chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Headache; fever; chills; fatigue; vomiting; ear infection; Achy; This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8734) via an unspecified route of administration in the arm left on an unknown date in Apr2021(at the age of 49-year-old) at 09:15 as a single dose for COVID-19 immunisation. Medical history included migraine, arthritis and COVID-19. Concomitant medications included mometasone furoate (FLONASE), topiramate (TOPAMAX), azelastine (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN)all from an unknown date for unknown indication. The patient previously took Ceftin and experienced drug allergy. Prior to the vaccination, the patient was 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 an unknown date in Apr2021 at 2.30 patient experienced Covid Arm + 5 days, Headache 2 days (48 hours after), Achy, fever, chills, fatigue, vomiting and ear infection post vaccine 3 days. Therapeutic measures were taken as a result of ear infection which included treatment with ear drop for Otitis media/externa. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events Covid Arm, Headache 2 days, Achy, fever, chills, fatigue, vomiting and ear infection were resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pustule, Scab
Clinical narrative: Blisters when busted they oozed yellow liquid; Itchy; Scabs; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6205) via an unspecified route of administration in the left arm on 09Mar2021 at 14:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received unspecified concomitant medication within two weeks of vaccination. The patient had no allergies to medications, food, or other products. 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 13Mar2021, on the fourth day after receiving the vaccine, the patient experienced blisters which when busted oozed yellow liquid, was very itchy and the patient had 5 on right foot, one near left elbow and one in back of throat. Even after a month the patient still had scabs. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with prescription antihistamine and steroid cream. The clinical outcome of the event blisters with oozed yellow liquid and itchy on right foot, left elbow and back of throat and scabs was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeding disorder, Malaise, Nausea
Clinical narrative: Unable to eat or drink; severe fatigue; malaise; Site pain; Chills; Profuse shaking; severe nausea; This is a spontaneous report from a contactable other health care professional. A 23-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration on the left arm on 14Mar2021 at 17:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included ibd (inflammatory bowel disease), ulcerative colitis and connective tissue disease/lupus. The patient had history of known allergies to penicillin (MANUFACTURER UNKNOWN), cefprozil (CEFZIL) and ibuprofen (MANUFACTURER UNKNOWN). Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL), mesalazine (MESALAMINE) and others, from an unknown date for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Mar2021 at 18:05, 20 minutes after 1st injection, the patient experienced chills, profuse shaking, and severe nausea, went to emergency, followed by 2 days on 15Mar2021, severe nausea (unable to eat or drink), severe fatigue, malaise and site pain. The patient also reported that she began to recover on 3rd day. The adverse event resulted in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Therapeutic measures were taken as a result of events chills, profuse shaking, severe nausea, unable to eat or drink, severe fatigue, malaise and site pain, which included treatment with ondansetron (ZOFRAN). The clinical outcomes of chills, profuse shaking, severe nausea, unable to eat or drink, severe fatigue, malaise and site pain were recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vaccination site pain
Clinical narrative: Unable to eat or drink; severe fatigue; malaise; Site pain; Chills; Profuse shaking; severe nausea; This is a spontaneous report from a contactable other health care professional. A 23-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration on the left arm on 14Mar2021 at 17:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included ibd (inflammatory bowel disease), ulcerative colitis and connective tissue disease/lupus. The patient had history of known allergies to penicillin (MANUFACTURER UNKNOWN), cefprozil (CEFZIL) and ibuprofen (MANUFACTURER UNKNOWN). Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL), mesalazine (MESALAMINE) and others, from an unknown date for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Mar2021 at 18:05, 20 minutes after 1st injection, the patient experienced chills, profuse shaking, and severe nausea, went to emergency, followed by 2 days on 15Mar2021, severe nausea (unable to eat or drink), severe fatigue, malaise and site pain. The patient also reported that she began to recover on 3rd day. The adverse event resulted in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Therapeutic measures were taken as a result of events chills, profuse shaking, severe nausea, unable to eat or drink, severe fatigue, malaise and site pain, which included treatment with ondansetron (ZOFRAN). The clinical outcomes of chills, profuse shaking, severe nausea, unable to eat or drink, severe fatigue, malaise and site pain were recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dry eye, Dry skin, Eye irritation, Eye pruritus
