chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: covid test date: 03Jan2021, covid test result: Positive; covid test date: 03Jan2021, covid test result: Positive; This is a spontaneous report from a contactable Other Health Professional (patient).  A 37-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, lot # EJ1685) at single dose at left arm on 02Jan2021 11:45 for covid-19 immunisation.  Medical history included post-traumatic stress disorder (PTSD), anxiety. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has received no other vaccines within 4 weeks prior to the COVID vaccine. On 03Jan2021 the patient has been tested for COVID-19 with rapid nasal swab test resulted positive. It was unknown if treatment was received. The outcome of events was unknown. Later the patient received the 2nd dose of bnt162b2 (BNT162B2, Lot # EL0140) at single dose at left arm on 23Jan2021 for covid-19 immunisation, administered at Pharmacy or drug store. The patient's concomitant medications in 2 weeks of this vaccination included: Lamictal, Klonopin, multivitamins, D, C, B, Zinc. On 24Jan2021 12:00 AM the patient experienced extreme tiredness, chills, fever, muscle aches, runny nose, sore throat, nausea, pale skin, malaise, night sweats. No treatment received for the adverse events. The outcome of events was recovering.; Sender's Comments: No effect of the suspect vaccine BNT162B2 could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Memory impairment
Clinical narrative: fatigue; difficulty concentrating and with memory; difficulty concentrating and with memory; This is a spontaneous report from a contactable physician reporting for herself. A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 04Jan2021 12:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history reported as none. There were no concomitant medications, no other medications was received in two weeks. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 on an unknown date in Dec2020 at left arm for covid-19 immunization and had fatigue and myalgias for 3 days after the 1st dose. After the second dose the patient had had 3 weeks of fatigue and difficulty concentrating and with memory, events started on 04Jan2021 20:00. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit. 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 not recovered.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Headache, Nasopharyngitis
Clinical narrative: exhaustion; feel like I had a cold coming; I was running a fever of 101.2/My fevers ranged from 100.1 to 103.2/fevers/have a low grade fever; had body aches; headache; no energy; my arm was extremely sore; This is a spontaneous report from a contactable nurse (patient).  A 35-year-old female (not pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm right on 20Jan2021 at 09:15 at single dose for COVID-19 immunization. The patient medical history included chronic constipation, depression and known allergies to latex, apples and adhesive, all from an unknown date and unknown if ongoing. The patient's concomitant medication included sertraline hydrochloride (ZOLOFT), trazodone, cetirizine hydrochloride (ZYRTEC), cholecalciferol (VITAMIN D). The patient previously received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm left on 30Dec2020.  The patient reported that: "on 21Jan2021 I started to feel like I had a cold coming when I woke in the morning.  As the day went on, I began to feel worse. I was running a fever of 101.2, had body aches, headache, no energy, and my arm was extremely sore. This continued 22Jan2021. My fevers ranged from 100.1 to 103.2. On the 23Jan2021 I continued to have a headache, fevers and no energy. On 24Jan2021 I continued to have a low-grade fever, no energy, and headache. I was only able to work 5 hours due to exhaustion". Therapeutic measures were taken as results of events and included treatment with TYLENOL 1000 mg and ibuprofen 600 mg every 6 hours. The patient underwent lab test and procedures which included SARS-COV-2 tests (nasal swab and rapid test) both negative on 22Jan2021. The patient outcome of the events was not recovered.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: exhaustion; feel like I had a cold coming; I was running a fever of 101.2/My fevers ranged from 100.1 to 103.2/fevers/have a low grade fever; had body aches; headache; no energy; my arm was extremely sore; This is a spontaneous report from a contactable nurse (patient).  A 35-year-old female (not pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm right on 20Jan2021 at 09:15 at single dose for COVID-19 immunization. The patient medical history included chronic constipation, depression and known allergies to latex, apples and adhesive, all from an unknown date and unknown if ongoing. The patient's concomitant medication included sertraline hydrochloride (ZOLOFT), trazodone, cetirizine hydrochloride (ZYRTEC), cholecalciferol (VITAMIN D). The patient previously received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm left on 30Dec2020.  The patient reported that: "on 21Jan2021 I started to feel like I had a cold coming when I woke in the morning.  As the day went on, I began to feel worse. I was running a fever of 101.2, had body aches, headache, no energy, and my arm was extremely sore. This continued 22Jan2021. My fevers ranged from 100.1 to 103.2. On the 23Jan2021 I continued to have a headache, fevers and no energy. On 24Jan2021 I continued to have a low-grade fever, no energy, and headache. I was only able to work 5 hours due to exhaustion". Therapeutic measures were taken as results of events and included treatment with TYLENOL 1000 mg and ibuprofen 600 mg every 6 hours. The patient underwent lab test and procedures which included SARS-COV-2 tests (nasal swab and rapid test) both negative on 22Jan2021. The patient outcome of the events was not recovered.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain
Clinical narrative: Pain at site of injection; fatigue; chills; This is a spontaneous report from a non-contactable pharmacist. An adult female patient received COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for covid-19 immunization.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced pain at site of injection, fatigue, chills on an unspecified date in Jan2021. The outcome of the event was recovered in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Full body hives, large, red; Full body hives, large, red; very itchy; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Right arm on 23Jan2021 at 10:00 AM as a single dose for COVID-19 immunisation, lot number: EL9262. Medical history included allergies to sulfa drugs, Cillin drugs, codeine, salvia officinalis (SAGE). Concomitant medications in two weeks prior to the vaccination included birth control prescription. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 23Jan2021 at 06:45 PM patient experienced full body hives, large, red, very itchy. Events resulted in Doctor or other healthcare professional office/clinic visit. Events were treated with Prednisone prescription. At the time of the report, patient had not recovered from the events.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymphadenopathy along the left collar bone; This is a spontaneous report from a contactable other hcp (patient).  This 60-Year-old female no pregnant patient received,at hospital, the second dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from lot# EL3246 on left arm  on 14Jan2021 07:30 at SINGLE DOSE for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  No other vaccine in four weeks.The patient previously took ibuprofen and experienced drug hypersensitivity.First dose details : lot number=EK9231,administration date= 24Dec2020,administration time= 07:30 AM,vaccine location= Left arm,dose number= 1.The patient experienced lymphadenopathy along the left collar bone on 16Jan2021 06:00 .No treatment received.Event outcome was not recovered.  No covid prior vaccination,No covid tested post vaccination.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Very intense itching all over the top of my scalp; This is a spontaneous report from a contactable consumer reporting for self. This 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) on 20Jan2021 at 9 O'clock in the morning at single dose for COVID-19 immunization. Medical history included anxiety depression. Concomitant medication included escitalopram oxalate (LEXAPRO) for anxiety depression. The patient previously received oxycodone hydrochloride; oxycodone terephthalate; paracetamol (PERCOCET) and experienced intense itching. The patient experienced very intense itching all over the top of her scalp for about an hour (as reported) on 20Jan2021 at 2 O'clock in the afternoon. Patient did not receive any treatment, it did go away on it's own, and only lasted about 2 hours (as reported). The outcome of event was recovered on 20Jan2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature increased, Burning sensation, Fear, Feeling abnormal
Clinical narrative: 103.5 fever; severe back pain; body aches; Nausea; felt horrible; a girl touched her arm, said it was burning; This is a spontaneous report from a contactable nurse reported for herself. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) by injection once to right deltoid on 25Jan2021 at single dose for COVID-19 immunization. Medical history included she had COVID, she was diagnosed, was positive on 29Dec2020, and spent 9 days in the hospital. concomitant mediation was none. Patient calling about the COVID vaccine; her boss texted, she had to leave work, she had a 103.5 fever (26Jan2021), she felt horrible, she got her first COVID vaccine yesterday, and woke up this morning and felt horrible.  a girl touched her arm, said it was burning, and she was very nauseous, and was trying to pass meds, and took her temperature and it was 103.5, and the thing is when you come into the facility, they took her temperature and it was 97.2, but those thermometers suck and she has an oral thermometer, and it was 103.5. It's improving. Also has severe back pain and body aches, she was scared with the fever. Felt nauseous this morning (26Jan2021), had chicken noodle soup and crackers, but it was pretty bad to point she had to pull the trash can behind her. she was on a ventilator in March for a week, not with COVID, she doesn't want to die, she thought she was going to die with COVID, she had every symptom. No Investigation Assessment. The last outcome of 103.5 fever, nausea and severe back pain was recovering, body aches was not recovered, outcome of other events was unknown. Reporter seriousness for 103.5 fever was Medically significant. For severe back pain, body aches and Nausea was Not serious. Relatedness of drug to reactions/events 103.5 fever, severe back pain, body aches and Nausea per source of assessment of Primary Source Reporter and Method of assessment of Global Introspection with drug result of Related.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event pyrexia and remaining events cannot totally be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Nausea, Pain, Pyrexia, Skin warm
