chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got her 2nd dose while she was covid positive (test positive the day after 2nd dose); got her 2nd dose while she was covid positive (test positive the day after 2nd dose); This is a spontaneous report from a contactable consumer (patient's child). This consumer reported similar events for two patient. This is the second of two reports. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient unknowingly got her 2nd dose while she was covid positive (test positive the day after 2nd dose) on an unspecified date. Reporter stated that the patient "was fine". Outcome of the events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130210 same reporter and drug, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 15Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 29Jan2021, the patient began to experience headaches, fatigue, cough and chest congestion. Then on 02Feb2021, the patient had tested positive for COVID-19. The outcome of the event, 'tested positive for COVID-19', was unknown. The patient was asking if she should get the second dose of vaccination or should wait three months post-infection; or should she begin the process again of taking the first and second dose; or should refrain completely from getting further vaccine doses.  Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Nervousness, Pain in extremity, Palpitations, Vaccination site pain
Clinical narrative: feeling shaky/she is nervous about the palpitations.; soreness and swelling at the injection site; soreness and swelling at the injection site; she experienced palpitations when she went to bed; her arm was sore; maybe she was dehydrated; This is a spontaneous report from a contactable consumer (patient). A 81-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) , lot EL9269, expiration date 20May2021, via an unspecified route of administration on 05Feb2021 (at the age of 81 years old) as a  SINGLE DOSE in the right arm for covid-19 immunisation.  Medical history included ongoing High Blood Pressure Diagnosed about 35 years ago (1986) and ongoing Diabetes Type 2 Diagnosed about 20 years ago (2001).  Concomitant medication included oral nifedipine  from Sep2020 and ongoing at 30 mg, 1x/day for High Blood Pressure, ubidecarenone (COQ-10), bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), acetylsalicylic acid (BABY ASPIRIN) one every other day.  Historical vaccine information included BNT162B2 on 15Jan2021, Lot number EL8982, Expiry 20May2021 first dose via injection into the left arm for COVID-19 immunisation at 81 years old. She had no reaction at all to the first dose. The patient's arm was sore the day of the vaccine on 05Feb2021. On 08Feb2021, she experienced palpitations when she went to bed. She got into bed and was trying to fall asleep, she started to get palpitations.She sat up and walked around, and took a acetaminophen (TYLENOL) and water, because she was thinking that maybe she was dehydrated in Feb2021 or something, and it seemed to go away, and she did fall asleep and she slept for several hours, very well. Then, around 7am this morning, the palpitations started a little again, but not as bad as last night. She had breakfast and then was okay again. Then she sat down in front of her computer, and the palpitations started again. The palpitations are not constant, they come and go. On 09Feb2021, the patient experienced feeling shaky but states this might be because she is nervous about the palpitations. On 09Feb2021, she experienced soreness and swelling at the injection site.  Treatment for palpitations was acetaminophen (TYLENOL). Outcome of her arm was sore, feeling shaky/she is nervous about the palpitations, soreness and swelling at the injection site and maybe she was dehydrated was unknown. Outcome of palpitations was not recovered
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: feeling shaky/she is nervous about the palpitations.; soreness and swelling at the injection site; soreness and swelling at the injection site; she experienced palpitations when she went to bed; her arm was sore; maybe she was dehydrated; This is a spontaneous report from a contactable consumer (patient). A 81-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) , lot EL9269, expiration date 20May2021, via an unspecified route of administration on 05Feb2021 (at the age of 81 years old) as a  SINGLE DOSE in the right arm for covid-19 immunisation.  Medical history included ongoing High Blood Pressure Diagnosed about 35 years ago (1986) and ongoing Diabetes Type 2 Diagnosed about 20 years ago (2001).  Concomitant medication included oral nifedipine  from Sep2020 and ongoing at 30 mg, 1x/day for High Blood Pressure, ubidecarenone (COQ-10), bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), acetylsalicylic acid (BABY ASPIRIN) one every other day.  Historical vaccine information included BNT162B2 on 15Jan2021, Lot number EL8982, Expiry 20May2021 first dose via injection into the left arm for COVID-19 immunisation at 81 years old. She had no reaction at all to the first dose. The patient's arm was sore the day of the vaccine on 05Feb2021. On 08Feb2021, she experienced palpitations when she went to bed. She got into bed and was trying to fall asleep, she started to get palpitations.She sat up and walked around, and took a acetaminophen (TYLENOL) and water, because she was thinking that maybe she was dehydrated in Feb2021 or something, and it seemed to go away, and she did fall asleep and she slept for several hours, very well. Then, around 7am this morning, the palpitations started a little again, but not as bad as last night. She had breakfast and then was okay again. Then she sat down in front of her computer, and the palpitations started again. The palpitations are not constant, they come and go. On 09Feb2021, the patient experienced feeling shaky but states this might be because she is nervous about the palpitations. On 09Feb2021, she experienced soreness and swelling at the injection site.  Treatment for palpitations was acetaminophen (TYLENOL). Outcome of her arm was sore, feeling shaky/she is nervous about the palpitations, soreness and swelling at the injection site and maybe she was dehydrated was unknown. Outcome of palpitations was not recovered
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Feeling cold, Hypersensitivity
Clinical narrative: drippy nose; She felt cold and chills but no fever; She felt cold and chills but no fever; lots of nasal congestion; chest congestion; productive cough; sinus infection; allergy symptoms; testing positive for Covid infection following administration for the first vaccine dose; testing positive for Covid infection following administration for the first vaccine dose; sore throat; This is a spontaneous report from a contactable nurse (patient).  A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), via an unspecified route of administration in Deltoid Left on 19Jan2021 11:30 at single dose for COVID-19 immunization.  Medical history included Slightly elevated blood pressure from Feb2021 and ongoing, Elevated cholesterol from Feb2021 and ongoing.  Concomitant medication included pravastatin (PRAVASTATIN) from Feb2021 and ongoing for Elevated cholesterol, lisinopril (LISINOPRIL) from Feb2021 and ongoing for Slightly elevated blood pressure.  The patient experienced testing positive for covid infection following administration for the first vaccine dose on 04Feb2021. COVID: Initially reported onset of symptoms as 29Jan2021, but clarified onset of symptoms night of, or morning of 28Jan2021. She always had allergy symptoms like a drippy nose; she was getting ready to go get allergy testing in a few weeks; but on 28Jan2021 she noticed a real increase of sicker drainage all through the night. She thought she might had had a sinus infection. She felt cold and chills but no fever; she never had a fever; but had chills daily. She also had really bad sore throat that went away the next day; and lots of nasal congestion; chest congestion; productive cough. She still had nasal congestion and a little bit of chest congestion but chest congestion was very light in color. She had had no trouble breathing or shortness of breath; other than from her nose being stopped up. Seriousness criteria: Caller reported no emergency room visit, doctor's office visit or hospitalization related to this event. The patient underwent lab tests and procedures which included Flu test: unknown results on 03Feb2021, SARS-CoV-2 RT-PCR test: positive on 04Feb2021.  The outcome of event sore throat was recovered 1 day later on unspecified date, lots of nasal congestion was not recovered, while for other events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test, Nasal congestion, Oropharyngeal pain, Productive cough, Respiratory tract congestion
Clinical narrative: drippy nose; She felt cold and chills but no fever; She felt cold and chills but no fever; lots of nasal congestion; chest congestion; productive cough; sinus infection; allergy symptoms; testing positive for Covid infection following administration for the first vaccine dose; testing positive for Covid infection following administration for the first vaccine dose; sore throat; This is a spontaneous report from a contactable nurse (patient).  A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), via an unspecified route of administration in Deltoid Left on 19Jan2021 11:30 at single dose for COVID-19 immunization.  Medical history included Slightly elevated blood pressure from Feb2021 and ongoing, Elevated cholesterol from Feb2021 and ongoing.  Concomitant medication included pravastatin (PRAVASTATIN) from Feb2021 and ongoing for Elevated cholesterol, lisinopril (LISINOPRIL) from Feb2021 and ongoing for Slightly elevated blood pressure.  The patient experienced testing positive for covid infection following administration for the first vaccine dose on 04Feb2021. COVID: Initially reported onset of symptoms as 29Jan2021, but clarified onset of symptoms night of, or morning of 28Jan2021. She always had allergy symptoms like a drippy nose; she was getting ready to go get allergy testing in a few weeks; but on 28Jan2021 she noticed a real increase of sicker drainage all through the night. She thought she might had had a sinus infection. She felt cold and chills but no fever; she never had a fever; but had chills daily. She also had really bad sore throat that went away the next day; and lots of nasal congestion; chest congestion; productive cough. She still had nasal congestion and a little bit of chest congestion but chest congestion was very light in color. She had had no trouble breathing or shortness of breath; other than from her nose being stopped up. Seriousness criteria: Caller reported no emergency room visit, doctor's office visit or hospitalization related to this event. The patient underwent lab tests and procedures which included Flu test: unknown results on 03Feb2021, SARS-CoV-2 RT-PCR test: positive on 04Feb2021.  The outcome of event sore throat was recovered 1 day later on unspecified date, lots of nasal congestion was not recovered, while for other events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Sinusitis
Clinical narrative: drippy nose; She felt cold and chills but no fever; She felt cold and chills but no fever; lots of nasal congestion; chest congestion; productive cough; sinus infection; allergy symptoms; testing positive for Covid infection following administration for the first vaccine dose; testing positive for Covid infection following administration for the first vaccine dose; sore throat; This is a spontaneous report from a contactable nurse (patient).  A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), via an unspecified route of administration in Deltoid Left on 19Jan2021 11:30 at single dose for COVID-19 immunization.  Medical history included Slightly elevated blood pressure from Feb2021 and ongoing, Elevated cholesterol from Feb2021 and ongoing.  Concomitant medication included pravastatin (PRAVASTATIN) from Feb2021 and ongoing for Elevated cholesterol, lisinopril (LISINOPRIL) from Feb2021 and ongoing for Slightly elevated blood pressure.  The patient experienced testing positive for covid infection following administration for the first vaccine dose on 04Feb2021. COVID: Initially reported onset of symptoms as 29Jan2021, but clarified onset of symptoms night of, or morning of 28Jan2021. She always had allergy symptoms like a drippy nose; she was getting ready to go get allergy testing in a few weeks; but on 28Jan2021 she noticed a real increase of sicker drainage all through the night. She thought she might had had a sinus infection. She felt cold and chills but no fever; she never had a fever; but had chills daily. She also had really bad sore throat that went away the next day; and lots of nasal congestion; chest congestion; productive cough. She still had nasal congestion and a little bit of chest congestion but chest congestion was very light in color. She had had no trouble breathing or shortness of breath; other than from her nose being stopped up. Seriousness criteria: Caller reported no emergency room visit, doctor's office visit or hospitalization related to this event. The patient underwent lab tests and procedures which included Flu test: unknown results on 03Feb2021, SARS-CoV-2 RT-PCR test: positive on 04Feb2021.  The outcome of event sore throat was recovered 1 day later on unspecified date, lots of nasal congestion was not recovered, while for other events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: started feeling symptoms 3 days ago; 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), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced started feeling symptoms 3 days ago on 06Feb2021. Caller stated she received the second dose of the Covid 19 vaccine 3 weeks ago and started feeling symptoms 3 days ago. Caller didn't explain symptoms and refused to provide a safety report. Still having symptoms 3 weeks after getting second dose. She had both doses and is having symptoms, but this will be 3 weeks since her second shot.  She would not think she would still be having them. Her main question is whether she should get a COVID test. The outcome of event was unknown.  Information on lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive COVID PCR test; This is a spontaneous report from a contactable consumer (patient's wife). A 58-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9264), via an unspecified route of administration in right arm on 29Jan2021 16:00 at single dose for covid-19 immunization. Medical history included ongoing type 2 diabetes, they believe he contracted Covid at that inoculation from unknown date and unknown if ongoing. There were no concomitant medications. Family medical history included: Diabetes. The patient experienced positive covid PCR test on 03Feb2021. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. The caller stated she was calling on behalf of her husband who received his first dose of the vaccine on 29Jan2021. They believe he contracted Covid at that inoculation. The caller asked if he should receive his second dose of the vaccine. Her husband 100% thinks he contracted it at the vaccine clinic and does not want to go back. She stated they read an article that they are finding folks who had Covid only need on dose of the vaccine. She stated this was an article from 01Feb titled "Had Covid, You May Need Only One Vaccine, Study Suggests" from (id). Caller's husband, the patient, received the Pfizer vaccine on 29Jan2021. There was no social distancing and other things occurred at the clinic he was. Patient ended up contracting COVID. Asked if patient needs second dose. Is scheduled for second dose on 19Feb2021. Started feeling symptoms on Wednesday, 03Feb2021. Had a positive COVID PCR test. Vaccination Facility Type: Hospital. No additional vaccines administered on same date of Pfizer suspect. No prior vaccinations within 4 weeks. No adverse events follow prior vaccinations. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 03Feb2021. The outcome of event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report from a contactable Consumer. A adult male patient received BNT162B2, via an unspecified route of administration on Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient had arm soreness on Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The treatment was not received for the adverse events. The outcome of the event was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Burning sensation, Dizziness, Paraesthesia
Clinical narrative: elevated blood pressure; a sensation of tingling on the right side of her chest and her right arm; burning sensation in my chest and right arm; felling dizzy/light-headed and "crummy"; This is a spontaneous report received from a contactable consumer (patient herself) via a Pfizer sponsored program Pfizer First Connect, and via Medical Information Team. An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number was not reported), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. Medical history included cancer and blood pressure issues (she had been treated prior to vaccination). The patient's concomitant medications were not reported. It was reported that, the patient received her first dose of Pfizer-Biontech Covid19 vaccine on 27Jan2021. She has since been feeling dizzy, light-headed and "crummy" in Jan2021. She reports going to the ER (emergency room) yesterday morning (08Feb2021) reporting an elevated blood pressure, with dizziness and a sensation of tingling on the right side of her chest and her right arm (the same arm that was vaccinated). Her MD says that she should not take the second dose, but her daughter-in-law who is a nurse says that it is her (the patient's) decision. On 27Jan2021, patient had been having issues with her blood pressure- sent to the ER yesterday morning- blood tests twice already. BP elevated and dizzy because she had a burning sensation in her chest and right arm in 2021. The patient supposed to get second dose on Wednesday doctor says not to take it, since she was experiencing adverse event, and her HCP sited the deaths in as a reason for her not to receive the second dose. The outcome of the events was reported as unknown.  Information on the lot/ batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: Have developed "severe" constipation subsequent to receipt of the vaccine.; This is a spontaneous report from a contactable consumer (patient). This 70-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL8982) via an unspecified route of administration on 21Jan2021 at 14:15 (at the age of 69-years-old) as a single dose in the left arm for COVID-19 immunization. The patient did not have any medical history. Prior to the vaccine the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included amlodipine-benazepril and tamsulosin from unknown dates, for unknown indications. The patient did not have any allergies to medications, food, or other products. On 26Jan2021 at 08:00 the patient developed "severe" constipation subsequent to the receipt of the vaccine. The event was reported as non-serious. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The outcome of constipation was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Myalgia
Clinical narrative: Exhaustion; muscle soreness; lack of sleep; This is a spontaneous report from a contactable consumer (patient).   This 54-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left arm on 08Feb2021 09:15 for COVID-19 immunisation. Medical history included allergy to Sulphur derived antibiotics. There were no concomitant medications. Previously the patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. On 08Feb2021 19:00, the patient experienced exhaustion, muscle soreness, lack of sleep with outcome of recovered on an unspecified date in Feb2021. No treatment required. The vaccine was administered at Workplace clinic.   Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on her both arms; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced rash on her both arms (non-serious) on an unspecified date with outcome of unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus, Lacrimation increased, Ocular hyperaemia
Clinical narrative: eye is itchy, it's bloodshot and tearing in one eye; eye is itchy, it's bloodshot and tearing in one eye; eye is itchy, it's bloodshot and tearing in one eye; This is a spontaneous report from a non-contactable consumer (wife). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 06Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced eye is itchy, it's bloodshot and tearing in one eye on 09Feb2021. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Fatigue
Clinical narrative: Now, he is extremely tired and weak, just sleepy; Now, he is extremely tired and weak, just sleepy; Now, he is extremely tired and weak, just sleepy; Loose stool / and had all he could do to get to the bathroom in time; threw up; began with chills and sweats/Chills; began with chills and sweats/Sweating; stomach hurt so bad; Feeling unwell; Hot flashes; arm was sore; This is a spontaneous report from a contactable consumer (patient's husband). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL0142, Expiration 31Mar2021, first dose) solution for injection intramuscular in the left arm on 06Feb2021 at 09:20 (at the age of 69-years-old) at 0.3 mL single dose for COVID-19 vaccination. Medical history included coronary heart disease, aneurysm in his stomach area, quadruple heart bypass in the 1990. There were no concomitant medications. Historical vaccine included flu shot and experienced arm was sore. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Feb2021 at 21:30, the patient experienced his arm was sore. On 08Feb2021, the patient experienced loose stool/and had all he could do to get to the bathroom in time, threw up, began with chills and sweats, stomach hurt so bad, feeling unwell, hot flashes. On 09Feb2021, now, he was extremely tired and weak, just sleepy. There was no emergency room or physician office for the events. No treatment was provided for the events pain in arm, threw up, chills, sweats, tired, weak, hot flashes, sleepy, stomach hurt so bad, feeling unwell. Unspecified treatment was provided for the even loose stool. The outcome of the events pain in arm, threw up was recovered in Feb2021. The outcome of the events loose stool, tired, weak, sleepy, stomach hurt so bad was unknown. The outcome of the events chills, sweats, hot flashes was recovering. The outcome of the event feeling unwell was not recovered.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Hyperhidrosis, Malaise, Pain in extremity, Somnolence
Clinical narrative: Now, he is extremely tired and weak, just sleepy; Now, he is extremely tired and weak, just sleepy; Now, he is extremely tired and weak, just sleepy; Loose stool / and had all he could do to get to the bathroom in time; threw up; began with chills and sweats/Chills; began with chills and sweats/Sweating; stomach hurt so bad; Feeling unwell; Hot flashes; arm was sore; This is a spontaneous report from a contactable consumer (patient's husband). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL0142, Expiration 31Mar2021, first dose) solution for injection intramuscular in the left arm on 06Feb2021 at 09:20 (at the age of 69-years-old) at 0.3 mL single dose for COVID-19 vaccination. Medical history included coronary heart disease, aneurysm in his stomach area, quadruple heart bypass in the 1990. There were no concomitant medications. Historical vaccine included flu shot and experienced arm was sore. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Feb2021 at 21:30, the patient experienced his arm was sore. On 08Feb2021, the patient experienced loose stool/and had all he could do to get to the bathroom in time, threw up, began with chills and sweats, stomach hurt so bad, feeling unwell, hot flashes. On 09Feb2021, now, he was extremely tired and weak, just sleepy. There was no emergency room or physician office for the events. No treatment was provided for the events pain in arm, threw up, chills, sweats, tired, weak, hot flashes, sleepy, stomach hurt so bad, feeling unwell. Unspecified treatment was provided for the even loose stool. The outcome of the events pain in arm, threw up was recovered in Feb2021. The outcome of the events loose stool, tired, weak, sleepy, stomach hurt so bad was unknown. The outcome of the events chills, sweats, hot flashes was recovering. The outcome of the event feeling unwell was not recovered.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Now, he is extremely tired and weak, just sleepy; Now, he is extremely tired and weak, just sleepy; Now, he is extremely tired and weak, just sleepy; Loose stool / and had all he could do to get to the bathroom in time; threw up; began with chills and sweats/Chills; began with chills and sweats/Sweating; stomach hurt so bad; Feeling unwell; Hot flashes; arm was sore; This is a spontaneous report from a contactable consumer (patient's husband). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL0142, Expiration 31Mar2021, first dose) solution for injection intramuscular in the left arm on 06Feb2021 at 09:20 (at the age of 69-years-old) at 0.3 mL single dose for COVID-19 vaccination. Medical history included coronary heart disease, aneurysm in his stomach area, quadruple heart bypass in the 1990. There were no concomitant medications. Historical vaccine included flu shot and experienced arm was sore. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Feb2021 at 21:30, the patient experienced his arm was sore. On 08Feb2021, the patient experienced loose stool/and had all he could do to get to the bathroom in time, threw up, began with chills and sweats, stomach hurt so bad, feeling unwell, hot flashes. On 09Feb2021, now, he was extremely tired and weak, just sleepy. There was no emergency room or physician office for the events. No treatment was provided for the events pain in arm, threw up, chills, sweats, tired, weak, hot flashes, sleepy, stomach hurt so bad, feeling unwell. Unspecified treatment was provided for the even loose stool. The outcome of the events pain in arm, threw up was recovered in Feb2021. The outcome of the events loose stool, tired, weak, sleepy, stomach hurt so bad was unknown. The outcome of the events chills, sweats, hot flashes was recovering. The outcome of the event feeling unwell was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia, Somnolence
Clinical narrative: being sleepy; tired; Body aches; low grade temperature; This is a spontaneous report from a contactable consumer reporting for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 25Jan2021 at 13:30 (at the age of 45 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 05Jan2021 at 12:00 (at the age of 44 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient did not experience any adverse events to previous vaccinations. Relevant medical history and concomitant medication were none. On 26Jan2021 in the evening, the patient experienced low grade temperature and body aches. On 28Jan2021, the patient experienced being sleepy and tired than normal. She said the sleepiness and tiredness has not lifted since she got the shot. She also said she gets tired anyway.  The events did not result in an ER or physician's office visit. The outcome of the events low grade temperature, body aches, being sleepy and tired was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Fatigue, Headache, Neck pain
Clinical narrative: Sever pain and swelling in arm pit (size of an orange); Sever pain and swelling in arm pit (size of an orange); severe headache; neck and elbow pain; neck and elbow pain; tired; This is a spontaneous report from a contactable health professional reporting for herself. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EL9269,  second dose (at the age of 35 years), via an unspecified route of administration in right arm on 08Feb2021 10:15 at single dose for covid-19 immunisation.  The patient previously received the first dose of BNT162B2, Lot number EL9262, in right arm on 21Jan2021 (at the age of 35 years).  COVID-19 vaccine was administered at hospital. Medical history included allergies to sulfa drugs. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC), diclofenac, venlafaxine hydrochloride (EFFEXOR), fluticasone propionate (FLONASE).  On 09Feb2021 the patient experienced severe pain and swelling in arm pit, severe headache, neck and elbow pain, tired. The patient was not treated for the events. The events were non-serious with outcome of recovering.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Sever pain and swelling in arm pit (size of an orange); Sever pain and swelling in arm pit (size of an orange); severe headache; neck and elbow pain; neck and elbow pain; tired; This is a spontaneous report from a contactable health professional reporting for herself. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EL9269,  second dose (at the age of 35 years), via an unspecified route of administration in right arm on 08Feb2021 10:15 at single dose for covid-19 immunisation.  The patient previously received the first dose of BNT162B2, Lot number EL9262, in right arm on 21Jan2021 (at the age of 35 years).  COVID-19 vaccine was administered at hospital. Medical history included allergies to sulfa drugs. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC), diclofenac, venlafaxine hydrochloride (EFFEXOR), fluticasone propionate (FLONASE).  On 09Feb2021 the patient experienced severe pain and swelling in arm pit, severe headache, neck and elbow pain, tired. The patient was not treated for the events. The events were non-serious with outcome of recovering.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pyrexia
Clinical narrative: flu like symptoms; fever; headache; This is a spontaneous report from a non-contactable consumer (patient herself) via a medical information team. A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, received first dose Saturday. The patient experienced flu like symptoms fever, headache on an unspecified date and stayed in bed yesterday (08Feb2021). The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Heart rate, Heart rate increased, Nervousness
Clinical narrative: weak feeling; heartbeat climb up and up; unnerving; This is a spontaneous report from a contactable consumer (patient). This 77-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318; expiration date 31May2021) via an unspecified route of administration on 05Feb2021 at 11:30 (at the age of 77-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included losartan, escitalopram, and atorvastatin from unknown dates for unspecified indications. The patient received dose 1 of BNT162B2 (lot number EL1284; left arm) on 15Jan2021 at 11:00. The patient previously received codeine on an unknown date for an unknown indication and experienced allergy. On 06Feb2021 at 13:00 the patient experienced a weak feeling and heartbeat climb up. The patient had a weak feeling, had to sit down and took her pulse with oximeter and her Apple watch. She watched her heartbeat climb up and up. She tried yoga breathing but could not slow it down. She was not sure how long this went on because it was very unnerving, but it reached as high as 105 before it started to go down. The beats went up, then down, finally started to keep going down. Once more there was a wave of the weakness through her before she stayed in the 73+ range. The patient was usually in the 60's. Since then the patient's heartbeats have been what is usual for her. During the episode the patient's husband found "rapid heartbeat" on the paper they received. The patient was concerned this happened a day after the vaccine, not within an hour. The events were reported as non-serious. The patient was not hospitalized and did not receive any treatment for the events. The outcomes of weak feeling and rapid heartbeat were recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: sore arm with both shots; Caller stated that he had an antibody test on 05Feb2021 and the test was negative.; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable physician (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 (first dose, lot number: EK5730) and 19Jan2021 14:00 (second dose, lot number: EL3248) both in left shoulder at 0.3 mL, single for prevention. The patient medical history was not reported. There were no concomitant medications. He had 2 doses of covid vaccine with no side effect. 15 days later, he had antibody test on 05Feb2021 and the test of IgM and IgG basically were negative. He had no antibodies to the coronavirus. So he was not sure whether or not he got a vaccine that was too old, not taken care of properly, but he had no immune response 15 days after the second dose he should have developed a response, developed antibodies. He was inquiring if that was effective and wanted to know if he should get another antibody test and take another dose of the Pfizer vaccine or get the Moderna vaccine. The patient stated seriousness as it was serious, it did not require hospitalization, he was not ill at least and had been self-isolating very well, but he was thinking long term, he was feeling well, had no problems, no complications related to the vaccine, other than a sore arm with both shots, that's it, it went smoothly, it was serious, he hoped to have some protection, but was concerned he had none. The patient had sore arm with both shots. The outcome of event antibody test negative was not recovered and event sore arm was unknown.; Sender's Comments: It was noted that patient had antibody test and the test of IgM and IgG basically were negative. He had no antibodies to the coronavirus.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 06Feb2021, at single dose, for COVID-19 immunisation. Medical history included pain in hip and ongoing asthma. Concomitant medications included ibuprofen (MOTRIN) and paracetamol (TYLENOL) both for pain in hip. The patient experienced sore arm (non-serious) on an unspecified date with outcome of unknown.    The information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A male patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a positive COVID-19 test on 06Feb2021. The clinical outcome of the event positive COVID-19 test was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (the patient's wife). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982), via an unspecified route of administration in the left arm on 25Jan2021 20:00 (at the age of 71-years-old) as a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The reporter stated she had the COVID virus back in Oct2020, but her husband (the patient) didn't get it at that time (negative). No other vaccines were given the same day or four weeks prior. No history of problems with vaccines in the past. The patient got the COVID-19 vaccine on 25Jan2021. Then on 02Feb2021, he got tested for COVID and was positive, after the vaccine. The patient had a lot of sinus drainage and drainage down the throat (Jan2021) prior to testing positive. The patient went to the physician's office, and the doctor ordered and gave a prescription (antibiotic) for the sinus drainage. The patient will finish the final dose tomorrow. The reporter wanted to know how unusual that was or if the vaccine made you more susceptible, if there was a connection or not. The patient was due for the next dose on 22Feb2021, and the reporter asked if he should proceed to get it. The clinical outcome of positive COVID-19 test with symptoms was not recovered.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site haemorrhage, Vaccination site pruritus, Wrong technique in product usage process
Clinical narrative: Bandaid at the injection site was itching; stopped when she took the Bandaid off; they hit a blood vessel and blood squirted out; they hit a blood vessel and blood squirted out; bruise; This is a spontaneous report from a contactable consumer, the patient.  A 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, EL9262), via an unspecified route of administration on 26Jan2021 at 16:30 (at the age of 81-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included an upper bowel blockage with hospitalization on an unspecified date reported as "two years ago." Concomitant medications were not reported. The patient was administered the vaccine at a facility clinic. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that she got her first dose of the Pfizer vaccine and they hit a blood vessel and blood squirted out. It left a bruise (3-4 inches) on her arm.  It has not bothered her and it's healing up, but it's in her left arm. She would like to get it on this arm again to keep it moving. The bruise is a size of a baseball.  She inquired as to if it is safe to get the second  shot in the same arm. She also mentioned that the Bandaid at the injection site was itching; it stopped when she took the Bandaid off. The clinical outcomes of the events wrong injection technique, vaccination site bleeding and contusion were reported as recovering. The clinical outcome of vaccination site itching was reported as recovered on an unspecified date.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9262, expiration date 31May2021), via an unspecified route of administration on 22Jan2021 at 15:15 (at the age of 34-years-old) as a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ethinylestradiol, norgestimate (MILI), oral from an unknown date for birth control (taken for two years). The patient did not receive other vaccines within 4 weeks prior to vaccination. On 28Jan2021, the patient experienced a Positive COVID-19 PCR test without symptoms. The clinical outcome of the event COVID-19 was unknown.