chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: her sister's face swelled; This is a spontaneous report from a contactable consumer. This consumer reported for similar events for 2 patients. This is 2 of 2 reports. This consumer reported for female patient (reporter sister). 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 an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Reason for no lot number: Caller unwilling to complete the report. Medical history included connective tissue disorder (her sister have Ehlers Danlos, which is a connective tissue disorder. It is genetic but it also impacts one part of the immune system. Neither of them have been diagnosed with this additional part because they do not think it is useful to go for a million tests for something that they are then not going to treat them any differently. Caller adds that this goes with mast cell activation disorder and a lot of people with Ehlers Danlos have mast cell activation disorder. It causes a lot of allergic reactions to a lot of things. Her sister, for instance, takes a ton of antihistamines and a lot of stuff and she takes it to prevent outbursts of hives.) from an unknown date and unknown if ongoing. Concomitant medication was not reported. Caller mentions that patient (her sister) also had a similar experience with the COVID-19 Vaccine. Report 2 was caller talking about her sister. Her sister had the same reaction to the COVID-19 Vaccine and patient have the same conditions. Caller adds that patient reaction was different in that face swelled. She did not have details or dates or anything but her sister sent caller a picture of her face. Caller adds both her and her sister are fine. The outcome of the event was recovered on 2021.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Nausea, Pain in extremity, Sleep disorder
Clinical narrative: pain in arm; prevented sleep; nausea; tiredness; loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 44-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 01May2021 at 15:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any medication within two weeks of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 00:00 the patient experienced pain in arm, prevented sleep, nausea, tiredness and loss of appetite. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event pain in arm, prevented sleep, nausea, tiredness and loss of appetite were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: This is a spontaneous report from a contactable consumer. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the arm left on 03May2021(at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Mar2021(at the age of 56-year-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient was diagnosed with COVID-19, prior to the vaccination. It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. On 03May2021, the patient experienced a little numbness on the left side of her jaw and tongue. It was unknown whether any therapeutic measures were taken as a result of the adverse event. It was unknown whether the patient had been tested for COVID-19, since the vaccination. The clinical outcome of the event little numbness on the left side of her jaw and tongue was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Concussion, Fall, Head injury, Muscular weakness
Clinical narrative: One wee after the first shot, my legs went weak and gave out while I was walking at work and I fell and got a concussion because I hit my head.; One wee after the first shot, my legs went weak and gave out while I was walking at work and I fell and got a concussion because I hit my head.; One wee after the first shot, my legs went weak and gave out while I was walking at work and I fell and got a concussion because I hit my head.; One wee after the first shot, my legs went weak and gave out while I was walking at work and I fell and got a concussion because I hit my head.; This is a spontaneous report from a contactable consumer (patient). A 45-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 27Jan2021 at 12:00 (at the age of 45-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history multiple sclerosis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received codeine from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 03Feb2021 at 12:45, the patient experienced one week after the first shot, his legs went weak and gave out while she was walking at work and she fell and got a concussion because she hit her head. Patient stated that 3-4 weeks after the second shot, I had the first major MS exacerbation I have had in 15 years. It was the worst I have ever had. My legs went weak when I stood up at home and my teenage son caught me so I would not fall and hit my head again. He took me to the ER 2 days later because I knew something else did not feel right. The neurologist on staff at the hospital made me get a 2 hour MRI and it showed so many lesions that it is sad. I only had 2 lesions 15 years ago. This was horrible. Patient visited doctor or other healthcare professional office/clinic visit due to events. The patient underwent lab tests and procedures which included blood test and Covid test was negative on 02Apr2021. The outcome of the events was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: One wee after the first shot, my legs went weak and gave out while I was walking at work and I fell and got a concussion because I hit