chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Herpes zoster, Muscle atrophy, Pain, Pain in extremity
Clinical narrative: could barely walk; lost 44 pounds since that shot; Muscle wasting is occuring.; Rheumatoid arthritis; shooting pain in his feet and lower legs; pain; outbreak of herpes/shingles; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: EW0151) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history, no known allergies. Concomitant medication included: TYLENOL. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose administration date: 19Mar2021, Batch/Lot No: ER8727, Location of injection: Arm Left), administration date: 19Mar2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: HERPES ZOSTER (disability) with onset 14Apr2021 03:00, outcome "not recovered", described as "outbreak of herpes/shingles"; PAIN IN EXTREMITY (disability) with onset 23Apr2021, outcome "not recovered", described as " shooting pain in his feet and lower legs"; PAIN (disability) with onset 16Apr2021, outcome "not recovered", described as "pain"; GAIT DISTURBANCE (disability), outcome "not recovered", described as "could barely walk"; WEIGHT DECREASED (disability), outcome "not recovered", described as "lost 44 pounds since that shot"; MUSCLE ATROPHY (disability), outcome "not recovered", described as "Muscle wasting was occurring."; RHEUMATOID ARTHRITIS (disability), outcome "not recovered", described as "Rheumatoid arthritis". The events "outbreak of herpes/shingles", " shooting pain in his feet and lower legs", "pain", "could barely walk", "lost 44 pounds since that shot", "muscle wasting is occurring." and "rheumatoid arthritis" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: weight: lost 44 pounds. Therapeutic measures were not taken as a result of herpes zoster, pain in extremity, pain, gait disturbance, weight decreased, muscle atrophy, rheumatoid arthritis. Clinical course: 5 days after the vaccine (14Apr2021 03:00) the patient had an outbreak of herpes, two week later (23Apr2021) shooting pain in his feet and lower legs, few more weeks shingles then another bout of shingles. The patient had been in pain since 1 week (16Apr2021) after second dose. He could barely walk, lost 44 pounds since that shot. Muscle wasting was occurring. He had to see a neurologist who has refereed him to a rheumatologist. Can't even get an appointment. Never had rheumatoid arthritis (RA) before this shot. He was an active man who exercised everyday. No COVID tested post vaccination. No other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rheumatoid arthritis, Weight, Weight decreased
Clinical narrative: could barely walk; lost 44 pounds since that shot; Muscle wasting is occuring.; Rheumatoid arthritis; shooting pain in his feet and lower legs; pain; outbreak of herpes/shingles; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: EW0151) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history, no known allergies. Concomitant medication included: TYLENOL. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose administration date: 19Mar2021, Batch/Lot No: ER8727, Location of injection: Arm Left), administration date: 19Mar2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: HERPES ZOSTER (disability) with onset 14Apr2021 03:00, outcome "not recovered", described as "outbreak of herpes/shingles"; PAIN IN EXTREMITY (disability) with onset 23Apr2021, outcome "not recovered", described as " shooting pain in his feet and lower legs"; PAIN (disability) with onset 16Apr2021, outcome "not recovered", described as "pain"; GAIT DISTURBANCE (disability), outcome "not recovered", described as "could barely walk"; WEIGHT DECREASED (disability), outcome "not recovered", described as "lost 44 pounds since that shot"; MUSCLE ATROPHY (disability), outcome "not recovered", described as "Muscle wasting was occurring."; RHEUMATOID ARTHRITIS (disability), outcome "not recovered", described as "Rheumatoid arthritis". The events "outbreak of herpes/shingles", " shooting pain in his feet and lower legs", "pain", "could barely walk", "lost 44 pounds since that shot", "muscle wasting is occurring." and "rheumatoid arthritis" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: weight: lost 44 pounds. Therapeutic measures were not taken as a result of herpes zoster, pain in extremity, pain, gait disturbance, weight decreased, muscle atrophy, rheumatoid arthritis. Clinical course: 5 days after the vaccine (14Apr2021 03:00) the patient had an outbreak of herpes, two week later (23Apr2021) shooting pain in his feet and lower legs, few more weeks shingles then another bout of shingles. The patient had been in pain since 1 week (16Apr2021) after second dose. He could barely walk, lost 44 pounds since that shot. Muscle wasting was occurring. He had to see a neurologist who has refereed him to a rheumatologist. Can't even get an appointment. Never had rheumatoid arthritis (RA) before this shot. He was an active man who exercised everyday. No COVID tested post vaccination. No other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Fall, Headache, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Patient presented in status epilepticus on 10/25, 6 days after receiving her COVID vaccine.  