chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I received my first Pfizer covid vaccine in Dec and 3 days later was diagnosed with covid; I received my first Pfizer covid vaccine in Dec and 3 days later was diagnosed with covid; This is a spontaneous report from a contactable physician (patient).  A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2) at single dose in Dec2020 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient received the 1st dose vaccine in Dec2020 and 3 days later was diagnosed with Covid on an unknown date.  The patient underwent lab tests and procedures which included Sars-cov-2 test: diagnosed with cCvid in Dec2020. Patient received the monoclonal antibody infusion and has recovered. Patient knew he/she needed to wait 90 days from the MCA infusion before having the second vaccination. Patient queried whether it would be recommended to start the series over with two additional vaccines since the timing between the first and second vaccines will be so long.    Information on the lot/batch number has been requested.; Sender's Comments: The COVID-19 infection occurred 3 days after the injection of suspect vaccine BNT162B2. No complete effect can be achieved against the target disease due to the short time interval. The COVID-19 is more likely pre-existing condition, unrelated to suspect vaccine BNT162b2.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hyperhidrosis, Off label use
Clinical narrative: Low grade fever; severe chills and shaking; severe chills and shaking; severe joint pain for 5 hours; sweats; Post fever fatigue; other vaccine same date vaccine date=21Jan2021; other vaccine same date vaccine date=21Jan2021; This is a spontaneous report from a contactable other HCP (patient). A 65-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 13:00 at single dose in right arm for COVID-19 immunisation. The patient medical history was not reported. There were no known allergies. Concomitant medication included irbesartan. 3 days post-vaccine on 24Jan2021 19:00, the patient experienced low grade fever, severe chills and shaking, severe joint pain for 5 hours and then sweats, post fever fatigue. No treatment received for these events, and these events were recovered on Jan2021. The patient received other vaccine on the same date 21Jan2021. The patient received COVID test post vaccination via Nasal Swab on 25Jan2021, COVID test result was Negative.   Information on the Lot/Batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product use issue, Pyrexia, SARS-CoV-2 test, Tremor
Clinical narrative: Low grade fever; severe chills and shaking; severe chills and shaking; severe joint pain for 5 hours; sweats; Post fever fatigue; other vaccine same date vaccine date=21Jan2021; other vaccine same date vaccine date=21Jan2021; This is a spontaneous report from a contactable other HCP (patient). A 65-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 13:00 at single dose in right arm for COVID-19 immunisation. The patient medical history was not reported. There were no known allergies. Concomitant medication included irbesartan. 3 days post-vaccine on 24Jan2021 19:00, the patient experienced low grade fever, severe chills and shaking, severe joint pain for 5 hours and then sweats, post fever fatigue. No treatment received for these events, and these events were recovered on Jan2021. The patient received other vaccine on the same date 21Jan2021. The patient received COVID test post vaccination via Nasal Swab on 25Jan2021, COVID test result was Negative.   Information on the Lot/Batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cough, Dysphonia, Throat clearing, Vaccination site pain
Clinical narrative: muscle pain in her arm where she received the injection; cough; hoarseness in her voice; clearing of the throat; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; unknown lot number and expiration date), via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. Medical history included has ongoing allergies and has to take an "allergy pill" every day for this condition, diabetes and hypothyroidism. Concomitant medication included levothyroxine, ertugliflozin pidolate (STEGLATRO), loratadine, montelukast, metformin, atorvastatin, lisinopril, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12), dulaglutide (TRULICITY) and ongoing allergy pill. She reported that she received her vaccine in a mass Covid vaccination. The reporter stated that she developed muscle pain in her arm where she received the injection, which she states that she understands this is a commonly reported side effect. She also developed a cough, hoarseness in her voice, and noticed that the cough was worse when she went to bed. She mentioned that her cough started on Wednesday, she felt like it was little bit worse on last night (unspecified date), than it was on Saturday, so she means it was only Sunday after that [pending clarification]. The reporter was heard clearing her throat multiple times on the phone during the conversation. She would like to know if the cough, hoarseness and clearing of the throat are commonly reported symptoms. The patient was informed that the injection side pain was reported last on average between 1-3 days. Per the EUA Prescribing Information, "Across both age groups, the mean duration of pain at the injection site after Dose 2 was 2.5 days" and that we did not have information on how long her mild respiratory symptoms may last and referred her to her HCP. The patient was encouraged to contact her healthcare professional if her symptoms did not go away or if they became worrisome and she verbalized understanding. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included blood work showed normal on 15Jan2021. The outcome of the event cough was not recovered while the outcome of the other events was unknown.  Information about Batch/Lot number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Visual impairment
Clinical narrative: Dizziness; Sudden worsening of vision; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration (left arm), on 19Jan2021 11:15, at single dose, for covid-19 immunization. The patient has no medical history. Concomitant medications included calcium citrate and, probiotics. The patient previously took tamoxifen and experienced allergies. The patient experienced dizziness starting on 22Jan2021 and worsening on 23Jan2021. The patient also experienced sudden worsening of vision on 22Jan2021. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. At the time of the report, the patient was recovering from the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Palpitations, SARS-CoV-2 test
Clinical narrative: shortness of breath; Several episodes of racing heart; chest pressure; fatigue; This is a spontaneous report from a contactable nurse (patient).  A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm right on 04Jan2021 at 15:30 at single dose for COVID-19 immunization. The patient medical history included allergies: shellfish from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. On 04Jan2021 at 15:45, the patient experienced several episodes of racing heart, shortness of breath, chest pressure and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 11Jan2021. Therapeutic measures were taken as a result of the events and included treatment with albuterol. The patient outcome of the event was recovering.  The information on the batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Decreased appetite, Depressed mood, Fatigue
Clinical narrative: feeling pretty bad/ feel awful; she doesn't want to eat; her back hurts; she's irritable; depressed; pain in the injection site; joint pain; muscle pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of  bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3247), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. The patient thinks she could have COVID last Mar2020. She was not sure because her doctor's office was close for around a month and she couldn't get tested. There were no concomitant medications. On that day, 19Jan2021, after she received the vaccine she started feeling pain in the injection site, joint pain, muscle pain and fatigue. On 25Jan2021, she was feeling pretty bad, she doesn't want to eat, her back hurts, she's irritable and depressed. The patient would like to know if these side effects could be associated with the vaccine in someone who had the virus. She felt awful and she felt like she has gone right back to where she was 8 months ago, 10 months ago and started over with fatigue and everything. It was awful. She thinks she could have had COVID in Mar2020 and the symptoms she was having now, she had then and when she has had basically the whole time and that would just come back worse. There was no treatment received for the events. The outcome for the events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Irritability, Myalgia, Vaccination site pain
Clinical narrative: feeling pretty bad/ feel awful; she doesn't want to eat; her back hurts; she's irritable; depressed; pain in the injection site; joint pain; muscle pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of  bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3247), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. The patient thinks she could have COVID last Mar2020. She was not sure because her doctor's office was close for around a month and she couldn't get tested. There were no concomitant medications. On that day, 19Jan2021, after she received the vaccine she started feeling pain in the injection site, joint pain, muscle pain and fatigue. On 25Jan2021, she was feeling pretty bad, she doesn't want to eat, her back hurts, she's irritable and depressed. The patient would like to know if these side effects could be associated with the vaccine in someone who had the virus. She felt awful and she felt like she has gone right back to where she was 8 months ago, 10 months ago and started over with fatigue and everything. It was awful. She thinks she could have had COVID in Mar2020 and the symptoms she was having now, she had then and when she has had basically the whole time and that would just come back worse. There was no treatment received for the events. The outcome for the events was unknown.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Pain in extremity
Clinical narrative: sore arm from which she could not raise arm; Dehydration; This is a spontaneous report from a contactable consumer. A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in the right arm, on 22Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant. The patient had no other vaccine administered in four weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 22Jan2021, the patient experienced sore arm from which she could not raise arm above shoulder and dehydration. The events were not treated. Outcome of the events was recovered on unspecified date in Jan2021.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: developed a  pink rash with itchiness around the injection site; developed a  pink rash with itchiness around the injection site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9263), via an unspecified route of administration on 22Jan2021 at single dose (upper left arm) for COVID-19 immunisation. Medical history included acid reflux and high blood pressure. Concomitant medications included metoprolol succinate (TOPROL XL), amlodipine, pantoprazole and an unspecified high blood pressure medication. The patient reported that she received the first dose of COVID-19 vaccine on Friday 22Jan2021 and she stated that she has no reaction at all the day she received the injection. She reported that 24 hours later, on 23Jan2021, she developed a pink rash with itchiness around the injection site and it was about an inch and a half in diameter. She stated that it lasted about 24 hours and was now fading and getting better. Patient stated that she would not call the them critical side effects, they were minor side effects. Patient described them as pink itching rash around the injection site. It was basically 24 hours it lasted. It started 24 hours after the injection and lasted 24 hours before it started fading, the patient still have it but it's fading away now and patient confirmed that the events were improving. The patient did not received therapy for the events. She was concerned that if she receives the second dose of the COVID-19 vaccine it could be worse and wants to know if she should receive the second dose. Patient was worried that in 3 weeks she will take the next second dose she might have an increased side effects. Outcome of events was recovering.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Off label use, Product use issue
Clinical narrative: Severe Nausea; severe headache; vomited once; slight dizziness; Dose 1 given on 18Dec2020 and Dose 2 on 15Jan2021 (Day 29); Dose 1 given on 18Dec2020 and Dose 2 on 15Jan2021 (Day 29); This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), intramuscular on 15Jan2021 06:30 at a single dose on right arm for COVID-19 immunization. Medical history included fistula repair resulting into placement of neurostimulator. The patient was not pregnant at the time of vaccination. No known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included ibuprofen (IBUPROFEN), biotin (BIOTIN) and Nature's Made multivitamins. The patient previously received first dose of BNT162B2 on 18Dec2020 for COVID-19 immunization (lot number: EK5730, administration time: 06:30 AM, route: Intramuscular, vaccine location: Right arm, dose number: 1). No other vaccines received 4 weeks prior to vaccination. On 16Jan2021 09:00, the patient experienced severe nausea, severe headache, vomiting once and slight dizziness. No treatment was given for the adverse events. The patient has not been tested for COVID post vaccination. The patient recovered from severe nausea, severe headache, vomiting once and slight dizziness on Jan2021.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe Nausea; severe headache; vomited once; slight dizziness; Dose 1 given on 18Dec2020 and Dose 2 on 15Jan2021 (Day 29); Dose 1 given on 18Dec2020 and Dose 2 on 15Jan2021 (Day 29); This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), intramuscular on 15Jan2021 06:30 at a single dose on right arm for COVID-19 immunization. Medical history included fistula repair resulting into placement of neurostimulator. The patient was not pregnant at the time of vaccination. No known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included ibuprofen (IBUPROFEN), biotin (BIOTIN) and Nature's Made multivitamins. The patient previously received first dose of BNT162B2 on 18Dec2020 for COVID-19 immunization (lot number: EK5730, administration time: 06:30 AM, route: Intramuscular, vaccine location: Right arm, dose number: 1). No other vaccines received 4 weeks prior to vaccination. On 16Jan2021 09:00, the patient experienced severe nausea, severe headache, vomiting once and slight dizziness. No treatment was given for the adverse events. The patient has not been tested for COVID post vaccination. The patient recovered from severe nausea, severe headache, vomiting once and slight dizziness on Jan2021.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, COVID-19, Condition aggravated, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; Blood pressure fluctuation; This is a spontaneous report from a contactable consumer reporting for himself and from another consumer. A 57-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK4176), via an unspecified route of administration in the right arm, on 05Jan2021 at 14:10, at single dose, for COVID-19 immunisation. Medical history included ongoing gout and ongoing blood pressure high. Concomitant medications included allopurinol (unknown manufacturer) from 2008 to an unknown date and from an unknown date to ongoing for gout, lisinopril (unknown manufacturer) from an unspecified date and ongoing for blood pressure high at 40 mg daily, an unspecified drug for blood pressure high from Dec2020 at 5 mg and an unspecified anti-inflammatory. The patient previously took allopurinol from 2008 for gout and experienced abdominal pain upper so the drug was stopped on unknown date but his uric acid levels get high and he had to go back on it again. The patient experienced COVID-19 virus test positive (medically significant) on 16Jan2021 with outcome of unknown and blood pressure fluctuation in Jan2021 with outcome of unknown. It was reported that the only symptom he had on 13Jan2021 at first was a crash in his blood pressure. It was in the 80's over 50's. After that he had a fever of 102.2 F on 13Jan2021 for which he took two Tylenol. On 13Jan2021 at 09:30 PM his temperature was back down to 98.8 F. He has not had anymore fever. He has not had any other symptoms since. His blood pressure fluctuated but they have made some changes with his medication. The patient underwent lab tests and procedures which included blood pressure: in the 80's over 50's on 13Jan2021, blood pressure: fluctuated in Jan2021, uric acid levels: high on unspecified date, body temperature: 102.2 F on 13Jan2021, body temperature: 98.8 F on 13Jan2021, COVID-19 virus test: positive on 16Jan2021. Therapeutic measures were taken as a result of the events.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Pain in extremity, Tremor, Weight, Weight decreased
Clinical narrative: Sore arm; lost a bunch when she had sugery; Tremors in her hands/hands started shaking non-stop; Tremors in her hands/hands started shaking non-stop; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 21Jan2021 at 10:40 at single dose for COVID-19 immunization. The relevant medical history included asthma, tremor (Tremors that runs on her mother's side of the family), neuropathy of hands and arms, high cholesterol, thyroid, neuropathy, vascular gait disorder, cervical stenosis operation from 2018. Concomitant medications included painkiller for neuropathy and unspecified medicines for high cholesterol, thyroid. She stated she received the first dose on 21Jan2021 and experienced tremors in her hands starting the following day. She stated that Friday her hands started shaking non-stop and had done that since then. She also reported having a sore arm. She had occasional tremors that didn't last very long. Since COVID-19 Vaccine had had nonstop shaking of hands since around Friday. Primary care doctor didn't treat her. Went to a pain center and neurologist. No further details provided. Tried to report online, but there were too many questions so she opted out. Does kind of get better if she is real still and lays down, but it still shakes. Never had this before. The patient stated that Friday or Saturday she didn't remember exactly when, sometimes they shake but not very long but this was like nonstop and it's a much more aggressive shaking. She hoped she could get the second one because she wanted the protection. She was not sure of her weight because she lost a bunch when she had surgery but she was about 115. When probed for treatment, she stated that it went away it was a day or so after but the hands were shaking and it's very intense shaking and it's going on and it's not stopping. She didn't have anything for it. It's never been like this before. The outcome of the event tremors in her hands/hands started shaking non-stop was not recovered, while other events were unknown.  Information about lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Lymphadenopathy, Malaise
Clinical narrative: Lump nodes swell; Feeling unwell; Nausea; Headaches; Dizziness; Weakness; Injection site pain; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 24Jan2021 (08:00) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the school/student health clinic. Medical history included asthma. There were no concomitant medications. The patient was not pregnant at the time of vaccination. On 24Jan2021 (14:00), the patient had "lump" nodes swelling; was feeling unwell; had nausea; headaches; dizziness; weakness; and injection site pain. The patient did not receive any treatment for the reported events. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Lump nodes swell; Feeling unwell; Nausea; Headaches; Dizziness; Weakness; Injection site pain; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 24Jan2021 (08:00) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the school/student health clinic. Medical history included asthma. There were no concomitant medications. The patient was not pregnant at the time of vaccination. On 24Jan2021 (14:00), the patient had "lump" nodes swelling; was feeling unwell; had nausea; headaches; dizziness; weakness; and injection site pain. The patient did not receive any treatment for the reported events. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Injection site extravasation, Underdose
Clinical narrative: substantial leakage of fluid (she presumes vaccine) from her injection site (no just a drop of liquid BUT a trail of fluid down her arm that wet her sweater); substantial leakage of fluid (she presumes vaccine) from her injection site (no just a drop of liquid BUT a trail of fluid down her arm that wet her sweater); This is a spontaneous report from a contactable physician. A female patient of an unspecified age received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that, when she received the vaccine, she noticed that there was a substantial leakage of fluid (she presumes vaccine) from her injection site, not just a drop of liquid, but a trail of fluid down her arm that wet her sweater. The reporting physician asked if the patient needs to assume that this qualified as a non-vaccination and needs to get a repeated dose and follow that with a true second dose in 3 weeks, or needs to assume that she got enough of a dose to call it a true first shot. The event onset date and outcome were not reported.  Information about Lot/Batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Streptococcus test, Streptococcus test positive
Clinical narrative: asthma; strep test came back positive.; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age (age: 62 unit: unspecified) received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient received the first vaccine on the 12Jan, in between that time, she went to the doctor to check on her asthma, her strep test came back positive. She was on an antibiotic. The patient asked if she was able to get the second dose. On 02Feb2021, the patient was due to go back to get the vaccine. Her doctor who also provided the vaccine said that it was okay for her to get the second vaccine. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Respiratory disorder, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a non-contactable consumer or other non hcp reported for her daughter.  A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included hypertension, asthma, hypersensitivity. It was unknown if the patient was pregnant at time of vaccination. Prior to vaccination the patient was not diagnosed COVID-19 positive. The patient's concomitant medications were not reported. The patient had a covid tested positive on 06Jan2021 with outcome of recovering. The patient was previously tested negative on 04Jan2021. Facility where she worked had outbreak. The events resulted in both emergency room visit and physician office visit. She was improving but her respiratory status still wasn't good. Pulmonologist just restarted 2nd round of steroids, and additional BP med started.  Can now sit up but quickly gets wiped out. She was not currently hospitalized.  No follow-up attempts are possible. No further information is expected. Batch/Lot numbers can not be obtained.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: throwing up/vomiting; got very sick; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 21Jan2021 to 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient reported that she was taking unspecified concomitant medications. On 21Jan2021 at 11:30, the patient got very sick, throwing up/vomiting and it lasted about 3 and a half hours until 3 or 3:30 or 4. The patient took Zofran to s top throwing up. The outcome oft he events was recovered on21Jan2021. The next dose is scheduled on 11Feb2021.  Information about lot and batch number was requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; chills, rigors; This is a spontaneous report from a non-contactable physician reported for herself. A 29-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3246), intramuscularly on left arm on 04Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received her first dose of BNT162B2 on 18Dec2020 for COVID-19 immunization (lot number=EK5730; administrator route=Intramuscular, vaccine location=Right arm). The patient experienced Fever, chills, rigors occurred approximately 10 hours after vaccine administration and lasted about 6 hours on 04Jan2021. Events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered in Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph noted above the clavicular line on the right (covid shot on right arm) noted after a day i got the covid 19 vaccine; This is a spontaneous report from a contactable nurse reported for herself. A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot unknown: true, lot unknown reason: unable to locate or read the details) intramuscularly at right arm on 08Jan2021 at 07:30 AM at a single dose for COVID-19 immunization. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot unknown: false) intramuscularly at right arm on 20Dec2020 at 11:30 AM at a single dose for COVID-19 immunization. No allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient was not pregnant at the time of vaccination. The patient experienced adverse events included swollen lymph noted above the clavicular line on the right (covid shot on right arm) noted after a day she got the covid 19 vaccine. She still could feel it at the reporting time. The event start date was reported on 09Jan2021 at 12:00 PM. The event was reported as non-serious. No treatment received for event. The outcome of event was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: left arm has a patch of discoloration; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 15Jan2021 at 09:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not allergic to medications, food or other products. 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 vaccination. On 22Jan2021, the patient's left arm had a patch of discoloration which appeared approximately one week after the vaccination. The patient did not receive treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "left arm has a patch of discoloration" was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on neck; This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 21Jan2021 at a single dose on right arm for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. No allergies to medications, food, or other products. There were no concomitant medications. The patient previously received first dose of BNT162B2 on 29Dec2020 for COVID-19 immunization (brand: Pfizer, lot number: EL1284, administration time: 02:45 PM, route: intramuscular, vaccine location: left arm, dose number: 1). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rash on neck on 23Jan2021 09:00. The event was reported as non-serious. The patient has not been tested for COVID since the vaccination. No treatment was received for the adverse event. The patient has not recovered from the event.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Body temperature increased, Headache, Hypertension
Clinical narrative: temp 37.1C; blood pressure 135/75; right part of the neck stiff; cannot open mouth big; headache was worse, especially when turning the head; This is a spontaneous report from a contactable consumer reported for himself.   A 74-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL8982) on 20Jan2021 at 13:00 at single dose in left arm for covid-19 immunisation. Medical history included high blood pressure. No allergies to medications, food, or other products. Concomitant medication included febuxostat (FEBUXOSTAT), benazepril hydrochloride/hydrochlorothiazide (BENAZEPRIL/HCTZ), finasteride and tamsulosin. On 21Jan2021 in the evening at 20:00 (reported as second day after vaccine) the patient experienced right part of the neck stiff and cannot open mouth big; on 22Jan2021 (reported as the third day after vaccine) headache was worse, especially when turning the head (headache started on an unspecified date in Jan2021); on 23Jan2021, 24Jan2021 and 25Jan2021 kept having headache, neck was still stiff; on 25Jan2021  temp was 37.1C and blood pressure 135/75. Events required office/clinic visit. The events were all non serious. It was unknown if treatment was given; the final outcome of all the events was not recovered.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Oral disorder
Clinical narrative: temp 37.1C; blood pressure 135/75; right part of the neck stiff; cannot open mouth big; headache was worse, especially when turning the head; This is a spontaneous report from a contactable consumer reported for himself.   A 74-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL8982) on 20Jan2021 at 13:00 at single dose in left arm for covid-19 immunisation. Medical history included high blood pressure. No allergies to medications, food, or other products. Concomitant medication included febuxostat (FEBUXOSTAT), benazepril hydrochloride/hydrochlorothiazide (BENAZEPRIL/HCTZ), finasteride and tamsulosin. On 21Jan2021 in the evening at 20:00 (reported as second day after vaccine) the patient experienced right part of the neck stiff and cannot open mouth big; on 22Jan2021 (reported as the third day after vaccine) headache was worse, especially when turning the head (headache started on an unspecified date in Jan2021); on 23Jan2021, 24Jan2021 and 25Jan2021 kept having headache, neck was still stiff; on 25Jan2021  temp was 37.1C and blood pressure 135/75. Events required office/clinic visit. The events were all non serious. It was unknown if treatment was given; the final outcome of all the events was not recovered.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Paraesthesia, Vaccination site pain
Clinical narrative: "pins-and-needles" sensation down to the elbow/sensation was identical to a limb that is "asleep"/including the painful jolts whenever touched; Random several-inch-long patches of the arm were completely numb to physical sensation, mostly on the forearm; soreness to touch or movement of the entire upper arm inclusive of the shoulder; soreness to touch or movement of the entire upper arm inclusive of the shoulder; The soreness aside from the injection site did not abate; This is a spontaneous report received from a contactable consumer (the patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3247), via an unspecified route of administration in the upper left arm on 21Jan2021 14:10 (at the age of 31-years-old) as a single dose for COVID-19 immunization. The patient's medical history included allergies to corn (zein). The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen on 16Jan2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received the vaccine around 14:10 (scheduled for 14:00 but there was a line). Upon standing (21Jan2021 14:15), there was a "pins-and-needles" sensation down to the elbow, and by the time seated for the 15 minute wait, the sensation was present in the whole arm. The sensation was identical to a limb that was "asleep", including the painful jolts whenever touched all the way to the tips of the fingers. This lasted until mid-morning 23Jan2021 (about 44 hours). Random several-inch-long patches of the arm were completely numb to physical sensation, mostly on the forearm (21Jan2021 14:15). These have shrunk but some are still present at the time of reporting. There was additional soreness to touch or movement of the entire upper arm inclusive of the shoulder (21Jan2021 14:15). The soreness aside from the injection site (21Jan2021 14:15) did not abate until late evening on 24Jan2021. The only noted adverse effects were related to physical sensation in the left arm. The patient did not receive any treatment for the events. The clinical outcome of "pins-and-needles" sensation down to the elbow/sensation was identical to a limb that is "asleep"/including the painful jolts whenever touched was recovered on 23Jan2021. The clinical outcome of random several-inch-long patches of the arm were completely numb to physical sensation, mostly on the forearm; soreness to touch or movement of the entire upper arm inclusive of the shoulder; and soreness aside from the injection site, was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Vomiting
Clinical narrative: Threw up 3 days after getting the COVID 19 vaccine; Feeling unwell; Having pain in his private area; This is a spontaneous report from a contactable consumer (patient's caregiver).  This 59-year-old male patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 22Jan2021 at a single dose on the left arm for COVID-19 immunisation. The patient was disabled. No additional medical history was provided. No relevant concomitant medications were provided. On 25Jan2021 (3 days after getting the COVID-19 vaccine), the patient threwup, once. After vaccine, the patient was feeling unwell and he was having pain in his private area. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure increased, Blood pressure measurement, Body temperature, Erythema
Clinical narrative: Face and chest became bright red; felt very hot; sinus pressure increased; blood pressure was up 155/94; pulse rate up; This is a spontaneous report received from a contactable consumer (the patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL 9261), via an unspecified route of administration in the left arm on 21Jan2021 15:45 (at the age of 65-years-old) as a single dose for COVID-19 immunization. The patient's medical history included high cholesterol, indoor and outdoor allergies, and allergies to latex and contrast. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient previously took and had allergies to: amoxicillin/ clavulanic acid (AUGMENTIN), sulfamethoxazole/ trimethoprim (BACTRIM), levofloxacin (LEVAQUIN), and gabapentin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Within 5 minutes of receiving the dose on 21Jan2021, at 15:45 (as reported), the patient's face and chest became bright red, felt very hot, sinus pressure increased. The EMT's took her blood pressure- was up 155/94, and her pulse rate was up (21Jan2021, 15:45 (as reported)). Her temperature and blood sugar were within normal limits (21Jan2021). The patient did not receive any treatment for the events. The clinical outcome of face and chest became bright red, felt very hot, sinus pressure increased, blood pressure was up 155/94, and pulse rate up was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate, Heart rate increased, Paranasal sinus discomfort
Clinical narrative: Face and chest became bright red; felt very hot; sinus pressure increased; blood pressure was up 155/94; pulse rate up; This is a spontaneous report received from a contactable consumer (the patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL 9261), via an unspecified route of administration in the left arm on 21Jan2021 15:45 (at the age of 65-years-old) as a single dose for COVID-19 immunization. The patient's medical history included high cholesterol, indoor and outdoor allergies, and allergies to latex and contrast. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient previously took and had allergies to: amoxicillin/ clavulanic acid (AUGMENTIN), sulfamethoxazole/ trimethoprim (BACTRIM), levofloxacin (LEVAQUIN), and gabapentin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Within 5 minutes of receiving the dose on 21Jan2021, at 15:45 (as reported), the patient's face and chest became bright red, felt very hot, sinus pressure increased. The EMT's took her blood pressure- was up 155/94, and her pulse rate was up (21Jan2021, 15:45 (as reported)). Her temperature and blood sugar were within normal limits (21Jan2021). The patient did not receive any treatment for the events. The clinical outcome of face and chest became bright red, felt very hot, sinus pressure increased, blood pressure was up 155/94, and pulse rate up was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: the injection site started to inch and it got a red blotch about 2 inches in diameter; the injection site started to inch and it got a red blotch about 2 inches in diameter; soreness; This is a spontaneous report from a contactable consumer reported for himself. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247) via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. Medical history included idiopathic thrombocytopenic purpura (ITP). Concomitant medications included romiplostim (NPLATE) for ITP. The patient stated he received his first dose of the vaccine on 15Jan2021, some soreness on 15Jan2021 afterwards but nothing that noticeable and about a week later on the 22Jan2021, the injection site started to inch and it got a red blotch about 2 inches in diameter. Just about it started a week after the injection. So, he was wondering if that was to be expected or was it unusual or how he should proceed. The events were reported as non-serious. No treatment received for events. Due date for the next shot was 05Feb2021. The outcome of event the injection site started to inch and it got a red blotch about 2 inches in diameter was not resolved, and of soreness was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling hot, Pain in extremity
Clinical narrative: warm sensation; anxiety; sore arm; This is a spontaneous report from a contactable consumer, reporting for herself. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration at the right arm on 23Jan2021 17:15 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. On 23Jan2021 17:30, the patient experienced warm sensation, anxiety and sore arm. No treatment was received. The patient was not pregnant at the time of vaccination. 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 has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.  Information on the batch/lot number has been requested.