chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Palpitations
Clinical narrative: About 2 mins. after receiving the shot, I experienced a very rapid heartbeat; sensation like I could not swallow. It passed in about a minute.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 24Mar2021 at 17:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not have any allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 24Mar2021 at 17:17 about 2 mins after receiving the shot, the patient experienced a very rapid heart beat and sensation like the patient could not swallow. It passed in about a minute. No therapeutic measures were taken as a result of the events. The clinical outcome of the events rapid heart beat and sensation like the patient could not swallow were recovered on 24Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Next day minor arm soreness that did not inhibit daily activities which resolved within 36 hours.; No other symptoms experienced beyond standard expected minor injection site soreness.; Approximately 5 minutes post injection, slight tingling in left pinky/ring finger of injected arm.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 09Apr2021 at 13:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient did not have any allergies to medications, food, or other products. Concomitant medications included naproxen sodium (ALEVE) since 4 days prior and for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 13:35, approximately 5 minutes post injection, the patient experienced slight tingling in left pinky/ring finger of injected arm. Not very painful but noticeable. Tingling was a bit intermittent and did not interfere with daily activities. It did not spread beyond fingers identified. No other symptoms experienced beyond standard expected minor injection site soreness was reported. After 30 minutes tingling still occurred; but did not worsen beyond initial feeling. The intermittent tingling began to fade during trip home and after approximately 1.5 hours, on 09Apr2021 at 15:05, total tingling resolved. Next day minor arm soreness that did not inhibit daily activities which resolved within 36 hours on an unknown date in Apr2021. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or care. No therapeutic measures were taken for the reported events. The clinical outcome of the events tingling was resolved on 09Apr2021, injection site soreness and minor arm soreness was resolved (after 36 hours) on unknown dates in Apr2021 at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Fever of 100.4; Aches; "Enlarged (swelling) of what I presume was the lymph gland below my left armpit extending over to my left breast"; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 25Mar2021 at 13:45 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and an allergy to "probably penicillin". Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included losartan potassium (LOSARTIN), rosuvastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and sodium phosphate dibasic, sodium phosphate monobasic (VISICOL). The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 27Mar2021 at 19:00, the patient experienced a fever of 100.4, aches, enlarged (swelling) of what the patient presumed was the lymph gland below her left armpit extending over to her left breast. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever of 100.4, aches and enlarged (swelling) of what the patient presumed was the lymph gland below her left armpit extending over to her left breast was resolved on an unspecified date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Paraesthesia
Clinical narrative: Tingling on face and arm on same side as injection site that started about 30 min after vaccination; Muscular twitch on face and arm on same side as injection site that started about 30 min after vaccination; This is a spontaneous report from a contactable consumer. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Mar2021(at the age of 39-years-old), as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no allergies to medications, food, or other products. On 23Mar2021, 30 minutes after vaccination, the patient experienced tingling and muscular twitch on face and arm on same side as injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tingling and muscular twitch on face and arm on same side as injection site was recovered on 23Mar2021, on the same day.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Heart rate increased, Hypopnoea, Musculoskeletal chest pain
Clinical narrative: Extreme pain in rib cage; pain in sternum; rapid heart rate; shallow breathing; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153), via an unspecified route of administration in the left arm on 10Apr2021 at 13:00 (at the age of 17-year-old), as a single dose for COVID-19 immunisation. Medical history included juvenile idiopathic arthritis, hypermobility and AMPS( amplified musculoskeletal pain syndrome). The patient did not have any known allergies to any food or medications or other products. Concomitant medication included birth control (unspecified) started from an unknown date for an unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the left arm on 20Mar2021 at 13:00 (at the age of 16-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, the patient experienced extreme pain in rib cage and sternum, causing rapid heart rate and shallow breathing. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events extreme pain in rib cage and sternum, rapid heart rate and shallow breathing was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Nausea; Headache; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 at 10:00, (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease and vertigo that was off and on for years. The patient was allergic to penicillin drugs (PCN). The patient received unspecified concomitant medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021, the patient experienced nausea, headache and dizziness. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events of nausea, headache and dizziness was not recovered at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Nausea, Pyrexia, Upper respiratory tract infection
Clinical narrative: Nausea (3 days); Headache (four days); Upper respiratory infection; No appetite; Low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8737) via an unspecified route of administration in the left arm on 01Apr2021 at 11:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto hypothyroidism, rheumatoid arthritis and raynaulds syndrome. The patient did not have any allergies to food, medications, or other products. The patient received other unspecified medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Apr2021 at 16:00, the patient experienced nausea (3 days), headache (four days), upper respiratory infection, no appetite and low-grade fever. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with unspecified antibiotics. The clinical outcome of the events nausea was recovered on 04Apr2021, headache was recovered on 05Apr2021. The clinical outcome of the event upper respiratory infection, no appetite and low grade were recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: Had persistent dry mouth after taking the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 07Apr2021 at 15:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products.  Concomitant medications included levothyroxine sodium (SYNTHROID) from unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 13:00, the patient experienced persistent dry mouth after taking the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event persistent dry mouth after taking the vaccine was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Extreme fatigue; Slept heavily; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 14:45 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma and the patient had no other relevant medical history. The patient had no allergies to food, medications, or other products. Concomitant medications included eyedrops (MANUFACTURER UNKNOWN) for glaucoma and vitamins (MANUFACTURER UNKNOWN), both taken from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 19:30, the patient experienced extreme fatigue and slept heavily for 16 hours after the vaccination. The patient experienced the events for one day only and was fine at the time of this report. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events extreme fatigue and slept heavily were resolved on 09Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: bad headache; felt very dizzy; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 24Mar2021 at 14:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), taken from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 03Mar2021 at 15:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 07:00, 2 weeks and 4 days following the second vaccine, the patient experienced a bad headache and felt very dizzy. The patient had to hold on to furniture and walls to avoid falling down, she had never experienced anything like that before and does not drink or take drugs. The dizziness lasted approximately 2 to 3 hours. Therapeutic measures were taken as a result of bad headache and included treatment with two Excedrin migraine pills and a glass of water. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event dizzy was resolved on 11Apr2021, while the clinical outcome of the event bad headache was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Tingling in left arm through finger tips for 30 minutes.; Pain at and around injection site; rash at and around injection site; swelling at and around injection sites; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 09Apr2021 at 10:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure, liver fibrosis, high cholesterol and COVID-19. The patient was allergic to latex. The patient was received medications (not specified) within two weeks of vaccination. The patient previously took erythromycin (MANUFACTURER UNKNOWN) and niacin (MANUFACTURER UNKNOWN), for unknown indications and on unknown dates, and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021, at 10:30 the patient experienced tingling in left arm through finger tips for 30 minutes, pain, rash and swelling at and around injection site. The patient had applied ice still the pain, rash and swelling at and around injection site was present (more than 72 hours later). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event of tingling was recovered, on 09Apr2021 after the duration of 30 minutes; while that of the clinical outcome of the events of pain, rash and swelling at and around the injection site was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected. .
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia oral
Clinical narrative: Felt sudden onset of numbness like novocain shot had been administered around nose lips, face, in nose, mouth and chin area.; Felt tingling lips.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 10Apr2021 at 11:00 (at the age of 49-years old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. The patient previously took Erythromycin, Levaquin, Bactrim, Phenylephrine; all on an unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 19:15 the patient experienced Felt tingling lips. On 12Apr2021 the patient experienced Felt sudden onset of numbness like Novocain shot had been administered around nose, lips, face in her nose, mouth and chin area. Felt as though she had been out in the snow and couldn't feel her face. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient receive any treatment for the reported events. The clinical outcome of the events tingling lips and Felt sudden onset of numbness like Novocain shot had been administered around nose, lips, face in her nose, mouth and chin area was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: severe chills; severe headache; very tired; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 09Apr2021 at 09:00 (at the age of 68-year-old), as single dose for COVID-19 immunisation. Medical history was reported as none and the patient did not have a history of allergies to any food or medications or other products. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 19Mar2021 at 09:00 (at the age of 68-year-old), as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Apr2021 at 21:00, the patient experienced severe chills, severe headache and very tired for 2 days. No therapeutic measures were taken for the events. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events severe chills, severe headache and very tired were recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vision blurred
Clinical narrative: "After feeling needle prick in upper arm", pricking sensation continued up arm at approximately 1 intervals over shoulder, up neck fading out aroundtop of head; Vision blurry/unable to drive for approx 10 minutes; 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: EP7534) via an unspecified route of administration in the left arm on 26Mar2021 at 10:00 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Medical history included temporary vision loss (temporary vision impairment) from an unknown date, 50 years before. The patient was allergic to mild latex. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN); liothyronine (MANUFACTURER UNKNOWN), krill oil (MANUFACTURER UNKNOWN) and theanine (MANUFACTURER UNKNOWN); all for an unknown indication, from an unknown date and unknown if ongoing. The patient previously took Codeine (MANUFACTURER UNKNOWN) on an unknown date and experienced temporary vision impairment 50 years ago. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 10:15, the patient felt needle prick in upper arm, pricking sensation continued up arm at approximately 1 interval over shoulder, up neck, fading out around top of head and vision blurry/unable to drive for approximately 10 minutes. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events felt needle prick in upper arm, pricking sensation continued up arm at approximately 1 interval over shoulder, up neck, fading out around top of head and vision blurry/unable to drive for approximately 10 minutes was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Fever 102 degrees; Severe headaches; Body muscle pain; Facial swelling; "Lymph neck swelling in extremities"; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0150) via an unspecified route of administration in the left arm on 07Apr2021 at 14:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included sjogren's autoimmune disorder and COVID-19. Concomitant medications included duloxetine hydrochloride (CYMBALTA), vitamin a nos (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and multivitamins; all for unknown indication from an unknown date. The patient previously took codein, valium and versed and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 22:00, the patient experienced fever 102 degrees, severe headaches, body muscle pain, facial swelling and lymph neck swelling in extremities. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events and included treatment with OTC fever, pain relievers and Flexeril for muscle. On 07Apr2021, the patient underwent lab test and procedure which included body temperature and the result was 102 degrees. The clinical outcome of the event fever 102 degrees, severe headaches, body muscle pain, facial swelling and "lymph neck swelling in extremities" was resolved with sequelae in 4 days (stop date:11Apr2021).  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Fever 102 degrees; Severe headaches; Body muscle pain; Facial swelling; "Lymph neck swelling in extremities"; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0150) via an unspecified route of administration in the left arm on 07Apr2021 at 14:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included sjogren's autoimmune disorder and COVID-19. Concomitant medications included duloxetine hydrochloride (CYMBALTA), vitamin a nos (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and multivitamins; all for unknown indication from an unknown date. The patient previously took codein, valium and versed and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 22:00, the patient experienced fever 102 degrees, severe headaches, body muscle pain, facial swelling and lymph neck swelling in extremities. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events and included treatment with OTC fever, pain relievers and Flexeril for muscle. On 07Apr2021, the patient underwent lab test and procedure which included body temperature and the result was 102 degrees. The clinical outcome of the event fever 102 degrees, severe headaches, body muscle pain, facial swelling and "lymph neck swelling in extremities" was resolved with sequelae in 4 days (stop date:11Apr2021).  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Reddness and swelling at injection site the size of 50 cent piece.; Reddness and swelling at injection site the size of 50 cent piece.; Sore to the touch.; Mild headache off and on.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 09Apr2021 at 12:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic. The patient was allergic to sulfonamide (sulfa durgs). Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and fusion gummy vitam. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 11Mar2021 at 17:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 04:00, the patient experienced redness and swelling at injection site the size of 50 cent piece, sore to the touch, mild headache off and on. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events redness and swelling at injection site the size of 50 cent piece, sore to the touch and mild headache were not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 55-year-old (non-pregnant)  female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 55, via an unspecified route of administration, left arm, on Apr 4, 2021, at 13:00, single dose, for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included amlodipine from unknown date for unknown indication. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 55, via an unspecified route of administration, left arm, on Mar 16, 2021, at 12:15, single dose, for COVID-19 immunisation. The patient previously took penicillin on unknown date for an unspecified indication; and experienced drug allergy. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On Apr 6, 2021, patient experienced sense of vibration in the body on day 2 and 3. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of sense of vibration in the body on day 2 and 3 after 2nd shot recovered on an unknown date in Apr 2021. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Stomatitis, Swelling face
Clinical narrative: Swollen face; Red face-like rash on face; Swollen bloody sores inside mouth cheeks, on gums, tongue, throat; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) in the left arm on 17Mar2021 at 12:00 (at the age of 49-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) in the left arm on 08Apr2021 at 15:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune diseases, COVID-19, allergy to latex and sulfa. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received codeine (MANUFACTURER UNKNOWN) and  morphine (MANUFACTURER UNKNOWN) and experienced allergy to both the drugs. On 17Mar2021 at 22:00, the patient experienced swollen face, red face which was like rash on face, swollen and bloody sores inside mouth cheeks, on gums, tongue and throat. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with BENADRYL every 4 hours around the clock. The clinical outcome of the events swollen face, red face which was like rash on face swollen and bloody sores inside mouth cheeks, on gums, tongue, throat were resolved with  lasting effects on an unknown date in 2021 at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Rash macular
Clinical narrative: Light-headed; Clammy/ sweating profusely; Blotchy; sweating profusely.; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 12Apr2021 at 10:30 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. 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 12Apr2021 at 10:45, the patient experienced light headed and started sweating profusely, got really clamy and blotchy. Therapeutic measures were taken as a result of event and included treatment with BENADRYL. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events light-headed, clammy, sweating profusely and blotchy were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: Rash all over body and is spreading. Started with just hands and feet, now everywhere.; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Feb2021 at 14:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patient did not report any relevant medical history. Concomitant medications included sertraline hydrochloride (ZOLOFT) for unknown indication and since an unknown date. The patient did not have any allergies to medication, food or any other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 03Mar2021, the patient experienced rash all over body. The patient reported that the arm where the injection was given was perfectly fine and the rash was spreading. It started with just hands and feet, then everywhere. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19.  On an unknown date in 2021, the patient underwent COVID-19 test and the result was negative. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event rash all over the body was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: Fever; headache; nausea; chills; diarrhea; hives; This is a spontaneous report from a contactable healthcare professional. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an intramuscular route of administration in left arm on 10Apr2021(at the age of 38-year-old), as a single dose for COVID-19 immunisation. Medical history included bronchial asthma and the patient had no known allergies to medications, food, or other products. The patient did not receive any other medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 11Apr2021, the patient experienced fever, headache, nausea, chills, diarrhea and hives. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included PCR (polymerase chain reaction) test on 10Apr2021 and tested negative. The events resulted in doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of adverse events which included treatment with antihistaminic medication. The clinical outcome of the events fever, headache, nausea, chills, diarrhea and hives was recovering at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: Fever; headache; nausea; chills; diarrhea; hives; This is a spontaneous report from a contactable healthcare professional. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an intramuscular route of administration in left arm on 10Apr2021(at the age of 38-year-old), as a single dose for COVID-19 immunisation. Medical history included bronchial asthma and the patient had no known allergies to medications, food, or other products. The patient did not receive any other medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 11Apr2021, the patient experienced fever, headache, nausea, chills, diarrhea and hives. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included PCR (polymerase chain reaction) test on 10Apr2021 and tested negative. The events resulted in doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of adverse events which included treatment with antihistaminic medication. The clinical outcome of the events fever, headache, nausea, chills, diarrhea and hives was recovering at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dysgeusia, Headache, Sleep disorder, Weight decreased
Clinical narrative: Had not gotten a full night sleep since the vaccine, kept tossing and turning at night; Loss of appetite; Metallic taste every time eat something; Lost 5 pounds since receiving the vaccine; Increased frequency of headaches; This is a spontaneous report from a contactable other healthcare professional, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 at 13:00 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 01Apr2021, since the vaccine, the patient had not gotten a full night sleep, kept tossing and turning at night, experienced loss of appetite and lost 5 pounds since receiving the vaccine. The patient experienced metallic taste every time patient ate something and increased frequency of headaches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events the patient had not gotten a full night sleep, kept tossing and turning at night, experienced loss of appetite and lost 5 pounds since receiving the vaccine, metallic taste every time patient ate something and increased frequency of headaches was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain in extremity, Pyrexia, Vaccination site erythema
Clinical narrative: Felt very nauseous; Low fever; Left arm was painful in large area of bicep for 24 hours; Left armpit lymph node swelled up for 3-4 days; Had 2 inch red area on left arm a few inches from vaccine injection point.; Area was warm and firm, created pain; Area was warm and firm; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 16:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included birth control. Concomitant medications included ethinylestradiol; norethisterone acetate (JUNEL) for birth control from unknown start date, cetirizine hydrochloride (ZYRTEC) and ibuprofen (ADVIL) for unknown indications from unknown start dates and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. The patient previously patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 11:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks of vaccination. On 08Apr2021 at 08:00, the patient had felt very nauseous, had a low fever for 36 hours, left arm was painful in large area of bicep for 24 hours. Left armpit lymph node swelled up for 3-4 days. Area was warm and firm, created pain. He had a 2-inch red area on left arm a few inches from vaccine injection point. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events low fever was recovered on 09Apr2021 after the duration of 36 hours and left arm painful was recovered on 09Apr2021 after the duration of 24 hours. The clinical outcome of the events felt very nauseous, left armpit lymph node swelled up, area was warm and firm, created pain and 2-inch red area on left arm a few inches from vaccine site was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.