chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Very intense headache and general body ache, I took acetaminophen and naproxen and nothing would take the pain away.; Very intense headache and general body ache, I took acetaminophen and naproxen and nothing would take the pain away.; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received bnt162b2 (lot:EK9231), via an unspecified route of administration in the left arm on 05Jan2021,16:30 at a single dose for covid-19 immunization. The patient's medical history included depression and migraines and covid-19 all from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medication included escitalopram (ESCITALOPRAM). On 05Jan2021 at 18:00, the patient experienced very intense headache and general body ache. Patient took acetaminophen and naproxen and nothing would take the pain away. Therapeutic measures were taken as a result of very intense headache and general body ache included acetaminophen and naproxen sodium but nothing would take the pain away. The outcome of the events was recovered on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Off label use
Clinical narrative: Fever more than 100.5F; severe headache; body aches/joint pain; body aches/joint pain; chills; left arm soreness; administration date=06Jan2021 dose number=2/administration date=18Dec2020 dose number=1; administration date=06Jan2021 dose number=2/administration date=18Dec2020 dose number=1; This is a spontaneous report from a contactable pharmacist (patient). A 31-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EK9231) via an unspecified route of administration in left arm on 06Jan2021 16:30 at single dose for COVID-19 immunisation. The patient received the first dose of BNT162B2 (Lot: EH9899) on 18Dec2020 16:30 at 31 years old at single dose for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. On 07Jan2021 06:00 AM, the patient experienced fever more than 100.5F, severe headache, body aches/joint pain, chills, and left arm soreness all lasting 12 hours. Dose received on 06Jan2021 4:30PM and side effects mostly subsided by 07Jan2021 430PM. No treatment was received for the adverse events. Events outcome of fever more than 100.5F, severe headache, body aches/joint pain, chills, and left arm soreness was recovering.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Product use issue, Pyrexia
Clinical narrative: Fever more than 100.5F; severe headache; body aches/joint pain; body aches/joint pain; chills; left arm soreness; administration date=06Jan2021 dose number=2/administration date=18Dec2020 dose number=1; administration date=06Jan2021 dose number=2/administration date=18Dec2020 dose number=1; This is a spontaneous report from a contactable pharmacist (patient). A 31-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EK9231) via an unspecified route of administration in left arm on 06Jan2021 16:30 at single dose for COVID-19 immunisation. The patient received the first dose of BNT162B2 (Lot: EH9899) on 18Dec2020 16:30 at 31 years old at single dose for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. On 07Jan2021 06:00 AM, the patient experienced fever more than 100.5F, severe headache, body aches/joint pain, chills, and left arm soreness all lasting 12 hours. Dose received on 06Jan2021 4:30PM and side effects mostly subsided by 07Jan2021 430PM. No treatment was received for the adverse events. Events outcome of fever more than 100.5F, severe headache, body aches/joint pain, chills, and left arm soreness was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on her hands and neck; This is a spontaneous report from a contactable other healthcare professional. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot unknown), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient's medical history included eczema from an unknown date and unknown if ongoing, and allergic to bananas and watermelon. She has been taking Benadryl for symptoms. The patient's concomitant medications were not reported. On 22Dec2020, the patient developed a rash on her hands and neck after receiving her Covid19 vaccine. Patient stated she had a history of eczema, but states this rash presents differently. The patient experienced rash on her hands and neck on 22Dec2020 with outcome of unknown. Therapeutic measures were taken as a result of rash on her hands and neck.