chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Tenderness at injection site; Tiredness; Headache; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN; EXP:31Jul2021) via an unspecified route of administration in the right arm on 24Mar2021 at 11:45 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. The patient medical history included ADD (attention deficit disorder), Hashimoto's, sleep apnea. The patient was allergic to molds, but not PCN (penicillin). Concomitant medications included Levothyroxine (MANUFACTURER UNKNOWN), piroxicam (PAXIL), bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3) and Iron (MANUFACTURER UNKNOWN). Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Mar2021, the patient experienced tenderness at injection site, tiredness and headache, all symptoms were mild. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had taken treatment for the events which included two extra strength acetaminophen (TYLENOL) caplets. The clinical outcomes of the events vaccination site tenderness, tiredness and headache were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Polymerase chain reaction, SARS-CoV-2 test, Vomiting
Clinical narrative: Nausea; Diarrhea; Vomit; This is a spontaneous report from a contactable consumer, the patient. A 36-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown), via an unknown route of administration in the left arm on 18Mar2021 at 13:45 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not tested for COVID-19. On 21Mar2021, after three days of vaccination, the patient experienced diarrhea, nausea and vomit which existed for 4 days. The patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures, which included nasal swab and rapid test on 24Mar2021, which were found to be negative. 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 diarrhea, nausea and vomit was recovering.   Information about lot/batch number cannot be obtained. No further information expected
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dysgeusia, Fatigue, Headache, Myalgia
Clinical narrative: Fever 102; severe arm pain from neck to wrist; fatigue; muscle aches; headache; metal taste; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: unknown) via an unspecified route of administration in the left arm on 24Mar2021 at 09:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medication were reported as no. 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 03Mar2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient reported that there were no known allergies. 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 has not tested for COVID-19. On 24Mar2021 at 22:00, the patient experienced fever 102, severe arm pain from neck to wrist, fatigue, muscle aches, headache and metal taste. The patients relevant tests included body temperature on 24Mar2021 and the result was 102-degree F. No treatment was received for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of fever 102, severe arm pain from neck to wrist, fatigue, muscle aches, headache and metal taste were resolving at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever 102; severe arm pain from neck to wrist; fatigue; muscle aches; headache; metal taste; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: unknown) via an unspecified route of administration in the left arm on 24Mar2021 at 09:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medication were reported as no. 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 03Mar2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient reported that there were no known allergies. 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 has not tested for COVID-19. On 24Mar2021 at 22:00, the patient experienced fever 102, severe arm pain from neck to wrist, fatigue, muscle aches, headache and metal taste. The patients relevant tests included body temperature on 24Mar2021 and the result was 102-degree F. No treatment was received for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of fever 102, severe arm pain from neck to wrist, fatigue, muscle aches, headache and metal taste were resolving at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash macular
Clinical narrative: the injection arm swelled; red blotch; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 19Mar2021 at 12:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia (CLL). The patient had a history of allergy (unspecified). Concomitant medications were reported as no. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on an unspecified date in Feb2021 at 17:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Since the vaccination, patient had not been tested for COVID-19. On 25Mar2021 at 09:30, six days after vaccination the patient had experienced swelling in the injected arm and a red blotch which was not at injection site. Adverse 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 reported events. The clinical outcome of the events the injection arm swelled and red blotches was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; Headache; Chills; Muscle ache; This is spontaneous report from contactable consumer, the patient. A 17-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in right arm on 24Mar2021, (at the age of 17-years -old), as a single dose for COVID-19 immunisation. The patients medical history was reported as reported as not applicable and she had no known allergies. The concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in right arm, on 02Mar2021 at 17:30, (at the age of 17-years-old), as a single dose for COVID-19 immunisation. 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 had not tested for COVID-19. On 25Mar2021 at 17:15, the patient experienced fever, headache, chills and muscle ache. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the events. The clinical outcome of fever, headache, chills and muscle ache was not recovered 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: Dizziness, Dyspnoea, Erythema, Heart rate irregular, Swelling face
Clinical narrative: This is a spontaneous report received from a non contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration on left arm on 25Mar2021 at 14:30 (at the age of 46- year-old) as a single dose, for COVID-19 immunisation. Past medical history included Novocain allergy. Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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. On 25Mar2021 at 15:15 the patient experienced difficulty breathing, red and slightly swollen face, irregular pulse, dizziness. The event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. No therapeutic measure was taken in response to the event. The clinical outcome of the event difficulty breathing, red and slightly swollen face, irregular pulse, dizziness was resolving at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: sore left arm; also had diarrhea from Saturday to Tuesday and my stool was bright yellow.; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via unspecified route of administration in the left arm on 13Mar2021 (at the age of 27-year-old) at 15:00 as a single dose for COVID-19 immunization. Medical history included asthma and COVID-19. The patient had no known allergies. Concomitant medication was not reported. The patient did not receive any other vaccine within four weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021 at 21:00, the patient experienced a sore left arm, diarrhoea from Saturday to Tuesday and his stool was bright yellow, which was not too serious. 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 adverse events. The clinical outcome of sore left arm was recovered on 15Mar2021, while that of diarrhoea was recovered on 16Mar2021 at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Prior to vaccination, was the patient diagnosed with COVID-19? Yes, added as Relevant Med History and vaccination Facility Country added.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Heart rate, Heart rate increased
Clinical narrative: Spike in BP; Spike in heart rate; Lighted; This is a spontaneous report received from a contactable consumer (patient). A 63-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP8727), via an unspecified route on 19Mar2021 at 10:15 (at age of 63-years old) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included thyroid, high cholesterol. The patient had no known allergies. The patient concomitant medications included levothyroxine with dose 125mcg and Atorvastatin with dose 20mg from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201), via an unspecified route on 26Feb2021 (at age of 63-years old) as dose 1, single for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 12:00, the patient experienced spike in BP, spike in heart rate and lighted. The patient received treatment IV fluids for events. The event resulted in emergency room visit The reporter assessed the case as non-serious. The outcome of the events was recovering.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Body chills; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 25Mar2021 at 14:45 (at the age of 53-years-old), as single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, diabetes, compromised immune system and COVID-19, which was diagnosed prior to the vaccination. Concomitant medication was not reported. The patient previously took morphine (MANUFACTURER UNKNOWN) for unspecified indication and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 04:15, the patient experienced body chills and body aches. The patient did not receive any treatment for the events. 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 the events body chills and body aches was resolving at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: slightly sore arm; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient 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 15Mar2021 at 12:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. Concomitant medication included paracetamol(TYLENOL), CBD salve (MANUFACTURER UNKNOWN), biotin vitamin (MANUFACTURER UNKNOWN) and moringa tea (MANUFACTURER UNKNOWN)) from unknown date for unspecified indication. The Patient did not have any allergies to medications, food, or other products, but can't take ibuprofen. 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 not tested for COVID-19. On, 15Mar2021 the patient experienced tiredness and slightly sore arm. 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 reported events. The clinical outcome of the tiredness and slightly sore arm was resolved on unknown date in Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Hypoaesthesia, Hypoaesthesia oral, Motor dysfunction, Paraesthesia
Clinical narrative: Numbness tingling and moderate paralysis and loss of motor function in left pinky, left thumb, left index, left forearm, left shoulder, left neck, left jawline, bottom lip of mouth, right shoulder
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral, Paralysis
Clinical narrative: Numbness tingling and moderate paralysis and loss of motor function in left pinky, left thumb, left index, left forearm, left shoulder, left neck, left jawline, bottom lip of mouth, right shoulder
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pain in extremity, Tremor
Clinical narrative: Some soreness on the left arm day of and the next day after the shot. 7/16 some muscle aches and really fatigued around 3:00p.m. On 7/17 fatigued, hand tremors and joint pain.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Eye movement disorder, Loss of consciousness, Malaise
Clinical narrative: patient came up to rx counter stated he wasn't feeling well his eyes rolled into the back of his head and he passed out we called 911 he was assessed and they recommended to not transport him since vitals were okay
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Cellulitis, Feeling hot, Hypersensitivity, Injection site induration
Clinical narrative: Six days after the shot (Thursday morning 07/15) my left armpit was sore. The following evening (Friday 07/16) I noticed red bumps/rash on my upper arm where the injection site was; it resembled and insect bite. Throughout the evening, the red bumps turned into a painful, itchy rash with hot-to-touch hard lump, that was about the size of a quarter. The next day (Saturday 07/17) the rash had progressed and worsened; it is very hot to touch, large lump under skin, swollen, very red. The area had grown to consume most of my upper arm. Later Saturday afternoon, I began to feel very hot, took my temperature and had a fever 100.00 and decided to go to an urgent care. I was diagnosed as an allergic reaction and cellulitis. I was giving three shots: 1. Decadron and the other two shots were Clindamycin.  I will begin Clindamycin capsule tomorrow.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site rash, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Six days after the shot (Thursday morning 07/15) my left armpit was sore. The following evening (Friday 07/16) I noticed red bumps/rash on my upper arm where the injection site was; it resembled and insect bite. Throughout the evening, the red bumps turned into a painful, itchy rash with hot-to-touch hard lump, that was about the size of a quarter. The next day (Saturday 07/17) the rash had progressed and worsened; it is very hot to touch, large lump under skin, swollen, very red. The area had grown to consume most of my upper arm. Later Saturday afternoon, I began to feel very hot, took my temperature and had a fever 100.00 and decided to go to an urgent care. I was diagnosed as an allergic reaction and cellulitis. I was giving three shots: 1. Decadron and the other two shots were Clindamycin.  I will begin Clindamycin capsule tomorrow.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Six days after the shot (Thursday morning 07/15) my left armpit was sore. The following evening (Friday 07/16) I noticed red bumps/rash on my upper arm where the injection site was; it resembled and insect bite. Throughout the evening, the red bumps turned into a painful, itchy rash with hot-to-touch hard lump, that was about the size of a quarter. The next day (Saturday 07/17) the rash had progressed and worsened; it is very hot to touch, large lump under skin, swollen, very red. The area had grown to consume most of my upper arm. Later Saturday afternoon, I began to feel very hot, took my temperature and had a fever 100.00 and decided to go to an urgent care. I was diagnosed as an allergic reaction and cellulitis. I was giving three shots: 1. Decadron and the other two shots were Clindamycin.  I will begin Clindamycin capsule tomorrow.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Computerised tomogram thorax, Dyspnoea, Dyspnoea exertional
Clinical narrative: I have been having trouble breathing since I had the vaccine done. I get really bad chest pains just from laying down and it is a daily struggle to do everyday things like walking because I get short of breath really easily after I had the vaccine done. It has been 3 and a half months now and I am still struggling trying to recover.  My treatment right now is that my pulmonologist put me on Symbicort to see if it could give me a little bit of relief and I am still being seen by the cardiologist as well, and I am also using my rescue inhaler Albuterol HFA more often than before. I am taking Singulair and I was also put on a heart monitor for 2 days to check my heart rhythm to see if that has anything to do with the chest pains I have been feeling
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram ambulatory, Loss of personal independence in daily activities, Pulmonary function test, X-ray
Clinical narrative: I have been having trouble breathing since I had the vaccine done. I get really bad chest pains just from laying down and it is a daily struggle to do everyday things like walking because I get short of breath really easily after I had the vaccine done. It has been 3 and a half months now and I am still struggling trying to recover.  My treatment right now is that my pulmonologist put me on Symbicort to see if it could give me a little bit of relief and I am still being seen by the cardiologist as well, and I am also using my rescue inhaler Albuterol HFA more often than before. I am taking Singulair and I was also put on a heart monitor for 2 days to check my heart rhythm to see if that has anything to do with the chest pains I have been feeling
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Blood test, Chest X-ray, Electrocardiogram, Pleurisy
Clinical narrative: On 7/12/21 started getting sharp pains left side it  felt like it was in my heart then on July 13, 2021 I want to  hospital. The ER they did bloodwork many test  chest x-ray the final diagnosis was pleurisy. I have never had any lung issues in my life except asthma when I was a young child  which I out grew it as a teenager. I am following up with a pulmonologist on Monday, July 19, 2021 as advised.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: On 7/12/21 started getting sharp pains left side it  felt like it was in my heart then on July 13, 2021 I want to  hospital. The ER they did bloodwork many test  chest x-ray the final diagnosis was pleurisy. I have never had any lung issues in my life except asthma when I was a young child  which I out grew it as a teenager. I am following up with a pulmonologist on Monday, July 19, 2021 as advised.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Left arm is sore.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 13:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on 24Feb2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 27Feb2021, the patient underwent nasal swab test for SARS-CoV-2 and result was found to be negative. On 25Mar2021 at 16:00, the patient's left arm was sore. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had not received treatment for the adverse event. The clinical outcome of the event left arm sore was recovering at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Moderate to moderately severe constant SOB WO WHEEZING
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Dizziness, Fatigue, Immediate post-injection reaction
Clinical narrative: Became dizzy immediately,.  Severe weakness and fatigue with nausea persisted for about three weeks.  Weakness and fatigue are still resolving.  It's the same reaction as to the fir vaccination, only more severe and longer lasting.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Became dizzy immediately,.  Severe weakness and fatigue with nausea persisted for about three weeks.  Weakness and fatigue are still resolving.  It's the same reaction as to the fir vaccination, only more severe and longer lasting.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tennitus, hissing sound in both ears; louder on the right side
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Discomfort, Headache
