chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Myalgia
Clinical narrative: headache; muscle pain; joint pain; moderate fatigue; Mild temperature of 99.0 F; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247; expiry date: unknown) via an unspecified route of administration in the left arm, on 21Jan2021 at 17:00, at a single dose, for COVID-19 immunization. Medical history included chronic migraine and polycystic ovaries (PCOS). Concomitant medications included drospirenone, ethinylestradiol (NIKKI), eletriptan hydrobromide (RELPAX), naproxen sodium (ALEVE), and unspecified prenatal vitamins. The patient previously took oxycodone hydrochloride;oxycodone terephthalate;paracetamol (PERCOCET) and morphine and experienced allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the workplace clinic. On 21Jan2021, the patient experienced mild temperature of 99.0 F. On 22Jan2021 at 14:00, the patient experienced headache, muscle and joint pain, and moderate fatigue. The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events was recovering.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; muscle pain; joint pain; moderate fatigue; Mild temperature of 99.0 F; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247; expiry date: unknown) via an unspecified route of administration in the left arm, on 21Jan2021 at 17:00, at a single dose, for COVID-19 immunization. Medical history included chronic migraine and polycystic ovaries (PCOS). Concomitant medications included drospirenone, ethinylestradiol (NIKKI), eletriptan hydrobromide (RELPAX), naproxen sodium (ALEVE), and unspecified prenatal vitamins. The patient previously took oxycodone hydrochloride;oxycodone terephthalate;paracetamol (PERCOCET) and morphine and experienced allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the workplace clinic. On 21Jan2021, the patient experienced mild temperature of 99.0 F. On 22Jan2021 at 14:00, the patient experienced headache, muscle and joint pain, and moderate fatigue. The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events was recovering.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac assistance device user, Chills, Livedo reticularis, Peripheral coldness, Tremor
Clinical narrative: Shaking chills, cold extremities, livedo reticularis on the thighs, lasted about 2 hours on the night of vaccination. Treated with tylenol. The next afternoon, he had documented ventricular tachycardia and his defibrillator fired 4 times in 1 hour, requiring EMS activation and hospitalization. His last ICD firing prior to that (only once)  was in August 2020 and prior to that more than 2 years of no ICD firing.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Ventricular tachycardia
Clinical narrative: Shaking chills, cold extremities, livedo reticularis on the thighs, lasted about 2 hours on the night of vaccination. Treated with tylenol. The next afternoon, he had documented ventricular tachycardia and his defibrillator fired 4 times in 1 hour, requiring EMS activation and hospitalization. His last ICD firing prior to that (only once)  was in August 2020 and prior to that more than 2 years of no ICD firing.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Flushing, Headache, Hot flush, Vaccination site pain
Clinical narrative: Very Flush; hot/cold flashes; hot/cold flashes; mild headache; sore at injection site; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, lot number=EL9261), via an unspecified route of administration on 23Jan2021 14:45 at single dose at left arm for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines within 4 weeks prior to the COVID vaccine. Medical history included allergies to sulfa, mold, asthma, multiple sclerosis, anemia. Concomitant medication included dimethyl fumarate, chorionic gonadotrophin (PROVIGIL), clonazepam, modafinil and Fl. The patient previously took Wellbutrin and experienced allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient experienced very flush, hot/cold flashes, mild headache, sore at injection site on 23Jan2021 17:00. The outcome of the events was recovered in Jan2021. No treatment received for the adverse events.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: itchy rash started on neck; itchy rash started on neck and it had been itchy since. It still had red marks left; itchy rash started on neck and it had been itchy since. It still had red marks left. It felt dry.; This is a spontaneous report from a contactable consumer reported for herself that a 38-years-old female patient received bnt162b2 (BNT162B2; brand=Pfizer, Lot number=EK5730) first dose, via an unspecified route of administration on 21Dec2020 11:00 AM at SINGLE DOSE at left arm for covid-19 immunisation. The patient medical history was not reported.  Concomitant medication included calcium, vitamin d, estradiol, apoaequorin, colecalciferol (PREVAGEN [APOAEQUORIN;COLECALCIFEROL]), iron. The patient previously took codeine and experienced drug hypersensitivity. After receiving the first dose of Pfizer, a itchy rash started on her neck and it has been itchy since. It still has red marks left. When I feel it, it felt dry. The events reported as non-serious. The patient was not pregnant at the time of vaccination. 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 has not been tested for COVID-19. Patient then received second dose of Pfizer COVID 19 vaccine (Lot number=EJ1685) on 11Jan2021 10:00 AM at Left arm. Outcome of events was not recovered, no treatment received for the adverse event.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered 1ml instead of 0.5ml
