chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: Having some major neurological problem; This is a spontaneous report from a contactable consumer or other non-hcp. This consumer reported for a male patient (nephew).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced having some major neurological problem. It was reported by the consumer that "my nephew has had an adverse reaction to the vaccine and the doctors in the hospital are not able to figure out what is going on with him and he is having some major neurological problem and so I just want to try to speak to somebody that can may be give us some guidance and find out if there is been some treatment or there is been something for that individuals that may have had this particular problems. You know our doctors here are not able to figure out what is going on and I really just want to get to somebody that may have had these issues, they know how to address them, and you know we can find some solutions for my nephew. That's an adverse reaction from COVID Vaccine." The clinical outcome of the event was unknown.  Information about Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient). An adult female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 21Jun2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. The patient's medical history included ongoing underweight. Concomitant medications were not reported. Concern: the patient stated, her concern is not really addressed in any of the option when she called and she is not getting any answer from the CDC. This is what happened, she got first COVID shot (on 21Jun2021) and "they used a little tiny needle, that was very short" and she did get a sore arm, about 6 hours later. 3 weeks later exactly (on 12Jul2021), she got her second shot and "they used a regular sized needle". The patient is an adult woman that weighs about 90 pounds. She is very underweight. Her concern is the first shot, because the needle was so short, "did I get the correct amount vaccine?" The patient confirmed the vaccine as COVID 19 Pfizer vaccine. The outcome of the event was unknown.  Follow-up attempts have been completed and no further information is expected. The lot/batch number is not available despite the follow-up attempts made.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Headache, Inflammation, Nervous system disorder, Vertigo
Clinical narrative: extreme anxiety; neuro inflammation; headaches; vertigo; Central nervous system irritation/neuro inflammation; This is spontaneous report received from a contactable nurse (patient). This nurse reported same events for herself and 2 patients (twin sister and daughter). This is the first of three reports.  This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 23May2021 16:00 (at the age of 46-year-old) (Lot Number: EW0177) as single dose for COVID-19 immunisation. Relevant medical history included anaemia. The patient was not pregnant. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 28Apr2021 16:00 (Lot number EW0176) for COVID-19 immunisation. On 24May2021 12:00, the patient experienced extreme anxiety, neuro inflammation, headaches, vertigo and central nervous system irritation; all the events were considered serious due to disability. The patient specified that "this causes neuro inflammation. My central nervous system was so irritated. I have had headaches, vertigo, and extreme anxiety ever since". The events resulted in Doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient received unspecified treatments for the events, and she specified that tests were ongoing. The patient had not recovered from the events. The patient did not have COVID-19 prior to vaccination, and she was not tested for COVID-19 post vaccination.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events anxiety, inflammation, vertigo, headache and CNS disorder and the suspect drug.  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. ,Linked Report(s) : US-PFIZER INC-202100911256 Same reporter/ drug/ AE, different patient.;US-PFIZER INC-202100911266 Same reporter/ drug/ AE, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Headache, Nervous system disorder, Neuritis, Vertigo
Clinical narrative: extreme anxiety; neuro inflammation; headaches; vertigo; central nervous system was so irritated/Central nervous system irritation; This is spontaneous report received from a contactable nurse (parent). This nurse reported same events for herself and 2 patients (twin sister and daughter). This is a second of three reports.   A female patient (reporter's daughter) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced neuro inflammation, central nervous system was so irritated/central nervous system irritation, headaches, vertigo, and extreme anxiety ever since. Events resulted in disability or permanent damage. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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,Linked Report(s) : US-PFIZER INC-202100911195 Same reporter/ drug/ AE, different patient.;US-PFIZER INC-202100911266 Same reporter/ drug/ AE, different patient.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Electrocardiogram, Hypopnoea, Oxygen saturation
