chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; This is a spontaneous report from a contactable consumer or other non hcp.   A 60-years-old male patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 26Mar2021 14:15 (at the age of 60-year-old) as dose 2, single for covid-19 immunisation.  The patient previously took BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, on 05Mar2021 (at the age of 60-year-old) as dose 1, single for covid-19 immunisation and experienced sore arm. The patient medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported; rosuvastatin taken for an unspecified indication, start and stop date were not reported; ezetimibe taken for an unspecified indication, start and stop date were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced fever, headache, body aches, dizziness, sore arm. No treatment was taken for the events. The outcome of the events were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Hypertension, Pain in extremity
Clinical narrative: Diarrhea; headache; dizziness; high blood pressure; sore arm; This is a spontaneous report from a non-contactable consumer or other non-health care professional (Patient). A 28-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955 and expiration date was not reported), first dose via an unspecified route of administration, administered in arm right on 26Mar2021 11:00 (at the age of 28 years) single for covid-19 immunisation. The patient's medical history included allergies Shrimp from an unknown date and unknown if ongoing known. Concomitant medications were not reported. 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 since the vaccination. The patient received Birth Control within 2 weeks of vaccination. On 27Mar2021 patient experienced dizziness, headache, high blood pressure, diarrhoea, and a sore arm. Most of the symptoms were gone within 24 hours except for the dizziness and soreness in the arm. Patient continued to feel dizzy, and arm was still sore. Reporter assessed the event as non-serious. Patient received Tylenol as treatment for the adverse events. The outcome of the events dizziness and sore arm are recovering, and other events are recovered on unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, SARS-CoV-2 test
Clinical narrative: Loss of taste; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration on an unspecified date (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient was allergic to pork, diary, beef and gluten. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19. On 20Mar2021, the patient experienced loss of taste. 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 underwent lab test on 22Mar2021 which included COVID-19 virus test and the test result was negative. The patient did not receive any treatment for the event loss of taste. The clinical outcome of the event loss of taste was recovering at the time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Pain
Clinical narrative: AFTERTASTE WITH ALL FOODS; BODYACHE THENIGHT OF VACCINATION; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in right arm on 18Mar2021 at 08:30 as a single dose for COVID-19 immunisation. The patient did not have any medical history. Any allergies to medications, food, or other products were not known. Concomitant medications included colagen (MANUFACTURER UNKNOWN) and unspecified supplements (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the right arm on 25Feb2021 at 16:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021, the night of vaccination, the patient experienced body ache. On 22Mar2021, three days after 2nd vaccination, the patient experienced aftertaste with all foods. 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 aftertaste and body ache was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Injection site soreness; Headache; Fever; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Lot 3248), via an unspecified route of administration in the left arm on 23Mar2021 at 10:30 (at the age of 43-years-old) as a 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 vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: El3248), via an unspecified route of administration in the left arm on 02Mar2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021 at 22:30, the patient had injection site soreness and experienced headache, fever and chills. 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 injection site soreness, headache, fever and chills. The clinical outcomes of the events injection site soreness, headache, fever and chills were recovering at the time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: Got lost/Little distracted; This is a spontaneous report received from a non-contactable physician. A 50-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 10Mar2021 at 13:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient medical history was none. The patient did not receive any other medication within 2 weeks of vaccination. 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 4 weeks prior to the COVID vaccine. The patient had not tested positive for COVID-19 since having the vaccine. On 10Mar2021, at 15:30, the patient experienced confusion. Patient received the vaccine and about two and half hour, the patient was driving through a very well-known place but patient not only got lost but also drove against the traffic. The patient was stopped by the police and was unable to understand that why patient was called because patient was convinced that she was right and they were wrong. It took a while to get clear and go back to normal and she felt a little distracted since then. No therapeutic measures were taken as a result of the event. 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 event confusion was recovered with sequelae.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Diarrhoea, Headache, Myalgia