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Headache, Pyrexia
Clinical narrative: woke up with burning in her ears; fever; Low grade headache/worse headache; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (BNT162B2), on Jan2021 07:30 PM at single dose in Right arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. 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. Medical history included Systemic Lupus Erythematosus. Concomitant medication received within 2 weeks of vaccination included denosumab (PROLIA), trazodone, ezetimibe, simvastatin (VYTORIN), duloxetine, hydroxychloroquine sulfate (PLAQUENIL), cevimeline. Low grade headache occurred the day after the vaccine on 22Jan2021 04:30 AM and has lasted until now. But 24Jan2021 the patient woke up with burning in her ears, a worse headache, and a fever. The outcome was Recovering. No treatment received for the adverse event. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. All the events were assessed non-serious.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: he has a little loss of smell, some smells he can smell, some he can't/Cannot smell a little bit, sometimes he can or sometimes he cant, loss of some sense of smell; This is a spontaneous report from a contactable consumer (patient's wife)   A 38-year-old male patient received first BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date in Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were reported as none. On 25Jan2021 the patient experienced a little loss of smell, some smells he can smell, some he can't, no fever, no nausea, no shaking. The reporter would ask if could be related to the vaccine. At the time of the reporting event outcome was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Nausea, SARS-CoV-2 test
Clinical narrative: low level nausea; loose stools; not feeling well; This is a spontaneous report from a Pfizer-sponsored program. A contactable other healthcare professional (patient) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunization. Medical history included immunodeficiency; patient should told the vaccinator if immunocompromised. But he didn't know this at that time, and no one asked him about it. The patient's concomitant medications were not reported. After vaccination, one of his co-workers tested positive for COVID, so he was exposed. Is this a problem with vaccine? After being exposed, patient had some low-level nausea, loose stools, and not feeling well. he didn't know if that was from the vaccine or if he had COVID because of exposure. The patient had COVID testing with unknown result in Jan2021. The outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest X-ray normal, Chest discomfort, Chills, Dyspnoea
Clinical narrative: I got my 2nd shot around 10am.  My arm started to feel sore within 1-2 hours.  At 7pm I started to feel pain in upper left back area with breathing. At 9pm I was in bed and started to have chest tightness and pain with breathing. Both arms and hands started to go numb and tingling. I got to ER around midnight and all testing was negative.  I was hooked up to IV fluids which seemed to calm the chest pain and numbness. I got home around 3am and went to sleep.  By 7am I was having sore muscles and body aches. I was fatigued and having chills.  I was also running a low grade fever.   I continue on like this for 24 hours.  The next 24 hours I was fatigued.  By day 3 I felt like I was getting back to normal.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Fatigue, Hypoaesthesia, Laboratory test, Myalgia
Clinical narrative: I got my 2nd shot around 10am.  My arm started to feel sore within 1-2 hours.  At 7pm I started to feel pain in upper left back area with breathing. At 9pm I was in bed and started to have chest tightness and pain with breathing. Both arms and hands started to go numb and tingling. I got to ER around midnight and all testing was negative.  I was hooked up to IV fluids which seemed to calm the chest pain and numbness. I got home around 3am and went to sleep.  By 7am I was having sore muscles and body aches. I was fatigued and having chills.  I was also running a low grade fever.   I continue on like this for 24 hours.  The next 24 hours I was fatigued.  By day 3 I felt like I was getting back to normal.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: I got my 2nd shot around 10am.  My arm started to feel sore within 1-2 hours.  