chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal discomfort, Ocular discomfort, Pain, Pain in extremity
Clinical narrative: body aches; hips were hurting; lost the sense of smell; pressure behind her eyes; stuffy nose; Headache; sore arm; felt a little feverish/It was a little elevated; feel as bad as she did; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200), via an unspecified route of administration, administered in Arm Left on 18Feb2021 16:00 (age at the vaccination 57-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus from Jul2020 to an unknown date and high blood pressure. Concomitant medications included metformin and metoprolol for high blood pressure. Patient had the Pfizer shot on 18Feb2021 which was last Thursday. The next day, 19Feb2021, she had a sore arm. Since patient developed stuffy nose and headache on 21Feb2021, body aches on 25Feb2021, lost sense of smell on 24Feb2021, patient also had pressure behind the eyes on 23Feb2021, patient felt a little feverish, but it did not register as a fever on an unspecified date in Feb2021. It was a little elevated. on day seven she had body aches. Specifically, both hips were hurting on 25Feb2021 It was achy like she had stretched too much. Today she feels a little better. Patient still has stuffiness, body aches, and still cannot smell. She does not feel as bad as she did on an unspecified date in Feb2021. Therapeutic measures were taken as a result of all events. The patient underwent lab tests and procedures which included feverish: little elevated on Feb2021, glycosylated haemoglobin (A1C): in the fives (numbers have been pretty good. A1C is in the fives), weight: about 160 lbs on an unspecified date. The outcome of the events stuffy nose, lost the sense of smell, body aches were not recovered, hips were hurting and feel as bad as she did was recovering and unknown for another events.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Weight
Clinical narrative: body aches; hips were hurting; lost the sense of smell; pressure behind her eyes; stuffy nose; Headache; sore arm; felt a little feverish/It was a little elevated; feel as bad as she did; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200), via an unspecified route of administration, administered in Arm Left on 18Feb2021 16:00 (age at the vaccination 57-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus from Jul2020 to an unknown date and high blood pressure. Concomitant medications included metformin and metoprolol for high blood pressure. Patient had the Pfizer shot on 18Feb2021 which was last Thursday. The next day, 19Feb2021, she had a sore arm. Since patient developed stuffy nose and headache on 21Feb2021, body aches on 25Feb2021, lost sense of smell on 24Feb2021, patient also had pressure behind the eyes on 23Feb2021, patient felt a little feverish, but it did not register as a fever on an unspecified date in Feb2021. It was a little elevated. on day seven she had body aches. Specifically, both hips were hurting on 25Feb2021 It was achy like she had stretched too much. Today she feels a little better. Patient still has stuffiness, body aches, and still cannot smell. She does not feel as bad as she did on an unspecified date in Feb2021. Therapeutic measures were taken as a result of all events. The patient underwent lab tests and procedures which included feverish: little elevated on Feb2021, glycosylated haemoglobin (A1C): in the fives (numbers have been pretty good. A1C is in the fives), weight: about 160 lbs on an unspecified date. The outcome of the events stuffy nose, lost the sense of smell, body aches were not recovered, hips were hurting and feel as bad as she did was recovering and unknown for another events.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature increased, Chest discomfort, Musculoskeletal stiffness, Myalgia
Clinical narrative: slight wheeze; Neck stiffness; temperature of 100; chest tightness; Moderate muscle/body aches; Moderate muscle/body aches; fever developed overnight and persistent through the day on 25Feb (with high temp of 101.5 25Feb evening).; armpit pain.; Sore arm started evening of 24Feb21.; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non- pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Right on 24Feb2021 11:45 (at the age of: 53-years-old) as dose 2, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included hypertension, blood cholesterol, overweight, Allergy to Penicillin, mushrooms. Concomitant medications included metoprolol, lisinopril and atorvastatin taken for an unspecified indication, start and stop date were not reported. Historical vaccine of BNT162B2 for COVID-19 immunization on 04Feb2021 at the age of 52 year. Prior to vaccination patient was not diagnosed with covid 19. Patient did not receive any other vaccine prior to four weeks of covid vaccination, not tested for covid since the vaccination, patient reported that she was allergic to penicillin and mushrooms. On 24Feb2021 patient experienced sore arm, moderate muscle and body pain, fever developed overnight and persistent through the day on 25feb2021, chest tightness, slight wheeze, neck stiffness and armpit pain on an unspecified date. 26Feb21 am temperature of 100, body aches starting to ease. The outcome of sore arm moderate muscle and body aches and fever was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Wheezing
