chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Intensive care, Pain, Painful respiration, Protein total normal, Red blood cell sedimentation rate
Clinical narrative: Chest pain started on day 3 post vaccination.  Mild to moderate heavy feeling pain, worse with breathing and movement, worse with lying on left side. Presented to urgent care, labs obtained with a troponin of 13.3, ESR and CRP.  Transferred to cardiac ICU, repeat labs on admission similar.  Normal EKG, normal echo on admission.  Given 2G IVIG and 30 mg solumedrol.  Troponin the following morning decreased to 4.35.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin
Clinical narrative: Chest pain started on day 3 post vaccination.  Mild to moderate heavy feeling pain, worse with breathing and movement, worse with lying on left side. Presented to urgent care, labs obtained with a troponin of 13.3, ESR and CRP.  Transferred to cardiac ICU, repeat labs on admission similar.  Normal EKG, normal echo on admission.  Given 2G IVIG and 30 mg solumedrol.  Troponin the following morning decreased to 4.35.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Extremely heavy menstrual period with intense cramps
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Since my vaccine, I have been experiencing awful headaches every night. They will not go away.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pyrexia
Clinical narrative: That evening if the dose I developed chills, fatigue, and weakness with a mild fever of 100°.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest pain, Dyspnoea, Electrocardiogram normal, Heart rate irregular
Clinical narrative: Within 2 hours of getting the second COVID vaccine I started to have frequent sharp shooting pains in my heart making it hard to breathe as well as having erratic heart beats and blurry vision. The symptoms worsened approximately 24 hours after to where it has and continues to be sharp shooting and constant pain in my heart that travels into my left arm. Simple things like walking and breathing make it extremely painful.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Painful respiration, Vision blurred, White blood cell count decreased
Clinical narrative: Within 2 hours of getting the second COVID vaccine I started to have frequent sharp shooting pains in my heart making it hard to breathe as well as having erratic heart beats and blurry vision. The symptoms worsened approximately 24 hours after to where it has and continues to be sharp shooting and constant pain in my heart that travels into my left arm. Simple things like walking and breathing make it extremely painful.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Pyrexia
Clinical narrative: Fever 103 at 9am loss of appetite
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test abnormal, Discoloured vomit, Faeces discoloured, Hiccups, Liver disorder
Clinical narrative: 1: He had his second Moderna vaccine shot at noon May 12,2021. Within one hour, he consistently had hiccups, then followed vomiting. It last for 24 hours without any food and sleeping. 2: 5/13/2021, he was sent to Urgent care, had infusion, and Ondansetron. But he constantly had hiccups and vomiting. He could not fall asleep due to the illness.3: 5/17/2021, his vomited dark brown color material, and his defection had black color. He was sent to urgent care second time, but transferred to ER at hospital.4: 5/24/21, he started hiccups and vomiting again. His 5/25 blood tests had significant problems in liver, kidney and pancreas ( details in blood test reports). These test results make us very anxious.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pancreatic disorder, Renal disorder, Sleep disorder, Vomiting
Clinical narrative: 1: He had his second Moderna vaccine shot at noon May 12,2021. Within one hour, he consistently had hiccups, then followed vomiting. It last for 24 hours without any food and sleeping. 2: 5/13/2021, he was sent to Urgent care, had infusion, and Ondansetron. But he constantly had hiccups and vomiting. He could not fall asleep due to the illness.3: 5/17/2021, his vomited dark brown color material, and his defection had black color. He was sent to urgent care second time, but transferred to ER at hospital.4: 5/24/21, he started hiccups and vomiting again. His 5/25 blood tests had significant problems in liver, kidney and pancreas ( details in blood test reports). These test results make us very anxious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Evening after the dose I developed fatigue, a headache and chills. They cleared up by morning. The injection site began to swell and was red from day 2 through day 4 and then cleared up as well.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: There was sweling at the site of injection and it hurt whenever the area was touched. The swelling and pain stopped after 2-3 days.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, X-ray
Clinical narrative: Acute right knee pain the day after 2nd covid vaccine
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased, Pain, Pain in extremity
Clinical narrative: No real pain at injection site. Next day I started getting pain in my shoulder, I didn?t think anything of this because everyone said the pain would be at the injection site. The pain in my shoulder has just gotten increasingly worse every day, I cannot lift my arm chest level or above without pain, simple household tasks are hard, even just washing and brushing my hair. I am now getting pain down my arm into my wrist. I have to take Tylenol/Advil multiple times a day just to get through it. Sleeping is painful and I wake up throughout the night in pain and the morning is especially sore.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: No real pain at injection site. Next day I started getting pain in my shoulder, I didn?t think anything of this because everyone said the pain would be at the injection site. The pain in my shoulder has just gotten increasingly worse every day, I cannot lift my arm chest level or above without pain, simple household tasks are hard, even just washing and brushing my hair. I am now getting pain down my arm into my wrist. I have to take Tylenol/Advil multiple times a day just to get through it. Sleeping is painful and I wake up throughout the night in pain and the morning is especially sore.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Menstruation irregular, Thirst
Clinical narrative: Day 1: pain at injection sight, mild headache, resolved with ibuprofen. Day 2:  menstruation occurred 2 weeks early, moderate bleeding, moderate uterine cramping, muscle pain, severe fatigue. Day 3-5: menstruation continues, moderate bleeding severe fatigue, extreme thirst.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine spasm
Clinical narrative: Day 1: pain at injection sight, mild headache, resolved with ibuprofen. Day 2:  menstruation occurred 2 weeks early, moderate bleeding, moderate uterine cramping, muscle pain, severe fatigue. Day 3-5: menstruation continues, moderate bleeding severe fatigue, extreme thirst.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Cardiac stress test abnormal, Catheterisation cardiac normal, Chest X-ray normal, Chest pain
Clinical narrative: About 2 weeks after I received my Covid vaccine  I experienced a sharp pain in my chest. I wasn't on going so I didn't worry about it but another week after that I began to feel palpitations and decided to go to the emergency room at Hospital. I was given an EKG and an X -Ray of my chest. They didn't notice any abnormalities so they told me to follow up with my physician. My doctor made an appointment for me to have a stress test. I was on the treadmill for 6 minutes and my blood pressure dropped so low that Dr. called an ambulance to take me to the hospital.  I was there from the 27th to the 30th of May taking test.  I  also had a cardiac cath test which came back inconclusive. Another symptom that now is troubling me is vertigo
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Palpitations, Vertigo
Clinical narrative: About 2 weeks after I received my Covid vaccine  I experienced a sharp pain in my chest. I wasn't on going so I didn't worry about it but another week after that I began to feel palpitations and decided to go to the emergency room at Hospital. I was given an EKG and an X -Ray of my chest. They didn't notice any abnormalities so they told me to follow up with my physician. My doctor made an appointment for me to have a stress test. I was on the treadmill for 6 minutes and my blood pressure dropped so low that Dr. called an ambulance to take me to the hospital.  I was there from the 27th to the 30th of May taking test.  I  also had a cardiac cath test which came back inconclusive. Another symptom that now is troubling me is vertigo
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Pruritus, Visual impairment
Clinical narrative: Nose bleed, itching at nose area and thru out head region, diminished sight
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Heart rate increased, Myalgia
Clinical narrative: The day after receiving the 1st dose of Pfizer vaccine on 5/19,  my heart beat increased to 95-103 beats per minute for the entire 24 hours. I was very tired and could not focus.  I also had muscle aches. Then, on 5/20, my heart beat decreased to 85 without any treatment and I felt much better.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Constant left shoulder joint, and shoulder blade pain. Day after second dose until current time. Already take Ibuprofen daily, but that doesn?t make it better. Going to have to go get my shoulder looked at.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Mastitis, Maternal exposure during breast feeding
Clinical narrative: I am a breastfeeding mother of a 3 month old. One day after my second Pfizer vaccine I began to have symptoms of mastitis in my left breast. By Sunday I had full blown mastitis, running a fever of 102.5. I received antibiotics from my primary care and the infection began to resolve after a few days.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Incoherent, Mental status changes, Pyrexia
Clinical narrative: the day  after  2 nd  covid shot, family called to report fever 101.3 , mental status changes, incoherence, fatigue/tiredness, was instructed to call 911/visit ER for eval/tx. was admitted at Hospital  and discharged after 24 h.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site swelling
Clinical narrative: Redness/swelling around injection site. No pain at time of report submission.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus since second vaccine shot!
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Asthenia, C-reactive protein, Computerised tomogram abdomen, Full blood count
Clinical narrative: Patient states he got the covid vaccine in the morning on 4/30/2021 and by afternoon he was having difficulty walking - states he was having trouble picking his feet up. Patient states he was feeling weak and the next day had to start using a cane (walked without assistance prior to vaccination). Patient states he started losing feeling/strength/movement in feet and legs 4/30/2021, with the weakness/paralysis moving up the legs over the course of a month. Patient states he went to primary doctor approximately 3 weeks after his vaccination and reported his symptoms but his doctor "wasn't concerned". On arrival to the ER 5/31/2021 patient was totally unable to sit up unassisted and stated his decreased sensation and loss of movement had risen to bilateral hips. Patient had to be lifted to the stretcher by four staff as he was unable to help at all, with legs dangling/flaccid paralysis obvious. Patient also reports loss of bowel/bladder control since vaccination - states started losing that control as decreased sensation/movement ascended to hips/pelvic region.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Lipase, Metabolic function test, Mobility decreased, Muscular weakness
Clinical narrative: Patient states he got the covid vaccine in the morning on 4/30/2021 and by afternoon he was having difficulty walking - states he was having trouble picking his feet up. Patient states he was feeling weak and the next day had to start using a cane (walked without assistance prior to vaccination). Patient states he started losing feeling/strength/movement in feet and legs 4/30/2021, with the weakness/paralysis moving up the legs over the course of a month. Patient states he went to primary doctor approximately 3 weeks after his vaccination and reported his symptoms but his doctor "wasn't concerned". On arrival to the ER 5/31/2021 patient was totally unable to sit up unassisted and stated his decreased sensation and loss of movement had risen to bilateral hips. Patient had to be lifted to the stretcher by four staff as he was unable to help at all, with legs dangling/flaccid paralysis obvious. Patient also reports loss of bowel/bladder control since vaccination - states started losing that control as decreased sensation/movement ascended to hips/pelvic region.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Paralysis, Sensory loss, Urinary incontinence, Urine analysis
Clinical narrative: Patient states he got the covid vaccine in the morning on 4/30/2021 and by afternoon he was having difficulty walking - states he was having trouble picking his feet up. Patient states he was feeling weak and the next day had to start using a cane (walked without assistance prior to vaccination). Patient states he started losing feeling/strength/movement in feet and legs 4/30/2021, with the weakness/paralysis moving up the legs over the course of a month. Patient states he went to primary doctor approximately 3 weeks after his vaccination and reported his symptoms but his doctor "wasn't concerned". On arrival to the ER 5/31/2021 patient was totally unable to sit up unassisted and stated his decreased sensation and loss of movement had risen to bilateral hips. Patient had to be lifted to the stretcher by four staff as he was unable to help at all, with legs dangling/flaccid paralysis obvious. Patient also reports loss of bowel/bladder control since vaccination - states started losing that control as decreased sensation/movement ascended to hips/pelvic region.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient scheduled for 2nd dose of moderna vaccine. Patient was administered a Pfizer vaccine instead of the 2nd dose of Moderna. No adverse reactions, full triage completed. No abnormalities.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Eye haemorrhage, Intra-ocular injection, Ophthalmological examination abnormal, Vision blurred
Clinical narrative: states "Last May 1st I got my 1st dose of the covid vaccine... on May 4th, when I woke up, I couldn't see  well. Blurry vision on my right eye, I couldn't even read even with my glasses on.  When I blinked I could see big blobs of different colors, black, blue, green, red, yellow... I made an appointment with an ophthalmalogist (May 7) and was told there was bleeding at the back of my eye and referred to a retina doctor. May 12, I saw a retina doctor and was given 2 shots right into my eye. Now I could still see black blobs but much smaller and wherever I look I could see like white clouds with sparkling tiny lights of different colors, even if my eyes are closed. "
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: states "Last May 1st I got my 1st dose of the covid vaccine... on May 4th, when I woke up, I couldn't see  well. Blurry vision on my right eye, I couldn't even read even with my glasses on.  When I blinked I could see big blobs of different colors, black, blue, green, red, yellow... I made an appointment with an ophthalmalogist (May 7) and was told there was bleeding at the back of my eye and referred to a retina doctor. May 12, I saw a retina doctor and was given 2 shots right into my eye. Now I could still see black blobs but much smaller and wherever I look I could see like white clouds with sparkling tiny lights of different colors, even if my eyes are closed. "
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Oropharyngeal pain
Clinical narrative: Moderna COVID-19 Vaccine EUA Persistent sore throat rash/swelling around injection site , over a week after receiving.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Oral pruritus, Pain
Clinical narrative: Itching in mouth, back of throat, head, face, neck arms, shoulders approx 30 mins to  1 hour after  Light headedness shortly after shot Body ache, joint pain started few hours after shot Terrible headache on 2nd day Intense joint pain especially knees 3rd day after Nothing other than the light headedness has stopped.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Throat irritation
Clinical narrative: Itching in mouth, back of throat, head, face, neck arms, shoulders approx 30 mins to  1 hour after  Light headedness shortly after shot Body ache, joint pain started few hours after shot Terrible headache on 2nd day Intense joint pain especially knees 3rd day after Nothing other than the light headedness has stopped.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Purpura, Skin discolouration
Clinical narrative: On the 4th day of my second COVID Vaccine, I got purpura. I got red or purple discolored spots on my left knee. I am so worried this symptom can cause a Cerebral hemorrhage. I never have a Cerebral hemorrhage Before! I need to contact the doctor.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Erythema, Laboratory test, Nausea, Urticaria
Clinical narrative: Res hives, nausea, sick to stomachache
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure normal, Dizziness, Dysarthria, Fatigue
Clinical narrative: May 28th 2021:  I cant confirm that this is related to the COV10 shot but considering the that I have never felt like this in the past leads me to thbinking was caused from the shot 1.  5am my jaw was jittery and shaking 2.   In conjunction I was squeezing my jaw very tight against my mouth 3.  Lighthead,  as if I was floating 4.  Sluring words ,  I truly felt it was a stroke 5.  Fatigue Due to the situation I really felt that It was the end for me,  I had my wife contact 911.  Emergency arrived and confirmed that my blood pressure was in control and no stroke occured.    May 29th, 2021 My left upper arm began to have pain,  but oddly no redness  nor swollen areas.  May 30th I suddenly had a significant increase in pain on my arm with a large bump.   When this occurred,  I related the feelings from the incident that my wife contacted the ambulance to the shot.  The arm redness and pain is where the shot has been administered.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site erythema, Injection site mass, Injection site pain, Muscle tightness
Clinical narrative: May 28th 2021:  I cant confirm that this is related to the COV10 shot but considering the that I have never felt like this in the past leads me to thbinking was caused from the shot 1.  5am my jaw was jittery and shaking 2.   In conjunction I was squeezing my jaw very tight against my mouth 3.  Lighthead,  as if I was floating 4.  Sluring words ,  I truly felt it was a stroke 5.  Fatigue Due to the situation I really felt that It was the end for me,  I had my wife contact 911.  Emergency arrived and confirmed that my blood pressure was in control and no stroke occured.    May 29th, 2021 My left upper arm began to have pain,  but oddly no redness  nor swollen areas.  May 30th I suddenly had a significant increase in pain on my arm with a large bump.   When this occurred,  I related the feelings from the incident that my wife contacted the ambulance to the shot.  The arm redness and pain is where the shot has been administered.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor, Trismus
Clinical narrative: May 28th 2021:  I cant confirm that this is related to the COV10 shot but considering the that I have never felt like this in the past leads me to thbinking was caused from the shot 1.  5am my jaw was jittery and shaking 2.   In conjunction I was squeezing my jaw very tight against my mouth 3.  Lighthead,  as if I was floating 4.  Sluring words ,  I truly felt it was a stroke 5.  Fatigue Due to the situation I really felt that It was the end for me,  I had my wife contact 911.  Emergency arrived and confirmed that my blood pressure was in control and no stroke occured.    May 29th, 2021 My left upper arm began to have pain,  but oddly no redness  nor swollen areas.  May 30th I suddenly had a significant increase in pain on my arm with a large bump.   When this occurred,  I related the feelings from the incident that my wife contacted the ambulance to the shot.  The arm redness and pain is where the shot has been administered.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Chills, Headache, Nausea
Clinical narrative: At 4:00 p.m. after shot, had nausea, fever, chills and headache. This lasted until 8:00 p.m (4hrs).  Symptoms went away but started again at 1:15 a.m and lasted until 4:15 a.m.  After waking up at 8:00 a.m. noticed pronounced ringing in my right ear.  Later that day noticed that the top of my toes (at the base of my toes) had a burning sensation, my lower back hurt and a general overall unwell feeling.  The ringing in my right ear has been nonstop since it started.  The other symptoms have come and gone intermittently but are still present.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: At 4:00 p.m. after shot, had nausea, fever, chills and headache. This lasted until 8:00 p.m (4hrs).  Symptoms went away but started again at 1:15 a.m and lasted until 4:15 a.m.  After waking up at 8:00 a.m. noticed pronounced ringing in my right ear.  Later that day noticed that the top of my toes (at the base of my toes) had a burning sensation, my lower back hurt and a general overall unwell feeling.  The ringing in my right ear has been nonstop since it started.  The other symptoms have come and gone intermittently but are still present.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Muscle spasms, Postmenopause
Clinical narrative: Cramping and bleeding on 5/5/2021 and 5/24/2021 in post-menopausal woman.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: dizziness and imbalance, ongoing for more than 5 weeks, severity ranges from moderate to mild, no treatment available
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus in right ear. It has not improved.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, C-reactive protein increased, Computerised tomogram abdomen abnormal, White blood cell count increased
Clinical narrative: Appendicitis
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Neck pain, Sensation of blood flow
Clinical narrative: neck pain; left sided beat in the head where the blood runs from head to neck; This is a spontaneous report from a contactable other health professional (patient). A 44-years-old female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: El3248), dose 1 via an unspecified route of administration, in left arm on 13Jan2021 08:00 (at 44-years age) as 1st dose, single dose for covid-19 immunisation. Medical history included food allergy (with pineapple and egg). The patient's concomitant medications were not reported. No other medications in two weeks of vaccination. No Covid prior vaccination and covid was not tested post vaccination. Two weeks after first dose (i.e on sunday 24Jan2021) in early morning at 3:30, the patient had a severe neck pain followed by a left sided beat in the head where the blood runs from head to neck. Ten minutes later it passed, and she went to hospital where they ran a CT that came out negative. The adverse event resulted in emergency room/urgency room. Treatment was received for the events with gabapentin 100mg. The outcome of the events was resolved in 2021.  Follow-up (03Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the translating. The response included: adverse events details reported.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no new AE; A medical assistant reported ROT ATEQ was improperly stored and administered. The vaccine had multiple excursions that started on 09 MAR 2021; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The reporter did not provide information about the patient's pertinent medical history, drug reactions, allergies, and concomitant medications.  Since 09-MAR-2021, the vaccine Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot # 1742461, expiration date 17-NOV-2021) has been under multiple temperature excursions. On that day, at 34.5 Fahrenheit (F) for a timeframe of 3,5 hours; on 12-MAR-2021, 34.90 F for a timeframe of 0,75 hour; on 14-MAR-2021, 34.70 F for a timeframe of 0,5 hour; and on 16-MAR-2021, 19-MAR-2021, 21-MAR-2021, 22-MAR-2021, 23-MAR-2021, 10-APR-2021 and 12-APR-2021, at 35.2 F for a timeframe of 0.25 hours. On 03-MAY-2021, this vaccine was administered to the patient orally (dose, strength, scheme of vaccination were not reported), as prophylaxis. The data logger did detect the temperatures excursions.   No additional adverse event (AE) (no adverse event).; Sender's Comments:  US-009507513-2105USA002236: US-009507513-2105USA002232: US-009507513-2105USA007108:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no further AEs reported; received an expired dose of ROTATEQ on 13MAY2021; This spontaneous report was received from a physician and refers to a 2-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-MAY-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660998, expiration date: 03-MAY-2021 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis. No adverse event was reported.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; the patient was administered expired M-M-R II; This spontaneous report was received from a registered nurse and refers to a 15-month-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 14-MAY-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II), lot # S014436, expiry date: 09-MAY-2021 (formulation, strength, dose, frequency, route of administration were not provided) for prophylaxis. No adverse events and temperature excursion were reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No PQC or additional AEs reported; expired dose of ROTATEQ was administered; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.  On 14-MAY-2021, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 milliliters (ml) administered orally for prophylaxis  (dose number and vaccination scheme frequency were not reported; lot number 1676324 has been verified to be valid, expiration date reported and validated as 21-ABR-2021) (expired product administered).  The reporter requested information regarding the potency of vaccine. No additional adverse events (AEs) reported.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no reported patient side effects; an expired dose of ROT ATEQ was administered; This spontaneous report as received from a nurse refers to a 4-month-old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 18-MAY-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660992, expiration date 30-APR-2021, 2 ml, orally (also reported as by mouth) x1dose for prophylaxis. There was no adverse effects reported.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dysgeusia
Clinical narrative: metal taste; This spontaneous report as received from a consumer via other company (Pfizer, manufacturer control # 2021279132) refers to a currently 62-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, reported as "in November", the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis and influenza vaccine (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced metal taste.  The outcome of the event and the relatedness between the event and the suspect vaccines were not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: VAQT A which was administered to a patient which was 3 weeks expired; This spontaneous report was received from a Nurse, referring to a patient of unknown age and gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided.      On 14-MAY-2021, the patient was vaccinated an expired dose of with hepatitis a vaccine, inactivated (VAQTA), with lot # T014590 and expiration date on 15-APR-2021 (route of administration was not provided) for prophylaxis.   The nurse also reported  "another issue" they had with an expired hepatitis a vaccine, inactivated (VAQTA) (MARRS # 2105USA007618).   This is one of two reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2105USA007618:
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Patient was administered expired ROTATEQ; This spontaneous report was received from a nurse practitioner referring to a 2 months old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.      On 19-MAY-2021, the patient was vaccinated with the expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose and strength were not reported, lot # 1660991, expiration date 27-APR-2021) orally for prophylaxis. No temperature excursion was reported for affected rotavirus vaccine, live, oral, pentavalent (ROTATEQ). No additional adverse event was reported. The reporter requested an evaluation for administered/expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ).
Sex: F
Vaccine: MMR
Symptoms: Hypersensitivity, Petechiae
Clinical narrative: an allergic reaction to an MMR vaccine (8 weeks of petichial rash); an allergic reaction to an MMR vaccine (8 weeks of petichial rash); This spontaneous report was received from a consumer via other company letter, and refers to a 12-year-old female patient. The patient's pertinent medical history included anaphylaxis to cashews and dairy. Information regarding the patient's concomitant therapies was not reported.    On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), as prophylaxis (dose, dose number, route of administration, lot number, and expiration date were not reported). The reporter stated the patient was having an alergiec reaction to the MMR vaccine (drug hypersensitivity): 8 weeks of petechial rash (petechiae).      The outcome of drug hypersensitivity and petechiae was unknown. The causal relationship between the occurred events and the suspect vaccine was implied.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: with symptoms similar to pneumonia for some time; This spontaneous report has been received from a lawyer, via a  FactSheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1907USA012306), concerning an elderly female patient.  On an unspecified day in 2010, the patient received Pneumococcal Vaccine (+) Polyvalent (23-valent) (PNEUMOVAX 23) (reported as PNEUMOVAX) (strength, dose, route, anatomical location, lot# and expiration date were not reported) as prophylaxis.  On an unspecified date, the patient presented with symptoms similar to pneumonia (Pneumonia) for some time.  The causality assessment between Pneumococcal Vaccine (+) Polyvalent (23-valent) (PNEUMOVAX 23) and the event symptoms similar to pneumonia was considered as related.  Upon internal review, pneumonia was determined to be medically significant.  Upon internal review, the case 1907USA012306, previously submitted with zoster vaccine live (ZOSTAVAX) and Pneumococcal Vaccine (+) Polyvalent (23-valent) (PNEUMOVAX 23) has been split per internal guidelines to capture separately the adverse events related to Pneumococcal Vaccine (+) Polyvalent (23-valent) (PNEUMOVAX 23).; Sender's Comments:  US-009507513-1907USA012306:
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G normal, Cerebellar ataxia, Encephalitis, Incorrect route of product administration, Magnetic resonance imaging head abnormal
Clinical narrative: Patient currently has a negative VZV IgG level.; Route of Administration: IM; acute cerebellar ataxia/ cerebellitis confirmed on MRI; This spontaneous report was received from a physician and refers to a currently 18-years-old female patient. The patient had none pertinent medical history and none concomitant medication. No known drug allergies (NKDA) was reported.  On an unknown date in 2003, reported as 18 years ago, the patient as an infant was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), 1 injection, intramuscularly (incorrect route of product administration) for varicella zoster virus (VZV) prophylaxis (exact dose, anatomical location, lot# and expiration date were not reported).  Within 10 days of receiving the vaccine, the patient experienced acute cerebellar ataxia/ cerebellitis (encephalitis) confirmed on magnetic resonance imaging (MRI) (date not reported). The patient sought medical attention and received "supportive management", other treatments (if any) were unknown by reporter (he was not involved in the patient's care at the time). The reporter stated, that there were no isolates from the event available, nor was the medication vial available. On an unknown date, reported as currently, she had a negative VZV IgG level (antibody test negative).  The outcome of acute cerebellar ataxia/ cerebellitis was reported as recovered on an unknown date. The outcome of negative VZV IgG level was not recovered. Action taken with varicella virus vaccine live (oka/merck) (VARIVAX) was reported as not applicable, however no further doses were administered.  The relatedness between acute cerebellar ataxia/ cerebellitis and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown as they could not definitively trace the symptoms to the vaccine administration at the time of the event. The causality assessment between the negative VZV IgG level and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.  The reporter considered the case as non-serious, but upon internal review, the event of cerebellitis was determined to be medically significant.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient that was to get her last dose of Rabavert in the series on the 25th and did not get it that day; Case reference number US-BN-2020-019901 is a spontaneous case report initially received from a pharmacist via Agency (reference number USBAV20-0243) on 28-Dec-2020, and concerns a 63-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 11-Dec-2020, the patient received RabAvert (Inactivated Rabies Virus Vaccine, Batch no. ARBA731A) at unknown dose for post-exposure prophylaxis.  On 14-Dec-2020, the patient received second dose of RabAvert at unknown dose for post-exposure prophylaxis.  On 18-Dec-2020, the patient received third dose of RabAvert at unknown dose for post-exposure prophylaxis.  The patient was to get her last dose of RabAvert in the series on the 25-Dec-2020 and did not get it that day (inappropriate schedule of vaccine administered).   *At the time of this repot it was confirmed that the patient did not experience any adverse event.*  Follow up information received from pharmacist on 13-Jan-2021 included confirmation that the patient didn't experience any adverse event; Reporter's Comments: Inappropriate schedule of vaccine administered is listed by convention. Reportedly, the patient did not receive the last dose of RabAvert on the day when it was scheduled which is considered to be inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered is not related to the vaccine itself, but to human action.; Sender's Comments: Inappropriate schedule of vaccine administered is listed by convention. Reportedly, the patient did not receive the last dose of RabAvert on the day when it was scheduled which is considered to be inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered is not related to the vaccine itself, but to human action.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient who is late on 3rd dose of RabAvert vaccine for post-exposure prophylaxis; Case reference number US-BN-2020-019904 is a spontaneous case report initially received from a nurse via Agency(reference number USBAV20-0247) on 28-Dec-2020, and concerns a 21-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 03-Dec-2020, the patient received RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dose for post-exposure prophylaxis.  On 11-Dec-2020, the patient received second dose of RabaVert (Batch no. was not provided) at unknown dose for post-exposure prophylaxis.  The patient was late on third dose of RabaVert vaccine for post-exposure prophylaxis (inappropriate schedule of vaccine administered).   *At the time of this report it was known that the patient had no known adverse reactions due to RabaVert.*  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).   Follow up information was received from a nurse on 27-Jan-2021: Information included updated patient's details and confirmation that the patient had no known adverse events due to RabaVert.; Reporter's Comments: Inappropriate schedule of vaccine administered is listed by convention. Reportedly, the patient was late on the third dose of RabAvert vaccine for post-exposure prophylaxis which is considered to be inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered is not related to the vaccine itself, but to human action.; Sender's Comments: Inappropriate schedule of vaccine administered is listed by convention. Reportedly, the patient was late on the third dose of RabAvert vaccine for post-exposure prophylaxis which is considered to be inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered is not related to the vaccine itself, but to human action.
Sex: F
Vaccine: RAB
Symptoms: Animal bite, Inappropriate schedule of product administration, No adverse event
Clinical narrative: The second dose was dive on day 5, instead of Day 3 due to the office being closed on the weekend; Case reference number US-BN-2021-000003 is a spontaneous case report initially received from nurse on 11-JAN-2021, and concerns a 19-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 09-Dec-2020, the patient started therapy with RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dose for a dog bite.   On 14-Dec-2020 (day 5), the patient received the second dose of RabaVert  (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at an unknown dose for a dog bite (Inappropriate schedule of vaccine administered). It was reported that the second dose was given on day 5 instead of day 3 due to "the office being closed on the weekend".  On 16-Dec-2020, the patient received the third dose of RabaVert  (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dose for dog bite.  On 23-Dec-2020, the patient received the last dose of RabaVert  (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dose for dog bite.  At the time of this report ,it was not known whether the patient developed any adverse event and It was known nurse stated that patient still need last dose.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed by convention. Reportedly, the patient received the second dose of RabaVert on day 5, instead of day 3, due to human action which is considered to be inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of product (vaccine) administration is not related to the RabaVert, but to human action.; Sender's Comments: Inappropriate schedule of product administration is listed by convention. Reportedly, the patient received the second dose of RabaVert on day 5, instead of day 3, due to human action which is considered to be inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of product (vaccine) administration is not related to the RabaVert, but to human action.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: patient did not come for their second dose; Case reference number US-BN-2021-000027 is a spontaneous case report initially received from nurse practitioner on 21-JAN-2021, and concerns a male patient.  The patient's medical history was not provided.  The patient's concomitant medication details were not provided  In middle of Dec of an unknown year (second week of December as reported), the patient started therapy with RabaVert  (Inactivated Rabies Virus Vaccine, Batch no.ARBA731B) at unknown dose for pre-exposure prophylaxis. After receiving the first dose, the patient did not come for their second dose and it has been a month and a half. (missed dose)  At the time of this report it was not known whether the patient developed any adverse event.  No further information was provided.; Reporter's Comments: Product dose omission issue is listed by convention. Reportedly, the patient did not come for the second dose of RabaVert, which is considered as product dose omission. Reported event is not related to RabaVert , but to human action.; Sender's Comments: Product dose omission issue is listed by convention. Reportedly, the patient did not come for the second dose of RabaVert, which is considered as product dose omission. Reported event is not related to RabaVert , but to human action.
Sex: U
Vaccine: RAB
Symptoms: Accidental exposure to product, Exposure to body fluid, Exposure to contaminated device, Injury associated with device
Clinical narrative: Upon removal of needle after administration, needle stuck left 4th finger of the site; Case reference number US-BN-2021-000032 is a spontaneous case report initially received from an Pharmacy Supervisor via GSK (reference number was not provided) on 21-Jan-2021 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medications details were not provided.  On an unspecified date, a second dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) was administered to the patient's right deltoid at unknown dose for unknown indication. Upon removal of needle after administration, needle stuck left fourth finger of the person who was administering the vaccine, blood present and site immediately rinsed with warm water and soap.  At the time of this report the outcome of the event was unknown ,and it was known that the reporter stated that there was no retraction mechanism in place for needles in the rabies kit and asked was that something the company had considered.  The reporter did not provide the seriousness and causality assessment.   Additional information received from Inpatient Pharmacy Supervisor on 22-Jan-2021 included confirmation that the country of occurrence.  Reporter refused to be contacted. No further follow up is possible.; Reporter's Comments: Injury associated with device is unlisted for RabaVert as per prescriber information and Agency. Reportedly, second dose of RabaVert was administered to the patient's right deltoid at unknown dose for unknown indication. Upon removal of needle after administration, needle stuck left fourth finger of the person who administered vaccine, which is considered as injury associated with device. Reported event is not related to RabaVert but to human action.; Sender's Comments: Injury associated with device is unlisted for RabaVert as per  prescriber information  and Agency. Reportedly, second dose of RabaVert was administered to the patient's right deltoid at unknown dose for unknown indication. Upon removal of needle after administration, needle stuck left fourth finger of the person who administered vaccine, which is considered as injury associated with device. Reported event is not related to RabaVert but to human action.