chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal, Oesophagogastroduodenoscopy, Peripheral swelling, Type 2 diabetes mellitus, Ultrasound Doppler normal
Clinical narrative: She had a stroke on April 1st, 2021 while at the Nurse's office, according to my mom & symptoms. She died on April 23rd as a result. Facility does not have a lot of equipment. She had tests done at another facility.   Mom had a stroke on April 1st, 2021. My sister and I recognized it as a stroke on the phone, just talking to my mom. The nurses & medical personnel at the facility did not acknowledge or seem to recognize that she had had a stroke. It took them all the next day to get her transported to the Hospital. The Hospital did say she had a stroke (see 1st page of medical report). We believe the vaccine & shot stroke may be related. The Facility may be trying to cover up something (esp. the stroke).  All day at Nurses office was admitted to hospital at facility later in the day.  They dragged her around all day until she had a stroke while there. Did not transport her until late on April 2nd.  Discharge Diagnosis:  Stroke Acute GI Bleeding Acute diastolic heart failure Aortic stenosis Arthritis, on chronic prednisone HTN DM2 Hyperlipidemia, unspecified Urinary tract infection  Surgical Procedures: ESOPHAGOGASTRODUODENOSCOPY EGD W/ peg tube 04/14/2021 14:21 placement  Hospital Course: Patient is an 83-year-old female with past medical history of prior ischemic stroke and cerebral aneurysm w/p coiling, as well as HTN and DM2, who presented from an outside facility due to new stroke.  The patient began feeling poorly several days prior to her admission to the outside hospital.  She became increasingly short of breath and developed lower extremity swelling.  She was evaluated in the ED and found to have an elevated BNP of 1700.  She was admitted and started on scheduled IV Lasix diuresis.  Around 8:45 PM the evening of transfer to our facility, the patient developed new slurred speech, difficulty swallowing, and left facial droop.  A CT of the head was done, and showed evidence of old stroke and prior aneurysm coiling but no acute abnormality. The case was discussed with MD of neurology and the patient was transferred to another facility for a higher level of care.  On arrival here, an MRI of the brain was done, and showed right frontal and left cerebellar infarcts.  MRA of the head was unremarkable.  2D echocardiogram showed a preserved LVEF of 75-80% without evidence of PFO of clot.  Carotid Doppler showed no significant stenosis.  The patient was evaluated by speech therapy, who recommended strict n.p.o. status due to her high risk of aspiration.  She ultimately required placement of a PEG tube on 04/14/2021.  Her ischemic stroke was otherwise managed with Plavix and a statin.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: She had a stroke on April 1st, 2021 while at the Nurse's office, according to my mom & symptoms. She died on April 23rd as a result. Facility does not have a lot of equipment. She had tests done at another facility.   Mom had a stroke on April 1st, 2021. My sister and I recognized it as a stroke on the phone, just talking to my mom. The nurses & medical personnel at the facility did not acknowledge or seem to recognize that she had had a stroke. It took them all the next day to get her transported to the Hospital. The Hospital did say she had a stroke (see 1st page of medical report). We believe the vaccine & shot stroke may be related. The Facility may be trying to cover up something (esp. the stroke).  All day at Nurses office was admitted to hospital at facility later in the day.  They dragged her around all day until she had a stroke while there. Did not transport her until late on April 2nd.  Discharge Diagnosis:  Stroke Acute GI Bleeding Acute diastolic heart failure Aortic stenosis Arthritis, on chronic prednisone HTN DM2 Hyperlipidemia, unspecified Urinary tract infection  Surgical Procedures: ESOPHAGOGASTRODUODENOSCOPY EGD W/ peg tube 04/14/2021 14:21 placement  Hospital Course: Patient is an 83-year-old female with past medical history of prior ischemic stroke and cerebral aneurysm w/p coiling, as well as HTN and DM2, who presented from an outside facility due to new stroke.  The patient began feeling poorly several days prior to her admission to the outside hospital.  She became increasingly short of breath and developed lower extremity swelling.  She was evaluated in the ED and found to have an elevated BNP of 1700.  She was admitted and started on scheduled IV Lasix diuresis.  Around 8:45 PM the evening of transfer to our facility, the patient developed new slurred speech, difficulty swallowing, and left facial droop.  A CT of the head was done, and showed evidence of old stroke and prior aneurysm coiling but no acute abnormality. The case was discussed with MD of neurology and the patient was transferred to another facility for a higher level of care.  On arrival here, an MRI of the brain was done, and showed right frontal and left cerebellar infarcts.  MRA of the head was unremarkable.  2D echocardiogram showed a preserved LVEF of 75-80% without evidence of PFO of clot.  Carotid Doppler showed no significant stenosis.  The patient was evaluated by speech therapy, who recommended strict n.p.o. status due to her high risk of aspiration.  She ultimately required placement of a PEG tube on 04/14/2021.  Her ischemic stroke was otherwise managed with Plavix and a statin.
