chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Blood pressure increased, Blood pressure measurement, Dry eye, Eye pain
Clinical narrative: Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips/ Left shoulder, arm hand numbness and tingling/ Left leg numbness and tingling; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Left eye pain and dryness; Left eye pain and dryness; Headache behind eye; Left shoulder, arm hand numbness and tingling/ Left leg numbness and tingling; Elevated blood pressure; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) at the age of 53-years-old, intramuscular in left arm on 22Apr2021 at 14:00 at 2nd dose, single for COVID-19 immunization. Medical history was reported as none. The patient has no known allergies. It was unknown if the patient has COVID prior to vaccination. Concomitant medication included macrogol 3350 (MIRALAX). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 53-years-old, via an unspecified route of administration on 26Mar2021 at 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at a pharmacy/ drug store. On 25Apr2021, the patient experienced Bell's palsy-like symptoms: left eye lid drooping and numbness in left check and lips. He also experienced left eye pain and dryness; headache behind the eye; left shoulder, arm, hand, and left leg numbness and tingling; and elevated blood pressure. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was given in response to the events. The patient underwent lab tests and procedures which included PCR nasal swab for COVID: negative on 15Apr2021 and blood pressure: elevated on 25Apr2021. The outcome of the events was not recovered.   Information on the lot/ batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot be totally 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: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eyelid ptosis, Headache, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips/ Left shoulder, arm hand numbness and tingling/ Left leg numbness and tingling; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Left eye pain and dryness; Left eye pain and dryness; Headache behind eye; Left shoulder, arm hand numbness and tingling/ Left leg numbness and tingling; Elevated blood pressure; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) at the age of 53-years-old, intramuscular in left arm on 22Apr2021 at 14:00 at 2nd dose, single for COVID-19 immunization. Medical history was reported as none. The patient has no known allergies. It was unknown if the patient has COVID prior to vaccination. Concomitant medication included macrogol 3350 (MIRALAX). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 53-years-old, via an unspecified route of administration on 26Mar2021 at 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at a pharmacy/ drug store. On 25Apr2021, the patient experienced Bell's palsy-like symptoms: left eye lid drooping and numbness in left check and lips. He also experienced left eye pain and dryness; headache behind the eye; left shoulder, arm, hand, and left leg numbness and tingling; and elevated blood pressure. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was given in response to the events. The patient underwent lab tests and procedures which included PCR nasal swab for COVID: negative on 15Apr2021 and blood pressure: elevated on 25Apr2021. The outcome of the events was not recovered.   Information on the lot/ batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot be totally 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: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips/ Left shoulder, arm hand numbness and tingling/ Left leg numbness and tingling; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Left eye pain and dryness; Left eye pain and dryness; Headache behind eye; Left shoulder, arm hand numbness and tingling/ Left leg numbness and tingling; Elevated blood pressure; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) at the age of 53-years-old, intramuscular in left arm on 22Apr2021 at 14:00 at 2nd dose, single for COVID-19 immunization. Medical history was reported as none. The patient has no known allergies. It was unknown if the patient has COVID prior to vaccination. Concomitant medication included macrogol 3350 (MIRALAX). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 53-years-old, via an unspecified route of administration on 26Mar2021 at 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at a pharmacy/ drug store. On 25Apr2021, the patient experienced Bell's palsy-like symptoms: left eye lid drooping and numbness in left check and lips. He also experienced left eye pain and dryness; headache behind the eye; left shoulder, arm, hand, and left leg numbness and tingling; and elevated blood pressure. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was given in response to the events. The patient underwent lab tests and procedures which included PCR nasal swab for COVID: negative on 15Apr2021 and blood pressure: elevated on 25Apr2021. The outcome of the events was not recovered.   Information on the lot/ batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot be totally 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Parosmia
