chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Feeling cold, Insomnia
Clinical narrative: aches; chills/shivering; generally not feeling well.; don't fall asleep; I have been feeling tired and like funny like a you have a cold or something/fatigue; I have been feeling tired and like funny like a you have a cold or something/cold; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 23Dec2020, this case now contains all required information to be considered valid.  This is a spontaneous report from two contactable consumers (including the patient). A 70-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number and expiration date were not provided), via an unspecified route of administration on 20Dec2020 at single dose for immunization. Medical history included hot flashes. There were no concomitant medications. The patient stated that she just got the shot yesterday (20Dec2020) at the hospital she just went. Today (21Dec2020), she was feeling like a kind of funny and further described she had been feeling tired and like funny like she had a cold or something. She had a shot in the arm. It was further reported that she received the vaccine on Sunday (20Dec2020) at the hospital she works at; reported side effects of aches, chills, and generally not feeling well. She also stated tiredness and fatigue, she didn't fall asleep even if she did a night shift. For 2 days, she felt achy, chills were bad, she was cold, and was shivering, then they went away. The patient had hot flashes before, but it wasn't like that. She was having cold. Then it would go away, took a while. She had them (feeling tired, feeling cold, generally not feeling well, didn't fall asleep) since Monday (21Dec2020), then yesterday (22Dec2020), she felt the chills, aches and fatigue. The patient wanted to know how long to expect the side effects to last. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: aches; chills/shivering; generally not feeling well.; don't fall asleep; I have been feeling tired and like funny like a you have a cold or something/fatigue; I have been feeling tired and like funny like a you have a cold or something/cold; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 23Dec2020, this case now contains all required information to be considered valid.  This is a spontaneous report from two contactable consumers (including the patient). A 70-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number and expiration date were not provided), via an unspecified route of administration on 20Dec2020 at single dose for immunization. Medical history included hot flashes. There were no concomitant medications. The patient stated that she just got the shot yesterday (20Dec2020) at the hospital she just went. Today (21Dec2020), she was feeling like a kind of funny and further described she had been feeling tired and like funny like she had a cold or something. She had a shot in the arm. It was further reported that she received the vaccine on Sunday (20Dec2020) at the hospital she works at; reported side effects of aches, chills, and generally not feeling well. She also stated tiredness and fatigue, she didn't fall asleep even if she did a night shift. For 2 days, she felt achy, chills were bad, she was cold, and was shivering, then they went away. The patient had hot flashes before, but it wasn't like that. She was having cold. Then it would go away, took a while. She had them (feeling tired, feeling cold, generally not feeling well, didn't fall asleep) since Monday (21Dec2020), then yesterday (22Dec2020), she felt the chills, aches and fatigue. The patient wanted to know how long to expect the side effects to last. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with the Pfizer-BioNTech COVID-19 Vaccine last week (in Dec2020). She claimed being diagnosed with shingles and has asked the nurse if it could be related to the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: left hip pain; This is a spontaneous report from a contactable physician.  A 71-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 17Dec2020 at, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller stated that he got the coronavirus vaccine last Thursday and on midday Saturday that he got left hip pain. reported that he has sticky hips. Stated that he does not experience pain normally. Stated that the day before on Wednesday that he did yoga at home. Stated that he has done yoga for years. Stated that every time that he does it the he could strain something. Stated that the pain was bad enough that he took 3 doses of Advil over the next 24 hours and it went away. Stated that it did not cause any major limping. Stated that he took 75 minutes walks on Saturday and Sunday and did yoga that evening. Stated that he is not sure that it is not related to the vaccine. Stated that this is his first dose of the vaccine. Stated that he is happy that he got the vaccine. Stated that he would get it again in a heartbeat. The outcome of the event was recovered.   Information on Lot /Batch Number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose increased, Condition aggravated, Musculoskeletal pain, Type 1 diabetes mellitus
