chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis reactive
Clinical narrative: possible monoreactive arthritis; right knee pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS REACTIVE (possible monoreactive arthritis) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CORTISONE ACETATE (CORTISONE SHOT) for Inflammation, PREDNISONE and METHOTREXATE for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced ARTHRITIS REACTIVE (possible monoreactive arthritis) (seriousness criterion medically significant) and ARTHRALGIA (right knee pain). At the time of the report, ARTHRITIS REACTIVE (possible monoreactive arthritis) and ARTHRALGIA (right knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vaccination site reaction
Clinical narrative: she was admitted to hospital due to big reaction after getting the first shot; nausea; the dizziness hit her/ woke up at 8pm and dizziness was still there and kept on going; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (she was admitted to hospital due to big reaction after getting the first shot) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Epilepsy and Vertigo (Get really dizzy.). Concomitant products included LAMOTRIGINE (LAMICTAL), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) and CARBAMAZEPINE (TEGRETOL) for an unknown indication.    On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced VACCINATION SITE REACTION (she was admitted to hospital due to big reaction after getting the first shot) (seriousness criterion hospitalization) and DIZZINESS (the dizziness hit her/ woke up at 8pm and dizziness was still there and kept on going). On an unknown date, the patient experienced NAUSEA (nausea). The patient was hospitalized on 19-Jun-2021 due to VACCINATION SITE REACTION. At the time of the report, VACCINATION SITE REACTION (she was admitted to hospital due to big reaction after getting the first shot), DIZZINESS (the dizziness hit her/ woke up at 8pm and dizziness was still there and kept on going) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 20-Jun-2021 patient went to the hospital and had blood work done  but no results were reported. Treatment reported is unknown nausea medication.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Faint; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Faint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.  Very limited information regarding this event has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Myocarditis, Pain in extremity, Scan
Clinical narrative: developed heart pain down both arms; myocarditis, every time his heart beat it hurt and he felt pressure; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis, every time his heart beat it hurt and he felt pressure) and PAIN IN EXTREMITY (developed heart pain down both arms) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced MYOCARDITIS (myocarditis, every time his heart beat it hurt and he felt pressure) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (developed heart pain down both arms) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to MYOCARDITIS and PAIN IN EXTREMITY. At the time of the report, MYOCARDITIS (myocarditis, every time his heart beat it hurt and he felt pressure) and PAIN IN EXTREMITY (developed heart pain down both arms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: high (High) high protein numbers. In 2021, Electrocardiogram: abnormal (abnormal) diagnosis of myocarditis. In 2021, Scan: abnormal (abnormal) diagnosis of myocarditis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was not given. No concomitant medication information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  Very limited information has been provided at this time. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information has been provided at this time. Further information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Purpura, Thrombocytopenia, Vaginal haemorrhage
Clinical narrative: her blood count showed zero platelets; heavy vaginal bleeding; red spots under ankle and wrists; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOCYTOPENIA (her blood count showed zero platelets) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOCYTOPENIA (her blood count showed zero platelets) (seriousness criteria hospitalization and medically significant), VAGINAL HAEMORRHAGE (heavy vaginal bleeding) and PURPURA (red spots under ankle and wrists). At the time of the report, THROMBOCYTOPENIA (her blood count showed zero platelets), VAGINAL HAEMORRHAGE (heavy vaginal bleeding) and PURPURA (red spots under ankle and wrists) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) blood count showed zero platelets and normal (normal) completely normal blood-test results less than a week before being vaccinated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had a checkup with completely normal blood-test results less than a week before being vaccinated. Patient had spent four days in the hospital, receiving platelet transfusions, immune globulins and steroids to restore her platelet count. Concomitant medication were not provided.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Further information has been requested   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Malaise
Clinical narrative: severe heart burn; overall not feeling well; This is a spontaneous report from a contactable consumer or other non HCP (patient himself).   A 70-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el8982), via an unspecified route of administration, administered in Left arm on 03Feb2021 12:00 PM (at the age of 70-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history was not reported. The patient had no known allergies to medications, food or other products. the patient received medications within 2 weeks of vaccination included blood pressure medication (unspecified). 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 has not been tested for COVID-19. On 04Feb2021 at 06:00 PM, the patient experienced severe heart burn and overall not feeling well. The events were reported as non-serious. No treatment received for the adverse event. The outcome of the events were not resolved.   Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, Skin discomfort
Clinical narrative: Chills; fever; achy all over; skin hurts to touch; very tired; This is a spontaneous report from a contactable consumer. A 46-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 04Feb2021 07:30 (at the age of 46-years-old) as dose 2, single for covid-19 immunisation in hospital. Medical history included penicillin allergy. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EK9231, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 01Jan2021 07:30 (at the age of 46-years-old) as dose 1, single for covid-19 immunisation. 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. On 04Feb2021 at 14:00, the patient experienced chills, fever, achy all over, skin hurts to touch and very tired. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: achiness; slight headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in arm right on 27Jan2021 10:15 (at the age of 73-years-old) as dose 1, single for covid-19 immunization. Medical history included chronic obstructive pulmonary disease (copd), high blood pressure (high bp), high cholesterol, essential tremor, gastroesophageal reflux disease (gerd), arthritis. The patient previously took Macrobid [nitrofurantoin] and experienced drug hypersensitivity (Allergies to medications, food, or other products: macrobid). Concomitant medication included propranolol (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; atorvastatin (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; pantoprazole (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; Olmesartan (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Jan2021 13:30, the patient experienced achiness, slight headache, nausea. The patient did not receive any treatment for the adverse event. The reported seriousness of the events was non-serious. The clinical outcome of the events was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: lower back muscle soreness; fever; chills/chattering teeth; This is a spontaneous report from a contactable other hcp. This HCP reported for himself that a 31-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL9263), dose 1 intramuscular, administered in Arm Right on 26Jan2021 16:45 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 31Jan2021 19:00, the patient experienced lower back muscle soreness; fever and chills/chattering teeth. Patient was not received treatment for events. The patient underwent lab tests and procedures which included body temperature: 102.3 fahrenheit on 31Jan2021 from 7 pm until 02Jan2021 afternoon,I had a fever, sars-cov-2 test: negative on 01Feb2021. It was reported that on 31Jan2021 from 07:00 pm until 01Feb2021 afternoon, patient had a fever of 102.3 degrees F with chills, chattering teeth and lower back muscle soreness. 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. Since the vaccination, patient has been tested for COVID-19. The clinical outcome of all events were recovering.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased
Clinical narrative: Blood sugar has stayed lower; This is a spontaneous report from a contactable consumer (patient himself).   A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: eh9899) via an unspecified route of administration, administered in arm left on 03Jan2021 (at the age of 66-year-old) as dose number unknown, single for covid-19 immunisation.Medical history included diabetes, high blood pressure and high cholesterol. Concomitant medications included insulin taken for an unspecified indication and other medication (unspecified) was received within 2 weeks of vaccination. The patient had no known allergies to medications, food, or other products. The patient didn't 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 had not tested for COVID-19. On 09Jan2021,the patient reported that, two weeks after the shot, upon review of my glucose meter my endocrinologist reduced the amount of long-acting insulin by 25 percentage. Blood sugar had stayed lower, and the treatment short term insulin use was reduced also. The patient visited doctor or other healthcare professional office/clinic visit. On 09Jan2021, the patient lab data included blood sugar had stayed lower and short-term insulin use is reduced also. The outcome of the event was unknown.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.  Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash in some areas of the body, itching.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles along S2-S3 dermatomes
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Feel week; Everything in body hurts feel so tired; This is a spontaneous report from a contactable other healthcare professional (reporting herself). A 35 year old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not available), via an unspecified route of administration in left arm on 04Feb2021 at 14:45 (age at the time of vaccination was 35 years) as a single dose for COVID-19 immunization. The patient's medical history included anaemic. The patient's concomitant medication was not reported. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication with in 2 weeks of COVID vaccination. The patient did not diagnose with COVID-19 prior to the vaccination. The patient did not test for COVID since the vaccination. On 04Feb2021 at 14:45, the patient experienced felt week, everything in body hurts felt so tired. The patient did not receive any treatment medication. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Swelling
