chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Thinking abnormal
Clinical narrative: waves of nausea for 2 days after; Dizziness; headache; difficulty with higher thought processes - feeling "zoned out"; difficulty with higher thought processes - feeling "zoned out"; This is a spontaneous report from a contactable other healthcare professional (patient).  A 51-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number unknown due to not available/provided to reporter at the time of report completion), intramuscular at left arm on 23Dec2020 09:00 at single dose for COVID-19 immunization at a "Nursing Home/Senior Living Facility". The patient's medical history included Gluten and FODMAP food allergy. Concomitant medications received within 2 weeks of vaccination: dietary supplements. No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested for COVID-19 post the vaccination. COVID-19 test post vaccination on 23Dec2020 result was negative. It was reported that on 23Dec2020 09:30, the patient experienced dizziness, headache, difficulty with higher thought processes - feeling "zoned out", and "waves of nausea for 2 days after". No treatment was taken for the above events. The outcome of the events was recovered in Dec2020.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Recurrence of redness, swelling, pain at injection site/Site reaction is identical to initial reaction occurring on days 2 and 3; Recurrence of redness, swelling, pain at injection site/Site reaction is identical to initial reaction occurring on days 2 and 3; Recurrence of redness, swelling, pain at injection site/Site reaction is identical to initial reaction occurring on days 2 and 3; This is a spontaneous report from a contactable nurse (patient). A 53-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 19Dec2020 at 10:15 AM in a hospital at a single dose for COVID-19 immunization. Medical history included asthma and GERD. The patient was not pregnant at the time of vaccination and had no known allergies. The patient had no other vaccine in four weeks, had no COVID-19 diagnosis prior to vaccination, and was not tested for COVID-19 post vaccination. Concomitant medication included omeprazole (PRILOSEC). On 27Dec2020 at 18:00, the patient experienced a recurrence of redness, swelling, and pain at injection site measuring 5.5 cm x 5.6 cm occurring on day 9 post injection. Site reaction was identical to the initial reaction occurring on days 2 and 3 of Dec2020, which resolved by day 4. The patient received no treatment for the events. Outcome of the events was not recovered/not resolved.  Information about the lot/batch has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH9899), via an unspecified route of administration on 28Dec2020 at 08:30 AM at a single dose; and the first dose 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. The patient was not pregnant at the time of vaccination, had no known allergies, and did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. The patient experienced sore arm on 28Dec2020 at 09:00. The patient received no treatment for the event. The outcome of the event was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: In response to the vaccine on 21Dec2020 I started to get a headache; This is a spontaneous report from a contactable nurse (patient). An 50-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH9899), via an unspecified route of administration in the left arm on 21Dec2020 at 12:00 PM in a hospital at 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, had no known drug allergies (NKDA), and did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included diazepam (VALIUM). In response to the vaccine on 21Dec2020, the patient started to get a headache, 600 mg ibuprofen was taken. Overnight, she woke up with a debilitating headache, stayed in bed on 22Dec2020 taking Tylenol 1000 mg q (every) 8 hours and Ibuprofen 600 mg q (every) 6 hours to keep the headache manageable. The entire week, she had 2 days where if she didn't keep rotating the doses of Tylenol and Ibuprofen, the headache would become severe. The side effects included "headache" but this was no common headache and she was not a person who routinely gets them. It has been a week since the injection and she still had to continue the cycling of Tylenol/ibuprofen to maintain this headache, to continue ADL's. Outcome of the event 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).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eyelid ptosis, Headache, Loss of personal independence in daily activities, Tension headache
Clinical narrative: In response to the vaccine on 21Dec2020 I started to get a headache; This is a spontaneous report from a contactable nurse (patient). An 50-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH9899), via an unspecified route of administration in the left arm on 21Dec2020 at 12:00 PM in a hospital at 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, had no known drug allergies (NKDA), and did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included diazepam (VALIUM). In response to the vaccine on 21Dec2020, the patient started to get a headache, 600 mg ibuprofen was taken. Overnight, she woke up with a debilitating headache, stayed in bed on 22Dec2020 taking Tylenol 1000 mg q (every) 8 hours and Ibuprofen 600 mg q (every) 6 hours to keep the headache manageable. The entire week, she had 2 days where if she didn't keep rotating the doses of Tylenol and Ibuprofen, the headache would become severe. The side effects included "headache" but this was no common headache and she was not a person who routinely gets them. It has been a week since the injection and she still had to continue the cycling of Tylenol/ibuprofen to maintain this headache, to continue ADL's. Outcome of the event 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).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Hypersensitivity, Investigation, Laboratory test, Nervousness
