chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Growing anxiety; Injection site pain; Muscle & joint pain; Muscle & joint pain; Tiredness; Headache; Coughing; Sneezing; Copious amount of mucous from nose/throat; Copious amount of mucous from nose/throat; Nausea; Vomiting; Diarrhea; Chills; Lightheaded/dizzy; Fever (99.1-99.3F); Sweating; Chest pressure; Back pain on left side from waist to neck; Difficulty breathing; Severe insomnia; Soft stools with loss of bowel control; Soft stools with loss of bowel control; This is a spontaneous report from a Non-contactable consumer (herself reporting). This 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534, Expiry date: Not reported) via an unspecified route of administration in left arm on Mar2021 as a single dose for COVID-19 immunisation. The patient was allergic to mycin,neosporin/bacitracin. The patient's medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior vaccination. After 24 to 48 hours of vaccination the patient experienced injection site pain spread to whole-body muscle & joint pain, tiredness, headache, coughing, sneezing, copious amount of mucous from nose/throat, nausea, vomiting, diarrhea, lightheaded/dizzy, chills/fever (99.1-99.3F)/sweating, chest pressure and back pain on left side from waist to neck, difficulty breathing, severe insomnia. After 48 to 72 hours of vaccination the patient experienced Soft stools with loss of bowel control. Growing anxiety due to chest pressure and back pain on left side from waist to neck, difficulty breathing and severe insomnia and all the above events except coughing, sneezing, mucous, vomiting and diarrhea and the patient was sent to emergency room/department or urgent care and hospitalized for one day. The patient received IV, EKG (electrocardiogram), blood panels, X-ray, Ibuprofen, Ativan (lorazepam) as treatment for the events. The patient underwent unknown COVID test post vaccination in ER (emergency room) which shown negative result. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: As of Monday 23Mar I tested positive for exposure to Covid-19. I am asymptomatic; As of Monday 23Mar I tested positive for exposure to Covid-19. I am asymptomatic; This is a spontaneous report received from a contactable consumer (patient herself) of an age 40-years-old female non pregnant received Second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration on 24Feb2021 12:45 Pm in Arm left and first dose (Lot number: EM9810) on 03Feb2021 01:00pm in Arm right both as SINGLE DOSE for covid-19 immunization. The patient medical history was reported as none. Patient had known allergies with azithromycin and experienced drug hypersensitivity. No medication was taken within four weeks prior to vaccination. No covid test was done prior to vaccination. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken within two weeks prior to vaccination. On 23Mar2021 Monday, the patient tested positive for exposure to covid-19 and patient said that she was asymptomatic and not appeared to have infected anyone in family and contacts were also asymptomatic. No therapeutic measures were taken. On 22Mar2021 post vaccination, the patient underwent lab tests and procedures which included sars-cov-2 test, results positive as of Monday 23Mar2021 and informed to get re-tested on 26Mar2021. The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: appendicitis; This is a spontaneous report from a contactable consumer (patient himself). A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration on 26Feb2021 02:30 PM at single dose in right arm for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) and doravirine (PIFELTRO). No other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced appendicitis on 16Mar2021 at 09:00 AM. Seriousness was given as hospitalization for one day. Treatment was given for event included surgery. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Since the vaccination, the patient had been tested for COVID-19. Patient has tested COVID on 16Mar2021 with the result negative post vaccination. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Haematoma, Loss of consciousness, Nausea, Wound
Clinical narrative: passed out; severe dizziness with nausea feeling; severe dizziness with nausea feeling; huge knot on head that is swollen and bruised; cut on my left side of neck; This is a spontaneous report from a contactable consumer (Patient). A 48-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7533), via an unspecified route of administration in left arm on 24Mar2021 at the age of 48 years old at a single dose for COVID-19 immunisation. Medical history included asthma controller, anxiety. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously took morphine and experienced allergy. Approximately 15hrs after receiving vaccine, On 25Mar2021 at 01:15, patient had severe dizziness with nausea feeling sat down and then passed out waking up after (unknown length of time) on the floor. Patient stated "i had struck my head and my left neck/shoulder on table and wall. Now I have huge knot on head that is swollen and bruised and a cut on my left side of neck." Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The outcome of the events was not recovered.  Follow-up Information has been requested.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: About 5 minutes after receiving vaccine, patient passed out unconscious and woke up about a minute later.; This is a spontaneous report received from a contactable consumer (patient). A 27-years-old male patient received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 11:55 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021, the patient about 5 minutes after receiving vaccine, passed out unconscious and woke up about a minute later. Treatment received for the event was unknown. Event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered.  Information about lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: received the first dose of the vaccine and then 5 days later was diagnosed with Covid; This is a spontaneous report from a contactable pharmacist. A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received the first dose of the vaccine and then 5 days later was diagnosed with COVID. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertensive crisis, Thrombosis, Vertigo
Clinical narrative: Hypertensive crisis at 180/95; Vascular thrombosis; Head is spinning; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198), via an unspecified route of administration in left arm, on 16Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. In Mar2021, the patient's head was spinning, there was a hypertensive crisis at 180/95 for 2 times, and there may be a vascular thrombosis. It was unknown if treatment was received for the adverse events. The events were considered non-serious by the patient. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Altered state of consciousness, Disorientation, Disturbance in attention, Dizziness
Clinical narrative: mind wasn't right; dizziness; disorientation; head was not focused right; This is a spontaneous report from a Contactable Consumer (patient). A 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included she was allergic to penicillin and had sensitivity to some drugs. The patient's concomitant medications were not reported. The patient experienced dizziness and disorientation after receiving the first dose. Patient stated that her mind wasn't right and her head was not focused right. Her reactions after the first dose of the covid vaccine stopped after five days. The patient had received the second dose of the vaccine. The outcome of the events was recovered after five days.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for COVID-19; positive for COVID-19; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was scheduled to receive the second dose this 27Mar2021. She is positive for COVID-19 and would have to postpone her vaccination. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Chills, Diarrhoea, Exophthalmos
Clinical narrative: vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urination; eyes feeling like they were popping out; tunnel vision; 104 fever; severe chills and quaking; severe chills and quaking; the worst headache in my life/slight headache on the back of my head, and continued into today; felt like broken shins; hip joints on fire; This is a spontaneous report from a contactable consumer herself (patient). A 60-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Mar2021 (Batch/Lot Number: EN6204) Solution for injection as Single Dose for covid-19 immunisation. Medical history included asthma, mild HP (Hypersensitivity pneumonitis) and I am fat. Concomitant medications included lovastatin, eszopiclone (LUNESTA), lisinopril and gabapentin. The patient previously took first dose of BNT162B2 (EN6198), on Left arm on 27Feb2021 for Covid-19 immunization. On 23Mar2021 02:00 patient experienced 104 fever, severe chills and quaking, the worst headache in my life, what felt like broken shins another friend said she had this as well, hip joints on fire, eyes feeling like they were popping out, vomiting after hours 26, tunnel vision, excessive urination, diarrhea started at hour 28. Lingering diarrhea into second day, slight headache on the back of her head, and continued into today, ringing in her left ear. The patient underwent lab tests and procedures which included body temperature: 104 on 23Mar2021. Patient did not test covid post vaccination. Patient did not have covid prior vaccination. The outcome of all events was recovered with sequelae.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Polyuria, Pyrexia, Tinnitus
Clinical narrative: vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urination; eyes feeling like they were popping out; tunnel vision; 104 fever; severe chills and quaking; severe chills and quaking; the worst headache in my life/slight headache on the back of my head, and continued into today; felt like broken shins; hip joints on fire; This is a spontaneous report from a contactable consumer herself (patient). A 60-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Mar2021 (Batch/Lot Number: EN6204) Solution for injection as Single Dose for covid-19 immunisation. Medical history included asthma, mild HP (Hypersensitivity pneumonitis) and I am fat. Concomitant medications included lovastatin, eszopiclone (LUNESTA), lisinopril and gabapentin. The patient previously took first dose of BNT162B2 (EN6198), on Left arm on 27Feb2021 for Covid-19 immunization. On 23Mar2021 02:00 patient experienced 104 fever, severe chills and quaking, the worst headache in my life, what felt like broken shins another friend said she had this as well, hip joints on fire, eyes feeling like they were popping out, vomiting after hours 26, tunnel vision, excessive urination, diarrhea started at hour 28. Lingering diarrhea into second day, slight headache on the back of her head, and continued into today, ringing in her left ear. The patient underwent lab tests and procedures which included body temperature: 104 on 23Mar2021. Patient did not test covid post vaccination. Patient did not have covid prior vaccination. The outcome of all events was recovered with sequelae.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Tunnel vision, Vomiting
Clinical narrative: vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urination; eyes feeling like they were popping out; tunnel vision; 104 fever; severe chills and quaking; severe chills and quaking; the worst headache in my life/slight headache on the back of my head, and continued into today; felt like broken shins; hip joints on fire; This is a spontaneous report from a contactable consumer herself (patient). A 60-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Mar2021 (Batch/Lot Number: EN6204) Solution for injection as Single Dose for covid-19 immunisation. Medical history included asthma, mild HP (Hypersensitivity pneumonitis) and I am fat. Concomitant medications included lovastatin, eszopiclone (LUNESTA), lisinopril and gabapentin. The patient previously took first dose of BNT162B2 (EN6198), on Left arm on 27Feb2021 for Covid-19 immunization. On 23Mar2021 02:00 patient experienced 104 fever, severe chills and quaking, the worst headache in my life, what felt like broken shins another friend said she had this as well, hip joints on fire, eyes feeling like they were popping out, vomiting after hours 26, tunnel vision, excessive urination, diarrhea started at hour 28. Lingering diarrhea into second day, slight headache on the back of her head, and continued into today, ringing in her left ear. The patient underwent lab tests and procedures which included body temperature: 104 on 23Mar2021. Patient did not test covid post vaccination. Patient did not have covid prior vaccination. The outcome of all events was recovered with sequelae.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Nausea, Syncope, Vertigo
Clinical narrative: I fainted; I was disoriented and the room was spinning.; I was disoriented and the room was spinning.; extremely nauseated; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 24Mar2021 at single dose in left arm for COVID-19 immunization. Medical history included Cancer. No known allergies. No covid prior vaccination. Patient was not pregnant at time of vaccination. Concomitant medication in two weeks included letrozole. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. It was reported that when patient woke up in the middle of the night. Patient was disoriented and the room was spinning. patient fainted and then was extremely nauseated all on 25Mar2021 02:00 AM. No treatment for adverse events. No covid tested post vaccination. The outcome of events was recovering.  Information about lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: I taste salt; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot Number: EP7533) dose 1 via an unspecified route of administration in Arm Right on 24Mar2021 11:45 as single dose for COVID-19 immunization. Medical history included Degenerative disc disease and moderate arthritis. Concomitant medications included pregabalin (LYRICA), celecoxib (CELEBREX) estradiol and omeprazole magnesium (PRILOSEC) and calcium pantothenate, folic acid, vitamins nos (MULTI-VITAMINS VITAFIT). On 24Mar2021 17:00 it was reported as the patient experienced i taste salt. Seriousness was reported as non-serious. Outcome of event was not recovered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea, Palpitations, Presyncope
Clinical narrative: felt very faint; lost visual clarity; profuse sweating; ears ringing; severe dizziness; heart palpitations; tension in my throat; severe nausea; This is a spontaneous report from a contactable consumer (patient) who reported for herself   A 28-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN5318), in left arm on 25Mar2021 at 14:30 (at 28 years) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On 25Mar2021 at 14:30 (as reported) the patient felt very faint, lost visual clarity, had profuse sweating, ears ringing, severe dizziness, heart palpitations, tension in her throat and severe nausea. Events were also described as follows: about 2 mins after (as reported) felt very faint, lost visual clarity, profuse sweating, ears ringing, severe dizziness, heart palpitations, tension in throat. Remained for about 5-10mins. Then severe nausea.  No treatment given for the events. The final outcome for all the events was reported as recovering.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Tinnitus, Visual acuity reduced
Clinical narrative: felt very faint; lost visual clarity; profuse sweating; ears ringing; severe dizziness; heart palpitations; tension in my throat; severe nausea; This is a spontaneous report from a contactable consumer (patient) who reported for herself   A 28-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN5318), in left arm on 25Mar2021 at 14:30 (at 28 years) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On 25Mar2021 at 14:30 (as reported) the patient felt very faint, lost visual clarity, had profuse sweating, ears ringing, severe dizziness, heart palpitations, tension in her throat and severe nausea. Events were also described as follows: about 2 mins after (as reported) felt very faint, lost visual clarity, profuse sweating, ears ringing, severe dizziness, heart palpitations, tension in throat. Remained for about 5-10mins. Then severe nausea.  No treatment given for the events. The final outcome for all the events was reported as recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Body ache; Chills; This is a spontaneous report received from a contactable other Health Care Professional (patient, self-reported). A 56-year-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247 and expiry date was not provided), via an unspecified route of administration, on 24Mar2021 10:15, as single dose for COVID-19 immunization, at Workplace Clinic. Patient's medical history was not reported. The patient had no allergies. Concomitant medications included escitalopram oxalate (LEXAPRO, 10 mg) at 10 mg and multivitamin (received within 2 weeks of vaccination). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247, Anatomical location of vaccine: Left arm), on 03Mar2021 at 02:30 PM for COVID-19 immunization. On 25Mar2021 at 06:30, the patient experienced Body ache and had chills on same day (25Mar2021, time not specified). The patient was received treatment for the adverse events with Ibuprofen. The patient was not diagnosed with COVID-19, prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. Outcome of the events was reported as recovering.  Information on the lot/batch number already available. Other information has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Headache, Pain
Clinical narrative: headache; Shortness of breath; Chest pain; Difficulty breathing; Heart palpitations; Aches; Extreme fatigue/fatigue; This is a spontaneous report received from a contactable consumer. A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch ER2613), via an unspecified route of administration in left arm on 19Mar2021 09:45 AM at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Medical history: hodgkins lymphoma survivor (1996), splenectomy. Concomitant medication was not reported. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. The patient experienced extreme fatigue on 19Mar2021 at 07:00 PM, aches on 20Mar2021, chest pain, difficulty breathing and heart palpitations on 22Mar2021, first episode of shortness of breath and headache on 24Mar2021. The patient assessed events as non-serious. Treatment received for the adverse event was unknown. Test Name: RT-PCR. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Veterans Administration facility. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Mar2021.  The patient was recovered from the event headache where not recovered from the events extreme fatigue, aches, chest pain, difficulty breathing, heart palpitations and first episode of shortness of breath.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 test
Clinical narrative: headache; Shortness of breath; Chest pain; Difficulty breathing; Heart palpitations; Aches; Extreme fatigue/fatigue; This is a spontaneous report received from a contactable consumer. A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch ER2613), via an unspecified route of administration in left arm on 19Mar2021 09:45 AM at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Medical history: hodgkins lymphoma survivor (1996), splenectomy. Concomitant medication was not reported. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. The patient experienced extreme fatigue on 19Mar2021 at 07:00 PM, aches on 20Mar2021, chest pain, difficulty breathing and heart palpitations on 22Mar2021, first episode of shortness of breath and headache on 24Mar2021. The patient assessed events as non-serious. Treatment received for the adverse event was unknown. Test Name: RT-PCR. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Veterans Administration facility. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Mar2021.  The patient was recovered from the event headache where not recovered from the events extreme fatigue, aches, chest pain, difficulty breathing, heart palpitations and first episode of shortness of breath.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Faeces discoloured, Muscle spasms, Nausea, SARS-CoV-2 test
Clinical narrative: Painful cramping center of chest, upper diaphragm moving to the right; Darkened stool; Nausea; Chills for only one night; This is a spontaneous report from a contactable consumer (patient himself). A 73-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 11:45 (Batch/Lot Number: EN2601) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 17Mar2021 11:45 (Batch/Lot Number: ER2613) as single dose for covid-19 immunisation. Medical history included myasthenia gravis, double hernia repaired at age 15 and thymectomy on Jun1973. The patient's concomitant medications were not reported. The patient experienced painful cramping center of chest, upper diaphragm moving to the right, darkened stool, nausea and chills for only one night on 02Mar2021 21:00. No treatment was received for the events. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient received some other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. No allergies to medications, food, or other products. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (post vaccination-Nasal Swab) on 21Mar2021. The outcome of the events were recovering.  Information about batch number and expiration date has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Tremor
Clinical narrative: Difficulty Breathing; Shakiness; Extremely Tires; This is a spontaneous report received from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 25Mar2021 (Batch/Lot Number: EP7534), expiration date: unknown) as SINGLE DOSE for covid-19 immunisation. Age at vaccination was 34 years. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient had difficulty in breathing, shakiness and extremely tires. Events were treated however details were not reported. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Defaecation disorder, Gastrointestinal disorder, Pollakiuria, Vomiting
Clinical narrative: Blood in urine 24 hours after injection.; Triggers for urination; Threw up 3 time between waking and 48 hours after injection.; defecation seem turned on; 36 hours after injection woke up with digestive system distress.; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FN6198), via an unspecified route of administration, administered in left arm on 22Mar2021 04:00PM at the age of 74 years old as single dose for COVID-19 immunisation. The medical history included type 2 diabetic and 25 year colon cancer survivor and concomitant medication included Lipitor, Metformin, Vascepa, Jardiance, Trulicity. Allergies to medications, food, or other products: Demerol. On 23Mar2021 at 4: 00pm the patient had blood in urine 24 hours after injection. Triggers for urination and defecation seem turned on. Threw up 3 time between waking and 48 hours after injection. Began feeling better 52 hours after injection. The patient assessed the events as non-serious. The adverse event resulted in emergency room. Antibiotics were prescribed in treatment received in response to digestive system distress after 36 Hours. At the time of reporting the event was resolving.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia, Vaccination site pain, Vision blurred
Clinical narrative: Alternating fever/Chills, temperature spikes from my norm of 97F to 101F; problems with eyes being able to focus; nausea; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 22Mar2021 14:15 (Batch/Lot Number: EN6207) (Age at vaccination: 56-years-old) as single dose for covid-19 immunisation. Medical history included allergy to erythromycin, high blood pressure, lung issues from 2004, obesity and depression. The patient previously received first single dose of BNT162B2 via an unspecified route of administration, administered in left arm on 01Mar2021 16.00 (Batch/Lot Number: EN6202) for Covid-19 immunization. The patient previously received second single dose of Shingrix on 12Feb2021 on left arm for unknown indication. Concomitant medications included vilazodone hydrochloride (VIIBRYD) taken for an unspecified indication. On 23Mar2021 14:30 the patient experienced alternating fever/chills, temperature spikes from my norm of 97f to 101f, problems with eyes being able to focus, nausea and injection site pain. The patient did not receive the treatment (as reported). The outcome of the events was recovering (as reported). 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 is not been tested for COVID-19.It was reported that he took 1000mg of Tylenol and drank Gatorade. At 36 hours fever broke, temp, vision, & appetite returned to normal. Injection site pain ended at 72hrs.  Follow up attempts needed. Further information is expected.; Sender's Comments: ~~~
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Blood disorder, Cardiac disorder, Feeling abnormal, Gait disturbance
Clinical narrative: eye blurriness; gate affected; auto immune system deterioration; practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); heart/organ issues; heart/organ issues; brain fog; joint and muscle stiffness/joint stiffness; joint and muscle stiffness; blood; limb numbness/toe numbness; neurological deficit; soreness injection site; mild right temporal headache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of bnt162b2 (BNT162B2, formulation: solution for injection)Batch/Lot # EP7534, via an unspecified route of administration in the right arm on 22Mar2021 14:00 (at the age of 78-years-old) as SINGLE DOSE for COVID-19 immunization. Medical history included heart dysfunction, heart surgery, kidney function abnormal and neural dysfunction. Concomitant medication included silodosin (RAPAFLO) at 8 mg daily. The patient previously took bnt162b2 (administration date=03/03/2021, administration time=02:15 PM, vaccine location=Left arm, dose number=1). On 23Mar2021 05:45, the patient experienced auto immune system deterioration, practitioner shook bottle and injected discolored (brown) vaccine right arm (# 2 injection march 22, 2021 - 2pm), heart/organ issues (cardiac disorder), brain fog, joint and muscle stiffness/joint stiffness, joint and muscle stiffness, limb numbness/toe numbness, neurological deficit, soreness injection site, mild right temporal headache. On 24Mar2021, the patient experienced eye blurriness, gate affected. Practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection 22Mar2021 - 2pm). The patient was concerned about current and future adverse effects as it relates to auto immune system deterioration, heart/organ issues, brain fog, joint and muscle stiffness, blood, limb numbness, neurological deficit and whether such existing health issues have been exacerbated by vaccine injection : currently soreness injection site, mild right temporal headache, toe numbness, joint stiffness, 24Mar early morning eye blurriness, gate affected. The patient did not receive any treatment for the events. The outcome of the events was unknown.   Follow-up (25Mar2021) and (31Mar2021): This is a follow-up spontaneous report from a contactable consumer. New information included: Lot/Batch number of the second dose, medical history updates.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Joint stiffness, Multi-organ disorder, Musculoskeletal stiffness
Clinical narrative: eye blurriness; gate affected; auto immune system deterioration; practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); heart/organ issues; heart/organ issues; brain fog; joint and muscle stiffness/joint stiffness; joint and muscle stiffness; blood; limb numbness/toe numbness; neurological deficit; soreness injection site; mild right temporal headache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of bnt162b2 (BNT162B2, formulation: solution for injection)Batch/Lot # EP7534, via an unspecified route of administration in the right arm on 22Mar2021 14:00 (at the age of 78-years-old) as SINGLE DOSE for COVID-19 immunization. Medical history included heart dysfunction, heart surgery, kidney function abnormal and neural dysfunction. Concomitant medication included silodosin (RAPAFLO) at 8 mg daily. The patient previously took bnt162b2 (administration date=03/03/2021, administration time=02:15 PM, vaccine location=Left arm, dose number=1). On 23Mar2021 05:45, the patient experienced auto immune system deterioration, practitioner shook bottle and injected discolored (brown) vaccine right arm (# 2 injection march 22, 2021 - 2pm), heart/organ issues (cardiac disorder), brain fog, joint and muscle stiffness/joint stiffness, joint and muscle stiffness, limb numbness/toe numbness, neurological deficit, soreness injection site, mild right temporal headache. On 24Mar2021, the patient experienced eye blurriness, gate affected. Practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection 22Mar2021 - 2pm). The patient was concerned about current and future adverse effects as it relates to auto immune system deterioration, heart/organ issues, brain fog, joint and muscle stiffness, blood, limb numbness, neurological deficit and whether such existing health issues have been exacerbated by vaccine injection : currently soreness injection site, mild right temporal headache, toe numbness, joint stiffness, 24Mar early morning eye blurriness, gate affected. The patient did not receive any treatment for the events. The outcome of the events was unknown.   Follow-up (25Mar2021) and (31Mar2021): This is a follow-up spontaneous report from a contactable consumer. New information included: Lot/Batch number of the second dose, medical history updates.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Nervous system disorder, Poor quality product administered, Product colour issue, Vaccination site pain, Vision blurred
Clinical narrative: eye blurriness; gate affected; auto immune system deterioration; practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); heart/organ issues; heart/organ issues; brain fog; joint and muscle stiffness/joint stiffness; joint and muscle stiffness; blood; limb numbness/toe numbness; neurological deficit; soreness injection site; mild right temporal headache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of bnt162b2 (BNT162B2, formulation: solution for injection)Batch/Lot # EP7534, via an unspecified route of administration in the right arm on 22Mar2021 14:00 (at the age of 78-years-old) as SINGLE DOSE for COVID-19 immunization. Medical history included heart dysfunction, heart surgery, kidney function abnormal and neural dysfunction. Concomitant medication included silodosin (RAPAFLO) at 8 mg daily. The patient previously took bnt162b2 (administration date=03/03/2021, administration time=02:15 PM, vaccine location=Left arm, dose number=1). On 23Mar2021 05:45, the patient experienced auto immune system deterioration, practitioner shook bottle and injected discolored (brown) vaccine right arm (# 2 injection march 22, 2021 - 2pm), heart/organ issues (cardiac disorder), brain fog, joint and muscle stiffness/joint stiffness, joint and muscle stiffness, limb numbness/toe numbness, neurological deficit, soreness injection site, mild right temporal headache. On 24Mar2021, the patient experienced eye blurriness, gate affected. Practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection 22Mar2021 - 2pm). The patient was concerned about current and future adverse effects as it relates to auto immune system deterioration, heart/organ issues, brain fog, joint and muscle stiffness, blood, limb numbness, neurological deficit and whether such existing health issues have been exacerbated by vaccine injection : currently soreness injection site, mild right temporal headache, toe numbness, joint stiffness, 24Mar early morning eye blurriness, gate affected. The patient did not receive any treatment for the events. The outcome of the events was unknown.   Follow-up (25Mar2021) and (31Mar2021): This is a follow-up spontaneous report from a contactable consumer. New information included: Lot/Batch number of the second dose, medical history updates.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: eye blurriness; gate affected; auto immune system deterioration; practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); heart/organ issues; heart/organ issues; brain fog; joint and muscle stiffness/joint stiffness; joint and muscle stiffness; blood; limb numbness/toe numbness; neurological deficit; soreness injection site; mild right temporal headache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of bnt162b2 (BNT162B2, formulation: solution for injection)Batch/Lot # EP7534, via an unspecified route of administration in the right arm on 22Mar2021 14:00 (at the age of 78-years-old) as SINGLE DOSE for COVID-19 immunization. Medical history included heart dysfunction, heart surgery, kidney function abnormal and neural dysfunction. Concomitant medication included silodosin (RAPAFLO) at 8 mg daily. The patient previously took bnt162b2 (administration date=03/03/2021, administration time=02:15 PM, vaccine location=Left arm, dose number=1). On 23Mar2021 05:45, the patient experienced auto immune system deterioration, practitioner shook bottle and injected discolored (brown) vaccine right arm (# 2 injection march 22, 2021 - 2pm), heart/organ issues (cardiac disorder), brain fog, joint and muscle stiffness/joint stiffness, joint and muscle stiffness, limb numbness/toe numbness, neurological deficit, soreness injection site, mild right temporal headache. On 24Mar2021, the patient experienced eye blurriness, gate affected. Practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection 22Mar2021 - 2pm). The patient was concerned about current and future adverse effects as it relates to auto immune system deterioration, heart/organ issues, brain fog, joint and muscle stiffness, blood, limb numbness, neurological deficit and whether such existing health issues have been exacerbated by vaccine injection : currently soreness injection site, mild right temporal headache, toe numbness, joint stiffness, 24Mar early morning eye blurriness, gate affected. The patient did not receive any treatment for the events. The outcome of the events was unknown.   Follow-up (25Mar2021) and (31Mar2021): This is a follow-up spontaneous report from a contactable consumer. New information included: Lot/Batch number of the second dose, medical history updates.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: my body broke into raised hives with a flaming itch/it covered all of my body at different points even my fingers and the soles of my feet; my body broke into raised hives with a flaming itch; covered with a full raised rash on most of my Torso,all extremities, soles of my feet; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 18Mar2021 at 16:00 (at the age of 51-years-old) as a single dose for COVID-19 vaccination. Medical history included multiple environmental allergies and high blood pressure(controlled). The concomitant medication included allergy shots, losartan 50mg, ethinylestradiol, norethisterone (NECON). On 23Mar2021 at 12:00, patient felt itchy, patient was completely covered with a full raised rash on most of Torso, all extremities, soles of my feet, everything except face, over the next 48 hours body broke into raised hives with a flaming itch every 5 hours. The patient reported that, it covered all of my body at different points even my fingers and the soles of my feet (as reported). The patient received zyrtec, and Levocetirizine, one each morning and night and prednisone 20 mg 3 tablets every day for 5 days as a treatment. The event resulted in physician office visit and emergency room visit. The patient had undergone, covid-19 PCR on 25Mar2021 and result was unknown. The seriousness of the events was reported as non-serious by the reporter. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chest pain, Chills, Dyspnoea
Clinical narrative: feeling unwell; sick to stomach; vomiting; chest pains; hard to breath; chills/freezing; weak; 104 fever; sore arm; sore muscles; This is a spontaneous report received from a contactable consumer (patient's mother). A 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 14:00 (02:00 PM) (Lot Number: EP6955) at the age of 18 years old as single dose for covid-19 immunisation. Medical history included Known allergies Morphine and sulfa antibiotics; Marphans syndrome, autistic, severe scoliosis & kyphosis. The patient's concomitant medications received within 2 weeks of vaccination included too many to put down here not enuf room. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The mother took care of the patient due to his sever disability iam filling this out for his as he was unable so he received shot (pending clarification), registered with v-safe, 22Mar2021 2pm. Fine, health check next 23Mar2021 day sore arm, kinda sore muscles, 24Mar2021, sore arm still sore muscles, 25Mar2021 13:00 (1pm), feeling unwell, sick to stomach started vomiting, chest pains, hard to breath, called 911 EMS advised him to stay home after vitals ok due to not wanting to expose the patient to actual Covid virus. At the time no fever 30 min after EMS left 104 fever sever chills, freezing coming in waves so weak. He can't get up to go to the bathroom. The reporter was worried and closely monitoring him. Treatment was received for the adverse event included Medication for vomiting, doctor apt in morning. The events were non-serious per the reporter. The patient underwent lab tests and procedures which included body temperature: no fever 25Mar2021, 104 30 min after EMS left on 25Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.