Clinical narrative: pain under left arm; swelling the size of half a baseball in armpit; fatigue; headache; This is a spontaneous report from a contactable other healthcare professional (patient) reporting herself. A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302, Expiry date was not reported), dose 2 via an unspecified route of administration, administered in left arm on 02Feb2021 (at 48-years-old) as single dose for covid-19 immunisation at hospital. Medical history included low thyroid, spondyloarthritis and fibromyalgia. The patient has allergy to celexa and zithromycin. Concomitant medications included levothyroxine, cetirizine hydrochloride (ZYRTEK), medroxyprogesterone acetate (DEPO PROVERA), ibuprofen, ascorbic acid, colecalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMIN) and apple cider vinegar gummies.The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1, intramuscular, administered in left arm on 13Jan2021 at 16:00 (Batch/Lot Number: EK9231, Expiry date was not reported) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and since vaccination the patient has not been tested for covid-19. It was reported that, on 04Feb2021, at 04:00 AM the patient experienced pain under left arm with swelling the size of half a baseball in armpit, fatigue and headache. There was no treatment received for the reported events. The outcome of the events was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Hyperhidrosis, Insomnia
Clinical narrative: My body started shivering uncontrollably/feel extremely chilled; I had trouble sleeping and was up most of the night; high fever/I checked my temperature last night ranged from 101.8 to a high of 103.7; I woke up soaked in sweat; severe migraine; I felt dizzy all through the night; This is a spontaneous report from a contactable other health care professional. A 52-years-old male patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248, age at vaccination 52 years), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 10:00 as dose 2, single for covid-19 immunisation. Medical history included irritable bowel syndrome (IBS), asthma, Low lung input and output, covid-19 covid prior vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient previously took BNT162B2, dose1, single (lot number EL3248) for covid 19- immunization on 14Jan2021, 11:00. The patient's concomitant medications were not reported. On 04Feb2021 22:30, the patient started to feel extremely chilled. He went to bed and covered up with 2 blankets. patient body started shivering uncontrollably. Patient normal temperature fluctuates from 94-95 degrees. He checked temperature last night ranged from 101.8 to a high of 103.7. patient had trouble sleeping and was up most of the night due to the high fever. He woke up soaked in sweat. He also had a severe migraine and he felt dizzy all through the night and into 05Feb2021. The patient underwent lab tests and procedures which included body temperature: ranged from 101.8 to a high of 103.7 on 04Feb2021. Seriousness was not serious. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Non-Allergies to medications, food, or other products. No treatment was received for the adverse events. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Pyrexia
Clinical narrative: My body started shivering uncontrollably/feel extremely chilled; I had trouble sleeping and was up most of the night; high fever/I checked my temperature last night ranged from 101.8 to a high of 103.7; I woke up soaked in sweat; severe migraine; I felt dizzy all through the night; This is a spontaneous report from a contactable other health care professional. A 52-years-old male patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248, age at vaccination 52 years), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 10:00 as dose 2, single for covid-19 immunisation. Medical history included irritable bowel syndrome (IBS), asthma, Low lung input and output, covid-19 covid prior vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient previously took BNT162B2, dose1, single (lot number EL3248) for covid 19- immunization on 14Jan2021, 11:00. The patient's concomitant medications were not reported. On 04Feb2021 22:30, the patient started to feel extremely chilled. He went to bed and covered up with 2 blankets. patient body started shivering uncontrollably. Patient normal temperature fluctuates from 94-95 degrees. He checked temperature last night ranged from 101.8 to a high of 103.7. patient had trouble sleeping and was up most of the night due to the high fever. He woke up soaked in sweat. He also had a severe migraine and he felt dizzy all through the night and into 05Feb2021. The patient underwent lab tests and procedures which included body temperature: ranged from 101.8 to a high of 103.7 on 04Feb2021. Seriousness was not serious. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Non-Allergies to medications, food, or other products. No treatment was received for the adverse events. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain, SARS-CoV-2 test
Clinical narrative: Body ache; swollen lymph node on injection site; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 35-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: QL9262, Expiration date not reported), via intramuscular route of administration in arm left on 03Feb2021 13:00 (at the age of 35-year-old) as single dose for COVID-19 immunisation. Medical history included Pre diabetic, hypertension, PCOS and allergic to Macadamia nuts; all from an unknown date and unknown if ongoing. The patient had COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced body ache, swollen lymph node on injection site and fatigue on 04Feb2021 14:00. The seriousness of all events was reported as non-serious. The patient underwent lab tests and diagnosis which include: COVID-19 prior to vaccination. The patient did not receive any treatment for the events. The outcome of all events was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Dizziness, Headache
Clinical narrative: Woke up in the night with chills and body shivers; Headache; Dizziness; Low grade fever; genaral body pain; Joint pain; No appetite; Generally felt ill; Pain at injection site; This is a spontaneous report from a non-contactable consumer. A 69-years-old female patient received second dose of bnt162b2(COMIRNATY, Solution for injection, intramuscular, Batch/Lot number was not reported) via unspecified route in right arm on 03Feb2021 on 15:30 as SINGLE DOSE for COVID-19 immunisation. The patient medical history included High blood pressure and thyroid. The patient concomitant medication was not reported. The patient historical vaccine included first dose of bnt162b2(COMIRNATY, Solution for injection, intramuscular, Batch/Lot number was not reported) via unspecified route in left arm on 13Jan2021 on 3:30 PM as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination, and since the vaccination, has the patient been tested for COVID-19. On 04Feb2021 04:30 AM, the patient woke up in the night with chills and body shivers, head-ache, dizziness, low grade fever, body ache, joint pain, no appetite, generally felt ill and pain at injection site. On an unspecified date, the events were resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Woke up in the night with chills and body shivers; Headache; Dizziness; Low grade fever; genaral body pain; Joint pain; No appetite; Generally felt ill; Pain at injection site; This is a spontaneous report from a non-contactable consumer. A 69-years-old female patient received second dose of bnt162b2(COMIRNATY, Solution for injection, intramuscular, Batch/Lot number was not reported) via unspecified route in right arm on 03Feb2021 on 15:30 as SINGLE DOSE for COVID-19 immunisation. The patient medical history included High blood pressure and thyroid. The patient concomitant medication was not reported. The patient historical vaccine included first dose of bnt162b2(COMIRNATY, Solution for injection, intramuscular, Batch/Lot number was not reported) via unspecified route in left arm on 13Jan2021 on 3:30 PM as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination, and since the vaccination, has the patient been tested for COVID-19. On 04Feb2021 04:30 AM, the patient woke up in the night with chills and body shivers, head-ache, dizziness, low grade fever, body ache, joint pain, no appetite, generally felt ill and pain at injection site. On an unspecified date, the events were resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort
Clinical narrative: sensation of chest tightness; burning sensation; This is a spontaneous report from a contactable Other Health Professional. A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported) via intramuscular route of administration, administered in Left Arm on 16Jan2021 at 14:30 (at the age of 54-years-old) as Dose number unknown, single for COVID-19 immunization at Hospital. The Patient had sulfa allergies. Concomitant medications included levothyroxine sodium (LEVOXYL). 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 has not been tested for COVID-19.On 16Jan2021,at 14:30,the patient experienced sensation of chest tightness, burning sensation.It was reported that no therapeutic measures were taken for the events experienced.The outcome of events not recovered/not resolved.  Information on the lot/batch number has been requested  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Fatigue, Pain
Clinical narrative: body aches; fatigue; Fever up to 101; cold chills; This is a spontaneous report from a contactable consumer (reported for himself). A 59-year-old male patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EM9810), dose 2 via an unspecified route of administration, administered in arm left on 03Feb2021 (at the age of 59-year-old) as dose 2, single for covid-19 immunisation at Hospital. Medical history included enlarged prostate elevated psa ongoing since 1990, hypertension ongoing since 2001, diabetes mellitus ongoing since 2019, blood cholesterol increased ongoing since 2019, prostatomegaly ongoing since 2019, cardiovascular disorder, arthropathy, immune system disorder, cardiac disorder and product communication issue. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. Concomitant medications included rosuvastatin tablets, metformin tablets, hydrochlorothiazide tablet, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) capsule ongoing since an unknown date for health, amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL) capsule, curcuma longa (TURMERIC) ongoing since an unknown date for cardiovascular disorder, arthropathy, immune system disorder, fish oil (FISH OIL) ongoing since an unknown date for cardiac disorder and serenoa repens (SAW PALMETO) ongoing since an unknown date for prostatomegaly. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL3249), dose 1 via an unspecified route of administration, administered in arm left on 13Jan2021 at 13:30 (at the age of 59-years-old) as dose 1, single for covid-19 immunisation at Hospital. On 04Feb2021 at 14:00, the patient experienced fever up to 101, cold chills, fatigue and at 14:30 body aches. No treatment was given for the events. The patient underwent lab tests and procedures which included covid-19: negative on 20Nov2020 and body temperature: up to 101 on 04Feb2021. The outcome of the event body aches was resolving, and remaining events were resolved on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: body aches; fatigue; Fever up to 101; cold chills; This is a spontaneous report from a contactable consumer (reported for himself). A 59-year-old male patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EM9810), dose 2 via an unspecified route of administration, administered in arm left on 03Feb2021 (at the age of 59-year-old) as dose 2, single for covid-19 immunisation at Hospital. Medical history included enlarged prostate elevated psa ongoing since 1990, hypertension ongoing since 2001, diabetes mellitus ongoing since 2019, blood cholesterol increased ongoing since 2019, prostatomegaly ongoing since 2019, cardiovascular disorder, arthropathy, immune system disorder, cardiac disorder and product communication issue. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. Concomitant medications included rosuvastatin tablets, metformin tablets, hydrochlorothiazide tablet, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) capsule ongoing since an unknown date for health, amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL) capsule, curcuma longa (TURMERIC) ongoing since an unknown date for cardiovascular disorder, arthropathy, immune system disorder, fish oil (FISH OIL) ongoing since an unknown date for cardiac disorder and serenoa repens (SAW PALMETO) ongoing since an unknown date for prostatomegaly. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL3249), dose 1 via an unspecified route of administration, administered in arm left on 13Jan2021 at 13:30 (at the age of 59-years-old) as dose 1, single for covid-19 immunisation at Hospital. On 04Feb2021 at 14:00, the patient experienced fever up to 101, cold chills, fatigue and at 14:30 body aches. No treatment was given for the events. The patient underwent lab tests and procedures which included covid-19: negative on 20Nov2020 and body temperature: up to 101 on 04Feb2021. The outcome of the event body aches was resolving, and remaining events were resolved on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: A couple of toes on both feet became painful, itchy and swollen; A couple of toes on both feet became painful, itchy and swollen; A couple of toes on both feet became painful, itchy and swollen; This is a spontaneous report from a contactable consumer or other non-healthcare professional.  A 47-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL9264 and Expiration date was not reported) via an unspecified route of administration, in right arm, on 01Feb2021 at 10:30 AM (at the age of 47-year-old), as a single dose for COVID-19 immunization.The patient medical history included drug hypersensitivity (Sulfa allergy) and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had 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. On 02Feb2021, patient had experienced a couple of toes on both feet became painful, itchy and swollen interfering with sleep and wearing shoes. No treatment was received. The outcome of the events was not recovered. The seriousness for the events was reported as non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Arm tender at injection site; Fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknow), via intramuscular, administered in Arm Right on 04Feb2021 at 08:00 AM as 2nd dose single for covid-19 immunization. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Allergies to medications, food, or other products: No. Concomitant medication included LISINOPRIL AND SIMVASTATIN. Historical vaccine of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknow), via intramuscular, administered in Arm Right on 14Jan2021 at 08:00 AM as 1ST DOSE SINGLE for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19: No. Since the vaccination, the patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Day after 2nd injection. Arm tender at injection site. Fatigue, no fever on 05Feb2021 at 09:00 AM. No treatment received for the adverse event. The outcome of events was recovered on Feb2021.  Information on the lot/batch number had been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Very stiff fingers, toes; Very stiff fingers, toes and other joints immediately after waking up; like arthritis; This is a spontaneous report from a contactable consumer or non health care professional reported for himself. A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262 and Expiration date was not reported), via an unspecified route of administration, administered in left arm, at 03:00 PM on 24Jan2021 (at the age of 58 years-old) as a first dose, single for covid-19 immunization at Public Health Clinic/Veterans Administration facility. The patient's medical history and concomitant medications were not reported. The patient past drug event included levoquin (allergies to medications, food, or other products). Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 31Jan2021, the patient had experienced very stiff fingers, toes, very stiff fingers, toes and other joints immediately after waking up, and like arthritis and patient got a little better during the day. The patient did not received any treatment for reported events. Seriousness reported as No. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling cold, Hypoaesthesia, Paraesthesia
Clinical narrative: left arm was freezing cold/hand went cold; hands and feet were numb; tingling throughout both arms and legs; chest pain; This is a spontaneous report from a contactable consumer. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL8982, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 13:00(at the age of 47 years) as dose 1, single for covid-19 immunisation.  Medical history included sulfa allergy, penicillin allergy. Concomitant medications included letrozole (LETROZOLE). Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Jan2021 the patient experienced left arm was freezing cold her hand went cold, hands and feet were numb, tingling throughout both arms and legs, she had chest pain.  The action taken in response to the event(s) for bnt162b2 was not applicable. Patient visited emergency room for occurred events. Patient did not receive any treatments. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Mouth ulceration, Oral pain
Clinical narrative: mild flu-like symptoms; Mouth sores/ulcers; Mouth sores/ulcers; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) intramuscularly on 03Feb2021 07:15 AM in left arm as dose 2 single for COVID-19 immunization at Hospital. Medical history and Concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE) intramuscularly in left arm on 13Jan2021 08:00 AM (at age of 32-year-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. 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 has not been tested for COVID-19. No allergies to medications, food, or other products. It was reported that patient experienced mild flu-like symptoms, mouth sores/ulcers on 04Feb2021. No treatment received for the adverse events. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: After taste in mouth; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). This consumer reported similar events for two patients. This is 1st of two reports. A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 68-year) in Right Arm on 05Feb2021 15:00 as dose 1, single for COVID-19 immunization. Medical history included Meniere's disease from an unknown date and unknown if ongoing. Concomitant medications included Multi Vitamins; rosuvastatin calcium (CRESTOR); furosemide and sertraline taken for an unspecified indication, start and stop date were not reported. The patient was having no known allergies. As reported the patient was not tested COVID, prior and post vaccination. On 05Feb2021 15:30 the patient experienced after taste in mouth, strong immediately after vaccine. No treatment was received. The clinical outcome of the event was recovered on an unspecified date of 2021.  Information about lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021157099 Same reporter/drug/event, different patient
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dizziness postural, Nausea
Clinical narrative: Dizziness on standing.; Light headed ness.; Slightly nauseous.; This is a spontaneous report from a non-contactable 54-year-old female consumer (patient herself). A 54-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9269) via an unspecified route of administration in left arm on 05Feb2021 13:30 as dose 1, single (at the age of 54-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as Public facility. Patient medical history included allergic to morphine and Hashimoto disease. The concomitant medications included levothyroxine, phentermine. On 08Feb2021 at 07:00 patient experienced dizziness on standing, lightheadedness and was slightly nauseous. Patient did not receive any treatment for the adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: I just was dizzy like light-headed/I got kind of light-headed; This is a spontaneous report from a contactable consumer or on health care professional (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 (at the age of 67 years old) as dose 1, single for COVID-19 immunization at  Health Department. No patient history and concomitant medications, other products were reported. The patient stated that she had her first dose of the Pfizer covid vaccine on 04Feb2021 and right after she had vaccine, she got kind of light-headed and it only lasted for five minutes. And also stated he do not have a headache. Patient was asked was it a serious side effect and just wondering that if she should get the second dose. No Investigation Assessment were provided. Seriousness was reported as No. Outcome of the event was resolved on 04Feb2021.  Call was transferred from Pfizer Medical Information by  Transferring agent stated, A female patient on the line who reported some light headedness more like dizziness after taking the Pfizer Vaccine. She said that she had the vaccine on 04Feb (not clarified), the first dose of the Pfizer Covid vaccine and she felt lightheaded which lasted for about five minutes and answered her questions already. When paraphrased the concern, consumer stated, just when she had the vaccine, she would say maybe five minutes after she got it and it only lasted for five minutes. Expiration Date and Dose: Consumer stated, it doesn't have an expiration date. Treatment: Consumer stated, "No." Consumer further stated, she got it at ( Health Department." Anatomical site of vaccine administration: Left Arm. Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  Follow-up attempts completed. No further information expected.