chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: earache; sore throat; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration, administered in left arm on 27Jan2021 at 11:00 (at the age of 65 years old) as a single dose for COVID-19 immunisation. The patient family history was none. The patient medical history and concomitant medications were not reported. Since the vaccination, the patient had been tested for COVID-19 with SARS-CoV-2 test and unknown results on unknown date. On 27Jan2021 the patient experienced sore throat reported as last night, is fairly mild. Is now in her ear. Earache: Mild earache, noticed this morning.  The patient wanted to know could that be a symptom of the vaccine, hasn't been tested for COVID throughout the pandemic. Knows earache and sore throat are a symptom of COVID but has no reason to think she has COVID. Asked if she can still get tested for COVID if she had the vaccine. Her appointment for her second vaccination was scheduled for eight weeks from the first. The patient asked if the vaccine could interfere with or cause a false positive on a Covid test. The outcome of the event earache was not recovered while Sore throat was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on her neck; \This is a spontaneous report from a contactable consumer (patient herself).  A 71-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3249, Expiry Date: Unknown), via an unspecified route of administration in arm left on 15Jan2021 (at the age of 71-year-old) as single dose for COVID-19 immunization. Dosage text given as dosage amount unknown. First dose in series, via injection. The patient's medical history and concomitant medications were not reported. Consumer stated that her 1st dose of the Pfizer Covid vaccine last 15Jan2021 and then on 20Jan2021, she developed a little rash on her neck which lasted for about 4-5 days before it went away last Monday. She wanted to know if that could be a side effect of the vaccine and if it's still recommended for her to get the 2nd dose on 05Feb2021. Consumer just thought that it might be from something else, but she saw her Gynecologist on 21Jan2021, and she showed her GYN the rash and he said that he could not tell her if it was from the vaccine or not, so he thought she should call and report it to Pfizer. Consumer has previously worked as a Pharmacy Technician. She had no other vaccines on the same day. Consumer stated for history, concomitant medications, and Investigations reported as none, between that time and the time she got the rash, she had not gone and gotten any new medications or anything. She states that the medicine she was on, she has been on since prior to getting the COVID vaccine. Consumer did not provide any other details about concomitant medications. She was wondering if that rash was contraindicated for her to get the second dose, because she was due for the second dose on the 5th. On 20Jan2021, the patient experienced rash on her neck. The outcome of the event was recovered on an unspecified date.  Follow-up (28Jan2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that: patient demographic, event details and suspect product details were updated.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Pain in extremity
Clinical narrative: sore arm other than injection site; light headedness; mild diarrhea; This is a spontaneous report from a contactable consumer, the patient.   A 76-year-old male patient received first dose of bnt162b2(BNT162B2; formulation: solution for injection; Lot number el9264) via an intramuscular route of administration in left arm on 27Jan2021 at 03:00 PM (Age at vaccination: 76) as single dose for COVID-19 immunization at workplace clinic. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no Allergies to medications, food, or other products and the patient received other medications within 2 weeks of vaccination, but unspecified. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Jan2021 at 09:00 PM (the date of the vaccination), the patient experienced sore arm other than injection site, light headedness, mild diarrhea. The patient did not received treatment for the adverse event. The outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: hands and feet started itching uncontrollably; This is a spontaneous report from a contactable consumer (patient). A 53-year-old (age at the vaccination) non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was Ej1686 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm right on 28Jan2021 at 09:00 as 1st dose, single for COVID-19 immunisation. The patient medical history included thyroid disease from an unknown date and unknown if ongoing. The patient concomitant medication included levothyroxine, liothyronine, and vitamin D, all administered at an unknown dose for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. The patient experienced feet started itching uncontrollably on 28Jan2021 at 18:30. It was reported that at 18:30 at night, right after eating dinner her hands and feet started itching uncontrollably. She immediately took a Benadryl which helped stop the itching. She also had taken 3 Motrin about 1/2 prior to eating. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: still has the itching all over again, but no body rash; This is a spontaneous report from a contactable consumer (patient's husband) or other non hcp. A 58-years-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 26Jan2021 (Batch/Lot Number: EN5318) as 2nd dose single for COVID-19 immunization. Reporter mentioned that his wife is having some kind of allergic reaction. Received the 1st dose (as historical vaccine) of the Pfizer-BioNTech COVID-19 Vaccine last 06Jan2021 then her arm became sore for a couple of days. On Day 3/4, mentioned she had to keep clearing her throat, was taken to the doctor and said she had Strep (sore throat, and she had pus bags on the side of her throat in the back). She was given amoxicillin but developed a bad itch all over her body. The Amoxicillin was stopped and replaced with Zyrtec and Benadryl. It was good for a couple of days and we've set an appointment on 10Jan2021 to the ENT. Wife received the second dose on 26Jan2021, and today she still has the itching all over again, but no body rash. Reporter is asking if it is okay to continue taking the antihistamines any other information since other doctors don't seem to know what it was and also states that he now thinks that what his wife is having, has something to do with the shot, because she has had nothing else for a few days. Reporter confirms that his wife had no other vaccines on the same day as the COVID vaccine. Medical history includes blood pressure abnormal from an unknown date and unknown if ongoing. Caller states that his wife does take blood pressure medicine. Concomitant medications included aspirin taken for an unspecified indication, start and stop date were not reported. The patient experienced still has the itching all over again, but no body rash on an unspecified date. The outcome of the event was not recovered.  Follow up (28Jan2021): This is a follow up spontaneous report from a contactable consumer. No information was received upon follow up.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: Severe headache; Muscle & joint pain; Muscle & joint pain; This is a spontaneous report from a contactable 64-year-old female consumer reported for herself that:  A 64-year-old female patient received BNT162B2 (COMIRNAT, solution for Injection, Batch/Lot number: Unknown), via Intramuscular route of administration administered at right arm as single dose on 25Jan2021 11:30 for COVID-19 immunization. The patient was allergies to penicillin, sulfa and codine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history included fibromyalgia, migraines, bipolar disorder, kidney disease and depression sinusitis. Patient has not had symptoms associated with COVID-19. Concomitant medications included Exceeding migraine (ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL), Azelastine HCI and Flucticasone. On 25Jan2021 at 12:15 the patient experienced severe headache, muscle & joint pain lasted 3 days after the vaccination. The events were assessed as non-serious. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19.  On an unspecified date, the outcome of the events were recovering.   Follow-up attempts have been completed and no further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypotension, Vaccination site hypoaesthesia, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 27Jan2021 (Batch/Lot Number: EL3247, expiration date:unknown) as 1st dose, single for COVID-19 immunization. Medical history include allergy to amoxicillin. The concomitant medications were not reported.The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 28Jan2021 at 11:00 AM, the patient experienced pain and numbness at injection site and low blood pressure 88/60. The events were not treated. The outcome of these events was recovering. Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Mouth ulceration, Myalgia
Clinical narrative: Fatigue; Headache; Oral ulcers; Muscle aches; This is a spontaneous report from a contactable nurse (patient). A 52-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Lot number: EL0142PF; Expiration date: unknown), via unspecified route in arm left on 06Jan2021 at 10:45 (patient was 52-year-old at the time of vaccination) as a 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history include history: hypothyroid, htn, depression, arthritis, Allergies to medications, food, or other products: TRAMADOL, AMITEZA. The patient received medications within 2 weeks of vaccination. The most recent COVID-19 vaccine was administered in hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination, has the patient been tested for COVID-19 was unknown. On 07Jan2021, at 7:00, the patient experienced Fatigue, Headache, Oral Ulcers, Muscle Aches. The events are not serious. The patient had not received any treatment for events. The patient received second dose of BNT162B2 on 27Jan2021(Lot number: EL3249) on right arm. The events were recovered on an unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Fall
Clinical narrative: Sudden dizziness while standing outdoors; extreme chills; heavy breathing difficulty; Nearly fell over; This is a spontaneous report was received from a contactable consumer (patient). A 96-years-old female patient (Non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 27Jan2021 11:30 as single dose for covid-19 immunisation. Medical history included allergies to medications, food, or other products maybe penicillin. Concomitant medications included lovastatin, thyroid patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021, at 11:00AM, the patient had experienced sudden dizziness while standing outdoors 48 hours after vaccine injection, extreme chills, and heavy breathing difficulty. Nearly fell over but son caught her. Treatment received for the adverse event are unknown. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (15-Apr-2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: sore arm; headache; transitory fever for about one hour; This is a spontaneous report from a contactable pharmacist. A 56-years-old male patient received second dose of bnt162b2 (BNT162B2 solution for injection, Batch/Lot number was not reported),  via an unspecified route of administration, administered in Arm Right on 27Jan2021 as single dose for covid-19 immunisation. Medical history included seasonal allergy. The patient's concomitant medications were not reported. He received his seasonal allergies SC injection 24 hours before receiving the second BNT 162 b2 injection. patient reports that he received his seasonal allergies SC injection 24 hours before receiving the second BNT 162 b2 injection on 27Jan2021 in his right deltoid muscle. Patient also reports that he took 50mg of Benadryl prior to his BNT162b2 injection. A couple hours after receiving the BNT 162b2 vaccine he experienced a transitory fever that lasted 1-2 hours and resolved. The next morning,28Jan2021, patient stated that he had a headache that lasted for a day and a half which was unresolved by sleep or ibuprofen, 400 mg taken 3-4 times in the day and 1/2 time period. On Thursday 28Jan he noticed a lump in his Right arm pit which was visible and sore. The lump resolved by after 4-5 days and he has been symptom free. On 27Jan2021, the patient experienced transitory fever for about one hour and sore arm, headache on 28Jan2021.The outcome of the events was recovered. This is a supplement to the previous report submitted 28Jan. Patient emailed (Name) with additional information pertaining to the original report, information was added. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: receiving covid 19 vaccine, encouraged to notify MD. currently taking celebrex or advil for pain; This is a spontaneous report from a contactable other hcp. A 56-years-old female patient received bnt162b2 (BNT162B2), Formulation: 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 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced  pain after receiving vaccine, encouraged to notify md. currently taking celebrex or advil for pain. Therapeutic measures were taken. The outcome of event was unknown.  Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a Pfizer-sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown) via an unspecified route of administration on 25Jan2021 as 1st dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 25Jan2021 after the vaccine, he was diagnosed with UTI. Treatment was received with antibiotics. The outcome was reported as an unknown.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Large red raised areas on both checks; This is a spontaneous report from a contactable nurse (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: E51686), dose 2 via an unspecified route of administration, administered in right arm on 27Jan2021 09:00AM as single dose for covid-19 immunization at Nursing Home/Senior Living Facility. Historical vaccine included dose 1of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL0140) via an unspecified route of administration, administered in Arm Left, on 06Jan2021 10:00AM. Medical history included anaemia, hypertriglyceridaemia and psoriasis. Patient had no known allergies. Concomitant medication's included piroxicam (PAXIL [PIROXICAM]), ferrous sulfate (IRON SULFATE), cyanocobalamin (B12 [CYANOCOBALAMIN]) and Multivitamin. Patient was tested with covid prior vaccination. Patient did not receive other vaccine in four weeks of vaccination. Patient has not been tested for covid, post vaccination. On 27Jan2021 09:00AM, the patient experienced large red raised areas on both checks. Patient did not receive treatment for the event. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Peripheral swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 39-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EL9262), via an unspecified route of administration, administered in arm right on 26 Jan 2021,15:00 at single for COVID-19 immunization (at the age of 39 years). Medical history included known allergies of Pollen, cats. The patient's concomitant medications were not reported. No covid prior to vaccination and no covid tested post vaccination. On 26Jan2021, the patient had severe swelling of arm, fever, headaches and flu like symptoms. No treatment given for all events. Outcome for all events was not recovered. No follow up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Injection site pain; headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), on 03Feb2021 at 10:30 (at the age of 46-years-old) at 1st dose, single, administered in right arm, for COVID-19 immunization. Medical history was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had not allergies to medications, food, or other products. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no medications were received within 2 weeks of vaccination. The patient experienced injection site pain and headache on 03Feb2021 at 13:30. The events were reported as non-serious. No treatment was received for the adverse events. The patient had recovered from the events in Feb2021.   Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Nausea; dizziness; tired; This is a spontaneous report from a contactable other HCP (reported for herself). A 37-year-old not pregnant female patient received first dose of BNT162B2 (solution for injection, Lot number: EL3302, Expiry date: unknown) via an unspecified route of administration in left arm on 26Jan2021 03:00 PM, as a first dose, single for Covid-19 immunization. Medical history included Hashimotos Thyroiditis. She had known allergies: Vicodin, Keflex. Concomitant medications in two weeks included levothyroxine sodium (SYNTHROID). On 27Jan2021 12:00 PM, the patient experienced nausea, dizziness and tired. She did not receive treatment for events. She had no other vaccine in four weeks. She did not have covid prior vaccination and was not tested for it post vaccination. On an unknown date, the patient recovered from the events of nausea, dizziness and tired.  Follow-up attempts were completed. No further information was expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleed; This is a spontaneous report from a contactable consumer or other non hcp.     A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261 and expiration date was not reported), via an unspecified route of administration in arm right on 28Jan2021 at 12:10 as single dose for covid-19 immunization. He had already set appointment for second dose. No further details provided. Medical history included diabetes mellitus from Mar2020 and ongoing. The patient's concomitant medications were not reported. The patient experienced nose bleed on 28Jan2021 13:00 with outcome of recovered. Patient just received the Covid-19 vaccine today about 10 minutes after 12. About 1pm today he started to get a nose bleed and it continued bleeding for about 40-50 minutes, but it has subsided and stopped. Thought he should call to inform Pfizer of this. No History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) and no Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. Pertinent Details was none and no Family history. The outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Anger, Delusion, Paranoia, SARS-CoV-2 test
Clinical narrative: delusional; paranoid; intense and sudden unwarranted anger; more easily agitated; This is a spontaneous report from a contactable Non-healthcare Professional reporting for a patient.   An 84-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) administered in left arm via an unknown route of administration, on 13Jan2021 as SINGLE DOSE for covid-19 immunization.  Medical history included cardiac failure congestive (CHF), severe tricuspid valve regurgitation, renal failure. Concomitant medications in two weeks included Apixaban (ELIQUIS), Simvastatin (SIMVASTATIN), Levothyroxine sodium (LEVOTHYROXIN) Atenolol (ATENOLOL), Spironolactone (SPIRONOLACTONE), Losartan (LOSARTAN) Torsemide (TORSEMIDE). On 15Jan2021, the patient was delusional, paranoid, intense and sudden unwarranted anger, more easily agitated. There was no treatment for the events. The outcome of the events was not recovered. It was reported that patient has become delusional and paranoid, intense and sudden unwarranted anger, more easily agitated. The patient underwent lab test Possible exposure to virus before vaccination although tested negative (weekly testing for about 4 weeks prior, every 2 weeks prior to that). The vaccine was administered at nursing Home/Senior Living Facility. No other vaccine was in four weeks. Prior to vaccination, patient has not had covid. It was unknown whether patient was tested for covid post vaccination. The patient had known allergies to Pneumonia Vaccine.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; This is a spontaneous report from a contactable consumer (patient himself).  This 72-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3248 with Expiration Date Apr2021), via an unknown route, on unknown date at single dose for COVID-19 immunisation. No relevant medical history was provided. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140 with Expiration Date Mar2021) administered on 22Dec2020 at 10:58 and developed lymph nodes swollen, sore throat, loss appetite, achy, tired and feel like sleeping all day. No relevant concomitant medications were provided. After second dose he developed injection site pain. He took ibuprofen (MOTRIN) 500. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020511614 same patient/reporter/drug, different dose (first dose)
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: flu-like symptoms; rising temperature during that time from 99.8 to 101; This is a spontaneous report from a contactable consumer. The 70-Year old male consumer reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided) via an unspecified route of administration in left arm on 27Jan2021 11:00 (at the age of 70-year-old) at single dose for COVID-19 immunisation. Relevant medical history included prostate cancer from 2019 (treated) and COVID-19. Concomitant medications included rosuvastatine 5mg and sildenafil citrate 20mg. The patient experienced flu-like symptoms beginning approximately 18 hours after vaccination, and lasting approximately 30 hours, with rising temperature during that time from 99.8 to 101. Onset date for both events was 28Jan2021 05:00. The patient had not tested for COVID post vaccination. The events were non-serious and resolved on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Mild to moderate headache beginning at around 6pm; fatigue; This is a spontaneous report from non-contactable consumer (patient).   A 31-years-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Feb2021 (Batch/Lot Number: EL3247) at the age of 31-year-old, as single dose for covid-19 immunisation.   The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), administered in Arm Left on 20Jan2021 02:00 PM.  Medical history included, asthma from an unknown date and unknown if ongoing. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; salbutamol (VENTOLIN [SALBUTAMOL]) taken for an unspecified indication, start and stop date were not reported.   The patient previously took, ciprofloxacin and experienced drug hypersensitivity.   The patient experienced mild to moderate headache beginning at around 6pm (non-serious) on 10Feb2021 18:00 with outcome of recovering, fatigue (non-serious) on 10Feb2021 18:00 with outcome of recovering.    No follow up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: Severe Chills; Mild nausea; achy muscles; Severe headache; This is a spontaneous report from a contactable consumer. A 40-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 10Feb2021 11:30, at 40 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID after vaccination. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered on 20Jan2021 at 11:30 AM in left arm. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication, start and stop date were not reported. On 10Feb2021 21:15 the patient experienced sever chills, mild nausea, achy muscles and severe headache. No treatment was administered. The reported events were resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Vaccination site pain
Clinical narrative: Soreness in site of injection; Headache; tiredness; mild chills; This is a spontaneous report from a contactable consumer (patient).    A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 09:00 (Batch/Lot number was not reported), age at vaccination of 50-years-old, as single dose for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. The patient was not pregnant and was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. tiredness on 10Feb2021 at 03:00 AM for 10-12 hours, and mild chills on 10Feb2021 at 03:00 AM for 6 hours. No treatments were given for the events.  The patient was not tested for covid prior vaccination nor post vaccination. The patient recovered from the event soreness in site of injection on 11Feb2021 (after 30 hours) and recovered from the events headache and tiredness and mild chills on 11Feb2021 (after 40 hours).  Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: Very bad headache; soreness in neck; This is a spontaneous report from a contactable consumer (patient).   A 65-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm right on 10Feb2021 at 18:30 (Batch/Lot Number: EL9269) as single dose for covid-19 immunisation.  Medical history included 3 joint arthroplasty and methylenetetrahydrofolate reductase deficiency (MTHFR). The patient's concomitant medications were not reported. On 11Feb2021 06:30, patient experienced very bad headache with outcome of not recovered, soreness in neck with outcome of not recovered.    Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Nausea
Clinical narrative: Coughing; nausea; SOB; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient not pregnant, received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in arm right on 10Feb2021 08:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Patient received the first dose of BNT162B2 on 20Jan2021 08.30 AM, intramuscular, administered in arm right. Medical history included asthma, cervix carcinoma in remission, allergy to shellfish.  The patient's concomitant medications included albuterol.  On 11Feb2021 05:00,  patient experienced coughing, nausea, shortness of breath (SOB). Therapeutic measures included continued care with albuterol. Outcome of events was not recovered.    Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 37-year-old female not pregnant patient  A 37-year-old female patient not pregnant, received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), unknown route of administration, administered in arm left on 10Feb2021 10:45 (Batch/Lot number EL3247) (age at vaccination 37 year) as single dose for COVID-19 immunization. Patient received the first dose of BNT162B2 (Batch/Lot number EL3247) on 20Jan2021, unknown route of administration, administered in left arm. Medical history included was not reported.  The patient's concomitant medications were not reported.  On 10Feb2021 11:00 PM,  patient experienced Pain at site of injection, mild muscles aches, mild tiredness. No treatment received. Outcome of events was recovering. No follow-up attempts are needed. Information about Lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Lymphadenopathy, Tongue disorder
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Feb2021 11:45 (Batch/Lot Number: EL3247) at the age of 45-year-old, as single dose for COVID-19 immunisation. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number EL3247) on 20Jan2021. Medical history included food allergy from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norelgestromin (XULANE) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity.  The patient experienced within 6 hours of vaccination my tongue started to hurt (sides and underside) and a few sores developed on right side of my tongue (glossodynia) (non-serious) on 10Feb2021 17:30 with outcome of recovering, my tongue are scalloped in appearance (tongue disorder) (non-serious) on 10Feb2021 17:30 with outcome of recovering , glands in my neck are also sore/inflamed (lymphadenopathy) (non-serious) on 10Feb2021 17:30 with outcome of recovering.
Sex: F
Vaccine: COVID19
Symptoms: Nervousness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported age: 78; Units: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10 Feb 2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On unknown date in 2021 she gets nervous. Patient stated she received the first shot of the Pfizer covid vaccine and her appointment is on 03 Mar 2021, but the card does not tell her what time she needs to be there by. Outcome of the event was unknown. Follow-up attempts are completed; information about lot number/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Nasal congestion, Pain, Pyrexia
Clinical narrative: chills; fever; body aches; cough; congestion; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 05Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date in Feb2021 the patient experienced chills, fever, body aches, cough and congestion, all non serious. The final outcome of the event was unknown.No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: arm pain; headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 10Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date in Feb2021 the patient experienced arm pain and headache, non serious. Patient asked if it was okay to take Tylenol for symptoms such as arm pain and headache and if the same applied for ibuprofen. The final outcome of the event was unknown.No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: arm  soreness; Headache; This is a spontaneous report received from a contactable consumer (patient was a relative of reporter). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in left arm on 10Feb2021 12:30 (at the age of 65-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history was not reported. No COVID prior vaccination was reported. The patient's concomitant medications in two weeks before vaccination included ibuprofen, from unspecified. No other vaccines were administered in four weeks before vaccination. On 10Feb2021 13:30 the patient experienced headache and arm soreness. No treatment for events were received. Patient was not tested for COVID post vaccination. It was unknown if patient recovered. The outcome of the events was unknown.  Information about lot and batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fever of a little over 100 degrees; pain in her arm; tiredness; This is a spontaneous report from a contactable consumer and a contactable other HCP. A female received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #EL3248) via an unspecified route of administration in left arm on 10Feb2021 09:30 (at the age of 39-year-old) at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Relevant medical history included allergy to latex. Concomitant medications were not reported. On 10Feb2021 120:00PM the patient had fever of a little over 100degrees. It was further mentioned that she had fever, pain in her arm, and tiredness. She still had fever at the time of report but was feeling better. The patient did not have COVID prior vaccination and was not tested for COVID after vaccination. No treatment was administered. The events were resolving.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hypopnoea, Vaccination site pain
Clinical narrative: severe pain at injection site; shallow breathing; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: E13302), via an unspecified route of administration, administered in left arm on 10Feb2021 at 10:00 (at the age of 65-years-old) as single dose for COVID-19 immunisation. The facility type vaccine was hospital. The patient did not received other vaccine in four weeks. Medical history included cancer, COPD and penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included clopidogrel bisulfate (PLAVIX), metoprolol, atorvastatin and gabapentin, all taken for an unspecified indication, start and stop date were not reported. On 10Feb2021 the patient experienced severe pain at injection site and shallow breathing. The patient did not receive treatment for events. The outcome of events was not recovered.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pustule, Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9264), via an unspecified route of administration in left arm on 06Feb2021 at 14:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included Hashimoto's disease, hypertension, known allergies: Food allergies (known allergies: Banana, kiwi), known allergies: Histamine reaction. Concomitant medications included levothyroxine, cetirizine hydrochloride (CETRIZINE), ergocalciferol (VITAMIN D), iodine (KELP), metopro; All drugs were received in two weeks within the vaccination. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. It was reported that, the patient experienced itchy rash all over body, 2 days after vaccination small pustules, strange tingles on 08Feb2021 at 16:00. No fever. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with IV fluids and medications. The outcome of the events was recovering.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Swelling, Tenderness, Vaccination site pain
Clinical narrative: Right knee pain; tenderness; swelling; Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), on 26Jan2021 at 12:00 (at the age of 76-years-old) at 1st dose, single administered in left arm for COVID-19 immunisation. Medical history included allergies. The patient was not pregnant. No COVID prior vaccination and no COVID tested post vaccination. Concomitant medications included calcium, tocopherol (MEMORALL), cetirizine, KETO, unspecified (all reported as other medications in two weeks). The patient previously took ampicillin and experienced allergies. No other vaccine received in four weeks. The patient experienced right knee pain, tenderness, swelling, continued. Pain at injection site lasting 24 hours. The events occurred on 30Jan2021 at 8:00. No treatment was received for the events. The patient had recovered from pain at injection site on 31Jan2021 at 08:00, had not recovered from the other events.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: patient developed diffused hives 12 hours after her vaccination/Hives; This is a spontaneous report from a contactable physician. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318 and expiration date was not reported), via an unspecified route of administration on 03Feb2021 as single dose for covid-19 immunization. Medical history included diabetes mellitus and hypertension. Concomitant medication(s) included metformin (METFORMIN); estradiol (ESTRADIOL) and escitalopram oxalate (LEXAPRO). The patient should take the second dose of the Pfizer COVID-19 vaccine considering that her patient developed diffused hives 12 hours after her vaccination on 04Feb2021. She said that she wouldn't categorize it as anaphylaxis. Her reaction lasted until Day 3 after the vaccination. The outcome of event was recovered.   Follow-up (10Feb2021): New Information received from the contactable consumer includes updated events and questions regarding events.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: soreness in the arm; not feeling well; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable female consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (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 soreness in the arm and not feeling well on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms, Neck pain
Clinical narrative: Fatigue; Muscle cramps; Neck is a little sore; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for covid-19 immunization. The patient reported feeling a lot of fatigue again and some muscle cramps and their neck is a little sore on an unspecified date, so they have been isolating a lot. The outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.