chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pregnant at the time of vaccination; Pregnant at the time of vaccination; Pregnant at the time of vaccination; bilateral nerve like pain; small headache; temp 100.3; enlarged axillary lymph nodes; pain in both shoulder joints; chest soreness; feel exhausted/feel tired; Braxton Hicks contractions; slight chills; injection site soreness/arm pain radiates around seems like nerve like pain with chest tightness; injection site soreness/arm pain radiates around seems like nerve like pain with chest tightness; arm pain radiates around seems like nerve like pain; This is a spontaneous report from a contactable other HCP.  A 31-year-old female other HCP reported for herself that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EKS730) into the left arm at single dose on 22Dec2020 at 05:30 PM  and received the second dose of BNT162B2 (Lot number EKS730) into the left arm on 08Jan2021 at 08:00 AM at single dose for COVID-19 immunization. The patient  is pregnant, last menstrual date 29Apr2020, gestational period 35 and estimated delivery date 07Feb2021. Concomitant drug included Prenatal vitamin. The patient reported that on 08Jan2021 she experienced injection site soreness at 20:00, the arm pain radiates around seems like nerve like pain with chest tightness. Temperature 97.7, she took Tylenol 1000 mg. On 09Jan2021 at 00:15 she had slight chills, at 01:20/01:30 chills, arm pain, chest more tight, Braxton Hicks contractions for about 1 hour,  temperature 99.9, she took Tylenol 1000mg and went to sleep. At 08:00 she had no chills temperature 98.8, pain in both shoulder joints, chest soreness- feel exhausted.  At 09:00 1000mg Tylenol, at 14:15 temperature 98.0, at 17:45 temperature 99.8, she took 750mg Tylenol. At 18:20 temperature 100.3, she took 250mg Tylenol, at 18:50 temperature 99.0 after shower, at 19:08 temp 98.8 and at 22:00 feeling slightly better, she had bilateral nerve like pain, chest pain, small headache. On 10Jan2021 at 02:45 temp 98.2 she took 1000mg Tylenol, at 09:00 temp 97.9, bilateral nerve like pain and enlarged axillary lymph nodes, chest sore, slight headache. At 17:00 temp 96.6 bilateral nerve/lymph node pain and felt tired. The patient did  not have Covid prior vaccination and she was not Covid tested post vaccination. At the time of reporting the patient was recovering.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: mild flu-like illness; This is a spontaneous report from a contactable physician.   A 69-years-old male patient started to receive bnt162b2 (BNT162B2) intramuscular on 07Jan2021 13:00 at SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and  degenerative joint disease (knees). Facility type vaccine: Hospital. vaccine location=Left arm, dose number 1. The patient's concomitant medications were not reported. The should be noted that patient had a covid-19 with an exposure date of 03Aug2020 with moderate symptoms lasting 2 weeks. The patient experienced mild flu-like illness on 08Jan2021 13:00 and lasting 20 hours with very abrupt termination of symptoms with outcome of recovered. The action taken was not applicable.  Information about lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: fatigue; Headache; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. lot number: EK5730), via an unspecified route of administration on 18Dec2020 10:45 in right arm at single dose for COVID-19 immunization. Medical history included Hashimotos thyroid disease and Mitral valve prolapse (MVP) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) and ferrous glycine sulfate (FE). The patient previously took Reglan iron infusions and experienced allergies. The patient experienced fatigue, headache and nausea on an unspecified date. The patient was not pregnant. The outcome of the event headache was not recovered and the outcome of the remaining events was unknown. The facility where the most recent COVID-19 vaccine was administered was in the hospital.   Other medical history: hashimotos thyroid disease mvp
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperaesthesia, Malaise, Nausea
Clinical narrative: Chills; Headaches; Fever; Skin sensitivity; Nausea; Feeling unwell; This is a spontaneous report from a contactable other health professional. A 22-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in the left arm, from 06Jan2021 08:00 at a SINGLE DOSE for COVID-19 immunization. Medical history included rubber/latex allergy. The patient was not pregnant. The patient had her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Dec2020 in the right arm and experienced injection site soreness/pain. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 07Jan2021 19:00, the patient experienced chills, headaches, fever (body temperature not provided), skin sensitivity, nausea and was feeling unwell. The outcome of events was reported as recovering. No treatment was received/required due to events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; Headaches; Fever; Skin sensitivity; Nausea; Feeling unwell; This is a spontaneous report from a contactable other health professional. A 22-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in the left arm, from 06Jan2021 08:00 at a SINGLE DOSE for COVID-19 immunization. Medical history included rubber/latex allergy. The patient was not pregnant. The patient had her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Dec2020 in the right arm and experienced injection site soreness/pain. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 07Jan2021 19:00, the patient experienced chills, headaches, fever (body temperature not provided), skin sensitivity, nausea and was feeling unwell. The outcome of events was reported as recovering. No treatment was received/required due to events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fever 102 F; headache; chills; body aches; This is a spontaneous report from a contactable Nurse reported for herself. A 63-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 22Dec2020 14:30 and the second dose single dose (lot number=EK9231) on 09Jan2021 19:15 for COVID-19 immunization. Vaccine location=Left arm, dose number 1 and dose number 2. Facility-type-vaccine: Hospital. Medical history included asthma. The patient's concomitant medications were not reported. On 10Jan2021 at 14:00 the patient experienced headache with outcome of not recovered, fever 102 °F with outcome of not recovered, chills with outcome of not recovered and body aches with outcome of not recovered. The action taken was not applicable.  Tylenol was received as therapeutic measures for fever.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Tenderness in armpit in the arm the vaccine was given; Possibly a lymph node reaction; This is spontaneous report from a contactable nurse (patient). This 23-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first single dose on 19Dec2020, second single dose on 08Jan2021, both intramuscular, in right arm, for COVID-19 immunization. No other vaccine was given in four weeks. Medical history included hc of SVT. The patient had no COVID19 before vaccination. The patient had no allergies. Concomitant medications included vitamin D, vitamin C and nylestradiol, levonorgestrel (ASHLYNA) for birth control. On 10Jan2021 at 08:00 the patient experienced tenderness in armpit in the arm the vaccine was given. The reporter was asking of a possible lymph node reaction. No treatment was given. COVID19 was not tested after vaccination. The events were resolving. Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (HCP) (Patient). A 34-year-old female patient not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 08Jan2021 12:00 PM as a single dose for COVID-19 immunization, lot number: unknown. Medical history and concomitant medications were not provided. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. Patient had not been tested for COVID-19 post vaccination. On 10Jan2021 09:00 PM patient experienced severe itching that started in lower extremities and has moved up into trunk. Event was treated with diphenhydramine hydrochloride (BENADRYL). Patient was recovering from the event, at the time of the report.  Information about Lot/Batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Rash erythematous, Rash pruritic, Sleep disorder, Urticaria
Clinical narrative: Muscle soreness in left arm for the first two days then marked fatigue on days 3-4, major urticaria developed on day 8 after vaccination with large patches of red, raised, very itchy rash on both sides of the anterior abdomen, with smaller patches on both of the lower legs and some on the posterior upper arms.  The itching made sleep very difficult for the next two nights.  The itching was decreased somewhat by the use of 1% hydrocortisone cream and moreso by 10 mg of Loratidine. The severity of the urticaria has decreased somewhat over the last 3 days since onset but is definitely still present.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Inappropriate schedule of product administration, Pain
Clinical narrative: woke up with fever to 102F; rigors; body aches; headache; R arm pain and redness at injection site; R arm pain and redness at injection site; R arm pain and redness at injection site; the 1st dose on 22Dec2020, the 2nd dose on 08Jan2021; This is a spontaneous report from a contactable Physician (patient). This 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the 1st dose on 22Dec2020, the 2nd dose (lot number: EL0142) on 08Jan2021; both at right arm via an unspecified route of administration at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. 12 hours after vaccine, the patient woke up with fever to 102F, rigors, body aches, and headache on 09Jan2021. Severe symptoms until around 24 hrs, then continued mild body aches and chills up to 50 hours after shot. Continued R arm pain and redness at injection site currently, at 72 hours after vaccine. No treatment was received for events. The patient had no COVID prior vaccination, no COVID tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of all events was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: woke up with fever to 102F; rigors; body aches; headache; R arm pain and redness at injection site; R arm pain and redness at injection site; R arm pain and redness at injection site; the 1st dose on 22Dec2020, the 2nd dose on 08Jan2021; This is a spontaneous report from a contactable Physician (patient). This 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the 1st dose on 22Dec2020, the 2nd dose (lot number: EL0142) on 08Jan2021; both at right arm via an unspecified route of administration at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. 12 hours after vaccine, the patient woke up with fever to 102F, rigors, body aches, and headache on 09Jan2021. Severe symptoms until around 24 hrs, then continued mild body aches and chills up to 50 hours after shot. Continued R arm pain and redness at injection site currently, at 72 hours after vaccine. No treatment was received for events. The patient had no COVID prior vaccination, no COVID tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of all events was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Ear pain, Ear pruritus, Ear swelling
