chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Hyperhidrosis, Insomnia, Joint range of motion decreased, Neck pain
Clinical narrative: chest flutters / still experiencing the flutters; runny nose; sweating / sweating on her forehead; staying hot; when the flutters happen there's a little pain/ very painful, extended into neck, armpit and lower arm that kept her up at night.; a little tightening that comes and goes; arm was swollen; couldn't lift the shoulder or arm up; it was red where the needle went in; it was red where the needle went in at the injection site, very painful; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; kept her up at night; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Aug2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of the Pfizer BioNTech Covid 19 vaccine on 07Aug2021 and is due for her second dose on 28Aug2021. About a week after in Aug2021 she developed a runny nose and developed flutters, chest flutters. Her nose was starting to dry out but was still experiencing the flutters and has been sweating on her forehead and staying hot. She said it didn't feel like a fever and hadn't taken her temperature but she did sweat and that she got hot. She had the flutters throughout the day, not constant, it came and went. She got the shot in the left arm. Sometimes when the flutters happen there was a little pain with it, a little tightening that came and went. However, there's not always pain that's associated with it. The sweating happened first and then she got the flutters. Her husband got the vaccine and had no problems. She had a TDaP shot in her left arm back on 15Oct2012 for immunization and had a severe reaction. She had done fine with other tetanus shots in the past but she said she was told that after age 40 you receive a combination and that's the one she had this reaction with. Her arm was swollen, couldn't lift the shoulder or arm up, it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm that kept her up at night. The outcome of chest flutters was not resolved, the outcome of other events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rhinorrhoea, Vaccination site erythema, Vaccination site pain
Clinical narrative: chest flutters / still experiencing the flutters; runny nose; sweating / sweating on her forehead; staying hot; when the flutters happen there's a little pain/ very painful, extended into neck, armpit and lower arm that kept her up at night.; a little tightening that comes and goes; arm was swollen; couldn't lift the shoulder or arm up; it was red where the needle went in; it was red where the needle went in at the injection site, very painful; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm; kept her up at night; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Aug2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of the Pfizer BioNTech Covid 19 vaccine on 07Aug2021 and is due for her second dose on 28Aug2021. About a week after in Aug2021 she developed a runny nose and developed flutters, chest flutters. Her nose was starting to dry out but was still experiencing the flutters and has been sweating on her forehead and staying hot. She said it didn't feel like a fever and hadn't taken her temperature but she did sweat and that she got hot. She had the flutters throughout the day, not constant, it came and went. She got the shot in the left arm. Sometimes when the flutters happen there was a little pain with it, a little tightening that came and went. However, there's not always pain that's associated with it. The sweating happened first and then she got the flutters. Her husband got the vaccine and had no problems. She had a TDaP shot in her left arm back on 15Oct2012 for immunization and had a severe reaction. She had done fine with other tetanus shots in the past but she said she was told that after age 40 you receive a combination and that's the one she had this reaction with. Her arm was swollen, couldn't lift the shoulder or arm up, it was red where the needle went in at the injection site, very painful, extended into neck, armpit and lower arm that kept her up at night. The outcome of chest flutters was not resolved, the outcome of other events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: I received my third dose of Pfizer Covid vaccine on 19Aug2021; I received my third dose of Pfizer Covid vaccine on 19Aug2021; just to the side of injection site on my arm it's kind of swollen like a two inch swollen area and it was red and sore; has a little swelling; just to the side of injection site on my arm it's kind of swollen like a two inch swollen area and it was red and sore; has a little swelling; just to the side of injection site on my arm it's kind of swollen like a two inch swollen area and it was red and sore; has a little swelling; This spontaneous report from contactable consumer (patient).   A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, on 19Aug2021, as a dose 3, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Batch/Lot number: not reported), via an unspecified route of administration, on unspecified date at, as a dose 1, single and dose 2, single for COVID-19 immunization. It was reported that patients first two doses were uneventful. On unspecified date patient experienced injection site on patient arm it was kind of swollen like a two inch swollen area and it was red and sore and now it's not sore but it was still had a little swelling. Patient was wondering how many days patient can expect that to last. Outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Odynophagia
Clinical narrative: lymph node and my neck under my jaw is swollen up so if I swallow it hurts; lymph node and my neck under my jaw is swollen up so if I swallow it hurts; This is spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FC3180), via an unspecified route of administration, as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. The patient past drug includes remicade for rheumatoid disease (I have rheumatoid disease so I am on immune depressant infusion once a month I take Remicade, they put that IV for 3 hours once a month it lowers my immune system). The patient stated that patient calling and was doing by the time to saw and was anywhere to get to the patient's doctors but the patient got the first shot the first of the week of this month and due for the second one today and the day after that the patient got the shot and had lymph node, the Covid vaccine (Captured as per verbatim) shot, the Pfizer. The patient got the shot the 1st of the month, the first one and due for the second one today but the patient lymph node and neck under and the jaw was swollen up so if it swallow it hurts and it was swollen but the patient had rheumatoid disease so on immune depressant infusion once a month the patient took Remicade and they put that IV for 3 hours once a month it lowers the patient's immune system. The patient did not know if they should get the second shot again while it was still swollen and also neck was. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Menopause, Postmenopausal haemorrhage, SARS-CoV-2 test
Clinical narrative: After 30 minutes, My heart rate would rise to 150-160 frequently for 3 days. It started my menstrual cycle back that had been gone for 2 years and restarted menopause.; After 30 minutes, My heart rate would rise to 150-160 frequently for 3 days. It started my menstrual cycle back that had been gone for 2 years and restarted menopause.; After 30 minutes, My heart rate would rise to 150-160 frequently for 3 days. It started my menstrual cycle back that had been gone for 2 years and restarted menopause.; This is a spontaneous report from a contactable nurse. A 52-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 (age at vaccination 52-years-old) (Batch/Lot Number: ER8729) as dose 1, single for covid-19 immunisation. Medical history included hyperthyroidism, meniere's disease, cardiac disorder and covid-19. Concomitant medication included levothyroxine sodium, hydrochlorothiazide, triamterene (DYAZIDE), magnesium and potassium. Patient had COVID prior to vaccination. Patient was tested for COVID-19 post vaccination. Patient did not receive any vaccines in 4 weeks. On 08Apr2021 10:00, after 30 minutes heart rate would rise to 150-160 frequently for 3 days. It started her menstrual cycle back that had been gone for 2 years and restarted menopause. The patient underwent lab tests and procedures which included heart rate rise to 150-160 on 08Apr2021. On an unspecified date in Jun2021, patient was tested for sars-cov-2 with nasal swab and showed negative results. Patient did not receive any treatment for events. At the time of this report, the outcome of event was recovering.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Ear canal erythema, Ear discomfort, Erythema, Erythema of eyelid, Eyelid irritation
Clinical narrative: redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; This is a spontaneous report from a contactable consumer (patient). This 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EM9809) on 24Feb2021, at the age of 71 years, as the second single dose, in right arm, for COVID-19 immunisation. No other vaccine was administered in 4 weeks. Medical history was none. The patient received the first dose of BNT162B2 vaccine on 03Feb2021 (lot EN5318), at the age of 71 years, in right arm. The patient did not have COVID prior vaccination. Concomitant medication included morniflumate (FLOMAX). On 03Mar2021 the patient experienced redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area. COVID was not tested after vaccination. The events resulted in Doctor or other healthcare professional office/clinic visit, required treatment (cortisone shot) and had not yet resolved.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Genital erythema, Skin irritation
Clinical narrative: redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; This is a spontaneous report from a contactable consumer (patient). This 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EM9809) on 24Feb2021, at the age of 71 years, as the second single dose, in right arm, for COVID-19 immunisation. No other vaccine was administered in 4 weeks. Medical history was none. The patient received the first dose of BNT162B2 vaccine on 03Feb2021 (lot EN5318), at the age of 71 years, in right arm. The patient did not have COVID prior vaccination. Concomitant medication included morniflumate (FLOMAX). On 03Mar2021 the patient experienced redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area. COVID was not tested after vaccination. The events resulted in Doctor or other healthcare professional office/clinic visit, required treatment (cortisone shot) and had not yet resolved.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Cough, Pain in extremity, Wheezing
Clinical narrative: Severe sore arm; asthmatic flare-ups for past 4 days (not improving with inhalers). Not severe enough to go to ER, but not able to go about my day without wheezing and having tightness in chest and induced cough due to the tightness.; Severe sore arm; asthmatic flare-ups for past 4 days (not improving with inhalers). Not severe enough to go to ER, but not able to go about my day without wheezing and having tightness in chest and induced cough due to the tightness.; Severe sore arm; asthmatic flare-ups for past 4 days (not improving with inhalers). Not severe enough to go to ER, but not able to go about my day without wheezing and having tightness in chest and induced cough due to the tightness.; Severe sore arm; asthmatic flare-ups for past 4 days (not improving with inhalers). Not severe enough to go to ER, but not able to go about my day without wheezing and having tightness in chest and induced cough due to the tightness.; Severe sore arm; asthmatic flare-ups for past 4 days (not improving with inhalers). Not severe enough to go to ER, but not able to go about my day without wheezing and having tightness in chest and induced cough due to the tightness.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20Aug2021 18:00 (at the age of 40-years-old) (Batch/Lot Number: FA7485) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma, hypoglycaemia, arthritis, Allergy: Latex, Known Allergies: oral steroids. Concomitant medications included ibuprofen (IBUPROFEN); paracetamol (TYLENOL); rimegepant sulfate (NURTEC ODT). The patient has Known Allergies: morphine, and external iodine. On 20Aug2021 21:00, the patient experienced Severe sore arm; asthmatic flare-ups for past 4 days (not improving with inhalers). Not severe enough to go to ER, but not able to go about her day without wheezing and having tightness in chest and induced cough due to the tightness. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered. The patient did not have COVID prior vaccination, and was not COVID tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm soreness; low fever; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number and Expiration date were not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the caller stated with first dose of the Pfizer covid vaccine she and her mother had similar reaction like arm soreness and low fever then it went away and wanted to know about how long mRNA stays in the body. The outcome of the events was recovered on an unspecified date.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dysgeusia, SARS-CoV-2 test, Weight
Clinical narrative: 18 pounds weight lost; Complete loss of taste and smell and then only partial of taste and smell; Complete loss of taste and smell and then only partial of taste and smell; Taste buds have changed drastically as everything tastes bad; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in left arm, on 13May2021 at 12:00 PM (at the age of 17 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included COVID-19 (prior vaccination). There were no concomitant medications. The patient had no known allergies. No other vaccine was administered in four weeks. The vaccine was administered in a public health clinic or administration facility. In 2021 (reported as 13Apr2021 at 04:00 PM; pending clarification), the patient experienced complete loss of taste and smell for 3 weeks and then only partial of taste and smell. Taste buds have changed drastically as everything tastes bad (2021). In 2021, the patient also experienced 18 pounds weight lost (lost 18 lbs). The events resulted in doctor or other healthcare professional office or clinic visit. No treatment was administered for the events. The patient underwent COVID-19 nasal swab test that was negative on 01Jun2021. The patient had not recovered from the events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: 18 pounds weight lost; Complete loss of taste and smell and then only partial of taste and smell; Complete loss of taste and smell and then only partial of taste and smell; Taste buds have changed drastically as everything tastes bad; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in left arm, on 13May2021 at 12:00 PM (at the age of 17 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included COVID-19 (prior vaccination). There were no concomitant medications. The patient had no known allergies. No other vaccine was administered in four weeks. The vaccine was administered in a public health clinic or administration facility. In 2021 (reported as 13Apr2021 at 04:00 PM; pending clarification), the patient experienced complete loss of taste and smell for 3 weeks and then only partial of taste and smell. Taste buds have changed drastically as everything tastes bad (2021). In 2021, the patient also experienced 18 pounds weight lost (lost 18 lbs). The events resulted in doctor or other healthcare professional office or clinic visit. No treatment was administered for the events. The patient underwent COVID-19 nasal swab test that was negative on 01Jun2021. The patient had not recovered from the events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Somatic symptom disorder
Clinical narrative: Numbness in face; diagnosed initially as potential bell's palsy then later updated to psychosomatic reaction; This is a spontaneous report from a contactable consumer (Pfizer Colleague).  An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 23Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history includes COVID-19 from unknown date and unknown if ongoing (reported as if covid prior vaccination Yes). There were no concomitant medications. It was unknown if other vaccine in four weeks and if other medications in two weeks. It was reported that the patient experienced numbness in face, diagnosed initially as potential bell's palsy then later updated to psychosomatic reaction on 23Aug2021. The event resulted in Emergency room/department or urgent care and hospitalization. It was unknown if treatment was initiated. The patient was not covid tested post vaccination. The outcome of the events was recovered.   No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches; This is a spontaneous report from a contactable consumer (patient). A 88-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included hyperthyroidism. The patient's concomitant medication included methimazole. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and she and her mother had similar reaction like arm soreness and low fever then it went away. On an unspecified date, the patient experienced body aches. Caller stated body aches comes and goes and they are not getting any less. Caller wanted to know if its normal. The outcome was recovered.  The lot number for the vaccine was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: every joint on her body has been hurting/joint issues and her fingers also hurt; hurt pretty bad; hurt pretty bad/injection site that hurt pretty bad; fibromyalgia; retaining water; she also had a bruise on that same arm; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 06Aug2021 (Batch/Lot Number: FA7484) as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination 50-years-old). The patient Medical history, family history and concomitant medications were none. It was reported that, patient still needs to get the 2nd shot of the Comirnaty vaccine but she was concerned if she should get it because the 1st shot hurt pretty bad and every joint on her body has been hurting for the last week and a half and was reported as worsened. As per caller, she clarified that it was the arm where she got the injection site that hurt pretty bad later afternoon. She added that she felt the injection go in and then she screamed because it hurt. She felt that for 2 and a half to 3 days and she also had a bruise on that same arm which was her left arm. Those symptoms went away and now she has body joint issues and her fingers also hurt. Caller received her 1st dose on 06Aug2021 and was set to receive the 2nd one this Friday. She was told that the 1st shot would not bother her and would only feel the side effects after the 2nd shot. She called to know if these are normal side effects of the vaccine because she was nervous to get the 2nd shot. She mentioned that she would be calling her doctor after the call as well. She stated that she felt comfortable knowing that these are normal side effects. She was nervous on day 6 it hurt pretty bad, she had pain when it happen and two and a half to three days later it hurt and bruising. For about a week and a half now every joint in her body hurts. Her husband said it did not hurt him. She hated needles, and she talked to her daughter and she said she also had pain in her joints. Hurt pretty bad: The pain stopped where she got the injection. It went away. The patient experienced hurt pretty bad/injection site that hurt pretty bad on 06Aug2021, every joint on her body has been hurting/joint issues and her fingers also hurt on 09Aug2021, she also had a bruise on that same arm, fibromyalgia and retaining water on an unspecified date in Aug2021. Her mother has fibromyalgia and she was thinking that was what she has. She was double checking with us and the doctor before the second shot. The patient did not receive any treatment. The patient not required to visit emergency room and physician office. There were no prior vaccinations (within 4 weeks). There were no relevant tests performed. Outcome of the events hurt pretty bad/injection site that hurt pretty bad was recovered on 09Aug2021, every joint on her body has been hurting/joint issues and her fingers also hurt was not recovered and unknown for other events.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Cold sweat, Confusional state, Dizziness
Clinical narrative: could feel I was about to faint any second/lightheaded; felt a wave of uneasiness come over me; felt confused & scared,everything sounded far away; felt confused & scared,everything sounded far away; my heart was beating rapidly & was sweating; my heart was beating rapidly & was sweating; began to feel terrified; got cold & clammy; got cold & clammy; face was pale; I was too weak; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 17Aug2021 14:45 (Batch/Lot Number: FC3182) as single dose for COVID-19 immunisation. Patient age at vaccination was 33-year-old. Medical history was none. Patient did not experienced COVID prior vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), clarithromycin (CLARITON) and women's daily vitamins (VITAMINS NOS), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included Tetanus Vaccine for immunization and experienced allergic to the Tetanus Vaccine. Patient got her vaccine and was feeling completely fine at first. While patient wait the"15 minutes," all of a sudden, she felt a wave of uneasiness come over her. It felt like slow motion and patient felt as if something just hit her body into shock. SHE felt confused & scared, everything sounded far away and she was too weak to yell for help. She was lightheaded and knew something was wrong. Her heart was beating rapidly and was sweating. She could feel she was about to faint any second and was fighting it as hard as she could not to faint b.c. She began to feel terrified. Her husband ran to her and then ran yelled to pharm for help. He said her body felt like lava when he reached to her and her body was covered in sweat. Patient then got cold and clammy. Her face was pale. The events onset on 17Aug2021 at 14:45. The events resulted in doctor or other healthcare professional office/clinic visit. The pharmacist gave her treatment which included cold rags, water, laid down. Outcome of the events was resolved in Aug2021. Patient did not test COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Heart rate, Heart rate increased, Hyperhidrosis
Clinical narrative: could feel I was about to faint any second/lightheaded; felt a wave of uneasiness come over me; felt confused & scared,everything sounded far away; felt confused & scared,everything sounded far away; my heart was beating rapidly & was sweating; my heart was beating rapidly & was sweating; began to feel terrified; got cold & clammy; got cold & clammy; face was pale; I was too weak; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 17Aug2021 14:45 (Batch/Lot Number: FC3182) as single dose for COVID-19 immunisation. Patient age at vaccination was 33-year-old. Medical history was none. Patient did not experienced COVID prior vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), clarithromycin (CLARITON) and women's daily vitamins (VITAMINS NOS), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included Tetanus Vaccine for immunization and experienced allergic to the Tetanus Vaccine. Patient got her vaccine and was feeling completely fine at first. While patient wait the"15 minutes," all of a sudden, she felt a wave of uneasiness come over her. It felt like slow motion and patient felt as if something just hit her body into shock. SHE felt confused & scared, everything sounded far away and she was too weak to yell for help. She was lightheaded and knew something was wrong. Her heart was beating rapidly and was sweating. She could feel she was about to faint any second and was fighting it as hard as she could not to faint b.c. She began to feel terrified. Her husband ran to her and then ran yelled to pharm for help. He said her body felt like lava when he reached to her and her body was covered in sweat. Patient then got cold and clammy. Her face was pale. The events onset on 17Aug2021 at 14:45. The events resulted in doctor or other healthcare professional office/clinic visit. The pharmacist gave her treatment which included cold rags, water, laid down. Outcome of the events was resolved in Aug2021. Patient did not test COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Pallor
Clinical narrative: could feel I was about to faint any second/lightheaded; felt a wave of uneasiness come over me; felt confused & scared,everything sounded far away; felt confused & scared,everything sounded far away; my heart was beating rapidly & was sweating; my heart was beating rapidly & was sweating; began to feel terrified; got cold & clammy; got cold & clammy; face was pale; I was too weak; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 17Aug2021 14:45 (Batch/Lot Number: FC3182) as single dose for COVID-19 immunisation. Patient age at vaccination was 33-year-old. Medical history was none. Patient did not experienced COVID prior vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), clarithromycin (CLARITON) and women's daily vitamins (VITAMINS NOS), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included Tetanus Vaccine for immunization and experienced allergic to the Tetanus Vaccine. Patient got her vaccine and was feeling completely fine at first. While patient wait the"15 minutes," all of a sudden, she felt a wave of uneasiness come over her. It felt like slow motion and patient felt as if something just hit her body into shock. SHE felt confused & scared, everything sounded far away and she was too weak to yell for help. She was lightheaded and knew something was wrong. Her heart was beating rapidly and was sweating. She could feel she was about to faint any second and was fighting it as hard as she could not to faint b.c. She began to feel terrified. Her husband ran to her and then ran yelled to pharm for help. He said her body felt like lava when he reached to her and her body was covered in sweat. Patient then got cold and clammy. Her face was pale. The events onset on 17Aug2021 at 14:45. The events resulted in doctor or other healthcare professional office/clinic visit. The pharmacist gave her treatment which included cold rags, water, laid down. Outcome of the events was resolved in Aug2021. Patient did not test COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Papule, Pruritus, Rash, Scratch
Clinical narrative: pruritus; Broke out in a rash on the top of both hands; left these hard raised bumps and dry skin from scratching; left these hard raised bumps and dry skin from scratching; left these hard raised bumps and dry skin from scratching; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 08Feb2021 09:45 (Batch/Lot Number: EL3302) (at age 29-years-old) as dose 2, single for covid-19 immunisation. Patient received the first dose on 18Jan2021 09:4 (lot number: EL3246) (at age 29-years-old) on the left arm. Medical history included gallbladder removal. There were no concomitant medications. Patient broke out in a rash on the top of both hands on 09Mar2021. The left side has recovered a lot a better than the right (it left these hard raised bumps and dry skin from scratching), but patient still get bouts of pruritus that affects her right hand more often on 09Mar2021. It can also extend to areas of her face but she does not feel the urge to scratch those areas. She was not prescribed treatment was use Aquaphor for the events. Outcome of the events was recovered with sequel. Patient was not diagnosed with covid prior to vaccination and had not been tested post vaccination.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Nausea
Clinical narrative: severe joint pain; dizziness; nausea; This is a spontaneous report from a contactable consumer (other Non-Hcp) reported for herself.   A 67-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EW0176) via unspecified route of administration, administered in Arm Left (left shoulder) on 24Jul2021 (age at the time of vaccination was 67-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 28Jul2021, the patient experienced severe joint pain. On 28-JUL-2021, the patient experienced severe joint pain. Dizziness and in nausea in Jul2021. Caller states she received her first dose of the Pfizer BioNTech Covid-19 Vaccine on 24Jul2021 and sub subsequently experienced severe joint pain, dizziness, and nausea. Caller states she got through it, but by the time I did it was time for the second dose. For severe joint pain Treatment - None, nothing made it go away she took Tylenol, ibuprofen, rubbed asper cream and be-gay . The clinical outcome of all the events was recovered on unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: body aches; fatigue; dry cough/Cough has continued to worsen; This is a spontaneous report received from a contactable consumer(patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE- solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on 22Jul2021,14:00, at age of 37-year-old into left arm, at dose1, single then via an unspecified route of administration, on an unspecified date at dose 2,single for covid-19 immunisation in a pharmacy or drug store. The patient medical history includes Kiwi allergy. The patient's concomitant medications include Ibuprofen (ADVIL), creatine, protein supplement. The patient did not receive other vaccine in four weeks. The patient did not have prior COVID vaccination and tested post vaccination. The patient tested Nasal Swab on 25Jul2021 and had negative result. The patient experienced body aches, fatigue, and dry cough on 25Jul2021 16:00 about 3 or 4 days after injection after the first dose. Most side effects went away but cough persisted. Day after second dose, the patient had extreme fatigue and body aches, cough increased. Cough has continued to worsen. Still have minor fatigue, but body aches are gone. The patient did not receive treatment in response to the events. The outcome of the events was not recovered for cough, while it was recovered for body ache and fatigue for the first episode and only recovered for body ache for second episode and not recovered for fatigue.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Just very bad headaches; This is a spontaneous report received from a non-contactable consumer(patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE- solution for injection; lot number and expiry date were not reported) via an unspecified route of administration into left arm, on 23Aug2021,11:00, at age of 27-year-old at dose 1,single for covid-19 immunisation in a school or student health clinic. The patient did not have any medical history and concomitant medications. The patient is not pregnant at the time of vaccination. The patient did not receive other vaccine in four weeks. The patient did not have prior COVID vaccination and was not tested post vaccination. The patient experienced just very bad headaches on 24Aug2021 12:00. The patient did not receive treatment in response to the events. The outcome of the events was not recovered at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Hearing loss; This is a spontaneous report from a non-contactable consumer (patient) received from a Pfizer sponsored program, regulatory authority support.  A female patient of unspecified age receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, 1 hour after the vaccination, the patient experienced hearing loss. The patient went to the website to look up the side effects of the vaccine but the side effect that she experienced was not listed there. It says that the side effect was not related to the vaccine but other people has also reported it. When the patient went to the pharmacy, they blew the patient off and said that the hearing loss was not related to the vaccine. The patient got her hearing back within a few days but was perturbed that it was not being acknowledged as a side effect. The patient was nervous about getting the second dose of the vaccine and asked if she can possibly get a permanent hearing loss from the second dose. Outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She tested positive for Covid-19 after receiving the second dose in Apr2021; She tested positive for Covid-19 after receiving the second dose in Apr2021; This is a spontaneous report from Pfizer-sponsored program. This report was also received from Product Quality Complaint. A contactable consumer (patient) reported that a 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 02Apr2021 (Batch/Lot Number: ER8732) as dose 1, single; then via an unspecified route of administration, administered in left arm on 25Apr2021 (Batch/Lot Number: EW0169) as dose 2, single for COVID-19 immunisation. The patient has no medical history and no concomitant medications. Family history included her dad had heart attack at age 41. There were no additional vaccines administered on the same date of the Pfizer vaccine. No other vaccines were given within four weeks prior to the first administration date of the suspect vaccine. The patient tested positive for COVID-19 on 14Aug2021 after receiving the second dose. She believes it is because of her grandkids. She is on her 10th day of quarantine. The events did not require a visit to emergency room and physician office. The outcome of the events was unknown. The Product Quality Complaints Group concluded that the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0169 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EW0169, fill lot EP8700, and the bulk formulated drug product EP8602. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Inappropriate schedule of vaccine administered; I received a positive COVID test on 23Aug; I received a positive COVID test on 23Aug; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female consumer reported for herself that she received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 02Mar2021 (at the age of 57 years) as dose 2, single and first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 02Mar2021 at 15:00 (at the age of 57 years) as dose 1, single for COVID-19 immunization.The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that patient received Dose 1 and Dose 2 on 02Mar2021. The patient experienced Covid on 21Aug2021. No treatment received for AE. The patient underwent lab tests and procedures which included Nasal Swab (COVID-19 Antigen rapid test): positive on 23Aug2021. The outcome of event was recovering.  Device Date: 27Aug2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, SARS-CoV-2 test
Clinical narrative: AFIB; This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in Arm Left on 15Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Feb2021 (Batch/Lot number was not reported) for covid-19 immunisation. Concomitant medications included valsartan (DIOVAN) taken for an unspecified indication, start and stop date were not reported; clonidine (CLONIDINE) taken for an unspecified indication, start and stop date were not reported; carvedilol (CARVEDILOL) taken for an unspecified indication, start and stop date were not reported. The patient experienced afib (resulting in hospitalization) on 15Apr2021 with outcome of unknown. The patient was hospitalized for afib for 3 days. The adverse event resulted in Emergency room/department or urgent care, Hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown on Nasal Swab. Therapeutic measures were taken as a result of event (Medication blood thinners, BP meds). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.