chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Palpitations
Clinical narrative: felt her heart pounding and took her pulse and it was 158; took her pulse and it was 158; feels fatigued currently; took her blood pressure (BP) and it was 151/113; This is a spontaneous report from a contactable other healthcare professional. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), intramuscularly in right arm on 18Dec2020 14:05 at single dose for Covid-19 immunisation. Medical history included allergies to penicillin, allergy to mussels (bronco constriction and itch), figs allergy (nausea, vomiting, dizziness, elevated heart rate), allergy to grass (welts), ongoing asthma (asthma environmental triggers (Flowers, perfume, chemicals, soil, grass)), breast cancer left (had radiation and tamoxifen) from 2005 and ongoing, radiotherapy from an unknown date and unknown if ongoing. Concomitant medication included vitamin b complex (VITAMIN B), vitamin C, calcium (CA), Zinc, albuterol [salbutamol] and multivatamins. The patient previously took ampicillin and experienced allergy-rash, previously vaccinated with influenza and experienced weakness in 2010, and previously received tamoxifen for breast cancer female. After one hour later (18Dec2020 15:00), she felt her heart pounding and took her pulse and it was 158 and no other symptoms. Denies chest pain. Staff took her blood pressure (BP) and it was 151/113 on a machine. Recheck 10 minutes later BP 151/112, P 126. EE was brought to the Occupational Medicine Dept, Recheck at 20 min BP 125/68 and an apical pulse of 88. Heart rate (HR) regular, rate and rhythm. Employee states she feels fatigued currently, denies shortness of breath, chest pain, itching, swelling on oral cavity. The outcome of events was recovered on 18Dec2020.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Palpitations
Clinical narrative: felt her heart pounding and took her pulse and it was 158; took her pulse and it was 158; feels fatigued currently; took her blood pressure (BP) and it was 151/113; This is a spontaneous report from a contactable other healthcare professional. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), intramuscularly in right arm on 18Dec2020 14:05 at single dose for Covid-19 immunisation. Medical history included allergies to penicillin, allergy to mussels (bronco constriction and itch), figs allergy (nausea, vomiting, dizziness, elevated heart rate), allergy to grass (welts), ongoing asthma (asthma environmental triggers (Flowers, perfume, chemicals, soil, grass)), breast cancer left (had radiation and tamoxifen) from 2005 and ongoing, radiotherapy from an unknown date and unknown if ongoing. Concomitant medication included vitamin b complex (VITAMIN B), vitamin C, calcium (CA), Zinc, albuterol [salbutamol] and multivatamins. The patient previously took ampicillin and experienced allergy-rash, previously vaccinated with influenza and experienced weakness in 2010, and previously received tamoxifen for breast cancer female. After one hour later (18Dec2020 15:00), she felt her heart pounding and took her pulse and it was 158 and no other symptoms. Denies chest pain. Staff took her blood pressure (BP) and it was 151/113 on a machine. Recheck 10 minutes later BP 151/112, P 126. EE was brought to the Occupational Medicine Dept, Recheck at 20 min BP 125/68 and an apical pulse of 88. Heart rate (HR) regular, rate and rhythm. Employee states she feels fatigued currently, denies shortness of breath, chest pain, itching, swelling on oral cavity. The outcome of events was recovered on 18Dec2020.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Throat irritation
Clinical narrative: lips began tingling; tongue was tingly/numb; tongue was tingly/numb; throat felt fuzzy like needed to clear it; This is a spontaneous report from a contactable nurse reporting for herself. This 36-year-old female patient (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EH9899) on 19Dec2020 at 08:25, intramuscular, in left arm, for COVID-19 immunization. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included rheumatoid arthritis from 2014. The patient had known allergies to adalimumab (HUMIRA).  The patient did not have COVID before vaccination. Family medical history relevant to AEs: none (sister allergic to cashews, dad allergic to bees).Concomitant medications included tofacitinib citrate (XELJANZ XR) from Feb2018, at 11 mg daily, for arthritis, ibuprofen (MOTRIN) at 600 mg, as needed (every day for years 600 mg PRN), vitamins NOS (MVI) daily, for years, omega-3 fatty acids. The patient received the vaccination on 19Dec2020 at 08:25 and waited at the facility 30 minutes. On 19Dec2020 at 09:10 the patient experienced lips began tingling, tongue was tingly/numb and throat felt fuzzy like needed to clear it. Symptoms persisted but did not worsen and at 09:37 she took diphenhydramine (BENADRYL) 25mg as treatment. At 10:30 symptoms were gone at 75%. Emergency room or physician office visit were not required. COVID was not tested after vaccination. Relevant tests: none. The events resolved on an unspecified date in Dec2020. The reporter considered there was a reasonable possibility that the event was related to suspect product.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Throat clearing, Throat irritation
