chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Fatigue, Headache, Mental impairment
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presents to urgent care one day after vaccination with fatigue, chest tightness, back pain, myalgias, headaches, right arm soreness, and decreased concentration. Patient states had COVID-19 illness in October 2020 and current symptoms are similar. Patient denies facial/throat swelling, palpitations, rash, or lesions and reports some symptom improvement with acetaminophen. Vitals within normal ranges except blood pressure 141/84 attributed to white coat syndrome. Advised to continue acetaminophen and discharged to home stable.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presents to urgent care one day after vaccination with fatigue, chest tightness, back pain, myalgias, headaches, right arm soreness, and decreased concentration. Patient states had COVID-19 illness in October 2020 and current symptoms are similar. Patient denies facial/throat swelling, palpitations, rash, or lesions and reports some symptom improvement with acetaminophen. Vitals within normal ranges except blood pressure 141/84 attributed to white coat syndrome. Advised to continue acetaminophen and discharged to home stable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Palpitations, Pyrexia
Clinical narrative: Fever to 102, chills, body aches. Palpitations headache, nausea everything started the day after symptoms lasted until 3/2/2021
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Computerised tomogram, Diverticulitis, Laboratory test
Clinical narrative: Pt with severe right lower quadrant pain - 48 hours after vaccine and required ER evaluation, labs, CT scan.  There was mild diverticulitis on the left side, did not explain her pain on the right side.  Placed on antibiotics which caused side effect of diarrhea. Required follow up telephone visit and follow up office visit.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Asthenia, Dehydration, Myalgia, Vision blurred
Clinical narrative: weakness, dehydration, blurred  vision, myalgias
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pain, Piloerection
Clinical narrative: chills, goosebumps, for about 2-3 hours and slight fever for about 12 hours. severe pain around injection site, more severe than a regular vaccine injected reaction site- lasted about 48 hours. fatigue and body pain about 12 hours
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills, goosebumps, for about 2-3 hours and slight fever for about 12 hours. severe pain around injection site, more severe than a regular vaccine injected reaction site- lasted about 48 hours. fatigue and body pain about 12 hours
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Feeling abnormal, Heart rate decreased, Nausea
Clinical narrative: Pt c/o "feeling different".  Paramedic assessed pt- HR- 49; B/P- 190/91; R-12; SpO2- 99%.  Pt states she was nauseated.  Per caregiver, pt tends to be hypotensive.  Rechecked B/P- 180/80; P-42.  Continued to talk with pt and caregiver.  Pt requested PHN call her PMD.  Attempted to call PMD- he was not in the office and staff didn't know what time he would be back.  Decision made to send pt to ER for evaluation as B/P continued to be elevated and HR was low.  Final vitals as leaving- B/P 191/91; HR-40.  Pt given Zofran in ambulance for nausea.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Red, hard, round area at injection site.  Just noticed today.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: 10 days after vaccination, patient developed a flat erythematous patch on her L arm below vaccination site. It continued to get larger for 2 days, as well as lighter red. Not itchy or painful.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Pharyngeal paraesthesia, Skin discolouration
Clinical narrative: Felt SOB, little headache. After getting home, felt more fatigued, tiredness, tingling in throat, eyelids appear darker. Biggest complaint is being tired and fatigued.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Stated itching around armpit area on same arm as injection. After going home stated that the itching stopped under the arms but moved to both legs. Suggested to take diphenhydramine.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gallbladder disorder, Hepatic enzyme increased, Vomiting
Clinical narrative: Patient ended up going to hospital, so don't know if they did a VAERS or not. He was vomitting and had elevated liver enzymes and gall bladder issues
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Anaemia, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Decreased appetite
Clinical narrative: Patient ended up going to hospital, so don't know if they did a VAERS or not. He was vomitting and had elevated liver enzymes and gall bladder issues
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count abnormal, Liver function test normal, Malaise, Nausea, Transaminases increased
Clinical narrative: Patient ended up going to hospital, so don't know if they did a VAERS or not. He was vomitting and had elevated liver enzymes and gall bladder issues
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting, Weight decreased
Clinical narrative: Patient ended up going to hospital, so don't know if they did a VAERS or not. He was vomitting and had elevated liver enzymes and gall bladder issues
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Pain, Rash