Clinical narrative: 103.5 fever; severe back pain; body aches; Nausea; felt horrible; a girl touched her arm, said it was burning; This is a spontaneous report from a contactable nurse reported for herself. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) by injection once to right deltoid on 25Jan2021 at single dose for COVID-19 immunization. Medical history included she had COVID, she was diagnosed, was positive on 29Dec2020, and spent 9 days in the hospital. concomitant mediation was none. Patient calling about the COVID vaccine; her boss texted, she had to leave work, she had a 103.5 fever (26Jan2021), she felt horrible, she got her first COVID vaccine yesterday, and woke up this morning and felt horrible.  a girl touched her arm, said it was burning, and she was very nauseous, and was trying to pass meds, and took her temperature and it was 103.5, and the thing is when you come into the facility, they took her temperature and it was 97.2, but those thermometers suck and she has an oral thermometer, and it was 103.5. It's improving. Also has severe back pain and body aches, she was scared with the fever. Felt nauseous this morning (26Jan2021), had chicken noodle soup and crackers, but it was pretty bad to point she had to pull the trash can behind her. she was on a ventilator in March for a week, not with COVID, she doesn't want to die, she thought she was going to die with COVID, she had every symptom. No Investigation Assessment. The last outcome of 103.5 fever, nausea and severe back pain was recovering, body aches was not recovered, outcome of other events was unknown. Reporter seriousness for 103.5 fever was Medically significant. For severe back pain, body aches and Nausea was Not serious. Relatedness of drug to reactions/events 103.5 fever, severe back pain, body aches and Nausea per source of assessment of Primary Source Reporter and Method of assessment of Global Introspection with drug result of Related.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event pyrexia and remaining events cannot totally be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling, Swelling face
Clinical narrative: her left side of her face which was the site that she had the shot on, on her arm was swelling; she had the shot on, on her arm was swelling; it could be a swollen lymph node; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EL8982, via an unspecified route of administration on 22Jan2021 at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient stated this morning on 23Jan2021 when she woke up her left side of her face which was the site that she had the shot on, on her arm was swelling and she was looking at all the paper work and it says it could be a swollen lymph node. Consumer stated, she asked a doctor about getting it and he said yes, is that the doctor you want.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness at the right side of face and neck; where I was administered I waited 30 minutes and I started feeling like it move across my face; This is a spontaneous report from Pfizer sponsored program from a contactable nurse (patient). A 40-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9263, intramuscular in the right deltoid on 23Jan2021 05:18 am at single dose for covid-19 immunisation.  Medical history included asthma, Sjoegren's syndrome and anxiety, all from an unknown date.  Concomitant medication included duloxetine hydrochloride (CYMBALTA). Historical Vaccine included first dose BNT162B2 for COVID-19 immunization. The patient said that she was still experiencing numbness at the right side of her face and neck after taking the second dose of the COVID-19 Vaccine. She stated she literally drove away from the injection (not clarified) or where she was administered she waited 30 minutes and she started feeling like it move across her face. As to start date of the event the nurse stated that's today 23Jan2021. There was no treatment received. The outcome of the event was not resolved. Relatedness of suspect to event was reported related.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Her arm is sore; This is a spontaneous report from a contactable consumer(patient) from a Pfizer sponsored program. A 76-year-old female patient received the first dose of BNT162B2 (lot number: EL8982), via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. The patient's medical history included asthma and allergy. Concomitant medications included unspecified medication for asthma and allergies. The patient received the first dose of the COVID-19 vaccine and her arm was sore after receiving it, she wanted to know if she can take Tylenol or use an ice pack. The outcome of the event was unknown.
Sex: M
Vaccine: PNC13
Symptoms: Anxiety, Decreased appetite, Hypoacusis, Sleep apnoea syndrome, Snoring
Clinical narrative: vision change; snoring; sleep apnea; change in appetite; anxiety; difficulty hearing; This is a spontaneous report from a Pfizer-sponsored program. A contactable other health professional reported for an 83-year-old male patient received pneumococcal 13- valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, Lot/Batch number not reported), via intramuscular on an unspecified date at 0.5 mL, single for immunisation. Medical history included dementia from 2015, hearing loss, hip replacement. Patient does not drive and need assistance with meal preparation. His wife lays out his clothing, changes his bed sheets. Patient able to shower, feed himself, toilets, shave, brush his hair, eats 3 meals per day. Amount he consumes fluctuates day by day, had difficulty remembering his birth date, was able to tell his name, the town and year. Patient's wife notes he has very poor memory and gets lost easily even if he walks out front of the house. Patient also gets agitated at times especially towards his wife and has gotten upset and broke furniture in his home especially chairs. The patient had a history of dementia and his wife was wanting him evaluated. On an unspecified date, the patient experienced vision change (chronic), difficulty hearing, snoring, sleep apnea, change in appetite and anxiety. The patient reported no dry eyes, irritation, ear pain, sore throat, bleeding gums, dry mouth, mouth ulcers, teeth problems, cough, wheezing, shortness of breath, coughing up blood, abdominal pain, vomiting, constipation, diarrhea, GERD, depression, sleep disturbances, feeling safe in a relationship, alcohol abuse, fever, night sweats, significant weight gain, significant weight loss, exercise intolerance, frequent nosebleeds, nose problems, sinus problems, chest pain, arm pain on exertion, shortness of breath when walking, shortness of breath when lying down, palpitations, known heart murmur, incontinence, difficulty urinating, hematuria, increased frequency, muscle aches, muscle weakness, arthralgias/joint pain, back pain, swelling in the extremities, abnormal mole, jaundice, rashes, laceration, loss of consciousness, weakness, numbness, seizures, dizziness, headaches, fatigue, swollen glands and bruising. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Visual impairment
Clinical narrative: vision change; snoring; sleep apnea; change in appetite; anxiety; difficulty hearing; This is a spontaneous report from a Pfizer-sponsored program. A contactable other health professional reported for an 83-year-old male patient received pneumococcal 13- valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, Lot/Batch number not reported), via intramuscular on an unspecified date at 0.5 mL, single for immunisation. Medical history included dementia from 2015, hearing loss, hip replacement. Patient does not drive and need assistance with meal preparation. His wife lays out his clothing, changes his bed sheets. Patient able to shower, feed himself, toilets, shave, brush his hair, eats 3 meals per day. Amount he consumes fluctuates day by day, had difficulty remembering his birth date, was able to tell his name, the town and year. Patient's wife notes he has very poor memory and gets lost easily even if he walks out front of the house. Patient also gets agitated at times especially towards his wife and has gotten upset and broke furniture in his home especially chairs. The patient had a history of dementia and his wife was wanting him evaluated. On an unspecified date, the patient experienced vision change (chronic), difficulty hearing, snoring, sleep apnea, change in appetite and anxiety. The patient reported no dry eyes, irritation, ear pain, sore throat, bleeding gums, dry mouth, mouth ulcers, teeth problems, cough, wheezing, shortness of breath, coughing up blood, abdominal pain, vomiting, constipation, diarrhea, GERD, depression, sleep disturbances, feeling safe in a relationship, alcohol abuse, fever, night sweats, significant weight gain, significant weight loss, exercise intolerance, frequent nosebleeds, nose problems, sinus problems, chest pain, arm pain on exertion, shortness of breath when walking, shortness of breath when lying down, palpitations, known heart murmur, incontinence, difficulty urinating, hematuria, increased frequency, muscle aches, muscle weakness, arthralgias/joint pain, back pain, swelling in the extremities, abnormal mole, jaundice, rashes, laceration, loss of consciousness, weakness, numbness, seizures, dizziness, headaches, fatigue, swollen glands and bruising. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: she felt just a little tired; she had pain in her left hand; This is a spontaneous report from a contactable consumer.   This 45-Year-Old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection)  from Lot# E81284 at single dose for covid-19 immunization.Medical history included blood pressure and birth control .Concomitant medication included lisinopril (LISINOPRIL) for blood pressure, ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) for birth control, pantoprazole (PANTOPRAZOLE).After the first dose , she felt nothing, just a little tired and she had pain in her left hand. Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Visual impairment
Clinical narrative: I am experiencing a fever of a 100.8; I have very low vision; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (reported as COVID-19 shot), via an unspecified route of administration on 22Jan2021 17:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated "I had the COVID shot last evening around 5 o' clock (22Jan2021 17:00) and now today (23Jan2021) I am experiencing a fever of a 100.8 and I wondered, I don't read well because I have very low vision, so I have to speak to someone, they gave me paper, but I can't read them. So, if you could tell me what I could do for the fever?" The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Headache, Muscle spasms, Pain