Clinical narrative: Back pain; Spasm and contractions around rib cage with a lot of discomfort and pressure; felt like he was losing his breath and breathing really shallow; pulse ox in the 90's; This is a spontaneous report from a contactable consumer (patient's mother).     A 26-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 15May2021 17:00 (Batch/Lot Number: EW0186) as single dose for covid-19 immunisation  .  The patient medical history was not reported.  In the past the patient received tetanus vaccine.   There were no concomitant medications.  The patient experienced spasm and contractions around rib cage with a lot of discomfort and pressure  on 17May2021 with outcome of unknown , felt like he was losing his breath and breathing really shallow  on 17May2021 with outcome of unknown , pulse ox in the 90's  on 17May2021 with outcome of unknown , back pain  on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included electrocardiogram: unknown result,  oxygen saturation: pulse ox in the 90's   on 17May2021  .  Therapeutic measures were taken as a result of the reported events.  Course of the event. Really bad muscle spasm and contractions around rib cage with a lot of discomfort and pressure: It was interfering with his breathing, like, he couldn't breathe and breaths became really shallow. It felt like he was losing his breath. 17May2021 was the day he ended up in the hospital, in the ER. He had the vaccine the Saturday before, in the afternoon. A few days later, he did have other pain, back pain. When he was back at work, when this started, he had pain in the back and ribs. He was treated with  a ton of stuff. They gave him Diazepam, steroid or something, troponin, valium.  They had it marked as emergency level 5, thinks it was a pretty high one.  They had prescribed him cyclobenzaprine (FLEXERIL) after that visit and naproxen sodium 500mg.  Follow-up activities closed: Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased
Clinical narrative: Back pain; Spasm and contractions around rib cage with a lot of discomfort and pressure; felt like he was losing his breath and breathing really shallow; pulse ox in the 90's; This is a spontaneous report from a contactable consumer (patient's mother).     A 26-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 15May2021 17:00 (Batch/Lot Number: EW0186) as single dose for covid-19 immunisation  .  The patient medical history was not reported.  In the past the patient received tetanus vaccine.   There were no concomitant medications.  The patient experienced spasm and contractions around rib cage with a lot of discomfort and pressure  on 17May2021 with outcome of unknown , felt like he was losing his breath and breathing really shallow  on 17May2021 with outcome of unknown , pulse ox in the 90's  on 17May2021 with outcome of unknown , back pain  on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included electrocardiogram: unknown result,  oxygen saturation: pulse ox in the 90's   on 17May2021  .  Therapeutic measures were taken as a result of the reported events.  Course of the event. Really bad muscle spasm and contractions around rib cage with a lot of discomfort and pressure: It was interfering with his breathing, like, he couldn't breathe and breaths became really shallow. It felt like he was losing his breath. 17May2021 was the day he ended up in the hospital, in the ER. He had the vaccine the Saturday before, in the afternoon. A few days later, he did have other pain, back pain. When he was back at work, when this started, he had pain in the back and ribs. He was treated with  a ton of stuff. They gave him Diazepam, steroid or something, troponin, valium.  They had it marked as emergency level 5, thinks it was a pretty high one.  They had prescribed him cyclobenzaprine (FLEXERIL) after that visit and naproxen sodium 500mg.  Follow-up activities closed: Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Headache, Inflammation, Nervous system disorder, Vertigo
Clinical narrative: extreme anxiety; neuro inflammation; headaches; vertigo; central nervous system was so irritated/central nervous system irritation/neuro inflammation; This is a spontaneous report from a contactable nurse. This nurse reported same events for herself and 2 patients (twin sister and daughter). This is a third of three reports.   A female patient (reporter's twin sister) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced neuro inflammation, central nervous system was so irritated/central nervous system irritation, headaches, vertigo, and extreme anxiety ever since. Events resulted in disability or permanent damage. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events anxiety, inflammation, vertigo, headache and CNS disorder and the suspect drug.  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. ,Linked Report(s) : US-PFIZER INC-202100911195 Same reporter/ drug/ AE, different patient.;US-PFIZER INC-202100911256 Same reporter/ drug/ AE, different patient.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Endocrine ophthalmopathy, Swelling of eyelid, Visual impairment