Clinical narrative: I am diabetic on a CGM and insulin pump. My blood sugar started to rise mid-afternoon and I couldn't get it below 200 despite giving myself increased amounts of insulin. It was up to 289 at bedtime. I count carbs and was very careful about what I ate yesterday. This morning I was back down to 169 when I got up, but I had increased my basal rates during the night. Second event that I'm not sure is related, but FYI, last evening I got some sharp pains in my left hip and continual aching in my left buttock while sitting watching TV. It continued until after I went to bed. It's back to normal this morning.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: injection site pain-minor; tiredness-moderate/fatigue; headache-mild to moderate; muscle pain-minor/muscle aches; chills; fever-low grade; injection site redness light pink; nausea-comes and goes; feeling unwell-mild to moderate; muscle weakness; weak; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 18Dec2020 12:15 on the right arm at a single dose for COVID-19 immunization. Medical history included allergies to anxiety medication. The patient's concomitant medications were not reported. On 18Dec2020 20:00, the patient experienced mild to moderate side effects: injection site pain (minor), tiredness (moderate), headache (mild to moderate), muscle pain (minor muscle aches), chills (sometimes), fever (low grade), injection site redness (light pink), nausea- (comes and goes), feeling unwell (mild to moderate), muscle weakness and feeling fatigue which were moderate Friday, Saturday, and Sunday and Monday. If patient was active, for example Christmas shopping for about an hour, she was very fatigue, weak and the nausea was strongly moderate and it would come and go. Outcome of the events was recovering. No treatment was received for the events. The events were considered non-serious. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested post vaccination.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Muscular weakness, Myalgia, Nausea
Clinical narrative: injection site pain-minor; tiredness-moderate/fatigue; headache-mild to moderate; muscle pain-minor/muscle aches; chills; fever-low grade; injection site redness light pink; nausea-comes and goes; feeling unwell-mild to moderate; muscle weakness; weak; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 18Dec2020 12:15 on the right arm at a single dose for COVID-19 immunization. Medical history included allergies to anxiety medication. The patient's concomitant medications were not reported. On 18Dec2020 20:00, the patient experienced mild to moderate side effects: injection site pain (minor), tiredness (moderate), headache (mild to moderate), muscle pain (minor muscle aches), chills (sometimes), fever (low grade), injection site redness (light pink), nausea- (comes and goes), feeling unwell (mild to moderate), muscle weakness and feeling fatigue which were moderate Friday, Saturday, and Sunday and Monday. If patient was active, for example Christmas shopping for about an hour, she was very fatigue, weak and the nausea was strongly moderate and it would come and go. Outcome of the events was recovering. No treatment was received for the events. The events were considered non-serious. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested post vaccination.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: injection site pain-minor; tiredness-moderate/fatigue; headache-mild to moderate; muscle pain-minor/muscle aches; chills; fever-low grade; injection site redness light pink; nausea-comes and goes; feeling unwell-mild to moderate; muscle weakness; weak; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 18Dec2020 12:15 on the right arm at a single dose for COVID-19 immunization. Medical history included allergies to anxiety medication. The patient's concomitant medications were not reported. On 18Dec2020 20:00, the patient experienced mild to moderate side effects: injection site pain (minor), tiredness (moderate), headache (mild to moderate), muscle pain (minor muscle aches), chills (sometimes), fever (low grade), injection site redness (light pink), nausea- (comes and goes), feeling unwell (mild to moderate), muscle weakness and feeling fatigue which were moderate Friday, Saturday, and Sunday and Monday. If patient was active, for example Christmas shopping for about an hour, she was very fatigue, weak and the nausea was strongly moderate and it would come and go. Outcome of the events was recovering. No treatment was received for the events. The events were considered non-serious. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested post vaccination.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Patient with a nut allergy, tongue became tingly 20-30 minutes following vaccine.  Patient was given 50 mg of diphenhydramine and was able to transport home with his wife.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: is 'fibril' until today/ fever; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on 18Dec2020 at single dose for COVID -19 immunization. The patient medical history and concomitant medications were not reported. The reporter asked to just call her back to give info Covid vaccine was administered to a physician last 18Dec2020 and was 'fibril' until today (pending clarification). Asking if there is info on the duration of the fever that occurs. The outcome of the event was not recovered.  Information on the Batch/Lot number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lower respiratory tract congestion, Myalgia, Oropharyngeal pain, Pain in extremity
