chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Pain in extremity, Rotator cuff syndrome, Scratch
Clinical narrative: left arm was sore/throbbing pain in her left arm; left arm was sore/throbbing pain in her left arm; tendinitis/tendonitis/it was in the shoulder area around the injection site and she has been scratching and then it went down her whole arm to her finger and it felt weird; shoulder area around the injection site and she has been scratching and then it went down her whole arm to her finger and it felt weird; tendinitis/tendonitis/it was in the shoulder area around the injection site and she has been scratching and then it went down her whole arm to her finger and it felt weird; shoulder area around the injection site and she has been scratching and then it went down her whole arm to her finger and it felt weird; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0202), via an unspecified route of administration administered in left arm on 09Aug2021 (21-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced her left arm was sore, throbbing pain in her left arm, tendinitis. The patient reported that she had her first dose of the Pfizer-BioNtech Covid-19 vaccine on 09Aug2021 in her left arm and her left arm was sore and that went away. Now the patient has throbbing pain in her left arm and her coach said it is tendinitis but she said she has not been in the weight room for a minute. The patient stated it was in the shoulder area around the injection site and she has been scratching and then it went down her whole arm to her finger and it felt weird. The patient stated now it is not hurting but yesterday it was going strong. The reporter stated she just had a question, she got the vaccine, the first dose, then her arm was sore, it went away, but now its like a throbbing pain in her arm, her coach said its just tendonitis but she doesn't really know. The patient wanted to know if this was normal and if it will go away and if it is safe to get the second dose after this. The patient stated that she got the first dose, she has not gotten the second one yet because she is scared to get it. The patient thinks she is 8 days past, something like that. The patient confirmed the throbbing pain is in her left arm, stated that is the arm she got the vaccine in. The reporter stated on social media it is going around that after the vaccine people are forming blood clots and it is compromising immune systems so there is information stating that everyone is going to die in two years. The reporter stated that she heard on social media that everyone who gets the vaccine is going to die in two years and she did not know if this was true. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: left arm was sore/throbbing pain in her left arm; left arm was sore/throbbing pain in her left arm; tendinitis/tendonitis/it was in the shoulder area around the injection site and she has been scratching and then it went down her whole arm to her finger and it felt weird; shoulder area around the injection site and she has been scratching and then it went down her whole arm to her finger and it felt weird; tendinitis/tendonitis/it was in the shoulder area around the injection site and she has been scratching and then it went down her whole arm to her finger and it felt weird; shoulder area around the injection site and she has been scratching and then it went down her whole arm to her finger and it felt weird; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0202), via an unspecified route of administration administered in left arm on 09Aug2021 (21-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced her left arm was sore, throbbing pain in her left arm, tendinitis. The patient reported that she had her first dose of the Pfizer-BioNtech Covid-19 vaccine on 09Aug2021 in her left arm and her left arm was sore and that went away. Now the patient has throbbing pain in her left arm and her coach said it is tendinitis but she said she has not been in the weight room for a minute. The patient stated it was in the shoulder area around the injection site and she has been scratching and then it went down her whole arm to her finger and it felt weird. The patient stated now it is not hurting but yesterday it was going strong. The reporter stated she just had a question, she got the vaccine, the first dose, then her arm was sore, it went away, but now its like a throbbing pain in her arm, her coach said its just tendonitis but she doesn't really know. The patient wanted to know if this was normal and if it will go away and if it is safe to get the second dose after this. The patient stated that she got the first dose, she has not gotten the second one yet because she is scared to get it. The patient thinks she is 8 days past, something like that. The patient confirmed the throbbing pain is in her left arm, stated that is the arm she got the vaccine in. The reporter stated on social media it is going around that after the vaccine people are forming blood clots and it is compromising immune systems so there is information stating that everyone is going to die in two years. The reporter stated that she heard on social media that everyone who gets the vaccine is going to die in two years and she did not know if this was true. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Dizziness, Head discomfort
