chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin burning sensation
Clinical narrative: Diffuse red splotches that appeared like severe sunburn; Rash appeared as red, raised areas causing itching and burning; Rash appeared as red, raised areas causing itching and burning; Raised hive like areas; itching - mostly on face, neck and head which were the areas most recently to erupt; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200), via an unspecified route of administration, administered in right arm on 23Feb2021 (at the age of 85 years old), at second dose, single dose for COVID-19 immunisation. Medical history included atrial fib, CAD, DM type 2, implanted pacer/defib, gout, and known allergies to Sulfa. Concomitant medications included glipizide, amiodarone, apixaban (ELIQUIS), propranolol hydrochloride (INDERAL), levothyroxine, atorvastatin, furosemide (LASIX), and lisinopril. On 04Mar2021, rash developed in groin area and forearms 9 days after the second injection. Rash appeared as red, raised areas causing itching and burning. Rash continued to evolve migrating to abdomen, chest, legs, buttocks, back, face and head between 05Mar2021 and 09Mar2021. Raised hive like areas would morph into diffuse red splotches that appeared like severe sunburn, usually within 24-48 hrs. The patient consulted his physician on 05Mar2021, and cortisone 120 mg injection was administered with further direction to take diphenhydramine (BENADRYL).On 08Mar2021, cetirizine (ZYRTEC) was added to the regimen. As of report date, the patient was still experiencing itching - mostly on face, neck and head which were the areas most recently to erupt. The patient has no other symptoms other than those related to the rash. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, and treatment received included cortisone injection, BENADRYL, and ZYRTEC. The patient had no COVID prior vaccination and was not COVID tested post vaccination. The patient experienced only soreness in arm following first injection of BNT162B2 given for COVID-19 immunisation. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash erythematous, Rash macular, Rash papular, Rash pruritic, Urticaria
Clinical narrative: Diffuse red splotches that appeared like severe sunburn; Rash appeared as red, raised areas causing itching and burning; Rash appeared as red, raised areas causing itching and burning; Raised hive like areas; itching - mostly on face, neck and head which were the areas most recently to erupt; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200), via an unspecified route of administration, administered in right arm on 23Feb2021 (at the age of 85 years old), at second dose, single dose for COVID-19 immunisation. Medical history included atrial fib, CAD, DM type 2, implanted pacer/defib, gout, and known allergies to Sulfa. Concomitant medications included glipizide, amiodarone, apixaban (ELIQUIS), propranolol hydrochloride (INDERAL), levothyroxine, atorvastatin, furosemide (LASIX), and lisinopril. On 04Mar2021, rash developed in groin area and forearms 9 days after the second injection. Rash appeared as red, raised areas causing itching and burning. Rash continued to evolve migrating to abdomen, chest, legs, buttocks, back, face and head between 05Mar2021 and 09Mar2021. Raised hive like areas would morph into diffuse red splotches that appeared like severe sunburn, usually within 24-48 hrs. The patient consulted his physician on 05Mar2021, and cortisone 120 mg injection was administered with further direction to take diphenhydramine (BENADRYL).On 08Mar2021, cetirizine (ZYRTEC) was added to the regimen. As of report date, the patient was still experiencing itching - mostly on face, neck and head which were the areas most recently to erupt. The patient has no other symptoms other than those related to the rash. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, and treatment received included cortisone injection, BENADRYL, and ZYRTEC. The patient had no COVID prior vaccination and was not COVID tested post vaccination. The patient experienced only soreness in arm following first injection of BNT162B2 given for COVID-19 immunisation. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Diffuse red splotches that appeared like severe sunburn; Rash appeared as red, raised areas causing itching and burning; Rash appeared as red, raised areas causing itching and burning; Raised hive like areas; itching - mostly on face, neck and head which were the areas most recently to erupt; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200), via an unspecified route of administration, administered in right arm on 23Feb2021 (at the age of 85 years old), at second dose, single dose for COVID-19 immunisation. Medical history included atrial fib, CAD, DM type 2, implanted pacer/defib, gout, and known allergies to Sulfa. Concomitant medications included glipizide, amiodarone, apixaban (ELIQUIS), propranolol