chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: received COVID Vaccine on 16Dec2020 and was asymptomatic for active COVID carrier; received COVID Vaccine on 16Dec2020 and was asymptomatic for active COVID carrier; This is a spontaneous report from a non-contactable nurse. A 35-year-old female patient started to receive bnt162b2 (reported as product=COVID 19, brand=Pfizer; lot number and expiry date unknown), via an unspecified route of administration on 16Dec2020 at 09:30 AM at single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. The patient reported that she received COVID Vaccine on 16Dec2020 and was asymptomatic for active COVID carrier. Covid test type post vaccination was nasal swab on 16Dec2020 with positive results. It was reported that prior to vaccination, patient was not diagnosed with COVID-19. It was further reported that since the vaccination, the patient has been tested positive for COVID-19. The outcome of the events was unknown.  Information on the batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspect vaccine in this patient cannot be completely excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue; moderate headache; This is a spontaneous report from a contactable Nurse reporting for herself.  A 34-years-old female patient  received bnt162b2 (BNT162B2; Lot # EL0140 )vaccine  , intramuscular  in the left arm on 18Dec2020 15:15 at single dose for covid-19 immunisation .  Medical history included hypersensitivity to medications including  amoxicillin sodium + clavulanate potassium] (AUGMENTIN)  from an unknown date.   The patient's concomitant medications were not reported.  On 18Dec2020 22:00  the patient experienced fatigue and headache (6/10) refractory to caffeine or hydration. The nurse did not try tylenol or NSAIDs as  wanted to prevent interference with immune response. The outcome of both the event was not recovered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Arm swelling; red circle size of a 50 cent piece; severe itching; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) (Manufacturer Pfizer-BionTech, lot# EH9899), via an unspecified route of administration in arm left, on 16Dec2020 at 01:45 PM, at single dose, for COVID-19 immunisation. Medical history included rheumatoid arthritis, Hashimoto's thyroiditis, vitiligo and alopecia all from an unknown date and unknown if ongoing. The patient had no allergies to medications, food or other products. Concomitant medications included unspecified drugs in two weeks. The patient experienced arm swelling, red circle size of a 50 cent piece and severe itching all on 16Dec2020 at 03:00 PM with outcome of recovering. The events were considered non serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Paraesthesia, Paraesthesia oral
Clinical narrative: right sided numbness; tingling to face,lips and arm to fingertips; slight headache within 15 minutes of vaccination; This is a spontaneous report from a contactable nurse. A 55-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: elo140), intramuscularly on 19Dec2020 13:15 at single dose for immunization. Vaccine location provided as Right arm. Medical history included asthma.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced slight headache within 15 minutes of vaccination on 19Dec2020. On 19Dec2020 13:45, 35 minutes after vaccination reported right sided numbness, tingling to face, lips and arm to fingertips. No treatment was received for all the events. The outcome of the events was recovered in Dec2020. The events were assessed as non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever; chills; body aches; headache; fatigue; This is a spontaneous report from a contactable Other Health Professional (patient). A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899) intramuscular at arm Left on 18Dec2020 15:45 at single dose for covid-19 immunization. Medical history included seasonal allergies, eczema, and diagnosed with COVID-19 prior vaccination. Concomitant medication included fluoxetine hydrochloride (Generic Prozac), krill oil, bifidobacterium lactis (PROBIOTIC), sambucus nigra (ELDERBERRY) and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, body aches, headache, fatigue on 19Dec2020 12:00 PM, no treatment received for the events. COVID was not tested post vaccination. The outcome of the events was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Chills, Dental paraesthesia, Heart rate increased
Clinical narrative: Increased blood pressure; Rapid heart rate; Chills( shaking); Chills( shaking); Chest and neck tightness; Chest and neck tightness; Teeth tingling; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730), via an unspecified route of administration on 19Dec2020 12:30 at single dose on left arm for COVID-19 immunization. Medical history included known allergies: Latex. Concomitant medications received within received within 2 weeks of vaccination included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID; CAFFEINE; PARACETAMOL]); ibuprofen. The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Dec2020 13:00 (01:00 PM), the patient experienced rapid heart rate, Increased blood pressure, Chills (shaking), Chest and neck tightness, Teeth tingling. The adverse events result in Emergency room/department or urgent care. The patient received ER monitoring, EKG (reported as "AE treatment") for the adverse events. The events were non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness
Clinical narrative: Increased blood pressure; Rapid heart rate; Chills( shaking); Chills( shaking); Chest and neck tightness; Chest and neck tightness; Teeth tingling; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730), via an unspecified route of administration on 19Dec2020 12:30 at single dose on left arm for COVID-19 immunization. Medical history included known allergies: Latex. Concomitant medications received within received within 2 weeks of vaccination included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID; CAFFEINE; PARACETAMOL]); ibuprofen. The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Dec2020 13:00 (01:00 PM), the patient experienced rapid heart rate, Increased blood pressure, Chills (shaking), Chest and neck tightness, Teeth tingling. The adverse events result in Emergency room/department or urgent care. The patient received ER monitoring, EKG (reported as "AE treatment") for the adverse events. The events were non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: fatigue; Fever 103.6/fever 100.3; headache; chills/chills with fever 100.3 after ibuprofen; Sore at injection site; body aches; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 18Dec2020 14:30 at single dose for COVID-19 immunization. Vaccine location was Left arm. Medical history included migraine, transient ischaemic attack (TIA), allergies: Penicillin, the patient had covid-19 prior to vaccination. Concomitant medication included buspirone hydrochloride (BUSPAR), cranberry, vitamin c (ascorbic acid), colecalciferol (VITAMIN D). The patient was not received other vaccine in four weeks. The patient experienced Sore at injection site, body aches, chills with fever 100.3 after ibuprofen, headache on 18Dec2020 19:00. And then the patient had Fever 103.6, headache, chills, fatigue on 18Dec2020 19:30, sore at injection site on 18Dec2020 19:00, body aches on 18Dec2020 19:00. Therapeutic measures were taken as a result of events fever and chills, no treatment was received for the other events. The outcome of the events was recovering. All events were assessed as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fatigue; Fever 103.6/fever 100.3; headache; chills/chills with fever 100.3 after ibuprofen; Sore at injection site; body aches; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 18Dec2020 14:30 at single dose for COVID-19 immunization. Vaccine location was Left arm. Medical history included migraine, transient ischaemic attack (TIA), allergies: Penicillin, the patient had covid-19 prior to vaccination. Concomitant medication included buspirone hydrochloride (BUSPAR), cranberry, vitamin c (ascorbic acid), colecalciferol (VITAMIN D). The patient was not received other vaccine in four weeks. The patient experienced Sore at injection site, body aches, chills with fever 100.3 after ibuprofen, headache on 18Dec2020 19:00. And then the patient had Fever 103.6, headache, chills, fatigue on 18Dec2020 19:30, sore at injection site on 18Dec2020 19:00, body aches on 18Dec2020 19:00. Therapeutic measures were taken as a result of events fever and chills, no treatment was received for the other events. The outcome of the events was recovering. All events were assessed as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling hot, Injection site pain
Clinical narrative: About 30 minutes after injection I suddenly felt a rush of heat throughout my body; felt dizzy, weak and a bit nauseated; felt dizzy, weak and a bit nauseated; felt dizzy, weak and a bit nauseated; tired/ fatigue; have some minor injection site pain; This is a spontaneous report from a contactable nurse reporting for herself.  A 42-years-old non-pregnant female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE): lot number: EJ1675,  intramuscular, in the left arm on 18Dec2020 at 13:15 (at the age of 42 years-old) as a single dose for COVID-19 immunization.  The patient received the vaccine at a hospital. Medical history included an allergy to cilantro. Concomitant medication included colecalciferol (VITAMIN D), zinc (ZINC) intermittently, and paracetamol (TYLENOL) once, all within 2 weeks of vaccination.  The patient previously took amitriptyline and experienced swelling of eyelid and palmar erythema.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Dec2020, the patient experienced a rush of heat throughout her body, felt dizzy, weak and a bit nauseated and minor injection site pain. The clinical course as follows: At 13:45, about 30 minutes after injection she suddenly felt a rush of heat throughout her body, felt dizzy, weak, nauseated.  This lasted about 30 minutes and then the warm feeling went away.  She still felt a little dizzy, weak, nauseated and very tired. The dizziness lasted about 1.5 hours and the weakness, fatigue and mild nausea lasted about 6 hours. She reported that It felt as though she had taken diphenhydramine (BENADRYL). She stated that had she not been working (RN in an Emergency Department), she just would have taken a nap and it would have been ok.  Having to work through it was not pleasant she said.  She never had a fever during this but had some minor injection site pain.  