chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Flushing, Hyperhidrosis
Clinical narrative: it made me turned flushed, really almost purple/ My face was red, arms were red, my neck was red; Sweating; The initial case was missing the following minimum criteria: adverse event nos. Upon receipt of follow-up information on (27Dec2020), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EH9899, expiry date not reported), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medications included metoprolol, hydrochlorothiazide, and lisinopril; all from unspecified dates for blood pressure high. The patient verbalized, "I had the vaccine on last Monday be 21st. I had an issue and ended up in the ER. It made me turned flushed, really almost purple, no anaphylactic nothing, just sweating, my face was red, arms were red, my neck was red but that is it. They gave me Pepcid and Benadryl in ER and watched me in the ER for about 40 minutes. I work at the hospital and I got it from them. I was fine the rest of the week, Thursday, my son came by to pick up a couple of holiday gifts only saw him for 5 minutes. He has now tested positive for COVID. We had masks on. I hugged him on his way out. He took the gifts and left. He is at home now. He got tested yesterday positive for COVID. My question is am I still at risk of getting it from that meeting after I only had one shot?" On an unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement: 133/85 and body temperature: 97.9. Therapeutic measures were taken as a result of the events that included Pepcid and Benadryl. Clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test, Trigeminal nerve disorder
Clinical narrative: Paresthesias in a trigeminal nerve distribution starting 3 days after vaccination; Paresthesias in a trigeminal nerve distribution starting 3 days after vaccination; This is a spontaneous report from a contactable physician. A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EH9899), via an unspecified route of administration on the left arm on 18Dec2020 15:45 at single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications were not reported. The patient experienced paraesthesias in a trigeminal nerve distribution starting 3 days after vaccination on 21Dec2020 18:30.  The patient underwent lab tests and procedures which included Nasal Swab/Antigen rapid: negative on 25Dec2020. Therapeutic measures were taken as a result of the event that included Medrol dose pack and famvir. Symptomology was mild, 80% improved one week later. Clinical outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Urticaria
Clinical narrative: flushed; noticed some hives on forehead and forearm; This is a spontaneous report from a non-contactable nurse. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK5730), intramuscular on the left arm on 18Dec2020 09:30 at single dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications were not reported. The patient previously took NSAIDS and experienced allergies. The patient flushed and noticed some hives on forehead and forearm on 18Dec2020 10:15. Therapeutic measure was taken as a result of the events that included Benadryl. Clinical outcome of flushing was not recovered while for hives recovered on Dec2020.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Severe fatigue; chills; headache; sore throat; muscle aches; This is a spontaneous report from a contactable Other HCP (patient). A 41-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number not provided), via an unspecified route of administration in left arm on 23Dec2020 16:45 at single dose for COVID-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was hospital. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications were not reported.  The patient experienced severe fatigue, chills, headache, sore throat, muscle aches on 24Dec2020. Case was non-serious. The patient underwent lab tests and procedures which included covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test date=26Dec2020, covid test result=Negative. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was recovering.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Severe fatigue; chills; headache; sore throat; muscle aches; This is a spontaneous report from a contactable Other HCP (patient). A 41-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number not provided), via an unspecified route of administration in left arm on 23Dec2020 16:45 at single dose for COVID-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was hospital. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications were not reported.  The patient experienced severe fatigue, chills, headache, sore throat, muscle aches on 24Dec2020. Case was non-serious. The patient underwent lab tests and procedures which included covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test date=26Dec2020, covid test result=Negative. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was recovering.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pruritus, Vaccination site pain, Vaccination site warmth
