chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Feeling abnormal, General physical condition, Headache
Clinical narrative: Within 30-40 min of vaccination on the way home (around 7 pm) , friend developed sudden headache; felt tingling around the nose and face; felt dizzy; had dry mouth; She was trembling; had rash around the collar for about 45 min to 1 hour; swollen right arm (injection site but no redness, vaccination arm); floating sensation; This is a spontaneous report from a non-contactable consumer (patient). A 55-year-old non-pregnant female patient received bnt162b2 (Lot Number: EN6202), via an unspecified route of administration on 12Mar2021 at 18:15 (at the age of 55 years old) as single dose for covid-19 immunization. Medical history included breast cancer left, cholecystectomy for stones, deep vein thrombosis (DVT) during pregnancy, oophorectomy. The patient's known allergies included chocolate-since 1997 received epinephrine and additional food allergy: banana, orange, almonds, fresh tomato, avocado and strawberries (burning of moth and tingling around the nose). The patient's concomitant medications were not reported. It was unknown that patient had other vaccine in four weeks. Within 30-40 min of vaccination on the way home (around 7 pm), friend developed sudden headache, felt tingling around the nose and face, felt dizzy and had dry mouth. Her husband was driving the car. They drove to (Name withheld) Emergency Room/Urgent Care in (Name withheld) where she was admitted for care and observation. Additional details: She was trembling and was brought in on the wheelchair, had rash around the collar for about 45 min to 1 hour. She was dizzy, felt like "floating". Eventually improved overtime. She stated that her vitals were stable, oxygenation was 98%. Per her report, she did not receive epinephrine. Diphenhydramine hydrochloride (BENADRYL) was suggested but she did not want to take it as she had "bad headache" post diphenhydramine hydrochloride. She remained in ER for about 5 hours and eventually was discharged home. She was improving on the 13Mar2021, but continued to have headache and dizziness/floating sensation throughout the day. Also reported swollen right arm (injection site but no redness, vaccination arm). All events occurred on 12Mar2021 at 06:15 PM. The patient had not COVID prior vaccination and did not have COVID tested post vaccination. Treatment for events included paracetamol (TYLENOL). The outcome of events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Paraesthesia, Rash, Tremor, Vaccination site swelling
Clinical narrative: Within 30-40 min of vaccination on the way home (around 7 pm) , friend developed sudden headache; felt tingling around the nose and face; felt dizzy; had dry mouth; She was trembling; had rash around the collar for about 45 min to 1 hour; swollen right arm (injection site but no redness, vaccination arm); floating sensation; This is a spontaneous report from a non-contactable consumer (patient). A 55-year-old non-pregnant female patient received bnt162b2 (Lot Number: EN6202), via an unspecified route of administration on 12Mar2021 at 18:15 (at the age of 55 years old) as single dose for covid-19 immunization. Medical history included breast cancer left, cholecystectomy for stones, deep vein thrombosis (DVT) during pregnancy, oophorectomy. The patient's known allergies included chocolate-since 1997 received epinephrine and additional food allergy: banana, orange, almonds, fresh tomato, avocado and strawberries (burning of moth and tingling around the nose). The patient's concomitant medications were not reported. It was unknown that patient had other vaccine in four weeks. Within 30-40 min of vaccination on the way home (around 7 pm), friend developed sudden headache, felt tingling around the nose and face, felt dizzy and had dry mouth. Her husband was driving the car. They drove to (Name withheld) Emergency Room/Urgent Care in (Name withheld) where she was admitted for care and observation. Additional details: She was trembling and was brought in on the wheelchair, had rash around the collar for about 45 min to 1 hour. She was dizzy, felt like "floating". Eventually improved overtime. She stated that her vitals were stable, oxygenation was 98%. Per her report, she did not receive epinephrine. Diphenhydramine hydrochloride (BENADRYL) was suggested but she did not want to take it as she had "bad headache" post diphenhydramine hydrochloride. She remained in ER for about 5 hours and eventually was discharged home. She was improving on the 13Mar2021, but continued to have headache and dizziness/floating sensation throughout the day. Also reported swollen right arm (injection site but no redness, vaccination arm). All events occurred on 12Mar2021 at 06:15 PM. The patient had not COVID prior vaccination and did not have COVID tested post vaccination. Treatment for events included paracetamol (TYLENOL). The outcome of events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Vaccination site pain