Clinical narrative: Headache; cramps; Woke up feeling terrible; Over all body ache; Like no energy; This is a spontaneous report from contactable Pharmacist (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)Lot number EL1284, expiration date 30Apr2021, Intramuscular on 13Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient previously received first dose of BNT162B2 on unknown date. The patient received her second dose of the Pfizer vaccine a week ago on Wednesday, '2 days ago' (not clarified), so it's 9 days ago and she was wondering if she could still have, she felt fine for over a week and then yesterday (22Jan2021) she woke up feeling terrible, just over all body ache, 'cramps' (voice feeble not clarified further) like no energy and she was wondering that. She was getting a headache now from this conversation. She did take Acetaminophen yesterday and she was ready to take it now, that's a bad headache. The outcome of all events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor, Vomiting
Clinical narrative: Uncontrollable shaking; Fever; Vomiting; Achiness; This is a spontaneous report from a contactable consumer(patient).  A patient of unspecified age and gender received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 08:30 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose BNT162B2 for COVID-19 immunization. Patient had second dose on 22Jan2021 about 08:30 AM and around 10 PM, patient had uncontrollable shaking for a couple of hours, just seem like patient couldn't get body to stop shaking and also experienced other side effects fever, vomiting, achiness, all in Jan2021. Outcome of events was unknown.  Information on the lot/ batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Got super dizzy later last night; arms were bit sore; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3248), via an unspecified route of administration in Jan2021 at single dose in arm for COVID-19 immunisation. Medical history was none. Concomitant medications included bupropion, buspirone, fexofenadine hydrochloride (ALLEGRA), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). The patient got the vaccine yesterday around noon and she was just looking at side effects and everything, one of them was listed under severe allergic reactions dizziness and she got super dizzy later last night (Jan2021), it's gone now. The patient wanted to know if that was something that she should go in for if it's okay because it went away. Patient stated because dizziness was listed under like a sign of a severe allergic reaction it didn't happen until probably about 8 hours after and it lasted a couple of hours, but now it's gone so she didn't know if that's something she needed go in for or not. The patient had taken some Advil just because her arms were bit sore (Jan2021) but other than, that was it. No Investigation Assessment. The outcome of the event "Got super dizzy later last night" was recovered in 2021, of "arms were bit sore" was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; 4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 4 patients, calling on behalf of another office. This report is for 4th of 4 patient.   A patient of unspecified age and gender received the 1st and 2nd doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient was tested positive for Covid after receiving the 2nd dose over 15 days before this report/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test 15 days after receiving the whole series on an unspecified date. The patient had no Covid symptoms, feeling fine after both doses. The patient underwent lab tests and procedures which included Sars-cov-2 test (rapid antigen test kit): positive. The outcome of events was unknown. Reporter was wondering if it was a false positive.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076785 same reporter/drug/event, different patient
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Soreness in the right side of neck; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient).   A 71-year-old male patient (weight 102.06 kg and height 178 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL2349) on 22Jan2021, at single dose, for COVID-19 immunisation. Relevant medical history included blood pressure abnormal and blood cholesterol abnormal. Concomitant medications included lisinopril 10 mg, from an unspecified date, for blood pressure abnormal. On 22Jan2021, about an hour after the vaccination, the patient experienced soreness in the right side of his neck. The patient was treated with Tylenol. The patient did not recover from the adverse event at time of this report. The next shot will be received 12Feb2021.   No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Mouth swelling, Swelling face
