chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Pain assessment
Clinical narrative: abdominal pain/pain level was 10 and now it was down to a 2 on a scale of 1 to 10; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 09Aug2021 17:00 (batch/lot number EW0196 and expiry date 30Sep2021) at 42 years of age as dose 1, single for covid-19 immunization in a hospital facility. The patient has no medical history including any illness at time of vaccination. Concomitant medications were not reported. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The patient has no history of all previous immunization with the Pfizer vaccine considered as suspect, has no additional vaccines administered on same date of the Pfizer suspect. The patient informed that his first dose of the Pfizer Covid-19 vaccine was on 09Aug2021 and today (10Aug2021), he was experiencing severe abdominal pain that has lasted for 3 hours, it was ongoing and improving. The patient informed that the pain started around 9:00 am, it got better and it improved around 12 pm. The patient's pain level was 10 and now it was down to a 2 on a scale of 1 to 10. The patient informed that he went to the hospital, thought it was the best thing to do. The patient went to the emergency room at 9:30. The patient had to wait so so long, the pain went down and by the time he was ready to be seen his pain level had gone down and he left. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). An elderly male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration, administered on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination the patient was not tested positive for covid-19. On an unspecified date in Aug2021 the patient underwent lab tests and procedures which included covid test which resulted positive. It was reported that on an unspecified date in Aug2021 the patient was symptomatic and tested positive for covid-19. It was further reported that the patient was not hospitalized. The patient received the treatment for the events was unknown. The patient was resolving from the event covid-19.  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, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID and was symptomatic.  I was able to confirm the person was NOT hospitalized.; Tested positive for COVID and was symptomatic.  I was able to confirm the person was NOT hospitalized.; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). An elderly nonpregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to the vaccination. On an unknown date in Aug2021, the patient was tested positive for covid and was symptomatic. It was confirmed that the patient was not hospitalized due to the event. On an unknown date in Aug2021, the patient had lab test to Sars-cov-2 infection and results were positive with symptomatic symptoms. It was unknown if the patient was treated for the event. The outcome of the event was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Head injury, Headache, Hypoaesthesia, Loss of consciousness
Clinical narrative: collapsed and hit his head and was unconscious; he collapsed and hit his head and was unconscious; numbness and pain in his head; numbness and pain in his head; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14Jul2021 13:30 (Batch/Lot Number: 187) (at age 69-years-old) as dose 1, single for covid-19 immunisation. Medical history included back pain from an unknown date and unknown if ongoing. Family history included heart attack (father died from this). Concomitant medication included acetylsalicylic acid, caffeine (BAYER BACK & BODY PAIN) for back pain. On 19Jul2021, patient collapsed and hit his head and was unconscious. He continued to experience numbness and pain in his head. His head, half of his head, his forehead and the top of his head is still numb since the fall. 8 days later he checked himself into the hospital with possible stroke or heart attack and recently got out of the hospital. He had no permanent damage as far as walking or talking but it knocked him down. He doesn't remember anything before the fall; he doesn't remember falling or being unconscious; he just remembers waking up on the floor. He didn't go to the hospital for about eight days, but it didn't get better so his children convinced him to go to the hospital. He was admitted on 30Jul2021 and discharged 02Aug2021. Events resulted in emergency room. He has indoor outdoor carpet with concrete and he hit his head on the concrete. He was getting on 03Aug2021, just a little feeling in his right forehead. He does not blame anyone and doesn't know if this is even related to the shot. He wanted Pfizer to know about his experience.   