chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Chest X-ray, Electrocardiogram, Magnetic resonance imaging, Paralysis
Clinical narrative: I had a stroke on the right side of my brain; My whole left side is paralyzed; This is a spontaneous report from a contactable consumer (patient).   A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Mar2021 at 10:30 (Lot Number: EN7539) (at the age of 68-year-old) as single dose for COVID-19 immunisation.  Medical history included diabetes from an unknown date and unknown if ongoing and pituitary tumor from 2004 to an unknown date. Concomitant medication included metformin taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 26Feb2021 at 10:30 (Lot Number: EN6205) (at the age of 68-year-old) as single dose for COVID-19 immunisation. On 19Mar2021 at 21:00, the patient reported that: "I had a stroke on the right side of my brain. My whole left side is paralyzed. I am an invalid walker. This has changed every aspect of my life". The events were serious, after emergency room visit the patient was hospitalized for 2 days, the events were also life-threatening and disabling. Therapeutic measures were taken as a result of the events and included physical therapy. On an unspecified date, the patient underwent lab tests and procedure which included electrocardiogram (ECG), chest X-rays, magnetic resonance imaging (MRI), all results were unknown. The patient outcome of the events was not recovered.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Computerised tomogram head abnormal, Electrocardiogram, Hemiparesis
Clinical narrative: I had a stroke on the right side of my brain; My whole left side is paralyzed; This is a spontaneous report from a contactable consumer (patient).   A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Mar2021 at 10:30 (Lot Number: EN7539) (at the age of 68-year-old) as single dose for COVID-19 immunisation.  Medical history included diabetes from an unknown date and unknown if ongoing and pituitary tumor from 2004 to an unknown date. Concomitant medication included metformin taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 26Feb2021 at 10:30 (Lot Number: EN6205) (at the age of 68-year-old) as single dose for COVID-19 immunisation. On 19Mar2021 at 21:00, the patient reported that: "I had a stroke on the right side of my brain. My whole left side is paralyzed. I am an invalid walker. This has changed every aspect of my life". The events were serious, after emergency room visit the patient was hospitalized for 2 days, the events were also life-threatening and disabling. Therapeutic measures were taken as a result of the events and included physical therapy. On an unspecified date, the patient underwent lab tests and procedure which included electrocardiogram (ECG), chest X-rays, magnetic resonance imaging (MRI), all results were unknown. The patient outcome of the events was not recovered.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal
Clinical narrative: I had a stroke on the right side of my brain; My whole left side is paralyzed; This is a spontaneous report from a contactable consumer (patient).   A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Mar2021 at 10:30 (Lot Number: EN7539) (at the age of 68-year-old) as single dose for COVID-19 immunisation.  Medical history included diabetes from an unknown date and unknown if ongoing and pituitary tumor from 2004 to an unknown date. Concomitant medication included metformin taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 26Feb2021 at 10:30 (Lot Number: EN6205) (at the age of 68-year-old) as single dose for COVID-19 immunisation. On 19Mar2021 at 21:00, the patient reported that: "I had a stroke on the right side of my brain. My whole left side is paralyzed. I am an invalid walker. This has changed every aspect of my life". The events were serious, after emergency room visit the patient was hospitalized for 2 days, the events were also life-threatening and disabling. Therapeutic measures were taken as a result of the events and included physical therapy. On an unspecified date, the patient underwent lab tests and procedure which included electrocardiogram (ECG), chest X-rays, magnetic resonance imaging (MRI), all results were unknown. The patient outcome of the events was not recovered.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves female patient experienced flu (influenza), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves female patient (age not reported) who got sick (illness), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported as the person (patient's husband) who never got the Flu shot and never got sick.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: deathly sick; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves female patient who was deathly sick (illness), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date, the patient who was deathly sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via social media.  This case involves a patient (age and gender unspecified) who had flu (influenza), after patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Additionally, it was reported that, patient had a mask still got the flu and sick for 2 weeks and patient reported that flu was rough.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  Patient reported event not totally gone till the time of reporting hence outcome of event was considered as not resolved.   There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves patient (unknown demographics) who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was also reported that patient always got the flu if patient got a flu shot. Since patient has stopped getting a flu shot, patient has not had any form of flu. Go figure. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event was reported as unknown. There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: This case involves male patient who had sore arm for less than 24 hours (pain in extremity), after he received  INFLUENZA VACCINE. Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided. On an unknown date in the end of the August-2020, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious sore arm for less than 24 hours (pain in extremity), (unknown latency) following the administration of INFLUENZA VACCINE. It was reported that other people with patient got their flu shot at the end of August and no side effects whatsoever. So they have never had effects from them. Laboratory data was not reported. It was not reported if the patient received any corrective treatment or not. The outcome of the event was recovered at the time of reporting. There will be no information on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Illness