Clinical narrative: swelling inside her mouth, lips, fingertips, and toes; swelling inside her mouth, lips, fingertips, and toes; swelling inside her mouth, lips, fingertips, and toes; generalized chills; head felt heavy; had a temperature of 101 degrees Fahrenheit; left underarm glands were tender and swollen; left arm was sore; felt like she had a bad flu reaction; felt dizzy walking; couldn't sit up; This is a spontaneous report from a contactable consumer, the patient. A 75-years-old female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 74-years-old) for covid-19 immunisation. The patient medical history included allergy to Naproxyn (Naproxen)-reactions included mouth and lips swell and feeling hot. Concomitant medications included levocetirizine dihydrochloride (XYZAL) and montelukast sodium (SINGULAIR). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that patient received the second and third dose of the Pfizer Covid-19 vaccines. She received the 3rd dose on 02Sep2021 and started having complaints of swelling inside her mouth, lips, fingertips, and toes with generalized chills, her head felt heavy, had a temperature of 101 degrees Fahrenheit, left underarm glands were tender and swollen, left arm was sore, felt like she had a bad flu reaction, felt dizzy walking, and felt like she couldn't sit up.   Caller stated that she had a similar reaction but milder with the second dose of the Pfizer Covid-19 vaccine.  Caller is asking if the 4th dose of the Pfizer Covid-19 vaccine going to be worse.  Caller is asking if other people have experienced what she has experienced. The patient stated that she had a similar reaction but milder with the second dose of the Pfizer Covid-19 vaccine.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lip swelling, Lymphadenopathy, Mouth swelling, Pain in extremity
Clinical narrative: swelling inside her mouth, lips, fingertips, and toes; swelling inside her mouth, lips, fingertips, and toes; swelling inside her mouth, lips, fingertips, and toes; generalized chills; head felt heavy; had a temperature of 101 degrees Fahrenheit; left underarm glands were tender and swollen; left arm was sore; felt like she had a bad flu reaction; felt dizzy walking; couldn't sit up; This is a spontaneous report from a contactable consumer, the patient. A 75-years-old female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 74-years-old) for covid-19 immunisation. The patient medical history included allergy to Naproxyn (Naproxen)-reactions included mouth and lips swell and feeling hot. Concomitant medications included levocetirizine dihydrochloride (XYZAL) and montelukast sodium (SINGULAIR). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that patient received the second and third dose of the Pfizer Covid-19 vaccines. She received the 3rd dose on 02Sep2021 and started having complaints of swelling inside her mouth, lips, fingertips, and toes with generalized chills, her head felt heavy, had a temperature of 101 degrees Fahrenheit, left underarm glands were tender and swollen, left arm was sore, felt like she had a bad flu reaction, felt dizzy walking, and felt like she couldn't sit up.   Caller stated that she had a similar reaction but milder with the second dose of the Pfizer Covid-19 vaccine.  Caller is asking if the 4th dose of the Pfizer Covid-19 vaccine going to be worse.  Caller is asking if other people have experienced what she has experienced. The patient stated that she had a similar reaction but milder with the second dose of the Pfizer Covid-19 vaccine.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Sitting disability
Clinical narrative: swelling inside her mouth, lips, fingertips, and toes; swelling inside her mouth, lips, fingertips, and toes; swelling inside her mouth, lips, fingertips, and toes; generalized chills; head felt heavy; had a temperature of 101 degrees Fahrenheit; left underarm glands were tender and swollen; left arm was sore; felt like she had a bad flu reaction; felt dizzy walking; couldn't sit up; This is a spontaneous report from a contactable consumer, the patient. A 75-years-old female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single (at the age of 74-years-old) for covid-19 immunisation. The patient medical history included allergy to Naproxyn (Naproxen)-reactions included mouth and lips swell and feeling hot. Concomitant medications included levocetirizine dihydrochloride (XYZAL) and montelukast sodium (SINGULAIR). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that patient received the second and third dose of the Pfizer Covid-19 vaccines. She received the 3rd dose on 02Sep2021 and started having complaints of swelling inside her mouth, lips, fingertips, and toes with generalized chills, her head felt heavy, had a temperature of 101 degrees Fahrenheit, left underarm glands were tender and swollen, left arm was sore, felt like she had a bad flu reaction, felt dizzy walking, and felt like she couldn't sit up.   Caller stated that she had a similar reaction but milder with the second dose of the Pfizer Covid-19 vaccine.  Caller is asking if the 4th dose of the Pfizer Covid-19 vaccine going to be worse.  Caller is asking if other people have experienced what she has experienced. The patient stated that she had a similar reaction but milder with the second dose of the Pfizer Covid-19 vaccine.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Heart rate, Heart rate increased, Palpitations, Throat tightness
