chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Skin exfoliation
Clinical narrative: Tiredness; Headache; bone and marrow pain; Nausea; Mild flu-like aches; Extremely dry skin; Flakey skin; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non- pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6200), via an unspecified route of administration in right arm on 08Mar2021 at 09:15 (at the age of 70-year-old), as a single dose for COVID-19 immunisation. Medical history included mild COPD, asthma and diet-exercise controlled diabetes. The patient was allergic to sulfa, cephalexin, neomycin, nickel, banana, soy & soy lecithin. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications received within two weeks of vaccination included umeclidinium bromide (INCRUSE), azilsartan kamedoxomil (EDARBI), vitamin D3 (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), ubiquinol (MANUFACTURER UNKNOWN) and ELLIPTA. All concomitant medications were taken from unspecified dates for unknown indication. On 09Mar2021 at 10:00, the patient experienced bone and marrow pain. On 10Mar2021, the patient experienced headache and tiredness. After a few days on an unknown date in Mar2021, the patient experienced nausea and mild flu-like aches. These last lasted on and off for a few days. She thought in that week her skin was extremely dry and flakey. It was reported that the patient had taken acetaminophen as a treatment measure for the reported event and took rest. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of bone and marrow pain, headache, tiredness, nausea, mild flu-like aches, dry and flakey skin was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy
Clinical narrative: lethargy; Ongoing headache; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 10Mar2021 at 00:00 as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food, or any other products. The patient received atorvastatin (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), atenolol (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) within 2 weeks of vaccination. The patient had not received any other vaccine within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. On 19Mar2021, the patient experienced headache and lethargy. The events had not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of headache and lethargy. The clinical outcome of the events headache and lethargy was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: Tinnitus; Lightheaded; This is a spontaneous report received from a contactable consumer, the patient. A 51-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in left arm on 22Mar2021, 12:30 PM, (at the age of 51-years-old) as a single dose, for COVID-19 immunisation. Medical history of the patient included hypothyroidism and obesity. The patient was allergic to medicine - too many to list. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included liothyronine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and azelastine hydrochloride (MANUFACTURER UNKNOWN) since from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 13:00, the patient experienced tinnitus (much louder than normal all of the time since the night of the vaccine) and at 12:40 (about 10 minutes after the shot), lightheaded (a few times that evening and the following day). Events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of events tinnitus and lightheaded was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test
Clinical narrative: Extreme muscle pain in both legs and arms; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via unspecified route of administration in the left arm on 16Mar2021 at 11:00 as a single dose (at the age of 72-years-old) for COVID-19 immunisation. The patient was not allergic to medications, food or other products. The medical history of the patient included type 1 diabetes. Concomitant medication was reported as insulin (MANUFACTURER UNKNOWN) for unknown indication. The patient received this medication within 2 weeks of vaccination and the exact therapy dates were not provided. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 00:00, the patient experienced extreme muscle pain in both legs and arms. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent nasal swab test on 28Feb2021 and the result was negative. The clinical outcome of muscle pain in both legs and arms was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Sleep disorder, Tenderness
Clinical narrative: Pain in chest above left breast; Tenderness in the area above and toward center; Couldnt sleep on side or stomach. Had to sleep on back so chest was more open; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration in the right arm on 23Mar2021 at 12:00 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medication included losartan (MANUFACTURER UNKNOWN) and fexofenadine (ALLEGRA); both for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 22:30, the patient experienced pain in her chest above left breast, tenderness in the area above and toward centre, couldn't sleep on side or stomach and had to sleep on back so chest was more open. It was not tightness and not hard to breathe. The events still present at the time of reporting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome for the events pain in chest above left breast, tenderness and sleep disturbance were not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: low grade fever; Sore throat; slight congestion; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old patient of unspecified gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: en6205), via an unspecified route of administration in the right arm on 16Mar2021 at 15:45 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to sulfa antibiotics (MANUFACTURER UNKNOWN), chlorthalidone (MANUFACTURER UNKNOWN), amoxicillin-pot clavulanate (MANUFACTURER UNKNOWN) and nitrofurantoin (MANUFACTURER UNKNOWN). Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) 10 mg, omeprazole (MANUFACTURER UNKNOWN) 40 mg and loratadine (MANUFACTURER UNKNOWN) 10 mg; all for unknown indication from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccination. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021, 2 days after the injection, the patient began to get a sore throat and slight congestion. The sore throat lasted for 5 days and worsened overnight into the mornings. The patient had a low-grade fever 100 (unit unspecified) 3 days after the sore throat which started 5 days after injection on 21Mar2021. It was reported that the symptoms were gone by day 8. On 21Mar2021, the patient had a body temperature of 100 (units unspecified). The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of sore throat, nose congestion and fever were resolved on 24Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Heart rate, Pain