Clinical narrative: eyes were affected along with vision; Graves eye disease; left eyelid began swelling; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 06Feb2021 10:15 at the age of 42-years-old (Lot Number: EM9810) as single dose for COVID-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included hashimotos hypothyroidism, known allergies: Ceclore, sulfa drugs, COVID prior vaccination. Concomitant medications included levothyroxine. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 administered in right arm on 16Jan2021 09:15 at the age of 42-years-old (Lot Number: EL3249) for COVID-19 immunisation. 2 days after second dose left eyelid began swelling. It was determined that was graves eye disease. Currently both eyes were affected along with vision, patient was waiting insurance prior authorization approval for treatment with Tepezza for the eye disease. The event onset was on 08Feb2021 06:00. AE resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment AE currently was no. The outcome of event was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lung opacity, Pericarditis, Pulmonary oedema, SARS-CoV-2 test
Clinical narrative: Pericarditis, ground glass opacity /fluid lungs; Pericarditis, ground glass opacity /fluid lungs; Pericarditis, ground glass opacity /fluid lungs; This is a spontaneous report from a contactable Other Healthcare professional (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 08Jan2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunization. The patient medical history was not reported. No known allergies. No covid prior vaccination. The patient was not pregnant. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 on 18Dec2020 10:00 AM in right arm for COVID-19 immunisation. The patient experienced pericarditis, ground glass opacity/fluid lungs on 15Jan2021 with outcome of recovering. The patient was hospitalized for the events for 6 days. The patient underwent lab tests and procedures which included covid test type post vaccination (nasal swab): negative on 19May2021, negative on 09Jun2021. AE treatment included lasix began.  The lot number for the vaccine bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of pericarditis, ground glass opacity/fluid lungs cannot be excluded.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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Illness, Loss of consciousness
Clinical narrative: passed out; Chills; nauseated; fever; body aches; got a little sick; feeling tired; after the second shot for two weeks and three days she felt better from her arthritis and fibromyalgia; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A 68-year-old female patient received second dose of bnt162b2 (Batch/Lot Number: EP7533; Expiration Date: 05Jul2033), via an unspecified route of administration, administered in Arm Left on 30Mar2021 at age of 68-year-old as single dose for covid-19 immunisation.  Medical history included arthritis and fibromyalgia. The patient received first dose of bnt162b2 (Batch/Lot Number: EN6208), on 09Mar2021 at age of 67-year-old as single dose for covid-19 immunisation. No family medical history relevant to AEs. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No AEs following prior vaccinations. There were no concomitant medications.  She already had both doses of the Pfizer COVID vaccine. She got a little sick the night of the second dose, chills, body aches, when she got up in the morning she was so sick during the night. She wasn't drinking or eating. She felt very nauseated and called for her husband, he came in and grabbed her and she passed out, and her husband had to call the ambulance. Body aches was all through the night with the other symptoms. She had four blankets and had an electric blanket she was running a fever. Fever started in the evening of the shot 30Mar2021 around 5 or 6 o'clock. Her appointment was at 1 and then it was 2 or 2:30 she started feeling tired. No treatment was received. She was really sick for 2 days. She had chills lasted until the following day. She recovered completely. Two days later she noticed her arthritis was gone and she doesn't have it anymore and wanted to report that. She started drinking and eating a little bit. She clarified that for two weeks and three days, she felt better than she has felt for the last 20 or 30 years but then it came back. Caller clarified it was after the second shot for two weeks and three days she felt better from her arthritis and fibromyalgia. Vaccine Administered at Facility (Vaccination Facility Type). The AEs did not require a visit to Emergency Room and Physician Office. No relevant tests. The outcome of event "after the second shot for two weeks and three days she felt better from her arthritis and fibromyalgia" was unknown, of other events was recovered (reported as recovered completely).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Therapeutic response unexpected
Clinical narrative: passed out; Chills; nauseated; fever; body aches; got a little sick; feeling tired; after the second shot for two weeks and three days she felt better from her arthritis and fibromyalgia; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A 68-year-old female patient received second dose of bnt162b2 (Batch/Lot Number: EP7533; Expiration Date: 05Jul2033), via an unspecified route of administration, administered in Arm Left on 30Mar2021 at age of 68-year-old as single dose for covid-19 immunisation.  Medical history included arthritis and fibromyalgia. The patient received first dose of bnt162b2 (Batch/Lot Number: EN6208), on 09Mar2021 at age of 67-year-old as single dose for covid-19 immunisation. No family medical history relevant to AEs. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No AEs following prior vaccinations. There were no concomitant medications.  She already had both doses of the Pfizer COVID vaccine. She got a little sick the night of the second dose, chills, body aches, when she got up in the morning she was so sick during the night. She wasn't drinking or eating. She felt very nauseated and called for her husband, he came in and grabbed her and she passed out, and her husband had to call the ambulance. Body aches was all through the night with the other symptoms. She had four blankets and had an electric blanket she was running a fever. Fever started in the evening of the shot 30Mar2021 around 5 or 6 o'clock. Her appointment was at 1 and then it was 2 or 2:30 she started feeling tired. No treatment was received. She was really sick for 2 days. She had chills lasted until the following day. She recovered completely. Two days later she noticed her arthritis was gone and she doesn't have it anymore and wanted to report that. She started drinking and eating a little bit. She clarified that for two weeks and three days, she felt better than she has felt for the last 20 or 30 years but then it came back. Caller clarified it was after the second shot for two weeks and three days she felt better from her arthritis and fibromyalgia. Vaccine Administered at Facility (Vaccination Facility Type). The AEs did not require a visit to Emergency Room and Physician Office. No relevant tests. The outcome of event "after the second shot for two weeks and three days she felt better from her arthritis and fibromyalgia" was unknown, of other events was recovered (reported as recovered completely).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Ataxia, Confusional state, Dyschezia, Dysphagia
Clinical narrative: Health is declining; confusion; Health is declining, now hospitalized; difficulty eating (has to be reminded to chew/swallow); Health is declining, now hospitalized; difficulty eating (has to be reminded to chew/swallow)drinking, peeing,; Health is declining, now hospitalized; difficulty eating (has to be reminded to chew/swallow)drinking, peeing,; Health is declining, now hospitalized; difficulty eating (has to be reminded to chew/swallow)drinking, peeing,pooping; loss of speech; loss motor skills; tremor; This is a spontaneous report from a contactable consumer (parent). A 26-years-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: ER8734), dose 2 via an unspecified route of administration, administered in Arm Left on 31Mar2021 at 15:45 (at the age of 26-years-old, non-pregnant) as DOSE 2, SINGLE for covid-19 immunization. Facility type vaccine-Other. Facility type vaccine other- Temporary site run by the military. Medical history included autism and intellectual disability from an unknown date and unknown if ongoing. Concomitant medications included gabapentin, topiramate, cetirizine hydrochloride (CETIRIZIN), montelukast, vitamin D, trazodone, sertraline hydrochloride (ZOLOFT) and chlorpromazine hydrochloride (CHLORPROMAZIN): all taken for an unspecified indication, start and stop date were not reported. Patient had known allergy to Kepler. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in arm left on 10Mar2021 at 16:45 (at the age of 26-years-old) as DOSE 1, SINGLE for covid-19 immunization and did not experience any reaction. No other vaccine was received in four weeks. On 02Apr2021 at 06:30, patient's health was declining, now hospitalized; difficulty eating (had to be reminded to chew/swallow), drinking, peeing, pooping, loss of speech, loss motor skills, tremor, confusion and was still suffering. Events resulted in emergency room and physician office visit. The seriousness reported as Hospitalization and Hospitalization prolonged, Life threatening illness (immediate risk of death from the event). The patient's hospitalization was prolonged as a result of this event (no days hospitalization was 12 days). It was unknown if patient received treatment for the events. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. The outcome of the events was not recovered.  Information about lot/ batch number is available. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Eating disorder, General physical health deterioration, Tremor