At 7pm I started to feel pain in upper left back area with breathing. At 9pm I was in bed and started to have chest tightness and pain with breathing. Both arms and hands started to go numb and tingling. I got to ER around midnight and all testing was negative.  I was hooked up to IV fluids which seemed to calm the chest pain and numbness. I got home around 3am and went to sleep.  By 7am I was having sore muscles and body aches. I was fatigued and having chills.  I was also running a low grade fever.   I continue on like this for 24 hours.  The next 24 hours I was fatigued.  By day 3 I felt like I was getting back to normal.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in her shoulder/ shoulder hurting; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient to received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 25Jan2021 at single dose in right arm (by injection once to right shoulder) for COVID-19 immunization. Medical history was none. Concomitant medications were none. Caller wanted to know if she can use Tylenol 8 hours to treat pain in her shoulder/ shoulder hurting (25Jan2021), she received the COVID-19 vaccine this morning. The patient had a COVID shot this morning, and shoulder was hurting so bad, she was going to take a Tylenol 8 hour, wanted to know if that was ok, and what about heat or ice. The Tylenol said for muscle aches, but she didn't know if she should take it, it had been hours since the vaccine, hurting a little bit, certain ways move it, was going to put heat, thought maybe ice. It was just a little sore, nothing she can stand, she didn't know whether to take a Tylenol for muscles, then heat or ice. Daughter kept vaccine card, caller had to go for the second dose, so her daughter kept the vaccine card in the car. Height: 5'6" to 5' 7". Weight: 170-180 pounds. No Investigation Assessment. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative, SARS-CoV-2 antibody test
Clinical narrative: Had COVID antibody testing and showed no immunity; This is a spontaneous report from a contactable consumer, she was an audiologist, she was a PhD doctor and not a medical.  A 70-year-old female patient received both doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), three weeks apart on unknown dates at single dose for COVID-19 immunization, via unspecified route of administration. The patient was on very high doses of steroids due to Temporomandibular joint syndrome pain. The patient had COVID antibody testing done after receiving both doses and showed no antibodies.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extreme fatigue; This is a spontaneous report from a contactable consumer reporting for her mother. A 90-year-old female patient received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer reported that her mother (female, 90 years old) received the first dose of the COVID vaccine and after 2 days she had been needing or requesting oxygen and she hadn't needed it for a long time so the consumer was wondering if that could be related to having gotten the vaccine, and if so, would it go away. The patient had extreme fatigue on an unspecified date then requested oxygen. The event outcome was unknown.  Information on the Lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered 1ml instead of 0.5ml
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiny fatigue; This is a spontaneous report from a contactable Other HCP (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included fluorouracil (EFUDEX, Strength 5%) Topical.  The patient received 1st dose of vaccine on 18Jan2021. 2nd dose scheduled for 09Feb2021. The patient stated "as far as side effects, nothing really. Tiny fatigue". He stopped his Fluorouracil/Efudex 5% chemo topical skin cream drug last night (24Jan2021) since he was not sure if he should continue to use with the vaccine. He had a "teledoc" appointment with his dermatologist on weds and will further discuss. He was asking if there was any "negatives to using cream after vaccination", or contraindication. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue; Headache; Fever (38.3 C) 12 hours following the second vaccine dose and lasting for 12 hours; This is a spontaneous report from a non-contactable pharmacist (patient).  A 26-year-old female patient received the second dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EL3247, via an unspecified route of administration on 19Jan2021 at single dose at left arm for covid-19 immunisation.  The patient medical history was reported as none. The patient was not allergy to medications, food, or other products. Concomitant medication included ethinylestradiol, norethisterone (ALYACEN 1/35) within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (lot number: EJ1685) on 29Dec2020 05:30 PM at Left arm for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue, headache, and fever (38.3 C) at 08:00 AM 20Jan2021, 12 hours following the second vaccine dose and lasting for 12 hours.No treatment received for the adverse events. The outcome of the events was resolved in Jan2021. The report was considered as non-serious.The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts possible. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Sweating; nausea; chills; fever of 100 F starting about 10 hours after dose was received. Continued until 48 hours after dose was received; This is a spontaneous report from a contactable consumer (patient). A 24-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL0142), via an unspecified route of administration in left arm on 22Jan2021 14:45 at second single dose for covid-19 immunisation. The patient medical history was not reported. Prior to 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 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 (Lot number=EL8982) in left arm on 04Jan2021 07:15 PM at first single dose for Covid-19 immunization. The patient experienced sweating, nausea, chills, fever of 100 F starting about 10 hours after dose was received. Continued until 48 hours after dose was received. Event start date: 23Jan2021 12:00 AM. Events were considered as non-serious. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered in Jan2021.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain of skin, Pruritus
Clinical narrative: Classic "COVID arm": Red patch on skin - very itchy and slightly painful to the touch. Started out about 3'' across with well defined rim.  Ultimately grew to ~6 inches long.  Today is the first day that all symptoms are gone.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness, Pain
Clinical narrative: chills; body aches; fever of 102.9; extreme weakness; dizzy; This is a spontaneous report from a contactable consumer reported for himself. This 78-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 22Jan2021 12:00 PM at single dose for covid-19 immunisation. Medical history included Seizures, low white cell count, enlarged prostate and COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included any other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Jan2021 08:00 AM (reported as 18 hours after injection), the patient experienced chills, body aches, fever of 102.9, extreme weakness, dizzy. At 4 am on 25Jan2021 the fever broke and now he was ok. No treatment received for the adverse event. Outcome of the events chills, body aches, extreme weakness and dizzy was recovered on an unspecified date, of the event fever of 102.9 was recovered on 25Jan2021. Since the vaccination, the patient had not been tested for COVID-19. Seriousness criteria was reported as non-serious.   Information on the lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, White blood cell count
Clinical narrative: chills; body aches; fever of 102.9; extreme weakness; dizzy; This is a spontaneous report from a contactable consumer reported for himself. This 78-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 22Jan2021 12:00 PM at single dose for covid-19 immunisation. Medical history included Seizures, low white cell count, enlarged prostate and COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included any other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Jan2021 08:00 AM (reported as 18 hours after injection), the patient experienced chills, body aches, fever of 102.9, extreme weakness, dizzy. At 4 am on 25Jan2021 the fever broke and now he was ok. No treatment received for the adverse event. Outcome of the events chills, body aches, extreme weakness and dizzy was recovered on an unspecified date, of the event fever of 102.9 was recovered on 25Jan2021. Since the vaccination, the patient had not been tested for COVID-19. Seriousness criteria was reported as non-serious.   Information on the lot/batch number has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Disease recurrence, Dizziness, Glycosylated haemoglobin, Hypertension
Clinical narrative: blood pressure was 169/91 woke up very dizzy/her pressure was causing her to feel dizzy; blood pressure was 169/91 woke up very dizzy and thought was coming down with a vertigo attack; blood pressure was 169/91 woke up very dizzy and thought was coming down with a vertigo attack; blood pressure going up/every day it had gone up, and it fluctuated.; This is a spontaneous report from a contactable consumer (patient).  