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: Chills; 100 temperature; Whole body soreness; Left arm severe pain; Left axilla lymph node swelling; Headache; the first dose administered on 19Dec2020 10:00 and the second dose administered on 05Jan2021; the first dose administered on 19Dec2020 10:00 and the second dose administered on 05Jan2021; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch EJ1685) via intramuscular on 19Dec2020 10:00 on left arm at a single dose and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch EL0142) via intramuscular on 05Jan2021 07:45 on left arm at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. Prior to vaccination, the patient did not diagnose with COVID 19. The patient was not allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive within 2 weeks of vaccination. The patient experienced chills, 100 temperature, Whole body soreness, left arm sever pain, left axilla lymph node swelling and headache on 05Jan2021 19:00. No treatment received for the adverse event. No covid tests post vaccination. The outcome of the events chills, 100 temperature, Whole body soreness, left arm sever pain, left axilla lymph node swelling and headache was recovering.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Chills; 100 temperature; Whole body soreness; Left arm severe pain; Left axilla lymph node swelling; Headache; the first dose administered on 19Dec2020 10:00 and the second dose administered on 05Jan2021; the first dose administered on 19Dec2020 10:00 and the second dose administered on 05Jan2021; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch EJ1685) via intramuscular on 19Dec2020 10:00 on left arm at a single dose and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch EL0142) via intramuscular on 05Jan2021 07:45 on left arm at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. Prior to vaccination, the patient did not diagnose with COVID 19. The patient was not allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive within 2 weeks of vaccination. The patient experienced chills, 100 temperature, Whole body soreness, left arm sever pain, left axilla lymph node swelling and headache on 05Jan2021 19:00. No treatment received for the adverse event. No covid tests post vaccination. The outcome of the events chills, 100 temperature, Whole body soreness, left arm sever pain, left axilla lymph node swelling and headache was recovering.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Night sweats, Pain in extremity
Clinical narrative: Sore arm; fatigue; night sweats; This is a spontaneous report from a contactable Other Health Professional (patient). A 39-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 22Dec2020 07:15 at a single dose for COVID-19 immunization at the hospital. Medical history included anxiety from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medications included ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE), escitalopram oxalate (LEXAPRO), birth control and unspecified MVI. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm, fatigue and night sweats on 22Dec2020 with outcome of recovering. No treatment was given for the events. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on batch/lot number was requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Middle insomnia
Clinical narrative: Severe diffuse abdominal pain awakened from sleep at night; Severe diffuse abdominal pain awakened from sleep at night; This is a spontaneous report from a contactable nurse (patient). A 63-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration in the left arm on 06Jan2021 14:00 at a single dose for COVID-19 immunization at the hospital. Medical history included high blood pressure and allergies to penicillin. Concomitant medication included losartan. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe diffuse abdominal pain awakened from sleep at night on 07Jan2021 01:00 AM. The patient took Tylenol. The events lasted 2 hours from 1am-3am. Outcome of events was recovered on 07Jan2021 03:00 AM. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Muscular weakness, Vaccination site pain
Clinical narrative: Left deltoid area is tender to touch, weak when lifting, painful with lifting objects and movement of arm that involves lifting of the arm.; Left deltoid area is tender to touch, weak when lifting, painful with lifting objects and movement of arm that involves lifting of the arm.; Left deltoid area is tender to touch, weak when lifting, painful with lifting objects and movement of arm that involves lifting of the arm.; This is a spontaneous report from a contactable nurse (patient) reported that a 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on the left arm on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history was reported as none. The patient was not pregnant. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), valacyclovir, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); all were taken from unspecified dates for unspecified indications. On 01Jan2021, it was reported that the patient's left deltoid area is tender to touch, weak when lifting, painful with lifting objects and movement of arm that involves lifting of the arm. The outcome of the events was not recovered. No therapeutic measures were taken as result of the reported events.   