hydrochloride (INDERAL), levothyroxine, atorvastatin, furosemide (LASIX), and lisinopril. On 04Mar2021, rash developed in groin area and forearms 9 days after the second injection. Rash appeared as red, raised areas causing itching and burning. Rash continued to evolve migrating to abdomen, chest, legs, buttocks, back, face and head between 05Mar2021 and 09Mar2021. Raised hive like areas would morph into diffuse red splotches that appeared like severe sunburn, usually within 24-48 hrs. The patient consulted his physician on 05Mar2021, and cortisone 120 mg injection was administered with further direction to take diphenhydramine (BENADRYL).On 08Mar2021, cetirizine (ZYRTEC) was added to the regimen. As of report date, the patient was still experiencing itching - mostly on face, neck and head which were the areas most recently to erupt. The patient has no other symptoms other than those related to the rash. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, and treatment received included cortisone injection, BENADRYL, and ZYRTEC. The patient had no COVID prior vaccination and was not COVID tested post vaccination. The patient experienced only soreness in arm following first injection of BNT162B2 given for COVID-19 immunisation. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: day after vaccine dizzy spells as soon as I got out of bed.Still having when bend down or move to fast on second day after.; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 67-years-old non-pregnant elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Right Arm on 07Mar2021 at 11:15 (at the age of 67-years old) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included seasonal allergy and had known allergies of morphine and Claritin. The concomitants includes (other medications within 2weeks) omeprazole, cetirizine hydrochloride, pravastatin and CoQ10. The patient did not suffer from COVID prior vaccination. The patient did not test COVID positive post vaccination. The patient did not receive any other vaccine within 4weeks of COVID vaccination. On 08Mar2021 06:00, (a day after vaccine), patient had dizzy spells as soon as she got out of bed, still having when bend down or move to fast on second day after. The patient did not receive treatment for the events. The outcome for the event was not recovered/not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Erythema, Fatigue, Pain, Pruritus
Clinical narrative: Severe and unusual itchiness; Bruised; Severe itchy throat; Ears achiness; Soreness; Lethargic feeling; This is a spontaneous report from a contactable consumer (patient herself). This 29-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly on the left arm on 06Mar2021 at 09:45 AM (Batch/Lot number EN6205) (at the age of 29-year old) at single dose for Covid-19 immunization. Relevant medical history included depression, polycystic ovarian syndrome (PCOS), food allergy to tree nuts, avocados, cantaloupe, sunflower seeds. Concomitant medications included bupropion, fluoxetine, spironolactone, cetirizine (ZYRTEC OTC). On 06Mar2021 at 11:00 AM the patient experienced severe and unusual itchiness, when scratched bruised immediately, severe itchy throat and ears achiness, soreness, lethargic feeling. The patient was treated with dyphenhydramine (BENADRYL), paracetamol (TYLENOL) and ibuprofen due to the events. The outcome of the events was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Throat irritation
Clinical narrative: Severe and unusual itchiness; Bruised; Severe itchy throat; Ears achiness; Soreness; Lethargic feeling; This is a spontaneous report from a contactable consumer (patient herself). This 29-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly on the left arm on 06Mar2021 at 09:45 AM (Batch/Lot number EN6205) (at the age of 29-year old) at single dose for Covid-19 immunization. Relevant medical history included depression, polycystic ovarian syndrome (PCOS), food allergy to tree nuts, avocados, cantaloupe, sunflower seeds. Concomitant medications included bupropion, fluoxetine, spironolactone, cetirizine (ZYRTEC OTC). On 06Mar2021 at 11:00 AM the patient experienced severe and unusual itchiness, when scratched bruised immediately, severe itchy throat and ears achiness, soreness, lethargic feeling. The patient was treated with dyphenhydramine (BENADRYL), paracetamol (TYLENOL) and ibuprofen due to the events. The outcome of the events was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Ear pain, Lethargy, Pain, Pruritus
Clinical narrative: Severe and unusual itchiness; Bruised; Severe itchy throat; Ears achiness; Soreness; Lethargic feeling; This is a spontaneous report from a contactable consumer (patient herself). This 29-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly on the left arm on 06Mar2021 at 09:45 AM (Batch/Lot number EN6205) (at the age of 29-year old) at single dose for Covid-19 immunization. Relevant medical history included depression, polycystic ovarian syndrome (PCOS), food allergy to tree nuts, avocados, cantaloupe, sunflower seeds. Concomitant medications included bupropion, fluoxetine, spironolactone, cetirizine (ZYRTEC OTC). On 06Mar2021 at 11:00 AM the patient experienced severe and unusual itchiness, when scratched bruised immediately, severe itchy throat and ears achiness, soreness, lethargic feeling. The patient was treated with dyphenhydramine (BENADRYL), paracetamol (TYLENOL) and ibuprofen due to the events. The outcome of the events was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: Severe and unusual itchiness; Bruised; Severe itchy throat; Ears achiness; Soreness; Lethargic feeling; This is a spontaneous report from a contactable consumer (patient herself). This 29-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly on the left arm on 06Mar2021 at 09:45 AM (Batch/Lot number EN6205) (at the age of 29-year old) at single dose for Covid-19 immunization. Relevant medical history included depression, polycystic ovarian syndrome (PCOS), food allergy to tree nuts, avocados, cantaloupe, sunflower seeds. Concomitant medications included bupropion, fluoxetine, spironolactone, cetirizine (ZYRTEC OTC). On 06Mar2021 at 11:00 AM the patient experienced severe and unusual itchiness, when scratched bruised immediately, severe itchy throat and ears achiness, soreness, lethargic feeling. The patient was treated with dyphenhydramine (BENADRYL), paracetamol (TYLENOL) and ibuprofen due to the events. The outcome of the events was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated
Clinical narrative: Migration of complex regional pain syndrome; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6206, Expiration date was unknown), via an unspecified route of administration, administered in left arm on 08Mar2021 at 07:30 as 1st dose, single dose for covid-19 immunization. The patient medical history was not reported. Patient had no other vaccine in four weeks. Patient had no COVID prior to vaccination. Concomitant medication(s) included propranolol and omeprazole (taken for an unspecified indication, start and stop date were not reported). On 08Mar2021 at 08:30 hours, patient had migration of complex regional pain syndrome. Patient received no treatment for the event. Patient was not tested for COVID post vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Complex regional pain syndrome
Clinical narrative: Migration of complex regional pain syndrome; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6206, Expiration date was unknown), via an unspecified route of administration, administered in left arm on 08Mar2021 at 07:30 as 1st dose, single dose for covid-19 immunization. The patient medical history was not reported. Patient had no other vaccine in four weeks. Patient had no COVID prior to vaccination. Concomitant medication(s) included propranolol and omeprazole (taken for an unspecified indication, start and stop date were not reported). On 08Mar2021 at 08:30 hours, patient had migration of complex regional pain syndrome. Patient received no treatment for the event. Patient was not tested for COVID post vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Movement disorder, Pain
Clinical narrative: 6 years ago I had chip in L elbow, pain.  could not bend elbow in comfort, to touch face difficult to dress etc.  2 days after vaccine I had the same thing happen; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (Pfizer BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Lot number: EN6206 and Expiration date: unknown), dose 1 via an unknown route of administration in left arm on 04Mar2021 11:45 as single dose for covid-19 immunization at  facility. Medical history included Aspirin Reyes syndrome as child. There were no concomitant medications. The patient has not tested positive for covid prior and post vaccination. No other vaccine in four weeks nor Other medications in two weeks. On 06Mar2021 09:00 (2 days after vaccine as reported), the patient experienced the same thing which happened 6 years ago, he had chip in l elbow, pain. could not bend elbow in comfort, to touch face difficult to dress etc. First time in 6 years. Possible coincidence, possible side effect, better: not well yet. It was unknown if patient received treatment. Outcome of event was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: 6 years ago I had chip in L elbow, pain.  could not bend elbow in comfort, to touch face difficult to dress etc.  2 days after vaccine I had the same thing happen; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (Pfizer BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Lot number: EN6206 and Expiration date: unknown), dose 1 via an unknown route of administration in left arm on 04Mar2021 11:45 as single dose for covid-19 immunization at  facility. Medical history included Aspirin Reyes syndrome as child. There were no concomitant medications. The patient has not tested positive for covid prior and post vaccination. No other vaccine in four weeks nor Other medications in two weeks. On 06Mar2021 09:00 (2 days after vaccine as reported), the patient experienced the same thing which happened 6 years ago, he had chip in l elbow, pain. could not bend elbow in comfort, to touch face difficult to dress etc. First time in 6 years. Possible coincidence, possible side effect, better: not well yet. It was unknown if patient received treatment. Outcome of event was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Muscle twitching
Clinical narrative: Flushed face; face twitching; Light headedness; This is a spontaneous report received from a contactable healthcare professional. A 43-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 in the left arm on 17Mar2021 at 15:00 PM (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included Diabetes Type 2 from an unknown date. The patient reported being allergic to Penicillin and Sulpha. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. On 17Mar2021 at 15:00 PM, the patient experienced flushed face after the vaccine was administered. He also felt both sides of the face being twitched and light headedness. The patient did not receive any treatment for flushed face, twitched face and light headedness. The clinical outcome of flushed face, twitched face and light headedness were reported as not recovered.   Information about Lot number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysstasia, Hypoaesthesia, Mobility decreased, Pain, Paraesthesia
Clinical narrative: I had the vaccine on my left side. The EMT who administered the vaccine did not properly inject the area on my shoulder. Due to the negligence I am sufferings a shoulder injury.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral coldness, Shoulder injury related to vaccine administration, X-ray
Clinical narrative: I had the vaccine on my left side. The EMT who administered the vaccine did not properly inject the area on my shoulder. Due to the negligence I am sufferings a shoulder injury.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Shoulder injury related to vaccine administration, Wrong technique in product usage process, X-ray limb
Clinical narrative: I had the vaccine on my left side. The EMT who administered the vaccine did not properly inject the area on my shoulder. Due to the negligence I am sufferings a shoulder injury.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: I had the vaccine on my left side. The EMT who administered the vaccine did not properly inject the area on my shoulder. Due to the negligence I am sufferings a shoulder injury.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Sluggishness, Syncope
Clinical narrative: Pt received vaccine and walked to chair, immediately after sitting patient said he felt light-headed then immediately passed out. He is unsure if he last conscious. The vaccine nurses immediately went to assess the patient and was awake and oriented. VS 44, 86/46 02 sat 98%. Pt is accompanied by his father. Both reported that the patient had a syncopal episode approximately 4 years ago after he had his blood taken. Currently, the BP is 110/62. 02 is 98% on 2l nasal cannula. Blood sugar is 126. paramedic arrived. VS 115/63 heart rate 55. Patient stood up and immediately felt light-headed again and felt as if he was going to pass out again. Pt transferred accompanied by paramedic to the hospital for further evaluation.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt received vaccine and walked to chair, immediately after sitting patient said he felt light-headed then immediately passed out. He is unsure if he last conscious. The vaccine nurses immediately went to assess the patient and was awake and oriented. VS 44, 86/46 02 sat 98%. Pt is accompanied by his father. Both reported that the patient had a syncopal episode approximately 4 years ago after he had his blood taken. Currently, the BP is 110/62. 02 is 98% on 2l nasal cannula. Blood sugar is 126. paramedic arrived. VS 115/63 heart rate 55. Patient stood up and immediately felt light-headed again and felt as if he was going to pass out again. Pt transferred accompanied by paramedic to the hospital for further evaluation.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Flushing, Hyperhidrosis, Hypotension, Syncope, Unresponsive to stimuli
Clinical narrative: Passed out; Warm sensation; Sweating; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 01Apr2021 (at the age of 46-year-old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On 01Apr2021 (10 mins after receiving the vaccine), the patient passed out, had warm sensation and sweating. Patient was later transported to medical centre. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Hyperhidrosis, Loss of consciousness
