 17Nov2021. The patient had covid booster 19Nov2021 and was very sick with flu like symptoms, nausea, diarrhea, arm rash and needed to stay in bed for 2 days but now much better. The events were reported to (Pharmacy name withheld) by Patient/Caregiver.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood creatinine increased, Blood pressure measurement, Colonoscopy, Hypertension, Illness
Clinical narrative: Blood pressure high/high blood pressure of 260/190; Sickness; Creatinine increased; Infection; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP) received by Pfizer from a company (manufacturer control number (21K-163-4172986-00). The reporter is the patient.  A 50-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Jun2021 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis, psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (hospitalization, medically significant) with onset 01Jun2021, outcome "unknown", described as "Blood pressure high/high blood pressure of 260/190"; ILLNESS (hospitalization) with onset Jun2021, outcome "unknown", described as "Sickness"; BLOOD CREATININE INCREASED (hospitalization, medically significant) with onset 2021, outcome "not recovered", described as "Creatinine increased"; INFECTION (hospitalization) with onset 2021, outcome "recovering", described as "Infection". The patient underwent the following laboratory tests and procedures: blood creatinine increased: (unspecified date) high; blood pressure measurement: (01Jun2021) 260/190; colonoscopy: (unspecified date) unknown. The action taken for adalimumab was dosage not changed. Clinical course: On 20Jun2021, patient received 2nd dose Covid-19 Vaccine manufactured by Pfizer/BioNTech, lot number Unknown, expiration date Unknown.  Causal relationship between the event(s) and the administration of HUMIRA was not reported as per reporter and no reasonable possibility as per manufacturer.  The reporter's assessment of the causal relationship of the events 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Hypertension , Illness, blood creatinine increased and infection 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 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: 50.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Infection
Clinical narrative: Blood pressure high/high blood pressure of 260/190; Sickness; Creatinine increased; Infection; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP) received by Pfizer from a company (manufacturer control number (21K-163-4172986-00). The reporter is the patient.  A 50-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Jun2021 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis, psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (hospitalization, medically significant) with onset 01Jun2021, outcome "unknown", described as "Blood pressure high/high blood pressure of 260/190"; ILLNESS (hospitalization) with onset Jun2021, outcome "unknown", described as "Sickness"; BLOOD CREATININE INCREASED (hospitalization, medically significant) with onset 2021, outcome "not recovered", described as "Creatinine increased"; INFECTION (hospitalization) with onset 2021, outcome "recovering", described as "Infection". The patient underwent the following laboratory tests and procedures: blood creatinine increased: (unspecified date) high; blood pressure measurement: (01Jun2021) 260/190; colonoscopy: (unspecified date) unknown. The action taken for adalimumab was dosage not changed. Clinical course: On 20Jun2021, patient received 2nd dose Covid-19 Vaccine manufactured by Pfizer/BioNTech, lot number Unknown, expiration date Unknown.  Causal relationship between the event(s) and the administration of HUMIRA was not reported as per reporter and no reasonable possibility as per manufacturer.  The reporter's assessment of the causal relationship of the events 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Hypertension , Illness, blood creatinine increased and infection 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 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture, Pyrexia
Clinical narrative: FRACTURED LEFT ANKLE; mild fever with second covid vaccine; This is a solicited report based (FACILITATED COLLECT) on the information received by Pfizer from AbbVie Inc. (MFR control no.: 21K-163-4166706-00). A contactable 52-year-old female consumer (patient) reported for herself that:  This solicited report by a consumer of a 52 month old female with events of non-serious mild fever with second covid vaccine, fractured left ankle and got COVID with HUMIRA (ADALIMUMAB). There was no reported medical history.  In Apr2020, the patient experienced GOT COVID. In May2021, the patient experienced MILD FEVER WITH SECOND COVID VACCINE. In Oct2021, the patient experienced fractured left ankle. in 2021, the mild fever with second covid vaccine resolved. on an unknown date, got COVID resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 28Apr2021, she received first dose COVID-19 Vaccine manufactured by Pfizer. On 19 May 2021, she received second dose COVID-19 Vaccine manufactured by Pfizer.    Causality for HUMIRA (ADALIMUMAB). The reporter's causality for the event(s) of mild fever with second covid vaccine with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of fractured left ankle and got COVID was not provided.  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 information provided and plausible temporal association, the causality between BNT162B2 and events cannot be completely 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Immunisation, Oropharyngeal pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 10:45 (Lot number: FG3527) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: OCUVITE [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;SODIUM SELENATE;TOCOPHERYL ACETATE;ZINC OXIDE]; BIOTIN. Vaccination history included: Bnt162b2 (previous dose product=COVID 19, Dose number: 1, brand: Pfizer, lot number: EN6208, administration date: 01Apr2021, administration time: 12:00PM, vaccine location: Right arm), administration date: 01Apr2021, when the patient was 57 years old, for Covid-19 immunization; Bnt162b2 (previous dose product=COVID 19, Dose number: 2, brand: Pfizer, lot number: ER2613, administration date : 23Apr2021, administration time: 12:00PM, vaccine location: Right arm), administration date: 23Apr2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Nov2021 10:45, outcome "unknown", described as "Booster"; OROPHARYNGEAL PAIN (non-serious), COUGH (non-serious) all with onset 17Nov2021 12:00, outcome "recovered" (Nov2021) and all described as "developed a sore throat that transitioned to a mild, dry cough". Therapeutic measures were not taken as a result of oropharyngeal pain, cough.  Additional information: No other vaccine was received in four weeks. Other medications in two weeks: eye medicine. It was reported that approximately 7 to 10 days after the booster shot developed a sore throat that transitioned to a mild, dry cough which lasted a couple days. The patient had not taken any COVID vaccination prior, patient was not tested COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood test, Hyperthyroidism, Immunisation, Optic nerve injury, Thyroid disorder