Clinical narrative: headache; earache; cough; chills; entire body aches/soreness; itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching; itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching; itchy red swollen rash on palms of hands; itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching; right ear swelling/itching; right ear swelling/itching; This is a spontaneous report from a contactable Other HCP (patient). This 32-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 08Jan2021 at single dose (lot number: e13246) for covid-19 immunisation. Medical history included PCOS, HSV2, ADHD, anxiety, depression. Concomitant medications included atenolol (NORTELOL), spironolactone, valaciclovir (VALACYCLOVIR), bupropion. The patient previously received erythromycin and experienced allergies, received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) at left arm on 14Dec2020 04:00 P.M for covid-19 immunisation. The patient experienced headache, earache, cough, chills, entire body aches/soreness, fatigue, Right arm pit tender/sore, itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching on 09Jan2021 12:00 A.M. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was recovering.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Peripheral swelling, Pruritus, Rash erythematous
Clinical narrative: headache; earache; cough; chills; entire body aches/soreness; itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching; itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching; itchy red swollen rash on palms of hands; itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching; right ear swelling/itching; right ear swelling/itching; This is a spontaneous report from a contactable Other HCP (patient). This 32-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 08Jan2021 at single dose (lot number: e13246) for covid-19 immunisation. Medical history included PCOS, HSV2, ADHD, anxiety, depression. Concomitant medications included atenolol (NORTELOL), spironolactone, valaciclovir (VALACYCLOVIR), bupropion. The patient previously received erythromycin and experienced allergies, received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) at left arm on 14Dec2020 04:00 P.M for covid-19 immunisation. The patient experienced headache, earache, cough, chills, entire body aches/soreness, fatigue, Right arm pit tender/sore, itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching on 09Jan2021 12:00 A.M. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was recovering.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: headache; earache; cough; chills; entire body aches/soreness; itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching; itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching; itchy red swollen rash on palms of hands; itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching; right ear swelling/itching; right ear swelling/itching; This is a spontaneous report from a contactable Other HCP (patient). This 32-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 08Jan2021 at single dose (lot number: e13246) for covid-19 immunisation. Medical history included PCOS, HSV2, ADHD, anxiety, depression. Concomitant medications included atenolol (NORTELOL), spironolactone, valaciclovir (VALACYCLOVIR), bupropion. The patient previously received erythromycin and experienced allergies, received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) at left arm on 14Dec2020 04:00 P.M for covid-19 immunisation. The patient experienced headache, earache, cough, chills, entire body aches/soreness, fatigue, Right arm pit tender/sore, itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching on 09Jan2021 12:00 A.M. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Chest discomfort, Dyspnoea, Fibrin D dimer increased, Muscle tightness
Clinical narrative: Developed chest tightness around right side of chest into back and SOB 50.5 hours after vaccination. Went to local ER and found to have a right lower lobe pulmonary embolism.  Treated with Xarelto and sent home with outpatient follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test negative, Troponin increased
Clinical narrative: Developed chest tightness around right side of chest into back and SOB 50.5 hours after vaccination. Went to local ER and found to have a right lower lobe pulmonary embolism.  Treated with Xarelto and sent home with outpatient follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Confusional state, Decreased appetite
