chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Myocarditis, Troponin increased, Ultrasound scan abnormal
Clinical narrative: Patient is a 39 y.o. male with no significant past medical history who came to the ED with a sudden onset of chest pain that radiated initially to his right shoulder then to his left shoulder, left arm and back with intensity of 7/10 starting Tuesday 4/13/21 associated with sob that is worse when laying flat or taking a deep breath   States he received his second Pfizer vaccine on Sunday, 4/11/2021 at 11 AM and started experiencing fever, chills, headaches, body aches and uncomfortable around 11 PM. He finally decided to take Tylenol x2 on Monday between 2 PM and 11 PM with some relief.  He felt a little better on Tuesday morning and did some work from home but later around 7 PM, he notes a temp of 100.2, experienced body aches which he attributes to Vaccine side effects because his wife was also not feeling well post Vaccine. He went to bed and woke up later with cold sweats, felt pain in his chest and back. He described his chest pain as constant pain/heaviness that "felt like someone is sitting on his chest", he later felt pain in his left arm and back prompting ED evaluation.  He denies similar episodes in the past, denies abdominal complaints, denies lightheadedness or dizziness, palpitations, shortness of breath at rest, orthopnea, PND, syncope, denies urinary complaints, denies smoking, drinks alcohol socially.  States his father has CAD and MI x2 with stent in his 50s, his mother is doing okay with no cardiac history.   In the emergency room, his EKG is consistent with pericarditis, initial troponin noted as 4.24 with repeat noted at 8.91, his LFTs are elevated at 107/123.  He received full dose aspirin, Lopressor 25 mg with improvement in pain.  IMG cardiology is on board with plan for cardiac cath today by doctor.  Echocardiogram showed EF of 35-40% with wall motion abnormalities with initial reading.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Patient is a 39 y.o. male with no significant past medical history who came to the ED with a sudden onset of chest pain that radiated initially to his right shoulder then to his left shoulder, left arm and back with intensity of 7/10 starting Tuesday 4/13/21 associated with sob that is worse when laying flat or taking a deep breath   States he received his second Pfizer vaccine on Sunday, 4/11/2021 at 11 AM and started experiencing fever, chills, headaches, body aches and uncomfortable around 11 PM. He finally decided to take Tylenol x2 on Monday between 2 PM and 11 PM with some relief.  He felt a little better on Tuesday morning and did some work from home but later around 7 PM, he notes a temp of 100.2, experienced body aches which he attributes to Vaccine side effects because his wife was also not feeling well post Vaccine. He went to bed and woke up later with cold sweats, felt pain in his chest and back. He described his chest pain as constant pain/heaviness that "felt like someone is sitting on his chest", he later felt pain in his left arm and back prompting ED evaluation.  He denies similar episodes in the past, denies abdominal complaints, denies lightheadedness or dizziness, palpitations, shortness of breath at rest, orthopnea, PND, syncope, denies urinary complaints, denies smoking, drinks alcohol socially.  States his father has CAD and MI x2 with stent in his 50s, his mother is doing okay with no cardiac history.   In the emergency room, his EKG is consistent with pericarditis, initial troponin noted as 4.24 with repeat noted at 8.91, his LFTs are elevated at 107/123.  He received full dose aspirin, Lopressor 25 mg with improvement in pain.  IMG cardiology is on board with plan for cardiac cath today by doctor.  Echocardiogram showed EF of 35-40% with wall motion abnormalities with initial reading.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Ejection fraction, Myocarditis, Troponin I
Clinical narrative: Patient is a 39 y.o. male with no significant past medical history who came to the ED with a sudden onset of chest pain that radiated initially to his right shoulder then to his left shoulder, left arm and back with intensity of 7/10 starting Tuesday 4/13/21 associated with sob that is worse when laying flat or taking a deep breath   States he received his second Pfizer vaccine on Sunday, 4/11/2021 at 11 AM and started experiencing fever, chills, headaches, body aches and uncomfortable around 11 PM. He finally decided to take Tylenol x2 on Monday between 2 PM and 11 PM with some relief.  He felt a little better on Tuesday morning and did some work from home but later around 7 PM, he notes a temp of 100.2, experienced body aches which he attributes to Vaccine side effects because his wife was also not feeling well post Vaccine. He went to bed and woke up later with cold sweats, felt pain in his chest and back. He described his chest pain as constant pain/heaviness that "felt like someone is sitting on his chest", he later felt pain in his left arm and back prompting ED evaluation.  