chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal inflammation, Hypersensitivity, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (friend). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Reporters friend had the second Pfizer shot and was hospitalized because she had an allergic reaction (Duration was not clarified for the Hospitalization). She was swelling and have hives and they were from 5 days and still looks like almost 2 weeks for her to cover from the allergic reaction and now, she had some intestinal problems and they think, her intestine were inflamed and calling regards to take hive. They wanted to know was that a report on reaction to COVID. Outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: broke out in a rash 2 to 3 weeks after; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. An 87-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number was not reported, Expiry date: unknown, at the age of 87-year-old), via an unspecified route of administration on 15Jun2021 as dose 1, single for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient experienced broke out in a rash 2 to 3 weeks after vaccination on an unspecified date in 2021 and called her physician and was started on Zyrtec. She was doing better today. Caller asking that can she receive the second dose of the Pfizer COVID-19 Vaccine that she was scheduled for tomorrow. The outcome of the event was resolving.   Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: Eyes were swollen; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored Program. A 34-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8735) via an unspecified route of administration in left arm on 26Apr2021 at 15:00 as dose 2 single (at the age of 34-year-old) for COVID-19 immunization. Medical history and concomitant medication was not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8732) via an unspecified route of administration in left arm on 29Mar2021 at 15:00 as dose 1 single (at the age of 34-year-old) for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient stated that she took the second dose of Pfizer Covid-19 vaccine back in 28Apr (later clarified) and during the week after she took the second dose her eyes started to swell and she was experiencing it until now. Her eyes were swollen. Patient stated she had not taken anything for treatment, but she was trying to ice them. The outcome of the event was not recovered.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248), via intramuscular route of administration in right arm on 01Mar2021 at 12:00 (at the age of 39-year-old) as dose 1, single and via intramuscular route of administration in left arm on 23Mar2021 at 12:00 (at the age of 39-year-old) (Batch/Lot Number: EP6955) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included omeprazole, sertraline hydrochloride (SERTRALINE A), generic multi vitamin; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. No COVID prior vaccination and tested with COVID post vaccination. It was reported that the patient was vaccinated in Mar2021. On 01Jul2021, the patient began experiencing COVID symptoms. On Saturday, patient went and got tested and on "Sunday", the patient got the positive result for COVID 19, "I am currently". On 01Jul2021 at 12:00, the patient had experienced horrible fever swings and body aches with no taste or smell. The patient received confirmed test results on "Sunday" 04Jul2021. Adverse events were resulted in doctor or other healthcare professional office or clinic visit. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included SARS-COV-2 RNA, QL, RT PCR(COVID-19): positive on 04Jul2021 (Nasal Swab). The outcome of COVID-19 was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Headache, Pyrexia, Rhinorrhoea
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient himself).   A 34-years-old male patient received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EL3248 expiry date: unknown) via an unspecified route of administration on 11Jan2021 and 01Feb2021 as DOSE 1, SINGLE and DOSE 2, SINGLE respectively for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. He had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested positive for COVID-19. Patient experienced COVID-19 symptoms (scratchy throat, runny nose, headache, fever, loss of taste) in the beginning of 04Jul2021. Lab test (COVID-19 rapid diagnostic test (NAAT)) confirmed positive for COVID-19 on 06Jul2021. Treatment was not given as a result of the adverse events. The outcome of the events was recovering.   Follow up activities closed as reporter was non-contactable. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Throat irritation, Vaccination failure
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient himself).   A 34-years-old male patient received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EL3248 expiry date: unknown) via an unspecified route of administration on 11Jan2021 and 01Feb2021 as DOSE 1, SINGLE and DOSE 2, SINGLE respectively for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. He had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested positive for COVID-19. Patient experienced COVID-19 symptoms (scratchy throat, runny nose, headache, fever, loss of taste) in the beginning of 04Jul2021. Lab test (COVID-19 rapid diagnostic test (NAAT)) confirmed positive for COVID-19 on 06Jul2021. Treatment was not given as a result of the adverse events. The outcome of the events was recovering.   Follow up activities closed as reporter was non-contactable. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Blood cholesterol, Blood test, Musculoskeletal discomfort
