chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Phantom smells, I kept smelling Eucalytus and mint when there wasn't any.; This is a spontaneous report received from a contactable consumer.   A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported), via an unspecified route of administration at the right arm on an unspecified date of Feb2021 at single dose for COVID-19 immunization at Health Clinic. The patient had no other medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not take other vaccine within 4 weeks. On an unspecified date on Feb-2021, the patient had phantom smells and kept smelling Eucalyptus and mint when there wasn't any. It was reported no other family members smelled it. Event was not treated. The patient had no COVID prior vaccination nor tested post vaccination. Outcome of event was reported as recovered on an unspecified date.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This is a spontaneous report from a contactable Nurse (patient) via Pfizer sales representative. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date as a single dose for Covid-19 immunization. The patient's medical history and concomitant medications wee not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). Pfizer representative stated, "I was talking to one of my Nurses and she had a COVID vaccine. She was telling me. She had nausea after I think her second shot on an unspecified date. She had said first shot was fine. You know her second shot she had a little nausea afterwards. It wasn't a big deal." The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: slight chills; slight fever (99F); tiredness; This is a spontaneous report from a contactable consumer. A 58-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247) via unspecified route of administration on right arm on 11Feb2021 at 12:00pm as a single dose for COVID-19 immunization. Patient's medical history included hypertension from an unknown date and unknown if ongoing controlled with medication. Patient's concomitant medications were not reported. The patiently previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247) via unspecified route of administration on right arm on 21Jan2021 at 12:00pm as a single dose for COVID-19 immunization. On 12Feb2021 at 10:00 am, patient experienced slight chills, slight fever (99 F) and tiredness. The patient underwent lab tests and procedures which included body temperature 99 Fahrenheit on slight. No treatment was given to the patient for the events. Outcome of the events was recovering.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: diarrhea; she had a sore arm the first night; This is a spontaneous report from a contactable consumer (patient).  A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EL3249) dose 1 intramuscularly, administered in upper right arm on 20Jan2021 at 13:00. Medical history included ulcer four year age, severe sepsis and kidney dialysis occurred four years ago. Concomitant medications included supplements and vitamins. Historical vaccination included flu shot on 04Oct2020. On 27Jan2021 the patient reported had diarrhea since a week after the first dose of the vaccine. It has been off and on since then, not continual. First it wasn't good and she crapped her pants a few times but it has been calming down. It was starting to look more normal yesterday, it was solid and was a better color. At first it was yellowish type stuff.  It was getting to be like runny in the morning, usually once or twice in the morning, but the rest of the day and evening it was fine. Today it was solid with a little bit of runniness, but not much. After lunch she ended up having to go to the bathroom again and she took Imodium. She has been taking Imodium off and on since she does not want to take too much. She had a stomach ache this morning twice and she did not have stomach aches prior to this morning. With the first dose she had a sore arm the first night on unspecified date Jan2021. States with the first dose it was nurses administering the vaccine. The outcome of event was Recovering for Diarrhea and Pain in arm was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pyrexia
Clinical narrative: flu like aches with fever; flu like aches with fever; unrelenting headache; This is a spontaneous report from a contactable consumer (patient) in response to Non-HCP letter. A 51-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 13Jan2021 (at age of 51-years-old), as single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL0140 and expiry dates was not provided), in Upper Left arm, on 23Dec2020 at 08:30 and experienced headache, Brain fog- decreasing cognitive response and Dizziness; all were at 08:00 PM. Patient stated that I took the 2nd dose on 13Jan2021, I had a reaction at that time-side effects that were slightly different; unrelating headcahe, flu like aches with fever in 2021. This 2nd set of effects lasted 36 hrs. Outcome of the events was recovered on an unknown date in 2021. The patient considered the suspect product had a causal effect to the adverse events.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, Chills, Headache, Nausea, Pain
