chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Posture abnormal, Somnolence
Clinical narrative: It was reported to this writer, RN that 11 year-old male minor patient accompanied by his mother was vaccinated on 11/08/2021 for Pfizer COVID-19 vaccination by LPN at 03:58pm. Patient and his mother reported patient initially tolerated vaccination well and was stable when escorted to clinical site. Around 4:04pm when patient was sitting in post-vaccination observation area with mother, his mother noticed that he was not feeling well while both were sitting in chairs. Mother reports she noticed that her son became disoriented and per her report ?began bobbing his head back and forth with his eyes closed?. It was reported to this writer that RN who was assisting in supervising patients in the post-vaccination observation area responded while patient was seated and assessed that he was pale and drowsy. RN reported she gave the patient apple juice. Shortly after the patient stated that he felt better and was escorted by RN with mother present to private medical cot area to lie down. This writer immediately responded to the medical incident to support clinical staff and observed the patient was stable but still pale. RN took serial vitals for patient that were within defined limits. Patient was given more apple juice and said he felt better at 04:09pm and told his mother with clinical staff present that he only had a small snack after school and 1 hour before his mother had picked him up from school. Patient also stated that when clinical staff in post-observation area began talking again about possible vaccine side effects with mother that patient said he got scared and anxious. After 10 minutes of resting on the medical cot with mother and RN staff present and another round of stable vital signs noted by RNs, patient stated he felt good and slowly stood up at the side of the cot. Patient denied any dizziness or feelings of weakness. Patient skin color returned with defined limits, no paleness noted. Patient ambulated in the care of his mother who was driving them both home at that time out of the clinic without any issues or adventitious findings at 04:21pm.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dysgraphia, Magnetic resonance imaging, Reading disorder
Clinical narrative: For about 10 minutes could not properly read or write. Upon hospitalization CTs, MRIs, and bloodwork did not show anything conclusive. Doctors diagnosed a TIA (mini stroke).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack, Ultrasound scan
Clinical narrative: For about 10 minutes could not properly read or write. Upon hospitalization CTs, MRIs, and bloodwork did not show anything conclusive. Doctors diagnosed a TIA (mini stroke).
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus
Clinical narrative: Patient was  itchy and slight difficulty in breathing.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Neck pain
Clinical narrative: Started shortly after midnight?. Chills for 3 hours, feeling as I had been buried in snow. Then, a fever of 100.2, took an Aleve, one hour later the fever was 101.2, took another Aleve and put a cool washcloth on my forehead.  Fever back to normal  at 6:00 a.m.  Then a huge headache and aches in my neck and shoulders. After 16 hours, the pain went away and I was really tired for three days. I wanted someone to know this because I am getting my booster this coming Friday, November 12,2021. I am hesitant on getting it since I had severe reactions to be my Covid-19 second shot.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Started shortly after midnight?. Chills for 3 hours, feeling as I had been buried in snow. Then, a fever of 100.2, took an Aleve, one hour later the fever was 101.2, took another Aleve and put a cool washcloth on my forehead.  Fever back to normal  at 6:00 a.m.  Then a huge headache and aches in my neck and shoulders. After 16 hours, the pain went away and I was really tired for three days. I wanted someone to know this because I am getting my booster this coming Friday, November 12,2021. I am hesitant on getting it since I had severe reactions to be my Covid-19 second shot.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Dizziness, Lethargy, Malaise, Myocardial infarction
Clinical narrative: Death- after vaccine patient was ill with dizziness and lethargia. Patient went to bed at 8pm that night. Patient was found deceased the next day when housemate went to wake him up. Patient had no prior history of underlying health complications. Cause of death ruled to be sudden unexpected heart attack.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Fever, chills, headache, body ache, lack of apetite, impaired sense of smell and taste, extremely sore arm, significant fatigue.  It's been more than one week, arm is still sore and still suffer from significant fatigue and overall lower feeling of wellbeing.  Also sense of taste and smell still impaired.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Pain in extremity, Pyrexia, Taste disorder
Clinical narrative: Fever, chills, headache, body ache, lack of apetite, impaired sense of smell and taste, extremely sore arm, significant fatigue.  It's been more than one week, arm is still sore and still suffer from significant fatigue and overall lower feeling of wellbeing.  Also sense of taste and smell still impaired.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Dry eye, Heavy menstrual bleeding, Hordeolum, Intermenstrual bleeding
Clinical narrative: Developed eye pain that turned into a sty in lower left eyelid. Sty burst 7 days later. Cycle started the day after eye symptom; heavier and spotted for three day after cycle normal 5 days. Canker sore in mouth 11/7/2021.  Started cycle again two weeks early 11/8/2021, second dose same day but after the cycle started.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Developed eye pain that turned into a sty in lower left eyelid. Sty burst 7 days later. Cycle started the day after eye symptom; heavier and spotted for three day after cycle normal 5 days. Canker sore in mouth 11/7/2021.  Started cycle again two weeks early 11/8/2021, second dose same day but after the cycle started.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Papule, Pruritus, Urticaria
Clinical narrative: Received the Pfizer covid 19 booster on 10/21/2021 and two days later started having hives on various parts of my torso: lower back, shoulders, thighs, stomach, and neck. Small bumps would pop up, itch like crazy for 15-20 minutes and then subside leaving a small red hive. Occurred mainly early evening and early morning. This lasted 10 days. Subsided a couple of das after I started taking Benadryl twice daily. I did not have this reaction of hives after either covid shot 1 or 2 that I received in early Feb 2021.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Rash pruritic, Urticaria
Clinical narrative: Received the Pfizer covid 19 booster on 10/21/2021 and two days later started having hives on various parts of my torso: lower back, shoulders, thighs, stomach, and neck. Small bumps would pop up, itch like crazy for 15-20 minutes and then subside leaving a small red hive. Occurred mainly early evening and early morning. This lasted 10 days. Subsided a couple of das after I started taking Benadryl twice daily. I did not have this reaction of hives after either covid shot 1 or 2 that I received in early Feb 2021.
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram abnormal, Face oedema, Laboratory test
Clinical narrative: @ approx 1900 on 02 Nov became SOB, edema around face, chest tightening, waited until AM come to clinic & was immediately sent to ED. Assessment done. Pt had stridor. Given IM epipen, solumedrol 125, & 25 Benadryl IVA. NS at 150 started. Then given 1mg Ativan IVP. EKG & Labs done SVT seen- 4 hrs she was then monitored in ED x 12 hrs.
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Stridor, Supraventricular tachycardia, Urogram
Clinical narrative: @ approx 1900 on 02 Nov became SOB, edema around face, chest tightening, waited until AM come to clinic & was immediately sent to ED. Assessment done. Pt had stridor. Given IM epipen, solumedrol 125, & 25 Benadryl IVA. NS at 150 started. Then given 1mg Ativan IVP. EKG & Labs done SVT seen- 4 hrs she was then monitored in ED x 12 hrs.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV1
Symptoms: Rash
Clinical narrative: Patient developed rash on R thigh on 11/1/2021  at  9:45 a.m.  This spread over 2 hours  to  R lower extremities, trunk, upper extremities & ears.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue lasting 24 hrs.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Hypertension, Palpitations
Clinical narrative: Patient had COVID-19 vaccine today and about 15 minutes after vaccine was given he had some pressure midsternal and heart racing; patient has history of anaphalasis symptoms in past from Tylenol and Motrin. PT remained alert, oriented x3; b/p was high to begin with; no trouble breathing. LS clear, pressure in chest decreases over next 10-20 minutes. Dr. called from clinic. She assessed patient and asked for patient to be given Benadryl 25mg. This was given. EMS was here to assess patient. Patient was feeling better and refused to go to hospital. Patient drank a bottle of water while episode occurred. Doctor called and case was discussed with her.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: 10/27/2021- I formed a large blood clot on my lower calf 10/25/2021 Another large blood clot had formed on my left inner arm Ultra sound was performed- 10/29/2021 was determined, i have blood clots
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: SkinRash Narrative:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Rash
Clinical narrative: Rash Erythema, pain, and edema away from injection site Narrative:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia, Fever, Chills Narrative:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Sedation
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia, Fever, Chills Narrative:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Palpitations, Pyrexia
Clinical narrative: Myalgia, Fever, Palpitations, Cramping in both calves. Narrative:  Employee was referred to his own primary care physician for lingering side effects and evaluation.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Sedation
Clinical narrative: Sedation, Fever, Chills Narrative:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pruritus, Pyrexia, Rash
Clinical narrative: Headache, Fever, SkinRash, UrticariaPruritus, Chills Narrative:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Headache, Fever, SkinRash, UrticariaPruritus, Chills Narrative:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Headache, Sedation, Myalgia, Fever, Chills; Pain,redness,swelling,itching at injection site Narrative:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Myalgia, Pyrexia, Sedation
Clinical narrative: Headache, Sedation, Myalgia, Fever, Chills; Pain,redness,swelling,itching at injection site Narrative:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Impaired work ability, Myalgia, Neck pain
Clinical narrative: Headache, Myalgia, chills, neck soreness Narrative:  Pt called into work on 11-5-21 from symptoms, stated mild and did not seek outside care
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: lymphadenopathy post clavicle both. tenderness to left clavicle Narrative:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Erythema, Injection site reaction
Clinical narrative: Diarrhea, NauseaVomiting, red tingling face, stomach pain, lightheaded, soreness with localized reaction to injection site, left axilla lymph node enlargement Narrative:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Local reaction, Lymphadenopathy, Nausea, Pain, Paraesthesia
Clinical narrative: Diarrhea, NauseaVomiting, red tingling face, stomach pain, lightheaded, soreness with localized reaction to injection site, left axilla lymph node enlargement Narrative:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Diarrhea, NauseaVomiting, red tingling face, stomach pain, lightheaded, soreness with localized reaction to injection site, left axilla lymph node enlargement Narrative:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Arteriosclerosis, Biopsy kidney abnormal, Blood creatinine increased, Blood electrolytes normal
Clinical narrative: Patient previously received one dose of Johnson and Johnson COVID vaccine on 3/15/2021 without complication. She was due for a booster and received one dose of the Moderna COVID vaccine on 10/29/2021. The day following vaccination, on 10/30/2021, patient developed hematuria. She was found to have acute kidney injury and was was hospitalized.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal scarring, Haematuria, IgA nephropathy, Pathology test, Proteinuria
Clinical narrative: Patient previously received one dose of Johnson and Johnson COVID vaccine on 3/15/2021 without complication. She was due for a booster and received one dose of the Moderna COVID vaccine on 10/29/2021. The day following vaccination, on 10/30/2021, patient developed hematuria. She was found to have acute kidney injury and was was hospitalized.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyuria, Renal tubular injury, Urinary casts, Urinary casts present, Urine analysis abnormal
Clinical narrative: Patient previously received one dose of Johnson and Johnson COVID vaccine on 3/15/2021 without complication. She was due for a booster and received one dose of the Moderna COVID vaccine on 10/29/2021. The day following vaccination, on 10/30/2021, patient developed hematuria. She was found to have acute kidney injury and was was hospitalized.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urine output
Clinical narrative: Patient previously received one dose of Johnson and Johnson COVID vaccine on 3/15/2021 without complication. She was due for a booster and received one dose of the Moderna COVID vaccine on 10/29/2021. The day following vaccination, on 10/30/2021, patient developed hematuria. She was found to have acute kidney injury and was was hospitalized.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal disorder
Clinical narrative: Per patient report: He received 0.25ml Moderna booster shot around 10am on 11/4/2021. At 3am on 11/5/2021 (roughly 14 hours after booster injection) patient could not move both legs and was admitted to local hospital. About 24hours after after initial onsey of symptoms, symptoms started resolving and patient completely back to baseline/normal on 11/7/2021 when he was discharged from hospital.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: [Moderna] use for COVID-19 under Emergency Use Authorization (EUA): Patient received two doses of vaccines and had breakthrough infection, hospitalization.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt was given dose #2 of moderna on 10/12/21. Expiration date 10/10/21. No adverse effects noted.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Ophthalmic migraine, Visual impairment
Clinical narrative: Received Moderna booster. 24 hrs later, aside from a headache which I previously experienced, I lost partial vision in one eye. Went to my opthomologist immediately. He determined that I had an ocular migraine. My vision did improve after couple of hours. Don't know if it was from the booster and he couldn't tell either. Never happened before.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Pain in extremity
Clinical narrative: Experiencing sore in arm, headache, chills, and an enlarged gland under the left arm. These symptoms are still ongoing despite taking Tylenol for 3 days
Sex: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: shingles; death; Information has been received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. In or around January 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the patient suffered shingles. As a direct and proximate result of the vaccine, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 23-JUL-2020. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered serious and dangerous side effects, including death, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered as not recovered. The cause of death was not reported. It was unknown if an autopsy was performed. The causality between patient's death, shingles and zoster vaccine live (ZOSTAVAX) was related.   The event of shingles was assessed as disabled by the lawyer.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test positive
Clinical narrative: Pt had a positive COVID test
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pt had a positive COVID test
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Pharyngeal swelling
Clinical narrative: Swollen neck; Swollen throat glands; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EM9809) via an unspecified route, administered in Left Arm on 13Feb2021 at 16:00 (53-year-old at vaccination) as Dose 1, Single for Covid-19 immunization. Vaccine was not administered at military facility. The patient's medical history included ongoing interstitial cystitis from 2015 and no relevant lab tests was reported for interstitial cystitis. The patient's concomitant medications included ongoing pentosan polysulfate sodium (ELMIRON) 800 mg per day, taken for Interstitial cystitis from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Feb2021 at 16:10 (immediately after 1st dose of vaccination), the patient experienced swollen neck and swollen throat glands. The patient received Benadryl 1 pill was taken 15 min after 1st dose of Covid vaccine. The clinical outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Swelling
Clinical narrative: Swollen neck; Swollen throat glands; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EM9809) via an unspecified route, administered in Left Arm on 13Feb2021 at 16:00 (53-year-old at vaccination) as Dose 1, Single for Covid-19 immunization. Vaccine was not administered at military facility. The patient's medical history included ongoing interstitial cystitis from 2015 and no relevant lab tests was reported for interstitial cystitis. The patient's concomitant medications included ongoing pentosan polysulfate sodium (ELMIRON) 800 mg per day, taken for Interstitial cystitis from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Feb2021 at 16:10 (immediately after 1st dose of vaccination), the patient experienced swollen neck and swollen throat glands. The patient received Benadryl 1 pill was taken 15 min after 1st dose of Covid vaccine. The clinical outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test negative
Clinical narrative: Lost the sense of smell while having food.; No sense of taste while having food; This is a spontaneous report from a contactable consumer (parent of patient). A 39-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 20Apr2021 13:30 (at the age of 39-year-old) as dose number unknown, single for covid-19 immunisation. Medical history included little bit allergic to lobster, shrimps etc. Usually suffer from pollen allergy every year with sneezing and teary eyes, thyroid and Cholesterol from unknown date and unknown if ongoing. Concomitant medication within 2 weeks included Claritin taken for pollen allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, did not patient been tested for COVID-19. Reporter stated, after couple of days on 22Apr2021, patient lost the sense of smell while having food. He was not able to smell the aroma of the cooked food, also had no sense of taste while having food. E.g. He tried raw red chillies / onions with food. But neither did he feel any reaction to his taste buds nor any smell. He could smell perfume, garlic from a close distance. However he did not feel any taste while having oranges. He contacted his doctor who ordered a covid test for him. No treatment was taken for events. On 23Apr2021, the patient underwent lab tests and procedures which included sars-cov-2(covid-19), molecular assay, NAA, PCR and nasal swab test all resulting negative. The outcome of the events was recovering at the time of reporting.  No follow-up attempts are possible. Information about lot/ batch no cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Nucleic acid test, Polymerase chain reaction, SARS-CoV-2 antibody test
Clinical narrative: Lost the sense of smell while having food.; No sense of taste while having food; This is a spontaneous report from a contactable consumer (parent of patient). A 39-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 20Apr2021 13:30 (at the age of 39-year-old) as dose number unknown, single for covid-19 immunisation. Medical history included little bit allergic to lobster, shrimps etc. Usually suffer from pollen allergy every year with sneezing and teary eyes, thyroid and Cholesterol from unknown date and unknown if ongoing. Concomitant medication within 2 weeks included Claritin taken for pollen allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, did not patient been tested for COVID-19. Reporter stated, after couple of days on 22Apr2021, patient lost the sense of smell while having food. He was not able to smell the aroma of the cooked food, also had no sense of taste while having food. E.g. He tried raw red chillies / onions with food. But neither did he feel any reaction to his taste buds nor any smell. He could smell perfume, garlic from a close distance. However he did not feel any taste while having oranges. He contacted his doctor who ordered a covid test for him. No treatment was taken for events. On 23Apr2021, the patient underwent lab tests and procedures which included sars-cov-2(covid-19), molecular assay, NAA, PCR and nasal swab test all resulting negative. The outcome of the events was recovering at the time of reporting.  No follow-up attempts are possible. Information about lot/ batch no cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Lost the sense of smell while having food.; No sense of taste while having food; This is a spontaneous report from a contactable consumer (parent of patient). A 39-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 20Apr2021 13:30 (at the age of 39-year-old) as dose number unknown, single for covid-19 immunisation. Medical history included little bit allergic to lobster, shrimps etc. Usually suffer from pollen allergy every year with sneezing and teary eyes, thyroid and Cholesterol from unknown date and unknown if ongoing. Concomitant medication within 2 weeks included Claritin taken for pollen allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, did not patient been tested for COVID-19. Reporter stated, after couple of days on 22Apr2021, patient lost the sense of smell while having food. He was not able to smell the aroma of the cooked food, also had no sense of taste while having food. E.g. He tried raw red chillies / onions with food. But neither did he feel any reaction to his taste buds nor any smell. He could smell perfume, garlic from a close distance. However he did not feel any taste while having oranges. He contacted his doctor who ordered a covid test for him. No treatment was taken for events. On 23Apr2021, the patient underwent lab tests and procedures which included sars-cov-2(covid-19), molecular assay, NAA, PCR and nasal swab test all resulting negative. The outcome of the events was recovering at the time of reporting.  No follow-up attempts are possible. Information about lot/ batch no cannot be obtained.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiotensin converting enzyme, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Blood immunoglobulin G normal, Blood immunoglobulin M
Clinical narrative: I woke up with blurred vision on April 8th 2001. The vision loss occurred two days after 2nd vaccine. Developed headache frontal region. no eye pain but not eye movement.  I couldn't see out of the lower half of my left eye. Temporal discomfort resolved after about two weeks. Vision loss was stable but appeared to be constricted on left. after onset  was evaluated by optometrist who found swelling in the left optic nerve on April 11th 2021.  I was sent to the ER where I had MRI at the Hospital which revealed interocular protrusion bilaterally. I was subsequently seen by ophthalmologist. who noted inferior arcuate ocular defect. The was optic disc edema with hyperemia of the left fundes and trace edema nasally of the right fundes. Enlargement of the  RSNL 193 microns that was temporal, sicken superior and inferiorly.  I have RNFL sickness of the right eye.  On Sunday I when to the optometrist. I had other things there. The neuron opthamologist. It has been months of trying to figure out what is wrong. I have permanent nerve damage in my left eye. It was from the vaccine. And it has killed the nerve. It can not repair. I had blood test and spinal tab Monday May 10th 2021. Lumbar Puncture. I was tested for lime disease.  I got tested for MS. I gave 12 valves of blood.  To check for blood pressure, build up. Nothing was found
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, C-reactive protein normal, Cerebral venous sinus thrombosis, HLA marker study, Headache
Clinical narrative: I woke up with blurred vision on April 8th 2001. The vision loss occurred two days after 2nd vaccine. Developed headache frontal region. no eye pain but not eye movement.  I couldn't see out of the lower half of my left eye. Temporal discomfort resolved after about two weeks. Vision loss was stable but appeared to be constricted on left. after onset  was evaluated by optometrist who found swelling in the left optic nerve on April 11th 2021.  I was sent to the ER where I had MRI at the Hospital which revealed interocular protrusion bilaterally. I was subsequently seen by ophthalmologist. who noted inferior arcuate ocular defect. The was optic disc edema with hyperemia of the left fundes and trace edema nasally of the right fundes. Enlargement of the  RSNL 193 microns that was temporal, sicken superior and inferiorly.  I have RNFL sickness of the right eye.  On Sunday I when to the optometrist. I had other things there. The neuron opthamologist. It has been months of trying to figure out what is wrong. I have permanent nerve damage in my left eye. It was from the vaccine. And it has killed the nerve. It can not repair. I had blood test and spinal tab Monday May 10th 2021. Lumbar Puncture. I was tested for lime disease.  I got tested for MS. I gave 12 valves of blood.  To check for blood pressure, build up. Nothing was found
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes simplex test negative, Laboratory test, Lyme disease, Lysozyme, Magnetic resonance imaging head normal
Clinical narrative: I woke up with blurred vision on April 8th 2001. The vision loss occurred two days after 2nd vaccine. Developed headache frontal region. no eye pain but not eye movement.  I couldn't see out of the lower half of my left eye. Temporal discomfort resolved after about two weeks. Vision loss was stable but appeared to be constricted on left. after onset  was evaluated by optometrist who found swelling in the left optic nerve on April 11th 2021.  I was sent to the ER where I had MRI at the Hospital which revealed interocular protrusion bilaterally. I was subsequently seen by ophthalmologist. who noted inferior arcuate ocular defect. The was optic disc edema with hyperemia of the left fundes and trace edema nasally of the right fundes. Enlargement of the  RSNL 193 microns that was temporal, sicken superior and inferiorly.  I have RNFL sickness of the right eye.  On Sunday I when to the optometrist. I had other things there. The neuron opthamologist. It has been months of trying to figure out what is wrong. I have permanent nerve damage in my left eye. It was from the vaccine. And it has killed the nerve. It can not repair. I had blood test and spinal tab Monday May 10th 2021. Lumbar Puncture. I was tested for lime disease.  I got tested for MS. I gave 12 valves of blood.  To check for blood pressure, build up. Nothing was found
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Papilloedema, Red blood cell sedimentation rate normal, Treponema test negative, Visual field defect
Clinical narrative: I woke up with blurred vision on April 8th 2001. The vision loss occurred two days after 2nd vaccine. Developed headache frontal region. no eye pain but not eye movement.  I couldn't see out of the lower half of my left eye. Temporal discomfort resolved after about two weeks. Vision loss was stable but appeared to be constricted on left. after onset  was evaluated by optometrist who found swelling in the left optic nerve on April 11th 2021.  I was sent to the ER where I had MRI at the Hospital which revealed interocular protrusion bilaterally. I was subsequently seen by ophthalmologist. who noted inferior arcuate ocular defect. The was optic disc edema with hyperemia of the left fundes and trace edema nasally of the right fundes. Enlargement of the  RSNL 193 microns that was temporal, sicken superior and inferiorly.  I have RNFL sickness of the right eye.  On Sunday I when to the optometrist. I had other things there. The neuron opthamologist. It has been months of trying to figure out what is wrong. I have permanent nerve damage in my left eye. It was from the vaccine. And it has killed the nerve. It can not repair. I had blood test and spinal tab Monday May 10th 2021. Lumbar Puncture. I was tested for lime disease.  I got tested for MS. I gave 12 valves of blood.  To check for blood pressure, build up. Nothing was found
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blindness unilateral, Blood test normal, Bordetella test negative, Eye movement disorder, Head discomfort
Clinical narrative: I woke up with blurred vision on April 8th 2001. The vision loss occurred two days after 2nd vaccine. Developed headache frontal region. no eye pain but not eye movement.  I couldn't see out of the lower half of my left eye. Temporal discomfort resolved after about two weeks. Vision loss was stable but appeared to be constricted on left. after onset  was evaluated by optometrist who found swelling in the left optic nerve on April 11th 2021.  I was sent to the ER where I had MRI at the Hospital which revealed interocular protrusion bilaterally. I was subsequently seen by ophthalmologist. who noted inferior arcuate ocular defect. The was optic disc edema with hyperemia of the left fundes and trace edema nasally of the right fundes. Enlargement of the  RSNL 193 microns that was temporal, sicken superior and inferiorly.  I have RNFL sickness of the right eye.  On Sunday I when to the optometrist. I had other things there. The neuron opthamologist. It has been months of trying to figure out what is wrong. I have permanent nerve damage in my left eye. It was from the vaccine. And it has killed the nerve. It can not repair. I had blood test and spinal tab Monday May 10th 2021. Lumbar Puncture. I was tested for lime disease.  I got tested for MS. I gave 12 valves of blood.  To check for blood pressure, build up. Nothing was found
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Laboratory test normal, Lumbar puncture normal, Magnetic resonance imaging abnormal, Optic disc hyperaemia
Clinical narrative: I woke up with blurred vision on April 8th 2001. The vision loss occurred two days after 2nd vaccine. Developed headache frontal region. no eye pain but not eye movement.  I couldn't see out of the lower half of my left eye. Temporal discomfort resolved after about two weeks. Vision loss was stable but appeared to be constricted on left. after onset  was evaluated by optometrist who found swelling in the left optic nerve on April 11th 2021.  I was sent to the ER where I had MRI at the Hospital which revealed interocular protrusion bilaterally. I was subsequently seen by ophthalmologist. who noted inferior arcuate ocular defect. The was optic disc edema with hyperemia of the left fundes and trace edema nasally of the right fundes. Enlargement of the  RSNL 193 microns that was temporal, sicken superior and inferiorly.  I have RNFL sickness of the right eye.  On Sunday I when to the optometrist. I had other things there. The neuron opthamologist. It has been months of trying to figure out what is wrong. I have permanent nerve damage in my left eye. It was from the vaccine. And it has killed the nerve. It can not repair. I had blood test and spinal tab Monday May 10th 2021. Lumbar Puncture. I was tested for lime disease.  I got tested for MS. I gave 12 valves of blood.  To check for blood pressure, build up. Nothing was found
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Optic nerve injury, Optic neuritis, Papilloedema, Retinal disorder, Vision blurred
Clinical narrative: I woke up with blurred vision on April 8th 2001. The vision loss occurred two days after 2nd vaccine. Developed headache frontal region. no eye pain but not eye movement.  I couldn't see out of the lower half of my left eye. Temporal discomfort resolved after about two weeks. Vision loss was stable but appeared to be constricted on left. after onset  was evaluated by optometrist who found swelling in the left optic nerve on April 11th 2021.  I was sent to the ER where I had MRI at the Hospital which revealed interocular protrusion bilaterally. I was subsequently seen by ophthalmologist. who noted inferior arcuate ocular defect. The was optic disc edema with hyperemia of the left fundes and trace edema nasally of the right fundes. Enlargement of the  RSNL 193 microns that was temporal, sicken superior and inferiorly.  I have RNFL sickness of the right eye.  On Sunday I when to the optometrist. I had other things there. The neuron opthamologist. It has been months of trying to figure out what is wrong. I have permanent nerve damage in my left eye. It was from the vaccine. And it has killed the nerve. It can not repair. I had blood test and spinal tab Monday May 10th 2021. Lumbar Puncture. I was tested for lime disease.  I got tested for MS. I gave 12 valves of blood.  To check for blood pressure, build up. Nothing was found
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Laboratory test, Lip swelling, Pharyngeal swelling, Speech disorder
Clinical narrative: Metallic taste in mouth roughly 30 minutes of vaccine, drove home and took Benadryl, Slept/doesn't remember the next 10 hours. Also experienced muscle weakness. Followed up with physician/hospital, but results unknown.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Metallic taste in mouth roughly 30 minutes of vaccine, drove home and took Benadryl, Slept/doesn't remember the next 10 hours. Also experienced muscle weakness. Followed up with physician/hospital, but results unknown.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Hypersomnia, Memory impairment, Muscular weakness
Clinical narrative: Metallic taste in mouth roughly 30 minutes of vaccine, drove home and took Benadryl, Slept/doesn't remember the next 10 hours. Also experienced muscle weakness. Followed up with physician/hospital, but results unknown.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Heavy menstrual bleeding, Intermenstrual bleeding, Maternal exposure before pregnancy, Pregnancy
Clinical narrative: Has one son, eight. No previous miscarriages. 1 previous pregnancy (healthy). Suffered miscarriages at 8 weeks.  No longer having regular periods.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Magnetic resonance imaging, Menstruation irregular, Ultrasound scan
Clinical narrative: Has one son, eight. No previous miscarriages. 1 previous pregnancy (healthy). Suffered miscarriages at 8 weeks.  No longer having regular periods.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Encephalopathy
Clinical narrative: Hospitilization, resulting in palliative care and death
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Hospitilization, resulting in palliative care and death
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Fatigue, Hot flush, Mental fatigue, Migraine
Clinical narrative: hot flashes; night sweats; Missed menstrual periods; tension; Physical & mental fatigue lasting daily for 14 days/physical exhaustion; Physical & mental fatigue lasting daily for 14 days/physical exhaustion; Muscle cramping; Severe migraines; The initial safety information received was reporting only non-serious adverse drug reactions, upon receipt of follow-up information on 25Oct2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received bnt162b2, dose 1 intramuscular, administered in left arm on 03Sep2021 14:30 (Lot Number: FC3184; Expiration Date: 31Oct2021) as single for COVID-19 immunization at the age of 30 years old. Medical history included attention deficit hyperactivity disorder (ADHD) from 15May2011 and ongoing, generalized anxiety from 01Apr2011 and ongoing, premenstrual dysphoric disorder (PMDD) from 01Feb2012 and ongoing, Herpes Simplex Type 1 from 12Feb2012 and ongoing, birthcontrol from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, and genital herpes from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for birth control from 2018 and ongoing; alprazolam taken for anxiety from 2016 and ongoing; and valaciclovir hydrochloride (VALTREX) taken for genital herpes from 2012 and ongoing. The patient experienced severe hot flashes 4-8x daily (persisting issue since 1st dose of vaccine), severe night sweats 1-4x per night (persisting issue since 1st dose of vaccine) and missed menstrual periods (persisting issue since 1st dose of vaccine) - 2 menstrual cycles with missed period to date on 04Sep2021 09:45 with outcome of not recovered. Events reported as serious important medical event. The patient also experienced tension, physical & mental fatigue lasting daily for 14 days/physical exhaustion in both left & right legs (from upper thighs to both feet) lasting daily for 3 days, muscle cramping, and severe migraines 3-5x/week for 2 weeks on 04Sep2021 09:45 with outcome of recovered with sequelae. All events required Doctor or other healthcare professional office/clinic visit. No treatment needed for the events nor hospitalization. The patient received the second dose (lot no. - FF2589) on 25Sep2021 15:00, intramuscular in the left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Night sweats
Clinical narrative: hot flashes; night sweats; Missed menstrual periods; tension; Physical & mental fatigue lasting daily for 14 days/physical exhaustion; Physical & mental fatigue lasting daily for 14 days/physical exhaustion; Muscle cramping; Severe migraines; The initial safety information received was reporting only non-serious adverse drug reactions, upon receipt of follow-up information on 25Oct2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received bnt162b2, dose 1 intramuscular, administered in left arm on 03Sep2021 14:30 (Lot Number: FC3184; Expiration Date: 31Oct2021) as single for COVID-19 immunization at the age of 30 years old. Medical history included attention deficit hyperactivity disorder (ADHD) from 15May2011 and ongoing, generalized anxiety from 01Apr2011 and ongoing, premenstrual dysphoric disorder (PMDD) from 01Feb2012 and ongoing, Herpes Simplex Type 1 from 12Feb2012 and ongoing, birthcontrol from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, and genital herpes from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for birth control from 2018 and ongoing; alprazolam taken for anxiety from 2016 and ongoing; and valaciclovir hydrochloride (VALTREX) taken for genital herpes from 2012 and ongoing. The patient experienced severe hot flashes 4-8x daily (persisting issue since 1st dose of vaccine), severe night sweats 1-4x per night (persisting issue since 1st dose of vaccine) and missed menstrual periods (persisting issue since 1st dose of vaccine) - 2 menstrual cycles with missed period to date on 04Sep2021 09:45 with outcome of not recovered. Events reported as serious important medical event. The patient also experienced tension, physical & mental fatigue lasting daily for 14 days/physical exhaustion in both left & right legs (from upper thighs to both feet) lasting daily for 3 days, muscle cramping, and severe migraines 3-5x/week for 2 weeks on 04Sep2021 09:45 with outcome of recovered with sequelae. All events required Doctor or other healthcare professional office/clinic visit. No treatment needed for the events nor hospitalization. The patient received the second dose (lot no. - FF2589) on 25Sep2021 15:00, intramuscular in the left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hot flush, Menstruation irregular, Mental fatigue, Migraine
Clinical narrative: hot flashes; night sweats; Missed menstrual periods; tension; Physical & mental fatigue lasting daily for 14 days/physical exhaustion; Physical & mental fatigue lasting daily for 14 days/physical exhaustion; Muscle cramping; Severe migraines; The initial safety information received was reporting only non-serious adverse drug reactions, upon receipt of follow-up information on 25Oct2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received bnt162b2, dose 1 intramuscular, administered in left arm on 03Sep2021 14:30 (Lot Number: FC3184; Expiration Date: 31Oct2021) as single for COVID-19 immunization at the age of 30 years old. Medical history included attention deficit hyperactivity disorder (ADHD) from 15May2011 and ongoing, generalized anxiety from 01Apr2011 and ongoing, premenstrual dysphoric disorder (PMDD) from 01Feb2012 and ongoing, Herpes Simplex Type 1 from 12Feb2012 and ongoing, birthcontrol from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, and genital herpes from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for birth control from 2018 and ongoing; alprazolam taken for anxiety from 2016 and ongoing; and valaciclovir hydrochloride (VALTREX) taken for genital herpes from 2012 and ongoing. The patient experienced severe hot flashes 4-8x daily (persisting issue since 1st dose of vaccine), severe night sweats 1-4x per night (persisting issue since 1st dose of vaccine) and missed menstrual periods (persisting issue since 1st dose of vaccine) - 2 menstrual cycles with missed period to date on 04Sep2021 09:45 with outcome of not recovered. Events reported as serious important medical event. The patient also experienced tension, physical & mental fatigue lasting daily for 14 days/physical exhaustion in both left & right legs (from upper thighs to both feet) lasting daily for 3 days, muscle cramping, and severe migraines 3-5x/week for 2 weeks on 04Sep2021 09:45 with outcome of recovered with sequelae. All events required Doctor or other healthcare professional office/clinic visit. No treatment needed for the events nor hospitalization. The patient received the second dose (lot no. - FF2589) on 25Sep2021 15:00, intramuscular in the left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.