Clinical narrative: he got pain on his shoulders; problem on my left shoulder really bad; arthritis/his hands have been arthritic; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer-sponsored program. A 76-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration on 17Feb2021 (at the age of 76-years-old) as dose 2, single for covid-19 immunisation. Medical history included Heart attack from 2000 to an unknown date, Blood pressure high from an unknown date and unknown if ongoing. The patient took first dose of BNT162B2 (at the age of 76-years-old) (LOT: EN5318) on 25Jan2021 for covid-19 immunization and experienced my right shoulder was hurt. Concomitant medications were not reported. On an unknown date the patient experienced he got pain on his shoulders, problem on my left shoulder really bad, arthritis/his hands have been arthritic. The patient reported that after the second shot started having problem, on my left shoulder really bad. It occurred after. The patient reported that he had a heart attack back in 2000, might been high blood pressure which he regulates with medications and he takes several medication. He stated that after he received the second dose he got severe side effects, he got pain on his shoulders, he said it was arthritis and his hands his hands have been arthritic ever since. He would like to know if there any other cases like these. The patient underwent lab tests and procedures on an unknown date which included blood cholesterol: all came back good, blood test: all came back good, physical examination: all came back good. The outcome of all the events was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Physical examination
Clinical narrative: he got pain on his shoulders; problem on my left shoulder really bad; arthritis/his hands have been arthritic; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer-sponsored program. A 76-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration on 17Feb2021 (at the age of 76-years-old) as dose 2, single for covid-19 immunisation. Medical history included Heart attack from 2000 to an unknown date, Blood pressure high from an unknown date and unknown if ongoing. The patient took first dose of BNT162B2 (at the age of 76-years-old) (LOT: EN5318) on 25Jan2021 for covid-19 immunization and experienced my right shoulder was hurt. Concomitant medications were not reported. On an unknown date the patient experienced he got pain on his shoulders, problem on my left shoulder really bad, arthritis/his hands have been arthritic. The patient reported that after the second shot started having problem, on my left shoulder really bad. It occurred after. The patient reported that he had a heart attack back in 2000, might been high blood pressure which he regulates with medications and he takes several medication. He stated that after he received the second dose he got severe side effects, he got pain on his shoulders, he said it was arthritis and his hands his hands have been arthritic ever since. He would like to know if there any other cases like these. The patient underwent lab tests and procedures on an unknown date which included blood cholesterol: all came back good, blood test: all came back good, physical examination: all came back good. The outcome of all the events was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Balance disorder, Cognitive disorder, Computerised tomogram head, Confusional state
Clinical narrative: Transient ischaemic attacks; memory was shot; balance, cognitive abilities were greatly reduced; confusion; loss of balance; memory loss; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP6955 and Expiry date: 30Jun2021), dose 1 via an unspecified route of administration on 11Mar2021 (at the age of 69-years-old) at 09:15 as first dose, single for Covid-19 immunization. Medical history included staph infection in his heart in Dec2014, obesity, onset date: Whole life or within the last 10 years, blood pressure. Concomitant medication included carvedilol and lisinopril both taken for blood pressure. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced transient ischaemic attacks.It was reported that patient had adverse reaction neurological, similar to TIAs after the first dose. On 11Mar2021, the patient experienced memory was shot balance, cognitive abilities were greatly reduced (they stayed reduced for weeks and weeks, gradually he began to remember things, very gradually, his cognitive abilities became gradually better, he was still not back to normal, but it was subtle at the time of reporting), confusion, loss of balance, memory loss. Patient went to emergency room the next morning and side effects continued for weeks. The patient underwent lab tests and procedures which included computerized tomogram head: nothing new on an unspecified date. The outcome of event memory was shot, cognitive abilities were greatly reduced, confusion, loss of balance, memory loss was recovering while the outcome of event transient ischaemic attacks was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Transient ischaemic attack
