chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Rash papular, Rash pruritic
Clinical narrative: very itchy and hot shoulder around injection site 48 hrs after injection; very itchy and hot shoulder around injection site 48 hrs after injection; Rash (small red bumps, itchy) on left hand 36 hrs after injection; Rash (small red bumps, itchy) on left hand 36 hrs after injection; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 23Apr2021 at 17:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0150) via an unspecified route of administration in the left arm on 02Apr2021 at 16:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 25Apr2021 at 05:45, 36 hours after injection, the patient experienced rash (small red bumps, itchy) on left hand. On 25Apr2021 at 17:45, 48 hours after injection, the patient experienced very itchy and hot shoulder around injection site. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash (small red bumps, itchy) on left hand and very itchy and hot shoulder around injection site was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Redness; Extreme itching; Rash; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on an unspecified date (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced redness, extreme itching and rash. The events resulted in a visit to the doctors or other healthcare professional office/clinic. Therapeutic measures were taken as a result of the events. The clinical outcome of the events redness, extreme itching and rash was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Arm hurts; Headache; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 21Apr2021, the patient experienced arm hurts, headache and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm hurts, headache and fever was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Facial tingling- was on the bottom half of face, mostly around mouth; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 30Mar2021 at 12:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of COVID-19 vaccine. On 30Mar2021 at 12:45, the patient experienced facial tingling on the bottom half of face, mostly around mouth, which came and went for a few days and very sporadically after that. The patient had no swelling or any other concerns. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event facial tingling around mouth was resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sores; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 11:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to penicillin and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications . On 19Apr2021 at 23:00, the patient experienced cold sores. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event cold sores and included treatment with unspecified medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event cold sores was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Lymph nodes inflation, under the right armpit.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Apr2021, the patient experienced lymph nodes inflation, under the right armpit. It was reported that it could be felt and seen from the outside. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lymph nodes inflation, under the right armpit was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: 40 hour Fever; Swollen lymph nodes in armpits; 24 hours body aches; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW 0172) via an unspecified route of administration in the left arm on 18Apr2021 at 12:15 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease, known allergies to soy and tuna. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT) and birth control pills (MANUFACTURER UNKNOWN), both for an unknown indication from an unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8734) via an unspecified route of administration in the left arm on 28Mar2021 at 12:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 00:00, the patient experienced 40 hours fever, swollen lymph nodes in armpits, 24 hours body aches and chills. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, axillary lymph nodes enlarged, body aches and chills were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Extremely fatigued; Reduction in energy level; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 14Apr2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes and asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:ER8727) via an unspecified route of administration in the right arm on 23Mar2021 at 14:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 09:00, the patient had been extremely fatigued and had a noticeable reduction in energy level since the day after receiving second dose. She was unsure if it is related or merely coincidental but felt that she should report it just in case. No therapeutic measures were taken as a result of the events. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely fatigued and had a noticeable reduction in energy level was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Lymphadenopathy, Myalgia, Pain
Clinical narrative: Fever; Cervical lymph nodes swelling; Body pain; A lot of tiredness; Muscle aches; This is a spontaneous report from a contactable nurse. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via intramuscular route of administration in the left arm on 14Apr2021 at 16:15 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 19Mar2021 at 16:30 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 17:15, next day after vaccination, the patient experienced a lot of tiredness and muscle aches. On 20Apr2021, 6 days after vaccination, the patient experienced 101.2 fever, cervical lymph nodes swelling and body pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen (MOTRIN) and paracetamol (TYLENOL). On 15Apr2021, the patient underwent body temperature test and the result was 101.2 (unspecified unit). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a lot of tiredness, muscle aches, 101.2 fever, cervical lymph nodes swelling and body pain was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Cervical lymph nodes swelling; Body pain; A lot of tiredness; Muscle aches; This is a spontaneous report from a contactable nurse. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via intramuscular route of administration in the left arm on 14Apr2021 at 16:15 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 19Mar2021 at 16:30 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 17:15, next day after vaccination, the patient experienced a lot of tiredness and muscle aches. On 20Apr2021, 6 days after vaccination, the patient experienced 101.2 fever, cervical lymph nodes swelling and body pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen (MOTRIN) and paracetamol (TYLENOL). On 15Apr2021, the patient underwent body temperature test and the result was 101.2 (unspecified unit). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a lot of tiredness, muscle aches, 101.2 fever, cervical lymph nodes swelling and body pain was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, SARS-CoV-2 test