Clinical narrative: Pain at injection site; fatigue; headache; overall did not feel well; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old non-pregnant female patient received bnt162b2 (Batch/Lot Number: EN6208, expiration date: Jun2021), dose 1 via an unspecified route of administration, administered in left arm on 12Mar2021 at 12:00 PM (at the age of 58 years old) as single dose for covid-19 immunization. Medical history included allergy to Sulfa. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient experienced pain at injection site, fatigue; headache and overall did not feel well on 13Mar2021. The patient had not COVID prior vaccination and did not have COVID tested post vaccination. No treatment for events. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Pain in extremity, Swelling
Clinical narrative: Severe pain in left scapulae; Chronic left arm pain; Swelling and chronic left armpit pain; Chronic left armpit pain; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6208) via an unspecified route of administration administered in left arm on 12Mar2021 at 05:30 (at 38 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included asthma from an unknown date. The patient had no known allergies. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. There were no concomitant medications. The patient experienced chronic left arm pain, swelling and chronic left armpit pain, and severe pain in left scapulae; all non-serious on 13Mar2021 at 19:30. No treatment received for the events. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6205) via an unspecified route of administration administered in right arm on 12Mar2021 at 11:30 (at 52 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. There was no relevant medical history or concomitant medications. The patient had no known allergies. The patient did not have COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient reported that the next day of the vaccination, patient started seeing floaters in left eye, which was non-serious on 13Mar2021 at 08:00. No treatment received for the event. Outcome of the event was not recovered. No follow-up attempts are possible; no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Rash papular
Clinical narrative: Developed macular popular rash on upper left trapezius and another 1 in spot over left scapula at 72 hours post shot; Developed macular popular rash on upper left trapezius and another 1 in spot over left scapula at 72 hours post shot; At 96 hours 4 spots of rash on upper middle chest. Fluid loses from papules and scabs over. Severe itching; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in left arm on unspecified date in Feb2021 at 11:00 as single dose for COVID-19 immunization.  There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included atopic dermatitis, osteoarthritis, mild asthma, and diarrhea-predominant irritable bowel syndrome (IBS-D). The patient had known allergies: sulfa. The patient previously used povidone-iodine (BETADINE) and experienced allergies. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast, and carisoprodol (SOMA); all from unspecified date for unspecified indication. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient developed macular popular rash on upper left trapezius and another 1 in spot over left scapula at 72 hours post shot. At 96 hours 4 spots of rash on upper middle chest. Fluid loses from papules and scabs over. Severe itching, all non-serious on 04Mar2021. No treatment received for the events. The patient received second dose of BNT162B2 via an unspecified route of administration administered in left arm on unspecified date on 08Mar2021 at 11:00 as single dose for COVID-19 immunization. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch no cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Experienced significant improvements in Multiple Sclerosis symptoms; This is a spontaneous report from a contactable consumer (patient).  A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EL9264 Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 18Feb2021 at 19:45 (at the age of 58 years old) as second dose, single for COVID-19 immunisation. The facility where the vaccine was administered was reported to be "other". Medical history included multiple sclerosis, restless leg, alopecia, lymphedema and venous insufficiency stasis, all from an unknown date. Patient has known allergies to interferon Beta-1A (REBIF), amoxicillin and hydrochlorothiazide on an unknown date.  The patient was not pregnant at the time of vaccination and prior to vaccine the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number: EN5318), via an unspecified route of administration, administered in right arm on 28Jan2021 at 05:00 PM (at the age of 58 years old) as single for COVID-19 immunisation. Concomitant medications included baclofen, furosemide, levothyroxine, mirabegron (MYRBETRIQ) and bupropion hydrochloride (WELLBUTRIN), all taken for an unspecified indication, start and stop date were not reported. On 19Feb2021 at 06:00, the  patient experienced unexpected therapeutic effect further described as significant improvements in multiple sclerosis symptoms including extreme reduction in inflammation. The patient was able to move her hands and feet freely, which are always stiff and difficult to move, and unable to make a fist with her hands. No treatment was received for the adverse event. Since vaccination, the patient has not been tested for COVID-19. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swollen left armpit; This is a spontaneous report from a non-contactable consumer or other non hcp (patient herself). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, expiration date not reported), via an unspecified route of administration, administered in the left arm on 13Mar2021 09:30 (at the age of 33-years-old), as second dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, expiration date not reported), via an unspecified route of administration, administered in the left arm on 20Feb2021 (at the age of 33-years-old), as first dose, single dose for COVID-19 immunisation. The patient has no known allergies. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient experienced swollen left armpit on 13Mar2021 21:00 (reported as starting about 12 hours post vaccine). No treatment was received as a result of the events. Patient did not seek consult to physician or urgent care. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vaccination site paraesthesia, Vaccination site reaction
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 61; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on an unspecified date as first dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, within 24 hours after receiving the vaccine, the patient experienced tingling and numbness of the left foot, fingers, at the injection site and perhaps a little on the right foot. The outcome of the events was unknown. The patient was stated that on the website it is listed as a potentially serious side effect, but there is nothing on the website.  She was querying if she should be concerned and if she can receive the second dose of the vaccine. No follow-up attempts are possible; information about Lot/Batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Hypertension, Palpitations
Clinical narrative: heart palpations; tachycardia; hypertensive; diarrhea; headache; fatigue; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported reaction after first dose and experienced heart palpations, tachycardia, hypertensive, diarrhea, headache, and fatigue, which were all non-serious on unspecified date in Mar2021. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: heart palpations; tachycardia; hypertensive; diarrhea; headache; fatigue; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported reaction after first dose and experienced heart palpations, tachycardia, hypertensive, diarrhea, headache, and fatigue, which were all non-serious on unspecified date in Mar2021. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Low fever; Body aches; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6206, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 11Mar2021 10:30 (at the age of 58-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included arthritis and COVID-19 both from an unknown date. Concomitant medications included hydroxychloroquine and estradiol (ESTROGEN) both taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On 12Mar2021, the patient experienced low fever and body aches. No treatment was received for the events. Since the vaccination the patient has been tested with COVID-19 using Nasal Swab: Results unknown. The outcome of the events was recovered.  No follow-up attempts are possible. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itching/Rash to bilateral arm, legs/torso/ back; This is a spontaneous report from a contactable nurse.   This 51-year-old female nurse (patient) received second dose (Lot Number: EL3248 expiry date was not reported) dose 2 via intramuscular route of administration at Arm Left on 27Jan2021 06:30 as 2ND DOSE, 0.3 ML SINGLE for covid-19 immunisation. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection first dose 0.3 ml (Lot Number: EL3248 expiry date was not reported) via an intramuscular route of administration at Left Arm on 09Jan2021: 06:30. Medical history included asthma from 01Jan2007 and ongoing. Patient received DTAP on 09Dec1981 at the age of 12 years and Tetanus Booster at the age of 25 years. Concomitant medication(s) included paracetamol (TYLENOL RAPID RELEASE GELS) taken for an unspecified indication from 09Jan2021 to an unspecified stop date. Patient did not have Prior vaccinations (within 4 weeks). On 27Jan2021 17:00 the patient experienced itching and rash to bilateral arm, legs/torso/back. Patient received Benadryl PO 25 mg due to event. Patient did not visit to physician office or emergency room due to event. The outcome of the event was resolving.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: BP remained higher than normal; This is a spontaneous report received from a contactable consumer (reported on herself) in response to non-HCP letter sent.  An 82-year-old female consumer received second dose of BNT162B2 (Solution for injection, Lot number: EM9809 Expiry date: 30Jun2021) via an intramuscular route 19Feb2021 02:00 pm, as a single dose for Covid-19 immunization. Medical history was not reported. The patient was not on any concomitant medications. There was no history of other prior vaccination. The patient received first dose of BNT162B2 (Solution for injection, Lot number: EL9262 expiry date: 31May2021) via an intramuscular route on 28Jan2021 12:40 pm, as a single dose for Covid-19 immunization. On an unknown date, after vaccination, the patient experienced that blood pressure (BP) reminded higher than normal/ High BP. The patient received treatment with Losartan and Hydroxyzine. The outcome of the event of BP) reminded higher than normal/High BP was reported as not resolved.     