chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Coronary artery thrombosis, Illness, Near death experience, Pain
Clinical narrative: almost passed away; blood clot in her heart; getting real sick; She was in terrible pain; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that:  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on May2021 at dose 2, single for covid-19 immunisation. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on Apr2021 at dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient was getting real sick and almost passed away, patient had a blood clot in her heart. She was out for 4 to 5 weeks. Patient was in the hospital for 9 days. Patient had a CT scan and that is how the blood clot was found since she did not know. Patient was in terrible pain. Now she is on blood thinners. Patient never had a blood clot or was on blood thinners before the shot. Patient does not know what is going on and is asking about compensation. She had both doses. The patient underwent lab tests and procedures which included computerised tomogram: blood clot was found on an unspecified date in 2021. Therapeutic measures were taken as a result of blood clot in her heart. At the time of reporting, the outcome of the events were unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: chest palpitations; feeling exceptionally tired/fatigue; headache; brain fog; out of breath easily; sweated a lot; Sweeping the floor or wiping the refrigerator was laborious for me; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0158), dose 1 via an unspecified route of administration, on 07Apr2021 at 04:15 PM (at the age of 29-year-old), in Left arm as dose 1, single for COVID-19 immunization. Medical history included penicillin allergy. Concomitant medication included TYLENOL taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 09Apr2021 the patient experienced chest palpitations, feeling exceptionally tired/fatigue, headache, brain fog, out of breath easily, sweated a lot, sweeping the floor or wiping the refrigerator was laborious for me. The patient did not receive any treatment. Outcome of the events was recovered on an unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Quality of life decreased
Clinical narrative: chest palpitations; feeling exceptionally tired/fatigue; headache; brain fog; out of breath easily; sweated a lot; Sweeping the floor or wiping the refrigerator was laborious for me; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0158), dose 1 via an unspecified route of administration, on 07Apr2021 at 04:15 PM (at the age of 29-year-old), in Left arm as dose 1, single for COVID-19 immunization. Medical history included penicillin allergy. Concomitant medication included TYLENOL taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 09Apr2021 the patient experienced chest palpitations, feeling exceptionally tired/fatigue, headache, brain fog, out of breath easily, sweated a lot, sweeping the floor or wiping the refrigerator was laborious for me. The patient did not receive any treatment. Outcome of the events was recovered on an unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Gait disturbance, Immunodeficiency, Inflammation, SARS-CoV-2 test
Clinical narrative: I couldnt stand or Walk at all.; I have an Immune Compromise and My Immune System is attacking itself.; I couldnt stand or Walk at all.; I had an Inflammatory Reaction to the Pizer Vaccine.; This is a spontaneous report from a contactable consumer (patient). A 31-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown, Expiry date: not reported), via an unspecified route of administration in left arm on 19Aug2021 09:15 (at age of 31-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included asthma, high blood pressure, ABPA (bronchopulmonary aspergillosis allergic) in my lumgs and fibromalgia, known allergy to dairy reaction is hives. Concomitant medication(s) included prednisone (PREDNISONE) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; verapamil hydrochloride (VERPAMIL) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported, vitamin E D. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 21Aug2021 at 23:00, the patient reported that the patient couldn't stand or walk at all, had an immune compromise and the immune system was attacking itself and had an inflammatory reaction to the pizer vaccine. The consumer reported that days after the bnt162b2 vaccine, the patient had to be transported by EMS to the hospital. The patient couldn't stand or walk at all. They said that the patient had an inflammatory reaction to the bnt162b2 vaccine. The patient had an immune compromise and her immune system was attacking itself. The adverse events resulted in emergency room visit. The patient was given morphine and nausea meds for adverse event treatment. Post the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 25Aug2021, sars-cov-2 test (Rapid Test): negative on 25Aug2021. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.  The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: My sister-in-law, who had been vacinated with both doses of the Pfizer vaccine in the Feb / Mar timeframe, contracted COVID-19, confirmed by a positive test, and required infusion therapy.  