Clinical narrative: she cound breath; both times was so sick; Initial information received on 11-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves female patient of an unknown age who experienced she cound breath (dyspnoea) and both times was so sick (illness), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received (twice) a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious she cound breath (dyspnoea) and both times was so sick (illness), (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that mother had the flu shot twice and both times was so sick she cound breath after that never took one again and never was sick.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This case involves a patient with unknown demography who experienced got sick (illness) and was in bed for 5 days, while he/she received vaccine INFLUENZA VACCINE. Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient got sick and was in bed for 5 days (illness), (unknown latency) following the administration of INFLUENZA VACCINE. It was reported that each time patient got those shots he/she got sick, then patient was told if he/she hadn't gotten the shot it would have been worse. Last shot, in bed for 5 days. That is how patients body reacted. Laboratory data was not reported. It was not reported if the patient received any corrective treatment or not. The outcome of the event was unknown at the time of reporting. There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves patient who experienced flu (influenza), after receiving INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, The patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. (Patient stated that: Yes you can. The only time the patient got the flu was the year he/she got the shot). No laboratory data reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome was not reported for the event influenza. There will be no information on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This case involves a male patient who got sicker than a dog (illness), while he received vaccine INFLUENZA VACCINE. Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient got sicker than a dog (illness), (unknown latency) following the administration of INFLUENZA VACCINE. It was reported that first shot was sicker than a dog for over 2 weeks, next year he broke it down to 2 shots again sick 10 to 13 days. His doctor told him no more of any kind of vaccine. Next one could kill him! Laboratory data was not reported. It was not reported if the patient received any corrective treatment or not. The outcome of the event was unknown at the time of reporting. There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Illness
Clinical narrative: This case involves a patient (age and gender unspecified) who got sick while he/she received PNEUMOCOCCAL VACCINE and INFLUENZA VACCINE. Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE and suspect PNEUMOCOCCAL VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient who got sick (illness) (Unknown latency) following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE. Other relevant laboratory data was not reported. It was not reported if the patient received any corrective treatment. At the time of reporting, event outcome was not reported for illness. There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: This case involves patient (unknown demographics) who experienced both times got sicker (illness), while he/she received vaccine INFLUENZA VACCINE. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious both times got sicker (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was also reported that both times got sicker than they have ever been, not getting another one. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event was reported as unknown. There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick.; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced sick (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that it does make some sick. Can be the preservative or the person can be allergic to an ingredient or the person immune system could fight the vaccine. Happened to patient twice and patient had no reason to be concerned because no other vaccine does that.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication, Wound
Clinical narrative: Never had the flu. Took the shot once. Almost wound up in the hospital. Never again.; Initial information was received on 11-Oct-2020 regarding an unsolicited valid serious case from a consumer or non-healthcare professional.  This case involves an adult patient who almost wound up in the hospital(hospitalization), after the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an intramuscular route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient almost wound up in the hospital (hospitalization) (unknown latency) following the administration of INFLUENZA VACCINE..  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown.  Information on the batch number is requested.; Sender's Comments: This case involves an adult patient who experienced wound (unknown latency) after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: arm  hurts; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves female patient experienced arm hurts (pain in extremity), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date, the patient developed a non-serious arm hurts (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pain in extremity.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: My wife always gets sick when she gets a flu shot I do not.; Initial information was received on 11-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via social media.  This case involves a female patient (age unspecified) who got sick while he/she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient who got sick (illness) (Unknown latency) following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  The patient always gets sick when she gets a flu shot.  Other relevant laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was not reported for illness.   There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This case involves patient (age not reported) who got sick (illness), while he/she received vaccine INFLUENZA VACCINE. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. Laboratory details were not reported. It was not reported if the patient received a corrective treatment. The event outcome was unknown for illness. There will be no information available on the batch number for this case.
