chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus in right ear, mild tinnitus in left ear; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GL9264), via an unspecified route of administration in left arm on 16Mar2021 at 19:30 (at the age of 56-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, hearing loss in right ear. The patient had no allergies to medications, food, or other products. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. The patient received amlodipine 5 mg daily within 2 weeks of vaccination. On 17Mar2021, the patient experienced severe tinnitus in right ear, mild tinnitus in left ear. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe tinnitus in right ear, mild tinnitus in left ear was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Aches; chills; Fatigue; Fever; This is a spontaneous report from a contactable consumer. A 50-year-old non-pregnant female patient received her unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the left arm on 15Mar2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within for weeks prior to the COVID-19 vaccine. On 16Mar2021, around 10:45 (24 hours after vaccine), the patient experienced chills and then fatigue and aches. The patient taken ADVIL which helped. Later that afternoon, patient had to take a nap and ran a fever. It reached 101.3 degrees. The patient woke up on 17Mar2021 and felt completely fine. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, fatigue and aches were recovered on 17Mar2021.  No follow-up attempts are needed. No further information is expected
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: irregular red, not raised from face, neck, anterior and posterior chess abdomen and back anterior; Itching; This is a spontaneous report received from a contactable physician. An 88-year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249) via intramuscular route of administration in the left arm on 21Jan2021 at 12:00 as single dose, for COVID-19 immunisation. Medical history included hypothyroidism and glaucoma. 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 medication included levothyroxine (MANUFACTURER UNKNOWN) and brimonidine (ALPHAGAN P) for unknown indication. The patient did not receive any other medications or vaccines within 4 weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH7899) via intramuscular route of administration in left arm on 31Dec2020 at 10:45 as a single dose, for COVID-19 immunisation. On 01Feb2021, the patient had irregular red, not raised from face and neck, anterior and posterior chest abdomen and back anterior and posterior thigh size 4 to 6 cm covering 90% of area with marked itching. The adverse events did not result in doctor or other healthcare professional office or clinic visit or emergency visit. The patient was treated with Benadryl 25mg (1 in 4 hours) and hydrocortisone (1 in 8 hours) for the reported events. The clinical outcome of events irregular red, not raised from face, neck, anterior and posterior chess abdomen and back anterior and itching was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms; fever; body aches; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ENG208) via unspecified route of administration in the left arm on 20Mar2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity. The patient did not have allergies to 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 did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included ADDERALL for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ENG202) via an unspecified route of administration in the left arm on 27Feb2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 20Mar2021 at 23:30, the patient experienced flu like symptoms, fever and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received ibuprofen as treatment for the events. The clinical outcome of the events flu like symptoms, fever and body aches were recovering.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Developed swollen and tender lymph node in left armpit area; Developed swollen and tender lymph node in left armpit area; Had full body aches; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 17Mar2021 at 10:00 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) 10 mg and bupropion (WELLBUTRIN) 300 mg; both for unspecified indications and ethinyl estradiol; drospirenone (YAZ) for contraception; all from unknown dates. The patient was allergic to propylene glycol. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 24Feb2021 at 10:00 (at the age of 30-years-old), 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. On 17Mar2021 at 23:00, the night of vaccination, the patient experienced full-body aches. On 19Mar2021, the patient developed swollen and tender lymph node in the left armpit area. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of body aches and included treatment with ibuprofen. The clinical outcome of the event full-body aches was recovered on an unknown date in Mar2021 and of the events swollen and tender lymph node in the left armpit area was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Musculoskeletal chest pain
Clinical narrative: Sharp pain in left ribs/under armpit; Sharp pain in left ribs/under armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 20-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 left arm on 17Mar2021 at 13:15 (at the age of 20-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 14:30, the patient experienced sharp pain in left ribs and under armpit, located under same arm where shot was given. The events resulted in emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of events rib pain and armpit pain was recovered with sequelae at the time of this report.   No follow-up attempts are possible. Information about lot number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Irritability, Rash
