chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pruritus, Urticaria
Clinical narrative: 3 bouts of severe diarrhea; itching; few penny size hives; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6198) via an unspecified route of administration, administered in left arm on 05Mar2021 at 14:30 (age at vaccination was 63-year-old), as dose number unknown, single for COVID-19 immunization. The patient's medical history included IBS (irritable bowel syndrome), Penicillin allergy and intolerant to nuts. Concomitant medications (medications in two weeks) was reported as paracetamol, aspirin, and caffeine (EXCEDRIN); and Essential Enzymes. The patient did not receive any other vaccine within 4 weeks. Prior to vaccination, the patient has not been diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The facility type where COVID-19 vaccine was administered was reported as other. On 06Mar2021 at 14:30 (after 24 hours of the vaccine), the patient had 3 bouts of severe diarrhea (very suddenly), she started itching and had a few penny size hives. It was reported that she took diphenhydramine (BENADRYL) which seemed to calm it down and by the next morning the patient was fine. Therapeutic measures were taken as a result of itching and few penny size hives which included treatment with diphenhydramine while no treatment was received for 3 bouts of severe diarrhea. Outcome of the events was recovered on 07Mar2021. No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Chills; Woke up with a fever of 100.7; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6205, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 08Mar2021 at 17:00 (at the age of 36 years old) as dose 1, single for COVID-19 immunisation in a Pharmacy or Drug Store. Medical history included thyroid cancer from an unknown date. The patient was not pregnant at the time of vaccination and prior to vaccination was not diagnosed with COVID-19. Concomitant medications included levothyroxine; calcitriol; colecalciferol (VITAMIN D 3) and magnesium - all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Mar2021 at 23:30, the patient experienced chills and she woke up with a fever of 100.7 (as reported). No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pruritus, Rash
Clinical narrative: Severe generalized itching; painful skin on back, trunk, arms; Rash on back; This is a spontaneous report from a contactable nurse (patient). An elderly non-pregnant female patient of an unspecified age (Age: 74; Units: Unknown, as reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6200, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 24Feb2021 at 09:45 as dose 1, single for COVID-19 immunisation. Medical history included psoriasis, cancer survivor, antibiotics allergy, and shellfish allergy. The patient previously took codeine and experienced allergy. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 28Feb2021, the patient experienced severe generalized itching, painful skin on back, trunk, arms, and rash on back. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included antihistamine and anti-inflammatory. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: lymph nodes on supraclavicular region were swollen; lymph nodes on supraclavicular region were tender; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EN6205; Expiration date was not reported), via an unspecified route of administration, administered in the left arm on 07Mar2021 01:00 PM (at the age of 32-years-old) as dose 2, single for COVID-19 immunisation at a Clinic/facility. Medical history included cashews allergy and nickel allergy, both from an unknown date and unknown if ongoing. Concomitant medications included testosterone cipionate, glycyrrhiza glabra (LICORICE), adrenal gland, aminobenzoic acid, calcium pantothenate, pyridoxine hydrochloride, riboflavin (ADRENOGEN); all taken for an unspecified indication, start and stop dates were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EL9267; Expiration date was not reported), via an unspecified route of administration, administered in the right arm on 13Feb2021 (at the age of 32-years-old) as dose 1, single for COVID-19 immunisation. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. On 08Mar2021, patient experienced that the lymph nodes on supraclavicular region were swollen and tender. First area was within 24 hrs, second area was within 48 hours. No treatment was taken for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Influenza, Pyrexia
Clinical narrative: chills; fever; sleep for 1 hour then wake up; tired; weak; feels like i have the flu; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number was not reported) via an unspecified route of administration, administered in left arm on 05Mar2021at 16:15 (age at vaccination was 54-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history included high blood pressure. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks. Prior to vaccination, the patient has not been diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The facility type where COVID-19 vaccine was administered was reported as Pharmacy or Drug Store. On 05Mar2021 at 23:15 (7 hours after vaccine), the patient experienced chills, fever and he would sleep for 1 hour then wake up. On 05Mar2021, he experienced being tired, weak, and feels like he have the flu. It was reported that it was 4 days later and the patient still felt the same. No therapeutic measures were taken as a result of the events. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: chills; fever; sleep for 1 hour then wake up; tired; weak; feels like i have the flu; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number was not reported) via an unspecified route of administration, administered in left arm on 05Mar2021at 16:15 (age at vaccination was 54-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history included high blood pressure. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks. Prior to vaccination, the patient has not been diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The facility type where COVID-19 vaccine was administered was reported as Pharmacy or Drug Store. On 05Mar2021 at 23:15 (7 hours after vaccine), the patient experienced chills, fever and he would sleep for 1 hour then wake up. On 05Mar2021, he experienced being tired, weak, and feels like he have the flu. It was reported that it was 4 days later and the patient still felt the same. No therapeutic measures were taken as a result of the events. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: Allergic reaction; Something like a rash; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot Number, and Expiration Date not reported) via an unspecified route of administration on 04Mar2021, as dose 1, single for COVID-19 immunisation. Medical history included allergic a while ago to all food, especially salmon. The patient's concomitant medications were not reported. The patient experienced allergic reaction and something like a rash on an unspecified date in Mar2021. Patient stated she has an "allergic reaction", all over her body she has "something like a rash", it started a day and a half after the dose, on the chest and goes down to her thighs. She stated she was allergic a while ago to all food, especially salmon but she has not eaten it. She called her doctor who sent her some prescriptions to the pharmacy but she was asking is she would have a stronger reaction to the second dose as her second dose was scheduled for 01Apr2021. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Nausea
Clinical narrative: Headache; muscle soreness; 101.4 degree fever; chills; nausea; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6199, Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 04Mar2021 at 12:15 (at the age of 32 years old) as dose number unknown, single for COVID-19 immunisation in a hospital. Medical history included COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included omeprazole; cetirizine hydrochloride (ZYRTEC) and fish oil - all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Mar2021, the patient experienced headache, muscle soreness, 101.4 degree fever, chills and nausea. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; muscle soreness; 101.4 degree fever; chills; nausea; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6199, Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 04Mar2021 at 12:15 (at the age of 32 years old) as dose number unknown, single for COVID-19 immunisation in a hospital. Medical history included COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included omeprazole; cetirizine hydrochloride (ZYRTEC) and fish oil - all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Mar2021, the patient experienced headache, muscle soreness, 101.4 degree fever, chills and nausea. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Decreased appetite, Hyperhidrosis, Imaging procedure
Clinical narrative: No appetite; Cold when he is typically a warm person; Temperature/Fever; sweated profusely; even the sheets, pillowcase and everything was wet; Flu-like symptoms; Soreness at the Injection Site; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 25Feb2021 (at the age of: 49-years-old) at 08:30 or quarter till 9:00 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications. The patient did not receive any other products. The patient did not receive any other vaccine with in 4 weeks prior to the vaccination. The reporter stated that she want to report a strange reaction, a more intense reaction, than they had anticipated. She states that they both had the vaccine on 25Feb2021. she states that they both had a mild reaction at first with soreness at the injection site and flu like feeling like she did rather go lay on the couch for 2 days than do anything else, type symptoms. reporter stated that the patient developed a more intense and had an extreme reaction, and still had a temperature. The reporter assumed that it was his left arm, since he was right handed. She was not sure if he was still had. The patient went to the hospital ER on Thursday, 04Mar2021, to be attended to and he was still not feeling well, a little better but still not well and they did a urinalysis and imaging of the abdomen, a Covid Test that was negative, Liver Function tests, and quite a few other tests, but the patient elected to go home because they did not find anything. The patient was extremely fit and works out every day and they never expected a reaction like this. He had a high fever that is going up and down, and he sweated profusely even the sheets, pillowcase and everything was wet. He had an erratic and sporadic reaction. On an unspecified date, the patient had no appetite, he did not want to eat and he was cold, when he was typically a warm person. The patient underwent lab tests and procedures which included body temperature with over 102 degrees on 02Mar2021 over 102 degrees Fahrenheit, imaging procedure with unknown result, liver function test with unknown result and sars-cov-2 test with negative on and urine analysis with unknown result. The outcome of the pyrexia, sweated profusely; even the sheets, pillowcase and everything was wet, no appetite, Cold when he is typically a warm person was recovering and Flu-like symptoms was not recovered and Soreness at the Injection Site was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Liver function test, Pyrexia, SARS-CoV-2 test, Urine analysis
Clinical narrative: No appetite; Cold when he is typically a warm person; Temperature/Fever; sweated profusely; even the sheets, pillowcase and everything was wet; Flu-like symptoms; Soreness at the Injection Site; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 25Feb2021 (at the age of: 49-years-old) at 08:30 or quarter till 9:00 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications. The patient did not receive any other products. The patient did not receive any other vaccine with in 4 weeks prior to the vaccination. The reporter stated that she want to report a strange reaction, a more intense reaction, than they had anticipated. She states that they both had the vaccine on 25Feb2021. she states that they both had a mild reaction at first with soreness at the injection site and flu like feeling like she did rather go lay on the couch for 2 days than do anything else, type symptoms. reporter stated that the patient developed a more intense and had an extreme reaction, and still had a temperature. The reporter assumed that it was his left arm, since he was right handed. She was not sure if he was still had. The patient went to the hospital ER on Thursday, 04Mar2021, to be attended to and he was still not feeling well, a little better but still not well and they did a urinalysis and imaging of the abdomen, a Covid Test that was negative, Liver Function tests, and quite a few other tests, but the patient elected to go home because they did not find anything. The patient was extremely fit and works out every day and they never expected a reaction like this. He had a high fever that is going up and down, and he sweated profusely even the sheets, pillowcase and everything was wet. He had an erratic and sporadic reaction. On an unspecified date, the patient had no appetite, he did not want to eat and he was cold, when he was typically a warm person. The patient underwent lab tests and procedures which included body temperature with over 102 degrees on 02Mar2021 over 102 degrees Fahrenheit, imaging procedure with unknown result, liver function test with unknown result and sars-cov-2 test with negative on and urine analysis with unknown result. The outcome of the pyrexia, sweated profusely; even the sheets, pillowcase and everything was wet, no appetite, Cold when he is typically a warm person was recovering and Flu-like symptoms was not recovered and Soreness at the Injection Site was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: No appetite; Cold when he is typically a warm person; Temperature/Fever; sweated profusely; even the sheets, pillowcase and everything was wet; Flu-like symptoms; Soreness at the Injection Site; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 25Feb2021 (at the age of: 49-years-old) at 08:30 or quarter till 9:00 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications. The patient did not receive any other products. The patient did not receive any other vaccine with in 4 weeks prior to the vaccination. The reporter stated that she want to report a strange reaction, a more intense reaction, than they had anticipated. She states that they both had the vaccine on 25Feb2021. she states that they both had a mild reaction at first with soreness at the injection site and flu like feeling like she did rather go lay on the couch for 2 days than do anything else, type symptoms. reporter stated that the patient developed a more intense and had an extreme reaction, and still had a temperature. The reporter assumed that it was his left arm, since he was right handed. She was not sure if he was still had. The patient went to the hospital ER on Thursday, 04Mar2021, to be attended to and he was still not feeling well, a little better but still not well and they did a urinalysis and imaging of the abdomen, a Covid Test that was negative, Liver Function tests, and quite a few other tests, but the patient elected to go home because they did not find anything. The patient was extremely fit and works out every day and they never expected a reaction like this. He had a high fever that is going up and down, and he sweated profusely even the sheets, pillowcase and everything was wet. He had an erratic and sporadic reaction. On an unspecified date, the patient had no appetite, he did not want to eat and he was cold, when he was typically a warm person. The patient underwent lab tests and procedures which included body temperature with over 102 degrees on 02Mar2021 over 102 degrees Fahrenheit, imaging procedure with unknown result, liver function test with unknown result and sars-cov-2 test with negative on and urine analysis with unknown result. The outcome of the pyrexia, sweated profusely; even the sheets, pillowcase and everything was wet, no appetite, Cold when he is typically a warm person was recovering and Flu-like symptoms was not recovered and Soreness at the Injection Site was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Mild rash especially on upper chest and back; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 08Mar2021 at 16:30 (at the age of 45-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient received other medications in two weeks which included store bought allergy medication - brand. The patient previously took sulfur and experienced allergy. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient experienced mild rash especially on upper chest and back on 09Mar2021 at 06:00. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspepsia, Flushing, Headache, Hypoaesthesia oral
Clinical narrative: painful injection; dizzy; stomach burned; tongue felt numb; glands in throat hurt; flushed; slight headache; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN9166, Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 09Mar2021 at 10:45 (at the age of 70 years old) as dose 1, single for COVID-19 immunisation. The facility where the most recent COVID-19 vaccine was administered was reported to be "other". Medical history included high BP (blood pressure), high cholesterol and osteoporosis. The patient was not pregnant at the time of vaccination and prior to vaccination was not diagnosed with COVID-19. Concomitant medications included olmesartan; nifedipine; colesevelam hydrochloride (WELCHOL); ezetimibe (ZETIA) and aspirin [acetylsalicylic acid] - all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin (ERYTHROMYCIN), nitrofurantoin (MACRODANTIN), oxycodone (OXYCODON) and barium Sulfate contrast (IVP dye) - all taken for an unspecified indication on an unspecified date and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Mar2021 at 10:45, the patient experienced  painful injection, dizzy, stomach burned (as reported), tongue felt numb, glands in throat hurt (as reported), was flushed and slight headache. All events resulted to Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Vaccination site pain
Clinical narrative: painful injection; dizzy; stomach burned; tongue felt numb; glands in throat hurt; flushed; slight headache; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN9166, Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 09Mar2021 at 10:45 (at the age of 70 years old) as dose 1, single for COVID-19 immunisation. The facility where the most recent COVID-19 vaccine was administered was reported to be "other". Medical history included high BP (blood pressure), high cholesterol and osteoporosis. The patient was not pregnant at the time of vaccination and prior to vaccination was not diagnosed with COVID-19. Concomitant medications included olmesartan; nifedipine; colesevelam hydrochloride (WELCHOL); ezetimibe (ZETIA) and aspirin [acetylsalicylic acid] - all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin (ERYTHROMYCIN), nitrofurantoin (MACRODANTIN), oxycodone (OXYCODON) and barium Sulfate contrast (IVP dye) - all taken for an unspecified indication on an unspecified date and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Mar2021 at 10:45, the patient experienced  painful injection, dizzy, stomach burned (as reported), tongue felt numb, glands in throat hurt (as reported), was flushed and slight headache. All events resulted to Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: mild body aches; low grade fever; This is a spontaneous report from a contactable consumer or non-healthcare professional (patient; Pfizer colleague). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number was not reported) via an unspecified route of administration, administered in left arm on 08Mar2021 at 13:30 (age at vaccination was 60-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included allergies to Penicillin. Concomitant medications (other medications in two weeks) were reported none. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient has not been diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The facility type where COVID-19 vaccine was administered was reported as workplace clinic. On 09Mar2021 at 11:30, the patient experienced mild body aches and low grade fever about 24 hours. The patient underwent lab test and procedure which included body temperature with a result of low grade fever on 09Mar2021 at 11:30. There was no therapeutic measures taken as a result of the events. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: nausea; Shakiness; Extreme fatigue; headache; low-grade temp (under 101.4); This is a spontaneous report from a contactable consumer (patient). A non-pregnant 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot Number, and Expiration Date not reported) via an unspecified route of administration, administered in the left arm on 06Mar2021 08:00 (at the age of 51-years-old), as dose 1, single for COVID-19 immunisation. Medical history included high cholesterol, and Known allergies: Penicillin, sulfa, latex, poison ivy. Concomitant medications included ascorbic acid (VIT C); ergocalciferol (VIT D); and unspecified vitamin B medication all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, shakiness, extreme fatigue, headache, and low-grade temp (under 101.4) on 06Mar2021 10:00. Events were reported as on and off for 80 hours. The patient underwent lab tests and procedures which included body temperature: under 101.4 fahrenheit (reported as low-grade temp, off and on, 80 hours so far) on 06Mar2021. No treatment was received and events did not result to either physician office or emergency room visit. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: nausea; Shakiness; Extreme fatigue; headache; low-grade temp (under 101.4); This is a spontaneous report from a contactable consumer (patient). A non-pregnant 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot Number, and Expiration Date not reported) via an unspecified route of administration, administered in the left arm on 06Mar2021 08:00 (at the age of 51-years-old), as dose 1, single for COVID-19 immunisation. Medical history included high cholesterol, and Known allergies: Penicillin, sulfa, latex, poison ivy. Concomitant medications included ascorbic acid (VIT C); ergocalciferol (VIT D); and unspecified vitamin B medication all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, shakiness, extreme fatigue, headache, and low-grade temp (under 101.4) on 06Mar2021 10:00. Events were reported as on and off for 80 hours. The patient underwent lab tests and procedures which included body temperature: under 101.4 fahrenheit (reported as low-grade temp, off and on, 80 hours so far) on 06Mar2021. No treatment was received and events did not result to either physician office or emergency room visit. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Skin disorder
Clinical narrative: terrible itches all over neck; neck looks like a turkey neck; could not sleep; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 05Mar2021 (at the age of 84-years-old) as dose 1, single for COVID-19 immunisation at a hospital. The patient's medical history and concomitant medications were not reported. The patient experienced had "terrible itches" all over neck, on the outside of neck, not inside on 05Mar2021. It was reported that it started that Friday evening, very light, and continued and worsened each day until today when the patient finally took medication for it. It was also reported that her neck looks like a turkey neck and could not sleep due to the terrible itching on an unspecified date in Mar2021. The patient called her doctor on 08Mar2021 (reported as yesterday) and was advised to take fexofenadine hydrochloride (ALLEGRA).  The patient took Allegra on 09Mar2021 as a result of the events "terrible itches" all over neck and neck looks like a turkey neck.  Her neck was feeling better on 09Mar2021 (reported as today). The outcome of the event "terrible itches" all over neck and neck looks like a turkey neck was recovering and outcome of event could not sleep was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lethargy, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: lethargic, can't walk more than a mile; soreness throughout body; soreness in shoulder, hips; soreness in buttocks; soreness in legs, thighs; burning when given/injected; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is the first of 2 reports. A male patient of an unspecified age (reported as age: 84; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 02Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced burning when given/injected on 02Mar2021, soreness in shoulder, buttocks, hips/legs, thighs on 03Mar2021. It was reported to went away on 04Mar2021. On 05Mar2021, the patient experienced soreness throughout body, and still sore. The patient was also "lethargic, can't walk more than a mile" on an unspecified date. It was reported that it was annoying because the patient was an active person. Patient was querying why he was sore when he get up. The outcome of the events burning when given/injected , soreness in shoulder, buttocks, hips/legs, thighs was recovered on 04Mar2021 (reported as went away), outcome of event soreness throughout body was not recovered and outcome of event "lethargic, can't walk more than a mile" was unknown. The patient was also querying if he can get COVID from the vaccine.  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-2021272981 Same reporter and product, similar events; different patients.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: lethargic, can't walk more than a mile; soreness throughout body; soreness in shoulder, hips; soreness in buttocks; soreness in legs, thighs; burning when given/injected; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is the first of 2 reports. A male patient of an unspecified age (reported as age: 84; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 02Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced burning when given/injected on 02Mar2021, soreness in shoulder, buttocks, hips/legs, thighs on 03Mar2021. It was reported to went away on 04Mar2021. On 05Mar2021, the patient experienced soreness throughout body, and still sore. The patient was also "lethargic, can't walk more than a mile" on an unspecified date. It was reported that it was annoying because the patient was an active person. Patient was querying why he was sore when he get up. The outcome of the events burning when given/injected , soreness in shoulder, buttocks, hips/legs, thighs was recovered on 04Mar2021 (reported as went away), outcome of event soreness throughout body was not recovered and outcome of event "lethargic, can't walk more than a mile" was unknown. The patient was also querying if he can get COVID from the vaccine.  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-2021272981 Same reporter and product, similar events; different patients.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Hypoaesthesia, Paraesthesia
Clinical narrative: "tingling" in her face; face felt numb; having a bruise underneath her chin; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot Number, and Expiration Date not reported) via an unspecified route of administration on 08Mar2021 (at the age of 43-years-old), as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced "tingling" in her face and face felt numb on 08Mar2021, having a bruise underneath her chin on an unspecified date in Mar2021. Patient reported having a bruise underneath her chin that was not there yesterday, before the vaccination. She also stated that she did not remember hurting herself. She also reported that last night she felt a "tingling" in her face. She states that her face felt numb and "tingly" for about a half hour and then this subsided. She said she spoke with two of her colleagues who reported feeling the same thing. Patient was requesting a list of the ingredients of the vaccine, as she may be concerned she had a reaction to a certain ingredient. The outcome of "tingling" in her face and face felt numb was recovered on an unspecified date in Mar2021 while bruise underneath her chin was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Lethargy