She reported that she never experienced an immune response to any vaccine (has had 6 in a day before and was fine). The patient was not hospitalized for the events. The patient was treated with 600 mg of naproxen sodium. The clinical outcome for the events of a rush of heat throughout her body, felt dizzy, weak and a bit nauseated and minor injection site pain, was recovered on an unspecified date in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: About 30 minutes after injection I suddenly felt a rush of heat throughout my body; felt dizzy, weak and a bit nauseated; felt dizzy, weak and a bit nauseated; felt dizzy, weak and a bit nauseated; tired/ fatigue; have some minor injection site pain; This is a spontaneous report from a contactable nurse reporting for herself.  A 42-years-old non-pregnant female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE): lot number: EJ1675,  intramuscular, in the left arm on 18Dec2020 at 13:15 (at the age of 42 years-old) as a single dose for COVID-19 immunization.  The patient received the vaccine at a hospital. Medical history included an allergy to cilantro. Concomitant medication included colecalciferol (VITAMIN D), zinc (ZINC) intermittently, and paracetamol (TYLENOL) once, all within 2 weeks of vaccination.  The patient previously took amitriptyline and experienced swelling of eyelid and palmar erythema.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Dec2020, the patient experienced a rush of heat throughout her body, felt dizzy, weak and a bit nauseated and minor injection site pain. The clinical course as follows: At 13:45, about 30 minutes after injection she suddenly felt a rush of heat throughout her body, felt dizzy, weak, nauseated.  This lasted about 30 minutes and then the warm feeling went away.  She still felt a little dizzy, weak, nauseated and very tired. The dizziness lasted about 1.5 hours and the weakness, fatigue and mild nausea lasted about 6 hours. She reported that It felt as though she had taken diphenhydramine (BENADRYL). She stated that had she not been working (RN in an Emergency Department), she just would have taken a nap and it would have been ok.  Having to work through it was not pleasant she said.  She never had a fever during this but had some minor injection site pain.  She reported that she never experienced an immune response to any vaccine (has had 6 in a day before and was fine). The patient was not hospitalized for the events. The patient was treated with 600 mg of naproxen sodium. The clinical outcome for the events of a rush of heat throughout her body, felt dizzy, weak and a bit nauseated and minor injection site pain, was recovered on an unspecified date in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: ear infection; This is a spontaneous report from a contactable other HCP (patient). A female patient of an unspecified age received bnt162b2 (reported PFIZER-BIONTECH COVID-19 VACCINE, Covid-19 Vaccine), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. PCT asked, "I got the Covid 19 vaccine yesterday, and this morning I woke up and went to the doctor because I had an ear infection. I was prescribed with oral antibiotics. Is it okay to take the antibiotics?". Patient stated, "I had a question about it actually. I got the vaccine yesterday and then today I was at the doctor, I have an ear infection and I was wondering if that would be a bad thing if I took antibiotic while still recovering from the vaccine."  The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster cutaneous disseminated, Rash
Clinical narrative: Classic Herpes Zoster(shingles) left T5 and T6 dermatomes. Received injection at 10AM and noticed rash when I got home from the hospital at 8:00PM same day. Not likely related but felt should report any; rash; This is a spontaneous report from a contactable physician (hospital based neurologist) reporting for a himself. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #ELO140) via an unspecified route of administration in left arm on 18Dec2020 10:00AM at single dose for COVID-19 immunization. The patient received the vaccine in hospital. Medical history included coronary artery disease (CAD), status post stent placement right marginal branch in 2015. The patient had no allergies outside of seasonal. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced classic herpes zoster (shingles) left T5 and T6 dermatomes and noticed rash when he got home from the hospital at 20:00 on 18Dec2020, same day of vaccination. The patient started on valacyclovir (VALTREX) 1 gm every 8 hours for treatment of events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered. The reporter considered not likely related but felt should report any.; Sender's Comments: Classic herpes zoster (shingles) /rash occurred on the same day of vaccination with BNT162B2 represents a coincidental viral infection caused by Herpes zoster, unrelated to the vaccine use.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pyrexia, Rhinorrhoea