Clinical narrative: Transient ischaemic attacks; memory was shot; balance, cognitive abilities were greatly reduced; confusion; loss of balance; memory loss; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP6955 and Expiry date: 30Jun2021), dose 1 via an unspecified route of administration on 11Mar2021 (at the age of 69-years-old) at 09:15 as first dose, single for Covid-19 immunization. Medical history included staph infection in his heart in Dec2014, obesity, onset date: Whole life or within the last 10 years, blood pressure. Concomitant medication included carvedilol and lisinopril both taken for blood pressure. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced transient ischaemic attacks.It was reported that patient had adverse reaction neurological, similar to TIAs after the first dose. On 11Mar2021, the patient experienced memory was shot balance, cognitive abilities were greatly reduced (they stayed reduced for weeks and weeks, gradually he began to remember things, very gradually, his cognitive abilities became gradually better, he was still not back to normal, but it was subtle at the time of reporting), confusion, loss of balance, memory loss. Patient went to emergency room the next morning and side effects continued for weeks. The patient underwent lab tests and procedures which included computerized tomogram head: nothing new on an unspecified date. The outcome of event memory was shot, cognitive abilities were greatly reduced, confusion, loss of balance, memory loss was recovering while the outcome of event transient ischaemic attacks was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood cholesterol
Clinical narrative: my right shoulder was hurt it when I rotated cup it was 2 weeks prior and after the second sho; This is a spontaneous report from a Pfizer-sponsored program. A 76-years-old male patient (who is also a reporter) received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 25Jan2021 as 1st dose, single for Covid-19 immunisation. Medical history included heart attack in 2000 and high blood pressure which he regulated with medications. Concomitant medications included patient took several medications. On an unknown date, patient reported his right shoulder was hurt it when he rotated cup it was 2 weeks prior and after the second shot started having problem, on his left shoulder really bad. The patient underwent lab tests and procedures which included blood cholesterol which was a normal blood work up for cholesterol and everything just a normal like a check-up for physical whatever all that is and result was reported as all came back good. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: my hair started to fall out; This is a spontaneous report from a contactable consumer. A female patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unknown date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history was not reported. No concomitant medication was reported. On an unspecified date, it was reported that she got the vaccine and a few days later her hair started to fall out. She would brush her hair in the morning and she would have a brush full of hair can you please tell me why I don't see anywhere that is one of the side effects. I have had to cut my hair short and was not happy about it so please help me. The outcome of Event was unknown.  Information on the lot/batch number has been requested
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (COVID 19), via an unspecified route of administration, administered in left arm on 02Mar2021 (Lot Number: EN6200) as dose 1, single, and then via an unspecified route of administration, administered in left arm on 02Mar2021 (Lot Number: EN6208) as dose 2, single, all at the age of 62-year-old for covid-19 immunization. No known allergies and no other medical history. Concomitant medications included serenoa repens (SAW PALMETTO) and minoxidil (ROGAINE, oral tablet) taken for an unspecified indication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. No other vaccine in four weeks. The patient received 1st and 2nd dose of bnt162b2 on the same date on 02Mar2021. The patient experienced following symptoms: cough, fatigue, congestion, muscle/body aches on 29Jun2021 and then he tested positive for covid on 04Jul2021. The patient underwent lab tests and procedures which included PCR (Nasal Swab): positive on 04Jul2021. Therapeutic measures were not taken as a result of tested positive for COVID with the following symptoms, cough, fatigue, congestion, muscle/body aches. The outcome of tested positive for COVID with the following symptoms, cough, fatigue, congestion, muscle/body aches was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid; I tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 24Feb2021 (Batch/Lot number: 6203 not confirmed It's either EN or FN) as single dose and dose 2 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (Batch/Lot number: FR not confirmed 2613 or 7613) as single dose (at the age of 53 year) for covid-19 immunization. The patient had no medical history and no concomitant medications. Patient was not probed for any medical conditions or concomitant medications. Patient was not received any other vaccine prior four weeks of vaccination. Patient reported I just want Pfizer to know that I was fully vaccinated with the Pfizer vaccine and I tested positive for Covid on unspecified date. I tested positive in Mexico, but I caught Covid from my mother before I left who was in the United stated, so United States. Patient was not performed any lab test. Patient stated I am taken some steroid (further clarification unknown) from my doctor's office and I am taken over the counter medication that help with the congestion and I am taken an inhaler (Further clarification unknown). Patient visited to physician's office for the events COVID-19. Therapeutic measures were taken as a result of the events. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration in right arm on 15Apr2021 (Lot number: ER8731, patient was 69-year-old at the time of vaccination) as single dose for COVID-19 immunisation/ because of the better protection for her. The patient's medical history included metastatic breast cancer. It was reported that patient also take ibrance (start date: Dec2020, dose: 100 mg daily for 3 weeks and one week off, Film-coated tablet) for metastatic breast cancer. There were no concomitant medications. Reported that she thinks that she caught COVID from someone. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EP6955, patient was 69-year-old at the time of vaccination), via an unspecified route of administration in right arm on 20Mar2021 as single dose for COVID-19 immunisation. On 02Jul2021, the patient experienced she has COVID/came back positive on 03Jul2021. On 02Jul2021, the patient underwent lab tests and procedures which included COVID nasal swab resulted as positive 03Jul2021 in the evening. Caller stated that her head is foggy on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Abdominal pain upper, COVID-19, Computerised tomogram, Decubitus ulcer, Dyspnoea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration in right arm on 15Apr2021 (Lot number: ER8731, patient was 69-year-old at the time of vaccination) as single dose for COVID-19 immunisation/ because of the better protection for her. The patient's medical history included metastatic breast cancer. It was reported that patient also take ibrance (start date: Dec2020, dose: 100 mg daily for 3 weeks and one week off, Film-coated tablet) for metastatic breast cancer. There were no concomitant medications. Reported that she thinks that she caught COVID from someone. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EP6955, patient was 69-year-old at the time of vaccination), via an unspecified route of administration in right arm on 20Mar2021 as single dose for COVID-19 immunisation. On 02Jul2021, the patient experienced she has COVID/came back positive on 03Jul2021. On 02Jul2021, the patient underwent lab tests and procedures which included COVID nasal swab resulted as positive 03Jul2021 in the evening. Caller stated that her head is foggy on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Haematochezia, Infection, Pulmonary thrombosis, SARS-CoV-2 test, Thrombosis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration in right arm on 15Apr2021 (Lot number: ER8731, patient was 69-year-old at the time of vaccination) as single dose for COVID-19 immunisation/ because of the better protection for her. The patient's medical history included metastatic breast cancer. It was reported that patient also take ibrance (start date: Dec2020, dose: 100 mg daily for 3 weeks and one week off, Film-coated tablet) for metastatic breast cancer. There were no concomitant medications. Reported that she thinks that she caught COVID from someone. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EP6955, patient was 69-year-old at the time of vaccination), via an unspecified route of administration in right arm on 20Mar2021 as single dose for COVID-19 immunisation. On 02Jul2021, the patient experienced she has COVID/came back positive on 03Jul2021. On 02Jul2021, the patient underwent lab tests and procedures which included COVID nasal swab resulted as positive 03Jul2021 in the evening. Caller stated that her head is foggy on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Lethargy, Malaise
Clinical narrative: Got sick and a little lethargic and out of it for a day or so; Got sick and a little lethargic and out of it for a day or so; He was not feeling well; This is a spontaneous report from a contactable consumer (patient's son) from a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got sick and a little lethargic on an unspecified date and was out of it for a day or so. The patient was not feeling well. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product preparation error, Product temperature excursion issue
Clinical narrative: a patient received a dose of the Pfizer Covid-19 vaccine after it was diluted and left in the syringe in the fridge for 4 days; a patient received a dose of the Pfizer Covid-19 vaccine after it was diluted and left in the syringe in the fridge for 4 days; Received Vaccine that was punctured more than the time of 6 hours.; This is a spontaneous report from a contactable other hcp via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0179, Expiration Date: 31Aug2021), via an unspecified route of administration on 06Jul2021 as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received vaccine that was punctured more than the time of 6 hours on 06Jul2021 and received a dose of the Pfizer Covid-19 vaccine after it was diluted and left in the syringe in the fridge for 4 days. The reporter wanted to know if the patient needed to receive another Pfizer Covid 19 Vaccine immediately or if the Pfizer Covid 19 dose already administered was okay. The outcome of the events was unknown.; Sender's Comments: Based on the information provided, the association between the event production preparation error and the vaccination cannot be completely ruled out.