Clinical narrative: I had a terrible smell of burnt toast, the day following the shot, then the next day, none,  then yesterday once again. No other side effects. Strangely my sister 500 miles from me also had smells of; This is a spontaneous report from a contactable consumer (patient herself).  A female patient (age not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route in the right arm, on 16Feb2021 15:30 at single dose for COVID-19 immunisation. The patient was not pregnant.  Relevant medical history included atrial fibrillation and asthma. Past drug history included allergy to penicillin. Relevant concomitant medications included phenobarbital, clonidine, levothyroxine sodium (SYNTHROID), and pantoprazole. The patient verbally reported ''I had a terrible smell of burnt toast, the day following the shot, then the next day, none, then yesterday once again''. No other side effects.  The patient stated also ''strangely my sister 500 miles from me also had smells of burning and gasoline''. Pre and Post vaccination COVID tests were not performed. The patient was not treated for the event. The patient was recovering from the event.  No follow-up attempts are possible. Information about Batch/Lot number cannot be obtained.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Completed suicide
Clinical narrative: he was COVID positive; he was COVID positive; took his own life by hanging himself; slept all day; chills; no appetite; he didn't feel right; diarrhea; sick; headache; tired; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number Ew0153), via an unspecified route of administration in the right arm on 19Apr2021 09:00 (at the age of 17-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. The patient did not have COVID prior to vaccination. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number Er8730), intramuscularly in the right arm on 29Mar2021 (at the age of 17-years-old) as a single dose for COVID-19 immunization and experienced headache, sore arm, lethargic. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021, the patient received the second dose, and the patient was sick that day, headache/tired, diarrhea. On Tuesday (20Apr2021), the patient slept all day, headache, chills, diarrhea, no appetite, said he didn't feel right. Wednesday (21Apr2021), tired/headache unable to stay online for school, diarrhea, slept for large portion of day. Thursday (22Apr2021), not feeling himself, up more but headache, diarrhea. Friday (23Apr2021) diarrhea - took his own life by hanging himself in the reporter's basement in the morning hours. The patient did not have history or signs of depression, anxiety, or mental illness. The reporter stated the patient was a social, outgoing, happy 17-year-old. A notice from the health department dated 28Apr2021 stated that the patient was COVID positive on an unspecified date. Treatment for the events was reported as paracetamol (TYLENOL). The outcome of took his own life by hanging himself was fatal. The outcome of the other events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021525146 similar report from same reporter; Reported Cause(s) of Death: took his own life by hanging himself
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Completed suicide, Decreased appetite, Diarrhoea
Clinical narrative: he was COVID positive; he was COVID positive; took his own life by hanging himself; slept all day; chills; no appetite; he didn't feel right; diarrhea; sick; headache; tired; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number Ew0153), via an unspecified route of administration in the right arm on 19Apr2021 09:00 (at the age of 17-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. The patient did not have COVID prior to vaccination. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number Er8730), intramuscularly in the right arm on 29Mar2021 (at the age of 17-years-old) as a single dose for COVID-19 immunization and experienced headache, sore arm, lethargic. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021, the patient received the second dose, and the patient was sick that day, headache/tired, diarrhea. On Tuesday (20Apr2021), the patient slept all day, headache, chills, diarrhea, no appetite, said he didn't feel right. Wednesday (21Apr2021), tired/headache unable to stay online for school, diarrhea, slept for large portion of day. Thursday (22Apr2021), not feeling himself, up more but headache, diarrhea. Friday (23Apr2021) diarrhea - took his own life by hanging himself in the reporter's basement in the morning hours. The patient did not have history or signs of depression, anxiety, or mental illness. The reporter stated the patient was a social, outgoing, happy 17-year-old. A notice from the health department dated 28Apr2021 stated that the patient was COVID positive on an unspecified date. Treatment for the events was reported as paracetamol (TYLENOL). The outcome of took his own life by hanging himself was fatal. The outcome of the other events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021525146 similar report from same reporter; Reported Cause(s) of Death: took his own life by hanging himself
