chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: 2 of the doctors did not convert with antibody test which was performed about 10-18 days after the 2nd Pfizer vaccine dose; This is a spontaneous report from contactable physician. This physician reported similar events for 2 patients. This report is second of two reports.   A patient of unspecified age and gender received the first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: note reported), both via an unspecified route of administration on an unspecified date at SINGLE DOSE for Covid-19 immunization. The patient was vaccinated/ received the product at a hospital. The patient medical history and concomitant medications were not reported. The physician reported that several doctors have received both vaccines and 2 of the doctors "did not convert with antibody test." HCP stated the test was performed "about 10-18 days after the 2nd Pfizer vaccine dose." The patient underwent lab tests and procedures which included COVID-19 antibody test: did not convert with antibody test on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130815 same drug/reporter/event, different patients
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia
Clinical narrative: more intense tingling sensation around the chin area/lower mouth area; extreme dizziness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration, on left arm, on 06Feb2021 15:30 (at the age of 50-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included type 1 diabetes and Raynaud's, patient had no known allergies. No COVID prior vaccination. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), and lansoprazole, all from unknown date for unknown indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration, on left arm, on 15Jan2021 15:30 (at the age of 50-year-old), at single dose, for COVID-19 immunization, and after receiving the first dose the patient experienced tingly sensation in her chin area. After receiving the second dose on 08Feb2021 13:00 (reported as "day three") patient experienced more intense tingling sensation around the chin area and extreme dizziness. Patient took diphenhydramine hydrochloride (BENADRYL) and meclozine hydrochloride (BONINE) as a result. On 09Feb2021 (reported as "day 4") patient still experienced the tingly sensation around chin and lower mouth area. Patient felt almost like a sensation of when, for example: your arm fell asleep. It was constant. No COVID tested post vaccination. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: they both have covid; they both have covid; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients (herself and her husband, the patient). This is the second of two reports.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 20Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The wife reported that she received the first dose of the Pfizer Covid vaccine on 18Jan2021, and the patient (her husband) received it on 20Jan2021. The wife stated she was diagnosed with Covid last Thursday and she got it from the patient - they both have Covid. They both received antibodies from (company name) as it was a mild case. She said she and the patient were congested, had fatigue and the antibodies made a difference. She then added that so many people can only take the first dose due to the side effects or some other reason. She wanted to know the time they needed to wait in order to get the second dose of the vaccine, if it was 90 days. The outcome of the events was unknown.  Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130575 same reporter, drug, and events, different patient
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Dizziness, Feeling abnormal
Clinical narrative: Fever; Dizzy; didn't feel right; little chills; Blood pressure was kind of low; This is a spontaneous report from a contactable consumer (the patient). An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration on 04Feb2021 around 14:30 or 14:45 (at the age of 83-years-old) as a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient previously received the first dose of the COVID-19 vaccine on an unspecified date, 3 weeks before, for COVID-19 immunization. On 05Feb2021, the patient experienced fever, dizzy, didn't feel right. On an unspecified date in Feb2021, the patient experienced little chills and blood pressure was kind of low. The clinical course was as follows: The patient got her second COVID shot last Thursday 04Feb2021. She felt fine. Then, on Friday evening (05Feb2021), she started feeling bad. She had a fever and was dizzy, little chills and her blood pressure was kind of low. She had been trying to drink not today (as reported). Today was Monday (08Feb2021), and she still had a low fever. She still didn't feel right. She hasn't felt right since Friday and was improving a little. Her fever wasn't that bad now, but at night it was a little over 100. The clinical outcome of fever, dizzy, didn't feel right was recovering. The outcome of other events was unknown.  Information on the lot/batch number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Pyrexia