Clinical narrative: tired/exhaustion; cough; runny nose; fever 100 "oral"/fever 100.3; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 16Dec2020 08:45 at single dose on right arm for COVID-19 immunization. The patient's medical history reported as none and no Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included exemestane, thyroid (ARMOUR THYROID), ergocalciferol (VIT D), ascorbic acid (VIT C), acetylsalicylic acid (ASPIRINE). The most recent COVID-19 vaccine was administered in Workplace clinic. It was reported that nothing on Wednesday. On 17Dec2020 19:00 (07:00 PM) (Thursday evening), the patient was very tired, cough, runny nose and fever 100 "oral" (as reported), Friday (18Dec2020) exhaustion and fever 100.3 with cough and runny nose. The events were non-serious and no treatment was received for the events. 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 hadn't been tested for COVID-19. The outcome of the events was not recovered.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Rash, Rash maculo-papular
Clinical narrative: Mild maculopapular rash across arms and facial and neck flushing. Rash did not itch; facial and neck flushing; other vaccine same date vaccine date on 17Dec2020; This is a spontaneous report from a non-contactable consumer (patient).   A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 17Dec2020 at 07:30 on Right Deltoid at single dose for COVID-19 immunization. Other vaccine was received on the same date on 17Dec2020 Right Deltoid. The patient medical history included Hypertension. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medication included Lisinopril (strength: 20 mg). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took tramadol and experienced allergy. The patient experienced mild maculopapular rash across arms and facial and neck flushing on 18Dec2020 at 13:30. Rash did not itch and resolved spontaneously in 24 hours. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events "mild maculopapular rash across arms and facial and neck flushing" was recovered in Dec2020 in 24 hours. The report was reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Injection site erythema
Clinical narrative: Chills; Headache; Fatigue; injection site soreness and redness; injection site soreness and redness; Shortness of breath; nausea; feeling unwell; This is a spontaneous report from a contactable other health professional (HCP) who reported for herself. A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) intramuscularly in the left arm on 19Dec2020 at 08:45 (at the age of 24-years-old) as a single dose for COVID-19 vaccination. Medical history included being diagnosed with COVID-19 prior to vaccination, on an unspecified date. Otherwise, other medical history and known allergies to medications, food, or other products were all reported as "no". The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Dec2020 at 00:30, the patient experienced chills, headache, fatigue, injection site soreness and redness, shortness of breath, nausea and feeling unwell. The events were reported as non-serious and the patient did not receive any treatment for the events. The clinical outcomes of the events chills, headache, fatigue, injection site soreness and redness, shortness of breath, nausea and feeling unwell were all recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Nausea
Clinical narrative: Chills; Headache; Fatigue; injection site soreness and redness; injection site soreness and redness; Shortness of breath; nausea; feeling unwell; This is a spontaneous report from a contactable other health professional (HCP) who reported for herself. A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) intramuscularly in the left arm on 19Dec2020 at 08:45 (at the age of 24-years-old) as a single dose for COVID-19 vaccination. Medical history included being diagnosed with COVID-19 prior to vaccination, on an unspecified date. Otherwise, other medical history and known allergies to medications, food, or other products were all reported as "no". The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Dec2020 at 00:30, the patient experienced chills, headache, fatigue, injection site soreness and redness, shortness of breath, nausea and feeling unwell. The events were reported as non-serious and the patient did not receive any treatment for the events. The clinical outcomes of the events chills, headache, fatigue, injection site soreness and redness, shortness of breath, nausea and feeling unwell were all recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Injection site pain, Myalgia, Nausea
Clinical narrative: Fever 100.5; chills; pain at injection site; muscle soreness; joint pain; very mild nausea; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 5926710001), intramuscular on 19Dec2020 10:00 at single dose for COVID-19 immunization. Medical history included covid-19. Concomitant medication in two weeks included bupropion, sertraline, ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), cetirizine hydrochloride (ZYRTEC), ergocalciferol (VITAMIN D).  The patient previously took minocycline, tetracycline and, amoxicillin; experienced drug hypersensitivity.  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. Since the vaccination, the patient had not been tested for COVID-19. The COVID-19 vaccine was administered at Hospital.  The patient experienced fever 100.5, chills, pain at injection site, muscle soreness, joint pain, very mild nausea on 20Dec2020 04:30 AM. The patient received paracetamol (TYLENOL) as treatment. The outcome of events was not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Fever 100.5; chills; pain at injection site; muscle soreness; joint pain; very mild nausea; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 5926710001), intramuscular on 19Dec2020 10:00 at single dose for COVID-19 immunization. Medical history included covid-19. Concomitant medication in two weeks included bupropion, sertraline, ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), cetirizine hydrochloride (ZYRTEC), ergocalciferol (VITAMIN D).  