Clinical narrative: Passed out; Warm sensation; Sweating; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 01Apr2021 (at the age of 46-year-old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On 01Apr2021 (10 mins after receiving the vaccine), the patient passed out, had warm sensation and sweating. Patient was later transported to medical centre. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Myalgia, Pain in extremity, Pelvic pain, Tinnitus
Clinical narrative: tinnitus and hearing loss in left ear.; tinnitus and hearing loss in left ear.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0161) via an unspecified route of administration, administered in the left arm on 11Apr2021 15:30 (at the age of 51 years old) as first dose, single dose for COVID-19 immunisation. Medical history included asthma, alopecia areata, atopic dermatitis and allergies to penicillin; all from unknown dates and unknown if ongoing. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), fish oil and vitamins. The patient did not receive any other vaccine in 4 weeks. The patient experienced tinnitus and hearing loss in left ear on 11Apr2021. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included prednisone. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: tinnitus and hearing loss in left ear.; tinnitus and hearing loss in left ear.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0161) via an unspecified route of administration, administered in the left arm on 11Apr2021 15:30 (at the age of 51 years old) as first dose, single dose for COVID-19 immunisation. Medical history included asthma, alopecia areata, atopic dermatitis and allergies to penicillin; all from unknown dates and unknown if ongoing. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), fish oil and vitamins. The patient did not receive any other vaccine in 4 weeks. The patient experienced tinnitus and hearing loss in left ear on 11Apr2021. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included prednisone. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye disorder, Injection, Magnetic resonance imaging, Tremor, Vision blurred
Clinical narrative: I suffered an eye stroke and tremors I went to my eye dr for a check on my right eye and told him I had very if little sight in my left eye they ran  tests and my dr said I had an eye stroke I been in his office approximately 14 days earlier befythe bust when he found the eye  stoke my left eye was perfectly fine then Before going to the eye dr I devoted really bad tremors and I had several tests  to see what caused it it has mostly went away I still have tremors aliitte
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ophthalmological examination, Retinal artery occlusion, Tremor
Clinical narrative: I suffered an eye stroke and tremors I went to my eye dr for a check on my right eye and told him I had very if little sight in my left eye they ran  tests and my dr said I had an eye stroke I been in his office approximately 14 days earlier befythe bust when he found the eye  stoke my left eye was perfectly fine then Before going to the eye dr I devoted really bad tremors and I had several tests  to see what caused it it has mostly went away I still have tremors aliitte
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Ear discomfort, Magnetic resonance imaging normal, Tinnitus
Clinical narrative: Sudden hearing loss in left ear; Tinnitus; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 07Apr2021 10:15 (at 49 years old) as 1st dose, single dose for COVID-19 immunization given in an public health department. The patient's medical history was none. Concomitant medication included amitriptyline taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested since vaccination. No known allergies. On 12Apr2021 07:00, the patient experienced sudden hearing loss in left ear and tinnitus. The patient had a physician office visit and was treated with prednisone and steroid injections. The reporter assessed the events as non-serious and the events did not lead to death or life threatening condition, hospitalization, disability, or congenital anomaly. The outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Sudden hearing loss in left ear; Tinnitus; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 07Apr2021 10:15 (at 49 years old) as 1st dose, single dose for COVID-19 immunization given in an public health department. The patient's medical history was none. Concomitant medication included amitriptyline taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested since vaccination. No known allergies. On 12Apr2021 07:00, the patient experienced sudden hearing loss in left ear and tinnitus. The patient had a physician office visit and was treated with prednisone and steroid injections. The reporter assessed the events as non-serious and the events did not lead to death or life threatening condition, hospitalization, disability, or congenital anomaly. The outcome of the events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Heart rate increased, Pain, Sleep disorder
Clinical narrative: 3/28/21: 3 days after the shot, started having extreme heart palpitations that was painful and kept the patient up at night. Lasted for 3 days Shortly after the heart related adverse event, patient started experiencing pain in her side that would "come and go" for months until 6/6/21, when the pain did not go away but was so severe that she started becoming nauseous from it. Patient went to the hospital where they found a clot to her kidney that cut circulation, resulting in the loss of part of her kidney
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Flank pain, Imaging procedure abnormal, Nausea, Pain
Clinical narrative: 3/28/21: 3 days after the shot, started having extreme heart palpitations that was painful and kept the patient up at night. Lasted for 3 days Shortly after the heart related adverse event, patient started experiencing pain in her side that would "come and go" for months until 6/6/21, when the pain did not go away but was so severe that she started becoming nauseous from it. Patient went to the hospital where they found a clot to her kidney that cut circulation, resulting in the loss of part of her kidney
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Renal vein thrombosis, Sleep disorder
Clinical narrative: 3/28/21: 3 days after the shot, started having extreme heart palpitations that was painful and kept the patient up at night. Lasted for 3 days Shortly after the heart related adverse event, patient started experiencing pain in her side that would "come and go" for months until 6/6/21, when the pain did not go away but was so severe that she started becoming nauseous from it. Patient went to the hospital where they found a clot to her kidney that cut circulation, resulting in the loss of part of her kidney
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Injection site reaction, Mobility decreased, Pain in extremity, Pruritus
Clinical narrative: the pain in my arm was bad; I developed a bright red welt (not like hives) about palm sized; just like an allergic reaction; An hour after shot I started itching all over my body; This is a spontaneous report from a contactable consumer (patient) via COVAES. A 36-years-old female patient received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), dose 1 via an unspecified route of administration, administered in right arm on 29Apr2021 (at the age of 36 years old) as 1st dose, single dose for covid-19 immunization. Medical history included allergy to penicillin from unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19. In Aug2020 patient had nasal Swab test which was negative. Since the vaccination, patient has been tested for COVID-19. On 29 Apr2021 an hour after shot patient started itching all over her body just like an allergic reaction. It went away after taking an allergy pill. The next day, the pain in her arm was bad and she developed a bright red welt (not like hives) about palm sized on the front of her arm about two inches below her injection site as well as a round welt on the backside of my arm (this looked more like an injection reaction). This dissipated a few days later. No pain or itching from the welt. The outcome of the events was recovered.  No follow up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: the pain in my arm was bad; I developed a bright red welt (not like hives) about palm sized; just like an allergic reaction; An hour after shot I started itching all over my body; This is a spontaneous report from a contactable consumer (patient) via COVAES. A 36-years-old female patient received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), dose 1 via an unspecified route of administration, administered in right arm on 29Apr2021 (at the age of 36 years old) as 1st dose, single dose for covid-19 immunization. Medical history included allergy to penicillin from unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19. In Aug2020 patient had nasal Swab test which was negative. Since the vaccination, patient has been tested for COVID-19. On 29 Apr2021 an hour after shot patient started itching all over her body just like an allergic reaction. It went away after taking an allergy pill. The next day, the pain in her arm was bad and she developed a bright red welt (not like hives) about palm sized on the front of her arm about two inches below her injection site as well as a round welt on the backside of my arm (this looked more like an injection reaction). This dissipated a few days later. No pain or itching from the welt. The outcome of the events was recovered.  No follow up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Pain in extremity, Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: the pain in my arm was bad; I developed a bright red welt (not like hives) about palm sized; just like an allergic reaction; An hour after shot I started itching all over my body; This is a spontaneous report from a contactable consumer (patient) via COVAES. A 36-years-old female patient received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), dose 1 via an unspecified route of administration, administered in right arm on 29Apr2021 (at the age of 36 years old) as 1st dose, single dose for covid-19 immunization. Medical history included allergy to penicillin from unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19. In Aug2020 patient had nasal Swab test which was negative. Since the vaccination, patient has been tested for COVID-19. On 29 Apr2021 an hour after shot patient started itching all over her body just like an allergic reaction. It went away after taking an allergy pill. The next day, the pain in her arm was bad and she developed a bright red welt (not like hives) about palm sized on the front of her arm about two inches below her injection site as well as a round welt on the backside of my arm (this looked more like an injection reaction). This dissipated a few days later. No pain or itching from the welt. The outcome of the events was recovered.  No follow up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever; headache; sore arm; This is a spontaneous report from a contactable consumer (patient). This 37-year old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0165) via an unspecified route of administration on 06May2021 at 16:45 (at the age of 37-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not take any concomitant medications. The patient previously received aspirin from an unknown date for an unknown indication and experienced allergy. The patient previously received dose 1 of BNT162B2 (lot number EW0162) on 15Apr2021 at 16:45 as a single dose in the left arm for COVID-19 immunization. On 07May2021 at 12:00 the patient experienced fever, headache and sore arm 24-48 hours after vaccine was administered. The patient did not receive any treatment for the events. The outcomes of fever, headache, and sore arm were not recovering (as reported). It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Echocardiogram, Electrocardiogram abnormal, Myocarditis, Troponin increased
Clinical narrative: chest pain and trouble breathing/diagnosed with myocarditis; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm, on 08May2021 11:30 (lot number: 0151), as 2nd dose, single dose, at age 17 years old, for COVID-19 immunisation, at a pharmacy/drug store. There was no medical history and no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2; (PFIZER-BIONTECH COVID-19 VACCINE), administered in the left arm, on 17Apr2021 10:30 (lot number: EW0151), at age 17 years old, for COVID-19 immunisation The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 09May2021, the patient experienced chest pain and trouble breathing. The hospital diagnosed the patient with myocarditis. The event resulted to emergency room visit and hospitalization on an unspecified date. Duration of hospitalization was 4 days. Treatment included ibuprofen. The patient was recovering from the event.  Follow-up attempts are needed. Further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: chest pain and trouble breathing/diagnosed with myocarditis; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm, on 08May2021 11:30 (lot number: 0151), as 2nd dose, single dose, at age 17 years old, for COVID-19 immunisation, at a pharmacy/drug store. There was no medical history and no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2; (PFIZER-BIONTECH COVID-19 VACCINE), administered in the left arm, on 17Apr2021 10:30 (lot number: EW0151), at age 17 years old, for COVID-19 immunisation The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 09May2021, the patient experienced chest pain and trouble breathing. The hospital diagnosed the patient with myocarditis. The event resulted to emergency room visit and hospitalization on an unspecified date. Duration of hospitalization was 4 days. Treatment included ibuprofen. The patient was recovering from the event.  Follow-up attempts are needed. Further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Echocardiogram, Electrocardiogram
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's mother) and a contactable other healthcare professional. This consumer reported similar events for two patients (twins). This is the first of two reports.  A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170), via an unspecified route of administration, administered in the left arm, on 26Apr2021 10:00 (at the age of 22-year-old) as 2nd dose, single dose for COVID-19 immunization, at a pharmacy/drug store. Medical history included ongoing rare metabolic disorder. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8735) received at age 22 years, on 05Apr2021, for COVID-19 immunisation. On 26Apr2021, the patient received the second dose of BNT162B2. In the evening of the same day, 26Apr2021, the patient experienced tiredness/fatigue, and headache. In the morning of 27Apr2021, the patient was feeling really crappy and they though it was like the flu and it would pass. In the evening of 27Apr2021, the patient didn't sleep at all and was uncomfortable all night and pain. On the same day, 27Apr2021, the patient had severe chest pain, chest tightness, and lightheadedness. On 28Apr2021, the pain didn't go away, and the twins had elevated ST evaluation on the EKG (electrocardiograph). ST evaluation was done by the reporter's husband who is a retired firefighter emergency medical technician. The reporter decided to take the patient to hospital and said that the other twin had the same symptoms but kept saying his wasn't as bad as his brother's because he did not want to go to the hospital. The doctor advised the reporter to bring the other twin. The twins had the same echo cardiogram on 28Apr2021 (unknown results). On 28Apr2021, their troponin levels were elevated, and their cardiac enzymes continued to go up. On the same day, 28Apr2021, the patient had a strange weird bilateral wrist pain severe. It was reported that the twins were hospitalized on 28Apr2021 with myocarditis/pericarditis and inflammation around the heart. Treatment for myocarditis/pericarditis included ibuprofen and colchicine; and Toradol for breakthrough pain. The reporter stated that the twins are two identical males with the same DNA, had the vaccine at the same time, had the reactions at the same length of time, have the same lifestyle and live at the same house. The reporter said it would go a long way if they help her understand the complication. The patient recovered "strange weird bilateral wrist pain severe" on 29Apr2021. The outcome of the event myocarditis and pericarditis/inflammation around the heart was not recovered.  Follow-up (14May2021): New information received from a contactable other healthcare professional includes: reporter details (other hcp added as a new reporter).  Follow-up attempts are needed. Further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ST segment elevation, Fatigue, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's mother) and a contactable other healthcare professional. This consumer reported similar events for two patients (twins). This is the first of two reports.  A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170), via an unspecified route of administration, administered in the left arm, on 26Apr2021 10:00 (at the age of 22-year-old) as 2nd dose, single dose for COVID-19 immunization, at a pharmacy/drug store. Medical history included ongoing rare metabolic disorder. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8735) received at age 22 years, on 05Apr2021, for COVID-19 immunisation. On 26Apr2021, the patient received the second dose of BNT162B2. In the evening of the same day, 26Apr2021, the patient experienced tiredness/fatigue, and headache. In the morning of 27Apr2021, the patient was feeling really crappy and they though it was like the flu and it would pass. In the evening of 27Apr2021, the patient didn't sleep at all and was uncomfortable all night and pain. On the same day, 27Apr2021, the patient had severe chest pain, chest tightness, and lightheadedness. On 28Apr2021, the pain didn't go away, and the twins had elevated ST evaluation on the EKG (electrocardiograph). ST evaluation was done by the reporter's husband who is a retired firefighter emergency medical technician. The reporter decided to take the patient to hospital and said that the other twin had the same symptoms but kept saying his wasn't as bad as his brother's because he did not want to go to the hospital. The doctor advised the reporter to bring the other twin. The twins had the same echo cardiogram on 28Apr2021 (unknown results). On 28Apr2021, their troponin levels were elevated, and their cardiac enzymes continued to go up. On the same day, 28Apr2021, the patient had a strange weird bilateral wrist pain severe. It was reported that the twins were hospitalized on 28Apr2021 with myocarditis/pericarditis and inflammation around the heart. Treatment for myocarditis/pericarditis included ibuprofen and colchicine; and Toradol for breakthrough pain. The reporter stated that the twins are two identical males with the same DNA, had the vaccine at the same time, had the reactions at the same length of time, have the same lifestyle and live at the same house. The reporter said it would go a long way if they help her understand the complication. The patient recovered "strange weird bilateral wrist pain severe" on 29Apr2021. The outcome of the event myocarditis and pericarditis/inflammation around the heart was not recovered.  Follow-up (14May2021): New information received from a contactable other healthcare professional includes: reporter details (other hcp added as a new reporter).  Follow-up attempts are needed. Further information is expected.