Clinical narrative: joint pain persisted; confusion; anorexia; chills began 19 hours after injection; low-grade fever (100.6); hypotension; hypoglycemia; lethargy; the 2nd dose on 08Jan2021 /1st dose on 20Dec2020; This is a spontaneous report from a contactable Physician (patient). This 72-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 08Jan2021 05:00 PM at single dose (lot number: EK9231) for covid-19 immunisation. Medical history included diabetes, idiopathic encapsulating peritonitis and known allergies to Latex. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), tamoxifen, apixaban (ELIQUIS), simvastatin. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) at left arm on 20Dec2020 01:00 PM for covid-19 immunisation. The patient experienced chills began 19 hours after injection, followed by low-grade fever (100.6), hypotension, hypoglycemia, lethargy, confusion and anorexia on 09Jan2021 12: 00 PM. Illness lasted 17 hours, treated with fluids, anti- inflammatories and sleep. Some new joint pain persisted. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event joint pain persisted was unknown. Outcome of other events was recovered/resolved with sequel.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoglycaemia, Hypotension, Inappropriate schedule of product administration, Lethargy, Pyrexia
Clinical narrative: joint pain persisted; confusion; anorexia; chills began 19 hours after injection; low-grade fever (100.6); hypotension; hypoglycemia; lethargy; the 2nd dose on 08Jan2021 /1st dose on 20Dec2020; This is a spontaneous report from a contactable Physician (patient). This 72-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 08Jan2021 05:00 PM at single dose (lot number: EK9231) for covid-19 immunisation. Medical history included diabetes, idiopathic encapsulating peritonitis and known allergies to Latex. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), tamoxifen, apixaban (ELIQUIS), simvastatin. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) at left arm on 20Dec2020 01:00 PM for covid-19 immunisation. The patient experienced chills began 19 hours after injection, followed by low-grade fever (100.6), hypotension, hypoglycemia, lethargy, confusion and anorexia on 09Jan2021 12: 00 PM. Illness lasted 17 hours, treated with fluids, anti- inflammatories and sleep. Some new joint pain persisted. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event joint pain persisted was unknown. Outcome of other events was recovered/resolved with sequel.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza, Myalgia, Oropharyngeal pain
Clinical narrative: Fever as high as 103.6, chills, muscle aches, sore throat, diuresis, fatigue, shooting pains, general decent flu symptoms. as of yet... its only been 6 hours.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Polyuria, Pyrexia
Clinical narrative: Fever as high as 103.6, chills, muscle aches, sore throat, diuresis, fatigue, shooting pains, general decent flu symptoms. as of yet... its only been 6 hours.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Body temperature, Chills, Diarrhoea
Clinical narrative: sinus pain; diarrhea; abdominal pain; severe myalgia; headache; low grade fever; chills; general weakness; This is a spontaneous report from a non-contactable physician (patient). This 37-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 08Jan2021 12:00 PM at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient previous received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Dec2020 12:00 PM at left arm for covid-19 immunisation. At the first day on 09Jan2021, the patient experienced severe myalgia and headache, low grade fever and chills, general weakness. At the second day on 10Jan2021, the patient experienced headache and sinus pain, moderate myalgia, diarrhea and abdominal pain. At the third day on 12Jan2021, the patient experienced weakness. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was recovered.   No follow up attempts are possible; Information on the lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Sinus pain
Clinical narrative: sinus pain; diarrhea; abdominal pain; severe myalgia; headache; low grade fever; chills; general weakness; This is a spontaneous report from a non-contactable physician (patient). This 37-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 08Jan2021 12:00 PM at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient previous received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Dec2020 12:00 PM at left arm for covid-19 immunisation. At the first day on 09Jan2021, the patient experienced severe myalgia and headache, low grade fever and chills, general weakness. At the second day on 10Jan2021, the patient experienced headache and sinus pain, moderate myalgia, diarrhea and abdominal pain. At the third day on 12Jan2021, the patient experienced weakness. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was recovered.   No follow up attempts are possible; Information on the lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dizziness postural, Feeling abnormal, Headache, Nausea
