chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Diarrhoea, Loss of consciousness, Malaise, Nausea
Clinical narrative: I received the Pfizer Bivalent COVID-19 booster on 10/18/2022. On 12/4/2022, I began sneezing; aside from the sneezing, I felt fine, though. I went to a family holiday celebration that day. I didn't think that sneezing was a symptom of COVID-19, so I didn't test myself that day. I also didn't sneeze that often. I probably sneezed twice while I was at the celebration and maybe three times at home, so it's as if the sneezing was constant. On 12/5/2022, I still had sneezing. I had some home antigen tests, so I took one, and the result was positive. I notified the other celebrants I had seen the day before, and ultimately, none of them ever tested positive for COVID-19. I contacted my doctor on 12/5/2022, and I was prescribed PAXLOVID. I began taking it that day. After I started the PAXLOVID, I actually felt sicker, but I think it was due to the medication rather than the virus. I had nausea, vomiting, and diarrhea, plus I also passed out on one occasion. I attribute those symptoms to the medication rather than COVID-19, though, because those symptoms didn't develop until after I started the medication. The worst day was 12/7/2022, and by the time 12/9/2022 rolled around, I felt like I was recovering. At the time of this writing, I feel that I have completely recovered and have no residual symptoms.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sneezing, Vomiting
Clinical narrative: I received the Pfizer Bivalent COVID-19 booster on 10/18/2022. On 12/4/2022, I began sneezing; aside from the sneezing, I felt fine, though. I went to a family holiday celebration that day. I didn't think that sneezing was a symptom of COVID-19, so I didn't test myself that day. I also didn't sneeze that often. I probably sneezed twice while I was at the celebration and maybe three times at home, so it's as if the sneezing was constant. On 12/5/2022, I still had sneezing. I had some home antigen tests, so I took one, and the result was positive. I notified the other celebrants I had seen the day before, and ultimately, none of them ever tested positive for COVID-19. I contacted my doctor on 12/5/2022, and I was prescribed PAXLOVID. I began taking it that day. After I started the PAXLOVID, I actually felt sicker, but I think it was due to the medication rather than the virus. I had nausea, vomiting, and diarrhea, plus I also passed out on one occasion. I attribute those symptoms to the medication rather than COVID-19, though, because those symptoms didn't develop until after I started the medication. The worst day was 12/7/2022, and by the time 12/9/2022 rolled around, I felt like I was recovering. At the time of this writing, I feel that I have completely recovered and have no residual symptoms.
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Paraesthesia, Seizure
Clinical narrative: Pt reported having mild tingling in left hand a few minutes after injection; while waiting in the pharmacy area, patient ended up having a seizure
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fatigue, Headache, Injection site reaction, Limb discomfort, Loss of personal independence in daily activities
Clinical narrative: The MenQuadfi vaccine was administered into the right arm on Dec. 20, 2022 without aspiration and the needle hit a capillary.  A subcutaneous hematoma formed afterwards at the injection site. My daughter got up at 5:30 AM on Dec. 23, 2022 with the following symptoms - heavy arms and heavy legs, shaking and a fever of 100.9 F.  Then she developed a headache and her body temperature reached 101.5 F.  She stayed in bed (skipped a school day) the whole day and was treated with motrin.  She still had a headache on Dec. 24, 2022, felt tired and looked pale. The fever ended by Sunday, December 25, 2022.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pallor, Pyrexia, Subcutaneous haematoma, Tremor
Clinical narrative: The MenQuadfi vaccine was administered into the right arm on Dec. 20, 2022 without aspiration and the needle hit a capillary.  A subcutaneous hematoma formed afterwards at the injection site. My daughter got up at 5:30 AM on Dec. 23, 2022 with the following symptoms - heavy arms and heavy legs, shaking and a fever of 100.9 F.  Then she developed a headache and her body temperature reached 101.5 F.  She stayed in bed (skipped a school day) the whole day and was treated with motrin.  She still had a headache on Dec. 24, 2022, felt tired and looked pale. The fever ended by Sunday, December 25, 2022.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left arm 2 inches below injection site to the elbow  became red and swollen, warm to touch and itchy . Started swelling with redness a few hours after injection and continued to swell and expand in redness the next day
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient was given a 2 pediatric doses of the peds moderna monovalent -0.5ml, instead of the adult moderna bivalent-0.5ml.
