chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: UNK, COVID19
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: I have horribly terribly internal pain - a pain in my nerves and is debilitating; I got a horrible case of shingles and on my left upper shoulder and both doses were given to me on my left arm. It was terrible and worse are these residual effects; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08May2021 (Lot number: EW0161) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Left Arm), administration date: 07Apr2021, for Covid-19 immunization. The following information was reported: NEURALGIA (disability) with onset 01Jul2021, outcome "not recovered", described as "I have horribly terribly internal pain - a pain in my nerves and is debilitating"; HERPES ZOSTER (disability) with onset 01Jul2021, outcome "not recovered", described as "I got a horrible case of shingles and on my left upper shoulder and both doses were given to me on my left arm. It was terrible and worse are these residual effects". The events "I have horribly terribly internal pain - a pain in my nerves and is debilitating" and "I got a horrible case of shingles and on my left upper shoulder and both doses were given to me on my left arm. It was terrible and worse are these residual effects" were evaluated at the physician office visit. Therapeutic measures were taken as a result of neuralgia, herpes zoster: AE treatment: acyclovir.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101742190 same reporter/drug/event, different pt
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute kidney injury, Blood creatinine increased, COVID-19
Clinical narrative: Lack of Effect - Patient entered the emergency room on 07/26/2021 with major breathing issues.  The hospital was told he was exposed to COVID-19.  Patients daughter requested monoclonal antibody on 07/27/2021 but the hospital Pulmonary doctor indicated that he did not know what this was. Pulmonary doctor told daughter that Patient had no antibodies from the vaccination.  Patient was placed on ventilator and then died on 08/04/2021.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antibody test negative, Death, Dyspnoea, Exposure to SARS-CoV-2, Mechanical ventilation
Clinical narrative: Lack of Effect - Patient entered the emergency room on 07/26/2021 with major breathing issues.  The hospital was told he was exposed to COVID-19.  Patients daughter requested monoclonal antibody on 07/27/2021 but the hospital Pulmonary doctor indicated that he did not know what this was. Pulmonary doctor told daughter that Patient had no antibodies from the vaccination.  Patient was placed on ventilator and then died on 08/04/2021.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Atrophy, Blood test normal, Magnetic resonance imaging neck, Magnetic resonance imaging normal, Muscle twitching
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 16:45 (Lot number: ER8732) at the age of 30 years as dose 2, single and administered in arm left, administration date 09Mar2021 16:45 (Lot number: EN6199) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Known allergies: ceclor, reaction(s): "known allergies: ceclor". The following information was reported: COVID-19 (medically significant) with onset 07Sep2021, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "covid test result=Positive / 07Sep2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Sep2021) positive, notes: Nasal swab. Additional information: The patient have not taken other vaccine in 4 week and no other medication in 2 weeks.The patient not have covid prior vaccination and patient tested covid post vaccination.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Neck pain, Ultrasound joint, Ultrasound scan normal
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 16:45 (Lot number: ER8732) at the age of 30 years as dose 2, single and administered in arm left, administration date 09Mar2021 16:45 (Lot number: EN6199) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Known allergies: ceclor, reaction(s): "known allergies: ceclor". The following information was reported: COVID-19 (medically significant) with onset 07Sep2021, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "covid test result=Positive / 07Sep2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Sep2021) positive, notes: Nasal swab. Additional information: The patient have not taken other vaccine in 4 week and no other medication in 2 weeks.The patient not have covid prior vaccination and patient tested covid post vaccination.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Hyperreflexia, Muscle atrophy, Muscle contractions involuntary