Clinical narrative: Shortness of breath/ out of breath walking around the house; Chest tightness /Feel a constant pressure on chest.; Shortness of breath and chest tightness with fatigue.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:  EW0161) via an unspecified route of administration in the left arm on 17Apr2021 at 12:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. The patient had no known 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 four weeks prior to the COVID-19 vaccine. Concomitant medications included vedolizumab (ENTYVIO) for an unknown indication from an unknown start date and unknown if ongoing. On 17Apr2021 at 12:30, immediately after receiving the vaccine, the patient had shortness of breath and chest tightness with fatigue. To date on 23Apr2021, the symptoms had not subsided. As on 23Apr2021, the patient had tested negative for COVID-19. The patient's vitals were fine. However, the patient was out of breath walking around the house and felt a constant pressure on the chest. The patient was physically active and normally worked out approximately 5 days a week. Being short of breath, with chest tightness was not something the patient was accustomed to. The patient had been assessed by a medical professional and did not have any other symptoms or fluid in my lungs. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 23Apr2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. The clinical outcome of the events shortness of breath, chest tightness with fatigue, out of breath walking around the house and felt a constant pressure on the chest was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ears are ringing since the day after the injection; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 25Mar2021 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included obese (obesity) and latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunization. On 26Mar2021 at 20:00, since the day after the injection the patient felt ears were ringing. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ears is ringing since the day after the injection was not recovered 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: Erythema, Periorbital swelling, Pruritus
Clinical narrative: Severe swelling around the eye area; Redness around the eye area; Itching around the eye area; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 09Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced severe swelling, redness, and itching around the eye area. The events resulted in emergency room/department visits or urgent care. The events resulted in doctor or other healthcare professional office/clinic visits. Therapeutic measures were taken as a result of the events included treatment with unspecified steroid. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe swelling, redness, and itching around the eye area were resolved on an unknown date in Apr2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Feeling abnormal, Pain
Clinical narrative: Severe body aches; Shortness of breath; Chest pains; Brain fog; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 17Apr2021 at 13:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included unspecified birth control medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took sulfur (MANUFACTURER UNKNOWN) and experienced drug allergy. On 22Apr2021 at 23:00, the patient experienced severe body aches, shortness of breath, chest pains, brain fog and fatigue. On 23Apr2021, the patient underwent SARS-CoV-2 test (blood test) and the result was negative. The event resulted in emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events severe body aches, shortness of breath, chest pains, brain fog and fatigue was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Severe body aches; Shortness of breath; Chest pains; Brain fog; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 17Apr2021 at 13:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included unspecified birth control medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took sulfur (MANUFACTURER UNKNOWN) and experienced drug allergy. On 22Apr2021 at 23:00, the patient experienced severe body aches, shortness of breath, chest pains, brain fog and fatigue. On 23Apr2021, the patient underwent SARS-CoV-2 test (blood test) and the result was negative. The event resulted in emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events severe body aches, shortness of breath, chest pains, brain fog and fatigue was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fever (101.5); Chills; Aches; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 25Apr2021 at 08:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa and nickel. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 04Apr2021 at 08:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 25Apr2021 at 22:30, the patient experienced sore arm, fever (101.5), chills and aches. On the same day, the patient underwent body temperature test and the result was 101.5 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, fever (101.5), chills and aches was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching, Pain in extremity