Clinical narrative: Health is declining; confusion; Health is declining, now hospitalized; difficulty eating (has to be reminded to chew/swallow); Health is declining, now hospitalized; difficulty eating (has to be reminded to chew/swallow)drinking, peeing,; Health is declining, now hospitalized; difficulty eating (has to be reminded to chew/swallow)drinking, peeing,; Health is declining, now hospitalized; difficulty eating (has to be reminded to chew/swallow)drinking, peeing,pooping; loss of speech; loss motor skills; tremor; This is a spontaneous report from a contactable consumer (parent). A 26-years-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: ER8734), dose 2 via an unspecified route of administration, administered in Arm Left on 31Mar2021 at 15:45 (at the age of 26-years-old, non-pregnant) as DOSE 2, SINGLE for covid-19 immunization. Facility type vaccine-Other. Facility type vaccine other- Temporary site run by the military. Medical history included autism and intellectual disability from an unknown date and unknown if ongoing. Concomitant medications included gabapentin, topiramate, cetirizine hydrochloride (CETIRIZIN), montelukast, vitamin D, trazodone, sertraline hydrochloride (ZOLOFT) and chlorpromazine hydrochloride (CHLORPROMAZIN): all taken for an unspecified indication, start and stop date were not reported. Patient had known allergy to Kepler. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in arm left on 10Mar2021 at 16:45 (at the age of 26-years-old) as DOSE 1, SINGLE for covid-19 immunization and did not experience any reaction. No other vaccine was received in four weeks. On 02Apr2021 at 06:30, patient's health was declining, now hospitalized; difficulty eating (had to be reminded to chew/swallow), drinking, peeing, pooping, loss of speech, loss motor skills, tremor, confusion and was still suffering. Events resulted in emergency room and physician office visit. The seriousness reported as Hospitalization and Hospitalization prolonged, Life threatening illness (immediate risk of death from the event). The patient's hospitalization was prolonged as a result of this event (no days hospitalization was 12 days). It was unknown if patient received treatment for the events. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. The outcome of the events was not recovered.  Information about lot/ batch number is available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood disorder, Paroxysmal nocturnal haemoglobinuria
Clinical narrative: the blood disorder (PNA); never seen this in his life but he seen it twice in a past 3 months; could be related to Covid vaccine/recent dx was PNH which is a blood disorder; the blood disorder (PNA); never seen this in his life but he seen it twice in a past 3 months; could be related to Covid vaccine/recent dx was PNH which is a blood disorder; This is a spontaneous report from a non-contactable consumer (patient) received via a sales representative. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was diagnosed with a blood disorder that was requiring her to a infusion every week for the rest of the life, the blood disorder reporter don't know exactly what it was referred to this PNA, the reporter was not familiar with that its less than a one in a million chance very few people ever get it, her oncologist said he never seen this in his life but he seen it twice in a past 3 months and her question to him to her oncologist whom reporter do not know and don't know his name or her name, was could be related to COVID vaccine and he said I don't know but if I see it again, to which he sees twice a three month. On further query reporter stated as, his neighbor had received the Pfizer vaccine and her recent dx was PNH which was a blood disorder and will require Solaris infusion every two weeks for life. She may seek a second opinion. Therapeutic measures were taken as a result of the adverse event. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died from the vaccine; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for 4 patients. This is one of four reports. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced died from the vaccine on an unspecified date. The reporter stated in his neighborhood 4 people died from the vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Follow-up attempts have been completed and no further information is expected. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100970595 same reporter, event and drug, different patient;US-PFIZER INC-202100970596 same reporter/drug/event, different pt;US-PFIZER INC-202100970597 same reporter, event and drug, different patient; Reported Cause(s) of Death: died from the vaccine
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Body height, Chills, Hypoxia, Influenza like illness