Clinical narrative: Extremely dry skin; Near cracking; Eyes burning; itchy eyes; dry eyes; headache; muscle ache; chills; tired; Sever pain at injection site.; skin warmed; This is a spontaneous report from a non-contactable consumer. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 08:15 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included LASIK(Laser-assisted in situ keratomileusis) eye surgery on Nov2020. Concomitant medications included lifitegrast (XIIDRA) for lasting headaches from dryness on third and last month of treatment. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 08:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. 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 06Apr2021 at 13:00, the patient experienced extremely dry skin, near cracking(chapped skin), eyes burning, itchy, dry (similar feel like seasonal allergies) and other typical symptoms like headache, muscle ache, chills, tired, skin warmed and severe pain at injection site(vaccination site). The patient took advil liquid gel 300 mg as treatment for the reported events. It was reported that all symptoms were muted after receiving Advil. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The clinical outcome of the events extremely dry skin, near cracking, eyes burning, eye itchy, headache, muscle ache, chills, tired, skin warmed and severe pain at injection site were recovered on 06Apr2021, while that of the event dry eyes was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Skin fissures, Skin warm
Clinical narrative: Extremely dry skin; Near cracking; Eyes burning; itchy eyes; dry eyes; headache; muscle ache; chills; tired; Sever pain at injection site.; skin warmed; This is a spontaneous report from a non-contactable consumer. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 08:15 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included LASIK(Laser-assisted in situ keratomileusis) eye surgery on Nov2020. Concomitant medications included lifitegrast (XIIDRA) for lasting headaches from dryness on third and last month of treatment. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 08:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. 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 06Apr2021 at 13:00, the patient experienced extremely dry skin, near cracking(chapped skin), eyes burning, itchy, dry (similar feel like seasonal allergies) and other typical symptoms like headache, muscle ache, chills, tired, skin warmed and severe pain at injection site(vaccination site). The patient took advil liquid gel 300 mg as treatment for the reported events. It was reported that all symptoms were muted after receiving Advil. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The clinical outcome of the events extremely dry skin, near cracking, eyes burning, eye itchy, headache, muscle ache, chills, tired, skin warmed and severe pain at injection site were recovered on 06Apr2021, while that of the event dry eyes was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Extremely dry skin; Near cracking; Eyes burning; itchy eyes; dry eyes; headache; muscle ache; chills; tired; Sever pain at injection site.; skin warmed; This is a spontaneous report from a non-contactable consumer. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 08:15 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included LASIK(Laser-assisted in situ keratomileusis) eye surgery on Nov2020. Concomitant medications included lifitegrast (XIIDRA) for lasting headaches from dryness on third and last month of treatment. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 08:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. 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 06Apr2021 at 13:00, the patient experienced extremely dry skin, near cracking(chapped skin), eyes burning, itchy, dry (similar feel like seasonal allergies) and other typical symptoms like headache, muscle ache, chills, tired, skin warmed and severe pain at injection site(vaccination site). The patient took advil liquid gel 300 mg as treatment for the reported events. It was reported that all symptoms were muted after receiving Advil. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The clinical outcome of the events extremely dry skin, near cracking, eyes burning, eye itchy, headache, muscle ache, chills, tired, skin warmed and severe pain at injection site were recovered on 06Apr2021, while that of the event dry eyes was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included was not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no allergies to any medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. 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 31Mar2021, the patient experienced sore arm. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event of pain in arm was recovered on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Lymphadenopathy, Myalgia, Oropharyngeal pain
Clinical narrative: Morning of 4/6 (4 days after shot), woke to sore throat; Swollen lymph nodes; Joint/muscle aches; Joint/muscle aches; Slight dizziness; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 14:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine.  Allergies to medications, food or other products were reported as none. 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 COVID-19 vaccine. On 06Apr2021, at 05:00 in the morning 4 days after the shot the patient woke up with sore throat, swollen lymph nodes, joint/muscle aches, and slight dizziness. The patient had no fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of events. The clinical outcome of the events sore throat, swollen lymph nodes, joint aches, muscle aches and dizziness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: a sore arm after getting the first dose.; red circle around initial injection site; warm to touch; initial injection site and was warm to touch and sore again.; and still looks swollen; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in left arm on 26Mar2021 at 14:00 (at the age of 43 years) as single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The 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 had not been tested for COVID-19. On 04Apr2021 at 09:00, patient experienced sore arm, red circle around initial injection site, warm to touch, vaccination site pain and injection site swelling. The patient reported that she had nothing but a sore arm after getting the first dose. 8 days after shot (4/4) her arm had a quarter size red circle around initial injection site and was warm to touch and sore again. It continued to grow and was then a 3"x3" area and still looked swollen and red. The patient did not receive any treatment for the reported adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm, red circle around initial injection site, warm to touch, vaccination site pain and injection site swelling were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Spread to the entire front of neck and chest and was slightly itchy.; red splotchy rash appeared on left side of neck/chest; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 03Apr2021 at 09:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis. Patient had no allergies to medications, food, or other products. Concomitant medications included hyoscine (SCOPOLAMINE) from, calcium (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and estrogens conjugated (PREMARIN), all for unknown indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6199), via an unspecified route of administration in the left arm on 11Mar2021 at 14:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. 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 04Apr2021 at 13:00, the patient experienced red rash. On 05Apr2021, the patient experienced itchy rash. Its reported that approx. 28 hours post second dose, a flat, red splotchy rash appeared on left side of neck/chest. 2 days post second dose, the rash had spread to the entire front of neck and chest and was no longer splotchy. It was all red and slightly itchy. The patient did not receive any treatment for the reported  events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of  red rash and itchy rash  were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid mass
Clinical narrative: Thyroid nodules; This is a spontaneous report received from a contactable Nurse. A 72-year-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number not provided), via an unspecified route of administration on an unspecified date (at the age of 72-year-old) as a single dose for COVID-19 immunization. The patient previously took bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included Lung Cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced Thyroid nodules. she reported that her mother had the same AE after her second dose of Pfizer-BioNTech COVID-19 Vaccine. Her mother is 72 and had lung cancer.The outcome of the event was unknown.  No more information was provided.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased, Blood alkaline phosphatase
