chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: large red swollen area at injection site, hot to touch, painful; large red swollen area at injection site, hot to touch, painful; large red swollen area at injection site, hot to touch, painful; large red swollen area at injection site, hot to touch, painful; Bodyaches; This is a spontaneous report from a contactable nurse (patient). A 47-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9261), via an unspecified route of administration (at the age of 47-year-old), administered in left arm on 21Jan2021 at 12:45 PM at a single dose (1ST DOSE, SINGLE) for covid-19 immunisation. Not pregnant at the time of vaccination. Medical history included Thyroiditis, Migraine, Headaches and SVT (supraventricular tachycardia). Patient allergic to Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID) and topiramate (TOPAMAX) received within 2 weeks. Patient was not diagnosed with COVID-19, prior to vaccination. No any other vaccines taken within 4 weeks prior to the COVID vaccine. The patient experienced large red swollen area at injection site, hot to touch, painful, Bodyaches on 22Jan2021. Patient been not tested for COVID-19, since the vaccination. No treatment was received for the events. The most recent COVID-19 vaccine was administered in hospital. Seriousness reported as non-serious. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eye irritation, Fatigue, Headache
Clinical narrative: Swollen lymph nodes; fatigue; headache; chills; burning sensation of eyes; joint pain; This is a spontaneous report received from a contactable consumer (patient). A 70-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262), via intramuscular, administered in right arm on 30Jan2021 at 15:00, (at the age of 70 -years) as 1st dose, for COVID-19 immunization. Patient's medical history included fibromyalgia, rheumatoid arthritis, ulcers, vertigo, osteoporosis, and hepatitis C. Patient's concomitant medications were not reported. Patient had allergy to penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not tested for COVID-19, since the vaccination. On 31Jan2021 at 18:00, the patient experienced swollen lymph nodes, fatigue, headache, chills, burning sensation of eyes, and joint pain. Patient did not receive any treatment for the events. The outcome of events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; fatigue; headache; chills; burning sensation of eyes; joint pain; This is a spontaneous report received from a contactable consumer (patient). A 70-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262), via intramuscular, administered in right arm on 30Jan2021 at 15:00, (at the age of 70 -years) as 1st dose, for COVID-19 immunization. Patient's medical history included fibromyalgia, rheumatoid arthritis, ulcers, vertigo, osteoporosis, and hepatitis C. Patient's concomitant medications were not reported. Patient had allergy to penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not tested for COVID-19, since the vaccination. On 31Jan2021 at 18:00, the patient experienced swollen lymph nodes, fatigue, headache, chills, burning sensation of eyes, and joint pain. Patient did not receive any treatment for the events. The outcome of events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vomiting
Clinical narrative: I was extra tired; I was woken up and violently throwing up; This is a spontaneous report from a contactable other HCP (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 intramuscular, administered in arm left on 15Jan2021 at 12:00 as 1st dose, single for COVID-19 immunization. Medical history included allergic to sulfa. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient's concomitant medication included sertraline 10 mg received within 2 weeks of COVID vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not undergo COVID test post vaccination. On 15Jan2021, the patient was vaccinated at noon and was fine the rest of the day into 16Jan2021. On 16Jan2021, late night/17Jan2021 early morning at 01:00 approximately, the patient woken up and violently throwing up. It lasted about 20 minutes and then it was over. The next day, the patient was extra tired. The patient did not receive any treatment for the events. The reporter assessed the events as non-serious. The outcome of the events was recovered.  Information on 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Headache, Malaise
Clinical narrative: Approximately 24 hours after the first vaccine was given, experienced severe abdominal pains; Diarrhea; Nausea; Headache; General malaise; Several hours later, severe chills; injection site was tender to the touch; This is a spontaneous report from a contactable other hcp.   A 63-year-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL1283 and Expiration date was not provided), intramuscular, administered in Arm Left on 27Jan2021 09:30 (age at vaccination 63-year-old) as 1st dose, single for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Medical history included diabetic. Patient's had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. 28Jan2021 09:45 the patient experienced approximately 24 hours after the first vaccine was given, experienced severe abdominal pain, diarrhea, nausea, headache did not subside until 24 hours later, general malaise, several hours later, severe chills which lasted nearly 3 hours. The injection site was neither red nor swollen. The injection site was tender to the touch. Prior to vaccination, the patient was not diagnosed with COVID-19 since the vaccination, the patient been not tested for COVID-1. Treatment received by the patient for adverse event was unknown. The case was non serious. The outcome of event was recovered on an unspecified date 2021.  Follow-up attempts are completed. No further information is expected
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Approximately 24 hours after the first vaccine was given, experienced severe abdominal pains; Diarrhea; Nausea; Headache; General malaise; Several hours later, severe chills; injection site was tender to the touch; This is a spontaneous report from a contactable other hcp.   A 63-year-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL1283 and Expiration date was not provided), intramuscular, administered in Arm Left on 27Jan2021 09:30 (age at vaccination 63-year-old) as 1st dose, single for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Medical history included diabetic. Patient's had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. 28Jan2021 09:45 the patient experienced approximately 24 hours after the first vaccine was given, experienced severe abdominal pain, diarrhea, nausea, headache did not subside until 24 hours later, general malaise, several hours later, severe chills which lasted nearly 3 hours. The injection site was neither red nor swollen. The injection site was tender to the touch. Prior to vaccination, the patient was not diagnosed with COVID-19 since the vaccination, the patient been not tested for COVID-1. Treatment received by the patient for adverse event was unknown. The case was non serious. The outcome of event was recovered on an unspecified date 2021.  Follow-up attempts are completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Skin swelling, Tenderness
Clinical narrative: arm is still very red, puffy, tender and swollen; arm is still very red, puffy, tender and swollen; arm is still very red, puffy, tender and swollen; arm is still very red, puffy, tender and swollen; This is a spontaneous report from a Pfizer-Sponsored Program Pfizer First Connect. An unknown age of female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: not reported) via unspecified route of administration on Jan2021 as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. Patient got her Covid vaccine on Tuesday and she had several side effects that went away, but on Jan2021 her arm was still very red, puffy, tender and swollen and she wants to know if that was normal or not. Patient provided PMI number and cold transferred to PSCC for AE, due to wait times, since patient had numerous side effects after getting the Covid vaccine. The outcome of the events was not recovered.  The information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Clumsiness, Discomfort, Feeling abnormal, Feeling drunk, Vision blurred
Clinical narrative: Within 40 minutes of injection, felt dazed and intoxicated as if on painkillers; Within 40 minutes of injection, felt dazed and intoxicated as if on painkillers; Vision blurred; Body grew heavy feeling; Cclumsiness of movement; This is a spontaneous report received from a contactable Other Health Care Professional. A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number; EL9262 and Expiration Date was not reported) via an unspeci-fied route of administration in Arm Left on 21Jan2021 15:00, as 1st dose, single for COVID-19 immunization. Medical history included hypothyroidism, diverticulum, asthma all from an unknown date and unknown if ongoing. Concomitant medication(s) included liothyronine sodium (CYTO-MEL); levothyroxine sodium (SYNTHROID); ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN LO) all taken for an unspecified indication, start and stop date were not reported.  Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Within 40 minutes of injection, felt dazed and intoxicated as if on painkillers, vision blurred, body grew heavy feeling, clumsiness of movement. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bursitis, Chills, Fatigue
Clinical narrative: Vaccination site pain left deltoid; joint pain, especially right shoulder joint where I have bursitis; joint pain, especially right shoulder joint where I have bursitis; fatigue; chills (freezing my ass off); a little headache; back pain; I also felt like I had smoked some good weed; This is a spontaneous report from a contactable Other HCP (reported for herself). A 68-year-old non-pregnant female received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN5318 and expiry date was not provided) via an unspecified route of administration in the left arm deltoid, on 29Jan2021 at 08:45 (at the age of 68-years-old) as a single dose for covid-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Medical history included anxiety, depression and allergies to sulfa drugs. Concomitant medications included aciclovir sodium (ACYCLOVIR), venlafaxine (VENLAFAXINE ER), bupropion and levocetirizine dihydrochloride (XYZAL). Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 29Jan2021 at 09:15, patient experienced vaccination site pain left deltoid, joint pain, especially right shoulder joint where have bursitis, fatigue, chills (freezing my ass off), a little headache, back pain and felt like had smoked some good weed. Everything was brighter and sharper especially the trees. No treatment was received. The outcome of all events was resolved.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Vaccination site pain
Clinical narrative: Vaccination site pain left deltoid; joint pain, especially right shoulder joint where I have bursitis; joint pain, especially right shoulder joint where I have bursitis; fatigue; chills (freezing my ass off); a little headache; back pain; I also felt like I had smoked some good weed; This is a spontaneous report from a contactable Other HCP (reported for herself). A 68-year-old non-pregnant female received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN5318 and expiry date was not provided) via an unspecified route of administration in the left arm deltoid, on 29Jan2021 at 08:45 (at the age of 68-years-old) as a single dose for covid-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Medical history included anxiety, depression and allergies to sulfa drugs. Concomitant medications included aciclovir sodium (ACYCLOVIR), venlafaxine (VENLAFAXINE ER), bupropion and levocetirizine dihydrochloride (XYZAL). Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 29Jan2021 at 09:15, patient experienced vaccination site pain left deltoid, joint pain, especially right shoulder joint where have bursitis, fatigue, chills (freezing my ass off), a little headache, back pain and felt like had smoked some good weed. Everything was brighter and sharper especially the trees. No treatment was received. The outcome of all events was resolved.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: slight sore on the arm; This is a spontaneous report from a contactable consumer (parent). A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 28Jan2021 as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 29Jan2021, the patient experienced slight sore on the arm after vaccinated on 28Jan2021. The outcome of the event was 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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hangover, Head discomfort, Pain in extremity
Clinical narrative: she felt pressure between eyes; dizzy; Her arm hurt more the 2nd day after 1st dose; hangover feeling; This is a spontaneous report received from a contactable consumer (patient).  A female patient of an unspecified age received the first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL1284 and expiry date: on an unspecified date in Apr2021) via an unspecified route of administration on an unspecified date as 1st dose single for covid-19 immunisation. Patient medical history and concomitant medications were not reported. On 1st day of the vaccination, the patient felt pressure between eyes and was slightly dizzy and hangover feeling for 5 minutes but then went away and felt fine. Her arm hurt more the 2nd day after 1st dose. 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.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity
Clinical narrative: She noted her arm was more sore than the first time; She noted her arm was more sore than the first time; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL9261 and expiry date: May2021) via an unspecified route of administration on 28Jan2021 (yesterday) as single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL1284 and expiry date: Apr2021) and felt pressure between eyes, was slightly dizzy, had hangover feeling, and arm was hurt. About 10 hours later, patient's arm was sorer than the first time. She was feeling fine today Events were recovering.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: felt sore in her arm; This is spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as 1st dose, single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. Reported that the patient had her first dose recently and felt sore in her arm for a little while but was fine.  No other adverse event was reported. The clinical outcome of the event was recovering.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiry date: unknown) via an unspecified route of administration on 28Jan2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced urinary tract infection. On the next day after vaccination, the patient got a call from the doctor that she had a urinary tract infection. They want to put her on ciprofloxacin. The outcome of the event was unknown.  Follow-up attempts are completed. No further information was expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain in extremity, Pyrexia
Clinical narrative: Headache; Fever of 99.6; Arm soreness began 2 hours after injection; This is a spontaneous report from a contactable consumer (patient). A 22-years-old non-pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3248 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Left Arm on 01Feb2021 14:00 as 2nd dose, single for COVID-19 immunization at workplace clinic. Historical vaccination included BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3248 and Expiry date: Unknown), via an unspecified route of administration, administered in left arm on 13Jan2021 05:45 1ST dose, single for COVID-19 immunization. The patient medical history was not reported. The patient received Birth control pill within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior vaccination. The patient had no covid prior vaccination, no covid tested post vaccination, and no known allergies. On 01Feb2021, after 2hours of vaccination (at 16:00) patient experienced arm soreness and after 8 hours, she had headache (at 22:00) lasted about 24 hours and fever of 99.6 lasted about 6 hours. The patient underwent lab tests and procedures which included body temperature: 99.6 on 01Feb2021. No treatment received. It was reported that events are non-serious. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Continuously headaches - something like poking inside my head; This is a spontaneous report from a contactable 45-year-old male Other health professional reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK9231, and Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 12Jan2021 (at the age of 45-year-old) as single dose for COVID-19 immunization. The patient medical history included raw shrimp allergy. No other medical history was reported. The concomitant medications for patient were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EJ1685, and Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 23Dec2020 at 03:30 PM as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. On 12Jan2021 at 14:00, the patient had an event described as "continuously headaches - something like poking inside my head". The patient had emergency room visit and physician office visit. The patient received unspecified pain medications as treatment. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: developed a very small cold sore on my lip/developed Another cold sore; This is a spontaneous report from a contactable 43-year-old female other health professional (patient). A 43-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an intramuscular route on 14Jan2021 at 16:30 (at the age of 43-years-old) as a single dose in the left arm for covid-19 immunisation. The patient's medical history included asthma and of HSV-1 (extremely rare-once every 2-3 years). The patient had allergies to eggs, different varieties of fish. The patient concomitant medications included levocetirizine dihydrochloride (XYZAL), Ibuprofen, Tramadol. On 21Jan2021 (6 days after vaccination), the patient developed a very small cold sore on her lip that did went away quickly and was completely healed within 3-4 days. After 4 days that she developed another cold sore, this time larger that she still currently had and patient due for the 2nd vaccine the next day. Patient concerned as this was not normal for her and wanted to know the vaccine lowered immunity where it would cause this kind of response and would the 2nd vaccine make this worse. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for the events. The events were assessed as non-serious. The patient was not recovered from the events.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Headache; fever; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer(patient). A 28-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: unknown and Expiration Date: unknown) via an unspecified route of administration in right arm on 28Jan2021 at 01:30 PM as 1ST DOSE, SINGLE for Covid-19 immunisation. Medical history included lupus, allergies to medications, food, or other products included benadryl. Concomitant medications were not reported. Facility was workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to patient was not diagnosed with COVID-19, while since vaccination the patient was tested for Covid-19; On 31Jan2021 at 08:00 AM, the patient experienced headache, fever, chills, nausea and vomiting. The adverse events resulted in visit of emergency room/department or urgent care. The lab test and procedures included nasal swab as a results of negative on 06Nov2020. Therapeutic measures were taken as a result of headache, fever, chills, nausea and vomiting with zofran. The outcome of events was recovering. The events were reported as non serious.  Follow-up attempts have been completed and information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache; fever; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer(patient). A 28-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: unknown and Expiration Date: unknown) via an unspecified route of administration in right arm on 28Jan2021 at 01:30 PM as 1ST DOSE, SINGLE for Covid-19 immunisation. Medical history included lupus, allergies to medications, food, or other products included benadryl. Concomitant medications were not reported. Facility was workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to patient was not diagnosed with COVID-19, while since vaccination the patient was tested for Covid-19; On 31Jan2021 at 08:00 AM, the patient experienced headache, fever, chills, nausea and vomiting. The adverse events resulted in visit of emergency room/department or urgent care. The lab test and procedures included nasal swab as a results of negative on 06Nov2020. Therapeutic measures were taken as a result of headache, fever, chills, nausea and vomiting with zofran. The outcome of events was recovering. The events were reported as non serious.  Follow-up attempts have been completed and information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Rash, Rash erythematous
Clinical narrative: Red rash on her face; It was a red rash on her face, upper body, and her two upper extremities. It was the whole arm down to wrist. The rash goes down to lower abdomen; This is a spontaneous report from a Contactable Nurse (patient, self-reported). This 72-year-old female nurse patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL1283 and expiry date: 30Apr2021), via an unspecified route of administration, in left upper arm, on 11Jan2021, as a single dose for COVID-19 immunization at vaccination facility. Time the vaccination was given between 11:15AM and 11:30AM. The patient's medical history included penicillin allergy (she had not done nothing out of the ordinary, no introduction of new foods into diet, she took vitamins and supplements. She had a rash. She was diagnosed with Penicillin allergy a long time ago. She didn't have NDC, lot, and expiry for Penicillin that she was allergic to. She assumes Penicillin was different. She didn't know if it was something in Penicillin or if it was the Penicillin it-self she is allergic to). Historical vaccine included Shingrix and Flu vaccine and had normal side effects. Concomitant medication included trazodone (she has taken trazadone for years). The patient reported that she received first dose on 11Jan2021. On 14Jan2021, she developed a rash, and she was not sure if it would be considered severe or moderate on the third day after vaccine. It was a red rash on her face, upper body, and her two upper extremities. It was the whole arm down to wrist. The rash goes down to lower abdomen. The rash started very close to 72 hours after vaccine. It could have been around 12 pm on 14Jan2021. She took Benadryl and within a couple of hours the rash was gone. She had no other symptoms like shortness of breath. She was due for second dose this coming Monday. She was concerned whether the second dose will produce the same delayed symptoms or more severe symptoms. She was afraid of anaphylactic reaction. She was just under 5 foot 3 inches. The event did not require a visit to emergency room and physician office. The seriousness criteria included that she would say not serious because it didn't affect her respiratory or blood pressure. The reason she was calling was because after reading the brochure that came with the vaccine a bad rash all over the body was one of the side effects listed under severe allergic reaction. That stood out and asked was the rash she described considered severe or moderate. Outcome of the events was recovered on 14Jan2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she had a very sore arm; This is a spontaneous report from contactable pharmacist (patient). This female pharmacist reported that: A female patient of unspecified age received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications were not reported. The clinical Pharmacist (patient) stated that she had a very sore arm for several days since an unspecified date after receiving the first dose of Pfizer COVID 19 vaccine. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Urinary incontinence
Clinical narrative: urinary incontinence; coughing; This is a spontaneous report from a contactable consumer or other non hcp. This report was received via a sales representative.  A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiry date was not reported), dose 1 via an unspecified route of administration on 25Jan2021, single dose for covid-19 immunisation. Medical history included tobacco user from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On Thursday 28Jan2021 late evening patient began new onset constant coughing-"profusely" which led to urinary incontinence. Cough got improved and patient does not have a prior history of persistent cough. The outcome the event cough was recovering on unspecified date of 2021. The outcome the event urinary incontinence was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Within a few hours she began to experience slight muscle pain; She also suffered from extreme chills; she continued to have some muscle pain and a headache; This is a spontaneous report from a Non-Contactable consumer. This (age: 32; unit: unknown) female consumer reported. A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 27Jan2021 (Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On27Jan2021, the patient experienced, she received the second dose of the vaccine on Wednesday. Within a few hours she began to experience slight muscle pain, but within a few hours the pain became very acute. She also suffered from extreme chills. The next day Thursday, 28Jan2021, she continued to have some muscle pain and a headache. On 29Jan2021, the outcome of event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: weird taste in my mouth like metal; This is a spontaneous report from a contactable other hcp (patient herself). A 45-year-old-female patient (non-pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EM9810, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 03Feb2021 15:45 (at the age of 45-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included food allergy (Soup), allergy to arthropod sting (wasps), drug hypersensitivity (medication). Concomitant medications were not reported. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Feb2021 06:00 PM the patient experienced, having a weird taste in my mouth like metal. The outcome of the event was reported as unknown.   Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: El9272, Expiration Date: not reported) via an unspecified route of administration in left arm on 27Jan2021 09:00 as 1st dose, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Facility where the most recent COVID-19 vaccine was administered was other. Medical history included dust allergy, mycotic allergy, allergy to animal, asthma, hysterectomy and hernia. Concomitant medications (within 2 weeks of vaccination) included zolpidem tartrate (AMBIEN); ropinirole; atorvastatin and solifenacin. The patient experienced diarrhea on 27Jan2021 at 12:00 AM. Treatment was not received for the adverse event. The event was recovered on an unspecified date.
Sex: M
Vaccine: COVID19
Symptoms: Rash maculo-papular
Clinical narrative: maculopapular rash; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This Pharmacist (patient's wife) reported for a 43-year-old male patient (husband) who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 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's medical history and concomitant medications were not reported. On an unknown date, a day after receiving the second dose of COVID-19 vaccine, the patient had maculopapular rash. The outcome of the event was reported as unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cold sweat
Clinical narrative: Shivering; cold sweat; This is a spontaneous report from a contactable pharmacist (Patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after the vaccination, the patient experienced shivering and cold sweat. The seriousness of the events was reported as non-serious. The clinical outcome of the events was unknown.  No follow-up attempts are possible; No further information expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Disturbance in attention, Headache, Neck pain, Pyrexia
Clinical narrative: having a heavy headache continuously...include when I sleep/continuous and severe headache; having problems concentrating on my job, read, work on the computer; Neck and back pain; Neck and back pain; Fever; This is a spontaneous report from a contactable other hcp (patient).   A 64-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW5318, Expiration date not reported), via an unspecified route of administration in arm left on 30Jan2021 18:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history allergies to medications, food and other products was reported as none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included fish oil (FISH OIL) and tocopherol (VITAMIN E [TOCOPHEROL]) both taken for an unspecified indication. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1283, Expiration date not reported), via an unspecified route of administration in arm left on 09Jan2021 11:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Beginning (24/36hs), after the vaccination the patient experienced neck and back pain, neck and back pain and fever on 31Jan2021 22:30, (01Feb2021) Monday, Tuesday, Wednesday, Thursday I'm having a heavy headache continuously include when i sleep/continuous and severe headache, having problems concentrating on my job, read, work on the computer on 01Feb2021. The patient received Tylenol for 24 hs as treatment for neck and back pain and fever and no treatment received for having a heavy headache continuously include when i sleep/continuous and severe headache, having problems concentrating on my job, read, work on the computer. The seriousness of all the events was reported as non-serious. The outcome of all the events was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Hyperhidrosis
Clinical narrative: feeling ill; Headache; sinus pressure; sore throat; chills; sweats; cough; extreme tirednes; arm was really sore; This is a spontaneous report received from a contactable consumer (reporting on herself).   A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration on 229Jan2021 12:00, as unknown, single dose for COVID-19 immunization.The patient medical history and concomitant medications were not reported. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose on Friday 29Jan2021. Friday, Saturday and Sunday her arm was really sore. Tuesday (on 02Feb2021) she began feeling ill. Headache, sinus pressure, sore throat, chills, sweats, cough,  no fever and extreme tiredness. These symptoms lasted through Thursday. Adverse event result in go to Emergency room/department or urgent care. No treatment received for the adverse event. Since the vaccination, the patient has tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Feb2021.  The outcome of the events was recovering.  Information on the lot/batch number has been requested.   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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain, Pain in extremity, Paranasal sinus discomfort, SARS-CoV-2 test
Clinical narrative: feeling ill; Headache; sinus pressure; sore throat; chills; sweats; cough; extreme tirednes; arm was really sore; This is a spontaneous report received from a contactable consumer (reporting on herself).   A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration on 229Jan2021 12:00, as unknown, single dose for COVID-19 immunization.The patient medical history and concomitant medications were not reported. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose on Friday 29Jan2021. Friday, Saturday and Sunday her arm was really sore. Tuesday (on 02Feb2021) she began feeling ill. Headache, sinus pressure, sore throat, chills, sweats, cough,  no fever and extreme tiredness. These symptoms lasted through Thursday. Adverse event result in go to Emergency room/department or urgent care. No treatment received for the adverse event. Since the vaccination, the patient has tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Feb2021.  The outcome of the events was recovering.  Information on the lot/batch number has been requested.   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: Hypersensitivity
Clinical narrative: allergic reaction to the 1st COVID vaccine; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. The patient medical history included allergic to a peg from an unknown date and unknown if ongoing, it was reported that her allergist told her she was allergic to a polyethylene glycol (PEG) and she wanted to know if that PEG was in a product that she was using at home for hair dye. The patient concomitant medications were not reported. The patient experienced an allergic reaction to the 1st COVID vaccine on an unspecified date. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Dry skin, Fatigue, Pruritus, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) via COVID-19 reporting system. A 69-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL926), via an unspecified route of administration, administered in arm left on 02Feb2021 16:30 (at the age of 69-years-old) as a single dose for covid-19 immunization. Medical history included Stroke in December of 2017, patient was also allergic to Phenothiazines from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medication(s) included: unspecified antibiotics, acetylsalicylic acid (ASPIRIN) 81 mg; clopidogrel 75 mg; tetryzoline (LISINE) taken for an unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 on 12Jan2021 via nasal swab procedure and the test was negative. On 03Feb2021 at 04:00, the patient experienced soreness in area of shot, itchiness throughout body, tiredness, dryness in skin and increase in pimples. No therapeutic measures were taken as result of the events. Post vaccination, the patient had been tested for COVID-19. The outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) via COVID-19 reporting system. A 69-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL926), via an unspecified route of administration, administered in arm left on 02Feb2021 16:30 (at the age of 69-years-old) as a single dose for covid-19 immunization. Medical history included Stroke in December of 2017, patient was also allergic to Phenothiazines from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medication(s) included: unspecified antibiotics, acetylsalicylic acid (ASPIRIN) 81 mg; clopidogrel 75 mg; tetryzoline (LISINE) taken for an unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 on 12Jan2021 via nasal swab procedure and the test was negative. On 03Feb2021 at 04:00, the patient experienced soreness in area of shot, itchiness throughout body, tiredness, dryness in skin and increase in pimples. No therapeutic measures were taken as result of the events. Post vaccination, the patient had been tested for COVID-19. The outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.