An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E1 1283), via an unspecified route of administration injected into right arm on 12Jan2021 14:00 at single dose for COVID-19 vaccination. The patient's medical history included vertigo (she hasn't had vertigo in the last ten years, she did not remember when the first time had it, it was years ago), congestive heart failure (CHF, diagnosed a little over a year ago), diabetes (diagnosed about 10-15 years ago, her A1C is always good, she has good control over that), and she got a pneumonia thing but not recently in the last 6-8 weeks. No further details provided about unspecified pneumonia thing. There was no concomitant medications, also she has no other recent vaccinations or started no new medications. Patient reported that she had been having challenges with her blood pressure going up after receiving first Pfizer COVID vaccination. Her appointment of 1st dose was at 13:45, she probably got it close to 14:00, she was out of there by 14:15-14:30. Patient reported that ever since she had the shot, her blood pressure continued to go up, so she would like to ask if she should get a second dose. She takes her blood pressure every morning since she was diagnosed with CHF and they advised her to take that every day and weigh herself to make sure she is not getting fluid build up. Patient said that on 16Jan2021 when her blood pressure was 169/91 she woke up very dizzy and thought she was coming down with a vertigo attack, which she usually has had in the past that when she had attacks her blood pressure doesn't go up, so she realized her pressure was causing her to feel dizzy. She took it later on in the day and it was 157/84. She looked back and every day it had gone up, and it fluctuated. She says on the time of reporting (on the 25th), it was 160/90. She is scheduled/due to get her second dose of the vaccine on 02Feb2021, and she could contact her doctor for her question. The patient underwent lab tests and procedures which included blood pressure: 136/69 on 30Dec2020, 134/86 on 31Dec2020, 132/76 on 02Jan2021, 138/73 on 04Jan2021, 133/68 on 10Jan2021, 142/72 on 11Jan2021, 149/75 on 12Jan2021, 150/81 on 13Jan2021, 156/86 on 14Jan2021, 146/77 on 15Jan2021, 169/91 on 16Jan2021, 157/84 on 16Jan2021, 160/90 on 25Jan2021. The outcome of the events was unknown.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: blood pressure was 169/91 woke up very dizzy/her pressure was causing her to feel dizzy; blood pressure was 169/91 woke up very dizzy and thought was coming down with a vertigo attack; blood pressure was 169/91 woke up very dizzy and thought was coming down with a vertigo attack; blood pressure going up/every day it had gone up, and it fluctuated.; This is a spontaneous report from a contactable consumer (patient).  An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E1 1283), via an unspecified route of administration injected into right arm on 12Jan2021 14:00 at single dose for COVID-19 vaccination. The patient's medical history included vertigo (she hasn't had vertigo in the last ten years, she did not remember when the first time had it, it was years ago), congestive heart failure (CHF, diagnosed a little over a year ago), diabetes (diagnosed about 10-15 years ago, her A1C is always good, she has good control over that), and she got a pneumonia thing but not recently in the last 6-8 weeks. No further details provided about unspecified pneumonia thing. There was no concomitant medications, also she has no other recent vaccinations or started no new medications. Patient reported that she had been having challenges with her blood pressure going up after receiving first Pfizer COVID vaccination. Her appointment of 1st dose was at 13:45, she probably got it close to 14:00, she was out of there by 14:15-14:30. Patient reported that ever since she had the shot, her blood pressure continued to go up, so she would like to ask if she should get a second dose. She takes her blood pressure every morning since she was diagnosed with CHF and they advised her to take that every day and weigh herself to make sure she is not getting fluid build up. Patient said that on 16Jan2021 when her blood pressure was 169/91 she woke up very dizzy and thought she was coming down with a vertigo attack, which she usually has had in the past that when she had attacks her blood pressure doesn't go up, so she realized her pressure was causing her to feel dizzy. She took it later on in the day and it was 157/84. She looked back and every day it had gone up, and it fluctuated. She says on the time of reporting (on the 25th), it was 160/90. She is scheduled/due to get her second dose of the vaccine on 02Feb2021, and she could contact her doctor for her question. The patient underwent lab tests and procedures which included blood pressure: 136/69 on 30Dec2020, 134/86 on 31Dec2020, 132/76 on 02Jan2021, 138/73 on 04Jan2021, 133/68 on 10Jan2021, 142/72 on 11Jan2021, 149/75 on 12Jan2021, 150/81 on 13Jan2021, 156/86 on 14Jan2021, 146/77 on 15Jan2021, 169/91 on 16Jan2021, 157/84 on 16Jan2021, 160/90 on 25Jan2021. The outcome of the events was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Developed a red swollen area at infection site one week following administration.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Body temperature increased, COVID-19, Gastrooesophageal reflux disease, Nasal congestion