Clinical narrative: Muscle spasm in my right eyebrow that has been ticking every 10 minutes for over 24 hours; Muscle spasm in my right eyebrow that has been ticking every 10 minutes for over 24 hours; Left arm in pain; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 00161) via an unspecified route of administration in the left arm on 24Apr2021 at 13:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, autoimmune pancreatitis, allergy and asthma; all from unknown date and unknown if ongoing at the time of this report. Concomitant medications included cetirizine hydrochloride (ZYRTEC), fluticasone propionate/salmeterol xinafoate (ADVAIR) and salbutamol (ALBUTEROL); all on an unknown date for unknown indication. The patient previously received amitriptyline (MANUFACTURER UNKNOWN) and morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 at 18:00, the patient experienced, left arm in pain (the patient was told about this) and muscle spasm in the right eyebrow that has been 'ticking' every 10 minutes for over 24 hours and this was concerning for the patient. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm in pain and muscle spasm in the right eyebrow that has been 'ticking' was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular, Rash pruritic, SARS-CoV-2 test
Clinical narrative: Rash on trunk and legs not going away; Rash on trunk , arms, and legs not going away.; Papular; Rash on trunk , arms, and legs not going away. Papular, itches, and burns; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 24Dec2020 at 00:00 (at the age of 34-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known drug allergies (NKDA). Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications. On 15Mar2021 at 00:00, the patient experienced rash on trunk, arms and legs and was not going away. The rash was papular, itched and burned. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of the events and included treatment with Me from dose pack (as reported). Since the vaccination, the patient had been tested for COVID-19. On 29Mar2021, the patient underwent COVID-19 virus test (via nasal swab) and the result was negative. The clinical outcome of the events rash on trunk, arms and legs; papular, itches and burns was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dyspnoea, Dysstasia, Fatigue
Clinical narrative: Could not stand for very long; Stomach hurt very bad; Diarrhea; Severe gas pains; Intercostal muscles started hurting very bad; Painful to breathe; Neuro pain from injection site down arm to fingers; Interdigital space between digits 1 and 2 went numb; Fatigue; Ache muscles; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old  non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 23Apr2021 at 14:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic atopy, chronic sinusitis, degenerative joint disease, lyme disease and very severe reaction to rabies vaccine all from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included paracetamol (TYLENOL), levocetirizine dihydrochloride (XYZAL), multivitamin and glucosamine /chon/msm (GLUCOSAMIN) all for unspecified indication from an unknown date and unknown if ongoing. The patient previously took local anesthesia, aminobenzoic acid(PABA), opioids, fluoxetine hydrochloride(PROZAC) and misoprostol(MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 01Apr2021 at 14:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 14:15 immediately after injection the patient experienced neuro pain from injection site down arm to fingers. Interdigital space between digits 1 and 2 went numb. With 30 min of vaccination fatigue started, similar to flu, with ache muscles. On 24Apr2021, next morning fatigue was worse. Throughout day fatigue became extreme, extreme muscle aches, could not stand for very long, stomach hurt very bad, diarrhea started and severe gas pains. Intercostal muscles started hurting very bad and made it very painful to breathe. The patient did not have health insurance, therefore did not to doctor.  The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events neuro pain from injection site down arm to fingers, interdigital space between digits 1 and 2 went numb, fatigue, ache, could not stand for very long, stomach hurt very bad, diarrhea, severe gas pains, intercostal muscles started hurting very bad and painful to breathe were resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Flatulence, Hypoaesthesia, Myalgia, Myalgia intercostal, Neuralgia
Clinical narrative: Could not stand for very long; Stomach hurt very bad; Diarrhea; Severe gas pains; Intercostal muscles started hurting very bad; Painful to breathe; Neuro pain from injection site down arm to fingers; Interdigital space between digits 1 and 2 went numb; Fatigue; Ache muscles; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old  non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 23Apr2021 at 14:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic atopy, chronic sinusitis, degenerative joint disease, lyme disease and very severe reaction to rabies vaccine all from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included paracetamol (TYLENOL), levocetirizine dihydrochloride (XYZAL), multivitamin and glucosamine /chon/msm (GLUCOSAMIN) all for unspecified indication from an unknown date and unknown if ongoing. The patient previously took local anesthesia, aminobenzoic acid(PABA), opioids, fluoxetine hydrochloride(PROZAC) and misoprostol(MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 01Apr2021 at 14:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 14:15 immediately after injection the patient experienced neuro pain from injection site down arm to fingers. Interdigital space between digits 1 and 2 went numb. With 30 min of vaccination fatigue started, similar to flu, with ache muscles. On 24Apr2021, next morning fatigue was worse. Throughout day fatigue became extreme, extreme muscle aches, could not stand for very long, stomach hurt very bad, diarrhea started and severe gas pains. Intercostal muscles started hurting very bad and made it very painful to breathe. The patient did not have health insurance, therefore did not to doctor.  The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events neuro pain from injection site down arm to fingers, interdigital space between digits 1 and 2 went numb, fatigue, ache, could not stand for very long, stomach hurt very bad, diarrhea, severe gas pains, intercostal muscles started hurting very bad and painful to breathe were resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Heart rate, Heart rate increased, Heart rate irregular