Clinical narrative: slight wheeze; Neck stiffness; temperature of 100; chest tightness; Moderate muscle/body aches; Moderate muscle/body aches; fever developed overnight and persistent through the day on 25Feb (with high temp of 101.5 25Feb evening).; armpit pain.; Sore arm started evening of 24Feb21.; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non- pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Right on 24Feb2021 11:45 (at the age of: 53-years-old) as dose 2, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included hypertension, blood cholesterol, overweight, Allergy to Penicillin, mushrooms. Concomitant medications included metoprolol, lisinopril and atorvastatin taken for an unspecified indication, start and stop date were not reported. Historical vaccine of BNT162B2 for COVID-19 immunization on 04Feb2021 at the age of 52 year. Prior to vaccination patient was not diagnosed with covid 19. Patient did not receive any other vaccine prior to four weeks of covid vaccination, not tested for covid since the vaccination, patient reported that she was allergic to penicillin and mushrooms. On 24Feb2021 patient experienced sore arm, moderate muscle and body pain, fever developed overnight and persistent through the day on 25feb2021, chest tightness, slight wheeze, neck stiffness and armpit pain on an unspecified date. 26Feb21 am temperature of 100, body aches starting to ease. The outcome of sore arm moderate muscle and body aches and fever was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Pain, Pruritus
Clinical narrative: quarter sized blister on right thigh; her leg started itching; It is not red, but kind of stings; burning just caught her attention; This is the spontaneous report from a contactable other health care professional (Nurse), reporting for herself. A 75-years-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch no: not reported, Lot Number: EL9269; expiration date: unknown) via an unknown route of administration, administered in left arm on 25Feb2021 (at the age of 75-years-old) as dose 2, single for covid-19 immunization. Patient medical history included Kidney stones, below normal kidney function and thyroid disease and concomitant medications were not reported. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch no: not reported /Lot Number: EL9269, expiration date: unknown) administered via unknown route on 04Feb2021 as dose 1, single for COVID-19 immunization. Patient stated that she had the second COVID vaccine on 25Feb2021 and on 26Feb2021, patient experienced quarter sized blister on her right thigh, when she woke up in morning. It was not red, but kind of stings. With the second COVID Vaccine there really was no problem and had no pain after the injection. But her leg started itching and noticed the big size blister. Seriousness was reported as not life threatening but the burning just caught her attention. Patient was asking could that be a reaction from the COVID Vaccine. Investigation Assessment was reported as No. Treatment included with cleaned out the blister and applied Neosporin. The outcome of the events is unknown.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching to arms and face, progressing to the Bilateral arms and back/ residual itching; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a female patient. A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: EN6201), via intramuscularly, on 10Feb2021 09:30 AM (at the age of 53-year-old) as a dose 2, single for COVID-19 immunization. The patient medical history included allergies to NKDA food, shellfish, shrimp, citrus, poultry, nuts, mushrooms and other medical history HTN (hypertension), anxiety and hypothyroidism. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: unknown), via unspecified route of administration on unspecified date as a dose 1, single for COVID-19 immunziation. The concomitant medication of the patient included levothyroxine sodium (LEVOTHYROXINE SODIUM) and bupropion hydrochloride (WELLBUTRIN). It was unknown if patient had taken other vaccine in four weeks and it was unknown if patient had COVID prior vaccination. It was unknown if patient tested post COVID vaccination. On 10Feb2021 10:15 approximately 10 minutes after vaccine the patient experienced itching to arms and face, progressing to the bilateral arms and back. Patient was taken to the first aid station and denies any SOB, swelling, no CP and patient was A & O x 3, VSS at blood pressure was 1238/76, heart rate was 76, RR 18, SaO2 at 95% on RA. On 10:25 AM patient Itching had improved with blood pressure of 126/68, heart rate of 80, RR 16, SaO2:96% on RA. On 10:45 itching improved but residual itching continues. Patient was observed for 45 minutes and discharged. Patient received the treatment of Benadryl 25mg Oral liquid. Patient communicated understanding and had no further question prior to discharge. The outcome of the event was recovered on unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Headache, Pain in extremity, Rash, SARS-CoV-2 test
Clinical narrative: rash; soreness in her arm /Pain in lower part of her arm, below elbow; Headache; Arm tender to touch; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.   A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247 and Expiry date: Unknown), via an dose 1 intramuscular, administered in Arm Left on 21Jan2021 as DOSE 1, SINGLE for Covid-19 immunization. Medical history included allergy to chemicals, allergy to synthetic fabric from an unknown date and unknown if ongoing polyester thread causes a rash , allergy to vaccine, bronchiectasis from an unknown date and unknown if ongoing Diagnosed in the early 90's. She guesses this is in her bronchial tubes. She has green mucus every day. /takes 1600 mg guaifenesin for bronchiectasis, , ongoing atypical mycobacterial infection Diagnosed in the early 90's. She explains this is in her right lung, either her lower lobe or middle lobe, she is not sure. She was told this never goes away , pneumonia from an unknown date and unknown if ongoing 150 mg of some type of penicillin on Mondays, Wednesdays, and Fridays. The patient's concomitant medications were not reported. The patient previously took pneumococcal vaccine for immunization, varicella zoster vaccine for immunization and experienced pain in extremity, azithromycin and experienced drug hypersensitivity, levaquin and experienced drug hypersensitivity. On an unspecified date the patient experienced rash, soreness in her arm /pain in lower part of her arm, below elbow, headache, arm tender to touch. She had pain for almost 2 weeks in the lower part of her arm .The patient underwent lab tests and procedures which included colonoscopy had no reaction on an unspecified date, sars-cov-2 test: negative on an unspecified date, weight: 20 lbs on gained. The outcome of event was unknown.  No follow up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Weight
Clinical narrative: rash; soreness in her arm /Pain in lower part of her arm, below elbow; Headache; Arm tender to touch; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.   A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247 and Expiry date: Unknown), via an dose 1 intramuscular, administered in Arm Left on 21Jan2021 as DOSE 1, SINGLE for Covid-19 immunization. Medical history included allergy to chemicals, allergy to synthetic fabric from an unknown date and unknown if ongoing polyester thread causes a rash , allergy to vaccine, bronchiectasis from an unknown date and unknown if ongoing Diagnosed in the early 90's. She guesses this is in her bronchial tubes. She has green mucus every day. /takes 1600 mg guaifenesin for bronchiectasis, , ongoing atypical mycobacterial infection Diagnosed in the early 90's. She explains this is in her right lung, either her lower lobe or middle lobe, she is not sure. She was told this never goes away , pneumonia from an unknown date and unknown if ongoing 150 mg of some type of penicillin on Mondays, Wednesdays, and Fridays. The patient's concomitant medications were not reported. The patient previously took pneumococcal vaccine for immunization, varicella zoster vaccine for immunization and experienced pain in extremity, azithromycin and experienced drug hypersensitivity, levaquin and experienced drug hypersensitivity. On an unspecified date the patient experienced rash, soreness in her arm /pain in lower part of her arm, below elbow, headache, arm tender to touch. She had pain for almost 2 weeks in the lower part of her arm .The patient underwent lab tests and procedures which included colonoscopy had no reaction on an unspecified date, sars-cov-2 test: negative on an unspecified date, weight: 20 lbs on gained. The outcome of event was unknown.  No follow up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia, Pruritus, Taste disorder
Clinical narrative: taste in her throat; bad headache; pins and needles sensation on the lower portion of her face and tongue; Itchy; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot Number: EN6198,Expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 25Feb2021 16:15 as 1ST DOSE, SINGLE for covid-19 immunisation,(Age at vaccination-68 years). Medical history included ongoing food allergy, ongoing drug hypersensitivity(Does not do well with Penicillin or Sulfa), blood pressure abnormal, thyroid atrophy,drug hypersensitivity (Does not do well with Penicillin or Sulfa) from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (TIROSINT) taken for an Thyroid, amlodipine taken for an blood pressure, zolpidem tartrate (AMBIEN) taken for an sleep ,unspecified start date and ongoing. On 25Feb2021 The patient experienced taste in her throat, bad headache, pins and needles sensation on the lower portion of her face and tongue, itchy. The patient had not received any other vaccine within 4 weeks. The patient visited emergency room/ physicians office. The clinical outcome was recovered.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Illness, Pharyngeal swelling
Clinical narrative: soreness at the injection site last; chills; fever; swelling of the tongue; swelling of the throat; headache; weakness; very sick for 4 days; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergic to shellfish (food allergy: shellfish), peanuts and different things and immune deficiency (low white blood cells), chemotherapy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that the patient was expected to receive the 2nd dose on 01Mar2021. However, following the first dose, the patient had soreness at the injection site last, chills, fever, swelling of the tongue, swelling of the throat, headache, weakness and very sick for 4 days on an unspecified date. It was reported that she was advised by her pharmacist to take Tylenol and Benadryl, every 4 hours to keep the fever down and to keep the tongue and throat from closing. Therapeutic measures were taken as a result of soreness at the injection site last, fever, swelling of the tongue, swelling of the throat, headache, weakness and very sick for 4 days. Outcome of all events were unknown.  Information about lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swollen tongue, Vaccination site pain
Clinical narrative: soreness at the injection site last; chills; fever; swelling of the tongue; swelling of the throat; headache; weakness; very sick for 4 days; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergic to shellfish (food allergy: shellfish), peanuts and different things and immune deficiency (low white blood cells), chemotherapy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that the patient was expected to receive the 2nd dose on 01Mar2021. However, following the first dose, the patient had soreness at the injection site last, chills, fever, swelling of the tongue, swelling of the throat, headache, weakness and very sick for 4 days on an unspecified date. It was reported that she was advised by her pharmacist to take Tylenol and Benadryl, every 4 hours to keep the fever down and to keep the tongue and throat from closing. Therapeutic measures were taken as a result of soreness at the injection site last, fever, swelling of the tongue, swelling of the throat, headache, weakness and very sick for 4 days. Outcome of all events were unknown.  Information about lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain, Skin irritation, Swelling, Vaccination site pain
Clinical narrative: tenderness at the site of injection; developed a rash on the same arm where the injection was; sore; Allergic reaction; had little bumps on it; it is kind of irritated; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 18Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced an allergic reaction to the Pfizer COVID-19 vaccine. She reported that she had the Pfizer COVID-19 vaccine injection and was a little sore, and allergic reaction area had little bumps on it; since then there are more bumps on it and it is kind of irritated. She called to ask what to do or to put on the allergic reaction. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: tenderness at the site of injection; developed a rash on the same arm where the injection was; sore; Allergic reaction; had little bumps on it; it is kind of irritated; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 18Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced an allergic reaction to the Pfizer COVID-19 vaccine. She reported that she had the Pfizer COVID-19 vaccine injection and was a little sore, and allergic reaction area had little bumps on it; since then there are more bumps on it and it is kind of irritated. She called to ask what to do or to put on the allergic reaction. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: red patch on her arm; This is a spontaneous report from a contactable consumer (patient). A 82-years-old female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on 23Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history included she did have reactions to a lot of medications, not like flu shots, but she does reaction to some medications, allergy medicines in particular. Stated did not react to pneumonia vaccine and verbalizes it did not itch. Concomitant medication was not reported. The patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration as dose 1, single for COVID-19 immunisation. Caller stated that she got her second Pfizer shot on Tuesday (23Feb2021). Caller stated that she was a person that had to wait 30 minutes after getting a new medicine, and so far everything was so good. But today (26feb2021), caller discovered a red patch on her arm, the arm she received the injection in, but not right at the injection site, it was a couple inches or so below that. Caller stated that it was about a half dollar, a silver dollar size, and it was not bright red but it was noticeable. Caller was wondering if this was a known side effect of the product. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Hyperhidrosis, Joint stiffness, Rhinorrhoea
Clinical narrative: Constant runny nose; feeling sluggish; joint stiffness; lungs and chest were tight/sore; weakness; sweat; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported. A male patient with unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, batch/lot number: unknown) via unknown route of administration on 11Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included triple bypass, carotid artery surgery, a thyroid condition, and diabetes. The patient stated that he was rather active and "not a couch potato". The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, batch/lot number: unknown) via unknown route of administration on 21Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation. After first dose patient had a sore arm and a change to his bowel movements which were daily and softer resulting in diarrhea for the remainder of the month, he had "never been that regular in his life", end of January his BMs changed. The patient also reported having had a "constant runny nose" since the first dose that was ongoing. After receiving the second shot on 11Feb2021 on day 21 as directed and had been "feeling sluggish" since. Last night, 25Feb2021, the patient was sweat so much he "completely soaked the bed", he had joint stiffness and weakness, and his lungs and chest were tight/sore when he took a deep breath. His symptoms have "kind of cleared up" but he was "just don't feel right" today.  At the time of this report the outcome of the event constant runny nose was not recovered and other events were unknown.  Information on the lot/batch number had been requested.  Follow-up attempts were completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: Constant runny nose; feeling sluggish; joint stiffness; lungs and chest were tight/sore; weakness; sweat; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported. A male patient with unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, batch/lot number: unknown) via unknown route of administration on 11Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included triple bypass, carotid artery surgery, a thyroid condition, and diabetes. The patient stated that he was rather active and "not a couch potato". The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, batch/lot number: unknown) via unknown route of administration on 21Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation. After first dose patient had a sore arm and a change to his bowel movements which were daily and softer resulting in diarrhea for the remainder of the month, he had "never been that regular in his life", end of January his BMs changed. The patient also reported having had a "constant runny nose" since the first dose that was ongoing. After receiving the second shot on 11Feb2021 on day 21 as directed and had been "feeling sluggish" since. Last night, 25Feb2021, the patient was sweat so much he "completely soaked the bed", he had joint stiffness and weakness, and his lungs and chest were tight/sore when he took a deep breath. His symptoms have "kind of cleared up" but he was "just don't feel right" today.  At the time of this report the outcome of the event constant runny nose was not recovered and other events were unknown.  Information on the lot/batch number had been requested.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fear of injection, Paraesthesia oral
Clinical narrative: She mentioned that she needle phobia and was already anxious when she got to their facility.; She mentioned that she had difficulty in breathing because of her double mask.; she felt light headed.; her lips started to tingle; This is a spontaneous report from a contactable consumer (patient). A female patient (Age: 54; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown, Expiry date: unknown), via an unspecified route of administration on 26Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history included needle phobia and concomitant medications were not reported. The patient reported, she received the 1st dose of the Pfizer vaccine about an hour ago today. She mentioned that she had needle phobia and was already anxious when she got to their facility. She mentioned that the person who injected her was really quick that she didn't feel it. They made her stay for 20 minutes and she was fine, she mentioned that she had difficulty in breathing because of her double mask. As she was walking to her car, she felt lightheaded. As she got in the car, her lips started to tingle. The outcome of events was unknown.  Information about Lot/Batch request has been requested.  Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Cluster headache, Dizziness, Inflammation
Clinical narrative: Dizziness; weakness; Inflammation in body; headaches; pain in joint and muscles; sleeplessness; My eyes would blur if I read, watched TV or looking at I Phone or computer; brain (felt like my body and brain were on fire); This is a spontaneous report from a contactable consumer. A 70-year-old male patient received BNT162B2 (BNT162B2, Pfizer-BIONTECH, COVIF-19 Vaccine, Solution for injection, Lot number: EL9267 and expiration date: Not reported),  via an unspecified route of administration, administered in Arm Left on 12Feb2021 09:45 as SINGLE DOSE for COVID-19 IMMUNISATION. The patient medical history included Polymyalgia, Rheumatica, Herpes, Afib, BPH, Sulfa allergy. Covid prior vaccination was No. Concomitant medication included prednisone, hydroxychloroquine silodosin. The patient previously took levofloxacin (LEVAQUIN), statin, metoprolol, fluoxetine, Nortriptyline, pregabalin (LYRICA), propafenone, Zolpidem and had allergies to these drugs. It was reported that the patient had experienced Dizziness, weakness, inflammation in body, brain (felt like my body and brain were on fire),headaches, pain in joints and muscles, sleeplessness. My eyes would blur if I read, watched TV or looking at I Phone or computer all on 12Feb2021 13.00. Covid tested post vaccination was No. Therapeutic measures were taken as a result of events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Vision blurred
Clinical narrative: Dizziness; weakness; Inflammation in body; headaches; pain in joint and muscles; sleeplessness; My eyes would blur if I read, watched TV or looking at I Phone or computer; brain (felt like my body and brain were on fire); This is a spontaneous report from a contactable consumer. A 70-year-old male patient received BNT162B2 (BNT162B2, Pfizer-BIONTECH, COVIF-19 Vaccine, Solution for injection, Lot number: EL9267 and expiration date: Not reported),  via an unspecified route of administration, administered in Arm Left on 12Feb2021 09:45 as SINGLE DOSE for COVID-19 IMMUNISATION. The patient medical history included Polymyalgia, Rheumatica, Herpes, Afib, BPH, Sulfa allergy. Covid prior vaccination was No. Concomitant medication included prednisone, hydroxychloroquine silodosin. The patient previously took levofloxacin (LEVAQUIN), statin, metoprolol, fluoxetine, Nortriptyline, pregabalin (LYRICA), propafenone, Zolpidem and had allergies to these drugs. It was reported that the patient had experienced Dizziness, weakness, inflammation in body, brain (felt like my body and brain were on fire),headaches, pain in joints and muscles, sleeplessness. My eyes would blur if I read, watched TV or looking at I Phone or computer all on 12Feb2021 13.00. Covid tested post vaccination was No. Therapeutic measures were taken as a result of events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pruritus
Clinical narrative: It (arm) does not hurt so bad; there is some discomfort/arm was sore; hand started to itch for about 3 minutes after; headache; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6201, Expiry Date: Unknown), dose 1 via an unspecified route of administration on 25Feb2021 (at the age of 70-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced it (arm) does not hurt so bad; there is some discomfort/arm was sore, hand started to itch for about 3 minutes after and headache. Reporter received the Pfizer-BioNTech COVID-19 Vaccine first dose yesterday (on 25Feb2021). Reporter had been advised by the vaccination Center to only take Tylenol but was seeking clarification. Reporter was also asking for the "time period to wait before" she can take her daily low dose aspirin? Reporter mentioned that her "arm hurts when I lift", and that her "hand started to itch for about 3 minutes after". Reporter said that she had "nothing to report". Her arm was sore, and she took Tylenol. She wanted to confirm when she should take a low dose of Aspirin or ibuprofen as she was regularly having a headache. She said, doctor had me on daily low dose Aspirin regimen, so I did not take that low dose Aspirin today because she said no Aspirin. Reporter stated, "Well I had my first dose of the vaccine by Pfizer (clarified Covid 19 vaccine), yesterday and I was told if I had any pain in my arm that was so uncomfortable that I needed to take something, that I should take Tylenol and not take aspirin and not take Ibuprofen or Aleve or anything, to take Tylenol only. This is my question, my arm does not hurt, at least it does not hurt so bad that I would take anything for it at all. I can tell you the truth, there was some discomfort but nothing to complaint about, but I am a senior citizen, and my doctor has me on daily low dose Aspirin regimen so, I did not take that low dose Aspirin today because she said no Aspirin. So, my question is how many days do I have to wait before I can take aspirin or Ibuprofen for a headache and go back to taking my Aspirin or just take Ibuprofen for back ache or for muscle pull or whatever, how many days?" Reporter stated, "I just want to know when I can take aspirin again that is all. That is all no pain, nothing. do not take this shot if you are allergic to vaccine or its ingredients but you do not tell us the ingredients until you give that person the shot." Therapeutic measures were taken as a result of the events. Outcome of all the events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Nausea
