chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: high fever; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 11Feb2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced high fever in Feb2021 on last Thursday. The patient underwent lab tests and procedures which included body temperature was high in Feb2021. Reporter would like to know if getting a shot would be contagious with covid for her daughter as they were together. The outcome of the event was unknown.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: a bruise on his left arm after the vaccine shot on his right arm; This is a spontaneous report from a contactable consumer or other non hcp (patient's son) from a Pfizer-sponsored program. A male patient (father of reporter) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that reporter called on behalf of his father and stated that on an unspecified date the patient experienced a bruise on his left arm after the vaccine shot on his right arm and reporter wanted to know if it's fine. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Headache; Body aches; Nausea; Fatigue; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On an unspecified date (reported event took place after use of product), the patient experienced headache, body aches, nausea, and fatigue. 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Dizziness, Dyspnoea, Feeling hot
Clinical narrative: difficulty breathing; started feeling warm & progressively got hotter; Felt jittery; shaky; heart rate increased; Felt dizzy as I was walking; started getting fidgety; hands and feet felt tingly; felt like I was burning up inside; Then started sweating/ neck and arms were wet w/sweat; experienced chills; felt nauseated; Tried throwing up; This is a spontaneous report from a contactable other HCP (patient). A 29-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9261) via an unspecified route of administration on 25Jan2021 at 13:00 (at the age of 29-years-old) in right arm as a single dose for covid-19 immunization. Medical history included crustacean allergy from an unknown date and unknown if ongoing. The patient did not receive any vaccine on same date or any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Concomitant medications received in two weeks included methylphenidate hydrochloride (METHYLPHENIDATE HYDROCHLORIDE) and fluoxetine (FLUOXETINE) both taken for an unspecified indication, start and stop date were not reported. On 25Jan2021 at 14:15, after 8-10 minutes of vaccination the patient felt warm and progressively got hotter. Felt jittery, shaky, started getting fidgety, heart rate increased, hands and feet felt tingly, then started sweating, experienced chills, and felt hot. She had difficulty breathing with cloth mask and felt nauseated. Se wanted to take mask off so went to rr and felt dizzy while walking. Neck and arms were wet with sweat, felt like she was burning up inside. She tried throwing up. After few minutes, splashed water on face and went back to waiting area. She again felt jittery, racing heart, and chills. She waited for 15 minutes and left. The patient did not receive any treatment. The outcome of all the events was resolved in 2021.  Follow-up attempts completed. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Heart rate increased, Hyperhidrosis, Nausea, Nervousness
Clinical narrative: difficulty breathing; started feeling warm & progressively got hotter; Felt jittery; shaky; heart rate increased; Felt dizzy as I was walking; started getting fidgety; hands and feet felt tingly; felt like I was burning up inside; Then started sweating/ neck and arms were wet w/sweat; experienced chills; felt nauseated; Tried throwing up; This is a spontaneous report from a contactable other HCP (patient). A 29-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9261) via an unspecified route of administration on 25Jan2021 at 13:00 (at the age of 29-years-old) in right arm as a single dose for covid-19 immunization. Medical history included crustacean allergy from an unknown date and unknown if ongoing. The patient did not receive any vaccine on same date or any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Concomitant medications received in two weeks included methylphenidate hydrochloride (METHYLPHENIDATE HYDROCHLORIDE) and fluoxetine (FLUOXETINE) both taken for an unspecified indication, start and stop date were not reported. On 25Jan2021 at 14:15, after 8-10 minutes of vaccination the patient felt warm and progressively got hotter. Felt jittery, shaky, started getting fidgety, heart rate increased, hands and feet felt tingly, then started sweating, experienced chills, and felt hot. She had difficulty breathing with cloth mask and felt nauseated. Se wanted to take mask off so went to rr and felt dizzy while walking. Neck and arms were wet with sweat, felt like she was burning up inside. She tried throwing up. After few minutes, splashed water on face and went back to waiting area. She again felt jittery, racing heart, and chills. She waited for 15 minutes and left. The patient did not receive any treatment. The outcome of all the events was resolved in 2021.  Follow-up attempts completed. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Restlessness, Vomiting
Clinical narrative: difficulty breathing; started feeling warm & progressively got hotter; Felt jittery; shaky; heart rate increased; Felt dizzy as I was walking; started getting fidgety; hands and feet felt tingly; felt like I was burning up inside; Then started sweating/ neck and arms were wet w/sweat; experienced chills; felt nauseated; Tried throwing up; This is a spontaneous report from a contactable other HCP (patient). A 29-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9261) via an unspecified route of administration on 25Jan2021 at 13:00 (at the age of 29-years-old) in right arm as a single dose for covid-19 immunization. Medical history included crustacean allergy from an unknown date and unknown if ongoing. The patient did not receive any vaccine on same date or any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Concomitant medications received in two weeks included methylphenidate hydrochloride (METHYLPHENIDATE HYDROCHLORIDE) and fluoxetine (FLUOXETINE) both taken for an unspecified indication, start and stop date were not reported. On 25Jan2021 at 14:15, after 8-10 minutes of vaccination the patient felt warm and progressively got hotter. Felt jittery, shaky, started getting fidgety, heart rate increased, hands and feet felt tingly, then started sweating, experienced chills, and felt hot. She had difficulty breathing with cloth mask and felt nauseated. Se wanted to take mask off so went to rr and felt dizzy while walking. Neck and arms were wet with sweat, felt like she was burning up inside. She tried throwing up. After few minutes, splashed water on face and went back to waiting area. She again felt jittery, racing heart, and chills. She waited for 15 minutes and left. The patient did not receive any treatment. The outcome of all the events was resolved in 2021.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: chills; fever; painful headache; neck ache; muscle and joint pain; nausea; extremely tired; muscle and joint pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot unknown: Not available), via an unspecified route in the left arm on 17Feb2021 at 09:30 (age at vaccination: 67-year-old), as a single dose for covid-19 immunization. Medical history included A-fib. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), telmisartan, apixaban (ELIQUIS) and tamsulosin, al. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot unknown: unknown), via an unspecified route in the left arm in Jan2021 at 09:30, as a single dose for covid-19 immunization. No known allergies were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 18Feb2021 at 01:00, tired about 16 hrs after the shot patient experienced chills, fever, a painful headache, neck ache, muscle and joint pain, nausea and extremely tired. Patient did not receive any treatment for the events. The clinical outcome of the events was recovered.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: chills; fever; painful headache; neck ache; muscle and joint pain; nausea; extremely tired; muscle and joint pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot unknown: Not available), via an unspecified route in the left arm on 17Feb2021 at 09:30 (age at vaccination: 67-year-old), as a single dose for covid-19 immunization. Medical history included A-fib. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), telmisartan, apixaban (ELIQUIS) and tamsulosin, al. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot unknown: unknown), via an unspecified route in the left arm in Jan2021 at 09:30, as a single dose for covid-19 immunization. No known allergies were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 18Feb2021 at 01:00, tired about 16 hrs after the shot patient experienced chills, fever, a painful headache, neck ache, muscle and joint pain, nausea and extremely tired. Patient did not receive any treatment for the events. The clinical outcome of the events was recovered.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Illness, Oropharyngeal discomfort
Clinical narrative: huge problem breathing; feeling like my throat isgetting tight; got sick; This is a spontaneous report from a contactable consumer (patient). A patient with unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 23Jan2021 as dose 1, single for Covid-19 immunisation. Patients medical history and concomitant medications were not reported. on an unspecified date patient got sick and was taken to the ER because patient had some small problems a huge problem breathing and felt like throat was getting tight. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: her mom got UTI and her doctor prescribed antibiotic wanted to ask if it will affect the vaccine; This is a spontaneous report from a contactable consumer via a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (2 weeks ago) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14Feb2021 (2 days ago), the patient got uti and her doctor prescribed antibiotic wanted to ask if it will affect the vaccine. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever; headache; Tired; nausea; aches; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: en6201), dose 2 via an unspecified route of administration, administered in Arm Right on 16Feb2021 01:15 (at the age of 71-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot number: el9261) on an unspecified date in Jan2021 01:30 AM for COVID-19 immunization. Facility where the COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On 17Feb2021, patient experienced fever, headache, tired, nausea, aches. There was no treatment for the events. The clinical outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Caller's wife had a fever of 101F after getting the 1st dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient (Reporter's wife).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced caller's wife had a fever of 101f after getting the 1st dose on an unspecified date. The patient underwent lab tests and procedures which included body temperature was 101 Fahrenheit (fever). The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Lower respiratory tract congestion
Clinical narrative: he experienced a slight bronchial congestion; cough; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer-sponsored program Covax US Support. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date, as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that week and half on an unknown date, he got the 1st dose and then he experienced a slight bronchial congestion and cough. The patient just wanted to know what would happen if tested positive for Covid-19 in between the 1st dose and 2nd dose. The clinical outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pyrexia
Clinical narrative: fever; really bad chest pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable female (Patient) consumer or other non-health care professional of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration on 13Feb2021 single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. On 13Feb2021 23:00 the patient experienced fever and on an unspecified date of 2021 patient had really bad chest pain. The outcome of the event fever was unknown. The outcome of the event really bad chest pain was not recovered.    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, Pain, Pyrexia
Clinical narrative: body aches; fever of 102; This is a spontaneous report from a non-contactable consumer (patient), from An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 13Feb2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported.  It was reported that, patient got vaccine Yesterday and today started with body aches and fever of 102. Advised that they contact her HCP since she is 83 yr old. The patient underwent lab tests and procedures which included fever (body temperature): 102 on an unspecified date. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-healthcare professional. A female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on Feb 7, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Husband reported on behalf of his wife. Feb 7, 2021 was the first dose of the COVID-19 vaccine. On Feb 12, 2021 patient had a rash and wanted to know if this was a side effect. The outcome of the event: unknown. Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: fever; sweating; chills; dizziness; body weakness; extreme fatigue; lymph node swollen and tender; This is a spontaneous report from a contactable consumer. This 33-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIOTECH COVID-19, Solution for injection), via an unspecified route of administration on 19Feb2021 12:00 PM (at the age of 33-year-old) on left arm as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historic vaccine included bnt162b2 (PFIZER-BIOTECH COVID-19) on 28Jan2021 at 06:45 PM (at the age of 33-year-old) at right arm, dose 1 for COVID-19 immunisation. The patient had not received any other vaccine in four weeks. The patient did not have covid prior vaccination. The patient was not tested positive with covid post vaccination. In Feb2021 at 11:00AM, the patient experienced fever, sweating, chills, dizziness, body weakness, extreme fatigue after 19 hours of vaccination and after 36 hours, lymph node swollen and tender on an unknown date in Feb2021. The patient did not receive any treatment for the events. The outcome of the events was recovering.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: fever; sweating; chills; dizziness; body weakness; extreme fatigue; lymph node swollen and tender; This is a spontaneous report from a contactable consumer. This 33-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIOTECH COVID-19, Solution for injection), via an unspecified route of administration on 19Feb2021 12:00 PM (at the age of 33-year-old) on left arm as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historic vaccine included bnt162b2 (PFIZER-BIOTECH COVID-19) on 28Jan2021 at 06:45 PM (at the age of 33-year-old) at right arm, dose 1 for COVID-19 immunisation. The patient had not received any other vaccine in four weeks. The patient did not have covid prior vaccination. The patient was not tested positive with covid post vaccination. In Feb2021 at 11:00AM, the patient experienced fever, sweating, chills, dizziness, body weakness, extreme fatigue after 19 hours of vaccination and after 36 hours, lymph node swollen and tender on an unknown date in Feb2021. The patient did not receive any treatment for the events. The outcome of the events was recovering.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: She had another patient with the exact same rash after the vaccine.; This is a spontaneous report received from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as unknown single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date, patient experienced rash after the vaccine. The outcome of event was unknown.    Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148608 same reporter, product and AE, different patient
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: headache; chills; fever 100:1; This is a spontaneous report from a non-contactable consumer (patient) received via Regulatory Agency. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 08Feb2021, at 11:00 (Lot Number: EC9269, at the age of 74 years old) as dose 2, single for COVID-19 immunisation. Medical history included seasonal allergies, cancer survivor, and two leaky heart valves. The patient has no known allergies and she was not pregnant at the time of report. Concomitant medications included montelukast sodium (SINGULAR), guaifenesin (MUCINEX), and vitamin D. She did not receive any other vaccines within four weeks prior to vaccination. The patient previously received first dose of BNT162B2, administered in the left arm on 18Jan2021, at 14:30 (Lot number: EL8982, at the age of 74 years old) for COVID-19 immunisation. On 09Feb2021, at 07:30, the patient experienced headache, chills, and fever 100:1 (as reported). The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the events. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: first dose of the Pfizer vaccine and they were sneezing repeatedly for about 24 hours. They reported that they were sneezing so much that they could hardly work that day; This is a spontaneous report received from a contactable consumer or other non hcp. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced a friend told me they received the first dose of the Pfizer vaccine and they were sneezing repeatedly for about 24 hours. they reported that they were sneezing so much that they could hardly work that day unspecified date in Jan2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Elevated heart rate, elevated resting heart rate, unable to walk outside without heart racing by the time I reach the trash can.; Elevated heart rate, elevated resting heart rate, unable to walk outside without heart racing by the time I reach the trash can.; This is a spontaneous report from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 54 years old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EM9810), via an unspecified route, administered in Left arm on 04Feb2021 (54-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included hypertension and known shellfish allergies. The patient's concomitant medication(s) included carvedilol 25mg 2x/day (twice daily); buspirone 7.5, 2x/day (twice daily); famotidine. The patient previously first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3246), via an unspecified route, administered in Left arm on 15Jan2021 at 13:00 (54-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. Facility type vaccine was reported as Other. The patient had no covid prior vaccination. The patient was not covid tested post vaccination. The patient had not received any other vaccine within 4 weeks of Covid-19 vaccination. On 08Feb2021 at 06:00 AM, the patient had experienced elevated heart rate, elevated resting heart rate, unable to walk outside without heart racing by the time she reached the trash. The patient had not received treatment medication for resulted events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information was expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Dyspepsia
Clinical narrative: stomach burning; Taste metallic; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN5318) via an unspecified route of administration, administered in Arm Right on 29Jan2021 at 13:30 (at the age of 80-year-old) as dose 1, single for COVID-19 immunisation. Patient's Medical History (including any illness at time of vaccination) was reported as no. Concomitant medications were reported as no. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. Patient family medical history was reported as none. It was reported that the patient received the first dose of the Pfizer COVID 19 vaccine on 29Jan2021 at 13:30 PM in the right arm. She never had any effects after the first dose but then people were telling her that the second shot was really bad. Now she was concerned and wanted to ask about expected side effects for the second shot. The patient was worried about the second shot and noticed a metallic taste in her mouth on 05Feb2021 (reported as starting last Friday) and duration of reaction was reported as 2 days. The patient also experienced stomach burning on 05Feb2021 (reported as starting last Friday). The patient stomach burning was reported as worsened. She was scheduled to get the next dose of the vaccine on 19Feb2021. Relevant test was reported as none. Outcome of the event taste metallic was recovered on 07Feb2021 and for stomach burning was not recovered.  Follow-up attempts completed. No further information expected
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Joint stiffness, Malaise
Clinical narrative: 102.0 F fever; fatigue; intermittent shooting sharp headaches; joint stiffness; dull pain (especially in hips, knees, back and fingers)(occurs most frequently with positional changes); intermittent shooting neuropathic pains in legs and feet; general malaise; intermittent sweating (waking up with soaked clothing); This is a spontaneous report from a non-contactable nurse (patient).   A non-pregnant 38-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK9231) via an unspecified route of administration, administered in arm left on 14Jan2021 14:45 (at the age of 38 years old) as dose 2, single for COVID-19 immunisation. Medical history included lyme disease, insulin dependent diabetes and known allergies on watermelon, mayonnaise, penicillin. Concomitant medication included insulin lispro (HUMALOG, via pump as reported). The patient previously received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK5730) administered on left arm on 23Dec2020 05:00 pm (at the age of 38 years old) as dose 1, single for COVID-19 immunsation and experienced mild fatigue, joint stiffness, and chills for 24 hours 1-day post first vaccine. On 15Jan2021, the patient experienced fatigue even after sleeping 8-10hrs, intermittent shooting sharp headaches (lasting 15- 30seconds), joint stiffness, and dull pain (especially in hips, knees, back and fingers) (occured most frequently with positional changes), intermittent shooting neuropathic pains in legs and feet, and general malaise. The events intermittent dull headaches, intermittent sweating (waking up with soaked clothing), all symptoms are intermittent. Since the patient received the 2nd vaccine, the symptoms have not gone away. On 10Feb2021, 26 days post 2nd vaccine the patient had a 102.0 F fever with only once occurrence. It was reported that the patient had no fevers since. No other vaccine in four weeks, the facility type vaccine was reported as hospital, no COVID prior vaccination and not COVID tested post vaccination. No treatment for the adverse events. The outcome of the event pyrexia was recovered on an unspecified date on 2021; outcome for all the other events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain, Pyrexia
Clinical narrative: 102.0 F fever; fatigue; intermittent shooting sharp headaches; joint stiffness; dull pain (especially in hips, knees, back and fingers)(occurs most frequently with positional changes); intermittent shooting neuropathic pains in legs and feet; general malaise; intermittent sweating (waking up with soaked clothing); This is a spontaneous report from a non-contactable nurse (patient).   A non-pregnant 38-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK9231) via an unspecified route of administration, administered in arm left on 14Jan2021 14:45 (at the age of 38 years old) as dose 2, single for COVID-19 immunisation. Medical history included lyme disease, insulin dependent diabetes and known allergies on watermelon, mayonnaise, penicillin. Concomitant medication included insulin lispro (HUMALOG, via pump as reported). The patient previously received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK5730) administered on left arm on 23Dec2020 05:00 pm (at the age of 38 years old) as dose 1, single for COVID-19 immunsation and experienced mild fatigue, joint stiffness, and chills for 24 hours 1-day post first vaccine. On 15Jan2021, the patient experienced fatigue even after sleeping 8-10hrs, intermittent shooting sharp headaches (lasting 15- 30seconds), joint stiffness, and dull pain (especially in hips, knees, back and fingers) (occured most frequently with positional changes), intermittent shooting neuropathic pains in legs and feet, and general malaise. The events intermittent dull headaches, intermittent sweating (waking up with soaked clothing), all symptoms are intermittent. Since the patient received the 2nd vaccine, the symptoms have not gone away. On 10Feb2021, 26 days post 2nd vaccine the patient had a 102.0 F fever with only once occurrence. It was reported that the patient had no fevers since. No other vaccine in four weeks, the facility type vaccine was reported as hospital, no COVID prior vaccination and not COVID tested post vaccination. No treatment for the adverse events. The outcome of the event pyrexia was recovered on an unspecified date on 2021; outcome for all the other events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: After cardio training day 5 body broke out in rash on left arm and back.; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 05Feb2021 at 08:00 (at the age of 50-years-old) in right arm as a single dose for covid-19 immunization. The patient medical history was not reported. The patient previously took doxycycline and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. The patient did not receive any other vaccine in four weeks. Concomitant medication received within two weeks included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient reported that after cardio training on day 5 i.e., on 10Feb2021 at 08:00, his body broke out in rash on left arm and back. The patient did not receive any treatment. The outcome of the event was resolving.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia
Clinical narrative: painful bumps on tongue; This is a spontaneous report from a contactable consumer. This consumer reported for a 38-year-old female patient (daughter).  A 38-year-old female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 10Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  On an unspecified date, next day after the vaccination, the patient experienced painful bumps on her tongue. On the day of report, they are less painful, but she still feels it.  She is concerned about the next shot.  She would like to know should she make the people aware. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (11MAY2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Severe joint pain; Low grade fever; Severe diarrhea; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 45-year-old female patient received BNT162B2 (PFIZER- 1, single for COVID-19 immunisation. Medical history included High blood pressure, high cholesterol, GERD, and anxiety. Concomitant medications included lisinopril; rosuvastatin calcium (CRESTOR); pantoprazole; celecoxib (CELEBIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration, administered in the right arm on 07Feb2021 13:15 (at the age of 45-years-old), as doseXA [CELECOXIB]); acetylsalicylic acid (BAYER ASPIRIN) all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Severe joint pain, Low grade fever, Severe diarrhea , and Tiredness on 08Feb2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 27Jan2021. No treatment was received as a result of the events. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Lymphadenopathy
Clinical narrative: 102 degree fever; chills; body trembling; headache; joint pain; swollen lymph nodes on left side; This is a spontaneous report from a non-contactable consumer (patient) received via a reporting program. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 08Feb2021 at 01:00 PM (Batch/Lot Number: EL9265) (at the age of 32 years old) as dose 2, single for COVID-19 immunisation in a workplace clinic. The patient has no relevant medical history and has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient was previously administered the first dose of BNT162B2 on 18Jan2021 at 01:00 PM, single (at the age of 32-years-old) (Lot number: EL1283) in the left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Feb2021 at 06:00 PM, the patient experienced 102 degree fever, chills and body trembling, headache, joint pain, swollen lymph nodes on left side. All persist even 48 hours after vaccination. The patient underwent lab tests and procedures on 08Feb2021 which included fever: 102 degree. The events did not result to physician office and emergency room visit. The patient did not receive treatment for the events. The patient did not recover from the events on the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: 102 degree fever; chills; body trembling; headache; joint pain; swollen lymph nodes on left side; This is a spontaneous report from a non-contactable consumer (patient) received via a reporting program. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 08Feb2021 at 01:00 PM (Batch/Lot Number: EL9265) (at the age of 32 years old) as dose 2, single for COVID-19 immunisation in a workplace clinic. The patient has no relevant medical history and has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient was previously administered the first dose of BNT162B2 on 18Jan2021 at 01:00 PM, single (at the age of 32-years-old) (Lot number: EL1283) in the left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Feb2021 at 06:00 PM, the patient experienced 102 degree fever, chills and body trembling, headache, joint pain, swollen lymph nodes on left side. All persist even 48 hours after vaccination. The patient underwent lab tests and procedures on 08Feb2021 which included fever: 102 degree. The events did not result to physician office and emergency room visit. The patient did not receive treatment for the events. The patient did not recover from the events on the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash 48 hours post 1st and 2nd doses of Covid 19 vaccine.  In both instances they resolved within a few days; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Right on 31Dec2020 (Batch/Lot Number: EL3246) and received second dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 23Jan2021 (Batch/Lot Number: EL8982) (at the age of 48-years-old) as SINGLE for covid-19 immunization and both were administered at Workplace clinic. Medical history included allergic to mollusks (conch etc) from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Also, the patient did not receive any other medication within two weeks. The patient previously took erythromycin and niacin and experienced allergy. The patient experienced rash 48 hours post 1st and 2nd doses of covid 19 vaccine and in both instances they resolved within a few days. The patient did not received any treatment. The outcome of event was resolved.    Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Chills, Lymph node pain, Lymphadenopathy, Nausea
Clinical narrative: I developed a swollen lymph node in my arm pit. It is sore and a lump.; I developed a swollen lymph node in my arm pit. It is sore and a lump.; I developed a swollen lymph node in my arm pit. It is sore and a lump.; I've experienced bodyaches; chills; slight fever; nausea; This is a spontaneous report from a non-contactable other health care professional (patient). A 33-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration, administered in the right arm on 08Feb2021 01:00 PM (at the age of 33-years-old) as dose 2, single for COVID-19 immunisation at a workplace clinic. Relevant medical history included penicillin allergy. The patient's concomitant medications were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in the right arm on 18Jan2021 03: 00 PM as dose 1, single for COVID-19 immunisation. The patient previously took doxycycline (reported as doexyclimine) and experienced allergy. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination. The patient experienced bodyaches, chills, slight fever, nausea on 09Feb2021 03:00 AM and a swollen lymph node in her arm pit, it is sore and a lump on 11Feb2021 01:00 PM (reported as after about 36 hours. No treatment was received for the events. The patient underwent lab tests and procedures which included COVID-19 test (Nasal swab): Negative on 10Feb2021. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: I developed a swollen lymph node in my arm pit. It is sore and a lump.; I developed a swollen lymph node in my arm pit. It is sore and a lump.; I developed a swollen lymph node in my arm pit. It is sore and a lump.; I've experienced bodyaches; chills; slight fever; nausea; This is a spontaneous report from a non-contactable other health care professional (patient). A 33-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration, administered in the right arm on 08Feb2021 01:00 PM (at the age of 33-years-old) as dose 2, single for COVID-19 immunisation at a workplace clinic. Relevant medical history included penicillin allergy. The patient's concomitant medications were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in the right arm on 18Jan2021 03: 00 PM as dose 1, single for COVID-19 immunisation. The patient previously took doxycycline (reported as doexyclimine) and experienced allergy. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination. The patient experienced bodyaches, chills, slight fever, nausea on 09Feb2021 03:00 AM and a swollen lymph node in her arm pit, it is sore and a lump on 11Feb2021 01:00 PM (reported as after about 36 hours. No treatment was received for the events. The patient underwent lab tests and procedures which included COVID-19 test (Nasal swab): Negative on 10Feb2021. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Malaise
Clinical narrative: Sick; Chills; Feeling terrible; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 10Feb2021 at 11:00 (at the age of 72-years) as dose 1, single in the right arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 11Feb2021 at 03:00, the patient experienced sick, chills, feeling terrible. Reporter stated, "She took Tylenol last night about 10 O' clock last night and she took some at 3 O'clock when she woke up in the morning." The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.