chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Suspected COVID-19
Clinical narrative: Sick; Lethargic; I ran a fever of 101; I have not felt well; I feel like i have covid19 all over again.; Cough is horrific, it kept me up all night long; tired; This is a spontaneous report from a contactable consumer (patient).  A 51-year-old patient of unknown gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: En6204), via an unspecified route of administration in left arm on 12Mar2021 at 12 am (at the age of 51-year-old) as a single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's 2 weeks prior vaccination included Effexor. The patient's medical history includes that the patient tested for COVID-19 prior vaccination. The concomitant medications were not reported.  The consumer stated, "So I have the vaccine done on 12March, and  I feel like i have covid19 all over again. Very tired with a horrible cough (on 12March, 01:00 AM). The next day (on 13Mar2021) I was very sick I was like just lethargic and tired. Then I ran a fever of 101, I have not felt well since I had it, and yesterday I developed like horrible cough and I just feel like I have Covid all over again. I just don't know what else I am supposed to do because this cough is horrific, it kept me up all night long so I am just looking for some direction."  The patient had not tested covid post vaccination. The patient visited physician office due to the events  and also not receive treatment for events "I feel like i have covid19 all over again. Very tired with a horrible cough, and I have not felt well". The outcome of the events was not resolved for event "I feel like i have covid19 all over again, I have not felt well, Cough is horrific, it kept me up all night long, and tired". The outcome of rest event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Nausea; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration, in left arm on 16Mar2021 at 13:30 (at the age of 57-years-old) as single dose for COVID-19 immunisation. Patients medical history includes asthma, eosinophilic esophagitis, vitiligo, palpitations and anxiety. The patient was allergic to egg and milk. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), LEXAPRO and ZETIA received for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was unknown whether she was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not tested positive for COVID-19. On 17Mar2021 at 07:00 the patient experienced nausea, headache and chills. The patient did not receive any treatment for the events. The clinical outcome of nausea, headache and chills were resolved.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Malaise, Myalgia, SARS-CoV-2 test
Clinical narrative: Pain at injection site; Muscle soreness in buttocks, legs,back; Right eye swelling lower lid; Tiredness; Feel unwell; This is a spontaneous report received from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number:Unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 17:30 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included Celexa (MANUFACTURER UNKNOWN), Zinc (MANUFACTURER UNKNOWN), Magnesium (MANUFACTURER UNKNOWN), Calcium (MANUFACTURER UNKNOWN), Vitamin D (MANUFACTURER UNKNOWN), Vitamin C (MANUFACTURER UNKNOWN), Vitamin B (MANUFACTURER UNKNOWN), and Clari (MANUFACTURER: UNKNOWN), all from unknown dates for unknown indication. The patient was not allergic to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested positive for COVID-19. The patient underwent lab tests and procedures which included COVID-19 virus test on an unknown date and tested negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 18Mar2021 at 09:30, the patient experienced injection site pain, muscle soreness, swelling of eyelid, tiredness and feeling unwell. The Patient did not receive any treatment for the events. The clinical outcome of the injection site pain, muscle soreness, swelling of eyelid, tiredness and feeling unwell was not recovered.   Information about lotnumber cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Pain at injection site; Muscle soreness in buttocks, legs,back; Right eye swelling lower lid; Tiredness; Feel unwell; This is a spontaneous report received from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number:Unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 17:30 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included Celexa (MANUFACTURER UNKNOWN), Zinc (MANUFACTURER UNKNOWN), Magnesium (MANUFACTURER UNKNOWN), Calcium (MANUFACTURER UNKNOWN), Vitamin D (MANUFACTURER UNKNOWN), Vitamin C (MANUFACTURER UNKNOWN), Vitamin B (MANUFACTURER UNKNOWN), and Clari (MANUFACTURER: UNKNOWN), all from unknown dates for unknown indication. The patient was not allergic to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested positive for COVID-19. The patient underwent lab tests and procedures which included COVID-19 virus test on an unknown date and tested negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 18Mar2021 at 09:30, the patient experienced injection site pain, muscle soreness, swelling of eyelid, tiredness and feeling unwell. The Patient did not receive any treatment for the events. The clinical outcome of the injection site pain, muscle soreness, swelling of eyelid, tiredness and feeling unwell was not recovered.   Information about lotnumber cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 63-year-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date not reported) via an unspecified route of administration, unspecified anatomical location on 16 Mar 2021 (at the age of 63-years-old) as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 17Mar2021, the patient had "fatigue, diffuse pain and diffuse pain (including eyes)". No therapeutic measures were taken for events. The clinical outcome of fatigue and diffuse pain and diffuse pain (including eyes) was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Patient's Country was added. For suspect vaccine, "Unknown" removed from Lot# field. Event "pain in eyes" updated as "diffuse pain (including eyes)" for "Description as Reported". "None" removed from "Concomitant Therapy" field since only "if other vaccine in four weeks: No" reported, not mention in took any drug. Final sentence "Batch/Lot number cannot be obtained. No follow up attempts are possible. No further information is expected." updated as "No follow-up attempts are possible; information about lot/batch number cannot be obtained." per SER055. Leading sentence "This is a spontaneous report received from a non-contactable other non-health care professional" updated as "This is a spontaneous report received from a non-contactable consumer." Initial information need review: adverse_event: Fatigue and diffuse pain (including eyes)
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Constant diarrhea along with other common vaccine side effects for over a week.; This is a spontaneous report from a contactable nurse, the patient. A 58-Year-old non-pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 10Mar2021 at 17:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The medical history includes diabetes, obesity, arthritis, hypertension, high cholesterol, chronic pain. Concomitant medication includes metformin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), nifedipine (MANUFACTURER UNKNOWN), novolog (MANUFACTURER UNKNOWN), lantus (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date. The patient had allergies to Shellfish, iodine, mangoes, latex, dental lidocaine, flagyl, Diflucan. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient has not tested positive for COVID-19 since vaccination. On 10Mar2021 at 17:30, the patient experienced Constant diarrhoea along with other common vaccine side effects for over a week. The clinical outcome of the event diarrhoea was not recovered at the time of report.   No follow-up attempts are needed. No follow-up information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: Malaise; Slight fever; This is a spontaneous report received from a non-contactable patient. A 53-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203) via an unspecified route of administration on the left arm, on 16Mar2021 at 02:45 PM (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route of administration on the left arm, on 23Feb2021 as a single dose for COVID-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination the patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021 at 12:30 PM, patient experienced malaise, slight fever (99.9 F) for approximately 24 hours. It was reported that no therapeutic measures were taken for the events experienced. The clinical outcome of the events malaise and slight fever was reported as recovered.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Musculoskeletal discomfort
Clinical narrative: Shoulder discomfort; chills; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old male patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration on 14Mar2021 (at the age 46-year-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 15Mar2021, the patient experienced shoulder discomfort and chills but not fever. The patient did not receive any treatment for the adverse events. The clinical outcome of shoulder discomfort and chills was recovering. No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Nausea, Pain
Clinical narrative: fever; body aches; Exhausted; alternating sweats; slept all day; Like having covid again; Little soreness; chills to the point of body shaking some/chills; some nausea; This is a spontaneous report received from a contactable consumer, the patient. A 49-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration, administered in left arm on 20Mar2021 10:15 (at the age of 49-years-old) as a single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus, covid-19 from Dec2020 to an unknown date. Concomitant medication(s) and received medications in two weeks included liraglutide (VICTOZA); metformin. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies. On 21Mar2021 12:00 am, the patient reported with little soreness during day as expected. About midnight chills to the point of body shaking some, some nausea, then around 4 am fever, body aches. Exhausted, alternating sweats and chills slept all day. Like having covid again." The patient did not receive any treatment. Outcome of the event was recovering, at the time of this report.  No follow-up attempts are needed. No further Information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Suspected COVID-19
Clinical narrative: fever; body aches; Exhausted; alternating sweats; slept all day; Like having covid again; Little soreness; chills to the point of body shaking some/chills; some nausea; This is a spontaneous report received from a contactable consumer, the patient. A 49-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration, administered in left arm on 20Mar2021 10:15 (at the age of 49-years-old) as a single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus, covid-19 from Dec2020 to an unknown date. Concomitant medication(s) and received medications in two weeks included liraglutide (VICTOZA); metformin. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies. On 21Mar2021 12:00 am, the patient reported with little soreness during day as expected. About midnight chills to the point of body shaking some, some nausea, then around 4 am fever, body aches. Exhausted, alternating sweats and chills slept all day. Like having covid again." The patient did not receive any treatment. Outcome of the event was recovering, at the time of this report.  No follow-up attempts are needed. No further Information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Hyperhidrosis, Middle insomnia, Migraine
Clinical narrative: severe chills; could not get warm; could go back to sleep; migraine; sweating; This is a spontaneous report received from a contactable consumer (patient).  This 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number unknown) as second single dose, in left arm, on 17Mar2021 at 12:30 PM (at 41 years of age), for COVID-19 immunisation. The patient's past medical history included obesity. The first single dose of BNT162B2 vaccine was administered in left arm on 22Feb2021 at 12:30 (at the age of 41 years), for COVID-19 immunisation. Concomitant medications included fluoxetine hydrochloride (PROZAC) and levothyroxine (unknown manufacturer). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19 and since the vaccination, she had not tested positive for COVID-19. On 18Mar2021 at 04:30,16 hours after the second dose, the patient woke up with severe chills, could not get warm or go back to sleep and woke up several hours later sweating and had a migraine from 04:30 till about 14:00. The patient did not receive any treatment for the adverse events. The events resolved on an unspecified date in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: age at vaccination added, age for historical vaccine added, Vaccine Facility Information added, Treatment Received selected as no, onset time updated in narrative to 04:30, coding additional events "could not get warm or go back to sleep".  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Oral herpes
Clinical narrative: cold sore/fever blister/ used abreva and it started spreading; This is a spontaneous report received from a contactable consumer.   A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP7534 and Expiration date was not reported), via intramuscular route of administration, in arm right, on 17Mar2021 (last Wednesday) (at the age of 77 years), as a single dose for COVID-19 immunization. Patient received ABREVA (Batch/lot number: D54N) on 20Mar2021 for oral herps. The patient medical history included appendectomy (Since she was 18 when she had an appendectomy). There is no Patient History and no Investigation Assessment. Patient stated that she had the Pfizer vaccine last Wednesday and the following day (18Mar2021) she had a cold sore or fever blister. Later clarified as cold sore. On 20March2021, she used abreva and it started spreading, while getting the abreva in store, a lady she was talking to, said she got one (cold sore) after her 2nd one. Patient asked if cold sore/fever blisters were reported by others after getting the vaccine. Patient stated that she was trying to treat the cold sore and it keeps spreading. Patient stated that she has not had a cold sore since she was 18 when she had an appendectomy. Stated that the pharmacy tech mentioned that she had the second shot and could not make the connection that it was to her cold sore. Stated that it was unknown which shot she had. Patient stated that she was using Abreva and has not dried it up. Stated that it has spread from her lip down to toward her chin. Stated that it is clusters and not just one spot. Clarified that the medication stopped the itching part but it is still growing. Stated that she was using a product and it has not helped. Provided a lot of BO193113Y. At the time of this report event outcome was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Hypersensitivity, Malaise
Clinical narrative: allergies; tested positive for COVID-19; did not feel well the next day after receiving the vaccine; fatigue; severe headache; This is a spontaneous report from contactable consumers (spouse and patient) via medical information team. A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 02Mar2021 at 13:36 (at the age of 66-year-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history included cough (ongoing) on 28Feb2021. The patient concomitant medications were not reported. It was reported that the patient was not feeling well the next day after receiving the vaccine and thought it may have just been side effects from receiving the vaccine. The next day 03Mar2021, the patient had a severe headache that persisted until 16Mar2021; fatigue that was improved; and a cough which he had a couple of days before getting the vaccination. Added they thought it was allergies. The cough was getting better now. On 09Mar2021 (reported as a week later), he felt worse and tested positive for COVID-19. After spoke with doctor this past Friday and she advised him that he should wait to receive their second dose as it might be too soon. He treated with zinc, vitamin C, vitamin A, vitamin D, and melatonin. The patient symptoms were all improving. The fatigue was tremendous. He was scheduled to receive their second dose tomorrow 23Mar2021. The patient asked if fatigue and cough would be considered symptoms of COVID-19 and if he should wait to receive the second dose of the Pfizer COVID-19 vaccine if they still have those symptoms. The patient further asked if he receive second dose of the Pfizer COVID-19 vaccine past the recommended 3 weeks would his first dose be null and void. Outcome of the event severe headache was recovered on 16Mar2021; for tested positive for COVID-19, did not feel well the next day after receiving the vaccine and fatigue was recovering while unknown for allergies.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021313502 same reporter/similar events, different patients
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: allergies; tested positive for COVID-19; did not feel well the next day after receiving the vaccine; fatigue; severe headache; This is a spontaneous report from contactable consumers (spouse and patient) via medical information team. A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 02Mar2021 at 13:36 (at the age of 66-year-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history included cough (ongoing) on 28Feb2021. The patient concomitant medications were not reported. It was reported that the patient was not feeling well the next day after receiving the vaccine and thought it may have just been side effects from receiving the vaccine. The next day 03Mar2021, the patient had a severe headache that persisted until 16Mar2021; fatigue that was improved; and a cough which he had a couple of days before getting the vaccination. Added they thought it was allergies. The cough was getting better now. On 09Mar2021 (reported as a week later), he felt worse and tested positive for COVID-19. After spoke with doctor this past Friday and she advised him that he should wait to receive their second dose as it might be too soon. He treated with zinc, vitamin C, vitamin A, vitamin D, and melatonin. The patient symptoms were all improving. The fatigue was tremendous. He was scheduled to receive their second dose tomorrow 23Mar2021. The patient asked if fatigue and cough would be considered symptoms of COVID-19 and if he should wait to receive the second dose of the Pfizer COVID-19 vaccine if they still have those symptoms. The patient further asked if he receive second dose of the Pfizer COVID-19 vaccine past the recommended 3 weeks would his first dose be null and void. Outcome of the event severe headache was recovered on 16Mar2021; for tested positive for COVID-19, did not feel well the next day after receiving the vaccine and fatigue was recovering while unknown for allergies.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021313502 same reporter/similar events, different patients
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: cold sore; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date for COVID-19 immunization. Medical history, concomitant medication and past drug history were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date for COVID-19 immunization. On an unspecified date, after second dose of vaccination patient had experienced cold sore (reporter states a lady she was talking to, says she got one (cold sore) after her 2nd one). Outcome of the event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo positional
Clinical narrative: Positional vertigo two weeks after first vaccine; This is a spontaneous report received from a contactable consumer, the patient. Regulatory authority. Safety Report. A 63-year-old male patient received first single dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; lot no: Fm9809) via an unspecified route of administration in the left arm on 15Feb2021 at 06:30 PM and the patient received second single dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; lot no: Enc199) via an unspecified route of administration in the right arm on 03Mar2021 at 04:30 PM for COVID-19 immunisation. Facility where the COVID-19 vaccine was administered was pharmacy or drug Store. Information about patient ethnicity and race were reported. The patient was having allergy to sulfa products. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since having the vaccine. Concomitant medications includes PRILOSEC, lisinopril (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN), CRESTOR. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 28Feb2021, at 12:00 AM, the patient experienced positional vertigo and no therapeutic measures were taken for this event. Clinical outcome of the event positional vertigo was recovering at the time of this report. No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; sore arm; This is a spontaneous report from a contactable consumer (patient).  A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6203; Expiration Date: Jun2021) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced  on an unspecified date headache and  sore arm. Outcome of events was unknown.    No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: On 3/17, headache, chills, and body pain; chills; body pain; This is a spontaneous report from a non-contactable reporter.  A male patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced on 17mar2021, headache, chills, and body pain. Took acetaminophen with relief. On 18Mar2021, the events were completely resolved .  No follow-up attempts are possible.inormation about batch/lot number has been requested. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Parosmia, Taste disorder
Clinical narrative: heightened sense of smell; fatigued; heightened sense of taste; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the right arm on 12Feb2021 at 11:00 hours (at the age of 67-years) as a single dose for COVID-19 immunisation. Medical history included idiopathic pain syndrome. Concomitant medications included Miacalcin and meloxicam (MANUFACTURER UNKNOWN) as sinus medication. The patient took these medications within 2 weeks of vaccination and exact therapy dates were not reported. The patient did not have allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Feb2021, the patient experienced heightened sense of smell and taste and was still fatigued. The patient did not receive any treatment for these events. The clinical outcome of the events heightened sense of smell and taste and fatigue was not resolved at the time of this report.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on right side of neck; This is a spontaneous report received from a contactable consumer. A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199) via an unspecified route of administration on the left arm on 13Mar2021 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. The patients medical history included penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patients concomitant medications included bupropion (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). On 13Mar2021, at 16:30 hours after the vaccination, the patient experienced a rash on the right side of the neck. The clinical outcome of the event rash on the right side of the neck was not recovered at the time of the report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: armpit was swollen; low grade fever; achy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced low grade fever and achy after vaccine on 15Mar2021. On 17Mar2021 (this morning), the patient woke up and armpit was swollen. All events were non-serious. Outcome of the events was unknown.  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.
Sex: M
Vaccine: COVID19
Symptoms: Seasonal allergy
Clinical narrative: having seasonal allergies; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know if he can take over the counter because he started having seasonal allergies, which was non-serious on unspecified date in Mar2021. The patient received the first vaccine dose on 09Mar2021. Outcome of the event was unknown.  Follow-up (05Apr2021): 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: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sore on my lips; This is a spontaneous report received from contactable Nurse (Patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 as 1ST DOSE, SINGLE  DOSE for covid-19 immunization. The patient's past medical history and concomitant medication was not reported. It was reported that 5 days after the administration of vaccine, the patient experienced cold sore on her lips on 17Mar2021.  The patient was treated with Abreva cream on the area. It was stated that she just don't know if that was the reaction to it and don't know why she developed a cold sore which she never ever had and just want to know if it was safe to get the second shot. The patient did not receive any other products. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral herpes
Clinical narrative: cold sore on her lips; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported for herself that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose1 via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced cold sore on her lips after her first dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Fatigue, Sinusitis
Clinical narrative: I had a sinus infection before I took the Pfizer (Covid vaccine) and this is reoccurring; I had a sinus infection before I took the Pfizer (Covid vaccine) and this is reoccurring; fatigue; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 71-Year-old (same age at vaccination) female received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot: ENG202) via unspecified route of administration on 27Feb2021 as single dose in left arm for COVID-19 immunization/ Because I am over 55 years old. Medical history reported was ongoing asthma, ongoing high blood pressure, ongoing cholesterol, hay fever and ongoing sinus infection. Concomitant medications reported was losartan for blood pressure high, atorvastatin for cholesterol, hydrochlorothiazide it's a water pills, salbutamol (ALBUTEROL) for asthma as needed (it's a Advair DISKUS 250/50), fluticasone propionate and salmeterol xinafoate (ADVAIR). When probed for the concern, consumer stated, she had called to find out, she had taken her first dose already (27Feb2021) and her second Pfizer dose was due today this evening and she was going to get it, but she never had this sinus infection and she have been taking Amoxiclav (treatment) and she wanted to know if there was any adverse reaction to the vaccine. Onset of events was reported as a week and a half ago, it probably may be around 7 days ago. Patient had a sinus infection before she took the Pfizer (Covid vaccine) and this was reoccurring. She had Hay fever (history). Patient was due on the 2nd shot today 20Mar2021, asking for the time. But she can get her 2nd dose today. Another concern, the patient already took amoxicillin for her sinus infection after taking the 1st shot. Had this infection before taking also the 1st shot. Also, she experienced fatigue for 3 days after taking 1st shot of the vaccine. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Lacrimation increased, Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID swab test on Sunday, 21Mar2021, and results came back as positive today; sick; fever inside; sometimes I have tears and vomiting; sometimes I have tears and vomiting; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration was not provided), via an unspecified route of administration on 13Mar2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was scheduled for second dose of Pfizer-Biontech Covid-19 vaccine on 01Apr2021. It was reported that I got my first dose on 13Mar2021 of the Pfizer Biontech Covid 19 vaccine; second dose scheduled on 01Apr2021. One week after first dose, I got sick and developed the following symptoms: "fever inside, sometimes I have tears and vomiting". I took a COVID swab test on Sunday, 21Mar2021, and results came back as positive today, 24Mar2021. She planned to follow-up with her primary care provider regarding the second dose. The patient underwent lab tests and procedures which included COVID swab test on Sunday, 21Mar2021 and results came back as positive today, on 24Mar2021. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: COVID swab test on Sunday, 21Mar2021, and results came back as positive today; sick; fever inside; sometimes I have tears and vomiting; sometimes I have tears and vomiting; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration was not provided), via an unspecified route of administration on 13Mar2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was scheduled for second dose of Pfizer-Biontech Covid-19 vaccine on 01Apr2021. It was reported that I got my first dose on 13Mar2021 of the Pfizer Biontech Covid 19 vaccine; second dose scheduled on 01Apr2021. One week after first dose, I got sick and developed the following symptoms: "fever inside, sometimes I have tears and vomiting". I took a COVID swab test on Sunday, 21Mar2021, and results came back as positive today, 24Mar2021. She planned to follow-up with her primary care provider regarding the second dose. The patient underwent lab tests and procedures which included COVID swab test on Sunday, 21Mar2021 and results came back as positive today, on 24Mar2021. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Nasal discomfort, Vaccination site pain
Clinical narrative: mild pain on the arm where I got my shot; nasal issues after shot; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer (Patient) reported that a male 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, administered in arm on 19Jan2021 as first dose, single dose and on 09Feb2021 as second dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced mild pain on the arm where she got her shot, nasal issues after shot. Patient stated that he took both covid vaccine. He also had nasal issues after shot. The patient underwent lab tests and procedures which included antibody test found and the result was under 3.8 (negative) as per his oncologist recommended. The outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Sars-COV-2; This is a spontaneous report received from a contactable consumer (Patient reported for herself) via medical information team. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: not reported), dose 1 via an unspecified route of administration on 09Mar2021, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 13Mar2021, the patient was tested positive for Sars-COV-2. The patient wanted to know that if she should and how to reschedule appointment, which was scheduled for second dose on 31Mar2021. The 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: White blood cell count, White blood cell count decreased
Clinical narrative: Routine blood work drawn after her first covid vaccine and found her White count to be low; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from company(manufacturer control number: US-company-USASL2021039875). This case was split from master case 2021292945 for a female patient took COVID-19 vaccine and experienced white blood cell count decreased.  This non-serious solicited report (USASL2021039875) was reported to the company on 11Mar2021 by a consumer from a commercial program (PSP00046b). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), on an unknown date in 2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history included ongoing rheumatoid arthritis. Concomitant medication(s) included etanercept (ENBREL) taken for rheumatoid arthritis from 2018 to an unspecified stop date. On 05Mar2021, after first dose COVID-19 vaccine, after a routine blood work drawn after her first COVID vaccine and found her white count to be low, while receiving Enbrel with Reusable Autoinjector. The patient began Enbrel with Reusable Autoinjector on an unknown date in 2018. Subsequently, the patient's physician advised her to held Enbrel for one week which was schedule on 11Mar2021. Additionally, the physician also advised to do not receive second dose of COVID-19 vaccine. No treatment information was received. The outcome of the event white blood cell count decreased was reported as unknown.   Follow up has been requested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow up(PRD/SRD 26Mar2021): The following information was received from the company: COVID-19 VACCINE was not specifically reported as suspect.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac function test, Electric shock sensation, Feeling abnormal, Sensory disturbance
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EP7534, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 18 Mar 2021 (at the age of 81-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history included chest pain, high cholesterol, congestion in her throat and lungs. It occurred prior to Christmas 2020. She had issues from COVID-19 and stated that she feels weaker because she used to walk like 4 miles a day and now, she was not walking due to the pandemic. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN], taken for high cholesterol; acetylsalicylic acid (ASPIRIN 81). Patient did a cardiac test, and they came back negative. Heart was fine. It still has not resolved though. Patient reported that she had the first dose last week and had a couple of things that she needed to report. She usually has a rapid heartbeat and has always been able to feel her heart beating and been able to hear heart beating. Caller said that she had her heart tested because of her having a rapid heart rate previously. Caller said that since the dose, she could not feel any sensations around her heart and even if she turns over to push up on her arm, she could usually feel her heartbeat and now she could not. She also could not hear it anymore. She said that it is kind of strange, unusual for her. Caller said that she could feel her heartbeat when she was watching TV. Caller said that she could not feel any sensations around her heart now on 18Mar2021. She said that the next night, 19Mar2021, she felt a buzz from her feet up her left size up to her neck. It was like a shock buzz, but it did not last. Last night, 21Mar2021, she had from her waist to her chest a big jolt to her system. It was just the one jolt. She tried to call her doctor to report this, and they directed her to call Pfizer. She said that she feels fine otherwise. She said that she has gained weight during the pandemic. Caller said that her not being able to feel the sensation in her heart started the evening of her receiving the vaccine 18Mar2021. Her toes do feel like there is a different sensation in them, but they are not really numb, but feel different. That started on the second night 19Mar2021 and this ongoing. It does not feel bad, just different. Second dose was scheduled for 08Apr2021. She may not get it if her symptoms are not resolved. The outcome of the event cannot feel any sensations around her heart and toes do feel like there was a different sensation in them was not resolved, outcome was resolved for events felt a buzz on 19Mar2021, outcome was resolved for event had from her waist to her chest, a big jolt to her system on 21Mar2021.