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Fatigue, Feeling abnormal, Headache, Hypersomnia
Clinical narrative: he was COVID positive; he was COVID positive; took his own life by hanging himself; slept all day; chills; no appetite; he didn't feel right; diarrhea; sick; headache; tired; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number Ew0153), via an unspecified route of administration in the right arm on 19Apr2021 09:00 (at the age of 17-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. The patient did not have COVID prior to vaccination. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number Er8730), intramuscularly in the right arm on 29Mar2021 (at the age of 17-years-old) as a single dose for COVID-19 immunization and experienced headache, sore arm, lethargic. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021, the patient received the second dose, and the patient was sick that day, headache/tired, diarrhea. On Tuesday (20Apr2021), the patient slept all day, headache, chills, diarrhea, no appetite, said he didn't feel right. Wednesday (21Apr2021), tired/headache unable to stay online for school, diarrhea, slept for large portion of day. Thursday (22Apr2021), not feeling himself, up more but headache, diarrhea. Friday (23Apr2021) diarrhea - took his own life by hanging himself in the reporter's basement in the morning hours. The patient did not have history or signs of depression, anxiety, or mental illness. The reporter stated the patient was a social, outgoing, happy 17-year-old. A notice from the health department dated 28Apr2021 stated that the patient was COVID positive on an unspecified date. Treatment for the events was reported as paracetamol (TYLENOL). The outcome of took his own life by hanging himself was fatal. The outcome of the other events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021525146 similar report from same reporter; Reported Cause(s) of Death: took his own life by hanging himself
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Illness, SARS-CoV-2 test
Clinical narrative: he was COVID positive; he was COVID positive; took his own life by hanging himself; slept all day; chills; no appetite; he didn't feel right; diarrhea; sick; headache; tired; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number Ew0153), via an unspecified route of administration in the right arm on 19Apr2021 09:00 (at the age of 17-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. The patient did not have COVID prior to vaccination. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number Er8730), intramuscularly in the right arm on 29Mar2021 (at the age of 17-years-old) as a single dose for COVID-19 immunization and experienced headache, sore arm, lethargic. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021, the patient received the second dose, and the patient was sick that day, headache/tired, diarrhea. On Tuesday (20Apr2021), the patient slept all day, headache, chills, diarrhea, no appetite, said he didn't feel right. Wednesday (21Apr2021), tired/headache unable to stay online for school, diarrhea, slept for large portion of day. Thursday (22Apr2021), not feeling himself, up more but headache, diarrhea. Friday (23Apr2021) diarrhea - took his own life by hanging himself in the reporter's basement in the morning hours. The patient did not have history or signs of depression, anxiety, or mental illness. The reporter stated the patient was a social, outgoing, happy 17-year-old. A notice from the health department dated 28Apr2021 stated that the patient was COVID positive on an unspecified date. Treatment for the events was reported as paracetamol (TYLENOL). The outcome of took his own life by hanging himself was fatal. The outcome of the other events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021525146 similar report from same reporter; Reported Cause(s) of Death: took his own life by hanging himself
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test, Seizure
Clinical narrative: Left side numbness and tingling, arm, face, back, leg.  Also occurred on 4-19 and 5-6, with ER visits and hospitalization detailed below
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, CSF test abnormal, Computerised tomogram, Hypoaesthesia, Inflammation
Clinical narrative: Left side numbness and tingling, arm, face, back, leg.  Also occurred on 4-19 and 5-6, with ER visits and hospitalization detailed below
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Paraesthesia