Clinical narrative: light headed; soreness to site of injection; felt a random itch run along from my hand to up along my arm; some warmth to the site; This is a spontaneous report from a contactable other HCP (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer), intramuscularly on 23Dec2020 07:30AM at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Medical history included depression from an unknown date. No allergies to medications, food, or other products. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. Concomitant medication included fluoxetine. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. At the day of 23Dec2020 at 7:30 am the time of injection patient felt okay. She was let go to go back straight in to work. Once at work she felt light headed for 30 minutes with soreness to site of injection. Patient also felt a random itch run along from her hand to up along her arm. She applied lotion to the site if irritation for some comfort. The next 2 days patient still felt soreness and some warmth to the site. It's unknown if patient received treatment for the other adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The date report was first received from source was 27Dec2020. The events were reported as non-serious.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Fine rash developed on arms and legs; Red, itchy patches on abdomen, back, neck and chin; Hot, burning sensation to palms of hands and soles of feet; Red, itchy patches on abdomen, back, neck and chin; Hot, burning sensation to palms of hands and soles of feet; This is a spontaneous report from a contactable nurse, the patient.  A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EJ1685), via an unspecified route of administration on 25Dec2020 at 03:00 PM (at the age of 46-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. Medical history included anemia. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) (MANUFACTURER UNKNOWN) and iron (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took sulfa (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced allergy. On 25Dec2020 at 08:00PM, a fine rash developed on arms and legs. Red, itchy patches on abdomen, back, neck and chin. Hot, burning sensation to palms of hands and soles of feet. The patient did not receive any treatment for the events. The clinical outcome of the events rash on legs & arms, Red, itchy patches on abdomen, back, neck and chin, and Hot, burning sensation to palms of hands and soles of feet was recovered on an unspecified date in Dec2020.  It was also reported that since the vaccination, the patient had not been tested for COVID-19. There were no other vaccines the patient received within 4 weeks of the vaccination.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: rash on the face; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash on the face on 25Dec2020 in the afternoon, it was  not bad, but it always happen in the afternoon. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: rash on the face; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash on the face on 25Dec2020 in the afternoon, it was  not bad, but it always happen in the afternoon. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: rash, hives type things on face/rash on the face after the COVID vaccine; rash, hives type things on face; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; NDC/UPC/batch/lot number and expiration date were unknown), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. Concomitant medications included mometasone furoate (ASMANEX) inhaler, pramipexole, simvastatin, montelukast, and gabapentin. The patient stated that she didn't know if she was having side effects from the vaccine or not since for the last three days, she had been getting almost like a rash, hives type things on face; nowhere else, just on her face from 25Dec2020. The patient believed it just started in the last couple of days and it didn't happen right at first and wanted to know what it's from. The patient considered herself as a first responder as she worked at the court house and did protection from abuse orders for people in domestic violence situations. The patient was still experiencing the problems and seemed to happen in the afternoon, every afternoon she seemed to get it. The patient further reported that she experienced rash on the face after the COVID vaccine and it happened in the afternoon. She got the COVID (19) vaccine on Wednesday and on Friday afternoon (also reported as the "25th, Christmas day"), she experienced rash on the face; she said it was not bad, but it happened in the afternoon. She still had it at the time of the report and it's just on her face. The patient did not receive any treatment for the events. The patient had no investigation assessment. The patient was not recovered from the events "rash, hives type things on face/rash on the face after the COVID vaccine."  Information on the batch/lot number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: rash, hives type things on face/rash on the face after the COVID vaccine; rash, hives type things on face; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; NDC/UPC/batch/lot number and expiration date were unknown), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. Concomitant medications included mometasone furoate (ASMANEX) inhaler, pramipexole, simvastatin, montelukast, and gabapentin. The patient stated that she didn't know if she was having side effects from the vaccine or not since for the last three days, she had been getting almost like a rash, hives type things on face; nowhere else, just on her face from 25Dec2020. The patient believed it just started in the last couple of days and it didn't happen right at first and wanted to know what it's from. The patient