chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Bilateral tinnitus; This is a spontaneous report from a contactable consumer reporting for self. A 52-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 01Mar2021 10:30 (Batch/Lot Number: EN6205) at the age of 52 years old as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced bilateral tinnitus on 12Mar2021 19:15. Event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Therapeutic measures were taken as a result included Hearing test and ENT visit. Outcome of event was not recovered.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, Nasal congestion, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: received his first dose of the Pfizer-Biontech covid19 vaccine 20Mar2021/05Apr2021 - tested positive; received his first dose of the Pfizer-Biontech covid19 vaccine 20Mar2021/05Apr2021 - tested positive/ Contracted Covid; started developing 01Apr cold like sx; Fatigue; Sore throat, a little bit; Congestion; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 35-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN6206 and Expiry date was unknown), via an unspecified route of administration, in the left arm on 20Mar2021 at 16:25 (at the age of 35-years-old) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications and relevant family medical history were not reported. As reported no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. The patient did not receive other vaccine in four weeks of vaccination. On 01Apr2021, patient started developing cold like sx, fatigue, sore throat, a little bit and congestion. On 06Apr2021, patient received his first dose of the Pfizer-Biontech covid19 vaccine 20Mar2021/05Apr2021 - tested positive/ contracted Covid. Treatments received ibuprofen (ADVIL) and a decongestant for his symptoms. Patient underwent Covid test on 05Apr2021 and result was positive on 06Apr2021. There were no unaddressed medical questions referred or forwarded to Medical Information. The outcome for the event patient received his first dose of the Pfizer-Biontech covid19 vaccine 20Mar2021/05Apr2021 - tested positive/ contracted Covid was not resolved and for other events was recovering.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: received his first dose of the Pfizer-Biontech covid19 vaccine 20Mar2021/05Apr2021 - tested positive; received his first dose of the Pfizer-Biontech covid19 vaccine 20Mar2021/05Apr2021 - tested positive/ Contracted Covid; started developing 01Apr cold like sx; Fatigue; Sore throat, a little bit; Congestion; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 35-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN6206 and Expiry date was unknown), via an unspecified route of administration, in the left arm on 20Mar2021 at 16:25 (at the age of 35-years-old) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications and relevant family medical history were not reported. As reported no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. The patient did not receive other vaccine in four weeks of vaccination. On 01Apr2021, patient started developing cold like sx, fatigue, sore throat, a little bit and congestion. On 06Apr2021, patient received his first dose of the Pfizer-Biontech covid19 vaccine 20Mar2021/05Apr2021 - tested positive/ contracted Covid. Treatments received ibuprofen (ADVIL) and a decongestant for his symptoms. Patient underwent Covid test on 05Apr2021 and result was positive on 06Apr2021. There were no unaddressed medical questions referred or forwarded to Medical Information. The outcome for the event patient received his first dose of the Pfizer-Biontech covid19 vaccine 20Mar2021/05Apr2021 - tested positive/ contracted Covid was not resolved and for other events was recovering.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye haemorrhage, Fatigue, Feeling abnormal, Headache
Clinical narrative: Blood Vessel Burst in left eye; Brain fog; Dizziness; Fatigue; Nausea; Soreness; Headache; This is a spontaneous report from a contactable consumer.  A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 33-years -old via an unspecified route of administration, administered in arm left on 05Apr2021 14:45 (Batch/Lot Number: EW0151) as single dose for covid-19 immunisation.  Medical history included polycystic ovaries from an unknown date and unknown if ongoing, gallbladder removed on an unspecified date, allergies: Sulfa from an unknown date and unknown if ongoing. Concomitant medications included calcium; colecalciferol (D3); fish oil; bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC); clarithromycin (CLARITIN); all taken for an unspecified indication, start and stop date were not reported.  The patient previously took amoxicillin and experienced allergies.  The patient experienced blood vessel burst in left eye, brain fog, dizziness, fatigue, nausea, soreness and headache on 05Apr2021 17:00. It was unknown if treatment was received for the events. The patient did not recover from the events.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Blood Vessel Burst in left eye; Brain fog; Dizziness; Fatigue; Nausea; Soreness; Headache; This is a spontaneous report from a contactable consumer.  A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 33-years -old via an unspecified route of administration, administered in arm left on 05Apr2021 14:45 (Batch/Lot Number: EW0151) as single dose for covid-19 immunisation.  Medical history included polycystic ovaries from an unknown date and unknown if ongoing, gallbladder removed on an unspecified date, allergies: Sulfa from an unknown date and unknown if ongoing. Concomitant medications included calcium; colecalciferol (D3); fish oil; bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC); clarithromycin (CLARITIN); all taken for an unspecified indication, start and stop date were not reported.  The patient previously took amoxicillin and experienced allergies.  The patient experienced blood vessel burst in left eye, brain fog, dizziness, fatigue, nausea, soreness and headache on 05Apr2021 17:00. It was unknown if treatment was received for the events. The patient did not recover from the events.