Clinical narrative: Fever; Dizzy; didn't feel right; little chills; Blood pressure was kind of low; This is a spontaneous report from a contactable consumer (the patient). An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration on 04Feb2021 around 14:30 or 14:45 (at the age of 83-years-old) as a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient previously received the first dose of the COVID-19 vaccine on an unspecified date, 3 weeks before, for COVID-19 immunization. On 05Feb2021, the patient experienced fever, dizzy, didn't feel right. On an unspecified date in Feb2021, the patient experienced little chills and blood pressure was kind of low. The clinical course was as follows: The patient got her second COVID shot last Thursday 04Feb2021. She felt fine. Then, on Friday evening (05Feb2021), she started feeling bad. She had a fever and was dizzy, little chills and her blood pressure was kind of low. She had been trying to drink not today (as reported). Today was Monday (08Feb2021), and she still had a low fever. She still didn't feel right. She hasn't felt right since Friday and was improving a little. Her fever wasn't that bad now, but at night it was a little over 100. The clinical outcome of fever, dizzy, didn't feel right was recovering. The outcome of other events was unknown.  Information on the lot/batch number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: Fever; Dizzy; didn't feel right; little chills; Blood pressure was kind of low; This is a spontaneous report from a contactable consumer (the patient). An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration on 04Feb2021 around 14:30 or 14:45 (at the age of 83-years-old) as a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient previously received the first dose of the COVID-19 vaccine on an unspecified date, 3 weeks before, for COVID-19 immunization. On 05Feb2021, the patient experienced fever, dizzy, didn't feel right. On an unspecified date in Feb2021, the patient experienced little chills and blood pressure was kind of low. The clinical course was as follows: The patient got her second COVID shot last Thursday 04Feb2021. She felt fine. Then, on Friday evening (05Feb2021), she started feeling bad. She had a fever and was dizzy, little chills and her blood pressure was kind of low. She had been trying to drink not today (as reported). Today was Monday (08Feb2021), and she still had a low fever. She still didn't feel right. She hasn't felt right since Friday and was improving a little. Her fever wasn't that bad now, but at night it was a little over 100. The clinical outcome of fever, dizzy, didn't feel right was recovering. The outcome of other events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cold sweat, Illness, Pain
Clinical narrative: more sick than expected; fever (100-101 degrees F); body aches; chills; cold sweats; This is a spontaneous report from a non-contactable consumer.  An adult male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW ), via an unspecified route of administration,  on an unspecified date in Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if prior to the vaccination, the patient was diagnosed with COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW), via an unspecified route of administration, on an unspecified date for COVID-19 immunization. It was reported that in Feb2021, the patient was more sick than expected. The weekend following the 2nd dose of Pfizer vaccine, the patient had a fever (100-101 degrees Fahrenheit), body aches, chills, and cold sweats. The patient underwent tests and procedures which included body temperature: 100-101 Fahrenheit  on unspecified date. No treatment was given for the events. The clinical outcome of more sick than expected, had a fever (100-101 degrees Fahrenheit), body aches, chills, and cold sweats was recovered. It was also reported that it was unknown if since the vaccination, the patient been tested for COVID-19.  No follow-up attempts are possible. Information about lot number could not be requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: more sick than expected; fever (100-101 degrees F); body aches; chills; cold sweats; This is a spontaneous report from a non-contactable consumer.  An adult male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW ), via an unspecified route of administration,  on an unspecified date in Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if prior to the vaccination, the patient was diagnosed with COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW), via an unspecified route of administration, on an unspecified date for COVID-19 immunization. It was reported that in Feb2021, the patient was more sick than expected. The weekend following the 2nd dose of Pfizer vaccine, the patient had a fever (100-101 degrees Fahrenheit), body aches, chills, and cold sweats. The patient underwent tests and procedures which included body temperature: 100-101 Fahrenheit  on unspecified date. No treatment was given for the events. The clinical outcome of more sick than expected, had a fever (100-101 degrees Fahrenheit), body aches, chills, and cold sweats was recovered. It was also reported that it was unknown if since the vaccination, the patient been tested for COVID-19.  No follow-up attempts are possible. Information about lot number could not be requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Pain on injection site, other arm; fever; terrific headache; aching ness; This is a spontaneous report from a contactable nurse (patient). A 77-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Feb2021 03:00 am at single dose at left arm for covid-19 immunization. Medical history included asthma, cll (chronic lymphocytic leukaemia), sulfa allergies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took prochlorperazine maleate (PCP) and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The patient experienced pain on injection site, other arm, fever both on 05Feb2021 with outcome of recovered on the same day, terrific headache for three days, aching ness for two days both on 05Feb2021 with outcome of recovered on unspecified date in Feb2021. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care.    Information on the batch/lot number has been requested.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Glossitis, Tongue erythema