Clinical narrative: Fever 101 for 6hrs; headache; chills; body aches; nausea; This is a spontaneous report from a contactable Other-health care professional (patient herself) of 55 years old female received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number: unknown) via intramuscular route of administration in the left arm on 12Feb2021 at 12:00PM and first dose on unspecified date via unknown route of administration both as a single dose for COVID-19 immunization. Patient medical history was not reported. Concomitant medications included escitalopram oxalate. The patient had no known allergies. The patient had COVID prior to vaccination. The patient was not tested for COVID-19 post vaccination. On an unknown date, the patient developed fever of 100 degree centigrade. On 12Feb2021 at 10.00 PM, the patient developed fever 101 for 6hrs and experienced headache, chills, body aches and nausea. The patient underwent lab tests and procedures which included body temperature: 100 centigrade an unknown date and body temperature: 101 centigrade on 12Feb2021 fever 101 for 6 hours. The clinical outcome for the events were considered as recovered.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia
Clinical narrative: Fever 101 for 6hrs; headache; chills; body aches; nausea; This is a spontaneous report from a contactable Other-health care professional (patient herself) of 55 years old female received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number: unknown) via intramuscular route of administration in the left arm on 12Feb2021 at 12:00PM and first dose on unspecified date via unknown route of administration both as a single dose for COVID-19 immunization. Patient medical history was not reported. Concomitant medications included escitalopram oxalate. The patient had no known allergies. The patient had COVID prior to vaccination. The patient was not tested for COVID-19 post vaccination. On an unknown date, the patient developed fever of 100 degree centigrade. On 12Feb2021 at 10.00 PM, the patient developed fever 101 for 6hrs and experienced headache, chills, body aches and nausea. The patient underwent lab tests and procedures which included body temperature: 100 centigrade an unknown date and body temperature: 101 centigrade on 12Feb2021 fever 101 for 6 hours. The clinical outcome for the events were considered as recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling of eyelid, Urticaria
Clinical narrative: had hives, like a rash/a rash on her face and her legs/hives on her face that were red and bumpy; her eye looks like a bee stung her eyelid,  it is swollen; her legs were itching; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient 's medical history and concomitant medications were not reported. It was reported that patient had hives, like a rash and today, eye looks like a bee stung her eyelid, swollen. Rash on her face and her legs and her legs were itching, it was like hives on her face that were red and bumpy. They are not as bumpy but it is still red. Patient was taking Prednisone but not sure if that is why its getting a little bit better but it is still really red and itching and the swollen eye. Outcome of events was unknown.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Low grade fever (chills & weakness); Injection site soreness; This is a spontaneous report received from a contactable male consumer (Patient herself) of 48-Year-old received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247, Expiration date: unknown) via an unspecified route of administration on right arm on 12Feb2021 01:00PM and first dose (Lot no: EL3247) on 21Jan2021 02:00 PM via unspecified route of administration both as single dose for COVID-19 Immunization. The patient's medical history and concomitant medication were not reported. Historical vaccine included for first dose. Patient was not reported to known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not received other vaccines within 4 weeks and within 2 weeks of prior to the COVID vaccine. Post vaccination patient was not tested with covid. On 13Feb2021 12:00pm (24 hours after second dose) patient experienced low grade fever (chills & weakness) and Injection site soreness for 24 hours. Patient did not receive any treatment for the events. Outcome of the event Low grade fever was recovered after approx 8 hrs and Injection site soreness on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Dizziness, Pyrexia
Clinical narrative: Fever; dizziness; upset stomach; This is a spontaneous report from a Non-contactable consumer. A female Patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced fever, dizziness, and upset stomach on unspecified date. Patient underwent lab tests and procedures which included body temperature. The outcome of the events was unknown.  No follow up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021196645 same reporter/SD/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine
Clinical narrative: Chills; bad migraine; This is a spontaneous report from a contactable other HCP (patient) via Pfizer Sales Representative. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Solution for injection, batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 on an unspecified date for covid-19 immunisation. Patient reported having adverse events after receiving the second dose of the Covid-19 vaccine. She was totally fine with the first dose within 12 hours after receiving the second dose she developed chills and a bad migraine on an unspecified date. The outcome of the events was resolved on an unspecified date.  information on the Lot/Batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Feels yucky; Feels like she has the flu; Feels tired and sluggish; Fever; Chills; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose bnt162b2 of (BNT162B2, Solution for injection, Lot number: EL9264), via an unspecified route of administration, in the left arm on 03Feb2021 09:30 (at the age of 70-years-old) as single dose for protection from Covid. Medical history included knee arthroplasty from an unspecified date in Sep2018, blood pressure measurement, thyroid disorder, anticoagulant therapy. Concomitant medications included levothyroxine sodium (SYNTHROID) (MANUFACTURER UNKNOWN); aspirin (ASPIRIN [ACETYLSALICYLIC ACID]) (MANUFACTURER UNKNOWN); losartan (MANUFACTURER UNKNOWN). On 03Feb2021 20:00, the patient experienced fever, chills, feels like she has the flu, feels tired and sluggish. On 04Feb2021 20:00, the patient experienced feels yucky. The patient underwent lab tests which included body temperature: 100.7 degrees and covid-19: she had covid on an unspecified date in Aug2020. The patient did not receive any treatment for the events. The clinical outcome of the fever was unknown, for chills, feels yucky were recovering and for feels like she has the flu, feels tired and sluggish were not recovered. No follow-up attempt are possible.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: had a lot of pain in his left shoulder; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982, Expiration date: unknown) via an unspecified route of administration on 02Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient medical history included psoriatic arthritis and diabetes. Concomitant medication was not reported. Upon Follow-up on 16Feb2021, it was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was on adalimumab (HUMIRA) for his psoriatic arthritis, but he didn't take this medication since he had the first dose of the BNT162B2 vaccine. Patient supposed to start adalimumab (HUMIRA) in February. Patient would take the second shot of the BNT162B2 vaccine on 02Mar2021. On an unspecified date in 2021, patient experienced pain in his left shoulder, at first no trouble at all. The last week his left shoulder started hurting, it maybe arthritis. The patient did not have Emergency Room/ Physician Office visit due to the event. The patient also received Humira for Psoriatic arthritis on an unspecified date. The outcome of the event was unknown.  Upon Follow-up on 16Feb2021: The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (16Feb2021), this case now contains all required information to be considered valid. This is a follow-up spontaneous report from a contactable consumer included patient's information (age, height, weight), medical history, event, outcome and clinical information.  No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Caller indicates husband received first dose 19JAN2021.  He was to receive second dose 09FEB2021, tested positive for SArS-Cov-2 06FEB2021; Caller indicates husband received first dose 19JAN2021.  He was to receive second dose 09FEB2021, tested positive for SArS-Cov-2 06FEB2021; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported) first dose via an unspecified route of administration on 19Jan2021 as single dose for COVID-19 immunization. The patient medical history included vascular graft from an unknown date. The patient concomitant medications were not reported. The patient experienced that receiving of first dose on 19Jan2021 He was to receive second dose 09Feb2021, tested positive for SArS-Cov-2 06Feb2021. The customer stated that symptom like free-ish. Wanted to go to today for second dose.  Says he has a history of double bypass. Looking for extended information. Potential AE. the outcome of the event was unknown.  Information about lot/batch number is requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Vaccinated on Jan 4th and tested positive for COVID-19 on Jan 6th; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable female patient reported for herself, she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on 04Jan2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 06Jan2021, the patient tested positive for COVID-19. The patient wants a clarification regarding the status of her vaccination. The clinical outcome of events was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test which was positive on 06Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Fever; rash at vaccine site which is hot, red, itchy; rash at vaccine site which is hot, red, itchy; rash at vaccine site which is hot, red, itchy; rash at vaccine site which is hot, red, itchy; This is a spontaneous report from contactable other healthcare professionals (one was patient herself). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249) via unknown route of administration on 01Feb2021 at single dose in left arm for COVID-19 immunization at Hospital. Medical history included HTN (Hypertension). No Known allergies. No covid prior vaccination. No other vaccine in four weeks. Concomitant medications in two weeks included valsartan, ibuprofen, multivitamin, vitamin b complex (VIT B COMPLEX). The patient previously took first dose (at 49-year-old) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) intramuscularly on 11Jan2021 03:00 PM at single dose in left arm for COVID-19 immunization. The patient experienced fever, rash at vaccine site which was hot, red, itchy on 03Feb2021. No treatment received for adverse events. No covid tested post vaccination. The outcome of events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Lymphadenopathy, Neck pain, Palpitations, SARS-CoV-2 test
