chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, FLU4
Symptoms: SARS-CoV-2 test negative, Vomiting
Clinical narrative: Pt received COVID booster and high-dose flu shot on 10/11/21, 8 hrs later had chills, fever, and cough. Dx'd with pneumonia Nov 3rd, then found to have swollen submandibular glands around Nov 9th. 11/14/2021 70-year-old female, non-smoker, who has been treated over the past month for progressive cough and shortness of breath. Symptoms started mid October and for a week or so she tried a number of over-the-counter medications. He was then put on a course of amoxicillin. A chest x-ray in November 3 showed some mild basilar infiltrates and she was put on doxycycline. She had a course of prednisone as well. She began to develop fever and worsening cough this week and on November 11 had a chest x-ray that showed increasing infiltrate. She was therefore put on azithromycin and cefuroxime on Thursday, November 11. She came to the emergency room tonight after having shortness of breath with home oximetry showing sats 89 to 90% and temperatures to 102. She describes her cough is dry and nonproductive. She had one episode of vomiting with a cough. She has noticed over the past week or 2 significant the swollen lymph nodes under her jaw as well. She has had some mild diarrhea. She has had a Covid vaccine and Covid PCR was negative tonight as it was on November 9. She says that ever since her teens she has had occasional bronchitis but is never persistent like this. She never has smoked tobacco. She is no pulmonary toxic exposures
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Drug eruption, Eosinophilia
Clinical narrative: Patient started on dupixent 10/20/31. 2 weeks later on 11/3 developed biopsy proven pustular drug eruption. Also had eosinophilia. Of note, 1 week prior additionally had Moderna vaccine booster.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Headache FATIGUE/CHILLS/ARM SORENESS Narrative:
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Cough, Throat tightness, Tremor
Clinical narrative: immediately went into shock after receiving the vaccine; throat had started to get scratchy; throat had tingled; her face got blue; blood pressure was really low; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Aug2021 between 8:00 AM and 8:30 AM (Lot Number: EW0185) at the age of 43 years old as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included ongoing allergic to latex. Prior Vaccinations (within 4 weeks) was none. There were no concomitant medications.  The patient experienced immediately went into shock after receiving the vaccine. She had to be transported to the emergency room and she said that she now has to carry an epi pen around and do all kinds of other things. She was admitted into inpatient at the hospital. She believes it was either 06Aug2021 or 07Aug2021 that she was released. She provided specific details that she was sitting in the waiting room and her throat had started to get scratchy and she had asked for a drink of water. They have to wear a mask in the building because she received it at a medical office and when she took the mask off to drink water the receptionist said that they have got to call withheld because the caller's face was blue. The patient guesses that her throat had tingled first and then her face got blue and then she remembered them giving her epi and a Benadryl drip. The patient didn't feel like she has recovered completely because her blood pressure was really low when she had left the hospital and it still is. While she was there they had trouble regulating it and now she is taking medicine to help bring her blood pressure up. Her blood pressure is getting better with the medicine and it is coming up. The patient was transferred to the emergency room on 03Aug2021, admitted on 03Aug2021 and she believes it was either 06Aug2021 or 07Aug2021 when she was released. The outcome of event blood pressure was really low was recovering, and others was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Cyanosis, Hypotension, Pharyngeal paraesthesia, Shock
Clinical narrative: immediately went into shock after receiving the vaccine; throat had started to get scratchy; throat had tingled; her face got blue; blood pressure was really low; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Aug2021 between 8:00 AM and 8:30 AM (Lot Number: EW0185) at the age of 43 years old as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included ongoing allergic to latex. Prior Vaccinations (within 4 weeks) was none. There were no concomitant medications.  The patient experienced immediately went into shock after receiving the vaccine. She had to be transported to the emergency room and she said that she now has to carry an epi pen around and do all kinds of other things. She was admitted into inpatient at the hospital. She believes it was either 06Aug2021 or 07Aug2021 that she was released. She provided specific details that she was sitting in the waiting room and her throat had started to get scratchy and she had asked for a drink of water. They have to wear a mask in the building because she received it at a medical office and when she took the mask off to drink water the receptionist said that they have got to call withheld because the caller's face was blue. The patient guesses that her throat had tingled first and then her face got blue and then she remembered them giving her epi and a Benadryl drip. The patient didn't feel like she has recovered completely because her blood pressure was really low when she had left the hospital and it still is. While she