Sex: F
Vaccine: UNK
Symptoms: Tenderness
Clinical narrative: Arm tenderness
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: upset stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "upset stomach".  Additional information: The patient wanted to know if she can take aspirin or alka-seltzer for her upset stomach.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: blood pressure being too high; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 88 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Mar2021 12:15 (Batch/Lot number: unknown) at the age of 88 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dementia" (unspecified if ongoing); "bad heart" (ongoing); "Cholesterol" (ongoing); "Stent placement" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: HYPERTENSION (non-serious) with onset 2021, outcome "unknown", described as "blood pressure being too high". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypertension.  Additional Information: The patient's wife called on behalf of her husband (patient). The patient had no family medical history relevant to adverse event. The caller stated patient takes many medications and declined to go through them all. Caller did state his heart was bad and that patient reported to be taking blood thinners for his heart and something for cholesterol. The lot number was reported as E (either a slant or a 1) 4698. It was reported that the patient had undergone heart surgery and scheduled to have the 2nd dose of the PFIZER-BIONTECH COVID-19 VACCINE tomorrow 26Mar2021. Caller stated that yesterday her husband had heart surgery and she was wondering if it was ok for him to get the second vaccine tomorrow. The caller also stated that patient was currently (at the time of this report) in hospital right now due to heart surgery, but it was not related to an adverse event. Caller stated this was due to a previous history of heart trouble. At this time, he had a stent put in, he was 80 percent blocked. Caller stated they were having trouble with his blood pressure being too high. He took medicine for that. Caller stated this was his 11th stent and patient should come home today if there were not things floating around in his blood. Asked if he could get the 2nd dose even after surgery. Investigation assessment was reported as no. The event did not result in emergency room or physician office visit. The patient did not receive prior vaccinations (within 4 weeks). Relevant tests included dementia.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: EN6198) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "mild hypothyroid", start date: 2016 (unspecified if ongoing), notes: Verbatim: mild hypothyroid; "IBS" (unspecified if ongoing), notes: The caller has had issues with IBS for a couple of years but was not dealing with it at the time she got the vaccine. The patient's concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 2021, outcome "recovering", described as "Diarrhea".  Additional information: The caller is calling about the Pfizer covid 19 vaccine. The caller wants to report that she had diarrhea afterwards, she had the diarrhea for 2-3 weeks. Event was started a couple days after the first dose of the vaccine. The caller is scared to get the second dose of the vaccine. The caller has had issues with IBS for a couple of years but was not dealing with it at the time she got the vaccine. The caller read there was PEG in the vaccine and didn't if that was related. The caller wants to know if anyone else has experienced this? The caller mentions that she knows other people who have experienced diarrhea after the vaccine too. Information about lot/ batch number has been requested.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Acquired factor V deficiency, Pulmonary thrombosis, Thrombosis
Clinical narrative: had a blood clot in the leg and in both his lungs; had a blood clot in the leg and in both his lungs; genetic disorder called Factor 5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY THROMBOSIS (medically significant), THROMBOSIS (medically significant), outcome "unknown" and all described as "had a blood clot in the leg and in both his lungs"; ACQUIRED FACTOR V DEFICIENCY (non-serious), outcome "unknown", described as "genetic disorder called Factor 5". Therapeutic measures were taken as a result of pulmonary thrombosis, thrombosis. The patient was now on blood thinners, takes Xarelto 20 mg once a day. The patient did not have a history of blood clots so his hematologist stated it was possible the vaccine can contribute to the blood clots. The patient was scheduled tomorrow evening for the booster dose and he was nervous about it. The patient's hematologist and family doctor stated there was a potential risk of blood clots if he gets Covid-19 and there was potential risk if he takes the vaccine. The patient wanted to know if there has been any reports of blood clots or if there were any issues with blood clots after receiving the vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Severe migraine for 8 days after.. and now having migraines periodically not associated with anything else.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101798301.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 (Lot number: ff2588) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1 Batch/Lot No: ew0185 Location of, injection: Arm Left, prev dose administration date=16May2021), administration date: 16May2021, when the patient was 43 years old, for Covid-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 25Sep2021 20:00, outcome "unknown", described as "shingles". The event "shingles" was evaluated at the physician office visit. Therapeutic measures were taken as a result of herpes zoster.  