She had been noted to have increasing depression and potential weakness over the week prior to presentation. Prior, she had been previously healthy and developmentally normal. After prolonged treatment course including multiple anti-epileptics, she began treatment for suspected acute encephalitis.  In addition to seizure, she has become nonverbal, unable to eat, and does not follow commands. She received 6 rounds of plasmapheresis, and has completed two courses of 2g/kg of IVIG, and 1x Rituximab. She has received 2 rounds of burst seizures and is now currently tapering on her steroids. At this time, 12/2 she is currently on Vimpat 250mg BID, Keppra 1500mg BID for seizures. She has had 2 seizures in the past week, one subclinical noted on EEG, and 1 lasting ~30seconds. She is currently receiving all feeds via NG as she is not take anything by mouth. On current exam, awake, will open eyes, can move all extremities, will not follow commands, she can take steps with assistance with PT.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mechanical ventilation, Seizure
Clinical narrative: Patient presented in status epilepticus on 10/25, 6 days after receiving her COVID vaccine.  She had been noted to have increasing depression and potential weakness over the week prior to presentation. Prior, she had been previously healthy and developmentally normal. After prolonged treatment course including multiple anti-epileptics, she began treatment for suspected acute encephalitis.  In addition to seizure, she has become nonverbal, unable to eat, and does not follow commands. She received 6 rounds of plasmapheresis, and has completed two courses of 2g/kg of IVIG, and 1x Rituximab. She has received 2 rounds of burst seizures and is now currently tapering on her steroids. At this time, 12/2 she is currently on Vimpat 250mg BID, Keppra 1500mg BID for seizures. She has had 2 seizures in the past week, one subclinical noted on EEG, and 1 lasting ~30seconds. She is currently receiving all feeds via NG as she is not take anything by mouth. On current exam, awake, will open eyes, can move all extremities, will not follow commands, she can take steps with assistance with PT.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, Asthenia, Depression, Electroencephalogram abnormal, Encephalitis
Clinical narrative: Patient presented in status epilepticus on 10/25, 6 days after receiving her COVID vaccine.  She had been noted to have increasing depression and potential weakness over the week prior to presentation. Prior, she had been previously healthy and developmentally normal. After prolonged treatment course including multiple anti-epileptics, she began treatment for suspected acute encephalitis.  In addition to seizure, she has become nonverbal, unable to eat, and does not follow commands. She received 6 rounds of plasmapheresis, and has completed two courses of 2g/kg of IVIG, and 1x Rituximab. She has received 2 rounds of burst seizures and is now currently tapering on her steroids. At this time, 12/2 she is currently on Vimpat 250mg BID, Keppra 1500mg BID for seizures. She has had 2 seizures in the past week, one subclinical noted on EEG, and 1 lasting ~30seconds. She is currently receiving all feeds via NG as she is not take anything by mouth. On current exam, awake, will open eyes, can move all extremities, will not follow commands, she can take steps with assistance with PT.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeding disorder, Gastrointestinal tube insertion, Immunoglobulin therapy, Plasmapheresis, Seizure
Clinical narrative: Patient presented in status epilepticus on 10/25, 6 days after receiving her COVID vaccine.  She had been noted to have increasing depression and potential weakness over the week prior to presentation. Prior, she had been previously healthy and developmentally normal. After prolonged treatment course including multiple anti-epileptics, she began treatment for suspected acute encephalitis.  In addition to seizure, she has become nonverbal, unable to eat, and does not follow commands. She received 6 rounds of plasmapheresis, and has completed two courses of 2g/kg of IVIG, and 1x Rituximab. She has received 2 rounds of burst seizures and is now currently tapering on her steroids. At this time, 12/2 she is currently on Vimpat 250mg BID, Keppra 1500mg BID for seizures. She has had 2 seizures in the past week, one subclinical noted on EEG, and 1 lasting ~30seconds. She is currently receiving all feeds via NG as she is not take anything by mouth. On current exam, awake, will open eyes, can move all extremities, will not follow commands, she can take steps with assistance with PT.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Status epilepticus
Clinical narrative: Patient presented in status epilepticus on 10/25, 6 days after receiving her COVID vaccine.  She had been noted to have increasing depression and potential weakness over the week prior to presentation. Prior, she had been previously healthy and developmentally normal. After prolonged treatment course including multiple anti-epileptics, she began treatment for suspected acute encephalitis.  In addition to seizure, she has become nonverbal, unable to eat, and does not follow commands. She received 6 rounds of plasmapheresis, and has completed two courses of 2g/kg of IVIG, and 1x Rituximab. She has received 2 rounds of burst seizures and is now currently tapering on her steroids. At this time, 12/2 she is currently on Vimpat 250mg BID, Keppra 1500mg BID for seizures. She has had 2 seizures in the past week, one subclinical noted on EEG, and 1 lasting ~30seconds. She is currently receiving all feeds via NG as she is not take anything by mouth. On current exam, awake, will open eyes, can move all extremities, will not follow commands, she can take steps with assistance with PT.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Arthritis, Back pain, Blood test, Computerised tomogram
Clinical narrative: booster shot; when she was in the hospital they found a blood clot in her left leg and she didn''t have swelling of her foot; pain was so excruciating; she started going downhill; she was feeling yucky; getting pains across her back like a worm inside under her breast in the back and didn''t know what it was; Caller states it bothers her and she can't get her head into it to sit and write.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "shoulder issues" (unspecified if ongoing); "arthroscopic rotator cuff surgery", start date: 2019 (unspecified if ongoing), notes: 2 years ago and it is re-torn. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose (her first two Pfizer shot she was perfectly fine).), for Covid-19 Immunization; Bnt162b2 (2nd dose (her first two Pfizer shot she was perfectly fine).), for Covid-19 Immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 27Sep2021, outcome "unknown", described as "booster shot"; THROMBOSIS (hospitalization) with onset 2021, outcome "unknown", described as "when she was in the hospital they found a blood clot in her left leg and she didn''t have swelling of her foot"; PAIN (hospitalization) with onset 2021, outcome "unknown", described as "pain was so excruciating"; MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "she started going downhill"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "she was feeling yucky"; BACK PAIN (non-serious) with onset 2021, outcome "unknown", described as "getting pains across her back like a worm inside under her breast in the back and didn''t know what it was"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Caller states it bothers her and she can't get her head into it to sit and write.". The patient was hospitalized for immunisation, thrombosis, pain (start date: 01Nov2021, discharge date: 05Nov2021, hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of pain included that steroids and muscle relaxers which were helping but not 100%. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Musculoskeletal chest pain, Thrombosis, X-ray abnormal
Clinical narrative: booster shot; when she was in the hospital they found a blood clot in her left leg and she didn''t have swelling of her foot; pain was so excruciating; she started going downhill; she was feeling yucky; getting pains across her back like a worm inside under her breast in the back and didn''t know what it was; Caller states it bothers her and she can't get her head into it to sit and write.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "shoulder issues" (unspecified if ongoing); "arthroscopic rotator cuff surgery", start date: 2019 (unspecified if ongoing), notes: 2 years ago and it is re-torn. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose (her first two Pfizer shot she was perfectly fine).), for Covid-19 Immunization; Bnt162b2 (2nd dose (her first two Pfizer shot she was perfectly fine).), for Covid-19 Immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 27Sep2021, outcome "unknown", described as "booster shot"; THROMBOSIS (hospitalization) with onset 2021, outcome "unknown", described as "when she was in the hospital they found a blood clot in her left leg and she didn''t have swelling of her foot"; PAIN (hospitalization) with onset 2021, outcome "unknown", described as "pain was so excruciating"; MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "she started going downhill"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "she was feeling yucky"; BACK PAIN (non-serious) with onset 2021, outcome "unknown", described as "getting pains across her back like a worm inside under her breast in the back and didn''t know what it was"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Caller states it bothers her and she can't get her head into it to sit and write.". The patient was hospitalized for immunisation, thrombosis, pain (start date: 01Nov2021, discharge date: 05Nov2021, hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of pain included that steroids and muscle relaxers which were helping but not 100%. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Immunisation, Loss of personal independence in daily activities, Malaise, Nausea
