chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0162), via an unspecified route of administration in arm left on 28Apr2021 at 04:45 AM (at the age of 44-year-old) as a dose 2, single for COVID-19 immunisation. The patient's medical history included HIV undetectable, peanuts, known allergies to toradol, tramadol, peanuts, spleen removed and immune suppressed. Past drug event included toradol and tramadol for known allergies. The patient's concomitant medications received within 2 weeks of vaccination was reported as no. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown, could not enter info on shots), via an unspecified route of administration on an unspecified date in Apr2021 at 04:45 PM (at the age of 44-year-old) as a dose 1, single for COVID-19 immunisation and experienced pain from my navel to my spine on my right side and it was extreme pain, I had hurt my back and shingles. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. It was reported that, after the first shot the patient had pain from his navel to his spine on his right side and it was extreme pain so he went to the emergency room and stated that, he had hurt his back, days passed and he went to another doctor and they said that, he indeed have shingles well nothing appeared until after the second shot and then he was covered and shingles overnight and the patient had been dealing with this since the first vaccine. Stated that, why was this not told to the public and especially the immune suppressed. Stated that, he had his spleen removed if he had knew all this. Stated that, he wouldn't have taken it and they all didn't do clinical trials on these types of people. The patient was very pissed off. Stated that, this wasn't the way they all should have ran things and he will be discussing this with his attorney. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the event included pain medicine and acyclovir. The outcome of the event was not recovered.  Follow-up attempts completed. No further information is expected.  Follow-Up 28Jul2021: Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0162), via an unspecified route of administration in arm left on 28Apr2021 at 04:45 AM (at the age of 44-year-old) as a dose 2, single for COVID-19 immunisation. The patient's medical history included HIV undetectable, peanuts, known allergies to toradol, tramadol, peanuts, spleen removed and immune suppressed. Past drug event included toradol and tramadol for known allergies. The patient's concomitant medications received within 2 weeks of vaccination was reported as no. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown, could not enter info on shots), via an unspecified route of administration on an unspecified date in Apr2021 at 04:45 PM (at the age of 44-year-old) as a dose 1, single for COVID-19 immunisation and experienced pain from my navel to my spine on my right side and it was extreme pain, I had hurt my back and shingles. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. It was reported that, after the first shot the patient had pain from his navel to his spine on his right side and it was extreme pain so he went to the emergency room and stated that, he had hurt his back, days passed and he went to another doctor and they said that, he indeed have shingles well nothing appeared until after the second shot and then he was covered and shingles overnight and the patient had been dealing with this since the first vaccine. Stated that, why was this not told to the public and especially the immune suppressed. Stated that, he had his spleen removed if he had knew all this. Stated that, he wouldn't have taken it and they all didn't do clinical trials on these types of people. The patient was very pissed off. Stated that, this wasn't the way they all should have ran things and he will be discussing this with his attorney. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the event included pain medicine and acyclovir. The outcome of the event was not recovered.  Follow-up attempts completed. No further information is expected.  Follow-Up 28Jul2021: Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dry eye, Dyskinesia, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: 19 Y female referred for L face tingling/numbness after COVID first vaccine dose 7 days prior-- >symptoms resolved but MRI showed lesions suspicious for MS. Per chart: -5/7/21 visit with pcp: L face numbness 1 week after first dose COVID vaccine (Pfizer, administered outside  on 4/25/21). Day of visit also with L sided headache, pressure. Noted to be under lot of stress with finals at school. -5/10/21 email to pcp that tingling gone on L face but "left side of my face and mouth are fully numb and I'm experiencing some discomfort swallowing and talking." -5/11/21 PCP TAV: L upper and lower facial tingling resolved but "c/o numbness of her left upper cheek and lower face, left side of her tongue, inside of her left side of cheek. Drooling when she drinks liquids intermittently since 5/3/21. Denies choking."-- >MRI brain with contrast recommended but done w/o contrast. MRI showed T2/flair lesions suspicious for MS.   Onset of tingling and numbness L side of face, scalp about May 2, one week after first COVID-19 Pfizer vaccine given. 1/2 tongue on L numb and some numbness feeling in throat. No actually trouble swallowing but some discomfort swallowing. Because can't feel mouth/face/tongue well food sometimes dribbles from L mouth. Had some drooling pool L side of mouth when lying on L side. Symptoms slowly progressed over about 1.5 weeks and then have not gotten better but haven't worsened.  No limb symptoms or visual symptoms. No weakness. No Bowel or bladder control issues  -Had decreased L upper and lower along with L mid and lateral scalp sensation, reflexes 3 knees but symmetrical, one repetitive beat with R forced ankle DF. -non-con MRI brain 5/14/21: L brachium pontis and bilateral supratentorial PV white matter, deep white matter and R internal capsule anterior limb lesions "suspicious for multiple sclerosis." -- >given oral dexamethasone 5/25.  19 yo woman with demyelinating attack 5/2021 approximately 1 week after receiving first COVID Pfizer vaccine. MRI brain with supratentorial demyelinating lesions and L brachium pontis lesion and f/u with gad and spinal MRIs w/o additional lesions and no enhancement (but MRI brain with contrast done about 6 weeks after attack onset).
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: 19 Y female referred for L face tingling/numbness after COVID first vaccine dose 7 days prior-- >symptoms resolved but MRI showed lesions suspicious for MS. Per chart: -5/7/21 visit with pcp: L face numbness 1 week after first dose COVID vaccine (Pfizer, administered outside  on 4/25/21). Day of visit also with L sided headache, pressure. Noted to be under lot of stress with finals at school. -5/10/21 email to pcp that tingling gone on L face but "left side of my face and mouth are fully numb and I'm experiencing some discomfort swallowing and talking." -5/11/21 PCP TAV: L upper and lower facial tingling resolved but "c/o numbness of her left upper cheek and lower face, left side of her tongue, inside of her left side of cheek. Drooling when she drinks liquids intermittently since 5/3/21. Denies choking."-- >MRI brain with contrast recommended but done w/o contrast. MRI showed T2/flair lesions suspicious for MS.   Onset of tingling and numbness L side of face, scalp about May 2, one week after first COVID-19 Pfizer vaccine given. 1/2 tongue on L numb and some numbness feeling in throat. No actually trouble swallowing but some discomfort swallowing. Because can't feel mouth/face/tongue well food sometimes dribbles from L mouth. Had some drooling pool L side of mouth when lying on L side. Symptoms slowly progressed over about 1.5 weeks and then have not gotten better but haven't worsened.  No limb symptoms or visual symptoms. No weakness. No Bowel or bladder control issues  -Had decreased L upper and lower along with L mid and lateral scalp sensation, reflexes 3 knees but symmetrical, one repetitive beat with R forced ankle DF. -non-con MRI brain 5/14/21: L brachium pontis and bilateral supratentorial PV white matter, deep white matter and R internal capsule anterior limb lesions "suspicious for multiple sclerosis." -- >given oral dexamethasone 5/25.  19 yo woman with demyelinating attack 5/2021 approximately 1 week after receiving first COVID Pfizer vaccine. MRI brain with supratentorial demyelinating lesions and L brachium pontis lesion and f/u with gad and spinal MRIs w/o additional lesions and no enhancement (but MRI brain with contrast done about 6 weeks after attack onset).
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Albumin CSF, CSF glucose normal, CSF immunoglobulin G index, CSF oligoclonal band present, CSF protein normal
Clinical narrative: 19 Y female referred for L face tingling/numbness after COVID first vaccine dose 7 days prior-- >symptoms resolved but MRI showed lesions suspicious for MS. Per chart: -5/7/21 visit with pcp: L face numbness 1 week after first dose COVID vaccine (Pfizer, administered outside  on 4/25/21). Day of visit also with L sided headache, pressure. Noted to be under lot of stress with finals at school. -5/10/21 email to pcp that tingling gone on L face but "left side of my face and mouth are fully numb and I'm experiencing some discomfort swallowing and talking." -5/11/21 PCP TAV: L upper and lower facial tingling resolved but "c/o numbness of her left upper cheek and lower face, left side of her tongue, inside of her left side of cheek. Drooling when she drinks liquids intermittently since 5/3/21. Denies choking."-- >MRI brain with contrast recommended but done w/o contrast. MRI showed T2/flair lesions suspicious for MS.   Onset of tingling and numbness L side of face, scalp about May 2, one week after first COVID-19 Pfizer vaccine given. 1/2 tongue on L numb and some numbness feeling in throat. No actually trouble swallowing but some discomfort swallowing. Because can't feel mouth/face/tongue well food sometimes dribbles from L mouth. Had some drooling pool L side of mouth when lying on L side. Symptoms slowly progressed over about 1.5 weeks and then have not gotten better but haven't worsened.  No limb symptoms or visual symptoms. No weakness. No Bowel or bladder control issues  -Had decreased L upper and lower along with L mid and lateral scalp sensation, reflexes 3 knees but symmetrical, one repetitive beat with R forced ankle DF. -non-con MRI brain 5/14/21: L brachium pontis and bilateral supratentorial PV white matter, deep white matter and R internal capsule anterior limb lesions "suspicious for multiple sclerosis." -- >given oral dexamethasone 5/25.  19 yo woman with demyelinating attack 5/2021 approximately 1 week after receiving first COVID Pfizer vaccine. MRI brain with supratentorial demyelinating lesions and L brachium pontis lesion and f/u with gad and spinal MRIs w/o additional lesions and no enhancement (but MRI brain with contrast done about 6 weeks after attack onset).
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Central nervous system lesion, Cerebral calcification, Demyelination, Drooling, Head discomfort
Clinical narrative: 19 Y female referred for L face tingling/numbness after COVID first vaccine dose 7 days prior-- >symptoms resolved but MRI showed lesions suspicious for MS. Per chart: -5/7/21 visit with pcp: L face numbness 1 week after first dose COVID vaccine (Pfizer, administered outside  on 4/25/21). Day of visit also with L sided headache, pressure. Noted to be under lot of stress with finals at school. -5/10/21 email to pcp that tingling gone on L face but "left side of my face and mouth are fully numb and I'm experiencing some discomfort swallowing and talking." -5/11/21 PCP TAV: L upper and lower facial tingling resolved but "c/o numbness of her left upper cheek and lower face, left side of her tongue, inside of her left side of cheek. Drooling when she drinks liquids intermittently since 5/3/21. Denies choking."-- >MRI brain with contrast recommended but done w/o contrast. MRI showed T2/flair lesions suspicious for MS.   Onset of tingling and numbness L side of face, scalp about May 2, one week after first COVID-19 Pfizer vaccine given. 1/2 tongue on L numb and some numbness feeling in throat. No actually trouble swallowing but some discomfort swallowing. Because can't feel mouth/face/tongue well food sometimes dribbles from L mouth. Had some drooling pool L side of mouth when lying on L side. Symptoms slowly progressed over about 1.5 weeks and then have not gotten better but haven't worsened.  No limb symptoms or visual symptoms. No weakness. No Bowel or bladder control issues  -Had decreased L upper and lower along with L mid and lateral scalp sensation, reflexes 3 knees but symmetrical, one repetitive beat with R forced ankle DF. -non-con MRI brain 5/14/21: L brachium pontis and bilateral supratentorial PV white matter, deep white matter and R internal capsule anterior limb lesions "suspicious for multiple sclerosis." -- >given oral dexamethasone 5/25.  19 yo woman with demyelinating attack 5/2021 approximately 1 week after receiving first COVID Pfizer vaccine. MRI brain with supratentorial demyelinating lesions and L brachium pontis lesion and f/u with gad and spinal MRIs w/o additional lesions and no enhancement (but MRI brain with contrast done about 6 weeks after attack onset).
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal normal, Multiple sclerosis
Clinical narrative: 19 Y female referred for L face tingling/numbness after COVID first vaccine dose 7 days prior-- >symptoms resolved but MRI showed lesions suspicious for MS. Per chart: -5/7/21 visit with pcp: L face numbness 1 week after first dose COVID vaccine (Pfizer, administered outside  on 4/25/21). Day of visit also with L sided headache, pressure. Noted to be under lot of stress with finals at school. -5/10/21 email to pcp that tingling gone on L face but "left side of my face and mouth are fully numb and I'm experiencing some discomfort swallowing and talking." -5/11/21 PCP TAV: L upper and lower facial tingling resolved but "c/o numbness of her left upper cheek and lower face, left side of her tongue, inside of her left side of cheek. Drooling when she drinks liquids intermittently since 5/3/21. Denies choking."-- >MRI brain with contrast recommended but done w/o contrast. MRI showed T2/flair lesions suspicious for MS.   Onset of tingling and numbness L side of face, scalp about May 2, one week after first COVID-19 Pfizer vaccine given. 1/2 tongue on L numb and some numbness feeling in throat. No actually trouble swallowing but some discomfort swallowing. Because can't feel mouth/face/tongue well food sometimes dribbles from L mouth. Had some drooling pool L side of mouth when lying on L side. Symptoms slowly progressed over about 1.5 weeks and then have not gotten better but haven't worsened.  No limb symptoms or visual symptoms. No weakness. No Bowel or bladder control issues  -Had decreased L upper and lower along with L mid and lateral scalp sensation, reflexes 3 knees but symmetrical, one repetitive beat with R forced ankle DF. -non-con MRI brain 5/14/21: L brachium pontis and bilateral supratentorial PV white matter, deep white matter and R internal capsule anterior limb lesions "suspicious for multiple sclerosis." -- >given oral dexamethasone 5/25.  19 yo woman with demyelinating attack 5/2021 approximately 1 week after receiving first COVID Pfizer vaccine. MRI brain with supratentorial demyelinating lesions and L brachium pontis lesion and f/u with gad and spinal MRIs w/o additional lesions and no enhancement (but MRI brain with contrast done about 6 weeks after attack onset).
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Odynophagia, Paraesthesia, Scan with contrast abnormal, Sinus disorder, Speech disorder
Clinical narrative: 19 Y female referred for L face tingling/numbness after COVID first vaccine dose 7 days prior-- >symptoms resolved but MRI showed lesions suspicious for MS. Per chart: -5/7/21 visit with pcp: L face numbness 1 week after first dose COVID vaccine (Pfizer, administered outside  on 4/25/21). Day of visit also with L sided headache, pressure. Noted to be under lot of stress with finals at school. -5/10/21 email to pcp that tingling gone on L face but "left side of my face and mouth are fully numb and I'm experiencing some discomfort swallowing and talking." -5/11/21 PCP TAV: L upper and lower facial tingling resolved but "c/o numbness of her left upper cheek and lower face, left side of her tongue, inside of her left side of cheek. Drooling when she drinks liquids intermittently since 5/3/21. Denies choking."-- >MRI brain with contrast recommended but done w/o contrast. MRI showed T2/flair lesions suspicious for MS.   Onset of tingling and numbness L side of face, scalp about May 2, one week after first COVID-19 Pfizer vaccine given. 1/2 tongue on L numb and some numbness feeling in throat. No actually trouble swallowing but some discomfort swallowing. Because can't feel mouth/face/tongue well food sometimes dribbles from L mouth. Had some drooling pool L side of mouth when lying on L side. Symptoms slowly progressed over about 1.5 weeks and then have not gotten better but haven't worsened.  No limb symptoms or visual symptoms. No weakness. No Bowel or bladder control issues  -Had decreased L upper and lower along with L mid and lateral scalp sensation, reflexes 3 knees but symmetrical, one repetitive beat with R forced ankle DF. -non-con MRI brain 5/14/21: L brachium pontis and bilateral supratentorial PV white matter, deep white matter and R internal capsule anterior limb lesions "suspicious for multiple sclerosis." -- >given oral dexamethasone 5/25.  19 yo woman with demyelinating attack 5/2021 approximately 1 week after receiving first COVID Pfizer vaccine. MRI brain with supratentorial demyelinating lesions and L brachium pontis lesion and f/u with gad and spinal MRIs w/o additional lesions and no enhancement (but MRI brain with contrast done about 6 weeks after attack onset).
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Stress, Vitamin D, White matter lesion
Clinical narrative: 19 Y female referred for L face tingling/numbness after COVID first vaccine dose 7 days prior-- >symptoms resolved but MRI showed lesions suspicious for MS. Per chart: -5/7/21 visit with pcp: L face numbness 1 week after first dose COVID vaccine (Pfizer, administered outside  on 4/25/21). Day of visit also with L sided headache, pressure. Noted to be under lot of stress with finals at school. -5/10/21 email to pcp that tingling gone on L face but "left side of my face and mouth are fully numb and I'm experiencing some discomfort swallowing and talking." -5/11/21 PCP TAV: L upper and lower facial tingling resolved but "c/o numbness of her left upper cheek and lower face, left side of her tongue, inside of her left side of cheek. Drooling when she drinks liquids intermittently since 5/3/21. Denies choking."-- >MRI brain with contrast recommended but done w/o contrast. MRI showed T2/flair lesions suspicious for MS.   Onset of tingling and numbness L side of face, scalp about May 2, one week after first COVID-19 Pfizer vaccine given. 1/2 tongue on L numb and some numbness feeling in throat. No actually trouble swallowing but some discomfort swallowing. Because can't feel mouth/face/tongue well food sometimes dribbles from L mouth. Had some drooling pool L side of mouth when lying on L side. Symptoms slowly progressed over about 1.5 weeks and then have not gotten better but haven't worsened.  No limb symptoms or visual symptoms. No weakness. No Bowel or bladder control issues  -Had decreased L upper and lower along with L mid and lateral scalp sensation, reflexes 3 knees but symmetrical, one repetitive beat with R forced ankle DF. -non-con MRI brain 5/14/21: L brachium pontis and bilateral supratentorial PV white matter, deep white matter and R internal capsule anterior limb lesions "suspicious for multiple sclerosis." -- >given oral dexamethasone 5/25.  19 yo woman with demyelinating attack 5/2021 approximately 1 week after receiving first COVID Pfizer vaccine. MRI brain with supratentorial demyelinating lesions and L brachium pontis lesion and f/u with gad and spinal MRIs w/o additional lesions and no enhancement (but MRI brain with contrast done about 6 weeks after attack onset).
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, Atrial fibrillation, COVID-19, Cardiac failure chronic, Death
Clinical narrative: Patient received both doses of the Moderna COVID vaccine on 1/29/2021 and 2/26/2021. Admitted to hospital on 4/13/21 for abdominal pain. Developed cough and then tested positive for COVID on 4/17/21. Abdominal pain improved but COVID symptoms did not and patient died on 5/9/21. Diverticulitis, follicular lymphoma, neutropenia and thrombocytoenia due to chemotherapy noted during hospital stay.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ejection fraction decreased, Follicular lymphoma, Hypoxia, SARS-CoV-2 test positive
Clinical narrative: Patient received both doses of the Moderna COVID vaccine on 1/29/2021 and 2/26/2021. Admitted to hospital on 4/13/21 for abdominal pain. Developed cough and then tested positive for COVID on 4/17/21. Abdominal pain improved but COVID symptoms did not and patient died on 5/9/21. Diverticulitis, follicular lymphoma, neutropenia and thrombocytoenia due to chemotherapy noted during hospital stay.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, Chemotherapy, Cough, Death
Clinical narrative: Patient received both doses of the Moderna COVID vaccine on 1/29/2021 and 2/26/2021. Admitted to hospital on 4/13/21 for abdominal pain. Developed cough and then tested positive for COVID on 4/17/21. Abdominal pain improved but COVID symptoms did not and patient died on 5/9/21. Diverticulitis, follicular lymphoma, neutropenia and thrombocytoenia due to chemotherapy noted during hospital stay.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Diverticulitis, Follicular lymphoma, Neutropenia, SARS-CoV-2 test positive, Thrombocytopenia
Clinical narrative: Patient received both doses of the Moderna COVID vaccine on 1/29/2021 and 2/26/2021. Admitted to hospital on 4/13/21 for abdominal pain. Developed cough and then tested positive for COVID on 4/17/21. Abdominal pain improved but COVID symptoms did not and patient died on 5/9/21. Diverticulitis, follicular lymphoma, neutropenia and thrombocytoenia due to chemotherapy noted during hospital stay.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: severe spike with tinnitus; mentally and emotionally run down; mentally and emotionally run down; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 19May2021 (Batch/Lot number: EW0176, Expiration Date: Aug2021) (at the age of 45-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The morning of 22May2021, the patient experienced a severe spike with tinnitus, and it has never calmed down. It has left her mentally and emotionally run down. She couldn't even get the second dose because there was no way that she could take that risk. It's so hard to tell but it is in her right ear but in her head. Patient stated that it is not like how some people can't walk or having hard inflammation, but tinnitus can affect you mentally and emotionally. It has been traumatic for her to get the COVID vaccine and not realize that this was a possible side effect but she thinks it is very rare but there is definitely threads about it online and it was a disappointment. She has all kinds of emotions with this, disappointment, angry and mad. She wasn't willing to take the 2nd dose since she never calmed down from the first and no one can guarantee that to her about the tinnitus. Just the thought of her walking around only half vaccinated and possibly never being able to get another vaccine again is scary. She is going to have to live in her house for the rest of her life. It is sad, it really is sad how it happened. She has read threads about it online and she is not the only one that is having this. She wishes she could go back in time and thinks about what if she got a different brand, but she has to move forward because she can't change what happened. Just the thought of it being permanent as the more time it goes on and doesn't get better, she loses hope. She loses hope because this could be this way for the rest of her life. The outcome of the event tinnitus was not recovered, while for the rest of events was unknown.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Emotional disorder, Mental disorder, Tinnitus
Clinical narrative: severe spike with tinnitus; mentally and emotionally run down; mentally and emotionally run down; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 19May2021 (Batch/Lot number: EW0176, Expiration Date: Aug2021) (at the age of 45-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The morning of 22May2021, the patient experienced a severe spike with tinnitus, and it has never calmed down. It has left her mentally and emotionally run down. She couldn't even get the second dose because there was no way that she could take that risk. It's so hard to tell but it is in her right ear but in her head. Patient stated that it is not like how some people can't walk or having hard inflammation, but tinnitus can affect you mentally and emotionally. It has been traumatic for her to get the COVID vaccine and not realize that this was a possible side effect but she thinks it is very rare but there is definitely threads about it online and it was a disappointment. She has all kinds of emotions with this, disappointment, angry and mad. She wasn't willing to take the 2nd dose since she never calmed down from the first and no one can guarantee that to her about the tinnitus. Just the thought of her walking around only half vaccinated and possibly never being able to get another vaccine again is scary. She is going to have to live in her house for the rest of her life. It is sad, it really is sad how it happened. She has read threads about it online and she is not the only one that is having this. She wishes she could go back in time and thinks about what if she got a different brand, but she has to move forward because she can't change what happened. Just the thought of it being permanent as the more time it goes on and doesn't get better, she loses hope. She loses hope because this could be this way for the rest of her life. The outcome of the event tinnitus was not recovered, while for the rest of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient had no illness at the time of vaccination and had no history of allergy to vaccine. The patient had no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days before report and there were no other suspected causes including co-administered vaccine(s)/risk factors present. The patient had no adverse event after any previous vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 and expiry date: 25-MAY-2021) dose was not reported, 1 total, administered on unspecified arm on 27-MAY-2021 for prophylactic vaccination (expired vaccine used). She had not received any concomitant medications including immune-modulating, immuno-suppressive medications or received other vaccines within past 30 days before report. On an unspecified date, the patient's coronavirus disease (COVID-19) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoglobulin (IgG), IgM and IgA antibody tests were negative (suspected immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccine failure and expired vaccine used was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210660757.; Sender's Comments: V0-20210747108-COVID-19 Vaccine Ad26.COV2.S-Suspected Immunological Vaccination Failure-This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient had no illness at the time of vaccination and had no history of allergy to vaccine. The patient had no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days before report and there were no other suspected causes including co-administered vaccine(s)/risk factors present. The patient had no adverse event after any previous vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 and expiry date: 25-MAY-2021) dose was not reported, 1 total, administered on unspecified arm on 27-MAY-2021 for prophylactic vaccination (expired vaccine used). She had not received any concomitant medications including immune-modulating, immuno-suppressive medications or received other vaccines within past 30 days before report. On an unspecified date, the patient's coronavirus disease (COVID-19) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoglobulin (IgG), IgM and IgA antibody tests were negative (suspected immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccine failure and expired vaccine used was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210660757.; Sender's Comments: V0-20210747108-COVID-19 Vaccine Ad26.COV2.S-Suspected Immunological Vaccination Failure-This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Swelling of eyelid
Clinical narrative: Swollen lymph nodes; my eyelids has also been swollen since then; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EW0164; Expiration Date: 31Aug2021), via an unspecified route of administration on 14May2021 as dose 2, single for COVID-19 immunization. Medical history included mixed connective tissue disease. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EW0170; Expiration Date: 31Aug2021), via an unspecified route of administration on 31Aug2021 for COVID-19 immunization. The patient experienced swollen lymph nodes and since then eyelids has also been swollen on an unspecified date in May2021. It was reported that the patient had second Pfizer vaccine last Friday and since then, she had a swollen lymph node which is a common side effect and her eyelids had also been swollen since then. She took cold compresses in tea bag, but she was not sure what else she tried for that she was not sure. The patient was not on medication other than she had a cream (further clarification unknown) for rash for external that she used tiny amount. So, she did not think that really matters other than that taking Tylenol, Advil (Further clarification unknown) once in a while but she had not had that in a couple of weeks. The patient underwent lab tests and procedures which included laboratory test: diagnosed with an autoimmune disease very mild Mixed connective tissue. Therapeutic measures were taken as a result of events (cold compresses in tea bag). The outcome of the events was unknown.  Follow up needed, further information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Lymphadenopathy, Swelling of eyelid
Clinical narrative: Swollen lymph nodes; my eyelids has also been swollen since then; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EW0164; Expiration Date: 31Aug2021), via an unspecified route of administration on 14May2021 as dose 2, single for COVID-19 immunization. Medical history included mixed connective tissue disease. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EW0170; Expiration Date: 31Aug2021), via an unspecified route of administration on 31Aug2021 for COVID-19 immunization. The patient experienced swollen lymph nodes and since then eyelids has also been swollen on an unspecified date in May2021. It was reported that the patient had second Pfizer vaccine last Friday and since then, she had a swollen lymph node which is a common side effect and her eyelids had also been swollen since then. She took cold compresses in tea bag, but she was not sure what else she tried for that she was not sure. The patient was not on medication other than she had a cream (further clarification unknown) for rash for external that she used tiny amount. So, she did not think that really matters other than that taking Tylenol, Advil (Further clarification unknown) once in a while but she had not had that in a couple of weeks. The patient underwent lab tests and procedures which included laboratory test: diagnosed with an autoimmune disease very mild Mixed connective tissue. Therapeutic measures were taken as a result of events (cold compresses in tea bag). The outcome of the events was unknown.  Follow up needed, further information has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Hypoaesthesia oral, Hypotension, Injection site pain, Intracranial pressure increased
Clinical narrative: I am now diagnosed with Trigeminal Neuralgia and Intracranial Hypertension with worsening symptoms; I am now diagnosed with Trigeminal Neuralgia and Intracranial Hypertension with worsening symptoms; some jaw pain; high blood pressure; lips tingle, chin tingles; lips tingle, chin tingles; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 19Mar2021 08:30 (Lot Number: EN6205), at the age of 36-year-old, as single dose for COVID-19 immunisation. Medical history included sleep apnea, known allergies Sulfa drugs. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and famotidine (PEPCID) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 on 26Feb2021 at 08:30 AM (Lot Number: EN6200) and 20-25 minutes after injection, roof of mouth cold like brain freeze, sore injection site. 1 Hr after jab: facial tingling, growing more severe - by 8 pm (12 hours) much of the face was numb. Nurse recommended Benadryl and stated that patient only need to come in if it affects his breathing. Right toe tingly, facial numbness. By 27Feb2021: throat, under tongue, and neck numb. 28Feb2021: hemifacial numbness, back of head cold and tingly. By 01Mar2021: hemifacial muscle spasms began and have continued today, headaches are common. On 19Mar2021, patient received Jab 2 (Lot EN 6205) and experienced much less severe reaction. He was told by the nurse to take Benadryl and Pepcid 1 hour before the jab, which he did. 10 minutes after jab: lips tingle, chin tingles. 15 minutes after: some jaw pain and high blood pressure (requiring a standby nurse to have him lie on a stretcher). As of 15Jul2021 he was now diagnosed with Trigeminal Neuralgia and Intracranial Hypertension with worsening symptoms. The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Patient was currently on Azetazolamide for Intracranial Hypertension. The outcome of the events was not recovered. No COVID prior vaccination. No COVID tested post vaccination.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging head, Muscle spasms, Pain in jaw, Paraesthesia
Clinical narrative: I am now diagnosed with Trigeminal Neuralgia and Intracranial Hypertension with worsening symptoms; I am now diagnosed with Trigeminal Neuralgia and Intracranial Hypertension with worsening symptoms; some jaw pain; high blood pressure; lips tingle, chin tingles; lips tingle, chin tingles; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 19Mar2021 08:30 (Lot Number: EN6205), at the age of 36-year-old, as single dose for COVID-19 immunisation. Medical history included sleep apnea, known allergies Sulfa drugs. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and famotidine (PEPCID) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 on 26Feb2021 at 08:30 AM (Lot Number: EN6200) and 20-25 minutes after injection, roof of mouth cold like brain freeze, sore injection site. 1 Hr after jab: facial tingling, growing more severe - by 8 pm (12 hours) much of the face was numb. Nurse recommended Benadryl and stated that patient only need to come in if it affects his breathing. Right toe tingly, facial numbness. By 27Feb2021: throat, under tongue, and neck numb. 28Feb2021: hemifacial numbness, back of head cold and tingly. By 01Mar2021: hemifacial muscle spasms began and have continued today, headaches are common. On 19Mar2021, patient received Jab 2 (Lot EN 6205) and experienced much less severe reaction. He was told by the nurse to take Benadryl and Pepcid 1 hour before the jab, which he did. 10 minutes after jab: lips tingle, chin tingles. 15 minutes after: some jaw pain and high blood pressure (requiring a standby nurse to have him lie on a stretcher). As of 15Jul2021 he was now diagnosed with Trigeminal Neuralgia and Intracranial Hypertension with worsening symptoms. The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Patient was currently on Azetazolamide for Intracranial Hypertension. The outcome of the events was not recovered. No COVID prior vaccination. No COVID tested post vaccination.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Trigeminal neuralgia
Clinical narrative: I am now diagnosed with Trigeminal Neuralgia and Intracranial Hypertension with worsening symptoms; I am now diagnosed with Trigeminal Neuralgia and Intracranial Hypertension with worsening symptoms; some jaw pain; high blood pressure; lips tingle, chin tingles; lips tingle, chin tingles; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 19Mar2021 08:30 (Lot Number: EN6205), at the age of 36-year-old, as single dose for COVID-19 immunisation. Medical history included sleep apnea, known allergies Sulfa drugs. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and famotidine (PEPCID) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 on 26Feb2021 at 08:30 AM (Lot Number: EN6200) and 20-25 minutes after injection, roof of mouth cold like brain freeze, sore injection site. 1 Hr after jab: facial tingling, growing more severe - by 8 pm (12 hours) much of the face was numb. Nurse recommended Benadryl and stated that patient only need to come in if it affects his breathing. Right toe tingly, facial numbness. By 27Feb2021: throat, under tongue, and neck numb. 28Feb2021: hemifacial numbness, back of head cold and tingly. By 01Mar2021: hemifacial muscle spasms began and have continued today, headaches are common. On 19Mar2021, patient received Jab 2 (Lot EN 6205) and experienced much less severe reaction. He was told by the nurse to take Benadryl and Pepcid 1 hour before the jab, which he did. 10 minutes after jab: lips tingle, chin tingles. 15 minutes after: some jaw pain and high blood pressure (requiring a standby nurse to have him lie on a stretcher). As of 15Jul2021 he was now diagnosed with Trigeminal Neuralgia and Intracranial Hypertension with worsening symptoms. The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Patient was currently on Azetazolamide for Intracranial Hypertension. The outcome of the events was not recovered. No COVID prior vaccination. No COVID tested post vaccination.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Intracranial pressure increased, Pain in jaw, Paraesthesia
Clinical narrative: I am now diagnosed with Trigeminal Neuralgia and Intracranial Hypertension with worsening symptoms; I am now diagnosed with Trigeminal Neuralgia and Intracranial Hypertension with worsening symptoms; some jaw pain; high blood pressure; lips tingle, chin tingles; lips tingle, chin tingles; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 19Mar2021 08:30 (Lot Number: EN6205), at the age of 36-year-old, as single dose for COVID-19 immunisation. Medical history included sleep apnea, known allergies Sulfa drugs. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and famotidine (PEPCID) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 on 26Feb2021 at 08:30 AM (Lot Number: EN6200) and 20-25 minutes after injection, roof of mouth cold like brain freeze, sore injection site. 1 Hr after jab: facial tingling, growing more severe - by 8 pm (12 hours) much of the face was numb. Nurse recommended Benadryl and stated that patient only need to come in if it affects his breathing. Right toe tingly, facial numbness. By 27Feb2021: throat, under tongue, and neck numb. 28Feb2021: hemifacial numbness, back of head cold and tingly. By 01Mar2021: hemifacial muscle spasms began and have continued today, headaches are common. On 19Mar2021, patient received Jab 2 (Lot EN 6205) and experienced much less severe reaction. He was told by the nurse to take Benadryl and Pepcid 1 hour before the jab, which he did. 10 minutes after jab: lips tingle, chin tingles. 15 minutes after: some jaw pain and high blood pressure (requiring a standby nurse to have him lie on a stretcher). As of 15Jul2021 he was now diagnosed with Trigeminal Neuralgia and Intracranial Hypertension with worsening symptoms. The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Patient was currently on Azetazolamide for Intracranial Hypertension. The outcome of the events was not recovered. No COVID prior vaccination. No COVID tested post vaccination.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Dehydration, Fatigue, Hypotension
Clinical narrative: Resting heart rate 130-138; Chest discomfort during deep breathing; Low blood pressure between 89/70 and 99/52; Fever of 102.5; achy; nausea; chills; exhaustion; dehydration; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 21-year-old non-pregnant female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0164, Expiration date: Unknown), via an unspecified route of administration, administered in arm left on 21Apr2021 (at the age of 21-year-old) as single dose for COVID-19 immunisation in other facility. No other vaccines were received in four weeks and no other medications in two weeks. The patient did not have Covid prior vaccination. The patient medical history was not reported. There were no concomitant medications. On 22Apr2021 at 16:00, the patient experienced resting heart rate 130-138, chest discomfort during deep breathing, low blood pressure between 89/70 and 99/52, fever of 102.5, achy, nausea, chills, exhaustion and dehydration. The events resulted in emergency room. The patient underwent lab tests and procedures which included blood pressure measurement: between 89/70 and 99/52 on 22Apr2021, body temperature: 102.5 on 22Apr2021, resting heart rate: 130-138 on 22Apr2021, sars-cov-2 test: negative on 22Apr2021. Therapeutic measures were taken as a result of the events with saline and Tylenol. The outcome of the events was resolved on an unspecified date in 2021.