Clinical narrative: pounding, fast heart rate/heart got up to 125-130s not just in the low 100s; tightness in her throat and chest; tightness in her throat and chest; pounding, fast heart rate/heart got up to 125-130s not just in the low 100s; This is a spontaneous report from a contactable nurse.  A 36-year-old female patient first dose of 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 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated on behalf of her niece inquiring about receiving the second dose of the Pfizer Covid-19 vaccine following a side effect from the first dose. Caller reported that her niece received her first dose of the vaccine and experienced a pounding, fast heart rate. Caller states "she actually had multiple symptoms. Her heart got up to 125-130s not just in the low 100s, she had tightness in her throat and chest." Caller asked should she get the second dose?. At the time of this report event outcome was unknown.   The lot number for the vaccine, was not provided and will be requested during follow up.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Extra dose administered, Fatigue
Clinical narrative: received his third dose of the vaccine; received his third dose of the vaccine; exacerbation of COPD; fatigued; His symptoms have worsened; shortness of breath; difficulty walking more than 10 feet; This is a spontaneous report from a contactable consumer (patient wife) from a Pfizer sponsored program regulatory authority Support. A 87-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: FD8448) via an unspecified route of administration on 16Aug2021 13:00 (age at the time of vaccination was 87 years) in left arm as dose 3, single for covid-19 immunisation; Influenza vaccine (FLU VACCINE VII), via an unspecified route of administration from 16Aug2021 (Batch/Lot number was not reported) on 16Aug2021, as dose number unknown, single for influenza. The patient medical history included ongoing chronic obstructive pulmonary disease had this condition for 6-7 years (stated it was Emphysema), limb injury from Jun2021 and ongoing almost completely healed. The patient concomitant medication(s) included prednisone (RAYOS) and dicloxacillin (DICLOXACILLIN) taken for wound treatment. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN6199) via an unspecified route of administration on 03Mar2021 as dose 1, single for COVID-19 immunisation and patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EP7534) via an unspecified route of administration on 27Mar2021 as dose 2, single for COVID-19 immunisation. On an unspecified date in Aug2021, the patient experienced shortness of breath more than usual, as well as difficulty walking more than 10 feet, his symptoms have worsened, exacerbation of copd and fatigued. The patient not visited to Emergency Room and Physician Office. The clinical outcome of the event shortness of breath and difficulty walking more than 10 feet were not recovered. The clinical outcome of the other events were unknown.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Off label use
Clinical narrative: received his third dose of the vaccine; received his third dose of the vaccine; exacerbation of COPD; fatigued; His symptoms have worsened; shortness of breath; difficulty walking more than 10 feet; This is a spontaneous report from a contactable consumer (patient wife) from a Pfizer sponsored program regulatory authority Support. A 87-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: FD8448) via an unspecified route of administration on 16Aug2021 13:00 (age at the time of vaccination was 87 years) in left arm as dose 3, single for covid-19 immunisation; Influenza vaccine (FLU VACCINE VII), via an unspecified route of administration from 16Aug2021 (Batch/Lot number was not reported) on 16Aug2021, as dose number unknown, single for influenza. The patient medical history included ongoing chronic obstructive pulmonary disease had this condition for 6-7 years (stated it was Emphysema), limb injury from Jun2021 and ongoing almost completely healed. The patient concomitant medication(s) included prednisone (RAYOS) and dicloxacillin (DICLOXACILLIN) taken for wound treatment. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN6199) via an unspecified route of administration on 03Mar2021 as dose 1, single for COVID-19 immunisation and patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EP7534) via an unspecified route of administration on 27Mar2021 as dose 2, single for COVID-19 immunisation. On an unspecified date in Aug2021, the patient experienced shortness of breath more than usual, as well as difficulty walking more than 10 feet, his symptoms have worsened, exacerbation of copd and fatigued. The patient not visited to Emergency Room and Physician Office. The clinical outcome of the event shortness of breath and difficulty walking more than 10 feet were not recovered. The clinical outcome of the other events were unknown.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pain in extremity
Clinical narrative: body aches; feels a little sore in left arm; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: SP8448), dose 2 via an unspecified route of administration, administered in Arm Left on 08Sep2021 (at the age of 21-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. No Patient History was reported. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (Batch/lot number: FC3180 Expiration: unknown) via an unspecified route of administration, administered in Arm Left on 16Aug2021 around 0900 (at the age of 21-years-old) as dose 1, single for covid-19 immunisation. On 08Sep2021, the patient experienced body aches, feels a little sore in left arm and not feeling well.  The patient wanted to know if she could take tea and Theraflu for her body ache she was having. When the patient took the shot she was fine then started feeling pain from 10pm-midnight and early morning around 1am and 6am. The she felt a little sore in left arm. The body aches come and goes, right now she was fine.  She received treatment with tylenol around 6am. She was at work. Clarified she was not having a fever. When she took first dose she was fine but for some reason the second dose affected her. Outcome of the events were unknown.  Follow-Up (09Sep2021): This is a spontaneous report from a contactable consumer. This consumer (patient) reported new information included date of birth, height, weight, event onset date, first dose information and clinical information.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Pain, Rash
Clinical narrative: shingles; pain; tired; rash that went back and forth on his arm and back; This is a spontaneous report from a contactable consumer (patient wife) and a contactable consumer or other non hcp (patient) via medical information team. A 80-year-old male patient received first dose of bnt162b2 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on 29Jan2021 at dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 31Jan2021, the patient experienced rash that went back and forth on his arm and back. On an unspecified date,The patient experienced shingles, pain and tired. It was reported that caller's husband was 80 years old and had his first dose on 29Jan2021 and two days later came down with a rash that went back and forth on his arm and back. Once the rash got worse, he went to the ER and they said it was shingles. Caller stated they have been to 12 different doctors and on prednisone and a few other medications since then. Caller stated he was having a lot of pain and asked what could be done to alleviate all of this. Caller stated he gets tired easily and never did before, he goes outside to work in the yard and gets very tired, asked was that normal. The patient (caller's husband) received his second dose 10 weeks after his first dose. He states he gets tired real easily and his balance wasn't what it used to be. The patient stated when he worked hard with his right arm with a wheelbarrow it seems to flare up and in the 90 degree heat it did the same thing, and asked what can he done to get rid of this. Patient states he has been to 12 or 14 doctors and none of them "knew crap". The patient states it was from the base of his neck down to his right arm and thumb and forefinger and his arm was like a piece of leather. Patient asked if they can give information to his physician. Patient stated he got the covid shot and got shingles that was still there but was not contagious after a week and had all this pain and had shots and medicine. Caller asked how long will this last. Caller stated they know one fella who has pain in his right arm after the Covid shot, shingles is being affected from the shot. Caller's husband asked if he was supposed to take the booster. Responded a third dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) administered at least 28 days following the second dose of this vaccine is authorized for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. Therapeutic measures were taken as a result of shingles, pain, rash that went back and forth on his arm and back. The outcome of the event shingles was not recovered. All other events were unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Investigation, Upper respiratory tract infection
Clinical narrative: upper respiratory infection; I got sick; This is a spontaneous report from a contactable consumer (patient) reported from a Pfizer Sponsored Program. A 77-years-old female patient second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 13Mar2021 as DOSE 2, SINGLE for covid-19 immunisation and received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 19Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included type 2 diabetes mellitus. The patient's concomitant medications were not reported. The patient reported that on an unspecified date in 2021, I got sick with an upper respiratory infection, which lasted 10 days-2 weeks and that's why I got the labs done. Patient reported lab test done in Jul2021, and it showed no antibodies. My doctor can't say anything. My endocrinologist didn't say anything. I need clarification on what I need to do. Patient stated that there were others like me; they didn't had antibodies. I need someone to advise me to take it again or not. No one can tell me that. It's the vaccine itself that didn't take in my system. The patient underwent lab tests and procedures which included lab test with result no antibodies on Jul2021 (testing negative for antibodies/it showed no antibodies). The outcome of the events were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: I have had shingles before (10 years ago) and recognized it. Since then it is slowly spreading in a circle around the outside of my underarm on both arms; I started having a burning sensation in the underarm area of my left arm; I had a rash area develop in the underarm of my left arm.; This is a spontaneous report from a contactable consumer (patient) or other HCP. A 50-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: FA7485) dose number unknown via an unspecified route of administration, administered in the left arm on 04Sep2021 17:45 (at the age of 50 years old) as dose number unknown, single for COVID-19 immunisation. Medical history included crohn's disease, anxiety, depression, palpitations (one chamber of heart beating out of rhythm with the others), shingles had shingles before (10 years ago). Patient had no known allergies. Concomitant medication(s) included escitalopram oxalate; fluticasone propionate; duloxetine; aspirin (acetylsalicylic acid), atorvastatin; clonazepam; melatonin; infliximab dyyb; nebivolol; trazodone and multivitamins start date and stop date was unknown. No other vaccines were given 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested COVID-19. On 05Sep2021 16:00 the patient experienced I have had shingles before (10 years ago) and recognized it, since then it is slowly spreading in a circle around the outside of my underarm on both arms, I started having a burning sensation in the underarm area of my left arm, I had a rash area develop in the underarm of my left arm. Therapeutic measures were taken as a result of I have had shingles before (10 years ago) and recognized it, since then it is slowly spreading in a circle around the outside of my underarm on both arms, I started having a burning sensation in the underarm area of my left arm, I had a rash area develop in the underarm of my left arm and included treatment with prescriptions for valacyclovir and gabapentin. All the events results physician office visit. The clinical outcome of the events was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Poor quality product administered
Clinical narrative: They should be like cloudy you know like off white and was completely clear; Mild pain in my shoulder; I am just like, I can't sleep its been 2 hours that I am here thinking about reading about.; This is a spontaneous report from a contactable nurse (patient). A 40-years-old patient of an unspecified gender received first dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration on 09Sep2021 (Batch/Lot Number: BA30130) (at the age of 40-years-old) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Sep2021, the patient took the vaccine and found the appearance as like cloudy like off white and was completely clear and had mild pain in her shoulder and patient was wondering about the appearance of the vaccine and wanted to make sure that she got the thing and was done in right way that's all. It was reported that patient couldn't slept for 2 hours. The patient did not received any treatment for the events. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Alcohol intolerance, Hangover
Clinical narrative: severe hangovers; has zero tolerance to alcohol; This is a spontaneous report from a contactable consumer reported for himself.   A 32-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that he has been having severe hangovers and has zero tolerance to alcohol. Caller wants to know if there have been any issues reported with the vaccine affecting the liver?. At the time of this report event outcome was unknown.   The lot number for was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She reports testing positive for the covid 19 virus last Friday; She reports testing positive for the covid 19 virus last Friday; This is a spontaneous case received from a contactable consumer (patient). A 49-year-old female patient received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, lot number were 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 unknown date, the patient reported of testing positive for the COVID-19 virus last Friday. She was supposed to get her second dose of the vaccination series today however said that she had heard two different things if she could get it or not. Caller reports that she was going to get tested again tomorrow and Monday will be her 10 days of quarantine. The patient underwent lab test which included COVID-19 virus test and was tested positive on 03Sep2021. The outcome of the events was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Illness, Limb discomfort
Clinical narrative: Guillain-Barre syndrome; slowly feeling something in her legs; ill; This is a spontaneous report from pharmacist via Pfizer sponsored program. A 61-year-old female patient received unspecified dose of bnt162b2 (Comirnaty, Solution for injection, Batch/Lot number was not reported, Expiry date: 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 Guillain-Barre syndrome, slowly feeling something in her legs and ill on an unspecified date in Jul2021. The outcome of the events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Based on the limited information available the causal association between the event Guillain-Barre syndrome and the vaccine BNT162B2 can neither be meaningfully assessed nor excluded. The case will be reassessed once detailed information is regarding vaccination details, medical history are available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Urticaria, Vaccination site pruritus
Clinical narrative: This is a spontaneous report received from a contactable other health care physician (patient) via physician. A 44-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: not provided) via an unspecified route of administration at left arm on 08Sep2021 (at the age of 44-year-old) as dose 1, single for COVID-19 immunisation. The patient does not have any medical history including any illness at time of vaccination. There were no concomitant medications. Patient did not receive any other vaccinations prior to vaccination within 4 weeks and It was yes Adverse events following prior vaccinations: to flu vaccine. It was mentioned that caller reported that she received her first Covid vaccine dose yesterday and afterwards experienced an allergic reaction on 08Sep2021. Caller reports that she received the shot between 4-4:30 and at 11pm the injection site started to itch on 08Sep2021, it then spread to her arm and neck. She went to Employee health and got Benadryl but states that she got hives and redness on the left arm also on an Sep2021. Now the caller is trying to get an exemption at work but it was declined. She doesn't want to get the second dose due to her reaction to the first, now wondering what she does. Further caller asking "What do I do if I don't want to get the second dose. Referred to HCP for evaluation and guidance. Caller states she went to employee health today. Caller relays it stopped after the Benadryl and today it started again on her arm, today the redness came back. Caller states she was an allergic person and was trying to get an exemption as she usually develops an allergy and itches with hives all over her body. States they didn't accept her exemption and want her to do the 2nd but she doesn't want to do it as she is allergic. Patient did not visit emergency room but visits the physician office for the events. Therapeutic measures were taken for the events. Outcome of the events allergic reaction, got hives and redness on the left arm also not recovered and injection site started to itch, it then spread to her arm and neck was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Palpitations
Clinical narrative: has a feeling of her heart racing or fluttering/her heart beating out of her chest it was a fluttering feeling; has a feeling of her heart racing or fluttering/her heart beating out of her chest it was a fluttering feeling; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 34-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on 19Aug2021 (age at the time of vaccination was 34 years) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. Caller stated that she was scheduled to receive the Pfizer COVID vaccine second dose today and she was questioning if she should get the second dose because the same night (19Aug2021) she got the first dose of the vaccine she had a feeling of her heart racing or fluttering. Caller would like to know if we have any recommendations for her regarding receiving the second dose. Caller stated that it was scary that night and you could see her heart beating out of her chest it was a fluttering feeling and that was the best way that she can describe it. The clinical outcome of the events were unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: Chills; Excessive heat; water bumps to left arm; itching; swelling under the arm; red blotches that have since healed; The red blotches in my arm left black spots, not red, and blue; This is a spontaneous report from a contactable Nurse who reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 28Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced chills, excessive heat, water bumps to left arm, itching, swelling under the arm, and red blotches that have since healed. The patient reported that, "the red blotches in my arm left black spots, not red, and blue" additionally occurred on an unspecified date in 2021. The patient wanted to know if as a result of the reaction, should she take the second dose of the vaccine. The outcome of the event "red blotches that have since healed" was reported as resolved on an unspecified date in 2021. The outcome of other events was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Skin discolouration
Clinical narrative: Chills; Excessive heat; water bumps to left arm; itching; swelling under the arm; red blotches that have since healed; The red blotches in my arm left black spots, not red, and blue; This is a spontaneous report from a contactable Nurse who reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 28Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced chills, excessive heat, water bumps to left arm, itching, swelling under the arm, and red blotches that have since healed. The patient reported that, "the red blotches in my arm left black spots, not red, and blue" additionally occurred on an unspecified date in 2021. The patient wanted to know if as a result of the reaction, should she take the second dose of the vaccine. The outcome of the event "red blotches that have since healed" was reported as resolved on an unspecified date in 2021. The outcome of other events was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Today Set 8, 2021 I was diagnose with COVID; Today Set 8, 2021 I was diagnose with COVID; This is a spontaneous report from a contactable consumer (Patient). A 48 Years old Non Pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8732 and Expiry date was not reported), via an unspecified route of administration on 31Mar2021 10:30 (at the age of 47-years-old) in Arm Left as dose 2, single for COVID-19 immunization. The Patient Medical history included cholesterol from an unknown date and unknown if ongoing , thyroid from an unknown date and unknown if ongoing , overweight from an unknown date and unknown if ongoing , Latex from an unknown date and unknown if ongoing , allergy to cats from an unknown date and unknown if ongoing , allergy to dogs from an unknown date and unknown if ongoing, allergy to dust from an unknown date and unknown if ongoing, allergy to mites from an unknown date and unknown if ongoing and allergy to IBA. The patient previously took penicillin and experienced drug hypersensitivity, lidocaine and experienced drug hypersensitivity. The Patient received other medications in two weeks was Allergy shot. The Patient was not pregnant at the time of vaccination. The Patient had not diagnosed with COVID-19 prior to vaccination and the patient had tested for COVID-19 post vaccination. On 12Apr2021 09:30, the patient experienced today set 8, 2021 she was diagnose with covid. The Patient visited physician office and emergency room visit. The Patient did not received treatment for the adverse event. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive Nasal Swab on 09Sep2021. The outcome for the events was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient (also the age at vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 19Aug2021 11:00 (Lot Number: FD8448) as single for COVID-19 immunization. Medical history included B12 deficiency, mild asthma, the patient also has several allergies; all from an unknown date and unknown if ongoing. The patient is not pregnant. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient experienced anaphylactic reaction on 19Aug2021 11:00 with outcome of not recovered. Event assessed as serious due to life threatening. The event was described as follows: anaphylactic reaction that needed epinephrine then to ER. The patient was also given steroids and Benadryl. Adverse reactions continues to present date. Symptoms were facial/ chest redness/facial numbness, similar to a mega dose of Novocaine. Jaw numbness/pain. Numb and sore lips and tongue/poor taste buds. Body weakness. Shortness of breath. Body feels like a foreign monster has entered it. Attacks of the body leads to weakness, shortness of breath. The attacked was severe to point of taking off feet for bed rest as it attacked back area, which caused shortness of breath, substantial body weakness. Event anaphylactic reaction resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and was assessed as life threatening illness (immediate risk of death from the event). The patient was not diagnosed of covid prior vaccination and has not been tested for covid post vaccination.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Hypoaesthesia, Lung disorder
Clinical narrative: Anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient (also the age at vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 19Aug2021 11:00 (Lot Number: FD8448) as single for COVID-19 immunization. Medical history included B12 deficiency, mild asthma, the patient also has several allergies; all from an unknown date and unknown if ongoing. The patient is not pregnant. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient experienced anaphylactic reaction on 19Aug2021 11:00 with outcome of not recovered. Event assessed as serious due to life threatening. The event was described as follows: anaphylactic reaction that needed epinephrine then to ER. The patient was also given steroids and Benadryl. Adverse reactions continues to present date. Symptoms were facial/ chest redness/facial numbness, similar to a mega dose of Novocaine. Jaw numbness/pain. Numb and sore lips and tongue/poor taste buds. Body weakness. Shortness of breath. Body feels like a foreign monster has entered it. Attacks of the body leads to weakness, shortness of breath. The attacked was severe to point of taking off feet for bed rest as it attacked back area, which caused shortness of breath, substantial body weakness. Event anaphylactic reaction resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and was assessed as life threatening illness (immediate risk of death from the event). The patient was not diagnosed of covid prior vaccination and has not been tested for covid post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Limb discomfort, Pain
Clinical narrative: hurts; feels kind of strange; discomfort in her arm from the first vaccine/she received the injection in the left arm in which that is the side she is experiencing discomfort; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional via medical information team. A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient stated that she still has discomfort in her arm from the first vaccine, in which the discomfort has progressed to her hand and felt like some issue with a nerve, like a nerve in her hand. she received the injection in the left arm in which that was the side she was experienced discomfort, she has had this discomfort for 3 weeks, asked if this was ok and why was she experienced this side effect for so long. She stated she has heard some state they experienced the same side effect for a few days or a week, but not as long as she was experiencing the discomfort. Patient described the feeling as she didn't know if it was a nerve, but it felt strange. Sometimes it hurts, but mostly felt kind of strange. She also stated that hand feels like something was not right about left arm and asked if she should receive the second dose. she consulted with the vaccination provider in which they stated she could receive the vaccine in her thigh instead and asked how long people experienced the pain in their arm as noted in the post authorization. Outcome of the events were not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Androgen deficiency
Clinical narrative: stopped producing testosterone; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A Non-contactable consumer(patient's parent) reported for a male patient (reporter's son) that: A 19-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was unknown) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stopped producing testosterone on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.