Clinical narrative: Diarrhea; Low grade 100.3 fever; Severe headache; Myalgia; Arthralgia; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 19Mar2021 at 17:15 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history included HTN, hypothyroidism, mild asthma, chronic migraines and latex allergy. The patient was allergic to sulfur. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 20Mar2021 at 17:00, the patient experienced 24 hours severe headache started with myalgia and arthralgia. At 48 hours, all the conditions, headache, myalgia and arthralgia increased severely and diarrhea, low grade 100.3 fever started off/on for 2 days. On 21Mar2021, the body temperature was reported as 100.3 (Units unspecified). The fever broke on 4th day and by 5th day symptoms subsided leaving over heating off and on with major activity only. The patient did not receive any treatment for 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 events severe headache, myalgia, arthralgia, diarrhea, low grade fever was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Diarrhea; Low grade 100.3 fever; Severe headache; Myalgia; Arthralgia; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 19Mar2021 at 17:15 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history included HTN, hypothyroidism, mild asthma, chronic migraines and latex allergy. The patient was allergic to sulfur. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 20Mar2021 at 17:00, the patient experienced 24 hours severe headache started with myalgia and arthralgia. At 48 hours, all the conditions, headache, myalgia and arthralgia increased severely and diarrhea, low grade 100.3 fever started off/on for 2 days. On 21Mar2021, the body temperature was reported as 100.3 (Units unspecified). The fever broke on 4th day and by 5th day symptoms subsided leaving over heating off and on with major activity only. The patient did not receive any treatment for 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 events severe headache, myalgia, arthralgia, diarrhea, low grade fever was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Nasopharyngitis, Pain in extremity
Clinical narrative: bad cold.; stomach started hurting; sore joints in wrist up to shoulder, and ankle; arm hurt for 3 days; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 at 01:00 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had a history of allergy to penicillin, sulfamethoxazole/trimethoprim, latex and bees. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021, after vaccine shot, the patient experienced arm hurt for 3 days. On the 15Mar2021, her stomach started hurting, then after from 15Mar2021 to 20Mar2021, she had sore joints in wrist up to shoulder, and ankle. Next on the 2Mar2021, the patient felt like she had a bad cold. 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 arm hurt for 3 days, stomach started hurting and bad cold was unknown while the outcome of sore joints in wrist up to shoulder and ankle was resolved on 20Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Rash; Fever; Headache; Fatigue; Swollen sore arm; Swollen sore arm; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration in the left arm on 18Mar2021 at 09:45 (at the age of 78-years-old), as single dose for COVID 19 immunisation. Medical history included acid reflux, coronary artery, pre-diabetic and bee venom allergy. Concomitant medication included omeprazole (MANUFACTURER UNKNOWN), levothyroxine (LEVOTHYROXIN), telmisartan (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), cefuroxime (FURO); all for unspecified indication from unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via an unspecified route of administration in the left arm on 25Feb2021 at 09:30 (at the age of 78-years-old) as single dose for COVID 19 immunisation. The patient previously took ampicillin (MANUFACTURER UNKNOWN), azithromycin (MANUFACTURER UNKNOWN), levofloxacin (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN); all from unknown dates to unknown dates for unknown indications and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 17:00, the patient experienced fever, headache, overall fatigue and swollen sore arm that lasted for 4 days. On 23Mar2021, fifth day onwards, the patient experienced rash and patient still had it on 24Mar2021 (sixth day). The patient did not receive any treatment for the events. The clinical outcome of the events fever, headache, overall fatigue, swollen arm and pain in arm were recovered on 22Mar2021 and rash was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; Fever; Headache; Fatigue; Swollen sore arm; Swollen sore arm; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration in the left arm on 18Mar2021 at 09:45 (at the age of 78-years-old), as single dose for COVID 19 immunisation. Medical history included acid reflux, coronary artery, pre-diabetic and bee venom allergy. Concomitant medication included omeprazole (MANUFACTURER UNKNOWN), levothyroxine (LEVOTHYROXIN), telmisartan (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), cefuroxime (FURO); all for unspecified indication from unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via an unspecified route of administration in the left arm on 25Feb2021 at 09:30 (at the age of 78-years-old) as single dose for COVID 19 immunisation. The patient previously took ampicillin (MANUFACTURER UNKNOWN), azithromycin (MANUFACTURER UNKNOWN), levofloxacin (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN); all from unknown dates to unknown dates for unknown indications and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 17:00, the patient experienced fever, headache, overall fatigue and swollen sore arm that lasted for 4 days. On 23Mar2021, fifth day onwards, the patient experienced rash and patient still had it on 24Mar2021 (sixth day). The patient did not receive any treatment for the events. The clinical outcome of the events fever, headache, overall fatigue, swollen arm and pain in arm were recovered on 22Mar2021 and rash was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Erythema, Fatigue