Follow-up (14Dec2021): This is a spontaneous follow-up report from same contactable female consumer This 44-year-old consumer(patient) reported for herself that Additional information regarding batch/LOT number was updated along with physician office visit.:  Follow-up(15Dec2021): This is a spontaneous follow-up report from a contactable Consumer. This female consumer(patient) reported  that: Updated Information: Pregnant field, Age at vaccination, Historical vaccination, Relevant medical history, Dose description, Lot number, Anatomical location, Event onset date, treatment received. .  Follow-Up (29DEC2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101797782 same reporter drug AE, different patient;US-PFIZER INC-202101797783 same reporter drug AE, different patient
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Cough
Clinical narrative: Coughing started that same evening - continued for about a month, then contacted doctor - ordered chest xray which showed air pockets which were not present in comparison xray from previous year. Prescribed inhaler with steroids. Finally stopped coughing about 2-3 months after first shot.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Drug intolerance, Fear, Feeling abnormal, Laboratory test
Clinical narrative: Body doesn't seem to process it very well; I had a speedy feeling like in terms of dose but it sent me to the emergency room 2 times; I will be sitting around and I get that speedy feeling; feels like it's hopping up my immune system.; I am not really okay when it gets real intense it scares me.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 58-year-old male patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Lot number: EN6206) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing), notes: Verbatim: Cancer. Concomitant medication(s) included: XARELTO; ESOMEPRAZOLE; SPIRIVA. The following information was reported: DRUG INTOLERANCE (non-serious), outcome "unknown", described as "Body doesn't seem to process it very well"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I had a speedy feeling like in terms of dose but it sent me to the emergency room 2 times; I will be sitting around and I get that speedy feeling; feels like it's hopping up my immune system."; FEAR (non-serious), outcome "unknown", described as "I am not really okay when it gets real intense it scares me.". The events "body doesn't seem to process it very well", "i had a speedy feeling like in terms of dose but it sent me to the emergency room 2 times; i will be sitting around and i get that speedy feeling; feels like it's hopping up my immune system." and "i am not really okay when it gets real intense it scares me." were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of drug intolerance, feeling abnormal, fear.  Additional information: treatment Consumer stated, "I am not sure but I am a cancer patient and I am on an immune therapy and I have done doses of Opdivo 'in blood like Opdivo is main', it's immune therapy treatment." The patient stated that the I just wish to know what was going on with the speedy feeling and I will be sitting around, and I get that speedy feeling, feels like it's 'hopping' up my immune system. Main thing I am worried about is how long does it take to the shot to get out of your system so the symptoms will go away."  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Pneumonia, Sepsis, Unresponsive to stimuli
Clinical narrative: Narrative; Per family report, patient died at hospital on 11/18/21. Discovered unresponsive in home on 11/16. Found to be septic secondary to pneumonia with possible stroke. "Not entirely certain of cause of death." Family wanted to draw attention to recent receipt of COVID-19 booster (11/13) in close proximity to this event. As event occurred at hospital, limited records available for review. COVID-19 vaccine dated: 1/30/21, 3/1/21, 11/13/321 (booster)
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Muscle disorder, Vaccination site pain
Clinical narrative: has been stretching the muscle; he got the booster vaccine; sore arm at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Nov2021 (Lot number: 30135BA) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "borderline diabetic" (unspecified if ongoing), notes: Verbatim: borderline diabetic. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot no. EN6206), administration date: 16Mar2021, when the patient was 60 years old, for Covid-19 Immunization; Bnt162b2 (Dose: 2, Lot no. FP7533), administration date: 07Apr2021, when the patient was 60 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "he got the booster vaccine"; VACCINATION SITE PAIN (non-serious) with onset 30Nov2021, outcome "not recovered", described as "sore arm at injection site"; MUSCLE DISORDER (non-serious), outcome "unknown", described as "has been stretching the muscle". Therapeutic measures were taken as a result of vaccination site pain.  Additional Information: Treated it with tylenol, iced it and has been stretching the muscle. Conditions: diagnosed about 40 years ago.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicectomy, Appendicitis, Computerised tomogram, Laparoscopic surgery
Clinical narrative: Appendicitis resulting in appendectomy.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Migraine, Tinnitus