Clinical narrative: lips began tingling; tongue was tingly/numb; tongue was tingly/numb; throat felt fuzzy like needed to clear it; This is a spontaneous report from a contactable nurse reporting for herself. This 36-year-old female patient (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EH9899) on 19Dec2020 at 08:25, intramuscular, in left arm, for COVID-19 immunization. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included rheumatoid arthritis from 2014. The patient had known allergies to adalimumab (HUMIRA).  The patient did not have COVID before vaccination. Family medical history relevant to AEs: none (sister allergic to cashews, dad allergic to bees).Concomitant medications included tofacitinib citrate (XELJANZ XR) from Feb2018, at 11 mg daily, for arthritis, ibuprofen (MOTRIN) at 600 mg, as needed (every day for years 600 mg PRN), vitamins NOS (MVI) daily, for years, omega-3 fatty acids. The patient received the vaccination on 19Dec2020 at 08:25 and waited at the facility 30 minutes. On 19Dec2020 at 09:10 the patient experienced lips began tingling, tongue was tingly/numb and throat felt fuzzy like needed to clear it. Symptoms persisted but did not worsen and at 09:37 she took diphenhydramine (BENADRYL) 25mg as treatment. At 10:30 symptoms were gone at 75%. Emergency room or physician office visit were not required. COVID was not tested after vaccination. Relevant tests: none. The events resolved on an unspecified date in Dec2020. The reporter considered there was a reasonable possibility that the event was related to suspect product.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: BNT162B2 was given to the patient subcutaneously instead of intramuscular; upset; crying; This is a spontaneous report from a contactable nurse via medical information team. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via subcutaneous on 19Dec2020 at single dose for COVID-19 immunization. Medical history included deep vein thrombosis (DVT) from 3 years ago and unknown if ongoing. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.) for DVT and multivitamins. The patient stated "BNT162B2 was given to me subcutaneously instead of intramuscular (IM)." She stated she works at (Name withheld) and it was administered by an employee and her hospital employee health will not talk to her and she was being brushed off. The patient asked what's needed to do moving forward. She stated she does not know the efficacy for subcutaneous administration. After providing information in attached document the patient asked what should her next steps be since the hospital will not answer do anything about this incorrect administration. BNT162B2 was administered her incorrectly. The patient was little upset and was crying about it in Dec2020. The outcome of the events was unknown.  Information on the lot number/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Crying, Emotional distress, Incorrect route of product administration
Clinical narrative: BNT162B2 was given to the patient subcutaneously instead of intramuscular; upset; crying; This is a spontaneous report from a contactable nurse via medical information team. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via subcutaneous on 19Dec2020 at single dose for COVID-19 immunization. Medical history included deep vein thrombosis (DVT) from 3 years ago and unknown if ongoing. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.) for DVT and multivitamins. The patient stated "BNT162B2 was given to me subcutaneously instead of intramuscular (IM)." She stated she works at (Name withheld) and it was administered by an employee and her hospital employee health will not talk to her and she was being brushed off. The patient asked what's needed to do moving forward. She stated she does not know the efficacy for subcutaneous administration. After providing information in attached document the patient asked what should her next steps be since the hospital will not answer do anything about this incorrect administration. BNT162B2 was administered her incorrectly. The patient was little upset and was crying about it in Dec2020. The outcome of the events was unknown.  Information on the lot number/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness on the right side of my face (jaw to just above right eye, not severe); This is a spontaneous report from a contactable consumer. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration at first dose right arm on 19Dec2020 07:15 AM at single dose for covid-19 immunization. None medical history. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced numbness on the right side of her face (jaw to just above right eye, not severe) on 19Dec2020 07:45 AM. Patient didn't receive treatment for the adverse event. The action taken in response to the events for BNT162B2 was not applicable. The outcome of event was recovering. The event was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Heart rate increased, Hyperhidrosis
Clinical narrative: Approximately 3 to 4 minutes after injection site I started to get hot with a feeling of an elevated heart rate; Approximately 3 to 4 minutes after injection site I started to get hot with a feeling of an elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 16Dec2020 at 12:00 on left arm deltoid at single dose for COVID-19 immunization. The patient medical history included anxiety, depression and prior to vaccination, patient was diagnosed with COVID-19. No known allergy. The patient's concomitant medications received within 2 weeks of vaccination included escitalopram oxalate (LEXAPRO) and cetirizine hydrochloride (ZYRTEC), both on 16Dec2020. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that approximately 3 to 4 minutes after injection site he started to get hot with a feeling of an elevated heart rate on 16Dec2020 at 12:00. Took off his hat and noticed his hair was sweaty. Was not clammy anywhere else. Symptoms improved around minute 10 to 12. After sitting in car in parking lot for an additional five or 10 minutes started to feel more baseline. He never experienced any chest pain, shortness of breath, angioedema, hives, difficulty breathing, swelling, he had a history of anxiety, which seemed to coincide with the symptoms. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for events. The outcome of the events was recovered on 16Dec2020. The report was reported as non-serious.  Information on the Batch/Lot number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: SOB; fever; tired; headache; chills; not feeling well; injection site pain; lymph node swollen under right arm; This is a spontaneous report from a contactable Consumer.   This 55-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on right arm on 17Dec2020 at 11:30 am at single dose (lot number: EK5730) for COVID-19 immunization. Medical history included having Covid in Jul2020 and husband had Covid prior to being vaccinated. Concomitant medications included escitalopram oxalate (LEXAPRO), estradiol, hydrochlorothiazide in two weeks. The patient experienced SOB, fever, tired, headache, chills, not feeling well for over 24 hours than on the 19th noted lymph node swollen under right arm with severe pain along with injection site pain from 18Dec2020 03:00 AM. All events were reported as non-serious. Age at vaccination was 55 years old. Not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. Outcome of all events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020504434 same reporter/same drug/different event
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Lymphadenopathy, Malaise, Pain, Pyrexia
Clinical narrative: SOB; fever; tired; headache; chills; not feeling well; injection site pain; lymph node swollen under right arm; This is a spontaneous report from a contactable Consumer.   This 55-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on right arm on 17Dec2020 at 11:30 am at single dose (lot number: EK5730) for COVID-19 immunization. Medical history included having Covid in Jul2020 and husband had Covid prior to being vaccinated. Concomitant medications included escitalopram oxalate (LEXAPRO), estradiol, hydrochlorothiazide in two weeks. The patient experienced SOB, fever, tired, headache, chills, not feeling well for over 24 hours than on the 19th noted lymph node swollen under right arm with severe pain along with injection site pain from 18Dec2020 03:00 AM. All events were reported as non-serious. Age at vaccination was 55 years old. Not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. Outcome of all events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020504434 same reporter/same drug/different event
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Injection site pain
Clinical narrative: SOB; fever; tired; headache; chills; not feeling well; injection site pain; lymph node swollen under right arm; This is a spontaneous report from a contactable Consumer.   This 55-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on right arm on 17Dec2020 at 11:30 am at single dose (lot number: EK5730) for COVID-19 immunization. Medical history included having Covid in Jul2020 and husband had Covid prior to being vaccinated. Concomitant medications included escitalopram oxalate (LEXAPRO), estradiol, hydrochlorothiazide in two weeks. The patient experienced SOB, fever, tired, headache, chills, not feeling well for over 24 hours than on the 19th noted lymph node swollen under right arm with severe pain along with injection site pain from 18Dec2020 03:00 AM. All events were reported as non-serious. Age at vaccination was 55 years old. Not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. Outcome of all events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020504434 same reporter/same drug/different event
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: SOB; fever; tired; headache; chills; not feeling well; injection site pain; lymph node swollen under right arm; This is a spontaneous report from a contactable Consumer.   This 55-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on right arm on 17Dec2020 at 11:30 am at single dose (lot number: EK5730) for COVID-19 immunization. Medical history included having Covid in Jul2020 and husband had Covid prior to being vaccinated. Concomitant medications included escitalopram oxalate (LEXAPRO), estradiol, hydrochlorothiazide in two weeks. The patient experienced SOB, fever, tired, headache, chills, not feeling well for over 24 hours than on the 19th noted lymph node swollen under right arm with severe pain along with injection site pain from 18Dec2020 03:00 AM. All events were reported as non-serious. Age at vaccination was 55 years old. Not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. Outcome of all events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020504434 same reporter/same drug/different event
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Injection site erythema, Injection site pain
Clinical narrative: Soreness; redness; tenderness just outside of the injection site (not at the site); On my anterior shoulder next to where my arm sits by my armpit. A large red and swollen mark approx 2 on in height, 1 1/2in wide; This is a spontaneous report from a contactable consumer (patient). This 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EH9899) via an unspecified route of administration in the left arm on 19Dec2020 at 11:45 at single dose for COVID-19 immunisation. Vaccination facility type was hospital. The patient did not receive other vaccines in four weeks. Relevant medical history included Graves' disease, hyperthyroidism and chronic spine pain. Concomitant medications included pregabalin (LYRICA), hydroxyzine and buprenorphine hydrochloride/naloxone hydrochloride (SUBOXONE). On 20Dec2020 at 08:00, the patient experienced soreness, redness, tenderness just outside of the injection site (not at the site). "On her anterior shoulder, next to where her arm sits by her armpit, a large red and swollen mark approximately 2 on in height, 1 1/2 in wide" appeared. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive corrective treatments. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she had not been tested for COVID-19. The patient had not recovered from the events.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pain, Tenderness
Clinical narrative: Soreness; redness; tenderness just outside of the injection site (not at the site); On my anterior shoulder next to where my arm sits by my armpit. A large red and swollen mark approx 2 on in height, 1 1/2in wide; This is a spontaneous report from a contactable consumer (patient). This 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EH9899) via an unspecified route of administration in the left arm on 19Dec2020 at 11:45 at single dose for COVID-19 immunisation. Vaccination facility type was hospital. The patient did not receive other vaccines in four weeks. Relevant medical history included Graves' disease, hyperthyroidism and chronic spine pain. Concomitant medications included pregabalin (LYRICA), hydroxyzine and buprenorphine hydrochloride/naloxone hydrochloride (SUBOXONE). On 20Dec2020 at 08:00, the patient experienced soreness, redness, tenderness just outside of the injection site (not at the site). "On her anterior shoulder, next to where her arm sits by her armpit, a large red and swollen mark approximately 2 on in height, 1 1/2 in wide" appeared. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive corrective treatments. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she had not been tested for COVID-19. The patient had not recovered from the events.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram head, Dizziness, Dyspnoea, Electrocardiogram ambulatory
Clinical narrative: Facial tingling and numbness in legs developed while driving a few hours post-vaccination. Resolved within a few hours.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Emotional distress, Fibrin D dimer, Full blood count, Headache, Metabolic function test
Clinical narrative: Facial tingling and numbness in legs developed while driving a few hours post-vaccination. Resolved within a few hours.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Panic reaction, Paraesthesia
Clinical narrative: Facial tingling and numbness in legs developed while driving a few hours post-vaccination. Resolved within a few hours.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Asthenia, Dizziness, Dyspnoea, Headache
Clinical narrative: Facial tingling and numbness in legs developed while driving a few hours post-vaccination. Resolved within a few hours.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Hyperventilation, Paraesthesia, SARS-CoV-2 test negative
Clinical narrative: Facial tingling and numbness in legs developed while driving a few hours post-vaccination. Resolved within a few hours.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Facial tingling and numbness in legs developed while driving a few hours post-vaccination. Resolved within a few hours.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia ear, Sensory disturbance, Skin warm
Clinical narrative: I felt my left ear become hot and then felt paresthesia of my left ear, side of cheek and jaw, and down side of neck; Felt like numbness after dental procedure; left ear become hot; This is a spontaneous report from a contactable consumer (patient). This 37-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EH9899, at single dose on 20Dec2020 18:45 on left arm for COVID-19 immunisation. Medical history was none. Concomitant medication was not reported. The consumer had no other vaccine in four weeks. The consumer had no covid prior vaccination. The consumer had no covid tested post vaccination. The consumer had no known allergies. The consumer was not diagnosed with COVID-19 Prior to vaccination. The consumer had not been tested for COVID-19 since the vaccination. Approx 12-15 min after injection (20Dec2020 19:00) the consumer felt her left ear become hot and then felt paresthesia of her left ear, side of cheek and jaw, and down side of neck. She felt like numbness after dental procedure. Waxed and waned over the course of 30-45 minutes. She had mostly resolved after 1.75 hours, though slight abnormal feeling still remained. No treatment was received for all events. The outcome of the events was resolving.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Feeling hot, Hypoaesthesia, Paraesthesia
Clinical narrative: I felt my left ear become hot and then felt paresthesia of my left ear, side of cheek and jaw, and down side of neck; Felt like numbness after dental procedure; left ear become hot; This is a spontaneous report from a contactable consumer (patient). This 37-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EH9899, at single dose on 20Dec2020 18:45 on left arm for COVID-19 immunisation. Medical history was none. Concomitant medication was not reported. The consumer had no other vaccine in four weeks. The consumer had no covid prior vaccination. The consumer had no covid tested post vaccination. The consumer had no known allergies. The consumer was not diagnosed with COVID-19 Prior to vaccination. The consumer had not been tested for COVID-19 since the vaccination. Approx 12-15 min after injection (20Dec2020 19:00) the consumer felt her left ear become hot and then felt paresthesia of her left ear, side of cheek and jaw, and down side of neck. She felt like numbness after dental procedure. Waxed and waned over the course of 30-45 minutes. She had mostly resolved after 1.75 hours, though slight abnormal feeling still remained. No treatment was received for all events. The outcome of the events was resolving.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Nausea
Clinical narrative: joint pain; Dizzy; tired; weak; nausea; This is a spontaneous report from a contactable Other HCP.   A 28-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EJ1685) on 18Dec2020 at 08:30 AM at single dose via intramuscular on left arm for COVID-19 immunization. Relevant medical history included cancer in 2018 and allergy reaction to bee sting. Concomitant medications were not reported. Prior to vaccination patient wasn't diagnosed with COVID-19 and was not already tested for COVID-19. On 18Dec2020 at 08:45 AM patient experienced dizzy, tired, weak, nausea, and joint pain. At the time of the reporting the patient was recovering.  No follow-up attempts are needed. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea
Clinical narrative: nausea; Headache; This is a spontaneous report from a contactable Nurse (patient).   This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot # EK5730), via an unspecified route of administration, on 17Dec2020 at 09:30 AM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 60-years-old. No other vaccine was received in four weeks. Medical history included colorectal cancer in 2008, and idiopathic thrombocytopenic purpura (ITP) in 1991 recovered on an unknown date. Concomitant medications included gabapentin, omeprazole, duloxetine. On 17Dec2020 at 01:00 PM, the patient experienced headache and nausea the first day, severe nausea the second and third day, nausea continuing but not as severe as the second and third day. The patient was treated with Zofran. Outcome was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation, Throat tightness
Clinical narrative: experienced itchy and tight throat that felt like a tickle in throat; experienced itchy and tight throat that felt like a tickle in throat; This is a spontaneous report from a contactable nurse. A 46-year-old non-pregnant female patient received 1st dose of bnt162b2 (brand = Pfizer, lot number: EJ1685), intramuscular in the left arm on 20Dec2020 09:00 at a single dose for COVID-19 immunization at the hospital. Medical history included atrial septal defect repair in 2011 to an unknown date. The patient has no known allergies. Concomitant medications included hydrocodone bitartrate, paracetamol (VICODIN) and diclofenac. The patient experienced itchy and tight throat that felt like a tickle in throat on 20Dec2020 09:00. Airway remained patent and no rash/hives. The AEs resulted in a visit to emergency room/department or urgent care. Outcome of the events was recovered in Dec2020. No treatment was given for the events. It was unknown if patient had COVID prior to vaccination. The patient was not tested for COVID post vaccination.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Throat tightness
Clinical narrative: experienced itchy and tight throat that felt like a tickle in throat; experienced itchy and tight throat that felt like a tickle in throat; This is a spontaneous report from a contactable nurse. A 46-year-old non-pregnant female patient received 1st dose of bnt162b2 (brand = Pfizer, lot number: EJ1685), intramuscular in the left arm on 20Dec2020 09:00 at a single dose for COVID-19 immunization at the hospital. Medical history included atrial septal defect repair in 2011 to an unknown date. The patient has no known allergies. Concomitant medications included hydrocodone bitartrate, paracetamol (VICODIN) and diclofenac. The patient experienced itchy and tight throat that felt like a tickle in throat on 20Dec2020 09:00. Airway remained patent and no rash/hives. The AEs resulted in a visit to emergency room/department or urgent care. Outcome of the events was recovered in Dec2020. No treatment was given for the events. It was unknown if patient had COVID prior to vaccination. The patient was not tested for COVID post vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Hives; felt itching to her scalp; This is a spontaneous report from a contactable other hcp (patient). This 38-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), intramuscularly on 21Dec2020 06:40 at single dose on left deltoid for COVID Prevention. Medical history included Polycystic ovarian syndrome, was diagnosed with this in her early 20's and ongoing, Hypothyroidism from 2015 and ongoing, Corneal abrasion from 2020 and ongoing (Patient got a corneal abrasion to her right eye, about a week ago and is currently using eye drops for prophylaxis against infection), and anaphylaxis. Concomitant medication included metformin tablet oral at 750mg, once daily for Polycystic ovarian syndrome, she has been taking the product on and off since being diagnosed with PCOS and ongoing, thyroid (ARMOUR THYROID) oral at 60 (unsure if the product is MG or MCG) once daily for Hypothyroidism, started product four or five years ago and ongoing, moxifloxacin hydrochloride (VIGAMOX) at 1 drop to right eye, three times daily for Infection prophylaxis from Dec2020 and ongoing, patient got a right corneal abrasion last week and is using the product as infection prophylaxis. The patient was a Physician Assistant, who works in the ER, who just received the COVID vaccine at work. The patient stated that she got hives after her injection. The patient received the vaccine today at about 6:40AM. She stated that she was instructed to wait 30 minutes after receiving the vaccine because she does have a history of anaphylaxis, but not to vaccines. So it was about 5 to 10 minutes before her 30 minute wait time was up, that she started getting the hives on 21Dec2020. She stated that the hives she got started on her left wrist, and then they worked to bilateral upper arms, and then she also felt itching to her scalp but states she did not feel a rash on her scalp. She took 50mg of Benadryl orally for treatment. It was stated that the hives have resolved at this time, but patient was unsure as far as outcome goes, because she took Benadryl and the hives are gone now, but she does not know if they will return or not. She stated that she only had to take Benadryl and she declined checking in to the ER, so she considers this, not serious. The outcome of hives was recovered, of felt itching to her scalp was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives; felt itching to her scalp; This is a spontaneous report from a contactable other hcp (patient). This 38-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), intramuscularly on 21Dec2020 06:40 at single dose on left deltoid for COVID Prevention. Medical history included Polycystic ovarian syndrome, was diagnosed with this in her early 20's and ongoing, Hypothyroidism from 2015 and ongoing, Corneal abrasion from 2020 and ongoing (Patient got a corneal abrasion to her right eye, about a week ago and is currently using eye drops for prophylaxis against infection), and anaphylaxis. Concomitant medication included metformin tablet oral at 750mg, once daily for Polycystic ovarian syndrome, she has been taking the product on and off since being diagnosed with PCOS and ongoing, thyroid (ARMOUR THYROID) oral at 60 (unsure if the product is MG or MCG) once daily for Hypothyroidism, started product four or five years ago and ongoing, moxifloxacin hydrochloride (VIGAMOX) at 1 drop to right eye, three times daily for Infection prophylaxis from Dec2020 and ongoing, patient got a right corneal abrasion last week and is using the product as infection prophylaxis. The patient was a Physician Assistant, who works in the ER, who just received the COVID vaccine at work. The patient stated that she got hives after her injection. The patient received the vaccine today at about 6:40AM. She stated that she was instructed to wait 30 minutes after receiving the vaccine because she does have a history of anaphylaxis, but not to vaccines. So it was about 5 to 10 minutes before her 30 minute wait time was up, that she started getting the hives on 21Dec2020. She stated that the hives she got started on her left wrist, and then they worked to bilateral upper arms, and then she also felt itching to her scalp but states she did not feel a rash on her scalp. She took 50mg of Benadryl orally for treatment. It was stated that the hives have resolved at this time, but patient was unsure as far as outcome goes, because she took Benadryl and the hives are gone now, but she does not know if they will return or not. She stated that she only had to take Benadryl and she declined checking in to the ER, so she considers this, not serious. The outcome of hives was recovered, of felt itching to her scalp was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Ear swelling
Clinical narrative: Ear pressure and swelling on same side as vaccine injection; Ear pressure and swelling on same side as vaccine injection; This is a spontaneous report from a contactable nurse (patient).  A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EJ1685), via an unspecified route of administration on the right arm on 21Dec2020 08:30 at SINGLE DOSE as COVID-19 immunization.  The patient had allergies to tree nuts.  Prior to vaccination, the patient was not diagnosed with COVID-19 and patient had not been tested for COVID-19 since vaccination. The patient's concomitant medications were not reported. On 21Dec2020 08:45,  the patient had ear pressure and swelling on same side as vaccine injection resulting to doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the adverse event. Outcome of the events were unknown.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: Nausea, Injection Site Pain, Vomiting, Diarrhea
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Injection site pain, Nausea, Vomiting
Clinical narrative: Nausea, Injection Site Pain, Vomiting, Diarrhea
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphoedema
Clinical narrative: lymphadenopathy/I was having reaction of lymphedema; This is a spontaneous report from a contactable consumer (medical dosimetrist and patient herself - pending clarification).  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EJ1685), via an unspecified route of administration in Dec2020 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Dec2020, the patient was having reaction of lymphedema/ lymphadenopathy and was wondering how long it last generally.  The patient also inquired if she would get the next vaccine in different arm. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Lymphoedema
Clinical narrative: lymphadenopathy/I was having reaction of lymphedema; This is a spontaneous report from a contactable consumer (medical dosimetrist and patient herself - pending clarification).  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EJ1685), via an unspecified route of administration in Dec2020 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Dec2020, the patient was having reaction of lymphedema/ lymphadenopathy and was wondering how long it last generally.  The patient also inquired if she would get the next vaccine in different arm. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: intense arm pain, migraine, nausea w/ vomiting; intense arm pain, migraine, nausea w/ vomiting; intense arm pain, migraine, nausea w/ vomiting; intense arm pain, migraine, nausea w/ vomiting; This is a spontaneous report from a contactable other healthcare professional. A 44-year-old female patient received the first dose of bnt162b2 (Covid-19 vaccine, manufacturer: Pfizer, lot no: EJ1685) intramuscular in left arm on 18Dec2020 13:00 at a single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus, known allergies to sulfa, penicillin group, tetracycline analogues group. Concomitant medication included metformin, fluoxetine hydrochloride (PROZAC), lisinopril, semaglutide (OZEMPIC), and insulin glargine (TOUJEO). The patient experienced intense arm pain, migraine, nausea w/ vomiting on 19Dec2020 04:00. The patient recovered from the events in Dec2020. The events were reported as non-serious. The patient did not receive treatment for events, had no covid prior to vaccination, and was not covid tested post vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Nausea, Pain in extremity, Vomiting
Clinical narrative: intense arm pain, migraine, nausea w/ vomiting; intense arm pain, migraine, nausea w/ vomiting; intense arm pain, migraine, nausea w/ vomiting; intense arm pain, migraine, nausea w/ vomiting; This is a spontaneous report from a contactable other healthcare professional. A 44-year-old female patient received the first dose of bnt162b2 (Covid-19 vaccine, manufacturer: Pfizer, lot no: EJ1685) intramuscular in left arm on 18Dec2020 13:00 at a single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus, known allergies to sulfa, penicillin group, tetracycline analogues group. Concomitant medication included metformin, fluoxetine hydrochloride (PROZAC), lisinopril, semaglutide (OZEMPIC), and insulin glargine (TOUJEO). The patient experienced intense arm pain, migraine, nausea w/ vomiting on 19Dec2020 04:00. The patient recovered from the events in Dec2020. The events were reported as non-serious. The patient did not receive treatment for events, had no covid prior to vaccination, and was not covid tested post vaccination.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lacrimation increased, Paraesthesia oral, Throat irritation
Clinical narrative: tingling on roof of mouth, watery eyes, and itchy throat; tingling on roof of mouth, watery eyes, and itchy throat; tingling on roof of mouth, watery eyes, and itchy throat; This is a spontaneous report from a contactable nurse.   A 34-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), intramuscular in the left arm  at hospital on 18Dec2020 09:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 18Dec2020 at 09:15 the patient experienced tingling on roof of mouth, watery eyes, and itchy throat with outcome of unknown. The events required emergency room visit and the patient received treatment.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Oral pruritus, Pharyngeal hypoaesthesia
Clinical narrative: elevated heart rate of 113; Itching to roof of her mouth; numbness to right side of her throat; This is a spontaneous report received from a contactable nurse. A 24-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in right arm, on 18Dec2020 10:45, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient was pregnant. It was reported that the patient experienced itching to roof of her mouth, numbness to right side of her throat and had elevated heart rate of 113 on 18Dec2020 at 11:00. The adverse events resulted in "Emergency room/department of urgent care". It was unknown if the patient received treatment for the events. The outcome of the events was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: feeling nauseated, hot; feeling nauseated, hot; headache; difficulty breathing; itchy all over the body, with redness and blotchiness in the face, neck and arms; itchy all over the body, with redness and blotchiness in the face, neck and arms; itchy all over the body, with redness and blotchiness in the face, neck and arms; Blood pressure elevated along with heart rate.; Blood pressure elevated along with heart rate.; This is a spontaneous report from a contactable other healthcare professional (HCP), who is also the patient.  This 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunisation. Vaccination facility type was hospital. Relevant medical history included polycystic ovaries, gastrooesophageal reflux disease, Hashimoto's disease and allergy to sulfa, penicillin, latex and hornets. Concomitant medications included thyroid (ARMOUR THYROID), omeprazole and vitamin D3. On 19Dec2020 at 12:15, 10 minutes after the injection, the patient started feeling nauseated, hot and developed a headache. A couple of minutes after that, she started experiencing difficulty breathing and itchy all over the body, with redness and blotchiness in the face, neck and arms and blood pressure elevated along with heart rate. The events resulted in emergency room/department visit or urgent care. Corrective treatments taken as a result of the events included methylprednisolone sodium succinate (Solu-medrol), diphenhydramine hydrochloride (BENADRYL) and famotadine along with intravenous (IV) fluids. The patient recovered with sequel from the events on an unspecified date.  The information on the lot/ batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthma, Chest X-ray normal, Condition aggravated, Dyspnoea, Hypersensitivity
Clinical narrative: feeling nauseated, hot; feeling nauseated, hot; headache; difficulty breathing; itchy all over the body, with redness and blotchiness in the face, neck and arms; itchy all over the body, with redness and blotchiness in the face, neck and arms; itchy all over the body, with redness and blotchiness in the face, neck and arms; Blood pressure elevated along with heart rate.; Blood pressure elevated along with heart rate.; This is a spontaneous report from a contactable other healthcare professional (HCP), who is also the patient.  This 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunisation. Vaccination facility type was hospital. Relevant medical history included polycystic ovaries, gastrooesophageal reflux disease, Hashimoto's disease and allergy to sulfa, penicillin, latex and hornets. Concomitant medications included thyroid (ARMOUR THYROID), omeprazole and vitamin D3. On 19Dec2020 at 12:15, 10 minutes after the injection, the patient started feeling nauseated, hot and developed a headache. A couple of minutes after that, she started experiencing difficulty breathing and itchy all over the body, with redness and blotchiness in the face, neck and arms and blood pressure elevated along with heart rate. The events resulted in emergency room/department visit or urgent care. Corrective treatments taken as a result of the events included methylprednisolone sodium succinate (Solu-medrol), diphenhydramine hydrochloride (BENADRYL) and famotadine along with intravenous (IV) fluids. The patient recovered with sequel from the events on an unspecified date.  The information on the lot/ batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Malaise, Rash
Clinical narrative: feeling nauseated, hot; feeling nauseated, hot; headache; difficulty breathing; itchy all over the body, with redness and blotchiness in the face, neck and arms; itchy all over the body, with redness and blotchiness in the face, neck and arms; itchy all over the body, with redness and blotchiness in the face, neck and arms; Blood pressure elevated along with heart rate.; Blood pressure elevated along with heart rate.; This is a spontaneous report from a contactable other healthcare professional (HCP), who is also the patient.  This 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunisation. Vaccination facility type was hospital. Relevant medical history included polycystic ovaries, gastrooesophageal reflux disease, Hashimoto's disease and allergy to sulfa, penicillin, latex and hornets. Concomitant medications included thyroid (ARMOUR THYROID), omeprazole and vitamin D3. On 19Dec2020 at 12:15, 10 minutes after the injection, the patient started feeling nauseated, hot and developed a headache. A couple of minutes after that, she started experiencing difficulty breathing and itchy all over the body, with redness and blotchiness in the face, neck and arms and blood pressure elevated along with heart rate. The events resulted in emergency room/department visit or urgent care. Corrective treatments taken as a result of the events included methylprednisolone sodium succinate (Solu-medrol), diphenhydramine hydrochloride (BENADRYL) and famotadine along with intravenous (IV) fluids. The patient recovered with sequel from the events on an unspecified date.  The information on the lot/ batch number has been requested.