He was scheduled for the 2nd dose of the Pfizer Covid-19 Vaccine on 04Aug2021 and he did not get it for fear that his body would reject it. Patient had all kinds of tests, MRI and a CAT SCAN. When ask for results he states there was a couple of abnormalities but they sent him home anyway. He thinks he should be under care, being monitored, and they should not have sent him home. Outcome of the event hit his head was not recovered, for event numbness in head was recovering and for the remaining events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: collapsed and hit his head and was unconscious; he collapsed and hit his head and was unconscious; numbness and pain in his head; numbness and pain in his head; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14Jul2021 13:30 (Batch/Lot Number: 187) (at age 69-years-old) as dose 1, single for covid-19 immunisation. Medical history included back pain from an unknown date and unknown if ongoing. Family history included heart attack (father died from this). Concomitant medication included acetylsalicylic acid, caffeine (BAYER BACK & BODY PAIN) for back pain. On 19Jul2021, patient collapsed and hit his head and was unconscious. He continued to experience numbness and pain in his head. His head, half of his head, his forehead and the top of his head is still numb since the fall. 8 days later he checked himself into the hospital with possible stroke or heart attack and recently got out of the hospital. He had no permanent damage as far as walking or talking but it knocked him down. He doesn't remember anything before the fall; he doesn't remember falling or being unconscious; he just remembers waking up on the floor. He didn't go to the hospital for about eight days, but it didn't get better so his children convinced him to go to the hospital. He was admitted on 30Jul2021 and discharged 02Aug2021. Events resulted in emergency room. He has indoor outdoor carpet with concrete and he hit his head on the concrete. He was getting on 03Aug2021, just a little feeling in his right forehead. He does not blame anyone and doesn't know if this is even related to the shot. He wanted Pfizer to know about his experience.   He was scheduled for the 2nd dose of the Pfizer Covid-19 Vaccine on 04Aug2021 and he did not get it for fear that his body would reject it. Patient had all kinds of tests, MRI and a CAT SCAN. When ask for results he states there was a couple of abnormalities but they sent him home anyway. He thinks he should be under care, being monitored, and they should not have sent him home. Outcome of the event hit his head was not recovered, for event numbness in head was recovering and for the remaining events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthropod sting, Local reaction, Pruritus
Clinical narrative: Bitten by wasps; Itchiness; Local reaction / local irritation; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jul2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported she was bitten by wasps on Saturday afternoon, 07Aug2021, and she was taking Benadryl 25mg three times a day for the wasps bite as well as for itchiness and local reaction/local irritation on an unknown date in Aug2021. The events were reported as non-serious. The patient was scheduled to have her second dose on 11Aug2021 and would like to know if she can continue with the vaccination as scheduled. Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247) via unspecified route of administration, in the left arm, on 04Feb2021 (at the age of 43-year-old), as single dose and the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247) via unspecified route of administration, in the left arm, on 15Jan2021 (at the age of 43-year-old), as single dose, both for COVID-19 immunization. The patient's medical history was not provided. Patient did not receive 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. List of any other medications the patient received within 2 weeks of vaccination included ZOLOFT, PLEXUS, CLARITIN, and DEPO PROVERA. The patient was tested positive for COVID-19. The patient underwent the lab tests and procedure which included the Rapid test antigen. Nasal Swab SARS-CoV-2 test and result was positive 09Aug2021. No treatment received for AE. Outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Inflammation
Clinical narrative: fall; inflammation; This is a spontaneous report from a contactable consumer or other non-HCP (patient reported for himself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported stating he was scheduled to receive his second dose of the vaccine on 13Aug2021. He received a steroid shot, he thinks for inflammation, on 08Aug2021 from a fall he had. The patient wanted to know if the steroid shot will affect the vaccine. The outcome of the events was unknown at the time of this report.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Skin discolouration