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 16:45 (Lot number: ER8732) at the age of 30 years as dose 2, single and administered in arm left, administration date 09Mar2021 16:45 (Lot number: EN6199) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Known allergies: ceclor, reaction(s): "known allergies: ceclor". The following information was reported: COVID-19 (medically significant) with onset 07Sep2021, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "covid test result=Positive / 07Sep2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Sep2021) positive, notes: Nasal swab. Additional information: The patient have not taken other vaccine in 4 week and no other medication in 2 weeks.The patient not have covid prior vaccination and patient tested covid post vaccination.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 16:45 (Lot number: ER8732) at the age of 30 years as dose 2, single and administered in arm left, administration date 09Mar2021 16:45 (Lot number: EN6199) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Known allergies: ceclor, reaction(s): "known allergies: ceclor". The following information was reported: COVID-19 (medically significant) with onset 07Sep2021, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "covid test result=Positive / 07Sep2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Sep2021) positive, notes: Nasal swab. Additional information: The patient have not taken other vaccine in 4 week and no other medication in 2 weeks.The patient not have covid prior vaccination and patient tested covid post vaccination.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: went achy; This is a spontaneous report received from a contactable reporter (nurse).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shot, for influenza immunisation, reaction(s): "no adverse effect". The following information was reported: PAIN (non-serious), outcome "unknown", described as "went achy".  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia, Somnolence
Clinical narrative: went achy; This is a spontaneous report received from a contactable reporter (nurse).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shot, for influenza immunisation, reaction(s): "no adverse effect". The following information was reported: PAIN (non-serious), outcome "unknown", described as "went achy".  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: went achy; This is a spontaneous report received from a contactable reporter (nurse).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shot, for influenza immunisation, reaction(s): "no adverse effect". The following information was reported: PAIN (non-serious), outcome "unknown", described as "went achy".  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antineutrophil cytoplasmic antibody positive, Arthralgia, Biopsy kidney, Blood test, Chemotherapy
Clinical narrative: The patient is a previously healthy 38 yo female with a history of biopsy-proven MPO ANCA vasculitis temporally associated with receipt of Covid vaccine Pfizer BioNTech dose #1 on 17 Feb 21 followed by receipt of dose #2 on 10 MAR 21. She experienced new onset intermittent ankle pain in the weeks after dose #1 followed by onset of pitting edema. Pt reports episodes of swelling to the ankle area daily for 2 or 3 weeks, from 22 Mar 2021.  Patient reports this would resolve with elevation of the feet.  Now over the last 12 days patient reports swelling has not completely resolved.  Patient recently flew to another town, March 19, 2021 returned yesterday March 21, 2021.  Patient notes increased swelling at this time.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Renal function test, Vasculitis
Clinical narrative: The patient is a previously healthy 38 yo female with a history of biopsy-proven MPO ANCA vasculitis temporally associated with receipt of Covid vaccine Pfizer BioNTech dose #1 on 17 Feb 21 followed by receipt of dose #2 on 10 MAR 21. She experienced new onset intermittent ankle pain in the weeks after dose #1 followed by onset of pitting edema. Pt reports episodes of swelling to the ankle area daily for 2 or 3 weeks, from 22 Mar 2021.  Patient reports this would resolve with elevation of the feet.  Now over the last 12 days patient reports swelling has not completely resolved.  Patient recently flew to another town, March 19, 2021 returned yesterday March 21, 2021.  Patient notes increased swelling at this time.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antineutrophil cytoplasmic antibody, Arthralgia, Biopsy kidney, Blood creatinine, Blood iron
Clinical narrative: The patient is a previously healthy 38 yo female with a history of biopsy-proven MPO ANCA vasculitis temporally associated with receipt of Covid vaccine Pfizer BioNTech dose #1 on 17 Feb 21 followed by receipt of dose #2 on 10 MAR 21. She experienced new onset intermittent ankle pain in the weeks after dose #1 followed by onset of pitting edema. Pt reports episodes of swelling to the ankle area daily for 2 or 3 weeks, from 22 Mar 2021.  Patient reports this would resolve with elevation of the feet.  Now over the last 12 days patient reports swelling has not completely resolved.  Patient recently flew to another town, March 19, 2021 returned yesterday March 21, 2021.  Patient notes increased swelling at this time.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood parathyroid hormone, Chest X-ray, Computerised tomogram kidney, Differential white blood cell count, Full blood count
