chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Malaise
Clinical narrative: chills; fever; Stiff neck; headache; aches; Malaise the morning after vaccination; fatigue; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3248, expiry date not reported) on 12Jan2021 15:00 at single dose via an unspecified route of administration in the left arm for COVID-19 immunization.  Medical history included allergy to eggplant, allergy to acetylsalicylic acid, COVID-19 from an unknown date and unspecified if ongoing, ulcerative colitis from an unknown date and unspecified if ongoing , psoriasis from an unknown date and unspecified if ongoing. The patient previously received the first single dose of BNT162B2 (lot number EL0140) on 22Dec2020 09:00 in the left arm for COVID-19 immunization. The patient was not pregnant. Concomitant medication included adalimumab (HUMIRA), apremilast (OTEZLA), calcium carbonat/colecalciferol (VITAMIN D 2000), dl-alpha tocopheryl acetate (VITAMIN E [DL-ALPHA TOCOPHERYL ACETATE]), aloe vera/pramocaine hydrochloride (ATARAX ANTI ITCH LOTION). The patient had not COVID test post vaccination. The patient experienced malaise the morning after vaccination on 13Jan2021 05:00; 26 hours after administration (on 13Jan2021 17:00), the patient got chills, fever (100 degrees Fahrenheit), stiff neck, headache, aches; the next 36- 48 hours continued with stiffness, fatigue (onset date unspecified, in Jan2021). No treatment received for the events. The events were resolved 55 hours after administration (14Jan2021 22:00).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: chills; fever; Stiff neck; headache; aches; Malaise the morning after vaccination; fatigue; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3248, expiry date not reported) on 12Jan2021 15:00 at single dose via an unspecified route of administration in the left arm for COVID-19 immunization.  Medical history included allergy to eggplant, allergy to acetylsalicylic acid, COVID-19 from an unknown date and unspecified if ongoing, ulcerative colitis from an unknown date and unspecified if ongoing , psoriasis from an unknown date and unspecified if ongoing. The patient previously received the first single dose of BNT162B2 (lot number EL0140) on 22Dec2020 09:00 in the left arm for COVID-19 immunization. The patient was not pregnant. Concomitant medication included adalimumab (HUMIRA), apremilast (OTEZLA), calcium carbonat/colecalciferol (VITAMIN D 2000), dl-alpha tocopheryl acetate (VITAMIN E [DL-ALPHA TOCOPHERYL ACETATE]), aloe vera/pramocaine hydrochloride (ATARAX ANTI ITCH LOTION). The patient had not COVID test post vaccination. The patient experienced malaise the morning after vaccination on 13Jan2021 05:00; 26 hours after administration (on 13Jan2021 17:00), the patient got chills, fever (100 degrees Fahrenheit), stiff neck, headache, aches; the next 36- 48 hours continued with stiffness, fatigue (onset date unspecified, in Jan2021). No treatment received for the events. The events were resolved 55 hours after administration (14Jan2021 22:00).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Inappropriate schedule of product administration, Myalgia
Clinical narrative: Chills; fever at 38.4 C; joint and muscular pain; joint and muscular pain; first dose on 27Dec2020 and second dose on 13Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on the right arm on 13Jan2021 at 11:00 at a single dose for COVID-19 immunization. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 27Dec2020 at 10:00. Both doses were administered at the workplace clinic. The patient had no medical history; she had no known allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient received the first dose on 27Dec2020 and second dose on 13Jan2021. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She was not tested for COVID post vaccination. On 13Jan2021 at 21:00, the patient experienced chills, fever at 38.4 Centigrade (C), and joint and muscular pain. Therapeutic measures were taken as a result of chills, fever at 38.4 C, and joint and muscular pain, which included acetaminophen and ibuprofen. The patient recovered from the events on an unspecified date.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; fever at 38.4 C; joint and muscular pain; joint and muscular pain; first dose on 27Dec2020 and second dose on 13Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on the right arm on 13Jan2021 at 11:00 at a single dose for COVID-19 immunization. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 27Dec2020 at 10:00. Both doses were administered at the workplace clinic. The patient had no medical history; she had no known allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient received the first dose on 27Dec2020 and second dose on 13Jan2021. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She was not tested for COVID post vaccination. On 13Jan2021 at 21:00, the patient experienced chills, fever at 38.4 Centigrade (C), and joint and muscular pain. Therapeutic measures were taken as a result of chills, fever at 38.4 C, and joint and muscular pain, which included acetaminophen and ibuprofen. The patient recovered from the events on an unspecified date.  Information on the lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Erythema, Induration, Pyrexia