He denies similar episodes in the past, denies abdominal complaints, denies lightheadedness or dizziness, palpitations, shortness of breath at rest, orthopnea, PND, syncope, denies urinary complaints, denies smoking, drinks alcohol socially.  States his father has CAD and MI x2 with stent in his 50s, his mother is doing okay with no cardiac history.   In the emergency room, his EKG is consistent with pericarditis, initial troponin noted as 4.24 with repeat noted at 8.91, his LFTs are elevated at 107/123.  He received full dose aspirin, Lopressor 25 mg with improvement in pain.  IMG cardiology is on board with plan for cardiac cath today by doctor.  Echocardiogram showed EF of 35-40% with wall motion abnormalities with initial reading.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Hypoaesthesia, Paraesthesia
Clinical narrative: Lump in her left armpit; Left side numbness and tingling; Left side numbness and tingling; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 09Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included sertraline hydrochloride (ZOLOFT), gabapentin, and calcium carbonate/ colecalciferol (VITAMIN D 2000).  The patient previously took ketorolac tromethamine (TORADOL) and experienced allergies; and the first dose of BNT162B2 on 21Dec2020 at 06:00 PM for COVID-19 immunization (intramuscular in left arm). The patient was not diagnosed with COVID-19 prior vaccination. The vaccine was administered in a hospital facility. On 11Jan2021, the patient had a lump in her left armpit and it finally has shrunk. The patient also had left side numbness and tingling on 11Jan2021. The adverse events resulted in emergency room or department or urgent care. No treatment was received for the adverse events. The patient has not been tested for COVID-19 post-vaccination. The patient was recovering from the events.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Cough, Therapeutic product effect delayed
Clinical narrative: Allergies got pretty bad after the first dose, probably a week and a half afterwards; Cough; delayed reaction; This is a spontaneous report from a contactable consumer (Patient). A 28-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 21Dec2020 08:30 (Batch/Lot Number: EJ1686) as SINGLE DOSE for covid-19 immunisation. Medical history included Allergies from an unknown date and unknown if ongoing. The patient's concomitant medications were reported as none. The patient had no family medical history. The patient did not receive any other vaccines on the same day of suspect vaccine. Caller was reporting he had a delayed reaction to the Covid vaccine (Dec2020). He saw his allergist and primary care provider. The primary care informed him that she had 2 other patients who this has happened with and they had rashes. Unable to provide any further details about the 2 other patients. Mentioned he also gets allergy injections. Also had the second one and his allergies were much worse. Allergies got pretty bad after the first dose, probably a week and a half afterwards. He also had a cough. He got the second dose and didnot think much of it and his allergies. Knows some have allergies worse than others. He ended up having flu like symptoms 12 hours afterwards and cough. It's been a month and he still has cough. The day before yesterday he had a lot of breathing issues that were so bad he had to get a updraft of Albuterol to help. Yesterday he saw the primary care provider and she gave him a steroid injection and it seemed to help quite a bit also. He still has some other minor issues, but they were not so bad. Outcome of the events allergy to vaccine and cough were not recovered and unknown for other event.  Follow-up attempts are completed. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Sudden diarrhea; This is a spontaneous report from a contactable consume (patient). A 84-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration in right arm on 03Feb2021 at 09:45 as single dose for COVID-19 immunization. Medical history included chronic kidney disease. Concomitant medications included Symbicort, Montelukast SOD, Terazosin, Famotidine. Historical vaccine included BNT162B2 (Lot unknown=False, Dose number=1) for COVID-19 immunization. On 05Feb2021, the patient experienced sudden diarrhea. Outcome of the event was recovered on an unspecified date 2021.  Information about lot/batch number requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: have been exposed to Covid and are going to go get tested today; This is a spontaneous report from a contactable consumer. This consumer reported similar events for himself and his wife. This report is for reporter's wife. This consumer reported for a female patient (wife) that:  A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 15Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Patient had first dose on the vaccine on 15Jan2021 and were scheduled to get our second dose on 05Feb. The patient medical history and concomitant medications were not reported. Patient had been exposed to Covid on an unspecified date and were going to go get tested today.  Patient was enquiring about to get the second dose if test positive. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021085494 same reporter/drug/event, different patient
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Back pain, Body temperature, Chills, Nasopharyngitis
Clinical narrative: slight fever 99.7 early evening 07Feb; lower abdomen pain thru to back; lower abdomen pain thru to back; then woke to cold and shivering lasting 2hours that night; then woke to cold and shivering lasting 2hours that night; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old male patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration in right arm on 06Feb2021 at 03:45 AM as single dose for COVID-19 immunization. Medical history included hypertension, chronic obstructive pulmonary disease. Allergies included shellfish allergy. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. On 07Feb2021 at 19:00, the patient experienced slight fever 99.7 early evening, lower abdomen pain thru to back, woke to cold and shivering lasting 2hours that night. The clinical outcome of the events slight fever 99.7 early evening, lower abdomen pain thru to back was unknown and the event woke to cold and shivering lasting 2hours was recovered. The patient underwent lab tests and procedures which included body temperature: 99.7 on 07Feb2021.  No follow-up attempts are possible and no further information is required.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: slight fever 99.7 early evening 07Feb; lower abdomen pain thru to back; lower abdomen pain thru to back; then woke to cold and shivering lasting 2hours that night; then woke to cold and shivering lasting 2hours that night; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old male patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration in right arm on 06Feb2021 at 03:45 AM as single dose for COVID-19 immunization. Medical history included hypertension, chronic obstructive pulmonary disease. Allergies included shellfish allergy. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. On 07Feb2021 at 19:00, the patient experienced slight fever 99.7 early evening, lower abdomen pain thru to back, woke to cold and shivering lasting 2hours that night. The clinical outcome of the events slight fever 99.7 early evening, lower abdomen pain thru to back was unknown and the event woke to cold and shivering lasting 2hours was recovered. The patient underwent lab tests and procedures which included body temperature: 99.7 on 07Feb2021.  No follow-up attempts are possible and no further information is required.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Musculoskeletal stiffness, Pain, Tenderness
Clinical narrative: muscle tenderness; stiffness in his upper shoulder and the neck; stiff neck and shoulder; local light pain; This is a spontaneous report from a contactable physician (patient). A 81-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: EL9261, expiration date: unknown), via an unspecified route of administration in the left arm on 21Jan2021at 12:50 as a SINGLE DOSE for COVID-19 immunization. Medical history included back pain and arthritis. Concomitant medications include propafenone taking for more 5 year still ongoing for indication atrial fibrillation and dutasteride taking for a year and half still ongoing for indication prostate. No history of all previous immunization with Pfizer vaccine and no prior vaccination in four weeks. On 21Jan2021, received first dose of the vaccine about 2 and a half weeks ago. He stated, it went fine but the day after, on 22jan2021 had some muscle tenderness (local light pain) and stiff neck and shoulder developed that was pretty mild but it was still going. It's about 2 and a half weeks now. In the morning it was maybe a tad more stiff mostly on left arm, it improved some when walking around and with exercising so he doesn't have to take medication. He stated, when you don't move it doesn't hurt, it's when you move the neck muscle that it was sore but not much at all. At his age you have back pain and a little arthritis. It was strange that it started the day of or day after. He stated he did report just a bit of local pain but only when you touch the area and a very mild muscle pain, but it has continued and he doesn't know if it was related. He asked if this was related to the vaccine and how long this typically lasts. Mentioned he has had this pain before but he feels that he has avoided exercise or yoga or anything that would cause it now. he does have arthritis in his back. He was scheduled to receive the second dose of the vaccine on 11Feb2021. He didn't receive any treatment for the events. The clinical outcome of the events was still unsure if he had this before vaccine or not and its persisting.The outcome of all events were not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Starting getting a rash in the form of chicken pox like bumps that itched all over my body.; Starting getting a rash in the form of chicken pox like bumps that itched all over my body.; This is a spontaneous report received from a contactable consumer (patient). A 39-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: El1284, Expiration date was not reported), via an unspecified route of administration in Arm Left on 16Jan2021 15:30 as single dose for covid-19 immunization. The patient had no relevant medical history and had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC), buspirone HCL and Yeast Gard supplement. On 26Jan2021, the patient started getting a rash in the form of chicken pox like bumps that itched all over my body. The patient's adverse event resulted in emergency room/department or urgent care. The patient received treatment with steroid pill and topical cream. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: I already received the 1st dose of the vaccine. We had a painter that did work in our house and he has been diagnosed with COVID, we're currently under quarantine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (age 78, unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (COVID-19 Vaccine). The patient medical history and concomitant medications were not reported. The patient experienced I already received the 1st dose of the vaccine. we had a painter that did work in our house and he has been diagnosed with covid, we're currently under quarantine (non-serious) on an unspecified date. Question: I already received the 1st dose of the vaccine. We had a painter that did work in our house and he has been diagnosed with COVID, we're currently under quarantine. I'm supposed to get the 2nd dose of the vaccine on Wednesday, 10Feb2021. Would it be okay for to take it on that day or should I wait until quarantine is over? Please help me. Would it cause harm if you got the first dose, and you didn't get the 2nd dose? The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: her husband has since tested positive for Sars-cov-2; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her husband has since tested positive for sars-cov-2. The report received as, consumer who received her first dose of Pfizer-Biontech covid19 vaccine, and her husband has since tested positive for Sars-cov-2. Her husband is quarantined in a separate room of the house, she's asking if she needs to continue to quarantine away from the rest of the world. This report type was non-serious. Outcome of the event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder pain; This is a spontaneous report from a contactable consumer. A 85years male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Deltoid Right on 08Feb2021 10:30 (Batch/Lot Number: EL9265) as single dose, dose 2 intramuscular, administered in Deltoid Left on 08Mar2021 10:45 (Batch/Lot Number: EN6205) as single dose for covid-19 immunization.The patient Medical history included blood pressure measurement, blood cholesterol, urinary incontinence, benign prostatic hyperplasia, hypothyroidism. (All ongoing). The Concomitant medications included irbesartan (IRBESARTAN, formulation: Tablet) taken 150 mg for blood pressure measurement, start and stop date were not reported; lovastatin (LOVASTATIN, formulation: Tablet) taken 20 Mg for cholesterol, start and stop date were not reported; oxybutyn-in chloride (OXYBUTYNIN CHLORIDE, formulation: Tablet) taken 15 mg for Bladder control, start and stop date were not reported; doxazosin (DOXAZOSIN, formulation: Tablet) taken 2mg  for benign prostatic hyperplasia, start and stop date were not reported; levothyroxine (LEVOTHYROXINE, formulation: Tablet) taken 50 Mg for thyroid, start and stop date were not reported.  It was re-ported that Scheduled for second dose more than 21 days. The patient wanted to know it was okay that the 2nd dose is scheduled 08Mar, 4 weeks after the 1st dose. He enquired to whom he should talk to about getting his appointment changed. The patient took the second vaccination on 08Mar2021 on the left shoulder. Both vaccination shoulder pain after 8 hrs. No treatment was provided for the event. The outcome of the event was recovered by morning after injection on unspecified date.  No follow-up attempts are needed. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: only had a sore arm; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (Daughter) reported for a 90-year-old female patient (mother) received second dose in left arm on 13Feb2021 at single dose for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. Patient received first dose of BNT162B2 (Lot Number: EL1283) on 21Jan2021. The patient reported that her mother received the 2nd dose of vaccine 3 weeks and 2 days (2 days late) on 13Feb2021. Patient only had a sore arm, no other symptoms, no treatment received. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up (22Mar2021): New information reported from a contactable consumer included: add event "only had a sore arm", remove event "Received the 2nd dose of vaccine 3weeks and 2 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure to SARS-CoV-2, Sputum discoloured
Clinical narrative: exposed to his son that tested positive; chills; green Phlegm; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient, self-reported). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration dates were unknown) on 21Jan2021 and second dose on 11Feb2021: both via an unspecified route of administration, as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated that she was exposed to his son that tested positive. Now she was experiencing chills and green Phlegm. At the time of reporting the outcome of the events were unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: got exposed to a COVID positive; This is a spontaneous report received from a contactable consumer (reporting on himself) via Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration on 23Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that on 23Jan2021 patient received his first dose of BNT162B2 and on 01Feb2021, got exposed to a COVID positive. He tested COVID positive. Patient was asking If he should take second dose of vaccine. The outcome of the event was unknow.    Information on the batch/lot number requested.     Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Increased viscosity of upper respiratory secretion, Pyrexia, Respiratory tract congestion
Clinical narrative: Night fever; chest congestion; Chill; Getting a little bit mucus/mucus is thick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 03Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included 20 years ago she had a walking pneumonia. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2) via an unspecified route of administration as SINGLE DOSE for covid-19 immunisation. It was reported that the patient got the second dose 6 days ago (03Feb2021) and currently experiencing Night fever and Chill and Getting a little bit mucus. The patient was asking if pneumonia or symptoms of pneumonia have been reported after gettting the second covid vaccination and if not how long with her congestion, mucous chills and fever last. She reported that 20 years ago she had a walking pneumonia that felt similar to this and was worried that the vaccine could cause her to have it again. She took her second shot on the third (03Feb2021). For the last two nights (Feb2021) she has had chills and a little fever. She is concerned if this can give pneumonia. She wanted to know has anyone reported pneumonia from it. She has chest congestion and her mucus is thick. It was six days ago. She knew it was something to expect, but she didn't know for how long. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: had a little aches and pains; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3302), dose 1 via an unspecified route of administration on 20Jan2021 as single dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient stated that, she received her first vaccine on 20Jan2021. Stated that she had a little aches and pains that day which resolved with Tylenol. Stated that she has a vaccination for tomorrow. Stated that she has been exposed to a Covid positive person in her family. Wanted to know if she should get a test, quarantining or get her second shot tomorrow. Stated that she does not want to miss the second vaccine and does not want to expose other people. Outcome of the event had a little aches and pains was recovered on 20Jan2021.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills and aches all over; Chills and aches all over; This is a spontaneous report received from a contactable consumer (patient).A 35 year old non-pregnant female patient received second dose of BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number - el3248) via an unspecified route of administration in the right arm on 08Feb2021 at 01:15 PM (at the age of 35year old ) as single dose for COVID-19 immunization. Patient historical vaccine included first dose of BNT162B2 (BNT162B2, Formulation: solution for injection, lot number unknown) via an unspecified route of administration on 20Jan2021 at 03:30 PM as single dose for COVID-19 immunization and no known allergies. The patient received flu vaccines within 4 weeks prior to the COVID-19 vaccination. The concomitant medication includes Flu. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19.On 09Feb2021 at 09:00 AM, the patient experienced Chills and aches all over. The outcome of the event was recovering.  No follow-up attempts are possible. No further information was expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Woke at 4 am with a the right side of my tongue swollen; This is a spontaneous report from a contactable 50-year-old non-pregnant female consumer reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN5318, Expiration date: unknown) via an unspecified route of administration on Left arm on 02Feb2021 at 20.45 at single dose for COVID-19 Immunization. The patient medical history included thyroid disease and Allergies to Augmentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. Concomitant medication included Levothyroxine sodium (88mcg). On 03Feb2021 04:00 am, the patient waited for 15 minutes required and did not feel anything, patient went home, went to bed. Woke at 4 am with a the right side of my tongue swollen. The patient did not receive any treatment. The outcome for event was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: Extreme debilitating depression for approximately 4 days post vaccine.; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number EL9264) via an unspecified route of administration, in left arm on 02Feb2021 at 22:00 as single dose for Covid-19 immunization. The patient was not pregnant. The patients medical history included coeliac disease, autoimmune thyroiditis, fibromyalgia and hypertension. Concomitant medications included hydrochlorothiazide, lisinopril, liothyronine sodium (T3), levothyroxine sodium (T4). The medical history include allergy to Compazine, Wellbutrin and Midrin. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. On 04Feb2021 the patient experienced extreme debilitating depression for approximately 4 days post vaccine. The patient did not receive any treatment for the event. The clinical outcome of the event was recovering.    No follow-up attempts are possible. No information is required.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Pain in extremity
Clinical narrative: swollen interphalangeal joints (both hands) with pain; I developed swollen interphalangeal joints (both hands) with pain and resolvable "locking" of my middle fingers; This is a spontaneous report from a contactable Pharmacist (Patient). A 59-Year-old male patient reported for himself that he received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number: EL0140; Expiry date: Unknown) via an unknown route of administration in the left arm on 11Jan2021 at 12:30PM as a single dose for COVID-19 immunization. The patient did not have COVID-19 prior to vaccination. The patients past medical history included Diabetes (Type 2), Hypertension and Hypercholesterolemia. The patient did not have any known allergies. Concomitant medication were not reported. On 18Jan2021, at 07:00 AM seven days after receiving initial COVID-19 vaccine, Patient developed swollen interphalangeal joints (both hands) with pain and resolvable "locking" of my middle fingers. Nine days after second COVID-19 vaccine, the issue resolved. The patient did not receive any treatment. The clinical outcome of developed swollen interphalangeal joints (both hands) with pain and resolvable "locking" of my middle fingers were considered recovered.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Pyrexia
Clinical narrative: feeling very cold; Chills; fever; severe headache; This is a spontaneous report from a contactable consumer or other non hcp. A 26-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration in left arm on 09Feb2021 02:45 (at 26-years age) as single dose for COVID-19 immunisation. Medical history included arthritis. Concomitant medication(s) included meloxicam (MELOXICAM) ;amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Previously he received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration in left arm on 19Jan2021 02:45 as single dose for COVID-19 immunisation. He received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Feb2021. The patient experienced chills and feeling very cold last night and this morning severe headache and fever on 10Feb2021 12:00. Patient not tested for COVID-19 after the vaccination. No treatment received for reported adverse event. The outcome of the events was not resolved.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Slight UTI infection; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ELT283), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunisation. Medical history included acid reflux and anxiety. Concomitant medications included lisinopril for blood pressure, levothyroxine (SYNTHROID) for thyroid from 10 years. The patient stated that she had her first shot of the Pfizer covid vaccine and she did fine. she is scheduled to get the second dose today and over the weekend she was prescribed Cephalexin for slight UTI infection, have not taken it yet, Famotidine took one dose 2 days ago antacid, sucralfate took one dose a day ago. Patient wanted to know any interactions with covid vaccine. It was reported that saturday night she had really bad acid reflux. she went to the hospital and she was prescribed Keflex. She knew she was going to get the second shot of the covid vaccine today and has not started taking Keflex. She was also given famotidine which she states is like a prescription pepcid. She took one famotidine one or two days ago. She has not taken any medication since she did not want to have any interaction with the vaccine. She was also given sucralfate and she took one sucralfate yesterday or the day before. Reports she has been on levothyroxine for her thyroid and lisinopril for her blood pressure for years. She is asking since she is supposed to be getting the second shot today if she can she start taking keflex after she has the shot or does she have to wait. She would like to start taking it. She took it upon herself and called the pharmacy since she could not get a hold of her doctor. She has not been able to get any answers. On 06Feb2021 she found out she had a slight urinary tract infection (UTI) when she went to the ER Saturday. She did not even know she had a UTI. Confirms she was not admitted to the hospital. She has struggled with acid reflux before, states it is not a reaction to the vaccine. Her acid reflux got really bad and she thinks it was due to some anxiety going on and it exasperated it. She is 69 years old. She just wanted to make sure nothing would interact. She has to leave to go to her appointment and does not have time to complete a report. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: headache; body ache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2, Solution for injection) via an unspecified route of administration in Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that on an unspecified date in 2021, she wanted to know if she can get the second dose a week later or earlier than the scheduled time like 2 days earlier. On unspecified date 2021 patient experienced headache and body ache upon receiving first dose of bnt162b2. The case was classified as non-serious. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: had their first vaccine on 26Jan2021; She tested positive 31Jan2021; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 1st of 2 reports. A 28 years female patient received first dose of vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: not provided), via an unspecified route of administration on 26Jan2021,as single dose for COVID-19 immunisation. The patient's medical history and concomitant was not reported. Reporter stated that she aged 28, and boyfriend, aged 23 had got Pfizer Covid vaccine three weeks ago, and then he tested positive on 28Jan2021. She tested positive on 31Jan2021. Patient stated her boyfriend was getting sick with it right before the vaccine but they did not know. He is no longer experiencing side effects and she is. Reporter stated that they both have an appointment scheduled for the 2nd vaccine and is wondering if it is okay to get it. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (10Feb2021): This is a follow-up spontaneous report from a contactable consumer.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Nausea, Neck pain, Pain in extremity
Clinical narrative: Neck pain/whiplash like neck pain/pain also moving up into neck / Neck tenderness persisted; severe nausea; pain down from injection site; pain down from injection site to in between 3rd and 4th fingers; pain also moving up into neck and upper spine that began; Neck pain/whiplash like neck pain/pain also moving up into neck / Neck tenderness persisted; This spontaneous report from a contactable Nurse (Patient).   A 33-year-old female patient (non-pregnant) received second dose BNT162B2 (PIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration, administered in Right arm on 02Feb2021 07:30 AM for COVID-19 immunisation. The patient medical history not reported. Concomitant medications included ibuprofen (The patient received ibuprofen within 2 weeks of vaccination). There were no allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Patient received first dose of BNT162B2 (PIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL5249), via an unspecified route of administration, administered in Right arm on 12 Jan 2021 09:00 AM for COVID-19 immunisation. On 02Feb2021, 9:30PM, the patient had neck pain stemmed from injection site approximately 14h post vaccination, along with severe nausea. 24h post vaccination whiplash like neck pain that lasted approximately 24h. Neck tenderness persisted, although not severe after 24H. "Tingly" pain down from injection site to in between 3rd and 4th fingers, pain also moving up into neck and upper spine that began about 4 days post vaccination. Unable to get relief with Tylenol, Motrin or muscle relaxers. At the time of this report event outcome was not recovered.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain
Clinical narrative: Neck pain/whiplash like neck pain/pain also moving up into neck / Neck tenderness persisted; severe nausea; pain down from injection site; pain down from injection site to in between 3rd and 4th fingers; pain also moving up into neck and upper spine that began; Neck pain/whiplash like neck pain/pain also moving up into neck / Neck tenderness persisted; This spontaneous report from a contactable Nurse (Patient).   A 33-year-old female patient (non-pregnant) received second dose BNT162B2 (PIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration, administered in Right arm on 02Feb2021 07:30 AM for COVID-19 immunisation. The patient medical history not reported. Concomitant medications included ibuprofen (The patient received ibuprofen within 2 weeks of vaccination). There were no allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Patient received first dose of BNT162B2 (PIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL5249), via an unspecified route of administration, administered in Right arm on 12 Jan 2021 09:00 AM for COVID-19 immunisation. On 02Feb2021, 9:30PM, the patient had neck pain stemmed from injection site approximately 14h post vaccination, along with severe nausea. 24h post vaccination whiplash like neck pain that lasted approximately 24h. Neck tenderness persisted, although not severe after 24H. "Tingly" pain down from injection site to in between 3rd and 4th fingers, pain also moving up into neck and upper spine that began about 4 days post vaccination. Unable to get relief with Tylenol, Motrin or muscle relaxers. At the time of this report event outcome was not recovered.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature abnormal, Bronchitis, Circumstance or information capable of leading to medication error
Clinical narrative: Received two steroid shots and curious if steroid shots weaken the COVID-19 Vaccine; Bronchitis; weak; Had a bad temperature on Thursday; did not feel good; tickling in her throat with a dry little cough; tickling in her throat with a dry little cough; This is a spontaneous report from a contactable consumer reporting for herself. An 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9262, expiration date: May2021), via an unspecified route of administration on left arm on 01Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient medical history included Minimal COPD and Had bronchitis all winter of last year. The patient did not receive any other products. The patient received two steroid shots in physician's office for bronchitis on left hip on 08Feb2021. The patient received flu shot in the Fall; not within 4 weeks prior to the COVID vaccine. Historical vaccines included first dose of BNT162B2; Solution for injection; Lot number: EL3246, expiration date: Apr2021), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization and had no problem with first COVID-19 Vaccine. The patient had no problem with first COVID-19 Vaccine. On an unspecified date after the second vaccine, the patient felt fine after she got the second COVID-19 Vaccine. Tuesday night, she started having tickling in her throat with a dry little cough. Wednesday, Thursday and Friday, she did not feel good. Had a bad temperature on Thursday (for one day). The patient thought that she was told not to get shots for 14 days after first vaccine. The patient felt curious if steroid shots weaken the COVID-19 Vaccine. The Treatment included the patient took Tylenol for the body temperature. The outcome of the events body temperature was recovered, and bronchitis was not recovered while other events was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Malaise, Throat irritation
Clinical narrative: Received two steroid shots and curious if steroid shots weaken the COVID-19 Vaccine; Bronchitis; weak; Had a bad temperature on Thursday; did not feel good; tickling in her throat with a dry little cough; tickling in her throat with a dry little cough; This is a spontaneous report from a contactable consumer reporting for herself. An 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9262, expiration date: May2021), via an unspecified route of administration on left arm on 01Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient medical history included Minimal COPD and Had bronchitis all winter of last year. The patient did not receive any other products. The patient received two steroid shots in physician's office for bronchitis on left hip on 08Feb2021. The patient received flu shot in the Fall; not within 4 weeks prior to the COVID vaccine. Historical vaccines included first dose of BNT162B2; Solution for injection; Lot number: EL3246, expiration date: Apr2021), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization and had no problem with first COVID-19 Vaccine. The patient had no problem with first COVID-19 Vaccine. On an unspecified date after the second vaccine, the patient felt fine after she got the second COVID-19 Vaccine. Tuesday night, she started having tickling in her throat with a dry little cough. Wednesday, Thursday and Friday, she did not feel good. Had a bad temperature on Thursday (for one day). The patient thought that she was told not to get shots for 14 days after first vaccine. The patient felt curious if steroid shots weaken the COVID-19 Vaccine. The Treatment included the patient took Tylenol for the body temperature. The outcome of the events body temperature was recovered, and bronchitis was not recovered while other events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: He had shot pain; This is a spontaneous report from a Pfizer sponsored program. A contactable unspecified aged male consumer (Patient himself) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection) via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date around after 2 days of vaccination, the patient experienced shot pain. He stated that recently he saw an article produced by (Company name) to avoid Ibuprofen / Advil because it may reduce the effectiveness of the vaccine. He wanted to know why the CDC or the HCP did not let them know or informed about it prior to the 1st dose and how many days he could take Cortisone shot after the 2nd dose of vaccine. The patient doesn't want to get transferred because he doesn't want to wait. The patient took Tylenol as a treatment for the event. The outcome of the event was unknown.  Information on the Lot/batch number has been requested.