chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Malaise
Clinical narrative: Site pain; tiredness; mild headache; muscle pain; chills; fever; not well; swollen lymph nodes; swollen face; aching; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on 08Mar2021 15:00 (at the age of 58-years-old) as unknown, single dose for COVID-19 immunisation. Medical history included COVID-19 (prior to vaccination) and Penicillin allergy; both from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) and vitamins (taken by the patient every day); both taken for an unspecified indication, start and stop dates were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient was not tested for COVID post vaccination. On 09Mar2021 12:00 PM, the patient experienced site pain, tiredness, mild headache, muscle pain, chills, fever, not well, swollen lymph nodes, swollen face and aching. No treatment was taken for the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Swelling face, Vaccination site pain
Clinical narrative: Site pain; tiredness; mild headache; muscle pain; chills; fever; not well; swollen lymph nodes; swollen face; aching; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on 08Mar2021 15:00 (at the age of 58-years-old) as unknown, single dose for COVID-19 immunisation. Medical history included COVID-19 (prior to vaccination) and Penicillin allergy; both from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) and vitamins (taken by the patient every day); both taken for an unspecified indication, start and stop dates were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient was not tested for COVID post vaccination. On 09Mar2021 12:00 PM, the patient experienced site pain, tiredness, mild headache, muscle pain, chills, fever, not well, swollen lymph nodes, swollen face and aching. No treatment was taken for the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Erythema, Hypoaesthesia, Migraine, Palpitations
Clinical narrative: Migraine headache; Face went numb; Hands turned red; Heart raced; This is a spontaneous report from a contactable consumer. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in left arm on 05Mar2021 12:15 (at the age of 45 years old) as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took azithromycin (ZITHROMAX) and, cefdinir (OMNICEF) and experienced allergies. The patient has no COVID history prior vaccination. The patient was not COVID tested post vaccination. On 05Mar2021 12:45, the patient's face went numb, hands turned red, heart raced, and had migraine headache progressively getting worse for four (4) days. The patient had to go to hospital for headache on 4th day, she has got treatment and her headache went away. It was also reported that she woke up on 5th day and her headache came back. The only persistent symptom is headache. The adverse events resulted in Emergency room/department or urgent care visit. The event migraine headache was treated with cocktail IV and CT scan was referred. The patient has not recovered from the event migraine headache, and was recovering from other events.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiration date not reported), via an unspecified route of administration, administered in the left arm on 08Mar2021 12:00 (at the age of 39-years-old), as first dose, single dose for COVID-19 immunisation. Patient had no pertinent medical history and no concomitant medications. The patient was not pregnant at the time of vaccination. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced extreme fatigue on 09Mar2021 05:00. No treatment was received as a result of the event. Patient did not seek consult to physician or urgent care. The outcome of event was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pruritus, Throat irritation
Clinical narrative: Swelling of throat; itching of face, throat and left arm; itching of face, throat and left arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old female patient received bnt162b2 (Lot Number: EN6206), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 16:15 (at the age of 58 years old) as single dose for covid-19 immunization. Medical history included high blood pressure, depression, diabetes, known allergies included Sulfa, codeine, phenergan, latex, mushrooms, ginger, carrots, celery, tomatoes, soy, bell peppers, romaine lettuce, mangoes, all mellons bananas, raw nuts. The patient did not have COVID prior vaccination. The patient did not have any other vaccine in four weeks and did not pregnant at time of vaccination. Concomitant medication in two weeks included Hydrochlorothiazide, Valsartan, Rosuvastatin, liraglutide (SAXENDA). The patient experienced swelling of throat, itching of face, throat and left arm on 05Mar2021 at 16:15. The patient had not been tested for COVID-19 post vaccination. Treatment for events included 50mg of diphenhydramine hydrochloride (BENADRYL); 2 hours later 50mg more of diphenhydramine hydrochloride. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hordeolum