Clinical narrative: Left side numbness and tingling, arm, face, back, leg.  Also occurred on 4-19 and 5-6, with ER visits and hospitalization detailed below
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Dizziness, Fatigue, Gait disturbance, Headache
Clinical narrative: Sick with symptoms very similar to when I had Covid in April 2020, everything but the fever, so headache, body aches and fatigue on 5/8/21 the whole day.  On 5/11/21 I experienced Vertigo, lightheadedness, inability to walk straight. Improved the next day, but I still had bouts of vertigo and developed nausea. I saw an ENT on 5/25/21 and he diagnosed Labyrinthitis and I started a  6 day course of Medrol today 5/26/21.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Sick with symptoms very similar to when I had Covid in April 2020, everything but the fever, so headache, body aches and fatigue on 5/8/21 the whole day.  On 5/11/21 I experienced Vertigo, lightheadedness, inability to walk straight. Improved the next day, but I still had bouts of vertigo and developed nausea. I saw an ENT on 5/25/21 and he diagnosed Labyrinthitis and I started a  6 day course of Medrol today 5/26/21.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Dizziness, Fatigue, Headache, Impaired work ability
Clinical narrative: Sick with symptoms very similar to when I had Covid in April 2020, everything but the fever, so headache, body aches and fatigue on 5/8/21 the whole day.  On 5/11/21 I experienced Vertigo, lightheadedness, inability to walk straight. Improved the next day, but I still had bouts of vertigo and developed nausea. I saw an ENT on 5/25/21 and he diagnosed Labyrinthitis and I started a  6 day course of Medrol today 5/26/21.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Labyrinthitis, Nausea, Pain, Physical examination, Vertigo
Clinical narrative: Sick with symptoms very similar to when I had Covid in April 2020, everything but the fever, so headache, body aches and fatigue on 5/8/21 the whole day.  On 5/11/21 I experienced Vertigo, lightheadedness, inability to walk straight. Improved the next day, but I still had bouts of vertigo and developed nausea. I saw an ENT on 5/25/21 and he diagnosed Labyrinthitis and I started a  6 day course of Medrol today 5/26/21.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Fatigue, Myalgia
Clinical narrative: Extreme pain all over body; Deep joint pain; fatigue; fever; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration in the left arm on 13Mar2021 at 09:00AM (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and obese. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's past drug history included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581), first dose via an unspecified route of administration in the left arm on 15Feb2021 at 05:45PM as a single dose for COVID-19 immunisation. The patient's concomitant medications included Zoloft (MANUFACRURER UNKNOWN), Lansoprazole (MANUFACRURER UNKNOWN) and Losartan potassium (MANUFACRURER UNKNOWN) all for unknown. On 14Mar2021 at 12:00PM (as reported), the patient experienced extreme pain all over body, deep joint pain, fatigue and fever. Therapeutic measures were not taken for the events. The clinical outcome of the events extreme pain all over body, deep joint pain, fatigue and fever were recovering. No follow up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Pain, Pyrexia
Clinical narrative: Extreme pain all over body; Deep joint pain; fatigue; fever; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration in the left arm on 13Mar2021 at 09:00AM (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and obese. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's past drug history included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581), first dose via an unspecified route of administration in the left arm on 15Feb2021 at 05:45PM as a single dose for COVID-19 immunisation. The patient's concomitant medications included Zoloft (MANUFACRURER UNKNOWN), Lansoprazole (MANUFACRURER UNKNOWN) and Losartan potassium (MANUFACRURER UNKNOWN) all for unknown. On 14Mar2021 at 12:00PM (as reported), the patient experienced extreme pain all over body, deep joint pain, fatigue and fever. Therapeutic measures were not taken for the events. The clinical outcome of the events extreme pain all over body, deep joint pain, fatigue and fever were recovering. No follow up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Brain scan normal, Chest X-ray normal, Disturbance in attention, Headache
Clinical narrative: SEVERE HEADACHE, TINITUS, DROWSY/GROGGY FEELING ( all day ) , LOW CONCENTRATION, FORGETTING ALOT OF COMMON THINGS.  He states he has been taking Motrin 800mg 1 TAB, PRN.   HE STATES HE HAS GONE TO SEVERAL DOCTORS FOR THESE ISSUES. THE FIRST DR. VISIT WAS ON 05/03/21 PCP- Dr. referred him to a neurologist... Dr. visit with neurologist was on 05/13/2021- MRI, LABS .. on 05/24/2021 - conclusion , MRI/LABS (normal).  Dr. recommended B3 vitamin and B12, states he started taking both of the vitamins yesterday.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Illness, Somnolence, Tinnitus