Clinical narrative: The patient is a previously healthy 38 yo female with a history of biopsy-proven MPO ANCA vasculitis temporally associated with receipt of Covid vaccine Pfizer BioNTech dose #1 on 17 Feb 21 followed by receipt of dose #2 on 10 MAR 21. She experienced new onset intermittent ankle pain in the weeks after dose #1 followed by onset of pitting edema. Pt reports episodes of swelling to the ankle area daily for 2 or 3 weeks, from 22 Mar 2021.  Patient reports this would resolve with elevation of the feet.  Now over the last 12 days patient reports swelling has not completely resolved.  Patient recently flew to another town, March 19, 2021 returned yesterday March 21, 2021.  Patient notes increased swelling at this time.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Nephrolithiasis, Oedema, Protein total, Renal function test
Clinical narrative: The patient is a previously healthy 38 yo female with a history of biopsy-proven MPO ANCA vasculitis temporally associated with receipt of Covid vaccine Pfizer BioNTech dose #1 on 17 Feb 21 followed by receipt of dose #2 on 10 MAR 21. She experienced new onset intermittent ankle pain in the weeks after dose #1 followed by onset of pitting edema. Pt reports episodes of swelling to the ankle area daily for 2 or 3 weeks, from 22 Mar 2021.  Patient reports this would resolve with elevation of the feet.  Now over the last 12 days patient reports swelling has not completely resolved.  Patient recently flew to another town, March 19, 2021 returned yesterday March 21, 2021.  Patient notes increased swelling at this time.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler, Vasculitis
Clinical narrative: The patient is a previously healthy 38 yo female with a history of biopsy-proven MPO ANCA vasculitis temporally associated with receipt of Covid vaccine Pfizer BioNTech dose #1 on 17 Feb 21 followed by receipt of dose #2 on 10 MAR 21. She experienced new onset intermittent ankle pain in the weeks after dose #1 followed by onset of pitting edema. Pt reports episodes of swelling to the ankle area daily for 2 or 3 weeks, from 22 Mar 2021.  Patient reports this would resolve with elevation of the feet.  Now over the last 12 days patient reports swelling has not completely resolved.  Patient recently flew to another town, March 19, 2021 returned yesterday March 21, 2021.  Patient notes increased swelling at this time.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Headache, Oropharyngeal discomfort, Pharyngeal swelling, Throat tightness
Clinical narrative: About 15 minutes after receiving the vaccine I had a mild anaphylactic reaction where the back of my throat felt really cold and my throat from the back of my mouth down to the base of my neck felt tight. I had already taken a Benadryl prep, 25 mg of Benadryl every eight hours for a day and a half, and had taken a Benadryl a half an hour prior to help advert a reaction.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Oropharyngeal discomfort, Skin test, Throat tightness
Clinical narrative: About 15 minutes after receiving the vaccine I had a mild anaphylactic reaction where the back of my throat felt really cold and my throat from the back of my mouth down to the base of my neck felt tight. I had already taken a Benadryl prep, 25 mg of Benadryl every eight hours for a day and a half, and had taken a Benadryl a half an hour prior to help advert a reaction.
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: child had high functioning autism. He had oral and auditory symptoms, and speech symptoms including a stutter.; her son was given a dose of the orange cap Pfizer Covid-19 vaccine that was "left out" for more than 12 hours; social anxiety; efficacy issue; her son was given a dose of the orange cap Pfizer Covid-19 vaccine that was "left out" for more than 12 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (002191). The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 08:45 (Lot number: FK5127) at the age of 6 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: AUTISM SPECTRUM DISORDER (medically significant), outcome "unknown", described as "child had high functioning autism. He had oral and auditory symptoms, and speech symptoms including a stutter."; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 19Nov2021 08:45, outcome "unknown", PRODUCT STORAGE ERROR (non-serious), outcome "unknown" and all described as "her son was given a dose of the orange cap Pfizer Covid-19 vaccine that was "left out" for more than 12 hours"; SOCIAL ANXIETY DISORDER (non-serious), outcome "unknown", described as "social anxiety"; THERAPEUTIC PRODUCT EFFECT VARIABLE (non-serious), outcome "unknown", described as "efficacy issue". The nurse said in the state of (state withheld), they have reported this same situation 3 times. It was beyond 12 hours. The patient did not have an official diagnosis of autism disorder, but mother thought her child had high functioning autism. The patient had appointment at 08:30 so he probably received the vaccine at 08:45. The nurse said it was just an efficacy issue. The nurse said everything was fine, and that he wouldn't have to get a 3rd shot. It was out of the 12 hour window. He is to return 10Dec2021 for his second dose. He got it in his right arm. There was nothing medically connected to it. She was just fearful of him might having autism and vaccines. The vaccine was not administered at Military Facility. The patient did not have previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not visit emergency room and physician office. The patient did not have prior vaccinations (within 4 weeks). The patient did not have diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient did not have following tests: blood tests, cerebrospinal fluid culture, bacterial sero-type and diagnostic imaging (e.g., chest X-ray, MRI).  Follow-Up (29Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests normal, Disorientation, Ear discomfort, Feeling abnormal, Headache
Clinical narrative: ear fullness; sensitivity to noise at normal volumes; tinnitus in both ears and head; brain fog; disorientation; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 12:30 (Lot number: FD0809) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 21Sep2021 20:00, outcome "not recovered", described as "brain fog"; DISORIENTATION (non-serious) with onset 21Sep2021 20:00, outcome "not recovered", described as "disorientation"; HEADACHE (non-serious) with onset 21Sep2021 20:00, outcome "not recovered", described as "headache"; EAR DISCOMFORT (non-serious) with onset 28Sep2021, outcome "not recovered", described as "ear fullness"; HYPERACUSIS (non-serious) with onset 28Sep2021, outcome "not recovered", described as "sensitivity to noise at normal volumes"; TINNITUS (non-serious) with onset 28Sep2021, outcome "not recovered", described as "tinnitus in both ears and head". The events "brain fog", "disorientation", "headache", "ear fullness", "sensitivity to noise at normal volumes" and "tinnitus in both ears and head" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of feeling abnormal, disorientation, headache, ear discomfort, hyperacusis, tinnitus.  Additional information: The patient received daily multivitamin within 2 weeks of vaccination (as reported). The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. It was reported that the brain fog and disorientation subsided after two weeks. One week after vaccination (as reported), ear fullness, sensitivity to noise at normal volumes, and tinnitus in both ears and head occurred. Events were still present at the time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Physical examination normal, Tinnitus
Clinical narrative: ear fullness; sensitivity to noise at normal volumes; tinnitus in both ears and head; brain fog; disorientation; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 12:30 (Lot number: FD0809) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 21Sep2021 20:00, outcome "not recovered", described as "brain fog"; DISORIENTATION (non-serious) with onset 21Sep2021 20:00, outcome "not recovered", described as "disorientation"; HEADACHE (non-serious) with onset 21Sep2021 20:00, outcome "not recovered", described as "headache"; EAR DISCOMFORT (non-serious) with onset 28Sep2021, outcome "not recovered", described as "ear fullness"; HYPERACUSIS (non-serious) with onset 28Sep2021, outcome "not recovered", described as "sensitivity to noise at normal volumes"; TINNITUS (non-serious) with onset 28Sep2021, outcome "not recovered", described as "tinnitus in both ears and head". The events "brain fog", "disorientation", "headache", "ear fullness", "sensitivity to noise at normal volumes" and "tinnitus in both ears and head" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of feeling abnormal, disorientation, headache, ear discomfort, hyperacusis, tinnitus.  Additional information: The patient received daily multivitamin within 2 weeks of vaccination (as reported). The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. It was reported that the brain fog and disorientation subsided after two weeks. One week after vaccination (as reported), ear fullness, sensitivity to noise at normal volumes, and tinnitus in both ears and head occurred. Events were still present at the time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disorientation, Ear discomfort, Feeling abnormal, Headache, Hyperacusis
Clinical narrative: ear fullness; sensitivity to noise at normal volumes; tinnitus in both ears and head; brain fog; disorientation; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 12:30 (Lot number: FD0809) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 21Sep2021 20:00, outcome "not recovered", described as "brain fog"; DISORIENTATION (non-serious) with onset 21Sep2021 20:00, outcome "not recovered", described as "disorientation"; HEADACHE (non-serious) with onset 21Sep2021 20:00, outcome "not recovered", described as "headache"; EAR DISCOMFORT (non-serious) with onset 28Sep2021, outcome "not recovered", described as "ear fullness"; HYPERACUSIS (non-serious) with onset 28Sep2021, outcome "not recovered", described as "sensitivity to noise at normal volumes"; TINNITUS (non-serious) with onset 28Sep2021, outcome "not recovered", described as "tinnitus in both ears and head". The events "brain fog", "disorientation", "headache", "ear fullness", "sensitivity to noise at normal volumes" and "tinnitus in both ears and head" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of feeling abnormal, disorientation, headache, ear discomfort, hyperacusis, tinnitus.  