Clinical narrative: Irregular increased heart beats and faster heart beats; Irregular heart beats; Increased chest discomfort; Coughing; Disruption of speeches; Affected sleep; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 13Apr2021 at 12:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included unspecified blood thinner, for an unknown indication from an unknown date and unknown if ongoing. On 18Apr2021, the patient began to experience irregular increased heart beats, and faster heart beats, increased chest discomfort starting about 5 days following the first dose of shot. It happened throughout the day. It happened during seating and sleeping. The irregular heartbeats and chest discomfort caused coughing and disruption of speeches. It began to become severe and affected sleeping. The events resulted in doctor or other healthcare professional office/clinic visit. On 18Apr2021, the patient underwent heart rate test and the result was increased. It was unknown if the patient received any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events irregular increased heart beats and faster heart beats, increased chest discomfort, coughing, disruption of speeches and affected sleep was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Speech disorder
Clinical narrative: Irregular increased heart beats and faster heart beats; Irregular heart beats; Increased chest discomfort; Coughing; Disruption of speeches; Affected sleep; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 13Apr2021 at 12:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included unspecified blood thinner, for an unknown indication from an unknown date and unknown if ongoing. On 18Apr2021, the patient began to experience irregular increased heart beats, and faster heart beats, increased chest discomfort starting about 5 days following the first dose of shot. It happened throughout the day. It happened during seating and sleeping. The irregular heartbeats and chest discomfort caused coughing and disruption of speeches. It began to become severe and affected sleeping. The events resulted in doctor or other healthcare professional office/clinic visit. On 18Apr2021, the patient underwent heart rate test and the result was increased. It was unknown if the patient received any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events irregular increased heart beats and faster heart beats, increased chest discomfort, coughing, disruption of speeches and affected sleep was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; chills; headaches; sore throat; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on an unknown date in Apr2021 at 16:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included hydrochloride (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Apr2021 at 06:30, the patient experienced lymph node armpit, fever, chills headaches and sore throat. On 18Apr2021, the patient underwent nasal swab and the result was pending. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with amoxicillin 875 (MANUFACTURER UNKNOWN). Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events lymph node armpit, fever, chills headaches and sore throat was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Miliaria, Pain, Pruritus
Clinical narrative: persistent chills and body aches for 3 days; Severe heat rash down the entire left side of  neck.; Lymph node swelling under bicep and in arm pit; Redness around injection site; Itchiness on upper back.; persistent chills and body aches for 3 days; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Concomitant medications included sumatriptan (IMITREX), verapamil (MANUFACTURER UNKNOWN) and lactobacillus nos (CULTURELLE); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021, the patient experienced persistent chills and body aches for 3 days, redness around injection site with lymph node swelling under bicep and in arm pit along with a severe heat rash down the entire left side of neck and she also had itchiness on upper back. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events persistent chills and body aches for 3 days was resolved on 23Apr2021. The clinical outcome of the events redness around injection site with lymph node swelling under bicep and in arm pit along with a severe heat rash down the entire left side of neck and itchiness on upper back was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: persistent chills and body aches for 3 days; Severe heat rash down the entire left side of  neck.; Lymph node swelling under bicep and in arm pit; Redness around injection site; Itchiness on upper back.; persistent chills and body aches for 3 days; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Concomitant medications included sumatriptan (IMITREX), verapamil (MANUFACTURER UNKNOWN) and lactobacillus nos (CULTURELLE); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021, the patient experienced persistent chills and body aches for 3 days, redness around injection site with lymph node swelling under bicep and in arm pit along with a severe heat rash down the entire left side of neck and she also had itchiness on upper back. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events persistent chills and body aches for 3 days was resolved on 23Apr2021. The clinical outcome of the events redness around injection site with lymph node swelling under bicep and in arm pit along with a severe heat rash down the entire left side of neck and itchiness on upper back was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Light pain in left arm; Fever; Chills; Muscle pain all over the body; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 at 10:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levonorgestrel (MIRENA) from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 03Apr2021 at 17:30 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. On 25Apr2021 at 04:00 the patient felt light pain in left arm during the day. Then in the middle of the night pain got sharper and had fever, chills, and muscle pain all over the body, which remained for whole next day and night. The following morning  the patient had very sharp arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events light pain in left arm, fever, chills and muscle pain all over the body were ongoing at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.