Clinical narrative: He woke up with his left side of his mouth and face, the lips, the cheeks of the left side are very swollen; He woke up with his left side of his mouth and face, the lips, the cheeks of the left side are very swollen; He woke up with his left side of his mouth and face, the lips, the cheeks of the left side are very swollen; This is a spontaneous report from a contactable consumer reporting on behalf of the husband. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER VACCINE, lot number: EL9262), via an unspecified route of administration on 20Jan2021 at about 9am at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received a first Pfizer vaccine on Wednesday (20Jan2021) morning at about 9am. And he woke up this morning everything was fine until this morning, Saturday morning (23Jan2021) and he woke up with his left side of his mouth and face, the lips, the cheeks of the left side are very swollen. They didn't do any lab work or blood. The patient did not receive any treatment. The only other question was whether he should go to the emergency room. He could breathe, he could swallow. The event outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Having serious side effects; not feeling well; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was having serious side effects and patient just wanted to make sure if it's normal or patient should get concerned. The patient was not feeling well on an unspecified date. The event outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: had soreness in the injection arm; had soreness and achy symptoms in another arm; This is a spontaneous report from a contactable consumer report for self. This patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at arm on 20Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got vaccine (Pfizer, COVID vaccine) on 20Jan2021, initial symptoms just had soreness in the injection arm. Patient woke up in the morning on an unspecified date and had soreness and achy symptoms in another arm. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: All day long I was so cold, my hands were really cold, I couldn't warm up; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients. This is 1st of two reports. A patient of unspecified age and gender received BNT162B2 (Pfizer COVID Vaccine), via an unspecified route of administration, on an unspecified date, at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had Pfizer shot on Thursday on an unspecified date. The patient had vaccination on Thursday and on Friday all day long the patient was so cold, the hands were really cold. Patient couldn't warm up. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021103196 same reporter/drug/event, different patient
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Skin lesion
Clinical narrative: spots on her legs and her arms, they were kind of fluffy; rash on her right cheek/ rash on the right cheek was bright red; This is a spontaneous report from a contactable consumer. An 83-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history was not reported. Concomitant medication included paracetamol (ACETAMINOPHEN), aspirin [acetylsalicylic acid] (ASPIRIN) Baby coated, calcium carbonate, colecalciferol, copper sulfate, magnesium oxide, manganese sulfate monohydrate, zinc oxide (CALTRATE PLUS WITH VITAMIN D AND MINERALS), carmellose sodium (CARBOXYMETHYLCELLULOSE SODIUM), cetirizine hydrochloride, famotidine, hydrochlorothiazide, oxybutynin hydrochloride (OXYBUTIN), simvastatin and Multivitamin. The patient had this vaccine on 21Jan2021 about in the afternoon and everything seem to be fine at that point and she stayed '30' minutes extra for observation and then she was released. About 9 o'clock in the evening she developed a rash on her right cheek. The next morning 21Jan2021 the rash on the right cheek was bright red but it did not itch. By evening, last evening 22Jan2021 the redness had began to fade some also last evening about bed time she noticed spots on her legs and her arms, they were not bright, they were kind of fluffy and again they do not itch." No treatment received for the events. Outcome of rash on the right cheek was bright red was recovering.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: She was so cold; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of 2nd reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient's friend had the Pfizer vaccine yesterday and she was complaining that she was so cold. She has to turn on thermostat in her house. Event outcome was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021103039 same reporter/drug/event, different patient
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Heart rate, Heart rate increased, Pain in extremity, Weight
Clinical narrative: Heart beat is high/I am having my heart beat is fast and usually it's low, I just feel weird; Sore on the arm; This is a spontaneous report from a contactable consumer reporting for self. This 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included acid reflux, stomach relaxer, IBS (irritable bowel syndrome). Concomitant medications included hyoscyamine sulfate for stomach relaxer, omeprazole (PRILOSEC), Vitamin D2, omeprazole for acid reflux. On 23Jan2021, the patient experienced heart beat was high, she was having heart beat was fast and usually it's low, she just feel weird, and also experienced sore on the arm. No treatment received. Lab data included Height: 5ft 5 inches and weight: 140 pounds on unspecified date. The outcome of events was not recovered.  Information about lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Rapid heartbeats; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3247), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rapid heartbeats on 22Jan2021 and did not received treatment. Consumer stated, "48 hours ago on 21Jan2021, I had the Covid-19 vaccine, first shot. I had a rapid heartbeat last night on 22Jan2021. And today this morning on 23Jan2021, I had a rapid heartbeat. It is more than 24 hours later I had rapid heartbeat and I still have it this morning on 23Jan2021". The patient underwent lab test which included Heart beat: increased on 22Jan2021. The outcome of the event was unknown.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: Pain in lower back and hip; Pain in lower back and hip; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included diabetes and hip replacement a year prior to the report. Concomitant medication included insulin degludec (TRESIBA) at 16 units a day for diabetes. The patient experienced pain in lower back and hip on 22Jan2021. Patient stated, he had the shot, the virus shot yesterday (22Jan2021). He woke up this morning with severe pain in his lower back and his hip and he wanted to see that can be a side effect, but he was to report it so he was reporting it. Patient stated event start date was last night (22Jan2021). Doctor told him to take Tylenol 500 mg as treatment. He was due to get the second shot on 11Feb. Therapeutic measures taken as a result of the events included Tylenol 500 mg. The patient didn't have any lab tests. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Periorbital swelling