Clinical narrative: severe ringing in the ears (level 7 on a scale of 1-10) followed by a severe headache; severe ringing in the ears (level 7 on a scale of 1-10) followed by a severe headache; 4 migraine headaches (of the optic nerve, on the same day and several days later); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 (Lot number: EN6203) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "enlarged prostate" (unspecified if ongoing); "Drug allergy" (unspecified if ongoing), notes: To codeine; "Heartbeats irregular" (unspecified if ongoing), notes: Rapid; "migraine headache" (unspecified if ongoing), notes: spaced at least 6 months apart. Concomitant medication(s) included: SIMVASTATIN; BUSPAR; METOPROLOL. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot  ER8732, in arm left, at 03:45 AM), administration date: 09Mar2021, when the patient was 76 years old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 31Oct2021 04:00, outcome "not recovered", HEADACHE (non-serious) with onset 31Oct2021, outcome "not recovered" and all described as "severe ringing in the ears (level 7 on a scale of 1-10) followed by a severe headache"; MIGRAINE (non-serious) with onset 31Oct2021, outcome "not recovered", described as "4 migraine headaches (of the optic nerve, on the same day and several days later)". The events "severe ringing in the ears (level 7 on a scale of 1-10) followed by a severe headache", "severe ringing in the ears (level 7 on a scale of 1-10) followed by a severe headache" and "4 migraine headaches (of the optic nerve, on the same day and several days later)" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of tinnitus, headache, migraine. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID-19 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: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site scab
Clinical narrative: soreness at the injection site; at the injection site / a little red; itching at the injection site; she scratched the scab off where they gave her the shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 84 year-old female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Lot number: EN6202) at the age of 84 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 06Mar2021, outcome "recovering", described as "itching at the injection site"; VACCINATION SITE PAIN (non-serious) with onset 07Mar2021, outcome "recovering", described as "soreness at the injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 07Mar2021, outcome "unknown", described as "at the injection site / a little red"; VACCINATION SITE SCAB (non-serious) with onset Mar2021, outcome "unknown", described as "she scratched the scab off where they gave her the shot".  Additional information: It was further reported that patient has been fine until Saturday (06Mar2021) then late at night, she started itching on the injection site itself. Patient thought she reached up and scratched during the night. Patient woke up on Sunday morning (07Mar2021) and notice the soreness at the injection site and she has been scratching it so it was a little red. When she went in the bathroom, she noticed that she scratched the scab off on where they gave the shot. It was reported that itching on the injection site was not as bad as it was and was ongoing but improved. The soreness at the injection site is ongoing but better than it was.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medications was not provided. On15-DEC-2021, the patient was vaccinated with an expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL injection, (lot #R017624, which was considered to be valid, expiration date: 17-MAR-2021), administered for prophylaxis (vaccination scheme frequency, anatomical location and route of administration were not provided) (expired vaccine administered). The reporter stated the vaccine did not experience any temperature excursion. No additional adverse event was reported.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous potential legal report received from a patient concerned a patient of unspecified age and sex. Initial information was processed along with the additional information received from a regulatory authority on 30-DEC-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose, start therapy date were not reported, administered 1 in total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was reported that on an unspecified dates, the patient caught covid twice(coded as suspected covid-19 infection and suspected clinical vaccination failure) and reporter also stated that "If anyone is doing a class action lawsuit against these clowns, hit me up. I want in". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000209391. The suspected product quality complaint has been confirmed to be voided(did not meet RA criteria) (as reported complaint was covid with no symptoms and test performed therefore did not meet RA criteria, hence was confirmed as voided) based on the RA evaluation/investigation performed.; Sender's Comments: V0: 20211263430 -Covid-19 vaccine ad26.cov2.s-Suspected clinical Vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 1) (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-MAY-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 28-DEC-2021, the patient experienced feeling tired, had headaches, fever, stuffy nose, chills, body aches, nasal congestion and cough (suspected covid-19 infection). On 30-DEC-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) positive (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case is associated to regulatory authority.; Sender's Comments: V0- 20211266010-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Irregular menstrual cycle.; period extremely heavy; bad cramping; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 10:00 (Lot number: Fd8448) at the age of 34 years as dose 2,single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZOLOFT; ORTHO-TRI-CYCLEN LO. Vaccination history included: Bnt162b2 (Dose: 1, Lot: Ew0176,, Time: 10:00 AM, vaccine location=Left arm), administration date: 28Jul2021, when the patient was 34 years old, for COVID-19 Immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 03Sep2021, outcome "recovering", described as "Irregular menstrual cycle."; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 03Sep2021, outcome "recovering", described as "period extremely heavy"; DYSMENORRHOEA (non-serious) with onset 03Sep2021, outcome "recovering", described as "bad cramping". Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding, dysmenorrhoea.  Additional Information: Irregular menstrual cycle, which is very unusual for me, especially considering I am on birth control. Began period almost two weeks early, and period extremely heavy with bad cramping. Hospitalization Prolonged was reported as no. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.Device Date : 04Sep2021  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Oligomenorrhoea, SARS-CoV-2 test negative
Clinical narrative: Breakthrough and heavy periods; longer period length; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 09:00 (Lot number: EP6955) as dose 1, single and administered in arm left, administration date 19Apr2021 10:00 (Lot number: ER8731) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALDACTONE [SPIRONOLACTONE]. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 07Jun2021, outcome "not recovered", described as "Breakthrough and heavy periods"; OLIGOMENORRHOEA (non-serious) with onset 07Jun2021, outcome "unknown", described as "longer period length". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No, prior to vaccination, was the patient diagnosed with COVID-19. Device Date: 27Sep2021.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Pain
Clinical narrative: tired; Patient reports feeling achy; chills; third dose of the COVID-19 vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 23Sep2021 (Batch/Lot number: unknown) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBRANCE, start date: 23Jul2021. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "tired"; PAIN (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "Patient reports feeling achy"; CHILLS (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "chills".  Additional information: Patient reports feeling achy, tired, and chills yesterday, likely due to the third dose of the COVID-19 vaccine administered 23Sep. Patient states he has no side effects today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Lymphadenopathy, Rhinorrhoea, Vaccination site pain
Clinical narrative: Now Lymph node swelling in armpit closest to jab site; Exhaustion; nose running; Sore arm at jab site/jab soreness; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 17Nov2021 (Lot number: FJ1620) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "gestational diabetes pre diabetes", start date: 2004 (ongoing), notes: Under control; "Haemophilia- A" (ongoing), notes: from Birth, Under control; "Pre-diabetes" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol increased, start date: 2021 (ongoing). Vaccination history included: Bnt162b2 (1st Dose, Anatomical site of injection: R upper arm, Route of administration: Intramuscular, batch/ Lot number: EW0150, 31Jul2021), administration date: 02Apr2021, when the patient was 55 years old, for Covid-19 Immunization; Bnt162b2 (2nd Dose, Anatomical site of injection: R upper arm, Route of administration: Intramuscular, batch/ Lot number: EW0176, 31Aug2021), administration date: 23Apr2021, when the patient was 55 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021 21:00, outcome "recovered" (19Nov2021), described as "Sore arm at jab site/jab soreness"; FATIGUE (non-serious) with onset 18Nov2021 08:00, outcome "recovered" (30Nov2021), described as "Exhaustion"; RHINORRHOEA (non-serious) with onset 18Nov2021 08:00, outcome "recovered" (21Nov2021), described as "nose running"; LYMPHADENOPATHY (non-serious) with onset 18Nov2021 10:00, outcome "recovered" (21Nov2021), described as "Now Lymph node swelling in armpit closest to jab site". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, rhinorrhoea, lymphadenopathy.  Additional Information: Prior Vaccinations (within 4 weeks): None, Specific relevant tests for thromboembolic events with thrombocytopenia :None. Vaccination Facility Type was PHARMACY, Vaccine was not Administered at Facility. Route of Simvastatin: By Mouth and taken in early 2021. Event: Sore arm at jab site. Exhaustion and nose running began approximately 20 hrs later. Description of Event: Part 2 - yesterday I submitted exhaustion and jab soreness. Now Lymph node swelling in armpit closest to jab site.  Follow-up attempts are completed and no further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Biopsy skin, Drug eruption, Rash
Clinical narrative: my torso was covered with a rash/rash spreadof over my entire body/she developed widespread, sevre erythrodermic skin eruption; She had skin biopsy conforming lichenoid drug eruption; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Apr2021 13:00 (Lot number: ER8731) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety /Depression", start date: 2009 (ongoing); "Anxiety /Depression", start date: 2009 (ongoing); "Hysterectomy", start date: 2011 (unspecified if ongoing), notes: Pertinent details: Hysterectomy. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, single, Time:01:00 PM, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: ER2613), administration date: 24Mar2021, for COVID-19 Immunization. The following information was reported: RASH (medically significant) with onset Apr2021, outcome "recovered" (2021), described as "my torso was covered with a rash/rash spreadof over my entire body/she developed widespread, sevre erythrodermic skin eruption"; DRUG ERUPTION (non-serious) with onset 2021, outcome "unknown", described as "She had skin biopsy conforming lichenoid drug eruption". The event "my torso was covered with a rash/rash spreadof over my entire body/she developed widespread, sevre erythrodermic skin eruption" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: biopsy: (2021) having a reaction to a medication, notes: A biopsy was taken from my skin is and it was determined I was having a reaction to a medication; biopsy skin: (23Sep2021) lichenoid dermatitis, notes: Lichenoid Dermatitis, compatible with lichenoid drug eruption. Therapeutic measures were taken as a result of rash.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: pyrexia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 71 year-old male patient received bnt162b2 (COMIRNATY), administration date Jan2021 (Batch/Lot number: unknown) at the age of 71 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "pyrexia".  Additional information: the patient didn't get any pain after the first dose. It was only after the second dose. Caller doesn't recall patient having any severe reactions with either dose. Patient had some pyrexia, the usual things that a person gets after the first and second dose. Patient was not really sick. Thinks patient got chills and fever and it went away. Nothing that caller would think was unusual. Attempted to clarify dates regarding fever, pyrexia, and chills. Caller doesn't know when this occurred or after which dose. Caller just remembers patient saying he was going to bed because he was cold. Attempted to clarify dates of Comirnaty vaccines: Caller had her first dose in Dec2020 and second dose in Jan2021. She thinks the patient had his first dose in middle of Jan2021 and second dose in Feb2021. Caller does not have patient's record card to provide any information about patient's Comirnaty vaccines. Indication: Both caller and the patient are in the medical field. They both see patients. Patient still walks around like he was a man from Mars. A couple months later, caller has not seen patient put the Volatren on. States it's regular. Patient mentioned recently that he should see someone about the pain, which was unlike him. Caller thinks the pain must be bothering the patient significantly. Caller doesn't know if patient was having pain or if patient was frustrated. Caller decided on her own to call and report this to Pfizer. Patient had the booster dose just recently. Doesn't believe patient's pain has gotten any worse since the booster shot, but she hasn't actually asked the patient that.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: the site of injection started to hurt; felt exhausted the rest of the day; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 40 years as dose 3(booster), single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: ANTACID [ALUMINIUM HYDROXIDE GEL;MAGNESIUM HYDROXIDE;SIMETICONE]. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 IMMUNIZATION; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Nov2021, outcome "unknown", described as "the site of injection started to hurt"; FATIGUE (non-serious) with onset 22Nov2021, outcome "unknown", described as "felt exhausted the rest of the day"; HEADACHE (non-serious) with onset 22Nov2021, outcome "unknown", described as "headache".  Additional Information: Concomitant therapy included vitamins.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: threw up; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 8 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset Nov2021, outcome "unknown", described as "threw up"; ILLNESS (non-serious) with onset Nov2021, outcome "unknown", described as "sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: adult male early 30s. complained of stomach issues on night of 11/26-11/27 believed to due to diet earlier 11/26.Probably vaccinated, but unsure which one and when.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset Nov2021, outcome "unknown", described as "adult male early 30s. complained of stomach issues on night of 11/26-11/27 believed to due to diet earlier 11/26.Probably vaccinated, but unsure which one and when.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: high blood pressure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure". The patient underwent the following laboratory tests and procedures: blood pressure measurement: high.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Palpitations, SARS-CoV-2 test
Clinical narrative: Rapid heartbeat; severe heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jul2021 (Batch/Lot number: unknown) at the age of 13 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 26Jun2021, when the patient was 13 years old, for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 11Aug2021, outcome "recovering", described as "Rapid heartbeat"; PALPITATIONS (non-serious) with onset 11Aug2021, outcome "recovering", described as "severe heart palpitations". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, palpitations.  Follow-up (30Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up activities closed. No further information is expected.