Clinical narrative: He say he needs oxygen; Flu-like symptoms; Restless; Nausea; Chills; he is very angry; Body ache; sleeps for couple of hour; This is a spontaneous report from a contactable consumer or other non hcp.  A 39-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration on 13Jul2021 (at the age of 39-years-old) as a single dose for covid-19 immunisation. Medical history included tobacco user from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On Thursday (15Jul2021) afternoon he got the side effects from it, they were like the flu symptoms and reporter stated that the patient was very angry, he was just restless. The patient he had a long sleep. It was like on and off, he sleeps for couple of hours and he had some little bit of nausea today (17Jul2021). The patient did not go to a doctor except MD urgent care because he had sick and got Antibiotic. The patient had chills and body ache. The patient was taking Tylenol or Advil one or two tablets (not sure). The patient stated that he needs oxygen. The reporter wanted him to get to an urgent care doctor and he was resisting. The reporter was asking what are they going to do and she wanted to find out what else she can do or what else he can do. The patient underwent lab tests and procedures which included body height: 5 feet 6 inches or 5 feet 7 inches on 5 feet 6 inches or 5 feet 7 inches, no I am not sure, physical examination: unknown results on. Therapeutic measures were taken as a result of he says he needs oxygen (hypoxia), flu-like symptoms, restless, nausea, chills, he is very angry, body ache, sleeps for couple of hours. The outcome of the events was hypoxia, nausea, chills, anger, pain, Somnolence was unknown flu-like symptoms, restless, was not recovered.   Information about the Lot/batch number has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Physical examination, Restlessness, Somnolence
Clinical narrative: He say he needs oxygen; Flu-like symptoms; Restless; Nausea; Chills; he is very angry; Body ache; sleeps for couple of hour; This is a spontaneous report from a contactable consumer or other non hcp.  A 39-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration on 13Jul2021 (at the age of 39-years-old) as a single dose for covid-19 immunisation. Medical history included tobacco user from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On Thursday (15Jul2021) afternoon he got the side effects from it, they were like the flu symptoms and reporter stated that the patient was very angry, he was just restless. The patient he had a long sleep. It was like on and off, he sleeps for couple of hours and he had some little bit of nausea today (17Jul2021). The patient did not go to a doctor except MD urgent care because he had sick and got Antibiotic. The patient had chills and body ache. The patient was taking Tylenol or Advil one or two tablets (not sure). The patient stated that he needs oxygen. The reporter wanted him to get to an urgent care doctor and he was resisting. The reporter was asking what are they going to do and she wanted to find out what else she can do or what else he can do. The patient underwent lab tests and procedures which included body height: 5 feet 6 inches or 5 feet 7 inches on 5 feet 6 inches or 5 feet 7 inches, no I am not sure, physical examination: unknown results on. Therapeutic measures were taken as a result of he says he needs oxygen (hypoxia), flu-like symptoms, restless, nausea, chills, he is very angry, body ache, sleeps for couple of hours. The outcome of the events was hypoxia, nausea, chills, anger, pain, Somnolence was unknown flu-like symptoms, restless, was not recovered.   Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Brain injury, Cerebrovascular accident, Chills, Computerised tomogram, Dizziness
Clinical narrative: shock like feeling keeps shooting down my arms; It felt like from the very first evening it gave me some sort of brain damage; They think I had a basal artery stroke since half my face is numb; Skin hypersensitivity; pain all over my body; severe muscle weakness; pain in my upper teeth; dizziness; feeling like I was going to faint and thrown up; my muscles feel weird like when you have the flu; I haven't been able to focus my eyes; The right side of my face, eyebrow, cheek, side of my nose, mouth, ear, scalp, roof of mouth, gums are all numb on one side/half of  face  and half of my my tongue; Chills; low blood pressure with a high pulse; low blood pressure with a high pulse; my head and my brain doesn't feel right; They think I had a basal artery stroke since half my face is numb; I was really sick; severe flu like symptoms; This is a spontaneous report from a contactable consumer reporting for herself. This consumer reported different events with first and second dose. This is the first of 2 reports. Only this case is serious. This female patient of unknown age received in Apr2021 second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient had first dose of BNT162B2 for Covid-19 immunization in Mar2021 and experienced arm pain and fatigue. In Apr2021, she's had, skin hypersensitivity, pain all over her body, severe muscle weakness, pain in my upper teeth, dizziness, feeling like I was going to faint and thrown up, that only lasted for a day, her muscles feel weird like when you have the flu, and ever since then she had been able to focus her eyes. The right side of my face, eyebrow, cheek, side of my nose, mouth, ear, scalp, roof of mouth, gums are all numb on one side/half of face and half of my tongue. Chills, shock like feeling keeps shooting down my arms, low blood pressure with a high pulse. Half of my head and face numb months later and severe weak muscles. It felt like from the very first evening it gave me some sort of brain damage. my head and my brain doesn't feel right. All of this started the evening after the second dose and by the time I woke up the next morning I was really sick (2021). The patient expected to have severe flu like symptoms  (2021) for a few days but those symptoms went away and all the others have stayed. The patient have seen doctors, urgent cares, emergency rooms. The patient had in 2021 cat scan, MRI and visited Neurologists who think she had a basal artery stroke since half face is numb. The ER doctors told me that and so did both of my neurologists. Final outcome for all the events was reported as unknown. Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021907988 same patient/drug, different event/dose