Clinical narrative: Extremely Achy, So Painful I could barely move, Developed a large lump in my left arm pit and neck, torso, under arms and groin area were covered in a red, hot rash.  Took benadryl and advil to help with pain and  rash.  When rash went away after three days I was then itchy to the point of wanting to rip my skin off.   Achiness lasted about 24 hours, the rash lasted two days with Benadryl and I still have the lump.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Before 2nd injection, intermittent burning and itching in hands and feet, with associated localized rash on hands and feet. At the age of sixty, I now break out in hives when I exercise, sweat, or get overheated in bed.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Livedo reticularis
Clinical narrative: developed livedo reticularis on bilateral legs; This is a spontaneous report from a contactable other hcp. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number:EL9261), intramuscular on the right arm, at the age of 48 years, on 20Jan2021 09:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and migraine from an unknown date and unknown if ongoing and covid-19 from Nov2020 to an unknown date. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), metoprolol (METOPROLOL) and amitriptyline (AMITRIPTYLINE). It was reported that 3-4 days after vaccination (24Jan2021), the patient developed livedo reticularis on bilateral legs. No treatment was received for the event. The outcome of the events was not recovered.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Vaccination site pain
Clinical narrative: Sore Arm after injection; Nausea; Muscle Aches; Headache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received first dose of BNT162B2, via an unspecified route of administration (vaccine location=left arm) on 01Feb2021 at a single dose for Covid-19 immunization at a workplace clinic. Medical history included unspecified allergies to medications, food, or other products. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She was not pregnant at the time of vaccination. The patient experienced sore arm after injection, nausea, muscle aches, headache, and fatigue on 01Feb2021. No treatment received for the events. The events were reported as non-serious (did not result to death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, and not congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: cold sore; This is a spontaneous report from a contactable consumer (the patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked if they could take another medication after taking Pfizer-BioNTech COVID-19 Vaccine. The patient had the vaccine yesterday and had a cold sore. The patient wanted to know if they could take an antiviral medication. The clinical outcome of cold sore was unknown.   Information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; stomach issue; This is a spontaneous report from a contactable consumer (patient). A male patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced stomach issues on an unknown date. He was scheduled for an scope on the esophagus and had a COVID test "on Sunday" which came back with a positive result. The patient has no symptoms and had a 96.5 temperature. He was scheduled for his second dose "today".  The clinical outcome of the event positive COVID-19 test with no symptoms and abdominal discomfort was unknown.   The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune system disorder, Joint swelling, Musculoskeletal discomfort, Off label use, Product use issue
Clinical narrative: seems to have an autoimmune response; She has hives wrapped around her entire left ankle; Other medical history: Graves disease; Other medical history: Graves disease; this is her ankle is swollen and not very comfortable; this is her ankle is swollen and not very comfortable; This is a spontaneous report from a contactable other health professional (patient).  A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, pending clarification), via an unspecified route of administration (at the age of 57-year-old) on 12Jan2021 (also reported as 19Jan2021, pending clarification) at a single dose for COVID-19 immunization. Medical history included Graves disease and COVID-19. Concomitant medication included metoprolol. Patient completed the report online at Pfizer, but does not have a reference number for that report. She is scheduled to get second shot tomorrow, however, she seems to have an autoimmune response. She has hives wrapped around her entire left ankle on 22Jan2021. She wants to know if she should get second dose or not. She works in a nursing home. She has been noticing here and there little dots of hives that were not a big deal and this is her ankle is swollen and not very comfortable. The patient would like to know if it would be safe for her to have the second dose given her autoimmune response to the first dose. No treatment received for the event "She has hives wrapped around her entire left ankle". The outcome of the events was unknown. The patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. Not COVID tested post vaccination.  Information on the lot/batch number has been requested (clarification).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: seems to have an autoimmune response; She has hives wrapped around her entire left ankle; Other medical history: Graves disease; Other medical history: Graves disease; this is her ankle is swollen and not very comfortable; this is her ankle is swollen and not very comfortable; This is a spontaneous report from a contactable other health professional (patient).  