Clinical narrative: developed a severe tachycardia with no other symptoms.; was nervous and kind of shaking; was nervous and kind of shaking; Allergic reaction; This is a spontaneous report from a contactable pharmacist. A 39-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJ1685), intramuscular in the left arm on 24Dec2020 at 08:00 AM in the hospital at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination, has no known allergies, had no other medications in two weeks, and did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. At 3:00 PM of 24Dec2020, the patient developed a severe tachycardia with no other symptoms. She walked herself to the ER (Emergency room/department or urgent care), was nervous and kind of shaking. By the time they got to her, her heart rate was stable and was at 88. Transient tachycardia was at around 120-140 for 7 minutes and resolved with no intervention. Basic labs came back normal. She got discharged from the ER. The patient didn't think they reported it but she was willing to cooperate in any way. The patient was not treated for the adverse events. As per the patient, she reported her adverse reaction (after the 1st dose) on the website as recommended. She experienced "very fast heart beat 8 hours after receiving the vaccine". The patient was inquiring if she would be contacted after. The patient also asked if the very fast heartbeat was related to the vaccine because the reaction did not happen right away like usual, she was not sure if it was an allergic reaction since it happened 8 hours later. Outcome of the event 'Tachycardia' was recovered in Dec2020, while for the other events was unknown. 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Tremor
Clinical narrative: developed a severe tachycardia with no other symptoms.; was nervous and kind of shaking; was nervous and kind of shaking; Allergic reaction; This is a spontaneous report from a contactable pharmacist. A 39-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJ1685), intramuscular in the left arm on 24Dec2020 at 08:00 AM in the hospital at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination, has no known allergies, had no other medications in two weeks, and did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. At 3:00 PM of 24Dec2020, the patient developed a severe tachycardia with no other symptoms. She walked herself to the ER (Emergency room/department or urgent care), was nervous and kind of shaking. By the time they got to her, her heart rate was stable and was at 88. Transient tachycardia was at around 120-140 for 7 minutes and resolved with no intervention. Basic labs came back normal. She got discharged from the ER. The patient didn't think they reported it but she was willing to cooperate in any way. The patient was not treated for the adverse events. As per the patient, she reported her adverse reaction (after the 1st dose) on the website as recommended. She experienced "very fast heart beat 8 hours after receiving the vaccine". The patient was inquiring if she would be contacted after. The patient also asked if the very fast heartbeat was related to the vaccine because the reaction did not happen right away like usual, she was not sure if it was an allergic reaction since it happened 8 hours later. Outcome of the event 'Tachycardia' was recovered in Dec2020, while for the other events was unknown. 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Upper-airway cough syndrome, Vaccination site hypoaesthesia
Clinical narrative: It felt a little numb on the part that was injected; I kept filling the medicine drip from my nose and since then I have been having really bad cough; I kept filling the medicine drip from  my nose and since then I have been having really bad cough; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in Dec2020 at a  single dose for COVID-19 immunization. The patient had no relevant medical history and no concomitant medications. The patient stated that she believed she had a little bit side effects on the vaccine in Dec2020. She took the vaccine about maybe more than a week ago and yesterday it felt a little numb on the part that was injected and she kept "filling the medicine" drip from her nose and since then she had been having really bad cough. The patient stated that for her cough, she took natural stuffs (unspecified). Outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Influenza virus test, SARS-CoV-2 test
Clinical narrative: Asthma exacerbation; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Lot number: ek5730), via an unspecified route of administration at the left arm on 18Dec2020 13:00 at a single dose for COVID-19 immunization. Medical history includes adult onset asthma, seasonal allergies, anxiety and depression. The patient was not pregnant at the time of vaccination. Concomitant medication included atomoxetine hydrochloride (STRATTERA), vortioxetine hydrobromide (TRINTELLIX), ethinylestradiol and levonorgestrel (SEASONIQUE). The patient experienced asthma exacerbation following vaccination that started 2 hours after (18Dec2020, 3PM) and worsened 1 day later. The pulmonologist advised to nebulize the patient with albuterol due to shortness of breath tightness and clear secretions despite MDI. The patient had to restart controller Symbicort (still with 3x day albuterol on 23Dec2020) and seen at an urgent care. Oral steroids were prescribed (Medrol dose pack). The patient was not hospitalized for the event but the resulted in Emergency room/department or urgent care visit. The event was reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has been tested for Flu and COVID (Nasal Swab, PCR) Testing on 23Dec2020 and results were negative. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: burning itching and having welts over her body; burning itching and having welts over her body; This is a spontaneous report from a non-contactable other healthcare professional (technologist, patient).  A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in Dec2020, the patient experienced burning itching and having welts over her body. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Extrasystoles, Heart rate, Palpitations
Clinical narrative: heart palpitations; felt like heart was skipping a beat almost every 3-5 minutes; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration at the right arm on 21Dec2020 08:00 at a single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination and had no known allergy. The patient had no concomitant medications. On 23Dec2020 at 11 pm, approximately 36 hours after getting vaccine, the patient had 36+ hours of heart palpitations, felt like heart was skipping a beat almost every 3-5 minutes.  Events subsided after 36-48 hours. The patient was not hospitalized for the events. There was no treatment given for the events. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received 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 recovering.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site pain
Clinical narrative: Headache; nausea; arm pain at the injection site; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ek5730), intramuscular at the left arm on 23Dec2020 14:30 at a single dose for COVID-19 immunization. Medical history included anxiety. The patient was not pregnant at the time of vaccination and had no known allergy. Concomitant medication included trazodone and fluoxetine hydrochloride (PROZAC). On 24Dec2020 6 am, the patient experienced headache and moderate nausea for about 48-32 hours with significant arm pain at the injection site. The patient was not hospitalized for the events and did not receive any treatment. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received 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 in Dec2020.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Flushing, Pyrexia, Rhinorrhoea
Clinical narrative: Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a non-contactable other-HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231) (Brand= Pfizer), via an unspecified route of administration on 24Dec2020 07:15AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was workplace clinic. None medical history. The patient's concomitant medications was not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies included Ibuprofen based pain medicine. On 24Dec2020, patient experienced injection site pain; chills; facial flushing. 25Dec2020 fever. 26Dec2020 rhinorrhea. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a non-contactable other-HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231) (Brand= Pfizer), via an unspecified route of administration on 24Dec2020 07:15AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was workplace clinic. None medical history. The patient's concomitant medications was not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies included Ibuprofen based pain medicine. On 24Dec2020, patient experienced injection site pain; chills; facial flushing. 25Dec2020 fever. 26Dec2020 rhinorrhea. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pharyngeal swelling, Productive cough, Rash erythematous
Clinical narrative: Fine raised red rash over her body; throat swelling; diarrhea; high pitched cough productive with clear thin secretions; This is a spontaneous report from a contactable nurse (patient herself). A 59-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on left arm from at 12:30 PM on 23Dec2020 at single dose for COVID-19 immunization. Medical history included depression. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), triazolam (HALCION), fluoxetine hydrochloride (PROZAC), paracetamol (TYLENOL). The patient previously took Lamictal and experienced rash, codeine and experienced hallucination, lamictal for drug allergy, codeine and experienced drug allergy. On 24Dec2020 mid-day (11:00 AM), the patient developed the following S/S (signs and symptoms, which were similar to a Lamictal rash): Fine raised red rash over her body, but significantly heavier to face, neck and lower legs; throat swelling with a high pitched cough (with no difficulty breathing) productive with clear thin secretions; diarrhea. The patient took 6 Benadryl every 4-6 hours, Pepcid twice daily, and had an epi pen available (but did not need it). The cough and rash resolved by late Sunday evening (27Dec2020). The patient did not report to ED because she felt the symptoms were manageable at home. All events reported as non-serious. The outcome of events red rash and cough were recovered on 27Dec2020, the outcome of rest events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Oral pruritus
Clinical narrative: numbness and itching in the roof of mouth; numbness and itching in the roof of mouth; This is a spontaneous report from a contactable healthcare professional.  A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ 1685), intramuscular on the left arm on Dec2020 at single dose for COVID-19 immunisation.  Medical history included hypertension and GERD.  Concomitant medication included metoprolol, dexlansoprazole, ondansetron and propranolol.  The patient previously took gadolinium and midazolam and experienced known allergies: gadolinium and midazolam.  The patient experienced numbness and itching in the roof of mouth on Dec2020. Patient received BENADRYL as treatment. The outcome of the events was recovering.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Intermittent dizziness and it doesn't last very long usually its usually couple of times a day; This is a spontaneous report from a contactable nurse, the patient. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot "EJ then it's either I or 1, I don't know then 685", Expiry Date: 31Mar2021) solution for injection intramuscular on 19Dec2020 (at the age of 31-years-old) as a single dose for COVID-19 vaccination. Pregnancy status was not reported. Medical history was unknown. Concomitant medication included multivitamins. The patient stated, "I just wanted to know if it's normal or not, I got this first half of the Covid Vaccine on the 19Dec2020 and ever since I have been having like intermittent dizziness (19Dec2020) and it doesn't last very long usually its usually couple of times a day but I just wanted to know if that's normal and if it is how long before it stops?" No treatment was provided for the event intermittent dizziness. The outcome of the event intermittent dizziness was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: patient had COVID two days after vaccination; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) via an unspecified route of administration on 26Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had COVID two days after vaccination (28Dec2020). The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Malaise
Clinical narrative: dizzy; weak; S/He had started feeling really bad; s/he didn't feel well; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) via an unspecified route of administration on 15Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 27Dec2020, the patient started feeling dizzy and weak. S/He had started feeling really bad; s/he didn't feel well. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: four days after getting her first COVID vaccine injection, she had a COVID positive test result (antigen rapid response test); four days after getting her first COVID vaccine injection, she had a COVID positive test result (antigen rapid response test); This is a spontaneous report from a contactable consumer. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730/expiration date unknown), dose number 1 via an unspecified route of administration on 23Dec2020 09:00 at a single dose on the left arm for COVID-19 immunization. Medical history included vaccination of unspecified flu vaccine in Oct2020. No vaccines or new medications were received on the day of the vaccination. The patient stated that on 27Dec2020, four days after getting her first COVID vaccine injection, she had a COVID positive test result (antigen rapid response test). The patient stated that she had been mostly asymptomatic for COVID. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; headache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced fever and headache for almost 10 days in Dec2020. The outcome of the events was not recovered. The reporter assessed the events as non-serious.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Palpitations
Clinical narrative: intermittent Heart palpitations that began at 0800; Severe fatigue that began 4 hours post injection and lasted approx 48 hrs; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received their first dose of BNT162B2 (lot number: Ek 5730; expiry date not reported), intramuscularly on the right arm on 26Dec2020 at 08:30 at single dose for COVID-19 immunization. Medical history included known allergies to milk and eggs. Concomitant medication included lisinopril.  The patient experienced severe fatigue that began 4 hours post injection and lasted approx. 48 hrs on 26Dec2020 and intermittent heart palpitations that began at 08:00 on 28Dec2020. The patient recovered from severe fatigue on an unspecified date in Dec2020 (reported as approx. 48hrs) while the outcome of intermittent heart palpitations was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: developed shingles outbreak 4 days later; This is a spontaneous report from a contactable consumer.   A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on 22Dec2020 at single dose in the upper arm via unspecified route of administration. The patient had not medical history. Concomitant medications were not reported. On 26Dec2020 the patient developed shingles outbreak. The outcome of the event was not recovered.   Information on the lot/batch number has been requested
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Night sweats, Pyrexia
Clinical narrative: Fever of 101.0 F; chills with fever; fatigue; night sweats; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 20Dec2020 15:00 at single dose for COVID-19 immunization. Vaccine location provided as Left arm. Medical history included Scleroderma, interstitial lung disease.  There were no Known allergies to medications, food, or other products. Concomitant medication (reported as other medications the patient received within 2 weeks of vaccination) included ibuprofen, ergocalciferol (VITAMIN D), cetirizine hydrochloride (CITIRIZINE), famotidine. There were no other vaccines received within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior vaccination. The patient experienced Fever of 101.0 F, chills with fever, fatigue, night sweats on 21Dec2020 20:00. No treatment received for all reported events. The patient had Covid tested via Nasal Swab post vaccination with PCR result negative on 23Dec2020.  The outcome of the events was recovered in Dec2020. This case was assessed as non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever of 101.0 F; chills with fever; fatigue; night sweats; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 20Dec2020 15:00 at single dose for COVID-19 immunization. Vaccine location provided as Left arm. Medical history included Scleroderma, interstitial lung disease.  There were no Known allergies to medications, food, or other products. Concomitant medication (reported as other medications the patient received within 2 weeks of vaccination) included ibuprofen, ergocalciferol (VITAMIN D), cetirizine hydrochloride (CITIRIZINE), famotidine. There were no other vaccines received within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior vaccination. The patient experienced Fever of 101.0 F, chills with fever, fatigue, night sweats on 21Dec2020 20:00. No treatment received for all reported events. The patient had Covid tested via Nasal Swab post vaccination with PCR result negative on 23Dec2020.  The outcome of the events was recovered in Dec2020. This case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test positive
Clinical narrative: tested positive after receiving the first dose; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events in two patients. This is the first of two reports.  A patient of unspecified age and gender received their first dose of  BNT162B2 (lot number and expiration date not reported), 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 reporter queried on after low long will the antibodies be present after receiving first dose and would it show up in antibody testing. Further reported they have 1-2 patients who tested positive after receiving the first dose. The reporter also queried any recommendations on vaccinating them for the 2nd dose if they test positive in between the two doses and that they have one vial left over from last week, today at noon the 5days will expire. If they dilute it now at 10am do they have to use it by noon or add 6hours from the time of dilution. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on an unspecified date. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020516039 same drug and event in a different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test positive
Clinical narrative: tested positive after receiving the first dose; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events in two patients. This is the second of two reports.  A patient of unspecified age and gender received their first dose of  BNT162B2 (lot number and expiration date not reported), 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 reporter queried on after low long will the antibodies be present after receiving first dose and would it show up in antibody testing. Further reported they have 1-2 patients who tested positive after receiving the first dose. The reporter also queried any recommendations on vaccinating them for the 2nd dose if they test positive in between the two doses and that they have one vial left over from last week, today at noon the 5days will expire. If they dilute it now at 10am do they have to use it by noon or add 6hours from the time of dilution. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020516038 same drug and event in a different patient
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: Headache; soreness at injection site; nausea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown since misplaced/discarded) via intramuscular on 26Dec2020 17:30 on left arm at a single dose for COVID-19 immunization. The patient medical history included anxiety and attention deficit hyperactivity disorder (ADHD). The patient allergy for reglan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included atomoxetine hydrochloride (STRATTERA) and sertraline hydrochloride (ZOLOFT). The patient experienced Headache, soreness at injection site, nausea, fatigue on 27Dec2020 08:00 AM. The patient received Excedrin as treatment for the events. The outcome of the events was recovering.  Information on the Lot/Batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Decreased appetite, Dry mouth, Dysgeusia
Clinical narrative: body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to explain it very well; change of sense of taste; loss of taste; body rash on upper torso only described as "not bad" and "not itchy" or bothersome; low grade fever 100.3; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration in left upper arm, on 21Dec2020  06:30 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was  hospital.The patient's weight was 67.13 kg and height was 173 cm. The patient's medical history included nausea and flu like symptoms. Concomitant medications included omeprazole(PROTONIX) from Dec2020 at 40mg once a day for nausea. The patient stated that a week before she received the vaccine she had flu like symptoms and she was tested for COVID-19 and the test result was negative in Dec2020. The patient experienced low grade fever 100.3 which started in the evening of the vaccine(21Dec2020) and she took Tylenol and went to sleep and the next day felt better, which resolved by the next day(22Dec2020). The patient experienced body aches on an unknown date, body rash on upper torso only described as "not bad" and "not itchy" or bothersome which started on 21Dec2020(a few hours after receiving vaccine) and resolved on 23Dec2020. The patient experienced change of sense of taste, "everything tastes metallic and it's kind of hard to explain it very well" on 24Dec2020. The patient experienced loss of tastewhich started on either 23Dec2020 or 24Dec2020. She was starting to be able to taste. She has anything it is bland. She can taste some saltiness. That started coming back on approximately Saturday, 26Dec2020. The patient experienced decreased appetite, "cotton mouth" on an unknown date.  The outcome of the events "low grade fever 100.3", "body rash on upper torso only described as "not bad" and "not itchy" or bothersome", "loss of taste" was recovered and of other events  was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash, SARS-CoV-2 antibody test, Taste disorder