Clinical narrative: SEVERE HEADACHE, TINITUS, DROWSY/GROGGY FEELING ( all day ) , LOW CONCENTRATION, FORGETTING ALOT OF COMMON THINGS.  He states he has been taking Motrin 800mg 1 TAB, PRN.   HE STATES HE HAS GONE TO SEVERAL DOCTORS FOR THESE ISSUES. THE FIRST DR. VISIT WAS ON 05/03/21 PCP- Dr. referred him to a neurologist... Dr. visit with neurologist was on 05/13/2021- MRI, LABS .. on 05/24/2021 - conclusion , MRI/LABS (normal).  Dr. recommended B3 vitamin and B12, states he started taking both of the vitamins yesterday.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Disturbance in attention, Headache, Laboratory test, Magnetic resonance imaging, Somnolence
Clinical narrative: SEVERE HEADACHE, TINITUS, DROWSY/GROGGY FEELING ( all day ) , LOW CONCENTRATION, FORGETTING ALOT OF COMMON THINGS.  He states he has been taking Motrin 800mg 1 TAB, PRN.   HE STATES HE HAS GONE TO SEVERAL DOCTORS FOR THESE ISSUES. THE FIRST DR. VISIT WAS ON 05/03/21 PCP- Dr. referred him to a neurologist... Dr. visit with neurologist was on 05/13/2021- MRI, LABS .. on 05/24/2021 - conclusion , MRI/LABS (normal).  Dr. recommended B3 vitamin and B12, states he started taking both of the vitamins yesterday.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: SEVERE HEADACHE, TINITUS, DROWSY/GROGGY FEELING ( all day ) , LOW CONCENTRATION, FORGETTING ALOT OF COMMON THINGS.  He states he has been taking Motrin 800mg 1 TAB, PRN.   HE STATES HE HAS GONE TO SEVERAL DOCTORS FOR THESE ISSUES. THE FIRST DR. VISIT WAS ON 05/03/21 PCP- Dr. referred him to a neurologist... Dr. visit with neurologist was on 05/13/2021- MRI, LABS .. on 05/24/2021 - conclusion , MRI/LABS (normal).  Dr. recommended B3 vitamin and B12, states he started taking both of the vitamins yesterday.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Disturbance in attention, Feeling abnormal, Headache, Magnetic resonance imaging
Clinical narrative: SEVERE HEADACHE, TINITUS, DROWSY/GROGGY FEELING ( all day ) , LOW CONCENTRATION, FORGETTING ALOT OF COMMON THINGS.  He states he has been taking Motrin 800mg 1 TAB, PRN.   HE STATES HE HAS GONE TO SEVERAL DOCTORS FOR THESE ISSUES. THE FIRST DR. VISIT WAS ON 05/03/21 PCP- Dr. referred him to a neurologist... Dr. visit with neurologist was on 05/13/2021- MRI, LABS .. on 05/24/2021 - conclusion , MRI/LABS (normal).  Dr. recommended B3 vitamin and B12, states he started taking both of the vitamins yesterday.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Deep vein thrombosis, Laboratory test
Clinical narrative: Pulmonary embolism; DVT; This is a spontaneous report from a contactable nurse (patient's wife). A 78-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201; Expiration Date: 30Jun2021), via an unspecified route of administration on 27Feb2021 (at the age of 78-year-old) as single dose for COVID-19 immunization. Medical history included diabetes mellitus, Liver cirrhosis, thrombocytopenia, kidney stone, sarcoidosis, blood pressure (unspecified condition) and high cholesterol and a pacemaker (cardiac pacemaker insertion). Concomitant medications included insulin (manufacturer unknown), simvastatin (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), carvedilol (COREG) taken for blood pressure, and omeprazole (PROTONIX).  On 12Mar2021, the patient developed pulmonary embolism and DVT (deep vein thrombosis) that requiring a hospitalization on 12Mar2021. The nurse reported, "He went into the hospital 12Mar2021 that's when they find out he had pulmonary embolism and DVT. They putted the IVC filter for blood clot." On 12Mar2021, the patient was hospitalized for pulmonary embolism and DVT. Therapeutic measures were taken as a result of pulmonary embolism and DVT. The clinical outcome of the events pulmonary embolism and DVT was unknown.  Additional information has been requested and will be provided as it becomes available.; Sender's Comments: Based on available information and known drug profile it  is unlikely that the reported  pulmonary embolism and DVT (deep vein thrombosis) were causally related to BNT162b2 .  These are intercurrent  medical conditions.  Case will be reassessed if additional information is received.  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-2021528357 same patient/reporter, different vaccine dose with different events separated by time gap.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: Pulmonary embolism; DVT; This is a spontaneous report from a contactable nurse (patient's wife). A 78-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201; Expiration Date: 30Jun2021), via an unspecified route of administration on 27Feb2021 (at the age of 78-year-old) as single dose for COVID-19 immunization. Medical history included diabetes mellitus, Liver cirrhosis, thrombocytopenia, kidney stone, sarcoidosis, blood pressure (unspecified condition) and high cholesterol and a pacemaker (cardiac pacemaker insertion). Concomitant medications included insulin (manufacturer unknown), simvastatin (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), carvedilol (COREG) taken for blood pressure, and omeprazole (PROTONIX).  