considered herself as a first responder as she worked at the court house and did protection from abuse orders for people in domestic violence situations. The patient was still experiencing the problems and seemed to happen in the afternoon, every afternoon she seemed to get it. The patient further reported that she experienced rash on the face after the COVID vaccine and it happened in the afternoon. She got the COVID (19) vaccine on Wednesday and on Friday afternoon (also reported as the "25th, Christmas day"), she experienced rash on the face; she said it was not bad, but it happened in the afternoon. She still had it at the time of the report and it's just on her face. The patient did not receive any treatment for the events. The patient had no investigation assessment. The patient was not recovered from the events "rash, hives type things on face/rash on the face after the COVID vaccine."  Information on the batch/lot number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate, Nausea, Pain in extremity
Clinical narrative: Tachycardia (over 100 bpm for 48hr); Nausea; Headache; Chills; arm pain; This is a spontaneous report from a contactable Nurse reporting for herself. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left arm on 18Dec2020 13:00 at single dose for covid-19 immunization. It was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included Reynald's, Irritable bowel syndrome (IBS), spontaneous pneumothorax. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had allergy to medication of Vicodin. The patient experienced tachycardia (over 100 bpm for 48hr), nausea, headache, chills, arm pain, started on 18Dec2020 13:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event Tachycardia was recovered on 20Dec2020 13:00, the outcome of the other event was recovered on an unknown date in Dec2020.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia (over 100 bpm for 48hr); Nausea; Headache; Chills; arm pain; This is a spontaneous report from a contactable Nurse reporting for herself. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left arm on 18Dec2020 13:00 at single dose for covid-19 immunization. It was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included Reynald's, Irritable bowel syndrome (IBS), spontaneous pneumothorax. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had allergy to medication of Vicodin. The patient experienced tachycardia (over 100 bpm for 48hr), nausea, headache, chills, arm pain, started on 18Dec2020 13:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event Tachycardia was recovered on 20Dec2020 13:00, the outcome of the other event was recovered on an unknown date in Dec2020.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Malaise, Nasal congestion
Clinical narrative: cough; change in taste and smell; change in taste and smell; injection site pain; feverish but afebrile; chills; intense headache; nasal congestion; malaise; This is a spontaneous report from a contactable nurse (patient herself). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EKS730, expiration date: unknown), via an unspecified route of administration on the left arm on 18Dec2020 at 13:00 at a single dose for COVID-19 immunization administered at the workplace clinic. Relevant medical history included hypertension (HTN), hypothyroidism, high cholesterol, and COVID-19 prior to vaccination. The patient had no known allergies. Concomitant medications included levothyroxine, amlodipine, and pravastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient experienced feverish but afebrile, chills, intense headache, nasal congestion, malaise, cough, change in taste and smell, and injection site pain on 19Dec2020 at 12:00. The events were assessed as non-serious. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered with sequelae/lasting effects from the events "feverish but afebrile, chills, intense headache, nasal congestion, malaise, cough, change in taste and smell, and injection site pain" on an unspecified date.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Pyrexia, Taste disorder, Vaccination site pain
Clinical narrative: cough; change in taste and smell; change in taste and smell; injection site pain; feverish but afebrile; chills; intense headache; nasal congestion; malaise; This is a spontaneous report from a contactable nurse (patient herself). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EKS730, expiration date: unknown), via an unspecified route of administration on the left arm on 18Dec2020 at 13:00 at a single dose for COVID-19 immunization administered at the workplace clinic. Relevant medical history included hypertension (HTN), hypothyroidism, high cholesterol, and COVID-19 prior to vaccination. The patient had no known allergies. Concomitant medications included levothyroxine, amlodipine, and pravastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient experienced feverish but afebrile, chills, intense headache, nasal congestion, malaise, cough, change in taste and smell, and injection site pain on 19Dec2020 at 12:00. The events were assessed as non-serious. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered with sequelae/lasting effects from the events "feverish but afebrile, chills, intense headache, nasal congestion, malaise, cough, change in taste and smell, and injection site pain" on an unspecified date.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Myalgia, Vaccination site pain