Clinical narrative: This is a spontaneous report received from a contactable consumer, the patient. A 23-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: ER 2613) via an unspecified route of administration on the left arm on 19Mar2021 at 02:00 PM (at the age of 23-year-old) as 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 had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Medical history and concomitant medication were not reported. On 21Mar2021 at 20:00, the patient experienced rash, irritating and red spot. 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 rash, irritating and red spots were unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Twitching in upper left arm where the shot was administered, the muscle started twitching as soon as the needle was removed; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old-male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 08Mar2021 at 13:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 08Mar2021 at 13:15, the patient experienced twitching in upper left arm where the shot was administered. The muscle started twitching as soon as the needle was removed and had continued since then. The twitching was not constant but had been persistent since 08Mar2021. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was reported that the patient did not receive any treatment for the event. The clinical outcome of the event muscle twitching was not resolved 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: Hypoaesthesia, Muscle twitching
Clinical narrative: About 20 minutes after right cheek started twitching intermittently then became more frequent.; Right cheek feels numb; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 22Mar2021 at 07:45 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure, COVID-19, shellfish allergy, penicillin allergy and angiotensin-converting enzyme (ACE) inhibitors allergy. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included BYSTOLIC, CLARITIN and BENICAR, all for unknown indications from unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination. the patient had not been tested for COVID-19. On 22Mar2021, about 20 minutes after, the patient's right cheek started twitching intermittently then became more frequent and about an hour later, the patient's right cheek felt numb. It was unknown if patient receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of facial twitching and numbness facial were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Severe headache; Chills; Exhaustion; Muscle & joint pains; Muscle & joint pains; shooting; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the right arm on 17Mar2021 at 15:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation . Medical history included ulcerative colitis, high-blood pressure (treated). The patient received concomitant medication within two weeks of vaccination that included nifedipine (MANUFACTURER UNKNOWN), desvenlafaxine (MANUFACTURER UNKNOWN), candesartan (MANUFACTURER UNKNOWN) all for unknown indications and from unknown date. 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 4 weeks prior to the COVID vaccine. The patient not had any known allergies. On 18Mar2021 at 03:30, patient experienced event severe headache, chills, exhaustion, muscle & joint pains, shooting. The patient did not receive any treatment for reported events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event severe headache, chills, exhaustion, muscle & joint pains, shooting were recovered on unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Severe headache; Chills; Exhaustion; Muscle & joint pains; Muscle & joint pains; shooting; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the right arm on 17Mar2021 at 15:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation . Medical history included ulcerative colitis, high-blood pressure (treated). The patient received concomitant medication within two weeks of vaccination that included nifedipine (MANUFACTURER UNKNOWN), desvenlafaxine (MANUFACTURER UNKNOWN), candesartan (MANUFACTURER UNKNOWN) all for unknown indications and from unknown date. 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 4 weeks prior to the COVID vaccine. The patient not had any known allergies. On 18Mar2021 at 03:30, patient experienced event severe headache, chills, exhaustion, muscle & joint pains, shooting. The patient did not receive any treatment for reported events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event severe headache, chills, exhaustion, muscle & joint pains, shooting were recovered on unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Hyperhidrosis, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 63-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 right arm 18Mar2021 at 08:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included colitis and possible lupus. The patient did not receive other medications within in two weeks of vaccination. The patient was allergic to biaxin. The patient did not receive any other vaccines in four weeks prior to COVID-19 vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. On 19Mar2021, the patient had chills, sweats, headaches, uneasy feelings and loss of appetite for four days. 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 chills, sweats, headaches, uneasy feelings and loss of appetite was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection
Clinical narrative: yeast infection; This is a spontaneous report from contactable female consumer via Pfizer Sponsored Program COVAX US Support.  An unspecified age female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not provided), via an unspecified route of administration on 03Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. On an unspecified date, after vaccine came down with yeast infection. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Significant left supraclavicular and cervical lymphadenopathy; Supraclavicular lymphadenopathy; This is a spontaneous report received from a non-contactable physician, the patient. A 38-year-old male patient 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 23Jan2021 (at the age of 38-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 23Feb2021, 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 vaccines within four weeks prior to the vaccine or any other medication within two weeks of the vaccination. On 06Feb021, the patient experienced significant left supraclavicular and cervical lymphadenopathy. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken for the events left supraclavicular and cervical lymphadenopathy which included ultrasound and biopsy. The clinical outcome of the events left supraclavicular and cervical lymphadenopathy was resolved.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: at injection site emerged that is red,; at injection site hot; at injection site itchy; Injection site pain; small bump/large raised lump at injection site about the size of two fingers; This is a spontaneous report from a contactable consumer, the patient. A 50-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 right arm on 13Mar2021 at 10:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, psoriasis, hidradenitis suppurativa, osteoarthritis. The patient had a history of allergy to nickel, sulfas, wool, alcohol and Neosporin. The concomitant medications included multivitamin (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN) and ALEVE. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not tested positive for COVID-19. The patient had not tested positive for COVID-19 since having the vaccine. On 13Mar2021, the patient had injection site pain and a small bump that lasted 3 days then went away. On 21Mar2021, a large, raised lump at injection site, about the size of 2 fingers, emerged that was red, hot and itchy. The patient did not receive any treatment for the reported events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for vaccination site pain, vaccination site warmth, vaccination erythema and vaccination site itchy was not resolved while that of vaccination site lump was resolved on 16Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Vomiting; Body aches; Fever; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 21Mar2021 at 13:15 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included thyroid cancer and breast cancer. The patient had unspecified allergies to medications, food, or other products. The concomitant medication included levothyroxine (SYNTHROID) and pantoprazole (MANUFACTURER UNKNOWN) from unknown indication since unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021, the patient experienced vomiting, body aches and fever. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events vomiting, body aches and fever was unknown at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hangover, Headache, Pain in extremity
Clinical narrative: Felt hungover; Headache; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in left arm on 10Mar2021 at 13:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included pravastatin (MANUFUTURER UNKNWON), allopurinol (MANUFUTURER UNKNWON) and famotidine (MANUFUTURER UNKNOWN) all for unknown indication and from an unknown date. On 11Mar2021 at 09:00, patient experienced sore arm. On 12Mar2021, the patient experienced moderate headache which lasted for 15 hours and on 13Mar2021, the patient felt hungover. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was reported that the patient did not receive any treatment for the event. The clinical outcome of sore arm, moderate headache and felt hungover was resolved 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: Headache, Nausea, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; Headache; Body aches; Low grade fever; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER6727), via an unspecified route of administration in the left arm on 21Mar2021 at 15:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma and high cholesterol. The patient was allergic to codeine (MANUFACTURER UNKNOWN) and BACTRIM. Concomitant medication included pravastatin (MANUFACTURER UNKNOWN) and fexofenadine (ALLEGRA); both for unknown indication from unknown date. The patient previously 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 28Feb2021 at 14:30 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. 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 22Mar2021 at 07:00, the patient experienced vaccination site pain, headache, body aches, low grade fever and nausea. The patient did not receive any treatment for the reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of vaccination site pain, headache, body aches, low grade fever and nausea were resolving at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Hyperhidrosis
Clinical narrative: tiredness all day; slight headache; diarrhea; chills; sweating; shaking; nausea; injection site pain; This is a spontaneous report from a contactable consumer. A 70-year-old non pregnant female patient received second dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: EN6207) via unspecified route of administration, in left arm on 20Mar2021 at 01:45 pm (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient has medical history of glaucoma and allergic to rhoppasa. Concomitant medication included Alphagan 0.1%, Lumigan-0.01% and Dorzolamide 2% used within 2 weeks of vaccination for an unknown indication. The patient received first dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: EN6203) via unspecified route of administration, in left arm on 27Feb2021 at 01:45 pm (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not tested positive for COVID-19 since having the vaccine. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021, same day after vaccination of second dose, the patient experienced vaccination site pain; On 21Mar2021 at 12:15 pm, the patient experienced tiredness all day, slight headache, diarrhea, chills, sweating, shaking and nausea. On 21Mar2021 at 06:15 pm, the patient received 2 dose of Tylenol as treatment. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. At the time of this report, outcome of clinical events were resolved. No follow-up attempts are possible. No further information is expected
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tremor, Vaccination site pain
Clinical narrative: tiredness all day; slight headache; diarrhea; chills; sweating; shaking; nausea; injection site pain; This is a spontaneous report from a contactable consumer. A 70-year-old non pregnant female patient received second dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: EN6207) via unspecified route of administration, in left arm on 20Mar2021 at 01:45 pm (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient has medical history of glaucoma and allergic to rhoppasa. Concomitant medication included Alphagan 0.1%, Lumigan-0.01% and Dorzolamide 2% used within 2 weeks of vaccination for an unknown indication. The patient received first dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: EN6203) via unspecified route of administration, in left arm on 27Feb2021 at 01:45 pm (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not tested positive for COVID-19 since having the vaccine. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021, same day after vaccination of second dose, the patient experienced vaccination site pain; On 21Mar2021 at 12:15 pm, the patient experienced tiredness all day, slight headache, diarrhea, chills, sweating, shaking and nausea. On 21Mar2021 at 06:15 pm, the patient received 2 dose of Tylenol as treatment. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. At the time of this report, outcome of clinical events were resolved. No follow-up attempts are possible. No further information is expected
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymph node pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: NOTICE PAIN UNDER ARM PIT. LYMPH NODES; PAIN LIFTING ARM.; NOTICE PAIN UNDER ARM PIT. LYMPH NODES; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208) via an unspecified route of administration in left arm on 17Mar2021at 13:15 (at an age of 44-year-old) as a single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 05Mar2021 the patient underwent COVID-19 nasal swab test and the test result was found to be negative. On 19Mar2021 at 17:00, the patient experienced events of pain lifting arm, pain under armpit and  lymph nodes pain. The patient did not receive any treatment for the reported events. Events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain lifting arm and pain under armpit were not recovered.   No follow-up attempts are possible. No further information is expected
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Pain in extremity, Pruritus, Vaccination site rash
Clinical narrative: After vaccination a rash appeared on my left forearm (itchy, raised red patchthat felt hot to the touch); Sweating; Dizzy; Itchy all over; Sore arm; This is a spontaneous report from a contactable consumer, patient. A 50-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8767) via unspecified route of administration in the right arm on 21 Mar2021 at 10:15 AM (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication includes Ibuprofen (UNKNOWN MANUFACTURER) on unknown date for unknown indications. The patient was allergic to sulfadrugs. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via unspecified route of administration in the left arm on 28Feb2021 at 11:15 AM (at the age of 50-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 for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 12:45 (approximately 2-3 hours after vaccination), the patient experienced a rash appeared on her left forearm (itchy, raised red patch that felt hot to the touch). Shortly thereafter another appeared on her left forearm. Later, the patient woke up in the middle of the night sweating a lot, dizzy when she changed her positions and itchy all over. The patient was able to go back to sleep and she was fine when she woke up. Just a sore arm. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure was taken as a result of event rash and included treatment with antihistamine. The clinical outcome for the events rash, sweaty, dizzy, sore arm and itchy were resolved on an unknown date.   No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: Lump; Redness; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via unspecified route of administration in the left arm on 18Mar2021 at 10:00 (at the age of 78-years-old) as a single dose for Covid-19 immunisation. Medical history included controlled HBP (as reported), diabetes and cholesterol. The patient received other unspecified medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: EL9262) via an unspecified route of administration in the left arm on 25Feb2021 at 10:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The patient previously received Rofecoxib (VIOXX) (no longer made) for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. On 18Mar2021, the patient experienced redness and lump persisting for 5 days. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the redness and lump was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report received from a contactable consumer, patient. A 71-year-old elderly non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date (at the age of 71 years), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. Concomitant medication was not reported. Patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: UNKNOWN), via an unspecified route of administration on 18Mar2021 at 16:00(at the age of 71 years) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient had no symptoms associated for COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 20Feb2021 at 16:00, the patient experienced dizziness which resulted in emergency room/department or urgent care. The patient did not receive any treatment for event. The clinical outcome of event dizziness was resolved with lasting effects on an unspecified date in 2021. No follow attempts are needed. Information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Nausea, Pain in extremity