Clinical narrative: pain and tenderness over the thyroid; left axillary adenopathy/lymphadenopathy; significant thyroiditis; neck pain; fatigue; palpitations; This is a spontaneous report from a contactable physician and a pharmacist. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular, administered in arm left on 10Jan2021 13:00 as a single dose (at the age of 41-years-old) for covid-19 immunization. The vaccine was administered at the hospital. The patient had no known allergies and no other medical history (reported as none). The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), administered in arm left on 20Dec2020 1:00 PM (at the age of 41-years-old) for covid-19 immunization. On 14Jan2021, the patient developed left axillary adenopathy which then subsided and developed left cervical lymphadenopathy and significant thyroiditis. The patient also experienced neck pain, fatigue and palpitations on 14Jan2021. On 15Jan2021, she had severe pain and tenderness over the thyroid. The reported events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received prednisone, propranolol, Tylenol, antibiotics as treatment for the events. The patient underwent lab tests and procedures included SARS-CoV-2 test both via PCR and Nasal Swab: negative on Jan2021, 17Jan2021 and 24Jan2021. The outcome of lymphadenopathy, thyroiditis, pain and tenderness over the thyroid was recovering and unknown for the rest of the events.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thyroid pain, Thyroiditis
Clinical narrative: pain and tenderness over the thyroid; left axillary adenopathy/lymphadenopathy; significant thyroiditis; neck pain; fatigue; palpitations; This is a spontaneous report from a contactable physician and a pharmacist. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular, administered in arm left on 10Jan2021 13:00 as a single dose (at the age of 41-years-old) for covid-19 immunization. The vaccine was administered at the hospital. The patient had no known allergies and no other medical history (reported as none). The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), administered in arm left on 20Dec2020 1:00 PM (at the age of 41-years-old) for covid-19 immunization. On 14Jan2021, the patient developed left axillary adenopathy which then subsided and developed left cervical lymphadenopathy and significant thyroiditis. The patient also experienced neck pain, fatigue and palpitations on 14Jan2021. On 15Jan2021, she had severe pain and tenderness over the thyroid. The reported events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received prednisone, propranolol, Tylenol, antibiotics as treatment for the events. The patient underwent lab tests and procedures included SARS-CoV-2 test both via PCR and Nasal Swab: negative on Jan2021, 17Jan2021 and 24Jan2021. The outcome of lymphadenopathy, thyroiditis, pain and tenderness over the thyroid was recovering and unknown for the rest of the events.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thyroiditis
Clinical narrative: pain and tenderness over the thyroid; left axillary adenopathy/lymphadenopathy; significant thyroiditis; neck pain; fatigue; palpitations; This is a spontaneous report from a contactable physician and a pharmacist. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular, administered in arm left on 10Jan2021 13:00 as a single dose (at the age of 41-years-old) for covid-19 immunization. The vaccine was administered at the hospital. The patient had no known allergies and no other medical history (reported as none). The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), administered in arm left on 20Dec2020 1:00 PM (at the age of 41-years-old) for covid-19 immunization. On 14Jan2021, the patient developed left axillary adenopathy which then subsided and developed left cervical lymphadenopathy and significant thyroiditis. The patient also experienced neck pain, fatigue and palpitations on 14Jan2021. On 15Jan2021, she had severe pain and tenderness over the thyroid. The reported events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received prednisone, propranolol, Tylenol, antibiotics as treatment for the events. The patient underwent lab tests and procedures included SARS-CoV-2 test both via PCR and Nasal Swab: negative on Jan2021, 17Jan2021 and 24Jan2021. The outcome of lymphadenopathy, thyroiditis, pain and tenderness over the thyroid was recovering and unknown for the rest of the events.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone, Computerised tomogram neck, Dysphagia, Ear infection, Fatigue
Clinical narrative: pain and tenderness over the thyroid; left axillary adenopathy/lymphadenopathy; significant thyroiditis; neck pain; fatigue; palpitations; This is a spontaneous report from a contactable physician and a pharmacist. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular, administered in arm left on 10Jan2021 13:00 as a single dose (at the age of 41-years-old) for covid-19 immunization. The vaccine was administered at the hospital. The patient had no known allergies and no other medical history (reported as none). The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), administered in arm left on 20Dec2020 1:00 PM (at the age of 41-years-old) for covid-19 immunization. On 14Jan2021, the patient developed left axillary adenopathy which then subsided and developed left cervical lymphadenopathy and significant thyroiditis. The patient also experienced neck pain, fatigue and palpitations on 14Jan2021. On 15Jan2021, she had severe pain and tenderness over the thyroid. The reported events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received prednisone, propranolol, Tylenol, antibiotics as treatment for the events. The patient underwent lab tests and procedures included SARS-CoV-2 test both via PCR and Nasal Swab: negative on Jan2021, 17Jan2021 and 24Jan2021. The outcome of lymphadenopathy, thyroiditis, pain and tenderness over the thyroid was recovering and unknown for the rest of the events.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy, Myalgia, Neck pain, Pain, Pyrexia