Sex: F
Vaccine: COVID19
Symptoms: Chronic lymphocytic leukaemia
Clinical narrative: has Leukemia CLL and she got both doses of Covid vaccine; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), first and second dose, via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  It was reported that the patient has Leukemia CLL and she got both doses of covid vaccine on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Concussion, Electrocardiogram, Fall, Loss of consciousness
Clinical narrative: Fainted about 12 hours after receiving the vaccine after waking up to go to the bathroom/diagnosed with a concussion and syncope; unconscious for an undetermined amount of time; Fell to ground and was then diagnosed with a concussion and syncope at the ER; Fell to ground and was then diagnosed with a concussion and syncope at the ER; fever; body aches; This is a spontaneous report from a contactable consumer (patient).  A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: er8735) at the age of 31-year-old, via an unspecified route of administration, administered in left arm on 03Apr2021 16:45 as single dose for COVID-19 immunisation. Medical history included allergies to penicillin and seafood, and was diagnosed with COVID-19 prior vaccination. Concomitant medication included clonazepam. The patient was not pregnant at the time of vaccination. On 04Apr2021 05:30AM, the patient fainted (also reported as about 12 hours after receiving the vaccine) after waking up to go to the bathroom, was unconscious for an undetermined amount of time, fell to ground, and was then diagnosed with a concussion and syncope at the ER. CT scan and EKG 12 lead were clear on an unspecified date. In addition to this, the patient also has fever and body aches on 04Apr2021 05:30AM. No treatment was received for the events. The event resulted to emergency room/department or urgent care. The patient underwent lab tests and procedures which included Nasal Swab: pending results on 04Apr2021. The outcome of the events was not recovered.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Syncope
Clinical narrative: Fainted about 12 hours after receiving the vaccine after waking up to go to the bathroom/diagnosed with a concussion and syncope; unconscious for an undetermined amount of time; Fell to ground and was then diagnosed with a concussion and syncope at the ER; Fell to ground and was then diagnosed with a concussion and syncope at the ER; fever; body aches; This is a spontaneous report from a contactable consumer (patient).  A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: er8735) at the age of 31-year-old, via an unspecified route of administration, administered in left arm on 03Apr2021 16:45 as single dose for COVID-19 immunisation. Medical history included allergies to penicillin and seafood, and was diagnosed with COVID-19 prior vaccination. Concomitant medication included clonazepam. The patient was not pregnant at the time of vaccination. On 04Apr2021 05:30AM, the patient fainted (also reported as about 12 hours after receiving the vaccine) after waking up to go to the bathroom, was unconscious for an undetermined amount of time, fell to ground, and was then diagnosed with a concussion and syncope at the ER. CT scan and EKG 12 lead were clear on an unspecified date. In addition to this, the patient also has fever and body aches on 04Apr2021 05:30AM. No treatment was received for the events. The event resulted to emergency room/department or urgent care. The patient underwent lab tests and procedures which included Nasal Swab: pending results on 04Apr2021. The outcome of the events was not recovered.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Fatigue, Feeling abnormal, Hypoacusis, Tinnitus
Clinical narrative: lost hearing in right ear; everything sounds muffled; constant buzzing; felt foggy, like brain fog; tired, really tired; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 41-years, at single dose in left upper arm on 16Mar2021 at 12:00 (Lot Number: EP6955) for covid-19 immunisation. The patient medical history was none. Weight was 99.79 kg and Height was 191 cm. There were no concomitant medications. The patient previously received tetanus vaccine for immunisation when he was a kid. The patient reported that he had his first shot and was scheduled to take second shot today (on 06Apr2021). He stated that two days after the first shot, on 18Mar2021, he didn't have any arm pain, nausea, vomiting, or headaches. He lost hearing out of right ear. He already went to the physician about it. He was scheduled to go to Ear Nose and Throat doctor on 12Apr2021. He stated they checked his ear and everything. The hearing loss was not related to any kind of ear wax or anything.  He went to urgent care, so they were limited to what they can do, and he was referred out to Ear Nose and Throat. He said everything sounded muffled and liked a constant buzzing in that ear. He had never had this problem. That doctor was going to check his ears and would do a hearing test on 12Apr2021. He confirmed that the hearing loss started on 18Mar2021. He also confirmed that the hearing loss was still ongoing and it was about the same, or persisting. The patient also reported that after the first one he didn't have the side effects that they claim to have. He hadn't died from it. He was just tired really tired, two to three hours after the shot, he got the shot at 12 noon, so about 2 to 3 o'clock. He laid down to rest and went to sleep. He woke up the next morning, went to work and was fine. He stated that other than that no headache, no arm pain, no diarrhea, no vomiting. He just felt foggy like brain fog the following morning after the vaccine till about mid-day and it went away. It only lasted four or five hours. He confirmed that was on 17Mar2021, as well as, that he had recovered completely. The patient received treatment and included that prescription medication for ear: Ofloxacin 0.3%. Instill five drops in the right ear two times a day for seven days. There was no additional vaccine administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Event outcome for Hearing loss, Muffled hearing in both ears and Ear buzzing was not recovered, while for Tiredness and Foggy feeling in head was recovered on 17Mar2021.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Skin exfoliation
Clinical narrative: Entire body turned red; Skin all over body peeled; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced the entire body turned red and skin all over body peeled on an unspecified date. It was reported tat the patient was hospitalized on an unknown date (at an unknown period of time). The outcome of the event was recovering.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: pulmonary embolism; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ep7534), via an unspecified route of administration, administered in right arm on 16Mar2021 15:00 as single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included verapamil. The patient previously took lisinopril and experienced allergies. The patient received first dose of bnt162b2 on 23Feb2021, 13:00 for Covid-19 immunization. On 19Mar2021, the patient started having challenges with shortness of breath. On 31Mar2021, after the challenge continued to grow he was checked into the hospital and was diagnosed with pulmonary embolism. Despite no travel nor history of family blood clots, nor was he was genetically dispositioned. The events resulted in emergency room/department or urgent care. Therapy for the events included Blood thinner. The patient had no other vaccine in 4 weeks, and no Covid prior vaccination. The patient was Covid tested post vaccination. The patient underwent lab tests and procedures which included nasal swab was negative on 31Mar2021. Outcome of events was recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Migraine, Neuropathy peripheral, Pain in extremity
Clinical narrative: Worsen neuropathic symptoms; migraine headache; Sore arm; fatigue; low grade fevers; chilled; This is a spontaneous report from a contactable consumer(patient).   This is the 1st of 2 reports, for the Second dose.   A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 24Mar2021 (at age of 43 years old) 11:45AM, via an unspecified route of administration, administered in Arm Left (Batch/Lot number was not reported) at single dose, for covid-19 immunisation.  Medical history included Ovarian cancer, blood clots, hypertension. known allergies Salfa. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 03Mar2021 (at age of 43 years old)  11:00 AM, via an unspecified route of administration, administered in Arm Left (Batch/Lot number was not reported) at single dose, for covid-19 immunisation and experienced Sore arm, Worsen neuropathic symptoms (existing side effects from chemo) - pains on fingers, wrists, feet, toes, back# fatigue, migraine headache for 15 days. Concomitant medication(s) in two weeks included duloxetine hydrochloride (CYMBALTA) 30 mg, warfarin 1mg and hydrochlorothiazide, all taken for an unspecified indication, start and stop date were not reported. Sore arm, Worsen neuropathic symptoms (existing side effects from chemo) - pains on fingers, wrists, feet, toes, back# fatigue, migraine headache for 15 days after the first dose. For second dose, same symptoms continuously for 11 days now and low grade fevers, chilled for first 4 days after the vaccine and on the 11th and 12th days after the second dose. No treatment received for events and The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19. Outcome for events was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021377679 Same patient/drug, diff event sep for different doses.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Worsen neuropathic symptoms; migraine headache; Sore arm; fatigue; low grade fevers; chilled; This is a spontaneous report from a contactable consumer(patient).   This is the 1st of 2 reports, for the Second dose.   A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 24Mar2021 (at age of 43 years old) 11:45AM, via an unspecified route of administration, administered in Arm Left (Batch/Lot number was not reported) at single dose, for covid-19 immunisation.  Medical history included Ovarian cancer, blood clots, hypertension. known allergies Salfa. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 03Mar2021 (at age of 43 years old)  11:00 AM, via an unspecified route of administration, administered in Arm Left (Batch/Lot number was not reported) at single dose, for covid-19 immunisation and experienced Sore arm, Worsen neuropathic symptoms (existing side effects from chemo) - pains on fingers, wrists, feet, toes, back# fatigue, migraine headache for 15 days. Concomitant medication(s) in two weeks included duloxetine hydrochloride (CYMBALTA) 30 mg, warfarin 1mg and hydrochlorothiazide, all taken for an unspecified indication, start and stop date were not reported. Sore arm, Worsen neuropathic symptoms (existing side effects from chemo) - pains on fingers, wrists, feet, toes, back# fatigue, migraine headache for 15 days after the first dose. For second dose, same symptoms continuously for 11 days now and low grade fevers, chilled for first 4 days after the vaccine and on the 11th and 12th days after the second dose. No treatment received for events and The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19. Outcome for events was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021377679 Same patient/drug, diff event sep for different doses.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity
Clinical narrative: Pain in her chest all the way to her arm; Pain in her chest all the way to her arm; This is a spontaneous report received from Pfizer-sponsored program. A contactable consumer (patient's spouse) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient has a scheduled appointment for a second dose due on 06Apr2021. The reporter wanted to reschedule because the patient was in the hospital and won't be able to get it on the scheduled date. Patient was hospitalized because she had pain in her chest all the way to her arm on unspecified date in 2021. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; nerve problem on right leg created drop foot, due to being in bed for 5 weeks; This is a spontaneous report from a contactable consumer (Patient). A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FL9269), dose 1 via an unspecified route of administration on 08Feb2021 15:00 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got the shot and had no symptoms before the shot, got very sick that week and became progressively worse after the shot. he was okay for the first couple of days and then he got sicker and sicker and weaker and weaker. Patient went to the ER on 15Feb2021, and he got a positive Covid test on 15Feb2021. He went into the hospital on 17Feb2021 because he was very weak and had a fever (Low grade fever until the time he was admitted to hospital) and he was in hospital for 6 days(Till 22Feb29021). Patient was all better now and he was treated with Remdesivir. he was in bed and weak for 5 weeks, he developed a nerve problem on his right leg on 21Mar2021. States it was created by the nerve thing, it is called drop foot, it improved slightly. Patient had took treatment for the event as IV, Remdesivir 4 Day Program, he was in the hospital for 6 days they gave him the Remdesivir plus antibiotics and other things that he doesn't know off the top of his head. Patient tested negative for Covid at the end of March. The outcome was recovered with sequels for the event covid-19 and for other it was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This is a spontaneous report from a non-contactable consumer. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 26Mar2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took glatiramer acetate injection and experienced pain. The patient reported that he has pain with his glatiramer acetate injections at times. He reported that it hurts more than the vaccine he got today, 26Mar2021 did. The outcome of the event was unknown. The event was assessed as serious, medically significant.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Ear, nose and throat examination
Clinical narrative: Lost of taste and smell, intermittently; Lost of taste and smell, intermittently; This is a spontaneous report from a contactable consumer, reporting for himself.  A 73-year-old male patient received the first and second doses of the bnt162b2 (BNT162B2) on 24Feb2021 at 16:40 (Lot Number: EN6203) and on 16Mar2021 about 10:30-11:00 (Lot Number: EP7534), respectively via an unspecified route of administration in the left arm at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced lost of taste and smell, intermittently, which was assessed as medically significant. The events did not require visit to emergency room.  The patient underwent lab tests and procedures which included ear, nose and throat (ENT): everything was fine on 30Mar2021. No treatment was administered. The clinical outcome of the event was not recovered. His symptoms started but said they were gradual and persisting.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Tested positive for COVID-19; This is a spontaneous report from a contactable consumer.  A 58-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8737), dose 1 intramuscular, administered in deltoid left on 07Apr2021 at 14:15 as single dose for covid-19 immunisation. Medical history included seasonal allergy and drug hypersensitivity (allergic to Codeine and Soma, like the heavier pain medications). The patient's concomitant medications were not reported. No Prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations. On 08Apr2021, the patient had allergies and he went to a walk-in clinic. He was given a rapid test and he was tested positive for COVID-19. He went to the doctor thinking it was just his allergies kicking in because it was that time of the year- it was Spring time and pollen starts popping up. He normally gets his seasonal allergies twice a year- Spring time and Fall. However, he found out it was COVID-19. The event considered as medically significant with outcome of unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots in legs where old injury was; This is a spontaneous report from a contactable consumer (patient). A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose 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 patient had an old leg injury several times in the past, which was fine. The patient's concomitant medications were not reported. The patient experienced blood clots in legs where old injury was on an unspecified date with outcome of unknown. Received call from consumer who stated she had a speech impediment. She was calling about the Pfizer COVID vaccine. She had the 1st shot. She had an old leg injury several times in the past, which was fine. This time it had big blood clots that appeared since the vaccine. She was afraid to go for second shot. She would like some guidance about getting second shot because she was afraid to go get it. Unable to confirm if speech impediment was prior to receiving vaccine or after. No further details provided.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test, Vaccination failure
Clinical narrative: We both have tested positive; he is in the hospital on oxygen because he tested positive.; We both have tested positive; he is in the hospital on oxygen because he tested positive.; Breathing difficulty and some of the Covid symptoms.; This is a spontaneous report from a contactable consumer. Reporter was reporting for both her husband and herself. This is the second case of two cases.  A 73-year-old male patient received first dose BNT162B2 (Solution for injection, lot number: EL9265) via an unspecified route of administration in arm on 04Feb2021 at single dose and second dose via an unspecified route of administration in arm (lot number: EN6202) on 25Feb2021 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Reporter stated, "they were calling about a specific batch of the Pfizer vaccine. Her husband and she received. They were vaccinated at the February 25th and we both have tested positive." Reporter stated, "they got both shots." Reporter stated, "04Feb2021 and 25Feb2021." When probed for whether husband and wife got the Covid Vaccine shots on same dates: Reporter stated, "Yes, together." Reporter stated, "For him it was 31Mar2021, for her it was 01Apr2021. He got tested would be 31Mar2021. Reporter stated, "I have you mean because of the testing positive, the symptoms. they don't have medical condition." Medical condition for husband, Reporter stated, "Well right now he was, he was in the hospital on oxygen because he tested positive on 30Mar2021." Date of hospitalization for husband, Reporter stated, "He entered the hospital same day he was tested, 31Mar2021. 30Mar2021 he went in." When probed if he was still in the hospital, Reporter stated, "He was still in the hospital." Reason for hospitalization, Reporter stated, "Because he was having breathing difficulty and some of the Covid symptoms on 30Mar2021. patients who took the Covid vaccine from Pfizer and have tested positive for month or two later." Outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Choking, Dizziness, Dyspnoea, Eating disorder, Insomnia
Clinical narrative: Muscle pain; I spit saliva with in combination with mucus; cannot sleep for 2 or 3 days; got dizzy; choking; shortness of breath; I can't eat anything; This is a spontaneous report from a contactable consumer, the patient.  A 57-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6205), via an unspecified route of administration on arm left on 06Mar2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6205), via an unspecified route of administration on arm left on 30Mar2021 for COVID-19 immunization. The patient medical history was not reported. The Concomitant medications were not reported. On an unspecified date, one day after, the patient experienced like choking, breathing air, shortness of breath and choking that patient can't eat anything and all food goes different ways in trachea was the first experience with first dose and also experienced first shot muscle pain, which is normal okay. The patient felt second shot was terrible, and had same symptoms and got muscle pain, got dizzy, then most hard time again had for 2 night 3 days a lot of saliva, saliva comes from gland. The patient felt water comes through saliva, and cannot sleep for 2 or 3 days." The patient had expel, expel choking in the day and when laid down the other night and spit saliva with in combination with mucus, mucus and saliva and cannot sleep for 3 days, Friday Saturday and Sunday. The outcome of the events was unknown.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Secretion discharge
Clinical narrative: Muscle pain; I spit saliva with in combination with mucus; cannot sleep for 2 or 3 days; got dizzy; choking; shortness of breath; I can't eat anything; This is a spontaneous report from a contactable consumer, the patient.  A 57-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6205), via an unspecified route of administration on arm left on 06Mar2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6205), via an unspecified route of administration on arm left on 30Mar2021 for COVID-19 immunization. The patient medical history was not reported. The Concomitant medications were not reported. On an unspecified date, one day after, the patient experienced like choking, breathing air, shortness of breath and choking that patient can't eat anything and all food goes different ways in trachea was the first experience with first dose and also experienced first shot muscle pain, which is normal okay. The patient felt second shot was terrible, and had same symptoms and got muscle pain, got dizzy, then most hard time again had for 2 night 3 days a lot of saliva, saliva comes from gland. The patient felt water comes through saliva, and cannot sleep for 2 or 3 days." The patient had expel, expel choking in the day and when laid down the other night and spit saliva with in combination with mucus, mucus and saliva and cannot sleep for 3 days, Friday Saturday and Sunday. The outcome of the events was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling hot, Headache, Insomnia, Musculoskeletal discomfort
Clinical narrative: I haven't slept in days; I had headache so badly that my right eye which is to the opposite side to where I got the shot/ like whenever I take a step to walk it's feels like my head is going to explode; really bad back ache; My face and my back started getting like hot, like heat, like very hot reaction/like radiating heat in my back it is like surrounding my spine, its right in the middle of my back; It feels like heat and pressure around my spine area; high pressure behind the right eye; My arm started hurting; the arm I got the shot in; This is a spontaneous report received from a non-contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733), intramuscular (reported as in the muscle) in left arm on 01Apr2021 (at the age of 43-year-old) at 0.3 ml, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that initially, right afterward she meant her arm started hurting which was normal the arm she got the shot in, she wasn't worried about that. But then her face and her back started getting like hot, like heat, like very hot reaction. She did not know how to describe it, it was like radiating heat in her back it was like surrounding her spine, it was right in the middle of her back. It felt like heat and pressure around her spine area. And in her head, it had not lit up. She had headache so badly that her right eye which was to the opposite side to where she got the shot. She had very high pressure behind the right eye. It was literally like whenever she took a step to walk it was felt like her head was going to explode. It was for her a headache and really bad back ache. When paraphrased the above concern, patient stated It was for days at the time of this report. First adverse reaction was on the actual day that she received the vaccine that was 01Apr2021. Second shot was reported as 29Apr2021. When probed for if patient still experiencing adverse event patient stated that she was still experiencing. As per outcome of event patient stated for its persisting. As per treatment she took an ibuprofen (ADVIL) for the first-time last night before the present report. Just because she needed to get sleep. She had not slept in days. So, she took ADVIL to get rid of the pain last night that was only the things she had done since Thursday 01Apr2021. But it didn't even work. She woke up and felt the exact same. Dose of Advil was reported as 200 mg, she took one 200 mg tablet. She just took it the day before the present report (04Apr2021). The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Pain in extremity
Clinical narrative: I haven't slept in days; I had headache so badly that my right eye which is to the opposite side to where I got the shot/ like whenever I take a step to walk it's feels like my head is going to explode; really bad back ache; My face and my back started getting like hot, like heat, like very hot reaction/like radiating heat in my back it is like surrounding my spine, its right in the middle of my back; It feels like heat and pressure around my spine area; high pressure behind the right eye; My arm started hurting; the arm I got the shot in; This is a spontaneous report received from a non-contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733), intramuscular (reported as in the muscle) in left arm on 01Apr2021 (at the age of 43-year-old) at 0.3 ml, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that initially, right afterward she meant her arm started hurting which was normal the arm she got the shot in, she wasn't worried about that. But then her face and her back started getting like hot, like heat, like very hot reaction. She did not know how to describe it, it was like radiating heat in her back it was like surrounding her spine, it was right in the middle of her back. It felt like heat and pressure around her spine area. And in her head, it had not lit up. She had headache so badly that her right eye which was to the opposite side to where she got the shot. She had very high pressure behind the right eye. It was literally like whenever she took a step to walk it was felt like her head was going to explode. It was for her a headache and really bad back ache. When paraphrased the above concern, patient stated It was for days at the time of this report. First adverse reaction was on the actual day that she received the vaccine that was 01Apr2021. Second shot was reported as 29Apr2021. When probed for if patient still experiencing adverse event patient stated that she was still experiencing. As per outcome of event patient stated for its persisting. As per treatment she took an ibuprofen (ADVIL) for the first-time last night before the present report. Just because she needed to get sleep. She had not slept in days. So, she took ADVIL to get rid of the pain last night that was only the things she had done since Thursday 01Apr2021. But it didn't even work. She woke up and felt the exact same. Dose of Advil was reported as 200 mg, she took one 200 mg tablet. She just took it the day before the present report (04Apr2021). The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Head injury, Headache
Clinical narrative: I fainted, I hit my head when I fainted; I fainted, I hit my head when I fainted; Tiredness; Headache; Muscle pain; Chills; Joint pain; Nausea; the arm hurt; This is a spontaneous report from a contactable consumer (patient). A 38-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 02Apr2021 at age of 38-year-old (Batch/Lot Number: ER8733) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were none. On an unspecified date in Apr2021, the patient got the tiredness, headache, muscle pain, the chills, the joint pain, the arm hurt, nausea, and then on 06Apr2021 patient fainted, I hit head when the patient fainted. Treatment in response to events was none. The outcome of the events was unknown.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Syncope
Clinical narrative: I fainted, I hit my head when I fainted; I fainted, I hit my head when I fainted; Tiredness; Headache; Muscle pain; Chills; Joint pain; Nausea; the arm hurt; This is a spontaneous report from a contactable consumer (patient). A 38-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 02Apr2021 at age of 38-year-old (Batch/Lot Number: ER8733) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were none. On an unspecified date in Apr2021, the patient got the tiredness, headache, muscle pain, the chills, the joint pain, the arm hurt, nausea, and then on 06Apr2021 patient fainted, I hit head when the patient fainted. Treatment in response to events was none. The outcome of the events was unknown.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dementia Alzheimer's type, Fatigue, Feeling abnormal, Haematoma
Clinical narrative: Become so forgetful since I had the injection that it feels like I have Alzheimer's; brain fog; Brain fog and fatigue is unreal/fatigue; chilling pain; it feels like I have Alzheimer's; Arm is till really hurting; Hematoma; This is a spontaneous report from a contactable consumer.  A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in Arm Left on 28Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included ongoing hypertension, anxiety, blood cholesterol increased, hypertriglyceridaemia, covid-19 from Sep2020 ("My wife was tested positive, I had it back in September, my wife was tested positive in January and that's when I started experiencing loss of smell and taste). Concomitant medications included lisinopril taken for hypertension, propranolol taken for hypertension, alprazolam (XANAX) taken for anxiety, atorvastatin calcium (LIPITOR) taken for blood cholesterol abnormal, bacopa monnieri, eleutherococcus senticosus root, rosmarinus officinalis essential oil, schisandra chinensis fruit (BACOPA COMPLEX) taken for hypertriglyceridaemia. On unknown date patient experienced "become so forgetful since i had the injection that it feels like I have Alzheimer's", fatigue, brain fog, chilling pain and on 01Apr2021, arm is till really hurting and hematoma (described as I went to ER last night and he said that the pharmacist might have punctured a vain or a capillary). Patient had no temperature, blood pressure is normal, patient stated he never had anything like that from other vaccines.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Pain, Pain in extremity
Clinical narrative: Become so forgetful since I had the injection that it feels like I have Alzheimer's; brain fog; Brain fog and fatigue is unreal/fatigue; chilling pain; it feels like I have Alzheimer's; Arm is till really hurting; Hematoma; This is a spontaneous report from a contactable consumer.  A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in Arm Left on 28Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included ongoing hypertension, anxiety, blood cholesterol increased, hypertriglyceridaemia, covid-19 from Sep2020 ("My wife was tested positive, I had it back in September, my wife was tested positive in January and that's when I started experiencing loss of smell and taste). Concomitant medications included lisinopril taken for hypertension, propranolol taken for hypertension, alprazolam (XANAX) taken for anxiety, atorvastatin calcium (LIPITOR) taken for blood cholesterol abnormal, bacopa monnieri, eleutherococcus senticosus root, rosmarinus officinalis essential oil, schisandra chinensis fruit (BACOPA COMPLEX) taken for hypertriglyceridaemia. On unknown date patient experienced "become so forgetful since i had the injection that it feels like I have Alzheimer's", fatigue, brain fog, chilling pain and on 01Apr2021, arm is till really hurting and hematoma (described as I went to ER last night and he said that the pharmacist might have punctured a vain or a capillary). Patient had no temperature, blood pressure is normal, patient stated he never had anything like that from other vaccines.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Diabetic coma
Clinical narrative: diabetic coma; blood sugar kept dropping; This is a spontaneous report from a contactable consumer (patient's neighbor). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diabetes and coronary artery disease, and back surgery. The patient's concomitant medications were not reported. They think the patient went into a diabetic coma from low blood sugar dropping on 01Apr2021 and the patient passed away in his sleep. Reporter does not know if it had anything to do with the shot or anything but he thought they may want to know that. The patient started having problems with his blood sugar on Thursday 01Apr2021. The patient's blood sugar kept dropping and he went to bed that night and died. Patient was found deceased Friday morning 02Apr2021.  Information about batch/lot number has been requested.; Reported Cause(s) of Death: Blood glucose decreased; diabetic coma
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis
Clinical narrative: Brain clot: acute thrombosis of the Left transverse sinus, left sigmoid sinus and upper left internal jugular vein cerebral sinus venous thrombosis; This is a spontaneous report from a contactable nurse. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (reported as 19Mar2021; pending clarification). (Batch/Lot Number: EL9266) as single dose for covid-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included desogestrel, ethinylestradiol (PIMTREA) taken for an unspecified indication, start and stop date were not reported. The patient previously took diflucan and experienced allergy. The patient experienced brain clot: acute thrombosis of the left transverse sinus, left sigmoid sinus and upper left internal jugular vein cerebral sinus venous thrombosis (hospitalization, disability, life threatening) on 10Mar2021 12:45. The patient was hospitalized for brain clot: acute thrombosis of the left transverse sinus, left sigmoid sinus and upper left internal jugular vein cerebral sinus venous thrombosis for 6 days. The patient was treated with Heparin and Coumadin. The event resulted in: doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received the second dose of bnt162b2 on an unspecified date (reported as 18Mar2021; pending clarification), lot number: EN6204, on right arm. The patient was recovering from the event. The patient was not diagnosed with COVID prior to vaccination. Patient has not been tested for COVID post vaccination.; Sender's Comments: Based on the current available information, the events occurred prior to BNT162B2 administration (this information need be clarified). The reported events are considered as an intercurrent or underlying condition which is not related to the suspected drug at this time.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.