Clinical narrative: slightly painful enlarged left axillary node that is on ipsilateral side of injection; slightly painful enlarged left axillary node that is on ipsilateral side of injection; paraspinal muscle pain resolved by next day; In evening had mild pain site injection gone in a day; This is a spontaneous report from a contactable physician (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EK5730), intramuscular on the left arm on 20Dec2020 12:00 at SINGLE DOSE as COVID-19 immunization at the hospital.  Medical history included Graves disease. The patient also had allergies with penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID), acetylsalicylic acid (BABY ASPIRIN), and colecalciferol (VITAMIN D). It was mentioned that prior to vaccination, the patient diagnosed was not with COVID-19 and had not been tested for COVID-19 since vaccination. On 21Dec2020 in evening, the patient had mild pain site injection gone in a day (22Dec2020). On 22Dec2020 (day after injection), the patient then had paraspinal muscle pain resolved by next day (23Dec2020). The patient took ibuprofen (MOTRIN) in evening and gone by morning. Day 7 (28Dec2020), the patient noticed slightly painful enlarged left axillary node that was on ipsilateral side of injection which was still present (no treatment was received for the events). The patient recovered from the event of mild pain site injection on 22Dec2020 and paraspinal muscle pain on 23Dec2020 while not recovered for the remaining events.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable nurse, who is also the patient. This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The reporting nurse stated that she received her first dose of the COVID-19 vaccine on Saturday (e.g. Dec2020). She had taken a PCR test on Thursday and received a negative result on Saturday, the same day she received her vaccination. She reported developing a fever on Monday night and testing positive for COVID-19 on Tuesday. At the time of the report, the outcome of the events was unknown.  The information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.  More information such as laboratory findings on viral nucleic acid /PCR test needed for meaningful medical assessment.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dizziness postural
Clinical narrative: Onset dizziness when turning to the left or going from  laying to sitting / standing. Does not occur sitting to standing; Onset dizziness when turning to the left or going from  laying to sitting / standing. Does not occur sitting to standing; This is a spontaneous report from a contactable nurse (patient).  A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on the left arm on 26Dec2020 10:00 at SINGLE DOSE as COVID-19 immunization at the hospital.  Medical history included psoriasis.  Concomitant medications included adalimumab (HUMIRA) and famotidine (FAMOTIDINE).  It was mentioned that prior to vaccination, the patient diagnosed was not with COVID-19 and had not been tested for COVID-19 since vaccination. On 26Dec2020 17:00, the patient experienced onset dizziness when turning to the left or going from laying to sitting / standing but does not occur sitting to standing. The patient did not receive any treatment for the events. Outcome of the events were not recovered.   Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: fatigue; Fever/Woke up on 27Dec2020 with 100.5F; some soreness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK5730), intramuscular on the right arm on 26Dec2020 10:45 at SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included hypertension.  Concomitant medications included lisinopril (LISINOPRIL), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), citalopram (CITALOPRAM), ascorbic acid (VITAMIN C), calcium (CALCIUM), loratadine (LORATADINE) and Sudaphrene pene (as reported). It was mentioned that prior to vaccination, the patient diagnosed was not with COVID-19 and had not been tested for COVID-19 since vaccination. On 26Dec2020 06:00 (as reported), the patient had fatigue, and some soreness at injection site. It was reported that the patient woke up on 27Dec2020 with 100.5 F that lasted most of day until 5 pm.  It was mentioned that the patient did not receive any treatment for the events. The patient recovered from fever on 27Dec2020 17:00 while recovering for the remaining events.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: fever; Diarrhea; headache; chills; feeling unwell; Joint pain; injection site pain; tiredness; This is a spontaneous report from a contactable consumer. A 53-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EK5730), intramuscular (Dose number 1, Arm left) on 23Dec2020, 13:45 at single dose for COVID-19 immunization. Medical history included diabetic, thyroidectomy, hysterectomy, tonsillectomy, and Known allergies: Sulfa. Concomitant medication included zolpidem, levothyroxine, and pantoprazole from unspecified dates for an unspecified indication. The patient experienced fever, diarrhea, headache, chills, feeling unwell, joint pain, injection site pain, and tiredness on 23Dec2020 13:45. No treatment for AE was given. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 since vaccination. Outcome of the events was not recovered. Events were reported as non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Vaccination site pain
Clinical narrative: fever; Diarrhea; headache; chills; feeling unwell; Joint pain; injection site pain; tiredness; This is a spontaneous report from a contactable consumer. A 53-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EK5730), intramuscular (Dose number 1, Arm left) on 23Dec2020, 13:45 at single dose for COVID-19 immunization. Medical history included diabetic, thyroidectomy, hysterectomy, tonsillectomy, and Known allergies: Sulfa. Concomitant medication included zolpidem, levothyroxine, and pantoprazole from unspecified dates for an unspecified indication. The patient experienced fever, diarrhea, headache, chills, feeling unwell, joint pain, injection site pain, and tiredness on 23Dec2020 13:45. No treatment for AE was given. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 since vaccination. Outcome of the events was not recovered. Events were reported as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: coughing; fatigue; body aches; This is a spontaneous report from a contactable healthcare professional (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 10:30 at a single dose for COVID-19 immunization. The patient's medical history was unknown. Concomitant medication included paracetamol (TYLENOL). The patient experienced having side effects that started on the night of 25Dec2020 including coughing, fatigue, and body aches. She received a Fact Sheet for Recipients and Caregivers as well as instructions on how to report her symptoms to VAERS.  She has not reported her symptoms to anyone yet. She stated her facility has antigen testing every day that results in 15 minutes and a COVID test every Monday with results in three days. She has been negative for her testing for 12 weeks and has not received any positive test results to date. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hordeolum, Hot flush, Vaccination site pain
Clinical narrative: Sore injection site, hot flashes with no fever, styes on both eyes; Sore injection site, hot flashes with no fever, styes on both eyes; Sore injection site, hot flashes with no fever, styes on both eyes; This is a spontaneous report from a contactable nurse (patient).  An adult female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on the left arm on 26Dec2020 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included suspected endometriosis. It was also reported that the patient had allergies to ranitidine (ZANTAC), omeprazole (PRILOSEC), famotidine (PEPCID), kiwi, and adhesive.  Concomitant medications included sertraline hydrochloride (ZOLOFT), fish oil (FISH OIL), and colecalciferol (VITAMIN D). It was mentioned that prior to vaccination, the patient diagnosed was not with COVID-19 and had not been tested for COVID-19 since vaccination. On 27Dec2020 07:00, the patient experienced sore injection site, hot flashes with no fever, and styes on both eyes. The patient did not receive any treatment for the events. Outcome of the events were unknown.  Information on the Batch/Lot number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Vaccination site pain
Clinical narrative: Left Red eye; Sore right arm; This is a spontaneous report from a contactable nurse. This 36-year-old female nurse reported for herself that a 36-years-old female patient started to receive bnt162b2 (BNT162B2; Brand: Pfizer; Dose number: 1), intramuscular on 24Dec2020 15:45 at SINGLE DOSE at Vaccine location of Right arm for covid-19 immunisation. Patient was not Pregnant at the time of vaccination. Medical history included Graves disease. Patient had none Known allergies. The patient had no Allergies to medications, food, or other products. Concomitant medication included spironolactone (ALDACTONE), methimazole (METHIMAZOLE) within 2 weeks of vaccination.  The patient experienced left red eye and sore right arm, both on 25Dec2020 with outcome of not recovered.  No treatment received. The events reported as non-serious.  Facility where the most recent COVID-19 vaccine was administered was Hospital. 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.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Left axillary lymphadenopathy; This is a spontaneous report from a non-contactable physician. A 33-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 21Dec2020 at single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Dec2020, the patient experienced left axillary lymphadenopathy. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. The case was assessed as non-serious. The outcome of the event was unknown.   No follow-up attempts are possible. Information about batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Swelling face
Clinical narrative: feeling flushed; facial swelling; This is a spontaneous report from a contactable physician reported for self. This 29-year-old female (No pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm on 23Dec2020 14:30 at single dose for COVID-19 immunization. No COVID prior vaccination, No COVID tested post vaccination. No known allergies or other medical history. No other vaccine in four weeks, No other medications in two weeks. The patient got the vaccine Wednesday afternoon (on 23Dec2020 14:30), then Thursday evening (>24h, 24Dec2020 07:45 PM) started feeling flushed and had facial swelling after dinner. No other symptoms. Resolved with Benadryl. Then again Saturday morning while brushing teeth and Saturday evening after dinner. One more time Sunday morning during breakfast. Each time the symptoms