chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain assessment, Vaccination site haemorrhage
Clinical narrative: constant pain in my neck. On a scale of 1-10 it's a 6-7; Upon getting shot in my left arm, not only did my arm bleed; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 15:00 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation, at 22 years old. The patient has no medical history. The patient's concomitant medications were not reported. Patient is not pregnant. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient has no known allergies. On 15Apr2021 15:15, upon getting shot in patient's left arm, not only did patient's arm bleed after, but a minute or two (15:16) after she had a constant pain in her neck. On a scale of 1-10 it's a 6-7. Treatment was not given. Outcome of the event was not recovered.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Lethargy, Pyrexia
Clinical narrative: 100.3 fever; Minor lethargy; Occasional chills; Minor headache; This is a spontaneous report from a contactable consumer (Patient).  A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL3247), dose 2 via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. The patient medical history was not reported. Concomitant medication included finasteride, 1mg daily for several years. The patient previously took first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. On 13Apr2021 the patient experienced 100.3 F fever, occasional chills, minor headache, and minor lethargy after 2nd dose of Pfizer vaccination. symptoms started approximately 20 hrs after vaccination. Patient stated that it was just his body immune response. He no underlying conditions, borderline obese and no significant allergies.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: came in for her second dose of the Pfizer covid vaccine, but tested positive for covid 19 yesterday; came in for her second dose of the Pfizer covid vaccine, but tested positive for covid 19 yesterday; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The pharmacist reported that a patient came in for her second dose of the Pfizer COVID vaccine, but tested positive for COVID 19 yesterday (14Apr2021) and asked if they need to start the series over. The outcome of the events was unknown.  Information about the lot/batch number requested.; Sender's Comments: Based on the limited information in the case report and known drug safety profile, A possible causal relationship between event Covid-19 and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Gastrooesophageal reflux disease, Headache, Taste disorder
Clinical narrative: Headache; presented tightness of chest; bad taste in her mouth./she still has the taste in her mouth; she has acid reflux; she felt really dizzy; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 15Apr2021 09:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 15APR2021, the patient experienced headache, presented tightness of chest, bad taste in her mouth/she still has the taste in her mouth, she has acid reflux, she felt really dizzy. Caller states she wants to know if that is normal and if she can take the second one. The events were considered as non-serious. The outcome of the event bad taste in her mouth was not recovered and other events was recovered in Apr2021.
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Malaise, Nausea, Nephrolithiasis, Obstructive airways disorder
Clinical narrative: felt like he had kidney stones; couldn't swallow his food and it felt like the "food wouldn't go down/wouldn't pass; almost turned blue; felt like his airway was closed up; felt deathly ill; he might throw up; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included the patient had "many health conditions" (unspecified) and was a smoker. Concomitant medications were not reported. On an unspecified date, after the first dose, the patient felt like he had kidney stones. On an unspecified date, the patient could not swallow his food and it felt like the food would not go down/ would not pass. His wife stated that he looked so uncomfortable and almost turned blue. The patient stated it felt like his airway was closed up. He said he laid in bed, feeling like he was deathly ill and like he might throw up for about 5 minutes, then the sensation passed. This happened at 4 meals following vaccination and has since resolved. The clinical outcome of felt like he had kidney stones was unknown; of "couldn't swallow his food and it felt like the "food wouldn't go down/wouldn't pass", almost turned blue, felt like his airway was closed up, felt deathly ill, he might throw up was resolved on an unspecified date.   No follow-up attempts are needed; information about lot or batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: felt like he had kidney stones; couldn't swallow his food and it felt like the "food wouldn't go down/wouldn't pass; almost turned blue; felt like his airway was closed up; felt deathly ill; he might throw up; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included the patient had "many health conditions" (unspecified) and was a smoker. Concomitant medications were not reported. On an unspecified date, after the first dose, the patient felt like he had kidney stones. On an unspecified date, the patient could not swallow his food and it felt like the food would not go down/ would not pass. His wife stated that he looked so uncomfortable and almost turned blue. The patient stated it felt like his airway was closed up. He said he laid in bed, feeling like he was deathly ill and like he might throw up for about 5 minutes, then the sensation passed. This happened at 4 meals following vaccination and has since resolved. The clinical outcome of felt like he had kidney stones was unknown; of "couldn't swallow his food and it felt like the "food wouldn't go down/wouldn't pass", almost turned blue, felt like his airway was closed up, felt deathly ill, he might throw up was resolved on an unspecified date.   