The patient previously took minocycline, tetracycline and, amoxicillin; experienced drug hypersensitivity.  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. Since the vaccination, the patient had not been tested for COVID-19. The COVID-19 vaccine was administered at Hospital.  The patient experienced fever 100.5, chills, pain at injection site, muscle soreness, joint pain, very mild nausea on 20Dec2020 04:30 AM. The patient received paracetamol (TYLENOL) as treatment. The outcome of events was not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Muscle aches; back pain; nausea; fatigue; headache; This is a spontaneous report from a contactable nurse reporting for the patient. A 32-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 18Dec2020 at 14:15 (at the age of 32-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included postural orthostatic tachycardia syndrome (POTS), Fibromyalgia, Migraines, Post-traumatic stress disorder (PTSD), anxiety, depression, and gastrooesophageal reflux disease (GERD), all from an unknown date. The patient did not have any allergies to medications, food or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient did receive concomitant medications within 2 weeks of vaccination (unspecified). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Dec2020, the patient experienced muscle aches, back pain, nausea, fatigue, and headache. Therapeutic measures were not given for the events. The clinical outcome of the events muscle aches, back pain, nausea, fatigue, and headache was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Defaecation urgency, Dyschezia, Nausea, Pain
Clinical narrative: Felt body needed to defecate but could not; Severe lower abdominal cramping on day 3 post vaccination. Intermittent pains throughout day but increased at night.; Intermittent pains; Some nausea; This is a spontaneous report from a contactable consumer, the patient.  A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 10Dec2020 at 10:45 (at the age of 40-years-old) as a single dose in the left arm for COVID-19 immunization. The patient previously received clindamycin and experienced allergy. The patient had no other relevant medical history or concurrent conditions. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications were not provided. The 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. On 05Dec2020 (as reported) at 16:30, the patient experienced severe lower abdominal cramping on day 3 post vaccination. The patient experienced intermittent pains throughout day but increased at night. The patient experienced some nausea. The patient felt her body needed to defecate but could not and pain persisted. The pain improved on day 4. Therapeutic measures were taken as a result of the events and included the patient received Pepto Bismol. The clinical outcome of the events severe lower abdominal cramping, intermittent pains and felt body needed to defecate but could not was recovering. The outcome of the nausea was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pyrexia
Clinical narrative: had fevers and chills up to 104.7 degrees Fahrenheit for a 36-hour period; lethargy; This is a spontaneous report from a contactable Physician. A 40-year-old non-pregnant female first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899) intramuscular at arm Left on 19Dec2020 11:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included COVID-19 in Mar2020 with 10 days of fevers and chills and bilateral interstitial pneumonia. The patient had no other medical history and no known allergies. Concomitant medication included silicon dioxide (VIVISCAL), ascorbic acid (VITAMIN C), calcium, colecalciferol (VITAMIN D) and Gummy vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was administered at 11am on 19Dec2020, fevers and chills up to 103 Fahrenheit, and lethargy were started around 11pm. It was reported that the patient have had fevers and chills for 36 hrs after getting the first shot of the vaccine. She had fevers and chills up to 104.7 degrees Fahrenheit for a 36-hour period. The patient wanted to know if this response of fevers and chills was related to her being positive last march with accompanying Pneumonia and that if it still safe for her to take the 2nd dose, if it was due to a second time being exposed to Covid which was through the vaccine, could this be a robust immune response. COVID was not tested post vaccination. Outcome of the events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Oropharyngeal pain, Pain