Clinical narrative: On April 19th, 16 days after vaccine administered, massive headaches began that left me bed ridden for roughly 2 weeks to a month afterwards. Severe headaches lasted all day with no breaks. Only relief I would have would be from laying down with head in a certain position.   A month after initial symptoms, the pain started to subside, but very slowly, taking several more weeks to calm down and to feel reduction in pain. Pressure would also set in around brain when pain was becoming less.  Several tests had been done after symptoms began which included: Bloodwork Lipid CT Scan without contrast CT Scan with contrast MRI without contrast  On June 15th, I was notified by my Neurologist that the MRI, which had been performed on June 10th, had showed a mild stroke had recently occurred.  I am now on blood pressure medication, as well as aspirin 81, reduce the likelihood of another stroke.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Lipids, Magnetic resonance imaging head abnormal, Mobility decreased, Scan with contrast, X-ray
Clinical narrative: On April 19th, 16 days after vaccine administered, massive headaches began that left me bed ridden for roughly 2 weeks to a month afterwards. Severe headaches lasted all day with no breaks. Only relief I would have would be from laying down with head in a certain position.   A month after initial symptoms, the pain started to subside, but very slowly, taking several more weeks to calm down and to feel reduction in pain. Pressure would also set in around brain when pain was becoming less.  Several tests had been done after symptoms began which included: Bloodwork Lipid CT Scan without contrast CT Scan with contrast MRI without contrast  On June 15th, I was notified by my Neurologist that the MRI, which had been performed on June 10th, had showed a mild stroke had recently occurred.  I am now on blood pressure medication, as well as aspirin 81, reduce the likelihood of another stroke.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Immediate post-injection reaction, Nausea
Clinical narrative: Felt dizzy immediately.  Severe weakness and fatigue began that night, worse the second day, with nausea.  Persisted for three weeks and was just resolving when I had the second vaccination.  When there is a booster, I'll have that.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: developed severe body aches and pain; severe headache; This is a spontaneous report from a non-contactable consumer, the patient. A 56-years-old male patient received first dose of BNT162b2(PFIZER-BIOTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 22Mar2021 (at the age of 56-year-old) for COVID-19 immunization. The patient medical history was not reported. The patient had no allergies to medications, food, or other products. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 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 an unknown date in Mar2021, within 12 hours of receiving the first vaccine, the patient developed severe body aches and pain and also a severe headache. These symptoms were still present 24 hours later. The patient did not receive any treatment for the 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 the events was severe headache and severe body aches, and pain was not recovered on an unspecified date at the time of this report.    Amendment: This follow-up report is being submitted to amend previously reported information: This is a spontaneous report from a contactable consumer, the patient" updated as "Non-contactable. For both events "developed severe body aches and pain" and "severe headache": Onset updated from "Mar2021" to "22Mar2021" per vaccination date 22Mar2021 and PRD 23Mar2021 and verbatim "These symptoms were still present 24 hours later". Adverse event Within 12 hours of receiving the first vaccine I developed severe body aches and pain. Also, a severe headache. These symptoms were still present 24 hours later. Event occurred in country. And events were not recovered on an unspecified date. The patient didn't receive any treatment.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Ringing in  both ears,; fullness feeling in both ears; This is a spontaneous report from a contactable other healthcare professional, the patient. A 52-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 the left arm on 20Mar2021 at 12:45 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergy to aspirin and sulfur. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and levothyroxine sodium (SYNTHROID) for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20 Mar2021 at 15:45, the patient had experienced ringing and fullness feeling in both ears. Adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient had received any therapeutic measures for the reported events. The clinical outcome of the events ringing and fullness feeling in both ears was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain after vaccination #1; This is a spontaneous report from a contactable consumer. A 47-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 on an unknown date (at the age of 47-years-old) 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 the patient had been tested for COVID-19, since the vaccination. It was unknown if the patient had received any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced arm pain after vaccination #1. It was unknown if the patient  had received any treatment for the event arm pain after vaccination #1. The clinical outcome of the event arm pain after vaccination #1 was unknown at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache
Clinical narrative: redness on neck and chest; headache; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old female patient received BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; lot number: ER8727) via an unspecified route of administration on an unknown date as a single dose for COVID 19 immunization (at the age 19-years-old). Medical history included dysautonomia and autoimmune autonomic ganglionopathy and past drug include amoxycillin. The patient had a history of allergy to penicillin and tree nuts. Concomitant medications were not reported. 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. On an unspecified date in 2021, the patient experienced redness on neck and chest and headache. Adverse 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 reported events. The clinical outcome of the events redness on neck and chest and headache was unknown at the time of report.   No follow-up attempts are possible. No further information is expected.  Follow-up (01Jul2021) Amendment: This follow-up report is being submitted to amend previously reported information: Verbatim in other relevant history tab row 1 and row 2 , updated to known allergies: penicillin and known allergies : tree nuts. Past Drug Event Amoxycillin was recoded to AMOXYCILLIN, not Amoxycillin. Relevant history autoimmune autonomic gangliopathy added. Final sentence should be updated to: No follow-up attempts are possible. No further information is expected. For all events, onset date added as 2021