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: 5 days after Covid vaccine dose 1 I experienced pain on the left side of my torso, On the evening of day 6 I noticed a quarter sized rash under my left arm, On day 7 was diagnosed with Shingles; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 22Apr2021 12:00, (at the age of 57-year-old) as dose 1, single for COVID-19 immunisation. Medical history included Multinodular goiter under control and Penicillin allergy. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) which the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19; did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient had not been tested for COVID-19 post vaccination. On 27Apr2021 07:00 (also reported as 5 days after Covid vaccine dose 1), the patient experienced pain on the left side of torso. On the evening of day 6 the patient noticed a quarter sized rash under left arm. On day 7 the patient was diagnosed with Shingles and started medication. The patient visited physician office and was treated with Antiviral medicines due to the event. The patient recovered from the event in Apr2021.  Information about Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Her daughter tested positive both on the rapid and RT-PCR Test for COVID-19. Her daughter is asymptomatic; Her daughter tested positive both on the rapid and RT-PCR Test for COVID-19. Her daughter is asymptomatic; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer sponsored program. This consumer reported for 20-Year-old female patient that received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration date was not reported), via an unspecified route of administration on 01Jul2021 dose 1 single as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reportedly, the reporter's son tested positive for COVID-19, so they all went out to get checked and her daughter tested positive both on the rapid and RT-PCR Test for COVID-19 on an unspecified date Jul2021. Her daughter was asymptomatic. Patient was scheduled to take her 2nd shot of the Pfizer vaccine on 22Jul2021. Reporter wanted to know if her daughter could still get the 2nd dose of the Pfizer COVID Vaccine on 22Jul2021. The outcome of each event was unknown. Information about batch/lot number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest pain, Dizziness, Headache, Nausea
Clinical narrative: maybe she is just stressed.; she has constant headaches at night; nausea; chest pain; dizziness; mild abdominal pain; This is a spontaneous report from a Pfizer sponsored program. A contactable 50-year-old female consumer (patient) via medical information team. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 01Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter was a consumer who received the 1st dose of the Pfizer-Biontech COVID19 vaccine on 01Jul2021 and six days after was still experiencing side effects which include headache that happens mostly at night, nausea, chest pain, and sometimes dizziness, as well as mild abdominal pain. She said that her main concern was the headache in which she takes Tylenol extra strength at 500 mg but it only works temporarily. She was not sure if the vaccine was causing the headache or maybe she is just stressed. The reporter was asked if it was normal for day 6 of being vaccinated to be having side effects. Medical questions were addressed by this program forwarded/referred to medical information. The outcome of the events was reported as not resolved.  Information about lot/batch number is requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: maybe she is just stressed.; she has constant headaches at night; nausea; chest pain; dizziness; mild abdominal pain; This is a spontaneous report from a Pfizer sponsored program. A contactable 50-year-old female consumer (patient) via medical information team. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 01Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter was a consumer who received the 1st dose of the Pfizer-Biontech COVID19 vaccine on 01Jul2021 and six days after was still experiencing side effects which include headache that happens mostly at night, nausea, chest pain, and sometimes dizziness, as well as mild abdominal pain. She said that her main concern was the headache in which she takes Tylenol extra strength at 500 mg but it only works temporarily. She was not sure if the vaccine was causing the headache or maybe she is just stressed. The reporter was asked if it was normal for day 6 of being vaccinated to be having side effects. Medical questions were addressed by this program forwarded/referred to medical information. The outcome of the events was reported as not resolved.  Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: the other 2 patients that were diagnosed with shingles after receiving the Covid-19 vaccine.; This is a spontaneous report from a contactable consumer (patient). This case is for patient 2 of other 2 patients. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced the other 2 patients that were diagnosed with shingles after receiving the covid-19 vaccine. on an unspecified date. The outcome of the events was Unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021856878 Same reporter/drug/AE, different patient
