chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: 16:35-Clients mother reported that client was having a reaction. As nurse turned to look over at client, Clients body was having an involuntary body contractions arms were stiff and straight outward with hands sticking outward; legs were pointing out at the same time with feet pointing out straight forward. Clients body relaxed and would contract straight forward and outward 2 more times, during these events Client did not respond to verbal or physical stimuli. Client was a/o to name only between events. pupils were dilated, and she became clamy, skin was cool to touch, and pale in color, and experienced an episode of emesis in between 1st and second event of body contractions. v/s assessed at 16:37B/p 60/48 O2:97% HR: 95 unable to obtain Respirations. Client became responsive and a/o x 3 immediatley. Nurse gave client water and 2 lollipops, and elevated her legs on a chair. Clients color started to return to normal skin tone. Client stated that she has only had a sandwich to eat all day. re-assessed v/s at 16:45- B/p 82/52 O2:95% HR:62 R: 15. Pt a/o x3. Not clamy anymore, skin warm to touch, and normal in color. Client states she is feeling better, drinking water and eating her lollipop.-16:57 assessed v/s B/p: 100/60 O2: 100% HR67 R:15. a/o x3. -17:10: B/P110/70 O2%98% HR:64 R: 17. Client is a/o x3, and states that she feels better. Nurse did teaching with client and clients mom on reporting todays reaction with PCP and regarding second dose vaccination, as well as eating appropriately and staying hydrated. Both verbalized understanding.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Head injury, Syncope
Clinical narrative: after 5 minutes of the patient's 2nd dose covid vaccine, i heard that this patient fainted and when i look at him he was sitting on the floor. i asked him what happened and if  he had a vaccine and he said yes. he said he fainted and said he bumped his head. and he mentioned that everytime he has a vaccine he sometimes feel dizzy. but he said on his 1st vaccine he did not faint. he seems fine so i ask him if he wants to seat down and he said he's fine. we told him one of the employee called paramedics.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blood test normal, Chills, Diarrhoea, Headache
Clinical narrative: I experienced extreme headaches, body aches, chills, inflammation in my joints, and diarrhea one month after receiving the vaccine. I informed my doctors of all the symptoms that I was experiencing and they all agreed that there was not enough information to say that the vaccine was the cause of my issues. The Naturopath increased my supplement that helps with inflammation by increasing the dosage. I am still experiencing the same symptoms and the supplements are not helping. My Urocologists ordered blood work in reference to my symptoms.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I experienced extreme headaches, body aches, chills, inflammation in my joints, and diarrhea one month after receiving the vaccine. I informed my doctors of all the symptoms that I was experiencing and they all agreed that there was not enough information to say that the vaccine was the cause of my issues. The Naturopath increased my supplement that helps with inflammation by increasing the dosage. I am still experiencing the same symptoms and the supplements are not helping. My Urocologists ordered blood work in reference to my symptoms.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Condition aggravated, Echocardiogram normal, Electrocardiogram normal, Fatigue
Clinical narrative: Had blood work done that was all negative had a EKG and echocardiogram that were negative. Also sleep study that was shown no signs of sleep. Continue to struggle with exhaustion & fatigue. This may be some better now due to adding some supplements  to help sleep. But I'm hoping to follow up with a neurologist to rule out other issues due to twitching in right hand & feet at night.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Muscle twitching, Sleep study abnormal
Clinical narrative: Had blood work done that was all negative had a EKG and echocardiogram that were negative. Also sleep study that was shown no signs of sleep. Continue to struggle with exhaustion & fatigue. This may be some better now due to adding some supplements  to help sleep. But I'm hoping to follow up with a neurologist to rule out other issues due to twitching in right hand & feet at night.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: paleness, sweating ,fainting
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site rash
Clinical narrative: Patient described a red circular area near the site of injection on the left arm. Patient stated that it was itchy and irritated. She stated that this rash developed after the second dose of her COVID-19 Vaccine (Pfizer).