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a 11 year old had received a Menactra in 2016 and then another dose in 2017, no AE; Initial information received on 02-Mar-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 12 years old female patient who received first dose of  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] at 11 years old in 2016 and had received another dose in 2017 via unknown route in unknown administration site for prophylactic vaccination  (batch number and expiration date of first dose in 2016 were not reported; 2017's batch number :U5514AC expiration date12-Mar-2018) (extra dose administered). Also reported that now she was 16 year old, and should they give her the booster dose, since she got 2 doses earlier?   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was an actual medication error due to extra dose administered.  No specific AE (adverse event) was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: a dose of expired Ipol was given to a patient/No AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional. This case involves a patient (with unknown demographics) who received expired dose of IPV (VERO) [IPOL].  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 17-Mar-2021, the patient received a 0.5 mL dose of suspect IPV (VERO) lot number not reported, expiry date 13-Mar-2021 via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (Latency same day).  The facility reported the event to their compliance quality organization. The caller stated she does not have additional details, including lot, patient ID, or patient dob. She stated she is helping out, but not familiar with all aspects of these situations including AE reporting, because the nurse who handles these situations is currently out of the office. AE template was not completed due to the caller providing all the information that is currently available to her.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Immunodeficiency, Medication error
Clinical narrative: immunocompromised; expired ACT-HIB administered; Initial information regarding an unsolicited valid serious case was received from a other health professional via regulatory authority (Reference number- 00525503) and transmitted to Sanofi on 18-Mar-2021.  This case involves a 65 year old female patient who had immunocompromised (immunodeficiency), while she received vaccine HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ158AAA and expiry date 26-Nov-2020) via unknown route in right deltoid for prophylactic vaccination.  On an unknown date, the patient developed a serious immunocompromised (immunodeficiency) unknown latency following the administration of HIB (PRP/T) VACCINE. This event was assessed as medically significant.  It was also medication error case due to expired ACT-HIB administered (expired product administered) (latency same day).  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown for immunocompromised .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: This case concerns 65 year old female patient who had immunodeficiency after vaccination with ACT-HIB. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Intensive care
Clinical narrative: DEATH Narrative:  LIMITED INFORMATION PROVIDED IN MEDICAL RECORD OTHER THAN SON CALLED TO REPORT PATIENT HAD BEEN TRANSFERRED OUT OF ICU TO HOSPICE CARE ON 03/02/21. No documentation regarding hospital admission or ICU care. Son called on 3/3/21 to report patient passed away peacefully and without pain. No previous COVID infection, no recent hospitalizations known, no immediate acute reaction to COVID vaccine. Unlikely that vaccine contributed to death, as patient was on hospice with advanced age of 91 years.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Acute kidney injury, Asymptomatic bacteriuria, Azotaemia, Body temperature increased
Clinical narrative: loss of appetite, abdominal pain, weight loss, death Narrative: 02/12/21: GI VISIT-ASSESSMENT: 1-R/O Gastric or Cecal Cancer with Peritoneal Carcinomatosis is most the cause of his weight loss and early satiety. Liver and Pancreas on CT Scan unremarkable. 2- Weight loss and early satiety may be due to Gastric Mass with metastasis or Colon Mass. 02/17/21: ED VISIT AND ADMISSION w/ CC 4 weeks of poor appetite and 2 weeks of inability to hold down food and abdominal pain, decreased BM and decreased urination Assessment on admission: acute kidney insufficiency, Possible partial Gastric outlet obstruction 2/2 malignancy, GI malignancy with peritoneal carcinomatosis as per CT scan 2/11, asymptomatic bacteruria hyperkalemia and AKI during admission 02/21/21: pt signed out of hospital AMA due to 'personal problems' 02/22/21: pt returned to hospital for continuation of care and was readmitted with same c/o 02/24/21: pt tachycardic and hypotensive w/ altered mental status; rapid response team called, transferred to icu; impression: acute severe sepsis with uremia; during procedure to place nephrostomy tubes, pt goes into wide complex vtach then vfib and ACLS done w/ compressions, ROSC @ 2255 w/ BP 70-41, Norepi started; pt intubated 02/25/21: pt extubated 02/25/21@2106: pt with inferior lateral stemi 03/01/21: pt w/ sudden deterioration with decreased LOC and increased WOB., intubated, found to be profoundly hypoxemic, developed severe metabolic acidosis and hyperkalemia, severe refractory hypotension 03/02/21: pt unresponsive without pulse or respirations, NOK declined autopsy no prior covid infection noted, no immediate reaction after covid vaccine, pt was hospitalized leading up to death with unrelenting abdominal pain, AKI, metabolic abnormalities. It is unlikely that vaccine led to patient's death.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Change of bowel habit, Computerised tomogram abdomen abnormal, Computerised tomogram liver, Computerised tomogram normal, Computerised tomogram pancreas normal
Clinical narrative: loss of appetite, abdominal pain, weight loss, death Narrative: 02/12/21: GI VISIT-ASSESSMENT: 1-R/O Gastric or Cecal Cancer with Peritoneal Carcinomatosis is most the cause of his weight loss and early satiety. Liver and Pancreas on CT Scan unremarkable. 2- Weight loss and early satiety may be due to Gastric Mass with metastasis or Colon Mass. 02/17/21: ED VISIT AND ADMISSION w/ CC 4 weeks of poor appetite and 2 weeks of inability to hold down food and abdominal pain, decreased BM and decreased urination Assessment on admission: acute kidney insufficiency, Possible partial Gastric outlet obstruction 2/2 malignancy, GI malignancy with peritoneal carcinomatosis as per CT scan 2/11, asymptomatic bacteruria hyperkalemia and AKI during admission 02/21/21: pt signed out of hospital AMA due to 'personal problems' 02/22/21: pt returned to hospital for continuation of care and was readmitted with same c/o 02/24/21: pt tachycardic and hypotensive w/ altered mental status; rapid response team called, transferred to icu; impression: acute severe sepsis with uremia; during procedure to place nephrostomy tubes, pt goes into wide complex vtach then vfib and ACLS done w/ compressions, ROSC @ 2255 w/ BP 70-41, Norepi started; pt intubated 02/25/21: pt extubated 02/25/21@2106: pt with inferior lateral stemi 03/01/21: pt w/ sudden deterioration with decreased LOC and increased WOB., intubated, found to be profoundly hypoxemic, developed severe metabolic acidosis and hyperkalemia, severe refractory hypotension 03/02/21: pt unresponsive without pulse or respirations, NOK declined autopsy no prior covid infection noted, no immediate reaction after covid vaccine, pt was hospitalized leading up to death with unrelenting abdominal pain, AKI, metabolic abnormalities. It is unlikely that vaccine led to patient's death.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Decreased appetite, Depressed level of consciousness, Dyspnoea, Endotracheal intubation
Clinical narrative: loss of appetite, abdominal pain, weight loss, death Narrative: 02/12/21: GI VISIT-ASSESSMENT: 1-R/O Gastric or Cecal Cancer with Peritoneal Carcinomatosis is most the cause of his weight loss and early satiety. Liver and Pancreas on CT Scan unremarkable. 2- Weight loss and early satiety may be due to Gastric Mass with metastasis or Colon Mass. 02/17/21: ED VISIT AND ADMISSION w/ CC 4 weeks of poor appetite and 2 weeks of inability to hold down food and abdominal pain, decreased BM and decreased urination Assessment on admission: acute kidney insufficiency, Possible partial Gastric outlet obstruction 2/2 malignancy, GI malignancy with peritoneal carcinomatosis as per CT scan 2/11, asymptomatic bacteruria hyperkalemia and AKI during admission 02/21/21: pt signed out of hospital AMA due to 'personal problems' 02/22/21: pt returned to hospital for continuation of care and was readmitted with same c/o 02/24/21: pt tachycardic and hypotensive w/ altered mental status; rapid response team called, transferred to icu; impression: acute severe sepsis with uremia; during procedure to place nephrostomy tubes, pt goes into wide complex vtach then vfib and ACLS done w/ compressions, ROSC @ 2255 w/ BP 70-41, Norepi started; pt intubated 02/25/21: pt extubated 02/25/21@2106: pt with inferior lateral stemi 03/01/21: pt w/ sudden deterioration with decreased LOC and increased WOB., intubated, found to be profoundly hypoxemic, developed severe metabolic acidosis and hyperkalemia, severe refractory hypotension 03/02/21: pt unresponsive without pulse or respirations, NOK declined autopsy no prior covid infection noted, no immediate reaction after covid vaccine, pt was hospitalized leading up to death with unrelenting abdominal pain, AKI, metabolic abnormalities. It is unlikely that vaccine led to patient's death.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal carcinoma, Hydronephrosis, Hypotension, Hypoxia, Intensive care
Clinical narrative: loss of appetite, abdominal pain, weight loss, death Narrative: 02/12/21: GI VISIT-ASSESSMENT: 1-R/O Gastric or Cecal Cancer with Peritoneal Carcinomatosis is most the cause of his weight loss and early satiety. Liver and Pancreas on CT Scan unremarkable. 2- Weight loss and early satiety may be due to Gastric Mass with metastasis or Colon Mass. 02/17/21: ED VISIT AND ADMISSION w/ CC 4 weeks of poor appetite and 2 weeks of inability to hold down food and abdominal pain, decreased BM and decreased urination Assessment on admission: acute kidney insufficiency, Possible partial Gastric outlet obstruction 2/2 malignancy, GI malignancy with peritoneal carcinomatosis as per CT scan 2/11, asymptomatic bacteruria hyperkalemia and AKI during admission 02/21/21: pt signed out of hospital AMA due to 'personal problems' 02/22/21: pt returned to hospital for continuation of care and was readmitted with same c/o 02/24/21: pt tachycardic and hypotensive w/ altered mental status; rapid response team called, transferred to icu; impression: acute severe sepsis with uremia; during procedure to place nephrostomy tubes, pt goes into wide complex vtach then vfib and ACLS done w/ compressions, ROSC @ 2255 w/ BP 70-41, Norepi started; pt intubated 02/25/21: pt extubated 02/25/21@2106: pt with inferior lateral stemi 03/01/21: pt w/ sudden deterioration with decreased LOC and increased WOB., intubated, found to be profoundly hypoxemic, developed severe metabolic acidosis and hyperkalemia, severe refractory hypotension 03/02/21: pt unresponsive without pulse or respirations, NOK declined autopsy no prior covid infection noted, no immediate reaction after covid vaccine, pt was hospitalized leading up to death with unrelenting abdominal pain, AKI, metabolic abnormalities. It is unlikely that vaccine led to patient's death.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Mental status changes, Metabolic acidosis, Metastases to peritoneum, Myocardial infarction, Nephrostomy
Clinical narrative: loss of appetite, abdominal pain, weight loss, death Narrative: 02/12/21: GI VISIT-ASSESSMENT: 1-R/O Gastric or Cecal Cancer with Peritoneal Carcinomatosis is most the cause of his weight loss and early satiety. Liver and Pancreas on CT Scan unremarkable. 2- Weight loss and early satiety may be due to Gastric Mass with metastasis or Colon Mass. 02/17/21: ED VISIT AND ADMISSION w/ CC 4 weeks of poor appetite and 2 weeks of inability to hold down food and abdominal pain, decreased BM and decreased urination Assessment on admission: acute kidney insufficiency, Possible partial Gastric outlet obstruction 2/2 malignancy, GI malignancy with peritoneal carcinomatosis as per CT scan 2/11, asymptomatic bacteruria hyperkalemia and AKI during admission 02/21/21: pt signed out of hospital AMA due to 'personal problems' 02/22/21: pt returned to hospital for continuation of care and was readmitted with same c/o 02/24/21: pt tachycardic and hypotensive w/ altered mental status; rapid response team called, transferred to icu; impression: acute severe sepsis with uremia; during procedure to place nephrostomy tubes, pt goes into wide complex vtach then vfib and ACLS done w/ compressions, ROSC @ 2255 w/ BP 70-41, Norepi started; pt intubated 02/25/21: pt extubated 02/25/21@2106: pt with inferior lateral stemi 03/01/21: pt w/ sudden deterioration with decreased LOC and increased WOB., intubated, found to be profoundly hypoxemic, developed severe metabolic acidosis and hyperkalemia, severe refractory hypotension 03/02/21: pt unresponsive without pulse or respirations, NOK declined autopsy no prior covid infection noted, no immediate reaction after covid vaccine, pt was hospitalized leading up to death with unrelenting abdominal pain, AKI, metabolic abnormalities. It is unlikely that vaccine led to patient's death.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pulse absent, Pyelocaliectasis, Renal mass, Respiratory arrest, Resuscitation
Clinical narrative: loss of appetite, abdominal pain, weight loss, death Narrative: 02/12/21: GI VISIT-ASSESSMENT: 1-R/O Gastric or Cecal Cancer with Peritoneal Carcinomatosis is most the cause of his weight loss and early satiety. Liver and Pancreas on CT Scan unremarkable. 2- Weight loss and early satiety may be due to Gastric Mass with metastasis or Colon Mass. 02/17/21: ED VISIT AND ADMISSION w/ CC 4 weeks of poor appetite and 2 weeks of inability to hold down food and abdominal pain, decreased BM and decreased urination Assessment on admission: acute kidney insufficiency, Possible partial Gastric outlet obstruction 2/2 malignancy, GI malignancy with peritoneal carcinomatosis as per CT scan 2/11, asymptomatic bacteruria hyperkalemia and AKI during admission 02/21/21: pt signed out of hospital AMA due to 'personal problems' 02/22/21: pt returned to hospital for continuation of care and was readmitted with same c/o 02/24/21: pt tachycardic and hypotensive w/ altered mental status; rapid response team called, transferred to icu; impression: acute severe sepsis with uremia; during procedure to place nephrostomy tubes, pt goes into wide complex vtach then vfib and ACLS done w/ compressions, ROSC @ 2255 w/ BP 70-41, Norepi started; pt intubated 02/25/21: pt extubated 02/25/21@2106: pt with inferior lateral stemi 03/01/21: pt w/ sudden deterioration with decreased LOC and increased WOB., intubated, found to be profoundly hypoxemic, developed severe metabolic acidosis and hyperkalemia, severe refractory hypotension 03/02/21: pt unresponsive without pulse or respirations, NOK declined autopsy no prior covid infection noted, no immediate reaction after covid vaccine, pt was hospitalized leading up to death with unrelenting abdominal pain, AKI, metabolic abnormalities. It is unlikely that vaccine led to patient's death.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis, Tachycardia, Ultrasound kidney abnormal, Unresponsive to stimuli, Urine output decreased
Clinical narrative: loss of appetite, abdominal pain, weight loss, death Narrative: 02/12/21: GI VISIT-ASSESSMENT: 1-R/O Gastric or Cecal Cancer with Peritoneal Carcinomatosis is most the cause of his weight loss and early satiety. Liver and Pancreas on CT Scan unremarkable. 2- Weight loss and early satiety may be due to Gastric Mass with metastasis or Colon Mass. 02/17/21: ED VISIT AND ADMISSION w/ CC 4 weeks of poor appetite and 2 weeks of inability to hold down food and abdominal pain, decreased BM and decreased urination Assessment on admission: acute kidney insufficiency, Possible partial Gastric outlet obstruction 2/2 malignancy, GI malignancy with peritoneal carcinomatosis as per CT scan 2/11, asymptomatic bacteruria hyperkalemia and AKI during admission 02/21/21: pt signed out of hospital AMA due to 'personal problems' 02/22/21: pt returned to hospital for continuation of care and was readmitted with same c/o 02/24/21: pt tachycardic and hypotensive w/ altered mental status; rapid response team called, transferred to icu; impression: acute severe sepsis with uremia; during procedure to place nephrostomy tubes, pt goes into wide complex vtach then vfib and ACLS done w/ compressions, ROSC @ 2255 w/ BP 70-41, Norepi started; pt intubated 02/25/21: pt extubated 02/25/21@2106: pt with inferior lateral stemi 03/01/21: pt w/ sudden deterioration with decreased LOC and increased WOB., intubated, found to be profoundly hypoxemic, developed severe metabolic acidosis and hyperkalemia, severe refractory hypotension 03/02/21: pt unresponsive without pulse or respirations, NOK declined autopsy no prior covid infection noted, no immediate reaction after covid vaccine, pt was hospitalized leading up to death with unrelenting abdominal pain, AKI, metabolic abnormalities. It is unlikely that vaccine led to patient's death.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Ventricular fibrillation, Ventricular tachycardia, Weight decreased
Clinical narrative: loss of appetite, abdominal pain, weight loss, death Narrative: 02/12/21: GI VISIT-ASSESSMENT: 1-R/O Gastric or Cecal Cancer with Peritoneal Carcinomatosis is most the cause of his weight loss and early satiety. Liver and Pancreas on CT Scan unremarkable. 2- Weight loss and early satiety may be due to Gastric Mass with metastasis or Colon Mass. 02/17/21: ED VISIT AND ADMISSION w/ CC 4 weeks of poor appetite and 2 weeks of inability to hold down food and abdominal pain, decreased BM and decreased urination Assessment on admission: acute kidney insufficiency, Possible partial Gastric outlet obstruction 2/2 malignancy, GI malignancy with peritoneal carcinomatosis as per CT scan 2/11, asymptomatic bacteruria hyperkalemia and AKI during admission 02/21/21: pt signed out of hospital AMA due to 'personal problems' 02/22/21: pt returned to hospital for continuation of care and was readmitted with same c/o 02/24/21: pt tachycardic and hypotensive w/ altered mental status; rapid response team called, transferred to icu; impression: acute severe sepsis with uremia; during procedure to place nephrostomy tubes, pt goes into wide complex vtach then vfib and ACLS done w/ compressions, ROSC @ 2255 w/ BP 70-41, Norepi started; pt intubated 02/25/21: pt extubated 02/25/21@2106: pt with inferior lateral stemi 03/01/21: pt w/ sudden deterioration with decreased LOC and increased WOB., intubated, found to be profoundly hypoxemic, developed severe metabolic acidosis and hyperkalemia, severe refractory hypotension 03/02/21: pt unresponsive without pulse or respirations, NOK declined autopsy no prior covid infection noted, no immediate reaction after covid vaccine, pt was hospitalized leading up to death with unrelenting abdominal pain, AKI, metabolic abnormalities. It is unlikely that vaccine led to patient's death.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: cardia arrest Narrative:  76 yo with CAD, carotid artery stenosis, abdominal aortic aneurism, history of MI, DM. Patient was given both COVID vaccinations with the 2nd and most recent on 2/27. On 3/20, patient was admitted to an outside local emergency room with cardiac arrest and passed away at the facility. They were unsure if this had anything to do with his covid vaccinations but thought we should at least report it.