chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Chills, Head discomfort, Headache, Migraine
Clinical narrative: Nauseas; Migraine; Throwing up non-stop; He felt his head was going to explode; Chills; Fever; Body aches; Headache/Acute non-intractable headache, unspecified type; This is a spontaneous report from a contactable consumer (Parent). A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in left arm on 07Apr2021 12:30 (at the age of 16 years old) as dose 2, single for covid-19 immunization. Medical history included seasonal allergies, asthma, allergic to tree pollen and grass, all from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication. The patient previously took the dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER2613), on 17Mar2021 11:30 AM, administered in left arm, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Apr201, it was reported that the patient developed chills, fever, body aches and headache at around 11:00 PM, but did not report to parents. At 2:00 AM on 08Apr2021, his symptoms got worse. By 4:00 AM on 08Apr2021, he had nauseas and developed a severe migraine. He began throwing up non-stop, in addition to the chills, body aches and fever. He felt his head was going to explode. He had to be taken to the emergency room. Emergency doctor ordered an Angiogram CT scan to rule out a brain aneurism. He was given IV fluids and was treated for headache and vomiting. His CT came back normal, no sign of bleeding in the brain. He was discharged at 9:00 AM and was continued to treat symptoms at home with fluids, Tylenol and Ibuprofen. He was diagnosed with acute non-intractable headache, unspecified type. Treatment received for the events included 0.9% sodium chloride bolus, Benadryl, and Reglan. The outcome of the events was recovering.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Nauseas; Migraine; Throwing up non-stop; He felt his head was going to explode; Chills; Fever; Body aches; Headache/Acute non-intractable headache, unspecified type; This is a spontaneous report from a contactable consumer (Parent). A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in left arm on 07Apr2021 12:30 (at the age of 16 years old) as dose 2, single for covid-19 immunization. Medical history included seasonal allergies, asthma, allergic to tree pollen and grass, all from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication. The patient previously took the dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER2613), on 17Mar2021 11:30 AM, administered in left arm, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Apr201, it was reported that the patient developed chills, fever, body aches and headache at around 11:00 PM, but did not report to parents. At 2:00 AM on 08Apr2021, his symptoms got worse. By 4:00 AM on 08Apr2021, he had nauseas and developed a severe migraine. He began throwing up non-stop, in addition to the chills, body aches and fever. He felt his head was going to explode. He had to be taken to the emergency room. Emergency doctor ordered an Angiogram CT scan to rule out a brain aneurism. He was given IV fluids and was treated for headache and vomiting. His CT came back normal, no sign of bleeding in the brain. He was discharged at 9:00 AM and was continued to treat symptoms at home with fluids, Tylenol and Ibuprofen. He was diagnosed with acute non-intractable headache, unspecified type. Treatment received for the events included 0.9% sodium chloride bolus, Benadryl, and Reglan. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vertigo
Clinical narrative: Just had my second COVID shot. Had bad side affects with fever,  nausea, and vertigo; Just had my second COVID shot. Had bad side affects with fever,  nausea, and vertigo; Just had my second COVID shot. Had bad side affects with fever,  nausea, and vertigo; This is a spontaneous report from a non-contactable consumer (patient) via sales representative. An 8-decade-old (mid 70's) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6208) via an unspecified route of administration on 03Apr2021 as a Dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6198) via an unspecified route of administration on 13Mar2021 as a Dose 1, single for COVID-19 immunization. The reporter stated that, he "just had his second COVID shot and had bad side effects with fever, nausea, and vertigo." The outcome of the events was unknown.  No follow up attempts are possible. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate, Heart rate increased, Myalgia
Clinical narrative: patient had a very rapid pulse rate that continued throughout the evening and night until the next morning; very sore arm; Extreme muscle pain; Chills and aches; Chills and aches; Extreme Headache; This is a spontaneous report from a Contactable consumer Consumer or other non HCP, (patient reported for self). A 73-year-old (non-pregnant) female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: TR8737), via unspecified route of administration, in the left arm, on 06Apr2021 at 08:30 (at the age of 73-years-old), as dose 2, single for COVID-19 immunization. The patient's medical history included slow atrial fibrillation and allergies to medications, food, or other products includes: THC (tetrahydro cannabinol) and raw nuts, carrots and apples. Concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had earlier received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EL9369), via unspecified route of administration, in the left arm, on 16Mar2021 at 08:30 as dose 1, single for COVID-19 immunization. On 06Apr2021 at 20:00, twelve hours after receiving the second dose of the Pfizer vaccine, patient had a very rapid pulse rate that continued throughout the evening and night until the next morning. In addition, patient had a very sore arm, extreme muscle pain, chills and aches and an extreme headache. The patient underwent lab tests and procedure which included heart rate measurement: rapid pulse rate on 06Apr2021. Since the vaccination, patient has not been tested for COVID-19. No treatment received for the adverse events. The events were non-serious. Outcome of the events was reported as not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: patient had a very rapid pulse rate that continued throughout the evening and night until the next morning; very sore arm; Extreme muscle pain; Chills and aches; Chills and aches; Extreme Headache; This is a spontaneous report from a Contactable consumer Consumer or other non HCP, (patient reported for self). A 73-year-old (non-pregnant) female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: TR8737), via unspecified route of administration, in the left arm, on 06Apr2021 at 08:30 (at the age of 73-years-old), as dose 2, single for COVID-19 immunization. The patient's medical history included slow atrial fibrillation and allergies to medications, food, or other products includes: THC (tetrahydro cannabinol) and raw nuts, carrots and apples. Concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had earlier received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EL9369), via unspecified route of administration, in the left arm, on 16Mar2021 at 08:30 as dose 1, single for COVID-19 immunization. On 06Apr2021 at 20:00, twelve hours after receiving the second dose of the Pfizer vaccine, patient had a very rapid pulse rate that continued throughout the evening and night until the next morning. In addition, patient had a very sore arm, extreme muscle pain, chills and aches and an extreme headache. The patient underwent lab tests and procedure which included heart rate measurement: rapid pulse rate on 06Apr2021. Since the vaccination, patient has not been tested for COVID-19. No treatment received for the adverse events. The events were non-serious. Outcome of the events was reported as not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye pruritus, Eye swelling, Ocular hyperaemia
Clinical narrative: Itching in right eye; I had itching in my right eye. It then became painful, very red and swollen.; I had itching in my right eye. It then became painful, very red and swollen.; I had itching in my right eye. It then became painful, very red and swollen.; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the left arm on 04Apr2021 at 11:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and COVID-19. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was 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 04Apr2021 at 13:00, within 2 hours of vaccination the patient experienced itching in right eye, painful, very red and swollen. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events eye itching, eye pain, eye red and swollen eyes were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Soreness; Sweats; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Apr2021 at 11:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) for an unknown indication and start date. The patient previously 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 09Mar2021 at 11:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. 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 been tested for COVID-19. On 07Apr2021 at 02:00, the patient experienced fever, headache, sweats and soreness. The events did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events fever, headache, sweats and soreness were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Pyrexia
Clinical narrative: 20 minutes of severe diarrhea, bad headache, fatigue, and fever.; 20 minutes of severe diarrhea, bad headache, fatigue, and fever.; 20 minutes of severe diarrhea, bad headache, fatigue, and fever.; 20 minutes of severe diarrhea, bad headache, fatigue, and fever.; This is a spontaneous report received from a contactable reporter consumer(patient) reported for herself that. A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 12:15 (Batch/Lot Number: Unknown) as DOSE 1 SINGLE for covid-19 immunization( Age at vaccination: 25).The patient past Medical history included asthma from an unknown date and unknown if ongoing , endometriosis from an unknown date and unknown if ongoing , gastroesophageal reflux disease from an unknown date and unknown if ongoing , pain from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing , anxiety from an unknown date and unknown if ongoing , dermatitis contact from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing  known allergies: prednisone and doxycycline. Concomitant medication(s) included citalopram (CITALOPRAM) taken for an unspecified indication, mirtazapine (MIRTAZAPINE) taken for an unspecified indication and montelukast sodium (SINGULAIR) taken for an unspecified indication. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Administration facility. 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 vaccine within 4 weeks prior to covid-19 vaccination. On 07Apr2021 19:00, 20 minutes after the administration of vaccine the patient experienced severe diarrhea, bad headache, fatigue and fever. No treatment was received. The event outcome was recovered on unspecified date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling cold, Pyrexia
Clinical narrative: started feeling really cold; shivering; fever/had 37; a bit tired right after/Felt beyond exhausted; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: er8729), via an unspecified route of administration in left arm on 05Apr2021 around 15:00 (at the age of 48-year-old) at single dose for COVID-19 immunisation. Medical history included low blood pressure (really low) and mild heart murmur. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included multivits, herbal supp t-48Hr and muscle relax t-24h. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208) via an unspecified route of administration on 15Mar2021 around 15:00 (at the age of 48-year-old) at single dose for COVID-19 immunisation. Patient received both shots around 15:00, for second shot on 05Apr2021, patient was a bit tired right after, physically tired though mentally ok. On 06Apr2021 at 11:30, patient started feeling really cold, shivering, and felt beyond exhausted. Patient had 37. Patient was still not taking any supplements, vitamins or paracetamol (TYLENOL), she just slept for 90 minutes and now the fever was gone. Though she still felt exhausted. 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. Therapeutic measures were taken as result of event fever included slept. It was unknown whether therapeutic measures were taken as a result of the other events. The clinical outcome of the event fever was recovered on 06Apr2021; outcome of events feeling cold and shivering was recovering and feeling exhausted was not recovered.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: patient age and age at vaccination updated to 48, event Exhaustion was removed.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, SARS-CoV-2 test
Clinical narrative: her left arm hurt; warm to the touch for about a week; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 65-year-old female patient received bnt162b2 (BNT162B2, formulation; Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EL9264) as DOSE 1, SINGLE (at the age of 65-year-old) for covid-19 immunisation. Medical history included ongoing cancer and metastatic thyroid cancer (had metastatic thyroid cancer in her lungs rare and it is working on her slowly from an unknown date and unknown if ongoing. Family Medical History Relevant to AE was none. Concomitant medication included lenvatinib mesilate (LENVIMA) taken for cancer from Jul2020 to an unspecified stop date. On an unspecified date, the patient stated with her first Covid shot, her left arm hurt and was warm to the touch for about a week. It was the only reaction she had from it. The patient underwent lab tests and procedures which included covid 19 test was positive on Nov2020 She had Covid, it she did not have a fever but had extraordinary fatigue and stated that she has that now too. She said that she walked to her car and back and she is fatigued. The outcome of the event left arm hurt was reported as not recovered and for the event warm to the touch was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate increased, Pain in extremity
Clinical narrative: increase in heart rate; she was "somewhat sensitive to caffeine" which is unusual; sore arm; This is a spontaneous report received from a contactable female consumer (). A 64-year-old female patient received second dose of bnt162b2 (BNT162B2, Formulation was Solution for injection, Lot Number: not reported), dose 2 via an unspecified route on 06Apr2021 at 01.00 as single dose for COVID-19 immunization (age at time of vaccination 64 years). The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 when patient woke up this morning and had a cup of tea, she was somewhat sensitive to caffeine which is unusual because Caller mentioned she liked drinking coffee. On an unspecified date in 2021 Patient experienced heart rate increased and sore arm. The outcome of all events was unknown.  No follow-up attempts are needed. Information related to batch/lot number cannot be requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021381325 Same reporter/drug/AE, different patient
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dizziness, Dyspnoea, Euphoric mood, Feeling abnormal
Clinical narrative: blurred vision 20 minutes after; Lightheadedness; Felt high all that first night; difficulty breathing; Asthma attack; Headache; Nausea; fog brain; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 59-years-old non-pregnant female patient received second dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, lot number: EN6199), via an unknown route of administration in left arm on 02Apr2021 (at the age of 59-years-old) as single dose for COVID-19 immunisation. The patient's medical history included known allergies from grass and some trees. Concomitant medication included meloxicam for an unknown indication from an unknown date. The patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, lot number: unknown), via an unknown route of administration on an unknown date as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Apr2021, the patient experienced blurred vision 20 minutes after, light headedness, felt high all that first night then felt great, day 3- fog brain. Now (5 and 6 days) she had difficulty breathing comes and goes, worst ever Asthma attack (inhaler), headache comes and goes, nausea comes and goes. The patient visited doctor or other healthcare professional office/clinic visit. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient received Albutetrol as treatment. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vision blurred
Clinical narrative: blurred vision 20 minutes after; Lightheadedness; Felt high all that first night; difficulty breathing; Asthma attack; Headache; Nausea; fog brain; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 59-years-old non-pregnant female patient received second dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, lot number: EN6199), via an unknown route of administration in left arm on 02Apr2021 (at the age of 59-years-old) as single dose for COVID-19 immunisation. The patient's medical history included known allergies from grass and some trees. Concomitant medication included meloxicam for an unknown indication from an unknown date. The patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, lot number: unknown), via an unknown route of administration on an unknown date as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Apr2021, the patient experienced blurred vision 20 minutes after, light headedness, felt high all that first night then felt great, day 3- fog brain. Now (5 and 6 days) she had difficulty breathing comes and goes, worst ever Asthma attack (inhaler), headache comes and goes, nausea comes and goes. The patient visited doctor or other healthcare professional office/clinic visit. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient received Albutetrol as treatment. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Diplopia, Ear pain, Facial asymmetry, Facial discomfort
Clinical narrative: Vertigo; Area in left cheek about an long was hard/stiff and the cheek was misshapen/Cheek was enlarged/Enlargement also spread to forehead, left lower jaw; Area in left cheek about an long was hard/stiff and the cheek was misshapen/Cheek was enlarged and face and facial features were asymmetrical; Double vision; Blurry vision in one eye; Severe light sensitivity; Left side of face felt very heavy and numb; Left side of face felt very heavy and numb; Eyelids not being open evenly/Enlargement also spread to eyelids; Sudden pain behind left earlobe; Could not properly smile or create facial expressions; Fall; Severe memory issues; Lack of cognitive function; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIOINTECH COVID-19 VACCINE; solution for injection; lot number: EW0150), via an unspecified route of administration, administered in the left arm on 05Apr2021 16:30 (at the age of 23-years-old) as dose 1, single for COVID-19 immunization. Medical history included Ehlers-Danlos syndrome, postural orthostatic tachycardia syndrome (POTS), dysautonomia, Sjogren's syndrome, pelvic floor dyssynergia, and asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) immediate release (IR) and extended release (XR), atenolol, lamotrigine, and testosterone enanthate (XYOSTED). The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) and metronidazole benzoate (FLAGYL) and experienced drug allergy with bot drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. On 05Apr2021, the patient experienced severe memory issues and lack of cognitive function which persisted and was still occurring at the time of the report. On 07Apr2021 00:15, the patient experienced sudden pain behind the left earlobe lasting a few seconds and sudden vertigo causing her to fall over towards the left. Shortly after, the patient noticed an area in her left cheek about an long was hard/stiff and the cheek was misshappen. The cheek was enlarged and her face and facial features were asymmetrical. The patient had double vision/blurry vision in one eye, possibly due to her eyelids not being open evenly. The patient also experienced severe light sensitivity. The left side of her face felt very heavy and numb. The patient could not properly smile or create facial expressions. Later that day, the enlargement also spread to her forehead, left lower jaw, and further to her eyelids. The events resulted in emergency room/department or urgent care visit. Therapeutic measures were not taken as result of the events. The outcome of the events was not recovered.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hypoaesthesia, Memory impairment, Photophobia, Reduced facial expression
Clinical narrative: Vertigo; Area in left cheek about an long was hard/stiff and the cheek was misshapen/Cheek was enlarged/Enlargement also spread to forehead, left lower jaw; Area in left cheek about an long was hard/stiff and the cheek was misshapen/Cheek was enlarged and face and facial features were asymmetrical; Double vision; Blurry vision in one eye; Severe light sensitivity; Left side of face felt very heavy and numb; Left side of face felt very heavy and numb; Eyelids not being open evenly/Enlargement also spread to eyelids; Sudden pain behind left earlobe; Could not properly smile or create facial expressions; Fall; Severe memory issues; Lack of cognitive function; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIOINTECH COVID-19 VACCINE; solution for injection; lot number: EW0150), via an unspecified route of administration, administered in the left arm on 05Apr2021 16:30 (at the age of 23-years-old) as dose 1, single for COVID-19 immunization. Medical history included Ehlers-Danlos syndrome, postural orthostatic tachycardia syndrome (POTS), dysautonomia, Sjogren's syndrome, pelvic floor dyssynergia, and asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) immediate release (IR) and extended release (XR), atenolol, lamotrigine, and testosterone enanthate (XYOSTED). The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) and metronidazole benzoate (FLAGYL) and experienced drug allergy with bot drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. On 05Apr2021, the patient experienced severe memory issues and lack of cognitive function which persisted and was still occurring at the time of the report. On 07Apr2021 00:15, the patient experienced sudden pain behind the left earlobe lasting a few seconds and sudden vertigo causing her to fall over towards the left. Shortly after, the patient noticed an area in her left cheek about an long was hard/stiff and the cheek was misshappen. The cheek was enlarged and her face and facial features were asymmetrical. The patient had double vision/blurry vision in one eye, possibly due to her eyelids not being open evenly. The patient also experienced severe light sensitivity. The left side of her face felt very heavy and numb. The patient could not properly smile or create facial expressions. Later that day, the enlargement also spread to her forehead, left lower jaw, and further to her eyelids. The events resulted in emergency room/department or urgent care visit. Therapeutic measures were not taken as result of the events. The outcome of the events was not recovered.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swelling of eyelid, Vertigo, Vision blurred
Clinical narrative: Vertigo; Area in left cheek about an long was hard/stiff and the cheek was misshapen/Cheek was enlarged/Enlargement also spread to forehead, left lower jaw; Area in left cheek about an long was hard/stiff and the cheek was misshapen/Cheek was enlarged and face and facial features were asymmetrical; Double vision; Blurry vision in one eye; Severe light sensitivity; Left side of face felt very heavy and numb; Left side of face felt very heavy and numb; Eyelids not being open evenly/Enlargement also spread to eyelids; Sudden pain behind left earlobe; Could not properly smile or create facial expressions; Fall; Severe memory issues; Lack of cognitive function; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIOINTECH COVID-19 VACCINE; solution for injection; lot number: EW0150), via an unspecified route of administration, administered in the left arm on 05Apr2021 16:30 (at the age of 23-years-old) as dose 1, single for COVID-19 immunization. Medical history included Ehlers-Danlos syndrome, postural orthostatic tachycardia syndrome (POTS), dysautonomia, Sjogren's syndrome, pelvic floor dyssynergia, and asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) immediate release (IR) and extended release (XR), atenolol, lamotrigine, and testosterone enanthate (XYOSTED). The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) and metronidazole benzoate (FLAGYL) and experienced drug allergy with bot drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. On 05Apr2021, the patient experienced severe memory issues and lack of cognitive function which persisted and was still occurring at the time of the report. On 07Apr2021 00:15, the patient experienced sudden pain behind the left earlobe lasting a few seconds and sudden vertigo causing her to fall over towards the left. Shortly after, the patient noticed an area in her left cheek about an long was hard/stiff and the cheek was misshappen. The cheek was enlarged and her face and facial features were asymmetrical. The patient had double vision/blurry vision in one eye, possibly due to her eyelids not being open evenly. The patient also experienced severe light sensitivity. The left side of her face felt very heavy and numb. The patient could not properly smile or create facial expressions. Later that day, the enlargement also spread to her forehead, left lower jaw, and further to her eyelids. The events resulted in emergency room/department or urgent care visit. Therapeutic measures were not taken as result of the events. The outcome of the events was not recovered.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Fatigue, Feeling abnormal, Heart rate
Clinical narrative: the next day all I felt was arm soreness and fatigue.; felt fatigued and still out of it.  the next day all I felt was arm soreness and fatigue.; felt a little odd; anxiety especially around needles/syringes; left arm turned a bluish pink color; I told the pharmacists and they took my heart rate which was over 100 but my breathing was fine and normal; hands were cold and clammy; Was wobbly; This is a spontaneous report from a contactable consumer, the patient. A 19-years-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 07Apr2021 at 14:45 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included depression/anxiety. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), clindamycin phosphate (MANUFACTURER UNKNOWN), tretinoin (MANUFACTURER UNKNOWN). The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not tested for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 07Apr2021 at 14:45, the patient experienced anxiety especially around needles/syringes so part of the reaction could have something to do with that and received vaccine and walked to the waiting area to wait 15 minutes to see if body would react. It did. The left (injected) arm turned a bluish pink color. The patient told the pharmacists and they recorded the heart rate which was over 100 but breathing was fine and normal but hands were cold and clammy. The patient was offered water and crackers that patient took and later stood up to see if the patient would get dizzy which the patient did, the patient was wobbly when stood up and stayed after 15 minutes to make sure the patient didn't have any more reactions which the patient did not and left, but still was not feeling 100%. The patient still felt a little odd, off balance, and slightly out of it. But nothing more severe than that. The throat did not close up, face did not swell up, never vomited, felt any itchiness, or get a hot flushed feeling. The next day after vaccination, the patient experienced arm soreness and fatigue. No therapeutic measures were taken for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events left (injected) arm turned a bluish pink color, heart rate which was over 100 but breathing was fine and normal but hands were cold and clammy, was wobbly, felt a little odd, off balance, and slightly out of it when stood up, arm soreness and fatigue was recovered in Apr2021. No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pain in extremity, Peripheral coldness, Vaccination site reaction
Clinical narrative: the next day all I felt was arm soreness and fatigue.; felt fatigued and still out of it.  the next day all I felt was arm soreness and fatigue.; felt a little odd; anxiety especially around needles/syringes; left arm turned a bluish pink color; I told the pharmacists and they took my heart rate which was over 100 but my breathing was fine and normal; hands were cold and clammy; Was wobbly; This is a spontaneous report from a contactable consumer, the patient. A 19-years-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 07Apr2021 at 14:45 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included depression/anxiety. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), clindamycin phosphate (MANUFACTURER UNKNOWN), tretinoin (MANUFACTURER UNKNOWN). The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not tested for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 07Apr2021 at 14:45, the patient experienced anxiety especially around needles/syringes so part of the reaction could have something to do with that and received vaccine and walked to the waiting area to wait 15 minutes to see if body would react. It did. The left (injected) arm turned a bluish pink color. The patient told the pharmacists and they recorded the heart rate which was over 100 but breathing was fine and normal but hands were cold and clammy. The patient was offered water and crackers that patient took and later stood up to see if the patient would get dizzy which the patient did, the patient was wobbly when stood up and stayed after 15 minutes to make sure the patient didn't have any more reactions which the patient did not and left, but still was not feeling 100%. The patient still felt a little odd, off balance, and slightly out of it. But nothing more severe than that. The throat did not close up, face did not swell up, never vomited, felt any itchiness, or get a hot flushed feeling. The next day after vaccination, the patient experienced arm soreness and fatigue. No therapeutic measures were taken for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events left (injected) arm turned a bluish pink color, heart rate which was over 100 but breathing was fine and normal but hands were cold and clammy, was wobbly, felt a little odd, off balance, and slightly out of it when stood up, arm soreness and fatigue was recovered in Apr2021. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Pruritus, Skin burning sensation
Clinical narrative: Itchiness and burning of the skin; Itchiness and burning of the skin; Chest tightness; Shortness of breath; This is a spontaneous report from a non-contactable Physician. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 01Apr2021 as dose number unknown, single for COVID-19 immunisation. (Reason for no Lot number: Not available/provided to reporter at the time of report completion). The patient medical history and concomitant medications were not reported. It was unknown if patient was pregnant at the time of vaccination. It was Unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient been tested for COVID-19 Since the vaccination and patient diagnosed with COVID-19 Prior to vaccination. The patient experienced itchiness and burning of the skin (pruritus and skin burning sensation), chest tightness, and shortness of breath on 04Apr2021. Patient received treatment for the adverse event, includes: Medrol Dosepak. It was unknown whether the patient had been tested for COVID-19 since the vaccination. The events were assessed as Non serious by reporter. The outcome of event was unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Gait disturbance
Clinical narrative: Mild shaking; Feeling malaise; By Thursday evening I had a headache; I was so weak and lightheaded; I required assistance to walk; Was having difficulty articulating herself; I became nauseated, but did not vomit/ Nausea; The exhaustion continued to worsen; my pulse was 48 just a few hours later; I had some chills; Intermittent pain on left side; I was so weak and lightheaded/ I started getting weak; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7533), via an unspecified route of administration in left arm on 06Apr2021 at 13:00 (at the age of 50-year-old) at single dose for COVID-19 immunisation. Medical history included adrenal Insufficiency, lupus, Crohn's, celiac, vitiligo (reported as Vitaligo), Raynauds-1, MTHFR mutation, migraines, gastroesophageal reflux disease (GERD), renal cysts, mild myopathy, mild neuropathy, patient had known allergies to penicillin, antihistamine, sulfa, gluten and contrast. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included belimumab (BENLYSTA), modafinil (PROVIGIL), levothyroxine sodium (SYNTHROID), hydrocortisone and R. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously took diazepam (VALIUM), codeine, tramadol, trazodone (reported as trazadone), risedronate sodium (ATELVIA) and all had known allergies. On 06Apr2021, within 4 minutes, the patient started getting weak. After 30 minutes at 13:30 on 06Apr2021, patient was so weak and lightheaded and required assistance to walk and had difficulty articulating herself. Patient became nauseated but did not vomit, and exhaustion continued to worsen and her pulse was 48 just a few hours later on 06Apr2021. The patient had some chills and intermittent pain on her left side on 06Apr2021. On 08Apr2021, by Thursday evening, patient had a headache that lasted almost 20 hours after 3 doses of paracetamol (TYLENOL). Nausea, mild shaking and felt malaise began Friday afternoon on 09Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of headache included paracetamol (TYLENOL). No treatment was received for the other events. The clinical outcome of headache was recovered on 09Apr2021; outcome of the other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate decreased, Malaise, Nausea
Clinical narrative: Mild shaking; Feeling malaise; By Thursday evening I had a headache; I was so weak and lightheaded; I required assistance to walk; Was having difficulty articulating herself; I became nauseated, but did not vomit/ Nausea; The exhaustion continued to worsen; my pulse was 48 just a few hours later; I had some chills; Intermittent pain on left side; I was so weak and lightheaded/ I started getting weak; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7533), via an unspecified route of administration in left arm on 06Apr2021 at 13:00 (at the age of 50-year-old) at single dose for COVID-19 immunisation. Medical history included adrenal Insufficiency, lupus, Crohn's, celiac, vitiligo (reported as Vitaligo), Raynauds-1, MTHFR mutation, migraines, gastroesophageal reflux disease (GERD), renal cysts, mild myopathy, mild neuropathy, patient had known allergies to penicillin, antihistamine, sulfa, gluten and contrast. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included belimumab (BENLYSTA), modafinil (PROVIGIL), levothyroxine sodium (SYNTHROID), hydrocortisone and R. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously took diazepam (VALIUM), codeine, tramadol, trazodone (reported as trazadone), risedronate sodium (ATELVIA) and all had known allergies. On 06Apr2021, within 4 minutes, the patient started getting weak. After 30 minutes at 13:30 on 06Apr2021, patient was so weak and lightheaded and required assistance to walk and had difficulty articulating herself. Patient became nauseated but did not vomit, and exhaustion continued to worsen and her pulse was 48 just a few hours later on 06Apr2021. The patient had some chills and intermittent pain on her left side on 06Apr2021. On 08Apr2021, by Thursday evening, patient had a headache that lasted almost 20 hours after 3 doses of paracetamol (TYLENOL). Nausea, mild shaking and felt malaise began Friday afternoon on 09Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of headache included paracetamol (TYLENOL). No treatment was received for the other events. The clinical outcome of headache was recovered on 09Apr2021; outcome of the other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Speech disorder, Tremor
Clinical narrative: Mild shaking; Feeling malaise; By Thursday evening I had a headache; I was so weak and lightheaded; I required assistance to walk; Was having difficulty articulating herself; I became nauseated, but did not vomit/ Nausea; The exhaustion continued to worsen; my pulse was 48 just a few hours later; I had some chills; Intermittent pain on left side; I was so weak and lightheaded/ I started getting weak; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7533), via an unspecified route of administration in left arm on 06Apr2021 at 13:00 (at the age of 50-year-old) at single dose for COVID-19 immunisation. Medical history included adrenal Insufficiency, lupus, Crohn's, celiac, vitiligo (reported as Vitaligo), Raynauds-1, MTHFR mutation, migraines, gastroesophageal reflux disease (GERD), renal cysts, mild myopathy, mild neuropathy, patient had known allergies to penicillin, antihistamine, sulfa, gluten and contrast. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included belimumab (BENLYSTA), modafinil (PROVIGIL), levothyroxine sodium (SYNTHROID), hydrocortisone and R. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously took diazepam (VALIUM), codeine, tramadol, trazodone (reported as trazadone), risedronate sodium (ATELVIA) and all had known allergies. On 06Apr2021, within 4 minutes, the patient started getting weak. After 30 minutes at 13:30 on 06Apr2021, patient was so weak and lightheaded and required assistance to walk and had difficulty articulating herself. Patient became nauseated but did not vomit, and exhaustion continued to worsen and her pulse was 48 just a few hours later on 06Apr2021. The patient had some chills and intermittent pain on her left side on 06Apr2021. On 08Apr2021, by Thursday evening, patient had a headache that lasted almost 20 hours after 3 doses of paracetamol (TYLENOL). Nausea, mild shaking and felt malaise began Friday afternoon on 09Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of headache included paracetamol (TYLENOL). No treatment was received for the other events. The clinical outcome of headache was recovered on 09Apr2021; outcome of the other events was not recovered.  No follow-up attempts are needed. No further information is expected.