Additional information: The patient received daily multivitamin within 2 weeks of vaccination (as reported). The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. It was reported that the brain fog and disorientation subsided after two weeks. One week after vaccination (as reported), ear fullness, sensitivity to noise at normal volumes, and tinnitus in both ears and head occurred. Events were still present at the time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: ear fullness; sensitivity to noise at normal volumes; tinnitus in both ears and head; brain fog; disorientation; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 12:30 (Lot number: FD0809) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 21Sep2021 20:00, outcome "not recovered", described as "brain fog"; DISORIENTATION (non-serious) with onset 21Sep2021 20:00, outcome "not recovered", described as "disorientation"; HEADACHE (non-serious) with onset 21Sep2021 20:00, outcome "not recovered", described as "headache"; EAR DISCOMFORT (non-serious) with onset 28Sep2021, outcome "not recovered", described as "ear fullness"; HYPERACUSIS (non-serious) with onset 28Sep2021, outcome "not recovered", described as "sensitivity to noise at normal volumes"; TINNITUS (non-serious) with onset 28Sep2021, outcome "not recovered", described as "tinnitus in both ears and head". The events "brain fog", "disorientation", "headache", "ear fullness", "sensitivity to noise at normal volumes" and "tinnitus in both ears and head" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of feeling abnormal, disorientation, headache, ear discomfort, hyperacusis, tinnitus.  Additional information: The patient received daily multivitamin within 2 weeks of vaccination (as reported). The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. It was reported that the brain fog and disorientation subsided after two weeks. One week after vaccination (as reported), ear fullness, sensitivity to noise at normal volumes, and tinnitus in both ears and head occurred. Events were still present at the time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Diarrhoea, Ear discomfort, Fatigue, Flushing
Clinical narrative: Tinnitus bilateral ears,  vibration sensations in his body
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Tinnitus
Clinical narrative: Tinnitus bilateral ears,  vibration sensations in his body
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Mixed deafness, Sensory disturbance, Tinnitus
Clinical narrative: Tinnitus bilateral ears,  vibration sensations in his body
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cataract, Eye disorder, Eye operation
Clinical narrative: couldn't see out of her left eye at all; cataracts in both eyes; eyes were kind of red; both her eyes were super blurry; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 05May2021 (Lot number: EW0172) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "cataract surgery", start date: Jan2021 (unspecified if ongoing), notes: had surgery in Jan2021 for cataract in the same eye; "cataract" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162B2 (1st dose, lot number ER8731), administration date: 14Apr2021, when the patient was 63 years old, for Covid-19 immunization. The following information was reported: BLINDNESS UNILATERAL (medically significant) with onset May2021, outcome "unknown", described as "couldn't see out of her left eye at all"; CATARACT (medically significant) with onset May2021, outcome "unknown", described as "cataracts in both eyes"; OCULAR HYPERAEMIA (non-serious) with onset May2021, outcome "unknown", described as "eyes were kind of red"; VISION BLURRED (non-serious) with onset May2021, outcome "unknown", described as "both her eyes were super blurry". The events "couldn't see out of her left eye at all", "cataracts in both eyes", "eyes were kind of red" and "both her eyes were super blurry" were evaluated at the physician office visit. Clinical details included: the patient couldn't see, her left eye was distorted and both her eyes were super blurry and she went to her ophthalmologist. She had a hole in her 'retina' and she had cataracts in both eyes. Before she had the second vaccine, she didn't had any real problems with her eyes. So, she was beginning to think she has had her surgery on her left eye for the hole in her 'macula'. It's all happened right after she got the second vaccine and her eyes were fine before that and now she barely could. Patient couldn't see out of her left eye at all and it was like instant right after she got the second vaccine. She noticed her eyes were kind of red and then all of sudden, she wasn't able to see through her glasses and it could have been a problem. She needed cataract surgery in both her eyes. She hadn't been able to work because she can't use her eyes. It was reported as all happened in May2021. Treatment in response to adverse event included: Just the eye drops, she had to take eye drops every day in her eyes and that's new because she never had to do that. She had surgery in January for cataract in the same eye and then she had to go back two months later and get cataract surgery in her other eye. Therapeutic measures were taken as a result of blindness unilateral, cataract, ocular hyperaemia, vision blurred included eye drops.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blindness unilateral, Cataract, Ocular hyperaemia, Vision blurred
Clinical narrative: couldn't see out of her left eye at all; cataracts in both eyes; eyes were kind of red; both her eyes were super blurry; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 05May2021 (Lot number: EW0172) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "cataract surgery", start date: Jan2021 (unspecified if ongoing), notes: had surgery in Jan2021 for cataract in the same eye; "cataract" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162B2 (1st dose, lot number ER8731), administration date: 14Apr2021, when the patient was 63 years old, for Covid-19 immunization. The following information was reported: BLINDNESS UNILATERAL (medically significant) with onset May2021, outcome "unknown", described as "couldn't see out of her left eye at all"; CATARACT (medically significant) with onset May2021, outcome "unknown", described as "cataracts in both eyes"; OCULAR HYPERAEMIA (non-serious) with onset May2021, outcome "unknown", described as "eyes were kind of red"; VISION BLURRED (non-serious) with onset May2021, outcome "unknown", described as "both her eyes were super blurry". The events "couldn't see out of her left eye at all", "cataracts in both eyes", "eyes were kind of red" and "both her eyes were super blurry" were evaluated at the physician office visit. Clinical details included: the patient couldn't see, her left eye was distorted and both her eyes were super blurry and she went to her ophthalmologist. She had a hole in her 'retina' and she had cataracts in both eyes. Before she had the second vaccine, she didn't had any real problems with her eyes. So, she was beginning to think she has had her surgery on her left eye for the hole in her 'macula'. It's all happened right after she got the second vaccine and her eyes were fine before that and now she barely could. Patient couldn't see out of her left eye at all and it was like instant right after she got the second vaccine. She noticed her eyes were kind of red and then all of sudden, she wasn't able to see through her glasses and it could have been a problem. She needed cataract surgery in both her eyes. She hadn't been able to work because she can't use her eyes. It was reported as all happened in May2021. Treatment in response to adverse event included: Just the eye drops, she had to take eye drops every day in her eyes and that's new because she never had to do that. She had surgery in January for cataract in the same eye and then she had to go back two months later and get cataract surgery in her other eye. Therapeutic measures were taken as a result of blindness unilateral, cataract, ocular hyperaemia, vision blurred included eye drops.  Follow-up attempts are completed. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Oropharyngeal pain, Sensation of foreign body
Clinical narrative: could not breathe; throat was sore; difficulty swallowing; feeling like a rock was in her throat; This is a spontaneous report received from a contactable reporter (nurse). The reporter is the parent.  A 9-year-old female patient (not pregnant) received BNT162B2, administered in arm right, administration date 02Dec2021 15:30 (Lot number: FK5217) at the age of 9 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. No drug known allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 034F21A, Location of injection: Arm Right, Vaccine Administration Time: 03:30 PM), administration date: 11Nov2021, when the patient was 9 years old, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: DYSPNOEA (medically significant) with onset 03Dec2021 02:30, outcome "recovered" (Dec2021), described as "could not breathe"; OROPHARYNGEAL PAIN (medically significant) with onset 03Dec2021 02:30, outcome "recovered" (Dec2021), described as "throat was sore"; DYSPHAGIA (medically significant) with onset 03Dec2021 02:30, outcome "recovered" (Dec2021), described as "difficulty swallowing"; OROPHARYNGEAL DISCOMFORT (medically significant) with onset 03Dec2021 02:30, outcome "recovered" (Dec2021), described as "feeling like a rock was in her throat". There was no wheezing to auscultation. Treatment received included 25 mg Benadryl given and symptoms subsided shortly after. Reporter monitored patient at home and did not seek emergency treatment. No recurrence of symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Dyspnoea, Oropharyngeal pain, Dysphagia and Oropharyngeal discomfort and BNT162B2.  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.