my head.; One wee after the first shot, my legs went weak and gave out while I was walking at work and I fell and got a concussion because I hit my head.; One wee after the first shot, my legs went weak and gave out while I was walking at work and I fell and got a concussion because I hit my head.; One wee after the first shot, my legs went weak and gave out while I was walking at work and I fell and got a concussion because I hit my head.; This is a spontaneous report from a contactable consumer (patient). A 45-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 27Jan2021 at 12:00 (at the age of 45-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history multiple sclerosis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received codeine from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 03Feb2021 at 12:45, the patient experienced one week after the first shot, his legs went weak and gave out while she was walking at work and she fell and got a concussion because she hit her head. Patient stated that 3-4 weeks after the second shot, I had the first major MS exacerbation I have had in 15 years. It was the worst I have ever had. My legs went weak when I stood up at home and my teenage son caught me so I would not fall and hit my head again. He took me to the ER 2 days later because I knew something else did not feel right. The neurologist on staff at the hospital made me get a 2 hour MRI and it showed so many lesions that it is sad. I only had 2 lesions 15 years ago. This was horrible. Patient visited doctor or other healthcare professional office/clinic visit due to events. The patient underwent lab tests and procedures which included blood test and Covid test was negative on 02Apr2021. The outcome of the events was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Feels a lump under the skin in the place he had his injection; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 03May2021 (at the age of 30-years-old) (Batch/Lot Number: EW01770) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Batch/Lot Number: ER8737) for COVID-19 immunization. On May2021, the patient felt a lump under the skin in the place he had his injection. Patient mentioned that if you touch it, it's not painful, but it's a lump under the skin. Patient wanted to know if this was normal. Outcome of the event was not recovered.  No Follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaginal haemorrhage
Clinical narrative: heavy vaginal bleeding; headache; fatigue; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 51-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 10:00 (Batch/Lot number and Expiry date was not reported) (at the age of 51-years-old) as DOSE 2, SINGLE for Covid-19 immunization. Medical history included: Uterine fibroids, migraines, lupus. There were no known allergies reported. Concomitant medications included: ethinylestradiol, norethisterone acetate (LOESTRIN), hydroxychloroquine, magnesium and fish oil. Start and stop dates and dosing regimen details were not reported. The patient previously received BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) for covid-19 immunization.The patient did not receive any other vaccine within 4 weeks of covid-19 vaccine administration. Prior to vaccination, the patient did not have covid and since vaccination the patient has not been tested for covid -19. On 06May2021, the patient experienced headache and fatigue. On 08May2021, the patient experienced heavy vaginal bleeding. It was reported that 2 days after vaccine, had severe headache & fatigue. On 08May2021, 4 days after, the patient had heavy vaginal bleeding. She reported that she did not have periods, as she takes birth control pills continuously to stop them. Therapeutic measures were taken as a result of heavy vaginal bleeding. The clinical outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Chest pain, Dehydration, Fatigue, Headache
Clinical narrative: Extreme fatigue; dehydration; chest pain; lump in armpit (golf ball size); pounding headache; muscle spasms; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 27 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 (Batch/Lot Number: ER8736) 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. The patient experienced extreme fatigue, dehydration, chest pain, lump in armpit (golf ball size), pounding headache and muscle spasms on 07May2021 with outcome of not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Extreme fatigue; dehydration; chest pain; lump in armpit (golf ball size); pounding headache; muscle spasms; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 27 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 (Batch/Lot Number: ER8736) 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. The patient experienced extreme fatigue, dehydration, chest pain, lump in armpit (golf ball size), pounding headache and muscle spasms on 07May2021 with outcome of not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Vaccination site erythema
Clinical narrative: Allergy and redness on the arm where the Covid-19 vaccine is injected; Allergy and redness on the arm where the Covid-19 vaccine is injected; This is a spontaneous report from a contactable consumer (patient) from a program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 20Apr2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 04May2021, patient was experiencing allergy and redness on the arm where the Covid-19 vaccine was injected. She got these symptoms 2 weeks after getting the first dose on 20Apr2021. She wants to know if these symptoms are normal. She also added that her second dose schedule would be on 11May2021. Caller hung up intentionally and so no transfer of call was made. The outcome of events was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Blood pressure measurement, Cough, Dry mouth