Clinical narrative: My tongue became very red, you may say inflamed; You may say inflamed and it felt that way; This is a spontaneous report from a contactable consumer, the patient. An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot GN5318, second dose) solution for injection intramuscular in the left arm on 05Feb2021 (at the age of 83-years-old) at single dose for COVID-19 vaccination. Medical history included depression. Concomitant medication included bupropion for depression. Historical vaccine included BNT162B2 (Lot unknown, first dose) for COVID-19 vaccination on an unknown date with no adverse effect reported. The patient stated, "my tongue became very red, you may say inflamed and it felt that way" on 06Feb2021. Treatment for the events tongue became very red and inflamed included diphenhydramine (BENADRYL). The outcome of the event tongue became very red was not recovered. The outcome of the event tongue inflamed was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Decreased appetite, Hypertension, Influenza like illness, Malaise
Clinical narrative: Was also feeling sick from that; flu-like symptoms; blood pressure varies/155/95 and 138/88; decreased appetite; Patient has also lost 8lbs; This is a spontaneous report from a contactable physician (patient) and a healthcare professional, based on information received by Pfizer(manufacturer control number: EC-2021-088083). This case refers to drug BNT162B2 and NORVASC (amlodipine besilate) for events Sickness, Flu-like symptoms and Blood pressure abnormal. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 at a single dose for COVID-19 immunization, amlodipine besilate (NORVASC), via an unspecified route of administration from Feb2021 at unknown dose for blood pressure, lenvatinib mesilate (LENVIMA) from 08Feb2021 to an unspecified date at 20 mg daily, from Feb2021 to an unspecified date at unknown dose, both via an unspecified route of administration for endometrial cancer (ICD C54.1). The patient's medical history included endometrial cancer (ICD C54.1). The concomitant medications were not reported. The patient's diagnosis was endometrial cancer (ICD C54.1). The patient was prescribed lenvatinib mesilate 20mg daily, start from 08Feb2021. Patient has also lost 8lbs since starting on lenvatinib mesilate, start Feb2021-unknown end date and had a decreased appetite, start Feb2021-unknown end date. Patient reported her blood pressure varies, and she was taking amlodipine besilate. Patient's readings was 155/95 and 138/88; patient was told to call her physician if it gets over 140/90, start Feb2021- unknown end date. The patient got her second COVID vaccine and was also feeling sick from that, flu-like symptoms but is getting better now which started Feb2021, (also reported as end Feb2021). The action taken in response to the event for products amlodipine besilate and lenvatinib mesylate was unknown. The outcome of event blood pressure varies, decreased appetite, patient has also lost 8lbs was unknown, outcome of the other events was recovering.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: Was also feeling sick from that; flu-like symptoms; blood pressure varies/155/95 and 138/88; decreased appetite; Patient has also lost 8lbs; This is a spontaneous report from a contactable physician (patient) and a healthcare professional, based on information received by Pfizer(manufacturer control number: EC-2021-088083). This case refers to drug BNT162B2 and NORVASC (amlodipine besilate) for events Sickness, Flu-like symptoms and Blood pressure abnormal. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 at a single dose for COVID-19 immunization, amlodipine besilate (NORVASC), via an unspecified route of administration from Feb2021 at unknown dose for blood pressure, lenvatinib mesilate (LENVIMA) from 08Feb2021 to an unspecified date at 20 mg daily, from Feb2021 to an unspecified date at unknown dose, both via an unspecified route of administration for endometrial cancer (ICD C54.1). The patient's medical history included endometrial cancer (ICD C54.1). The concomitant medications were not reported. The patient's diagnosis was endometrial cancer (ICD C54.1). The patient was prescribed lenvatinib mesilate 20mg daily, start from 08Feb2021. Patient has also lost 8lbs since starting on lenvatinib mesilate, start Feb2021-unknown end date and had a decreased appetite, start Feb2021-unknown end date. Patient reported her blood pressure varies, and she was taking amlodipine besilate. Patient's readings was 155/95 and 138/88; patient was told to call her physician if it gets over 140/90, start Feb2021- unknown end date. The patient got her second COVID vaccine and was also feeling sick from that, flu-like symptoms but is getting better now which started Feb2021, (also reported as end Feb2021). The action taken in response to the event for products amlodipine besilate and lenvatinib mesylate was unknown. The outcome of event blood pressure varies, decreased appetite, patient has also lost 8lbs was unknown, outcome of the other events was recovering.   Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea
Clinical narrative: Chills; Nausea; Diarrhea; This is a spontaneous report from a non-contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Feb2021 12:00 at single dose at left arm for covid-19 immunization. Medical history included TAVR, blood pressure, acid reflux from an unknown date and unknown if ongoing. Concomitant medications included lisinopril for blood pressure, atorvastatin, omeprazole for acid reflux, hydrochlorothiazide for water pill, spironolactone; all ongoing. The patient experienced chills, nausea, diarrhea all on 09Feb2021 with outcome of recovering. These symptoms were still there, but they're almost gone. Stated it seemed like they all came on together. No additional vaccines administered on the same date of the Pfizer vaccine considered as suspect. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Stated she had never had a reaction after previous vaccinations.   No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: experienced 3 days of coughing; This is a spontaneous report from a contactable consumer reporting for her friend.  A 53-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced 3 days of coughing after the first dose on an unspecified date with outcome of unknown. Information about Lot/Batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: sinuses shut down; This is a spontaneous report from a contactable consumer reported for a patient (Reporter's wife).   A female patient of unknown age received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration on 08Feb2021 11:00 AM for COVID-19 immunization. Medical history and concomitant medications were not reported. On unknown date the patient experienced sinuses shut down. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Off label use
Clinical narrative: patient received first dose on 25Jan2021 08:15 and second dose on 05Feb2021; patient received first dose on 25Jan2021 08:15 and second dose on 05Feb2021; Chills; Headache; This is a spontaneous report from a non-contactable consumer (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the right arm, on 05Feb2021 (at the age of 33-years-old) at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3248), in the right arm, on 25Jan2021 at 08:15 (at the age of 33-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced chills and headache on 05Feb2021 at 10:15, which were reported as non-serious. The patient received first dose on 25Jan2021 08:15 and second dose on 05Feb2021. The patient did not receive any treatment for the chills and headache. The clinical outcome of chills and headache was recovered on an unspecified date and of patient received first dose on 25Jan2021 08:15 and second dose on 05Feb2021 was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Lymphadenopathy, Nightmare, Pain
Clinical narrative: Sleeplessness throughout the night.; aches with no fever 12 hours after the vaccination.  / aches with no fever 24 hours after vaccination lasting 12 hours; Chills; Swollen lymph node in armpit of vaccinated arm 48 hours after vaccination.; Vivid nightmares 14 hours after vaccination.; This is a spontaneous report from a non-contactable other healthcare professional (patient).  A non-pregnant 44-years-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL3247, via an unspecified route of administration on 06Feb2021 09:45  (at the age of 44 years old) at SINGLE DOSE in the left arm for COVID-19 immunisation.  The patient medical history was not reported.  There were no concomitant medications.  The patient had no allergies.Historical vaccine information included BNT162B2, Lot EL9269, on 16Jan2021 10:00 AM in the Left arm, Dose number 1.  Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Feb2021 21:00, the patient experienced chills and aches with no fever 12 hours after the vaccination, sleeplessness throughout the night.  The chills and aches with no fever 24 hours after vaccination lasting 12 hours. Patient experienced vivid nightmares 14 hours on unspecified date in Feb2021 after vaccination. Patient experienced swollen lymph node in armpit of vaccinated arm 48 hours on unspecified date in Feb2021 after vaccination. No treatment was received for the events. Outcome of the vivid nightmares, Ache , Sleeplessness throughout the night, chills, Swollen lymph node in armpit  was recovered in Feb2021.  No follow up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Fever; chills; headache; sweating; fatigue; This is a spontaneous report from a consumer or other non hcp. A 28-year-old male patient started to receive bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration from 18Feb2021 09:45 to 18Feb2021 09:45 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation. On 18Feb2021 22:00, the patient experienced fever, chills, headache, sweating, fatigue. The action taken in response to the event for bnt162b2 was not applicable. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Neuropathy peripheral
Clinical narrative: neuropathy; arthritis; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient, self-reported). A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry dates were not provided), via an unspecified route of administration on an unspecified date, as SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that patient wants to know that if she supposed to take Tylenol after having first shot of Vaccine. On an unspecified patient experienced neuropathy and arthritis. Patient took the medication Tylenol after the first dose. The outcome of the events was unknown.     Information of lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Hyperhidrosis
Clinical narrative: Sweating; Weakness/too weak; loss of appetite; Chills; Headache; Nausea; felt sick; This is a spontaneous report from a Nurse (Patient). A 76-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number, Expiry Date: unknown, NDC number: unknown), on right arm, via an unspecified route of administration on 08Feb2021 at single dose for covid-19 immunization. Covid vaccine was a Pfizer product. Covid vaccine manufacturer was unspecified. No lot number of Covid vaccine was not provided as complainant (patient) does not have the product with them at the time of call. Medical history included Heart attack five years ago, Open heart surgery four years ago, Pulmonary hypertension about 10 years ago, Diastolic dysfunction about 10 years ago. The patient's concomitant medications were not reported. Age at time of onset event was 76 years. Caller (patient) stated that on Monday 08Feb2021, she had her first dose of the Pfizer Covid vaccine and what happened was she waited 15 minutes and the girl came and she said she was fine which she was and she went and sat on the chair and in an hour and a half, she started to feel sick and had a slight headache, and nausea, about an hour and half later it went away. Stated the next morning she got up, sort of too weak to get out of bed, went to the bathroom and went bed and woke up about 5 hours later, felt alright, not so bad. Still did not feel very strong and she sat in her recliner and she was playing on her tablet and she didn't have an appetite, and then she got the chills and then after she got the chills she had to take everything off because she started to sweat. Did not have the strength to go get her thermometer, after she started to sweat she started to feel fine. Caller would like to know if she should get the second dose. NDC, Lot, and expiration date unknown, caller does not have her patient card. The patient experienced sweating, weakness, loss of appetite, chills on 09Feb2021; felt sick, headache, nausea on 08Feb2021. The outcome of the event sweating, weakness, chills was recovered on 09Feb2021; nausea, felt sick, headache was recovered on 08Feb2021; loss of appetite was not recovered (still ongoing).  Information regarding lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea
Clinical narrative: Sweating; Weakness/too weak; loss of appetite; Chills; Headache; Nausea; felt sick; This is a spontaneous report from a Nurse (Patient). A 76-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number, Expiry Date: unknown, NDC number: unknown), on right arm, via an unspecified route of administration on 08Feb2021 at single dose for covid-19 immunization. Covid vaccine was a Pfizer product. Covid vaccine manufacturer was unspecified. No lot number of Covid vaccine was not provided as complainant (patient) does not have the product with them at the time of call. Medical history included Heart attack five years ago, Open heart surgery four years ago, Pulmonary hypertension about 10 years ago, Diastolic dysfunction about 10 years ago. The patient's concomitant medications were not reported. Age at time of onset event was 76 years. Caller (patient) stated that on Monday 08Feb2021, she had her first dose of the Pfizer Covid vaccine and what happened was she waited 15 minutes and the girl came and she said she was fine which she was and she went and sat on the chair and in an hour and a half, she started to feel sick and had a slight headache, and nausea, about an hour and half later it went away. Stated the next morning she got up, sort of too weak to get out of bed, went to the bathroom and went bed and woke up about 5 hours later, felt alright, not so bad. Still did not feel very strong and she sat in her recliner and she was playing on her tablet and she didn't have an appetite, and then she got the chills and then after she got the chills she had to take everything off because she started to sweat. Did not have the strength to go get her thermometer, after she started to sweat she started to feel fine. Caller would like to know if she should get the second dose. NDC, Lot, and expiration date unknown, caller does not have her patient card. The patient experienced sweating, weakness, loss of appetite, chills on 09Feb2021; felt sick, headache, nausea on 08Feb2021. The outcome of the event sweating, weakness, chills was recovered on 09Feb2021; nausea, felt sick, headache was recovered on 08Feb2021; loss of appetite was not recovered (still ongoing).  Information regarding lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Body temperature increased, Headache, Pyrexia
Clinical narrative: full blown auto immune flare/ a great big flare; mild headache; temperature of 102 degrees; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration on 21Jan2021 (at age of 66 years old) at single dose for COVID-19 immunization. The patient's medical history included autoimmune diseases (She had a host of autoimmune diseases. Her body was one big inflammatory responses). Concomitant medications were not reported. The had reactions and was concerned about getting the second dose. She had a host of autoimmune diseases. Her body was one big inflammatory responses. Her doctor figured she would feel it. She started with a mild headache. On the 7th day she was slammed. Her doctor said it was pretty unusual after this long. She had a temperature of 102 degrees. It was like having a full blown auto immune flare that lasted for two days and went away. She was left with a great big flare. She was not able to provide full details as she had an appointment that she had to pay out of pocket for. She was not concerned about the reaction that takes a day or 2 to get over. She was having hell from her usual responses. She was afraid in six months she would be crippled. The outcome of events was unknown. She was due to receive the second dose on Tuesday.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: minor diarrhea; This is a spontaneous report from a contactable Other healthcare professional. A 54-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK3247), via an unspecified route of administration on Left arm on 29Jan2021 13:30 at single dose for covid-19 immunisation administered at workplace clinic. Medical history included none. No Allergies were reported to medications, food, or other products. The patient's concomitant medications were not reported within 2 weeks of vaccination. The patient reported, Both my 1st dose on Jan 29 (Friday) and 2nd Dose on Feb 19 (Friday, 1:30-1:40pm), I have minor diarrhea within 12-24h, not serious. Later it disappeared within 1-2days. This side effect was not included in the list sheet. Adverse event start date and time is 30Jan2021, 09:00 AM. The patient didn't receive any treatment for the event. 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; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events recovered.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: 12 hours after the second shot I had chills; followed by a low fever of 100.4 and body aches; followed by a low fever of 100.4 and body aches; This is spontaneous report from a contactable consumer (patient). An 40-year-old non pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on left arm on 11Feb2021 12: 00 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first single dose of bnt162b2 on 21Jan2021 12:00 via unknown route on left arm single for Covid-19 immunization. The patient had no allergy. The patient not-receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient not received within 2 weeks of vaccination; Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. it was reported 12 hours after the second shot (11Feb2021) patient had chills. This was followed by a low fever of 100.4 and body aches. The chills and body aches continued for 24 hours until they subsided. Event duration was 24 hours. Patient not received treatment. The outcome of the events was recovered on 12Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain, Presyncope
Clinical narrative: felt like she was going to pass out; Dizziness and lightheaded/felt a heaviness in her head; get achy`; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old female patient received second dose of BNT162B2 (lot number was EL9262, expiration date was unknown) via intramuscular in left arm on 11Feb2021 around 10:00at single dose for preventative.  Medical history included ongoing autoimmune condition diagnosed three years ago, ongoing primary biliary cirrhosis diagnosed three years ago, ongoing acid reflux diagnosed 5 years ago, blood pressure abnormal, cholesterol abnormal, cardiac disorder. She had one stent.  Ongoing concomitant medication included ursodiol for autoimmune condition and primary biliary cirrhosis, simvastatin for cholesterol, ezetimibe (ZETIA) for cholesterol, losartan potassium for blood pressure, clopidogrel bisulfate (PLAVIX) since she had one stent, acetylsalicylic acid (BABY ASPIRIN) for the heart, hydrochlorothiazide for blood pressure, omeprazole for acid reflux. She received flu shot in Sep2020 or Oct2020 for immunization and she was fine. Patient received first dose of BNT162B2 (lot number was EL3249) via intramuscular in left arm on 21Jan2021 around 10:00 a.m. for COVID-19 immunization. Patient got something to eat and while she was on the phone around 12:30pm on 11Feb2021, she felt like she was going to pass out, she was dizzy and lightheaded. It lasted all night. On 12Feb2021 she felt a little better, but she still felt a heaviness in her head. It felt like pressure and the pressure was like dizziness. Her health care professional told her that it was normal, and she was told to hydrate, drink water and rest. She took her time getting up now since she was afraid. She wished she was one of the lucky ones to just get achy. Events not required visit to emergency room and physician office. There were no relevant tests. The outcome of event "Dizziness and lightheaded/felt a heaviness in her head" was recovering. The outcome of other events was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: The headache was present after the first dose; This is a spontaneous report from a contactable consumer (patient self-reported). A 30-year-old female patient (who was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247, expiry date not provided) via an unspecified route of administration, in arm left, on 29Jan2021 12:15, as single dose for COVID-19 immunisation, at workplace clinic. The patient medical history was not reported. The patient concomitant medication included Ibuprofen (ADVIL). Patient had no Allergies to medications, food, or other products. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. It was reported that the headache was present after the first dose on an unknown date in Jan2021. No treatment was received by patient for headache. Seriousness of the events was reported as non-serious. The outcome of the event was recovered on an unknown date in Feb2021.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, SARS-CoV-2 test
Clinical narrative: suffered a neurological setback following the first injection; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date in Dec2020 at a single dose for COVID-19 immunization. The vaccine facility type was reported as the nursing home/senior living facility. Relevant medical history included multiple sclerosis (advanced stages), diabetes, and COVID-19 prior vaccination; all from an unknown date and unknown if ongoing. The patient had other medications in two weeks, which included diabetic medications (meds, pills), anti depressants, etc. The patient had no other vaccine in four weeks. The patient was not pregnant at the time of vaccination. On an unspecified date in Dec2020, the patient suffered a neurological setback following the first injection, although it wasn't terribly obvious at that time. The event was considered serious as it resulted in disability or permanent damage. The patient underwent lab tests and procedures, which included an unknown COVID-19 test via nasal swab: negative on an unspecified date in Jan2021. It was unknown if the patient received any treatment for the adverse event (AE). The patient was not recovered from the event.  Information on the batch/lot number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Diarrhoea, Nausea, Vomiting
Clinical narrative: Very high glucose + 300 with need for more than 10 extra units insulin per day for 4 days; Diarrhea; Vomiting day 4 to day 6; Continuing nausea; Continuing nausea with loss of 5 lbs; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9810), via an unspecified route of administration, right arm on 14Feb2021 12:15 PM at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient wasn't pregnant at the time of vaccination. The patient's medical history included Allergies to medications, food, or other products included Sulfa, gluten and cortisone meds, diabetes since age 5 and heart failure. List of any other medications the patient received within 2 weeks of vaccination included Thyroid, metoprolol succinate (TOPROL XL), KCL, furosemide (LASIX [FUROSEMIDE]) (reported as Lasux), spironolactone. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced very high glucose + 300 with need for more than 10 extra units insulin per day for 4 days on 17Feb2021 12:00 PM, diarrhea and vomiting day 4 to day 6 and now continuing nausea with loss of 5 lbs because of nausea at day 11 on Feb2021. The patient received additional insulin as a treatment and call to cardiac physician. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the event Blood glucose increased, Diarrhea, Vomiting, Weight loss was recovering and outcome of event Nausea was not recovered.  Information regarding lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Very high glucose + 300 with need for more than 10 extra units insulin per day for 4 days; Diarrhea; Vomiting day 4 to day 6; Continuing nausea; Continuing nausea with loss of 5 lbs; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9810), via an unspecified route of administration, right arm on 14Feb2021 12:15 PM at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient wasn't pregnant at the time of vaccination. The patient's medical history included Allergies to medications, food, or other products included Sulfa, gluten and cortisone meds, diabetes since age 5 and heart failure. List of any other medications the patient received within 2 weeks of vaccination included Thyroid, metoprolol succinate (TOPROL XL), KCL, furosemide (LASIX [FUROSEMIDE]) (reported as Lasux), spironolactone. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced very high glucose + 300 with need for more than 10 extra units insulin per day for 4 days on 17Feb2021 12:00 PM, diarrhea and vomiting day 4 to day 6 and now continuing nausea with loss of 5 lbs because of nausea at day 11 on Feb2021. The patient received additional insulin as a treatment and call to cardiac physician. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the event Blood glucose increased, Diarrhea, Vomiting, Weight loss was recovering and outcome of event Nausea was not recovered.  Information regarding lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: felt very tired; Minimum pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration in the left arm on 23Feb2021 11:45 at a single dose for COVID-19 immunisation. The patient's medical history included crohn's disease. The patient was not pregnant at the time of vaccination. Concomitant medications included azathioprine (IMURAN) and multivitamins. The patient previously took the first dose of bnt162b2 in the left arm on 03Feb2021 11:45 at the age of 42 years old for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 23Feb2021 15:00, the patient felt very tired and experienced minimum pain at the injection site. No treatment were received for the events. Outcome of the events was recovering. The events were considered non-serious.  Information on the lot/batch number has been requested.