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Oropharyngeal discomfort, Oropharyngeal pain
Clinical narrative: could not breathe; throat was sore; difficulty swallowing; feeling like a rock was in her throat; This is a spontaneous report received from a contactable reporter (nurse). The reporter is the parent.  A 9-year-old female patient (not pregnant) received BNT162B2, administered in arm right, administration date 02Dec2021 15:30 (Lot number: FK5217) at the age of 9 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. No drug known allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 034F21A, Location of injection: Arm Right, Vaccine Administration Time: 03:30 PM), administration date: 11Nov2021, when the patient was 9 years old, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: DYSPNOEA (medically significant) with onset 03Dec2021 02:30, outcome "recovered" (Dec2021), described as "could not breathe"; OROPHARYNGEAL PAIN (medically significant) with onset 03Dec2021 02:30, outcome "recovered" (Dec2021), described as "throat was sore"; DYSPHAGIA (medically significant) with onset 03Dec2021 02:30, outcome "recovered" (Dec2021), described as "difficulty swallowing"; OROPHARYNGEAL DISCOMFORT (medically significant) with onset 03Dec2021 02:30, outcome "recovered" (Dec2021), described as "feeling like a rock was in her throat". There was no wheezing to auscultation. Treatment received included 25 mg Benadryl given and symptoms subsided shortly after. Reporter monitored patient at home and did not seek emergency treatment. No recurrence of symptoms. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Dyspnoea, Oropharyngeal pain, Dysphagia and Oropharyngeal discomfort and BNT162B2.  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.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: He reports his arm was not sore like it was from the first vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administration date 27Jan2021 (Lot number: EL1283) at the age of 62 years as dose 1 single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "He reports his arm was not sore like it was from the first vaccine".  Additional information: The Paramedic wants to report this as a potential counterfeit. Paramedic provided the second vaccine Lot as EL3428 ,no expiration provided. Pfizer employee has not been able to confirm the Lot number at this time. Paramedic received the second vaccination 17Feb2021, time of vaccination was not provided. He reports his arm was not sore like it was from the first vaccine, like he expects from an IM injection and like the first dose was. The paramedic received his first dose with no issue, he called Pfizer to confirm the second lot number and Pfizer was not able to confirm the Lot EL3428. The paramedic received his first dose with no issue, he called Pfizer to confirm the second lot number and Pfizer was not able to confirm the Lot EL3428. A complaint was made and the complaint number was provided to the paramedic from that report.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy!  Nerve Pain in my hands, left leg and toes
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Magnetic resonance imaging, Neuralgia
Clinical narrative: Bells Palsy!  Nerve Pain in my hands, left leg and toes
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Chest X-ray normal, Chest pain, Electrocardiogram normal, Fibrin D dimer
Clinical narrative: pericarditis
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension
Clinical narrative: pericarditis
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Fatigue, Pericarditis
Clinical narrative: pericarditis
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram abnormal, Electrocardiogram, Pericardial effusion, Pericarditis, Troponin I normal
Clinical narrative: pericarditis
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anosmia, Cough, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: 12/8/21  presenting today for Headache (coughing, sore throat, no smell X 3 days) and Covid-19 Positive Review of Systems  Constitutional: Negative for diaphoresis, fatigue and fever.  HENT: Positive for sore throat.   Respiratory: Positive for cough. Negative for shortness of breath.   Neurological: Negative for headaches.  All other systems reviewed and are negative.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anosmia, COVID-19, Cough, Headache, Oropharyngeal pain
Clinical narrative: 12/8/21  presenting today for Headache (coughing, sore throat, no smell X 3 days) and Covid-19 Positive Review of Systems  Constitutional: Negative for diaphoresis, fatigue and fever.  HENT: Positive for sore throat.   Respiratory: Positive for cough. Negative for shortness of breath.   Neurological: Negative for headaches.  All other systems reviewed and are negative.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 12/8/21  presenting today for Headache (coughing, sore throat, no smell X 3 days) and Covid-19 Positive Review of Systems  Constitutional: Negative for diaphoresis, fatigue and fever.  HENT: Positive for sore throat.   Respiratory: Positive for cough. Negative for shortness of breath.   Neurological: Negative for headaches.  All other systems reviewed and are negative.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid +
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid +
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Within 2 minutes of the shot, patient had a reaction.  Her entire body became tense, eyes rolled back in her head, urinated, and passed out.  She came to after approx 30 sec where she was somewhat disoriented and then vomited approx 1 minutes later.  EMT was called and they tested her heart, sugar, and BP all had stabilized,
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disorientation, Eye movement disorder, Loss of consciousness, Tension, Urinary incontinence
Clinical narrative: Within 2 minutes of the shot, patient had a reaction.  Her entire body became tense, eyes rolled back in her head, urinated, and passed out.  She came to after approx 30 sec where she was somewhat disoriented and then vomited approx 1 minutes later.  EMT was called and they tested her heart, sugar, and BP all had stabilized,
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Within 2 minutes of the shot, patient had a reaction.  Her entire body became tense, eyes rolled back in her head, urinated, and passed out.  She came to after approx 30 sec where she was somewhat disoriented and then vomited approx 1 minutes later.  EMT was called and they tested her heart, sugar, and BP all had stabilized,