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Nausea, Pyrexia
Clinical narrative: Dizzy; diarrhea; nausea; fever; tired; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN620), via an unspecified route of administration in the left arm on 23Mar2021 at 09:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for an unspecified indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 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 24Mar2021, the patient experienced dizzy, diarrhea, nausea, fever and tired. 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 patient did not receive any treatment for the reported events. The clinical outcome of the dizzy, diarrhea, nausea, fever and tired was recovering at the time of report.  No follow-up attempts are needed. No further information expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Myalgia, Vaccination site erythema
Clinical narrative: trouble sleeping; Fatigue,; general muscle soreness all over; injection site soreness; skin redness at injection site; headaches; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 23Mar2021 at 11:00 (at the age 48-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, GERD and sleep apnea. The patient was allergic to casein and dust mites. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), paracetamol (TYLENOL), pravastatin (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and ESCILOP, all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 01Mar2021 at 10:30 (at the age 48-years-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. On 23Mar2021 at 23:00, the patient experienced fatigue, general muscle soreness all over, injection site soreness, skin redness at injection site, headaches and had trouble sleeping. 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 received treatment with paracetamol (TYLENOL) for the events fatigue, general muscle soreness all over, injection site soreness, skin redness at injection site, headaches and trouble sleeping. The clinical outcomes of the events fatigue, general muscle soreness all over, injection site soreness, skin redness at injection site, headaches and trouble sleeping were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: trouble sleeping; Fatigue,; general muscle soreness all over; injection site soreness; skin redness at injection site; headaches; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 23Mar2021 at 11:00 (at the age 48-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, GERD and sleep apnea. The patient was allergic to casein and dust mites. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), paracetamol (TYLENOL), pravastatin (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and ESCILOP, all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 01Mar2021 at 10:30 (at the age 48-years-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. On 23Mar2021 at 23:00, the patient experienced fatigue, general muscle soreness all over, injection site soreness, skin redness at injection site, headaches and had trouble sleeping. 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 received treatment with paracetamol (TYLENOL) for the events fatigue, general muscle soreness all over, injection site soreness, skin redness at injection site, headaches and trouble sleeping. The clinical outcomes of the events fatigue, general muscle soreness all over, injection site soreness, skin redness at injection site, headaches and trouble sleeping were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia
Clinical narrative: severe headache at back of head behind earon side of injection.; feeling a strong tingling in my neck, jaw and inner ear on side of injection site; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8733) via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 63-years-old) at 11:00 as a single dose for COVID-19 immunisation. Medical history included high cholesterol. No known allergies were reported for the patient. Concomitant medications included atorvastatin 10 mg (MANUFACTURER UNKNOWN) for unknown indication received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19, since the vaccination. On 25Mar2021 at 12:30, about 1.5 hours after the vaccination, the patient started feeling a strong tingling in her neck, jaw and inner ear on side of injection site which stayed all day but lessened after about 6 hours. In the next day morning after 22 hours, on 26Mar2021, the patient had severe headache at back of head behind ear on side of injection. The patient did not receive any treatment for the reported events. Adverse 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 feeling a strong tingling in my neck, jaw and inner ear on side of injection site and severe headache at back of head behind ear on side of injection was resolving at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Extremely high fever keeps gettinghigher.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via unspecified route of administration in the left arm on 25Mar2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via unspecified route of administration in the left arm on 04Mar2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have allergies to medications, food, or other products. On 26Mar2021 at 02:00, the patient experienced extremely high fever which keeps getting higher and currently over 103 (unit unspecified). The event 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 event. The clinical outcome of the event extremely high fever was not resolved at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Sore injection site; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old-male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8739) via unspecified route of administration in the left arm on 25Mar2021 at 10:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, COVID-19 and diabetes. The patient was allergic to penicillin. Concomitant medication included metformin (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 13:00, the patient experienced sore vaccination site and headache. 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 treatment for the reported events. The clinical outcome of vaccination site pain and headache was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.