She is rec; My sister-in-law, who had been vacinated with both doses of the Pfizer vaccine in the Feb / Mar timeframe, contracted COVID-19, confirmed by a positive test, and required infusion therapy.  She is rec; This is a spontaneous report from a contactable consumer. This consumer reported for 64-year-old female patient (sister-in law). A 64-year-old female non-pregnant patient received second dose of dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not provided) via intramuscular route of administration on Mar2021 as dose 2, single and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not provided) via intramuscular route of administration on Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took steroids. It was unknown If patient receive any other vaccine in four weeks and other medications that patient receives in two weeks. Patient did not have COVID prior vaccination, and it was yes Covid tested after post vaccination. The patient concomitant medications were not reported. known allergies I do not believe so. On 13Aug2021, it was reported that my sister-in-law, who had been vaccinated with both doses of the Pfizer vaccine in the Feb / Mar timeframe, contracted COVID-19, confirmed by a positive test, and required infusion therapy. She was recovering. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 15Aug2021. Therapeutic measures were taken for the events. Patient visits the physician office for the events. Outcome of events was recovering.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fibrin D dimer, Haematemesis, Malaise
Clinical narrative: It's more nausea and thrown out blood and cough, and coughing; Body ache; Just feeling unwell, Just feeling like sluggish; My legs are so hurting; Shortness of breath; Just feeling unwell, Just feeling like sluggish; Nausea; Coughing; This is a spontaneous report from a contactable consumer (patient herself). A 30-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 23Aug2021 (lot number: FD8448) (age at vaccination 30-year-old) as dose 1, single for COVID-19 immunisation at pharmacy. The patient medical history included asthma, anxiety, heart problem and blood clot history from an unknown date and unknown if ongoing. The patient take tylenol for asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient had no prior vaccinations. The patient would like to report the side effects, as taken the COVID-19, the Pfizer first dose. The patient experienced as It's more nausea and thrown out blood and cough, and coughing, nausea, body ache, shortness of breath, just feeling unwell, just feeling like sluggish, legs are so hurting on 24Aug2021. I don't take the second one into the 13th of next month. The patient laboratory investigation included D-dimer test which revealed no clotting. The patient stated she had no body aches no more. She wanted to know, Why her legs were so hurting but it was not like persisting. It's more nausea and thrown out blood and cough, and coughing. The outcome of the event It's more nausea and thrown out blood and cough, and coughing, shortness of breath, just feeling unwell, just feeling like sluggish, nausea was unknown, legs are so hurting was recovering, body ache was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Sluggishness
Clinical narrative: It's more nausea and thrown out blood and cough, and coughing; Body ache; Just feeling unwell, Just feeling like sluggish; My legs are so hurting; Shortness of breath; Just feeling unwell, Just feeling like sluggish; Nausea; Coughing; This is a spontaneous report from a contactable consumer (patient herself). A 30-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 23Aug2021 (lot number: FD8448) (age at vaccination 30-year-old) as dose 1, single for COVID-19 immunisation at pharmacy. The patient medical history included asthma, anxiety, heart problem and blood clot history from an unknown date and unknown if ongoing. The patient take tylenol for asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient had no prior vaccinations. The patient would like to report the side effects, as taken the COVID-19, the Pfizer first dose. The patient experienced as It's more nausea and thrown out blood and cough, and coughing, nausea, body ache, shortness of breath, just feeling unwell, just feeling like sluggish, legs are so hurting on 24Aug2021. I don't take the second one into the 13th of next month. The patient laboratory investigation included D-dimer test which revealed no clotting. The patient stated she had no body aches no more. She wanted to know, Why her legs were so hurting but it was not like persisting. It's more nausea and thrown out blood and cough, and coughing. The outcome of the event It's more nausea and thrown out blood and cough, and coughing, shortness of breath, just feeling unwell, just feeling like sluggish, nausea was unknown, legs are so hurting was recovering, body ache was recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Maternal exposure timing unspecified, Suspected COVID-19
Clinical narrative: contracted Covid in early Aug2021; contracted Covid in early Aug2021; currently pregnant; This is a spontaneous report from a contactable consumer (patient). A 28-year-old (currently pregnant) female patient received bnt162b2 (BNT162B2), in Jan2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history and the medications were not reported.  The patient was vaccinated in Jan2021 and contracted Covid in early Aug2021. She was planning on getting her booster vaccine. The patient was pregnant. The outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, Off label use, Pain, Vaccination site pain