Clinical narrative: arm soreness at injection site; Body aches; chills; sore throat; This is a spontaneous report from a contactable other health professional (patient). A 43-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730), intramuscularly on 17Dec2020 10:15 at single dose on left arm for COVID-19 immunization. The patient's medical history reported as none and no known- allergies. Concomitant medications received within 2 weeks of vaccination included colecalciferol (VITAMIN D [COLECALCIFEROL]), thyroid (ARMOUR THYROID), zinc vitamin, magnesium vitamin. The most recent COVID-19 vaccine was administered at Hospital. On 19Dec2020 19:00 (07:00 PM), the patient's arm soreness at injection site for 2 days. Body aches and chills and sore throat. No treatment received for the adverse events. 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 hadn't been tested for COVID-19. The outcome of the events was not recovered.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: Extreme fatigue, slept for most of Saturday; Extreme fatigue, slept for most of Saturday; This is a spontaneous report from a contactable health care professional, the patient. A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 18Dec2020 at 13:00 (at the age of 27-years-old) as a single dose in the left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 19Dec2020 at 09:00, the patient experienced extreme fatigue and slept for most of Saturday (as reported). Treatment was not received for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "extreme fatigue, slept for most of Saturday" was resolving.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: feeling symptoms and that she felt like she had the flu; felling sick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EY1685), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller reported receiving Pfizer Bontech covid 19 vaccine on 18Dec2020. She was feeling symptoms and that she felt like she had the flu (Dec2020). Consumer further stated she work here at the Hospital and Friday she appeared for the shot (Covid Vaccine) and she was just felling sick (Dec2020) and she didn't know what she had to do if it was normal, she had to report it to somebody for this or be around people or can she went back to work tomorrow, she didn't know. The outcome of the events was unknown.  No follow up attempts are possible. information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Initially pain at injection site; headache; Next day had body aches; low grade fever 100 degrees; This is a spontaneous report from a contactable consumer. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at first dose left arm on 18Dec2020 08:00 at single dose for covid-19 immunization. None medical history. No Known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. There was no other vaccine in four weeks or two weeks. The patient experienced initially pain at injection site next day had body aches, low grade fever 100 degrees, and headache on 19Dec2020 07:30 AM. Patient received acetaminophen as 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. The events were non-serious.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Feeling abnormal, Headache, Hypersomnia
Clinical narrative: Caller states she cant focus/She just can't focus; this is horrible/I have a hard time focusing; I'm like you know fogged; I just want to sleep/I have been sleeping all weekend that was horrible; I have some headache; I just don't feel right this is terrible; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in the arm on 18Dec2020 at single dose for covid-19 immunization. Medical history included seizure. Concomitant medication included celecoxib (CELEXA), levothyroxine sodium (SYNTHROID), phenobarbitone [PHENOBARBITAL] for seizure. The patient stated that she could not focus, this was horrible and had a hard time focusing on 18Dec2020, the patient also stated that "like you know fogged" on 18Dec2020, the patient just wanted to sleep and she had been sleeping all weekend that was horrible on an unspecified date in Dec2020, the patient had some headache on an unspecified date Dec2020, she just took some Ibuprofen for the headache, the patient just didn't feel right this was terrible on an unspecified date in Dec2020. The outcome of 'could not focus' was not recovered and the outcome of the other events was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: chills; low grade fever to 38.4; body aches; felt very tired; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), intramuscularly on left arm at 18:15 on 18Dec2020 at single dose for COVID-19 immunization. Medical history included COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). There were no concomitant medications (No other vaccine in four weeks, no other medications in two weeks). The patient had chills, low grade fever to 38.4, body aches and felt very tired at 15:00 on 19Dec2020. All events were reported as non-serious. The patient did not receive any treatment for all events. The outcome of events was recovering. COVID was not tested post vaccination.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Laboratory test, Visual impairment