A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, pending clarification), via an unspecified route of administration (at the age of 57-year-old) on 12Jan2021 (also reported as 19Jan2021, pending clarification) at a single dose for COVID-19 immunization. Medical history included Graves disease and COVID-19. Concomitant medication included metoprolol. Patient completed the report online at Pfizer, but does not have a reference number for that report. She is scheduled to get second shot tomorrow, however, she seems to have an autoimmune response. She has hives wrapped around her entire left ankle on 22Jan2021. She wants to know if she should get second dose or not. She works in a nursing home. She has been noticing here and there little dots of hives that were not a big deal and this is her ankle is swollen and not very comfortable. The patient would like to know if it would be safe for her to have the second dose given her autoimmune response to the first dose. No treatment received for the event "She has hives wrapped around her entire left ankle". The outcome of the events was unknown. The patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. Not COVID tested post vaccination.  Information on the lot/batch number has been requested (clarification).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, Rash, Urticaria
Clinical narrative: seems to have an autoimmune response; She has hives wrapped around her entire left ankle; Other medical history: Graves disease; Other medical history: Graves disease; this is her ankle is swollen and not very comfortable; this is her ankle is swollen and not very comfortable; This is a spontaneous report from a contactable other health professional (patient).  A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, pending clarification), via an unspecified route of administration (at the age of 57-year-old) on 12Jan2021 (also reported as 19Jan2021, pending clarification) at a single dose for COVID-19 immunization. Medical history included Graves disease and COVID-19. Concomitant medication included metoprolol. Patient completed the report online at Pfizer, but does not have a reference number for that report. She is scheduled to get second shot tomorrow, however, she seems to have an autoimmune response. She has hives wrapped around her entire left ankle on 22Jan2021. She wants to know if she should get second dose or not. She works in a nursing home. She has been noticing here and there little dots of hives that were not a big deal and this is her ankle is swollen and not very comfortable. The patient would like to know if it would be safe for her to have the second dose given her autoimmune response to the first dose. No treatment received for the event "She has hives wrapped around her entire left ankle". The outcome of the events was unknown. The patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine in four weeks. Not COVID tested post vaccination.  Information on the lot/batch number has been requested (clarification).
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; vomiting; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced nausea and vomiting on an unspecified date after receiving the first vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This is a spontaneous report from a Pfizer-sponsored program, . A contactable consumer (patient) reported that a female patient of unspecified age received first dose of BNT162B2 (Pfizer Covid-19 vaccine), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient asked if it is ok to take pain medicine (ibuprofen) while she already had the 1st dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: After the 2nd dosage I had antibody testing done and was negative for antibodies; This a spontaneous report from a contactable consumer. A male patient of an unspecified age received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  After the 2nd dosage patient had antibody testing done and was negative for antibodies. This was 2.5 weeks after 2nd dosage. Outcome of event was unknown.   Information about Lot/Batch number is requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Fatigue, Headache, Pyrexia
Clinical narrative: Low grade fever; headache; cough; fatigue; diarrhea; This is a spontaneous report from a contactable consumer (patient). This 65-year-old female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247) via an unspecified route of administration on 28Jan2021 at 14:30 (at the age of 65-years-old) as a single dose in the right arm for COVID-19 immunization. The patient had no medical history (as reported). The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was diagnosed with COVID-19 on an unspecified date. Concomitant medications included levothyroxine from an unspecified date for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient did not have any allergies to medications, food, or other products. On 01Feb2021, the patient experienced low-grade fever, headache, cough, fatigue, and diarrhea. The events were reported as non-serious. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The outcomes of low-grade fever, headache, cough, fatigue, and diarrhea were recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: lots of covid symptoms; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced lots of covid symptoms on an unspecified date with outcome of unknown. Caller mentioned that she had "lots of covid symptoms" and that when she "asked the other girl" where the covid vaccine was manufactured "they told me I had to ask you".   Information on lot number/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: received 2nd dose on 28Jan2021/experienced sore arm the first day; First Dose: arm was sore; This is a spontaneous report from a contactable consumer (patient's wife). A 66-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on the arm, first dose on 07Jan2021 and then second dose on 28Jan2021, at single dose, COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient's wife and patient both went to get their first dose of the COVID vaccine on 07Jan2021, through a drive thru site and reported that the next day (08Jan2021), their arms were sore, but it was okay, nothing bad. The patient's wife heard Dr. (name) saying that the second dose is really bad. When they went for their second dose on 28Jan2021, the patient had a sore arm the first day, that resolved but the patient's wife had no symptoms. She doubt that the person that gave her the vaccine because she didn't feel anything and had zero symptoms. She feel frightened, scared, worried and regret going there and stated that they need to train these people. The person that vaccinated her did put the needle but didn't push the plunger. She also asks if they should  get an antibody test after the vaccine. The outcome of the event was recovered.   Information on the Lot/Batch number has been requested.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Dry eye, Erythema, Eye pruritus, Pruritus, Rash
Clinical narrative: Like a rash reaction; it itches around my neck and on my face; It kind of comes and goes on my face; sometimes my face would be red and the next day it won't be there; I can still feel the itchiness around the eyes. They look like they are really dry; I can still feel the itchiness around the eyes. They look like they are really dry; Like a rash reaction; it itches around my neck and on my face; This is a spontaneous report from a contactable consumer. A 71-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283, expiry date was not reported), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization. Medical history included Plantar fasciitis on left foot, glaucoma, Allergy and thyroid (thyroid disorder-Taking Concomitant Product Euthyrox For Thyroid). Concomitant medications included levothyroxine sodium (EUTHYROX) 100 ug, bimatoprost (LUMIGAN) and dorzolamide hydrochloride, timolol maleate (DORZOLAMIDE/TIMOLOL [DORZOLAMIDE HYDROCHLORIDE;TIMOLOL MALEATE]) for glaucoma and cetirizine hydrochloride (ALLERTEC) for allergy. The patient experienced like a rash reaction; it itches around my neck and on my face, it kind of comes and goes on my face; sometimes my face would be red and the next day it won't be there. I can still feel the itchiness around the eyes. they look like they are really dry on unspecified date. Reporter stated "I had a Pfizer's vaccine (Unspecified Vaccine) almost 3 weeks ago, 14Jan2021, and I am having some; like a rash reaction and I don't know if it's from that or if it's something else, it itches around my neck and on my face. it is Pfizer BioNtech."It kind of comes and goes on my face, sometimes my face would be red and the next day it won't be there but I can still feel the itchiness around the eyes. They look like they are really dry." As treatment, the patient stated "Yes, I am using a cream not on my face; on my neck" Consumer stated, "Triamcinolone". Therapeutic measures were taken as a result of like a rash reaction; it itches around my neck and on my face. The outcome of the events was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive, she had no symptoms for COVID; tested positive, she had no symptoms for COVID; This is a spontaneous report from a contactable nurse, reporting for herself. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246, expiry date: 30Apr2021), via an unspecified route of administration at the left deltoid on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient tested positive, she had no symptoms for COVID on 22Jan2021. The patient got the first dose of the COVID vaccine on 06Jan2021, and tested positive, she had no symptoms for COVID, but tested positive on 22Jan2021. She tested negative on 24Jan2021and again 28Jan2021, both negative. And she was due on 27Jan2021 for the next dose, but was told she had to wait 10 days, then 3 months, she doesn't know what to do, which was why was she calling. She wants the second vaccine, she was just not sure what the answer was. She didn't feel sick, she was ok, it was serious that she tested positive, yes, but she was ok. She added there were two doses in the vial, and she watched the nurse drew hers up. Added she was asymptomatic. The patient was tested due to presurgical testing, she was supposed to get her gallbladder out, and surgery needed to be canceled. She was asking if after testing positive, can she get the second dose and when can she get it. The outcome of the events was unknown.; Sender's Comments: The contributory role of the suspect product to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: slept for 1 1/2 days directly after the shot; slept the whole day; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140 and expiry date: unknown), intramuscular on the left arm, on 07Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications.  When she had the first dose she slept for 1 1/2 days directly after the shot on 07Jan2021. She got the shot in the morning and she slept until 10, so she was not really sure how long she slept. The next day she slept the whole day too. She had no pain and is better. Outcome of the event was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart racing throughout the night; This is a spontaneous report from a contactable consumer (the patient).  A 79-year-old  male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW), via an unspecified route of administration, in the left arm on 29Jan2021 at 11:00 AM (at the age of 78-years) as a single dose for COVID-19 immunization. Medical history included atrial fibrillation. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on 07-JAN-2021for COVID-19 immunization. On 31Jan2021 at 11:00 PM the patient experienced heart racing throughout the night. The patient did not receive treatment for the event. The clinical outcome of the event heart racing throughout the night was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information requested on lot number.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Full blood count, Headache, Investigation, Malaise
Clinical narrative: Nauseated; Fogginess; Light headache; Just not feeling general malaise, Do not feel good; This is a spontaneous report from a contactable nurse (patient herself). A 74-year-old female patient BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EN5318, Expiry date: 31May2021), via an unspecified route of administration on left deltoid, first dose on 30Jan2021 13:30 at single dose for COVID-19 vaccination. Medical history included condition on thyroid from an unknown date and unknown if ongoing for thyroid. Concomitant medication included levothyroxine. Patient had given her side effects. She had her vaccine 2 days ago (30Jan2021 13:30). She have had fogginess and have been nauseated, light headache and just not feeling, general malaise, all on an unspecified date in 2021. Due date of Second Vaccine was on 20Feb2021. Treatment in response to the event was trying to get liquids and rest. She got the vaccine at an hospital. Patient had a thyroid test, CBC test and a CMP, they are all normal and had COVID test that was negative on unspecified dates. The action taken in response to the event was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test, Thyroid function test
Clinical narrative: Nauseated; Fogginess; Light headache; Just not feeling general malaise, Do not feel good; This is a spontaneous report from a contactable nurse (patient herself). A 74-year-old female patient BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EN5318, Expiry date: 31May2021), via an unspecified route of administration on left deltoid, first dose on 30Jan2021 13:30 at single dose for COVID-19 vaccination. Medical history included condition on thyroid from an unknown date and unknown if ongoing for thyroid. Concomitant medication included levothyroxine. Patient had given her side effects. She had her vaccine 2 days ago (30Jan2021 13:30). She have had fogginess and have been nauseated, light headache and just not feeling, general malaise, all on an unspecified date in 2021. Due date of Second Vaccine was on 20Feb2021. Treatment in response to the event was trying to get liquids and rest. She got the vaccine at an hospital. Patient had a thyroid test, CBC test and a CMP, they are all normal and had COVID test that was negative on unspecified dates. The action taken in response to the event was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Headache; nausea; chills; fatigue; This is a spontaneous report from a non-contactable consumer (patient).  A 31-year-old female patient, who is also 31-year-old at the time of vaccination, received first dose of bnt162b2 (BNT162B2), lot number: EN 5318, via an unspecified route of administration on right arm on 29Jan2021 09:45 as SINGLE DOSE for COVID-19 immunization.  Medical history included none.  The patient's concomitant medications were not reported. On 29Jan2021 18:00, the patient experienced headache, nausea, chills, and fatigue. The outcome of the events was recovered. No treatment was given for the events. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Oropharyngeal pain, Vomiting
Clinical narrative: throat is still sore; Vomiting; Migraine; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261 and expiry date: unknown) via an unspecified route of administration on the left deltoid, on 27Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included ongoing type 2 diabetic for at least 15 years. There were no concomitant medications and no prior vaccinations within 4 weeks. On 28Jan2021, patient got a migraine and on 29Jan2021, the vomiting started which was so bad her throat was still sore. The migraine resolved as of the morning of 01Feb2021. The vomiting lasted 3-4 hours and resolved the same day (29Jan2021). It was done at a clinic at a local church. There were no treatment, she just waited it out and rehydrated. Outcome of the event throat was still sore was not recovered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Chills, Dizziness
Clinical narrative: she was sick for about 8 hours; Throwing up; Unable to keep anything down; Headache; Chills; Ringing in the ears; Hot flashes; Blood pressure went up; Was so dizzy if she moved her eyes she would nearly pass out; Was so dizzy if she moved her eyes she would nearly pass out; Very weak and tired; Very weak and tired; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL3247; expiration date: unknown) at vaccination age of 69-year-old via an unspecified route of administration left arm on 28Jan2021 10:00 at a single dose for To keep from getting COVID (covid-19 immunization). The patient medical history was none. The patient's concomitant medications were not reported. The patient stated that she got the first vaccine the other day and within 12 hours (28Jan2021 22:00), she was not feeling well. At 8:30 the next morning (29Jan2021), she was sick for about 8 hours. She was throwing up, had a headache, chills, ringing in the ears, hot flashes, her blood pressure went up, she was unable to get anything down, not even medication [pending clarification]. She was so dizzy if she moved her eyes, she would nearly pass out. She could not move out of the chair for about 6-8 hours. The dizziness was severe and awful. She added only one ear is ringing really bad, the right ear. It is off and on and persisting. Her very weak and tired which was persistent. One hour it may be bad and the next she will be drained. The patient inquired if it is true since she heard the second dose is worse. She also wants to know if she should get the second dose or not. The received treatment for the adverse events was reported as none [pending clarification]. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement) was reported that her blood pressure went up and recovered on 29Jan2021, and weight was 175-180 pounds on an unspecified date. The outcome of the event feeling unwell was unknown, as for the events weakness, tiredness and ringing in ears were not recovered, while the outcome of the other events was recovered on 29Jan2021.  Information about Lot/Batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hot flush, Illness, Malaise
Clinical narrative: she was sick for about 8 hours; Throwing up; Unable to keep anything down; Headache; Chills; Ringing in the ears; Hot flashes; Blood pressure went up; Was so dizzy if she moved her eyes she would nearly pass out; Was so dizzy if she moved her eyes she would nearly pass out; Very weak and tired; Very weak and tired; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL3247; expiration date: unknown) at vaccination age of 69-year-old via an unspecified route of administration left arm on 28Jan2021 10:00 at a single dose for To keep from getting COVID (covid-19 immunization). The patient medical history was none. The patient's concomitant medications were not reported. The patient stated that she got the first vaccine the other day and within 12 hours (28Jan2021 22:00), she was not feeling well. At 8:30 the next morning (29Jan2021), she was sick for about 8 hours. She was throwing up, had a headache, chills, ringing in the ears, hot flashes, her blood pressure went up, she was unable to get anything down, not even medication [pending clarification]. She was so dizzy if she moved her eyes, she would nearly pass out. She could not move out of the chair for about 6-8 hours. The dizziness was severe and awful. She added only one ear is ringing really bad, the right ear. It is off and on and persisting. Her very weak and tired which was persistent. One hour it may be bad and the next she will be drained. The patient inquired if it is true since she heard the second dose is worse. She also wants to know if she should get the second dose or not. The received treatment for the adverse events was reported as none [pending clarification]. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement) was reported that her blood pressure went up and recovered on 29Jan2021, and weight was 175-180 pounds on an unspecified date. The outcome of the event feeling unwell was unknown, as for the events weakness, tiredness and ringing in ears were not recovered, while the outcome of the other events was recovered on 29Jan2021.  Information about Lot/Batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Tinnitus, Vomiting, Weight
Clinical narrative: she was sick for about 8 hours; Throwing up; Unable to keep anything down; Headache; Chills; Ringing in the ears; Hot flashes; Blood pressure went up; Was so dizzy if she moved her eyes she would nearly pass out; Was so dizzy if she moved her eyes she would nearly pass out; Very weak and tired; Very weak and tired; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL3247; expiration date: unknown) at vaccination age of 69-year-old via an unspecified route of administration left arm on 28Jan2021 10:00 at a single dose for To keep from getting COVID (covid-19 immunization). The patient medical history was none. The patient's concomitant medications were not reported. The patient stated that she got the first vaccine the other day and within 12 hours (28Jan2021 22:00), she was not feeling well. At 8:30 the next morning (29Jan2021), she was sick for about 8 hours. She was throwing up, had a headache, chills, ringing in the ears, hot flashes, her blood pressure went up, she was unable to get anything down, not even medication [pending clarification]. She was so dizzy if she moved her eyes, she would nearly pass out. She could not move out of the chair for about 6-8 hours. The dizziness was severe and awful. She added only one ear is ringing really bad, the right ear. It is off and on and persisting. Her very weak and tired which was persistent. One hour it may be bad and the next she will be drained. The patient inquired if it is true since she heard the second dose is worse. She also wants to know if she should get the second dose or not. The received treatment for the adverse events was reported as none [pending clarification]. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement) was reported that her blood pressure went up and recovered on 29Jan2021, and weight was 175-180 pounds on an unspecified date. The outcome of the event feeling unwell was unknown, as for the events weakness, tiredness and ringing in ears were not recovered, while the outcome of the other events was recovered on 29Jan2021.  Information about Lot/Batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip oedema, Mouth swelling, Paraesthesia oral