Clinical narrative: I received the first dose of the Pfizer Covid19 vaccine on 13Jan2021 and tested positive for Covid 19 on 19Jan2021.; I received the first dose of the Pfizer Covid19 vaccine on 13Jan2021 and tested positive for Covid 19 on 19Jan2021.; I had a 100.5 fever for one day; nasal congestion; aches and pains; stomach cramps; acid reflux; This is a spontaneous report from a contactable consumer (patient).   A 62-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 13Jan2021 for Covid-19 immunisation, as being a health care provider, a music therapist at a nursing home.  The patient medical history and concomitant medications were not reported.  The patient was tested positive for covid 19 on 19Jan2021 so she has been quarantining. In Jan2021 she had a 100.5 fever for one day, nasal congestion, aches and pains, stomach, acid reflux. The patient underwent lab tests and procedures which included body temperature: 100.5 fever, Sars-cov-2 test: positive on 19Jan2021. On 25Jan2021 was the best she has felt, where she was getting my energy back.  As of 25Jan2021, her symptoms have been diminishing. She was told that if feeling better she could go and get retested on 29Jan2021, at urgent care. The outcome of was tested positive for covid 19 was unknown, of ad a 100.5 fever, nasal congestion, stomach cramps and acid reflux was recovering.  Patient queried if she should still get second dose after testing positive after the first dose. She was scheduled for the second dose on 03Feb2021.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I received the first dose of the Pfizer Covid19 vaccine on 13Jan2021 and tested positive for Covid 19 on 19Jan2021.; I received the first dose of the Pfizer Covid19 vaccine on 13Jan2021 and tested positive for Covid 19 on 19Jan2021.; I had a 100.5 fever for one day; nasal congestion; aches and pains; stomach cramps; acid reflux; This is a spontaneous report from a contactable consumer (patient).   A 62-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 13Jan2021 for Covid-19 immunisation, as being a health care provider, a music therapist at a nursing home.  The patient medical history and concomitant medications were not reported.  The patient was tested positive for covid 19 on 19Jan2021 so she has been quarantining. In Jan2021 she had a 100.5 fever for one day, nasal congestion, aches and pains, stomach, acid reflux. The patient underwent lab tests and procedures which included body temperature: 100.5 fever, Sars-cov-2 test: positive on 19Jan2021. On 25Jan2021 was the best she has felt, where she was getting my energy back.  As of 25Jan2021, her symptoms have been diminishing. She was told that if feeling better she could go and get retested on 29Jan2021, at urgent care. The outcome of was tested positive for covid 19 was unknown, of ad a 100.5 fever, nasal congestion, stomach cramps and acid reflux was recovering.  Patient queried if she should still get second dose after testing positive after the first dose. She was scheduled for the second dose on 03Feb2021.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I received the first dose of the Pfizer Covid19 vaccine on 13Jan2021 and tested positive for Covid 19 on 19Jan2021.; I received the first dose of the Pfizer Covid19 vaccine on 13Jan2021 and tested positive for Covid 19 on 19Jan2021.; I had a 100.5 fever for one day; nasal congestion; aches and pains; stomach cramps; acid reflux; This is a spontaneous report from a contactable consumer (patient).   A 62-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 13Jan2021 for Covid-19 immunisation, as being a health care provider, a music therapist at a nursing home.  The patient medical history and concomitant medications were not reported.  The patient was tested positive for covid 19 on 19Jan2021 so she has been quarantining. In Jan2021 she had a 100.5 fever for one day, nasal congestion, aches and pains, stomach, acid reflux. The patient underwent lab tests and procedures which included body temperature: 100.5 fever, Sars-cov-2 test: positive on 19Jan2021. On 25Jan2021 was the best she has felt, where she was getting my energy back.  As of 25Jan2021, her symptoms have been diminishing. She was told that if feeling better she could go and get retested on 29Jan2021, at urgent care. The outcome of was tested positive for covid 19 was unknown, of ad a 100.5 fever, nasal congestion, stomach cramps and acid reflux was recovering.  Patient queried if she should still get second dose after testing positive after the first dose. She was scheduled for the second dose on 03Feb2021.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Body temperature increased, COVID-19, Gastrooesophageal reflux disease, Nasal congestion
Clinical narrative: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a Pfizer Sponsored Program. Information received from a contactable Consumer reporting for herself.  A female patient of an unspecified age  received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient had a  positive covid-19 test  on 19Jan2021 with outcome of unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a Pfizer Sponsored Program. Information received from a contactable Consumer reporting for herself.  A female patient of an unspecified age  received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient had a  positive covid-19 test  on 19Jan2021 with outcome of unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a Pfizer Sponsored Program. Information received from a contactable Consumer reporting for herself.  A female patient of an unspecified age  received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient had a  positive covid-19 test  on 19Jan2021 with outcome of unknown.  Information about lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Chills, Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: body aches; She feels like she has shortness of breath; feeling really tired/fatigued; chills and sweats; chills and sweats; sore at injection site; lost sense of smell; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN5318), intramuscular in left deltoid on 23Jan2021 15:35 at SINGLE DOSE for covid-19 immunisation. She typically got sick when she got the flu vaccine or any vaccine in general for immunization, she got deathly sick. She always got the flu after getting the flu vaccine. She did not get the flu shot this year and she did not get the flu. She did not know the name of the flu vaccine or any vaccine that she was referring to and she did not have lot number to provide. Other medical history was reported as none. There were no concomitant medications. Relevant Tests were reported as none. The patient experienced lost sense of smell on 23Jan2021 with outcome of not recovered, feeling really tired on 24Jan2021 with outcome of not recovered, chills and sweats on 24Jan2021 with outcome of recovered on 25Jan2021, sore at injection site on 24Jan2021 with outcome of not recovered, body aches and Shortness of breath on an unspecified date with outcome unknown.  Details were as follows: the patient had a list of the expected side effects and she did not see loss of sense of smell on the list. Reported she completely lost her sense of smell, she cannot smell anything at all. She was asking if she should be concerned. On Friday prior to getting the vaccine she could smell everything. She thought the loss of smell started Sunday, reported it may have started Saturday (23Jan2021). She noticed when she put her body spray on Sunday and she was washing her hands that she could not smell. She can taste fine. She can handle the body aches and all the other stuff. She clarifies she was experiencing body aches, she was feeling really tired, fatigued. She was feeling better. She could not call earlier because she was so tired. She had the chills and sweats that started Sunday evening and recovered today (25Jan2021). Reported her sheets were drenched with sweat when she woke up. She did not have a fever. She thought most of her side effects started Sunday night. Reported the injection site was sore and that started the day after receiving her injection, it was still sore. She did not go to work today (25Jan2021). She felt like she had shortness of breath but she was checking her oxygen level and it was fine, stated it just felt like she was short of breath and it was ongoing and persisting. No additional vaccines Administered on Same Date. The events did not require a visit to Emergency Room and Physician Office.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Pain, Vaccination site pain
Clinical narrative: body aches; She feels like she has shortness of breath; feeling really tired/fatigued; chills and sweats; chills and sweats; sore at injection site; lost sense of smell; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN5318), intramuscular in left deltoid on 23Jan2021 15:35 at SINGLE DOSE for covid-19 immunisation. She typically got sick when she got the flu vaccine or any vaccine in general for immunization, she got deathly sick. She always got the flu after getting the flu vaccine. She did not get the flu shot this year and she did not get the flu. She did not know the name of the flu vaccine or any vaccine that she was referring to and she did not have lot number to provide. Other medical history was reported as none. There were no concomitant medications. Relevant Tests were reported as none. The patient experienced lost sense of smell on 23Jan2021 with outcome of not recovered, feeling really tired on 24Jan2021 with outcome of not recovered, chills and sweats on 24Jan2021 with outcome of recovered on 25Jan2021, sore at injection site on 24Jan2021 with outcome of not recovered, body aches and Shortness of breath on an unspecified date with outcome unknown.  