Clinical narrative: little pain between shoulder blades; eyes are a little baggy; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL, it is 0 or an O, 142 and Expiration Date unknown) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included a reaction once to fish, but when tested his allergies, the allergist said patient did not have the allergy. The concomitant medications were not reported. Patient did not have really any strong side effects. He had little pain between shoulder blades a couple hours when stood up a couple hours later on 22Jan2021. And when woke up this morning and that was gone. His eyes are a little baggy in Jan2021 but that was not concern. Patient wanted to know about whether or not there is squalene in the product. The outcome of events was unknown without treatment given.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Its itching/All the problems that I might be having now like itching around my breast; Rash; This is a spontaneous report from a contactable consumer (wife) and a non-contactable consumer (patient, husband). A (age: 81; unit: unknown) male patient (husband) received BNT162B2 (Pfizer) on 20Jan2021 at single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Patient took the Covid shot on Wednesday (20Jan2021) and he has a rash and its itching. Patient stated problem he might be having now like itching around his breast. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Last night my wife spike to temperature 102.1 and it seem like a long time afterwards; This is a spontaneous report from a contactable consumer. An 83-year-old female patient (wife) was received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 19Jan2021 at single dose for covid-19 immunisation. Medical history was none. There is quite a number of concomitant medications. patient received the Covid 19 vaccine at 1:30 on Tuesday afternoon, they have had no problems since then but last night (22Jan2021) patient spike to temperature 102.1 and it seemed like a long time afterwards that she, because there has been no problems up to that point and it had been over 70 hours since the shot, reporter asked if that was a normal reaction. Treatment for the event was Tylenol. The last outcome of the event was unknown.   Information about lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Throat irritation
Clinical narrative: I had a metallic taste in base of my throat and after that I have like burning in my throat; I had a metallic taste in base of my throat and after that I have like burning in my throat; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 65-year-old female patient received bnt162b2 (BNT162B2, Covid Vaccine, lot: EL3247, Expiration Date: 30May2021), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were none. Consumer stated, "I had the shot (Covid vaccine, Pfizer) a couple of days ago and I experienced the weird side effects. I just wanted to know if that was normal things or if I need to report this? I had a metallic taste in base of my throat and after that I have like burning in my throat. I had another question before you change. I was reading the pamphlets that was given to me at the clinic and it says that it is been in clinic trial an approximately 20,000 individuals have received the vaccine is that all? I had the vaccine on 21Jan2021 and it started immediately afterwards. No, it went away on following day." No treatment received. The outcome of the event was recovered in Jan2021.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysstasia, Gait disturbance, Inflammation, Joint swelling
Clinical narrative: inflamed a little bit in the areas to the interior of my knee toward her upper leg; very painful to stand on or walk on; Very painful to stand on or walk on; left knee had some pain and like a swelling; left knee had some pain and like a swelling; This is a spontaneous report from a contactable consumer (patient). This 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history included blood cholesterol (abnormal) and psoriasis. Concomitant medications included ixekizumab (TALTZ) for psoriasis and statins for cholesterol. The patient took injection on Thursday (21Jan2021) morning. Yesterday (22Jan2021) the patient began to get, her left knee had some pain and like a swelling. The patient didn't know if that's related to the injection. It was not her right knee also, it was only her left knee and it looked like it's inflamed a little bit in the areas to the interior of my knee toward her upper leg. It was very painful to stand on or walk on. The patient did not have any pain at the injection site. She did not have any fever that she was aware of, she had no nausea, she was not dizzy. The patient wanted to know if the reaction that she had in her left knees was possibly connected to the injection. The patient put some ice on it and had no other treatment. Outcome of all events was unknown.   Information on the batch/lot number has been requested.