Clinical narrative: High fever but was able to bring down to a low fever in an hour with ibuprofen, dizziness and confusion the first day afterword. Localized swelling to the size of a soft ball; red, hard, and hot to the touch
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Swelling
Clinical narrative: High fever but was able to bring down to a low fever in an hour with ibuprofen, dizziness and confusion the first day afterword. Localized swelling to the size of a soft ball; red, hard, and hot to the touch
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: bad headache; have a lot of soreness in my arm; This is a spontaneous report from a contactable other HCP (patient). A 32-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at 14:30 at single dose for covid-19 immunization. Medical history included joint pain, thyroidic of the bladder, allergies: penicillin. There were no concomitant medications. The patient previously took codeine and experienced allergies: codeine. The patient experienced bad headache, and had a lot of soreness in her arm on 14Jan2021 at 17:30. Event details: 3 hours after getting the vaccine have a lot of soreness in her arm and bad headache that wouldn't leave even after 24 hours and taking paracetamol (TYLENOL) for treatment. The patient did not receive treatment for soreness in her arm. The outcome of the events was resolving.   Information on the Lot/Batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Electrocardiogram normal, Muscular weakness, Nausea, Oxygen saturation
Clinical narrative: 2 hours after vaccine given, experienced jerking in arms, legs were weak, nausea and vomiting and itching, Now, 1 week later, I have a rash on left arm and face
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Sinus rhythm, Vomiting
Clinical narrative: 2 hours after vaccine given, experienced jerking in arms, legs were weak, nausea and vomiting and itching, Now, 1 week later, I have a rash on left arm and face
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Peripheral swelling, Throat irritation, Urticaria
Clinical narrative: left arm is "double swollen"; broke out in hives; Have troubles trying to swallow; feels like "something is cutting" through her throat; This is a spontaneous report from a non-contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the vaccine at 10:30 and then started experiencing "bad side effects" almost 10 hours later. She said her left arm is "double swollen", she broke out in hives, have troubles trying to swallow, and she feels like "something is cutting" through her throat. With this, she wanted to know what temperature should the vaccines be stored in since she noticed that the place where she got the vaccine was "kind of warm". The outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: headache; Mild body aches; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 13Jan2021 at 09:00 at single dose on right arm for covid-19 immunisation. Medical history included blood cholesterol increased. Concomitant medication included naproxen, simvastatin and ASA, all from unknown date for unknown indication. The patient previously took bupropion hydrochloride (WELLBUTRIN) and experienced allergy. The patient experienced mild body aches and headache beginning 12 hours after dose on 13Jan2021 with outcome resolved. No treatment received.  Information on the Lot/Batch number has been requested. .
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Swelling
Clinical narrative: It?s been over a week and I still have a red circle and swelling from where the shot was given. The itchy part of it finally went away.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: her chest was broken out with raised red blotches; itchy; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient (also reported as age at vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 13Jan2021 at 08:15 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took codeine and azithromycin (AZITHROMAX) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that the patient took the shot on 13Jan2021. When she woke up the next morning (14Jan2021), her chest was broken out with raised red blotches. She also felt itchy on 14Jan2021. She visited her physician on the 15th and was given Benadryl as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Rash pruritic, Swelling of eyelid, Urticaria
Clinical narrative: Full body rash with itching; Swelling in my upper and lower eyelids; Urticaria; Soreness at site; Headache; Fatigue; This is a spontaneous report from a contactable other HCP (patient).  This 67-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1284), via an unknown route, on 13Jan2021 (at 15:00) at single dose on the left arm, for COVID-19 immunization, administered at hospital. Historical vaccine included the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899) on 24Dec2020 (at 10:00) administered at single dose on the left arm. Relevant medical history included hypertension, benign prostatic hyperplasia, and allergy to NAIDs. Past drug history included allergy to acetylsalicylic acid (ASPIRIN). Relevant concomitant medications included losartan, simvastatin, eszopiclone (LUNESTA), dutasteride (AVODART) and tamsulosin. On 14Jan2021 (at 10:00), the patient had soreness at site, headache, and fatigue. On 15Jan2021, same symptoms but lower intensity. On 16Jan2021, she woke up with full body rash with itching, and swelling in her upper and lower eyelids. She took cetirizine hydrochloride (ZYRTEC) and the urticaria resolved within 90 minutes. Pre-vaccination and post-vaccination COVID tests were not performed. No therapeutic measures were taken as result of the events 'soreness at site', 'headache', 'fatigue' and 'swelling of eyelid'. All the events resolved in Jan2021.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Full body rash with itching; Swelling in my upper and lower eyelids; Urticaria; Soreness at site; Headache; Fatigue; This is a spontaneous report from a contactable other HCP (patient).  This 67-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1284), via an unknown route, on 13Jan2021 (at 15:00) at single dose on the left arm, for COVID-19 immunization, administered at hospital. Historical vaccine included the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899) on 24Dec2020 (at 10:00) administered at single dose on the left arm. Relevant medical history included hypertension, benign prostatic hyperplasia, and allergy to NAIDs. Past drug history included allergy to acetylsalicylic acid (ASPIRIN). Relevant concomitant medications included losartan, simvastatin, eszopiclone (LUNESTA), dutasteride (AVODART) and tamsulosin. On 14Jan2021 (at 10:00), the patient had soreness at site, headache, and fatigue. On 15Jan2021, same symptoms but lower intensity. On 16Jan2021, she woke up with full body rash with itching, and swelling in her upper and lower eyelids. She took cetirizine hydrochloride (ZYRTEC) and the urticaria resolved within 90 minutes. Pre-vaccination and post-vaccination COVID tests were not performed. No therapeutic measures were taken as result of the events 'soreness at site', 'headache', 'fatigue' and 'swelling of eyelid'. All the events resolved in Jan2021.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash under injection site that appeared over a week (9 days) after immunization
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Diarrhoea, Headache, Pain
Clinical narrative: Body ache; diarrhea; Headache; Elevated temperature; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3302), via an unspecified route of administration in the left arm, on 14Jan2021 at 09:00 (at the age of 70-years-old) at a single dose for COVID-19 immunization. Medical history included heart disease and high blood pressure (HBP). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included acetylsalicylic acid, clopidogrel (PLAVIX PLUS). Other concomitant medications included unspecified blood pressure medication, unspecified cholesterol medication, and unspecified thyroid medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced body ache, diarrhea, headache, and elevated temperature on 15Jan2021 at 14:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included body temperature: elevated on 15Jan2021. The patient did not receive any treatment for the events. The clinical outcome of body ache, diarrhea, headache, and elevated temperature was not recovered.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Fall, Hemiplegia, Magnetic resonance imaging, Pyrexia
Clinical narrative: stroke; unresponsive; unable to move one side of her body; fell down the stairs; fever; felt groggy; This is a spontaneous report from a contactable consumer and a non-contactable consumer (patient's sister). A 37-year-old female patient received 1st dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for an covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was an oncology nurse practitioner working received the Pfizer BioNtech vaccine on Thursday 14Jan2021. On Friday 15Jan2021, the patient visited her family members and told them she had a fever and felt groggy. She went to sleep around 8pm-9pm that evening (15Jan2021). Around 2am-3am in the morning Saturday 16Jan2021, the patient fell down the stairs and her family member found her - unresponsive and unable to move one side of her body. Her family member moved her to the couch. Around 7am-7:30am, the patient was still unresponsive and unable to move one side of her body. Her family dialed an ambulance took her to an hospital. At present - her family reported that the healthcare professional they spoke to said the patient had a stroke. She had received multiple scans (MRI, brain scan) in the hospital and was awaiting a Neuro consult. It was unknown if treatment received. The outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Scan brain, Somnolence, Unresponsive to stimuli
Clinical narrative: stroke; unresponsive; unable to move one side of her body; fell down the stairs; fever; felt groggy; This is a spontaneous report from a contactable consumer and a non-contactable consumer (patient's sister). A 37-year-old female patient received 1st dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for an covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was an oncology nurse practitioner working received the Pfizer BioNtech vaccine on Thursday 14Jan2021. On Friday 15Jan2021, the patient visited her family members and told them she had a fever and felt groggy. She went to sleep around 8pm-9pm that evening (15Jan2021). Around 2am-3am in the morning Saturday 16Jan2021, the patient fell down the stairs and her family member found her - unresponsive and unable to move one side of her body. Her family member moved her to the couch. Around 7am-7:30am, the patient was still unresponsive and unable to move one side of her body. Her family dialed an ambulance took her to an hospital. At present - her family reported that the healthcare professional they spoke to said the patient had a stroke. She had received multiple scans (MRI, brain scan) in the hospital and was awaiting a Neuro consult. It was unknown if treatment received. The outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Body temperature increased, COVID-19, Chills, Fatigue
Clinical narrative: I had a positive Covid test on December 16th with mild symptoms (Headaches, fatigue and loss of smell only). Day after vaccine i had severe chills, body ache and 101 temperature. following morning i was fine except for lingering COVID fatigue, and headaches. I am only sharing this for your records/study so you have it. otherwise  I am fine.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: I had a positive Covid test on December 16th with mild symptoms (Headaches, fatigue and loss of smell only). Day after vaccine i had severe chills, body ache and 101 temperature. following morning i was fine except for lingering COVID fatigue, and headaches. I am only sharing this for your records/study so you have it. otherwise  I am fine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:15 (at the age of 60-years-old) at a single dose for COVID-19 immunization. Medical history included arthritis (knees), sulfa drugs allergy, poison ivy allergy (severe), and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and furosemide (LASIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain on 16Jan2021 at 13:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative (test name: Binex) on 12Jan2021 and COVID-19 test: unknown results (post vaccination) on an unspecified date. Therapeutic measures were taken as a result of the events, which included naproxen sodium (ALEVE); it was reported that the treatment did not work. The clinical outcome of headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain was unknown.  The batch/lot number for the vaccine, BNT162B2, was provided and has been requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, SARS-CoV-2 test, Tremor
Clinical narrative: Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:15 (at the age of 60-years-old) at a single dose for COVID-19 immunization. Medical history included arthritis (knees), sulfa drugs allergy, poison ivy allergy (severe), and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and furosemide (LASIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain on 16Jan2021 at 13:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative (test name: Binex) on 12Jan2021 and COVID-19 test: unknown results (post vaccination) on an unspecified date. Therapeutic measures were taken as a result of the events, which included naproxen sodium (ALEVE); it was reported that the treatment did not work. The clinical outcome of headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain was unknown.  The batch/lot number for the vaccine, BNT162B2, was provided and has been requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fever, 100.5 chills extreme upper body aches headache
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia, Vaccination site erythema
Clinical narrative: Sore arm; mild nausea; mild headache; low grade fever; an odd red mark on my left shoulder about 2 or 3 inches from the injection site; This is a spontaneous report from a contactable consumer (reporting for herself). A non-pregnant 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), via an unspecified route of administration in the left arm on to 14Jan2021 07:15 at a single dose for COVID-19 immunization.  Medical history included asthma, chronic obstructive pulmonary disease (COPD), known allergies: animals.  Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), lorazepam (ATIVAN), biotin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN).  The patient previously received a typhoid shot (MANUFACTURER UNKNOWN), for immunization and had very adverse reaction to third typhoid shot.  The patient experienced sore arm, mild nausea, mild headache and low-grade fever and an odd red mark on left shoulder about 2 or 3 inches from the injection site on 14Jan2021 21:00.  No treatment was received for the events.  The outcome of the events was recovering.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Palpitations, Urticaria
Clinical narrative: Hives developed on the injection arm and spread across her chest; intense heart palpitations; weakness/dizziness; weakness/dizziness; This is a spontaneous report from a contactable Nurse (patient).   A 29-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm on 07Jan2021 13:00 at SINGLE DOSE for COVID 19 vaccination. The patient was not pregnant. Medical history included Shellfish allergy. There were no concomitant medications. Historical vaccine included first dose of bnt162b2 on 17Dec2020 07:00 AM at left arm for COVID 19 vaccination. On 07Jan2021, hives developed on the injection arm and spread across her chest within 5 minutes of receiving the vaccine, along with intense heart palpitations and weakness/dizziness. Resolved spontaneously after 10 minutes without any use of epinephrine or other medications. Oral diphenhydramine was taken afterwards. Treatment drug oral diphenhydramine received for events. The outcome of the events was recovered in Jan2021. No covid prior vaccination, no covid test post vaccination. Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Tachycardia, Throat tightness, Urticaria, Vomiting
Clinical narrative: Tightness in throat, hypertensive, tachycardia, hives on face and upper chest, vomitting
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever up to 104 for 12 hours; This is a spontaneous report from a contactable physician (patient). A 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) intramuscular on the left arm on 14Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included HTN (hypertension). Concomitant medication included metoprolol, losartan and HCTZ. The patient previously received 1st dose of BNT162B2 on 24Dec2020 12:00 AM for COVID-19 immunization. The patient experienced Fever up to 104 for 12 hours on 15Jan2021 01:00 AM. Therapeutic measure was taken as a result of the event which included acetaminophen. 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. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fine motor skill dysfunction, Pain, Sensory loss
Clinical narrative: Sensory loss on right hand; fine motor skills (unable to hold a pen to write - sleepy hand); chills; slight body aches; This is a spontaneous report from a contactable nurse.  A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EK9231), intramuscular at right arm on 15Jan2021 17:00  at single dose for COVID-19 immunization. There was no known allergies, no other medical history. There were no concomitant medications, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EK9231), intramuscular at right arm on 28Dec2020 12:30 for COVID-19 immunization. The patient had no COVID prior to vaccination, and had not been tested for COVID since the vaccination. It was reported that, on 16Jan2021 10:00, the patient experienced "sensory loss on right hand-fine motor skills (unable to hold a pen to write - sleepy hand)" that started the next day after receiving vaccine. By the time of reporting, which is the second day post vaccination this symptom still persist. The patient also experienced some chills and slight body aches, the patient took some paracetamol (TYLENOL) which helped. No treatment was received for the event "sensory loss on right hand-fine motor skills (unable to hold a pen to write - sleepy hand)". The outcome of the event "sensory loss on right hand-fine motor skills (unable to hold a pen to write - sleepy hand)" was not recovered, while for the rest of events was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Hypoaesthesia, Lymphadenopathy
Clinical narrative: face went numb and a lymph node under my tongue was sore and swollen for an hour
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; fever; This is a spontaneous report from a contactable nurse (patient).  A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date unknown) via an unspecified route of administration in the right arm on 07Jan2021 at 8:30 AM at a single dose for for COVID-19 immunization.  The patient medical history was not reported. The patient has not had COVID prior to vaccination. Concomitant medications included doxycycline, lisinopril, thyroid, ubidecarenone (COQ10 [UBIDECARENONE]) on unspecified dates for unspecified indications.  The patient previously took EES (erythromycin ethylsuccinate)  and experienced allergies, and previously received the first dose of BNT162B2 on 17Dec2020 for COVID-19 immunization. The patient had no other vaccines in four weeks. 07Jan2021 at 20:00, the patient experienced chills and fever. It was reported that patient missed three days of work. It was unknown if treatment was received for the adverse events. The outcome of events was recovered on unspecified date in Jan2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date: unknown), via an unspecified route of administration in right arm, on 16Jan2021 14:45 at a single dose for covid-19 immunization. Medical history included stage 3 breast cancer, tall cell thyroid cancer, chronic lymphocytic leukemia, diabetes, and known allergies: penicillin. The patient's concomitant medications were not reported. The patient is not pregnant. The patient had no other vaccine in four weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 17Jan2021 0800, the patient experienced minor pain at injection site and mild headache. Events were not treated. Outcome of the events was recovering.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Malaise, Pyrexia
Clinical narrative: General unwell feeling, chills,slight fever99,diarrhea
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema
Clinical narrative: Employee presented to employee health a little before 2 pm with generalized erythema and shortness of breath. He was taken to same day clinic where he received one dose Epipen IM and diphenhydramine 50 mg IM, and 911 was called. He started to feel better, had less labored breathing and decreased erythema. Paramedics arrived and he was taken to local hospital.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Feeling hot, Palpitations, Paraesthesia
Clinical narrative: close to passing out; felt "heat waves" throughout my body; tingling; palpitations; My BP was taken and it was 166/86 (my normal BP is usually 100/60).; This is a spontaneous report from a contactable Physician (the patient).  A 56-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm, second dose, on 15Jan2021 14:30 at SINGLE DOSE for covid-19 immunisation.  Medical history included hypothyroidism and gastrooesophageal reflux disease, both from an unknown date and unknown if ongoing.  Concomitant medication included levothyroxine sodium (SYNTHROID), esomeprazole magnesium (NEXIUM), estradiol, norethisterone acetate (AMABELZ), estradiol, levonorgestrel (CLIMARA PRO).   Patient previously received the first dose of BNT162B2 in left arm, on 24Dec2020 08:15 AM. No other vaccine in four weeks. Vaccination Facility type: Hospital. No COVID prior vaccination. COVID was not tested post vaccination.  No Known allergies. On 15Jan2021 about 5 minutes after the vaccination the patient experienced close to passing out, felt "heat waves" throughout my body, tingling, palpitations, blood pressure (BP) was taken and it was 166/86 (her normal BP is usually 100/60). No treatment was given. The symptoms slowly resolved over the next 45 minutes, with BP returning back to normal.  Information on Lot/Batch has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported "close to passing out". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Mobility decreased
Clinical narrative: He tried to get up from the couch to go lay down, but couldn't as he kept getting dizzy. It lasted for at least 30 mins. He eventually made it to his bed and laid down.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Myalgia, Nausea
Clinical narrative: nausea; vomiting; diarrhea; headache; chills; low grade fever; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EK9231), on 15Jan2021 13:30 at SINGLE DOSE in Left arm for COVID-19 immunisation. Facility type vaccine was Doctor's office/urgent care. Medical history included High blood pressure, chronic obstructive pulmonary disease (COPD). Concomitant medication in two weeks included acetylsalicylic acid (ASPIRIN), carbamazepine, lisinopril, metoprolol. The patient experienced Nausea, vomiting, diarrhea, headache, chills, low grade fever, muscle pain on 16Jan2021 19:00. The outcome was recovering. No treatment for AE. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: nausea; vomiting; diarrhea; headache; chills; low grade fever; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EK9231), on 15Jan2021 13:30 at SINGLE DOSE in Left arm for COVID-19 immunisation. Facility type vaccine was Doctor's office/urgent care. Medical history included High blood pressure, chronic obstructive pulmonary disease (COPD). Concomitant medication in two weeks included acetylsalicylic acid (ASPIRIN), carbamazepine, lisinopril, metoprolol. The patient experienced Nausea, vomiting, diarrhea, headache, chills, low grade fever, muscle pain on 16Jan2021 19:00. The outcome was recovering. No treatment for AE. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lip swelling, Pain, Pruritus
Clinical narrative: Whole body itching; severe lip swelling; chills/rigors; body aches; This is a spontaneous report from a contactable Physician (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration at left arm on 11Jan2021 13:00 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient experienced whole body itching, severe lip swelling, chills, body aches, rigors 14Jan2021 16:00. Treatment received for the events included Allegra and Benadryl. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was Recovered with lasting effects.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: maculopapular rash appearing on arms/ same rash but now involving arm, forearm, thighs, chest, abdomen and was very itchy; maculopapular rash appearing on arms/ same rash but now involving arm, forearm, thighs, chest, abdomen; This is a spontaneous report from a contactable physician (patient himself). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EIC4176, expiry date unknown), via an unspecified route of administration (left arm), on 11Jan2021 17:00, at single dose, for covid-19 immunization. Medical history included diabetes, hypertension and, migraine. Concomitant medication included metformin for diabetes; metoprolol for hypertension; and galcanezumab (EMGALITY) for migraine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH9899, expiry date unknown), via an unspecified route of administration (left arm), on 21Dec2020 16:30, at single dose, for covid-19 immunization at the age of 42-years-old. The patient experienced maculopapular rash appearing on arms on 15Jan2021 14:00 which resolved/recovered on Jan2021 with Benadryl. On 16Jan2021, same rash but now involving arm, forearm, thighs, chest, abdomen and was very itchy - also resolved/recovered on Jan2021 with Benadryl. The patient had no other vaccine in four weeks, had no Covid prior vaccination, and had not been Covid-tested post vaccination.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: The patient was at the center for half an hour after received vaccination, he did not have any symptoms and left, half an hour later mother called because the patient developed a hive in the site of the injection, we brought back the patient to the center and administer Benadryl  (25 mg) IM in his left Gluteus. The patient is Ok, with no other symptoms, no fever, no rash and he is alert.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Malaise, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable physician (patient). A 57-year-old female patient received the second dose of BNT162B2 (lot number: EL1283), via an unspecified route of administration in left arm on 06Jan2021 14:00 at single dose for covid-19 immunization. The patient's known allergies: latex (rash, occ. mild bronchospasm); dysphoria c valium; innumerable food reactions - dairy & eggs, nuts/seeds/grains, fish, latex associated foods, nightshades, meat -but none anaphylactic (occ. debilitating headache, very occ. mild bronchospasm; mostly cholinergic urticaria / joint pain / diarrhea). Other medical history included atopic incl. Raynauds; parox. atrial tach (after ablation for PA-fib.); almost-asx'tic asthma; endometriosis c small bowel resection (terminal ileum). Concomitant medication included metoprolol and a very long list of supplements. The patient previously received the first dose of BNT162B2 (lot number: EH9899), at the age of 57-year-old, via an unspecified route of administration in left arm on 18Dec2020 10:00 at single dose for covid-19 immunization and experienced deltoid soreness. The patient experienced trivial deltoid soreness for maybe 36 h after injection, starting about 4-6h later (06Jan2021) (same as after 1st injection, tho maybe lasted a bit longer); not sore enough to limit her use of the arm even a little bit. However, post injection day #4 (10Jan2021) after mod. intense workout for 2nd day in a row (swimming 1mi, including butterfly & synchro; usu. She wait 1-2 days between workouts) She developed a mod./severe headache, joint aches and malaise. She neglected to take a temp; and interestingly the injection site got sore again. This lasted about 48h; fortunately she was not scheduled to work. No sx since then, 1week. No treatment received. No pregnant. The outcome of the events was recovered on Jan2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: pain at the injection site; fatigue; muscle/joint pain; muscle/joint pain; chills; headache; This is a spontaneous report from a contactable nurse (patient). A 49-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular at left arm on 22Dec2020 13:00 at single dose for covid-19 immunization. Medical history included fibromyalgia, depression, anxiety, migraines, gastrooesophageal reflux disease (GERD), menopause, allergy to sulfa. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included other medications within 2 weeks of vaccination. The patient experienced pain at the injection site, fatigue, muscle/joint pain, chills and headache on 22Dec2020 14:00 with outcome of recovered on an unspecified date.  No treatment received for the adverse events. The patient received the second dose of BNT162B2 (lot number: EK9231) at left arm on 10Jan2021. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; fatigue; muscle/joint pain; muscle/joint pain; chills; headache; This is a spontaneous report from a contactable nurse (patient). A 49-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular at left arm on 22Dec2020 13:00 at single dose for covid-19 immunization. Medical history included fibromyalgia, depression, anxiety, migraines, gastrooesophageal reflux disease (GERD), menopause, allergy to sulfa. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included other medications within 2 weeks of vaccination. The patient experienced pain at the injection site, fatigue, muscle/joint pain, chills and headache on 22Dec2020 14:00 with outcome of recovered on an unspecified date.  No treatment received for the adverse events. The patient received the second dose of BNT162B2 (lot number: EK9231) at left arm on 10Jan2021. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident was vaccinated on 1/13/21.  Resident passed away on 1/16/21
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Chills, Headache, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 12:00 at single dose on right arm for COVID-19 immunisation. Medical history included mild osteoarthritis. Concomitant medication included vitamin D, meloxicam and multivitamin. The patient experienced violent vomiting 24 hours after injection lasting 5 hours with fever chills headache. Followed by weakness and headache. Events onset at 15Jan2021 15:00. No treatment was received for all events. Outcome of the events was resolving. This case was reported as non-serious.  Information on the lot/batch number has been requested.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Blindness unilateral, Multiple sclerosis, Neurological examination abnormal, Optic neuritis
Clinical narrative: Blinding in right eye 2 days post-vaccination. Diagnosed with optic neuritis. The following months after many more tests I was diagnosed with vaccine-induced multiple sclerosis.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration at left arm on 15Jan2021 02:30 at single dose for COVID-19 immunization. Medical history included complex regional pain syndrome (reported as CRPS) and seizure disorder. No known allergy. Concomitant medication included lamotrigine (LAMICTAL) and birth control, multi-vit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache and fatigue approx. 24 hours following vaccine, headache worsened overnight and felt "un-well", achy on 16Jan2021 15:00 with outcome of not recovered. Therapeutic measures were taken as a result of events included Tylenol/advil. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.