chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Palpitations
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 43-year-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 in the right arm on 16Mar2021 at 16:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation.  Medical history included hypo thyroid, lupus, sjogrens. The patient had a history of allergy to penicillin, contrast dye and percocet The concomitant medications included amphetamine (ADDERALL), levothyroxine (SYNTHROID), acetaminophen (TYLENOL), ibuprofen (ADVIL), loratadine (CLARITIN) and vit (MANUFACTURER UNKNOWN) for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 17March2021, the patient experienced headache, neck pain, heart palpitations. No therapeutic measures were taken for the reported event. The clinical outcome of the headache, neck pain, heart palpitations were not resolved at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Vertigo
Clinical narrative: Dizziness; developed dizziness with the room spinning briefly; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 18Mar2021 at 13:15 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune disorder. The patient had a history of known allergies (unspecified). The patient received second dose of pneumonia vaccine within 4 weeks prior to the COVID-19 vaccine on 25Feb2021 in left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient had received other medications (unspecified) within 2 weeks of vaccination. On 22Mar2021 at 11:15, the patient developed dizziness with the room spinning briefly. The patients husband took her blood pressure but it was normal. The patient sat for a while and upon getting up almost fell. She drank some Gatorade as a therapeutic measure to see if it would help. The spinning stopped but she still felt lightheaded and unstable when she bent over. 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 dizziness and spinning briefly was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle tightness
Clinical narrative: Tightness  that traveled from the shoulder (site of the vaccine) to the wrist; numbness that traveledfrom the shoulder (site of the vaccine)to the wrist.; This is a spontaneous report from a contactable consumer. A 49 -year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP6955,) via an unspecified route of administration in the left arm on 22Mar2021 at 11.00 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included overweight and hemochromatosis. The patient did not have any allergies to medications, food or other products. Concomitant medication included ADDERALL, for unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 12:00, the patient experienced tightness and numbness that travelled from the shoulder (site of the vaccine) to the wrist which subsided completely after about three hours. The patient did not receive any treatment for the events. 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 tightness and numbness was resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Nausea, Paraesthesia
Clinical narrative: Redness at injection site; Left wrist tingling; Joint pain; Muscle pain in thighs; Nausea; Fever; Tiredness; This is a spontaneous report received from a contactable healthcare professional, the patient. A 32-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6203), via an unspecified route of administration in the left arm on 19Mar2021 at 10:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food, or other products. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medications included ADDERALL 20 mg and ritual prenatal vitamins (MANUFACTURER UNKNOWN), for unknown indications and taken from unknown dates. 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 COVID vaccine. On 19Mar2021 at 10:45, the patient experienced left wrist tingling and joint pain, muscle pain in thighs, nausea, fever, tiredness and redness at injection site. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events left wrist tingling and joint pain, muscle pain in thighs, nausea, fever, tiredness and redness at injection site. The clinical outcomes of the events left wrist tingling and joint pain, muscle pain in thighs, nausea, fever, tiredness and redness at injection site were recovering at the time of the report. No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema
Clinical narrative: Redness at injection site; Left wrist tingling; Joint pain; Muscle pain in thighs; Nausea; Fever; Tiredness; This is a spontaneous report received from a contactable healthcare professional, the patient. A 32-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6203), via an unspecified route of administration in the left arm on 19Mar2021 at 10:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food, or other products. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medications included ADDERALL 20 mg and ritual prenatal vitamins (MANUFACTURER UNKNOWN), for unknown indications and taken from unknown dates. 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 COVID vaccine. On 19Mar2021 at 10:45, the patient experienced left wrist tingling and joint pain, muscle pain in thighs, nausea, fever, tiredness and redness at injection site. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events left wrist tingling and joint pain, muscle pain in thighs, nausea, fever, tiredness and redness at injection site. The clinical outcomes of the events left wrist tingling and joint pain, muscle pain in thighs, nausea, fever, tiredness and redness at injection site were recovering at the time of the report. No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Very painful at shot location; Area is swollen about 1 inch around the area of injection; The area is also very red, and itches; Area was tender to the touch.; The area is also very red; Area was tender to the touch and Very warm.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration on the left arm on 18Mar2021 at 10:00 (at the age of 59 years), as single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included XIIDRA for unknown indication on an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration on the left arm on 25Feb2021 at 10:00, as a single dose for COVID-19 immunisation. On 18Mar2021 at 20:00, the patient experienced pain at the shot location, which was tender to touch, very warm, area was swollen about 1 inch around the injection site and the area was very red and itchy. It was reported that the events have been going on for 4 days. The patient had taken ice and treated with ibuprofen for the reported events which had taken the edge off but have lost sleep because of the discomfort. The clinical outcome of the events vaccination site pain, vaccination site tenderness, vaccination site warmth, vaccination site swelling, vaccination site erythema and vaccination site pruritis were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Flatulence, Migraine
Clinical narrative: body aches; Migraines; upper respiratory cough; congestion; Extreme muscle cramps; increase gi issues (gas); General fatigue; chills; sleep disturbance; This is a spontaneous report from a contactable nurse, the patient. A 65-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in left arm on 13Mar2021 10:00, (at the age of 65-years), as single dose for COVID-19 immunisation. Medical history included glaucoma and hypothyroidism. It was unknown whether the patient had any 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 positive for COVID-19. Concomitant medications included SYNTHROID, EFFEXOR, AZOPT, ROCKLATAN; all from unknown dates taken for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809) via an unspecified route of administration in left arm on 20Feb2021 14:00 (at the age of 65-years), as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Mar2021 14:00, the patient experienced body aches, migraines, upper respiratory cough, congestion, extreme muscle cramps, increase gastrointestinal (GI) issues (gas), general fatigue, chills, sleep disturbance all lasting greater than 1 week. The patient did not receive any treatment for 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 body aches, migraines, upper respiratory cough, congestion, extreme muscle cramps, increase gastrointestinal (GI) issues (gas), general fatigue, chills, sleep disturbance were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nasal congestion, Pain, Sleep disorder
Clinical narrative: body aches; Migraines; upper respiratory cough; congestion; Extreme muscle cramps; increase gi issues (gas); General fatigue; chills; sleep disturbance; This is a spontaneous report from a contactable nurse, the patient. A 65-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in left arm on 13Mar2021 10:00, (at the age of 65-years), as single dose for COVID-19 immunisation. Medical history included glaucoma and hypothyroidism. It was unknown whether the patient had any 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 positive for COVID-19. Concomitant medications included SYNTHROID, EFFEXOR, AZOPT, ROCKLATAN; all from unknown dates taken for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809) via an unspecified route of administration in left arm on 20Feb2021 14:00 (at the age of 65-years), as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Mar2021 14:00, the patient experienced body aches, migraines, upper respiratory cough, congestion, extreme muscle cramps, increase gastrointestinal (GI) issues (gas), general fatigue, chills, sleep disturbance all lasting greater than 1 week. The patient did not receive any treatment for 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 body aches, migraines, upper respiratory cough, congestion, extreme muscle cramps, increase gastrointestinal (GI) issues (gas), general fatigue, chills, sleep disturbance were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: Early arrival/irregular menstruation (1week early) not normal; This is a spontaneous report received from a contactable consumer, the patient. A 36-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the right arm on 18Mar2021 at 15:15 (at the age of 36-years-old) as a single dose, for COVID-19 immunisation. No relevant medical history and allergic history were reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included KELNOR for unknown indication and from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 21Mar2021, the patient had early arrival/irregular menstruation, one week early (polymenorrhoea) which was usually not normal. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of event early arrival/irregular menstruation was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pruritus
Clinical narrative: Inappropriate schedule of vaccine administered; Severe itching on my back, legs, buttocks, hands; This is a spontaneous report received from a contactable consumer, the patient. A 53-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown) via an unspecified route of administration in left arm the 18Mar2021, as single dose for COVID-19 immunisation (at the age of 53-years old). Medical history included blood pressure high. Concomitant medication included Diphenhydramine HCL (BENADRYL) within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in left arm on 04Mar2021 at 11:30 (at the age of 53-year-old), as a single dose for COVID-19 immunisation. 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-19 vaccine. The patient had no known allergies to medications, food, or other products. On 18Mar2021, the patient experienced severe itching on my back, legs, buttocks, hands. The vaccine was administered outside the range of 19-42 days after the first dose (Inappropriate schedule of vaccine administered). No therapeutic measures were taken as result of the 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 event itching was not recovered and inappropriate schedule of vaccine administered was unknown at the time of this report.   