Clinical narrative: 1.5 hours after the vaccine, one eye vision was down to light perception only. The event lasted 15 minutes and resolved completely. ER eval and Ophtholology eval did not find a cause for the event.; This is a spontaneous report from a contactable physician. A 66-year-old male patient received bnt162b2 (reported as COVID 19, Covid vaccine, lot/batch number and expiry date were not provided), via an unspecified route of administration from 17Dec2020 12:30 at single dose for covid-19 immunisation.  Medical history included gout, abnormal glucose, hyperlipidemia, hypertension. Prior to vaccination, the patient was not diagnosed with COVID-19.  No Known allergies. Concomitant medications the patient received within 2 weeks of vaccination included atorvastatin, prednisone, lisinopril, allopurinol, famotidine (PEPCID). The patient experienced 1.5 hours after the vaccine, one eye vision was down to light perception only. The event lasted 15 minutes and resolved completely. ER eval and Ophtholology eval did not find a cause for the event. CT and labs done. Event onset date was on 17Dec2020 14:00.  The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse event. Case was non-serious. Facility where the most recent COVID-19 vaccine was administered at Hospital. The adverse event result in the following: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of event was recovered on 17Dec2020 14:15.   Information on the Batch/Lot number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Mild injection site reaction- red, firm, swollen, tender; Mild injection site reaction- red, firm, swollen, tender; Mild injection site reaction- red, firm, swollen, tender; Mild injection site reaction- red, firm, swollen, tender. Most noticeable day 3 after injection. Note that I had COVID dx 21Apr; This is a spontaneous report from a contactable consumer reporting for herself. This 33-year-old female patient (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ1685) on 17Dec2020 at 07:45, in left arm, for COVID-19 immunization. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included immune thrombocytopenia 2/2, COVID from 21Apr2020, chronic B12 deficiency, ADHD, depression, anxiety and migraine. Allergies to medications, food, or other products: none. Concomitant medications included sertraline HCl (ZOLOFT), lisdexamfetamine mesilate (VYVANSE), lorazepam (ATIVAN), ondansetron (ZOFRAN) and sumatriptan succinate (IMITREX). On 17Dec2020 the patient experienced mild injection site reaction- red, firm, swollen, tender. It was most noticeable on day 3 after injection. No treatment was given. COVID was not tested after vaccination. The events were resolving.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Hypotonia, Pain
Clinical narrative: muscle aches, pain, and chills that were minor but not fever. He is now experiencing loss of muscle tone in his left foot and feels as if his foot is dropping.; it's hard to walk; muscle aches, pain, and chills that were minor but not fever. He is now experiencing loss of muscle tone in his left foot and feels as if his foot is dropping.; muscle aches, pain, and chills that were minor but not fever. He is now experiencing loss of muscle tone in his left foot and feels as if his foot is dropping.; muscle aches, pain, and chills that were minor but not fever. He is now experiencing loss of muscle tone in his left foot and feels as if his foot is dropping.; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization, carbamazepine (TEGRETOL), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose and frequency for an unspecified indication. Medical history included ongoing diabetes; ongoing congestive heart problems; ongoing blood pressure high; ongoing mild kidney disease; ongoing gastroparesis; peripheral neuropathy, pain. Concomitant medication included hydrocodone bitartrate, paracetamol (NORCO) for pain, insulin glargine (LANTUS) for diabetes, insulin lispro (HUMALOG) for diabetes, carvedilol (COREG) for congestive heart problem, lisinopril for high blood pressure, spironolactone for high blood pressure, furosemide for high blood pressure, insulin for diabetes. The patient received the Covid-19 vaccine on 18Dec2020. After receiving the vaccine he had muscle aches, pain, and chills on 18Dec2020 that were minor but not fever. He was now experiencing loss of muscle tone in his left foot and feels as if his foot is dropping. The patient noticed on 20Dec2020 that his left foot it's not muscle tone it's kind of flopping there, it's hard to walk. The patient just took Tylenol and took his normal Narcan and Tylenol nothing in addition and one hot shower but it was more of nuisance. The patient stated that the main thing was that the loss of muscle tone in his left foot, that's what bothers him more than chills and everything like that because it was making difficult to walk and he want to walk around. The patient also stated that one of his health problems was peripheral neuropathy and that was what it just seem to make it why he can't feel his foot at all or he can do was move his big toe just a little bit and it was just kind of due to that. The patient just concerned whether that was supposed to go away in a couple of days. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Gallbladder disorder, Nausea, Pain in extremity, Vomiting
Clinical narrative: nausea/sick to stomach; vomiting; sore arm; might be having a Gall bladder issue; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, Expiry Date: Mar2021), via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization.  There was no medical history. There were no concomitant medications. The patient experienced nausea, vomiting, sore arm on 19Dec2020. She was feeling better today.  She might be having a gall bladder issue, she started feeling sick to stomach yesterday evening (19Dec2020). It had been several hours after she got the vaccine. No treatment received for events. The outcome of events was recovering.