Clinical narrative: pain and tenderness over the thyroid; left axillary adenopathy/lymphadenopathy; significant thyroiditis; neck pain; fatigue; palpitations; This is a spontaneous report from a contactable physician and a pharmacist. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular, administered in arm left on 10Jan2021 13:00 as a single dose (at the age of 41-years-old) for covid-19 immunization. The vaccine was administered at the hospital. The patient had no known allergies and no other medical history (reported as none). The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), administered in arm left on 20Dec2020 1:00 PM (at the age of 41-years-old) for covid-19 immunization. On 14Jan2021, the patient developed left axillary adenopathy which then subsided and developed left cervical lymphadenopathy and significant thyroiditis. The patient also experienced neck pain, fatigue and palpitations on 14Jan2021. On 15Jan2021, she had severe pain and tenderness over the thyroid. The reported events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received prednisone, propranolol, Tylenol, antibiotics as treatment for the events. The patient underwent lab tests and procedures included SARS-CoV-2 test both via PCR and Nasal Swab: negative on Jan2021, 17Jan2021 and 24Jan2021. The outcome of lymphadenopathy, thyroiditis, pain and tenderness over the thyroid was recovering and unknown for the rest of the events.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Thyroxine free, Tri-iodothyronine free
Clinical narrative: pain and tenderness over the thyroid; left axillary adenopathy/lymphadenopathy; significant thyroiditis; neck pain; fatigue; palpitations; This is a spontaneous report from a contactable physician and a pharmacist. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular, administered in arm left on 10Jan2021 13:00 as a single dose (at the age of 41-years-old) for covid-19 immunization. The vaccine was administered at the hospital. The patient had no known allergies and no other medical history (reported as none). The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), administered in arm left on 20Dec2020 1:00 PM (at the age of 41-years-old) for covid-19 immunization. On 14Jan2021, the patient developed left axillary adenopathy which then subsided and developed left cervical lymphadenopathy and significant thyroiditis. The patient also experienced neck pain, fatigue and palpitations on 14Jan2021. On 15Jan2021, she had severe pain and tenderness over the thyroid. The reported events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received prednisone, propranolol, Tylenol, antibiotics as treatment for the events. The patient underwent lab tests and procedures included SARS-CoV-2 test both via PCR and Nasal Swab: negative on Jan2021, 17Jan2021 and 24Jan2021. The outcome of lymphadenopathy, thyroiditis, pain and tenderness over the thyroid was recovering and unknown for the rest of the events.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea
Clinical narrative: since I got the second dose on 29Jan21 the shortness of breath has been worse, it's been more frequent, when I'm doing minor activities I'm getting out of breath really quick; since I got the second dose on 29Jan21 the shortness of breath has been worse, it's been more frequent, when I'm doing minor activities I'm getting out of breath really quick; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received  second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 29Jan2021 as single dose for covid-19 immunization. The patient had historical vaccine (BNT162B2) and dose 1 and experienced shortness of breath and very sore arm. The patient's concomitant medications were not reported. It was reported that since patient got the second dose on 29Jan2021, the shortness of breath has been worse, it's been more frequent, when he was doing minor activities. He was getting out of breath really quick on Jan2021. Outcome of the events was unknown.  Information on lot number/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: arm where she received the vaccine turned blood red, had a lot of rash, and it was itching; arm where she received the vaccine turned blood red, had a lot of rash, and it was itching; arm where she received the vaccine turned blood red, had a lot of rash, and it was itching; This is a spontaneous report from a contactable consumer (patient). This is report 2 of 2 (for 2nd dose of vaccine). A 71-year-old female patient received BNT162B2 (Solution for injection), dose 2 intramuscular (left arm) on 30Jan2021 at 13:00 (at the age of 71-year-old) (Lot Number: EL1283) at SINGLE DOSE for COVID-19 vaccination. Medical history included allergies, toxemia/ preeclampsia. The patient's concomitant medications were not reported. The patient previously took phenobarbital for toxemia/ preeclampsia and BNT162B2 in left arm on 11Jan2021 (Lot EK9231) (at the age of 71-year-old) for covid-19 vaccination.  It was reported that the patient was looking at the vaccination sheet for the Covid-19 vaccine. She said that she had a bad reaction on the arm where she received the injection. It was reported that the arm where she received the vaccine turned blood red, had a lot of rash, and it was itching on 01Feb2021. She said that it was down to her elbow. The patient had lots of allergies. She had the shingles shot and pneumonia shot with no reaction. She had the Covid vaccine on Saturday 30Jan2021 and went to the doctor on Monday 01Feb2021 and they gave her a steroid cream for it, and it did not help much. She had been taking Allegra and Benadryl instead. It was reported that the dermatologist did not think her symptoms were from the shot itself. She said that the doctor said that she had seen people who received flu shots whose arms looked 10 times worse than hers. The reporter said that her shot was Saturday afternoon 30Jan2021 and she noticed the place on her arm on Monday 01Feb2021 or about a day and a half later. Everyone she spoke too said that they felt like they had the flu and she said that she felt lucky until she had the issue with her arm. She said that the itching was a little better but stated that it was a week later, and she was still itching, and it was driving her nuts. She said that the itching comes worse at night. She said that she only lays under 2 sheets and she thinks it may be the heat making it worse at night. She had no reaction from the first dose, only the second dose. The patient had lots of allergies to lots of medication and has broken out before. The patient had toxemia when she had her daughter 50 years ago. She said that she thinks it is called Preeclampsia now but stated that they gave her Phenobarbital, and she broke out in huge water blisters. The reporter did not have a NDC, Lot, or expiration date. The patient had no prior Vaccinations (within 4 weeks). The outcome of the event vaccination site pruritus was not recovered while for other events was recovering.  No further information provided.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Exposure to SARS-CoV-2, Fatigue
Clinical narrative: She was exposed at school, that's where they suspect she and her mother caught it from her pre-school aged daughter who was asymptomatic; Loss of smell; Loss of taste; Fatigue; Cousin began to have COVID symptoms the same date as her aunt, 27Jan2021; This is a spontaneous report from a non-contactable consumer or other non hcp. This is report 2 of 2 for caller's cousin. The report is cross referenced to report ID: 91UGN7DB (patient: caller's aunt). A 34-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EL3246; Expiration Date: unknown), dose 1 intramuscularly on 22Jan2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's cousin began to have covid symptoms the same date as her aunt, on 27Jan2021, she was exposed at school, that's where they suspect she and her mother caught it from her pre-school aged daughter who was asymptomatic (exposure to sars-cov-2) on an unspecified date. The caller confirms her cousin began to have COVID symptoms the same date as her aunt, 27Jan2021. Her cousin was vaccinated the same date with the same Lot number and doesn't know if her cousin was tested. After doing exposure tracing, it was discovered she was exposed at school, that's where they suspect she and her mother caught it from her pre-school aged daughter who was asymptomatic. The patient experienced loss of smell, loss of taste, fatigue on 27Jan2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test negative
Clinical narrative: tested for covid last Monday and the results came back negative; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 08Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On Feb2021, the patient experienced tested for COVID (sars-cov-2 test) last Monday and the results came back negative. The outcome of event was unknown.  Information on the Lot/Batch number has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Pain in extremity
Clinical narrative: Left arm pain for 48 hours; Weakness for 48 hours; Lightheadedness for 24 hours; This is a spontaneous report from a contactable other hcp. A 56-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 10:15 as SINGLE DOSE for an unspecified indication. Medical history included depression, bipolar i disorder, insomnia, hypercholesterolaemia from an unknown date. Concomitant medications included asa (ASA); atomoxetine hydrochloride (STRATTERA); escitalopram oxalate (LEXAPRO); gabapentin (NEURONTIN); trazodone. The patient experienced left arm pain for 48 hours (pain in extremity), weakness for 48 hours (asthenia), lightheadedness for 24 hours (dizziness) on 04Feb2021 at 12:00. Therapeutic measures were taken as a result of left arm pain for 48 hours (pain in extremity), weakness for 48 hours (asthenia), lightheadedness for 24 hours (dizziness), acetaminophen was provided. The action taken in response to the event(s) for bnt162b2 was not applicable. Outcome of the event lightheadedness was recovered on 05Feb2021 at 12:00 and event left arm pain and weakness was recovered on 06Feb2021 at 12:00.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: severe back pain; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced severe back pain (non-serious) on Feb2021. Therapeutic measures were taken as a result of severe back pain (back pain). The caller got first dose last 05Feb2021. After the vaccine she was prescribed by her doctor to take prednisone for her severe back pain. She took the medicine today and needs to continue until 18Feb2021. The second dose will be on 26Feb2021. She had the first dose of the Pfizer covid vaccine on 05Feb2021. Yesterday she saw her doctor since she was having severe back pain which the doctor thought was a bulging disc. The doctor wrote a prescription for prednisone. She wanted to know if taking prednisone would compromise anything. She trusted her doctor. When she received the vaccine she was asked if she was on prednisone and she told them no. She was wondering why it was asked. She wanted to know if prednisone is ok to take. She would take it for 8 days and then be off of prednisone 7 days before she gets the second dose. She used the v-safe and will ask them. She declined to provide mailing address or email. She was upset since she has been on hold for almost an hour and the transferring agent took down all her information and transferred to this department to answer her question. She declined to complete report or provide any further details. The outcome of event was unknown.  Information about the Lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm pain; This is a spontaneous report from a contactable other hcp (patient). A 48-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 13:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had no prior COVID vaccination. The patient had not tested for COVID post vaccination. No known allergies. The patient experienced left arm pain on 05Feb2021 21:00. The patient did not receive any treatment for AE. Outcome of the event was recovered in Feb2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Rash
Clinical narrative: rash on her thigh; very sore arm; she feels worn out; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable female consumer (Patient herself) of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: not provided), via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant was not reported. After receiving first dose of vaccine, patient reported that she experienced a rash on her inner thighs and event was better for next day morning, but she woke up during the night with a very sore arm and she felt worn out for next day morning. The outcome of the events rash was recovering and felt worn out, very sore arm events outcome was unknown.  Information on the batch/lot number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Rash, Swelling face
Clinical narrative: facial swelling; fever; body aches; chills; Rash on the neck spreading to head/rash on ears; This is a spontaneous report from a contactable other HCP (Patient). A 42-years-old non-pregnant female patient received second dose BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EL3302) via an unspecified route of administration, administered in Arm Left on 03Feb2021 as SINGLE DOSE for covid-19 immunisation. Historical vaccination first dose of BNT162B2 (Lot number: EL3302) via an unspecified route of administration in Arm Left on 13Jan2021 10:00 for covid-19 immunisation. Patient medical history reported none. Known allergies: IV ANCEF [cefazolin sodium]. The patient concomitant medications included multivitamins. On 13Feb2021 19:00 (after 10 days following 2nd dose) the patient experienced rash on the neck spreading to head and facial swelling, fever, body aches and chills and rash on ears. Patient received treatment as Prednisone, H2 Blockers and Antihistamine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No covid tested post vaccination. The outcome of the event was not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on neck; This is a spontaneous report from a contactable consumer. This 64-year-old female consumer reported that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9264, Expiration date: unknown) in Left arm on 04Feb2021, at 09:00 PM as single dose for COVID-19 immunization. Patient medical history included recently diagnosed with asthma. concomitant medications included Trelegy, Meloxicam, C abergilene, Yuvafem Olmesartan. Patient experienced rash on neck on 08Feb2021.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. Patient had known allergies to penicillin and sulfa (nausea from either). The outcome of the event was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received her first dose, She has since tested positive for Covid; received her first dose, She has since tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: Unknown, NDC number: Unknown, Expiry date: Unknown), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient tested positive for Covid. She states she received her first dose of the Pfizer Covid vaccine. She has since tested positive for Covid and wants to know when she can get the second dose of the vaccine. Patient stated tomorrow she was to have the second one, but she is sick now. She was talking about the COVID Vaccine. She is positive for COVID. She was asking when can she have second dose. There was a product problem complaint. The patient underwent lab work and procedures which showed Covid-19 was positive. The outcome of the events was unknown.  Information about the Lot/batch number has been requested.