Clinical narrative: Prolonged sore shoulder for at least 23 hours where the vaccine was injected; stye in right eye lid (I don't think it's related though); This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EJ3247; Expiration date was not reported), via an unspecified route of administration on 09Mar2021 10:00 (at the age of 34-years-old) as first dose, single dose for COVID-19 immunisation at a workplace clinic. Medical history included bowel obstruction removal in 2011; and thyroid nodule, cephalosporin allergy which caused itch both from an unknown date and unknown if ongoing. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included vitamin B complex and folic acid (FOLATE); both taken for an unspecified indication, start and stop dates were not reported. On 09Mar2021 10:00 AM, the patient experienced prolonged sore shoulder for at least 23 hours where the vaccine was injected and stye in right eye lid. The patient thought that the stye was not related to the vaccine. No treatment was taken for the event. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: E19266, expiration date not reported), via an unspecified route of administration, administered in the left arm on 16Feb2021 16:15 (at the age of 62-years-old), as first dose, single dose for COVID-19 immunisation. Medical history included shrimp allergy. The patient received an unspecified concomitant medication within two weeks of vaccination. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced blurred vision (reported as for 2 days) on 17Feb2021 13:00. No treatment was received as a result of the event. The outcome of event was recovered on 19Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Migraine, Pain, Vomiting
Clinical narrative: Vomiting; Diarrhea; Body aches; Migraine; felt run down; This is a spontaneous report from a contactable health care professional (patient; other HCP). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on an unspecified date (at the age of 24-years-old) as fist dose, single dose for COVID-19 immunisation. Medical history included chronic migraines from an unknown date and unknown if ongoing. Concomitant medications included topiramate and spironolactone; both taken for an unspecified indication, start and stop dates were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. On 02Mar2021 03:00AM (reported as Early Tuesday morning), the patient experienced vomiting, diarrhea, body aches, migraine and felt run down. No treatment was taken for the events. The outcome of the events was recovering. The patient was vaccinated with the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6206) intramuscularly in the left arm on 06Mar2021 04:45 PM.  No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Felt like crap; Sore throat; Tired; Achy; Nausea; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH CPVID-19 VACCINE; solution for injection; lot number was not provided), via an unspecified route of administration on 01Mar2021 (at the age of 82-years-old) as 2nd dose, single dose for COVID-19 immunization. Medical history included direct exposure to granddaughter who tested positive for COVID-19 in Apr2021. The patient's concomitant medications were not reported. The patient previously received the 1st dose of BNT162B2 (lot number was not provided) on an unspecified date for COVID-19 immunization. In Mar2021 (3-4 days after the vaccination), the patient experienced side effects. She felt like crap, sore throat, tired, achy, and nausea. The patient mentioned that she was fine on the first few days. The patient reported that her granddaughter, who was 10, had tested positive for COVD-19 in Apr2021. The patient has been around her granddaughter who tested positive for COVID-19. The patient wanted to know if she's immune since she has had both doses of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Experiencing some pain in that arm; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 10Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 09Mar2021 (lot number: EM9809) as 1st dose, single dose for COVID-19 immunization. Medical history included diabetes and dental extraction. Concomitant medications included glipizide, metformin, and pioglitazone - all for diabetes. The patient reported that she took BNT162B2 on 09Mar2021 and was experiencing some pain in that arm. The patient mentioned that the doctor told her that she could take some Tylenol, but she doesn't have Tylenol, what she had were some Aleve and Naprosyn - the patient asked if it would affect the vaccine. The patient also asked about concomitant use with dental extraction and diabetic medications metformin, glipizide, and pioglitazone. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little pain where we got the shot; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients (Himself and His Wife) This is the 2nd of 2 reports. This consumer (Husband) reported that a 68-year-old female patient (Wife) received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number; was not reported), via an unspecified route of administration on 21Feb2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). The patient concomitant medications were not reported. The patient experienced a little pain where she got the shot on the next day (22Feb2021), but it was fine. The patient got an appointment reminder for the second dose on 26Mar2021 which was beyond the 3 weeks period. It should be 14Mar2021. The patient inquired about the change in appointment. The patient did not have any adverse events to report. The patient reported that they will try to get it change to the 14Mar2021 but if not then maybe they will have to keep it for the 26Mar2021. The outcome of the event (little pain where we got the shot) 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-2021246838 same reporter, drug, event/different patients