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Storage and handling excursion- Patient was given a dose of pfizer vaccine past BUD time of 6 hours- with labeled expiration time of 3:00PM of 8/11/2021 dose was given at 3:45PM .
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Food allergy, Gastrointestinal disorder, Loss of consciousness, Malaise
Clinical narrative: After both vaccines, I passed out, however, I pass out after every vaccine I receive so that was normal. Since I have received the vaccine, I have gotten sick easier. My stomach has been more sensitive to food and drinks that I regularly ate and drank before. I feel more exhausted day to day since the vaccine as well.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Biopsy bone abnormal, Biopsy kidney abnormal, Blood creatine increased, Chest X-ray normal
Clinical narrative: 51 year old male with no significant history except depression taking Celexa for years.  Had routine lab work December 2020 at primary doctor which was normal.  Started feeling headache and lethargy week of 6/7/2021, one month after second dose of Pfizer Covid Vaccine.  Initially treated with steroids and antibiotics by primary physician for supposed sinus infection.  Symptoms progressively got worse with loss of appetite, vomiting and diarrhea.  Primary physician then started course of Levaquin with no relief.  CXR and Covid test ordered and results Negative.  Patient admitted to hospital on 7/2/21 with diagnosis of ARF .   Creatine 12.74.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Diarrhoea, Headache, Lethargy, Light chain analysis
Clinical narrative: 51 year old male with no significant history except depression taking Celexa for years.  Had routine lab work December 2020 at primary doctor which was normal.  Started feeling headache and lethargy week of 6/7/2021, one month after second dose of Pfizer Covid Vaccine.  Initially treated with steroids and antibiotics by primary physician for supposed sinus infection.  Symptoms progressively got worse with loss of appetite, vomiting and diarrhea.  Primary physician then started course of Levaquin with no relief.  CXR and Covid test ordered and results Negative.  Patient admitted to hospital on 7/2/21 with diagnosis of ARF .   Creatine 12.74.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nephropathy, SARS-CoV-2 test negative, Sinusitis, Vomiting
Clinical narrative: 51 year old male with no significant history except depression taking Celexa for years.  Had routine lab work December 2020 at primary doctor which was normal.  Started feeling headache and lethargy week of 6/7/2021, one month after second dose of Pfizer Covid Vaccine.  Initially treated with steroids and antibiotics by primary physician for supposed sinus infection.  Symptoms progressively got worse with loss of appetite, vomiting and diarrhea.  Primary physician then started course of Levaquin with no relief.  CXR and Covid test ordered and results Negative.  Patient admitted to hospital on 7/2/21 with diagnosis of ARF .   Creatine 12.74.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Nausea, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Headache, nausea, vomiting, cough, runny nose, sore throat, bilateral achilles pain.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Tendon pain, Vomiting
Clinical narrative: Headache, nausea, vomiting, cough, runny nose, sore throat, bilateral achilles pain.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Nausea, Visual impairment
Clinical narrative: Patient felt light headed, her vision went dark, felt n/v, hot sweaty . we have her sat on the floor, got her some water and some pretzels. She felt better after awhile and begin to feel better after .
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Patient felt light headed, her vision went dark, felt n/v, hot sweaty . we have her sat on the floor, got her some water and some pretzels. She felt better after awhile and begin to feel better after .
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Crying, Seizure like phenomena, Tremor
Clinical narrative: Excessive crying in excess of 20 plus minutes multiple times over course of 48 hours, at the 42 hour mark after receiving vaccines patient started to shake in seizure like manner for roughly 10 minutes before stopping.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Blood pressure decreased, Diarrhoea, Disturbance in attention, Dizziness
Clinical narrative: 30mins after shot, started with nausea, dizziness, flushed, and felt my BP dropping.  Took one benedryl.  Symptoms settled.  6pm symptoms came back and stronger.  Took one benedryl.  At 3am woke up with severe reaction.   Room is spinning, nausea, diarrhea, throat constricted, body tremors.  Took 2 benedryl.  Symptoms turned to violent whole body jerking, head getting fuzzy.  2 hrs after the two benedryl my symptoms calmed enough to fall back sleep.  Next morning I go to Urgent Care.  My body is trembling, my left leg and arm and very weak.  My leg does not want to cooperate when I walk.  They give me the steroid Dexamethasone in an attempt to lesson my symptoms.  It does not work.  I lay on the couch all day with my body continuing to tremble/jerk.  I have trouble concentrating.  I'm dizzy.  My symptoms continue to get worse.  My husband calls the ambulance on June 2nd.  My body shaking has turned violent and I lost the ability to talk.  I'm stuttering and struggling to get words out.  I can't even think to get the words to stay in my head.  My left leg is very weak and going numb.  Hospital does nothing.  My heart rate was fine.  They did not consider my issues life threatening.  They observe me in the waiting room for 5hrs then send me home.   Doctors don't know what happened or what is wrong.  For two full weeks, I could not walk, talk or think.  Very slowing, my speech came back.  I still struggle to find words.  I have done my own physical therapy at home to try to strengthen my left side.  My left leg remains weak and there is lasting nerve damage.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Dysphemia, Feeling abnormal, Flushing, Gait inability
Clinical narrative: 30mins after shot, started with nausea, dizziness, flushed, and felt my BP dropping.  Took one benedryl.  Symptoms settled.  6pm symptoms came back and stronger.  Took one benedryl.  At 3am woke up with severe reaction.   Room is spinning, nausea, diarrhea, throat constricted, body tremors.  Took 2 benedryl.  Symptoms turned to violent whole body jerking, head getting fuzzy.  2 hrs after the two benedryl my symptoms calmed enough to fall back sleep.  Next morning I go to Urgent Care.  My body is trembling, my left leg and arm and very weak.  My leg does not want to cooperate when I walk.  They give me the steroid Dexamethasone in an attempt to lesson my symptoms.  It does not work.  I lay on the couch all day with my body continuing to tremble/jerk.  I have trouble concentrating.  I'm dizzy.  My symptoms continue to get worse.  My husband calls the ambulance on June 2nd.  My body shaking has turned violent and I lost the ability to talk.  I'm stuttering and struggling to get words out.  I can't even think to get the words to stay in my head.  My left leg is very weak and going numb.  Hospital does nothing.  My heart rate was fine.  They did not consider my issues life threatening.  They observe me in the waiting room for 5hrs then send me home.   Doctors don't know what happened or what is wrong.  For two full weeks, I could not walk, talk or think.  Very slowing, my speech came back.  I still struggle to find words.  I have done my own physical therapy at home to try to strengthen my left side.  My left leg remains weak and there is lasting nerve damage.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hemiparesis, Hypoaesthesia, Magnetic resonance imaging head normal, Muscular weakness, Nausea
Clinical narrative: 30mins after shot, started with nausea, dizziness, flushed, and felt my BP dropping.  Took one benedryl.  Symptoms settled.  6pm symptoms came back and stronger.  Took one benedryl.  At 3am woke up with severe reaction.   Room is spinning, nausea, diarrhea, throat constricted, body tremors.  Took 2 benedryl.  Symptoms turned to violent whole body jerking, head getting fuzzy.  2 hrs after the two benedryl my symptoms calmed enough to fall back sleep.  Next morning I go to Urgent Care.  My body is trembling, my left leg and arm and very weak.  My leg does not want to cooperate when I walk.  They give me the steroid Dexamethasone in an attempt to lesson my symptoms.  It does not work.  I lay on the couch all day with my body continuing to tremble/jerk.  I have trouble concentrating.  I'm dizzy.  My symptoms continue to get worse.  My husband calls the ambulance on June 2nd.  My body shaking has turned violent and I lost the ability to talk.  I'm stuttering and struggling to get words out.  I can't even think to get the words to stay in my head.  My left leg is very weak and going numb.  Hospital does nothing.  My heart rate was fine.  They did not consider my issues life threatening.  They observe me in the waiting room for 5hrs then send me home.   Doctors don't know what happened or what is wrong.  For two full weeks, I could not walk, talk or think.  Very slowing, my speech came back.  I still struggle to find words.  I have done my own physical therapy at home to try to strengthen my left side.  My left leg remains weak and there is lasting nerve damage.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve injury, Throat tightness, Tremor, Vertigo
Clinical narrative: 30mins after shot, started with nausea, dizziness, flushed, and felt my BP dropping.  Took one benedryl.  Symptoms settled.  6pm symptoms came back and stronger.  Took one benedryl.  At 3am woke up with severe reaction.   Room is spinning, nausea, diarrhea, throat constricted, body tremors.  Took 2 benedryl.  Symptoms turned to violent whole body jerking, head getting fuzzy.  2 hrs after the two benedryl my symptoms calmed enough to fall back sleep.  Next morning I go to Urgent Care.  My body is trembling, my left leg and arm and very weak.  My leg does not want to cooperate when I walk.  They give me the steroid Dexamethasone in an attempt to lesson my symptoms.  It does not work.  I lay on the couch all day with my body continuing to tremble/jerk.  I have trouble concentrating.  I'm dizzy.  My symptoms continue to get worse.  My husband calls the ambulance on June 2nd.  My body shaking has turned violent and I lost the ability to talk.  I'm stuttering and struggling to get words out.  I can't even think to get the words to stay in my head.  My left leg is very weak and going numb.  Hospital does nothing.  My heart rate was fine.  They did not consider my issues life threatening.  They observe me in the waiting room for 5hrs then send me home.   Doctors don't know what happened or what is wrong.  For two full weeks, I could not walk, talk or think.  Very slowing, my speech came back.  I still struggle to find words.  I have done my own physical therapy at home to try to strengthen my left side.  My left leg remains weak and there is lasting nerve damage.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Contant backache beggining around 30 to 45 days after vaccination  backache seems to be consistant but not serious pain
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Headache, Nausea, Vomiting
Clinical narrative: Shortness of breath, chest pain, nausea, vomiting, headache
Age: 35.0
Sex: M
Vaccine: UNK
Symptoms: Biopsy brain abnormal, Brain neoplasm, Brain stem glioma, Magnetic resonance imaging head abnormal
Clinical narrative: I?ve got diagnosed with Brain Tumor (grade 4) in the brainstem, on 06/23/2021 at hospital. Then confirmed after a biopsy surgery, with Grade 4 Difuse Midlining Glioma in the brainstem. All the symptoms started after the vaccine. Please contact me regarding that
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Pain in extremity, Pyrexia
Clinical narrative: arm pain, irregular heart beat, fever
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Storage and handling excursion- Patient was given a dose of Pfizer vaccine past BUD time of 6 hours described in EUA - with labeled expiration time of 3:00PM of 8/11/2021 dose was given at 6:03PM 8/11/2021 . No adverse events reported, extra dose not required at this time
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Flushing, Head discomfort, Immediate post-injection reaction, Pruritus
Clinical narrative: Shortness of breath, itching, head congestion, flushed feeling that progressed immediately following injection.  Patient took 75 mg diphenhydramine and symptoms resolved after 2 hours.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: Frequent sensation of hot water or hot air pouring down right lower leg.  Not a burning or pain sensation, but "hot".  Symptoms last about 30 seconds, but the frequency is increasing rather than decreasing.  Current sensations are about 1-2 times per hour, intermittently
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, Pain, Pyrexia
Clinical narrative: When I got my 1st Moderna vaccine, I had no side effects. When I got my 2nd Moderna vaccine, I had mild aches and pains. Now, after my 3rd Moderna vaccine, I have had a fever of 100 degrees Fahrenheit and aches and pains and felt tired. After taking 1000 mg of acetaminophen my fever went down to 98 degrees, but after 6 hours the fever of 100 degrees Fahrenheit came back.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Loss of consciousness
Clinical narrative: Pt is at the clinic to get J&J covid vaccination today. @1620 Rapid response was called. Pt shook for less than a minute after receiving vaccine and lost consciousness. Dr. and rapid response team on scene. Dr. assessed pt. Pt AOx4 breathing even and unlabored, was not in distress. Estimated time less than 2 minutes of losing consciousness. Pt is coherent, color is back to of skin patients regular skin color after regaining consciousness, temp: warm/WNL, R and L eyes PERL. Pt denies the following: pain, CP, palpitation, and c/o nausea. See vitals: WNL, Pt's glucose today 100 mg/dl. Per Dr. observation for 30 minutes. Pt taken to ER per Dr. via boyfriend.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Aura, Chills, Dizziness, Fatigue
Clinical narrative: Started with  a bright aura which turned in nausea and vomiting  around 15 minutes later then started a severe migraine immediately after (I do have history of migraines this was the worst I have had in 5 years).  I had blurry vision, dizziness, pain down the back of the head into the neck.  I got chills and body aches.  I was sensitive to light and sound. This all occurred over 22 hours. I took Imitrex 100 mg two times.  I slept for 22 hours.. I woke up around 8 hours into the 22 hour mark to call off work and take Imitrex.   I woke up feeling like I was run over by a truck. after 22 hours.  The next day I worked a half day and was exhausted.  I had the next 2 days off and I had to rest those days to get my energy back
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperacusis, Impaired work ability, Migraine, Nausea
Clinical narrative: Started with  a bright aura which turned in nausea and vomiting  around 15 minutes later then started a severe migraine immediately after (I do have history of migraines this was the worst I have had in 5 years).  I had blurry vision, dizziness, pain down the back of the head into the neck.  I got chills and body aches.  I was sensitive to light and sound. This all occurred over 22 hours. I took Imitrex 100 mg two times.  I slept for 22 hours.. I woke up around 8 hours into the 22 hour mark to call off work and take Imitrex.   I woke up feeling like I was run over by a truck. after 22 hours.  The next day I worked a half day and was exhausted.  I had the next 2 days off and I had to rest those days to get my energy back
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Photophobia, Vision blurred, Vomiting
Clinical narrative: Started with  a bright aura which turned in nausea and vomiting  around 15 minutes later then started a severe migraine immediately after (I do have history of migraines this was the worst I have had in 5 years).  I had blurry vision, dizziness, pain down the back of the head into the neck.  I got chills and body aches.  I was sensitive to light and sound. This all occurred over 22 hours. I took Imitrex 100 mg two times.  I slept for 22 hours.. I woke up around 8 hours into the 22 hour mark to call off work and take Imitrex.   I woke up feeling like I was run over by a truck. after 22 hours.  The next day I worked a half day and was exhausted.  I had the next 2 days off and I had to rest those days to get my energy back
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Body aches; fever; chills; headache; This is a spontaneous report from a contactable healthcare professional. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Apr2021 at 16:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the left arm on 21Mar2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Apr2021 at 01:00, the patient experienced body aches, fever, chills and headache. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen (MANUFACTURER UNKNOWN). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events body aches, fever, chills and headache were not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No additional adverse events reported.; the administration of expired dose of GARDASIL 9; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant medication and drug reactions or allergies were not provided.   On 09-JUL-2021, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (0.5 ml, lot# R029515, expiration date 08-JUL-2021; route unknown) for prophylaxis (Expired product administered). No additional adverse events reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R029515; expirationdate: 08-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 0.75
Sex: M
Vaccine: HEP, HEP
Symptoms: Product storage error
Clinical narrative: No signs of symptoms have been reported; Improper storage of product in use; This spontaneous report was received from a registered nurse concerning a 9-month-old male patient.      The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 27-JUL-2021, a temperature excursion occurred due to power outage. Temperature excursion was reported as follows: temperature -0.5 Celcius degrees (C) (1 hour 30 minutes) and 13.6 C (1 hour 40 minutes); time frame 2 hours 10 minutes (cumulative). There was no other previous temperature excursion. It was reported that there was miscommunication when reporting high/low reading of temperature, and initially, the site received clearance to use vaccines on 28-JUL-2021. On 29-JUL-2021, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscularly in the left thigh (lot # T033149, expiration date 19-NOV-2022) for prophylaxis (product storage error) at the private doctor's office/hospital. On that date, temperature readings were corrected which changed outcome, but the vaccine had already been administered. No signs or symptoms were reported and no treatment was administered. The patient's physician was notified and the patient would have the vaccine repeated later. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck. devicelotnumber: T033149; expirationdate: 19-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA008895: US-009507513-2107USA008894:
Age: 0.75
Sex: M
Vaccine: HEP, HEP
Symptoms: Product storage error
Clinical narrative: No signs of symptoms have been reported; Improper storage of product in use; This spontaneous report was received from a registered nurse concerning a 9-month-old male patient.      The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 27-JUL-2021, a temperature excursion occurred due to power outage. Temperature excursion was reported as follows: temperature -0.5 Celcius degrees (C) (1 hour 30 minutes) and 13.6 C (1 hour 40 minutes); time frame 2 hours 10 minutes (cumulative). There was no other previous temperature excursion. It was reported that there was miscommunication when reporting high/low reading of temperature, and initially, the site received clearance to use vaccines on 28-JUL-2021. On 29-JUL-2021, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscularly in the left thigh (lot # T033149, expiration date 19-NOV-2022) for prophylaxis (product storage error). On that date, temperature readings were corrected which changed outcome, but the vaccine had already been administered. No signs or symptoms were reported. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033149; expirationdate: 19-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA008884:
Sex: F
Vaccine: HEP, HEP
Symptoms: Product storage error
Clinical narrative: No signs of symptoms have been reported; Improper storage of product in use; This spontaneous report was received from a registered nurse concerning a 9-month-old female patient.      The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 27-JUL-2021, a temperature excursion occurred due to power outage. Temperature excursion was reported as follows: temperature -0.5 Celcius degrees (C) (1 hour 30 minutes) and 13.6 C (1 hour 40 minutes); time frame 2 hours 10 minutes (cumulative). There was no other previous temperature excursion. It was reported that there was miscommunication when reporting high/low reading of temperature, and initially, the site received clearance to use vaccines on 28-JUL-2021. On 29-JUL-2021, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscularly in the left thigh (lot # T033149, expiration date 19-NOV-2022) for prophylaxis (product storage error). On that date, temperature readings were corrected which changed outcome, but the vaccine had already been administered. No signs or symptoms were reported. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck devicelotnumber: T033149; expirationdate: 19-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA008884:
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy, Facial pain, Facial paralysis, Herpes zoster, Pain
Clinical narrative: herpes zoster; post herpetic trigeminal neuralgia; bell's palsy; post herpetic neuralgia; Seventh Nerve Palsy of the right eye; Information has been was received from a lawyer regarding a case in litigation and refers to a female patient (pt.) of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 19-SEP-2017, the pt. was inoculated with zoster vaccine live (ZOSTAVAX), for routine health maintenance and for the prevention of shingles (herpes zoster) (dose, route, anatomical site, lot #, and expiration date were not provided). On an unspecified date (reported as shortly after receiving the vaccine), the pt. suffered painful lesions, facial pain and blurry vision and was diagnosed with herpes zoster, post herpetic trigeminal neuralgia (trigeminal neuralgia), Bell's palsy, post herpetic neuralgia (PHN) and seventh nerve palsy of the right eye (facial paralysis). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not presented prior to using zoster vaccine live (ZOSTAVAX). The pt. also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt. sustained severe and permanent personal injuries. The pt. suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, and other damages including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered herpes zoster, trigeminal neuralgia, Bell's palsy, PHN, and seventh nerve facial paralysis to be disabling events.  Upon internal review, the events Bell's palsy and facial paralysis were determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Skin lesion, Trigeminal neuralgia, Vision blurred
Clinical narrative: herpes zoster; post herpetic trigeminal neuralgia; bell's palsy; post herpetic neuralgia; Seventh Nerve Palsy of the right eye; Information has been was received from a lawyer regarding a case in litigation and refers to a female patient (pt.) of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 19-SEP-2017, the pt. was inoculated with zoster vaccine live (ZOSTAVAX), for routine health maintenance and for the prevention of shingles (herpes zoster) (dose, route, anatomical site, lot #, and expiration date were not provided). On an unspecified date (reported as shortly after receiving the vaccine), the pt. suffered painful lesions, facial pain and blurry vision and was diagnosed with herpes zoster, post herpetic trigeminal neuralgia (trigeminal neuralgia), Bell's palsy, post herpetic neuralgia (PHN) and seventh nerve palsy of the right eye (facial paralysis). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not presented prior to using zoster vaccine live (ZOSTAVAX). The pt. also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt. sustained severe and permanent personal injuries. The pt. suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, and other damages including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered herpes zoster, trigeminal neuralgia, Bell's palsy, PHN, and seventh nerve facial paralysis to be disabling events.  Upon internal review, the events Bell's palsy and facial paralysis were determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia, VIth nerve paralysis
Clinical narrative: The pt suffered persistent diplopia and was diagnosed with VIth nerve palsy; Information has been was received from a lawyer regarding a case in litigation and refers to a male patient (pt.) of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 29-SEP-2017, the pt. was inoculated with zoster vaccine live (ZOSTAVAX), for routine health maintenance and for the prevention of shingles (herpes zoster) (dose, route, anatomical site, lot #, and expiration date were not provided). On an unspecified date (reported as shortly after receiving the vaccine), the pt. suffered persistent diplopia and was diagnosed with 6th cranial nerve palsy (VIth nerve paralysis). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presented prior to using zoster vaccine live (ZOSTAVAX). The pt. also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt. sustained severe and permanent personal injuries. The pt. suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, and other damages including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the event was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered VIth nerve paralysis to be disabling event.  Upon internal review, the event VIth nerve paralysis was determined to be medically significant.
Age: 56.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AEs; patient received the first dose on 30JUN2021, and the second dose was administered on 22JUL2021; This spontaneous report as received from a nurse prescriber refers to a 56 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.     The patient was vaccinated with the first dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) 1 time dose (strength, route, lot number, and expiration date not provided) for prophylaxis on 30-JUN-2021. Then, the patient received the second dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) 1 time dose (strength, route, lot number, and expiration date not provided) for prophylaxis on 22-JUL-2021. No adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; This spontaneous report was received from a lawyer referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. In or around November 2014, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, route, dosage schedule, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles.        On an unknown date the patient experienced postherpetic neuralgia.  As a direct and proximate result, Plaintiff's symptoms have resulted in physical limitations not present prior. Plaintiffs also experience mental and emotional distress due to resulting physical limitations and seriousness of Plaintiffs' condition. Plaintiffs sustained severe, serious, progressive, incurable, and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of postherpetic neuralgia was assessed as not recovered.   The reporter considered postherpetic neuralgia to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, postherpetic neuralgia was considered as disabling due to "severe and permanent injuries".
Sex: U
Vaccine: VARZOS
Symptoms: Chest pain, Herpes zoster
Clinical narrative: chest pain; herpes zoster; This spontaneous report was received from a lawyer referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, route, dosage schedule, lot number and expiration date were not reported) for prophylaxis.        On an unknown date the patient experienced herpes zoster and chest pain.  As a direct and proximate result, Plaintiff's symptoms have resulted in physical limitations not present prior. Plaintiffs also experience mental and emotional distress due to resulting physical limitations and seriousness of Plaintiffs' condition. Plaintiffs sustained severe, serious, progressive, incurable, and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of chest pain and herpes zoster was assessed as not recovered.   The reporter considered herpes zoster and chest pain to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, the events herpes zoster and chest pain were considered as disabling due to "severe and permanent injuries".
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the customer's daughter has her 1st dose of GARDASIL 9 as a teenager and is now "in her 30´s" and has just received the second dose of GARDASIL 9; No additional AE reported. N o PQC; This spontaneous report was received from a pharmacist via company representative, referring to a currently 30-year-old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On an unknown date, the teenager customer's daughter was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported).  On an unknown date (reported as "now in her 30´s"), the patient had just received the second dose of  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). No additional adverse event reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphagia, Dyspnoea, Erythema, Oropharyngeal discomfort
Clinical narrative: Tightness in Chest; Tightness in throat; Difficulty in Breathing; Redness on face and chest; difficulty in swallowing; Throat irritation; Urticaria; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in Chest), OROPHARYNGEAL DISCOMFORT (Tightness in throat), DYSPNOEA (Difficulty in Breathing), ERYTHEMA (Redness on face and chest) and DYSPHAGIA (difficulty in swallowing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to antibiotics.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST DISCOMFORT (Tightness in Chest), OROPHARYNGEAL DISCOMFORT (Tightness in throat), DYSPNOEA (Difficulty in Breathing), ERYTHEMA (Redness on face and chest) and DYSPHAGIA (difficulty in swallowing). 08-Mar-2021, the patient experienced THROAT IRRITATION (Throat irritation) and URTICARIA (Urticaria). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) 08-Mar-2021 for Adverse event, at a dose of 25 mg twice a day. At the time of the report, CHEST DISCOMFORT (Tightness in Chest), OROPHARYNGEAL DISCOMFORT (Tightness in throat), DYSPNOEA (Difficulty in Breathing), ERYTHEMA (Redness on face and chest), DYSPHAGIA (difficulty in swallowing), THROAT IRRITATION (Throat irritation) and URTICARIA (Urticaria) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up was received from regulatory authority on 18-MAY-2021. Accepted VAERS ICSR as FU.  Dose of treatment medication- 'Benadryl' was updated. Additional events- throat irritation and Urticaria. were added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Urticaria
Clinical narrative: Tightness in Chest; Tightness in throat; Difficulty in Breathing; Redness on face and chest; difficulty in swallowing; Throat irritation; Urticaria; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in Chest), OROPHARYNGEAL DISCOMFORT (Tightness in throat), DYSPNOEA (Difficulty in Breathing), ERYTHEMA (Redness on face and chest) and DYSPHAGIA (difficulty in swallowing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to antibiotics.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST DISCOMFORT (Tightness in Chest), OROPHARYNGEAL DISCOMFORT (Tightness in throat), DYSPNOEA (Difficulty in Breathing), ERYTHEMA (Redness on face and chest) and DYSPHAGIA (difficulty in swallowing). 08-Mar-2021, the patient experienced THROAT IRRITATION (Throat irritation) and URTICARIA (Urticaria). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) 08-Mar-2021 for Adverse event, at a dose of 25 mg twice a day. At the time of the report, CHEST DISCOMFORT (Tightness in Chest), OROPHARYNGEAL DISCOMFORT (Tightness in throat), DYSPNOEA (Difficulty in Breathing), ERYTHEMA (Redness on face and chest), DYSPHAGIA (difficulty in swallowing), THROAT IRRITATION (Throat irritation) and URTICARIA (Urticaria) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up was received from regulatory authority on 18-MAY-2021. Accepted VAERS ICSR as FU.  Dose of treatment medication- 'Benadryl' was updated. Additional events- throat irritation and Urticaria. were added.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration
Clinical narrative: induration; redness; This case was reported by a other health professional via sales rep and described the occurrence of induration in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced induration and erythema. On an unknown date, the outcome of the induration and erythema were unknown.   It was unknown if the reporter considered the induration and erythema to be related to Shingrix.  Additional details were provided as follows: The reporter was a medical assistant. The age at vaccination was reported. The patient had redness and induration after receiving a dose of Shingrix vaccine. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The patient received Shingles vaccine and still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization schedule, time to onset for event and laboratory confirmation of shingles were not provided.