were milder than before. Took Benadryl as needed. No new foods, meds etc. The outcome of event was recovered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: I got the Covid Vaccine and Wondering I have been having increasingly shortness of breath for last few days; gotten worse everyday its a little bit worse; This is a spontaneous report from a contactable nurse. This nurse reported for self that the 37-year-old female patient received first dose of bnt162b2 (BNT162B2, lot: EJ1685, Expiration Date: Mar2021), via Intramuscular on left deltoid on 20Dec2020 at single dose for covid-19 immunisation. Medical history was none. Concomitant medications included Multivitamins  and escitalopram oxalate (LEXAPRO). Nurse stated, "I was wondering I got the Pfizer (Covid) Vaccine on 20th and I have been having increasingly shortness of breath for last few days and I am wondering if that's the typical side effect of that. It wasn't prescribed, it was something given out to all the healthcare providers. It was like the first dose. It was first dose. I got an Intramuscular shot in left shoulder. Because I wanted to not spread it (Covid). I am not sure if it is due to the product, I got "6" (not clarified) from another patient, that's why I am calling, I want to know if this is like the typical side effect of vaccination or should I go get tested. I haven't taken any treatment yet. It's gotten worse everyday its a little bit worse." The outcome of the events was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: All over my back, my butt, my legs; Itching; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received bnt162b2 (BNT162B2, Lot: EL0140, Exp:Mar2021), via an unspecified route of administration on 21Dec2020 for first dose at single dose for COVID-19 immunisation. Medical history included blood pressure high and anxiety. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]) for Blood pressure high and an anxiety medicine. The patient experienced itching there was nothing on 25Dec2020, in the morning of 26Dec2020, suddenly had rash all over back, butt, leg, she would like have the rash over body and she knew the reaction like the people like said it was within a couple of hours but this was more than couple of hours it is few days. At the time of reporting, no treatment received, she might go emergency to see if I get good dose of Benadryl. The event outcome was unknown.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: Urine is dark red, I mean like dark orange; This is a spontaneous report from a contactable physician (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number and expiration date not reported, via an unspecified route of administration from 22Dec2020 to 22Dec2020 as single dose (into the deltoid) for COVID-19 immunization. Medical history included Hair loss. Concomitant medication included finasteride 2.5 mg, daily for Hair loss. The patient stated, "So, I got the COVID 19 Vaccine on Tuesday, and I had no fever or anything like that. It was the first shot I got it into the deltoid and today (25De2020), I noticed my urine is dark red, I mean like dark orange. I didn't know if it's a common side effect or not?" Physician stated, "I never had it before, it's very unusual. When asked for treatment, physician stated, "No, I didn't. Just water.". The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Still having pain in right arm a week after injection; Warmth/redness and hardness of injection site; Warmth/redness and hardness of injection site; Warmth/redness and hardness of injection site; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 19Dec2020 19:15 at single dose on right arm for COVID-19 immunization in hospital. Medical history was reported as none and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced still having pain in right arm a week after injection, warmth/redness and hardness of injection site from 19Dec2020 19:15. No treatment received for the adverse events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.  The information on the batch number has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Headache, Myalgia
Clinical narrative: Mild discomfort the day after at the injection site; Nausea; extreme fatigue; Muscle ache/ Muscle pain; Cough; Sore throat; Headache; All of joints were painful; This is a spontaneous report from a contactable physician reported for self. This 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left arm (IM in left shoulder) on 22Dec2020 at single dose for COVID-19 immunization. None medical history nor concomitant medications. Three hours after the vaccine (on 22Dec2020) patient started developing nausea that was pretty much and it was enough that patient had to stay at home instead of going out to shoot golf balls, it was so significant nausea. Then he had some extreme fatigue, muscle ache/muscle pain, started developing cough, sore throat and headache. Then all of his joints were painful. Patient had a mild discomfort the day after at the injection site. The next day (on 23Dec2020) when he woke up nausea was gone. Patient might just have some general labs at the family practitioner just to check cholesterol. The outcome of "nausea" was recovered on 23Dec2020, of "mild discomfort at the injection site" was unknown, outcome of else events was not recovered. The reporting physician considered all events "related" to the Covid 19 Vaccine, Physician stated 100 percent it is from the vaccine.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Vaccination site discomfort
Clinical narrative: Mild discomfort the day after at the injection site; Nausea; extreme fatigue; Muscle ache/ Muscle pain; Cough; Sore throat; Headache; All of joints were painful; This is a spontaneous report from a contactable physician reported for self. This 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left arm (IM in left shoulder) on 22Dec2020 at single dose for COVID-19 immunization. None medical history nor concomitant medications. Three hours after the vaccine (on 22Dec2020) patient started developing nausea that was pretty much and it was enough that patient had to stay at home instead of going out to shoot golf balls, it was so significant nausea. Then he had some extreme fatigue, muscle ache/muscle pain, started developing cough, sore throat and headache. Then all of his joints were painful. Patient had a mild discomfort the day after at the injection site. The next day (on 23Dec2020) when he woke up nausea was gone. Patient might just have some general labs at the family practitioner just to check cholesterol. The outcome of "nausea" was recovered on 23Dec2020, of "mild discomfort at the injection site" was unknown, outcome of else events was not recovered. The reporting physician considered all events "related" to the Covid 19 Vaccine, Physician stated 100 percent it is from the vaccine.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This is a spontaneous report from contactable consumer (parent).  A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number and expiration date not reported, via an unspecified route of administration from 22Dec2020 to 22Dec2020 as single dose for COVID-19 immunization.  Medical history included asthma and allergy.  Concomitant medication included cetirizine hydrochloride (ZYRTEC) for Allergy and budesonide, formoterol fumarate (SYMBICORT) for Asthma.  The patient's parent stated that the patient experienced dizzy on 25Dec2020. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Oropharyngeal pain, Vaccination site pain
Clinical narrative: sore throat; coughing; headache; soreness of injection site; tiredness; This is a spontaneous report from a contactable Other HCP (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 26Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the Covid vaccine yesterday (26Dec2020) and is now experiencing headache, soreness of injection site and tiredness. Additionally, she is also experiencing sore throat and coughing which started today (27Dec2020). The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: The patient's wife felt soreness and some warmth to the site. The patient (husband) felt the warmth as well; This is a spontaneous report from a contactable other health care professional. A male patient of an unspecified age started to receive 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. The wife felt soreness and some warmth to the site. The patient (husband) felt the warmth as well. No other symptoms reported. 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Her arm was very sore; Intermittent stabbing headache; This is a spontaneous report from a non-contactable consumer (patient's Sister). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. On 27Dec2020 patient experienced an "intermittent stabbing headache" and her arm was very sore but much better the day of the report. Patient would not take paracetamol (TYLENOL) because she was still very functional. Outcome of the events was unknown. Information about lot/Batch number cannot be obtained. No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itching at injection site; This is a spontaneous report from a contactable Other health care professional (HCP) reporting for herself. A 59-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 23Dec2020 at 06:30 PM at single dose for COVID-19 immunization. Medical history included breast cancer (Currently healthy). Concomitant medications included Tamoxifen and vitamin D. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 25Dec2020 patient experienced Itching at injection site. No treatment was received for the event. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient had not recovered from the event at the time of the report. Information about lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test positive
Clinical narrative: I am not feeling well; had a Covid PCR done swapped on yesterday and I am Covid positive; had a Covid PCR done swapped on yesterday and I am Covid positive; This is a spontaneous report from a contactable nurse. This nurse reported for herself that the 35-year-old female patient who received bnt162b2 (BNT162B2), via unknown route of administration on 23Dec2020 at single dose for covid-19 immunisation. Medical history was none. Concomitant medications were none. Nurse stated, "I received the Pfizer Vaccine this Wednesday and right before getting the vaccine, I had a Covid test (captured as per verbatim) on before the vaccine on Tuesday (22Dec2020) was negative. I had a Covid PCR done swapped on yesterday (25Dec2020) and I am Covid positive. So I have the vaccine and I am Covid positive" Nurse stated "It's "140" "130" pounds (further bot clarified)." The patient was not feeling well. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the SARS-CoV-2 test positive and vaccination with BNT162B2 cannot be excluded.