No follow up attempts were possible. No further information was expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 12Mar2021 at 13:50 (Batch/Lot Number: EL3247) (at the age of 55-years-old) as 1st dose, single dose for COVID-19 immunisation. Patient's medical history was reported as none. Concomitant medication included ascorbic acid, biotin, boron, calcium, calcium pantothenate, chlorine, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine hydrochloride, tocopherol, vanadium, zinc (CENTRUM SILVER) taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 at 01:50 (approximately 12 hours later), patient experienced soreness at the injection site, which was partially relieved with a 400 mg dose of Advil (two 200mg liqui-gels). Some residual soreness continued as of this report. No other symptoms were noted. Outcome of event was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dry mouth, Dry skin, Pyrexia
Clinical narrative: lost his smell; fever; lost his taste; dry skin; dry mouth; This is a spontaneous report from a contactable consumer. The reporter reported for two patients. This is first case out of 2 cases.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date as unknown dose number, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lost his smell, fever and lost his taste and experienced the dry skin and dry mouth on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was sore after receiving the Covid-19 Vaccine; This is a spontaneous report from a contactable consumer. A 60-years-old male consumer (patient) reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6203; NDC number and expiry date were reported as unknown) via an unspecified route of administration on 09Mar2021 in left arm as a single dose for covid-19 immunization. Medical history, other products, investigation assessment and concomitant medications were not reported. On 10Mar2021, in the morning the patient reported that his arm was a little sore after receiving the Covid-19 Vaccine. He received the vaccine in his left arm, and he was left-handed. He also received a flu shot. The patient does not have the physician email address or address to provide, and he was going for a physical tomorrow. He stated that his aunt (96-years-old) got the first dose of vaccine a couple of weeks ago and also got the second dose. She was fine and her arm was not even sore like his arm. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis
Clinical narrative: bad cold; feeling tired and significant fatigue; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2, via an unspecified route of administration, administered in right arm on 12Mar2021 11:30 (Batch/Lot Number: EL3247) at 46 years old as 2nd dose, single dose for COVID-19 immunisation. Medical history was none. No known allergies. No COVID prior vaccination. Not COVID tested post vaccination. There were no concomitant medications; no other medications in two weeks and no other vaccine in four weeks. The patient previously took BNT162B2 on 19Feb2021 (Batch/Lot Number: EL3247) as 1st dose (right arm) for COVID-19 immunisation. On 13Mar2021 07:30 (the next day), the patient was feeling tired and significant fatigue. He felt like he had a bad cold. No treatment provided. Outcome of events were recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Headache, Illness, Swelling face
Clinical narrative: got very sick; I thought I was having an anaphylactic reaction, i have a nut allergy, but my face never got swollen; woke up with bad headache; terrible asthma attack; This is a spontaneous report from a contactable consumer or other non hcp (Patient) reported himself that.  A 59-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, Batch/Lot Number: EN6204, Expiry date: unknown), dose 1 via an unspecified route of administration on 12Mar2021 at 17:30 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patent medical history included asthma he hasn't had a bad asthma attack like this since he was 5yrs old and Nut allergy. Patient Concomitant medication included Trospium Chloride. After the First 1st dose on Friday (12Mar2021) and 5-6hours later at around 11:30pm he had a terrible asthma attack, he had difficulty breathing, it started out with a cough then wheezing that kept getting worse, he did not have an inhaler that was not at least 10yrs old. He was lying down, so he sat up and that helped him. he didn't' want have the ambulance come over or take him to the hospital because it's too expensive and he don't have insurance. He thought he was having an anaphylactic reaction, like the caption drive ship in the storm. So, he sat up for 2 hours because I could not lie down could not breathe when he lies down. So, he sat up and pulled for breath and he had a terrible asthma attack, terrible wheeze, and coughing. If he would have started to get blotchy and swollen, then he probably would have call back the ambulance. He called the information for the number, hospital, they gave me the neurology department in the hospital for whatever reason he does not know. Then he called the police station and then googled phone number for the hospital that does not work anymore, and he could not call the hospital then he called the police station they tell him not to keep following. That is quite alright he had that Covid shot if he dies overnight then you can document what he told but he did not die overnight because he is feeling better, but the question is has not had an asthma attack like that since he was like 5 years old. The outcome is Unknown for all the events  Response: Unable to determine how someone will react to 1st or 2nd dose. Referred to HCP on recommendations for 2nd dose.