Clinical narrative: Symptom of hyperthyroid/high thyroid levels in blood; nerve damage in left eye; Symptom of hyperthyroid/high thyroid levels in blood; thyroid issues after had third covid vaccine; Dose 3;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (not available). The reporter is the patient. Other Case identifier(s): 21K-163-4164592-00 (Company).  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (citrate free)) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 vaccination, reaction(s): "symptom of hyperthyroid/high thyroid levels in blood", "nerve damage in left eye", "thyroid issues after had third covid vaccine"; Bnt162b2 (2nd dose), for COVID-19 vaccination, reaction(s): "symptom of hyperthyroid/high thyroid levels in blood", "nerve damage in left eye", "thyroid issues after had third covid vaccine".  The following information was reported: HYPERTHYROIDISM (medically significant), THYROID HORMONES INCREASED (non-serious), outcome "unknown" and all described as "Symptom of hyperthyroid/high thyroid levels in blood"; OPTIC NERVE INJURY (medically significant), outcome "unknown", described as "nerve damage in left eye"; THYROID DISORDER (non-serious), outcome "unknown", described as "thyroid issues after had third covid vaccine"; IMMUNISATION (non-serious), outcome "unknown", described as "Dose 3". The patient underwent the following laboratory tests and procedures: blood test: unknown results, notes: Thyroid issues; thyroid function test: high. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the event with the suspect product 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported  events 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 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, UNK
Symptoms: Thyroid function test, Thyroid hormones increased
Clinical narrative: Symptom of hyperthyroid/high thyroid levels in blood; nerve damage in left eye; Symptom of hyperthyroid/high thyroid levels in blood; thyroid issues after had third covid vaccine; Dose 3;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (not available). The reporter is the patient. Other Case identifier(s): 21K-163-4164592-00 (Company).  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (citrate free)) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 vaccination, reaction(s): "symptom of hyperthyroid/high thyroid levels in blood", "nerve damage in left eye", "thyroid issues after had third covid vaccine"; Bnt162b2 (2nd dose), for COVID-19 vaccination, reaction(s): "symptom of hyperthyroid/high thyroid levels in blood", "nerve damage in left eye", "thyroid issues after had third covid vaccine".  The following information was reported: HYPERTHYROIDISM (medically significant), THYROID HORMONES INCREASED (non-serious), outcome "unknown" and all described as "Symptom of hyperthyroid/high thyroid levels in blood"; OPTIC NERVE INJURY (medically significant), outcome "unknown", described as "nerve damage in left eye"; THYROID DISORDER (non-serious), outcome "unknown", described as "thyroid issues after had third covid vaccine"; IMMUNISATION (non-serious), outcome "unknown", described as "Dose 3". The patient underwent the following laboratory tests and procedures: blood test: unknown results, notes: Thyroid issues; thyroid function test: high. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the event with the suspect product 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported  events 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 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, UNK
Symptoms: Blood test, Hyperthyroidism, Optic nerve injury, Thyroid function test
Clinical narrative: Symptom of hyperthyroid/high thyroid levels in blood; nerve damage in left eye;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (not available). The reporter is the patient. Other Case identifier(s): 21K-163-4164592-00 (Company).  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single and intramuscular (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (citrate free (40 mg,1 in 14 d)) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTHYROIDISM (medically significant), outcome "unknown", described as "Symptom of hyperthyroid/high thyroid levels in blood"; OPTIC NERVE INJURY (medically significant), outcome "unknown", described as "nerve damage in left eye". The patient underwent the following laboratory tests and procedures: blood work: thyroid issues; thyroid level: high. The action taken for adalimumab was unknown.  The reporter's causality for the event(s) of symptom of hyperthyroid/high thyroid levels in blood with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility and causality for the event(s) of nerve damage IN LEFT EYE with HUMIRA 40MG/0.4ML(ADALIMUMAB) was a reasonable possibility. The reporter's assessment of the causal relationship of the events with 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.   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 available information and a possible contributory role of suspect product BNT162B2 to the development of events hyperthyroidism and nerve damage in left eye cannot be totally excluded. This case will be reassessed when additional information becomes 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Immunisation
Clinical narrative: Chills; Covid vaccine booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; IMMUNISATION (non-serious), outcome "unknown", described as "Covid vaccine booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Renal impairment