was there they had trouble regulating it and now she is taking medicine to help bring her blood pressure up. Her blood pressure is getting better with the medicine and it is coming up. The patient was transferred to the emergency room on 03Aug2021, admitted on 03Aug2021 and she believes it was either 06Aug2021 or 07Aug2021 when she was released. The outcome of event blood pressure was really low was recovering, and others was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: immediately went into shock after receiving the vaccine; throat had started to get scratchy; throat had tingled; her face got blue; blood pressure was really low; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Aug2021 between 8:00 AM and 8:30 AM (Lot Number: EW0185) at the age of 43 years old as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included ongoing allergic to latex. Prior Vaccinations (within 4 weeks) was none. There were no concomitant medications.  The patient experienced immediately went into shock after receiving the vaccine. She had to be transported to the emergency room and she said that she now has to carry an epi pen around and do all kinds of other things. She was admitted into inpatient at the hospital. She believes it was either 06Aug2021 or 07Aug2021 that she was released. She provided specific details that she was sitting in the waiting room and her throat had started to get scratchy and she had asked for a drink of water. They have to wear a mask in the building because she received it at a medical office and when she took the mask off to drink water the receptionist said that they have got to call withheld because the caller's face was blue. The patient guesses that her throat had tingled first and then her face got blue and then she remembered them giving her epi and a Benadryl drip. The patient didn't feel like she has recovered completely because her blood pressure was really low when she had left the hospital and it still is. While she was there they had trouble regulating it and now she is taking medicine to help bring her blood pressure up. Her blood pressure is getting better with the medicine and it is coming up. The patient was transferred to the emergency room on 03Aug2021, admitted on 03Aug2021 and she believes it was either 06Aug2021 or 07Aug2021 when she was released. The outcome of event blood pressure was really low was recovering, and others was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Booster; their doses of the vaccine were invalid/ it was stored at 32 degrees; their doses of the vaccine were invalid/ it was stored at 32 degrees; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old female patient received bnt162b2 (COMIRNATY),( COVID 19 Vaccine, mRNA) (Formulation: Solution for injection, Lot Number: not reported) via an unspecified route of administration on 20Sep2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (Pfizer Covid 19 vaccine) via an unspecified route of administration and experience sore arm and was tired for a few hours that afternoon and also received the second dose of BNT162b2 at the time of second dose did not experience any side effects for COVID-19 immunisation. On 20Sep2021, patient experienced booster, their doses of the vaccine were invalid/ it was stored at 32 degrees and their doses of the vaccine were invalid/ it was stored at 32 degrees with outcome of unknown.The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101528612 same reporter/product/event, different patient
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Poor quality product administered, Product storage error
Clinical narrative: Booster; their doses of the vaccine were invalid/ it was stored at 32 degrees; their doses of the vaccine were invalid/ it was stored at 32 degrees; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old female patient received bnt162b2 (COMIRNATY),( COVID 19 Vaccine, mRNA) (Formulation: Solution for injection, Lot Number: not reported) via an unspecified route of administration on 20Sep2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (Pfizer Covid 19 vaccine) via an unspecified route of administration and experience sore arm and was tired for a few hours that afternoon and also received the second dose of BNT162b2 at the time of second dose did not experience any side effects for COVID-19 immunisation. On 20Sep2021, patient experienced booster, their doses of the vaccine were invalid/ it was stored at 32 degrees and their doses of the vaccine were invalid/ it was stored at 32 degrees with outcome of unknown.The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101528612 same reporter/product/event, different patient
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Booster; their doses of the vaccine were invalid/ it was stored at 32 degrees; their doses of the vaccine were invalid/ it was stored at 32 degrees; This is a spontaneous report from a contactable consumer or other non hcp.  