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: slight temperature of 99.1; chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 12Mar2021 at 11:15 (Batch/Lot Number: EL3247) (at the age of 48-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient is not pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient has no allergies to medications, food, or other products. The patient's medical history was not reported. Concomitant medications included zinc chloride; biotin; polycarbophil calcium (FIBERCON) and vitamin D, all for an unspecified indications, start and stop dates were not reported. The patient received these concomitant medications within 2 weeks of vaccination. The patient previously received the 1st dose of BNT162B2 on an unspecified date for COVID-19 immunization. On 13Mar2021 at 14:00 (also reported as 2-2:30 PM), the patient experienced slight temperature of 99.1, body aches and chills. Patient took Tylenol every 4-6 hours x 3 doses. The adverse events resulted in nothing and there was no treatment (as reported). The outcome of the event was recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: headache; tiredness/ bouts of extreme fatigue; Sore arm; This is a spontaneous report from contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 04Mar2021 08:30 (Batch/Lot number was not reported) at the age of 53 years old as second dose, single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication wasreported as none. Prior vaccinations within four weeks was reported as none. The patient previously received first dose of BNT162B2, anatomical site of injection: left arm on 09Feb2021 at 8:45 AM for COVID-19 immunization. The patient experienced tiredness on 04Mar2021 at 12:00, headache on 04Mar2021 at 17:00 and sore arm on 04Mar2021 (also reported as "07Apr2021", pending clarification) at 9:00. Patient also stated that "I received the second dose of vaccine on 3Apr. Since then I have had bouts of extreme fatigue. Is this a long term side effect?" (pending clarification)  The events did not required treatment (initiation of new medication/other treatment/ procedure). The outcome of the event "tiredness/bouts of extreme fatigue" was recovered on 25Mar2021, for headache was recovered on 05Mar2021 and for "Sore arm" was recovered on 06Mar2021.  No follow up attempts are possible. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable Other HCP.   This 37-year-old female other HCP reported for herself that who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot number and expiry date was not reported) via an unspecified route of administration at left arm on 10FEB2021 08:00 and second dose (Lot Number and expiry date was not reported) via unspecified route of administration at Arm Left on 03Mar2021 as a single dose for covid-19 immunisation. Patient was not on other vaccines in four weeks and not on other medication in two weeks. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient did not have any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Mar2021 the patient experienced headache. No treatment was received due to the event. The outcome of event was not recovered. Event occurred in a country different from that of the reporter.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Muscle ache; Slight fever; Felt a little sick; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine; solution for injection), via an unspecified route of administration on 10Feb2021 (batch/lot number was not reported) as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (batch/lot number was not reported), via an unspecified route of administration on 20Jan2021 as 1st dose, single dose for COVID-19 immunization. The patient reported that she had a "reaction to her second shot". On an unspecified date, the patient experienced a slight fever and felt a little sick for 1 day on an unspecified date following her second dose. The patient also experienced muscle ache on an unspecified date. The outcome of the events slight fever and feeling sick was recovered while the outcome of the event muscle ache was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: hives inside lower forearm of right arm; This is a spontaneous report from a contactable consumer, the patient.   A 68-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration, in the right arm on 15Mar2021 at 01.15 PM as a single dose (at the age of 68-years-old) for COVID-19 Immunisation. Medical history included high cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications include simvastatin (Manufacturer unknown), ezetimibe (Manufacturer unknown), aspirin (Manufacturer unknown) and melatonin (Manufacturer unknown) all for an unspecified indication. The patient previously received acetaminophen for an unknown indication and experienced allergy. On 16Mar2021 at 08:30 pm, the patient experienced hives inside lower forearm of right arm. The patient did not receive any treatment for the event. The clinical outcome of the hives inside lower forearm of right arm was not recovered. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: pain and redness (redness came in today) at the injection site on the right arm; pain and redness (redness came in today) at the injection site on the right arm; This is a spontaneous report from a contactable consumer (patient).  A 81-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 09Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included memory impairment ongoing from an unknown date. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) for covid-19 immunisation and experienced  some itching at the injection site in left arm. The patient's concomitant medications were not reported.  The patient experienced pain at the injection site (in Mar2021) and redness at the injection site (on 12Mar2021) on the right arm. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: she broke out in shingles; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9261 and expiry date: unknown), dose 1 via an unspecified route of administration on 23Jan2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The caller was supposed to get the second shot on 13Feb2021 but the caller's doctor said to wait because she still had shingles. The patient medical history and concomitant medications were not reported. The patient experienced she broke out in shingles on an unspecified date. The caller wanted to know if the second dose of the vaccine was effective because she had shingles. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: herpes outbreak; This is a spontaneous report from a contactable Other Health Professional (patient). A 39-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; batch/Lot number was not reported), via an intramuscular route of administration in arm right on 06Mar2021 11:30 (at age of 39-year-old) as first dose, single dose for covid-19 immunization. The patient's medical history included HSV2 (herpes simplex). The patient did not have other vaccine in four weeks and not have other medications in two weeks. Prior to vaccination, the patient was not diagnosed with covid. Post vaccination, the patient had not been tested for covid. The had no known allergies.Concomitant medications was not reported. On 09Mar2021 10:00, two days after the vaccine the patient showed symptoms listed in side effects as well as experienced herpes outbreak. The patient received treatment with anti-viral medication but event with medicine the outbreak was not clearing up. Asked if this had been reported as a side effect for people with HSV1 or HSV2. The outcome of the event was not resolved.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Based on the plausible temporal relation, the association between the event "Herpes Outbreak" and the suspect product of BNT162B2 cannot be completely ruled out. The patient's medical history of HSV2 (Herpes Simplex) is a confounding factor.
Sex: M
Vaccine: COVID19
Symptoms: Stress, Therapeutic response unexpected
Clinical narrative: stressed from various things; This week I got a cold sore (stressed from various things) , which I get every few years. This time, it was very small, and lasted only a very short time; This is a spontaneous report from a contactable physician (patient) received from a Pfizer-sponsored program, Pfizer.com - General Company Information. A male patient of an unspecified age received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on Feb2021 (at an unspecified age) at 2nd dose, single dose for COVID-19 immunisation. Medical history included cold sores (which the patient gets every few years). The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 received on an unspecified date for COVID-19 immunisation. The patient reported that on Mar2021, the patient got a cold sore, because he was stressed from various things, which the patient gets every few years. However, this time, it was very small and lasted only for a very short time. The patient wonders if the vaccine reduced the severity and duration of the cold sore. The patient stated that it was an interesting coincidence or perhaps a causal relationship. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Pulmonary oedema
Clinical narrative: fluid build up in lungs; difficulty in breathing; weakness; tiredness; This is a spontaneous report from a contactable consumer received from a Pfizer sponsored Program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a 2nd dose, single dose for COVID-19 immunisation. The patient's medical history included open heart surgery, preexisting condition Mac bacteria complication during open heart surgery a few years ago that caused the other side of the heart to weaken that led to ascites. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a 1st dose, single dose for COVID-19 immunization. It was reported that, during 2nd Co-Vid vaccine injection side effect of weakness, tiredness and fluid build-up in lungs. Complained of difficulty in breathing. It had been 10 days since the second vaccine injection and no change. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Low grade fever; This is a spontaneous report from a contactable consumer (patient's husband) from Pfizer-sponsored Program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 21Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation; metronidazole (manufacturer unknown), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 500 mg for an unspecified indication; doxycycline hyclate (manufacturer unknown), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 100 mg for an unspecified indication; enoxaparin (manufacturer unknown), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 40 mg for an unspecified indication. Medical history included skin infection. The patient's concomitant medications were not reported. Patient has gotten an appointment tomorrow morning to get her second Pfizer, Covid-19 (vaccine) shot and she just had an operation 4 days ago. Her doctor (said) that she could get the second shot after the enquire search to do so. But the problem was she had developed a low grade fever, she has "100" (not clarified) something temperature right now. When called after, they think it's from skin infection that she previously had and it's not from the operation but it might be. She was on three types of medications, the first antibiotic is Doxycycline 100mg, Metronidazole 500 mg, these two were antibiotics and the last one was, the third one, it's an injection and it's a type of blood thinner for blood clots, it Enoxaparin 40 mg syringe (injection). It was further stated by the reporter that it's not from the first vaccination that was 3 weeks ago and she was not having any symptoms. Reporter asked if his wife still can proceed with her second dose (14Mar2021) or should be rescheduled. His wife got her first dose on 21Feb2021 and had an operation four days ago 09Mar2021 and taking antibiotics. The action taken in response to events for doxycycline hyclate, metronidazole and enoxaparin was unknown. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on data provided, the event pyrexia is assessed as unrelated to BNT162B2 and is possibly related to metronidazole and/or doxycycline. This case will be reviewed. upon receipt of more information.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: Extreme hoarseness; This is a spontaneous report from a contactable consumer (patient's child). A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on the left arm on 27Feb2021 12:00 (Batch/Lot number was not reported) at the age of 90 years old as 2nd dose, single for COVID-19 immunisation. Medical history included Chronic lymphocytic leukemia. The patient had no known allergies. Concomitant medications included vitamin B complex (VITAMIN B); omeprazole; and losartan potassium; all were reported as medications in two weeks. The patient previously had the first dose of BNT162B2, via an unspecified route of administration on the left arm on 30Jan2021 12:00 (Batch/lot number not reported) at the age of 90 years old as 1st dose, single for COVID-19 immunisation. The patient didn't have COVID prior to vaccination. The patient hadn't been tested post vaccination. On 28Feb2021 08:00 the patient experienced extreme hoarseness which resulted in doctor or other healthcare professional office/clinic visit. The patient didn't receive treatment for the event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: bad itching all over her body; Rash all over; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Mar2021 12:00 (Batch/Lot Number: EN6198) at the age of 68 years old as 2nd dose, single dose for COVID-19 immunisation. Medical history included allergy to codeine. Patient was not pregnant at the time of vaccination. Concomitant medications were not specified. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took 1st dose of BNT162B2 administered in left arm on 13Feb2021 04:00 AM (also reported as PM) (Batch/Lot Number: Kn9808) for COVID-19 immunisation. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient took her second COVID-19 vaccine last 06Mar2021 (Saturday). A week later, on 13Mar2021, the patient experienced rash all over her body itching, this bad itching all over her body and it's really irritating. She has taken diphenhydramine (BENADRYL) thinking that would maybe help it and she was not getting any relief. She confirmed that diphenhydramine was taken as a treatment. The patient was wondering what else can she do and if had this reported from others. Outcome of events were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Irritability, Pruritus, Rash, Rash erythematous
Clinical narrative: bad itching all over her body; Rash all over; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Mar2021 12:00 (Batch/Lot Number: EN6198) at the age of 68 years old as 2nd dose, single dose for COVID-19 immunisation. Medical history included allergy to codeine. Patient was not pregnant at the time of vaccination. Concomitant medications were not specified. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took 1st dose of BNT162B2 administered in left arm on 13Feb2021 04:00 AM (also reported as PM) (Batch/Lot Number: Kn9808) for COVID-19 immunisation. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient took her second COVID-19 vaccine last 06Mar2021 (Saturday). A week later, on 13Mar2021, the patient experienced rash all over her body itching, this bad itching all over her body and it's really irritating. She has taken diphenhydramine (BENADRYL) thinking that would maybe help it and she was not getting any relief. She confirmed that diphenhydramine was taken as a treatment. The patient was wondering what else can she do and if had this reported from others. Outcome of events were not recovered.  No follow-up attempts are needed. No further information is expected.