Clinical narrative: Sore throat, mild bronchial congestion, mild muscle aches, soreness in left arm; Sore throat, mild bronchial congestion, mild muscle aches, soreness in left arm; Sore throat, mild bronchial congestion, mild muscle aches, soreness in left arm; Sore throat, mild bronchial congestion, mild muscle aches, soreness in left arm; This is a spontaneous report from a  contactable nurse (reported for herself). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on left arm on 21Dec2020 08:45 at a single dose for immunization. Medical history included rosacea, primary hypertension, Hashimoto's Thyroiditis  and penicillin allergy. The patient's concomitant medications were not reported. The patient experienced sore throat, mild bronchial congestion, mild muscle aches, and soreness in left arm; all on 22Dec2020 at 06:30. The patient did not receive treatment for the events. Outcome of the events was recovering.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: patient called to report nausea, vomiting headache low grade fever abd pain
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Illness, Insomnia
Clinical narrative: Extreme fatigue; nausea; lightheadedness; diarrhea; muscle ache; inability to sleep; sickness; This is a spontaneous report from a contactable physician (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: unknown), intramuscular (left arm) on 21Dec2020 16:00 at single dose for COVID-19 immunization. The patient has no medical history. No known allergies. The patient has no allergies to medications, food, or other products. Concomitant medications were not reported. The patient has received other medications (unspecified) within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020 (18:00), the patient experienced extreme fatigue, nausea, lightheadedness, diarrhea, muscle ache, inability to sleep, and worst sickness of entire life (as reported). The patient received over the counter medication as treatment for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. This case is non-serious (as reported).  Information on the lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Extreme fatigue; nausea; lightheadedness; diarrhea; muscle ache; inability to sleep; sickness; This is a spontaneous report from a contactable physician (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: unknown), intramuscular (left arm) on 21Dec2020 16:00 at single dose for COVID-19 immunization. The patient has no medical history. No known allergies. The patient has no allergies to medications, food, or other products. Concomitant medications were not reported. The patient has received other medications (unspecified) within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020 (18:00), the patient experienced extreme fatigue, nausea, lightheadedness, diarrhea, muscle ache, inability to sleep, and worst sickness of entire life (as reported). The patient received over the counter medication as treatment for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. This case is non-serious (as reported).  Information on the lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Intensive care, Pyrexia
Clinical narrative: Subject received vaccination Wednesday Dec 16th in the afternoon.  He became symptomatic (shortness of breath, low grade fever) the next day.  Went to the Emergency room on Saturday Dec. 26th, 2020 due to shortness of breath, had an 02 Sat of 60%,  and was hospitalized in the ICU at another hospital (due to bed unavailability).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Brown spots in the shape of a circle at different locations in the body all appearing within a few hours; This is a spontaneous report from a contactable nurse (patient).  A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EH9899), via an unspecified route of administration on the right arm on 22Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital.  The patient had allergies with detergent and soap products. Concomitant medications included fenofibrate (FENOFIBRATE) and vitamin D from unknown dates and indications. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since vaccination. On 22Dec2020, the patient experienced brown spots in the shape of a circle at different locations in the body all appearing within a few hours.  No treatment was received for the event. Outcome of the event was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Fever; Chills/rigors; Nausea; Vomiting (one episode); Headache; Myalgia; Change in taste; Generalized weakness; This is a spontaneous report from a non-contactable physician (patient). A 44-year-old male patient received one dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 1647, expiration date not reported), via an unspecified route of administration (left arm), on 21Dec2020 at 12:30 at a single dose, for COVID-19 immunization. Medical history included hypertension and COVID-19 from an unknown date. Concomitant medication included lisinopril and amlodipine. On 22Dec2020 at 04:30, the patient experienced 8 hours of severe symptoms: fever, chills/rigors, nausea/vomiting (one episode), headache, myalgia, change in taste, generalized weakness. The patient took Tylenol and naproxen as treatment. The patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Taste disorder, Vomiting
Clinical narrative: Fever; Chills/rigors; Nausea; Vomiting (one episode); Headache; Myalgia; Change in taste; Generalized weakness; This is a spontaneous report from a non-contactable physician (patient). A 44-year-old male patient received one dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 1647, expiration date not reported), via an unspecified route of administration (left arm), on 21Dec2020 at 12:30 at a single dose, for COVID-19 immunization. Medical history included hypertension and COVID-19 from an unknown date. Concomitant medication included lisinopril and amlodipine. On 22Dec2020 at 04:30, the patient experienced 8 hours of severe symptoms: fever, chills/rigors, nausea/vomiting (one episode), headache, myalgia, change in taste, generalized weakness. The patient took Tylenol and naproxen as treatment. The patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Immediate post-injection reaction, Nausea