Clinical narrative: booster shot; when she was in the hospital they found a blood clot in her left leg and she didn''t have swelling of her foot; pain was so excruciating; she started going downhill; she was feeling yucky; getting pains across her back like a worm inside under her breast in the back and didn''t know what it was; Caller states it bothers her and she can't get her head into it to sit and write.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "shoulder issues" (unspecified if ongoing); "arthroscopic rotator cuff surgery", start date: 2019 (unspecified if ongoing), notes: 2 years ago and it is re-torn. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose (her first two Pfizer shot she was perfectly fine).), for Covid-19 Immunization; Bnt162b2 (2nd dose (her first two Pfizer shot she was perfectly fine).), for Covid-19 Immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 27Sep2021, outcome "unknown", described as "booster shot"; THROMBOSIS (hospitalization) with onset 2021, outcome "unknown", described as "when she was in the hospital they found a blood clot in her left leg and she didn''t have swelling of her foot"; PAIN (hospitalization) with onset 2021, outcome "unknown", described as "pain was so excruciating"; MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "she started going downhill"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "she was feeling yucky"; BACK PAIN (non-serious) with onset 2021, outcome "unknown", described as "getting pains across her back like a worm inside under her breast in the back and didn''t know what it was"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Caller states it bothers her and she can't get her head into it to sit and write.". The patient was hospitalized for immunisation, thrombosis, pain (start date: 01Nov2021, discharge date: 05Nov2021, hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of pain included that steroids and muscle relaxers which were helping but not 100%. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Thrombosis
Clinical narrative: booster shot; when she was in the hospital they found a blood clot in her left leg and she didn''t have swelling of her foot; pain was so excruciating; she started going downhill; she was feeling yucky; getting pains across her back like a worm inside under her breast in the back and didn''t know what it was; Caller states it bothers her and she can't get her head into it to sit and write.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "shoulder issues" (unspecified if ongoing); "arthroscopic rotator cuff surgery", start date: 2019 (unspecified if ongoing), notes: 2 years ago and it is re-torn. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose (her first two Pfizer shot she was perfectly fine).), for Covid-19 Immunization; Bnt162b2 (2nd dose (her first two Pfizer shot she was perfectly fine).), for Covid-19 Immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 27Sep2021, outcome "unknown", described as "booster shot"; THROMBOSIS (hospitalization) with onset 2021, outcome "unknown", described as "when she was in the hospital they found a blood clot in her left leg and she didn''t have swelling of her foot"; PAIN (hospitalization) with onset 2021, outcome "unknown", described as "pain was so excruciating"; MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "she started going downhill"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "she was feeling yucky"; BACK PAIN (non-serious) with onset 2021, outcome "unknown", described as "getting pains across her back like a worm inside under her breast in the back and didn''t know what it was"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Caller states it bothers her and she can't get her head into it to sit and write.". The patient was hospitalized for immunisation, thrombosis, pain (start date: 01Nov2021, discharge date: 05Nov2021, hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of pain included that steroids and muscle relaxers which were helping but not 100%. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arterial haemorrhage, Endoscopy, Endotracheal intubation, Gastrointestinal haemorrhage, Imaging procedure
Clinical narrative: Mesenteric arterial gastrointestinal bleed severe; This is a spontaneous report from a contactable nurse.   An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date 05Nov2021 10:00 (Lot number: 33026BD) at the age of 83 years as DOSE 1, SINGLE for COVID-19 immunisation, in nursing home/senior living facility. No other vaccine in four weeks. Relevant medical history included: "Chronic DM2" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing). No COVID prior vaccination. Concomitant medications included: ASPRIN; CYMBALTA; LISINOPRIL; TYLENOL; COREG; METFORMIN. The following information was reported: MESENTERIC HAEMORRHAGE (hospitalization, life threatening) with onset 11Nov2021 13:30, outcome "not recovered", described as "Mesenteric arterial gastrointestinal bleed severe". Clinical course: mesenteric arterial gastrointestinal bleed severe, requiring hospitalization w/ transfer to hospital w/higher level of care. ICU Intubated and received multiple units of blood, GI scope w/interventions, currently still hospitalized w/ no estimated discharge date. The patient was hospitalized for mesenteric haemorrhage (hospitalization duration: 7 days). The event "mesenteric arterial gastrointestinal bleed severe" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of mesenteric haemorrhage and included treatment with multiple units of blood. No COVID tested post vaccination; Sender's Comments: Based on the available information in the case, the causal association between the event mesenteric haemorrhage and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Laboratory test, Transfusion, Vascular cauterisation