Clinical narrative: Chills; Fever 101.5; Headache; Nausea; joint ache; Injection Site: red; Injection Site swollen; Injection Site pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Arm Left on 24Feb2021 17:15 (at the age of 67-year-old) as dose 2, single for covid-19 immunisation. Medical history included High Blood Pressure, High cholesterol, obesity. Known allergies were reported as no. The concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Other medications in two weeks were reported as High Blood Pressure, High Cholesterol meds. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 03Feb2021 17:15 (at the age of 67-year-old) as dose 1, single for covid-19 immunisation. Patient did not have covid prior vaccination and covid was not tested post vaccination. The patient experienced chills, fever 101.5, headache, nausea, joint ache, injection site: red, injection site swollen, injection site pain on 25Feb2021 10:00. The patient underwent lab tests and procedures which included body temperature: 101.5 on 25Feb2021. Patient did not receive any treatment for adverse events. The outcome of all events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Chills; Fever 101.5; Headache; Nausea; joint ache; Injection Site: red; Injection Site swollen; Injection Site pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration, administered in Arm Left on 24Feb2021 17:15 (at the age of 67-year-old) as dose 2, single for covid-19 immunisation. Medical history included High Blood Pressure, High cholesterol, obesity. Known allergies were reported as no. The concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Other medications in two weeks were reported as High Blood Pressure, High Cholesterol meds. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 03Feb2021 17:15 (at the age of 67-year-old) as dose 1, single for covid-19 immunisation. Patient did not have covid prior vaccination and covid was not tested post vaccination. The patient experienced chills, fever 101.5, headache, nausea, joint ache, injection site: red, injection site swollen, injection site pain on 25Feb2021 10:00. The patient underwent lab tests and procedures which included body temperature: 101.5 on 25Feb2021. Patient did not receive any treatment for adverse events. The outcome of all events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pain, Pain in extremity, Paraesthesia, Sunburn
Clinical narrative: her throat began to feel thick and she felt shaky; Within about 5 minutes after the injection my face started tingling; felt like I had a bad sunburn; The morning after I had the typical vaccine side effects of sore arm; A little body aches; This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: EN6201) via an unspecified route of administration in Left arm on 19Feb2021 16:30 as single dose for COVID-19 immunisation. Patient medical history included breast cancer in 2014 and chemo. Concomitant medications included colecalciferol (VITAMIN D 3) and exemestane. Patient previously took Docetaxel and experienced with Severe anaphylaxis from chemotherapy. On 19Feb2021 16:45 patient stated that about 15 minutes after the injection her face started tingling and soon after felt like she had a bad sunburn. At the same time her throat began to feel thick and she felt shaky. She wasn't shaking but she felt shaky on the inside. She could talk and breathe ok but her throat felt thick inside. After she went home, the thick throat feeling went away in about 40 minutes and the sunburn feeling was gone by the next morning. The morning after she had the typical vaccine side effects of sore arm and a little body aches. Throat and face felt fine. Treatment was not received for events. Outcome of events was recovered on an unspecified date in 2021.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Pyrexia
Clinical narrative: pharmacist accidentally injected a COVID vaccine to a 4 year old on 2/24.; pharmacist accidentally injected a COVID vaccine to a 4 year old on 2/24.; fever; This is a spontaneous report from a contactable pharmacist via medical information team. A 4-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number was not reported, Expiry date was not reported), via an unspecified route of administration on 24Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the child experienced fever within 24 hours. The reporter stated, that at one of the mass immunization site, the pharmacist accidentally injected a COVID vaccine to a 4-year-old on 24Feb. The child experienced fever within 24 hours. The child was now acting normal. They are wondering how they should proceed and what advice to be given. The outcome of the event fever was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Oral disorder
Clinical narrative: Oral lesions; This is a spontaneous report from a contactable other healthcare professional (patient). A 69-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection lot Number: EN6198), intramuscular, administered in right arm on 20Feb2021 at 10:15 (age at the time of vaccination was 69 years) as single dose for COVID-19 immunisation. Other medical history included coronary artery disease from an unknown date and unknown if ongoing and Known allergies were reported as no. The patient's concomitant medications were not reported. If other vaccine in four weeks was reported as no and the patient did not have COVID prior vaccination. On 20Feb2021 at 19:15, the patient experienced oral lesions. AE treatment was reported as no and the patient was not tested for COVID post vaccination. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral swelling
Clinical narrative: Something odd is going on with toes; Sort of looks like COVID toes, a mild case but not extreme; This is a spontaneous report from a contactable consumer (patient wife). A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9263, as reported), via an unspecified route of administration on 08Feb2021 (Lot Number: EM9809) as dose number unknown single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient wife stated, she was actually going to put patient husband on. It is really his question. We both had the Pfizer COVID-19 vaccine about 2 weeks ago and coincidently, he felt fine and everything still does feel fine but something odd is going on with his toes. And patient know there is something called COVID toes and we looked it up online, that's sort of what it looks like, a mild case but not extreme. But really our question is related to, could this be a side effect from the vaccine. I will put him on. When requested for permission to probe questions for a safety report, patient stated not sure what questions was answering, what questions are you talking about informed that the questions would be related to demographic details, medical history, patient stated, this is taking way too long. I'll have to call back patient have the number and the option and will call back in a later date. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Pharyngeal swelling, Swelling face, Swollen tongue
Clinical narrative: Swelling in face; Swelling in tongue; Swelling in Throat; sweating; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: En6206), via an unspecified route of administration in right arm on 27Feb2021 at 13:45 (at the age of 35 years old) as single dose for COVID-19 immunisation. Medical history included fatty liver disease. The patient known allergies included demerol and shellfish. The patient's concomitant medications were not reported. The patient did not receive any other medications in two weeks. 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 the vaccination, the patient hasn't been tested for COVID-19. The patient experienced swelling in face, tongue, throat, sweating, and dizziness on an unspecified date. Had to ambulance received EpiPen's, Benadryl, and other medications. Was in the hospital for 6 hours. Therapeutic measures were taken as a result of swelling in face, swelling in tongue, swelling in throat, sweating, dizziness with EpiPen's, Benadryl, tylenol, steroids and other med. The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was recovering.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Varicose vein
Clinical narrative: There was accompanied pain in the knee and ankles; There was accompanied pain in the knee and ankles; I had varicose veins in my right leg that after the vaccination became very badly swollen and then one appeared in my left leg.; This is a spontaneous report from a contactable consumer or other non hcp.   A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EL9261; Expiration Date: unknown), dose 1 via an intramuscular in Arm Left on 27JAN2021 11:45 as single dose and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EN6200; Expiration Date: unknown), dose 2 via intramuscular in Arm Left on 28Feb2021 11:40 as single dose for COVID-19 immunization. Medical history included blood pressure increased from an unknown date and Kidney Stone from 28Nov2017 to 4Feb2018. Patient surgical procedure includes Catheter operation 1Dec2017, Removal 1 , 15Jan2018 and Removal 2, 14Feb2018 The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced varicose veins in right leg that after the vaccination became very badly swollen and then one appeared in left leg, accompanied pain in the knee and ankles. The outcome of the events was not recovered.   No follow up attempts are possible. No further information is expected.