chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain
Clinical narrative: vertigo; dizziness; fatigue; chills; headache; elevated temperature (around 100F); light nausea; achiness; muscle and joint aches; muscle and joint aches; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Feb2021 13:00 (Batch/Lot Number: EL3247) at the age of 38 years, as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. He was not diagnosed with COVID-19 prior to vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), in left arm on 27Jan2021 (Batch/Lot Number: EL3247) at the age of 38 years, as dose 1, single for COVID-19 immunization and experienced mild pain at the side of vaccination (left arm). On 17Feb2021 21:00, about 8h after the vaccination, the patient experienced chills, headache, elevated temperature (around 100F), light nausea, achiness/ muscle and joint aches, and fatigue. The patient was informed about the possibility of these common side effect by the person who administered the vaccine. The symptoms ceased about 48h after. In addition, the patient started experiencing nausea and vertigo/ dizziness on 22Feb2021, 4th day after the vaccination. The patient did not think that they were related to the vaccine but still wanted to report them. He reported that he cleaned his ear with a q-tip on 21Feb2021 which might have caused the symptoms. The patient did not receive treatment for the events. Outcome of chills, headache, elevated temperature (around 100F), light nausea, achiness/ muscle and joint aches, and fatigue was recovered on 19Feb2021 21:00; of remaining events was unknown. Patient was not tested for COVID-19 post-vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events vertigo, dizziness and the suspect drug BNT162B2.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; dizziness; fatigue; chills; headache; elevated temperature (around 100F); light nausea; achiness; muscle and joint aches; muscle and joint aches; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Feb2021 13:00 (Batch/Lot Number: EL3247) at the age of 38 years, as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. He was not diagnosed with COVID-19 prior to vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), in left arm on 27Jan2021 (Batch/Lot Number: EL3247) at the age of 38 years, as dose 1, single for COVID-19 immunization and experienced mild pain at the side of vaccination (left arm). On 17Feb2021 21:00, about 8h after the vaccination, the patient experienced chills, headache, elevated temperature (around 100F), light nausea, achiness/ muscle and joint aches, and fatigue. The patient was informed about the possibility of these common side effect by the person who administered the vaccine. The symptoms ceased about 48h after. In addition, the patient started experiencing nausea and vertigo/ dizziness on 22Feb2021, 4th day after the vaccination. The patient did not think that they were related to the vaccine but still wanted to report them. He reported that he cleaned his ear with a q-tip on 21Feb2021 which might have caused the symptoms. The patient did not receive treatment for the events. Outcome of chills, headache, elevated temperature (around 100F), light nausea, achiness/ muscle and joint aches, and fatigue was recovered on 19Feb2021 21:00; of remaining events was unknown. Patient was not tested for COVID-19 post-vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events vertigo, dizziness and the suspect drug BNT162B2.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Headache, Hot flush, Lethargy
Clinical narrative: Lethargic; sore at the injection site; fever; shivering; cold sweats; hot flashes; body aches; headache; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient (not pregnant at the time of vaccination) received second dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection and batch no: not reported/lot number: EL3247), via an unspecified route of administration, administered in Left arm on 19Feb2021 10:30 (at the age of 26-year-old) as dose 2, single for covid-19 immunization at workplace clinic. Medical history included fibromyalgia. Concomitant medications included fish oil and gabapentin, via an unspecified route at an unknown dose from an unknown date for unspecified indication. Historical vaccine included as patient received her first dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection, batch no: not reported/lot number: EL3247) via an unspecified route of administration, in left arm on 29Jan2021 10:30 AM (at the age of 25-year-old) as dose 1, single for covid-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination. On 19Feb2021 at 11:00 PM, patient reported that she was lethargic and sore at the injection site several hours after the vaccination. After 12 hours symptoms included fever, shivering, cold sweats, hot flashes, body aches, headache. Symptoms persisted for 32 hours. Headache remained up to 60 hours after the vaccine was administered. The outcome of the events was recovered on an unknown date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: Lethargic; sore at the injection site; fever; shivering; cold sweats; hot flashes; body aches; headache; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient (not pregnant at the time of vaccination) received second dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection and batch no: not reported/lot number: EL3247), via an unspecified route of administration, administered in Left arm on 19Feb2021 10:30 (at the age of 26-year-old) as dose 2, single for covid-19 immunization at workplace clinic. Medical history included fibromyalgia. Concomitant medications included fish oil and gabapentin, via an unspecified route at an unknown dose from an unknown date for unspecified indication. Historical vaccine included as patient received her first dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection, batch no: not reported/lot number: EL3247) via an unspecified route of administration, in left arm on 29Jan2021 10:30 AM (at the age of 25-year-old) as dose 1, single for covid-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination. On 19Feb2021 at 11:00 PM, patient reported that she was lethargic and sore at the injection site several hours after the vaccination. After 12 hours symptoms included fever, shivering, cold sweats, hot flashes, body aches, headache. Symptoms persisted for 32 hours. Headache remained up to 60 hours after the vaccine was administered. The outcome of the events was recovered on an unknown date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Caller experienced arthritis after the 2nd dose; This is a spontaneous report from a Pfizer-sponsored progra via a contactable consumer (patient).  A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unspecified date after receiving second dose of vaccination, patient experienced arthritis. Patient wants to know what kind of Tylenol she could take. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: My left nostril of the nose started bleeding; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. Reportedly, received first dose of Pfizer vaccine at 6.30 pm. The patient medical history and concomitant medications were not reported. On an unspecified date patient had no complications and after finishing dinner was just sitting and left nostril of the nose started bleeding. It has stopped after some cold-water therapy.  Therapeutic measures were taken as a result of my left nostril of the nose started bleeding (epistaxis). Outcome of events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Illness, Nausea
Clinical narrative: terrible shakes; chills; nausea; pain; headache; Fever; Very tired; sick; This is a spontaneous report from a contactable other hcp (patient).  A 51-years-old (Age group: Adult 18-64 Years) non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200, Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 22Feb2021 08:30 (age at vaccination 51 years) as dose number unknown, single for covid-19 immunisation.  Medical history included Ulcerative colitis, prior covid-19 from an unknown date and unknown if ongoing. Concomitant medication(s) included mesalazine (ASACOL); probiotics (PROBIOTICS); diphenhydramine hydrochloride (BENADRYL); paracetamol (TYLENOL); ibuprofen (MOTRIN [IBUPROFEN]). Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Feb2021 17:00 the patient experienced the first night after vaccine terrible shakes, chills, nausea, pain, headache, Day after she continued being sick, fever, very tired in feb2021. Second night still had fever. Second day after shot still fever and very tired. The patient received treatment of Took Vicodin for reported events. The outcome of fever was not recovered rest of all events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: terrible shakes; chills; nausea; pain; headache; Fever; Very tired; sick; This is a spontaneous report from a contactable other hcp (patient).  A 51-years-old (Age group: Adult 18-64 Years) non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200, Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 22Feb2021 08:30 (age at vaccination 51 years) as dose number unknown, single for covid-19 immunisation.  Medical history included Ulcerative colitis, prior covid-19 from an unknown date and unknown if ongoing. Concomitant medication(s) included mesalazine (ASACOL); probiotics (PROBIOTICS); diphenhydramine hydrochloride (BENADRYL); paracetamol (TYLENOL); ibuprofen (MOTRIN [IBUPROFEN]). Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Feb2021 17:00 the patient experienced the first night after vaccine terrible shakes, chills, nausea, pain, headache, Day after she continued being sick, fever, very tired in feb2021. Second night still had fever. Second day after shot still fever and very tired. The patient received treatment of Took Vicodin for reported events. The outcome of fever was not recovered rest of all events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: headaches; fever; chills; muscle pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported about herself. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2; Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on 21Feb2021 for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received the first dose last Sunday on 21Feb2021 and asked if it was possible to experience side effects in 3 days. Patient experienced headaches, fever, chills, and muscle pain after the first dose on unspecified date in Feb2021. Patient was not sure if this was from the vaccine or not since this was not normal for her. At the time of this report, outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Should pain after vaccine from Pfizer; This is a spontaneous report from a contactable physician (patient) via a sales representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. the patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced should pain after vaccine from Pfizer. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain, Pyrexia
Clinical narrative: migraine; slight fever; body aches; This is a spontaneous report received from a contactable consumer via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 21Feb2021 (Batch/lot number not reported), as dose 1, single, for COVID-19 immunisation. In Feb2021, the patient experienced migraine, slight fever and body aches. The reporter was wondering how long the reactions will last. 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.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: she had fever after getting her first covid vaccine shot; This is a spontaneous report from a contactable consumer(Patient). This female consumer of an unspecified age reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation.  Medical history included she had COVID in unspecified date in August. The patient's concomitant medications were not reported. Caller stated that she got her first Pfizer Covid shot in Mar2021 and she had fever after getting her first Covid vaccine shot. She was told not to take Tylenol for 24 hours. She wanted to know if Pfizer had any information on that. She wanted to know if she could use antipyretics after vaccination with the Pfizer- BioNTech COVID-19 vaccine or not. She was told that she could take medication after getting the vaccine. She heard people with COVID had more of severe a reaction after getting the first shot. Caller reported that she had 101 fever post vaccination. The patient underwent lab tests and procedures which included body temperature: 101 on Mar2021. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever; Sore arm; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient) reported herself. A 53-years-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, lot number: EL3247), via an unknown route of administration in left arm on 04Mar2021 at 09:45 (at the age of 53-years-old) as single for COVID-19 immunisation. The patient's medical history was none. He had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 04Mar2021 at 23:00, the patient experienced fever, sore arm, chills and nausea. patient for this report and reporter became aware of the symptoms during the night following the vaccine administration, which occurred on 04Mar2021. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No treatment received. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: had high fever up 107°F; shaking; breathing troubles. She could not take deep breath, had to breath thought her nose and release air though her mouth for 35 min; cough; fatigue; chilling; headache; muscle soreness; This is a spontaneous report from a contactable consumer (patient) via medical information team.  A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: unknown), via an unspecified route of administration, on 04Mar2021 (at the age of 72 years old) as a dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown) on 10Feb2021 (at the age of 72-year-old) as a dose 1, single for covid-19 immunization. On unspecified date on Friday in the middle of the night she had some breathing troubles. She could not take deep breath, had to breath thought her nose and release air though her mouth for 35 min. She was also chilling and shaking and had high fever up 107 degree F; when she started taking Advil and Tylenol the fever broke twice. Leaving that aside she had also fatigue, cough, muscle soreness, headache till this morning, no sore throat or congestion. She wanted to report this but wanted to be sure that since she got all the symptoms that everyone that had covid had, would she still be infectious. She thinks that the vaccine gave her covid 19. The outcome of the events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperpyrexia, Myalgia, Tremor
Clinical narrative: had high fever up 107°F; shaking; breathing troubles. She could not take deep breath, had to breath thought her nose and release air though her mouth for 35 min; cough; fatigue; chilling; headache; muscle soreness; This is a spontaneous report from a contactable consumer (patient) via medical information team.  A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: unknown), via an unspecified route of administration, on 04Mar2021 (at the age of 72 years old) as a dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown) on 10Feb2021 (at the age of 72-year-old) as a dose 1, single for covid-19 immunization. On unspecified date on Friday in the middle of the night she had some breathing troubles. She could not take deep breath, had to breath thought her nose and release air though her mouth for 35 min. She was also chilling and shaking and had high fever up 107 degree F; when she started taking Advil and Tylenol the fever broke twice. Leaving that aside she had also fatigue, cough, muscle soreness, headache till this morning, no sore throat or congestion. She wanted to report this but wanted to be sure that since she got all the symptoms that everyone that had covid had, would she still be infectious. She thinks that the vaccine gave her covid 19. The outcome of the events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Dizziness, Fatigue, Nausea
Clinical narrative: Fever 100.4; sore arm; light headed; nausea; stomach pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female non pregnant patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number and expiration date was not reported) via an unspecified route of administration in Arm Left on 03Mar2021 at 09:45 AM (at the age of 54-year-old) as dose number unknown, single for COVID-19 immunisation. No other medical history was there. There were no known allergies. Concomitant medications included pantoprazole taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; omeprazole (PROTONIX) taken for an unspecified indication, start and stop date were not reported. No other vaccine was taken by the patient in four weeks, No COVID prior vaccination was taken by the patient and was not COVID tested post vaccination. The patient experienced Fever 100.4, sore arm, lightheaded, nausea, stomach pain, fatigue on 04Mar2021 at 04:00 AM. The patient underwent lab test and procedure which included Fever: 100.4 Units: unspecified on 04Mar2021. No treatment was taken for the events. The outcome of all the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever 100.4; sore arm; light headed; nausea; stomach pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female non pregnant patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number and expiration date was not reported) via an unspecified route of administration in Arm Left on 03Mar2021 at 09:45 AM (at the age of 54-year-old) as dose number unknown, single for COVID-19 immunisation. No other medical history was there. There were no known allergies. Concomitant medications included pantoprazole taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; omeprazole (PROTONIX) taken for an unspecified indication, start and stop date were not reported. No other vaccine was taken by the patient in four weeks, No COVID prior vaccination was taken by the patient and was not COVID tested post vaccination. The patient experienced Fever 100.4, sore arm, lightheaded, nausea, stomach pain, fatigue on 04Mar2021 at 04:00 AM. The patient underwent lab test and procedure which included Fever: 100.4 Units: unspecified on 04Mar2021. No treatment was taken for the events. The outcome of all the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Weight
Clinical narrative: body ache; fever; nausea; This is a spontaneous report from a contactable other HCP. A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: not reported) via an unspecified route of administration in Mar2021 (a week ago) as dose 2, single for COVID-19 immunization. The patient medical history included weight loss (reports intentional weight loss for "last several months" feels better) and concomitant medications were not reported. On an unspecified date, the patient had symptoms of fever, body aches, nausea, was able to restart XELJANZ on 04Mar2021. She reported no adverse events from missed doses of XELJANZ from 13Jan2021 to 04Mar2021 as last reported on 20Jan2021. On an unspecified date the patient underwent lab tests which included weight loss on unspecified date (reports intentional weight loss for "last several months" feels better), MD aware. The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: mild body aches; very sore arm/sore arm and tired after first dose; felt tired/sore arm and tired after first dose; This is a spontaneous report from a contactable other healthcare professional. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EH9899), via an unspecified route of administration, administered in Arm Left on 28Dec2020 (at the age of 67-year-old) as dose 1, single for covid-19 immunisation. Medical history included Heart condition, rheumatic fever (When she was 10 years old since then she had been taking the flu shot), hypertension from 2006 to an unknown date, impaired mitral valve (diagnosed at 10 years old). The patient concomitant medications were not reported. Historical vaccine included flu shot (I had rheumatic fever when I was 10 years old since then I been taking the flu shot). The patient reported the on 28Dec2021, she felt tired, very sore arm and had mild body aches after getting the first dose of the vaccine but had zero symptoms not even a sore arm after the second dose. The patient was worried that the dose was ineffective either it was left out for too long and not kept cold or it was a bad dose. She wanted to know if she needs to repeat the dose. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: 100.9 fever; chills; muscle aches; extreme lethargy; swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 at 14:00 (at the age of 41-years-old) as a dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications in two weeks included metoprolol (METOPROLOL), trazodone (TRAZODONE), norethindrone [norethisterone] (NORETHINDRONE [NORETHISTERONE]), amlodipine (AMLODIPINE) all were taken for an unspecified indication, start and stop date were not reported. Other vaccine received in four weeks was none. Patient did not have covid prior vaccination and was not tested for covid post vaccination. On 06Mar2021 06:00, the patient experienced 100.9 fever, chills, muscle aches, extreme lethargy and swollen lymph node under armpit on same side of injection. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9266), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 as a DOSE 2, SINGLE for covid-19 immunisation. Patient did not receive any treatment for the event. The patient underwent lab tests and procedures which included pyrexia that was 100.9 on 06Mar2021. Outcome of all the events were recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site mass
Clinical narrative: small bruise; circular bump in the injection site; This is spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for female patient (reporter's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. on an unspecified date caller stated his mother got the 1st dose this afternoon 05Mar2021, and they want to confirm if his mother can take Tylenol. He stated that his mother had a circular bump in the injection site and a small bruise. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Confusional state, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: increase in fatigue; confusion/dizziness; confusion/dizziness; lethargy; flushed; brain fog; soreness on injection site; fatigue; This is a spontaneous report from a contactable consumer. A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection),via an unspecified route of administration, administered in Arm Left on 06Mar2021 10:45 (Age at vaccination 29 years old) (Batch/Lot Number: Unknown) as Dose 1,Single for covid-19 immunization. Medical history included polycythaemia vera, hiv infection from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken within 2 weeks of vaccination.On 06Mar2021 at 15:00, the patient experienced fatigue, on 07Mar2021 at 15:00 soreness on injection site, on 08Mar2021 at 15:00 lethargy, flushed brain fog, on 09Mar2021 at 15:00 increase in fatigue confusion/dizziness. Outcome of events was not recovered. Information on the lot/batch number has been requested.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Lethargy, Vaccination site pain
Clinical narrative: increase in fatigue; confusion/dizziness; confusion/dizziness; lethargy; flushed; brain fog; soreness on injection site; fatigue; This is a spontaneous report from a contactable consumer. A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection),via an unspecified route of administration, administered in Arm Left on 06Mar2021 10:45 (Age at vaccination 29 years old) (Batch/Lot Number: Unknown) as Dose 1,Single for covid-19 immunization. Medical history included polycythaemia vera, hiv infection from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken within 2 weeks of vaccination.On 06Mar2021 at 15:00, the patient experienced fatigue, on 07Mar2021 at 15:00 soreness on injection site, on 08Mar2021 at 15:00 lethargy, flushed brain fog, on 09Mar2021 at 15:00 increase in fatigue confusion/dizziness. Outcome of events was not recovered. Information on the lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache, Hyperhidrosis, Pain
Clinical narrative: headache; body aches; clammy and sweaty; blood pressure spiked; heart pounding; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot Number: EN6205), via an unspecified route of administration, administered in Arm Right on 27Feb2021 14:00 (at the age of 67-years-old) as dose 1, single for COVID-19 immunization. Medical history included mitral valve prolapse (no medications); arthritis (no medications being taken). Concomitant medication(s) included atorvastatin, levothyroxine taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks, patient had no COVID prior vaccination, no COVID tested post vaccination and no known allergies. The patient about 8 hours after receiving the vaccine his blood pressure spiked to 152. He do not normally have high BP and it usually around 115-120 and as low as 110 in the mornings. He could feel his heart pounding and his hands and feet were clammy and sweaty. This continued for about an hour and then it began to drop to normal on 27Feb2021 22:00. The following day had body aches and a headache but his BP was at 120 on 28Feb2021. No treatment was received in response to event. The patient underwent lab tests and procedures which included blood pressure measurement: around 115-120 and as low as 110 in the mornings on unspecified date, blood pressure measurement: spiked to 152 on 27Feb2021, blood pressure measurement: 120 on 28Feb2021. The outcome of events were resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: headache; body aches; clammy and sweaty; blood pressure spiked; heart pounding; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot Number: EN6205), via an unspecified route of administration, administered in Arm Right on 27Feb2021 14:00 (at the age of 67-years-old) as dose 1, single for COVID-19 immunization. Medical history included mitral valve prolapse (no medications); arthritis (no medications being taken). Concomitant medication(s) included atorvastatin, levothyroxine taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks, patient had no COVID prior vaccination, no COVID tested post vaccination and no known allergies. The patient about 8 hours after receiving the vaccine his blood pressure spiked to 152. He do not normally have high BP and it usually around 115-120 and as low as 110 in the mornings. He could feel his heart pounding and his hands and feet were clammy and sweaty. This continued for about an hour and then it began to drop to normal on 27Feb2021 22:00. The following day had body aches and a headache but his BP was at 120 on 28Feb2021. No treatment was received in response to event. The patient underwent lab tests and procedures which included blood pressure measurement: around 115-120 and as low as 110 in the mornings on unspecified date, blood pressure measurement: spiked to 152 on 27Feb2021, blood pressure measurement: 120 on 28Feb2021. The outcome of events were resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Pain
Clinical narrative: Aches; chills; facial redness; tired; This is a spontaneous report from a contactable consumer or other non-health care professional. A 35-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EN 6206, Expiry date not reported) dose 1 via an unspecified route of administration, administered in Left arm on 05Mar2021 11:30 (age at vaccination 35 years old) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication(s) included paracetamol (TYLENOL EXTRA STRENGTH), ibuprofen both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 05Mar2021 at 17:00 the patient experienced aches, chills, facial redness and tired. Patient did not receive treatment for adverse events. Outcome of events was recovered on unspecified date in Mar2021.     Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable other hcp. A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as dose 1, single (age at vaccination 77-year-old) for COVID-19 immunization. Medical history included pulmonary fibrosis. The patient's concomitant medications were not reported. The patient previously took Xeljanz XR and experienced cough with pale greenish/yellowish phlegm, occasional wheezing and shortness of breath, sore throat. The patient experienced headache on an unknown date in 2021. Denied any fever. Per patient, he stopped the Xeljanz 4 days ago due to symptoms. The outcome of the event headache was recovered on an unknown date in 2021.   Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy
Clinical narrative: Achy joints in both shoulders; Swollen lymph nodes (worse on right side/injection side); This is a spontaneous report from a contactable consumer (reporting herself). A 40-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 19Feb2021, the patient experienced swollen lymph nodes (worse on right side/injection side) and on an unknown date, the patient experienced achy joints in both shoulders. Referred caller to HCP for further discussion. Provided off-label disclaimer. Informed caller that Pfizer was unable to make treatment recommendations. Spoke from attached document CONS-Pfizer-BioNTech COVID-19 Vaccine - timing of Dose 2 (v1.0). Offered to provide state/local health dept. contact information but caller declined stating she has already contacted. The outcome of event was recovering.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough
Clinical narrative: Cough; Chest hurt; This is a spontaneous report from a contactable consumer or other non hcp. A 99-years-old female patient received BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution of injection Lot Number: EN6207), via an unspecified route of administration on 12Mar2021 10:00 as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 12Mar2021 at 18:30, the patient experienced cough and chest hurt. It continued all day Saturday and was gone by Sunday morning. The patient was asking if she can take second one or not. The patient also asked who should not get the Pfizer vaccine. The clinical outcome of the events was unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Somnolence, Vaccination site pain
Clinical narrative: Body aches; Pain at the site of injection; Fever; Really bad fatigue; Just want to sleep; This is a spontaneous report from a contactable consumer or other non hcp.     A 66-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. It was Reported that, Caller stated for herself and husband we had a few side effects after receiving the second dose of the Pfizer COVID-19 vaccine 10 days ago. Nothing severe. The first dose was no problem both had body aches, pain at the site of injection, fever and really bad fatigue. The fatigue is getting better but it's still there. We felt so tired we just want to sleep. Caller's husband is 73 years old. She was 66 years old. Caller wants to know if we have any data on how long the fatigue should last. Caller heard generally within 2-3 days side effects starts to lessen. The outcome of the events was unknown on an unspecified date and the case was assessed as non serious.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Eye irritation, Vision blurred
Clinical narrative: Spike in blood pressure; blurry vision; burning eyes; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 73-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6206, Expiry date: unknown, at the age of 73-year-old), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. Medical history included rheumatoid arthritis and hypersensitivity (known allergies: yes). It was reported as no covid prior to vaccination and no covid was tested post vaccination. No other vaccine was received in four weeks. Concomitant medications included certolizumab pegol (CIMZIA), levothyroxine sodium (SYNTHROID), cholestyramine and omeprazole (taken for an unspecified indication, start and stop dates were not reported for all medications). The patient experienced spike in blood pressure, blurry vision and burning eyes on 10Mar2021 09:30. The patient underwent lab tests and procedures which included blood pressure measurement showed spike on 10Mar2021. No treatments was received by patient for adverse events. Events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of events was recovered with sequelae (recovered with lasting effects) on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Derealisation, Feeling abnormal
Clinical narrative: The vaccine made her feel like she was on cloud; When she went to lay down it felt like an after birth like a big blob; Little blisters on her arm; This is a spontaneous report received from a Pfizer sponsored program via a contactable consumer (patient, self-reported).  A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date she had the vaccine made her feel like she was on cloud, when she went to lay down it felt like an after birth like a big blob, and little blisters on her arm. The patient wanted to know if there was a third dose- Relayed FAQ. The vaccine made her feel like she was on cloud 9 like she could go for a run When she went to lay down it felt like an after birth like a big blob Little blisters on her arm-Cold. Her doctor thought she probably caught a whiff of something that affected her breathing but it was in no way covid again. Those two shots have been awesome and have helped her COPD and her immune system. When you have COPD you were always catching colds and infections and stuff. When you have COPD and you leave the house, you weren't sure you were coming home. If I could, I'd get a booster every day. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.