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: malaise; felt weak-ringing in ears.; Chills began then fever; fever; Headache shortly after exhaustion; next day headache+ Exhausted; This is a spontaneous report from a contactable consumer (Patient). A 53-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6205, Expiration date: unknown), via intramuscular route of administration, in left arm, on 08Mar2021 at 08:00 (at the age of 53-year-old), as a single dose for COVID-19 immunization. The patient medical history includes ongoing anxiety and depression and concomitant medications included ongoing sertraline hydrochloride (ZOLOFT) orally for Anxiety/Depression. On 08Mar2021, after the vaccination at 20:30 PM, 12 Hours post vaccine, the patient experienced Chills began then fever, Headache shortly after exhaustion, then 24 Hours in felt weak ringing in ears. Patient felt like was going to pass out-Sat down on bed and collapsed + Passed out- Woke up shortly after. Felt malaise ace day stayed at bed, 18 Hours next day headache+ Exhausted- Felt more like self is 72 Hours. + malaise all day. Treatment received includes Advil. Outcome of the events was reported as recovered on an unspecified date in 2021. The seriousness criteria was reported as non-serious.  No follow-up attempts possible. No further information expected.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: malaise; felt weak-ringing in ears.; Chills began then fever; fever; Headache shortly after exhaustion; next day headache+ Exhausted; This is a spontaneous report from a contactable consumer (Patient). A 53-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6205, Expiration date: unknown), via intramuscular route of administration, in left arm, on 08Mar2021 at 08:00 (at the age of 53-year-old), as a single dose for COVID-19 immunization. The patient medical history includes ongoing anxiety and depression and concomitant medications included ongoing sertraline hydrochloride (ZOLOFT) orally for Anxiety/Depression. On 08Mar2021, after the vaccination at 20:30 PM, 12 Hours post vaccine, the patient experienced Chills began then fever, Headache shortly after exhaustion, then 24 Hours in felt weak ringing in ears. Patient felt like was going to pass out-Sat down on bed and collapsed + Passed out- Woke up shortly after. Felt malaise ace day stayed at bed, 18 Hours next day headache+ Exhausted- Felt more like self is 72 Hours. + malaise all day. Treatment received includes Advil. Outcome of the events was reported as recovered on an unspecified date in 2021. The seriousness criteria was reported as non-serious.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing; This is a spontaneous report from a contactable consumer. Report 2 of 3. A female patient (Reporters neighbours mother) of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: was not reported) via unspecified route of administration on 18Apr2021 as single dose for COVID-19 immunization.Medical history and concomitant medications were not reported. Patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: was not reported) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization.Reporter stated she was calling regarding the Pfizer Covid 19 vaccine. She had been doing some research and her neighbour and her mother had the Pfizer covid virus vaccine. She gave them a ride to pick up their car, which is about 15 minutes from her house. She had done some research and unfortunately, she was supposed to stay away from them. They were in her car. Her neighbour and her neighbours mother were both fully vaccinated with Pfizer and the caller is having massive and horrible headaches. Reporter confirmed she herself never had the covid vaccine. They (neighbour and neighbours mother) said they had received their vaccines at the end of Apr2021. They had both doses of the Pfizer vaccine. Reporter gave them a ride in her car 23Jun2021, it was the day before her birthday. She had been perfectly fine and healthy during the whole pandemic and had a mask on and everything. It was known that they were fully vaccinated at the end of Apr2021. Reporter stated that the ladies gave her numbers but does not have the number of the vaccine shot from their card. They said it was the Pfizer second dose was on 18Apr2021, she did not write down the numbers. Breathing or coughing in small, confined areas coming from those that had injections. The mother was coughing on an unspecified date in Apr2021. The outcome of the event was unknown.   Information about batch/lot number has been requested
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Joint range of motion decreased
Clinical narrative: can't lift his arm; feeling a lot of numbness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in arm right on 07Jul2021 (Lot Number: FA6780) as a single dose at the age of 59-year-old for covid-19 immunisation.  Medical history included hypertension (diagnosed a million years ago). The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route on 03Jun2021 (Lot Number: EV0179 or EVI079) as a single dose at the age of 59-year-old for covid-19 immunisation. The patient's concomitant medications were not reported.  The patient feeling a numbness started a few hours after the shot and unable to lift his arm started on 07Jul2021 night. The outcome of the events was not recovered.  No follow-up attempts are possible; No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Bone densitometry, Cough
Clinical narrative: Constant pain in both hip area radiating down bilateral thighs worse at nights.; bilateral thighs worse at nights.; Pain in lower back; Constant cough; General body weakness with sleepless nights.; sleepless nights; This is a spontaneous report from a contactable female nurse (patient) via medical information team. An elderly female patient (non pregnant) unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in arm left on 06Feb2021 14:00 (Lot Number: EL9269) as a single dose at the age of 71 year old for covid-19 immunisation from hospital.  Medical history included high blood pressure. Concomitant medications included levothyroxine, hydrochlorothiazide and diltiazem all taken for an unspecified indication, start and stop date were not reported. The patient previously took betamethasone benzoate, diltiazem. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in arm left on 16Jan2021 14:00 (Lot Number: EL3249) as a single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. On 02Mar2021 03:00,  patient experienced Constant pain in both hip area radiating down bilateral thighs worse at nights. Pain in lower back. Constant cough. General body weakness with sleepless nights which result doctor or other healthcare professional office/clinic visit. Patient was treated with pain medication, x-ray of hip, bone density, refera in repose to the event. The patient underwent lab tests and procedures which included X-ray of hips, bone density measurement (report not provided). The outcome of the events was not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, X-ray of pelvis and hip
Clinical narrative: Constant pain in both hip area radiating down bilateral thighs worse at nights.; bilateral thighs worse at nights.; Pain in lower back; Constant cough; General body weakness with sleepless nights.; sleepless nights; This is a spontaneous report from a contactable female nurse (patient) via medical information team. An elderly female patient (non pregnant) unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in arm left on 06Feb2021 14:00 (Lot Number: EL9269) as a single dose at the age of 71 year old for covid-19 immunisation from hospital.  Medical history included high blood pressure. Concomitant medications included levothyroxine, hydrochlorothiazide and diltiazem all taken for an unspecified indication, start and stop date were not reported. The patient previously took betamethasone benzoate, diltiazem. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in arm left on 16Jan2021 14:00 (Lot Number: EL3249) as a single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. On 02Mar2021 03:00,  patient experienced Constant pain in both hip area radiating down bilateral thighs worse at nights. Pain in lower back. Constant cough. General body weakness with sleepless nights which result doctor or other healthcare professional office/clinic visit. Patient was treated with pain medication, x-ray of hip, bone density, refera in repose to the event. The patient underwent lab tests and procedures which included X-ray of hips, bone density measurement (report not provided). The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, COVID-19
Clinical narrative: tested positive after getting the first dose (Jul2021), but patient did not have any symptoms; This is a spontaneous report from a Pfizer sponsored Program. The contactable consumer (patient's mother) reported for her daughter (the patient).   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were unknown), via an unspecified route of administration, on 01Jul2021, as single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received the first dose of COVID-19 vaccine on the first of this month (01Jul2021) and then tested positive after getting the first dose (Jul2021), but patient did not have any symptoms and just wanted to report that now what reporter should if patient should get the second dose. Reporter wanted to know if patient should go on 22Jul2021 for her second dose. Outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Headache, Hypoaesthesia, Nausea
Clinical narrative: difficulty in breathing; chest pain; numbness; severe headache; nausea; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient experienced difficulty in breathing, chest pain, numbness, nausea and severe headache on an unspecified date. Event took place after use of product. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Running with fever 102.1; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 07Jul2021 (Lot Number: Unknown) as a single dose 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 mRNA VACCINE), via an unspecified route of administration on unspecified date as a single dose for covid-19 immunisation. The patient received vaccine shot yesterday (on Jul2021, second one) and she left with she is running with fever 102.1. Patient took one tylenol for the event and patient's husband told she shouldn't take that, so she didn't take the second (Tylenol). The reported want to know can patient take the tylenol with the vaccine if she has the fever. The outcome of event was unknown.  No follow-up attempts are possible; No further information is expected.