Details were as follows: the patient had a list of the expected side effects and she did not see loss of sense of smell on the list. Reported she completely lost her sense of smell, she cannot smell anything at all. She was asking if she should be concerned. On Friday prior to getting the vaccine she could smell everything. She thought the loss of smell started Sunday, reported it may have started Saturday (23Jan2021). She noticed when she put her body spray on Sunday and she was washing her hands that she could not smell. She can taste fine. She can handle the body aches and all the other stuff. She clarifies she was experiencing body aches, she was feeling really tired, fatigued. She was feeling better. She could not call earlier because she was so tired. She had the chills and sweats that started Sunday evening and recovered today (25Jan2021). Reported her sheets were drenched with sweat when she woke up. She did not have a fever. She thought most of her side effects started Sunday night. Reported the injection site was sore and that started the day after receiving her injection, it was still sore. She did not go to work today (25Jan2021). She felt like she had shortness of breath but she was checking her oxygen level and it was fine, stated it just felt like she was short of breath and it was ongoing and persisting. No additional vaccines Administered on Same Date. The events did not require a visit to Emergency Room and Physician Office.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: high fever; muscle cramps; nauseas; This is a spontaneous report from a contactable consumer (patient's daughter). A 75-year-old female patient (mother) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient started developing a high fever, muscle cramps and nauseas on the 21Jan2021 and is still experiencing symptoms. She has had bloodwork done and she has tested negative for coronavirus. Patient daughter asked whether it is common to get side effects this late after the vaccine, whether she could give her mom any medicines like tylenol or motrin. She is scheduled to receive second dose on 05Feb2021 and daughter wanted to know if this is okay. Whether she could use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The outcome of the events was not recovered. Information on the Batch/Lot number has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered 1ml instead of 0.5ml
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Pain in his arm; Fever (at night); Tiredness; Shivers; Headache; This is a spontaneous report from a contactable consumer (patient himself). An 81-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not experience symptoms until yesterday (after getting wet in the rain): pain in his arm, fever (at night), tiredness, shivers, headache in Jan2021. He chose not to go out of his house yesterday and today he felt better, only headache persists. Caller also reported it was cold outside and he was not sure if his symptoms were associated to the Pfizer-BioNTech COVID-19 vaccine, or symptoms of a cold (probably caused by exposure to rain and cold). Outcome of headache was not recovered, and outcome of other events was recovering.   Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Feeling hot, Malaise
Clinical narrative: Left side of body felt very warm and felt like it was melting; red rash on left side face, neck, chest, arm; Facial spasms; Fever; Confusion/lightheaded; Confusion/lightheaded; Palpitations; Feeling of being unwell; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right arm single dose for COVID-19 immunization on 22Jan2021, 05:45 PM, at 28-year-old. Medical history included: COVID-19. No allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included: daily vitamins, lisdexamfetamine mesilate (VYVANSE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient left side of body felt very warm and felt like it was melting. The patient had red rash on left side face, neck, chest, arm. The patient had facial spasms, fever, confusion/lightheaded, palpitations, feeling of being unwell, fatigue. All on 22Jan2021, 06:45 PM, and was reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit, no treatment received. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the event was resolving.  Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Palpitations, Pyrexia, Rash erythematous
Clinical narrative: Left side of body felt very warm and felt like it was melting; red rash on left side face, neck, chest, arm; Facial spasms; Fever; Confusion/lightheaded; Confusion/lightheaded; Palpitations; Feeling of being unwell; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right arm single dose for COVID-19 immunization on 22Jan2021, 05:45 PM, at 28-year-old. Medical history included: COVID-19. No allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included: daily vitamins, lisdexamfetamine mesilate (VYVANSE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient left side of body felt very warm and felt like it was melting. The patient had red rash on left side face, neck, chest, arm. The patient had facial spasms, fever, confusion/lightheaded, palpitations, feeling of being unwell, fatigue. All on 22Jan2021, 06:45 PM, and was reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit, no treatment received. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the event was resolving.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site inflammation, Injection site pruritus, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Red ring around injection site, itchy, splotchy and warm to the touch.