Information about lot number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Broke out about 9 days after 2nd vaccination with dark red spots/rash throughout my body-I have pictures; This is a spontaneous report received from a contactable consumer, the patient. A 72-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 24Feb2021 at 19:45 (at the age of 72 years), as a single dose for COVID-19 immunisation. Medical history included High blood pressure controlled, high triglycerides controlled and essential tremor controlled on an unspecified date. Concomitant therapies included lengthy-3 prescriptions and many supplements. The patient was allergic to pain killers-codeine. Past drug history included CoQ10 supplements (taken but heard other experienced these hives as well). Patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 02Feb2021 at 03:45, as a single dose for COVID-19 immunisation. The patient had not received 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 been tested for COVID-19. The patient experienced red spotty rash on 05Mar2021 at 16:00. (Broke out about 9 days after 2nd vaccination with dark red spots/rash throughout body). The patient mentioned that he had pictures with him. The patient received treatment for the reported events with antihistamine-generic and unspecified steroid treatment.   The clinical outcome of red spotty rash was resolving.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Severe lower back pain; This is a spontaneous report from a contactable consumer, the patient. A 36-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 20Mar2021 at 10:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patients medical history included mitral valve prolapse on an unspecified date. Concomitant medications included Citalopram (MANUFACTURER UNKNOWN) 25 mg daily started on an unknown date for unknown indication. The patient had not received 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 been tested for COVID-19. The patient had no allergies to medications, food, or other products.  The patient experienced severe lower back pain on 21Mar2021 at 08:00. The patient did not receive any treatment for the event.   Clinical outcome of the severe lower back pain was recovering.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Breast mass, Breast swelling, Musculoskeletal stiffness, Nipple pain, Pain in extremity
Clinical narrative: Lump or swollen left breast; Lump or swollen left breast; Nipple is sore to the touch or pushing in on it is sore.; Feel some aching in left hand like arthritis; Feel some stiffness; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via unspecified route of administration in left arm on 25Feb2021 at 19:00 (at the age of 50 years) as a single dose for COVID-19 immunisation. Medical history included human immunodeficiency virus (HIV) and back pain. Concomitant medications within two weeks of vaccination included BIKTARVY, meloxicam (MANUFACTURER UNKNOWN), SEROQUEL, gabapentin (MANUFACTURER UNKNOWN) and vit D (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 have allergies to medications, food, or other products. On 03Mar2021 at 00:00, the patient experienced lump or swollen left breast, the nipple was sore to the touch or pushing in on it was sore, felt some aching in left hand like arthritis, stiffness and typical left arm soreness. Visual swelling compared to right breast was noticeable and swelling was right under the nipple size of quarter. It was unknown if any therapeutic measures were taken for the reported events. The clinical outcome for the events breast lump, breast swelling, sore nipple, hand pain and stiffness was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Nausea
Clinical narrative: Rash on torso (trunk); Chills; Very cold; Nauseated; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 08:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergic history.The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 09:00 as a single dose for COVID-19 immunisation Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, Concomitant medications included Trazodone 50mg (MANUFACTURER UNKNOWN) 2 tablets per day, Baby asprin (MANUFACTURER UNKNOWN), within 2 weeks of vaccination and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021, the patient experienced chills, cold and nauseated. On 17Mar2021, the patient experienced rash on torso (trunk). Patient stated that after getting the 2nd dose, that evening patient started getting the chills and was very cold and felt like he had the flu. Patient also felt nauseated but did not throw up and took some Tylenol which helped but he did not check his temperature. Patient stated this lasted nearly 48 hours. On day 2 after getting the 2nd vaccine patient began getting a rash on his torso (trunk). It was mainly on the front side of his body but also some on back. The rash was fairly solid and looked like a sun burn. This lasted nearly a week with itching starting at about day 4 lasting about a full week from getting the 2nd dose. Patient was not feeling very well until about day 4 when he started getting energy to do things. At a week after patient pretty much back to normal. The clinical outcome of the events chills, cold, nauseated and rash on torso (trunk) was resolved on an unknown date in Mar2021.Patient has not tested positive for COVID-19 since having the vaccination.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Pain in extremity
Clinical narrative: stomach pain; severe diarrhea; Fatigue; Sore arm; headaches; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8727), via an unspecified route of administration in the right arm on 19Mar2021 at 08:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. The patient medical history included milk sensitivity. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested positive for COVID-19. The patient did not take other medications within the two weeks of vaccination. On 20Mar2021 (day1), the patient experienced sore arm and headaches. On 21Mar2021 at 08:00 (day 2), the patient experienced stomach pain, severe diarrhoea and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events sore arm, headaches, stomach pain, severe diarrhoea and fatigue was resolving at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Malaise, Pain in extremity
