chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Pain in extremity, Physical examination
Clinical narrative: Pressure on head, Fog head; Pressure on head, Fog head; Dizzy tiny bit; Bruise on left arm, where shot was; Twitching in the left eyelid, eyebrow; Sore arm, were shot was, left; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8737) via an unspecified route of administration, administered in Arm Left on 03Apr2021 10:50 (age at vaccination 47-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing seasonal allergy. The patient's concomitant medication: everything she took was over the counter. No investigation assessment was performed. No additional vaccines were administered. On 03Apr2021, the patient experienced a sore left arm at the shot site. On 04Apr2021, the patient experienced twitching in the left eyelid, eyebrow. It lasted all day long. For 4 days in a row it was noticeable. Then it went away, but came back. It was not as strong, not as noticeable, not continuous but frequent. She could still feel it even today she had it. She had it now for 12 days. On 05Apr2021, the patient had bruise on left arm, where shot site was. She confirmed the bruise was not there anymore but did not know when it went away. On an unspecified date, she felt pressure on the head, fog head. She felt dizzy tiny bit. Dizzy over a week even a couple of days ago. She stated she did have seasonal allergies so was unsure if that was related. No emergency room and physician office visit. The patient underwent lab tests and procedures on an unspecified date which included blood test and physical examination and results were normal. The outcome of the event bruise on left arm, where shot site was unknown. The outcome of the event twitching in the left eyelid, eyebrow, pressure on head, fog head and dizzy tiny bit was recovering. The outcome of the event sore arm, were shot was, left was recovered on 05Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Erythema, Malaise
Clinical narrative: Arm shows redness and bruising spots; Arm shows redness and bruising spots; I have experienced a bad reaction after my Covid-19 Pfizer vaccine; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A patient of unspecified age and gender received 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 dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced arm shows redness and bruising spots and experienced a bad reaction after covid-19 pfizer vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Groin pain, Malaise, Myalgia
Clinical narrative: Chills; Fever; Tiredness; Shaky; Muscle pain; Groin pain; Feeling not well; Injection site swelling; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1 ,single for COVID-19 immunization. The patient mentioned wanted to know, patient having some reaction to COVID, Pfizer shot. The patient wanted to speak to someone. The patient provided the reactions had on this past Tuesday, the shot my second. The patient experienced chills, fever, tiredness, shaky, muscle pain, groin pain, feeling not well and Injection site swelling. And also wanted to know, how long these symptoms will last. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Tremor, Vaccination site swelling
Clinical narrative: Chills; Fever; Tiredness; Shaky; Muscle pain; Groin pain; Feeling not well; Injection site swelling; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1 ,single for COVID-19 immunization. The patient mentioned wanted to know, patient having some reaction to COVID, Pfizer shot. The patient wanted to speak to someone. The patient provided the reactions had on this past Tuesday, the shot my second. The patient experienced chills, fever, tiredness, shaky, muscle pain, groin pain, feeling not well and Injection site swelling. And also wanted to know, how long these symptoms will last. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Pyrexia
Clinical narrative: Terrible Headache; Fever; Stomach pain; This is a spontaneous report from a non-contactable consumer (patient himself/herself). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Expiry Date: Unknown), via an unspecified route of administration on 01Apr2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, patient had Pfizer vaccine on 01Apr, The first week was nothing, No Pain, Nothing. Now, the patient get headache, very terrible headache and now patient was getting fever and stomach pain and patient want to know, how long it last, patient took two Aspirin (Treatment) and Its goes away then come back again. On an unspecified date, the patient experienced Terrible Headache, Fever and Stomach pain. I took two Aspirin and Its goes away then come back again. Therapeutic measures were taken as a result of events Terrible Headache, Fever and treatment included with took two aspirin. The outcome was unknown for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Decreased appetite, Fatigue
Clinical narrative: Low temperature fever; Tiredness; Cough; Muscle pain; Joint pain; Have loss of my appetite; Arm swelling; Chills; This is a spontaneous report from a contactable consumer (Patient himself). A 33-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EL9265, Expiry date, NDC number, UPC number was not reported), via an unspecified route of administration on 08Apr2021 (Age at vaccination 33-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced low temperature fever, tiredness, cough on 16Apr2021. The patient experienced chills, arm swelling, muscle pain, joint pain, have loss of him appetite on Apr2021. It has been eight days from the first shot, and he was still having low temperature fever and he cough a few times and he was tired a little bit. Consumer stated, he got his vaccination from Pfizer, last Thursday afternoon at around like 2:00 PM on 8April, he got the first shot from Pfizer vaccine (COVID Vaccine). After that, he developed, he had a low temperature fever, chills, tiredness, arm swelling and cough, muscle pain and joint pain. Also, he had loss of his appetite somewhere, he did not feel like itching or anything like that. So, he did not know because it had been eight days from the first shot, and he was still having low temperature fever and he cough a few times and he was tired a little bit. He did not know whether it was normal, and he want to know, how long it will take to get normal and what should he do. Consumer stated, he got it at a Pharmacy, it was a pharmacy. Consumer stated, he only had two pills of Tylenol. Therapeutic measures were taken for the events. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: Low temperature fever; Tiredness; Cough; Muscle pain; Joint pain; Have loss of my appetite; Arm swelling; Chills; This is a spontaneous report from a contactable consumer (Patient himself). A 33-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EL9265, Expiry date, NDC number, UPC number was not reported), via an unspecified route of administration on 08Apr2021 (Age at vaccination 33-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced low temperature fever, tiredness, cough on 16Apr2021. The patient experienced chills, arm swelling, muscle pain, joint pain, have loss of him appetite on Apr2021. It has been eight days from the first shot, and he was still having low temperature fever and he cough a few times and he was tired a little bit. Consumer stated, he got his vaccination from Pfizer, last Thursday afternoon at around like 2:00 PM on 8April, he got the first shot from Pfizer vaccine (COVID Vaccine). After that, he developed, he had a low temperature fever, chills, tiredness, arm swelling and cough, muscle pain and joint pain. Also, he had loss of his appetite somewhere, he did not feel like itching or anything like that. So, he did not know because it had been eight days from the first shot, and he was still having low temperature fever and he cough a few times and he was tired a little bit. He did not know whether it was normal, and he want to know, how long it will take to get normal and what should he do. Consumer stated, he got it at a Pharmacy, it was a pharmacy. Consumer stated, he only had two pills of Tylenol. Therapeutic measures were taken for the events. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dysgeusia
Clinical narrative: I feel almost like a metallic taste in my mouth, like a metallic like a funny taste in my mouth; Loss of sense of taste and smell; Loss of sense of taste and smell; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).  A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot number and Expiry date: not reported), via an unspecified route of administration on 14Apr2021 14:30 (at the age of 59-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Apr2021, the patient felt almost like a metallic taste in her mouth, like a metallic like a funny taste in her mouth and experienced loss of sense of taste and smell. She just started experiencing like after 17:00 on 15Apr2021. The patient did not receive treatment for the events. The outcome of the events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Nausea, Pain
Clinical narrative: Headache; Body aches; Fever; Nausea; Loss of appetite; Chills; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 administered on an unspecified date for COVID-19 immunization. On an unspecified date the patient experienced headache, body aches, fever, nausea, loss of appetite, chills. It was reported that all these are the side effects of the second dose of the vaccine. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Body aches; Fever; Nausea; Loss of appetite; Chills; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 administered on an unspecified date for COVID-19 immunization. On an unspecified date the patient experienced headache, body aches, fever, nausea, loss of appetite, chills. It was reported that all these are the side effects of the second dose of the vaccine. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache
Clinical narrative: chills; cough; headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Historical vaccine included 1st dose of BNT162B2 (Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date for COVID-19 immunization and experienced shortness of breath, palpitations, scratchy throat. Medical history included patient had high blood pressure and took medicine for it. The patient's concomitant medications were not reported. After 2nd vaccine, symptoms were less severe but, the patient experienced chills, cough and headache on an unspecified date. Patient went to ER was checked and no problems were found with her heart or lungs. Labs were normal. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: developed a bumpy red rash on the side of her face; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer-sponsored program reporting for herself (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: not reported, expiry: unknown) via an unspecified route of administration on 16Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Apr2021 after 6 hours of vaccination, the patient developed a bumpy red rash on the side of her face. She asked how to prevent these side effects from the vaccine. The outcome of event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash; pruritis; This is a spontaneous report from a contactable consumer (patient). A adult female (Age not reported) patient received first 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 DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash, pruritis. Therapeutic measures were taken as a result of rash, pruritis with steroids and continued Benadryl. After completing 5-day course of steroids her rash and pruritis recurred. Completed an additional 6 days of steroids. Patient was a part of clinical trial. 3 days later developed rash and pruritis after the first dose. This reaction was already reported to the study investigator according to the patient. The outcomes of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Off label use, Product use issue, Pyrexia
Clinical narrative: off label use; Drug use in unapproved population; fever today; sweating; chills; This is a spontaneous report from a Pfizer sponsored program via a non-contactable consumer or other non-healthcare professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 12Apr2021 as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient has a fever that day, sweating, and chills. She was also breastfeeding. She reported adverse event online. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Off label use, Product use issue, Pyrexia
Clinical narrative: She has a fever; sweating; chills; Drug exposure via breast milk; Drug exposure via breast milk; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12Apr2021 as dose 1, single for COVID-19 immunization. Medical history included sars-cov-2 antibody test positive from an unknown date and unknown if ongoing covid positive. The patient concomitant medications were not reported. The patient was breastfeeding. On an unspecified date, the patient has a fever, sweating, chills and drug exposure via breast milk. The outcome of the events was unknown.  No follow-up attempts are needed. Information related to batch/lot number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Muscular weakness, Pain in extremity
Clinical narrative: slight headache; painful weak left arm/shoulder socket; painful weak left arm/shoulder socket; painful weak left arm/shoulder socket; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via intramuscularly, administered in arm left on 02Mar2021 13:00 as dose 2, single for COVID-19 immunization (age at vaccination: 64-years-old). The patient medical history was not reported. Concomitant medications included zinc taken for immune enhancement therapy from an unspecified start date and ongoing, acetylsalicylic acid (ASPIRIN (E.C.)) taken for thrombosis from an unspecified start date and ongoing; colostrum taken for immune enhancement therapy from an unspecified start date and ongoing, allium sativum bulb (GARLIC EXTRACT [ALLIUM SATIVUM BULB]) taken for immune enhancement therapy from an unspecified start date and ongoing. The patient previously took first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number: unknown, Expiry date: unknown) via Intramuscular, administered in center of left arm on 09Feb2021 16:15 as dose 1, single for COVID-19 immunization and experienced lower back pain, soreness, chills and weakness in body. On 02Mar2021 the patient experienced slight headache and painful weak left arm/shoulder socket. Sometimes, have to use right arm to help move/lift my left arm, especially when it's been in one position for a while. It was reported that the patient was in process to seek physical therapy. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Headache, Lymphadenopathy, Malaise
Clinical narrative: swollen lymph nodes; trouble with breathing; trouble swallowing; headaches; low fever; felt sick; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-year-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VAC-CINE, solution for injection, Batch/Lot Number: EM9802) via an unspecified route of administration, administered in arm right on 18Feb2021 11:00 (at the age of 76-year-old) at dose 2, single for covid-19 immunisation. Medical history included ongoing thyroid. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for thyroid via oral route from an unspecified start date and ongoing. Patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9265) via an unspecified route of administration, ad-ministered in arm left on 28Jan2021 11:00 (at the age of 76-year-old) at dose 1, single for covid-19 immunisation and experienced rash 5 hrs later on 28Jan2021, received treatment and got resolved. On 18Feb2021 the patient experienced swollen lymph nodes, trouble with breathing, trouble swallowing, headaches, low fever, felt sick. Narrative description of the sequence of events hives after first vaccine this to dermatologist after second vaccine and had symptoms of swollen lymph nodes, trouble with breathing and swallowing, headache and low fever for about a week felt sick and had similar symptoms in 2020, which lasted for months, and never got tested and didn't want to be hospitalized. Onset time: next morning. Adverse events resulted in physician office visit. Patient did not receive treatment for the adverse events. Outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: swollen lymph nodes; trouble with breathing; trouble swallowing; headaches; low fever; felt sick; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-year-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VAC-CINE, solution for injection, Batch/Lot Number: EM9802) via an unspecified route of administration, administered in arm right on 18Feb2021 11:00 (at the age of 76-year-old) at dose 2, single for covid-19 immunisation. Medical history included ongoing thyroid. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for thyroid via oral route from an unspecified start date and ongoing. Patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9265) via an unspecified route of administration, ad-ministered in arm left on 28Jan2021 11:00 (at the age of 76-year-old) at dose 1, single for covid-19 immunisation and experienced rash 5 hrs later on 28Jan2021, received treatment and got resolved. On 18Feb2021 the patient experienced swollen lymph nodes, trouble with breathing, trouble swallowing, headaches, low fever, felt sick. Narrative description of the sequence of events hives after first vaccine this to dermatologist after second vaccine and had symptoms of swollen lymph nodes, trouble with breathing and swallowing, headache and low fever for about a week felt sick and had similar symptoms in 2020, which lasted for months, and never got tested and didn't want to be hospitalized. Onset time: next morning. Adverse events resulted in physician office visit. Patient did not receive treatment for the adverse events. Outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; Fever; This is a spontaneous report from a contactable consumer. An 18-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: unknown, expiry date: unknown, Age at vaccination: 18-year-old), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, patient experienced headache and fever. The outcome of events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Flushing, Headache
Clinical narrative: Headache began 38 hrs post jab, face flushing too, belly upset today (next morning); Headache began 38 hrs post jab, face flushing too, belly upset today (next morning); Headache began 38 hrs post jab, face flushing too, belly upset today (next morning); This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age 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 single for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced headache began 38 hrs post jab, face flushing too, belly upset today (next morning), abdominal discomfort. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: fever; chills; malaise; This is a spontaneous report from a contactable consumer (patient, self-reported).  A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 12Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Apr2021, after second dose of BNT162b2 vaccine (week of 4/12/21), patient experienced fever, chills, malaise for 24 hours and symptoms resolved. Event took place after use of product. Outcome of the events was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Nausea; Chills; Aches; Experienced progressive fever; This is a spontaneous report from a contactable Consumer or other non-HCP (patient) communicated to Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 16Apr2021 (Lot number was not reported), as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced progressive fever, nausea, chills and aches. It was reported that the patient got first dose yesterday-16Apr2021 (second dose is on 07May) and on an unknown date, she experienced progressive fever, nausea, chills and aches. She was asking if it would be okay to take Tylenol. The patient outcome of the events was unknown at the time of this report.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Now has a rash all over her body; 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, Batch/Lot number was not reported), via an unspecified route of administration on 12Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced now has a rash all over her body on 13Apr2021. The outcome of event was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pyrexia
Clinical narrative: Fatigue; low grade temperature; joint pain; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration, administered in Arm right on 26Mar2021 15:15 (at the age of 57 years) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included Pantoprazole sodium DR 20mg QD. It was reported that the Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8731) via intramuscular administered in Right left on 16Apr2021 15:15 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had known allergies NKA. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. On 03Apr2021 08:00 the patient experienced fatigue, low grade temperature between 99.5 and 100.3 degrees and joint pain. It was reported that I was the patient and became aware of the AEs in 14Apr2021. Patient had no treatment received. The patient underwent lab data and procedure which include low grade temperature between 99.5 and 100.3 degrees on 03Apr2021.The outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia
Clinical narrative: Can not move right arm but received vaccine in left arm; right arm starting from her shoulder she has huge pain; This is a spontaneous report from Pfizer Support program reported from a contactable consumer (reported for herself). A 68-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0162/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 18Apr2021 at 15:30 (at the age of 68-years-old) as dose 2, single for covid-19 immunisation at Pharmacy. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8727/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 26Mar2021 (at the age of 68-years-old) as dose 1, single for covid-19 immunisation and experienced headache, body pain and feeling like she had the flu at Pharmacy. On 18Apr2021, the patient experienced cannot move right arm but received vaccine in left arm and right arm starting from her shoulder she has huge pain. The clinical course was as follows: Patient right arm starting from her shoulder she has huge pain, and she can't even move her arm, she says, but they put the vaccine in her left arm, and it is her right arm that is hurting. Reporter started with the pain, and she took neuropain for the pain and she took two Tylenol (Lot number: 201097A, UPC: 0904673060, Expiry Date: on an unspecified date in Mar2022) and reporter stating that, she will take another 2 to see if it gets better for the pain. Therapeutic measures were taken as a result of events included treatment with Neuropain and Tylenol. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: bad sinus infection; radiating chest pain; Having low grade fevers; Headache; body ache; nausea; diarrhea; This is a spontaneous report received from contactable consumer (patient) a female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced after 45 minutes of second dose, low grade fevers, headaches, body aches, nausea, bad sinus infection, diarrhea, and radiating chest pain. The outcome of events was unknown.  No follow-up attempts were needed. Information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sinusitis
Clinical narrative: bad sinus infection; radiating chest pain; Having low grade fevers; Headache; body ache; nausea; diarrhea; This is a spontaneous report received from contactable consumer (patient) a female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced after 45 minutes of second dose, low grade fevers, headaches, body aches, nausea, bad sinus infection, diarrhea, and radiating chest pain. The outcome of events was unknown.  No follow-up attempts were needed. Information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site swelling
Clinical narrative: She had lymph at her underarm; a little bit of swelling under my arm; I have a little bit of swelling under my arm where my vaccine shot was given; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) from a Pfizer Sponsored Program COVAX US Support. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6207), via an unspecified route of administration, administered in arm on 20Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on 27Feb2021 as dose 1, single for COVID-19 immunization. On an unspecified date in Mar2021, the patient experienced she had lymph at her underarm; a little bit of swelling under my arm , i have a little bit of swelling under my arm where my vaccine shot was given. It was further reported that patient has an appointment for Mammography on 27Apr2021. She was asking if she can undergo Mammography after completing the 1st and 2nd dose of Covid-19 vaccine. She added that she had lymph at her underarm after taking the 2nd dose of Covid-19 vaccine last 20Mar2021. Moreover, her 1st dose was completed 1st dose last 27Feb021. Patient stated, I have a question, I took my second dose on 20Mar (not clarified) and I have a little bit of swelling under my arm where my vaccine shot was given. Also, I will be having on 27Apr, a mammogram, so my question is, is it safe for me to do the mammogram or do I need to reschedule or wait because I was thinking about it. She further stated, I just want answer to my question because I was waiting for five hours and I just want to know, is it is safe or not. In response to further probing, patient stated, I have given already all my information to the first person that I spoke to first, I gave her all my information, to that first lady. So, I will just call the other department to make sure. (further clarification unknown if consumer called in Pfizer Drug Safety earlier, hence report type captured as initial report). She stated, I do not know about the expiration date, I took the first dose on 27Feb (not clarified). Reason of delay: Daily spike of incoming calls due to COVID19 vaccine. The clinical outcome of all the events was reported as unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Dysstasia
Clinical narrative: hard breathing; Dizziness; cannot control herself when standing.; This is a spontaneous report from regulatory authority program . A contactable reporter (husband) reporting for his (wife) female patient reporting that:  A female patient of an unspecified age received bnt162b2 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 18Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took historical vaccine bnt162b2 on 28Mar2021 as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced hard breathing, dizziness and cannot control herself when standing. The outcome of the events unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chapped lips, Dry mouth, Hypoaesthesia oral, Lip dry, Lip swelling
Clinical narrative: Dry, swollen, chapped, cracked lips; Dry, swollen, chapped, cracked lips; Dry, swollen, chapped, cracked lips; dry mouth; numbness of upper gums in mouth; This is a spontaneous report from a non-contactable consumer (patient). This report was received via a sales representative.   A patient of unspecified age and gender 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 an unspecified date as DOSE 2, SINGLE and via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced dry, swollen, chapped, cracked lips, dry mouth, numbness of upper gums in mouth. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: 5 silver dollar size bruises appeared in various spots all over the body; This is a spontaneous report from a contactable consumer or other non HCP. This report was received via a sales representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced 5 silver dollar size bruises appeared in various spots all over the body (contusion) 5-6 days past getting Covid vaccine on an unspecified date. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Illness, Nasal congestion, Pain
Clinical narrative: 12 days of being sick; High fever; cough; congestion; very, very severe" body aches; no sense of taste; headaches; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reports that for a day and a half she was fine and on 18Mar2021 (Thursday) evening, she started experiencing very, very severe body aches and high fever of 101 and 102. She stated that these side effects lasted almost 5 days, with the fever subsiding, and then reports that it moved into a severe cough and congestion. She stated that these side effects lasted about 5 to 6 more days. She also reported that throughout this course of time, she had no sense of taste, which subsequently came back about a week ago. She also reported having headaches that stopped about a week ago but stated that today she has another one. Caller stated that these severe symptoms lasted for about 2 straight weeks and then reported that she started feeling like herself, only very, very run down. She stated that today she did not feel much better and more herself, but again reports having the same kind of headache she had through the course of this. Caller would like to know, based on these side effects, what to expect with her second dose of the vaccine. She was concerned that her side effects will be worse with the second dose.  The events outcome was reported as unknown  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Taste disorder
Clinical narrative: 12 days of being sick; High fever; cough; congestion; very, very severe" body aches; no sense of taste; headaches; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reports that for a day and a half she was fine and on 18Mar2021 (Thursday) evening, she started experiencing very, very severe body aches and high fever of 101 and 102. She stated that these side effects lasted almost 5 days, with the fever subsiding, and then reports that it moved into a severe cough and congestion. She stated that these side effects lasted about 5 to 6 more days. She also reported that throughout this course of time, she had no sense of taste, which subsequently came back about a week ago. She also reported having headaches that stopped about a week ago but stated that today she has another one. Caller stated that these severe symptoms lasted for about 2 straight weeks and then reported that she started feeling like herself, only very, very run down. She stated that today she did not feel much better and more herself, but again reports having the same kind of headache she had through the course of this. Caller would like to know, based on these side effects, what to expect with her second dose of the vaccine. She was concerned that her side effects will be worse with the second dose.  The events outcome was reported as unknown  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Ear discomfort, Eye swelling, Pruritus
Clinical narrative: Face and eye swelling 10 hrs post vaccine injection; Face and eye swelling 10 hrs post vaccine injection; Describes feeling a "chemical burn" in her throat; Her ears are plugged up; Cough; Feels dizzy; Feels itchy every evening for the past 2 weeks; This is a spontaneous report from a 70-year-old female contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced face and eye swelling 10 hours (post vaccine injection). Describes feeling a "chemical burn" in her throat. Her ears are plugged up and has similar reaction to what she had experienced with penicillin. Currently has a cough and feels dizzy. Patient was given 50 milligrams Benadryl as well as steroids. Feels itchy every evening for the past 2 weeks. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Throat irritation
Clinical narrative: Face and eye swelling 10 hrs post vaccine injection; Face and eye swelling 10 hrs post vaccine injection; Describes feeling a "chemical burn" in her throat; Her ears are plugged up; Cough; Feels dizzy; Feels itchy every evening for the past 2 weeks; This is a spontaneous report from a 70-year-old female contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced face and eye swelling 10 hours (post vaccine injection). Describes feeling a "chemical burn" in her throat. Her ears are plugged up and has similar reaction to what she had experienced with penicillin. Currently has a cough and feels dizzy. Patient was given 50 milligrams Benadryl as well as steroids. Feels itchy every evening for the past 2 weeks. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.