A 73-years-old male patient received bnt162b2 (COMIRNATY; Solution for injection; Batch/Lot number: Unknown), via an unspecified route of administration on Sep2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history included the first dose and second dose of bnt162b2 (COMIRNATY; Solution for injection; Batch/Lot number: Unknown), for covid-19 immunisation. The patient's concomitant medications were not reported. The patient experienced booster (immunisation), their doses of the vaccine were invalid/ it was stored at 32 degrees (product temperature excursion issue) and their doses of the vaccine were invalid/ it was stored at 32 degrees (poor quality product administered) in Sep2021. The reporter and her husband both received the Pfizer COVID 19 vaccine initial two doses and then the booster dose about a month and a half ago. She states that about a week and a half after they received the booster dose the (name) where they were administered called to let them know that their doses of the vaccine were invalid and that they would need to come back in to receive another dose of the vaccine. She states that the only information she is aware of is that it was stored at 32 degrees. She does not have information on if the vaccine was diluted or undiluted, where it was stored for the excursion, how long or any other details that would be needed to determine stability. The reporter had booster at (name) on 20Sep2021, and a week and a half later, they called and said there was a problem with storage and it was not kept at the temperature it should have been and she should come in and get a 4th shot. She does not know what to do. She called her healthcare professional. The same thing happened to her husband. This report is to capture information for him. She and her husband had theirs administered a day apart. Patient did not have information on if the vaccine was diluted or undiluted, where it was stored for the excursion, how long or any other details that would be needed to determine stability. Patient would like to know if dose was considered invalid or not and if another dose was needed. The clinical outcome of all events were reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101528611 same reporter/product/event, different patient
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Booster; their doses of the vaccine were invalid/ it was stored at 32 degrees; their doses of the vaccine were invalid/ it was stored at 32 degrees; This is a spontaneous report from a contactable consumer or other non hcp.  A 73-years-old male patient received bnt162b2 (COMIRNATY; Solution for injection; Batch/Lot number: Unknown), via an unspecified route of administration on Sep2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history included the first dose and second dose of bnt162b2 (COMIRNATY; Solution for injection; Batch/Lot number: Unknown), for covid-19 immunisation. The patient's concomitant medications were not reported. The patient experienced booster (immunisation), their doses of the vaccine were invalid/ it was stored at 32 degrees (product temperature excursion issue) and their doses of the vaccine were invalid/ it was stored at 32 degrees (poor quality product administered) in Sep2021. The reporter and her husband both received the Pfizer COVID 19 vaccine initial two doses and then the booster dose about a month and a half ago. She states that about a week and a half after they received the booster dose the (name) where they were administered called to let them know that their doses of the vaccine were invalid and that they would need to come back in to receive another dose of the vaccine. She states that the only information she is aware of is that it was stored at 32 degrees. She does not have information on if the vaccine was diluted or undiluted, where it was stored for the excursion, how long or any other details that would be needed to determine stability. The reporter had booster at (name) on 20Sep2021, and a week and a half later, they called and said there was a problem with storage and it was not kept at the temperature it should have been and she should come in and get a 4th shot. She does not know what to do. She called her healthcare professional. The same thing happened to her husband. This report is to capture information for him. She and her husband had theirs administered a day apart. Patient did not have information on if the vaccine was diluted or undiluted, where it was stored for the excursion, how long or any other details that would be needed to determine stability. Patient would like to know if dose was considered invalid or not and if another dose was needed. The clinical outcome of all events were reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101528611 same reporter/product/event, different patient
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral normal, Antinuclear antibody negative, Arteriogram carotid normal, Back pain, Borrelia test negative
Clinical narrative: BELLS PALSY; CRANIAL NEURITIS; TREMORS; DEPRESSION; HEADACHE; ELECTRICAL SENSATION DOWN THE BODY WITH TINGLING IN HANDS AND FEET; UNABLE TO WORK; This spontaneous report received from a patient concerned a 50 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) dose was not reported, 01 total was administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that, in AUG-2021, the patient got vaccinated and two days later she developed a very strange headache for a week. It then went down hill from there and she ended up with bells palsy. A couple days later her whole face was paralyzed and then the electrical sensation down in the body with tingling in her hands and feet (cranial neuritis). Headache was still continuing. After about two weeks the inflammation in her brain started going down, but then she developed tremors. Till date she was taking primidone to help with the tremors (did not take it all away). She has not been able to work since SEP-2021 and developed depression which was increasing since then.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, unable to work, tremors, depression, cranial neuritis, and electrical sensation down the body with tingling in hands and feet, and the outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211145266-COVID-19 VACCINE AD26.COV2.S-bell's palsy, cranial neuritis. 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).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, CSF cell count, CSF protein increased, Cranial nerve disorder, Demyelination
Clinical narrative: BELLS PALSY; CRANIAL NEURITIS; TREMORS; DEPRESSION; HEADACHE; ELECTRICAL SENSATION DOWN THE BODY WITH TINGLING IN HANDS AND FEET; UNABLE TO WORK; This spontaneous report received from a patient concerned a 50 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) dose was not reported, 01 total was administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that, in AUG-2021, the patient got vaccinated and two days later she developed a very strange headache for a week. It then went down hill from there and she ended up with bells palsy. A couple days later her whole face was paralyzed and then the electrical sensation down in the body with tingling in her hands and feet (cranial neuritis). Headache was still continuing. After about two weeks the inflammation in her brain started going down, but then she developed tremors. Till date she was taking primidone to help with the tremors (did not take it all away). She has not been able to work since SEP-2021 and developed depression which was increasing since then.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, unable to work, tremors, depression, cranial neuritis, and electrical sensation down the body with tingling in hands and feet, and the outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211145266-COVID-19 VACCINE AD26.COV2.S-bell's palsy, cranial neuritis. 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).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysarthria, Electrophoresis protein normal, Eye pain, Facial paralysis, Full blood count normal
Clinical narrative: BELLS PALSY; CRANIAL NEURITIS; TREMORS; DEPRESSION; HEADACHE; ELECTRICAL SENSATION DOWN THE BODY WITH TINGLING IN HANDS AND FEET; UNABLE TO WORK; This spontaneous report received from a patient concerned a 50 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) dose was not reported, 01 total was administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that, in AUG-2021, the patient got vaccinated and two days later she developed a very strange headache for a week. It then went down hill from there and she ended up with bells palsy. A couple days later her whole face was paralyzed and then the electrical sensation down in the body with tingling in her hands and feet (cranial neuritis). Headache was still continuing. After about two weeks the inflammation in her brain started going down, but then she developed tremors. Till date she was taking primidone to help with the tremors (did not take it all away). She has not been able to work since SEP-2021 and developed depression which was increasing since then.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, unable to work, tremors, depression, cranial neuritis, and electrical sensation down the body with tingling in hands and feet, and the outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211145266-COVID-19 VACCINE AD26.COV2.S-bell's palsy, cranial neuritis. 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).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Lumbar puncture, Magnetic resonance imaging head abnormal, Microangiopathy, Mucosal hypertrophy
Clinical narrative: BELLS PALSY; CRANIAL NEURITIS; TREMORS; DEPRESSION; HEADACHE; ELECTRICAL SENSATION DOWN THE BODY WITH TINGLING IN HANDS AND FEET; UNABLE TO WORK; This spontaneous report received from a patient concerned a 50 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) dose was not reported, 01 total was administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that, in AUG-2021, the patient got vaccinated and two days later she developed a very strange headache for a week. It then went down hill from there and she ended up with bells palsy. A couple days later her whole face was paralyzed and then the electrical sensation down in the body with tingling in her hands and feet (cranial neuritis). Headache was still continuing. After about two weeks the inflammation in her brain started going down, but then she developed tremors. Till date she was taking primidone to help with the tremors (did not take it all away). She has not been able to work since SEP-2021 and developed depression which was increasing since then.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, unable to work, tremors, depression, cranial neuritis, and electrical sensation down the body with tingling in hands and feet, and the outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211145266-COVID-19 VACCINE AD26.COV2.S-bell's palsy, cranial neuritis. 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).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Neuritis cranial, Neurological examination, Red blood cell sedimentation rate increased, SARS-CoV-2 test negative