Clinical narrative: Patient became visibly flushed within five minutes after inoculation, and she reported having "waves of nausea." A cool compress was applied to her neck.  While she was closely being monitored, she admitted feeling "dizzy right after the shot bit didn't want to tell anyone because she [ic] was embarrased."  At 1532, patient denied that she was allergic to Benadryl, so Benadryl 50 mg/mL IM was injected into her right deltoid.  At 1545, patient reported an alleviation of symptoms.  She was advised to go home to rest, but to immediately contact 911 or go to the ER if symptoms worsened.  Patient voiced understanding and left the facility with coordinated ambulation and in stable condition.  RN  12/29/2020 @ 1318
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: light headache; Low grade fever; Muscle ache; Pain; This is a spontaneous report from a contactable consumer (parent) reported that a 49-year-old female patient received single dose of (BNT162B2, Solution for injection, lot number was not provided), via an unspecified route of administration on the left arm on 18Dec2020 for covid-19 immunization. Medical history included ongoing hypertension that was diagnosed when she was 32-years-old, after she gave birth to her second child; she was diagnosed with COVID-19 on 25Aug2020, and now was 4 months out from having COVID-19; reportedly she was tired and had a lot of "nervously" feeling, like heart palpitations before she took the COVID-19 vaccine. There were no concomitant medications. On 19Dec2020, the patient experienced light headache, low grade fever, muscle ache and pain. The patient underwent lab tests and procedures which included weight: 212-213 lbs on an unspecified date. The outcome of the events was recovered on 19Dec2020.   Information about lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysphonia, Fatigue, Headache, Injection site pain
Clinical narrative: Raspy voice, body and joint pain, pain at injection site, fatigue, headache
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Raspy voice, body and joint pain, pain at injection site, fatigue, headache
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: myalgia; chills; headache; fatigue; Loss of appetite; This is a spontaneous report from a non-contactable physician. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 21Dec2020 14:30 in left arm at single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. Concomitant medication included omeprazole. After vaccination, 12-15 hours later, the patient pronounced myalgia joined 18 hours later with chills, headache, fatigue and loss of appetite. The patient experienced myalgia on 22Dec2020 05:00; chills, headache, loss of appetite and fatigue on 22Dec2020. Treatment such as acetaminophen and rest was given to patient for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The events were considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect. The outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Nausea, Pain
Clinical narrative: Headache; nausea; mild body aches; hot flashes; This is a spontaneous report from a contactable nurse (patient).  A 39-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), intramuscular at right arm on 21Dec2020 17:45 at single dose for COVID-19 immunization at a hospital. The patient's medical history included migraines, bipolar II, anxiety, attention deficit hyperactivity disorder (ADHD) and insomnia. No allergies to medications, food, or other products. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), diphenhydramine hydrochloride (BENADRYL), lamotrigine (LAMICTAL), nortriptyline, alprazolam (XANAX) and multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination, and since the vaccination, the patient been had not tested for COVID-19. It was reported that on 22Dec2020 17:45, the patient experienced headache, nausea, mild body aches, and hot flashes. Treatment for the reported events included that the patient took ondansetron (ZOFRAN) and acetaminophen (Tylenol) that she had at home. She took them on her own. No doctor needed. The outcome of the events was recovered in Dec2020.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Arm pain/Pain in arm was so severe; Pain in arm was so severe I could not sleep; Extreme body aches the aches intensified throughout the day; Headaches; sore throat; head and chest congestion; head and chest congestion; This is a spontaneous report from a contactable other hcp (patient). A 49-year-old female patient received bnt162b2 via an unspecified route of administration on arm left, first dose on 16Dec2020 12:45 at single dose for COVID-19 immunization.  Other vaccine same date product included Pfizer-Biontech first dose on 16Dec2020 on left arm (pending clarification). Medical history included COVID-19 prior vaccination from an unknown date. Not pregnant at the time of vaccination. No known allergies. No other medical history. Concomitant medication included bupropion from 2020. No other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm pain. Pain in arm was so severe she could not sleep. Applied an ice pack throughout the night. Extreme body aches the aches intensified throughout the day. Headaches, sore throat, head and chest congestion. Adverse event start date was on 16Dec2020. The event was reported as non-serious. Therapeutic measures were taken as a result of arm pain/pain in arm was so severe, treatment included ice pack. No treatment was received for other events. The outcome of the events was recovering.  Information about Lot/batch no has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Sleep disorder