Clinical narrative: Mesenteric arterial gastrointestinal bleed severe; This is a spontaneous report from a contactable nurse.   An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date 05Nov2021 10:00 (Lot number: 33026BD) at the age of 83 years as DOSE 1, SINGLE for COVID-19 immunisation, in nursing home/senior living facility. No other vaccine in four weeks. Relevant medical history included: "Chronic DM2" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing). No COVID prior vaccination. Concomitant medications included: ASPRIN; CYMBALTA; LISINOPRIL; TYLENOL; COREG; METFORMIN. The following information was reported: MESENTERIC HAEMORRHAGE (hospitalization, life threatening) with onset 11Nov2021 13:30, outcome "not recovered", described as "Mesenteric arterial gastrointestinal bleed severe". Clinical course: mesenteric arterial gastrointestinal bleed severe, requiring hospitalization w/ transfer to hospital w/higher level of care. ICU Intubated and received multiple units of blood, GI scope w/interventions, currently still hospitalized w/ no estimated discharge date. The patient was hospitalized for mesenteric haemorrhage (hospitalization duration: 7 days). The event "mesenteric arterial gastrointestinal bleed severe" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of mesenteric haemorrhage and included treatment with multiple units of blood. No COVID tested post vaccination; Sender's Comments: Based on the available information in the case, the causal association between the event mesenteric haemorrhage and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mesenteric haemorrhage
Clinical narrative: Mesenteric arterial gastrointestinal bleed severe; This is a spontaneous report from a contactable nurse.   An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administration date 05Nov2021 10:00 (Lot number: 33026BD) at the age of 83 years as DOSE 1, SINGLE for COVID-19 immunisation, in nursing home/senior living facility. No other vaccine in four weeks. Relevant medical history included: "Chronic DM2" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing). No COVID prior vaccination. Concomitant medications included: ASPRIN; CYMBALTA; LISINOPRIL; TYLENOL; COREG; METFORMIN. The following information was reported: MESENTERIC HAEMORRHAGE (hospitalization, life threatening) with onset 11Nov2021 13:30, outcome "not recovered", described as "Mesenteric arterial gastrointestinal bleed severe". Clinical course: mesenteric arterial gastrointestinal bleed severe, requiring hospitalization w/ transfer to hospital w/higher level of care. ICU Intubated and received multiple units of blood, GI scope w/interventions, currently still hospitalized w/ no estimated discharge date. The patient was hospitalized for mesenteric haemorrhage (hospitalization duration: 7 days). The event "mesenteric arterial gastrointestinal bleed severe" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of mesenteric haemorrhage and included treatment with multiple units of blood. No COVID tested post vaccination; Sender's Comments: Based on the available information in the case, the causal association between the event mesenteric haemorrhage and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral normal, Arthralgia, Back pain, Chest X-ray normal, Computerised tomogram head normal
Clinical narrative: Client started to get a HA, myalgias, congestion, neck and shoulder pain, weakness in bilateral extremities, tingling in  hands along with numbness in tongue. Client has been dx with Guillain-Barre syndrome and been in hospital for over a month, currently still inpatient.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electromyogram normal, Endotracheal intubation, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Client started to get a HA, myalgias, congestion, neck and shoulder pain, weakness in bilateral extremities, tingling in  hands along with numbness in tongue. Client has been dx with Guillain-Barre syndrome and been in hospital for over a month, currently still inpatient.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunoglobulin therapy, Loss of personal independence in daily activities, Lumbar puncture normal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal
Clinical narrative: Client started to get a HA, myalgias, congestion, neck and shoulder pain, weakness in bilateral extremities, tingling in  hands along with numbness in tongue. Client has been dx with Guillain-Barre syndrome and been in hospital for over a month, currently still inpatient.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Myalgia, Neck pain, Pain, Paraesthesia
Clinical narrative: Client started to get a HA, myalgias, congestion, neck and shoulder pain, weakness in bilateral extremities, tingling in  hands along with numbness in tongue. Client has been dx with Guillain-Barre syndrome and been in hospital for over a month, currently still inpatient.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Plasmapheresis, Respiratory distress, Respiratory tract congestion, Scan with contrast normal, Tobacco user