Clinical narrative: Feel bad; Bad headache; Nausea; Dizzy happens when I move around and change position; Dizzy happens when I move around and change position; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date was not reported) on the left arm on 06Jan2021 (15:00) at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication included ibuprofen. On 07Jan2021 (12:30 AM), the patient had felt bad; bad headache; nausea; and was dizzy which happened when she moved around and changed position. The patient had received paracetamol (TYLENOL) and diphenhydramine (BENADRYL) as treatment for the reported adverse events. The outcome of the events, 'felt bad', 'bad headache', 'nausea' and 'dizzy which happened when she moved around and changed position', was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested since the vaccination. The patient had COVID-19 test which was negative on 08Jan2021.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Feel bad; Bad headache; Nausea; Dizzy happens when I move around and change position; Dizzy happens when I move around and change position; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date was not reported) on the left arm on 06Jan2021 (15:00) at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication included ibuprofen. On 07Jan2021 (12:30 AM), the patient had felt bad; bad headache; nausea; and was dizzy which happened when she moved around and changed position. The patient had received paracetamol (TYLENOL) and diphenhydramine (BENADRYL) as treatment for the reported adverse events. The outcome of the events, 'felt bad', 'bad headache', 'nausea' and 'dizzy which happened when she moved around and changed position', was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested since the vaccination. The patient had COVID-19 test which was negative on 08Jan2021.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Nausea, Pain in extremity
Clinical narrative: Feel bad; Bad headache; Nausea; Dizzy happens when I move around and change position; Dizzy happens when I move around and change position; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date was not reported) on the left arm on 06Jan2021 (15:00) at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication included ibuprofen. On 07Jan2021 (12:30 AM), the patient had felt bad; bad headache; nausea; and was dizzy which happened when she moved around and changed position. The patient had received paracetamol (TYLENOL) and diphenhydramine (BENADRYL) as treatment for the reported adverse events. The outcome of the events, 'felt bad', 'bad headache', 'nausea' and 'dizzy which happened when she moved around and changed position', was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested since the vaccination. The patient had COVID-19 test which was negative on 08Jan2021.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Tachycardia
Clinical narrative: Slight dizziness and tachycardia lasting for about 10 min
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein, Full blood count, Lymphadenopathy, Malaise
Clinical narrative: Patient experienced lymphadenopathy in the supraclavicular and axillary lymph nodes as well as generalized malaise and arthralgias.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Red blood cell sedimentation rate
Clinical narrative: Patient experienced lymphadenopathy in the supraclavicular and axillary lymph nodes as well as generalized malaise and arthralgias.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity, Vaccination site bruising
Clinical narrative: Could not raise it above shoulder, when turning steering wheel pain with up and over motion, could not lift anything; patient's left arm was very sore, achy; Bruise on injection site; This is a spontaneous report from a contactable other hcp.  A 49-years-old female patient started to receive bnt162b2 (BNT162B2) , via an unspecified route of administration, lot number: EH9899, from 23Dec2020 11:00 at a SINGLE DOSE for COVID-19 immunization.  Medical history included obesity, hyperthyroid and vit d deficiency. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included topiramate (TOPAMAX), bupropion, darifenacin (ENABLEX) and levothyroxine. On 23Dec2020 15:00, the patient's left arm was very sore, achy, could not raise it above shoulder, when turning steering wheel pain with up and over motion, could not lift anything. Pain was described as worse than flu shot which lasted 24 hours. She also had bruise on injection site that lasted two weeks. Outcome of events was recovered. No treatment was received/required due to events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: Temperature spike to 104.6; received first dose of bnt162b2 on 20Dec2020 and second dose on 08Jan2021 13:15; This is a spontaneous report from a contactable consumer. A 38-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration, on the left arm on 08Jan2021 13:15 at a single dose for COVID-19 immunization. Medical history included prediabetic kidney disease. Concomitant medications included salmo salar oil (OMEGA-3 [SALMO SALAR OIL]), lisinopril, furosemide, escitalopram, and rosuvastatin calcium (CRESTOR). The patient is reported to have received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 15:45, on the left arm, for COVID-19 immunization. The patient had no prior Covid vaccination. The patient was not tested for Covid post vaccination. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient received first dose of bnt162b2 on 20Dec2020 and second dose on 08Jan2021 13:15. On 09Jan2021 at 04:30, the patient experienced temperature spike to 104.6, brought down with TYLENOL to hover around 101.0 to 102.0 for 24 hours, normal after that. The patient called a nurse who instructed to go the emergency room/physician office visit. Outcome of the event Temperature spike to 104.6 was recovered on unspecified date in Jan2021.  Information about lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Pharyngeal paraesthesia, Pharyngeal swelling, Speech disorder
Clinical narrative: Dizziness/light-headed, difficulty speaking, difficulty swallowing, mild tongue and throat swelling, constant need to clear throat, tingle/tickle in throat
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Throat clearing
Clinical narrative: Dizziness/light-headed, difficulty speaking, difficulty swallowing, mild tongue and throat swelling, constant need to clear throat, tingle/tickle in throat
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a non-contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 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 patient who is a nurse visited last weekend in the reporter's home for a few hours was advised that she tested positive for COVID today (unspecified date) and her family as well. She was vaccinated recently with the Pfizer vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: I had fever and severe chills/ shaking
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Off label use, Product use issue, Urticaria
Clinical narrative: Chills; Malaise; Hives; Other vaccine same date details: [{other vaccine same date product= Pfizer/Bio, other vaccine same date vaccine date= 08Jan2021}]; Other vaccine same date details: [{other vaccine same date product= Pfizer/Bio, other vaccine same date vaccine date= 08Jan2021}]; This is a spontaneous report from a contactable other hcp. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, intramuscular on 08Jan2021 11:30 at a SINGLE DOSE and via an unspecified route of administration on 08Jan2021 at a SINGLE DOSE for covid-19 immunisation. Other vaccine same date details: [{other vaccine same date product= Pfizer/Bio, other vaccine same date vaccine date= 08Jan2021}]. Medical history included drug hypersensitivity to Penicillin from an unknown date and unknown if ongoing. Concomitant medication included lisinopril (LISINOPRIL) and atorvastatin (ATORVASTATIN). The patient previously took clindamycin and experienced drug hypersensitivity.  The patient experienced Hives, Chills, Malaise on 08Jan2021 18:00. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: I have had 5 nose bleeds in the past 2 weeks, the first occurring 8 days after dose 1 of the Pfizer COVID vaccine. I hadn?t had a nose bleed prior to that for at least 10 years and I?ve been on the same low dose aspirin dose once daily for several years.  No petechiae, bruising or other bleeding.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: chills and rigor; fever/febrile; headache; nausea; whole body muscle aches; This is a spontaneous report from a non-contactable nurse (patient). A 30-year-old adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ej1686), via an unspecified route of administration on 10Jan2021 10:30 AM at single dose on the left arm for COVID-19 immunisation. The patient is not pregnant at the of report. COVID-19 vaccine was administered in the hospital.  Medical history included migraine, Polycystic ovarian syndrome (Pcos), seasonal allergies, penicillin and sulfa antibiotics allergies. Concomitant medications (Other medications in two weeks) included levothyroxine sodium (SYNTHROID), spironolactone, montelukast sodium (SINGULAIR), loratadine (CLARITIN [LORATADINE]) and calcium levomefolate (DEPLIN). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ej1685) on 21Dec2020 03:15 PM on the left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. The patient reported that on 11Jan2021 12:00 AM, 14 hours post receiving the second dose, she had chills and rigor and ended up with a fever. Patient took Tylenol, fever broke and 4 hours later again had chills and rigor febrile again and took ibuprofen. The patient also had headache, nausea, and whole body muscle aches. The events were assessed as non-serious. Outcome of the events was recovering. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Chills, Dyspnoea, Fatigue, Flushing
Clinical narrative: I received the first dose of the COVID 19 (Moderna) on 01/15/2021 in the evening. The next morning I woke up at 05:45am with a sore arm, which I was told was one of the side effect. However I was sore and aching all over my body. As my day continued, I became tired and feeling flushed within the face. I felt my heart rate beating faster than normal. I began having cold chills and the aching within my body progressed through out the day (12 hr shift). When I clocked out at 07:08 pm and got home from work, I was unable to hardly move with out hurting and I felt like I had a fever. My husband checked my temperature and I had a low grade temp of 99.4 with an increase work of breathing and had ,a difficult time catching a breath. My husband took me to the hospital ER and before arriving to the ER I was having a stridor episode and when the nurse checked my temperature it read 102.3. I could not complete a full sentence and began vomiting. I was given epinephrine nebulized, solumedrol, benadryl, zofran, lidocaine nebulized. I had a CT with contrast of my neck and a chest xray. All images came back normal, I had been treated for an allergic reaction from the COVID vaccine and discharged home once the symptoms and stridor subsided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypersensitivity, Injection site pain, Nasopharyngitis, Pain
Clinical narrative: I received the first dose of the COVID 19 (Moderna) on 01/15/2021 in the evening. The next morning I woke up at 05:45am with a sore arm, which I was told was one of the side effect. However I was sore and aching all over my body. As my day continued, I became tired and feeling flushed within the face. I felt my heart rate beating faster than normal. I began having cold chills and the aching within my body progressed through out the day (12 hr shift). When I clocked out at 07:08 pm and got home from work, I was unable to hardly move with out hurting and I felt like I had a fever. My husband checked my temperature and I had a low grade temp of 99.4 with an increase work of breathing and had ,a difficult time catching a breath. My husband took me to the hospital ER and before arriving to the ER I was having a stridor episode and when the nurse checked my temperature it read 102.3. I could not complete a full sentence and began vomiting. I was given epinephrine nebulized, solumedrol, benadryl, zofran, lidocaine nebulized. I had a CT with contrast of my neck and a chest xray. All images came back normal, I had been treated for an allergic reaction from the COVID vaccine and discharged home once the symptoms and stridor subsided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: I received the first dose of the COVID 19 (Moderna) on 01/15/2021 in the evening. The next morning I woke up at 05:45am with a sore arm, which I was told was one of the side effect. However I was sore and aching all over my body. As my day continued, I became tired and feeling flushed within the face. I felt my heart rate beating faster than normal. I began having cold chills and the aching within my body progressed through out the day (12 hr shift). When I clocked out at 07:08 pm and got home from work, I was unable to hardly move with out hurting and I felt like I had a fever. My husband checked my temperature and I had a low grade temp of 99.4 with an increase work of breathing and had ,a difficult time catching a breath. My husband took me to the hospital ER and before arriving to the ER I was having a stridor episode and when the nurse checked my temperature it read 102.3. I could not complete a full sentence and began vomiting. I was given epinephrine nebulized, solumedrol, benadryl, zofran, lidocaine nebulized. I had a CT with contrast of my neck and a chest xray. All images came back normal, I had been treated for an allergic reaction from the COVID vaccine and discharged home once the symptoms and stridor subsided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Feeling hot, Migraine, Pain
Clinical narrative: generalized body soreness.; severe migraine; severe weakness; left arm (same arm she received vaccine) broke out in a red itchy rash; red itchy rash; feeling hot; dry heaving; severe painful coughing; severe painful coughing lasted about an hour along with post nasal drip appearing; within 2 hours my skin became blotchy and itchy; within 2 hours my skin became blotchy and itchy; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142 and expiry date: unknown), via an unspecified route of administration on the left arm on 05Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included autoimmune progesterone dermatitis, Reynaud's syndrome, skin mottling, gastrooesophageal reflux disease (GERD), migraines, post-traumatic stress disorder (PTSD), sulfa allergy, and depression. Patient was not pregnant. The patient's concomitant medications included PEPCID.  The patient previously took progesterone, miconazole and hydroxychloroquine sulfate (PLAQUENIL) and experienced allergy.The patient experienced within 2 hours her skin became blotchy and itchy on 05Jan2021 18:45. She took a shower and symptoms resolved. Next morning on 06Jan2021, patient's left arm (same arm she received vaccine) broke out in a red itchy rash. She took Prednisone 40mg around 10am and rash resolved. Around 3-4pm the rash reappeared along with feeling hot on the same day. She ran outside and began dry heaving and coughing. The severe painful coughing lasted about an hour along with post nasal drip appearing on 06Jan2021. During that hour patient took Zofran,12 puffs of Albuterol total, and Benzedrex nasal spray. She was already on Pepcid 20mg- 2 tablets BID for GERD prior to reaction; cough improved. On 07Jan2021, around 2-3am morning woke up with a severe migraine and cough returned along with severe weakness. Patient went to the clinic she worked and received steroid shots to help along with Maxalt and more Albuterol. By Sunday, 10Jan2021, she was almost back to base like, generalized body soreness. Monday (11Jan2021) back to base line for the most part. The patient underwent lab tests and procedures which included nasal swab: negative on 08Jan2021. Outcome of the events was recovered with sequel. The reporter considered the events as non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination.