chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Erythema, Gait disturbance, Pain in extremity, Peripheral swelling
Clinical narrative: tendon inflammation; red dots all over my legs; I could not just walk; on my left leg down I have a bump and it's painful; on my left leg down I have a bump and it's painful; This is a spontaneous report from a contactable consumer or other non hcp. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14May2021 (at the age of 47 years old) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No relevant medical history. The patient reported that he got first dose of PFIZER-BIONTECH COVID-19 VACCINE on 14May2021 and was scheduled to get his second dose on 04Jun2021. The patient looking for guidance if he should get a second dose today as he experienced adverse reactions after first dose. On 30May2021, when he woke up in the morning he could not just walk, stated never happened before. His right thigh, right leg completely painful, he got crutches and started to walk. On 31May2021, he went to emergency room, where they did an X- ray and blood tests for blood clots but they did not see any blood clots. They gave him some gel and some muscle relaxants and told him that maybe he had tendon inflammation, but he did not run or he did not even exercise. Now after 4-5 days (Jun2021), cannot walk and now he started walking a little bit, but pain was still there. His thigh was swollen, and he had red dots all over his legs and on his left leg down he had a bump, and it was painful. He also had this red and red dots everywhere. The patient underwent lab tests and procedures which included X- ray and blood tests: did not see any blood clots on 31May2021. The outcome of the events red dots all over my leg, tendon inflammation was unknown, i could not just walk was recovering, on my left leg down i have a bump and it's painful was not recovered.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Tendon disorder, X-ray
Clinical narrative: tendon inflammation; red dots all over my legs; I could not just walk; on my left leg down I have a bump and it's painful; on my left leg down I have a bump and it's painful; This is a spontaneous report from a contactable consumer or other non hcp. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14May2021 (at the age of 47 years old) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No relevant medical history. The patient reported that he got first dose of PFIZER-BIONTECH COVID-19 VACCINE on 14May2021 and was scheduled to get his second dose on 04Jun2021. The patient looking for guidance if he should get a second dose today as he experienced adverse reactions after first dose. On 30May2021, when he woke up in the morning he could not just walk, stated never happened before. His right thigh, right leg completely painful, he got crutches and started to walk. On 31May2021, he went to emergency room, where they did an X- ray and blood tests for blood clots but they did not see any blood clots. They gave him some gel and some muscle relaxants and told him that maybe he had tendon inflammation, but he did not run or he did not even exercise. Now after 4-5 days (Jun2021), cannot walk and now he started walking a little bit, but pain was still there. His thigh was swollen, and he had red dots all over his legs and on his left leg down he had a bump, and it was painful. He also had this red and red dots everywhere. The patient underwent lab tests and procedures which included X- ray and blood tests: did not see any blood clots on 31May2021. The outcome of the events red dots all over my leg, tendon inflammation was unknown, i could not just walk was recovering, on my left leg down i have a bump and it's painful was not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Dizziness, Feeling abnormal
Clinical narrative: vomiting; fever; chills; diarrhea; dizzy and shaky; dizzy and shaky; she "felt [her] gut and pieces of tissues from [her] gut were coming out; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 01Jun2021 (at the age of 60-year-old) as single dose for COVID-19 immunization. Patient medical history included COVID-19 in Nov2020 and long haulers before getting the vaccine. Concomitant medications were not reported. On an unspecified date in Jun2021, after receiving first dose of vaccine, patient experienced violent vomiting, fever at 101.9F, chills, diarrhea, felt dizzy and shaky. Patient explained she was sitting on the bowl, had diarrhea, and had her "head in a bucket" but the force at which she was vomiting was unbelievable. Patient described she felt [her] gut and pieces of tissues from [her] gut were coming out; and the content sprayed on her walls, even 6 feet away reaching the shower. Patient specified she didn't vomit when she was infected with COVID-19. Patient explained that she feels better this morning but would like to know if she was contagious. Patient asked if she should quarantine for 14 days after experiencing side effects from the Pfizer-BIoNTech COVID-19 vaccine. Outcome of the events was unknown.  Information about lot/batch no has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: vomiting; fever; chills; diarrhea; dizzy and shaky; dizzy and shaky; she "felt [her] gut and pieces of tissues from [her] gut were coming out; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 01Jun2021 (at the age of 60-year-old) as single dose for COVID-19 immunization. Patient medical history included COVID-19 in Nov2020 and long haulers before getting the vaccine. Concomitant medications were not reported. On an unspecified date in Jun2021, after receiving first dose of vaccine, patient experienced violent vomiting, fever at 101.9F, chills, diarrhea, felt dizzy and shaky. Patient explained she was sitting on the bowl, had diarrhea, and had her "head in a bucket" but the force at which she was vomiting was unbelievable. Patient described she felt [her] gut and pieces of tissues from [her] gut were coming out; and the content sprayed on her walls, even 6 feet away reaching the shower. Patient specified she didn't vomit when she was infected with COVID-19. Patient explained that she feels better this morning but would like to know if she was contagious. Patient asked if she should quarantine for 14 days after experiencing side effects from the Pfizer-BIoNTech COVID-19 vaccine. Outcome of the events was unknown.  Information about lot/batch no has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Chills, Cough, Diarrhoea
Clinical narrative: Chills; Diarrheas; Vomiting; Fever; Headache; Sore throat; Cough; gets really tired easy; Short of breath; vomited again yesterday, comes back for a couple of days every week (diarrhea); This is a spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer (mother) or other non hcp. A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8736 and expiry date: unknown), dose 2 via intramuscular, administered in Arm Right on 23Apr2021 as 2nd dose, single dose for covid-19 immunisation. The patient previously took the dose 1 of the vaccine on 02Apr2021 (Lot Number / Expiry Date: ER8734, No expiry date, Route, Anatomical Location: Left arm) for covid-19 immunisation. He had no issues after the first dose of the vaccine. The patient medical history and concomitant medications were not reported. The patient's family history was none (Diabetes, thyroid issues, and anemia were in distant relatives, but not in immediate family). No vaccinations were given within four weeks prior to first administration of the vaccine. Adverse events following prior vaccinations were none. Additional vaccines administered on the same date were none. The patient experienced chills, fever, headache, diarrheas, vomiting on 24Apr2021, sore throat on Apr2021, cough, tired, short of breath and vomited again yesterday, comes back for a couple of days every week on 2021. After receiving the vaccine, the patient got sick; had chills, diarrheas, with vomiting twice. Did have a sore throat for a little but that has gone away. They had seen their HCP and have had Blood, urine, thyroid testing done and all came back negative; they took a stool sample also. They were being referred to the hospital and was waiting to hear back from the infectious disease doctor. His blood pressure was normal and had not gotten better since he had gotten the second vaccine. Arms don't hurt. The patient was not lethargic but he did feel himself, he got short of breath when he tried skate boarding and he got really tired easily. His diarrhea started initially 24Apr2021 through 27Apr2021 then went away for a couple of weeks, but came back for a couple of day every week. He had it then for 5 days in a row that time. It was usually 2-3 days before. The patient underwent lab tests and procedures which included blood pressure measurement: normal, blood test: normal on 20May2021 came back negative, pyrexia: 102.7, pyrexia: 99.3 to 102, pyrexia: 99.7 on 04Jun2021, stool analysis: unknown on 04Jun2021, thyroid function test: normal on 29May2021 came back negative, urine analysis: normal on 20May2021 came back negative. Outcome of the events Chills, Diarrheas, Fever and Headache was not recovered, Vomiting, Cough, Tired, Short of breath and vomited again yesterday, comes back for a couple of days every week (diarrhea) was unknown, Sore throat was recovered in Apr2021.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Chills; Diarrheas; Vomiting; Fever; Headache; Sore throat; Cough; gets really tired easy; Short of breath; vomited again yesterday, comes back for a couple of days every week (diarrhea); This is a spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer (mother) or other non hcp. A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8736 and expiry date: unknown), dose 2 via intramuscular, administered in Arm Right on 23Apr2021 as 2nd dose, single dose for covid-19 immunisation. The patient previously took the dose 1 of the vaccine on 02Apr2021 (Lot Number / Expiry Date: ER8734, No expiry date, Route, Anatomical Location: Left arm) for covid-19 immunisation. He had no issues after the first dose of the vaccine. The patient medical history and concomitant medications were not reported. The patient's family history was none (Diabetes, thyroid issues, and anemia were in distant relatives, but not in immediate family). No vaccinations were given within four weeks prior to first administration of the vaccine. Adverse events following prior vaccinations were none. Additional vaccines administered on the same date were none. The patient experienced chills, fever, headache, diarrheas, vomiting on 24Apr2021, sore throat on Apr2021, cough, tired, short of breath and vomited again yesterday, comes back for a couple of days every week on 2021. After receiving the vaccine, the patient got sick; had chills, diarrheas, with vomiting twice. Did have a sore throat for a little but that has gone away. They had seen their HCP and have had Blood, urine, thyroid testing done and all came back negative; they took a stool sample also. They were being referred to the hospital and was waiting to hear back from the infectious disease doctor. His blood pressure was normal and had not gotten better since he had gotten the second vaccine. Arms don't hurt. The patient was not lethargic but he did feel himself, he got short of breath when he tried skate boarding and he got really tired easily. His diarrhea started initially 24Apr2021 through 27Apr2021 then went away for a couple of weeks, but came back for a couple of day every week. He had it then for 5 days in a row that time. It was usually 2-3 days before. The patient underwent lab tests and procedures which included blood pressure measurement: normal, blood test: normal on 20May2021 came back negative, pyrexia: 102.7, pyrexia: 99.3 to 102, pyrexia: 99.7 on 04Jun2021, stool analysis: unknown on 04Jun2021, thyroid function test: normal on 29May2021 came back negative, urine analysis: normal on 20May2021 came back negative. Outcome of the events Chills, Diarrheas, Fever and Headache was not recovered, Vomiting, Cough, Tired, Short of breath and vomited again yesterday, comes back for a couple of days every week (diarrhea) was unknown, Sore throat was recovered in Apr2021.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Stool analysis, Symptom recurrence, Thyroid function test, Urine analysis, Vomiting
Clinical narrative: Chills; Diarrheas; Vomiting; Fever; Headache; Sore throat; Cough; gets really tired easy; Short of breath; vomited again yesterday, comes back for a couple of days every week (diarrhea); This is a spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer (mother) or other non hcp. A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8736 and expiry date: unknown), dose 2 via intramuscular, administered in Arm Right on 23Apr2021 as 2nd dose, single dose for covid-19 immunisation. The patient previously took the dose 1 of the vaccine on 02Apr2021 (Lot Number / Expiry Date: ER8734, No expiry date, Route, Anatomical Location: Left arm) for covid-19 immunisation. He had no issues after the first dose of the vaccine. The patient medical history and concomitant medications were not reported. The patient's family history was none (Diabetes, thyroid issues, and anemia were in distant relatives, but not in immediate family). No vaccinations were given within four weeks prior to first administration of the vaccine. Adverse events following prior vaccinations were none. Additional vaccines administered on the same date were none. The patient experienced chills, fever, headache, diarrheas, vomiting on 24Apr2021, sore throat on Apr2021, cough, tired, short of breath and vomited again yesterday, comes back for a couple of days every week on 2021. After receiving the vaccine, the patient got sick; had chills, diarrheas, with vomiting twice. Did have a sore throat for a little but that has gone away. They had seen their HCP and have had Blood, urine, thyroid testing done and all came back negative; they took a stool sample also. They were being referred to the hospital and was waiting to hear back from the infectious disease doctor. His blood pressure was normal and had not gotten better since he had gotten the second vaccine. Arms don't hurt. The patient was not lethargic but he did feel himself, he got short of breath when he tried skate boarding and he got really tired easily. His diarrhea started initially 24Apr2021 through 27Apr2021 then went away for a couple of weeks, but came back for a couple of day every week. He had it then for 5 days in a row that time. It was usually 2-3 days before. The patient underwent lab tests and procedures which included blood pressure measurement: normal, blood test: normal on 20May2021 came back negative, pyrexia: 102.7, pyrexia: 99.3 to 102, pyrexia: 99.7 on 04Jun2021, stool analysis: unknown on 04Jun2021, thyroid function test: normal on 29May2021 came back negative, urine analysis: normal on 20May2021 came back negative. Outcome of the events Chills, Diarrheas, Fever and Headache was not recovered, Vomiting, Cough, Tired, Short of breath and vomited again yesterday, comes back for a couple of days every week (diarrhea) was unknown, Sore throat was recovered in Apr2021.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This is a spontaneous report from a contactable consumer (patient).  A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date was not reported) via an unspecified route of administration on 02Jun2021 as unknown dose single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On Jun2021, the patient experienced fever and chills. The patient wanted to know what to do with the side effects. The patient received information that, these side effects usually start within a day or two of getting the vaccine. Side effects might affect ability to do daily activities, but they should go away in a few days and get tips on what to after getting vaccinated. The outcome of events was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: noticed a dramatic improvement in my headaches (sinus and migraine). I've had these headaches since I was a child; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program. A 38-year-old female patient received first and second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCUBE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. Medical history included headaches (sinus and migraine). The patient concomitant medications were not reported.  On an unspecified date, the patient noticed a dramatic improvement in headaches (sinus and migraine). She had these headaches since she was a child. She reported that she had both covid vaccine doses and it was about a month out from her 2nd shot. She just wanted report that she had noticed a dramatic improvement in her headaches (sinus and migraine). She had these headaches since she was a child. She did not know if there was a connection or not but she wanted to bring it to our attention. The outcome was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Neuralgia, Pain in extremity, Restless legs syndrome
Clinical narrative: Minor muscle aches; Sore arm; Minor chills second night; Sig increase in neuropathic leg/feet pain plus restless leg interrupting sleep frequently.; Sig increase in neuropathic leg/feet pain plus restless leg interrupting sleep frequently.; Sig increase in neuropathic leg/feet pain plus restless leg interrupting sleep frequently.; This is a spontaneous report received from a contactable consumer(patient). A 68-year-old male patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0185), via an unspecified route of administration in left arm on 03Jun2021 at 14:30(at the age of 68-years-old) 2ND DOSE SINGLE DOSE as single dose for COVID-19 immunization. The medical history of the patient included diabetes II, hypertension, a-fib and COVID-19 on Dec2020. The patient allergic reactions included hay fever. The concomitant medications of the patient included apixaban(ELIQUIS), diltiazem(DILTIAZEM), atenolol(ATENOLOL), sitagliptin(JANUVIA) and melatonin(MELATONIN). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8736), via an unspecified route of administration in left arm on 14May2021 at 14:00 as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. After the second dose the patient experienced minor muscle aches, sore arm, minor chills second night and sig increase in neuropathic leg/feet pain plus restless leg interrupting sleep frequently on 03Jun2021 at 18:00. The patient stated that notes from his initial infection with COVID last December show the same intensification of neuropathy symptoms for several nights. It was reported that no treatment was received. The outcome of all the events was reported as resolving.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Minor muscle aches; Sore arm; Minor chills second night; Sig increase in neuropathic leg/feet pain plus restless leg interrupting sleep frequently.; Sig increase in neuropathic leg/feet pain plus restless leg interrupting sleep frequently.; Sig increase in neuropathic leg/feet pain plus restless leg interrupting sleep frequently.; This is a spontaneous report received from a contactable consumer(patient). A 68-year-old male patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0185), via an unspecified route of administration in left arm on 03Jun2021 at 14:30(at the age of 68-years-old) 2ND DOSE SINGLE DOSE as single dose for COVID-19 immunization. The medical history of the patient included diabetes II, hypertension, a-fib and COVID-19 on Dec2020. The patient allergic reactions included hay fever. The concomitant medications of the patient included apixaban(ELIQUIS), diltiazem(DILTIAZEM), atenolol(ATENOLOL), sitagliptin(JANUVIA) and melatonin(MELATONIN). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8736), via an unspecified route of administration in left arm on 14May2021 at 14:00 as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. After the second dose the patient experienced minor muscle aches, sore arm, minor chills second night and sig increase in neuropathic leg/feet pain plus restless leg interrupting sleep frequently on 03Jun2021 at 18:00. The patient stated that notes from his initial infection with COVID last December show the same intensification of neuropathy symptoms for several nights. It was reported that no treatment was received. The outcome of all the events was reported as resolving.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Headache, Nausea
Clinical narrative: Severe burning of skin over entire body; Hypersensitive to touch including fabric; Swollen neck and hands; Swollen neck and hands; Pain in pelvic area and anus; Pain in pelvic area and anus; Severe lower back pain accompanied with chills; Severe lower back pain accompanied with chills; Headache; Fever; Nausea; Fatigue; This is a spontaneous report from a contactable consumer (patient).   A 23-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot number: EW0202), via an unspecified route in the right arm on 04Jun2021 at 11:00, as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included topiramate 50mg and norethrindrone 35mg (medications the patient received within 2 weeks of vaccination). Patient previously received first dose of BNT162B2 (Pfizer covid-19 vaccine, Lot number: EW0202), via on an unspecified route in the right arm on 14May2021 at 11:00, as a single dose for covid-19 immunization. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 04Jun2021 at 22:00, patient experienced severe burning of skin over entire body, hypersensitive to touch including fabric, swollen neck and hands, pain in pelvic area and anus, severe lower back pain accompanied with chills, headache, fever, nausea and fatigue. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pelvic pain, Peripheral swelling, Proctalgia, Pyrexia, Sensitive skin
Clinical narrative: Severe burning of skin over entire body; Hypersensitive to touch including fabric; Swollen neck and hands; Swollen neck and hands; Pain in pelvic area and anus; Pain in pelvic area and anus; Severe lower back pain accompanied with chills; Severe lower back pain accompanied with chills; Headache; Fever; Nausea; Fatigue; This is a spontaneous report from a contactable consumer (patient).   A 23-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot number: EW0202), via an unspecified route in the right arm on 04Jun2021 at 11:00, as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included topiramate 50mg and norethrindrone 35mg (medications the patient received within 2 weeks of vaccination). Patient previously received first dose of BNT162B2 (Pfizer covid-19 vaccine, Lot number: EW0202), via on an unspecified route in the right arm on 14May2021 at 11:00, as a single dose for covid-19 immunization. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 04Jun2021 at 22:00, patient experienced severe burning of skin over entire body, hypersensitive to touch including fabric, swollen neck and hands, pain in pelvic area and anus, severe lower back pain accompanied with chills, headache, fever, nausea and fatigue. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation, Swelling
Clinical narrative: Severe burning of skin over entire body; Hypersensitive to touch including fabric; Swollen neck and hands; Swollen neck and hands; Pain in pelvic area and anus; Pain in pelvic area and anus; Severe lower back pain accompanied with chills; Severe lower back pain accompanied with chills; Headache; Fever; Nausea; Fatigue; This is a spontaneous report from a contactable consumer (patient).   A 23-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Lot number: EW0202), via an unspecified route in the right arm on 04Jun2021 at 11:00, as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included topiramate 50mg and norethrindrone 35mg (medications the patient received within 2 weeks of vaccination). Patient previously received first dose of BNT162B2 (Pfizer covid-19 vaccine, Lot number: EW0202), via on an unspecified route in the right arm on 14May2021 at 11:00, as a single dose for covid-19 immunization. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 04Jun2021 at 22:00, patient experienced severe burning of skin over entire body, hypersensitive to touch including fabric, swollen neck and hands, pain in pelvic area and anus, severe lower back pain accompanied with chills, headache, fever, nausea and fatigue. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Memory impairment
Clinical narrative: Forgetting where I parked car; not getting everything I went to the store for. Burning food on stove.; patient took 1st and 2nd dose both on 02Apr2021; This is a spontaneous report received from a contactable consumer or other non hcp (patient). A 60-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0150, expiration date not reported), via an unspecified route of administration in left arm on 02Apr2021 10:30 (age at vaccination 60years old) as 1st dose, single dose for covid-19 immunisation. Reportedly, same day patient was administered second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0167, expiration date not reported) via an unspecified route of administration in right arm on 02Apr2021 as 2nd dose, single dose for covid-19 immunisation. The most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Medical history included fibromyalgia, allergies to tannins from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On 27May2021 11:30 the patient experienced forgetting where he parked car, not getting everything he went to the store for and burning food on stove. The patient did not receive any treatment for the adverse events. The case was assessed as non-serious as per the reporter. The clinical outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Now I'm sick; This is a spontaneous report received from a non-contactable consumer or other non hcp via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date as 1st dose, single and received second dose via an unspecified route of administration on an unknown date as 2nd dose, single both for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient got sick. Patient wanted to know that what could he do about it. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia
Clinical narrative: Burning sensation followed by numbness starting at the injection side (left)  going up to the left ear and left rear head.; Burning sensation followed by numbness starting at the injection side (left)  going up to the left ear and left rear head.; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 15May2021 (at the age of 43-year-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any medications within 2 weeks of vaccination and any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced burning sensation followed by numbness starting at the injection side (left) going up to the left ear and left rear head, which resulted in doctor or other healthcare professional office/clinic visit. Patient stated it persisted for about 2.5 weeks after the first shot. The patient did not receive any treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Rash pruritic, Urticaria
Clinical narrative: Terribly itchy rash, with red bumps and welps on sides and buttocks; terribly itchy rash, with red bumps and welps on sides and buttocks; terribly itchy rash, with red bumps and welps on sides and buttocks; This is a spontaneous report from a contactable consumer (patient, self-reported). A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8737 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 07Apr2021 at 10:30 AM, as a single dose for COVID-19 immunization at hospital. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6206 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 10Mar2021 at 10:30 AM, as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included Rheumatoid arthritis (RA) and known allergies: penicillin. Concomitant medications included Enbrel for RA. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 22Apr2021, she had terribly itchy rash, with red bumps and welps on sides and buttocks. The events were resulted in doctor or other healthcare professional office/clinic visit. The patient received 2 rounds of prednisone and hydroxyzine as treatment for the events. Outcome of the events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: All post viral symptoms instantaneously resolved; This is a spontaneous report from a contactable physician (patient). This report was received via a sales representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. Medical history included covid-19 and severe post-viral symptoms. The patient's concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) 1st dose on unspecified date for COVID-19 Immunization. The patient experienced all post viral symptoms instantaneously resolved on an unspecified date. It was reported that patient suffered from severe post-viral symptoms for 7 months after recovering from COVID. One week after their second dose of the Pfizer COVID -19 vaccine, they commented that all post viral symptoms instantaneously resolved. The outcome for event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Neck pain, Pain of skin, Thirst
Clinical narrative: Headache; neck pain; skin hurts; extreme fatigue; pain in arm where injection was given; extreme thirst; This is a spontaneous report from a contactable consumer or other non HCP (Patient).A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Lot number and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccination the patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for Covid-19 immunization. On an unspecified date, after vaccination, the patient experienced headache, neck pain, skin hurts, extreme fatigue, pain in arm where injection was given and extreme thirst. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Headache; neck pain; skin hurts; extreme fatigue; pain in arm where injection was given; extreme thirst; This is a spontaneous report from a contactable consumer or other non HCP (Patient).A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Lot number and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccination the patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for Covid-19 immunization. On an unspecified date, after vaccination, the patient experienced headache, neck pain, skin hurts, extreme fatigue, pain in arm where injection was given and extreme thirst. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: First shot was feel little bit pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0172) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date when confirmed that the patient got the adverse reaction after the second shot, he stated that yeah, the second shot was the problem, first shot was little bit pain. The outcome of event was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Neurological symptom, Paraesthesia, Paraesthesia oral
Clinical narrative: neurological side effects; Paresthesia, the tingling in the legs and in arms and the tongue, both leg, both arms and the tongue; Paresthesia, the tingling in the legs and in arms and the tongue, both leg, both arms and the tongue; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0177 and Expiration date: unknown), dose 2 via intramuscular route, administered in left arm on 21May2021 15:30 as SINGLE DOSE for covid-19 immunisation. The patient had no medical history and concomitant medications. Patient previously received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0172 and Expiration date: unknown), dose 1 via intramuscular route, administered in left arm on 30Apr2021 15:30 as single dose for covid-19 immunisation. Patient has not received any other vaccine 4 weeks prior to COVID-19 vaccine. In May2021 (within 24 hours after second shot), the patient reported that she was going to ER (today as reported) to see neurologist because she experienced neurological side effects, paresthesia, the tingling in the legs and in arms and the tongue, both legs, both arms and the tongue. The patient underwent lab tests and procedures which included blood work with unknown results on an unknown date. Outcome of events was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Diarrhea; stomach hurt; This is a spontaneous report from a contactable 35-year-old female consumer reported for herself. A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0168 and expiration date was not reported), via an unspecified route of administration, administered on left on 29May2021(35-year-old at the age of vaccination) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0182) on 08May2021, 01:22 pm (13:22) (at the age of 35-year-old) The patient did not have prior vaccinations within 4 weeks. The reporter stated that, she got second vaccine from Pfizer on Saturday 29May2021. Since that day the patient had diarrhoea, stomach hurts. So, the patient wanted to know if that is the side effect or reaction or what she can do because diarrhoea (Incomplete sentence)." The patient did not receive treatment for the events and wanted to know, if that is alright. The outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Illness, Nasopharyngitis
Clinical narrative: Feel so tired; he has no energy; he felt like sick again like a cold all over; he felt like sick again like a cold all over; This is a spontaneous report from a contactable consumer (Patient).   A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 28May2021 (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that since the patient got his shot, that's last Friday, second day he felt like he got a reaction to it, on 29May2021 he felt like sick again like a cold all over but he said that would pass away. Today it's almost 'Friday' but this whole week he felt so tired, he has no energy. He was thinking that if this was a side effect, how long would it go like this. When confirmed the manufacturer as Pfizer consumer stated, Yes that was the Pfizer Vaccine, he meant, his wife and 2 kids took it. They have no problem but he does have this problem that he was so tired, he has no energy to get up and go to work. The outcome of the events were unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Fatigue; Calf muscle pain; Bad headache; This is a spontaneous report from a non-contactable pharmacist reported for a 14-years-old male patient.    A 14-years-old male patient received second dose of bnt162b2 (BNT162B2, Pfizer covid vaccine), via an unspecified route of administration on 03Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (BNT162B2, Pfizer covid vaccine), via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. On 04Jun2021, after second dose of vaccine administration, the patient experienced fatigue, calf muscle pain and bad headache. The outcome of the events fatigue, calf muscle pain and bad headache was unknown.  No follow-up attempts are possible and information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: 101 fever; Body aches; Swelling and redness around injection site; Swelling and redness around injection site; This is a spontaneous report from a contactable consumer received via a sales representative. A 12-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 on an unspecified date administered for COVID-19 Immunization. The reporter stated that patient experienced 101 fever, body aches, swelling and redness around injection site. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date. Therapeutic measures were taken for the events with Motrin and symptoms were improved after use. The outcome of the events was resolved on an unspecified date.  Information on the lot/batch number has been requested.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; little fatigue; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. A contactable consumer reported for a 13-year-old female patient who received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 20May2021 (Batch/Lot Number: EW0177) as a single dose for covid-19 immunization. Medical history included athletic induced asthma (she was diagnosed maybe 3 years ago, 2018 or maybe it was 2016) and horseshoe kidney (the patient was diagnosed with a horseshoe kidney a year or two ago, meaning when the patient was in the her mother's womb, her kidneys while they were developing never separated so she has to be careful not to get kidney infections and not to get hit in the stomach when she's playing sports). On 20May2021, the patient experienced sore arm, little fatigue. Caller (reporter) stated that there was a report that came out. Caller states her daughter got her first dose, she was 13, and had no reaction other than a sore arm and a little fatigue the first day. Caller states the reports says it's causing enlarged heart in a lot of teens; she asked her doctor about it and the doctor said the benefits of getting the vaccine outweigh the risks and advised the caller to still get it for her daughter. The outcome of the events was unknown.   Pfizer Covid Vaccine: Caller confirms the patient received the Pfizer Covid Vaccine. NDC: Unknown; Expiry Date: Unknown; Unknown Dosage; Indication: Caller states they are pretty good about not going anywhere, but they certainly venture out more than she does. Caller states she wants to make sure she was protected. Caller states she learned a day or two before she scheduled the shot that her daughter's school is not offering school from home next year. Caller states it's called E classroom, they are also doing hybrid but her daughter opted to stay home. Caller states she learned they weren't doing any of that next year. Caller confirms her daughter is scheduled for her second dose on 10Jun2021. PSCC Communication: Report 2 of 7. Caller does not provide any further information on patient; therefore, no further information obtained or verified.  Additional information has been requested.