chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Lymphadenopathy, Swelling, Tenderness
Clinical narrative: 5 days post-vaccination, temperature ranging from 99.0-99.6F.; 4 days post-vaccination noticed lymphadenopathy behind right ear.; Mild swelling; sensitive to touch; This is a spontaneous report from a contactable nurse (patient). A 22-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), intramuscular in arm left on 17Dec2020 17:30 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included none.  No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported.  The patient experienced 4 days post-vaccination (21Dec2020) noticed lymphadenopathy behind right ear. Mild swelling, sensitive to touch. 5 days post-vaccination (22Dec2020), temperature ranging from 99.0-99.6F. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. The case was non-serious. The outcome of events was recovering.  Information on the Lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Nasopharyngitis
Clinical narrative: can't smell or taste anything; can't smell or taste anything; Head cold; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 18Dec2020 at single dose for immunization. Medical history and concomitant medications were no. Patient got the Covid vaccine on 18Dec2020, towards the end of her shift around 1800 on 22Dec2020, she felt like she was getting a head cold. On 23Dec2020 morning, patient stated she cannot smell or taste anything. Outcome of all events was not recovered.   Reporter seriousness for cannot smell or taste as not serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Feeling tired after the vaccine; This is a spontaneous report from a contactable consumer (Patient). A 34-year-old male patient received (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 23Dec2020 09:00 at single dose for covid-19 immunization (Front line health care worker). Vaccine location was left arm and it was the first dose. He was scheduled to get the second dose in Jan2021. The COVID-19 vaccine was administered at Hospital. Medical history included attention deficit hyperactivity disorder (ADHD). Concomitant medication included ongoing methylphenidate hydrochloride (CONCERTA) for ADHD taking for five years. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was feeling tired after the vaccine on 23Dec2020, Stated he just got the vaccine and he was now just really tired, not sick or anything and he was at work. He was considering going home from work and they told him he had to call Pfizer. Reported he received the COVID 19 vaccine today at work at the at 0900 23Dec2020 in the left arm. About 20 minutes after the injection he started to feel tired and like he wanted to go home from work. His feeling was staying the same. The outcome of the event was not recovered.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm only; This is a spontaneous report from a non-contactable other HCP (patient). A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) via intramuscular on 22Dec2020 08:30 on left arm at a single dose for COVID-19 immunization. The patient allergy to Percocet and medical history included hypothyroidism. 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 of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced sore arm only on 23Dec2020 18:00 and no treatment received. The outcome of the event was recovered in Dec2020.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Oral mucosal eruption, Oral pruritus, Pyrexia
Clinical narrative: Difficulty breathing, itchy mouth rash, very bad cough, fever (103)
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: chills; fatigue; headache; arm pain; body aches; Fever; This is a spontaneous report from a contactable nurse(patient). A 29-year-old female patient received the first dose of BNT162B2 (Lot number: EL0140), via intramuscular, in arm left, on 22Dec2020 18:15 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included Covid 19, pneumonia, anxiety/depression. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. No allergies to medications, food, or other products. No other vaccines were received within 4 weeks prior to the COVID vaccine. The other medication that the patient received within 2 weeks of vaccination was MULTIVITAMIN, sertraline hydrochloride(ZOLOFT), VITAMIN D3, ZINC, VITAMIN C. The patient experienced fever, chills, arm pain, body aches, headache, fatigue on 23Dec2020 09:00 AM. No treatment was received for the events. The outcome of the events was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; fatigue; headache; arm pain; body aches; Fever; This is a spontaneous report from a contactable nurse(patient). A 29-year-old female patient received the first dose of BNT162B2 (Lot number: EL0140), via intramuscular, in arm left, on 22Dec2020 18:15 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included Covid 19, pneumonia, anxiety/depression. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. No allergies to medications, food, or other products. No other vaccines were received within 4 weeks prior to the COVID vaccine. The other medication that the patient received within 2 weeks of vaccination was MULTIVITAMIN, sertraline hydrochloride(ZOLOFT), VITAMIN D3, ZINC, VITAMIN C. The patient experienced fever, chills, arm pain, body aches, headache, fatigue on 23Dec2020 09:00 AM. No treatment was received for the events. The outcome of the events was not recovered.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Loss of consciousness, Tonic clonic movements, Tremor
Clinical narrative: As the MA was leaving the room after giving the Gardasil and Flu vaccines, sister ran out of the room stating that her brother needed help.  MA went straight back in and found him "passed out"  / slumping to the floor.  Mother and MA report that he had a "tremor" and had a couple of tonic-clonic beats of his arms (but not legs / was standing up though and slumping, so legs might have been missed).  Mother got hold of him and put in in supine position on the exam table. He was observed for 30 minutes after the event and vital signs remained stable.  He returned to completely normal within a couple of minutes.  Tonic-clonic movements lasted on a few seconds (less than 20 seconds).  +sibling with known seizure disorder, so referral neurology was ordered
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain, Sleep disorder
Clinical narrative: Chills; sweats; aches and pain; Reports she was up all night opening the window and tuning on the heating blanket during the night; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number "CJ1685 and 228255" pending clarify), via an unspecified route of administration on 22Dec2020 08:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that she got the covid-19 vaccine yesterday (22Dec2020) at 08:30 A.M. Reported that all night long (22Dec2020) she had chills, sweats, aches and pains. She was told that she should be fine by Christmas. She was up all night opening the window and tuning on the heating blanket during the night. She was wrapped in blankets. Patient was advised to contact healthcare professional for treatment recommendations. Patient declined any treatment to the events. Patient also mentioned that her doctor did not want her to get the vaccine. She works as a certified nurse assistant (CNA) in the hospital. For the lot number, NDC number, and expiration date, she provided details from the card she was given for the vaccine. She read first dose COVID-19: "CJ1685 and 228255". She put her glasses on to read the card. The patient she wanted to lay down. The outcome of the event chills, aches and pains was not recovered, for event sweats was recovering, for the rest of event was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Nausea
Clinical narrative: At about 15 minutes the patient experienced nausea, headache, then face flushing.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever/steady fever/Caller says his fever got as high as 101.5 degrees Fahrenheit; This is a spontaneous report from a contactable Other Health Professional (patient) from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). An 82 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EL0140) via an unspecified route of administration on 21Dec2020 at single dose in left arm for COVID-19 immunisation. Medical history and concomitant medications were none. Warm transfer in regards to the COVID vaccine which he received Monday morning. Agent reports caller said since then he has had a steady fever and has questions in regards to side effects. As for Height: Caller says he is shrinking, he is about 5 feet 9 inches tall. No further details provided about shrinking. Caller clarifies his doctor title and says that he is not a physician or medical doctor, he has a PhD in psychology. Caller says he doesn't have a prescribing provider, he got the vaccine at a retirement home called (facility name and location). Caller says that his fever started the day he got the shot. He says he got the shot that morning, clarified to being about noon, and had a fever that evening. Caller clarifies that he takes Advil, not Aspirin for his fever. He says when he takes the Advil it goes away, it gets rid of it, but when the Advil wears off the fever comes back again. He says he has no idea what side effects of this drug are, so he thought he would give a call because others were worried about it and pressured him to ask. Caller says the only information he has is the card, the COVID-19 Vaccine Record Card, which says Pfizer, then below it EL0140, which could be either 0 or letter O, probably 0. He says it has the date 21Dec2020 on it from when he got it and he got it in his left arm, it was his first injection of it, he has another to come. Caller says his fever got as high as 101.5 degrees Fahrenheit on 22Dec2020, and he also has a fever right now. Therapeutic measures were taken as a result of fever and included treatment with Advil. Outcome of event was not recovered.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Mobility decreased, Pain
Clinical narrative: after 2 hours headache lasted for 3-4 hours; left arm injection site soreness worse at night unable to raise arm due to pain lasted up to 48 hours from time of injection; unable to raise arm due to pain; This is a spontaneous report from a contactable other hcp (patient). A 64-year-old male patient received bnt162b2 (Lot: EK5730), via an unspecified route of administration at Left arm, first dose on 20Dec2020 10:30 at single dose, for COVID-19 immunization. Medical history included diabetes, high cholesterol and hypertension (HTN) from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. No Known allergies. Concomitant medication included metformine, lisinopril, atorvastatin and finasteride. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that after 2 hours headache lasted for 3-4 hours left arm injection site soreness worse at night unable to raise arm due to pain lasted up to 48 hours from time of injection. The adverse event start on 20Dec2020, at 12:15 PM. The events are reported as non-serious. Therapeutic measures were taken as a result of after 2 hours headache lasted for 3-4 hours left arm injection site soreness worse at night unable to raise arm due to pain lasted up to 48 hours from time of injection, treatment included ibuprofen. The outcome of the event was recovering.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Head discomfort, Headache
Clinical narrative: After a few minutes started experiencing a headache pressure feeling and dry mouth
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness at the site that was more noticeable; some tenderness; This is a spontaneous report from a contactable nurse (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EH9899), via an unspecified route of administration on 21Dec2020 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness at the site that was more noticeable, and some tenderness in Dec2020 with outcome of unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Patient woke up with nausea, vomiting, and a headache this morning. OTC treatment, not see by physician.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Dizziness, Fatigue, Gait disturbance, Malaise
Clinical narrative: Groggy/sleepy; mild cognitive impairment; mild unsteady gait; light headed; malaise; tired; This is a spontaneous report from a contactable other health professional (patient). A 55-year-old female patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EJ1685), intramuscularly on 22Dec2020 06:30 AM at left arm, at single dose for covid-19 immunization. Medical history included Rheumatoid arthritis, hypothyroid and remission of DM2, known allergies: Penicillin. Concomitant medication included arginine hydrochloride, ascorbic acid, calcium, calcium pantothenate, cyanocobalamin, ferrous fumarate, folic acid, magnesium, methionine, nicotinic acid, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine hydrochloride, tocopheryl acetate, triticum aestivum, zinc (MULTI VITAMIN), methotrexate, thyroid, sertraline. The patient previously took tramadol and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. The patient experienced Groggy, mild cognitive impairment, mild unsteady gait, light headed, malaise, tired, sleepy on 22Dec2020 11:00 AM. No treatment was received for all events. The patient underwent lab tests and procedures which included covid test: negative on 21Dec2020 (Nasal Swab). The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Somnolence
Clinical narrative: Groggy/sleepy; mild cognitive impairment; mild unsteady gait; light headed; malaise; tired; This is a spontaneous report from a contactable other health professional (patient). A 55-year-old female patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EJ1685), intramuscularly on 22Dec2020 06:30 AM at left arm, at single dose for covid-19 immunization. Medical history included Rheumatoid arthritis, hypothyroid and remission of DM2, known allergies: Penicillin. Concomitant medication included arginine hydrochloride, ascorbic acid, calcium, calcium pantothenate, cyanocobalamin, ferrous fumarate, folic acid, magnesium, methionine, nicotinic acid, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine hydrochloride, tocopheryl acetate, triticum aestivum, zinc (MULTI VITAMIN), methotrexate, thyroid, sertraline. The patient previously took tramadol and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. The patient experienced Groggy, mild cognitive impairment, mild unsteady gait, light headed, malaise, tired, sleepy on 22Dec2020 11:00 AM. No treatment was received for all events. The patient underwent lab tests and procedures which included covid test: negative on 21Dec2020 (Nasal Swab). The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Sore injection site; This is a spontaneous report from a contactable other HCP. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Intramuscularly on 22Dec2020 02:45 PM in left arm at single dose for covid-19 immunization. The COVID-19 vaccine was administered at hospital. Medical history included diabetes. The concomitant drugs were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore injection site on 23Dec2020 05:00 AM. No treatment received for the event. 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 event was recovering.  No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache
Clinical narrative: Extreme headache, as bad as I has while sick with covid. Exhaustion, shortness of breath while talking
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Heart rate increased, Palpitations
Clinical narrative: Slightly elevated heart rate - most of that afternoon through early morning  Slightly elevated blood pressure - most of that afternoon through early morning  Palpitations at night - when I went to bed that's when I noticed it up until 1:30'ish in the morning  I took one (1) 500 mg tylenol at around 1:00 am and felt a bit better; that was it
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Diarrhoea, Dizziness
Clinical narrative: headache; ear neck back pain; ear neck back pain; ear neck back pain; chills/shivers; sweaty; nausea; vomiting; diarrhea; dizzy; weak; sore muscles; heavy feeling in both arms; tingling in lower legs; This is a spontaneous report from a contactable Nurse reported for herself. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, EK5730), intramuscular on 21Dec2020 08:30 AM at single dose for covid-19 immunization. Vaccine location was Right arm and it was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included rheumatoid arthritis and high blood pressure. Concomitant medication included quetiapine, metoprolol succinate, cyclobenzaprine, levothyroxine, omeprazole, tofacitinib citrate (XELJANZ). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's Known allergies included Iodine, Morphine. The patient experienced headache, ear neck back pain, chills, shivers, sweaty, nausea, vomiting, diarrhea, dizzy, weak, sore muscles, heavy feeling in both arms, tingling in lower legs on 21Dec2020 11:00 AM. No treatment received for the events. 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 on an unknown date in Dec2020.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Hyperhidrosis, Limb discomfort, Myalgia
Clinical narrative: headache; ear neck back pain; ear neck back pain; ear neck back pain; chills/shivers; sweaty; nausea; vomiting; diarrhea; dizzy; weak; sore muscles; heavy feeling in both arms; tingling in lower legs; This is a spontaneous report from a contactable Nurse reported for herself. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, EK5730), intramuscular on 21Dec2020 08:30 AM at single dose for covid-19 immunization. Vaccine location was Right arm and it was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included rheumatoid arthritis and high blood pressure. Concomitant medication included quetiapine, metoprolol succinate, cyclobenzaprine, levothyroxine, omeprazole, tofacitinib citrate (XELJANZ). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's Known allergies included Iodine, Morphine. The patient experienced headache, ear neck back pain, chills, shivers, sweaty, nausea, vomiting, diarrhea, dizzy, weak, sore muscles, heavy feeling in both arms, tingling in lower legs on 21Dec2020 11:00 AM. No treatment received for the events. 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 on an unknown date in Dec2020.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Paraesthesia, Vomiting
Clinical narrative: headache; ear neck back pain; ear neck back pain; ear neck back pain; chills/shivers; sweaty; nausea; vomiting; diarrhea; dizzy; weak; sore muscles; heavy feeling in both arms; tingling in lower legs; This is a spontaneous report from a contactable Nurse reported for herself. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, EK5730), intramuscular on 21Dec2020 08:30 AM at single dose for covid-19 immunization. Vaccine location was Right arm and it was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included rheumatoid arthritis and high blood pressure. Concomitant medication included quetiapine, metoprolol succinate, cyclobenzaprine, levothyroxine, omeprazole, tofacitinib citrate (XELJANZ). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's Known allergies included Iodine, Morphine. The patient experienced headache, ear neck back pain, chills, shivers, sweaty, nausea, vomiting, diarrhea, dizzy, weak, sore muscles, heavy feeling in both arms, tingling in lower legs on 21Dec2020 11:00 AM. No treatment received for the events. 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 on an unknown date in Dec2020.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache
Clinical narrative: Headache; felling warm; This is a spontaneous report from a non-contactable other HCP. A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via intramuscular on 22Dec2020 15:30 on left deltoid at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient denied any history of previous adverse reactions to vaccines. The patient was given the Pfizer vaccination in the left deltoid muscle. During her 15 minutes waiting period after the injection, the patient began to experience headache and felling warm. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis. The patient was told to receive Tylenol and no side effects. The patient was stable to go home and follow up with PCP. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring abnormal, Electrocardiogram, Heart rate increased
Clinical narrative: heart rate increased to 100BPM; This is a spontaneous report from a contactable Other Health Professional (patient). A 47-year-old female patient received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EJ1685) via an unspecified route of administration on 18Dec2020 04:30 PM at single dose in left arm for COVID-19 immunisation. Medical history included Asthma, Known allergies: Sulfa, Peanuts, Shell Fish and Peas. Concomitant medications included cetirizine hydrochloride (ALEGRA), montelukast sodium (SINGULAIR), fluticasone propionate (FLOVENT) and ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS) and Probiotics. The patient previously took Iodine and Erythromycin and experienced known allergies. At 18Dec2020 04:45 PM, her heart rate increased to 100BPM and continued for 45 min, and this result in Emergency room/department or urgent care. The patient underwent lab test and included EKG and heart rate count. Therapeutic measures were taken as a result of event and included treatment with Pepcid, Benadryl, EKG and Monitored her heart rate. Outcome of event was recovered on Dec2020.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Carotid pulse abnormal, Flushing
Clinical narrative: 3 hours after patient received vaccine on 12/27/2020 @ 2pm she started to feel flushed in the face and hands. She also started to get blisters on both hands. Pt. took a  25mg tab of Benadryl by mouth and symptoms resolved. She awoke at 3:30 am and felt that her carotid artery was pulsating.  Patient informed Primary Care Physician's office on 12/28/2020 of symptoms who then prescribed patient an Epi-pen.  Advised to receive emergency medical service if symptoms worsened.  On 12/29/2020 patient feels good and all symptoms have subsided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Periorbital swelling, Swelling face
Clinical narrative: her upper face was swollen, clarifying more on the left side, and mostly around her eyes.; her upper face was swollen, clarifying more on the left side, and mostly around her eyes.; her eyes are a little red; This is a spontaneous report from a contactable consumer(patient). A 61-year-old female patient received BNT162B2 via an unspecified route of administration at Deltoid Right on 22Dec2020 14:00 at the 61 years old at single dose for COVID-19 immunization. The medical history included Type 2 diabetes mellitus from 1995 and ongoing(diagnosed about 25 years ago, controlled diabetic with a Hemoglobin A1C of 5) and Blood pressure high from 1995 and ongoing (diagnosed with high blood pressure about the same time as her diabetes, clarified as 25 years ago. She stated she has controlled blood pressure). The concomitant medications were not reported. The patient previously received a flu shot in Oct2020. On 23Dec2020 the patient reported her upper face was swollen, clarifying more on the left side, and mostly around her eyes. She said her eyes were a little red, too. She said she does not have any swelling around her mouth. The patient reported the facial swelling had slightly improved. She said she keeps looking at her face, so it was hard for her to tell, but her boss said her face was swollen. The patient reported she took a generic Benadryl 30 mg tablet this morning. She said she normally takes a Benadryl 30 mg tablet every night along with Melatonin for sleep. She said she has a big bottle of the generic Benadryl 30 mg at home and the bottle is almost empty. She said she rather take the Benadryl and Melatonin. The outcome of the events upper face was swollen and mostly around her eyes was Recovering, the event eyes were a little red was Not Recovered.  Information about batch/lot number has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Sudden visual loss
Clinical narrative: Employee c/o of sudden loss of vision and  fell forward on the floor. Employee states he did not have any lunch yet. Emergency team called and assess the employee.  Client refused to be taken to the ER for further evaluation. VS monitored and stable . No SOB, no difficulty of breathing.  No Taking po fluids.  Client d/c with steady gait and no c/o.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Impaired work ability, Influenza virus test positive
Clinical narrative: The day after on 12/18 soreness at at the injection  site. On 12/19 symptoms exp headache and fatigue. Then on 12/20 started chills, fever and headache. I went to see the doctor on 12/21 and got several test Covid ,Flu and Strep results positive for all. Since then symptoms has continued. I have had to miss 6 days of work.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia, SARS-CoV-2 test positive, Streptococcus test positive
Clinical narrative: The day after on 12/18 soreness at at the injection  site. On 12/19 symptoms exp headache and fatigue. Then on 12/20 started chills, fever and headache. I went to see the doctor on 12/21 and got several test Covid ,Flu and Strep results positive for all. Since then symptoms has continued. I have had to miss 6 days of work.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Fatigue, Myalgia
Clinical narrative: muscle aches; chills; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date: 31Mar2021), via an unspecified route of administration on 19Dec2020 19:30 at single dose to prevent Covid. Medical history included COVID-19 from 30Oct2020 to 24Nov2020.  There were no concomitant medications. Eight hours after getting the vaccine (20Dec2020 03:30), she had muscle aches and chills, she also had fatigue on 20Dec2020. She was worried. She was concerned that she had done something crazy. She was through Covid for sure. She wasn't able too much. She was off work that day and didn't have to do anything. She would not have been able to work. The muscle aches were rivaling the worst days of Covid. She had Covid for 3 weeks. Then she had to wait another 10 days to get over the symptoms. She never had to go to the hospital. These muscle aches that she experienced after the injection were as intense as when she had Covid. The Lot on the patient card was difficult read. The information was hand written and squished in. She was unsure if it was EK5B30 or EK5030 or EK5730. The patient underwent lab tests and procedures which included COVID test: positive on 30Oct2020, negative on 24Nov2020. The outcome of muscle aches and chills was recovered on 21Dec2020, fatigue was recovering. The event muscle ache reported as serious, with serious criteria medically significant.   Information about lot/batch number has been requested.; Sender's Comments: The Company considers there is a reasonable possibility that the reported muscle ache is related to the administration of BNT162B2, based on the plausible temporal association and the known safety profile of the suspect.   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 RA, IEC, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Low-grade fever and chills (99.5 Fahrenheit); Low-grade fever and chills (99.5 Fahrenheit); headache; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received her fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provide), intramuscularly on right arm at 09:30 AM on 21Dec2020 at single dose for COVID-19 immunization. Medical history included deep vein thrombosis (DVT), covid-19 prior vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO), rivaroxaban (XARELTO), atenolol, multivitamins. The patient experienced severe headache at 18:00 on 21Dec2020. Low-grade fever and chills (99.5 Fahrenheit) Q (every) 90 mins from 22:00 21Dec2020 till 04:00 22Dec2020. The events were assessed as non-serious. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event headache was recovered in Dec2020, the outcome of events chills and low grade fever was recovered at 04:00 on 22Dec2020.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: I felt a little flushed; My heart is breathing; This is a spontaneous report from a contactable consumer (patient). This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 21Dec2020 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient stated: I felt a little flushed and my heart is breathing on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a non-contactable healthcare professional. A 72 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EH9899), intramuscular on the right leg (right deltoid muscle) on 22Dec2020 17:30 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced dizziness on 22Dec2020 17:45, during her 15 minute waiting period after the injection. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. The patient was monitired for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with wheezing and dyspnea, vomiting, abdominal pain, hypotension, dysrhythmia, chest pain and collapse. On an unspecified date, the patient underwent lab tests and procedures which included blood sugar: 108 and vital signs measurement: normal. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Asthma, Condition aggravated, Cough
Clinical narrative: About 10 minutes after vaccine a red injection site appeared and then also was red further up around the shoulder (noticed because shoulder was itchy).  I also felt warm.  I have been diagnosed in the past with exercise induced asthma.  Asthma started to flare up shortly after but did not require intervention.  Was monitored by a doctor at facility where vaccine was given and symptoms did not worsen.  No medication required.  I noticed unusual muscle aches starting the next morning and persisted for a week after vaccine.  Left arm where vaccine was given did not hurt, but other right arm, shoulders and thighs were aching.  Hands seemed arthritic with movement at work.  Feet occasionally felt tingly when walking for 5 days after vaccine.  Asthma flare-ups continued after vaccine.  Had to stop and rest after climbing stairs which is  unusual for me.  The worst asthma flare-ups persisted for up to 5 days.  After 10 days at time of reporting adverse effects, asthma is still triggered but to a lesser extent.  Can climb stairs without pause now.  Airways have not fully recovered yet and I have a residual cough.  Started self treating with albuterol rescue inhaler if needed.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Myalgia, Pain in extremity
Clinical narrative: About 10 minutes after vaccine a red injection site appeared and then also was red further up around the shoulder (noticed because shoulder was itchy).  I also felt warm.  I have been diagnosed in the past with exercise induced asthma.  Asthma started to flare up shortly after but did not require intervention.  Was monitored by a doctor at facility where vaccine was given and symptoms did not worsen.  No medication required.  I noticed unusual muscle aches starting the next morning and persisted for a week after vaccine.  Left arm where vaccine was given did not hurt, but other right arm, shoulders and thighs were aching.  Hands seemed arthritic with movement at work.  Feet occasionally felt tingly when walking for 5 days after vaccine.  Asthma flare-ups continued after vaccine.  Had to stop and rest after climbing stairs which is  unusual for me.  The worst asthma flare-ups persisted for up to 5 days.  After 10 days at time of reporting adverse effects, asthma is still triggered but to a lesser extent.  Can climb stairs without pause now.  Airways have not fully recovered yet and I have a residual cough.  Started self treating with albuterol rescue inhaler if needed.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: About 10 minutes after vaccine a red injection site appeared and then also was red further up around the shoulder (noticed because shoulder was itchy).  I also felt warm.  I have been diagnosed in the past with exercise induced asthma.  Asthma started to flare up shortly after but did not require intervention.  Was monitored by a doctor at facility where vaccine was given and symptoms did not worsen.  No medication required.  I noticed unusual muscle aches starting the next morning and persisted for a week after vaccine.  Left arm where vaccine was given did not hurt, but other right arm, shoulders and thighs were aching.  Hands seemed arthritic with movement at work.  Feet occasionally felt tingly when walking for 5 days after vaccine.  Asthma flare-ups continued after vaccine.  Had to stop and rest after climbing stairs which is  unusual for me.  The worst asthma flare-ups persisted for up to 5 days.  After 10 days at time of reporting adverse effects, asthma is still triggered but to a lesser extent.  Can climb stairs without pause now.  Airways have not fully recovered yet and I have a residual cough.  Started self treating with albuterol rescue inhaler if needed.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Developed swollen lymph node under right arm; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730) intramuscularly at right arm on 20Dec2020 at 10:15 a.m. at a single dose (dose number=1) for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant. Facility type vaccine was at hospital. No other vaccine in four weeks. The patient developed swollen lymph node under right arm on 21Dec2020 at 11:00 a.m. The event was reported as non-serious. with outcome of recovering. No treatment received for the event. No COVID-19 diagnosed prior vaccination and no COVID-19 tested post vaccination. No known allergies (no allergies to medications, food, or other products).  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills and body aches
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; nausea; This is a spontaneous report from a contactable other health professional (other HCP) (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration at right arm on 21Dec2020 at 10:00 a.m. at a single dose (dose number: 1) for COVID-19 immunization. Medical history included hypothyroid and hyperlipidemia. Concomitant medications in two weeks included levothyroxine, simvastatin (ZOCOR), ergocalciferol (VITAMIN D), ascorbic acid (VITAMIN C) and calcium (reported as calcium mul, to be clarified). No other vaccine in four weeks. The patient was not pregnant. Facility type vaccine was hospital. No COVID-19 diagnosed prior vaccination and no COVID-19 tested post vaccination. No known allergies (no allergies to medications, food, or other products).  The patient experienced headache, nausea on 22Dec2020 at 12:00 p.m. with outcome of resolved in Dec2020. The events were reported as non-serious. No treatment received for events.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity, Paraesthesia
Clinical narrative: Bilateral parasthesia to fingers 4 hours post injection.  This passed in 15 minutes, About 7 Pm on 12/28/20, bilateral parasthesia to hands & feet. On 12/29/20 (AM) foot pain--painful to walk, went away in about 5 minutes, but still felt tingling to both feet. Still having tingling sensation to both feet (constant) and both hands (intermittent)
Age: 9.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMRV
Symptoms: Syncope
Clinical narrative: Child had a syncope attack while receiving vaccines.  Hepatitis A,  Hepatitis B, Inactivated Polio, Influenza vaccine, HPV9,and  MMRV.  had been administered.  Tdap that was scheduled to be given had been drawn but could not be given as child had a reaction.   The episode lasted for about 2 minutes.   BP 86/54 P-62.  Benadryl 125mg/5ml   5mls po was given stat.  .  Child was kept in the clinic for observation for 2 hours.  Father was instructed to take the child to the ER   a letter to take to the ER  describing the incident was given to child's  father.  All information was given to  child's father in his native language using a interpreter.  Father voiced understanding of all information given.   Child was in stable condition when he left the clinic.  he was walking and denied any other problems.       On December 23rd 2020 the father was contacted  by telephone on  the contact number on file at the clinic .  The call was answered by the family friend  who took patient and his father to the ER the day of the incident.   Family Friend stated that the child was seen in the ER the same day of the incident, nothing abnormal was noted.  He  reported that the  child was sent home the same day with no further treatment.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Nausea
Clinical narrative: Upset stomach; Nausea; Mild headache; This is a spontaneous report from a contactable nurse reporting for herself. This 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) on 22Dec2020 14:25 at a single dose intramuscularly in the left arm for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included sertraline hydrochloride (ZOLOFT).  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced upset stomach, nausea and mild headache on 23Dec2020. The events were non-serious, no treatment received for the events. The patient was recovering from the events.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was under the age of 18 when Covid-19 vaccine was administered
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a non-contactable healthcare professional (HCP). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899) on 22Dec2020 17:30 intramuscularly at a single dose in the left arm (in the left deltoid muscle) for COVID-19 vaccination. No relevant medical history. The patient denied any history of previous adverse reactions to vaccines. The patient's concomitant medications were not reported.  During her 15 minute waiting period after the injection, the patient began to experience dizziness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. She was then assessed in the emergency bay area, monitored for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, vomiting, abdominal pain, hypotension, dysrhythmia, chest pain and collapse. Vitals were normal, glucose was 100. The event dizziness was non-serious. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes; Injection site pain; Tiredness; This is a spontaneous report from a contactable Nurse(patient). A 31-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 22Dec2020 20:45 at single dose at left arm for COVID-19 immunization. The patient was not pregnant. There were no known allergies or other medical history. There were no other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included ascorbic acid (VITAMIIN C), ergocalciferol (VIT D), vitamin b complex (SUPER B COMPL); reported as prenatal. The patient experienced swollen lymph nodes, injection site pain, tiredness; all on 23Dec2020 14:00 with outcome of not recovered. The events were non-serious. No treatment received for the events.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site bruising, Injection site induration, Injection site muscle weakness
Clinical narrative: Moderna COVID-19 Vaccine EUA  Day1- none Day2- Injection site: soreness, firmness, and weakness. General symptoms: none Day3- Injection site: bruising, tenderness. General symptoms: fatigue Day4- Injection site: bruising, tenderness. General symptoms: fatigue, body aches, joint pains, difficulty waking in the morning Day5- Injection site: bruising, tenderness. General symptoms: fatigue, body aches, joint pains, difficulty waking in the morning Day6- Injection site: bruising, tenderness. General symptoms: fatigue, body aches, joint pains, difficulty waking in the morning  I am currently on day 6 from getting the Moderna COVID-19 Vaccine and the injection side bruising and tenderness still persist along with the general symptoms of fatigue, body aches, joint pains, and difficulty waking up in the morning.