Clinical narrative: 103 F fever; racing heartbeat with rates between 120-150 bpm; Rigors; headache; body aches; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 22Mar2021 at 10:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 01Mar2021 at 10:30, as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced 103 F fever 8 hours post-dose and it continued for 24 hours, racing heartbeat with rates between 120-150 bpm (palpitation), headache, body aches and rigors on 22Mar2021 at 19:30. The patient did not received treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fever and rigors was resolved on 23Mar2021 while that of palpitation, headache, body ache was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: 103 F fever; racing heartbeat with rates between 120-150 bpm; Rigors; headache; body aches; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 22Mar2021 at 10:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 01Mar2021 at 10:30, as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced 103 F fever 8 hours post-dose and it continued for 24 hours, racing heartbeat with rates between 120-150 bpm (palpitation), headache, body aches and rigors on 22Mar2021 at 19:30. The patient did not received treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fever and rigors was resolved on 23Mar2021 while that of palpitation, headache, body ache was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Hyperhidrosis, Nausea, Restlessness
Clinical narrative: Sweating; Headache; Nausea; Restlessness; Hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration on 22Mar2021 at 09:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patients medical history was not reported. The patient was allergic with penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and biotin (MANUFACTURER UNKNOWN). On 23Mar2021 at 06:00, the patient experienced sweating, headache, nausea, restlessness and hot flashes. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events sweating, headache, nausea, restlessness and hot flashes was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Fatigue; Vaccination site pain; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247) via an unspecified route of administration in left arm on 22Mar2021 at 15:00 hours (at the age of 29-Year-old) as a single dose for COVID-19 immunisation. The patient did not have medical history. The patient had allergy to goat cheese. Concomitant medication included citalopram (MANUFACTURER UNKNOWN) since an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced fatigue and vaccination site pain on 23Mar2021 at 17:00 hours. The therapeutic measures taken as a result of fatigue and vaccination site pain was none. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fatigue and pain at the injection was resolved on an unknown date. No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: Headache; Fever; Chills; Shakes; Body aches; Muscle aches; Fatigue; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. An 80-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ED7534) via an unknown route of administration in the left arm on 19Mar2021 at 17:15 (at the age of 80-years old) as single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), emphysema, angina, diabetes, hypertension and COVID-19 prior to vaccination. The patient had no allergies to medications, food, or other products. Concomitant medications included potassium (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 09:00, the patient experienced headache, fever, chills, shakes, body aches, muscle arches, fatigue and shortness of breath. Any therapeutic measures were not taken as a result of events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events body aches, chills, fatigue, fever, headache, muscle aches, shakes and shortness of breath was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Headache; Fever; Chills; Shakes; Body aches; Muscle aches; Fatigue; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. An 80-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ED7534) via an unknown route of administration in the left arm on 19Mar2021 at 17:15 (at the age of 80-years old) as single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), emphysema, angina, diabetes, hypertension and COVID-19 prior to vaccination. The patient had no allergies to medications, food, or other products. Concomitant medications included potassium (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 09:00, the patient experienced headache, fever, chills, shakes, body aches, muscle arches, fatigue and shortness of breath. Any therapeutic measures were not taken as a result of events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events body aches, chills, fatigue, fever, headache, muscle aches, shakes and shortness of breath was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Incorrect dose administered, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in left arm on 23Mar2021 at 09:00 (at the age of 29-years-old) as single dose for COVID-19 immunisation. The patients medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medication within 2 weeks of vaccination. On 23Mar2021 at 09:00, as the nurse was administering the vaccine, the needle separated from the syringe and the contents of the vaccine sprayed onto the patients arm and the nurse face shield. It could not be determined how much of the dose the patient received. The patient also experienced that the site of the injection was tender. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The therapeutic measures and treatment were not taken as a result of the events. The clinical outcome of incorrect dose administered, accidental exposure while administering the drug and vaccination site pain was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Headache, Pain in extremity
Clinical narrative: sleepy; Back and knee are a little sore; feeling weak; a little headache; Back and knee are a little sore; Arm a little sore from the shot; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old male patient received an unknown dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 08:15 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medication, food or other products. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient experienced little soreness in the arm from the shot, felt weak and sleepy. The patient also had little headache, little sore in back and knee. The clinical outcome of the events pain in arm, weakness, sleepy, headache, sore back and pain knee were unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: sleepy; Back and knee are a little sore; feeling weak; a little headache; Back and knee are a little sore; Arm a little sore from the shot; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old male patient received an unknown dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 08:15 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medication, food or other products. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient experienced little soreness in the arm from the shot, felt weak and sleepy. The patient also had little headache, little sore in back and knee. The clinical outcome of the events pain in arm, weakness, sleepy, headache, sore back and pain knee were unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Malaise, Nausea
Clinical narrative: nauseous; Diarrhoea.; Tired; Feel sick; This is a spontaneous report received from a contactable consumer, the patient. A 50-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in right arm on 20Mar2021 at 09:30 hours (at the age of 50-years-old) as single dose, for COVID-19 immunisation. Medical history included breast cancer stage IV. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 20Mar2021 at 10:30 hours, the patient experienced nauseous, diarrhoea, tiredness and feeling sick. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for events. The clinical outcome of events nauseous, diarrhoea, tiredness and feeling sick were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, SARS-CoV-2 test
Clinical narrative: flat bullseye non-painful bruise onfront of left hip.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number=EJ1685) via unspecified route of administration on 12Dec2020 at 12:30 as a single dose for COVID-19 immunisation. The patient had also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number=EK9231) via unspecified route of administration on 22Jan2021 at 13:15 as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), nebivolol hydrochloride (BYSTOLIC), fluticasone (MANUFACTURER UNKNOWN), niacin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) for an unspecified indication from an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. After vaccination, on an unspecified date, the patient experienced flat bull's eye, non-painful bruise on front of left hip. No signs or knowledge of any bug bites and exposure to ticks. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for flat bull's eye, non-painful bruise on front of left hip. The patient underwent lab tests and procedures for COVID-19 virus test (saliva in a tube) on 15Mar2021, and the result was negative. The clinical outcome of flat bull's eye non-painful bruise on front of left hip was not recovered at the time of report.   No follow-up attempts are possible; No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Headache; Chills; Low grade fever 100; Lack of energy; This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 20Mar2021 at 10:00 (at the age of 51-years-old), as single dose for COVID-19 immunisation. The patients medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not have any allergies to food, medications, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. On 21Mar2021 10:00 (next day), the patient experienced headache, chills, low grade fever 100 (unspecified units) and lack of energy. The patient did not receive any treatment for the events. The clinical outcome of the headache, chills, low grade fever (100), and lack of energy were recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus, Rash papular, Skin burning sensation
Clinical narrative: Itchiness; Burning on the top of my hands; Small red bumps; Blisters; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non pregnant female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no:EJ1685) via an unspecified route on the left arm, on 03Mar2021 at 16:15 hours (at the age of 55 years) for COVID-19 immunisation. The patients medical history included asthma, sun sensitivity, eczema, seasonal allergy and lactose intolerance and mild flu and stomach issues in Feb2020, mild respiratory symptoms, chills in Aug2020. The Concomitant medication were not reported. Prior to vaccination, it was unsure if the patient had COVID-19 and since the vaccination the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 20Mar2021 at 12:00 hours, the patient experienced itching in the forearms, burning on top of the hands, small red bumps, blisters on fingers split near knuckles. The patient was also treating the dog for some unspecified eye disorder with OPTIMMUNE and neomycin, polymyxin b sulphate and dexamethasone ophthalmic suspension (MANUFACTURER UNKNOWN). The patient used to apply the Neosporin to the affected areas and used gloves while treating the dogs and also took asthma medications for respiratory symptoms. The clinical outcome for the events forearms, burning on top of the hands, small red bumps, blisters, chills and respiratory symptoms were recovering at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased, Palpitations
Clinical narrative: Rapid heartbeat; Unusual heart palpitations; Elevated blood pressure; This is a spontaneous report received from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via unspecified route of administration in the left arm on 22Mar2021 at 09:15 (at the age of 67-year-old) as single dose for COVID-19 immunisation. Medical history included blood pressure high (HBP). Concomitant medications included calcium (MANUFACTURER UNKNOWN), Colecalciferol (VITAMIN D3), enalapril (MANUFACTURER UNKNOWN), hydrochlorotiazid (HCTZ), enalapril maleate (MANUFACTURER UNKNOWN), all from an unknown date for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via unspecified route of administration in the left arm on 01Mar2021 at 09:30 (at the age of 67-year-old) as single dose for COVID-19 immunisation.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced rapid heartbeat, unusual heart palpitations (less than 4 hours), and elevated blood pressure on 22Mar2021 at 22:00. The patients resting heart rate 102 and elevated blood pressure of 157/86 (units unspecified). Further it was reported that the symptoms started at 2200 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of rapid heartbeat, unusual heart palpitations, and elevated blood pressure was recovered on unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling face
Clinical narrative: Swollen face with rash on face, necknd arms plus itching; Swollen face with rash on face, necknd arms plus itching; Swollen face with rash on face, necknd arms plus itching; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old elderly non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration in the left arm on 23Mar2021 at 09:15 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine (SYNTHROID) from an unknown date and for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EN6200), via an unspecified route of administration in the left arm on 02Mar2021 at 09:15 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. The patient had known allergies to morphine, codeine, penicillin and shellfish. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 23Mar2021 at 11:00, the patient experienced swollen face with rash on face, neck, arms plus itching. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken as a result of the reported events. The clinical outcome of swollen face, rash and itching was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Musculoskeletal stiffness, Oropharyngeal pain
Clinical narrative: Stiff neck, couldn't move around day 2&3; Sore throat; having trouble swallowing without pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number. ER8727), via an unspecified route of administration in the left arm on 22Mar2021 at 09:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021 at 09:00, the patient had stiff neck, couldn't move around day 2 and 3. The patient had sore throat and was having trouble swallowing without pain. The patient also experienced fatigue. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events stiff neck, couldn't move around day 2 and 3, sore throat, having trouble swallowing without pain and fatigue. The clinical outcomes of the events stiff neck, couldn't move around day 2 and 3, sore throat, having trouble swallowing without pain and fatigue were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy, Neck pain
Clinical narrative: Neck aching; Lethargic; Head aching; Tired; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the right arm on 23Mar2021 at 10:00 (at the age of 53-years-old) as a single dose for COVID 19 immunisation. Medical history reported as none. The patient did not have any allergies to food, medications, or other products. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the right arm on 01Mar2021 at 10:00 (at the age of 53-years-old) as a single dose for COVID 19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021, the patient experienced neck and head aching, patient was tired and lethargic. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the event neck pain, headache, tiredness and lethargic was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nerve compression, Pain
Clinical narrative: pinched nerve feeling in upper back, neck on and off; muscle spasms; dull ache; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ep7534), via an unspecified route of administration in the right arm on 16Mar2021 at 11:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included fluoxetine hydrochloride 10 mg (PROZAC) for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Mar2021, the patient had a dull ache, muscle spasms and pinched nerve feeling in her upper back, neck on and off that started a few days after, and had not gone away completely. The patient did not receive any treatment for the events dull ache, muscle spasms and pinched nerve feeling in upper back, neck on and off. The clinical outcomes of the events dull ache, muscle spasms and pinched nerve feeling in upper back, neck on and off were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives across  face , back and legs. Hives lasted  days.; This is a spontaneous report from a contactable other health care professional. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: en6199), via an intramuscular route in the left arm on 12Mar2021 at 13:00 (at the age of 49-years-old), as a single dose for COVID-19 Immunisation. Medical history included hypertension, reflux and allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021, about 30 mins after the vaccination, the patient had hives across her face, back and legs. It was reported that hives lasted for many days. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of hives across face, back and legs were recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Wheezing
Clinical narrative: Productive cough; Wheezing; This is a spontaneous report from a contactable physician, the patient. A 71-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 20Mar2021 at 13:00 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, hyperlipidaemia, adult-onset asthma, aortic valve replacement, cataracts and penicillin allergy. The patient received unspecified medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the left arm on 27Feb2021 at 15:00 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 23:00, ten hours after second shot, the patient developed asthma symptoms including a very productive cough and wheezing, which lasted for four days. On second day, the patient was treated for the events with prednisone 40mg/d. Although, the patient had adult-onset asthma but had not received any episode like this in ten years. The symptoms were 90% improved (as reported). The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of very productive cough and wheezing was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Sore throat; Low grade fever; Runny nose; Cough; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 (at the age of 69-years-old) at 10:00 as a single dose for COVID-19 immunisation. The patients medical history was not reported. The patient known allergies including sulfa drugs. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), esomeprazole (MANUFACTURER UNKNOWN) for unknown indication since an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 17Mar2021 at 07:00, within 24 hours after the injection, patient experienced sore throat. Within the next couple of days in Mar2021, low-grade fever and developed a runny nose, cough. It has been over a week still patient experienced sore throat, cough and low-grade fever. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events sore throat, runny nose, cough and low-grade fever was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: slightly headache; Minor fatigue; This is a spontaneous report from a contactable consumer, the patient. A 62-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in left arm on 18Mar2021 (at the age of 62-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and depression. The patient was allergic to drug DEMEROL. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration left arm on 25Feb2021 at 12:15 (at the age of 62-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included desvenlafaxine succinate monohydrate (PRISTIQ), losartan (MANUFACTURER UNKNOWN), Liothyronine (NP THYROID), vitamin D (MANUFACTURER UNKNOWN), strontium (MANUFACTURER UNKNOWN) all started from an unknown date and for unknown indications. On 19Mar2021 at 05:30, the patient experienced slight headache for 36 hours and minor fatigue for 12 hours, both started about 12-14 hours after second dose. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of headache and fatigue was resolved with sequelae on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: severe headache; fever; chills; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: unknown), via an unspecified route of administration on 23Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. It was unknown if patient was tested for COVID-19 since the vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On an unspecified date in Mar2021, the patient had experienced severe headache, fever and chills. It was unknown if the patient received any treatment for the reported events. The clinical outcome of the events headache, fever and chills was resolving at the time of this report. No follow up attempts are possible; Information about lot/batch number cannot be obtained.