Clinical narrative: Body aches; Fatigue; Injection site soreness; Received third COVID vaccine shot; Received third COVID vaccine shot; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included crohn's disease and immunodeficiency. Patient has Crohn's disease being treating with humira. Concomitant medications included adalimumab (HUMIRA). Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose, second dos e of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient experienced body aches, fatigue and injection site soreness on an unspecified date. It was reported that received third COVID vaccine shot about 4 months after second due to doctors recommendation and being immunocompromised. The next day had body aches, fatigue and injection site soreness. Event took place after use of product. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Depressed mood, Oropharyngeal pain, Pyrexia
Clinical narrative: Received first Pfizer Covid 19 vaccine dose on 20Jul2021 and then tested Positive for Covid 19 on 24Jul2021; Fever/temperature of 100.3 F; Sore throat; Feeling down; This is a spontaneous report from a contactable consumer (patient's mother). A 12-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 20Jul2021 as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Patient received first Pfizer Covid 19 vaccine dose on 20Jul2021 and then tested Positive for Covid 19 on 24Jul2021. On an unspecified date in Jul2021 patient experienced a fever/temperature of 100.3 F, sore throat and feeling down for three days. As of current, mother explains that daughter was perfectly fine now. She would like to know if it is ok for daughter to get second dose. The patient underwent lab test which included body temperature measurement, with results as 100.3 Fahrenheit, on an unspecified date in Jul2021, and Covid 19 with positive results on 24Jul2021. The outcome of event for coivd-19 was unknown, and for the rest it was recovered on an unspecified date in Jul2021.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Received first Pfizer Covid 19 vaccine dose on 20Jul2021 and then tested Positive for Covid 19 on 24Jul2021; Fever/temperature of 100.3 F; Sore throat; Feeling down; This is a spontaneous report from a contactable consumer (patient's mother). A 12-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 20Jul2021 as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Patient received first Pfizer Covid 19 vaccine dose on 20Jul2021 and then tested Positive for Covid 19 on 24Jul2021. On an unspecified date in Jul2021 patient experienced a fever/temperature of 100.3 F, sore throat and feeling down for three days. As of current, mother explains that daughter was perfectly fine now. She would like to know if it is ok for daughter to get second dose. The patient underwent lab test which included body temperature measurement, with results as 100.3 Fahrenheit, on an unspecified date in Jul2021, and Covid 19 with positive results on 24Jul2021. The outcome of event for coivd-19 was unknown, and for the rest it was recovered on an unspecified date in Jul2021.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: everything hurts today; This is a spontaneous report from a Pfizer-sponsored program from a non contactable consumer (patient) reported for himself.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. As reported: Consumer stated he took our covax and ended up in the hospital and is asking what should he do because everything hurts today. Outcome for event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Immune system disorder, Immunology test
Clinical narrative: Her immune system went down to 300. This year it went up to 900; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a female patient of an unspecified age that she received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The medical history included COPD (chronic obstructive pulmonary disease) (She have COPD for a year and a half) from an unknown date. The historical vaccine included received bnt162b2 (BNT162B2), as DOSE 1, SINGLE for covid-19 immunisation. The patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine in Mar2020 and had been receiving immunity injections monthly. She said that she was receiving a drug caller Gammagard as an IgG infusion. She had COPD for a year and a half, and her doctors performed test and wanted her to her a trial. She had been in the hospital for 2 or 3 weeks for a few years and she took blood test because her immune system went down to 300 on an unspecified date (medically significant). This year it went up to 900 on an unspecified date in 2021 (medically significant). She wanted to get the third dose and wanted to know if it was the same as the first and second dose. She was asking how long she should wait to get the third dose. She was asking how long the interval should be for the vaccine and her infusion. She said that she did some research and found out that she had to wait 3 days. Response: Provided information from internal document. Referred to HCP. The patient underwent lab tests and procedures which included blood test: Unknown results on an unspecified date, immunology test was noted to be 300 went down on an unspecified date, immunology test was noted to be 900 in 2021 went up. The outcome of the event was unknown.  Follow-up was being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Heart rate, Heart rate decreased, Hyperhidrosis
Clinical narrative: Pt was diaphoretic and pale; Pt was diaphoretic and pale; BP 90/50; Pulse 64; This is a spontaneous report from a contactable nurse. A 26-year-old male patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3183), intramuscular, administered in left arm on 27Aug2021 14:45 (at the age of 26-year old), as dose 1, single for COVID-19 immunisation. Medical history included patient appeared to be nervous and having a lot of anxiety prior to immunization. The patient confirmed no allergies, was not in quarantine, not sick and denied any medical problems. Concomitant medications were not reported. On 27Aug2021, the patient presented for the vaccine; he tolerated the vaccine and walked with his wife to the waiting room. After about 5 minutes in the waiting room, the nurse was in unit and assisted in care, the patient's blood pressure (BP) and pulse which were found to be 90/50 and 64. At 15:00, the patient was diaphoretic and pale, therefore oxygen was administered and patient was monitored until emergency teams arrived. Once they arrived, the patient had started to come around, his color returned and he was not as sweaty. He got up and walked to stretcher and exited with emergency teams. The events resulted in emergency room/department or urgent care. Outcome of the event diaphoretic and pale was recovered on 27Aug2021 and of the remaining events was recovered on an unspecified date in Aug2021.; Sender's Comments: .As per temporal association , causal association of events(Hypotension, low pulse rate, Hyperhidrosis, pale) 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: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor
Clinical narrative: Pt was diaphoretic and pale; Pt was diaphoretic and pale; BP 90/50; Pulse 64; This is a spontaneous report from a contactable nurse. A 26-year-old male patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3183), intramuscular, administered in left arm on 27Aug2021 14:45 (at the age of 26-year old), as dose 1, single for COVID-19 immunisation. Medical history included patient appeared to be nervous and having a lot of anxiety prior to immunization. The patient confirmed no allergies, was not in quarantine, not sick and denied any medical problems. Concomitant medications were not reported. On 27Aug2021, the patient presented for the vaccine; he tolerated the vaccine and walked with his wife to the waiting room. After about 5 minutes in the waiting room, the nurse was in unit and assisted in care, the patient's blood pressure (BP) and pulse which were found to be 90/50 and 64. At 15:00, the patient was diaphoretic and pale, therefore oxygen was administered and patient was monitored until emergency teams arrived. Once they arrived, the patient had started to come around, his color returned and he was not as sweaty. He got up and walked to stretcher and exited with emergency teams. The events resulted in emergency room/department or urgent care. Outcome of the event diaphoretic and pale was recovered on 27Aug2021 and of the remaining events was recovered on an unspecified date in Aug2021.; Sender's Comments: .As per temporal association , causal association of events(Hypotension, low pulse rate, Hyperhidrosis, pale) 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Headache, Neck pain
Clinical narrative: Fever; Chills; Headache; loss of appetite; dizziness; tingling in extremity; cervical soreness; This is a spontaneous report received from a contactable consumer(patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,  solution for injection; lot number: FC3180 and expiry date not reported) via an unspecified route of administration, at the age of 53-year-old, on 24Aug2021 12:15, at the right arm, at dose1, single for covid-19 immunisation in a Pharmacy/drug store. Relevant medical history included COVID prior vaccination. The patient no known allergies. Concomitant medications was reported as none. The patient is not pregnant at the time of vaccination. The patient did not have other vaccine in four weeks. The patient did not have other medications in two weeks. It was unknown if the patient was tested for covid post vaccination. On 24Aug2021, 20:45, the patient experienced fever, chills, headache, loss of appetite, dizziness, tingling in extremities, cervical soreness. It was unknown whether the patient took any treatment. The outcome of the event was unknown at the time of report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Fever; Chills; Headache; loss of appetite; dizziness; tingling in extremity; cervical soreness; This is a spontaneous report received from a contactable consumer(patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,  solution for injection; lot number: FC3180 and expiry date not reported) via an unspecified route of administration, at the age of 53-year-old, on 24Aug2021 12:15, at the right arm, at dose1, single for covid-19 immunisation in