Clinical narrative: Function kidney decreased; Pain in arm; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 21K-163-4167928-00.  A 55 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single, intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at unknown dose (citrate free) for moderate to severe rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL IMPAIRMENT (medically significant), on an unknown date, outcome "not recovered", described as "Function kidney decreased"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Pain in arm". The action taken for adalimumab was dosage not changed. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "function kidney decreased" and "pain in arm" related (reported as probable) to bnt162b2. The reporter considered "function kidney decreased" and "pain in arm" unrelated (reported as no reasonable possibility) to adalimumab.  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 information in the case report, a possible causal association between the events and suspect drug BNT162B2 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.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Myalgia, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Nov2021 11:00 (Lot number: EW0217) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Mild Asthma" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; LIPITOR. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 09Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0176, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 05May2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 11:00, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious), MYALGIA (non-serious) all with onset 24Nov2021 19:00, outcome "recovering" and all described as "Muscle soreness at injection site"; FATIGUE (non-serious) with onset 24Nov2021 19:00, outcome "recovering", described as "general fatigue". Therapeutic measures were not taken as a result of vaccination site pain, myalgia, fatigue. Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Chills, Fatigue, Immunisation
Clinical narrative: Fever 102  all nigh and the next day; Severe arm pain; under arm pain; breast pain; neck pain; chills; tired; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 18:00 (Lot number: FH8028) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "NO" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Fish oil, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 16:15), administration date: 16Mar2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 16:15), administration date: 06Apr2021, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 18:00, outcome "unknown", described as "booster"; PYREXIA (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "Fever 102  all nigh and the next day"; PAIN IN EXTREMITY (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "Severe arm pain"; AXILLARY PAIN (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "under arm pain"; BREAST PAIN (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "breast pain"; NECK PAIN (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "neck pain"; CHILLS (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "chills"; FATIGUE (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain in extremity, axillary pain, breast pain, neck pain, chills, fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Fever 102  all nigh and the next day; Severe arm pain; under arm pain; breast pain; neck pain; chills; tired; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 18:00 (Lot number: FH8028) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "NO" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Fish oil, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 16:15), administration date: 16Mar2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 16:15), administration date: 06Apr2021, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 18:00, outcome "unknown", described as "booster"; PYREXIA (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "Fever 102  all nigh and the next day"; PAIN IN EXTREMITY (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "Severe arm pain"; AXILLARY PAIN (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "under arm pain"; BREAST PAIN (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "breast pain"; NECK PAIN (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "neck pain"; CHILLS (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "chills"; FATIGUE (non-serious) with onset 24Nov2021 23:00, outcome "not recovered", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain in extremity, axillary pain, breast pain, neck pain, chills, fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: Soreness at injection site starting about 8 hours after vaccination; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-years-old male patient received third dose of bnt162b2 (BNT162B2, Batch/Lot number: FH8027)  administered in arm left, administration date 24Nov2021 (at 12:00) (age at the time of vaccination was 64-years-old) as DOSE 3 (booster), SINGLE for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 10Nov2021; ATORVASTATIN; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 24Mar2021, when the patient was 63 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 03Mar2021, when the patient was 63 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 14:00, outcome "unknown", described as "Dose Number: 3"; VACCINATION SITE PAIN (non-serious) with onset 24Nov2021 22:00, outcome "recovering", described as "Soreness at injection site starting about 8 hours after vaccination". Therapeutic measures were not taken as a result of vaccination site pain.  Follow-up attempts are completed. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: fever 100-105 Fahrenheit; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 8 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 13:30 (Lot number: FL0007) at the age of 8 years as dose 1 (tris), single for covid-19 immunisation. No other vaccine in four weeks. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (medically significant) with onset 21Nov2021 01:00, outcome "recovered", described as "fever 100-105 Fahrenheit"; VOMITING (non-serious) with onset 21Nov2021 01:00, outcome "recovered", described as "Vomiting". The events happened also reported as beginning 60 hours after receiving vaccine. Fever lasted 24 hours. No covid prior vaccination. Covid tested post vaccination included Nasal Swab on 23Nov2021 with result of pending. The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) 100-105 Fahrenheit; sars-cov-2 test: (23Nov2021) unknown results. Therapeutic measures were not taken as a result of pyrexia, vomiting.   Follow-up attempts are completed. No further information is expected.