Clinical narrative: Nausea; Fatigue; Arm pain; Confusion; This is a spontaneous report from a contactable consumer, the patient. A 54-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 20:15 as a single dose for COVID-19 immunisation. Medical history included hashimotos thyroiditis, history of lung cancer, gastro-oesophageal reflux disease (GERD) and high cholesterol. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient is allergic to latex. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested positive for COVID-19 since having the vaccine. On 20Mar2021 at 05:00, the patient experienced nausea, fatigue, arm pain and confusion. No treatment was received for the events. Event had not resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome for nausea, fatigue, arm pain, confusion was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Lethargy, Pain
Clinical narrative: Flu-like symptoms; Body aches; Lethargic; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 19Mar2021 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination, the patient was not diagnosed for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, the patient experienced flu-like symptoms, body aches and lethargic but no fever or cough. It went away within 24 hours and patient felt completely fine, even ran 9 miles. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of flu-like symptoms, body aches and lethargic was resolved on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Urticaria
Clinical narrative: Allergies in my whole body; Hives; Rashes; This is a spontaneous report from a contactable consumer. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 08Mar2021 at 11:00 (at the age of 33-year-old), as a single dose for COVID-19 immunisation. The patients medical history was not reported. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN) for unknown indication from unknown date. 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 00:15, the patient experienced allergies in her whole body, hives and rashes. The patient received different types of treatment for these events but nothing was working. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events allergy, rash and hives were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable consumer, the patient. A 25-years-old male 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 18Mar2021 at 18:45 as single dose, for COVID-19 immunisation. Medical history and concomitant medication was not reported. Past drug history included allergies to Dramamine. 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 4 weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced headache. The patient did not receive any treatment for headache. The clinical outcome of headache was recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Paraesthesia oral, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: A hot large rash around my injection site; Large rash around my injectionsite and pain in that area; swollen at injection site; Shortness of breath; tingly mouth; This is a spontaneous report from a contactable consumer, the patient. A 41-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 right arm on 16Mar2021 at 1715 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included asthma. The patient had soy and sulfa allergy. Concomitant medications included singulair (MANUFACTURER UNKNOWN), zyrtec (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN) for unknown indications received on unknown dates. The patient previously 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 23Feb2021 at 1900, 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 vaccine. On 17Mar2021 at 1800, the patient experienced typical allergic reaction which was vaccination swelling, shortness of breath and tingly mouth. On 19Mar2021, the patient noticed a hot large rash and pain around her injection site. Therapeutic measure taken as a result of the events vaccination swelling, shortness of breath and tingly mouth included benadryl (MANUFACTURER UNKNOWN) and it relieved most symptoms. The clinical outcome of the events  vaccination site swelling, shortness of breath, tingling mouth, hot large rash and pain around her injection site were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Paraesthesia
Clinical narrative: my right foot started to feel weird- felt wet or tingly sometimes; my first menstruation after vaccinehad many small blood clots, which isnot normal for me; This is a spontaneous report from a contactable consumer, the patient. A 40 -year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6206) via an unspecified route of administration in the right arm on 04Mar2021 at 18:30 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included patient was allergic to shellfish. No concomitant therapies. 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 did not receive any other vaccines within four weeks prior to the vaccination. The. Three days after the vaccine, on 07Mar2021 at 11:00 the patient experienced right foot started to feel weird and felt wet or tingly sometimes however the foot was not swollen. The patient still had those sensations 18 days after vaccine. Also, the patient first menstruation after the vaccine had many small blood clots, which was not normal for her. 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 tingling foot and small blood clots in menstruation was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.