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Head discomfort, Heart rate increased, Hyperaesthesia, Hypoaesthesia
Clinical narrative: shock like feeling keeps shooting down my arms; It felt like from the very first evening it gave me some sort of brain damage; They think I had a basal artery stroke since half my face is numb; Skin hypersensitivity; pain all over my body; severe muscle weakness; pain in my upper teeth; dizziness; feeling like I was going to faint and thrown up; my muscles feel weird like when you have the flu; I haven't been able to focus my eyes; The right side of my face, eyebrow, cheek, side of my nose, mouth, ear, scalp, roof of mouth, gums are all numb on one side/half of  face  and half of my my tongue; Chills; low blood pressure with a high pulse; low blood pressure with a high pulse; my head and my brain doesn't feel right; They think I had a basal artery stroke since half my face is numb; I was really sick; severe flu like symptoms; This is a spontaneous report from a contactable consumer reporting for herself. This consumer reported different events with first and second dose. This is the first of 2 reports. Only this case is serious. This female patient of unknown age received in Apr2021 second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient had first dose of BNT162B2 for Covid-19 immunization in Mar2021 and experienced arm pain and fatigue. In Apr2021, she's had, skin hypersensitivity, pain all over her body, severe muscle weakness, pain in my upper teeth, dizziness, feeling like I was going to faint and thrown up, that only lasted for a day, her muscles feel weird like when you have the flu, and ever since then she had been able to focus her eyes. The right side of my face, eyebrow, cheek, side of my nose, mouth, ear, scalp, roof of mouth, gums are all numb on one side/half of face and half of my tongue. Chills, shock like feeling keeps shooting down my arms, low blood pressure with a high pulse. Half of my head and face numb months later and severe weak muscles. It felt like from the very first evening it gave me some sort of brain damage. my head and my brain doesn't feel right. All of this started the evening after the second dose and by the time I woke up the next morning I was really sick (2021). The patient expected to have severe flu like symptoms  (2021) for a few days but those symptoms went away and all the others have stayed. The patient have seen doctors, urgent cares, emergency rooms. The patient had in 2021 cat scan, MRI and visited Neurologists who think she had a basal artery stroke since half face is numb. The ER doctors told me that and so did both of my neurologists. Final outcome for all the events was reported as unknown. Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021907988 same patient/drug, different event/dose
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Illness, Influenza like illness, Magnetic resonance imaging, Muscular weakness
Clinical narrative: shock like feeling keeps shooting down my arms; It felt like from the very first evening it gave me some sort of brain damage; They think I had a basal artery stroke since half my face is numb; Skin hypersensitivity; pain all over my body; severe muscle weakness; pain in my upper teeth; dizziness; feeling like I was going to faint and thrown up; my muscles feel weird like when you have the flu; I haven't been able to focus my eyes; The right side of my face, eyebrow, cheek, side of my nose, mouth, ear, scalp, roof of mouth, gums are all numb on one side/half of  face  and half of my my tongue; Chills; low blood pressure with a high pulse; low blood pressure with a high pulse; my head and my brain doesn't feel right; They think I had a basal artery stroke since half my face is numb; I was really sick; severe flu like symptoms; This is a spontaneous report from a contactable consumer reporting for herself. This consumer reported different events with first and second dose. This is the first of 2 reports. Only this case is serious. This female patient of unknown age received in Apr2021 second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient had first dose of BNT162B2 for Covid-19 immunization in Mar2021 and experienced arm pain and fatigue. In Apr2021, she's had, skin hypersensitivity, pain all over her body, severe muscle weakness, pain in my upper teeth, dizziness, feeling like I was going to faint and thrown up, that only lasted for a day, her muscles feel weird like when you have the flu, and ever since then she had been able to focus her eyes. The right side of my face, eyebrow, cheek, side of my nose, mouth, ear, scalp, roof of mouth, gums are all numb on one side/half of face and half of my tongue. Chills, shock like feeling keeps shooting down my arms, low blood pressure with a high pulse. Half of my head and face numb months later and severe weak muscles. It felt like from the very first evening it gave me some sort of brain damage. my head and my brain doesn't feel right. All of this started the evening after the second dose and by the time I woke up the next morning I was really sick (2021). The patient expected to have severe flu like symptoms  (2021) for a few days but those symptoms went away and all the others have stayed. The patient have seen doctors, urgent cares, emergency rooms. The patient had in 2021 cat scan, MRI and visited Neurologists who think she had a basal artery stroke since half face is numb. The ER doctors told me that and so did both of my neurologists. Final outcome for all the events was reported as unknown. Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021907988 same patient/drug, different event/dose
Sex: F
Vaccine: COVID19
Symptoms: Pain, Presyncope, Shock, Toothache, Vision blurred
Clinical narrative: shock like feeling keeps shooting down my arms; It felt like from the very first evening it gave me some sort of brain damage; They think I had a basal artery stroke since half my face is numb; Skin hypersensitivity; pain all over my body; severe muscle weakness; pain in my upper teeth; dizziness; feeling like I was going to faint and thrown up; my muscles feel weird like when you have the flu; I haven't been able to focus my eyes; The right side of my face, eyebrow, cheek, side of my nose, mouth, ear, scalp, roof of mouth, gums are all numb on one side/half of  face  and half of my my tongue; Chills; low blood pressure with a high pulse; low blood pressure with a high pulse; my head and my brain doesn't feel right; They think I had a basal artery stroke since half my face is numb; I was really sick; severe flu like symptoms; This is a spontaneous report from a contactable consumer reporting for herself. This consumer reported different events with first and second dose. This is the first of 2 reports. Only this case is serious. This female patient of unknown age received in Apr2021 second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient had first dose of BNT162B2 for Covid-19 immunization in Mar2021 and experienced arm pain and fatigue. In Apr2021, she's had, skin hypersensitivity, pain all over her body, severe muscle weakness, pain in my upper teeth, dizziness, feeling like I was going to faint and thrown up, that only lasted for a day, her muscles feel weird like when you have the flu, and ever since then she had been able to focus her eyes. The right side of my face, eyebrow, cheek, side of my nose, mouth, ear, scalp, roof of mouth, gums are all numb on one side/half of face and half of my tongue. Chills, shock like feeling keeps shooting down my arms, low blood pressure with a high pulse. Half of my head and face numb months later and severe weak muscles. It felt like from the very first evening it gave me some sort of brain damage. my head and my brain doesn't feel right. All of this started the evening after the second dose and by the time I woke up the next morning I was really sick (2021). The patient expected to have severe flu like symptoms  (2021) for a few days but those symptoms went away and all the others have stayed. The patient have seen doctors, urgent cares, emergency rooms. The patient had in 2021 cat scan, MRI and visited Neurologists who think she had a basal artery stroke since half face is numb. The ER doctors told me that and so did both of my neurologists. Final outcome for all the events was reported as unknown. Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021907988 same patient/drug, different event/dose
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: Heart arrhythmia; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EP7533 expiry date was not reported) via an unspecified route of administration at arm left on 29Jun2021 09:30 (at the age of 60-years-old) as a dose 2,single dose for covid-19 immunisation. Patient had history of allergies from an unknown date and unknown if ongoing known. Concomitant medication(s) included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported. Patient received first dose of BNT162B2 (Lot number: ER8733 expiry date was not reported) via unspecified route of administration at left arm 08Jun2021 01:30 PM as a single dose for covid-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 30Jun2021 the patient experienced heart arrhythmia (medically significant). Therapeutic measures were taken as a result of heart arrhythmia (arrhythmia) was Zio Heart Monitor. Outcome of the event was not recovered.  Follow-Up (23Jul2021): Follow-up attempts are completed. No further information is expected.