Age: 27.0
Sex: M
Vaccine: COVID19-2
Symptoms: Alanine aminotransferase increased, Amnesia, Aphasia, Aspartate aminotransferase increased, Back pain
Clinical narrative: First noticed events approximately 1 month and 1 week after vaccination, on 12/28/22.  Symptoms were severe leg and back pain, altered mental status, inability to speak normally or think of normal thoughts/common everyday things/answer basic questions. Was unable to recall anything at all from the days 12/28/22 through 12/30/22, and for 12/31/22 through 1/1/23 was only able to recall that I was laying in bed all day due to extreme leg and back pain. Unable to recall doing anything else.
Age: 27.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood creatine phosphokinase increased, Blood creatinine normal, Blood urea increased, Cerebral haemorrhage, Computerised tomogram head abnormal
Clinical narrative: First noticed events approximately 1 month and 1 week after vaccination, on 12/28/22.  Symptoms were severe leg and back pain, altered mental status, inability to speak normally or think of normal thoughts/common everyday things/answer basic questions. Was unable to recall anything at all from the days 12/28/22 through 12/30/22, and for 12/31/22 through 1/1/23 was only able to recall that I was laying in bed all day due to extreme leg and back pain. Unable to recall doing anything else.
Age: 27.0
Sex: M
Vaccine: COVID19-2
Symptoms: Loss of personal independence in daily activities, Mental status changes, Myoglobin blood increased, Neutrophil count increased, Pain in extremity
Clinical narrative: First noticed events approximately 1 month and 1 week after vaccination, on 12/28/22.  Symptoms were severe leg and back pain, altered mental status, inability to speak normally or think of normal thoughts/common everyday things/answer basic questions. Was unable to recall anything at all from the days 12/28/22 through 12/30/22, and for 12/31/22 through 1/1/23 was only able to recall that I was laying in bed all day due to extreme leg and back pain. Unable to recall doing anything else.
Age: 27.0
Sex: M
Vaccine: COVID19-2
Symptoms: Thinking abnormal, White blood cell count increased
Clinical narrative: First noticed events approximately 1 month and 1 week after vaccination, on 12/28/22.  Symptoms were severe leg and back pain, altered mental status, inability to speak normally or think of normal thoughts/common everyday things/answer basic questions. Was unable to recall anything at all from the days 12/28/22 through 12/30/22, and for 12/31/22 through 1/1/23 was only able to recall that I was laying in bed all day due to extreme leg and back pain. Unable to recall doing anything else.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine given prior to return date (too early)
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Pt began to experience pain in arm soon after administration of Prevnar-20 vaccine.Pain radiated from shoulder down to hand.Pt states she could not lift arm for three days after. As of 1/18/23 pt still has some pain in arm although it has lessened in severity.
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccinator Administered a bivalent booster out of sequence to a patient
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary, Bell's palsy, Biopsy skin abnormal, Chest X-ray, Dizziness
Clinical narrative: 1/16/22 mid morning had left side facial numbness and paralysis came accompanied with dizziness and decreased sensation to left arm and upper leg to Er in the evening and diagnosed with bells palsy treated with antiviral, steroids, and antibiotic follow up with  primary.   9/22/22 er visit for decreased numbness and tingling to bilateral upper and lower extremities and facial numbness
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Hypoaesthesia, Laboratory test, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: 1/16/22 mid morning had left side facial numbness and paralysis came accompanied with dizziness and decreased sensation to left arm and upper leg to Er in the evening and diagnosed with bells palsy treated with antiviral, steroids, and antibiotic follow up with  primary.   9/22/22 er visit for decreased numbness and tingling to bilateral upper and lower extremities and facial numbness
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Paralysis, Small fibre neuropathy
Clinical narrative: 1/16/22 mid morning had left side facial numbness and paralysis came accompanied with dizziness and decreased sensation to left arm and upper leg to Er in the evening and diagnosed with bells palsy treated with antiviral, steroids, and antibiotic follow up with  primary.   9/22/22 er visit for decreased numbness and tingling to bilateral upper and lower extremities and facial numbness
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Diarrhoea haemorrhagic, Pain
Clinical narrative: About 24 hours after dose, I started having lower abdominal cramps, then fever, vomiting followed by painful diarrhea for two days. Day 3 vomiting and fever stopped by diarrhea continued. The diarrhea on the 3rd day had blood in it.  From Day 1, severe chills.  Day 4 bleeding stopped, diarrhea slowed enough where I could leave the floor of the bathroom where I was laying and go to bed for periods of time.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: About 24 hours after dose, I started having lower abdominal cramps, then fever, vomiting followed by painful diarrhea for two days. Day 3 vomiting and fever stopped by diarrhea continued. The diarrhea on the 3rd day had blood in it.  From Day 1, severe chills.  Day 4 bleeding stopped, diarrhea slowed enough where I could leave the floor of the bathroom where I was laying and go to bed for periods of time.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Laboratory test
Clinical narrative: PT HAD  A STROKE
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dysarthria, Facial paralysis, Feeling abnormal, Hypoaesthesia
Clinical narrative: Patient came to the pharmacy about 6pm stating that he felt a little funny after his vaccination and that his right side felt numb.  He was slurring his words and the right side of his face appeared to be drooping.  I suggested we call an ambulance but he refused.  The manager took him to call his wife to go to the emergency room.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Barium double contrast, Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Vomiting started about 24 hours after vaccination, found to have intussusception diagnosed 24 hours after that.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The patient got an expired vaccine possibly, we are still following up with cdc and pfizer
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Lipoma, Oesophageal disorder, Pancreatic disorder, Ultrasound abdomen
Clinical narrative: Extreme vomiting and diarrhea in 5/21 causing pancreatic damage and esophagus.   Appearance of lipomas on triceps arms legs etc.   Now tiny lipomas everywhere.  Had nothing of the sort before.   Nurse practitioners and some docs think it could be worth looking into but not sure how busy you may be with your caseload to make any effective analysis or contact/research/recourse.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Extreme vomiting and diarrhea in 5/21 causing pancreatic damage and esophagus.   Appearance of lipomas on triceps arms legs etc.   Now tiny lipomas everywhere.  Had nothing of the sort before.   Nurse practitioners and some docs think it could be worth looking into but not sure how busy you may be with your caseload to make any effective analysis or contact/research/recourse.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angioedema, Mechanical urticaria, Urticaria
Clinical narrative: Urticaria starting on 1/1/23 on neck. Progressed to scalp, face, and throughout body. Angioedema of face on 1/3/23. Responded partially to increased antihistamines (twice a day Zyrtec and famotidine). Started prednisone taper 1/4/23.  Symptoms improved, but returned after steroids complete. Now experiencing dermatographia approximately 10-12 hours after last antihistamine dose.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Diplegia, Mobility decreased, Syncope
Clinical narrative: Lower body gave out, resulting in collapse.  Lower body basically paralyzed for approximately 20 minutes. Could not sit up or turn over to get up.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given Pfizer 5-11 vaccine on 1/14/23 that had a 10 week fridge expiration date of 1/11/23.   No adverse reaction.  Just given expired vaccine.
Age: 13.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Blood glucose normal, Fall, Syncope
Clinical narrative: Shortly after patient received their 2 vaccine, Patient fainted & fell to the floor.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMRV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: 10:00am Immediately following receiving PROQUAD, SQ R-thigh had redness & swelling of inj. site. Cold compress applied & ibuprofen given. After one hour, redness & swelling decrease. No difficulty breathing. At 2:18pm, redness & swelling decreased. 10/22/2022 mother reports RT thigh is fine.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Mobility decreased, Peripheral artery thrombosis, Peripheral swelling, Ultrasound Doppler abnormal
Clinical narrative: Narrative: referred to hematology for newly diagnosed RUE brachial vein DVT (4/9/21) in the setting of recent COVID vaccination (3/5/21). He reported RUE swelling and Doppler report revealed acute mid-right brachial vein thrombus. Per H/O, it is likely that the current DVT IS provoked in the setting of immobility and possibly recent COVID vaccination.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19-2, COVID19-2, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative: Patient tested positive for COVID-19 and was hospitalized despite full vaccination (Pfizer 1,2, and 1st booster ) and 2nd booster of Pfizer vaccine.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Biopsy bone, Bone disorder, Computerised tomogram head, Neck pain
Clinical narrative: early September 2020 - jaw pain, right mandible went away but came back again around October Jaw pain stayed, headache also, daily. Increased pain as day wore on. Nov 17 Braces removed. Panorama xray showed no abnormalities. Complaining of headaches jaw pain, neck and upper back pain. Chiropractor visits Began late Nov., then jaw swelling in early Dec. Dentist xry on 12/ /2020 showed bone
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: New daily persistent headache, Orthodontic procedure, Pain in jaw, Swelling face, X-ray dental
Clinical narrative: early September 2020 - jaw pain, right mandible went away but came back again around October Jaw pain stayed, headache also, daily. Increased pain as day wore on. Nov 17 Braces removed. Panorama xray showed no abnormalities. Complaining of headaches jaw pain, neck and upper back pain. Chiropractor visits Began late Nov., then jaw swelling in early Dec. Dentist xry on 12/ /2020 showed bone
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: X-ray dental abnormal
Clinical narrative: early September 2020 - jaw pain, right mandible went away but came back again around October Jaw pain stayed, headache also, daily. Increased pain as day wore on. Nov 17 Braces removed. Panorama xray showed no abnormalities. Complaining of headaches jaw pain, neck and upper back pain. Chiropractor visits Began late Nov., then jaw swelling in early Dec. Dentist xry on 12/ /2020 showed bone
Age: 67.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Death, Eye movement disorder, Loss of consciousness, Respiratory arrest, Syncope
Clinical narrative: stopped breathing; out walking, collapsed; eyes rolled back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022SA509379.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation; influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE MOVEMENT DISORDER (death) with onset 29Oct2022, outcome "fatal", described as "eyes rolled back"; LOSS OF CONSCIOUSNESS (death, medically significant) with onset 29Oct2022, outcome "fatal", described as "out walking, collapsed"; RESPIRATORY ARREST (death, medically significant) with onset 29Oct2022, outcome "fatal", described as "stopped breathing". The patient date of death was 29Oct2022. Reported cause of death: "stopped breathing", "eyes rolled back", "out walking, collapsed". It was not reported if an autopsy was performed. Clinical course: On an unknown date, the patient received a dose of suspect influenza quadrivial A-B high dose HV vaccine and Pfizer biontech Covid-19 vaccine via unknown route in unknown administration site of Prophylactic vaccination. On 29Oct2022 the patient who went out walking, collapsed (loss of consciousness), eye roiled back (eye movement disorder) and stopped breathing (respiratory arrest) (unknown latency) following the administration of Pfizer biontech covid-19 vaccine. Final diagnosis was (fatal) stopped breathing. It was not reported the patient received a corrective treatment for the events. It was unknown if an autopsy was done. The cause of death was reported as Respiratory arrest.  Company comment: Sanofi company comment on 16Dec2022. This case involved 67 years female patient who went out walking, collapsed, eyes rolled back and stopped breathing after receiving vaccines Pfizer biontech Covid-19 vaccine and influenza quadrival A-B high dose vaccine [Fluzone high dose quadrivalent]. This reported event stopped breathing was assessed as medically significant and fatal. Further information regarding medical history during vaccination, previously vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully access this case. Based upon the reported information, the role of the individual suspect vaccine cannot be addressed.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: stopped breathing; eyes rolled back; out walking, collapsed
Age: 30.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19-2, COVID19-2, COVID19-2, COVID19-2, COVID19-2, FLUR4, FLUR4, VARZOS
Symptoms: Injection site pain, Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: On 12/16/22, pharmacist prepared several vaccines including Shingrix, Covid-19, Flu vaccines, for patients who arrived at the same time. Then took all of the vaccines to the consultation room for administration.   Pharmacist accidentally injected about 0.1 ml of Shingrix vaccine of another patient to but retracted the needle quickly upon noticing the error before pushing the entire 0.5 ml.   Pharmacist immediately informed patient of the error, and advised patient to wait in the pharmacy waiting area for 20 minutes for observation.  After 20 minutes, Pharmacist asked patient whether she is experiencing any adverse effects, she said none, and Pharmacist requested her to watch out for any adverse effects and if any adverse effects call the pharmacy to let us know, and if any serious adverse effect, then go to E.R.  After a day or two, Pharmacist called patient, and she said she is just experiencing mild soreness at the injection site.  Pharmacist reported the incident to Corporate.    Pharmacist and the pharmacy manager went over the Q&A Review.  Changes to the policy and procedures are as follows.  1.  Prepare vaccine(s) for just one patient at a time, and make sure the patient is right by name and DOB.  2.  Verify all of the above steps with patient before administration to make sure this incident does not occur again the future.
Age: 37.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Angiogram, Blood test, Cerebrovascular accident, Computerised tomogram, Echocardiogram
Clinical narrative: I saw this patient in consultation today, I am a hematologist.  He is a young healthy firefighter with no comorbidities who had a viral type illness in late December 2022.  Is likely influenza A as his children tested positive for this at the same time.  On 1/4/2023 he underwent bivalent COVID booster vaccination(I do not know which one he received) at a different facility.  3 days later he presented to the local hospital with strokelike symptoms of aphasia right arm weakness and numbness.  He underwent thrombolytic therapy with improvement in his symptoms.  MRI of the brain done after thrombolytics was consistent with cerebral infarction.  There was no obvious precipitating event.  He was found to have a PFO.  He was discharged from the hospital after unrevealing extensive hematologic work-up.  He continues to improve in his symptoms.
Age: 37.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Intensive care, Magnetic resonance imaging, Neurological examination, Scan with contrast, Ultrasound Doppler
Clinical narrative: I saw this patient in consultation today, I am a hematologist.  He is a young healthy firefighter with no comorbidities who had a viral type illness in late December 2022.  Is likely influenza A as his children tested positive for this at the same time.  On 1/4/2023 he underwent bivalent COVID booster vaccination(I do not know which one he received) at a different facility.  3 days later he presented to the local hospital with strokelike symptoms of aphasia right arm weakness and numbness.  He underwent thrombolytic therapy with improvement in his symptoms.  MRI of the brain done after thrombolytics was consistent with cerebral infarction.  There was no obvious precipitating event.  He was found to have a PFO.  He was discharged from the hospital after unrevealing extensive hematologic work-up.  He continues to improve in his symptoms.
Age: 37.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Venogram
Clinical narrative: I saw this patient in consultation today, I am a hematologist.  He is a young healthy firefighter with no comorbidities who had a viral type illness in late December 2022.  Is likely influenza A as his children tested positive for this at the same time.  On 1/4/2023 he underwent bivalent COVID booster vaccination(I do not know which one he received) at a different facility.  3 days later he presented to the local hospital with strokelike symptoms of aphasia right arm weakness and numbness.  He underwent thrombolytic therapy with improvement in his symptoms.  MRI of the brain done after thrombolytics was consistent with cerebral infarction.  There was no obvious precipitating event.  He was found to have a PFO.  He was discharged from the hospital after unrevealing extensive hematologic work-up.  He continues to improve in his symptoms.
Age: 37.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Aphasia, Atrial septal defect, Cerebral infarction, Hypoaesthesia, Magnetic resonance imaging head abnormal
Clinical narrative: I saw this patient in consultation today, I am a hematologist.  He is a young healthy firefighter with no comorbidities who had a viral type illness in late December 2022.  Is likely influenza A as his children tested positive for this at the same time.  On 1/4/2023 he underwent bivalent COVID booster vaccination(I do not know which one he received) at a different facility.  3 days later he presented to the local hospital with strokelike symptoms of aphasia right arm weakness and numbness.  He underwent thrombolytic therapy with improvement in his symptoms.  MRI of the brain done after thrombolytics was consistent with cerebral infarction.  There was no obvious precipitating event.  He was found to have a PFO.  He was discharged from the hospital after unrevealing extensive hematologic work-up.  He continues to improve in his symptoms.
Age: 37.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Muscular weakness, Neurological symptom, Thrombolysis
Clinical narrative: I saw this patient in consultation today, I am a hematologist.  He is a young healthy firefighter with no comorbidities who had a viral type illness in late December 2022.  Is likely influenza A as his children tested positive for this at the same time.  On 1/4/2023 he underwent bivalent COVID booster vaccination(I do not know which one he received) at a different facility.  3 days later he presented to the local hospital with strokelike symptoms of aphasia right arm weakness and numbness.  He underwent thrombolytic therapy with improvement in his symptoms.  MRI of the brain done after thrombolytics was consistent with cerebral infarction.  There was no obvious precipitating event.  He was found to have a PFO.  He was discharged from the hospital after unrevealing extensive hematologic work-up.  He continues to improve in his symptoms.
Age: 74.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Interchange of vaccine products, Pemphigoid, SARS-CoV-2 test
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 10:00 as dose 4 (booster), single (Lot number: Gh97036) at the age of 74 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Oct2021 at 11:00 as dose 1, single (Lot number: 026D21A), in right arm, on 03Nov2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 04May2022 at 11:00 as dose 3 (booster), single (Lot number: 059M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Peritoneal dialysis" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA, start date: 04Oct2022, stop date: 04Oct2022; ATORVASTATIN; AMLODIPINE; LISINOPRIL; HYDRALAZINE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (25Nov2022) Negative.  Clinical course: The patient had no known allergies. Patient received other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Drug ineffective, Nasopharyngeal swab, Suspected COVID-19
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 10:00 as dose 4 (booster), single (Lot number: Gh97036) at the age of 74 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Oct2021 at 11:00 as dose 1, single (Lot number: 026D21A), in right arm, on 03Nov2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 04May2022 at 11:00 as dose 3 (booster), single (Lot number: 059M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Peritoneal dialysis" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA, start date: 04Oct2022, stop date: 04Oct2022; ATORVASTATIN; AMLODIPINE; LISINOPRIL; HYDRALAZINE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (25Nov2022) Negative.  Clinical course: The patient had no known allergies. Patient received other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Failure to thrive, Gastrointestinal haemorrhage, Headache, Inappropriate schedule of product administration
Clinical narrative: if covid tested post vaccination: Yes; if covid tested post vaccination: Yes; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2021 as dose 1, single (Lot number: FF2590) intramuscular, in right arm and on 04Nov2021 as dose 2, single (Lot number: FH8030) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "bradycardia" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: penicillin, reaction(s): "allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "if covid tested post vaccination: Yes". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: If covid tested post vaccination: Yes.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Overdose, SARS-CoV-2 test, Sinus node dysfunction, Syncope
Clinical narrative: if covid tested post vaccination: Yes; if covid tested post vaccination: Yes; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2021 as dose 1, single (Lot number: FF2590) intramuscular, in right arm and on 04Nov2021 as dose 2, single (Lot number: FH8030) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "bradycardia" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: penicillin, reaction(s): "allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "if covid tested post vaccination: Yes". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: If covid tested post vaccination: Yes.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab
Clinical narrative: if covid tested post vaccination: Yes; if covid tested post vaccination: Yes; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Nov2021 as dose 1, single (Lot number: FF2590) intramuscular, in right arm and on 04Nov2021 as dose 2, single (Lot number: FH8030) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "bradycardia" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: penicillin, reaction(s): "allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "if covid tested post vaccination: Yes". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: If covid tested post vaccination: Yes.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Device connection issue, Incorrect dose administered, No adverse event, Poor quality device used, Syringe issue
Clinical narrative: no adverse reactions; it started leaking out around the hub and did not come out of the needle; none of the medication went in the patient because there was still 1/2 of it in the syringe as well as what leaked out around hub.; From where did the leaking occur? Between the syringe hub/Luer lock and syringe needle? YES; This spontaneous report was received from a nurse referring to a 12-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were unknown by reporter. On an unknown date in 2022, the nurse received 1 box containing 2 cartons of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with 5 pre-filled syringes per carton; 10 pre-filled syringes total. Nurse stated they used the first 5 pack with no problems.  On 19-DEC-2022, the patient was vaccinated with 1 dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (ml), lot #U019413, expiration date: 01-NOV-2023, administered intramuscularly (IM) as prophylactic vaccine for Human Papillomavirus (HPV) (strength 0.5 mL).  On 19-DEC-2022, the nurse opened the second carton of 5 syringes and took one out and attached the needle to the hub/luer lock part of the syringe. It seemed to be securely attached and then she felt a click and it kept turning. As she pushed the vaccine through the syringe and tip of needle to get the air out, it started leaking out around the hub and did not come out of the needle so she disposed of it and got another pre-filled syringe from the carton. She stated this one seemed to be fine and the needle securely attached to the syringe without issues but while administering to the patient, the liquid came out all around the hub where the needle connects (syringe issue; poor quality device used; device connection issue). She said she knows none of the medication went in the patient because there was still 1/2 of it in the syringe as well as what leaked out around hub. The patient had no adverse reactions and did not need treatment (no adverse event). The outcome of all the events was unknown (also reported as recovered). The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding all the events was not applicable (also reported as therapy discontinued).  The causal relationship between all the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs; Caller reported child received first dose of PROQUAD on 7/21/2011 and 2nd dose on 1/12/2023.  No other information provided.  No additional AEs or PQC reported.; Caller reported child received first dose of PROQUAD on 7/21/2011 and 2nd dose on 1/12/2023.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a registered nurse and refers to a child patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported.  On 21-JUL-2011, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (dose, lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis. On 12-JAN-2023, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (dose, lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis(Inappropriate schedule of product administration, Product administered to patient of inappropriate age). No additional adverse events or product quality complaint were reported .
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available. No additional AE reported. No PQC.; Medical assistant reports administration of VARIVAX after temperature excursion. Product experienced temperature excursion yesterday 1/11/2023 and was administered today 1/12/2023.; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age or gender.  The patient's medical history, concurrent conditions, concomitant therapies, drugs reactions or allergies were not reported.  On 12-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot #W006412, expiration date: 23-FEB-2024, administered for prophylaxis (vaccination scheme, route of administration were not provided) following a temperature excursion of -14 degree Celsius (C) up to -10C for 30 minutes (product storage error), it was stated that no previous temperature excursion occurred before. No additional adverse event reported. No PQC..
Sex: F
Vaccine: PNC13, PPV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE's reported; Pharmacist called stating that a patient was accidently administered either PNEUMOVAX 23 or PREVNAR 13 via their intravenous port. Reporting pharmacist only has information that she has received via email. Vaccine was administered via the wrong route; This spontaneous report was received from a pharmacist and refers to a 48-year-old female patient. There was no information about the patient's concomitant therapies, drug reactions, allergies or medical history provided.  On 13-JAN-2023, the patient was accidently vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, or pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), administered via intravenous (IV) port for prophylaxis (dose, dose number, lot #, and expiry date were not provided). The staff was not sure if it was pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, or pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) administered to the patient. The vaccine was administered via the wrong route in an outpatient infusion center at the hospital. Per medical records, the patient has had no adverse side effects. No additional adverse events (AE's) were reported. At the reporting time, there was no further information provided.
Sex: F
Vaccine: SMALLMNK
Symptoms: Incorrect dose administered
Clinical narrative: A nurse gave one mililiter instead of 0.5 mililiter; Case reference number US-BN-2022-004893, is a spontaneous case report initially received on 15-Dec-2022 from a health care professional via Communication (reference number: USBAV22-2136) and concerns female patient born 29-Apr-2003.  The patient's relevant medical history and concomitant medications were not reported.  On 13-Dec-2022, the patient was vaccinated with first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00014) administered subcutaneously, at unknown anatomical location, at dose reported as 1ml (2 vials) (explicitly coded as 'Overdose'), for monkeypox prophylaxis.   Additional information received from Bavarian Nordic on 15-Dec-2022 included local BN case ID.; Reporter's Comments: A female patient born in 2003, was vaccinated with first dose of Jynneos vaccine, administered subcutaneously, at unknown anatomical location, at dose reported as 1ml (2 vials, which is considered as overdose), for monkeypox prophylaxis. Overdose is considered listed per company conventions. The patient's relevant medical history and concomitant medications were not reported. At this point, it is unknown if a patient experienced any adverse events with Jynneos vaccine. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient born in 2003, was vaccinated with first dose of Jynneos vaccine, administered subcutaneously, at unknown anatomical location, at dose reported as 1ml (2 vials, which is considered as overdose), for monkeypox prophylaxis. Overdose is considered listed per company conventions. The patient's relevant medical history and concomitant medications were not reported. At this point, it is unknown if a patient experienced any adverse events with Jynneos vaccine. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: An expired vaccine was administered to a patient after expiration, was given 24 hours after being drawn up; Jynneos vaccine was given intradermally.; Case reference number US-BN-2022-004899 is a spontaneous case report initially received from an other-health care professional via Communication (reference number: USBAV22-2148) on 16-Dec-2022 and concerns a patient of unspecified age.  The patient's relevant medical history and concomitant medication details were not provided.  On 16-Dec-2022, the patient was vaccinated with the first dose of expired Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00042), 24 hours after the vaccine was drawn up, at an unknown dose, intradermally, on an unspecified anatomical site location, for unknown indication (explicitly coded as 'expired vaccine used' and 'intradermal injection').  At the time of this report, it was unknown if the patient experienced any adverse events due to Jynneos vaccination.  Additional information received from Bavarian Nordic on 16-Dec-2022 included local BN case ID.; Reporter's Comments: A patient of unspecified age was vaccinated with the first dose with an expired Jynneos vaccine, 24 hours after the vaccine was drawn up, at an unknown dose, intradermally, on an unspecified anatomical site location, for unknown indication. No associated adverse events were reported. Expired product administered and intradermal injection are listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Expired product administered and intradermal injection are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age was vaccinated with the first dose with an expired Jynneos vaccine, 24 hours after the vaccine was drawn up, at an unknown dose, intradermally, on an unspecified anatomical site location, for unknown indication. No associated adverse events were reported. Expired product administered and intradermal injection are listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Expired product administered and intradermal injection are not related to Jynneos, but to a human factor. The case is non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion (10.5 hours) Product Administered; Initial Report Received on 29-NOV-2022  This is a spontaneous report received from a registered nurse in the regarding a 32-year-old female patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 29-NOV-2022, dose 1 of HEPLISAV B (Lot #937783, expiration date 29-SEP-2023, NDC #43528-003-05), route and site not specified, was administered for hepatitis B immunisation.   The dose had undergone a temperature excursion of 18.9°C for 10 hours and 30 minutes.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion (10.5 hours) Product Administered; Initial Report Received on 29-NOV-2022  This is a spontaneous report received from a registered nurse regarding a 51-year-old female patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 29-NOV-2022, dose 1 of HEPLISAV B (Lot #937783, expiration date 29-SEP-2023, NDC #43528-003-05), route and site not specified, was administered for hepatitis B immunisation.   The dose had undergone a temperature excursion of 18.9°C for 10 hours and 30 minutes.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Received Heplisav-B 2 Weeks Prior to Finding Out Pregnant; Initial Report Received on 01-DEC-2022, 02-DEC-2022 , 05-DEC-2022  This is a spontaneous report received from a pharmacist in the regarding a female patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On an unknown date, dose 1 of HEPLISAV B (Lot # unknown, expiration date unknown, NDC # unknown), route and site not specified, was administered for hepatitis B immunisation.   The patient received the dose about 2 weeks prior to finding out she was pregnant.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.