Clinical narrative: BELLS PALSY; CRANIAL NEURITIS; TREMORS; DEPRESSION; HEADACHE; ELECTRICAL SENSATION DOWN THE BODY WITH TINGLING IN HANDS AND FEET; UNABLE TO WORK; This spontaneous report received from a patient concerned a 50 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) dose was not reported, 01 total was administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that, in AUG-2021, the patient got vaccinated and two days later she developed a very strange headache for a week. It then went down hill from there and she ended up with bells palsy. A couple days later her whole face was paralyzed and then the electrical sensation down in the body with tingling in her hands and feet (cranial neuritis). Headache was still continuing. After about two weeks the inflammation in her brain started going down, but then she developed tremors. Till date she was taking primidone to help with the tremors (did not take it all away). She has not been able to work since SEP-2021 and developed depression which was increasing since then.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, unable to work, tremors, depression, cranial neuritis, and electrical sensation down the body with tingling in hands and feet, and the outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211145266-COVID-19 VACCINE AD26.COV2.S-bell's palsy, cranial neuritis. 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).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast abnormal, Tremor, Urine albumin/creatinine ratio, White blood cell count increased, White matter lesion
Clinical narrative: BELLS PALSY; CRANIAL NEURITIS; TREMORS; DEPRESSION; HEADACHE; ELECTRICAL SENSATION DOWN THE BODY WITH TINGLING IN HANDS AND FEET; UNABLE TO WORK; This spontaneous report received from a patient concerned a 50 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) dose was not reported, 01 total was administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that, in AUG-2021, the patient got vaccinated and two days later she developed a very strange headache for a week. It then went down hill from there and she ended up with bells palsy. A couple days later her whole face was paralyzed and then the electrical sensation down in the body with tingling in her hands and feet (cranial neuritis). Headache was still continuing. After about two weeks the inflammation in her brain started going down, but then she developed tremors. Till date she was taking primidone to help with the tremors (did not take it all away). She has not been able to work since SEP-2021 and developed depression which was increasing since then.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, unable to work, tremors, depression, cranial neuritis, and electrical sensation down the body with tingling in hands and feet, and the outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211145266-COVID-19 VACCINE AD26.COV2.S-bell's palsy, cranial neuritis. 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).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Depression, Headache, Impaired work ability, Neuritis cranial
Clinical narrative: BELLS PALSY; CRANIAL NEURITIS; TREMORS; DEPRESSION; HEADACHE; ELECTRICAL SENSATION DOWN THE BODY WITH TINGLING IN HANDS AND FEET; UNABLE TO WORK; This spontaneous report received from a patient concerned a 50 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) dose was not reported, 01 total was administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that, in AUG-2021, the patient got vaccinated and two days later she developed a very strange headache for a week. It then went down hill from there and she ended up with bells palsy. A couple days later her whole face was paralyzed and then the electrical sensation down in the body with tingling in her hands and feet (cranial neuritis). Headache was still continuing. After about two weeks the inflammation in her brain started going down, but then she developed tremors. Till date she was taking primidone to help with the tremors (did not take it all away). She has not been able to work since SEP-2021 and developed depression which was increasing since then.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, unable to work, tremors, depression, cranial neuritis, and electrical sensation down the body with tingling in hands and feet, and the outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211145266-COVID-19 VACCINE AD26.COV2.S-bell's palsy, cranial neuritis. 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).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Tremor
Clinical narrative: BELLS PALSY; CRANIAL NEURITIS; TREMORS; DEPRESSION; HEADACHE; ELECTRICAL SENSATION DOWN THE BODY WITH TINGLING IN HANDS AND FEET; UNABLE TO WORK; This spontaneous report received from a patient concerned a 50 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) dose was not reported, 01 total was administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that, in AUG-2021, the patient got vaccinated and two days later she developed a very strange headache for a week. It then went down hill from there and she ended up with bells palsy. A couple days later her whole face was paralyzed and then the electrical sensation down in the body with tingling in her hands and feet (cranial neuritis). Headache was still continuing. After about two weeks the inflammation in her brain started going down, but then she developed tremors. Till date she was taking primidone to help with the tremors (did not take it all away). She has not been able to work since SEP-2021 and developed depression which was increasing since then.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, unable to work, tremors, depression, cranial neuritis, and electrical sensation down the body with tingling in hands and feet, and the outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211145266-COVID-19 VACCINE AD26.COV2.S-bell's palsy, cranial neuritis. 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).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: The patient  had no prior history of  Chest pains, dizziness, staggering, heart issues before  The Pfizer shots!! ?? after the 2nd shot he had lingering side effects  Of nausea, vomiting, awful  dizziness ?? chest pains, Racing heart, etc!  ??
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac disorder, Cardiac stress test, Chest pain, Death
Clinical narrative: The patient  had no prior history of  Chest pains, dizziness, staggering, heart issues before  The Pfizer shots!! ?? after the 2nd shot he had lingering side effects  Of nausea, vomiting, awful  dizziness ?? chest pains, Racing heart, etc!  ??
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Endotracheal intubation, Gait disturbance, Intensive care
Clinical narrative: The patient  had no prior history of  Chest pains, dizziness, staggering, heart issues before  The Pfizer shots!! ?? after the 2nd shot he had lingering side effects  Of nausea, vomiting, awful  dizziness ?? chest pains, Racing heart, etc!  ??
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Liver disorder, Mechanical ventilation, Multiple organ dysfunction syndrome, Myocardial infarction, Nausea
Clinical narrative: The patient  had no prior history of  Chest pains, dizziness, staggering, heart issues before  The Pfizer shots!! ?? after the 2nd shot he had lingering side effects  Of nausea, vomiting, awful  dizziness ?? chest pains, Racing heart, etc!  ??
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Renal disorder, Sepsis, Vomiting
Clinical narrative: The patient  had no prior history of  Chest pains, dizziness, staggering, heart issues before  The Pfizer shots!! ?? after the 2nd shot he had lingering side effects  Of nausea, vomiting, awful  dizziness ?? chest pains, Racing heart, etc!  ??
Age: 56.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Death, Dyspnoea, Ejection fraction decreased, Electrocardiogram abnormal, Infection
Clinical narrative: Passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 01-Nov-2021 The patient died on 01-Nov-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            Patient passed away on 01-NOV-2021 at the age of 56. Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter. Company Comment : This spontaneous case concerns a 56-year-old patient, of unknown gender, with no medical history reported, who experienced the unexpected, serious event of death. The patient passed away on 01Nov2021 after administration of an unspecified dose of the Moderna mRNA-1273. The cause of death was not reported. Very limited information has been provided via social media. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 56-year-old patient, of unknown gender, with no medical history reported, who experienced the unexpected, serious event of death. The patient passed away on 01Nov2021 after administration of an unspecified dose of the Moderna mRNA-1273. The cause of death was not reported. Very limited information has been provided via social media. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 56.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Intensive care, Jaundice, Left atrial enlargement, Malaise
Clinical narrative: Passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 01-Nov-2021 The patient died on 01-Nov-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            Patient passed away on 01-NOV-2021 at the age of 56. Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter. Company Comment : This spontaneous case concerns a 56-year-old patient, of unknown gender, with no medical history reported, who experienced the unexpected, serious event of death. The patient passed away on 01Nov2021 after administration of an unspecified dose of the Moderna mRNA-1273. The cause of death was not reported. Very limited information has been provided via social media. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 56-year-old patient, of unknown gender, with no medical history reported, who experienced the unexpected, serious event of death. The patient passed away on 01Nov2021 after administration of an unspecified dose of the Moderna mRNA-1273. The cause of death was not reported. Very limited information has been provided via social media. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 56.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Multiple organ dysfunction syndrome, Muscle atrophy, Peripheral swelling, Sinus tachycardia
Clinical narrative: Passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 01-Nov-2021 The patient died on 01-Nov-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            Patient passed away on 01-NOV-2021 at the age of 56. Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter. Company Comment : This spontaneous case concerns a 56-year-old patient, of unknown gender, with no medical history reported, who experienced the unexpected, serious event of death. The patient passed away on 01Nov2021 after administration of an unspecified dose of the Moderna mRNA-1273. The cause of death was not reported. Very limited information has been provided via social media. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 56-year-old patient, of unknown gender, with no medical history reported, who experienced the unexpected, serious event of death. The patient passed away on 01Nov2021 after administration of an unspecified dose of the Moderna mRNA-1273. The cause of death was not reported. Very limited information has been provided via social media. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 56.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 01-Nov-2021 The patient died on 01-Nov-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            Patient passed away on 01-NOV-2021 at the age of 56. Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter. Company Comment : This spontaneous case concerns a 56-year-old patient, of unknown gender, with no medical history reported, who experienced the unexpected, serious event of death. The patient passed away on 01Nov2021 after administration of an unspecified dose of the Moderna mRNA-1273. The cause of death was not reported. Very limited information has been provided via social media. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 56-year-old patient, of unknown gender, with no medical history reported, who experienced the unexpected, serious event of death. The patient passed away on 01Nov2021 after administration of an unspecified dose of the Moderna mRNA-1273. The cause of death was not reported. Very limited information has been provided via social media. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chills, Headache, Pain
Clinical narrative: Initially developed headache on 11/6 followed by fevers up to 103 F a few days after that. Also noted to have mild rash, mild conjunctivitis, that followed. A few days before her admission to the Hospital on 11/19, she also developed a dry cough. On admission, noted to have elevated inflammatory markers with CRP 10.1, ferritin 657.4. Also pro-BNP 1513, CK 628, normal troponin. Negative EBV and CMV serology, negative hepatitis panel, RVP, ANA panel, coags, blood culture. Unremarkable EKG, echo. Noted to be positive for SARS-CoV2 spike protein Abs but negative for nucleocapsid Abs.  Fevers continued to be elevated to 103 F but began to improve after starting doxycycline on 11/23 to cover for possible tickborne illness or sinusitis. Some infectious workup still pending (especially for tickborne illnesses), but otherwise, considering possible MIS-V due to constellation of symptoms occurring shortly after administration of vaccine.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Urine analysis
Clinical narrative: Initially developed headache on 11/6 followed by fevers up to 103 F a few days after that. Also noted to have mild rash, mild conjunctivitis, that followed. A few days before her admission to the Hospital on 11/19, she also developed a dry cough. On admission, noted to have elevated inflammatory markers with CRP 10.1, ferritin 657.4. Also pro-BNP 1513, CK 628, normal troponin. Negative EBV and CMV serology, negative hepatitis panel, RVP, ANA panel, coags, blood culture. Unremarkable EKG, echo. Noted to be positive for SARS-CoV2 spike protein Abs but negative for nucleocapsid Abs.  Fevers continued to be elevated to 103 F but began to improve after starting doxycycline on 11/23 to cover for possible tickborne illness or sinusitis. Some infectious workup still pending (especially for tickborne illnesses), but otherwise, considering possible MIS-V due to constellation of symptoms occurring shortly after administration of vaccine.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time shortened, Alanine aminotransferase increased, Antinuclear antibody negative, Aspartate aminotransferase increased, Blood creatine phosphokinase increased
Clinical narrative: Initially developed headache on 11/6 followed by fevers up to 103 F a few days after that. Also noted to have mild rash, mild conjunctivitis, that followed. A few days before her admission to the Hospital on 11/19, she also developed a dry cough. On admission, noted to have elevated inflammatory markers with CRP 10.1, ferritin 657.4. Also pro-BNP 1513, CK 628, normal troponin. Negative EBV and CMV serology, negative hepatitis panel, RVP, ANA panel, coags, blood culture. Unremarkable EKG, echo. Noted to be positive for SARS-CoV2 spike protein Abs but negative for nucleocapsid Abs.  Fevers continued to be elevated to 103 F but began to improve after starting doxycycline on 11/23 to cover for possible tickborne illness or sinusitis. Some infectious workup still pending (especially for tickborne illnesses), but otherwise, considering possible MIS-V due to constellation of symptoms occurring shortly after administration of vaccine.