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node under collarbone on left side; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 03Mar2021 at 10:15 (Batch/Lot Number: EL3247) (at the age of 47-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included amlodipine besylate taken for an unspecified indication, start and stop date were not reported. The patient experienced swollen lymph node under collarbone on left side on 07Mar2021 (also reported appeared 4 days post vaccination) and continues through day 7. The patient did not received any treatment for the event. The patient did not have Covid prior to vaccination and had not tested for Covid post vaccination. Outcome of event was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Swollen lymph node under collarbone on left side; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 03Mar2021 at 10:15 (Batch/Lot Number: EL3247) (at the age of 47-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included amlodipine besylate taken for an unspecified indication, start and stop date were not reported. The patient experienced swollen lymph node under collarbone on left side on 07Mar2021 (also reported appeared 4 days post vaccination) and continues through day 7. The patient did not received any treatment for the event. The patient did not have Covid prior to vaccination and had not tested for Covid post vaccination. Outcome of event was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Body temperature, Chills, Headache
Clinical narrative: Body temperature of 101F/Fever almost 101; Headache; Shivering/Chills; Body aches; Joint aches; Stomach aches; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6202), via an unspecified route of administration, administered in the left arm on 24Feb2021 (at the age of 65-years-old) as 1st dose, single dose for COVID-19 immunization. Medical history included blood pressure high. Concomitant medication included irbesartan taken for blood pressure high. In Mar2021 (almost 2 weeks after the vaccination), the patient experienced headache, shivering/chills, body temperature of 101F/fever almost 101, body aches, joint aches, and stomach aches. The patient had taking Tylenol to keep the fever down so it's better. The outcome of the event fever was recovering while the outcome of the remaining events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body temperature of 101F/Fever almost 101; Headache; Shivering/Chills; Body aches; Joint aches; Stomach aches; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6202), via an unspecified route of administration, administered in the left arm on 24Feb2021 (at the age of 65-years-old) as 1st dose, single dose for COVID-19 immunization. Medical history included blood pressure high. Concomitant medication included irbesartan taken for blood pressure high. In Mar2021 (almost 2 weeks after the vaccination), the patient experienced headache, shivering/chills, body temperature of 101F/fever almost 101, body aches, joint aches, and stomach aches. The patient had taking Tylenol to keep the fever down so it's better. The outcome of the event fever was recovering while the outcome of the remaining events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little bit of a sore arm; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), dose 1 via an unspecified route of administration on 09Mar2021 14:00 as single dose for covid-19 immunization. The patient's medical history included one glass of wine before he ate dinner and concomitant medications were not reported. The patient stated that his only side effect experienced was a "little bit of a sore arm" but stated feeling fine otherwise. He stated that he exercises regularly and would like to know if it's okay for him to resume exercising following the vaccine. He also stated that he normally had one glass of wine before he ate dinner and would like to know if it is okay to do so following the vaccine. He stated he already asked the pharmacist who gave him his vaccine and was told it was okay. The outcome of event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: her lymph nodes on her clavicle swelled; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration, administered in right upper arm on 26Feb2021 (also reported as 27Feb2021) 12:00 (at the age of 48 years old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No prior vaccinations within 4 weeks. On 04Mar2021 (reported as in the morning, like 9:00 AM), the patient experienced her lymph nodes on her clavicle swelled. It was reported that she received the first dose of Pfizer COVID vaccine on 27Feb2021 (also reported as 26Feb2021) on Saturday then 5 days later, her lymph nodes on her clavicle swelled and they were still currently swollen on 10Mar2021. Patient was wondering if she should get the second dose. She has a question due to having a reaction 5 days after the vaccine. Stated that her lymph nodes in her clavicle swelled, three of them swelled. One was the size of quarter and the other two were the size of a nickel. She was supposed to get the second shot in 20Mar2021. She was wondering if she should have concern regarding getting the second shot due to event that occurred. No history of all previous immunizations with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer suspect. The AEs did not require a visit to the emergency room and physician office. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm; shakes; body aches; fever; chills; headaches; This is a spontaneous report from a contactable consumer (patient).   A 38-year-old female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received the first dose on Thursday (as reported) experienced sore arm but then developed shakes, body aches fever chills and headaches. These symptoms were worst on Monday (as reported). The patient is asking how long do symptoms usually last. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: sore arm; shakes; body aches; fever; chills; headaches; This is a spontaneous report from a contactable consumer (patient).   A 38-year-old female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received the first dose on Thursday (as reported) experienced sore arm but then developed shakes, body aches fever chills and headaches. These symptoms were worst on Monday (as reported). The patient is asking how long do symptoms usually last. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Eczema, Erythema, Pruritus, Psoriasis
Clinical narrative: red and sometimes burns.; rashes that look like eczema or psoriasis around the trunk of my body; red and sometimes burns.; itching in other places; rashes that look like eczema or psoriasis around the trunk of my body; rashes that look like eczema or psoriasis around the trunk of my body; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient 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 28Feb2021 at 15:00 (at the age of 71 years old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs.  There were no concomitant medications. The patient previously took BNT162B2, at left arm on 07Feb2021 at 15:00, as 1st dose, for COVID-19 immunisation; and, codeine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. On 05Mar2021 at 13:15, starting a week after the injection, it was reported that the patient began getting rashes that look like eczema or psoriasis around the trunk of her body. For 2 days, the patient also had itching in other places that did not have patches particularly on her head. The patient took diphenhydramine (BENADRYL) for 3 days, and the itching seems to have subsided and the patches may be improving. No new foods or detergent. The patient underwent laboratory test and procedures for nasal swab on 04Mar2021 and 11Mar2021 and showed negative. The outcome of the event itching was recovering, while for the remaining events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Smear test
Clinical narrative: red and sometimes burns.; rashes that look like eczema or psoriasis around the trunk of my body; red and sometimes burns.; itching in other places; rashes that look like eczema or psoriasis around the trunk of my body; rashes that look like eczema or psoriasis around the trunk of my body; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient 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 28Feb2021 at 15:00 (at the age of 71 years old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs.  There were no concomitant medications. The patient previously took BNT162B2, at left arm on 07Feb2021 at 15:00, as 1st dose, for COVID-19 immunisation; and, codeine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. On 05Mar2021 at 13:15, starting a week after the injection, it was reported that the patient began getting rashes that look like eczema or psoriasis around the trunk of her body. For 2 days, the patient also had itching in other places that did not have patches particularly on her head. The patient took diphenhydramine (BENADRYL) for 3 days, and the itching seems to have subsided and the patches may be improving. No new foods or detergent. The patient underwent laboratory test and procedures for nasal swab on 04Mar2021 and 11Mar2021 and showed negative. The outcome of the event itching was recovering, while for the remaining events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain in extremity, Rash
Clinical narrative: noticed a rash yesterday that started on both arms and has been creeping up on her neck and face; light headed; sore arm; slight headache; physically exhausted; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 05Mar2021 11:30 (Batch/Lot Number: EN6200) (at the age of 30-years-old) as first dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included fluticasone propionate (FLONASE ALLERGY RELIEF); levocetirizine dihydrochloride (XYZAL); fluvoxamine maleate and valaciclovir (VALACYCLOVIR); all taken for an unspecified indication, start and stop date were not reported.  After the first dose, patient stated she went to Urgent Care this morning because she noticed a rash on 06Mar2021 that started on both arms and has been creeping up on her neck and face. Patient stated while at Urgent Care she received a steroid shot. Patient stated on Monday she went running in the same area she always has and she has not used any new products other than the Covid vaccine she received. Patient stated she had a telehealth visit with her primary care doctor yesterday and they instructed her to take Allegra. Patient would like to know if she should receive the second dose of the vaccine. Patient also reported sore arm, light headed, physically exhausted and slight headache on 06Mar2021. The events required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the events was recovering. The patient did not have Covid prior to vaccination and had not test for Covid post vaccination.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue
Clinical narrative: Strong taste of metal in her mouth; Tiredness; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6205), via an unspecified route of administration, administered in the left arm on 07Mar2021 14:45 (at the age of 70-years-old) as 1st dose, single dose for COVID-19 immunization. Medical history included mitral valve prolapse with regurgitation and contrast dye allergy. The patient was not pregnant at the time of vaccination. The patient had no COVID prior to the vaccination. Concomitant medications included fish oil, alendronate sodium (FOSAMAX), colecalciferol (VIT D3), and an unspecified multivitamin. The patient previously took naproxen and experienced allergy. The patient did not receive any other vaccines within four weeks of the COVID-19 vaccination. On 07Mar2021 15:45, the patient had a strong taste of metal in her mouth. The patient called the pharmacy where she got the shot and the patient was told to take a Benadryl, which she did. The taste went away in about 45 minutes. The patient also experienced tiredness on the same day. The patient was not tested for COVID post vaccination. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Fatigue, Feeling abnormal, Feeling of body temperature change
Clinical narrative: Metal taste in mouth; dizzy; headache; nausea; hot / cold; brain fog; exhausted feeling; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the first dose of BNT162B2 (Lot number was not reported), via an unspecified route of administration, administered in left arm on 10Mar2021 09:45 (at the age of 38-year-old) as single dose for COVID-19 immunization. The patient is not pregnant. Medical history included ADHD, psoriasis, multiple joint arthritis and allergies. The patient's concomitant medications were not reported. On 10Mar2021 at 11:15 AM, the patient experienced metal taste in mouth, dizzy, headache, nausea, hot / cold, brain fog, and exhausted feeling. It was unknown if there are treatment received for the events. No Covid prior vaccination. Covid not tested post vaccination. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Metal taste in mouth; dizzy; headache; nausea; hot / cold; brain fog; exhausted feeling; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the first dose of BNT162B2 (Lot number was not reported), via an unspecified route of administration, administered in left arm on 10Mar2021 09:45 (at the age of 38-year-old) as single dose for COVID-19 immunization. The patient is not pregnant. Medical history included ADHD, psoriasis, multiple joint arthritis and allergies. The patient's concomitant medications were not reported. On 10Mar2021 at 11:15 AM, the patient experienced metal taste in mouth, dizzy, headache, nausea, hot / cold, brain fog, and exhausted feeling. It was unknown if there are treatment received for the events. No Covid prior vaccination. Covid not tested post vaccination. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 08Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced injection site pain on an unspecified date but did not bother to report as she thought it "wasn't worth reporting". She is scheduled for her second dose on 25Mar2021 (17 days after dose 1) and the patient was asking if this would be valid. The outcome of the event was unknown.    No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: mild allergic reaction from the vaccine; This is a spontaneous report from a contactable consumer (patient).   A 54-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient is asking if it is okay to take Benadryl, she's having a mild allergic reaction from the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: En6205), via an unspecified route of administration, administered in left arm on an unspecified date (at the age of 39-year-old) as single dose for COVID-19 immunization. The patient is not pregnant. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. No Covid prior vaccination. Not tested with Coved post vaccination. The patient experienced sore arm on 04Mar2021 20:00. No treatment for the event. The outcome of the event was unknown.    No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient (non-pregnant at the time of the vaccination) received first dose of bnt162b2 (BNT162B2; Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 09Mar2021 18:30 (at the age of 43-years) as single dose for COVID-19 immunisation. The patient was vaccinated at a public health clinic/veterans administration facility. Medical history included mitral valve prolapse (MVP) and multiple sclerosis. Concomitant medications included ibuprofen; metoprolol; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); and celecoxib (CELEXA). There were no other vaccines in four weeks. The patient had previously known allergies to cefprozil (CEFZIL). The patient experienced soreness at injection site on 09Mar2021 21:00 with outcome of recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: experienced headache; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on 01Mar2021, as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date in Mar2021. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site erythema, SARS-CoV-2 test
Clinical narrative: big red shot below area of needle; the red are begin healing and turn dark; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 27Feb2021 (Batch/Lot Number: En6203) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation then from 23Feb2021 started cancer treatment with carboplatin (manufacturer unknown) intravenous at 50 mg; dexamethasone, diphenhydramine hydrochloride (BENADRYL), famotidine, ondansetron hydrochloride (ZOFRAN) all route of administration and dose were not reported; taxol via an unspecified route of administration at 100 mg. Medical history included asthma, chronic obstructive pulmonary disease (COPD), lung cancer, hypothyroidism, irritable bowel syndrome (IBS), allergies to penicillin, sulfa, and latex. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included pembrolizumab (KEYTRUDA) from 09Feb2021. The patient previously took the first dose of bnt162b2 (Lot number: El9261) in the left arm on 06Feb2021 for COVID-19 immunisation then erythromycin and aspirin [acetylsalicylic acid] and experienced allergies to both. On 23Feb2021, as a cancer patient, the patient started the chemo after the first vaccine. On 27Feb2021, the patient received the second vaccine in the right arm with no side effect. Until 2/4 two days after second chemotherapy treatment, the patient had big red shot below area of needle. This red are begin healing and turn dark. On 09Mar2021, the patient took the third chemotherapy treatment and the same area around previous area that had turn dark got red again and expanded. These events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient underwent lab tests and procedures which included nasal swab COVID test was negative on 05Mar202. The action taken in response to the events for carboplatin, dexamethasone, diphenhydramine hydrochloride, famotidine, ondansetron hydrochloride, and taxol was unknown. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Spots in vision; This is a spontaneous report from a non-contactable consumer (patient). An elderly female patient of unspecified age received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 10Mar2021 08:30 (at an unspecified age) at 2nd dose, single dose for COVID-19 immunisation. Medical history included neurological conditions associated with neck/back, and the patient was getting physical therapy for this. It was unknown if patient has known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included methylphenidate hydrochloride (RITALIN), meloxicam, hydroxychloroquine sulfate (PLAQUENIL), and calcium (reported as calcium supplements). Historical vaccination included first dose of BNT162B2 (lot number: unknown) received on an unspecified date for COVID-19 immunisation. On 10Mar2021 14:30, the patient experienced spots in vision. The patient received no treatment for the event. The patient had no COVID prior vaccination, has not tested for COVID post vaccination, and had no other vaccines in four weeks. The patient was vaccinated in a school or student health clinic. Outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pleurisy, X-ray
Clinical narrative: pleurisy; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 08Mar2021 12:45 (Batch/Lot Number: EN6199) at the age of 62 years old as 1st dose, single dose for COVID-19 immunisation. Medical history included high cholesterol and Ulcerative Colitis that has been in remission for 11 years (not taking any medications). The patient had allergies to penicillin and "GOLIGHTLY." The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (medications the patient received within 2 weeks of vaccination) included estradiol, lovastatin, plecanatide (TRULANCE) and abaloparatide (TYMLOS), all taken for unspecified indications, start and stop dates were not reported. The patient received the first dose of Pfizer-BioNTech COVID-19 Vaccine on 08Mar2021 (Monday) at 12:45. The next day (on 09Mar2021) at 23:45 (11:45 PM), she went to urgent care and was diagnosed with pleurisy and the X-ray results showed "biapical pleural thickening." She wanted to know if this has been reported before. 1000 mg TYLENOL or ibuprofen beforehand (as reported). She is trying to figure out if this event was actually a side effect from Pfizer-BioNTech COVID-19 Vaccine or coincidence. It would be very odd because they have not seen this event, did not know of anyone else who reported that with the Pfizer-BioNTech COVID-19 Vaccine but she wanted to ask Pfizer directly because they know more about the product than the urgent care would. The Urgent care doctor told her to take ADVIL before the test and now her doctor says take TYLENOL 1000 mg, curious if anyone with Pfizer could provide information about this recommendation and event. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the diagnosis of pleurisy was COVID 19 vaccination related. Adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received included IV anti-inflammatory and IV fluids and aspirin. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance
Clinical narrative: Dizziness; I could hardly walk; This is a spontaneous report received from a contactable consumer (Patient, reported for self).   A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198; Expiration date: UNKNOWN), via an unspecified route of administration in Left arm, on an unknown date in Mar2021 as a single dose for COVID-19 immunization. The patient medical history included Atrial fibrillation from an unspecified date and unknown if ongoing. Patient concomitant medications included Atenolol at an unspecified dose from an unspecified date and unknown if ongoing.  The consumer (patient) stated, he was fine he felt a little dizziness right after he got his first injection (Tuesday morning around 11 O clock), it wasnt anything serious. So then patient felt good that night, he felt good on Wednesday, felt good on Thursday went of a walk and then last night (as reported) patient started feeling kind of dizzy and this was like four days into the injection and then this morning (as reported), patient got up and he could hardly walk, he was so dizzy. Patient stated that he was wondering if that was it doesn't sound like it's a common side effect, would that be common side effect, possible side effects of the injection, first injection. No Investigation Assessment reported. The patient has not taken any treatment, he just took an aspirin today (as reported) and been drinking a lot of water. The events, dizziness and could hardly walk were non-serious. Out-come of the events were unknown.  No follow up attempts are possible. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain, Vomiting
Clinical narrative: Diarrhea; Chills; Vomiting; Pain/Ache; This is a spontaneous report from a contactable consumer (the patient).  A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Mar 2021 (on Friday as reported) as unknown,0.3ml single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date,the patient experienced diarrhea, chills, vomiting , pain, ache. The patient stated that he got some pretty bad symptoms.Consumer stated that he did not get it from the hospital.No Lab work was done.Therapeutic measures were taken as a result of diarrhea and included treatment with Imodium. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained