chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: basically thought she had COVID all over again; basically thought she had COVID all over again; Pain at the injection site; Joint pain; Feeling unwell; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for COVID-19 immunization.  Medical history included COVID a month ago in 2020.  There were no concomitant medications. The patient experienced pain at the injection site, headache, myalgia, joint pain, chills, nausea, feeling unwell, fatigue in Dec2020. The patient basically thought she had COVID all over again. The patient  stated, "I was calling because I just had the COVID vaccine which has caused so many adverse reactions which is the side effects? I am experiencing all the side effects but it is calming down because today is day three. Pain at the injection site, headache, myalgia, joint pain, fatigue, chills, nausea, feeling unwell. Basically I had COVID a month ago and I had vaccine three days ago (Dec2020) and I basically thought I have COVID all over again. I took the vaccine on Friday started with the symptoms pretty much on Saturday." The patient received ibuprofen (ADVIL) as treatment. The outcome of events was unknown. The physician assessed events pain at the injection site, headache, myalgia, chills, nausea, feeling unwell, fatigue was related with vaccine.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2  in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea
Clinical narrative: basically thought she had COVID all over again; basically thought she had COVID all over again; Pain at the injection site; Joint pain; Feeling unwell; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for COVID-19 immunization.  Medical history included COVID a month ago in 2020.  There were no concomitant medications. The patient experienced pain at the injection site, headache, myalgia, joint pain, chills, nausea, feeling unwell, fatigue in Dec2020. The patient basically thought she had COVID all over again. The patient  stated, "I was calling because I just had the COVID vaccine which has caused so many adverse reactions which is the side effects? I am experiencing all the side effects but it is calming down because today is day three. Pain at the injection site, headache, myalgia, joint pain, fatigue, chills, nausea, feeling unwell. Basically I had COVID a month ago and I had vaccine three days ago (Dec2020) and I basically thought I have COVID all over again. I took the vaccine on Friday started with the symptoms pretty much on Saturday." The patient received ibuprofen (ADVIL) as treatment. The outcome of events was unknown. The physician assessed events pain at the injection site, headache, myalgia, chills, nausea, feeling unwell, fatigue was related with vaccine.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2  in this patient cannot be completely excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Myalgia
Clinical narrative: I have like muscle pain; I am having like chest pain, pain in my chest; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, lot number EJ1685) on 21Dec2020 for COVID-19 immunization. The patient's medical history included high blood pressure and asthma. Concomitant medications were not reported. On 21Dec2020, the patient reported that she had like muscle pain, and had like chest pain/ pain in her chest. The outcome of the events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: chronic cough; Itchy welt in the lower of my back, its more like swell; whelps; This is a spontaneous report from a contactable nurse reported for herself.  This 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EJ1685, Expiry Date: 31Mar2021) via an unspecified route of administration at single dose in the right deltoid on 22Dec2020 08:00am for Covid-19 immunisation. Medical history included stage 0 breast cancer, she had a lumpectomy and radiation in 2016,  she also just her Zyrtec for her seasonal allergies a few minutes.  Concomitant medications were not reported. The patient experienced whelps on 22Dec2020 02:00pm with outcome of not recovered, chronic cough on an unspecified date with outcome of unknown, itchy welt in the lower of my back, its more like swell on an unspecified date with outcome of unknown.  The events were described as follows: After getting the vaccine she noticed raised whelps on her lower back. They are about 1-2 cm in length and that was the largest and the smaller ones are about 1/2 a centimeter long. There are 4-5 on her lower back and there is one right around her upper scapula area. She describes them as itchy, red, and raised. She has never had this happen to her before and so she immediately took Benadryl. The patient also reported that she has a chronic cough which has been described as a combination of things. It is an asthma variant cough, she has drainage and a hyper-reactive airway but doesn't not have asthma technically.  The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: left arm soreness; extreme fatigue for 4 days; severe headache day 3,4; This is a spontaneous report from a contactable physician, who is also the patient. This 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 18Dec2020 at 07:00 at single dose for COVID-19 immunisation. Vaccination facility type: hospital. Relevant medical history included penicillin allergy. There were no concomitant medications. On 18Dec2020 at 15:00, the patient experienced left arm soreness and extreme fatigue for 4 days and in Dec2020 she experienced severe headache day 3, 4. The patient did not receive corrective treatments. She recovered from the events in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she had not been tested for COVID-19.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I had a fever last night; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 21Dec2020 at a single dose for Covid-19 immunization. The patient's medical history was and concomitant medications were not reported. The patient had the Pfizer vaccine yesterday (on 21Dec2020) and had a fever at night. The patient asked if patient has to quarantine because of that. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headache; This is a spontaneous report from a non-contactable consumer (patient husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe headache on an unspecified date with outcome of unknown.    No follow-up attempts are possible, information about lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Musculoskeletal chest pain, Nausea, Vomiting
Clinical narrative: she woke up this morning with vomiting, loose stool and her chest wall muscles are extremely painful; she woke up this morning with vomiting, loose stool and her chest wall muscles are extremely painful; she woke up this morning with vomiting, loose stool and her chest wall muscles are extremely painful; nausea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know about her symptoms after receiving the covid 19 vaccine. The patient reported that she woke up this morning (an unspecified date) with vomiting, loose stool and her chest wall muscles were extremely painful, and she wanted advice on what to do about her nausea. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Malaise
Clinical narrative: metallic taste in mouth; general malaise; This is a spontaneous report from a contactable other HCP (Nurse anesthetist) reporting for himself.  A 42-year-old male patient received bnt162b2 (BNT162B2, Batch/lot # EL0140) at single dose at left deltoid on 21Dec2020 08:30 for immunisation.  Medical history and concomitant medications were none.  On 22Dec2020 he was feeling just some general malaise that has since improved. On 23Dec2020, he woke up with a metallic taste in his mouth around 6:30 am and it is persisting. The patient stated he felt fine, he was afebrile, could still smell, went for a 7 mile run, but still had this metallic taste in his mouth. The outcome of malaise was recovering, of metallic taste in mouth was not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: intractable vomiting; This is a spontaneous report from a contactable physician (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EK5730), intramuscular on 22Dec2020 at 13:00 at single dose in right deltoid for covid-19 immunization. There were no medical history or concomitant medications. The patient experienced intractable vomiting on 22Dec2020. The reporter was a physician, she received the Covid-19 vaccine on 22Dec2020 at 1:00 pm. At night on 22Dec2020, she started experiencing intractable vomiting, it was less frequent at time reporting, happening every 2-3 hours. The outcome of the event was resolving.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Pain
Clinical narrative: dry throat; arm feeling sore; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports.   A 43-year-old female patient received bnt162b2 (BNT162B2; lot number: EH9899), via an unspecified route of administration on 21Dec2020 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Dec2020, it was reported that she had a "weird very dry throat 3 hours after the vaccine at the same time that my arm started feeling sore." She also commented that her coworker also had a dry throat 2-3 hours after the shot and thought it was just talking to his student too much. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020510803 same reporter, suspect drug, event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Dry throat
Clinical narrative: dry throat; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports.    A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced dry throat 2-3 hours after the shot and thought it was just talking to his student too much. The outcome of the event was unknown.   Information on the lot/ batch number has been requested.; Sender's Comments: Agree with the reporting consumer, the reported dry throat reported as " just talking to his student too much" is considered unrelated to the administration of BNT162B2 for COVID-19 immunization,Linked Report(s) : US-PFIZER INC-2020510790 same reporter, suspect drug, event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Oropharyngeal pain
Clinical narrative: fatigue; headache; sore throat; feeling crummy; This is a spontaneous report from a contactable physician (patient). A 32-year-old male patient received first dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue, headache, sore throat, feeling crummy all on an unspecified date with outcome of unknown. Caller stated that he got the COVID vaccine on Saturday, got fatigue, headache and sore throat, kind of feeling crummy. Wanted to know if this was a side effect of the vaccine. Wanted to know if it was worth getting a test. Wanted to know will the test come up positive due to the vaccine. Wanted to know if he needed to quarantined. Wanted to know if what he got was good. Stated that this was his first dose.   Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Rhinorrhoea
Clinical narrative: chills; body aches; runny nose; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills, body aches and runny nose on an unspecified date. All events were reported as non-serious. Outcome of events were unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Malaise
Clinical narrative: Feeling a bit unwell/I am not feeling good; Chills; little weak; Little bit tired; This is a spontaneous report from a contactable consumer (patient herself). A 56-year-old female patient received the first dose of (Pfizer-BioNTech COVID-19 vaccine, lot# EK5730), via an unspecified route of administration on 20Dec2020 at single dose for covid-19 immunization. Medical history included allergy. Consumer stated, she guessed its environmental allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for allergy. Patient had the vaccine on Sunday and was feeling a bit unwell on 22Dec2020. Consumer further stated, because she had the vaccine the first shot on Sunday and today (22Dec2020) she was not feeling good, she was wondering it could be a side effect. When probed for the adverse events, Consumer stated, she was feeling like little bit like chills, little bit tired and a little weak. Consumer stated she got it from work at the hospital. Outcome of events were unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Developed sore muscle pain after the injection; Little more tired than normal/had to go to bed earlier than usual, around 10-10:30pm instead of midnight to 1am; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old female patient received bnt162b2, via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was asked that if patients develop sore muscle pain at site of injection, did that mean the body was mounting an immune response to the vaccine? The patient developed sore muscle pain after the injection on 21Dec2020, it continued 22Dec2020, but it is gone and better on 23Dec2020. It was also reported that the last few nights, she had been a "little more tired than normal". She had to go to bed earlier than usual, around 10-10:30 pm instead of midnight to 1am. The outcome of event tiredness was unknown; of another event was recovered on 23Dec2020.  Information on the lot/batch number has been requested. .
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Condition aggravated
Clinical narrative: back pain has been getting worse; This is a spontaneous report from a contactable other healthcare professional (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history included back pain. The patient's concomitant medications were not reported. The patient back pain had been getting worse on 20Dec2020. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Nausea
Clinical narrative: he felt weakness; fever/100.1 degrees; chills; nausea; tiredness; headache; This is a spontaneous report from a contactable consumer (patient himself). A 25-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration at site of left arm (reported left shoulder) at 11:00 on 22Dec2020 at single dose for COVID-19 immunization. Before vaccination, patient was recently COVID-19 positive by a nasal swab COVID-19 test and had ended his quarantine period a few days before receiving the COVID-19 vaccine. There were no concomitant medications. After vaccination, he had chills, fever, nausea, tiredness, and headache around 10:00 PM on 22Dec2020, and throughout today, he had been experiencing these side effects. The side effects all hit at once. He felt weakness this morning on 23Dec2020, and then had a severe headache and chills. He had a headache and fever of 100.1 degrees. he had taken a generic dextromethorphan hydrobromide guaifenesin paracetamol pseudoephedrine hydrochloride (DAYQUIL, liqui-gels for his symptoms. and about 30 minutes later, his symptoms dissipated, and he was good for 3 hours until the symptoms came back. The outcome of event 'felt weakness' was unknown, of rest events was not recovered.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: he felt weakness; fever/100.1 degrees; chills; nausea; tiredness; headache; This is a spontaneous report from a contactable consumer (patient himself). A 25-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration at site of left arm (reported left shoulder) at 11:00 on 22Dec2020 at single dose for COVID-19 immunization. Before vaccination, patient was recently COVID-19 positive by a nasal swab COVID-19 test and had ended his quarantine period a few days before receiving the COVID-19 vaccine. There were no concomitant medications. After vaccination, he had chills, fever, nausea, tiredness, and headache around 10:00 PM on 22Dec2020, and throughout today, he had been experiencing these side effects. The side effects all hit at once. He felt weakness this morning on 23Dec2020, and then had a severe headache and chills. He had a headache and fever of 100.1 degrees. he had taken a generic dextromethorphan hydrobromide guaifenesin paracetamol pseudoephedrine hydrochloride (DAYQUIL, liqui-gels for his symptoms. and about 30 minutes later, his symptoms dissipated, and he was good for 3 hours until the symptoms came back. The outcome of event 'felt weakness' was unknown, of rest events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Oropharyngeal pain
Clinical narrative: sore throat and L ear pain about 22 hours after vaccination; sore throat and L ear pain about 22 hours after vaccination; This is a spontaneous report from a contactable pharmacist.   A 48-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# eL1284), intramuscular from 22Dec2020 15:45 to 22Dec2020 15:45, single for COVID-19 immunisation. Medical history was none.  The patient's concomitant medications were not reported. Vaccine location was left arm. No other vaccine was received in four weeks.  The patient experienced sore throat and left ear pain about 22 hours after vaccination on 23Dec2020 13:30. No treatment was administered. The action taken in response to the events for bnt162b2 was not applicable. The events outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Muscle aches; Chills; Fever little over 100; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on Dec2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced muscle aches, chills and fever little over 100 on Dec2020 with outcome of unknown.    Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Tongue coated
Clinical narrative: metallic taste in my mouth; tongue feels like it's being coated with something; This is a spontaneous report from a contactable consumer reported for himself. This 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL0140), via an unspecified route of administration at single dose on 22Dec2020 for Covid-19 immunisation.  Medical history included cholesterol. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient stated, "I get the vaccine about an hour ago and I didn't see anything stating with the side effects but I have got the metallic taste in my mouth and now my tongue feels like it's being coated with something" on 22Dec2020 with outcome of unknown.  No treatment was performed.