Clinical narrative: Fatigue; Malaise; Minor arm pain; 101.7 Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration on 19Mar2021 at 15:30 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included HTN (hypertension), hypothyroidism, PCN (penicillin) allergy, codeine allergy and Sulfa allergy. Concomitant medications included BYSTOLIC, Losartan/HCTZ (MANUFACTURER UNKNOWN), SYNTHROID and milk thistle (MANUFACTURER UNKNOWN), all taken for unknown indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E19267) via an unspecified route of administration on 16Feb2021 at 16:00 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 09:30, the patient experienced fatigue, malaise and minor arm pain, 18 hours post vaccination and experienced 101.7 fever and chills, 29 hours post vaccination. The patient did not receive treatment for fatigue, malaise, minor arm pain, fever and chills. The clinical outcome of the events fatigue, malaise, minor arm pain, fever and chills was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fatigue; Malaise; Minor arm pain; 101.7 Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration on 19Mar2021 at 15:30 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included HTN (hypertension), hypothyroidism, PCN (penicillin) allergy, codeine allergy and Sulfa allergy. Concomitant medications included BYSTOLIC, Losartan/HCTZ (MANUFACTURER UNKNOWN), SYNTHROID and milk thistle (MANUFACTURER UNKNOWN), all taken for unknown indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E19267) via an unspecified route of administration on 16Feb2021 at 16:00 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 09:30, the patient experienced fatigue, malaise and minor arm pain, 18 hours post vaccination and experienced 101.7 fever and chills, 29 hours post vaccination. The patient did not receive treatment for fatigue, malaise, minor arm pain, fever and chills. The clinical outcome of the events fatigue, malaise, minor arm pain, fever and chills was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 42 years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route administration in right arm on 20Mar2021 at 17:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication taken within two weeks included vitamin D (MANUFACTURER UNKNOWN) from unknown date and for unknown indication. The patient did not have any allergies to food, medications, or other products. The patient did not receive any treatment for events stomach cramps and nausea. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within two weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route administration in left arm on 27Feb2021 at 17:30 (at the age of 42-years-old) as a single dose, for COVID-19 immunisation. On 21Mar2021, the patient experienced stomach cramps and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events stomach cramps and nausea. The clinical outcome of the events stomach cramps and nausea was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report received from a contactable consumer, the patient. A 48-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 17:30 (at the age of 48-years) as single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin and Advil. The concomitant medications included warfarin (MANUFACTURER UNKNOWN) and Armour thyroid. The patient received these medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient was not tested for COVID-19. The patient experienced chest pain after 5 hours of vaccination on 19Mar2021 at 22:30. The clinical outcome of chest pain was not resolved at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Dizziness; Red at the injection site; Pain at the injection site; Itching with a hard knotthe size of a quarter at the injection site; Diarrhea; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-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 in right arm on 18Mar2021 at 13:15 (at the age of 59-year-old), as a single dose for COVID-19 immunisation. Medical history included auto immune disease. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 18Mar2021 at 22:00, the patient had red, pain and itching with a hard knot the size of a quarter at the injection site and she also experienced dizziness and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The clinical outcome of red at the injection site, pain at the injection site, itching at the injection site, dizziness and diarrhea was unknown at the time of this report. Information about lot number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Productive cough, Rhinorrhoea
Clinical narrative: Increase phlegm and mucus; Increased mucus; muscle aches; Sporadic fatigue; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ELP266) via an unspecified route of administration on 13Mar2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma and hypertension. The patient was allergic to iodine and shell fish. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and emtricitabine (MANUFACTURER UNKNOWN) all for an unknown indication and from an unknown date. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Mar2021, the patient experienced increased phlegm, increased mucous, occasional muscle aches and sporadic fatigue. The patient did not receive any treatment for the events. The clinical outcome of the events increased phlegm, nasal mucous increased, occasional muscle aches and sporadic fatigue were unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sore (mouth); This is a spontaneous report received from a contactable consumer, the patient. A 55-years-old, female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 15Mar2021 at 14:45 as a single dose for COVID-19 immunisation. The patients medical history included sore mouth. The patient mentioned that she had experienced cold sores infrequently for the past 40 years. It was reported that patient had no allergies to medications, food or other products. The concomitant medication included Nexium for unknown indication. The patient received it within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 22Feb2021 at 14:45 as a first dose for COVID-19 immunisation. It was reported that, prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced cold sore mouth on 18Mar2021 at 22:00 (3 days after receiving vaccine). No treatment was received as a result of the event. The clinical outcome of cold sore mouth was not resolved.   Information about lot/batch number cannot be obtained. No further information is expected
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE BIONTECH, Lot number: unknown) via an unspecified route of administration in the left arm on 20Mar2021 at 15:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced arm pain on 20Mar2021 at 22:45. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for event. The outcome of the event arm pain was unknown.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: sugar before dinner and it was extremely high for me; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration in the left arm on 20Mar2021 at 11:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure, cholesterol and hypothyroidism. Concomitant medications included losartan (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), ACTOS, PREMPRO, aspirin (MANUFACTURER UNKNOWN), hctz (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown), via an unspecified route in the right arm on 27Feb2021 (at the age of 53-years-old) at 09:00, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.On 20Mar2021 at 18:00, the patient blood glucose increased. The patient normal blood sugar was between 132-165. After the vaccine she checked her sugar before dinner and it was extremely high for her. It was 263 (units unspecified) at 18:00. The patient did not receive any treatment for the reported event. The clinical outcome of the event blood glucose increased was unknown.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Delusion, Diarrhoea, Vomiting
Clinical narrative: Vomiting; Diarrhea; Shivers; Delusional thoughts; This is a spontaneous report from a contactable consumer. A 63-year-old patient of unspecified gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 15:45 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. The patient medical history included penicillin allergy. Concomitant medications were not received in two weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 20Mar2021 at 17:45, the patient experienced vomiting, diarrhoea, shivers, delusional thoughts. No therapeutic measures were taken as a result of the 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 vomiting, diarrhoea, shivers, delusional thoughts was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Body aches; Headache; Chills; Fatigue; This is a spontaneous report from a non-contactable consumer. A 46-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in left arm, on an unknown date in Mar2021 at 11:00 at the age of 46 years as a single dose for COVID-19 immunisation. Past medical history was not provided. Past drug history included allergic to sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included allegra (MANUFACTURER UNKNOWN) for an unknown indication, dymista (MANUFACTURER UNKNOWN) for an unknown indication and prozac (MANUFACTURER UNKNOWN) for an unknown indication these medications were used within 2 weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in left arm on an unknown date in Feb2021 as a single dose for COVID-19 Immunisation. The facility where the most recent COVID-19 vaccine was administered was at a workplace clinic. On an unknown date in Mar2021 (9 hours after 2nd injection), the patient experienced body aches, headache, chills and body aches during sleep time. Fatigue with worse body aches next day and night and into next day. The patient received advil and alleviated some discomfort as a therapeutic measure. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events body aches, headache, chills and fatigue was recovered on an unknown date. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Drug interaction rash on my chest. It was veryitchy.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 06Mar2021 at 10:45 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. The patients medical history were not reported. The patient did not have any allergies to medications, food or other products. 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 COVID-19 vaccine. The patient did not receive any medications within two weeks of the vaccination. On 15Mar2021 at 12:00, the patient experienced a diagnosed drug interaction rash on her chest, which was very itchy. The adverse event result in a visit to the doctors or other healthcare professional office/clinic visit. The patient was treated for rash pruritic with ZYRTEC, BENADRYL and topicial cortisone cream (MANUFACTURER UNKNOWN). The clinical outcome of the event drug interaction rash on her chest, which was very itchy was not recovered.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Chills; fever; extreme body aches; headache; fatigue; nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via unspecified route of administration in the left arm on 18Mar2021 at 17:00 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergies to amoxicillin, penicillin and wheat/gluten. Concomitant medications included mesalamine (MANUFACTURER UNKNOWN) and loratadine (CLARITIN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via unspecified route of administration in left arm on 25Feb2021 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021, at 03:00, the patient developed chills, fever, extreme body aches, headache, fatigue and nausea. The patient did not receive any treatment for 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 chills, fever, extreme body aches, headache, fatigue and nausea was resolved in Mar2021.   No follow-up attempts are possible. No further information is expected.