On 12Mar2021, the patient developed pulmonary embolism and DVT (deep vein thrombosis) that requiring a hospitalization on 12Mar2021. The nurse reported, "He went into the hospital 12Mar2021 that's when they find out he had pulmonary embolism and DVT. They putted the IVC filter for blood clot." On 12Mar2021, the patient was hospitalized for pulmonary embolism and DVT. Therapeutic measures were taken as a result of pulmonary embolism and DVT. The clinical outcome of the events pulmonary embolism and DVT was unknown.  Additional information has been requested and will be provided as it becomes available.; Sender's Comments: Based on available information and known drug profile it  is unlikely that the reported  pulmonary embolism and DVT (deep vein thrombosis) were causally related to BNT162b2 .  These are intercurrent  medical conditions.  Case will be reassessed if additional information is received.  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-2021528357 same patient/reporter, different vaccine dose with different events separated by time gap.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Thrombocytopenia
Clinical narrative: SEVERE THROMBOCYTOPENIA; DEATH; Initial information was processed along with the additional information received on 20-MAY-2021. This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic. The patient had no known allergies. The patient had no any drug abuse or illicit drug usage. The patient did not use any medication and did not have any medical history prior to vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, 2 days after vaccination the patient started experiencing dizziness, headache and severe bruising. The patient was hospitalized (date unspecified) and was diagnosed with severe thrombocytopenia. It was reported that the patient was hospitalized for 14 days and within a week later he died. On 04-MAY-2021, the patient died from an unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused/Prolonged).; Sender's Comments: V0: 20210534916- covid-19 vaccine ad26.cov2.s-Death, severe thrombocytopenia patient. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Dizziness, Headache, Increased tendency to bruise, Platelet count decreased
Clinical narrative: SEVERE THROMBOCYTOPENIA; DEATH; Initial information was processed along with the additional information received on 20-MAY-2021. This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic. The patient had no known allergies. The patient had no any drug abuse or illicit drug usage. The patient did not use any medication and did not have any medical history prior to vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, 2 days after vaccination the patient started experiencing dizziness, headache and severe bruising. The patient was hospitalized (date unspecified) and was diagnosed with severe thrombocytopenia. It was reported that the patient was hospitalized for 14 days and within a week later he died. On 04-MAY-2021, the patient died from an unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused/Prolonged).; Sender's Comments: V0: 20210534916- covid-19 vaccine ad26.cov2.s-Death, severe thrombocytopenia patient. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Acute promyelocytic leukaemia, Biopsy bone marrow abnormal, Contusion, Gingival bleeding, Immunoglobulin therapy
Clinical narrative: SEVERE THROMBOCYTOPENIA; DEATH; Initial information was processed along with the additional information received on 20-MAY-2021. This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic. The patient had no known allergies. The patient had no any drug abuse or illicit drug usage. The patient did not use any medication and did not have any medical history prior to vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, 2 days after vaccination the patient started experiencing dizziness, headache and severe bruising. The patient was hospitalized (date unspecified) and was diagnosed with severe thrombocytopenia. It was reported that the patient was hospitalized for 14 days and within a week later he died. On 04-MAY-2021, the patient died from an unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused/Prolonged).; Sender's Comments: V0: 20210534916- covid-19 vaccine ad26.cov2.s-Death, severe thrombocytopenia patient. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Leukocytosis, Platelet count decreased, Thrombocytopenia, White blood cell count increased