Clinical narrative: slight headaches; muscle aches; Severe fever 102-103+; low temp of 95.2; sweaty; clammy; AST 57; ALT 203; Alkaline phosphate137; EBV Nuclear 509; EBV VCAIgG>750+; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-year-old non-pregnant female first dose of BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6198, Expiry date: Jun 2021), via an unspecified route of administration in Arm Left on 01Mar2021 14:30 (age at the time of vaccination 64-years-old), as a single dose for COVID-19 immunization. The patient's medical history included hypothroid, Reynauds, hypertension, allergy to sulfa meds, and had Covid in Dec 2020. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Mar2021 04:00 AM, the patient experienced Severe fever 102-103+, low temp of 95.2, sweaty, clammy, AST 57, ALT 203, Alkaline phosphate 137, EBV Nuclear 509, EBV VCAIgG>750+, fatigue, slight headaches, and muscle aches. On an unspecified date, the patient underwent lab tests and procedures which included ALT, Alanine aminotransferase: High; AST, Aspartate aminotransferase: High; Body temperature: 95.2; Alkaline phosphate: 137; SARS-CoV-2 antibody test: positive; and on an unspecified date Dec2021, SARS-CoV-2 test: Positive. No treatment received for the adverse event. Patient went to urgent care 5 days later. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Upon follow-up(22Apr2021), expiry date of dose, past medical history, adverse events, and lab tests were added; patient stated, she was advised to not get the second dose until her liver cleared; there is no product complaint to report; there is no medical information request. She was told that there is a window of time to get the second dose of the vaccine, or she will have to start over. She would like to know more about that. Confirms there are no new events to report. The outcome for all the events was recovered with sequel; outcome of slight headaches, and muscle aches was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood alkaline phosphatase increased, Body temperature, Body temperature decreased, Cold sweat, Epstein-Barr virus antibody positive
Clinical narrative: slight headaches; muscle aches; Severe fever 102-103+; low temp of 95.2; sweaty; clammy; AST 57; ALT 203; Alkaline phosphate137; EBV Nuclear 509; EBV VCAIgG>750+; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-year-old non-pregnant female first dose of BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6198, Expiry date: Jun 2021), via an unspecified route of administration in Arm Left on 01Mar2021 14:30 (age at the time of vaccination 64-years-old), as a single dose for COVID-19 immunization. The patient's medical history included hypothroid, Reynauds, hypertension, allergy to sulfa meds, and had Covid in Dec 2020. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Mar2021 04:00 AM, the patient experienced Severe fever 102-103+, low temp of 95.2, sweaty, clammy, AST 57, ALT 203, Alkaline phosphate 137, EBV Nuclear 509, EBV VCAIgG>750+, fatigue, slight headaches, and muscle aches. On an unspecified date, the patient underwent lab tests and procedures which included ALT, Alanine aminotransferase: High; AST, Aspartate aminotransferase: High; Body temperature: 95.2; Alkaline phosphate: 137; SARS-CoV-2 antibody test: positive; and on an unspecified date Dec2021, SARS-CoV-2 test: Positive. No treatment received for the adverse event. Patient went to urgent care 5 days later. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Upon follow-up(22Apr2021), expiry date of dose, past medical history, adverse events, and lab tests were added; patient stated, she was advised to not get the second dose until her liver cleared; there is no product complaint to report; there is no medical information request. She was told that there is a window of time to get the second dose of the vaccine, or she will have to start over. She would like to know more about that. Confirms there are no new events to report. The outcome for all the events was recovered with sequel; outcome of slight headaches, and muscle aches was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Epstein-Barr virus antigen positive, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: slight headaches; muscle aches; Severe fever 102-103+; low temp of 95.2; sweaty; clammy; AST 57; ALT 203; Alkaline phosphate137; EBV Nuclear 509; EBV VCAIgG>750+; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-year-old non-pregnant female first dose of BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6198, Expiry date: Jun 2021), via an unspecified route of administration in Arm Left on 01Mar2021 14:30 (age at the time of vaccination 64-years-old), as a single dose for COVID-19 immunization. The patient's medical history included hypothroid, Reynauds, hypertension, allergy to sulfa meds, and had Covid in Dec 2020. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Mar2021 04:00 AM, the patient experienced Severe fever 102-103+, low temp of 95.2, sweaty, clammy, AST 57, ALT 203, Alkaline phosphate 137, EBV Nuclear 509, EBV VCAIgG>750+, fatigue, slight headaches, and muscle aches. On an unspecified date, the patient underwent lab tests and procedures which included ALT, Alanine aminotransferase: High; AST, Aspartate aminotransferase: High; Body temperature: 95.2; Alkaline phosphate: 137; SARS-CoV-2 antibody test: positive; and on an unspecified date Dec2021, SARS-CoV-2 test: Positive. No treatment received for the adverse event. Patient went to urgent care 5 days later. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Upon follow-up(22Apr2021), expiry date of dose, past medical history, adverse events, and lab tests were added; patient stated, she was advised to not get the second dose until her liver cleared; there is no product complaint to report; there is no medical information request. She was told that there is a window of time to get the second dose of the vaccine, or she will have to start over. She would like to know more about that. Confirms there are no new events to report. The outcome for all the events was recovered with sequel; outcome of slight headaches, and muscle aches was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: slight headaches; muscle aches; Severe fever 102-103+; low temp of 95.2; sweaty; clammy; AST 57; ALT 203; Alkaline phosphate137; EBV Nuclear 509; EBV VCAIgG>750+; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-year-old non-pregnant female first dose of BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6198, Expiry date: Jun 2021), via an unspecified route of administration in Arm Left on 01Mar2021 14:30 (age at the time of vaccination 64-years-old), as a single dose for COVID-19 immunization. The patient's medical history included hypothroid, Reynauds, hypertension, allergy to sulfa meds, and had Covid in Dec 2020. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Mar2021 04:00 AM, the patient experienced Severe fever 102-103+, low temp of 95.2, sweaty, clammy, AST 57, ALT 203, Alkaline phosphate 137, EBV Nuclear 509, EBV VCAIgG>750+, fatigue, slight headaches, and muscle aches. On an unspecified date, the patient underwent lab tests and procedures which included ALT, Alanine aminotransferase: High; AST, Aspartate aminotransferase: High; Body temperature: 95.2; Alkaline phosphate: 137; SARS-CoV-2 antibody test: positive; and on an unspecified date Dec2021, SARS-CoV-2 test: Positive. No treatment received for the adverse event. Patient went to urgent care 5 days later. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Upon follow-up(22Apr2021), expiry date of dose, past medical history, adverse events, and lab tests were added; patient stated, she was advised to not get the second dose until her liver cleared; there is no product complaint to report; there is no medical information request. She was told that there is a window of time to get the second dose of the vaccine, or she will have to start over. She would like to know more about that. Confirms there are no new events to report. The outcome for all the events was recovered with sequel; outcome of slight headaches, and muscle aches was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site reaction
Clinical narrative: Softball sized raised lump at injection site that was red, hot, itchy, sore, and hard. Painful to the touch.; Softball sized raised lump at injection site that was red, hot, itchy, sore, and hard. Painful to the touch.; Softball sized raised lump at injection site that was red, hot, itchy, sore, and hard. Painful to the touch.; This is a spontaneous report from a contactable other health care professional (Patient).    A 36-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0151 and expiration date was not re-ported), via an unspecified route of administration, administered in Arm Right on 22Apr2021 13:30 (at the age of 36 years), as single for covid-19 immunization. Medical history included depression, anxiety, low back pain, known allergies: Latex, adhesive, Strattera, Wellbutrin. Concomitant medi-cations included metoprolol tartrate, hydrochlorothiazide, esomeprazole sodium (NEXIUM), ven-lafaxine hydrochloride (EFFEXOR SR) taken for an unspecified indication, start and stop date were not reported taken in two weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and unknown if covid tested post vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6217 and expiration date was not re-ported), first dose an unspecified route of administration, administered in Arm Right on 01Apr2021 15:30 (at the age of 36 years), as single for covid-19 immunization. On 23Apr2021 02:00, the pa-tient experienced Softball sized raised lump at injection site that was red, hot, itchy, sore, and hard. Painful to the touch. The outcome of the events was reported as resolving.    No follow-up attempts were possible. No further information was expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Confusional state, Dizziness, Headache, Language disorder
Clinical narrative: confused / 'out of it' and did not realize it until later; struggling to find words; Head felt like a 2x4 hit her in the front and back; heart palpitations; dizzy; nauseous; dose number= 1, administration date=26Mar2021; dose number= 2, administration date=26Mar2021; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left leg on 26Mar2021 13:15 (Batch/Lot Number: FR8733) (at the age of 52 years old) as single dose, and the second dose via an unspecified route of administration, administered in left leg on 26Mar2021 (Batch/Lot Number: EW0170) (at the age of 52 years old) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medications included bupropion (BUPROPION) taken for an unspecified indication, start and stop date were not reported; methylphenidate (METHYLPHENIDATE) taken for an unspecified indication, start and stop date were not reported. The patient had known allergies with tetracycline, erythromycin, and biaxin. After the vaccines doses, on 26Mar2021 at 14:00, the patient reported her head felt like a 2x4 hit her in the front and back. She had heart palpitations, and was very dizzy, later becoming very nauseous. She was 'out of it' and did not realize it until later when she felt better. Her partner had to come pick her up, as she was confused and struggling to find words. Patient did not receive treatment for the events. The patient visited her physician. It was reported that dose number 1, administration date was 26Mar2021 13:15; and dose number 2, administration date was 26Mar2021. Outcome of the events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations
Clinical narrative: confused / 'out of it' and did not realize it until later; struggling to find words; Head felt like a 2x4 hit her in the front and back; heart palpitations; dizzy; nauseous; dose number= 1, administration date=26Mar2021; dose number= 2, administration date=26Mar2021; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left leg on 26Mar2021 13:15 (Batch/Lot Number: FR8733) (at the age of 52 years old) as single dose, and the second dose via an unspecified route of administration, administered in left leg on 26Mar2021 (Batch/Lot Number: EW0170) (at the age of 52 years old) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medications included bupropion (BUPROPION) taken for an unspecified indication, start and stop date were not reported; methylphenidate (METHYLPHENIDATE) taken for an unspecified indication, start and stop date were not reported. The patient had known allergies with tetracycline, erythromycin, and biaxin. After the vaccines doses, on 26Mar2021 at 14:00, the patient reported her head felt like a 2x4 hit her in the front and back. She had heart palpitations, and was very dizzy, later becoming very nauseous. She was 'out of it' and did not realize it until later when she felt better. Her partner had to come pick her up, as she was confused and struggling to find words. Patient did not receive treatment for the events. The patient visited her physician. It was reported that dose number 1, administration date was 26Mar2021 13:15; and dose number 2, administration date was 26Mar2021. Outcome of the events was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Erythema, Feeling abnormal, Feeling hot, Hypertension
Clinical narrative: felt very foggy, almost cloudy; my skin turned bright red and very hot to the touch; my skin turned bright red and very hot to the touch; heart started to race; blood pressure was very high; throat was itchy as well as my whole body from like the inside out; throat was itchy as well as my whole body from like the inside out; This is a spontaneous report from a contactable other hcp (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 42-year-old administered in Arm Right on 01Apr2021 13:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included svt (supraventricular tachycardia), mvp (mitral valve prolapse), high blood pressure, anxiety, known allergies: yes. Concomitant reported as the patient received unspecified drug within 2 weeks of vaccination. On 01Apr2021 13:00, within 20 seconds of receiving the vaccine, the patient felt very foggy, almost cloudy, her skin turned bright red and very hot to the touch, her heart started to race, they called an ambulance her blood pressure was very high but her o2 was at 98 despite the fact that her throat was itchy as well as her whole body from like the inside out. Events caused patient visit emergency room/department or urgent care. Events were treated with monitoring and allergy medication. The outcome of the events was recovered. The patient is not pregnant.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information, the causal association between the events feeling abnormal, erythema, feeling hot, palpitation, hypertension, pruritus, throat irritation and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Palpitations, Pruritus, Throat irritation
Clinical narrative: felt very foggy, almost cloudy; my skin turned bright red and very hot to the touch; my skin turned bright red and very hot to the touch; heart started to race; blood pressure was very high; throat was itchy as well as my whole body from like the inside out; throat was itchy as well as my whole body from like the inside out; This is a spontaneous report from a contactable other hcp (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 42-year-old administered in Arm Right on 01Apr2021 13:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included svt (supraventricular tachycardia), mvp (mitral valve prolapse), high blood pressure, anxiety, known allergies: yes. Concomitant reported as the patient received unspecified drug within 2 weeks of vaccination. On 01Apr2021 13:00, within 20 seconds of receiving the vaccine, the patient felt very foggy, almost cloudy, her skin turned bright red and very hot to the touch, her heart started to race, they called an ambulance her blood pressure was very high but her o2 was at 98 despite the fact that her throat was itchy as well as her whole body from like the inside out. Events caused patient visit emergency room/department or urgent care. Events were treated with monitoring and allergy medication. The outcome of the events was recovered. The patient is not pregnant.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information, the causal association between the events feeling abnormal, erythema, feeling hot, palpitation, hypertension, pruritus, throat irritation and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Supraventricular tachycardia
Clinical narrative: Acute occlusive SVT - 8.4 cm; This is a spontaneous report received from a contactable consumer.  A 67-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318 expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 02Feb2021 14:30 as (At the age of 67-years), as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing and Known allergies: Sulfa. Concomitant medication included atenolol 50 mg and simvastatin 25mg all was taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced acute occlusive SVT - 8.4 cm (supraventricular tachycardia) on 15Mar2021 11:00. Patient underwent Ultrasound and blood thinner treatment for the event. Post the vaccination the patient underwent lab tests and procedures which included covid-19: negative on 13Mar2021. The events were assessed as Non serious by reporter. The outcome of event was reported as recovering.  Follow-up attempts completed. No further information was expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Condition aggravated, Erythromelalgia, Pain
Clinical narrative: very sore arm; soreness spread to my whole body/My pain right at the moment is at a 7; Erythromelalgia/Since the shot, this rare condition has not stopped flaring; Erythromelalgia/Since the shot, this rare condition has not stopped flaring; My blood sugar has stayed over 250 with a top number on the evening of the last shot of 419; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Apr2021 18:30 (Batch/Lot Number: EW0171) (at the age of 60 years old) as single dose for covid-19 immunisation. Medical history included diabetes, hypertension (HBP), ongoing erythromelalgia, overweight. Patient was not pregnant at the time of vaccination. Patient did not have Covid prior to vaccination. No known allergies. The first dose was administered on an unknown date for covid-19 immunisation where patient felt nothing. Concomitant medication included oxycodone taken for erythromelalgia, start and stop date were not reported. After the second dose, on 28Apr2021, her blood sugar has stayed over 250 with a top number on the evening of the last shot of 419. On 29Apr2021 01:00, she developed a very sore arm, unlike the first shot where she felt nothing, her soreness spread to her whole body. Patient would be in more pain than the level 5 she was at but she took Oxycodone 10.05-325 for a rare condition called erythromelalgia. Since the shot, this rare condition has not stopped flaring. Her pain right at the moment was at a 7 (29Apr2021). Therapeutic measures were taken as a result of all the events. Increased insulin. Patient was not tested for Covid after vaccination. Outcome of the events was not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, Pain in extremity
Clinical narrative: very sore arm; soreness spread to my whole body/My pain right at the moment is at a 7; Erythromelalgia/Since the shot, this rare condition has not stopped flaring; Erythromelalgia/Since the shot, this rare condition has not stopped flaring; My blood sugar has stayed over 250 with a top number on the evening of the last shot of 419; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Apr2021 18:30 (Batch/Lot Number: EW0171) (at the age of 60 years old) as single dose for covid-19 immunisation. Medical history included diabetes, hypertension (HBP), ongoing erythromelalgia, overweight. Patient was not pregnant at the time of vaccination. Patient did not have Covid prior to vaccination. No known allergies. The first dose was administered on an unknown date for covid-19 immunisation where patient felt nothing. Concomitant medication included oxycodone taken for erythromelalgia, start and stop date were not reported. After the second dose, on 28Apr2021, her blood sugar has stayed over 250 with a top number on the evening of the last shot of 419. On 29Apr2021 01:00, she developed a very sore arm, unlike the first shot where she felt nothing, her soreness spread to her whole body. Patient would be in more pain than the level 5 she was at but she took Oxycodone 10.05-325 for a rare condition called erythromelalgia. Since the shot, this rare condition has not stopped flaring. Her pain right at the moment was at a 7 (29Apr2021). Therapeutic measures were taken as a result of all the events. Increased insulin. Patient was not tested for Covid after vaccination. Outcome of the events was not recovered.