No follow-up attempts are needed; information about lot or batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: so his granddaughter went to get tested and was positive for COVID/probably contracted COVID before the vaccine but tested positive after receiving the vaccine; so his granddaughter went to get tested and was positive for COVID/probably contracted COVID before the vaccine but tested positive after receiving the vaccine; This is a spontaneous report from a contactable pharmacist. A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 28Mar2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient had her first Pfizer COVID 19 vaccine on 28Mar2021 and her coworker tested positive so the patient went to get tested and was positive for COVID. The reporter stated that the patient was feeling much better now but she had the vaccine on 28Mar2021 and probably contracted COVID before the vaccine but tested positive after receiving the vaccine. The reporter stated the patient was scheduled for her second dose on 18Apr2021 and wondering if she can get the vaccine since she has had COVID in between the vaccines. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm next day; This is a spontaneous report from a contactable consumer (patient). This 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 18:15 (Lot :EN9581) at single dose for COVID-19 immunisation. Medical history included hepatitis b chronic from 05Sep2002 , high blood pressure from 25Jan1995 , late effect of cardioembolic stroke from 14Jan2005 , nerve entrapment of hand ,neuroma hand from  10Jan2006 , diabetes type 2 without retinopathy from 20Dec2006 , atrial fibrillation from 23Aug2007 , coronary artery disease from 01May2009 , depression from 06Mar2010 , left heart failure from 29Apr2013 , slow heart rate from 18Apr2014 and bradycardia  from 27Apr2014, duodenal ulcer from Apr1997, gallstone and acute cholecystitis with obstruction from 27Jul2016, clotting or bleeding disorder (coagulopathy) from 27Jul2016, lipoma (fatty mass) from 27Aug2016, moderate chronic kidney (disease) from 16Sep2017, left ventricular (hypertrophy) from 16Sep2017, Chronic low back pain with lumbar radiculopathy from 16Jan2019 and lumbar disc herniation with radiculopathy from 17Jan2019, iliac artery aneurysm (left and right) from 27Feb2019, right iliopsoas bursitis from 26Mar2018, Benign prostatic hyperplasia from 11Apr2018, Arthritis of (right and left hand) from 17Apr2018. Concomitant medications included warfarin; entecavir; metoprolol; losartan; bupropion; glipizide; metformin; diltiazem hydrochloride (DILT-XR); atorvastatin, all were ongoing. Patient felt sore arm next day on 28Jan2021. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary congestion
Clinical narrative: chest congestion for one and half week; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown date (at an unknown age) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient had chest congestion for one and half week and was prescribed azithromycin (Z-PAK) and MUCINEX (expectorant). The outcome of the event chest congestion was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, Body temperature decreased, Chills
Clinical narrative: Low body temperature; Fatigue; Anxiety; Brain fog; High BP/Pressure in head and high blood pressure; Severe chills; Strange redness across her shoulders; Arm hurt after shot; Pressure in head; Very loose stools; Nausea; This is a spontaneous report from a contactable consumer reporting for herself.  A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 13:30 (Batch/Lot Number: EP7533) as single dose for covid-19 immunisation  (Age at vaccination: 59 years) .  Medical history included liver disorder , hypersensitivity, hepatitis C  from , osteopetrosis , arthropod sting allergy , drug hypersensitivity  , gluten sensitivity  (She is borderline celiac, and she will get really bad gastro problems for 2 or 3 days after digesting gluten) , penicillin hypersensitivity  (She has itching, rash, nausea) , peanuts allergy (Keeps an EPI pen for this). Concomitant medications  included d-ribose, polypeptide (TRANSFER FACTOR [D-RIBOSE;POLYPEPTIDE]) taken for hepatitis C from 2003 to 03Apr2021; ascorbic acid (VITAMIN C ACID) taken for an unspecified indication from an unspecified start date to 03Apr2021; vitamin D3 (VITAMIN D3) taken for osteopetrosis from an unspecified start date to Apr2021; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported.   The patient experienced high bp/pressure in head and high blood pressure  on 05Apr2021 with outcome of unknown , fatigue  on an unspecified date with outcome of unknown , severe chills  on 05Apr2021 with outcome of unknown , low body temperature on an unspecified date with outcome of unknown , strange redness across her shoulders  on 05Apr2021 with outcome of recovered , arm hurt after shot  on 05Apr2021 with outcome of unknown , pressure in head  on 05Apr2021 with outcome of unknown , very loose stools on 05Apr2021 with outcome of unknown , nausea  on 05Apr2021 with outcome of unknown , brain fog  on 06Apr2021 with outcome of not recovered , anxiety on an unspecified date with outcome of unknown. Hypertension was considered an Important Medical Event. The remaining events were non serious.  The patient underwent lab tests and procedures which included blood pressure increased: 179/98, 170/97   on   unknown date  , blood pressure measurement: 152/87 on 06Apr2021   , body temperature decreased: low  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Fatigue, Feeling abnormal, Head discomfort
Clinical narrative: Low body temperature; Fatigue; Anxiety; Brain fog; High BP/Pressure in head and high blood pressure; Severe chills; Strange redness across her shoulders; Arm hurt after shot; Pressure in head; Very loose stools; Nausea; This is a spontaneous report from a contactable consumer reporting for herself.  A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 13:30 (Batch/Lot Number: EP7533) as single dose for covid-19 immunisation  (Age at vaccination: 59 years) .  Medical history included liver disorder , hypersensitivity, hepatitis C  from , osteopetrosis , arthropod sting allergy , drug hypersensitivity  , gluten sensitivity  (She is borderline celiac, and she will get really bad gastro problems for 2 or 3 days after digesting gluten) , penicillin hypersensitivity  (She has itching, rash, nausea) , peanuts allergy (Keeps an EPI pen for this). Concomitant medications  included d-ribose, polypeptide (TRANSFER FACTOR [D-RIBOSE;POLYPEPTIDE]) taken for hepatitis C from 2003 to 03Apr2021; ascorbic acid (VITAMIN C ACID) taken for an unspecified indication from an unspecified start date to 03Apr2021; vitamin D3 (VITAMIN D3) taken for osteopetrosis from an unspecified start date to Apr2021; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported.   The patient experienced high bp/pressure in head and high blood pressure  on 05Apr2021 with outcome of unknown , fatigue  on an unspecified date with outcome of unknown , severe chills  on 05Apr2021 with outcome of unknown , low body temperature on an unspecified date with outcome of unknown , strange redness across her shoulders  on 05Apr2021 with outcome of recovered , arm hurt after shot  on 05Apr2021 with outcome of unknown , pressure in head  on 05Apr2021 with outcome of unknown , very loose stools on 05Apr2021 with outcome of unknown , nausea  on 05Apr2021 with outcome of unknown , brain fog  on 06Apr2021 with outcome of not recovered , anxiety on an unspecified date with outcome of unknown. Hypertension was considered an Important Medical Event. The remaining events were non serious.  The patient underwent lab tests and procedures which included blood pressure increased: 179/98, 170/97   on   unknown date  , blood pressure measurement: 152/87 on 06Apr2021   , body temperature decreased: low  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Nausea, Pain in extremity
Clinical narrative: Low body temperature; Fatigue; Anxiety; Brain fog; High BP/Pressure in head and high blood pressure; Severe chills; Strange redness across her shoulders; Arm hurt after shot; Pressure in head; Very loose stools; Nausea; This is a spontaneous report from a contactable consumer reporting for herself.  A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 13:30 (Batch/Lot Number: EP7533) as single dose for covid-19 immunisation  (Age at vaccination: 59 years) .  Medical history included liver disorder , hypersensitivity, hepatitis C  from , osteopetrosis , arthropod sting allergy , drug hypersensitivity  , gluten sensitivity  (She is borderline celiac, and she will get really bad gastro problems for 2 or 3 days after digesting gluten) , penicillin hypersensitivity  (She has itching, rash, nausea) , peanuts allergy (Keeps an EPI pen for this). Concomitant medications  included d-ribose, polypeptide (TRANSFER FACTOR [D-RIBOSE;POLYPEPTIDE]) taken for hepatitis C from 2003 to 03Apr2021; ascorbic acid (VITAMIN C ACID) taken for an unspecified indication from an unspecified start date to 03Apr2021; vitamin D3 (VITAMIN D3) taken for osteopetrosis from an unspecified start date to Apr2021; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported.   The patient experienced high bp/pressure in head and high blood pressure  on 05Apr2021 with outcome of unknown , fatigue  on an unspecified date with outcome of unknown , severe chills  on 05Apr2021 with outcome of unknown , low body temperature on an unspecified date with outcome of unknown , strange redness across her shoulders  on 05Apr2021 with outcome of recovered , arm hurt after shot  on 05Apr2021 with outcome of unknown , pressure in head  on 05Apr2021 with outcome of unknown , very loose stools on 05Apr2021 with outcome of unknown , nausea  on 05Apr2021 with outcome of unknown , brain fog  on 06Apr2021 with outcome of not recovered , anxiety on an unspecified date with outcome of unknown. Hypertension was considered an Important Medical Event. The remaining events were non serious.  The patient underwent lab tests and procedures which included blood pressure increased: 179/98, 170/97   on   unknown date  , blood pressure measurement: 152/87 on 06Apr2021   , body temperature decreased: low  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. On an unspecified date, after the first dose of vaccination, the patient had pain to the point of needing to get a steroid shot. The outcome of the event was unknown. The patient had not taken the second dose of vaccination (at the time of reporting) because of her rheumatoid arthritis, and was asking for data on the effect of vaccination to rheumatoid arthritis on patients who do not take steroids.  Follow-up attempts are possible. Information of lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable consumer (patient). This consumer reported that a patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included rheumatoid arthritis, chronic fatigue, and hasimotoes disease. There were no concomitant medications. The patient stated that received both covid-19 vaccinations with minimal side effects, sore arm.  Outcome of event was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: he is having lower back pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male 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 13Apr2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the 1st dose of the Pfizer covid19 vaccine, but he was having lower back pain. He would like to confirm if he can take any pain reliever. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oxygen saturation, Oxygen saturation decreased, Throat irritation
Clinical narrative: O2 dropped to 92; Coughing; having itching in throat within 10 minutes of the shot; This is a spontaneous report from a contactable consumer. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. Medical history included severe allergies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient who has a history of severe allergies started coughing and having itching in throat within 10 minutes of the shot, O2 dropped to 92. Patient was given an EpiPen and was taken to the hospital, and was there for a few hours. Patient was given 'an IV,' Benadryl and steroids and then released. The outcome of the events was recovered on an unspecified date in 2021.  Information on the Lot/Batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: he had was a sore arm for 24 hours; heavy chills; This is a spontaneous report received from a contactable consumer (patient). A  male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number: EN6201 and expiry date was not provided), via an unspecified route of administration, in the right arm, on 14Feb2021 at 14:00  as a single dose for covid-19 immunisation. Medical history of the patient was reported as none. Concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine considered as suspect. Patient did not have adverse event following prior vaccinations. Patient did not receive other vaccine in four weeks of vaccination. No additional vaccines administered. On 14Feb2021, patient experienced sore arm (for 24 hours) and heavy chills (for 4 hour). Reporter seriousness for events were unspecified. No treatment was received. The outcome of events was resolved on 14Feb2021.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Wound haemorrhage
Clinical narrative: pulled a scab off and it bled; itching at the injection site; swollen; soreness at the injection site; This is a spontaneous report from a contactable consumer (patient).   A 59-years-old female (not pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 09:00 (Lot Number: EW0151) as single dose for covid-19 immunisation.  Medical history included known allergies to mold, penicillium plant, dogs, cock roaches. Concomitant medication(s) included valsartan and montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported.  The patient previously took metoclopramide hydrochloride (REGLAN) and experienced drug hypersensitivity, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6207) via an unspecified route of administration in Mar2021 09:15 AM at left arm single dose for covid-19 immunisation.  Twice since second shot patient had itching at the injection site. In inadvertently pulled a scab off and it bled the first time (a few days ago). It's itching again and feels swollen. Interestingly, soreness at the injection site is the only symptom patient have had. The first time it went away and that was it. But this is the second time since the swelling went down that patient have had itching at the injection site and this time it's swollen a little. the initial post shot swelling subsided but it has returned in the past week or so. And it didn't even bleed after the shot. Patient's band-aid came off clean the next day. Patient have not received treatment. Patient filled out this form as soon as the itching returned and realized it was the same. Events onset date reported as 03Apr2021 09:00 AM. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Swelling face
Clinical narrative: Facial swelling.; Some swelling in mouth on right side.; This is a spontaneous report from a contactable consumer (patient).   A 46-years-old female patient received second dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration, administered in right arm on 12Apr2021 at 16:15 (at the age of 46 year old) as single dose for Covid-19 immunization. The patient's medical history included seafood, antibiotics, and shellfish allergy. The patient's concomitant medications were not reported. The patient previously took 2 Benadryl before vaccination. Patient historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration as single dose for COVID-19 immunization and experienced facial swelling. The patient did not take any other medication within two weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, it was unknown if patient was diagnosed with COVID-19. It was unknown whether the patient had been tested for COVID-19 since the vaccination. On 12Apr2021 at 17:45, the patient experienced facial swelling and some swelling in mouth on right side. The patient did not receive treatment for events. The outcome of the events recovering.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site movement impairment
Clinical narrative: Some of worst pain he had in his life in his arm; he was not able to raise his arm up, it was agonizing; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of bnt162b2 (BNT162B2, lot number: EW0158), via an unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Some of worst pain he had in his life in his arm, the patient guess it just the fourth day it was better today (unspecified), the patient could nearly lift arm all the way up, it had been very sore but for two days he was not able to raise his arm up, it was agonizing, the third day he could, yesterday he could kind of raise a little bit but today he raised it but it's still hurt. The last 11 years he was on top of the world, he never had a vaccine for anything that hurt like this did and he was not really feeling safe about going and getting another one if it is going to be worse. The patient would like some guidance from somebody. He had not talked to anybody that hurts like this (Clarification unknown). Treatment just took Tylenol. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cough, Headache, Pain in extremity
Clinical narrative: sore arm; Cough; Headache; Upset stomach; This is a spontaneous report from a Non-contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on an unknown date as single dose for COVID-19 immunization. Medical history, concomitant medications and past drug history were not reported. Reporter stated that she had a couple questions nothing bad. Her question was, if she had the first vaccine and there was no symptom, just a sore arm, but then she starts to develop couple weeks later a cough, headache, upset stomach, unsure if its related to the vaccine or could be covid 19 exposure. Patient asking is it possible to still get the second vaccine, if there were body aches but no fever and did not test positive for covid. At the time of this report event outcome was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Intermenstrual bleeding, Menstruation irregular, Movement disorder, Pelvic pain
Clinical narrative: She started spotting and having periods way earlier than she normally does; Difficulty picking that foot up on that side; Not really feeling herself; She started spotting and having periods way earlier than she normally does.; Left side pelvic pain; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 29Mar2021 at single dose for covid-19 immunization. Medical history was not reported. The patient's concomitant medications were not reported. On 29Mar2021 and exactly a week, 7 days after first dose, 05Apr2021, she started to have left side pelvic pain. The pain had consistently been there. She started spotting and having periods way earlier than she normally does. This was concerning to her. She had since then started experiencing a little difficulty picking that foot up on that side, referring to her left side; and she was not really feeling herself. Her second dose was this upcoming Monday on 19Apr2021. This report is not related to a study or program. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: her left arm that is swollen; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 03Apr2021 11:00 as SINGLE DOSE (at the age of 57-years) in Arm Left for covid-19 immunization. The patient had no relevant medical history. The patient did not receive any prior vaccinations (within 4 weeks). The patient's concomitant medications were not reported. On 03Apr2021 at 12:00, the patient's left arm was swollen after her first shot. She reported that her left arm that is swollen, the arm she got the shot in. It was still swollen and worsened. She enquired whether she should go to the hospital. The patient did not receive any treatment. The outcome of event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Palpitations, Tachycardia
Clinical narrative: Patient reports a normal resting heart rate in the 70s, immediately after inject felt her heart racing and had tachycardia to the 140s; Patient reports a normal resting heart rate in the 70s, immediately after inject felt her heart racing and had tachycardia to the 140s; This is a spontaneous report from a non-contactable physician.   A 21-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Left Arm on 15Apr2021 16:00 (Batch/Lot Number: EW0150) as SINGLE DOSE (at the age of 21 years) for covid-19 immunisation.  Medical history included seasonal allergy from an unknown date, hypersensitivity of environmental allergies from an unknown date and food allergy from peanuts from an unknown date. Concomitant medications included loratadine (LORATADINE) taken for an unspecified indication; pseudoephedrine (PSEUDOEPHEDRINE) taken for an unspecified indication; albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for an unspecified indication and montelukast (MONTELUKAST) taken for an unspecified indication.  The patient was not pregnant when she received the vaccine. The patient did not have any other vaccine in four weeks.  The patient reports a normal resting heart rate in the 70s, immediately after injection felt her heart racing and had tachycardia to the 140s (palpitations) on 15Apr2021 16:00 with outcome of recovering.   The patient underwent lab tests and procedures which included heart rate: 70s on unspecified date and palpitations: 140s on 15Apr2021.  The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.   Therapeutic measures were taken as a result of patient heart racing and had tachycardia to the 140s. The events persisted for 5 hours and improved only after IV (0.9% normal saline) fluid bolus.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Heart racing and Tachycardia cannot be excluded.  The case will be reassessed if additional information becomes available.  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.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face, Swollen tongue
Clinical narrative: tongue swelled immediately; chin and lip remained swollen; chin and lip remained swollen; This is a spontaneous report received from a contactable consumer (the patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history included: allergy and blood clots. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient received both shots. After receiving the second shot, the patient's tongue swelled immediately; after a week the tongue swelling went down, but the chin and lip remained swollen. The outcome of tongue swelled immediately was recovering. The outcome of chin and lip remained swollen was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Seizure
Clinical narrative: Low fever beginning on 1:00AM Monday 12Apr; Experienced nausea Monday 12Apr evening and seizure; Experienced nausea Monday 12Apr evening and seizure; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: ENG201) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nausea monday 12Apr evening and seizure and low fever beginning on 1:00am monday 12apr at 01:00. The patient was hospitalized for experienced nausea monday 12apr evening and seizure and for low fever beginning on 1:00am monday 12apr for 4 days. Therapeutic measures were taken as a result of low fever beginning on 1:00am monday 12apr. It was unknown if therapeutic measures were taken for the events Experienced nausea Monday 12Apr evening and seizure. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia
Clinical narrative: super numb; exhausted; This is a spontaneous report from a non-contactable consumer (patient's friend). A female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 12Apr2021 (Lot Number: ER8730) as single dose, for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 22Mar2021 (Lot number: EN6207) for COVID-19 Immunization and did not presented any symptoms. On 12Apr2021 , the patient mentioned that her arm in which she received the vaccine (left arm) got super numb for 6 or 7 hours after receiving the vaccine, as if she did not even could feel the arm normally that she was exhausted as if it was a run over sensation. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Vaccination site bruising
Clinical narrative: bruises around injection site and all around the left arm; bruises around injection site and all around the left arm; severe fatigue; This is a spontaneous report from a contactable consumer(patient). A 21-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8733; Expiration Date: 31Jul2021), first dose via an unspecified route of administration, administered in left arm on 07Apr2021 as SINGLE DOSE for covid-19 immunization. Patient was 21 years old at the time of vaccination. Patient's medical history and concomitant medications were not reported. Patient did not receive any prior vaccinations within 4 weeks of first administration of vaccination. On 08Apr2021 patient experienced severe fatigue, stated it was really bad. On 11Apr2021 patient had bruises around injection site and all around the left arm, a lot of them. States the fatigue has improved some but he was just so exhausted. Wanted to also know is there any chance he is having low platelet counts. The outcome of the event bruises around injection site and all around the left arm was unknown and severe fatigue was reported as recovering.  No follow-up attempts are needed; No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Pyrexia, Weight decreased
Clinical narrative: Fever; lack of appetite/ lost her appetite, she is having a hard time eating and very rarely felt like eating anything; weight loss/ lost 8 pounds; Headaches; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 83-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration in right arm on 11Feb2021 at 17:00-18:00 and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration on 03Mar2021 at 12:00, both as single dose for COVID-19 immunization. The patient's medical history included flu vaccination for years and pneumonia vaccine. Concomitant medication(s) included Vitamin D 2000. On 25Feb2021, patient had headaches starting 2.5 weeks after her first shot. On 15Mar2021, patient experienced weight loss/ lost 8 pounds, patient also stated she was between 129-130 pounds when this started. On 15Mar2021, patient experienced lack of appetite/ lost her appetite, she was having a hard time eating and very rarely felt like eating anything. Patient also stated that she used to enjoy breakfast and lunch but then she was forcing them down, sometimes she could eat dinner. On an unspecified date, patient experienced fever. Patient mentioned that one night she felt like mashed potatoes and so her husband made her mashed potatoes and she ate a lot of them. Also mentioned that she forced herself to eat because she knows she had to. Patient was not losing anymore weight but she was not putting any back on like she thought she should be either. In the evening, she tried to eat pasta or potatoes. Patient mentioned that she had been to the doctor on 10Mar2021 and he gave her a B12 shot for her lack of appetite and said if she doesn't improve, to come back; she had been to the doctor twice. Patient stated that she lived on Tylenol and started taking it every 7-8 hours then down to every 4 hours because she needed relief. Her temperature would go from 97.1 to 99. Patient reported that no fever now and the highest it got was 99.8 and as soon as she took Tylenol, her temperature would go down. Patient wanted to know if anyone else has had this reaction. Outcome of the fever was recovered on an unspecified date, headache was recovered on 14Mar2021 while the events; lost her appetite and weight loss was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: He had a reaction, his tongue was swelling on the left side; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (BNT162B2, Pfizer Covid-19 vaccine), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: EP6955) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had a reaction, his tongue was swelling on the left side on 21Mar2021 (not clarified further). Also, like two days after like on the 23rd, patient woke up at 8:30 and his tongue was swollen. So, reporter had to give patient Benadryl (treatment) and it did go down. The outcome was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Neck pain, Tinnitus
Clinical narrative: This is a different pain, it is back of my neck around the collarbone or where got your rib bone go up, it is right around in there. Yesterday a little bit, but now it's excruciating, it hurts, worse; joint pain; In patient right ear she had tinnitus; Patient arthritis pain is mostly in back leg on the side and in patient knees; This is a spontaneous report from a contactable 79-year-old female consumer reported for herself that the patient had received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection LOT number:5050), via an unspecified route of administration on an unspecified date (Age at vaccination: unknown) at single dose for Covid-19 immunization. The patient's concomitant medication included Tylenol (Exp date: Jun2024). The patient's medical history was not reported. The consumer reported that he had taken the vaccine and he was not sure what the date was, he has taken it on '4/5' (not clarified further) think that was Monday. And he has now he was reading the side effects of what could happen. So, he had arthritis it's a joint pain, but this is a different pain, it is back of his neck around the collarbone or where got your rib bone go up, it is right around in there and it started like yesterday a little bit, but now it's excruciating. he has arthritis joint pain, but this is a different pain, it's not from the arthritis, his arthritis pain is mostly in his back leg on the side, in his knees that's what, but this one is like on side of my shoulder like from the neck it's like aching I am in pain, it is just started like yesterday a little bit and then he was hoping it would go away and stuff, but it of course it hurts, worse. Outcome of events was unknown  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Ear disorder, Ear infection
Clinical narrative: Fluid in right ear, wax build up in left ear; Fluid in right ear, wax build up in left ear; Ear infection; Dizzy; This is a spontaneous report from a contactable consumer (patient). An 81-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration Date: Jun2021), via an unspecified route of administration, in left arm (shoulder) on 25Mar2021 at 15:30 as single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication(s) included dimenhydrinate (DRAMAMINE) (Lot number: P118702 and Expiration date: 01Feb2023) 50 mg pills/100 count taken for motion sickness, patient mentioned that it did not help. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient mentioned that he and his wife had the COVID virus and they had to wait 90 days for their first shot. On 27Mar2021 in morning, the patient experienced dizzy and went to the doctor. The doctor checked his ears. On 05Apr2021 in morning, the patient experienced fluid in right ear, wax build up in left ear and ear infection. The patient was given drops for a week. On 12Apr2021, he went back to the doctor and reports that everything looked good. The doctor flushed the wax out of his left ear, but noted that he has an ear infection. The patient visited physician office due to events. The patient is taking is Amoxicillin 875 mg tablet, take one tablet by mouth every 12 hours. The patient would like to know if he should still take the, second vaccine, as he has 7 more days left for his antibiotic. The patient asked the doctor if he should take his second vaccine, and the doctor didn't know. The patient thinks the dizziness was the fluid and wax buildup in his ears. He believed it will get better and does not think the vaccine caused the dizziness. He is still dizzy at times but not as dizzy as he was. The wax is gone and the ear infection is not as bad as it was. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.