Clinical narrative: my tongue and inside mouth started tingling; Inside mouth must have swelled, as I have bit the right side of the inside of my mouth; I also notice that my bottom lip feels puffy; This is a spontaneous report from a contactable consumer reported for herself. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EN6201), via an unspecified route of administration on 15Feb2021 10:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Patient was not pregnant at the time of vaccination. Medical history included allergy to Sulfa based meds, Penicillin. Concomitant medication included estradiol, bupropion, fluoxetine, levothyroxine. The patient previously took dilaudid and experienced drug allergy, alendronate and experienced drug allergy, risedronate and experienced drug allergy. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 15 minutes of injection, patient's tongue and inside mouth started tingling. Inside mouth must have swelled, as she had bit the right side of the inside of mouth. She also noticed that her bottom lip felt puffy. The event onset date was reported as 15Feb2021 10:45 AM. Patient received treatment for the adverse event included Benadryl. The outcome of event was recovering. The case was reported as non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mouth swelling, Paraesthesia oral, Swollen tongue
Clinical narrative: my tongue and inside mouth started tingling; Inside mouth must have swelled, as I have bit the right side of the inside of my mouth; I also notice that my bottom lip feels puffy; This is a spontaneous report from a contactable consumer reported for herself. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EN6201), via an unspecified route of administration on 15Feb2021 10:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Patient was not pregnant at the time of vaccination. Medical history included allergy to Sulfa based meds, Penicillin. Concomitant medication included estradiol, bupropion, fluoxetine, levothyroxine. The patient previously took dilaudid and experienced drug allergy, alendronate and experienced drug allergy, risedronate and experienced drug allergy. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 15 minutes of injection, patient's tongue and inside mouth started tingling. Inside mouth must have swelled, as she had bit the right side of the inside of mouth. She also noticed that her bottom lip felt puffy. The event onset date was reported as 15Feb2021 10:45 AM. Patient received treatment for the adverse event included Benadryl. The outcome of event was recovering. The case was reported as non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: Sore arm at injection site; Slightly dizzy for about 1 h after vaccination; This is a spontaneous report from a contactable consumer (patient himself).  57-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: EL3247), via an unspecified route of administration on the left arm, first dose on 12Feb2021 09:00 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021, the patient experienced sore arm at injection site (24 to 48 h post injection) and was slightly dizzy for about 1 h after vaccination. Facility where the most recent COVID-19 vaccine was administered was at a workplace clinic. Treatment was not received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered. Case was reported as non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate, Heart rate increased, Nausea
Clinical narrative: chills; slight headache; mild nausea; elevated heart rate; This is a spontaneous report from a non-contactable other hcp.   A 26-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular into Left arm on 15Feb2021 11:15 at SINGLE DOSE for covid-19 immunisation. Medical history included Allergies to medications, food, or other products: shellfish, plant pollen. Historical vaccine included first dose of bnt162b2 on 27Jan2021 11:00 AM Intramuscular into Left arm for covid-19 immunisation. Concomitant medication included estradiol, bicalutamide, progesterone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported acute onset of chills and slight headache beginning 13 hours after injection, followed by mild nausea and elevated heart rate lasting 3+ hours, events started on 16Feb2021 12:15 AM. No treatment received for the events. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: knocked her out; 101 degree fever; This is a spontaneous report from a non-contactable consume. An adult female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date to an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced her second dose 'knocked her out' and she had 101 degree fever on an unspecified date. Outcome of events was unknown.    No follow-up attempts are possible. No further information is expected
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral, Pruritus
Clinical narrative: Tongue tingly lower; inside of upper and lower  lips swelled; itch on palm of hands, bottom of feet and thighs and face; This is a spontaneous report from a contactable 81-year-old female consumer reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot En5318)  single dose on 04Feb2021 at 14:30 at right arm for COVID-19 immunisation. Medical history included osteoporosis, reflux, spinal stenosis and macular degeneration, asthma, hypertension. The patient had known allergies. Concomitant drugs included Atenolol, calcium, fish oil, cyanocobalamin (B12), loratadine, tocopherol (VIT E). The patient had tongue tingly lower and inside of upper and lower lips swelled, itch on palm of hands, bottom of feet and thighs and face on 04Feb2021 at 14:30. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received steroid injection and diphenhydramine hydrochloride (BENADRYL) as treatment. The event was reported non-serious. Patient recovered from the event with lasting effects.