Clinical narrative: right hand knuckles are red and swollen; painful joints all over; headache; muscle aches; chills and rigors; severe fatigue; right hand knuckles are red and swollen; Fever 101.5F; This is a spontaneous report from a contactable other healthcare professional. A 59-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6198), via unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hypothyroidism, hyperparathyroidism and HTN (as reported). The patient previously received diphenhydramine (MANUFACTURER UNKNOWN) and unspecified stains for unspecified indication and experienced drug allergy. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID), bisoprolol (MANUFACTURER UNKNOWN), mometasone furoate (ASMANEX) and salbutamol (ALBUTEROL) for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6198), via unspecified route of administration in the left arm on 05Mar2021 at 13:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID19. On 23Mar2021 at 22:45, the patient experienced fever 101.5F, chills and rigors, painful joints all over, right hand knuckles were red and swollen, headache, muscle aches all over and severe fatigue. 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 fever 101.5F, chills and rigors, painful joints all over, right hand knuckles were red and swollen, headache, muscle aches all over and severe fatigue was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Joint swelling, Myalgia, Pyrexia
Clinical narrative: right hand knuckles are red and swollen; painful joints all over; headache; muscle aches; chills and rigors; severe fatigue; right hand knuckles are red and swollen; Fever 101.5F; This is a spontaneous report from a contactable other healthcare professional. A 59-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6198), via unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hypothyroidism, hyperparathyroidism and HTN (as reported). The patient previously received diphenhydramine (MANUFACTURER UNKNOWN) and unspecified stains for unspecified indication and experienced drug allergy. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID), bisoprolol (MANUFACTURER UNKNOWN), mometasone furoate (ASMANEX) and salbutamol (ALBUTEROL) for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6198), via unspecified route of administration in the left arm on 05Mar2021 at 13:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID19. On 23Mar2021 at 22:45, the patient experienced fever 101.5F, chills and rigors, painful joints all over, right hand knuckles were red and swollen, headache, muscle aches all over and severe fatigue. 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 fever 101.5F, chills and rigors, painful joints all over, right hand knuckles were red and swollen, headache, muscle aches all over and severe fatigue was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Flushing, Hypoaesthesia oral, Pruritus, Tachycardia
Clinical narrative: Severe itching; Numbness of lips, tongue and mouth roof; Flushing; tachycardia; anxiety; Possible worsening of eyesight on right eye; This is a spontaneous report from a contactable nurse, the patient. A 56-Year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6207) via an unspecified route of administration in left arm on 11Mar2021 at 09:00 hrs (at the age of 56-Year-old) as a single dose for COVID-19 immunisation. Medical history included fillers 3 weeks before vaccine and patient had both. Past drug history included lisinopril from which patient had allergy. Patient received unspecified concomitant medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 at 09:15 hrs, patient experienced severe itching, numbness of lips, tongue and roof of mouth, flushing, tachycardia, anxiety and possible worsening of eyesight on right eye. 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 events severe itching, numbness of lips, tongue and roof of mouth, flushing, tachycardia, anxiety and possible worsening of eyesight on right was resolved. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Severe itching; Numbness of lips, tongue and mouth roof; Flushing; tachycardia; anxiety; Possible worsening of eyesight on right eye; This is a spontaneous report from a contactable nurse, the patient. A 56-Year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6207) via an unspecified route of administration in left arm on 11Mar2021 at 09:00 hrs (at the age of 56-Year-old) as a single dose for COVID-19 immunisation. Medical history included fillers 3 weeks before vaccine and patient had both. Past drug history included lisinopril from which patient had allergy. Patient received unspecified concomitant medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 at 09:15 hrs, patient experienced severe itching, numbness of lips, tongue and roof of mouth, flushing, tachycardia, anxiety and possible worsening of eyesight on right eye. 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 events severe itching, numbness of lips, tongue and roof of mouth, flushing, tachycardia, anxiety and possible worsening of eyesight on right was resolved. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain
Clinical narrative: Topical redness after 1 week of the vaccine; a bit sore; This is a spontaneous report from a non contactable consumer, the patient. A 50-year-old non-pregnant female patient received unknown dose of BNTI62b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on 16Mar2021 at 09:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient medical history included Hypermobile Ehlers-Danlos syndrome (hEDS), Fibromyalgia, Small fibre neuropathy. The patient was allergic and reported that she can have side effects, nothing deadly. The patient received unspecified concomitant medications within two weeks of COVID vaccine. he patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. T On 19Mar2021, the patient experienced topical redness after 1 week of the vaccine. hEDS. A bit sore, nothing else bothers her. The adverse events didn't 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 adverse events. The clinical outcome of the events topical redness and pain was unknown.    Information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy after 2nd dose; This is a spontaneous report from a non-contactable consumer, the patient. A 36-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 on an unknown date (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was allergic to peanuts, shellfish, methimazole, proparacaine and onion. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient was not tested positive for COVID-19 since vaccination. On an unknown date, the patient experienced dizzy after the second dose. The clinical outcome of the event dizzy was unknown at the time of report.   Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Arm sore at injection site; Muscle achiness; Fatigue after shot and next day; Joint achiness the next day; This is a spontaneous report received from a non-contactable other health care professional, the patient. A non-pregnant female patient of unspecified age 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 01Mar2021 and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 22Mar2021 at 14:30, each as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis. 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 had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks of vaccination. On an unspecified date in Mar2021, the patient experienced fatigue after the vaccination and the next day, the patient also experienced arm sore at injection site, muscle and joint achiness. The patient did not receive any treatment for the reported events. 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 arm sore at injection site, muscle and joint achiness and fatigue were recovered on an unspecified date in Mar2021.  Information about lot number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site swelling, Myalgia, Pain assessment
Clinical narrative: Extreme exhaustion; serious muscle pain; joint pain; Injection site swelling; Injection site redness; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration on 22Mar2021 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. It was unknown if the patient was allergic to any medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration on 01Mar2021 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. On 22Mar2021, the patient experienced extreme exhaustion, serious muscle and Joint pain, swelling and redness at the site of injection. It was unknown the patient received treatment for the reported events. The patient was tested for pain scale and the result was 6 on a scale of 1-10. 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 extreme exhaustion, serious muscle and joint pain, swelling and redness at the site of injection were recovered on an unknown date at the time of this report  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Extreme exhaustion; serious muscle pain; joint pain; Injection site swelling; Injection site redness; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration on 22Mar2021 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. It was unknown if the patient was allergic to any medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration on 01Mar2021 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. On 22Mar2021, the patient experienced extreme exhaustion, serious muscle and Joint pain, swelling and redness at the site of injection. It was unknown the patient received treatment for the reported events. The patient was tested for pain scale and the result was 6 on a scale of 1-10. 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 extreme exhaustion, serious muscle and joint pain, swelling and redness at the site of injection were recovered on an unknown date at the time of this report  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Severe body aches; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received second dose BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot no: unknown), via an unspecified route of administration in the right arm on 23Mar2021 at 17:00 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, bleeding disorder and allergy (peroxide). Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot no: unknown), via an unspecified route of administration in the right arm on an unknown date, as a single dose for COVID-19 immunisation and amoxicillin; clavulanate potassium (AUGMENTIN); on unknown date for unspecified indication and experienced drug allergy. 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 tested for COVID-19. On 23Mar2021 at 18:00, the patient experienced severe body aches. Therapeutic measures were taken as a result of severe body aches and included treatment with Tylenol heating pad. 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 general body pain was recovering at the time of this report.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: Body aches; Low grade fever 99; chills; headache; fatigue; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 23Mar2021 at 13:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was 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 medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 06Mar2021 at 13:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 23Mar2021 at 13:00, the patient had inappropriate schedule of vaccine administration. On 24Mar2021 at 03:30, approximately 12 hours later after second injection, the patient experienced low grade fever 99, chills, body aches, headache and fatigue. 