Clinical narrative: SEVERE THROMBOCYTOPENIA; DEATH; Initial information was processed along with the additional information received on 20-MAY-2021. This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic. The patient had no known allergies. The patient had no any drug abuse or illicit drug usage. The patient did not use any medication and did not have any medical history prior to vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, 2 days after vaccination the patient started experiencing dizziness, headache and severe bruising. The patient was hospitalized (date unspecified) and was diagnosed with severe thrombocytopenia. It was reported that the patient was hospitalized for 14 days and within a week later he died. On 04-MAY-2021, the patient died from an unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused/Prolonged).; Sender's Comments: V0: 20210534916- covid-19 vaccine ad26.cov2.s-Death, severe thrombocytopenia patient. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Gingival bleeding, Hypoxia, Leukocytosis, Petechiae
Clinical narrative: SEVERE THROMBOCYTOPENIA; DEATH; Initial information was processed along with the additional information received on 20-MAY-2021. This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic. The patient had no known allergies. The patient had no any drug abuse or illicit drug usage. The patient did not use any medication and did not have any medical history prior to vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, 2 days after vaccination the patient started experiencing dizziness, headache and severe bruising. The patient was hospitalized (date unspecified) and was diagnosed with severe thrombocytopenia. It was reported that the patient was hospitalized for 14 days and within a week later he died. On 04-MAY-2021, the patient died from an unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused/Prolonged).; Sender's Comments: V0: 20210534916- covid-19 vaccine ad26.cov2.s-Death, severe thrombocytopenia patient. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Respiratory failure, Shock, Thrombocytopenia, White blood cell count increased
Clinical narrative: SEVERE THROMBOCYTOPENIA; DEATH; Initial information was processed along with the additional information received on 20-MAY-2021. This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic. The patient had no known allergies. The patient had no any drug abuse or illicit drug usage. The patient did not use any medication and did not have any medical history prior to vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, 2 days after vaccination the patient started experiencing dizziness, headache and severe bruising. The patient was hospitalized (date unspecified) and was diagnosed with severe thrombocytopenia. It was reported that the patient was hospitalized for 14 days and within a week later he died. On 04-MAY-2021, the patient died from an unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused/Prolonged).; Sender's Comments: V0: 20210534916- covid-19 vaccine ad26.cov2.s-Death, severe thrombocytopenia patient. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Acute leukaemia, Condition aggravated, Thrombocytopenia
Clinical narrative: SEVERE THROMBOCYTOPENIA; DEATH; Initial information was processed along with the additional information received on 20-MAY-2021. This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic. The patient had no known allergies. The patient had no any drug abuse or illicit drug usage. The patient did not use any medication and did not have any medical history prior to vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, 2 days after vaccination the patient started experiencing dizziness, headache and severe bruising. The patient was hospitalized (date unspecified) and was diagnosed with severe thrombocytopenia. It was reported that the patient was hospitalized for 14 days and within a week later he died. On 04-MAY-2021, the patient died from an unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused/Prolonged).; Sender's Comments: V0: 20210534916- covid-19 vaccine ad26.cov2.s-Death, severe thrombocytopenia patient. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Death, Thrombocytopenia
Clinical narrative: SEVERE THROMBOCYTOPENIA; DEATH; Initial information was processed along with the additional information received on 20-MAY-2021. This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic. The patient had no known allergies. The patient had no any drug abuse or illicit drug usage. The patient did not use any medication and did not have any medical history prior to vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, 2 days after vaccination the patient started experiencing dizziness, headache and severe bruising. The patient was hospitalized (date unspecified) and was diagnosed with severe thrombocytopenia. It was reported that the patient was hospitalized for 14 days and within a week later he died. On 04-MAY-2021, the patient died from an unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused/Prolonged).; Sender's Comments: V0: 20210534916- covid-19 vaccine ad26.cov2.s-Death, severe thrombocytopenia patient. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH