chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Blood immunoglobulin M, Condition aggravated, Ocular hyperaemia
Clinical narrative: So I went up and got a rapid test for the heck of it and I tested positive; So I went up and got a rapid test for the heck of it and I tested positive; My eyes were itching; This is a spontaneous report from a contactable consumer (herself). A female patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced so I went up and got a rapid test for the heck of it and I tested positive (drug ineffective) (covid-19), my eyes were itching on an unspecified date. Caller stated, her eyes were itching she do have allergies so she put drop in and it goes away. So she went up and got a rapid test for the heck of it and she tested positive. but she felt fine, she had no symptoms other than her itchy eyes that went away with her allergies. She was great but she had to quarantine for 10 days. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date. The treatment measures taken as a result of event my eyes were itching included drop. The clinical outcome of the event my eyes were itching was resolved on an unknown date.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Depression, Dysmenorrhoea, Heavy menstrual bleeding, Mood altered
Clinical narrative: Severe menstrual bleeding and cramps; Severe menstrual bleeding and cramps; Very significant change in mood; Depression symptoms; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 39-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration, administered in arm left on 17Mar2021 08:30 (at the age of 39-year-old) as dose 1, single for covid-19 immunization. The patient was not pregnant at time of vaccination. Patient's relevant medical history noted dairy allergy and covid-19. Concomitant medication was not reported. Prior to vaccination, the patient was diagnosed with covid-19 and since the vaccination, the patient had not been tested for covid-19. The patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Ew0162) via an unspecified route of administration, administered in arm left on 14Apr2021 as dose 2, single within four weeks of vaccination. The patient did not receive any other medications within two weeks of vaccination. On 18Mar2021 13:00, patient experienced severe menstrual bleeding and cramps; very significant change in mood and depression symptoms when patient had never had an issue before. The patient did not receive any treatment for adverse events. The patient did not seek medical attention because she felt embarrassed and was not confident in her doctor or insurance. Outcome of the events was recovering.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101422825 same reporter/drug, different patients.;US-PFIZER INC-202101422824 same reporter/drug, different patients.;US-PFIZER INC-202101422823 same reporter/drug, different patients.;US-PFIZER INC-202101422826 same reporter/drug, different patients.
Age: 46.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Computerised tomogram, Headache, Hypertension, Immunisation, Magnetic resonance imaging
Clinical narrative: I developed severe headaches and hypertension starting on the 5th day after vaccination.  I was getting 4-5 headaches per day. I'm continuing to get 1-2 headaches per day; I developed severe headaches and hypertension starting on the 5th day after vaccination.  I was getting 4-5 headaches per day. I'm continuing to get 1-2 headaches per day; The pain starts at the back of the neck on the right side and will migrate up and over the ear towards the temple; patient took flu shot and covid vaccine pfizer on 29Sep2021; BOOSTER; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was FF2589 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 29Sep2021 at 17:30 hours (Age at vaccination was 46 years) as dose 3 (booster), single for covid-19 immunization and influenza vaccine taken for immunization from 29Sep2021 to 29Sep2021 on right arm. Medical history included hypertension from an unknown date and unknown if ongoing. The patient did not have covid prior to vaccination. The patient did not have known allergies. Concomitant medication(s) included valsartan taken for an unspecified indication, start and stop date were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EL9264 and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 06Feb2021 at 09:00 hours as dose 2, single and dose 1 (lot number was EL8982 and expiration date were not reported) via an unspecified route of administration, administered in left arm, on 16Jan2021 at 09:00 hours as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. No known allergies. On 05Oct2021 at 06:00 hours patient developed severe headaches and hypertension starting on the 5th day after vaccination. He was getting 4 to 5 headaches per day and was seen in the emergency room on 09Oct2021. Patient continuing to get 1 to 2 headaches per day. The pain starts at the back of the neck on the right side and will migrate up and over the ear towards the temple. Physical will acerbate the headaches and will cause a headache to start. Adverse events resulted in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. On an unspecified date the patient underwent lab tests and procedures which included computerised tomogram with unknown result, magnetic resonance imaging with unknown result. The patient did not tested covid post vaccination. Patient took steroids, ubrevly, systolic as therapeutic measures. The outcome of events was not recovered.  Follow-Up (28Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pain, Product use issue
Clinical narrative: I developed severe headaches and hypertension starting on the 5th day after vaccination.  I was getting 4-5 headaches per day. I'm continuing to get 1-2 headaches per day; I developed severe headaches and hypertension starting on the 5th day after vaccination.  I was getting 4-5 headaches per day. I'm continuing to get 1-2 headaches per day; The pain starts at the back of the neck on the right side and will migrate up and over the ear towards the temple; patient took flu shot and covid vaccine pfizer on 29Sep2021; BOOSTER; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was FF2589 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 29Sep2021 at 17:30 hours (Age at vaccination was 46 years) as dose 3 (booster), single for covid-19 immunization and influenza vaccine taken for immunization from 29Sep2021 to 29Sep2021 on right arm. Medical history included hypertension from an unknown date and unknown if ongoing. The patient did not have covid prior to vaccination. The patient did not have known allergies. Concomitant medication(s) included valsartan taken for an unspecified indication, start and stop date were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EL9264 and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 06Feb2021 at 09:00 hours as dose 2, single and dose 1 (lot number was EL8982 and expiration date were not reported) via an unspecified route of administration, administered in left arm, on 16Jan2021 at 09:00 hours as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. No known allergies. On 05Oct2021 at 06:00 hours patient developed severe headaches and hypertension starting on the 5th day after vaccination. He was getting 4 to 5 headaches per day and was seen in the emergency room on 09Oct2021. Patient continuing to get 1 to 2 headaches per day. The pain starts at the back of the neck on the right side and will migrate up and over the ear towards the temple. Physical will acerbate the headaches and will cause a headache to start. Adverse events resulted in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. On an unspecified date the patient underwent lab tests and procedures which included computerised tomogram with unknown result, magnetic resonance imaging with unknown result. The patient did not tested covid post vaccination. Patient took steroids, ubrevly, systolic as therapeutic measures. The outcome of events was not recovered.  Follow-Up (28Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: With her first shot all she had was a sore arm; This is a spontaneous report from a contactable consumer (patient).  An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EC3247, Expiry date was not reported), via an unspecified route of administration on 29Jan2021 (at the age of 80-year-old) in left arm as DOSE 1, SINGLE for COVID-19 immunization. No relevant medical history was reported. The concomitant medications were not reported. The Patient was not received other products. On an unspecified date in 2021, the patient experienced sore arm. The outcome for the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: Cardiac arrest one week later, on 03Mar died 3 months later; Cardiac arrest one week later, on 03Mar died 3 months later; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 24Feb2021 02:00 (at the age of 73-years-old) (Batch/Lot Number: En6302) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported. The patient has no known allergies. The patient did not have covid prior vaccination and was not covid tested post vaccination. On 03Mar2021 07:00, the patient experienced cardiac arrest one week later, on 03Mar2021 died 3 months later. Therapeutic measures were taken as a result of the events. The patient died on 03Mar2021.  It was not reported if an autopsy was performed. The outcome of the event cardiac arrest was not recovered.   Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest one week later, on 03Mar died 3 months later
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Decreased appetite, Gait disturbance, Headache
Clinical narrative: start getting stiff painful joints; start getting stiff painful joints; difficulty walking and moving; difficulty walking and moving; low energy; headaches; nausea; loss of appetite; This is a spontaneous report from a contactable consumer(patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: El0142 and expiry date was not reported) via an unspecified route of administration into the left arm, at the age of 54-year-old, on 28Jan2021, as dose 2, single for covid-19 immunization. Medical history includes arthritis, vitamin D deficiency, and tested positive for COVID-19 infection, all from an unknown date. The patient had known allergies. The patient was not pregnant at the time of report. Concomitant medication within 2 weeks of vaccination included paracetamol (TYLENOL A) as needed.  Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot numbers: Fl0140 and expiry dates were not reported) via an unspecified route of administration into the left arm, at the age of 54-year-old, on 07Jan2021, as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Feb2021, the patient experienced stiff and painful joints, difficulty walking and moving, low energy, headaches, nausea, and loss of appetite. The adverse events resulted in doctor or other healthcare professional office/clinic visit. On 07Sep2021, nasal swab test was conducted and had negative result. The patient received treatment in response to the events which included prednisone, sulfasalazine, duloxetine, pregabalin, b12 and tylenol extra strength. The outcome of the events was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Movement disorder, Nausea, SARS-CoV-2 test
Clinical narrative: start getting stiff painful joints; start getting stiff painful joints; difficulty walking and moving; difficulty walking and moving; low energy; headaches; nausea; loss of appetite; This is a spontaneous report from a contactable consumer(patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: El0142 and expiry date was not reported) via an unspecified route of administration into the left arm, at the age of 54-year-old, on 28Jan2021, as dose 2, single for covid-19 immunization. Medical history includes arthritis, vitamin D deficiency, and tested positive for COVID-19 infection, all from an unknown date. The patient had known allergies. The patient was not pregnant at the time of report. Concomitant medication within 2 weeks of vaccination included paracetamol (TYLENOL A) as needed.  Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot numbers: Fl0140 and expiry dates were not reported) via an unspecified route of administration into the left arm, at the age of 54-year-old, on 07Jan2021, as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Feb2021, the patient experienced stiff and painful joints, difficulty walking and moving, low energy, headaches, nausea, and loss of appetite. The adverse events resulted in doctor or other healthcare professional office/clinic visit. On 07Sep2021, nasal swab test was conducted and had negative result. The patient received treatment in response to the events which included prednisone, sulfasalazine, duloxetine, pregabalin, b12 and tylenol extra strength. The outcome of the events was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report from a contactable consumer reporting same events under the same suspect product for 3 patients. This is the first of 3 reports. A patient of unspecified age and gender received unknown dose number of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that 3 people died from COVID after getting Pfizer's Vaccine. Three (3) individuals had the Pfizer's shot and died from COVID. The patient died on an unspecified date. It was not reported if an autopsy was performed.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101441264 same reporter/drug/event, different patient;US-PFIZER INC-202101441268 same reporter/drug/event, different patient; Reported Cause(s) of Death: COVID; COVID
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report from a contactable consumer reporting same events under the same suspect product for 3 patients. This is the second of 3 reports. A patient of unspecified age and gender received unknown dose number of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that 3 people died from COVID after getting Pfizer's Vaccine. Three (3) individuals had the Pfizer's shot and died from COVID. The patient died on an unspecified date. It was not reported if an autopsy was performed.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101441253 same reporter/drug/event, different patient;US-PFIZER INC-202101441268 Same reporter/vaccine/event, different patient; Reported Cause(s) of Death: COVID; COVID
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report from a contactable consumer reporting same events under the same suspect product for 3 patients. This is the third of 3 reports.  A patient of unspecified age and gender received unknown dose number of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that 3 people died from COVID after getting Pfizer's Vaccine. Three (3) individuals had the Pfizer's shot and died from COVID. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101441253 Same reporter/vaccine/event, different patient;US-PFIZER INC-202101441264 Same reporter/vaccine/event, different patient; Reported Cause(s) of Death: covid; covid
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 5 people she knew were vaccinated and died; This is a spontaneous report received from Pfizer sponsored program from a non-contactable consumer. This consumer reported same event for 5 patients. This is the 1st of 5 reports.  A female patient of unspecified age received bnt162b2 (COMIRNATY), via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The consumer stated during conversation that 5 people she knew were vaccinated and died. She did not have any other information. The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101451923 same reporter/drug/event, different PTs;US-PFIZER_INC-202101451924 same reporter/drug/event, different PTs;US-PFIZER_INC-202101451925 same reporter/drug/event, different PTs;US-PFIZER_INC-202101451926 same reporter/drug/event, different PTs; Reported Cause(s) of Death: 5 people she knew were vaccinated and died.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 5 people she knew were vaccinated and died; This is a spontaneous report received from Pfizer sponsored program.   A Non-contactable female consumer reporting same event(s) under the same suspect product(s) for 5 patients. This is the second of five reports:  A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  She also stated during conversation that 5 people she knew were vaccinated and died. She did not have any other information.  The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101451919 same reporter/drug/event, different PTs; Reported Cause(s) of Death: 5 people she knew were vaccinated and died.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 5 people she knew were vaccinated and died; This is a spontaneous report received from Pfizer sponsored program from a non-contactable consumer. This consumer reported same event for 5 patients. This is the 3rd of 5 reports.  A patient of unspecified age and gender received BNT162B2 (COMIRNATY), via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The consumer stated during conversation that 5 people she knew were vaccinated and died. She did not have any other information. The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101451919 same reporter/drug/event, different PTs; Reported Cause(s) of Death: 5 people she knew were vaccinated and died
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 5 people she knew were vaccinated and died; This is a spontaneous report received from Pfizer sponsored program. A Non-contactable consumer reporting same event under the same suspect product for 5 patients. This is 4 of 5 reports.  A patient of unspecified age and gender received bnt162b2 (COMIRNATY) on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter stated that she had J & J vaccine in March. She wanted to start over with the Pfizer Covid vaccines but her Provider was saying she could only have Pfizer Covid Booster. Wondering if there are any clinical trials she could get in to. Also wondering if steroids affect the Pfizer Covid vaccine. She would call back the day after reporting to speak with them. She also stated during conversation that 5 people she knew were vaccinated and died. It was unknown if Autopsy Done. The outcome of the event was fatal.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101451919 same reporter/drug/event, different patient.; Reported Cause(s) of Death: 5 people she knew were vaccinated and died
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 5 people she knew were vaccinated and died; This is a spontaneous report received from Pfizer sponsored program from a non-contactable consumer. This consumer reported same event for 5 patients. This is the 5th of 5 reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated during conversation that 5 people she knew were vaccinated and died. She did not have any other information. The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101451919 same reporter/drug/event, different PTs; Reported Cause(s) of Death: 5 people she knew were vaccinated and died
Sex: M
Vaccine: COVID19
Symptoms: Metastatic lymphoma
Clinical narrative: Diagnosed with metastatic lymphoma after first vaccine; This is a spontaneous report from a contactable consumer (daughter). A 60-years-old male patient (father) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/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 had injection site pain in his shoulder with redness, he was tired, he had a headache, and muscle pain in his shoulder. He also was not feeling well, had swollen lymph nodes and his eye and part of his face was swollen. He went to the hospital and was admitted, and he was diagnosed with metastatic lymphoma. The patient died on 14Jul2021.  It was not reported if an autopsy was performed.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Diagnosed with metastatic lymphoma after first vaccine
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Motion sickness, Nausea
Clinical narrative: dizzy/ her head was swimming so bad, she could hardly get her head off the pillow; car sick; weak; nauseated; This is a spontaneous report from a contactable consumer (patient). A 95-years-old female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6201) via an unspecified route of administration on 13Feb2021 at 13:00 (at the age of 95-years-old) in left arm as dose 1, single for covid-19 immunisation. Medically history included that years ago, she took smallpox vaccination and got really sick, fever, ached all over. She was healthy and wasn't like this before vaccine. She was in very good health and was walking a mile every day before she had the covid-19 Vaccine. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect, prior vaccinations (within 4 weeks, adverse events following prior vaccinations, family medical history relevant to adverse events were reported as none. The patient's concomitant medications were not reported. The patient reported that she thought she had food poisoning. She clarified she felt like she was car sick. She said she wanted to throw up but could not. She said she had no diarrhoea. She said her head was swimming so bad, she could hardly get her head off the pillow. She said she took Ibuprofen, and eventually was alright. She said she has not had any dizzier spells and was walking with her cane now.  The patient asked if it was OK for her to get her second COVID-19 Vaccine since she had a side effect to the first COVID-19 Vaccine. The patient was nauseated in Feb2021. Since she had the dizziness, she had not felt as strong. She said what she experienced has left her body weak. She said she took her cane out, so she has her cane with her when she walks just in case, she needed the cane. She said she felt so bad when her dizziness started that she didn't know what was going on. The adverse events do not require visit to emergency room or physician office. It was reported that she took probably a total of 3 Ibuprofen 600mg tablets from last week into this week. She said she took only 1 Ibuprofen 600mg tablet on a given day. She said the Ibuprofen 600mg tablets are a prescription that are dispensed in a pharmacy bottle with no NDC, lot and expiration date listed.  Relevant tests were reported as none. The outcome of the event asthenia was not recovered, for nausea was unknown and for all other events was resolved in Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: quiver on the left side of her neck between her thyroid and jugular vein; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported, expiry date was not reported.) via an unspecified route of administration on an unknown date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced quiver on the left side of her neck between her thyroid and jugular vein. The clinical outcome of the events was unknown.  Follow-up (06-APR-2021) no new information obtained.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling hot, Headache
Clinical narrative: headache; chills; Feeling hot; Weakness; tiredness; This is a spontaneous report from a contactable consumer(Patient). A 71-year-old female received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, lot number:EN6202) via an unspecified route of administration into arm left on 24Feb2021 as DOSE 2, SINGLE for covid-19 immunization(at an age of 71 years) The patient medical history had included A-fib (Caller initially calls this a rapid heartbeat situation, and was diagnosed about 5 months ago maybe.) and blood pressure high (Caller said this was diagnosed about 25-28 years ago). The patient concomitant medication were not reported. The patient previously took bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, lot number: EL9269) via an unspecified route of administration in left arm on 03Feb2021 as DOSE 1, SINGLE for covid-19 immunization and she had no problems with her first dose. On 25Feb2021, the patient had experienced tiredness, headache, felling hot, chills and weakness. Caller said her side effects are tiredness, headache, and chills. She said she doesn't have a thermometer to take her temp but she feels hot so she thinks she has a temp. She said she was also feeling weak. She said she took a Tylenol because she doesn't know what else to do, which was why she called today. She said she also drank some tea to get rid of chills. The clinical outcome of the events were unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Coordination abnormal, Gait disturbance, Pain in extremity
Clinical narrative: she is unable to step on her left leg due to pain in her left heel; she had to move on her tip toes,she had to move on her tip toes, her husband had to support her, she has to use a cane; sharp pains in her leg that shot into her heel; This is a spontaneous report from a contactable consumer or other non-health care practitioner (patient herself). A female patient of an unspecified age received BNT162B2 (BNT162B2 solution of injection Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 26Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. she had a reaction to her second dose of the Covid vaccine on 26Feb and asks if her reaction is a side effect to the vaccine. On the 27th everything was fine, on 28Feb the patient started having sharp pains in her leg that shot into her heel, she had to move on her tip toes, her husband had to support her, she has to use a cane. On day 3 the caller is unable to stand on her left leg at all. When the patient had received this vaccine, she was given paper-work and the paperwork said if they had any problems, she would have to call this number, she is calling today to find out what to do next. The patient wants to know if it is a vaccine reaction, just to make sure, and if it could be determined as a yes then she wants to know what to do in this case. The patients states that she understands, she mentions that she is going to see this new doctor next week. The patient wants to know if we can we get her on the phone with a doctor, she has been unable to get in with her doctor. The patient was again informed that Pfizer does not medically advice callers and we do not have a doctor service to medically advise her. The outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (Patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/Lot number: EN6202 and Expiry date was not reported) via an unspecified route of administration, on 24Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's relevant Medical history and Concomitant medication were not reported. On an unspecified date in 2021, patient experienced Headache. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient). A 73-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6198, Expiry date: not reported), via an unspecified route of administration in left arm on 28Feb2021 at 14:45 (at age of 73-years-old) as dose 1, single for covid-19 immunization in school or student health clinic. Medical history included high blood pressure, restless leg syndrome, intersitial cystitis, history of deep vein thrombosis. Concomitant medication(s) included donepezil hcl, taken for an unspecified indication, start and stop date were not reported; gabapentin taken for an unspecified indication, start and stop date were not reported; folic acid taken for an unspecified indication, start and stop date were not reported; duloxetine hcl taken for an unspecified indication, start and stop date were not reported; calcium carbonate, vitamin d nos (CALCIUM + VIT D) taken for an unspecified indication, start and stop date were not reported; metoprolol tartrate taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported; memantine hcl taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 28Feb2021 at 22:00, the patient experienced sore arm. The event was assessed as non-serious. Therapeutic measures were taken as a result of sore arm. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: feeling dizzy and this symptom persists; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot Number: EN6203; Expiration Date: Jun2021) via an unspecified route of administration, administered in left arm on 20Feb2021 09:00 (age at vaccination 63 years) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Feb2021, the patient experienced feeling dizzy and this symptom persists. They would like to know if that a normal side effect. The patient received unspecified medication to treat the event, but it was not helped. Outcome of the event was not recovered  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen right hand two days after vaccine.; This is a spontaneous report from a contactable consumer (patient).   A 63-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in arm right on 18Feb2021 at 11:30 (age at vaccine 63-years-old) as dose 1, single for covid-19 immunisation. The patient was not a pregnant at the time of vaccination. The patient medical history included cerebrovascular accident on 11Aug2021. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 post vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced swollen right hand two days after vaccine. The patient did not receive treatment for the adverse event. The patient visited doctor or other healthcare professional office/clinic visit. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: achy; Tired; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was tired and achy after the second dose of the Pfizer Covid-19 vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Nightmare, Poor quality sleep
Clinical narrative: She has days where she will suddenly get tired, her husband says the same; The caller explains one of the symptoms she had that her husband had to, was restless sleep and bad dreams.; The caller explains one of the symptoms she had that her husband had to, was restless sleep and bad dreams.; Anxiety; This is a spontaneous report from a contactable consumer or other non hcp reported for reporter's husband. The report is cross referenced to report ID: 2021224002. This is report 2 of 2. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient has days where reporter will suddenly get tired, her husband says the same, the caller explains one of the symptoms she had that her husband had to, was restless sleep and bad dreams, anxiety. Reporter declines to fill out report for her husband stating that man is as strong as an ox. patient is fine. reporter mentions patient did have some anxiety. and mentions she has heard things from people like impending sense of doom and restless sleep and things like that. reporter had other friends describe it so it's no big deal and people move out of it. No further details were provided or obtained. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021224002 Same reporter/drug/, different patient/event
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza, Nasal congestion
Clinical narrative: sore arm; like a cold coming on; congestion like a head cold and nose running and my throat is kind of flamed up a little bit; little runny nose; drainage in throat; Little aches and chills; It is hard for me to stay warm; Little aches and chills; It is hard for me to stay warm; fatigued, little tired; flu symptoms; little headache; itchy throat; This is a spontaneous report from a contactable consumer (patient, reported for self). A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number and Expiry date: unknown), via an unspecified route of administration, administered in arm right on 26Feb2021 12:30 (at the age of 75-year-old) as dose 1, single for COVID-19 immunisation at Pharmacy. Medical history included ongoing prostate problems, prostate cancer, allergic reaction to penicillin (He had an allergic reaction to penicillin. He had something they gave him penicillin for when he was around 14 years old. It made him pass out). Concomitant medications included dutasteride (AVODART) oral 0.5 mg gel cap one a day: morniflumate (FLOMAX) oral 0.4 mg capsule one a day both taken for prostate infection from unspecified date(s) and ongoing. No history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. No Adverse events following prior vaccinations. On 27Feb2021 the patient experienced congestion like a head cold and nose was running, and his throat was kind of flamed up a little bit. Little aches and chills. It was hard for him to stay warm, little tired. Patient was having flu symptoms. He got a little headache, little runny nose, and little symptoms in his glands in his throat, he clarified his glands did not feel swollen, he just had throat drainage. He had a sore arm for a day maybe a day and a half (unspecified date). He was also fatigued. His throat it itched (itchy throat), like a cold coming on or like the flu. Adverse event did not require a visit to Emergency Room/Physician Office. No investigation assessment. Therapeutic measures were taken as a result of the event(headache). Patient has been taking over the counter medicine and wants to know if its ok. He's been taking daytime and nighttime Nyquil and he took Aleve for his headache. Patient has been taking the recommended dosage for Nyquil because it comes with that little cup. He's taken Aleve when his headache gets kind of bad, he takes 1 pill, they are 220 milligrams. The events were non-serious. The outcome of the event sore arm was unknown and that of other events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal discomfort, Pain, Pain in extremity, Rhinorrhoea
Clinical narrative: sore arm; like a cold coming on; congestion like a head cold and nose running and my throat is kind of flamed up a little bit; little runny nose; drainage in throat; Little aches and chills; It is hard for me to stay warm; Little aches and chills; It is hard for me to stay warm; fatigued, little tired; flu symptoms; little headache; itchy throat; This is a spontaneous report from a contactable consumer (patient, reported for self). A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number and Expiry date: unknown), via an unspecified route of administration, administered in arm right on 26Feb2021 12:30 (at the age of 75-year-old) as dose 1, single for COVID-19 immunisation at Pharmacy. Medical history included ongoing prostate problems, prostate cancer, allergic reaction to penicillin (He had an allergic reaction to penicillin. He had something they gave him penicillin for when he was around 14 years old. It made him pass out). Concomitant medications included dutasteride (AVODART) oral 0.5 mg gel cap one a day: morniflumate (FLOMAX) oral 0.4 mg capsule one a day both taken for prostate infection from unspecified date(s) and ongoing. No history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. No Adverse events following prior vaccinations. On 27Feb2021 the patient experienced congestion like a head cold and nose was running, and his throat was kind of flamed up a little bit. Little aches and chills. It was hard for him to stay warm, little tired. Patient was having flu symptoms. He got a little headache, little runny nose, and little symptoms in his glands in his throat, he clarified his glands did not feel swollen, he just had throat drainage. He had a sore arm for a day maybe a day and a half (unspecified date). He was also fatigued. His throat it itched (itchy throat), like a cold coming on or like the flu. Adverse event did not require a visit to Emergency Room/Physician Office. No investigation assessment. Therapeutic measures were taken as a result of the event(headache). Patient has been taking over the counter medicine and wants to know if its ok. He's been taking daytime and nighttime Nyquil and he took Aleve for his headache. Patient has been taking the recommended dosage for Nyquil because it comes with that little cup. He's taken Aleve when his headache gets kind of bad, he takes 1 pill, they are 220 milligrams. The events were non-serious. The outcome of the event sore arm was unknown and that of other events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.