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Fatigue
Clinical narrative: fatigued; disoriented; This is a spontaneous report from a contactable physician (patient) via a Pfizer sales representative. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On Dec2020, the patient was fatigued and disoriented for 3 days. He felt fine now. Outcome of the event was recovered on Dec2020.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Injection site haemorrhage
Clinical narrative: when they were drawing the needle back out of her arm there was unusual amount of blood that came out; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs), by a contactable pharmacist.   A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at 0.3 mL, single on 22Dec2020 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced that when they were drawing the needle back out of her arm there was unusual amount of blood that came out on 22Dec2020 with outcome of unknown. We don't know if we needed to re-dose or revaccinate her since it was unusual amount that came out.  Information on the Lot/Batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Headache; Muscle pain; Chills; This is a spontaneous report from a contactable consumer (healthcare medical assistant) reporting for herself.  This 39 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK5730, expiry date 03Jan2021) on 21Dec2020, at single dose, for COVID-19 immunization. Medical history included thyroid (no other information reported). The patient was exposing herself to patients with COVID, she worked in a health care. Concomitant medication included an unspecified thyroid medication. The patient experienced headache, muscle pain and chills on an unspecified date in Dec2020. The reporter asked if she could take like paracetamol (TYLENOL). Events outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Pain
Clinical narrative: general body aches; discomfort; This is a spontaneous report from a contactable physician reporting for himself, received via a Pfizer sales representative.  This healthy 31-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 22Dec2020 the patient experienced general body aches during the day. Aches may have begun a day or two before 22Dec2020. Aches caused discomfort but did not interfere with ability to perform normal tasks / activities. Events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling abnormal, Nervousness, Pain in extremity, Paraesthesia oral
Clinical narrative: her tongue felt a little weird; she got nervous; her arm was really sore; something about her tongue was like feeling lazy or heavy or something like that; she had like a taste of metal, like a lingering taste of metal; she was starting to feel a little weird, overall she was getting weird; This is a spontaneous report from a non-contactable consumer.  An approximately 47 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Dec2020, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Dec2020 the patient experienced her tongue felt a little weird, she got nervous, her arm was really sore, something about her tongue was like feeling lazy or heavy or something like that, she had like a taste of metal, like a lingering taste of metal and she was starting to feel a little weird, she just said overall she was getting weird. Last night, on 21Dec2020, the reporter was speaking to her sister who took the COVID vaccine and she said her tongue felt a little weird and she was starting to feel a little weird and she got nervous and she got up and started walking around just to like clear herself and just to make sure there was nothing going on. She said it took about half an hour, it happened about half an hour but sure went ahead. No treatment was given. Events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This is a spontaneous report from a non-contactable consumer. A 52-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sinus infection in Dec2020. The patient wanted to know the efficacy of the covid vaccine after getting the first dose. The outcome of the event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had a sore arm after receiving Pfizer's Covid 19 vaccine; This is a spontaneous report from contactable consumer received via a sales representative.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced sore arm after receiving Pfizer's COVID-19 VACCINE. The patient outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: mild injection site soreness; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced mild injection site soreness on Dec2020. The patient outcome of the event was unknown.  Information about Lot/Batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Sense of taste is gone; This is a spontaneous report from a contactable nurse reporting for himself. A 49-year-old male patient received the 1st  dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BionTech), via an unspecified route of administration, on 20Dec2020, at single dose, for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included procaterol hydrochloride (PRO-AIR) as needed (inhaler) for asthma. The patient experienced sense of taste is gone on 21Dec2020 with outcome of unknown.    The information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Tongue feel tingly; This is a spontaneous report from a contactable consumer reporting for herself. A 27-year-old female patient received bnt162b2 (BNT162B2) (lot# EK5730), via an unspecified route of administration, on 22Dec2020, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced tongue feel tingly on 22Dec2020 1 hour after vaccination with outcome of unknown. Therapeutic measures were taken as a result of the event and included treatment with Tylenol.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain in extremity
Clinical narrative: Sore throat; Headache; Left arm pain; This is a spontaneous report from a contactable nurse.  A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on the left arm on 22Dec2020 18:15 at single dose for COVID-19 immunisation.  Medical history included she was COVID positive a few months ago.  There were no concomitant medications.  The patient previously got flu vaccine in Oct2020 for immunisation.  The patient experienced sore throat and headache on 23Dec2020 and left arm pain on 22Dec2020. The outcome of sore throat and headache were recovering and left arm pain was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: experienced loss of taste; Cannot taste or smell red wine vinegar or bleach respectively.; This is a spontaneous report from a contactable other healthcare professional. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Dec2020 at a single dose for COVID-19 immunization. The patient's medical history includes wears a CPAP (ongoing). Concomitant medications were not reported. The patient received vaccine 20Dec2020 and experienced loss of taste. He wears a CPAP. He went to the doctor on 21Dec2020 and was prescribed amoxicillin. The patient cannot taste or smell red wine vinegar or bleach respectivel. Outcome of the events was unknown.   Information on Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: threw up about 3 hours ago; fever which started last night; This is a spontaneous report from a contactable other healthcare professional (reporting for herself). A female patient (Age: 22; Units: unknown) received bnt162b2 (also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were unknown), via an unspecified route of administration on 23Dec2020 11:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got Covid vaccine yesterday at around 1130 am and had fever which started last night (23Dec2020) and "threw up" about 3 hours ago this morning (24Dec2020) and mentioned that it was just on 1 occasion, but it was a lot. She wanted to know if it's normal. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hot flush, Pain in extremity
Clinical narrative: I had a headache quite severe and arm pain; I had a headache quite severe and arm pain; Dizziness; Hot flashes; This is a spontaneous report from a contactable consumer for herself.  A 55-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EJ1685) vaccine , via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunisation .  The patient medical history was not reported.  Concomitant medication included liraglutide (VICTOZA).  The patient had a headache quite severe,  arm pain, dizziness and hot flashes  on 19Dec2020 with outcome of recovered.  The patient also stated that everything was fine by Sunday.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable other health professional received via Medical Information Team.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at 09:00 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced fever on 23Dec2020. The patient outcome of the event was unknown.    Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymphadenopathy in her cervical area; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age (reported as 59, unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient noticed lymphadenopathy in her cervical area yesterday (23Dec2020). Outcome of event was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: slight fever; cold; This is a spontaneous report from a contactable other health professional received via Medical Information Team.  A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced slight fever and cold on Dec2020. The patient outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: Flushing after an hour of receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 21Dec2020, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 21Dec2020, the patient experienced flushing after an hour of receiving the vaccine and on 22Dec2020, the episode was lasting quite a bit longer. Clinical outcome of the adverse event was unknown at time of this report.   Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site haemorrhage, Injection site pain, Peripheral coldness
Clinical narrative: the injection site is extremely painful; bleed a lot; there was lot of blood, it was more than usual; I could barely move; Rest of the arm feels cold like really cold; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient (weight 68.04 kg, height 160 cm) received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 22Dec2020, at single dose, for COVID-19 immunisation. Relevant medical history included asthma and allergy from an unspecified date and ongoing. Concomitant medications were none. On 22Dec2020, the injection site was extremely painful and bleed a lot; there was lot of blood, it was more than usual. She could barely move and rest of the arm felt cold like really cold. Patient put 3 band aids on injection site. Clinical outcome of the events was unknown at time of this report.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Circumoral swelling, Periorbital swelling, Rash
Clinical narrative: Swelling reported around mouth and eyes; Swelling reported around mouth and eyes; rash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer-BIONTECH COVID-19 vaccine), via an unspecified route of administration on 22Dec2020 16:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took doxycycline in 2019 and experienced swelling reported around mouth and eyes and rash. On an unspecified date in Dec2020, the patient experienced swelling reported around mouth and eyes and rash. The outcome of the events was unknown.  Information on the lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: body aches and fever; body aches and fever; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient was having body aches and fever. The outcome of the events was unknown.    Information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ear ringing; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (age: 63; Unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received vaccine on Sunday 20Dec2020 and indicated experiencing ear ringing started Monday 21Dec2020 that has been persistent. The patient's blood pressure was "fine". The outcome of the event was not recovered.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I had body hives for 24 hours; This is a spontaneous report from contactable nurse (patient).  A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  On an unspecified date in Dec2020, the patient had body hives for 24 hours. The patient recovered from the event on an unspecified date in Dec2020.  Information on the lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Nausea
Clinical narrative: headache; nausea; cough; fatigue; This is a spontaneous report from a contactable nurse. A male patient of an unspecified age received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 18Dec2020 at a single dose for immunization. The patient's medical history and patient's concomitant medications were not reported. On 22Dec2020, the patient experienced cough and fatigue. On 23Dec2020, the patient got severe nausea, severe headache that continued through the night. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 21Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, "I received my vaccine on Monday the 21st and on Tuesday (22Dec2020) I had a sore throat. I don't see on the fact sheet this as a commonly reported side effect. Should I get tested?" The outcome of the event was unknown.  Information about Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Influenza like illness, Injection site pain
Clinical narrative: flu like symptoms; fever 99.5 this morning; feel weak; fatigue; injection site pain; upper arm pain; breathing heavier now; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. Medical history included COVID-19 in Jul2020. The patient's concomitant medications were not reported. On 24Dec2020, the patient experienced flu like symptoms, fever 99.5 this morning, feel weak, fatigue, injection site pain, upper arm pain and was breathing heavier. The patient took paracetamol (TYLENOL) for the events injection site pain and upper arm pain. Outcome of the events "upper arm pain" and "injection site pain" was recovering while the outcome of the events "flu like symptoms", "fever 99.5 this morning", "feel weak", "fatigue" and "breathing heavier" was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: flu like symptoms; fever 99.5 this morning; feel weak; fatigue; injection site pain; upper arm pain; breathing heavier now; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. Medical history included COVID-19 in Jul2020. The patient's concomitant medications were not reported. On 24Dec2020, the patient experienced flu like symptoms, fever 99.5 this morning, feel weak, fatigue, injection site pain, upper arm pain and was breathing heavier. The patient took paracetamol (TYLENOL) for the events injection site pain and upper arm pain. Outcome of the events "upper arm pain" and "injection site pain" was recovering while the outcome of the events "flu like symptoms", "fever 99.5 this morning", "feel weak", "fatigue" and "breathing heavier" was unknown.   Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Malaise, Nausea
Clinical narrative: Swollen painful axillary lymph node, malaise, constant headache, nausea for several days; Swollen painful axillary lymph node, malaise, constant headache, nausea for several days; Swollen painful axillary lymph node, malaise, constant headache, nausea for several days; Swollen painful axillary lymph node, malaise, constant headache, nausea for several days; Swollen painful axillary lymph node, malaise, constant headache, nausea for several days; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the left arm on 18Dec2020 at 09:00 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included celiac disease and hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID) and paroxetine hydrochloride (PAXIL). Past drug history included known allergies: minocycle, tetracycline and acetylsalicylic acid (ASPIRIN). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 22Dec2020, the patient experienced swollen painful axillary lymph node, malaise, constant headache, nausea for several days. No treatment was provided for the events swollen painful axillary lymph node, malaise, constant headache, nausea. The outcome of the events swollen painful axillary lymph node, malaise, constant headache, nausea was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate increased
Clinical narrative: get hot with a feeling of an elevated heart rate /she also experienced similar reactions to her vaccine; get hot with a feeling of an elevated heart rate/she also experienced similar reactions to her vaccine; This is a spontaneous report from a contactable consumer (nephew of the patient). A female patient of unknown age received BNT162B2 on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Approximately 3 to 4 minutes after injection site, the patient started to get hot with a feeling of an elevated heart rate. The action taken with BNT162B2 was not applicable. The outcome of the event swas unknown. Information for Lot/Batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Diarrhea; Nausea; This is a spontaneous report from a contactable Other health care professional (HCP) (patient). A 20-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020 at 06:00 PM at single dose in Right arm for COVID-19 immunization, Lot number: EK9231. Medical history included covid. No known allergy to medications, food or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and trazodone. On 23Dec2020 patient experienced diarrhea and nausea. Patient received anti diarrheal as treatment. Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the events.