chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinus congestion, Tachycardia, Vaccination site pain
Clinical narrative: chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest in supine); headaches; nasal/sinus congestion; fatigue; dehydration; dizziness; sore throat; GI issues; Sore arm; This is a spontaneous report from a contactable other hcp (patient).  A 41-year-old female patient received first dose of BNT162B2 (COVID-19 vaccine, lot number EK5730), via an unspecified route of administration on 28Dec2020 11:00 at single dose on left arm for COVID-19 immunization.  Medical history included COVID-19, hyperthyroidism, Grave's Disease, benign PVCs (Premature ventricular contractions), PACs (Premature atrial contraction) from an unknown date and unknown if ongoing, allergies, Penicillin allergy, allergy to pineapple, kiwi and pomegranate, and NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list) from an unknown date and ongoing. Concomitant medication included cetirizine, fluticasone, propylthiouracil.  The patient previously took clindamycin and methimazole and experienced drug allergy.  On 28Dec2020 the patient experienced sore arm (like flu vaccine) the day of the vaccination. Early the following morning (on 29Dec2020 04:00) developed chills & shivering. Progressed to high fevers (peaked 102.7), tachycardia (noted to be 148 standing, 120's at rest in supine), headaches, nasal/sinus congestion, fatigue, associated dehydration & dizziness. Subsequent sore throat & GI issues. Symptoms lasted 4-5 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included covid test type post vaccination (nasal swab): negative   on 02Jan2021, body temperature: high fevers (peaked 102.7) on 29Dec2020, tachycardia: noted to be 148 standing, 120's at rest in supine on 29Dec2020.  No treatment received for the adverse events.  The outcome of the events was resolved on an unspecified date.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Heart rate increased, Mobility decreased, Nausea
Clinical narrative: Severe Lightheadedness/Dizziness; Nausea; My hands wouldn't stop shaking; My heart was beating very fast; I cannot move my arm; It is hurting pretty bad and it is kind of swollen; I am feeling like hot again/My ears like my neck was like on fire; I cannot move my arm; It is hurting pretty bad and it is kind of swollen; I cannot move my arm; It is hurting pretty bad and it is kind of swollen; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 11:00 AM at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the vaccine on 30Dec2020 at 11 O' clock. Four minutes after the patient was given this injection and also now the patient mean today (30Dec2020) after like 3 to 4 minutes like it was given to the patient. The patient had severe lightheadedness, dizziness, nausea, hands wouldn't stop shaking, the patient's ears like the patient's neck was like on fire, the patient felt like the patient's heart was beating very fast. The patient mean the patient's arm the patient knew that it will be a little sore from it. But it was more than just like, like the patient cannot move my arm. It was hurting pretty bad and it was kind of swollen and right now the patient was feeling like hot again. The patient asked that what can the patient do. The outcome of the events was unknown. Information about Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Tremor
Clinical narrative: Severe Lightheadedness/Dizziness; Nausea; My hands wouldn't stop shaking; My heart was beating very fast; I cannot move my arm; It is hurting pretty bad and it is kind of swollen; I am feeling like hot again/My ears like my neck was like on fire; I cannot move my arm; It is hurting pretty bad and it is kind of swollen; I cannot move my arm; It is hurting pretty bad and it is kind of swollen; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 11:00 AM at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the vaccine on 30Dec2020 at 11 O' clock. Four minutes after the patient was given this injection and also now the patient mean today (30Dec2020) after like 3 to 4 minutes like it was given to the patient. The patient had severe lightheadedness, dizziness, nausea, hands wouldn't stop shaking, the patient's ears like the patient's neck was like on fire, the patient felt like the patient's heart was beating very fast. The patient mean the patient's arm the patient knew that it will be a little sore from it. But it was more than just like, like the patient cannot move my arm. It was hurting pretty bad and it was kind of swollen and right now the patient was feeling like hot again. The patient asked that what can the patient do. The outcome of the events was unknown. Information about Lot/Batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure diastolic decreased, Blood pressure measurement, Body temperature, Flushing, Heart rate
Clinical narrative: feeding flush with increased heart rate 99; feeding flush with increased heart rate 99; B/P114/24; This is a spontaneous report from a contactable nurse. A 34-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular at left arm on 28Dec2020 11:44 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient received the vaccine at 11:44 AM, approximate 10 mins later (28Dec2020 11:54), the patient complained of (reported as c/o) feeding flush with increased heart rate (HR) 99, respiratory rate (reported as R) 18, blood pressure (B/P) 120/80, oxygen saturation (reported as sats) 99%. On 28Dec2020 11:49 AM, lab data included B/P 114/24, HR 76, R 16, sats 99%, temp 98.1. On 28Dec2020 11:54 AM, lab data included B/P116/75, HR 70. No treatment received for the adverse events. The events outcome was recovered on an unspecified date in Dec2020. No COVID prior vaccination, it was unknown if the patient had been tested for COVID-19 since the vaccination. It was not reported as serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Oxygen saturation, Respiratory rate
Clinical narrative: feeding flush with increased heart rate 99; feeding flush with increased heart rate 99; B/P114/24; This is a spontaneous report from a contactable nurse. A 34-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular at left arm on 28Dec2020 11:44 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient received the vaccine at 11:44 AM, approximate 10 mins later (28Dec2020 11:54), the patient complained of (reported as c/o) feeding flush with increased heart rate (HR) 99, respiratory rate (reported as R) 18, blood pressure (B/P) 120/80, oxygen saturation (reported as sats) 99%. On 28Dec2020 11:49 AM, lab data included B/P 114/24, HR 76, R 16, sats 99%, temp 98.1. On 28Dec2020 11:54 AM, lab data included B/P116/75, HR 70. No treatment received for the adverse events. The events outcome was recovered on an unspecified date in Dec2020. No COVID prior vaccination, it was unknown if the patient had been tested for COVID-19 since the vaccination. It was not reported as serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for the Covid antigen with no signs or symptoms; tested positive for the Covid antigen with no signs or symptoms; This is a spontaneous report from a contactable consumer(an administrator of skilled nursing facility).  A patient of unspecified age and gender received BNT162B2 (Covid vaccine) , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The reporter stated the pharmacy did a Pfizer vaccine clinic at his facility, stated that after looking at the FAQs he would like to know if they should not expect a positive antigen test after the vaccine, states the reason he was asking was because the patient they tested today(31Dec2020) that got the vaccine tested positive for the Covid antigen with no signs or symptoms. Outcome of event was unknown. Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever the morning after; sore arm; headache; chills; body aches; developed a rash around injection site, chest, neck, and face; developed a rash around injection site, chest, neck, and face; This is a spontaneous report from a contactable other HCP (patient). A 28-years-old female patient (pregnant: No) received first dose bnt162b2 (BNT162B2 lot number: EH9899), intramuscular on Left arm on 30Dec2020 12:00 at single dose for covid-19 immunisation. Medical history included known allergies: Penicillin, Sulfa, Other-medical-history: Allergy induced asthma. No other-vaccine-in-four weeks. No other-medications-in-two weeks. Since 30Dec2020 13:00 Started with sore arm and headache shortly after injection. Since 30Dec2020 6-8 hours later chills and body aches started. At some point in the same time range, developed a rash around injection site, chest, neck, and face. Fever the morning after on 31Dec2020. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Treatment received for AE included Steroid and Benadryl Injection. The event outcome was recovering. No-covid-tested-post-vaccination. The events were non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: Fever the morning after; sore arm; headache; chills; body aches; developed a rash around injection site, chest, neck, and face; developed a rash around injection site, chest, neck, and face; This is a spontaneous report from a contactable other HCP (patient). A 28-years-old female patient (pregnant: No) received first dose bnt162b2 (BNT162B2 lot number: EH9899), intramuscular on Left arm on 30Dec2020 12:00 at single dose for covid-19 immunisation. Medical history included known allergies: Penicillin, Sulfa, Other-medical-history: Allergy induced asthma. No other-vaccine-in-four weeks. No other-medications-in-two weeks. Since 30Dec2020 13:00 Started with sore arm and headache shortly after injection. Since 30Dec2020 6-8 hours later chills and body aches started. At some point in the same time range, developed a rash around injection site, chest, neck, and face. Fever the morning after on 31Dec2020. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Treatment received for AE included Steroid and Benadryl Injection. The event outcome was recovering. No-covid-tested-post-vaccination. The events were non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: given the Covid 19 vaccine and subsequently tested positive for SARS CoV2 a day or so later; given the Covid 19 vaccine and subsequently tested positive for SARS CoV2 a day or so later; This is a spontaneous report from a non-contactable healthcare professional via Pfizer sales representative. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, from an unspecified date, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient was given the COVID 19 vaccine and subsequently tested + for SARS CoV2 a day or so later on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Dizziness, Nausea, Pain
Clinical narrative: Severe nausea; heaving; vomiting; coughing; fever of 101.2; feeling dizzy; achy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's mother) reported that a female patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. Relevant medical history included mild case of Covid in mid-Nov2020. The patient's concomitant medications were not reported. The patient works at a hospital delivering food to patients rooms. She received her first dose of the vaccine on 30Dec2020 and 12-14 hours later (unspecified date in Dec2020), she started feeling dizzy and achy. This was followed by heaving, vomiting, coughing, and a fever of 101.2 on 31Dec2020. At the time of the report, it was her third day with fever. When receiving her first dose, she was asked if she had a mild case of Covid, or if she was hospitalized and needed an IV drip, and she stated she had a mild case. The reporter wanted to know if the patient should have been given the first dose of the vaccine to begin with. The patient also experienced severe nausea on an unspecified date. The patient underwent further lab tests and procedures, which included a positive corona virus disease (CoVid) test in mid-Nov2020. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Retching, SARS-CoV-2 test, Vomiting
Clinical narrative: Severe nausea; heaving; vomiting; coughing; fever of 101.2; feeling dizzy; achy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's mother) reported that a female patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. Relevant medical history included mild case of Covid in mid-Nov2020. The patient's concomitant medications were not reported. The patient works at a hospital delivering food to patients rooms. She received her first dose of the vaccine on 30Dec2020 and 12-14 hours later (unspecified date in Dec2020), she started feeling dizzy and achy. This was followed by heaving, vomiting, coughing, and a fever of 101.2 on 31Dec2020. At the time of the report, it was her third day with fever. When receiving her first dose, she was asked if she had a mild case of Covid, or if she was hospitalized and needed an IV drip, and she stated she had a mild case. The reporter wanted to know if the patient should have been given the first dose of the vaccine to begin with. The patient also experienced severe nausea on an unspecified date. The patient underwent further lab tests and procedures, which included a positive corona virus disease (CoVid) test in mid-Nov2020. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 45-year-old female patient received first dose of bnt162b2 (BNT162B2 also reported as COVID-19 vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unspecified date at single dose, for Covid-19 immunisation. Medical history included rheumatoid arthritis and allergic reactions (unspecified). Concomitant medications were not reported.  After receiving the first dose of the vaccination the patient experienced a sore arm on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable Nurse reported for self. This 42-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 22Dec2020 08:00 on Left arm at single dose (Lot # EH9899) for covid-19 immunisation. Medical history, concomitant medications were none. The patient tested positive for Covid in 25Dec2020. The patient was scheduled to receive the second dose in 08Jan2021 so should the patient get it. (Further clarified the dates and years). Outcome of the events were unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: When she went back to work on 25Dec2020 it was positive/On the weekend she had to come back to do a PCR test on28Dec2020 and it was positive.; When she went back to work on 25Dec2020 it was positive/On the weekend she had to come back to do a PCR test on28Dec2020 and it was positive.; This is a spontaneous report from a contactable nurse. A 43-year-old female patient receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration given in the left arm on 22Dec2020 at a single dose for covid-19 immunization. The patient medical history included "patient's a blood donor" reported as, she donated blood on 12Sep2020 and it was negative for covid. The patient's concomitant medications were not reported. The patient experienced "when she went back to work on 25Dec2020 it was positive/on the weekend she had to come back to do a pcr test on28dec2020 and it was positive" on 25Dec2020 with an unknown outcome. It was further reported that the patient was a registered nurse that works night shift. She clarified that the rapid test was taken each time she goes to work. When she went to work on the night of 21Dec2020 the rapid test was negative.Then she got the Covid vaccine in the morning of 22Dec2020. When she went back to work the night of 22Dec2020 the rapid test was negative. When she went back to work on 25Dec2020 it was positive. On the weekend she had to come back to do a PCR test on28Dec2020 and it was positive. Caller clarifies that the rapid tests were Nasal Swabs. The patient's latest test was on 28Dec2020, she was told that when she comes back, they do not have to do the rapid test daily anymore, it will now be every 90 days. The patient did not have a test before the vaccine. She has had no issues with Vaccines in the past.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for corona virus infection based on the known safety profile. However given the short duration of 3 days since the vaccine first dose, it is unlikely patient would have fully developed immunity.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, Fatigue, Hypersomnia, Muscular weakness
Clinical narrative: excessive sleeping; Extreme fatigue; temp 100; sore throat; loss of balance; Muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration in the left arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization. The patient's medical history included COVID-diagnosis from Mar2020 that resulted in blood clots and pneumonia both on 2020, and allergies to shellfish, eggs, peanuts. The patient was not pregnant. Concomitant medications included acyclovir [aciclovir], levothyroxine sodium (SYNTHROID), apixaban (ELIQUIS), escitalopram oxalate (LEXAPRO), and bupropion hydrochloride (WELLBUTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Dec2020 06:00, the patient experienced extreme fatigue, temperature of 100, sore throat, loss of balance, muscle weakness, and excessive sleeping. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent other lab tests and procedures which included COVID test nasal swab was negative on 28Dec2020. Outcome of the events was not recovered. The events were considered non-serious by the reporter.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: excessive sleeping; Extreme fatigue; temp 100; sore throat; loss of balance; Muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration in the left arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization. The patient's medical history included COVID-diagnosis from Mar2020 that resulted in blood clots and pneumonia both on 2020, and allergies to shellfish, eggs, peanuts. The patient was not pregnant. Concomitant medications included acyclovir [aciclovir], levothyroxine sodium (SYNTHROID), apixaban (ELIQUIS), escitalopram oxalate (LEXAPRO), and bupropion hydrochloride (WELLBUTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Dec2020 06:00, the patient experienced extreme fatigue, temperature of 100, sore throat, loss of balance, muscle weakness, and excessive sleeping. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent other lab tests and procedures which included COVID test nasal swab was negative on 28Dec2020. Outcome of the events was not recovered. The events were considered non-serious by the reporter.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Lymphadenopathy, SARS-CoV-2 test positive
Clinical narrative: Left axillary, supraclavicual, and cervical chain lymphadenopathy > 1-week post-injection.; since the vaccination, has the patient been tested for COVID-19?: Yes; since the vaccination, has the patient been tested for COVID-19?: Yes; This is a spontaneous report from a contactable healthcare professional.  A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on the left arm on 21Dec2020 20:00 at single dose for COVID-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced left axillary, supraclavicual, and cervical chain lymphadenopathy > 1-week post-injection on 22Dec2020 16:00. in which the patient received no treatment. It was also reported on Dec2020, "since the vaccination, has the patient been tested for COVID-19?: Yes". The patient has other pending test. The outcome of left axillary, supraclavicual, and cervical chain lymphadenopathy > 1-week post-injection was not recovered and other events was unknown.; Sender's Comments: Based on the information provided, the COVID-19 test positive are possibly related to drug ineffective of BNT162B2 vaccine.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Weight
Clinical narrative: I have like tingling and it is not really numbness but feels like my hands are asleep; I have like tingling and it is not really numbness but feels like my hands are asleep; This is a spontaneous report from a contactable nurse.  A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EK5730), via an unspecified route of administration on at single dose for preventive measure for Covid.  Medical history included postural orthostatic tachycardia syndrome, migraine, cardiac disorder and ventricular tachycardia.  Concomitant medication included sertraline hydrochloride (ZOLOFT), topiramate (TROKENDI XR) and nadolol.  The patient stated that on 31Dec2020, "I have like tingling and it is not really numbness but feels like my hands are asleep".  The patient underwent lab tests and procedures which included weight: 130 lbs on an unspecified date.  The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: One of my partners was the same way, tested positive after getting the vaccine; One of my partners was the same way, tested positive after getting the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 2 patient. This is the second of 2 reports.   A patient of unspecified age and gender received bnt162b2 (BNT162B2, Pfizer biontech Covid-19 Vaccine, solution for injection, lot number and expiation date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was tested positive after getting the vaccine. The outcome of the event was unknown.  Information on Lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (SARS CoV2 test positive) with BNT162b2 can not be fully excluded.,Linked Report(s) : US-PFIZER INC-2020510419 same reporter/ drug/similar events, different patient
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Somnolence, Vomiting
Clinical narrative: Dizziness for hours; vomiting; sleepiness; This is a spontaneous report from a contactable healthcare professional.  A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the right arm on 30Dec2020 16:00 at single dose for COVID-19 immunisation.  The patient had no medical history.  There were no concomitant medications.  The patient known allergies: amoxicillin. The patient experienced dizziness for hours, vomiting, sleepiness on 31Dec2020 22:00. The patient received no treatment.  The outcome of the events was recovering.   Information on the lot number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; This is a spontaneous report from a non-contactable nurse.  A 42-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the left arm on 19Dec2020 11:30 at single dose for COVID-19 immunisation.  The patient medical history was not reported.  Concomitant medication included levothyroxine.  The patient experienced deep ache left deltoid at injection site with severe nerve pain when lifting left arm on 23Dec2020 16:30. The patient received no treatment. The outcome of the events was not recovered.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: Following day, had minor lower body half aches and chills; Following day, had minor lower body half aches and chills; Typical arm soreness similar to flu shot.; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH 9899), via an unspecified route of administration in the right arm on 29Dec2020 at 15:45 at a single dose as COVID vaccine. The patient had no other vaccines within four weeks prior to the COVID vaccine, was not diagnosed with COVID prior to vaccination, and was not tested for COVID post vaccination. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. Past drug history included flu shot. On 30Dec2020 at 10:00 AM, the patient experienced typical arm soreness similar to flu shot. The following day, 31Dec2020, he had minor lower body half aches and chills. The patient received no treatment for the events. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Epicondylitis, Oedema, Tenderness
Clinical narrative: acute mild edema to affected forearm with light bruising of unknown origin without known injury; acute mild edema to affected forearm with light bruising of unknown origin without known injury; unknown origin without known injury, tenderness to touch; Tennis elbow of opposite vaccine extremity around same time as vaccine, just after; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in the right arm on 10Dec2020 in a hospital at a single dose for COVID vaccination. Medical history included anxiety and chronic migraines with aura. The patient has no known allergies. The patient was not pregnant at the time of vaccination, did not receive any other vaccine in four weeks, was not diagnosed with COVID prior to the vaccination, and was not tested for COVID post-vaccination. Concomitant medications included desvenlafaxine succinate (PRISTIQ), bupropion hydrochloride (WELLBUTRIN), and cyclobenzaprine. In Dec2020, the patient had tennis elbow of opposite vaccine extremity around the same time as the vaccine, just after. On 01Jan2021 at 04:00 AM, the patient experienced acute mild edema to affected forearm with light bruising of unknown origin without known injury, tenderness to touch. The patient did not receive any treatment for the events. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).  Information on the lot/batch number has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Pain, Pyrexia
Clinical narrative: fever 103.5; Chills; achy; has no energy; This is a spontaneous report from a contactable consumer (patient's wife). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231), intramuscular (right deltoid) on 30Dec2020 0900, at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient has been in bed since 30Dec2020. The patient was achy, has no energy, and has chills on 30Dec2020. Patient also has a fever with temperature of 103.5 on 31Dec2020. Reporter asked if this was normal. Event outcome for achy and chills was recovered on 31Dec2020, not recovered for has no energy and unknown for fever 103.5.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Mouth swelling
Clinical narrative: Bottom lip is not crooked or nothing like it but inside it is kind of little swelled; Mouth is kind of swollen up; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: Apr2021), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had the COVID shot on Tuesday (29Dec2020) and thinks her mouth is kind of swollen up. Her bottom lip is not crooked or nothing like it but inside it is kind of a little swelled. The patient started experiencing the adverse events in the morning of 31Dec2020. No treatment was administered for the events, and the patient was advised to contact primary healthcare professional. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: stuffy nose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration on 31Dec2020 at single dose for Covid-19 immunization. Medical history included exposed prior to the vaccine. Concomitant medications were not reported. The patient informed that she got the vaccine on 31Dec2020 and was recently told she had been exposed prior to the vaccine. The patient currently has a stuffy nose and was wondering if she should get tested. The outcome of the event stuffy nose was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation
Clinical narrative: 1 big whelp that is red, hot to touch on arm/gotten an inflammation; This is a spontaneous report from a contactable pharmacist (patient).  A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730, Expiration Date 31Mar2021), via an unspecified route of administration into left arm on 29Dec2020 16:45 at 0.3 mL, single for preventive as front line healthcare worker.  Medical history included compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, chronic sinusitis (took allergy medication for that).  Family medical history was None. No Relevant test. Concomitant medication included fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA-D), levocetirizine dihydrochloride (XYZAL) and montelukast sodium (SINGULAIR). No additional vaccines administered on same date of the BNT162B2. The patient experienced 1 big whelp that is red, hot to touch on arm - immediately after, so around 16:45. They were required to stay in clinic for 15 minutes after receiving it, and it was immediately after 16:45 on 29Dec2020. She didn't believe she received it intramuscularly. She believed the needle was a little short to be the 1 inch needle. Now she had a huge red whelp on left arm where she was vaccinated. She was not sure if she need to report it or not. She also wanted to know if there were studies about alternate routes. If it was not given intramuscularly, would she need to receive an additional dose? It was one big whelp. You can see bumps superficially. It was not where the muscle was. She was quite fat on her arm. It is superficial, right on skin. You would usually have to press on skin if it was intramuscular. This you just press on skin lightly, and it was red. She was not able to answer question about serious criteria for both events. With anything, she probably should not have gotten an inflammation. She does not have a lot or expiration or dose for any of those. Right after administration of injection. No emergency room or physician's office required. The outcome of event was not recovered. lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: symptomatic of Covid; symptomatic of Covid; inoculated on 15Dec2020; patient was scheduled on 04Jan2021 for 2nd dose; inoculated on 15Dec2020; patient was scheduled on 04Jan2021 for 2nd dose; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via an unspecified route of administration on 15Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was inoculated on 15Dec2020 and currently on 28Dec2020 the patient was symptomatic of Covid. The patient was scheduled on 04Jan2021 for 2nd dose. The outcome of the events symptomatic of Covid was unknown.  Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pruritus, Urticaria, Vital signs measurement
Clinical narrative: dizziness; itching/small hives on forearm (same side as injection but not at injection site); hives on chin/upper lip; This is a spontaneous report from a contactable pharmacist (patient). A 50-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number:  EK9231), via an unspecified route of administration (arm right) on 02Jan2021 08:15 at single dose for Covid-19 immunization. Medical history included asthma, hypothyroidism, and migraines. Concomitant medications included cetirizine hydrochloride (ZYRTEC), famotidine, salbutamol (ALBUTEROL), fluticasone propionate (FLOVENT), and fluticasone propionate (FLONASE). The patient previously took Keflex [cefalexin] and experienced drug allergies: hives, angioedema. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 30 minutes after the injection on 02Jan2021 (08:45 AM), the patient experienced dizziness and itching/small hives on forearm (same side as injection but not at injection site). Vital signs were measured, all was normal. It was also reported that 36 hours after the injection, the patient got hives on chin/upper lip. The patient was treated with Benadryl, Pepcid, and Zyrtec to stop itching and resolve the hives. Benadryl was taken at home, upon advice from nurse. The outcome of events was recovered on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, SARS-CoV-2 test positive
Clinical narrative: got the vaccine within the past 24 hours and resulted positive for the test; got the vaccine within the past 24 hours and resulted positive for the test; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on an unspecified date in 2020 at a single dose for COVID-19 immunization. There were no medical history or concomitant medications. The patient got the vaccine within the past 24 hours and resulted positive for the test, the patient took 48 hours ago like was that going to some adverse reaction like patient had the positive results before knowing the result patient got the vaccine so at present patient was just kind of anxious about what going to happen. Next shot will be due on 20Jan2021. The outcome of events was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Minor nausea; Mild Headache; Tiredness; Chills; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK5730), via an unspecified route of administration in the left arm on 18Dec2020 07:00 at a single dose for COVID-19 immunization. The patient was vaccinated in a facility. Medical history included histoplasmosis, degenerative disc disease, and penicillin allergy. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included diclofenac sodium, methocarbamol, diphenhydramine hydrochloride (BENADRYL), and atorvastatin (LIPITOR). The patient did not receive other vaccine in the last four weeks. On 18Dec2020 16:00, the patient experienced minor nausea, mild headache, tiredness, and chills for about 18 hours. The patient did not receive any treatment for the reported adverse events. The outcome of the events was recovered on 19Dec2020 10:00. The report was considered non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Chills; subjective fevers less than 100; fatigue; soreness at injection site; This is a spontaneous report from a contactable physician (the patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 16Dec2020 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 16Dec2020, the patient experienced chills, subjective fevers less than 100, fatigue, and soreness at injection site 24 hours. The clinical outcome of chills, subjective fevers less than 100, fatigue, was recovered on an unspecified date. The clinical outcome of soreness at injection site 24 hours was recovered on 17Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.     Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid a week after receiving the vaccine; tested positive for Covid a week after receiving the vaccine; patient stated that she was pregnant; patient stated that she was pregnant; patient stated that she was pregnant; This is a spontaneous report from a contactable nurse (patient) from a Pfizer sponsored program. A 37-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), via an unspecified route of administration on 18Dec2020 at left deltoid for Covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced tested positive for Covid a week after receiving the vaccine on 28Dec2020 (as reported), the patient stated that she was pregnant. The patient underwent lab tests and procedures which included Covid test: positive on 28Dec2020. The outcome of events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: vomiting; severe headache; This is a spontaneous report from a contactable nurse. A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH9899, expiry date not reported), intramuscular on 30Dec2020 16:00 at a single dose in the left arm as Covid vaccine. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. The patient had no known allergies; no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no other medications the patient received within 2 weeks of vaccination. Patient received vaccine on 30Dec2020 at 4pm. On 01Jan2021, at approximately 3am, patient woke up with a severe headache, and approximately 6am, patient started vomiting which lasted until after 7pm. The headache was not as intense but it was still there today. Since the vaccination, the patient has not been tested for COVID-19. No treatments received in response to the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The outcome of the events headache and vomiting was reported as recovering.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Myalgia, Nausea, Pyrexia
Clinical narrative: Injection site pain; Muscle pain; Joint pain; Fever up to a 100.2; Nausea; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot: EK9231, via an unspecified route of administration on 01Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated, "I had the COVID shot today (01Jan2021). This morning I had the first shot of the medicine Covid-19 Vaccine Pfizer. This is what is happening. I had the shot around may be 10-10:30. I felt great all the day and after 7 O?clock I started getting injection site pain, muscle pain, joint pain, and fever up to a 100.2, nausea on 01Jan2021. Is there anything that I can do home for the fever especially? Let me give you the number that I got on my vaccination record card. It is Pfizer EK9231 (not clarified)." The patient further stated, "I wanted someone to tell me if I can take Tylenol. Do I have a situation like to go to the hospital?." The patient was advised to visit the nearest emergency room or can contact the physician as the department is closed. The patient further stated, "I will probably go to the hospital if I threw or some temperature if it is higher. I got to do something. I got so many symptoms. I had probably 19 in Nov, in Nov I spent three days on bed in Hospital. It is fine now and I was in hospital. I do not know what is happening now. It was good all the day but then at night these things." The patient underwent lab tests and procedures which included body temperature: 100.2 on 01Jan2020. The outcome of the events was unknown.