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 low grade fever 99, chills, body aches, headache and fatigue. The clinical outcomes of the events low grade fever 99, chills, body aches, headache and fatigue were recovering at the time of the report while that of inappropriate schedule of vaccine administered was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches; Low grade fever 99; chills; headache; fatigue; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 23Mar2021 at 13:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was 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 medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 06Mar2021 at 13:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 23Mar2021 at 13:00, the patient had inappropriate schedule of vaccine administration. On 24Mar2021 at 03:30, approximately 12 hours later after second injection, the patient experienced low grade fever 99, chills, body aches, headache and fatigue. 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 low grade fever 99, chills, body aches, headache and fatigue. The clinical outcomes of the events low grade fever 99, chills, body aches, headache and fatigue were recovering at the time of the report while that of inappropriate schedule of vaccine administered was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Induration, Pain in extremity, Pruritus
Clinical narrative: Left arm indurated; Left arm hot; Left arm red; Left arm itchy; Left arm painful rectangular area measuringabout 3X4 inches; This is spontaneous report from non-contactable nurse, the patient. A 68-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the left arm on 03Mar2021 at 07:30 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history included high cholesterol, degenerative joint disease and osteoarthritis. Concomitant medications included rosuvastatin calcium (CRESTOR) for unknown indication from unknown date. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 10Mar2021 at 11:00, the patient's left arm was red, hot, indurated, itchy and had painful rectangular area measuring about 3X4 inches. 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 left arm red, left arm hot, left arm indurated, left arm itchy, left arm painful was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: VERY DIZZY; HAVING A VERY LIGHT BUZZING SOUND IN MY HEAD THAT COMES AND GOES; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration in the left arm on 01Mar2021 at 11:00 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer (20-year survivor). The patient had allergies to penicillin, aspirin, codine. 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. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN) 40mg, citalopram hydrobromide (MANUFACTURER UNKNOWN) 20 mg for unknown indication from unknown date. On 23Mar2021, patient experienced very dizzy for 3 days, very light buzzing sound in head that comes and goes. 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 very dizzy, very light buzzing sound was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Breakthrough menstrual bleeding when I wasn't supposed to have my period; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number EN6204), via an unspecified route of administration in the left arm on 21Mar2021 at 14:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and GERD (as reported). The patient received unspecified medications within 2 weeks of vaccination. The patient previously received penicillin (MANUFACTURER UNKNOWN) for unspecified indication 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 had not received any other vaccines within four weeks prior to the vaccination. On 23Mar2021, the patient experienced breakthrough menstrual bleeding when it wasn't supposed to have the period. The patient did not receive any treatment medication for 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 menstrual bleeding was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever over 101.5; This is a spontaneous report from a contactable physician. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in left arm on 07Mar2021 as a single dose for COVID-19 immunisation. Medical history included asthma, hormonal imbalance and thyroid disorder. Concomitant medications included Levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication, Progesterone (MANUFACTURER UNKNOWN) for an unknown indication and Bioidentical hormone replacement therapy (HRT) (MANUFACTURER UNKNOWN) from an unknown date and it was unknown if ongoing. The patient was allergic to Sulfa drugs. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since the vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 07Mar2021, the patient experienced pyrexia. The patient had fever over 101.5 (unspecified units) for one day after the administration of vaccine. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as result of the event fever included antibiotics (unspecified). The clinical outcome of the event pyrexia was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Ear discomfort, Myalgia, Nightmare, Ocular discomfort
Clinical narrative: Pressure in eyes; Pressure in  ears; soreness in complete body; sleepy; restless; bad dreams; diarrhea; This is a spontaneous report from non-contactable consumer, the patient. A 50-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) in the right arm on 22Mar2021 at 14:00 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. The patients medical history included penicillin allergy, grass allergy and tetracycline. Prior to 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 COVID-19 vaccine. The patient did not received medication within 2 weeks of vaccination. The past drug history included codeine (CODEINE). On 22Mar2021 the patient experienced pressure in eyes and ears, soreness in complete body, sleepy, restless, bad dreams and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The therapeutic measures and treatment were not taken as a result of the events. The clinical outcomes of the events Pressure in eyes and ears, soreness in complete body, sleepy, restless, bad dreams and diarrhea were recovering at the time of report.   No follow-up attempts are possible; Information about batch cannot be obtained.