Clinical narrative: right arm pain; Difficult breathing; fast heartbeat; weakness; tingling; numbness off my upper body and face jaw locking; hands locking stomach painful cramps; numbness off my upper body and face jaw locking, hands locking stomach painful cramps; vomiting; high blood pressure elevated to 190/110; dry mouth follow by thrust develop a mild cough and right arm pain; dry mouth follow by thrust develop a mild cough and right arm pain; This is a spontaneous report from a contactable Consumer. A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0169), dose 1 via an unspecified route of administration, administered in Arm Left on 07May2021 15:00 (at the age of 42-years-old) as a single dose for covid-19 immunization. Medical history included anaphylactic reaction from 07May2021 to an unknown date and high blood pressure. Concomitant medication(s) in two weeks included hydrochlorothiazide; losartan; iron (FERROUS [IRON]). The patient was not pregnant at the time of vaccination. It was unknown, the patient had any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown the patient had been tested for COVID-19. On 07May2021 15:15, the patient experienced "difficult breathing fast heartbeat weakness tingling follow by numbness off my upper body and face jaw locking, hands locking stomach painful cramps follow by vomiting high blood pressure elevated to 190/110, dry mouth follow by thrust develop a mild cough and right arm pain". The adverse event resulted in patient to visit emergency room/department or urgent care. The patient was treated with Paramedics help, oxygen given. The patient underwent lab tests and procedures which included blood pressure measurement: 190/110. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Hypertension, Hypoaesthesia, Muscle spasms
Clinical narrative: right arm pain; Difficult breathing; fast heartbeat; weakness; tingling; numbness off my upper body and face jaw locking; hands locking stomach painful cramps; numbness off my upper body and face jaw locking, hands locking stomach painful cramps; vomiting; high blood pressure elevated to 190/110; dry mouth follow by thrust develop a mild cough and right arm pain; dry mouth follow by thrust develop a mild cough and right arm pain; This is a spontaneous report from a contactable Consumer. A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0169), dose 1 via an unspecified route of administration, administered in Arm Left on 07May2021 15:00 (at the age of 42-years-old) as a single dose for covid-19 immunization. Medical history included anaphylactic reaction from 07May2021 to an unknown date and high blood pressure. Concomitant medication(s) in two weeks included hydrochlorothiazide; losartan; iron (FERROUS [IRON]). The patient was not pregnant at the time of vaccination. It was unknown, the patient had any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown the patient had been tested for COVID-19. On 07May2021 15:15, the patient experienced "difficult breathing fast heartbeat weakness tingling follow by numbness off my upper body and face jaw locking, hands locking stomach painful cramps follow by vomiting high blood pressure elevated to 190/110, dry mouth follow by thrust develop a mild cough and right arm pain". The adverse event resulted in patient to visit emergency room/department or urgent care. The patient was treated with Paramedics help, oxygen given. The patient underwent lab tests and procedures which included blood pressure measurement: 190/110. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Vomiting
Clinical narrative: right arm pain; Difficult breathing; fast heartbeat; weakness; tingling; numbness off my upper body and face jaw locking; hands locking stomach painful cramps; numbness off my upper body and face jaw locking, hands locking stomach painful cramps; vomiting; high blood pressure elevated to 190/110; dry mouth follow by thrust develop a mild cough and right arm pain; dry mouth follow by thrust develop a mild cough and right arm pain; This is a spontaneous report from a contactable Consumer. A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0169), dose 1 via an unspecified route of administration, administered in Arm Left on 07May2021 15:00 (at the age of 42-years-old) as a single dose for covid-19 immunization. Medical history included anaphylactic reaction from 07May2021 to an unknown date and high blood pressure. Concomitant medication(s) in two weeks included hydrochlorothiazide; losartan; iron (FERROUS [IRON]). The patient was not pregnant at the time of vaccination. It was unknown, the patient had any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown the patient had been tested for COVID-19. On 07May2021 15:15, the patient experienced "difficult breathing fast heartbeat weakness tingling follow by numbness off my upper body and face jaw locking, hands locking stomach painful cramps follow by vomiting high blood pressure elevated to 190/110, dry mouth follow by thrust develop a mild cough and right arm pain". The adverse event resulted in patient to visit emergency room/department or urgent care. The patient was treated with Paramedics help, oxygen given. The patient underwent lab tests and procedures which included blood pressure measurement: 190/110. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Eye pain, Headache, Pain