a Pharmacy/drug store. Relevant medical history included COVID prior vaccination. The patient no known allergies. Concomitant medications was reported as none. The patient is not pregnant at the time of vaccination. The patient did not have other vaccine in four weeks. The patient did not have other medications in two weeks. It was unknown if the patient was tested for covid post vaccination. On 24Aug2021, 20:45, the patient experienced fever, chills, headache, loss of appetite, dizziness, tingling in extremities, cervical soreness. It was unknown whether the patient took any treatment. The outcome of the event was unknown at the time of report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I'm getting headaches that come on strongly; This is a spontaneous report received from a contactable consumer(patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,  solution for injection; lot number: Fc3181 and expiry date not reported) via an unspecified route of administration, at the age of 46-year-old, on 24Aug2021, at the left  arm, at dose 1, single for covid-19 immunisation in a Pharmacy/drug store. Relevant medical history included Lupus and Hypothyroidism. The patient had no known allergies. Concomitant medications in two weeks included hydroxychloroquine, celecoxib, codeine phosphate, paracetamol (APA CODEINE) and trazadone hydrochloride (TRAZO).  The patient is not pregnant at the time of vaccination. The patient did not have other vaccine in four weeks. The patient did not have prior COVID vaccination and was not tested post vaccination. On 25Aug2021, the patient experienced headaches that come on strongly in the same place. It comes and goes but when it comes it's on top of her head and it was a strong headache. The patient did not receive treatment in response to the events. The outcome of the events was not recovered at the time of report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Loss of consciousness, Pain
Clinical narrative: passed out twice; Headache; severe body aches; severe fatigue; weakness; vomiting & dry heaving; vomiting & dry heaving; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 54-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8727) via an unspecified route of administration, administered in left arm on 26Mar2021 16:00 (at the age of 54-year-old) as dose 2, single for covid-19 immunization. Medical history included asthma and Grave's disease from an unknown date and unknown if ongoing. The patient was allergic to dust, sulfa based drugs, had seasonal allergy, molds allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), rizatriptan benzoate (MAXALT), ibuprofen, estradiol and azelastine taken for an unspecified indication, start on an unspecified date in 2021 and stop date was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205) administered in left arm on 05Mar2021 04:00 PM (at the age of 54-years-old) as dose 1 single for COVID-19 immunization. On 27Mar2021 at 05:00 the patient experienced passed out twice, headache, severe body aches, severe fatigue, weakness, vomiting and dry heaving. Called paramedics. Vitals were okay when paramedics arrived did not go to the hospital. Paramedics checked patient vitals after passing out. The patient visited to emergency room for the AEs. Patient received treatment for the events. Outcome of the events were resolved on an unspecified date in 2021.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Retching, Vomiting
Clinical narrative: passed out twice; Headache; severe body aches; severe fatigue; weakness; vomiting & dry heaving; vomiting & dry heaving; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 54-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8727) via an unspecified route of administration, administered in left arm on 26Mar2021 16:00 (at the age of 54-year-old) as dose 2, single for covid-19 immunization. Medical history included asthma and Grave's disease from an unknown date and unknown if ongoing. The patient was allergic to dust, sulfa based drugs, had seasonal allergy, molds allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), rizatriptan benzoate (MAXALT), ibuprofen, estradiol and azelastine taken for an unspecified indication, start on an unspecified date in 2021 and stop date was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205) administered in left arm on 05Mar2021 04:00 PM (at the age of 54-years-old) as dose 1 single for COVID-19 immunization. On 27Mar2021 at 05:00 the patient experienced passed out twice, headache, severe body aches, severe fatigue, weakness, vomiting and dry heaving. Called paramedics. Vitals were okay when paramedics arrived did not go to the hospital. Paramedics checked patient vitals after passing out. The patient visited to emergency room for the AEs. Patient received treatment for the events. Outcome of the events were resolved on an unspecified date in 2021.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscle spasms, Pyrexia
Clinical narrative: Fever; muscular spasms; tiredness; headache; This is a spontaneous report received from a contactable consumer(patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: FC3180 and expiry date not reported) via an unspecified route of administration, at the age of 35-year-old, on 27Aug2021 13:45, at the left arm, at dose 2, single for covid-19 immunisation in a Pharmacy/drug store. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number- FC3180 and expiry date was not reported) via unspecified route of administration, at the age of 35-year-old, on 06Aug2021, 12:00, at the left arm, at dose 1, single, for covid-19 immunisation. The patient is not pregnant at the time of vaccination. The patient did not have other vaccine in four weeks. The patient did not have other medications in two weeks. The patient did not have prior COVID vaccination and was not tested post vaccination. On 27Aug2021, 22:45, the patient experienced fever, muscular spasms, tiredness, headache after 9 hours from the second shot. The patient did not receive treatment in response to the events. The outcome of the event was recovering at the time of report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This is a spontaneous report received from a contactable consumer(patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, at the age of 43-year-old, on 28Aug2021 15:30, at the left arm, at dose 1, single for covid-19 immunisation in a Pharmacy/drug store. Relevant medical history was reported as none. Concomitant medications were as none. The patient had no known allergies. The patient is not pregnant at the time of vaccination. The patient did not have other vaccine in four weeks. The patient did not have other medications in two weeks. The patient did not have prior COVID vaccination and was not tested post vaccination. On 28Aug2021 22:00, the patient experienced sore throat. The patient did not receive treatment in response to the events. The outcome of the event was unknown at the time of report.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19 virus; Covid-19 virus; This is a spontaneous report from a Pfizer sponsored program regulatory authority Support from a contactable consumer reported for a male patient (father). A male patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date of Jan2021 as dose 1, single, dose 2 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter's daddy got vaccines same date as reporter's mama did and his positive Covid test was done the night of the 20Aug2021. Reporter's daddy was getting a monoclonal antibody infusion at this moment. She declined to complete report for her daddy. The patient was doing ok; and they know that the vaccine was not going to stop you from doing it, it's just supposed to stop you from being hospitalized. They called reporter's Daddy in from the parking lot and tested him for Covid. They told him it would be a couple of hours before they got the results; so, he told them to just put it in his chart. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Aug2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Influenza virus test, SARS-CoV-2 test
Clinical narrative: Now she has diminished breathing.; This is a spontaneous report from a contactable consumer (patient's mother). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration in Arm Left on 20Aug2021 (last Friday, at the age of 22-years old) as dose 1, single for COVID-19 immunisation. Medical history included PMPD (unspecified), mild asthma, insulin resistance, ileostomy, thyroid disease, allergies to various foods (the list is very long) and flu B. Concomitant medication included progesterone taken for birth control and anti-anxiety (unspecified). The reporter stated that the patient did not took prior vaccination (4 weeks). The reporter stated that she believed her daughter had the severe reaction to the Pfizer vaccine. She (the patient) received it on last Friday (she did not know, what the time was; it was like after breakfast or before lunch) and now she diminished breathing (24Aug2021), she went to urgent care today. Reporter further stated she needs to know what to do, her daughter was having hard time breathing from their vaccination so, what the next step so far, how do she get medical help for her daughter, her school was making her mandatory vaccinate, how could she, get her medical assumption, she knew was am doing all the right things by reporting it but, Frankly, that was not very helpful and needed assistance. The due date for second shot for the patient was on Monday or Friday (must be on 03Oct2021). The patient was put on nebulizer 4 times a day as well as the rescue inhaler (intent treatment). The reporter stated that symptoms worsened, improved and were persisting. The patient underwent lab test which included covid test: negative and flu test: positive both on an unspecified date. The outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Headache, Pain, Restlessness
Clinical narrative: chest hurting; Sneezing; Running nose; had a bad headache; Body ache; Feeling bad and being a little restless; Feeling bad and being a little restless; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 31Jul2021 (Lot Number: FC3180) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the first vaccine and had like chest hurting, sneezing, running nose, had a bad headache, body ache, feeling bad and being a little restless on an unspecified date in 2021. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: chest hurting; Sneezing; Running nose; had a bad headache; Body ache; Feeling bad and being a little restless; Feeling bad and being a little restless; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 31Jul2021 (Lot Number: FC3180) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the first vaccine and had like chest hurting, sneezing, running nose, had a bad headache, body ache, feeling bad and being a little restless on an unspecified date in 2021. The outcome of the events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: on the site of my shot the whole under of my arm like my armpit area is very, very swollen I mean like a size of lemon; very tender and swollen; tender; This is a spontaneous report from a contactable consumer (patient).   A 36-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (at the age of 36-years-old) as dose 2 (Lot Number: FF2588) and as dose 1, single (Lot Number: EW0181) for covid-19 immunization.  Medical history included hypertension. Concomitant medications included amlodipine and losartan taken for hypertension.  Patient experienced swelling under armpit area on the site of vaccine shot. It was reported that the swelling had like a size of a lemon and it was very tender and swollen. The events were treated with Tylenol 3 times since yesterday 500 mg. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away; This is a spontaneous report received from a non-contactable consumer from a Pfizer-sponsored program. The consumer reported same events for two patients (two friends). This is one of the two reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single; dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took both doses and passed away on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101123341 Same reporter/drug/event, different patient; Reported Cause(s) of Death: passed away
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: swollen armpit; Pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer Support. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 27Aug2021 08:00 (Lot number was not reported) (at the age of 35-years-old) as dose 1, single for covid-19 immunisation. Medical history was none and there was no family medical history relevant to event. There were no concomitant medications. The patient did not receive any vaccination 4 weeks prior to COVID 19 Vaccine. In Aug2021, the patient experienced swollen armpit and had pain because of it. At the time of reporting, she was in an emergency room experiencing swollen armpit. The patient took the powdered Aspirin BC and Tylenol PM as treatment for the events. The patient's second dose was scheduled on 17Sep2021. The outcome of local swelling was not recovered, and outcome of pain was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Dizziness, Mental disorder, SARS-CoV-2 test
Clinical narrative: dizzy; not in her "right mind"; weakness; speech impairment; Covid positive at one point; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, on 27Aug2021, 3:30PM (age at vaccination: 68), as dose 2, single for COVID-19 immunization. The patient medical history included very weak immune system. The patient's concomitant medications were not reported. Historical vaccine reported as BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, on unspecified date as dose 1, single for COVID-19 immunization and had different reactions to both. The patient experienced dizzy, not in right mind, weakness and speech impairment and covid positive at one point . The patient underwent lab tests and procedures which included sars-cov-2 test: positive at one point. Outcome of all events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Speech disorder
Clinical narrative: dizzy; not in her "right mind"; weakness; speech impairment; Covid positive at one point; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, on 27Aug2021, 3:30PM (age at vaccination: 68), as dose 2, single for COVID-19 immunization. The patient medical history included very weak immune system. The patient's concomitant medications were not reported. Historical vaccine reported as BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, on unspecified date as dose 1, single for COVID-19 immunization and had different reactions to both. The patient experienced dizzy, not in right mind, weakness and speech impairment and covid positive at one point . The patient underwent lab tests and procedures which included sars-cov-2 test: positive at one point. Outcome of all events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Dyspnoea, Gait disturbance
Clinical narrative: dizzy; not in her "right mind"; weakness; speech impairment; Covid positive at one point; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, on 27Aug2021, 3:30PM (age at vaccination: 68), as dose 2, single for COVID-19 immunization. The patient medical history included very weak immune system. The patient's concomitant medications were not reported. Historical vaccine reported as BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, on unspecified date as dose 1, single for COVID-19 immunization and had different reactions to both. The patient experienced dizzy, not in right mind, weakness and speech impairment and covid positive at one point . The patient underwent lab tests and procedures which included sars-cov-2 test: positive at one point. Outcome of all events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.