Clinical narrative: Darkening skin around her neck which went down to her chest/indenting around her clavicle was  solid black and it went blotchy on her chest; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0182), via an unspecified route of administration, administered in left arm on 10May2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0170) in the left arm on 19Apr2021 for COVID-19 immunization and everything was fine. The patient also previously received flu shot on 1980 for immunization and experienced sick off (mentions in early 1980s she took the flu shot and was sick off and on most of the winter). The vaccination facility type was pharmacy/drug store. On 12May2021 (2 days after the second dose of the vaccine), the patient noticed darkening skin around her neck which went down to her chest. She mentioned indenting around her clavicle was solid black and it went blotchy on her chest. The symptoms lasted 2 days and went away. Her doctor said it was blood but did not say anything else. She was concerned and wanted to know if this is a normal side effect of the vaccine. She reported that she did see her doctor who said it was blood and that was all he said. She can not find out if this is blood, and would like to know if she should be concerned. She mentioned she has hip surgery scheduled for 21Sep2021. She reported that the black blotchy skin did go away; by the second day it was completely gone. Her daughter and granddaughter saw it. She saw the dark around her neck; and then pulled down her shirt and saw the black on her chest. The event did not require emergency room visit and resulted in physician office visit. The patient underwent lab tests and procedures which included EKG: something about her heart on an unspecified date. The outcome of the event skin discoloration was recovered on 14May2021.   Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dizziness, Dyspnoea, Heart rate
Clinical narrative: blacking out; Dizziness; weakness; violent tremors in extremities; heart rate in 130's; slight shortness of breath; pressure in lungs; cough; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 10Aug2021 12:15 (Batch/Lot Number: EW0177) (at the age of 43 years old) dose number was unknown, single dose for Covid-19 immunisation. Medical history included asthma, allergies, Penicillin allergy, and Covid-19, all from unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included montelukast sodium (SINGULAIR); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); colecalciferol (VITAMIN D [COLECALCIFEROL]); ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE); all taken for an unspecified indication, start and stop date were not reported. The patient previously took morphine and experienced allergy. On 10Aug2021 at 00:15, the patient experienced blacking out, dizziness, weakness, violent tremors in extremities, heart rate in 130's, slight shortness of breath, and pressure in lungs with cough. Therapeutic measures were taken as result of all the events. The patient was given apple juice, Pepcid, 2 Zyrtec, and 2 Benadryl. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Loss of consciousness, Lung disorder, Tremor
Clinical narrative: blacking out; Dizziness; weakness; violent tremors in extremities; heart rate in 130's; slight shortness of breath; pressure in lungs; cough; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 10Aug2021 12:15 (Batch/Lot Number: EW0177) (at the age of 43 years old) dose number was unknown, single dose for Covid-19 immunisation. Medical history included asthma, allergies, Penicillin allergy, and Covid-19, all from unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included montelukast sodium (SINGULAIR); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); colecalciferol (VITAMIN D [COLECALCIFEROL]); ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE); all taken for an unspecified indication, start and stop date were not reported. The patient previously took morphine and experienced allergy. On 10Aug2021 at 00:15, the patient experienced blacking out, dizziness, weakness, violent tremors in extremities, heart rate in 130's, slight shortness of breath, and pressure in lungs with cough. Therapeutic measures were taken as result of all the events. The patient was given apple juice, Pepcid, 2 Zyrtec, and 2 Benadryl. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he received his first dose of PFE covid-19 vaccine in (state name) and 2 weeks later, but before his 2nd PFE vaccine dose, he tested positive for covid-19; he received his first dose of PFE covid-19 vaccine and 2 weeks later, but before his 2nd PFE vaccine dose, he tested positive for covid-19; This is a spontaneous report from a contactable consumer or other non-health care professional. A 34-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that yesterday I spoke with a friend (34 year old male) who indicated that back in Apr2021, he received his first dose of PFE covid-19 vaccine in (state name) and 2 weeks later, but before his 2nd PFE vaccine dose, he tested positive for covid-19. I learned of this yesterday. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The clinical outcome of the events was reported as unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: tested positive for COVID months after being fully vaccination; tested positive for COVID months after being fully vaccination; This is a spontaneous report from a non-contactable consumer. A adult male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical and concomitant medication history were reported. If other vaccine in four weeks reported as unknown. No COVID prior vaccination. Adverse event start on 10Aug2021. Tested positive for COVID months after being fully vaccination. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: positive on Aug2021. Treatment received for adverse event reported as unknown. The outcome of the events were unknown.   No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report from a contactable consumer.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient got vaccinated and several months later on an unspecified date patient had a heart attack. Patient never had any heart problems. The outcome of the event was unknown.  Information on lot/ batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: arm was quite sore; terrible pain on right side from hips down; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2, via an unspecified route of administration, administered in left arm on 28Jan2021 12:45 (Batch/Lot Number: el3302) at the age of 71 years old as dose 2, single for COVID-19 immunisation. Medical history included sleep apnoea syndrome, allergy to penicillin and sulfur drug. Patient was not pregnant. Concomitant medication(s) included citalopram, metformin, montelukast and omeprazole, all taken for unspecified indications, start and stop dates were not reported. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (Batch/Lot Number: ek9231), administered in left arm on 07Jan2021 at 13:00. On 29Jan2021 at 03:00, after receiving the 2nd Pfizer dose the patient's arm was quite sore; after waking up early the next day (as reported) she was in terrible pain on right side from hips down. Eventually went to emergency room, she had horrible pain. The doctor gave her several pain killers over several hour, Morphine, valium, and several others to calm the pain down. She was able to go home several hours later. Events resulted in Emergency room/department or urgent care with treatment received (several pain killers). The patient recovered with lasting effects. No COVID prior vaccination and was COVID tested post vaccination. COVID test post vaccination: COVID rapid test (Nasal Swab) was Negative. Outcome of events were recovered with sequelae.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Was fully vaccinated and got a positive covid test; Was fully vaccinated and got a positive covid test; This is a spontaneous report from a contactable consumer or other non hcp. A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727, Expiry date: unknown), dose 1 intramuscular, administered in Arm Left on 24Mar2021 15:00 as dose 1, single, dose 2 via an unspecified route of administration, administered in Arm Left at hospital on 2021 (Batch/Lot Number: ER8731) as dose 2, single for covid-19 immunization. Medical history included colon cancer and diabetes mellitus. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included allopurinol (ALLOPURINOL), metformin (METFORMIN), lisinopril (LISINOPRIL), acetylsalicylic acid (BABY ASPIRIN) and atorvastatin (ATORVASTATIN) (patient received within 2 weeks of vaccination). The patient underwent lab tests and procedures which included sars-cov-2 test showed positive on 07Aug2021. The patient experienced was fully vaccinated and got a positive covid test (medically significant) on 10Aug2021 08:00. The clinical outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.  Follow-Up (16Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected."; Sender's Comments: Based on plausible dose-event temporal relationship the causal role of  bnt162b2 vaccine cannot be excluded for reported events of lack of efficacy.  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: 16.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid on 06Aug2021/Tested positive for Covid 19 virus/3 weeks after receiving the Covid 19 vaccine first dose; tested positive for Covid on 06Aug2021/Tested positive for Covid 19 virus/3 weeks after receiving the Covid 19 vaccine first dose; This is a spontaneous report from a Pfizer-sponsored program contactable consumer or other non hcp (Patient's mother). A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm on 16Jul2021 at 14:00 (Age at vaccination:16year-old), as DOSE 1SINGLE for covid-19 immunisation at Pharmacy/Drug Store. Medical History (including any illness at time of vaccination) was reported as none. The patient's concomitant medications were not reported. Vaccine administered at facility was reported as no. The patient tested positive for covid on 06Aug2021 tested positive for covid 19 virus/3 weeks after receiving the covid 19 vaccine first dose. Caller on the line who was calling on behalf of her daughter who received the first dose of the Covid 19 vaccine and before getting her second dose of the Covid 19 vaccine her daughter tested positive for the Covid 19 virus. She was calling for information on when her daughter can receive her second dose. She reported her daughter's nose was swabbed and the Covid 19 virus test was the quick test and she received the answer right away which was positive. She was due to receive her second Covid 19 vaccine on 06Aug2021 but tested positive for the Covid 19 virus on 06Aug2021. When probing NDC/Lot/Expiry for the Covid 19 vaccine she stated she knows it is a Pfizer product but she did not have the Covid 19 vaccine information card with her at the time of this call. She was not sure which arm her daughter received the Covid 19 vaccine in. Any AE(s) did not require a visit to emergency room and physician Office.  The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Fatigue, Myalgia, Nausea
Clinical narrative: her leg muscles hurt (both legs in calves and at top of legs); very weak; fatigued; has lost 30 pounds because she can't eat due to nausea; has lost 30 pounds because she can't eat due to nausea; This is a spontaneous report from a contactable consumer or other non hcp (patient) via Medical information team. A 75-year-old female patient received second dose of BNT162B2 (COMIRNATY, Formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on 28Jan2021 DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine includes first dose of COVID vaccine (COMIRNATY, solution for injection) as DOSE 1, SINGLE for covid-19 immunisation. Patient received her second Pfizer Covid vaccine dose on 28Jan2021 and has been experiencing side effects ever since. She has seen her MD and reports her bloodwork was normal. Patient states she was very weak, fatigued, has lost 30 pounds because she cannot eat due to nausea, and her leg muscles hurt (both legs in calves and at top of legs) on an unspecified date in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: her leg muscles hurt (both legs in calves and at top of legs); very weak; fatigued; has lost 30 pounds because she can't eat due to nausea; has lost 30 pounds because she can't eat due to nausea; This is a spontaneous report from a contactable consumer or other non hcp (patient) via Medical information team. A 75-year-old female patient received second dose of BNT162B2 (COMIRNATY, Formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on 28Jan2021 DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine includes first dose of COVID vaccine (COMIRNATY, solution for injection) as DOSE 1, SINGLE for covid-19 immunisation. Patient received her second Pfizer Covid vaccine dose on 28Jan2021 and has been experiencing side effects ever since. She has seen her MD and reports her bloodwork was normal. Patient states she was very weak, fatigued, has lost 30 pounds because she cannot eat due to nausea, and her leg muscles hurt (both legs in calves and at top of legs) on an unspecified date in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Asthenia, Back pain, Blood test normal, Chest X-ray normal
Clinical narrative: her leg muscles hurt (both legs in calves and at top of legs); very weak; fatigued; has lost 30 pounds because she can't eat due to nausea; has lost 30 pounds because she can't eat due to nausea; This is a spontaneous report from a contactable consumer or other non hcp (patient) via Medical information team. A 75-year-old female patient received second dose of BNT162B2 (COMIRNATY, Formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on 28Jan2021 DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine includes first dose of COVID vaccine (COMIRNATY, solution for injection) as DOSE 1, SINGLE for covid-19 immunisation. Patient received her second Pfizer Covid vaccine dose on 28Jan2021 and has been experiencing side effects ever since. She has seen her MD and reports her bloodwork was normal. Patient states she was very weak, fatigued, has lost 30 pounds because she cannot eat due to nausea, and her leg muscles hurt (both legs in calves and at top of legs) on an unspecified date in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Depression, Electrocardiogram normal, Feeling abnormal, Nausea, Sleep disorder
Clinical narrative: her leg muscles hurt (both legs in calves and at top of legs); very weak; fatigued; has lost 30 pounds because she can't eat due to nausea; has lost 30 pounds because she can't eat due to nausea; This is a spontaneous report from a contactable consumer or other non hcp (patient) via Medical information team. A 75-year-old female patient received second dose of BNT162B2 (COMIRNATY, Formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on 28Jan2021 DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine includes first dose of COVID vaccine (COMIRNATY, solution for injection) as DOSE 1, SINGLE for covid-19 immunisation. Patient received her second Pfizer Covid vaccine dose on 28Jan2021 and has been experiencing side effects ever since. She has seen her MD and reports her bloodwork was normal. Patient states she was very weak, fatigued, has lost 30 pounds because she cannot eat due to nausea, and her leg muscles hurt (both legs in calves and at top of legs) on an unspecified date in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Dyspnoea, Illness, Immune system disorder
Clinical narrative: felt like A. Fib; Redness in site of vaccination; severe swelling to site; shortness in breath; weak; "my immune system is a mess"; missed a lot of work due to being sick; Still's disease/Still; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 14Jun2021 14:38 (Batch/Lot Number: EW0177) as dose 2, single for COVID-19 immunization at a pharmacy. The patient's medical history was not reported. Concomitant medications were reported as none. The patient previously received the 1st dose of bnt162b2 (Lot number: Pfizer EW0177) on 24May2021 2:35 PM, at right upper arm at 51 years old for COVID-19 immunization and experienced Headache, Fever, Flu symptoms, and Congestion nasal. No relevant tests were done. On 14Jun2021 16:38, 2 hours after the 2nd dose, the patient went to the emergency room and the immunologist considers Still's disease/still and was given an unspecified treatment. On an unspecified date, the patient had felt something like A. fib, redness in site of vaccination and severe swelling to site, shortness in breath, and weak. The patient added that "my immune system is a mess. I have missed a lot of work due to being sick." The patient will be seeing an Immunologist. The outcome of the event Still's disease/still was not recovered, while for the rest of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Still's disease, Vaccination site erythema, Vaccination site swelling
Clinical narrative: felt like A. Fib; Redness in site of vaccination; severe swelling to site; shortness in breath; weak; "my immune system is a mess"; missed a lot of work due to being sick; Still's disease/Still; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 14Jun2021 14:38 (Batch/Lot Number: EW0177) as dose 2, single for COVID-19 immunization at a pharmacy. The patient's medical history was not reported. Concomitant medications were reported as none. The patient previously received the 1st dose of bnt162b2 (Lot number: Pfizer EW0177) on 24May2021 2:35 PM, at right upper arm at 51 years old for COVID-19 immunization and experienced Headache, Fever, Flu symptoms, and Congestion nasal. No relevant tests were done. On 14Jun2021 16:38, 2 hours after the 2nd dose, the patient went to the emergency room and the immunologist considers Still's disease/still and was given an unspecified treatment. On an unspecified date, the patient had felt something like A. fib, redness in site of vaccination and severe swelling to site, shortness in breath, and weak. The patient added that "my immune system is a mess. I have missed a lot of work due to being sick." The patient will be seeing an Immunologist. The outcome of the event Still's disease/still was not recovered, while for the rest of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test on 09Aug2021. Fully vaccinated on 19Mar2021; Positive COVID-19 test on 09Aug2021. Fully vaccinated on 19Mar2021; This is a spontaneous report from a non-contactable consumer (patient). A 44-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6203), dose 2 via an unspecified route of administration on 19Mar2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications was not reported. Device Date was reported as 10Aug2021. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as (at the age of 44-year-old) single dose for COVID-19 immunization. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 05Aug2021 the patient experienced positive covid-19. It was reported that Positive COVID-19 test on 09Aug2021. fully vaccinated on 19mar2021. AE resulted in [Doctor or other healthcare professional office/clinic visit]. No treatment was received. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Aug2021. The outcome of event was Not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection) both doses (Lot number: not reported) in Feb2021, both via unspecified route of administration as single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient was not diagnosed with COVID-19, prior to vaccination. Patient been tested for COVID-19, post and since the vaccination. On 10Aug 2021, patient was contracted COVID-19 and was fully vaccinated. Treatment received was unknown. Lab test included positive COVID-19 test on 10Aug2021. The outcome of event was not resolved.  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: Epistaxis, Haematochezia, SARS-CoV-2 test
Clinical narrative: Bloody stools; Abnormal nose bleeds; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in right arm in a pharmacy or drug store facility on 04Aug2021 04:45 (Batch/Lot number was not reported) (at the age of 27-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with covid-19 prior to vaccination. Since the vaccination, the patient has been tested for covid-19. The patient had no relevant medical history and there were no concomitant medications. The patient had no known allergies. On 05Aug2021, the patient experienced bloody stools and abnormal nose bleeds. The patient further stated that it's been consist and starting to worry her. No treatment received for the events. The patient underwent lab tests and procedures which included covid test (nasal swab) post vaccination which was negative on 17Sep2020 (pending clarification). The patient had not yet recovered from the events.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Helicobacter test, Laboratory test, Magnetic resonance imaging, Metabolic function test
Clinical narrative: Entire head felt swollen; This is a spontaneous report from a contactable consumer (patient).   A 45-year-old male patient received the second dose of BNT162B2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot. EW0175) at single dose, in the left deltoid, on 23Apr2021 at 11:00, at the age of 44 years, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient previously, on 02Apr2021 at 11:00, received the first dose of BNT162B2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot. ER8737) at single dose, in the left deltoid, for COVID-19 immunisation. After the first dose, since 03Apr2021, the patient experienced severe headache, nausea, no appetite. The patient received treatment from 11Apr2021. Symptoms persist. On an unspecified date, in Jul2021, the patient's entire head felt swollen. Relevant laboratory test included CBC with differential platelet (full blood count) unknown results on 30Apr2021, Helicobacter test (H. Pylori test) negative on 30Apr2021, laboratory test (unspecified): nothing abnormal on 29Apr2021, magnetic resonance imaging (MRI) TBD on 02Aug2021 and metabolic panel unknown results on 30Apr2021. Clinical outcome of the adverse event was unknown at time of this report. The adverse event was assessed non-serious (Medically Significant).  Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Entire head felt swollen; This is a spontaneous report from a contactable consumer (patient).   A 45-year-old male patient received the second dose of BNT162B2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot. EW0175) at single dose, in the left deltoid, on 23Apr2021 at 11:00, at the age of 44 years, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient previously, on 02Apr2021 at 11:00, received the first dose of BNT162B2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot. ER8737) at single dose, in the left deltoid, for COVID-19 immunisation. After the first dose, since 03Apr2021, the patient experienced severe headache, nausea, no appetite. The patient received treatment from 11Apr2021. Symptoms persist. On an unspecified date, in Jul2021, the patient's entire head felt swollen. Relevant laboratory test included CBC with differential platelet (full blood count) unknown results on 30Apr2021, Helicobacter test (H. Pylori test) negative on 30Apr2021, laboratory test (unspecified): nothing abnormal on 29Apr2021, magnetic resonance imaging (MRI) TBD on 02Aug2021 and metabolic panel unknown results on 30Apr2021. Clinical outcome of the adverse event was unknown at time of this report. The adverse event was assessed non-serious (Medically Significant).  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) from program.   A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation, solution for injection, lot number: EL3246), via an unspecified route of administration on 25Jan2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EL0140), via an unspecified route of administration on 04Jan2021 as dose 1, single for covid-19 immunisation. The patient stated that had no know contacts and developed covid symptoms, tested positive on 06Aug2021. The patient lab test included SARS-CoV-2 molecular test was positive on 08Aug2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Fully vaccinated and tested positive for COVID-19; Fully vaccinated and tested positive for COVID-19; This is a spontaneous report from a non-contactable consumer or other non hcp. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, and received dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single both for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not test COVID-19 positive prior to vaccination. The patient had tested positive for COVID-19 since the vaccination. On 04Aug2021, the patient after both doses of vaccine and fully vaccinated and tested positive for COVID-19. The patient did not received treatment for the events. the events were medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Aug2021. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Mast cell activation syndrome, Rash, Urticaria
Clinical narrative: Cell mast disorder; hives; Headache; rash/starts as small spots/it creates a full body rash; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 45-years-old, via an unspecified route of administration, administered in arm left on 08Aug2021 11:00 (lot number: FA7485; expiry date: unknown) as dose 1, single for COVID-19 immunization. Medical history included food allergy (any foods that increase histamine). Concomitant medications included over the counter (OTC) anti-histamines within 2 weeks of vaccination. The vaccine was administered in a pharmacy or drug store. The patient did not receive other vaccines within 4 weeks prior to the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. On 09Aug2021, at 11:00 am, the patient experienced cell mast disorder, hives, headache and rash/starts as small spots/it creates a full body rash. The patient did not receive treatment for the events. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the events was recovering.