Clinical narrative: Fever is really high like 100 and 101 constantly; Bedridden and can't move; Really in pain in her head, body and eyes; Really in pain in her head, body and eyes; Really in pain in her head, body and eyes; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date was unknown), via an unspecified route of administration on 04May2021 at 12:00 (at the age of 33-years-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Other products and patient history not provided. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 06Apr2021 as single dose for COVID-19 immunization. The patient was calling about the Pfizer vaccine she clarified the COVID vaccine. The patient received her dose yesterday, at 12 in the afternoon and it had been about 26 hours since she got the second dose. Attempted to clarify what caller had said due to call being inaudible for a moment. She got a fever last night after 12 hours and the fever was really high like 100 and 101 constantly. The patient wanted to ask if it was normal or if she should do something about it and she had been bedridden and could not move. She was really in pain in her head, body and eyes. The patient was on a different call. That call got dropped. The patient was waiting to talk to a medical representative through Pfizer. Attempted to clarify with caller which department caller was talking with at time of disconnect. Caller clarified that it was a constant message being played then the call dropped. The patient underwent lab tests and procedures which included body temperature: high (100 - 101 constantly) on 04May2021. The outcome of events was unknown.  PSCC Communication: Asked caller if she would like to complete a safety report and stated if that helps in reporting official, to get her help, she would complete the report. Made caller aware that she does not have to fill out the report and that she could be directed to medical information if she would like further information regarding side effects of the vaccine. Informed caller that we would not be able to give her medical advice over the phone and that we suggest she contact her primary health care provider if she had further questions about what she should do next. Caller asked to be sent back to the line where she was holding for her questions. Re-attempted to explain to caller that we suggest she reach out to her doctor with any medical questions she may have. Medical information may only be able to provide her with information regarding side effects in relation to the vaccine.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever is really high like 100 and 101 constantly; Bedridden and can't move; Really in pain in her head, body and eyes; Really in pain in her head, body and eyes; Really in pain in her head, body and eyes; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date was unknown), via an unspecified route of administration on 04May2021 at 12:00 (at the age of 33-years-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Other products and patient history not provided. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 06Apr2021 as single dose for COVID-19 immunization. The patient was calling about the Pfizer vaccine she clarified the COVID vaccine. The patient received her dose yesterday, at 12 in the afternoon and it had been about 26 hours since she got the second dose. Attempted to clarify what caller had said due to call being inaudible for a moment. She got a fever last night after 12 hours and the fever was really high like 100 and 101 constantly. The patient wanted to ask if it was normal or if she should do something about it and she had been bedridden and could not move. She was really in pain in her head, body and eyes. The patient was on a different call. That call got dropped. The patient was waiting to talk to a medical representative through Pfizer. Attempted to clarify with caller which department caller was talking with at time of disconnect. Caller clarified that it was a constant message being played then the call dropped. The patient underwent lab tests and procedures which included body temperature: high (100 - 101 constantly) on 04May2021. The outcome of events was unknown.  PSCC Communication: Asked caller if she would like to complete a safety report and stated if that helps in reporting official, to get her help, she would complete the report. Made caller aware that she does not have to fill out the report and that she could be directed to medical information if she would like further information regarding side effects of the vaccine. Informed caller that we would not be able to give her medical advice over the phone and that we suggest she contact her primary health care provider if she had further questions about what she should do next. Caller asked to be sent back to the line where she was holding for her questions. Re-attempted to explain to caller that we suggest she reach out to her doctor with any medical questions she may have. Medical information may only be able to provide her with information regarding side effects in relation to the vaccine.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pruritus, Rash
Clinical narrative: Whole-body rash; Itching; Tingling tongue; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06May2021 at 16:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and escitalopram oxalate (LEXAPRO); both for unspecified indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 11:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07May2021 at 14:00, the patient experienced whole-body rash, itching and tingling tongue. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of whole-body rash, itching and tingling tongue and included treatment with Benadryl. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events whole-body rash, itching and tingling tongue was recovered on an unspecified date in May2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Eye pruritus, Eye swelling, Ocular hyperaemia
Clinical narrative: allergy to the vaccine; itchy eyes started from eyebrows; eye redness; swollen really bad; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 14Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE on 24Mar2021. On 21Apr2021, the patient experienced allergy to the vaccine, itchy eyes started from eyebrows, eye redness, swollen really bad. The events assessed as non-serious. Case narrative: Caller stated that she would like to talk to someone to ask them about a reaction to the vaccine she had. She states that she had some reaction. Two or three people told her it might be a reaction to the vaccine, and she wanted to know if it is or not. She got her second shot 14Apr2021, after a week she developed itchy eyes started from eyebrows, her eyes, both eyes and around her eyebrows started itching getting red and keeps getting swollen really bad. Sought consultation to ophthalmologist 28April2021 or 29April2021 and she was advised that it might be an allergic reaction to something, became worst as days went by. She was seen by her primary care doctor and prescribed cream for itchiness. She will visit her dermatologist tomorrow, since her eyes are itching and bothering her. She is going to see a doctor to calm down the swollen and itching, she couldn't really see. She does not feel good. She heard from her friend that she also had itchiness after being vaccinated for COVID 19, did not specifically mentioned that it was Pfizer. She wants to know if itchiness of her eyes is an allergic reaction from the COVID 19 vaccine that she had. The event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Malaise
Clinical narrative: allergy to the vaccine; itchy eyes started from eyebrows; eye redness; swollen really bad; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 14Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE on 24Mar2021. On 21Apr2021, the patient experienced allergy to the vaccine, itchy eyes started from eyebrows, eye redness, swollen really bad. The events assessed as non-serious. Case narrative: Caller stated that she would like to talk to someone to ask them about a reaction to the vaccine she had. She states that she had some reaction. Two or three people told her it might be a reaction to the vaccine, and she wanted to know if it is or not. She got her second shot 14Apr2021, after a week she developed itchy eyes started from eyebrows, her eyes, both eyes and around her eyebrows started itching getting red and keeps getting swollen really bad. Sought consultation to ophthalmologist 28April2021 or 29April2021 and she was advised that it might be an allergic reaction to something, became worst as days went by. She was seen by her primary care doctor and prescribed cream for itchiness. She will visit her dermatologist tomorrow, since her eyes are itching and bothering her. She is going to see a doctor to calm down the swollen and itching, she couldn't really see. She does not feel good. She heard from her friend that she also had itchiness after being vaccinated for COVID 19, did not specifically mentioned that it was Pfizer. She wants to know if itchiness of her eyes is an allergic reaction from the COVID 19 vaccine that she had. The event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: Fever of 101 degree Fahrenheit; Headache; Nausea; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09May2021 at 16:15 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included vitamin d nos (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 16:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 09May2021 at 20:30, the patient experienced fever of 101degF, headache, nausea, chills and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 09May2021, the patient underwent body temperature and the result was 101degF. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever of 101degF, headache, nausea, chills and fatigue was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 101 degree Fahrenheit; Headache; Nausea; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09May2021 at 16:15 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included vitamin d nos (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 16:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 09May2021 at 20:30, the patient experienced fever of 101degF, headache, nausea, chills and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 09May2021, the patient underwent body temperature and the result was 101degF. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever of 101degF, headache, nausea, chills and fatigue was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pruritus, Pyrexia, Rash
Clinical narrative: Itchy; 101.5 degree fever; Chills; Skin rash all over my torso; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08May2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included slight allergy possibly to a liquid laundry detergent containing perfume. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 09:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 09May2021, in the evening, the patient experienced fever, chills and skin rash all over torso. On 11May2021, after 2 days, fever subsided and skin rash faded a little, but became very itchy. Every once a while it became incredibly itchy which was impossible to resist and he started to scratch himself everywhere on his torso. The patient further stated that, after 10 - 15 minutes, the itch goes away but usually comes back within few hours. On 09May2021, the patient underwent body temperature test and the result was 101.5 degrees (unspecified unit). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event fever was resolved on 11May2021, after the duration of 2 days. The clinical outcome of the events chills and itchy were not resolved; while that of the event skin rash all over torso was resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Decreased appetite
Clinical narrative: No sense of taste since injection.; No sense of taste or appetite since injection.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06May2021 at 14:30 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included fluoxetine hydrochloride (PROZAC), vitamin (MANUFACTURER UNKNOWN) and acetylcysteine (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 06May2021, the patient experienced no sense of taste or appetite since injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events no sense of taste or appetite since injection were not resolved at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling cold, Feeling hot
Clinical narrative: Developed a dry constant cough about 12 hours after the vaccine that is getting worse four days later; Constant flashed between freezing cold and boiling hot; Constant flashed between freezing cold and boiling hot; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0170) via an unspecified route of administration in the arm left on 07May2021 at 16:30 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. The medical history included trigger finger, asthma, allergy to pollen and mushrooms. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included fluticasone propionate (FLONASE), levocetirizine dihydrochloride (XYZAL), amoxicillin (MANUFACTURER UNKNOWN) and ephedrine hydrochloride,  guaifenesin (PRIMATENE), all from unknown dates and for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 15:30 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. On 08May2021 at 05:00, about 12 hours after the vaccination, the patient experienced a dry constant cough, which was getting worse four days later and also had constant flashed between freezing cold and boiling hot. The adverse events resulted in emergency room/department or urgent care. It was unknown whether the patient received any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dry constant cough, constant flashed between freezing cold and boiling hot was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash around knee on left leg,; Itchy skin; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07May2021 at 12:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included loratadine (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 14Apr2021 at 08:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. On 10May2021 at 16:00, the patient experienced rash around knee on left leg, itchy skin. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash around knee on left leg, itchy skin was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Myalgia, Oxygen saturation
Clinical narrative: Severe chest pain; extremely breathing difficulty; Patient's parent suspected that the chest pain was casued by surrounding muscle aches, which caused breathing difficulties and lack of oxygen; This is a spontaneous report from a contactable consumer or other non hcp (reported for herself). A 17-years-old non-regnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in Arm Left ((at the age of 17 years) on 07May2021 15:45 (Batch/Lot number was not reported) as DOSE 2, SINGLE for Covid-19 Immunisation. The patient medical history and concomitant medications were none. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route of administration on 16Apr2021 at 10.30 AM, dose 1 single administered in Left arm for Covid-19 Immunisation. Patient did not have Covid prior to vaccination. Patient did not test for Covid-post vaccination. Patient had severe chest pain and extremely breathing difficulty 36 hours after 2nd dose on 09May2021 8:00 AM. Blood oxygen level in 70-80% range. Checked into ER at 1pm. Blood tests, urine tests, and x-ray all were normal. Finally, a simple Tylenol (650 mg) took care of the chest pain. Patient's parent suspected that the chest pain was caused by surrounding muscle aches, which caused breathing difficulties and lack of oxygen. The outcome of events was recovered on an unknown date in May2021.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.