Clinical narrative: red bruise like spots on the legs appeared; tiredness; feeling lethargic; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot Number, and Expiration Date not reported) via an unspecified route of administration on 22Feb2021 (at the age of 63-years-old), as dose 1, single for COVID-19 immunisation. Patient has no relevant medical history. There were no concomitant medications. Patient has no allergies to medications, food, or other products. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced red bruise like spots on the legs appeared, tiredness, and feeling lethargic on 28Feb2021. An appointment was made with patient's dermatologist and patient expressed a lot of anxiety about receiving the second dose. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: had a rash on neck, going up cheeks and on the back of neck; redness; itchy; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A 48-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 13:00 (at the age of 48-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included Known allergies to Sulfa drugs. The concomitant medications/Other medications in two weeks included unspecified medication. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient was not covid tested post vaccination. It was reported that, the patient received first immunization Friday 05Mar2021, on Saturday 06Mar2021, the patient had a rash on neck, going up cheeks, and on the back of neck, red, itchy took Benadryl and used hydrocortisone cream, started becoming less on Monday did not switch soaps, perfumes, etc. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received the treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible:information about lot/batch number cannot been obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: mild itchy rash on left forearm which stayed same x4 days, then day5 rash spread to right arm, then day 6 left arm worsened; Rash is spending to upper chest and left axilla; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 25Feb2021 13:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Hx of ovarian, melanoma cancer, aortic.stenosis, asthma. Patient previously received sulfur and experienced known allergy. Patient previously received Compazine and experienced known allergy. Patient previously received proparapaine eye drops and experienced known allergy. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, from unknown start date; losartan (LOSARTAN) taken for an unspecified indication, from unknown start date; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for an unspecified indication, from unknown start date; amlodipine (AMLODIPINE) taken for an unspecified indication, from unknown start date; montelukast sodium (SINGULAIR) taken for an unspecified indication, from unknown start date. The patient previously took sulfur for hypersensitivity, compazine spansule for hypersensitivity, proparacaine hcl for hypersensitivity. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Feb2021 08:00, the patient experienced mild itchy rash on left forearm which stayed same x4 days, then day5 rash spread to right arm, then day 6 left arm worsened, rash is spending to upper chest and left axilla. Doctor seen day7 given short acting cortisone and meds for itching rash improved day 8 then worsened day9 thru current date day11 is 08Mar21 rash was extremely itchy could not sleep itching only relieved with ice. Rash is spending to upper chest and left axilla. She was miserable with itching no other symptoms. Therapeutic measures were taken as a result of mild itchy rash on left forearm which stayed same x4 days, then day5 rash spread to right arm, then day 6 left arm worsened, rash is spending to upper chest and left axilla. Event resulted in Doctor or other healthcare professional office/clinic visit. The clinical outcome of events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Pyrexia
Clinical narrative: Back pain fever headache 05Mar2021-08Mar2021 still experiencing; Back pain fever headache 05Mar2021-08Mar2021 still experiencing; Back pain fever headache 05Mar2021-08Mar2021 still experiencing; This is a spontaneous report from a Contactable Consumer (patient) reported for herself. A 20-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: Unknown), via an unspecified route in the left arm on 04Mar2021 at 19:00 (age at vaccination: 20-year-old), as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1/20). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Patient has not been tested for COVID-19 post vaccination. On 05Mar2021 at 13:00, patient experienced back pain, fever and headache. It was unknown if patient received any treatment for the adverse events. The clinical outcome of the events was not recovered/still experiencing as of 08Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Red itchy rash all over body; itchy rash all over body; there would first be raised welts; Rash appeared monday morning after the 2nd dose; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 26Feb2021 at 02:00 PM (at the age of 43 years old) as DOSE 2, SINGLE DOSE for covid-19 immunization. The patient was not pregnant at the time of the vaccination. The patient medical history was not reported. No known allergies reported. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 12Feb2021 at 03:30 PM as DOSE 1, SINGLE DOSE for covid-19 immunization. No other vaccines were received within four weeks prior to the administration of bnt162b2. On 01Mar2021 at 07:00 AM, Monday morning after second dose, the patient developed red itchy rash all over body. As spread to new areas, there would first be raised welts. The events resulted in visit to doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result the events which included unspecified oral steroid. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.