No follow-up attempts are possible; information about lot number was already obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: Lymphadenopathy and fatigue; Lymphadenopathy and fatigue; First dose of BNT162B2 administered on 17Dec2020 and second dose on 04Jan2021 (18 days apart); This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 04Jan2021 at 10:00 (second dose) on the right arm, and on 17Dec2020 at 15:00 (first dose) on the left arm; both via unspecified routes of administration at a single dose for immunization. Medical history included hypertension and liver disease. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), ibuprofen, paracetamol (TYLENOL), propanol, and sennoside a+b (SENOKOT). The patient experienced lymphadenopathy and fatigue on 05Jan2021 at 05:00. The patient did not receive treatment for the adverse events. Outcome of the events was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Chills, Headache, Impaired work ability
Clinical narrative: Severe headache; chills; nausea; inability to work for several days; bloating; abdominal pain; This is a spontaneous report from a contactable Physician (patient). A 29-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot: EH9899) via an unspecified route of administration in left arm on 20Dec2020 10:00 at single dose for COVID-19 immunisation. There was no relevant medical history, no known allergies. The patient was not allergic to medications, food, or other products. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, chills, nausea on 30Dec2020, 01:00 AM 10 days after first dose, requiring COVID-19 testing and inability to work for several days, and nausea, bloating, and abdominal pain persistent for 3 days. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The patient received COVID test post vaccination via nasal Swab on 30Dec2020 with result of Negative. Events outcome was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test
Clinical narrative: Severe headache; chills; nausea; inability to work for several days; bloating; abdominal pain; This is a spontaneous report from a contactable Physician (patient). A 29-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot: EH9899) via an unspecified route of administration in left arm on 20Dec2020 10:00 at single dose for COVID-19 immunisation. There was no relevant medical history, no known allergies. The patient was not allergic to medications, food, or other products. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, chills, nausea on 30Dec2020, 01:00 AM 10 days after first dose, requiring COVID-19 testing and inability to work for several days, and nausea, bloating, and abdominal pain persistent for 3 days. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The patient received COVID test post vaccination via nasal Swab on 30Dec2020 with result of Negative. Events outcome was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: the patient's arm has been giving him pain since the vaccine shot; This is a spontaneous report from a contactable consumer. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on 05Jan2021 at 13:15 on the left arm at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's arm has been giving him pain since the vaccine shot on 05Jan2021 at 14:30. The patient did not receive treatment for the adverse event. Outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Pain
Clinical narrative: left arm/shoulder soreness; Left arm/shoulder soreness; headache; light headedness; fatigue; aches; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 56-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 07Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, allergic to certain types of chocolates. Concomitant medication included Levothyroxine and vitamins. The patient was also allergic to Quinine, tramadol, Dilaudid, Msg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced left arm/shoulder soreness, headache, light headedness, fatigue and aches on 07Jan2021 11:45 AM. The patient received Tylenol and bed rest as treatment. Events outcome was not recovered.  Information about lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm/shoulder soreness; Left arm/shoulder soreness; headache; light headedness; fatigue; aches; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 56-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 07Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, allergic to certain types of chocolates. Concomitant medication included Levothyroxine and vitamins. The patient was also allergic to Quinine, tramadol, Dilaudid, Msg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced left arm/shoulder soreness, headache, light headedness, fatigue and aches on 07Jan2021 11:45 AM. The patient received Tylenol and bed rest as treatment. Events outcome was not recovered.  Information about lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Headache, Muscle spasms, Muscle tightness, Swelling face
Clinical narrative: Right eye and cheek is swollen; Right eye and cheek is swollen; right sided headache; right sided neck muscle spasm and tightness.; right sided neck muscle spasm and tightness.; This is a spontaneous report from a contactable Other HCP. This Other HCP (patient) reported that the 33-year-old female patient who received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular on Arm right on 30Dec2020 at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Asthma and Behcets syndrome. No Known allergies to medications, food, or other products. Concomitant medications included the patient received within 2 weeks of vaccination: Albuterol inhaler (Inhalation vapour, solution), Magnesium, ergocalciferol (VIT D), Ashwagandha. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced right eye and cheek is swollen, right sided headache and right sided neck, muscle spasm and tightness from 07Jan2021 07:00AM. No COVID prior vaccination. No COVID tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment was received for the adverse event included OTC ADVIL, PPI, Sudafed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Malaise, Palpitations, Rash
Clinical narrative: feeling unwell; headaches; small rashes on the left shoulder area, just in front of her chest; she experienced a racing heart rate for a short time; This is a spontaneous report from a non-contactable consumer (patient). This 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received the Covid-19 Vaccine last 18Dec2020 and was due to have the 2nd dose on an unspecified date (reported as tomorrow). However, she said she was feeling unwell. She said she was experiencing headaches, and small rashes on the left shoulder area, just in front of her chest. Patient mentioned that the rashes appeared 15 days after she received her 1st dose in Jan2020. She also mentioned that she experienced a racing heart rate for a short time and said it happened within 24 hours after receiving the 1st dose, but not immediately. Patient wanted to know if receiving the 2nd dose of the Covid-19 Vaccine later than 21 days would affect the efficacy of the vaccine. Outcome of the events was unknown.  No follow-up attempts are possible; Information about Lot/Batch could not be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy
Clinical narrative: Swollen lymph nodes in armpit, sore arm at injection site, severe great toe joint pain; Swollen lymph nodes in armpit, sore arm at injection site, severe great toe joint pain; Swollen lymph nodes in armpit, sore arm at injection site, severe great toe joint pain; This is a spontaneous report from a  non-contactable other healthcare professional. A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), second dose on 06Jan2021 at 07:30, and first dose on 16Dec2020 at 10:45; both via unspecified route of administration on the right arm at a single dose for immunization. Medical history included asthma. The patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included diphtheria vaccine toxoid, tetanus vaccine toxoid (TD) on 29Dec2020 at right upper arm. The patient experienced swollen lymph nodes in armpit, sore arm at injection site, and severe great toe joint pain on 06Jan2021 at  21:00. The patient did not receive treatment for the adverse events. Outcome of the events was not recovered.  No follow-up attempts are possible. Information on the batch/lot number cannot be obtained.  No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Hypersensitivity, Nausea, Rhinitis
Clinical narrative: chills; nausea; had mild allergic reaction; shortness of breath; rhinitis; This is a spontaneous report from a contactable pharmacist reported for self. This 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Left arm on 07Jan2021 13:30 PM on left arm at single dose for COVID-19 immunisation. Medical history included asthma, seasonal allergies. hypothyroid, IBS and known allergies: corn, yeast. Concomitant medications included ascorbic acid (VITAMIN C), vitamin d3, magnesium, probiotic. No other vaccine in four weeks. He had mild allergic reaction on 07Jan2021 13:45 PM, after receiving first dose on 07Jan2021 13:45 PM, shortness of breath for about 1 1/2 hours, rhinitis on 07Jan2021 13:45 PM; also had chills/nausea for about 3 hours starting right after receiving vaccine on 07Jan2021 16:30. No Covid prior vaccination. No Covid tested post vaccination. No treatments were received. Outcome of the event shortness of breath recovered on 07Jan2021 15:15. Outcome of other events were recovered on 07Jan2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: lost her sense of taste and smell; lost her sense of taste and smell; This is a spontaneous report from a non-contactable consumer.  A 78-year-old female patient received BNT162B2 (also reported as Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that after receiving the vaccine, the patient lost her sense of taste and smell on an unspecified date. The outcome of the events is unknown.  No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Hypoaesthesia, Pain in extremity, Paraesthesia oral
Clinical narrative: Right side of face is numb; Tingling in lips; Ear feels plugged, like there is water in it or popping on an airplane; Severe arm pain; This is a spontaneous report from a contactable consumer reporting for self. This 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) on 06Jan2021 at 13:20 at single dose in right upper arm for COVID-19 immunisation. Medical history was none. Concomitant medications included ascorbic acid (VITAMIN C) and ibuprofen.  The patient got the flu shot every year for immunisation, and got arm pain with the flu shot. No prior vaccinations within 4 weeks. The patient received Pfizer COVID-19 Vaccine on 06Jan2021, at 13:20. By 15:30-15:45, the right side of her face was numb. Had tingling in her lips. Stated the experience was similar to the feeling of receiving procaine hydrochloride (NOVOCAIN) or similar to the feeling when procaine hydrochloride begins to wear off. Her ear was plugged like she was on an airplane. Sated feels like she has water in her ear or like her ear is popping on an airplane. The whole right side of her face was doing something funny. Her lips began to tingle first, then face went numb, then her ear clogged. She talked to an ER physician who advised her to take a diphenhydramine hydrochloride (BENADRYL). ER physician stated these side effects are being seen. No further details provided.  Clarified did not require ER Visit, just talked to an Emergency Physician and explained symptoms. She took diphenhydramine hydrochloride at home and the numbness and tingling went away after a couple hours. Her ear is still plugged today. Everything was echoing in her head and it was driving her crazy.  Stated she also experienced severe arm pain happened evening of 06Jan2021. Arm pain in only in injection arm.  Outcome of right side of her face was numb and tingling in her lips was recovered, outcome of ear feels plugged was not recovered, outcome of other event was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Mouth ulceration
Clinical narrative: Severe dizziness; Mouth breaking out in ulcers; extreme tiredness; headache; This is a spontaneous report from a contactable healthcare professional reporting for self. This 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Dec2020 04:30 PM at single dose (vaccine location: left arm) for COVID-19 immunisation. The patient previously experienced allergies with penicillin and levofloxacin (LEVOQUIN). Concomitant medications in two weeks included cetirizine hydrochloride (ZYRTEC), colecalciferol (VIATAMIN D) and hormone replacement pellets. Patient did not have other vaccine in four weeks. Patient was not pregnant at the time of vaccination. The patient experienced severe dizziness 36 hours after vaccination, mouth breaking out in ulcers, extreme tiredness and headache on 01Jan2021. No treatment received for events. Patient did not have COVID prior vaccination, and did not have COVID tested post vaccination. The outcome of events was recovering.   Information on the Lot/Batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Swelling
Clinical narrative: Swollen lymph nodes upon palpation to left armpit; visible swelling to left armpit; pain to left armpit; This is a spontaneous report from a contactable nurse (patient).  A 33-year-old female patient received the second dose of BNT162B2 (also reported as Pfizer brand, lot no: EK5730), intramuscular on 06Jan2021 at 06:30 at a single dose on the left arm (as reported, also reported as left deltoid) for COVID-19 immunization.  Medical history included anaphylaxis to "unknown chemical substance" while jogging in Oct2014 that resulted in a 4 hr hospitalization in an emergency department. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 16Dec2020 at 8:00 PM intramuscular on the left arm for COVID-19 immunization. The patient reported swollen lymph nodes upon palpation to left armpit with noted visible swelling to left armpit as well as pain to left armpit on 07Jan2021 at 6:30 AM. The symptoms were present 24 hours post vaccination intramuscular to the left deltoid (as reported). The patient did not receive any treatment for the reported adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Headache, Insomnia
Clinical narrative: a weird rash on her left shoulder area; not feeling quite well; Fever of 99.5/ her fever continued at 99.7 and her symptoms were 10 fold; Left arm soreness; Increased dry cough; Nasal congestion; Chills; Headache; Unable to sleep- tossing and turning; This is a spontaneous report from a contactable nurse reporting for self. This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: Apr2021) on 04Jan2021 around 10:30 AM at 0.3 mL single by injection in the left arm for COVID-19 immunisation. Medical history and concomitant medications were none. Prior to getting the vaccine patient had her temperature taken on unspecified date, which was 97.4. She had the injection in her left arm on 04Jan2021 around 10:30 AM. After she felt perfectly fine that day. She felt nothing. Then around 8 PM her side effects started. That night her left arm got sore, she had increased dry cough (reported as feels like a bronchial spasm that an asthmatic would have), nasal congestion, chills, and a headache. She went to bed unable to sleep- tossing and turning. She woke up around 2 AM or so. The next morning, 05Jan2021, she felt somewhat okay. She went to work. She had a normal temperature that morning at work. Then around 10 AM, her arm was still sore, she was not feeling quite well, she started to feel chills again, and had a fever of 99.5, along with a headache still. They sent her home. The next day, 06Jan2021, her fever continued at 99.7 and her symptoms were 10 fold. Then her fever broke around 10 AM.  On 05Jan2021, she took a shower from all the sweating with her fever, and she did not notice any rash. She took another shower this morning (07Jan2021) and she noticed a weird rash on her left shoulder area. It does not itch, it is just there. She took a picture of it so she could monitor it. It is blotchy.  For left arm soreness, she can now move it without feeling it, but then you touch it, it is sore and tender. The event fever broke yesterday around 10 AM. This morning (07Jan2021) her temperature was 98.6. Chills would come and go with the fever off and on. Treatment for all events included over the counter medications. Lab data included COVID test was negative on 28Dec2020 and 04Jan2021. Outcome of left arm soreness, increased dry cough, nasal congestion was recovering, outcome of chills, headache, unable to sleep- tossing and turning was recovered on 06Jan2021, fever was recovered on 06Jan2021 10 AM, outcome of rash was not recovered,  outcome of other event was unknown.  Relatedness of product to all events was reported as related, the reporter considered all events as non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasal congestion, Pain in extremity, Pyrexia, Rash
Clinical narrative: a weird rash on her left shoulder area; not feeling quite well; Fever of 99.5/ her fever continued at 99.7 and her symptoms were 10 fold; Left arm soreness; Increased dry cough; Nasal congestion; Chills; Headache; Unable to sleep- tossing and turning; This is a spontaneous report from a contactable nurse reporting for self. This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: Apr2021) on 04Jan2021 around 10:30 AM at 0.3 mL single by injection in the left arm for COVID-19 immunisation. Medical history and concomitant medications were none. Prior to getting the vaccine patient had her temperature taken on unspecified date, which was 97.4. She had the injection in her left arm on 04Jan2021 around 10:30 AM. After she felt perfectly fine that day. She felt nothing. Then around 8 PM her side effects started. That night her left arm got sore, she had increased dry cough (reported as feels like a bronchial spasm that an asthmatic would have), nasal congestion, chills, and a headache. She went to bed unable to sleep- tossing and turning. She woke up around 2 AM or so. The next morning, 05Jan2021, she felt somewhat okay. She went to work. She had a normal temperature that morning at work. Then around 10 AM, her arm was still sore, she was not feeling quite well, she started to feel chills again, and had a fever of 99.5, along with a headache still. They sent her home. The next day, 06Jan2021, her fever continued at 99.7 and her symptoms were 10 fold. Then her fever broke around 10 AM.  On 05Jan2021, she took a shower from all the sweating with her fever, and she did not notice any rash. She took another shower this morning (07Jan2021) and she noticed a weird rash on her left shoulder area. It does not itch, it is just there. She took a picture of it so she could monitor it. It is blotchy.  For left arm soreness, she can now move it without feeling it, but then you touch it, it is sore and tender. The event fever broke yesterday around 10 AM. This morning (07Jan2021) her temperature was 98.6. Chills would come and go with the fever off and on. Treatment for all events included over the counter medications. Lab data included COVID test was negative on 28Dec2020 and 04Jan2021. Outcome of left arm soreness, increased dry cough, nasal congestion was recovering, outcome of chills, headache, unable to sleep- tossing and turning was recovered on 06Jan2021, fever was recovered on 06Jan2021 10 AM, outcome of rash was not recovered,  outcome of other event was unknown.  Relatedness of product to all events was reported as related, the reporter considered all events as non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: a weird rash on her left shoulder area; not feeling quite well; Fever of 99.5/ her fever continued at 99.7 and her symptoms were 10 fold; Left arm soreness; Increased dry cough; Nasal congestion; Chills; Headache; Unable to sleep- tossing and turning; This is a spontaneous report from a contactable nurse reporting for self. This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: Apr2021) on 04Jan2021 around 10:30 AM at 0.3 mL single by injection in the left arm for COVID-19 immunisation. Medical history and concomitant medications were none. Prior to getting the vaccine patient had her temperature taken on unspecified date, which was 97.4. She had the injection in her left arm on 04Jan2021 around 10:30 AM. After she felt perfectly fine that day. She felt nothing. Then around 8 PM her side effects started. That night her left arm got sore, she had increased dry cough (reported as feels like a bronchial spasm that an asthmatic would have), nasal congestion, chills, and a headache. She went to bed unable to sleep- tossing and turning. She woke up around 2 AM or so. The next morning, 05Jan2021, she felt somewhat okay. She went to work. She had a normal temperature that morning at work. Then around 10 AM, her arm was still sore, she was not feeling quite well, she started to feel chills again, and had a fever of 99.5, along with a headache still. They sent her home. The next day, 06Jan2021, her fever continued at 99.7 and her symptoms were 10 fold. Then her fever broke around 10 AM.  On 05Jan2021, she took a shower from all the sweating with her fever, and she did not notice any rash. She took another shower this morning (07Jan2021) and she noticed a weird rash on her left shoulder area. It does not itch, it is just there. She took a picture of it so she could monitor it. It is blotchy.  For left arm soreness, she can now move it without feeling it, but then you touch it, it is sore and tender. The event fever broke yesterday around 10 AM. This morning (07Jan2021) her temperature was 98.6. Chills would come and go with the fever off and on. Treatment for all events included over the counter medications. Lab data included COVID test was negative on 28Dec2020 and 04Jan2021. Outcome of left arm soreness, increased dry cough, nasal congestion was recovering, outcome of chills, headache, unable to sleep- tossing and turning was recovered on 06Jan2021, fever was recovered on 06Jan2021 10 AM, outcome of rash was not recovered,  outcome of other event was unknown.  Relatedness of product to all events was reported as related, the reporter considered all events as non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: A stream of blood was dripping down arm at the moment of the needle being removed from my arm.; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 55-year-old (report "age at vaccination: 55 years" and "current age: 55") female patient (pregnant: no) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified rout of administration at left arm on 07Jan2021 02:00 PM at single dose for COVID-19 immunization. Medical history included Heart murmur, known allergies to sulfites, latex and ingredients in common suntan lotion. Patient received within 2 weeks of vaccination included ibuprofin, OTC sleeping pills, multivitamin, C. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took monosodium glutamate (MSG) and doxycycline and had allergy to them. It was reported stream of blood was dripping down arm at the moment of the needle being removed from her arm on 07Jan2021 on 02:00 PM. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was non serious case. Not results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating nor congenital anomaly/birth defect. No treatment received for the event. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Decreased appetite, Disturbance in attention, Eye irritation, Feeling cold
Clinical narrative: body is cold; Occasionally some nauseous sensation but didn't throw up; Eyes feel so tired; hard to concentrate; it bother my sleep; first dose on 19Dec2020, second dose on 06Jan2021; heaviness in the head when I woke up next day; some hot/spicy sensation around eyes area; didn't even have good appetite during lunch time on day 2; sever headache started at night of day one; This is a spontaneous report from a contactable Other HCP (patient).  A 33-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number EK9231), on 06Jan2021 14:30 via an unspecified route of administration in the left arm at single dose COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730) on 19Dec2020 09:45 in the left arm at single dose for COVID-19 immunisation. On 06Jan2021 at 23:00, started at night of day one, the patient experienced severe headache. The patient experienced also heaviness in the head when she woke up next day (07Jan2021) and had some hot/spicy sensation around eyes area (07Jan2021). The patient needed to take paracetamol (TYLENOL) to get some relieve and she did not even have good appetite during lunch time on day 2 (07Jan2021). On unspecified date the patient had no fever and her body was cold; occasionally some nauseous sensation but didn't throw up. Eyes feel so tired and hard to concentrate. Hopefully those symptoms go away soon as days pass since it bothered patient sleep. The patient had a doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. The patient took also guaifenesin (MUCINEX). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Inappropriate schedule of product administration, Nausea, Sleep disorder
Clinical narrative: body is cold; Occasionally some nauseous sensation but didn't throw up; Eyes feel so tired; hard to concentrate; it bother my sleep; first dose on 19Dec2020, second dose on 06Jan2021; heaviness in the head when I woke up next day; some hot/spicy sensation around eyes area; didn't even have good appetite during lunch time on day 2; sever headache started at night of day one; This is a spontaneous report from a contactable Other HCP (patient).  A 33-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number EK9231), on 06Jan2021 14:30 via an unspecified route of administration in the left arm at single dose COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730) on 19Dec2020 09:45 in the left arm at single dose for COVID-19 immunisation. On 06Jan2021 at 23:00, started at night of day one, the patient experienced severe headache. The patient experienced also heaviness in the head when she woke up next day (07Jan2021) and had some hot/spicy sensation around eyes area (07Jan2021). The patient needed to take paracetamol (TYLENOL) to get some relieve and she did not even have good appetite during lunch time on day 2 (07Jan2021). On unspecified date the patient had no fever and her body was cold; occasionally some nauseous sensation but didn't throw up. Eyes feel so tired and hard to concentrate. Hopefully those symptoms go away soon as days pass since it bothered patient sleep. The patient had a doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. The patient took also guaifenesin (MUCINEX). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza, Malaise, Pain, Pyrexia
Clinical narrative: she felt really bad; fever; chills; body aches; flu; This is a spontaneous report from a non-contactable nurse (patient). A 35-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date of Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient said she already received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, and was scheduled to receive the 2nd dose today (unspecified date). However, due to her flu, she said she was unable to receive it. She wanted to know if she can receive the 2nd dose of the vaccine later than the 21-day timeframe. She also mentioned that her flu was unrelated to the vaccine. However, she also mentioned that after receiving the 1st dose of the vaccine, she felt "really bad," had fever, chills and body aches on an unspecified date. The outcome of events  was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event flu with BNT162b2 can not be fully excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: fever off and on/ temperature was 100.4; Chills; severe body aches; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 16Dec2020 at 0.3 mL, single; then the second dose on the left arm (reported as 'left shoulder') to 05Jan2021 at 0.3 mL, single for COVID-19 immunization. Medical history included Raynaud's disease probably diagnosed like 7 years ago, but she was not taking anything for it. There were no concomitant medications. The patient reported that she was a dietician. She works in the ICU at the hospital, but was not a healthcare professional. She just got the second dose on Tuesday (05Jan2021), and had severe body aches, fever on and off, and chills with the body aches. Severe body aches started Tuesday evening, but were not really bad, she was just achy, then around midnight on Tuesday, they became severe and she had a fever. They resolved kind of this morning, right now she is a little achy, not like before, where her full body was hurting, it hurt to lay down or do anything, she had to lay in bed for 24 hours. Fever started at midnight, so she guess on 06Jan2020, now she doesn't feel feverish, but she didn't check, she thinks it broke again last night, she was taking Advil. She took acetaminophen (TYLENOL) the first night, at midnight, when she got the fever, she took acetaminophen, and tried to go back to sleep, and woke up at 6AM, with severe body aches still, and her temperature was 100.4 so she took ibuprofen (ADVIL). Acetaminophen for some reason bothers her stomach, so she took ibuprofen. She felt like the acetaminophen didn't do anything. She came to work today. After that, she was taking ibuprofen yesterday through the day. The chills were along with the fever and body aches and are not ongoing right now. She had symptoms after the first round of the Pfizer COVID vaccine too, but they were not as bad. The outcome of the event severe body aches was recovering, of chills was recovered on an unspecified date, and of fever was unknown.