Clinical narrative: body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to explain it very well; change of sense of taste; loss of taste; body rash on upper torso only described as "not bad" and "not itchy" or bothersome; low grade fever 100.3; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration in left upper arm, on 21Dec2020  06:30 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was  hospital.The patient's weight was 67.13 kg and height was 173 cm. The patient's medical history included nausea and flu like symptoms. Concomitant medications included omeprazole(PROTONIX) from Dec2020 at 40mg once a day for nausea. The patient stated that a week before she received the vaccine she had flu like symptoms and she was tested for COVID-19 and the test result was negative in Dec2020. The patient experienced low grade fever 100.3 which started in the evening of the vaccine(21Dec2020) and she took Tylenol and went to sleep and the next day felt better, which resolved by the next day(22Dec2020). The patient experienced body aches on an unknown date, body rash on upper torso only described as "not bad" and "not itchy" or bothersome which started on 21Dec2020(a few hours after receiving vaccine) and resolved on 23Dec2020. The patient experienced change of sense of taste, "everything tastes metallic and it's kind of hard to explain it very well" on 24Dec2020. The patient experienced loss of tastewhich started on either 23Dec2020 or 24Dec2020. She was starting to be able to taste. She has anything it is bland. She can taste some saltiness. That started coming back on approximately Saturday, 26Dec2020. The patient experienced decreased appetite, "cotton mouth" on an unknown date.  The outcome of the events "low grade fever 100.3", "body rash on upper torso only described as "not bad" and "not itchy" or bothersome", "loss of taste" was recovered and of other events  was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Somnolence, Wheezing
Clinical narrative: Wheezing; Cough; Profound sleepiness; This is a spontaneous report from a contactable other healthcare professional (HCP). A 52-year-old female patient received the first dose of bnt162b2 (lot number: EK9231), intramuscular on the left arm on 24Dec2020 at 11:30 at a single dose for immunization. Medical history included HBP, asthma, radicular pain and migraines. The patient's concomitant medications were not reported. The patient previously took tetracycline and experienced drug allergy. The facility where the most recent COVID-19 vaccine was administered was at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 and has not been tested for COVID-19. On 26Dec2020 at 05:00, the patient experienced wheezing, cough and profound sleepiness, and was prescribed Proair Inhaler as treatment for the events. The outcome of the events was not resolved.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: ringing in the ears; slight headache; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the first dose of bnt162b2 (Batch/lot number: EH9899), via an unspecified route of administration (reported as one injection to left arm) on 16Dec2020 at a single dose for COVID-19 vaccination. Medical history included allergy. Concomitant medication included prednisolone acetate (PREDNISOLONE ACETATE, Manufacturer: Pacific Pharma. NDC: 60758119-05, Lot: E88990, Exp. date: Feb2023) 1%, four eyedrops a day until she is out, 7 days at most or a week for allergy. The nurse called as a patient about the Pfizer COVID-19 vaccine, which she received on 16Dec and had a headache - only a slight headache, the day after and ringing in her ears that has not gone away. She says it was her first injection of the vaccine. The patient says she was given the vaccine through her work, and says she had a headache that evening and then a slight headache the next day. She says that the ringing in the ear, she noticed the next day in the morning. She says it is hard to tell if the ringing is just one ear or not, the ringing is staying about the same, and is more in her right ear. She says she has not had treatment for either the headache or the ringing in her ears, and the headache improved on its own. She had no new medications and didn't receive any other vaccines when she got this one. She says that she went to the eye doctor in the past week and he started her on eye drops, she has never been on prednisone for allergies, and for her eyes he gave her prednisone drops and allergy drops. She says she started that medication on the evening she got it, Monday 21Dec. She would like to know if there could be some type of allergy, she doesn't know if she should take the second dose of the vaccine. She says she doesn't know if there is something she should do for the ringing in her ears, like a common treatment or anything, or if others have been reporting this. She says she saw on the website that one side effect said ringing in ears, but she isn't sure if the website was either of those provided by call handler for further information. The outcome of the events slight headache was resolving while ringing in the ears had not resolved.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Condition aggravated, Lip swelling
Clinical narrative: angioedema; swelling of the lips; This is a spontaneous report from a non-contactable nurse (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as COVID-19 vaccine. Medical history included angioedema 23 years ago. Concomitant medications were not reported. The caller wanted to report AE for the COVID-19 vaccine. AE reported that she took the COVID-19 vaccine and after 23 hours, she developed angioedemia on unspecified date. Additionally, she said that she woke up with swelling of the lips on an unspecified date. Given the AE from the first request, it was inquired if it was recommended to get a second dose. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of angioedemia with lip swelling cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema
Clinical narrative: angioedema; swelling of the lips; This is a spontaneous report from a non-contactable nurse (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as COVID-19 vaccine. Medical history included angioedema 23 years ago. Concomitant medications were not reported. The caller wanted to report AE for the COVID-19 vaccine. AE reported that she took the COVID-19 vaccine and after 23 hours, she developed angioedemia on unspecified date. Additionally, she said that she woke up with swelling of the lips on an unspecified date. Given the AE from the first request, it was inquired if it was recommended to get a second dose. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of angioedemia with lip swelling cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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