Clinical narrative: Client started to get a HA, myalgias, congestion, neck and shoulder pain, weakness in bilateral extremities, tingling in  hands along with numbness in tongue. Client has been dx with Guillain-Barre syndrome and been in hospital for over a month, currently still inpatient.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tongue discomfort
Clinical narrative: Client started to get a HA, myalgias, congestion, neck and shoulder pain, weakness in bilateral extremities, tingling in  hands along with numbness in tongue. Client has been dx with Guillain-Barre syndrome and been in hospital for over a month, currently still inpatient.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Guillain-Barre syndrome, Headache, Hypoaesthesia oral, Muscular weakness
Clinical narrative: Client started to get a HA, myalgias, congestion, neck and shoulder pain, weakness in bilateral extremities, tingling in  hands along with numbness in tongue. Client has been dx with Guillain-Barre syndrome and been in hospital for over a month, currently still inpatient.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Neck pain, Paraesthesia, Respiratory tract congestion
Clinical narrative: Client started to get a HA, myalgias, congestion, neck and shoulder pain, weakness in bilateral extremities, tingling in  hands along with numbness in tongue. Client has been dx with Guillain-Barre syndrome and been in hospital for over a month, currently still inpatient.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Endotracheal intubation, Gait inability, Guillain-Barre syndrome, Headache
Clinical narrative: Client started to get a HA, myalgias, congestion, neck and shoulder pain, weakness in bilateral extremities, tingling in  hands along with numbness in tongue. Client has been dx with Guillain-Barre syndrome and been in hospital for over a month, currently still inpatient.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunoglobulin therapy, Intensive care, Lumbar puncture normal, Muscular weakness, Myalgia
Clinical narrative: Client started to get a HA, myalgias, congestion, neck and shoulder pain, weakness in bilateral extremities, tingling in  hands along with numbness in tongue. Client has been dx with Guillain-Barre syndrome and been in hospital for over a month, currently still inpatient.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory distress, Respiratory symptom, Respiratory tract congestion
Clinical narrative: Client started to get a HA, myalgias, congestion, neck and shoulder pain, weakness in bilateral extremities, tingling in  hands along with numbness in tongue. Client has been dx with Guillain-Barre syndrome and been in hospital for over a month, currently still inpatient.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Exposure to SARS-CoV-2, Pneumonia
Clinical narrative: Falls.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute left ventricular failure, COVID-19, Chronic left ventricular failure, Condition aggravated, Fall
Clinical narrative: Falls.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Falls.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 19-Nov-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications was provided.   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow-up received: Additional reporter added.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 19-Nov-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications was provided.   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow-up received: Additional reporter added.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vasculitis
Clinical narrative: blue/purple discoloration to the plantar distal surface of his feet, causing pain
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: blue/purple discoloration to the plantar distal surface of his feet, causing pain
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Lactic acidosis, Neurological decompensation, Respiratory failure
Clinical narrative: Dystonic episodes after injection. Fever 14 days later death.
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood culture, Condition aggravated, Culture urine, Death, Dystonia
Clinical narrative: Dystonic episodes after injection. Fever 14 days later death.
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Lactic acidosis, Metabolic function test, Pyrexia, Viral test
Clinical narrative: Dystonic episodes after injection. Fever 14 days later death.
Age: 52.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye haemorrhage, Rash pruritic, SARS-CoV-2 test, Urticaria
Clinical narrative: A blood vessel in my eye burst, then a few days later, I developed a red rash on my chest, back and ears.  It was itchy and swelling.  My ears were seeping liquid from the top.  I developed small red spots on my arms and legs.  My eyes swelled almost shut.  It let up a little, then came back and got worse.
Age: 52.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Eye haemorrhage, Pruritus, Rash, Rash erythematous
Clinical narrative: A blood vessel in my eye burst, then a few days later, I developed a red rash on my chest, back and ears.  It was itchy and swelling.  My ears were seeping liquid from the top.  I developed small red spots on my arms and legs.  My eyes swelled almost shut.  It let up a little, then came back and got worse.
Age: 52.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash papular, Rash pruritic, Swelling, Swelling of eyelid
Clinical narrative: A blood vessel in my eye burst, then a few days later, I developed a red rash on my chest, back and ears.  It was itchy and swelling.  My ears were seeping liquid from the top.  I developed small red spots on my arms and legs.  My eyes swelled almost shut.  It let up a little, then came back and got worse.
Age: 52.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Ear swelling, Eye haemorrhage, Otorrhoea, Rash
Clinical narrative: A blood vessel in my eye burst, then a few days later, I developed a red rash on my chest, back and ears.  It was itchy and swelling.  My ears were seeping liquid from the top.  I developed small red spots on my arms and legs.  My eyes swelled almost shut.  It let up a little, then came back and got worse.
Age: 52.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash erythematous, Urticaria
Clinical narrative: A blood vessel in my eye burst, then a few days later, I developed a red rash on my chest, back and ears.  It was itchy and swelling.  My ears were seeping liquid from the top.  I developed small red spots on my arms and legs.  My eyes swelled almost shut.  It let up a little, then came back and got worse.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: Pain at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 (Lot number: EW0217) at the age of 27 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, lot number:FF2587, expiry date was not reported,at arm left), administration date: 07Sep2021, when the patient was 27 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Sep2021, outcome "not recovered", described as "Pain at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient didn't 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, the patient has not been tested for COVID-19
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 (Lot number: EW0217) at the age of 27 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, lot number:FF2587, expiry date was not reported,at arm left), administration date: 07Sep2021, when the patient was 27 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Sep2021, outcome "not recovered", described as "Pain at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient didn't 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, the patient has not been tested for COVID-19
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test, Chest pain, Electrocardiogram, Mesenteric vein thrombosis
Clinical narrative: BLOOD CLOTS IN CHEST; SEVERE PAIN ON RIGHT HAND SIDE OF THE STOMACH; ABDOMEN PROBLEM; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included: operation in intestine, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 and expiry: UNKNOWN) dose was not reported, 1 total, administered in left arm on 04-MAY-2021 for prophylactic vaccination. The dose number series was 1. No concomitant medications were reported.  On 23-MAY-2021, the patient experienced blood clots in chest, severe pain on right hand side of the stomach and abdomen problem. The patient was admitted to hospital by a helicopter on 23-MAY-2021 and was hospitalized for 3 weeks (18 days) and discharged on 9-JUN-2021. The patient stated he had blood clots and abdomen problem for which he received an intestinal operation during his hospital stay which was not related to vaccine. On MAY-2021, the patient received MRI and injections on his leg and was diagnosed with 2 blood clots on his chest. The patient was treated with apixaban for a little over 5 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe pain on right hand side of the stomach, blood clots in chest and abdomen problem was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and abdomen problem as not related. Company causality between covid-19 vaccine ad26.cov2.s and abdomen problem as not related. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20211164945- covid-19 vaccine ad26.cov2.s  blood clot in chest, severe pain on right hand side of the stomach and abdomen problem. 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: M
Vaccine: COVID19, COVID19
Symptoms: Portal vein thrombosis
Clinical narrative: BLOOD CLOTS IN CHEST; SEVERE PAIN ON RIGHT HAND SIDE OF THE STOMACH; ABDOMEN PROBLEM; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included: operation in intestine, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 and expiry: UNKNOWN) dose was not reported, 1 total, administered in left arm on 04-MAY-2021 for prophylactic vaccination. The dose number series was 1. No concomitant medications were reported.  On 23-MAY-2021, the patient experienced blood clots in chest, severe pain on right hand side of the stomach and abdomen problem. The patient was admitted to hospital by a helicopter on 23-MAY-2021 and was hospitalized for 3 weeks (18 days) and discharged on 9-JUN-2021. The patient stated he had blood clots and abdomen problem for which he received an intestinal operation during his hospital stay which was not related to vaccine. On MAY-2021, the patient received MRI and injections on his leg and was diagnosed with 2 blood clots on his chest. The patient was treated with apixaban for a little over 5 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe pain on right hand side of the stomach, blood clots in chest and abdomen problem was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and abdomen problem as not related. Company causality between covid-19 vaccine ad26.cov2.s and abdomen problem as not related. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20211164945- covid-19 vaccine ad26.cov2.s  blood clot in chest, severe pain on right hand side of the stomach and abdomen problem. 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).