chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood test, Brief resolved unexplained event, Dyspnoea, Echocardiogram
Clinical narrative: They thought she might have had a laryngospasm and her daughter was having gastric upset; They thought she might have had a laryngospasm and her daughter was having gastric upset; near SIDS event; inflammation in her throat; GI pain; screaming; Mother sensed daughter wasn't breathing; Mother received Pfizer COVID-19 Vaccine while breastfeeding.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 day-old female patient was exposed to bnt162b2 (BNT162B2), transmammary, administration date 28May2021 (Lot number: EW0191, Expiration Date: 30Sep2021) as dose 1, single and transmammary, administration date 18Jun2021 (Lot number: EW0191) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: BRIEF RESOLVED UNEXPLAINED EVENT (hospitalization) with onset Jul2021, outcome "unknown", described as "near SIDS event"; LARYNGOSPASM (hospitalization), ABDOMINAL DISCOMFORT (hospitalization), outcome "unknown" and all described as "They thought she might have had a laryngospasm and her daughter was having gastric upset"; EXPOSURE VIA BREAST MILK (non-serious) with onset 28May2021, outcome "unknown", described as "Mother received Pfizer COVID-19 Vaccine while breastfeeding."; PHARYNGEAL INFLAMMATION (non-serious), outcome "unknown", described as "inflammation in her throat"; GASTROINTESTINAL PAIN (non-serious), outcome "unknown", described as "GI pain"; SCREAMING (non-serious), outcome "unknown", described as "screaming"; DYSPNOEA (non-serious), outcome "unknown", described as "Mother sensed daughter wasn't breathing". The patient was hospitalized for brief resolved unexplained event (start date: 13Jul2021, discharge date: Jul2021, hospitalization duration: 3 day(s)); for laryngospasm, abdominal discomfort (hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: blood test: unknown results, notes: she had blood work and monitoring; echocardiogram: unknown results; ultrasound scan: unknown results.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200269007 maternal, infant cases
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk, Gastrointestinal pain, Laryngospasm, Pharyngeal inflammation, Screaming
Clinical narrative: They thought she might have had a laryngospasm and her daughter was having gastric upset; They thought she might have had a laryngospasm and her daughter was having gastric upset; near SIDS event; inflammation in her throat; GI pain; screaming; Mother sensed daughter wasn't breathing; Mother received Pfizer COVID-19 Vaccine while breastfeeding.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 day-old female patient was exposed to bnt162b2 (BNT162B2), transmammary, administration date 28May2021 (Lot number: EW0191, Expiration Date: 30Sep2021) as dose 1, single and transmammary, administration date 18Jun2021 (Lot number: EW0191) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: BRIEF RESOLVED UNEXPLAINED EVENT (hospitalization) with onset Jul2021, outcome "unknown", described as "near SIDS event"; LARYNGOSPASM (hospitalization), ABDOMINAL DISCOMFORT (hospitalization), outcome "unknown" and all described as "They thought she might have had a laryngospasm and her daughter was having gastric upset"; EXPOSURE VIA BREAST MILK (non-serious) with onset 28May2021, outcome "unknown", described as "Mother received Pfizer COVID-19 Vaccine while breastfeeding."; PHARYNGEAL INFLAMMATION (non-serious), outcome "unknown", described as "inflammation in her throat"; GASTROINTESTINAL PAIN (non-serious), outcome "unknown", described as "GI pain"; SCREAMING (non-serious), outcome "unknown", described as "screaming"; DYSPNOEA (non-serious), outcome "unknown", described as "Mother sensed daughter wasn't breathing". The patient was hospitalized for brief resolved unexplained event (start date: 13Jul2021, discharge date: Jul2021, hospitalization duration: 3 day(s)); for laryngospasm, abdominal discomfort (hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: blood test: unknown results, notes: she had blood work and monitoring; echocardiogram: unknown results; ultrasound scan: unknown results.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200269007 maternal, infant cases
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: They thought she might have had a laryngospasm and her daughter was having gastric upset; They thought she might have had a laryngospasm and her daughter was having gastric upset; near SIDS event; inflammation in her throat; GI pain; screaming; Mother sensed daughter wasn't breathing; Mother received Pfizer COVID-19 Vaccine while breastfeeding.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 day-old female patient was exposed to bnt162b2 (BNT162B2), transmammary, administration date 28May2021 (Lot number: EW0191, Expiration Date: 30Sep2021) as dose 1, single and transmammary, administration date 18Jun2021 (Lot number: EW0191) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: BRIEF RESOLVED UNEXPLAINED EVENT (hospitalization) with onset Jul2021, outcome "unknown", described as "near SIDS event"; LARYNGOSPASM (hospitalization), ABDOMINAL DISCOMFORT (hospitalization), outcome "unknown" and all described as "They thought she might have had a laryngospasm and her daughter was having gastric upset"; EXPOSURE VIA BREAST MILK (non-serious) with onset 28May2021, outcome "unknown", described as "Mother received Pfizer COVID-19 Vaccine while breastfeeding."; PHARYNGEAL INFLAMMATION (non-serious), outcome "unknown", described as "inflammation in her throat"; GASTROINTESTINAL PAIN (non-serious), outcome "unknown", described as "GI pain"; SCREAMING (non-serious), outcome "unknown", described as "screaming"; DYSPNOEA (non-serious), outcome "unknown", described as "Mother sensed daughter wasn't breathing". The patient was hospitalized for brief resolved unexplained event (start date: 13Jul2021, discharge date: Jul2021, hospitalization duration: 3 day(s)); for laryngospasm, abdominal discomfort (hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: blood test: unknown results, notes: she had blood work and monitoring; echocardiogram: unknown results; ultrasound scan: unknown results.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200269007 maternal, infant cases
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: pulmonary embolism; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 30 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) at the age of 30 years as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "Clotting Disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PULMONARY EMBOLISM (death, medically significant), outcome "fatal", described as "pulmonary embolism". The event "pulmonary embolism" was evaluated at the emergency room visit. It was reported that within an hour he was in the emergency department and died from a pulmonary embolism. The patient date of death was unknown. The reported cause of death was pulmonary embolism. It was not reported if an autopsy was performed.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: pulmonary embolism
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 9 days after Covid booster with Pfizer mRNA vaccine I started to have severe exacerbation of typically well controlled chronic headaches; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 17:15 (Lot number: 33130BA) at the age of 51 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing); "s/p mastectomies" (unspecified if ongoing), notes: s/p mastectomies; "known allergies: Cephalosporin" (unspecified if ongoing), notes: known allergies: Cephalosporin. Concomitant medication(s) included: INFLUENZA taken for immunisation, administration date 13Nov2021; DEXILANT; DEPAKOTE. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose number unknown), for COVID-19 immunization. The following information was reported: HEADACHE (hospitalization) with onset 19Dec2021 21:00, outcome "recovering", described as "9 days after Covid booster with Pfizer mRNA vaccine I started to have severe exacerbation of typically well controlled chronic headaches". The patient was hospitalized for headache (hospitalization duration: 1 day(s)). The event "9 days after covid booster with pfizer mrna vaccine i started to have severe exacerbation of typically well controlled chronic headaches" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of headache. Depakote and required steroid course in January to February, as well as multiple other medications. Now, two months later, headaches are slowly getting better. No other trigger identified. No laboratory or brain imaging changes. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.Device Date : 14Feb2022; Sender's Comments: Based on the available information in the case, the causal association between the event Headache and the 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: 29.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site nodule, Nodule, Skin mass, Swelling face
Clinical narrative: New nodules now in upper and lower lips; Swelling in right mid cheek area; new nodule lateral to tear trough; multiple nodules in the injection areas; This is a spontaneous report received from contactable reporter(s) (Physician). GL-021122-3676. A 29 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; hyaluronic acid, lidocaine (RESTYLANE L), since 05Nov2021 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: INJECTION SITE NODULE (non-serious) with onset 14Dec2021, outcome "recovering", described as "multiple nodules in the injection areas"; SKIN MASS (non-serious) with onset 20Jan2022, outcome "recovering", described as "new nodule lateral to tear trough"; SWELLING FACE (non-serious) with onset 03Feb2022, outcome "recovering", described as "Swelling in right mid cheek area"; NODULE (non-serious) with onset 08Feb2022, outcome "unknown", described as "New nodules now in upper and lower lips". The events "multiple nodules in the injection areas", "new nodule lateral to tear trough", "swelling in right mid cheek area" and "new nodules now in upper and lower lips" were evaluated at the physician office visit. Therapeutic measures were taken as a result of injection site nodule, skin mass, swelling face, nodule.  Additional information: Physician reported a patient had injections of Restylane L in the left and right anterior medial cheeks and upper and lower lips on 05Nov2021 and patient was seen back in the office for follow up on 14Dec2021 complaining of multiple nodules in the injection areas. Physician provided the following mitigation efforts. On 14Dec2021: Colchicine 6.8 mg BID, ibuprofen 400 mg TID for 5 days. On 11Jan2022, nodules had improved with Colchicine and ibuprofen but then had a recurrence of the nodules. Treated that day with Hylenex and prednisone, 20 mg for 7 days. On 20Jan2022, nodules improved but not resolved and new nodule lateral to tear trough. Treated with Hylenex and prednisone, 20 mg. On 25Jan2022, Improvement in nodules but still present. Treated with Hylenex and increased prednisone to 40 mg for 3 days. On 03Feb2022, Swelling in right mid cheek area was better. Treated with Hylenex again. On 08Feb2022: New nodules now in upper and lower lips. Treated with 40 mg prednisone for 3 days then 20 mg prednisone for 3 days. 1 1/2 vials of Hylenex to the lips and cheeks. Patient received Pfizer Covid-19 vaccinations 1 and 2 on unknown dates and then the booster two weeks prior to the November Restylane-L injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: She was diagnosed with Guillain-Barre and hospitalized; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, medically significant), outcome "unknown", described as "Guillain-Barre". The patient was hospitalized for guillain-barre syndrome (start date: 05Sep2021).  Reported verbatim: The reporter wanted to find out whether reporter's daughter had a reaction to the Pfizer vaccine shot. She was diagnosed with Guillain-Barre and hospitalized. It was in the fall, so she was not hospitalized now but she was hospitalized. Discharge date was reported as 08Sep (year not clarified). Reason of hospitalization: Guillain-Barre.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Concussion, Incorrect dose administered, Syncope
Clinical narrative: had 4 doses of unspecified Covid vaccines; "3 weeks ago" she fainted, was unconscious and had a concussion; "3 weeks ago" she fainted, was unconscious and had a concussion; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. Other Case identifier(s): private (Merck).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 4 (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 Immunization; Covid-19 vaccine (Dose:2, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:3, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: SYNCOPE (medically significant), CONCUSSION (non-serious) all with onset Jan2022, outcome "unknown" and all described as ""3 weeks ago" she fainted, was unconscious and had a concussion"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "had 4 doses of unspecified Covid vaccines". The patient underwent the following laboratory tests and procedures: antibody test: never produced antibodies.  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 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 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
Symptoms: Chills, Headache, Idiopathic intracranial hypertension, Myalgia, Visual impairment
Clinical narrative: idiopathic intercranial hypertension or psuedotumore cerebri; chills; myalgia; Headache; vision impairment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 10:45 (Lot number: F38757) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "avocado" (unspecified if ongoing), notes: known allergies: avocado; "raw spanish" (unspecified if ongoing), notes: known allergies: raw spinach; "melon/cantelope" (unspecified if ongoing), notes: known allergies: melon/cantelope; "eggplant" (unspecified if ongoing), notes: known allergies: eggplant; "zucchini" (unspecified if ongoing), notes: known allergies: zucchini; "dill" (unspecified if ongoing), notes: known allergies: dill. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8721, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 19Mar2021, when the patient was 49 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN0158, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 07Apr2021, for covid-19 immunization, reaction(s): "headache". The following information was reported: IDIOPATHIC INTRACRANIAL HYPERTENSION (medically significant) with onset 2021, outcome "unknown", described as "idiopathic intercranial hypertension or psuedotumore cerebri"; CHILLS (non-serious) with onset 2021, outcome "recovered", described as "chills"; MYALGIA (non-serious) with onset 2021, outcome "recovered", described as "myalgia"; HEADACHE (non-serious) with onset 2021, outcome "recovered", described as "Headache"; VISUAL IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "vision impairment". The events "idiopathic intercranial hypertension or psuedotumore cerebri", "chills", "myalgia", "headache" and "vision impairment" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of idiopathic intracranial hypertension, chills, myalgia, headache, visual impairment.  Clinical Course: It was reported that, the patient had continued headaches after dose 2 and the booster dose and then after 4 weeks, had vision impairment in left eye which had been diagnosed as IIHT (idiopathic intercranial hypertension or pseudotumor cerebri). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient had been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Blood bicarbonate, Blood calcium, Blood chloride, Blood creatinine, Blood glucose
Clinical narrative: Electrocardiography (ECG) showed sinus tachycardia with no ST or T-wave abnormalities; This is a literature report for the following literature source(s):  A 29 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 vaccination. The following information was reported: TACHYCARDIA (hospitalization, medically significant), outcome "recovered", described as "Electrocardiography (ECG) showed sinus tachycardia with no ST or T-wave abnormalities". The event "electrocardiography (ecg) showed sinus tachycardia with no st or t-wave abnormalities" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood bicarbonate (23-32): 22 mmol/L; blood calcium (8.6-10.3): 8.6 mg/dl; blood chloride (98-108): 107 mmol/L; blood creatinine (0.6-1.1): 1 mg/dl; blood glucose (70-99): 106 mg/dl; blood potassium (3.5-5.3): 4.3 mmol/L; blood pressure measurement: 152/99 mmHg; blood sodium (135-145): 138 mmol/L; blood thyroid stimulating hormone (0.27-4.20): normal limits; 0.24 IU/l; blood urea (6-20): 10 mg/dl; body temperature: 37.4 Centigrade; computerised tomogram: chest showed no evidence of pulmonary embolism or, notes: any identifiable pathology; drug screen: unknown results; electrocardiogram: showed sinus negative; fibrin d dimer (normal high range 0.5): normal limits; 0.41 ug/ml; full blood count: normal limits; haematocrit (36-47): 36.5 %; haemoglobin (12-16): 12.1 g/dl; heart rate: 135; metabolic function test: normal limits; oxygen saturation: 100 %; platelet count (140-440): 252 x10 9/l; pregnancy test: unknown results; thyroxine free (0.8-1.7): normal limits; 1.5 ng/dL; troponin (normal high range 14): normal limits; less than 6; less than 14; urine analysis: no rbc, wbc or bacteria; vital signs measurement: unknown result; white blood cell count (4-11): 7.9 x10 9/l. Therapeutic measures were taken as a result of tachycardia.; Sender's Comments: Based on the  information in the case report, a possible causal relationship 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.
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, Blood pressure measurement, Blood sodium, Blood thyroid stimulating hormone, Blood urea
Clinical narrative: Electrocardiography (ECG) showed sinus tachycardia with no ST or T-wave abnormalities; This is a literature report for the following literature source(s):  A 29 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 vaccination. The following information was reported: TACHYCARDIA (hospitalization, medically significant), outcome "recovered", described as "Electrocardiography (ECG) showed sinus tachycardia with no ST or T-wave abnormalities". The event "electrocardiography (ecg) showed sinus tachycardia with no st or t-wave abnormalities" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood bicarbonate (23-32): 22 mmol/L; blood calcium (8.6-10.3): 8.6 mg/dl; blood chloride (98-108): 107 mmol/L; blood creatinine (0.6-1.1): 1 mg/dl; blood glucose (70-99): 106 mg/dl; blood potassium (3.5-5.3): 4.3 mmol/L; blood pressure measurement: 152/99 mmHg; blood sodium (135-145): 138 mmol/L; blood thyroid stimulating hormone (0.27-4.20): normal limits; 0.24 IU/l; blood urea (6-20): 10 mg/dl; body temperature: 37.4 Centigrade; computerised tomogram: chest showed no evidence of pulmonary embolism or, notes: any identifiable pathology; drug screen: unknown results; electrocardiogram: showed sinus negative; fibrin d dimer (normal high range 0.5): normal limits; 0.41 ug/ml; full blood count: normal limits; haematocrit (36-47): 36.5 %; haemoglobin (12-16): 12.1 g/dl; heart rate: 135; metabolic function test: normal limits; oxygen saturation: 100 %; platelet count (140-440): 252 x10 9/l; pregnancy test: unknown results; thyroxine free (0.8-1.7): normal limits; 1.5 ng/dL; troponin (normal high range 14): normal limits; less than 6; less than 14; urine analysis: no rbc, wbc or bacteria; vital signs measurement: unknown result; white blood cell count (4-11): 7.9 x10 9/l. Therapeutic measures were taken as a result of tachycardia.; Sender's Comments: Based on the  information in the case report, a possible causal relationship 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.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Computerised tomogram, Drug screen, Electrocardiogram, Fibrin D dimer
Clinical narrative: Electrocardiography (ECG) showed sinus tachycardia with no ST or T-wave abnormalities; This is a literature report for the following literature source(s):  A 29 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 vaccination. The following information was reported: TACHYCARDIA (hospitalization, medically significant), outcome "recovered", described as "Electrocardiography (ECG) showed sinus tachycardia with no ST or T-wave abnormalities". The event "electrocardiography (ecg) showed sinus tachycardia with no st or t-wave abnormalities" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood bicarbonate (23-32): 22 mmol/L; blood calcium (8.6-10.3): 8.6 mg/dl; blood chloride (98-108): 107 mmol/L; blood creatinine (0.6-1.1): 1 mg/dl; blood glucose (70-99): 106 mg/dl; blood potassium (3.5-5.3): 4.3 mmol/L; blood pressure measurement: 152/99 mmHg; blood sodium (135-145): 138 mmol/L; blood thyroid stimulating hormone (0.27-4.20): normal limits; 0.24 IU/l; blood urea (6-20): 10 mg/dl; body temperature: 37.4 Centigrade; computerised tomogram: chest showed no evidence of pulmonary embolism or, notes: any identifiable pathology; drug screen: unknown results; electrocardiogram: showed sinus negative; fibrin d dimer (normal high range 0.5): normal limits; 0.41 ug/ml; full blood count: normal limits; haematocrit (36-47): 36.5 %; haemoglobin (12-16): 12.1 g/dl; heart rate: 135; metabolic function test: normal limits; oxygen saturation: 100 %; platelet count (140-440): 252 x10 9/l; pregnancy test: unknown results; thyroxine free (0.8-1.7): normal limits; 1.5 ng/dL; troponin (normal high range 14): normal limits; less than 6; less than 14; urine analysis: no rbc, wbc or bacteria; vital signs measurement: unknown result; white blood cell count (4-11): 7.9 x10 9/l. Therapeutic measures were taken as a result of tachycardia.; Sender's Comments: Based on the  information in the case report, a possible causal relationship 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.
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Haematocrit, Haemoglobin, Heart rate, Metabolic function test
Clinical narrative: Electrocardiography (ECG) showed sinus tachycardia with no ST or T-wave abnormalities; This is a literature report for the following literature source(s):  A 29 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 vaccination. The following information was reported: TACHYCARDIA (hospitalization, medically significant), outcome "recovered", described as "Electrocardiography (ECG) showed sinus tachycardia with no ST or T-wave abnormalities". The event "electrocardiography (ecg) showed sinus tachycardia with no st or t-wave abnormalities" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood bicarbonate (23-32): 22 mmol/L; blood calcium (8.6-10.3): 8.6 mg/dl; blood chloride (98-108): 107 mmol/L; blood creatinine (0.6-1.1): 1 mg/dl; blood glucose (70-99): 106 mg/dl; blood potassium (3.5-5.3): 4.3 mmol/L; blood pressure measurement: 152/99 mmHg; blood sodium (135-145): 138 mmol/L; blood thyroid stimulating hormone (0.27-4.20): normal limits; 0.24 IU/l; blood urea (6-20): 10 mg/dl; body temperature: 37.4 Centigrade; computerised tomogram: chest showed no evidence of pulmonary embolism or, notes: any identifiable pathology; drug screen: unknown results; electrocardiogram: showed sinus negative; fibrin d dimer (normal high range 0.5): normal limits; 0.41 ug/ml; full blood count: normal limits; haematocrit (36-47): 36.5 %; haemoglobin (12-16): 12.1 g/dl; heart rate: 135; metabolic function test: normal limits; oxygen saturation: 100 %; platelet count (140-440): 252 x10 9/l; pregnancy test: unknown results; thyroxine free (0.8-1.7): normal limits; 1.5 ng/dL; troponin (normal high range 14): normal limits; less than 6; less than 14; urine analysis: no rbc, wbc or bacteria; vital signs measurement: unknown result; white blood cell count (4-11): 7.9 x10 9/l. Therapeutic measures were taken as a result of tachycardia.; Sender's Comments: Based on the  information in the case report, a possible causal relationship 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.
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Platelet count, Pregnancy test, Tachycardia, Thyroxine free
Clinical narrative: Electrocardiography (ECG) showed sinus tachycardia with no ST or T-wave abnormalities; This is a literature report for the following literature source(s):  A 29 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 vaccination. The following information was reported: TACHYCARDIA (hospitalization, medically significant), outcome "recovered", described as "Electrocardiography (ECG) showed sinus tachycardia with no ST or T-wave abnormalities". The event "electrocardiography (ecg) showed sinus tachycardia with no st or t-wave abnormalities" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood bicarbonate (23-32): 22 mmol/L; blood calcium (8.6-10.3): 8.6 mg/dl; blood chloride (98-108): 107 mmol/L; blood creatinine (0.6-1.1): 1 mg/dl; blood glucose (70-99): 106 mg/dl; blood potassium (3.5-5.3): 4.3 mmol/L; blood pressure measurement: 152/99 mmHg; blood sodium (135-145): 138 mmol/L; blood thyroid stimulating hormone (0.27-4.20): normal limits; 0.24 IU/l; blood urea (6-20): 10 mg/dl; body temperature: 37.4 Centigrade; computerised tomogram: chest showed no evidence of pulmonary embolism or, notes: any identifiable pathology; drug screen: unknown results; electrocardiogram: showed sinus negative; fibrin d dimer (normal high range 0.5): normal limits; 0.41 ug/ml; full blood count: normal limits; haematocrit (36-47): 36.5 %; haemoglobin (12-16): 12.1 g/dl; heart rate: 135; metabolic function test: normal limits; oxygen saturation: 100 %; platelet count (140-440): 252 x10 9/l; pregnancy test: unknown results; thyroxine free (0.8-1.7): normal limits; 1.5 ng/dL; troponin (normal high range 14): normal limits; less than 6; less than 14; urine analysis: no rbc, wbc or bacteria; vital signs measurement: unknown result; white blood cell count (4-11): 7.9 x10 9/l. Therapeutic measures were taken as a result of tachycardia.; Sender's Comments: Based on the  information in the case report, a possible causal relationship 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.
Sex: F
Vaccine: COVID19
Symptoms: Troponin, Urine analysis, Vital signs measurement, White blood cell count
Clinical narrative: Electrocardiography (ECG) showed sinus tachycardia with no ST or T-wave abnormalities; This is a literature report for the following literature source(s):  A 29 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 vaccination. The following information was reported: TACHYCARDIA (hospitalization, medically significant), outcome "recovered", described as "Electrocardiography (ECG) showed sinus tachycardia with no ST or T-wave abnormalities". The event "electrocardiography (ecg) showed sinus tachycardia with no st or t-wave abnormalities" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood bicarbonate (23-32): 22 mmol/L; blood calcium (8.6-10.3): 8.6 mg/dl; blood chloride (98-108): 107 mmol/L; blood creatinine (0.6-1.1): 1 mg/dl; blood glucose (70-99): 106 mg/dl; blood potassium (3.5-5.3): 4.3 mmol/L; blood pressure measurement: 152/99 mmHg; blood sodium (135-145): 138 mmol/L; blood thyroid stimulating hormone (0.27-4.20): normal limits; 0.24 IU/l; blood urea (6-20): 10 mg/dl; body temperature: 37.4 Centigrade; computerised tomogram: chest showed no evidence of pulmonary embolism or, notes: any identifiable pathology; drug screen: unknown results; electrocardiogram: showed sinus negative; fibrin d dimer (normal high range 0.5): normal limits; 0.41 ug/ml; full blood count: normal limits; haematocrit (36-47): 36.5 %; haemoglobin (12-16): 12.1 g/dl; heart rate: 135; metabolic function test: normal limits; oxygen saturation: 100 %; platelet count (140-440): 252 x10 9/l; pregnancy test: unknown results; thyroxine free (0.8-1.7): normal limits; 1.5 ng/dL; troponin (normal high range 14): normal limits; less than 6; less than 14; urine analysis: no rbc, wbc or bacteria; vital signs measurement: unknown result; white blood cell count (4-11): 7.9 x10 9/l. Therapeutic measures were taken as a result of tachycardia.; Sender's Comments: Based on the  information in the case report, a possible causal relationship 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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: mostly recent outbreak was 60 plus people that was fully vaccine booster; mostly recent outbreak was 60 plus people that was fully vaccine booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (UNKNOWN MANUFACTURER, DOSE 1,SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "mostly recent outbreak was 60 plus people that was fully vaccine booster".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: patient had stroke; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (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: Bnt162b2 (dose number=2), for COVID-19 immunization; Bnt162b2 (dose number=1), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (death, hospitalization) with onset 03Feb2022, outcome "fatal", described as "patient had stroke". It was unknown if therapeutic measures were taken as a result of cerebrovascular accident. The patient date of death was 08Feb2022. The reported cause of death was cerebrovascular accident. It was not reported if an autopsy was performed.  Course of the event: The patient had stroke on 03Feb2022 after getting Pfizer booster in December2021. She was hospitalized and passed on 08Feb2022. Additional details are unknown  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported  event cerebro vascular accident and the 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; Reported Cause(s) of Death: Cerebrovascular accident
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: pretty intense upper right quadrant pain, pressure; pretty intense upper right quadrant pain, pressure; she got Covid last week; she got Covid last week; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Apr2021 11:54 (Lot number: ER8733, Expiration Date: 31Jul2021) at the age of 53 years as dose 2, 0.3 ml single and administered in arm right, administration date 16Mar2021 11:50 (Lot number: EN6199, Expiration Date: 30Jun2021) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis", start date: 2005 (ongoing); "Breast cancer" (unspecified if ongoing); "she had a left mastectomy" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Xeljanz for immunosuppressant, notes: she takes Xeljanz 5mg twice a day, an immunosuppressant, and her doctor had her stop it for 24 hours before starting Paxlovid. Caller states she held it about 30 hours before starting the Paxlovid.; Xeljanz for arthritis, notes: she takes immunosuppressive for arthritis; Levothyroxine for thyroid medication, notes: Caller states her doctor had her hold her Levothyroxine 88mcg a day, thyroid medication also. The following information was reported: VACCINATION FAILURE (medically significant) with onset 09Feb2022, outcome "unknown", COVID-19 (medically significant) with onset 09Feb2022, outcome "recovering" and all described as "she got Covid last week"; ABDOMINAL PAIN UPPER (medically significant), ABDOMINAL DISCOMFORT (medically significant) all with onset 14Feb2022, outcome "recovered" and all described as "pretty intense upper right quadrant pain, pressure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Feb2022) positive, notes: she had the Covid test done Wednesday, 09Feb2022 about 2pm and got result Thursday about 11 am. Therapeutic measures were taken as a result of covid-19. Clinical course: Patient had not gotten her booster and got Covid last week. Patient is at higher risk so this was prescribed.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Vaccination failure, COVID-19, abdominal pain upper, abdominal discomfort 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.
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Thrombosis, Vaccination site pain
Clinical narrative: blood clots and she will be going to the Emergency Room to have the knot evaluated.; Agent states that caller reports injection arm pain that began a few days after the second shot; caller also recently noticed the development of a knot near her wrist in the same arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1.), administration date: 06Dec2021, for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots and she will be going to the Emergency Room to have the knot evaluated."; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Agent states that caller reports injection arm pain that began a few days after the second shot"; NODULE (non-serious), outcome "unknown", described as "caller also recently noticed the development of a knot near her wrist in the same arm.".Clinical course was reported as, reporter stated she Patient had received her first Pfizer Covid Vaccine on 06Dec2021 and her second dose on 27Dec2021. Patient had reported injection arm pain that began a few days after the second shot and continued. Also recently noticed the development of a knot near her wrist in the same arm. patient later stated she had a history of blood clots and she will be going to the Emergency Room to have the knot evaluated. PQC was not present. AE Present was reported as yes. Case was reported as Non-Serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia streptococcal, SARS-CoV-2 test
Clinical narrative: She is seeing people get streptococcal pneumonia right after the shots. They are saying its COVID but they do extensive testing and see its either a bacteria pneumonia or streptococcal pneumonia; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA STREPTOCOCCAL (medically significant), outcome "unknown", described as "She is seeing people get streptococcal pneumonia right after the shots. They are saying its COVID but they do extensive testing and see its either a bacteria pneumonia or streptococcal pneumonia". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: nobody comes back positive for COVID.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, the event streptococcal pneumonia most likely represents an intercurrent medical condition and is unrelated to Bnt162b2 vaccine. Case will be re-assessed upon the additional information provided. 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.