Clinical narrative: Arm pain/Pain in arm was so severe; Pain in arm was so severe I could not sleep; Extreme body aches the aches intensified throughout the day; Headaches; sore throat; head and chest congestion; head and chest congestion; This is a spontaneous report from a contactable other hcp (patient). A 49-year-old female patient received bnt162b2 via an unspecified route of administration on arm left, first dose on 16Dec2020 12:45 at single dose for COVID-19 immunization.  Other vaccine same date product included Pfizer-Biontech first dose on 16Dec2020 on left arm (pending clarification). Medical history included COVID-19 prior vaccination from an unknown date. Not pregnant at the time of vaccination. No known allergies. No other medical history. Concomitant medication included bupropion from 2020. No other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm pain. Pain in arm was so severe she could not sleep. Applied an ice pack throughout the night. Extreme body aches the aches intensified throughout the day. Headaches, sore throat, head and chest congestion. Adverse event start date was on 16Dec2020. The event was reported as non-serious. Therapeutic measures were taken as a result of arm pain/pain in arm was so severe, treatment included ice pack. No treatment was received for other events. The outcome of the events was recovering.  Information about Lot/batch no has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Significant arm soreness, headache.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle soreness; This is a spontaneous report from a contactable physician (patient). A patient of an unspecified age (reported as 35, unit unknown) and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 15Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that after he got the shot (Dec2020), he had experienced "just a little muscle soreness". The outcome of event was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle soreness; This is a spontaneous report from a contactable physician (patient).  An adult patient (Age: 44; Unit: Unknown) of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on 14Dec2020 at SINGLE DOSE for COVID-19 immunization.  Medical history and concomitant medications were not reported. It was reported that the patient had side effects that were minimal - muscle soreness in Dec2020 for 24 hours, that's about it. The patient recovered from the event in Dec2020.   No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Throat tightness, Tongue discomfort
Clinical narrative: Received Moderna vaccine, approximately 11:40AM. Onset of throat fullness, tongue fullness about 12:30 PM Mild difficulty swallowing associated. ANAPHYLAXIS, INIT -     diphenhydrAMINE Injection 50 mg (BENADRYL) -     EPINEPHrine (ADRENACLICK/EPIPEN) 0.3 mg/0.3 mL Injection AutoInjector; Inject 0.3 mL intramuscularly as needed for severe allergic reaction . Inject in upper thigh -     predniSONE (ORASONE) 20 mg Oral Tab; Take 2 tablets by mouth daily with a meal Mild reaction. Improved with PO Benadryl. Reviewed home care, handout provided. Home epi prescribed. Prednisone 2 day course.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Rhinitis, SARS-CoV-2 test false positive, Upper-airway cough syndrome
Clinical narrative: I started getting profused rhinitis; I am got a little hoarse and it lasted all night long; I started getting profused rhinitis; I am got a little hoarse and it lasted all night long; I had enough Postnasal drip that I got a little bit of cough and no fever and didn't know if this was related to the vaccine; I had enough Postnasal drip that I got a little bit of cough and no fever and didn't know if this was related to the vaccine; This is a spontaneous report from a contactable physician who was also the patient. A 71-year-old male patient  received bnt162b2 (BNT162B2 lot: EK5730, expiry: Mar2021), intramuscular in left arm on 17Dec2020 at a singe dose for covid-19 immunisation. The patient's medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included olmesartan medoxomil (BENICAR) for hypertension and unspecified vitamins. On a unspecified date, the patient started getting profused rhinitis, he got a little hoarse and it lasted all night long. Patient actually had enough Postnasal drip (Captured as suspect conservatively) that got a little bit of cough and no fever and didn't know if this was related to the vaccine or not and needed to find out if that's the case. It was also reported that the patient took a rapid Covid test in the morning and whould like to know if that would to be 'false' positive because of taking the virus shot or Covid shot. It was reported that an RN administered the vaccine. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Allergic respiratory symptom, Pain in extremity, Sneezing
Clinical narrative: Pain in arm; Kind of allergy you know like sneezing a lot, the whole day I have been sneezing; Kind of allergy you know like sneezing a lot, the whole day I have been sneezing; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on 18Dec2020 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Consumer stated, "I have a question about, I just had Pfizer on last Friday so I didn't have any symptom anything, the next day on 19Dec2020 I have like my arm pain, not swollen just pain and then I have kind of allergy you know like sneezing a lot, it is  the whole day I have been sneezing and just like the whole day. Is it allergy to the Pfizer or should I just have another like second shot should I have it or is it the allergic reaction or what is that? It is the COVID the one COVID I had from Pfizer (COVID Vaccine). Because of I am afraid to have second shot if I have like more allergy or." The outcome of the events unknown.   Information on the Batch/Lot number has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Softball size swelling in left arm at injection site. Injection site is hot to the touch. Injection site has redness approximately 1.5 inches by 1.5 inches.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Pain
Clinical narrative: Spiked the temperature during the night; Body ache; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899), via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient was not having any serious side effects but she was having like probably spiked temperature during the night, body ache, and fatigue on 22Dec2020. The patient want to make sure if it is okay to take paracetamol (TYLENOL) or ibuprofen (MOTRIN) generally. Outcome of the events was unknown. The reporter assessed that the events were related to the suspect drug.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: bad headache; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Dec2020 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 22Dec2020, the patient experienced bad headache. The clinical outcome of the bad headache was unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Feeling abnormal, Pyrexia, SARS-CoV-2 test
Clinical narrative: I have COVID after getting the vaccine. Fever, chills, and I feel very bad.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Stridor, Tachypnoea
Clinical narrative: Respiratory:  Laryngeal stridor going into the trachea and the central bronchial tubes.   No wheeze out on the periphery.  , Respirations: Tachypneic, Breath sounds: Stridor.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: lightheaded/dizzy; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), first dose via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was vaccinated yesterday with the Pfizer COVID-19. The patient felt lightheaded/dizzy after the injection and for many hours after in Dec2020. The patient felt these events before with other vaccines. The outcome of the event was unknown.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cyanosis, Malaise, Paraesthesia, Peripheral coldness
Clinical narrative: chills; malaise; raynauds in left fingers cold,blue; tingling; This is a spontaneous report from a contactable physician (patient). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 21Dec2020 06:15PM, at right arm, at single dose for covid-19 immunization. Medical history included Guillain barre after flu vaccine in 2010, covid-19 prior vaccination. The patient's concomitant medications were not reported. The patient previously received flu vaccine in 2010. The patient experienced chills, malaise, raynauds in left fingers cold, blue, tingling on 22Dec2020 08:00 AM. No treatment received for all events. The outcome of events was recovering. Patient had not tested for COVID-19 post vaccination. 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: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Raynaud's phenomenon
Clinical narrative: chills; malaise; raynauds in left fingers cold,blue; tingling; This is a spontaneous report from a contactable physician (patient). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 21Dec2020 06:15PM, at right arm, at single dose for covid-19 immunization. Medical history included Guillain barre after flu vaccine in 2010, covid-19 prior vaccination. The patient's concomitant medications were not reported. The patient previously received flu vaccine in 2010. The patient experienced chills, malaise, raynauds in left fingers cold, blue, tingling on 22Dec2020 08:00 AM. No treatment received for all events. The outcome of events was recovering. Patient had not tested for COVID-19 post vaccination. 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Injection site pain, Malaise
Clinical narrative: Headache Fever (101.3) with chills body aches/malaise nausea/decreased appetite site injection-arm pain
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Headache Fever (101.3) with chills body aches/malaise nausea/decreased appetite site injection-arm pain
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea
Clinical narrative: Episode of nausea; Right-sided preauricular and superficial cervical lymphadenopathy; This is a spontaneous report from a contactable physician (patient herself).  This 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unspecified route of administration, at single dose on 19Dec2020 at 08:45 AM for COVID-19 immunisation. Vaccine location was left arm.  The patient was vaccinated at hospital, age at vaccination was 36-year-old. No other vaccine was received in four weeks. The patient was not pregnant. The patient did not have a relevant medical history. Relevant concomitant medications included ibuprofen and 20 Ethinyl Estradiol-3 Drospirenone. On 21Dec2020, the patient developed right-sided preauricular and superficial cervical lymphadenopathy. On 22Dec2020, the patient had an episode of nausea. The patient did not perform COVID test before and after vaccination. No therapeutic measures were taken as result of the events. The outcome of the events was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: On day to the left arm had some redness at the injection site and was sore.  This was listed as unknown possible side effect. On the days following a became increasingly red and itchy.  I took Benadryl to help resolve the itching.  Redness and itching continued and then on Sunday 12/27/20 The site became increasingly read painful to touch  and warm to touch.  On Monday morning I contacted my immediate supervisor advised her that I was having something outside of what I believed to be a ?normal? reaction or side effect.  I went to urgent care to see occupational health.  I was given prescriptions for keflex and naproxen for cellulitis.  My arm is extremely painful to touch.  I was advised if the area worsens or spreads to see the ER because I may need IV antibiotics.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient (no pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via intramuscularly on 22Dec2020 06:15 AM on left arm at single dose for COVID-19 immunization. The patient's medical history included hyperthyroidism/goiter and not allergy to medications, food, or other products. 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 concomitant drug included vitamins within 2 weeks of vaccination. The patient experienced sore arm on 22Dec2020 06:15 AM. No treatment for sore arm. The outcome of the events was recovering.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Left deltoid soreness; This is a spontaneous report from a non-contactable physician (patient). A 28-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), intramuscular in left arm on 22Dec2020 08:15 at single dose for COVID-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included asthma (Prior history of asthma). No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL), ascorbic acid, betacarotene, biotin, capsicum annuum fruit, colecalciferol, collagen marine, curcuma longa, cysteine hydrochloride, equisetum arvense, fallopia japonica, hyaluronic acid, iodine, keratin, lysine, methionine, piper nigrum, selenium, serenoa repens, tocotrienols nos, withania somnifera, zinc (NUTRAFOL). The patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced left deltoid soreness (non-serious) on 22Dec2020 10:00.  No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Breast pain, Neck pain, Oropharyngeal pain
Clinical narrative: "whole body aches everywhere."/whole body is so sore today, my breast, my back, shoulders, my neck; My throat gets a little sore; I just threw up everywhere; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 22Dec2020 08:20 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient reported that her "whole body aches everywhere/her whole body hurts." Healthcare professional (HCP) had not been made aware of this at time of call. The patient further reported that her whole body was so sore today (23Dec2020), my breast, my back, shoulders, my neck. Also, her throat gets a little sore and she just threw up everywhere on an unspecified date in Dec2020. The patient was working in a nursing home. No treatment was given for the events. "Lab test: Consumer stated, "No, just the Covid test but I passed it so (sentence incomplete)." The outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Vomiting
Clinical narrative: "whole body aches everywhere."/whole body is so sore today, my breast, my back, shoulders, my neck; My throat gets a little sore; I just threw up everywhere; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 22Dec2020 08:20 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient reported that her "whole body aches everywhere/her whole body hurts." Healthcare professional (HCP) had not been made aware of this at time of call. The patient further reported that her whole body was so sore today (23Dec2020), my breast, my back, shoulders, my neck. Also, her throat gets a little sore and she just threw up everywhere on an unspecified date in Dec2020. The patient was working in a nursing home. No treatment was given for the events. "Lab test: Consumer stated, "No, just the Covid test but I passed it so (sentence incomplete)." The outcome of the events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Hypertension
Clinical narrative: Anxious, dizzy, hypertensive, lightheaded for 30 min-- monitored throughout -- resolved without intervention -- discharged home
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 2 inch diameter at injection site; swelling, redness, tender for 3 days after; 2 inch diameter at injection site; swelling, redness, tender for 3 days after; 2 inch diameter at injection site; swelling, redness, tender for 3 days after; This is a spontaneous report from a contactable other health professional (patient).  A 40-years-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 17Dec2020 16: 30 at single dose on left arm for COVID-19 immunization in hospital. Medical history included attention deficit hyperactivity disorder (ADHD), idiopathic retinitis. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), gabapentin, naproxen sodium (ALEVE), ergocalciferol (VIT D), magnesium supplement and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 2 inch diameter at injection site; swelling, redness, tender for 3 days after, stated from 18Dec2020 12:00 PM. Then gone. No treatment received for the adverse events. The events outcome was recovered in Dec2020. No COVID prior vaccination, since the vaccination, the patient hadn't been tested for COVID-19. The seriousness was reported as no.  The information on the batch number has been requested.