chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 72 years old male patient with no drug reactions/allergies. Patient's medical history and concurrent condition were not reported. On 25-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # K023621, expiry date: 19-FEB-2016), 0.65 ml, subcutaneous for prevention of shingles. Concomitant therapies included OXYCODONE. Subsequently, on an unknown date in 2015 (reported as "last couple of days"), the patient experienced itchy, painful, bumpy rash on both arms and both legs. The outcome of the events was not reported. The patient sought medical attention - family member called the pharmacist. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling abnormal, Injection site pain, Injection site pruritus, Rash erythematous, Vaccination site reaction
Clinical narrative: Pt reports itching and burning, describes it as a "jaggy" feeling, red rash on upper arm where vaccine was given.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm swelling for 4 to 5 days with soreness.
Age: 0.55
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given a Kinrix vaccine instead of the DTaP and Polio that would normally be given at her age.
Sex: U
Vaccine: MMR
Symptoms: No therapeutic response, Seroconversion test negative
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with MMR II (dose and route of administration were not reported, indication reported as vaccination). On an unknown date, the patients who have been vaccinated with MMR II, failed to seroconvert. The nurse also statd that the patients verbalized their vaccination history, and sometimes were unsure if they got one or two doses of MMR II. The outcome of the event was unknown. The relatedness between the event and vaccination with MMR II was not reported. Additional information is not expected. The nurse did not want to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported) for the prevention of shingles. Other suspect and concomitant therapies were not reported. On an unknown date after receiving ZOSTAVAX, the patient experienced rash generalized. It was unspecified it the patient sought medical attention, if treatment was given for the rash generalized and if lab diagnostics studies were performed. The outcome of rash generalized was unknown. The relatedness between rash generalized and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unknown dates, the patients were administered with unknown number of doses of improperly stored RECOMBIVAX HB (dose strength, route, lot # unspecified). No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the unspecified number of patients were vaccinated (Oka/Merck) VARIVAX (dose strength, route unspecified) that were improperly stored. No adverse experiences reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via company representative, refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patient were vaccinated with ZOSTAVAX subcutaneously (dose and lot# were not reported). On an unknown dates, the patient developed redness at the injection site after an unspecified amount of time. Cold compress and BENADRYL were given for the treatment. The outcome of the event was reported as recovered/resolved (dates unknown). The relatedness between the event ZOSTAVAX was not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not specified by the reporter. On approximately 24-MAR-2015 (reported as two weeks ago), the patient was vaccinated by unspecified pharmacist with ZOSTAVAX (lot#/batch#, dose and route of administration, indication were unspecified). The patient developed shingles after getting ZOSTAVAX (on an unspecified date in 2015). It was not reported if the patient sought medical attention. The outcome of shingles was not reported. Action taken with ZOSTAVAX was reported as not applicable. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: M
Vaccine: DTAP
Symptoms: Arthralgia, Insomnia
Clinical narrative: This case was reported by a consumer and described the occurrence of sleep loss in a male patient who received DTPa (Reduced antigen). On an unknown date, the patient received dTpa vaccine at an unknown date. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced sleep loss and joint pain. On an unknown date, the outcome of the sleep loss and joint pain were unknown. It was unknown if the reporter considered the sleep loss and joint pain to be related to dTpa vaccine. Additional information received: Patient experienced some symptoms following his Tdap vaccination that were not listed as common side effects. He experienced sleep loss and joint pain and is continuing to have symptoms and treat for these symptoms.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Activities of daily living impaired, Burning sensation, Chest pain, Confusional state, Disorientation
Clinical narrative: I received the flu shot in left arm and pneumonia shot in right arm. I went home felt bad, arm hurt (right) very bad. Right arm swollen, red, burning. Pain shooting thru arm, chest. That night I feel dizzy, nauseous, pain everywhere, shaking, confused, disoriented. Went to hospital. On the day I took the shots, I had to go to the ER at Medical Center. To this day, I have felt really awful. My body aches all over every day. My left hand hurts so bad I can't pick things up. It has been hard at times to walk and I'm quite disoriented at times. My head and neck hurts, which makes me take EXCEDRIN and Ibuprofen 600 every day. My eyes keep getting red and burning. My ears are ringing constantly and loud. It even hurts to write this letter with my right hand. I can't type well anymore either. I do know it was caused from the pneumonia shot, I have no doubt. I know I am 66 and I have never drank or smoked anything in my life. I was not perfect but now I'm going thru many physical things that last too long.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Dizziness, Erythema, Eye irritation, Feeling abnormal, Gait disturbance
Clinical narrative: I received the flu shot in left arm and pneumonia shot in right arm. I went home felt bad, arm hurt (right) very bad. Right arm swollen, red, burning. Pain shooting thru arm, chest. That night I feel dizzy, nauseous, pain everywhere, shaking, confused, disoriented. Went to hospital. On the day I took the shots, I had to go to the ER at Medical Center. To this day, I have felt really awful. My body aches all over every day. My left hand hurts so bad I can't pick things up. It has been hard at times to walk and I'm quite disoriented at times. My head and neck hurts, which makes me take EXCEDRIN and Ibuprofen 600 every day. My eyes keep getting red and burning. My ears are ringing constantly and loud. It even hurts to write this letter with my right hand. I can't type well anymore either. I do know it was caused from the pneumonia shot, I have no doubt. I know I am 66 and I have never drank or smoked anything in my life. I was not perfect but now I'm going thru many physical things that last too long.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Headache, Nausea, Neck pain, Ocular hyperaemia, Pain
Clinical narrative: I received the flu shot in left arm and pneumonia shot in right arm. I went home felt bad, arm hurt (right) very bad. Right arm swollen, red, burning. Pain shooting thru arm, chest. That night I feel dizzy, nauseous, pain everywhere, shaking, confused, disoriented. Went to hospital. On the day I took the shots, I had to go to the ER at Medical Center. To this day, I have felt really awful. My body aches all over every day. My left hand hurts so bad I can't pick things up. It has been hard at times to walk and I'm quite disoriented at times. My head and neck hurts, which makes me take EXCEDRIN and Ibuprofen 600 every day. My eyes keep getting red and burning. My ears are ringing constantly and loud. It even hurts to write this letter with my right hand. I can't type well anymore either. I do know it was caused from the pneumonia shot, I have no doubt. I know I am 66 and I have never drank or smoked anything in my life. I was not perfect but now I'm going thru many physical things that last too long.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling, Tinnitus, Tremor
Clinical narrative: I received the flu shot in left arm and pneumonia shot in right arm. I went home felt bad, arm hurt (right) very bad. Right arm swollen, red, burning. Pain shooting thru arm, chest. That night I feel dizzy, nauseous, pain everywhere, shaking, confused, disoriented. Went to hospital. On the day I took the shots, I had to go to the ER at Medical Center. To this day, I have felt really awful. My body aches all over every day. My left hand hurts so bad I can't pick things up. It has been hard at times to walk and I'm quite disoriented at times. My head and neck hurts, which makes me take EXCEDRIN and Ibuprofen 600 every day. My eyes keep getting red and burning. My ears are ringing constantly and loud. It even hurts to write this letter with my right hand. I can't type well anymore either. I do know it was caused from the pneumonia shot, I have no doubt. I know I am 66 and I have never drank or smoked anything in my life. I was not perfect but now I'm going thru many physical things that last too long.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Grip strength decreased, Headache, Nausea, Neck pain, Ocular hyperaemia
Clinical narrative: I received the flu shot in left arm and pneumonia shot in right arm. I went home felt bad, arm hurt (right) very bad. Right arm swollen, red, burning. Pain shooting thru arm, chest. That night I feel dizzy, nauseous, pain everywhere, shaking, confused, disoriented. Went to hospital. On the day I took the shots, I had to go to the ER at Medical Center. To this day, I have felt really awful. My body aches all over every day. My left hand hurts so bad I can't pick things up. It has been hard at times to walk and I'm quite disoriented at times. My head and neck hurts, which makes me take EXCEDRIN and Ibuprofen 600 every day. My eyes keep getting red and burning. My ears are ringing constantly and loud. It even hurts to write this letter with my right hand. I can't type well anymore either. I do know it was caused from the pneumonia shot, I have no doubt. I know I am 66 and I have never drank or smoked anything in my life. I was not perfect but now I'm going thru many physical things that last too long.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling, Tinnitus, Tremor
Clinical narrative: I received the flu shot in left arm and pneumonia shot in right arm. I went home felt bad, arm hurt (right) very bad. Right arm swollen, red, burning. Pain shooting thru arm, chest. That night I feel dizzy, nauseous, pain everywhere, shaking, confused, disoriented. Went to hospital. On the day I took the shots, I had to go to the ER at Medical Center. To this day, I have felt really awful. My body aches all over every day. My left hand hurts so bad I can't pick things up. It has been hard at times to walk and I'm quite disoriented at times. My head and neck hurts, which makes me take EXCEDRIN and Ibuprofen 600 every day. My eyes keep getting red and burning. My ears are ringing constantly and loud. It even hurts to write this letter with my right hand. I can't type well anymore either. I do know it was caused from the pneumonia shot, I have no doubt. I know I am 66 and I have never drank or smoked anything in my life. I was not perfect but now I'm going thru many physical things that last too long.
Age: 2.0
Sex: F
Vaccine: FLUN4, HEPA
Symptoms: Pyrexia
Clinical narrative: Possible seizure activity, febrile, seen in local emergency room, referred to pediatric neurology.
Age: 1.1
Sex: M
Vaccine: FLU4, MMR
Symptoms: Biopsy bone marrow abnormal, Contusion, Differential white blood cell count abnormal, Full blood count abnormal, Injection site bruising
Clinical narrative: Bruising all over limbs and torso. Petechiae on torso.
Age: 1.1
Sex: M
Vaccine: FLU4, MMR
Symptoms: Neutropenia, Pancytopenia, Petechiae, Red blood cell count decreased, White blood cell count decreased
Clinical narrative: Bruising all over limbs and torso. Petechiae on torso.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urticaria
Clinical narrative: Mom called Health Dept at 12:30 stating infant got up this morning with welps from head to toe; MD closed this afternoon; encouraged eval at ER.
Age: 0.18
Sex: M
Vaccine: DTAP
Symptoms: Constipation, Feeling abnormal, Vomiting
Clinical narrative: Child began throwing up and vomit continues until today, 4/24/15.  Child also suffered from bouts of constipation followed by diarrhea. Child was taken back to Dr's office but Dr. dismissed symptoms as "normal" and nothing to be concerned about.  However, child is still vomiting and has not been normal self.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Rash, Respiratory tract congestion, Rhinorrhoea, Urticaria
Clinical narrative: 7pm- rash to buttocks. 8pm- red spot on cheek. 4/24/2015- woke up with hives from head to toes, congestion and runny nose; Mom gave Benadryl.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Upper extremity mass
Clinical narrative: Pt arm was swollen, red, itchy and has a pea size lump.  Patient unsure when it started.  Daughter states that she started complaining about it around 4/22/15.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Condition aggravated, Kawasaki's disease
Clinical narrative: Mother has concern with history of Kawasaki disease following rotavirus administration.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal pain upper, Abnormal behaviour, Biopsy skin abnormal, Chapped lips, Cheilitis
Clinical narrative: Mother has concern with history of Kawasaki disease following rotavirus administration.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cough, Discomfort, Dyskinesia, Dyspnoea, Eating disorder
Clinical narrative: Mother has concern with history of Kawasaki disease following rotavirus administration.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Febrile convulsion, Immunoglobulin therapy, Indifference, Irritability
Clinical narrative: Mother has concern with history of Kawasaki disease following rotavirus administration.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Kawasaki's disease, Lip haemorrhage, Nail disorder, Nasal congestion, Nasopharyngitis
Clinical narrative: Mother has concern with history of Kawasaki disease following rotavirus administration.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Ocular hyperaemia, Psoriasis, Pyrexia, Rash, Rash generalised
Clinical narrative: Mother has concern with history of Kawasaki disease following rotavirus administration.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Screaming, Skin exfoliation, Stridor
Clinical narrative: Mother has concern with history of Kawasaki disease following rotavirus administration.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood culture, Blood ethanol, Blood glucose increased, Blood lactic acid increased, Blood urea increased
Clinical narrative: Febrile seizure on 4/8/15.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Drug screen, Febrile convulsion, Full blood count, Influenza virus test, Respiratory syncytial virus test
Clinical narrative: Febrile seizure on 4/8/15.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Crying, Injection site reaction, Rash, Rash erythematous
Clinical narrative: Given vaccines (PEDIARIX, PREVNAR)-cried afterwards, then given neb. tx (albuterol)-still crying x 10 minutes. Dad came out of exam room to notify staff infant broke out in red rash to face, torso, arms, leg. No swelling, no breathing difficulty, no SOB-observed x 30 minutes-normal exam rash resolved. Pt sent home w/ instructions to call for any further reactions 911/vaccine like adverse.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Received varicella vacine on 3/26/15. On 4/4/15 noticed bumps on breast and face, then on neck and back.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Pruritus, Rash, Rash erythematous, Rash macular
Clinical narrative: Next day red spots on chin, cheeks, back of hands. Dr. prescribed BENADRYL to stop burning itching. Became blotches, looked like burns on chin, cheeks, back of hands. Rx steroid cream. Didn't help. Dr prescribed ZANTAC and ZYRTEC finally cleared up hives after weeks.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Next day red spots on chin, cheeks, back of hands. Dr. prescribed BENADRYL to stop burning itching. Became blotches, looked like burns on chin, cheeks, back of hands. Rx steroid cream. Didn't help. Dr prescribed ZANTAC and ZYRTEC finally cleared up hives after weeks.
Age: 50.0
Sex: F
Vaccine: HEPAB, HEPAB, TYP
Symptoms: Back pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of acute back pain in a 50-year-old femalel patient who received TWINRIX adult (batch number 3JR4, expiry date 19th February 2016). Co-suspect products included TYPHIM VI (batch number K1183, expiry date 6th April 2016). The patient's past medical history included hives (Zyban-hives) and allergy (Erythromycin causes cramps/diarrhea). Concurrent medical conditions included irritable bowel syndrome, blood cholesterol increased, social alcohol drinker, seasonal allergy and smoker (Smokes 1/2 pack for 30 years). Concomitant products included ALIGN, biotin, fiber, pravastatin and Vitamin D. On  9th March 2015 10:30, the patient received the 1st dose of TWINRIX adult (intramuscular) 1 ml. On 9th March 2015, the patient started TYPHIM VI (intramuscular) at an unknown dose and frequency. On 10th March 2015 03:00, 1 days after receiving TWINRIX adult, the patient experience acute back pain. On 13th March 2015, the outcome of the acute back pain was recovering/resolving. The reporter considered the acute back pain to be unlikely related to TWINRIX adult. Additional information received: The patient came in to office for a dose of TWINRIX and TYPHIM prior to travel. The patient received the dose of TWINRIX at 10:30 AM in the morning and at 3:00 AM awoke with severe back pain. She went to the emergency room and was treated with muscle relaxants and NSAIDs.
Age: 50.0
Sex: F
Vaccine: HEPAB, HEPAB, TYP
Symptoms: Back pain, Urine analysis normal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of acute back pain in a 50-year-old femalel patient who received TWINRIX adult (batch number 3JR4, expiry date 19th February 2016). Co-suspect products included TYPHIM VI (batch number K1183, expiry date 6th April 2016). The patient's past medical history included hives (Zyban-hives) and allergy (Erythromycin causes cramps/diarrhea). Concurrent medical conditions included irritable bowel syndrome, blood cholesterol increased, social alcohol drinker, seasonal allergy and smoker (Smokes 1/2 pack for 30 years). Concomitant products included ALIGN, biotin, fiber, pravastatin and Vitamin D. On  9th March 2015 10:30, the patient received the 1st dose of TWINRIX adult (intramuscular) 1 ml. On 9th March 2015, the patient started TYPHIM VI (intramuscular) at an unknown dose and frequency. On 10th March 2015 03:00, 1 days after receiving TWINRIX adult, the patient experience acute back pain. On 13th March 2015, the outcome of the acute back pain was recovering/resolving. The reporter considered the acute back pain to be unlikely related to TWINRIX adult. Additional information received: The patient came in to office for a dose of TWINRIX and TYPHIM prior to travel. The patient received the dose of TWINRIX at 10:30 AM in the morning and at 3:00 AM awoke with severe back pain. She went to the emergency room and was treated with muscle relaxants and NSAIDs.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Vaccination site induration, Vaccination site pain
Clinical narrative: Arm were vaccine was given 2 wks go-hard and painful-no redness.
Age: 46.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Gingival pain, Gingival swelling
Clinical narrative: New employee with (-) VZ and Hep B titers given one dose each vaccine 4/16/15. Approx 24 hours later, gums felt swollen and irritated. No Tmt. Lasted until 4/19/15. Symptom free 4/20/15.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of upper leg, left thigh.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: Red, itchy area-large.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Irritability, Pyrexia
Clinical narrative: Fever with fussiness 4 days after immunizations, large red bump on left thigh 10 days after immunization.
Age: 4.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site rash, Papule
Clinical narrative: 12 days after immization-rash around site and scattered papules on body.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Area hard, warm, and size of an apple, per daughter and swollen.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Generalised erythema, Rash generalised
Clinical narrative: Rash, erythema, whole body. No treatment.
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Blood pressure increased, Heart rate increased, Rash
Clinical narrative: Pt came to the office with rash, elevated heart rate, and elevated BP.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Anotia, Apparent death, Bone disorder, Cardiac disorder, Cardiac operation
Clinical narrative: I BECAME VERY SICK AND WAS UNABLE TO GET OUT OF BED WITH A FEVER.  MY CHILD WAS LATER BORN ON 09/07/2012 WITH A HEART CONDITION AND MANY BIRTH DEFECTS INCLUDING CLEFT LIP, MISSING EAR AND EAR DRUM, SCOLIOSIS, MUSCLE THAT DO NOT WORK ON THE LEFT SIDE OF HIS FACE, MISSING BONE IN NECK AND MANY MORE BIRTH DEFECTS.  HE HAS HAD TWO HEART SURGERIES, IS DUE FOR A THIRD.  HE HAS A FEEDING TUBE, TAKES MEDICINE TWICE A DAY FOR HIS HEART, AND ALMOST DIED WHEN HE WAS BORN DUE TO HIS HEART.  HE WAS ON A BREATHING TUBE FOR THE FIRST MONTH OF HIS LIFE BEFORE HIS HEART SURGERY.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cleft lip, Congenital anomaly, Foetal exposure during pregnancy, Gastrointestinal tube insertion, Mechanical ventilation
Clinical narrative: I BECAME VERY SICK AND WAS UNABLE TO GET OUT OF BED WITH A FEVER.  MY CHILD WAS LATER BORN ON 09/07/2012 WITH A HEART CONDITION AND MANY BIRTH DEFECTS INCLUDING CLEFT LIP, MISSING EAR AND EAR DRUM, SCOLIOSIS, MUSCLE THAT DO NOT WORK ON THE LEFT SIDE OF HIS FACE, MISSING BONE IN NECK AND MANY MORE BIRTH DEFECTS.  HE HAS HAD TWO HEART SURGERIES, IS DUE FOR A THIRD.  HE HAS A FEEDING TUBE, TAKES MEDICINE TWICE A DAY FOR HIS HEART, AND ALMOST DIED WHEN HE WAS BORN DUE TO HIS HEART.  HE WAS ON A BREATHING TUBE FOR THE FIRST MONTH OF HIS LIFE BEFORE HIS HEART SURGERY.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscle disorder, Scoliosis
Clinical narrative: I BECAME VERY SICK AND WAS UNABLE TO GET OUT OF BED WITH A FEVER.  MY CHILD WAS LATER BORN ON 09/07/2012 WITH A HEART CONDITION AND MANY BIRTH DEFECTS INCLUDING CLEFT LIP, MISSING EAR AND EAR DRUM, SCOLIOSIS, MUSCLE THAT DO NOT WORK ON THE LEFT SIDE OF HIS FACE, MISSING BONE IN NECK AND MANY MORE BIRTH DEFECTS.  HE HAS HAD TWO HEART SURGERIES, IS DUE FOR A THIRD.  HE HAS A FEEDING TUBE, TAKES MEDICINE TWICE A DAY FOR HIS HEART, AND ALMOST DIED WHEN HE WAS BORN DUE TO HIS HEART.  HE WAS ON A BREATHING TUBE FOR THE FIRST MONTH OF HIS LIFE BEFORE HIS HEART SURGERY.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Anomaly of middle ear congenital, Anotia, Apparent life threatening event, Bone disorder, Cardiac disorder
Clinical narrative: I BECAME VERY SICK AND WAS UNABLE TO GET OUT OF BED WITH A FEVER.  MY CHILD WAS LATER BORN ON 09/07/2012 WITH A HEART CONDITION AND MANY BIRTH DEFECTS INCLUDING CLEFT LIP, MISSING EAR AND EAR DRUM, SCOLIOSIS, MUSCLE THAT DO NOT WORK ON THE LEFT SIDE OF HIS FACE, MISSING BONE IN NECK AND MANY MORE BIRTH DEFECTS.  HE HAS HAD TWO HEART SURGERIES, IS DUE FOR A THIRD.  HE HAS A FEEDING TUBE, TAKES MEDICINE TWICE A DAY FOR HIS HEART, AND ALMOST DIED WHEN HE WAS BORN DUE TO HIS HEART.  HE WAS ON A BREATHING TUBE FOR THE FIRST MONTH OF HIS LIFE BEFORE HIS HEART SURGERY.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cardiac operation, Cleft lip, Congenital anomaly, Foetal exposure during pregnancy, Gastrointestinal tube insertion
Clinical narrative: I BECAME VERY SICK AND WAS UNABLE TO GET OUT OF BED WITH A FEVER.  MY CHILD WAS LATER BORN ON 09/07/2012 WITH A HEART CONDITION AND MANY BIRTH DEFECTS INCLUDING CLEFT LIP, MISSING EAR AND EAR DRUM, SCOLIOSIS, MUSCLE THAT DO NOT WORK ON THE LEFT SIDE OF HIS FACE, MISSING BONE IN NECK AND MANY MORE BIRTH DEFECTS.  HE HAS HAD TWO HEART SURGERIES, IS DUE FOR A THIRD.  HE HAS A FEEDING TUBE, TAKES MEDICINE TWICE A DAY FOR HIS HEART, AND ALMOST DIED WHEN HE WAS BORN DUE TO HIS HEART.  HE WAS ON A BREATHING TUBE FOR THE FIRST MONTH OF HIS LIFE BEFORE HIS HEART SURGERY.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Mechanical ventilation, Muscle disorder, Scoliosis
Clinical narrative: I BECAME VERY SICK AND WAS UNABLE TO GET OUT OF BED WITH A FEVER.  MY CHILD WAS LATER BORN ON 09/07/2012 WITH A HEART CONDITION AND MANY BIRTH DEFECTS INCLUDING CLEFT LIP, MISSING EAR AND EAR DRUM, SCOLIOSIS, MUSCLE THAT DO NOT WORK ON THE LEFT SIDE OF HIS FACE, MISSING BONE IN NECK AND MANY MORE BIRTH DEFECTS.  HE HAS HAD TWO HEART SURGERIES, IS DUE FOR A THIRD.  HE HAS A FEEDING TUBE, TAKES MEDICINE TWICE A DAY FOR HIS HEART, AND ALMOST DIED WHEN HE WAS BORN DUE TO HIS HEART.  HE WAS ON A BREATHING TUBE FOR THE FIRST MONTH OF HIS LIFE BEFORE HIS HEART SURGERY.
Age: 55.0
Sex: F
Vaccine: HEPAB, IPV, MMR, PPV, TYP
Symptoms: Erythema, Infection, Mass, Skin warm, Swelling
Clinical narrative: Pt reported that she had redness, warmth, and a large raised bump that formed a week after her injection. She had to take 10 days worth of antibiotic, her primary care physician told her she had an infection, and she continues to have a lump under the skin.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema, swelling of injection site with spread.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphemia, Electroencephalogram normal, Frustration, Self injurious behaviour
Clinical narrative: My son started to stutter slightly, which quickly escalated into a severe stutter with intervals of normalcy in-between.  He was so frustrated by the inability to express himself that each bout of severe stuttering was followed by very violent self-hitting. He, at times, was completely unable to talk.  These proceeded for hours until he went to sleep. It was less severe the next morning and then disappeared for roughly a day and a half.  The stutter came back and lasted for a few days - the hitting has become rare.  It has been losing frequency and seems to reoccur every few weeks for a few days.  I gave him charcoal for one week following the shot.  He received an EEG, results were normal.  No other treatment yet except for some vitamin supplementation to try and help.  We are in the process of scheduling a speech evaluation.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Gait disturbance, Headache, Pain in extremity, Sleep disorder
Clinical narrative: Shortly after getting home for the pharmacy I had a splitting headache that eventually went to the back of my head and down the back of my neck. Then 1 1/2 hrs later I could hardly walk due to extreme pain in my legs and lower back. After 3 days I finally went to the E.R. They took a CT Scan and took x-rays. Nothing showed up as the cause. My doctor was on vacation and I had to wait one week before I saw him. Condition was still the same. Has difficulty walking and could not sleep due to the pain in my hips. Doctor sent me to P.T. for 5 weeks. After three months from when it started (condition) I finally back to 90%. I never had this kind of problem until I had the Shingles vaccine shot. My doctor says he doesn't know what I had. My back did not go out.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Patient noticed quarter sized red dots (4 of them) on left arm and chest upon awakening. Dots are slightly raised but not itching or bothersome.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Fear, Hormone level abnormal, Inflammation, Malaise, Palpitations
Clinical narrative: After the immunization in October 2014, I starting experiencing inflammation in the facial area and eyes. My heart was racing 24 hours a day. My hormones became extremely unbearable feeling. I suddenly felt too fearful and ill to get out of bed or leave the house. After all of these months of suffering and hospitals lying and ignoring my symptoms, I have finally found an in-home care doctor's service to help me. For months I had been fighting the inflammation and adverse effects with health foods and herbal teas. I honestly do not know the exact day or time the symptoms began. I only know it was right after the immunization.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Gait disturbance, Paraesthesia
Clinical narrative: tingling in finger tips and bottoms of feet. some wobbly walking.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: There was no adverse event. Pt received Tdap 13 months previously from physician and pharmacist unaware until after injection given.
Sex: M
Vaccine: RV5
Symptoms: Intussusception, Rectal haemorrhage, Surgery
Clinical narrative: This spontaneous report was received from a consumer refers to her grandson of an unknown age. The patient's medical history or concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of ROTATEQ (oral by default, dose and lot number were not provided). Concomitant medications were not provided. On an unknown date, one week and four days later, the patient developed intussusception. The patient experienced having a diaper full of blood. Subsequently, the patient underwent surgery and was currently hospitalized (length of stay was unknown). The patient sought medical attention, spoke with healthcare provider. At the time of the report, the patient did not recover from the adverse event. Upon internal review intussusception was considered to be medically significant, as patient had to undergo surgery. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: Information has been received from a pharmacist referring to a 60 years old female patient. The patient's concurrent condition included hypothyroid, hypertension and hypercholesterolaemia. On 11-APR-2015 the patient was vaccinated with a dose of 0.65ml ZOSTAVAX (lot # K021624, expiration date 07-FEB-2015; route not reported). The area where the patient received the vaccine was lateral, proximal area of the deltoid muscle through which nerves travel. It was unknown if the patient received the vaccine subcutaneously or intramuscularly. After the vaccination, on an unknown date in April 2015 the patient experienced radiating pain from her injection site to the base of her skull. She had not taken any pain relievers because she "got stomach pain from most (unspecified) over-the-counter analgesics (manufacturers not specified)" (it was also reported that the patient had no known drug reaction/allergies). No treatment was given for the events. No lab test was performed for the events. At the time of reporting, the result of the events was reported as not recovered. The causality between the events and ZOSTAVAX was unknown. The event "radiating pain from her injection site to the base of her skull/new-onset pain" was considered as disability by the reporter. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Feeling hot, Somnolence
Clinical narrative: Patient states developed symptoms of feeling tired, warm and he was drowning for few days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Red, inflamed at site of administration. Entire upper arm is red and swollen. Doctor prescribed steroid cream and antibiotics for arm.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pruritus, Vaccination site erythema, Vaccination site induration
Clinical narrative: Erythema/induration/itching at vaccine administration site. Treated with cold compresses, H-1 blockers and NSAID.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Local swelling, Pain, Tenderness
Clinical narrative: Local redness/swelling and pain on Day #1 then central clearing but surrounding redness on day 2 (+) tender.
Age: 1.1
Sex: F
Vaccine: MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Child was given VARIVAX and MMRV together. No symptoms at present. Merck called to observe for local reaction or any symptoms.
Age: 1.11
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient presented to clinic twice for eval of rash. Dx'd 4-24-15 with (R) upper thoracic shingles.
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of confusion in a adult female patient who received Influenza vaccine (batch number unknown, expiry date unknown). Concomitant products included ACTOS, lisinopril and NORVASC. In October 2014, the patient received Influenza vaccine. On an unknown date, the dose was an unknown dose. In October 2014, less than a month after receiving influenza vaccine, the patient experienced contusion. On an unknown date, the outcome of the contusion was unknown. The reporter considered the contusion to be almost certainly related to influenza vaccine. Additional details provided as follows: The reporter was the patient's son. The patient's contusion was described as bruising on arms and hands.
Sex: F
Vaccine: DTAP
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer and described the occurrence of muscle pain in a female patient who received DTPa vaccine. In December 2014, the patient received DTaP vaccine. On an unknown date, less than a month after receiving DTaP vaccine, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown. It was unknown if the patient considered the muscle pain to be related to DTap vaccine. Additional information received: In December 2014 the patient received a tdap vaccine, which caused a extreme reaction. Her muscles became extremely painful and not working. Patient notifyed the company of this reaction in January 2015. Then, she went to the Doctors 4 times trying to figure out why and what this is doing to her body. Her 5th appointment was coming up.
Age: 68.0
Sex: F
Vaccine: HEPAB
Symptoms: Contusion, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of exacerbation of pain in a 68-year-old female patient who received TWINRIX adult (batch number 925P2, expiry date 22nd March 2016). Previously administered products included TWINRIX adult (doses 1 and 2). On an unknown date, the patient received the 3rd dose of TWINRIX adult 1 ml. On 12th February 2015, unknown after receiving TWINRIX adult, the patient experienced exacerbation of pain and contusion. On an unknown date, the outcome of the exacerbation of pain and contusion were unknown. It was unknown if the reporter considered the exacerbation of pain and contusion to be related to TWINRIX adult. Additional information received: The patient developed increased pain with 3rd injections vs dose 1 and 2. The bruising did not go away and remained for 2wks. No additional information available at the time of reporting.
Age: 67.0
Sex: F
Vaccine: HPV4, VARZOS
Symptoms: Wrong technique in drug usage process
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 67 year old patient of unknown gender. On 16-MAR-2015 at 11:30 hrs, the patient was in the office to receive a dose of ZOSTAVAX. However, the medical assistant inadvertently reconstituted the ZOSTAVAX with a vial of GARDASIL (instead of the sterile diluent) and administered it to the patient (dose, lot numbers and expiration dates were not reported). Additionally, the reporter thinks, that the dose was given intramuscularly, but she was not sure. No symptoms reported. Concomitant medication was not reported. Follow up information has been received on 21-APR-2015, which reported that the patient with diabetes mellitus, hypertension and hearing loss, who received the first dose of ZOSTAVAX (lot # K018173, expiration date not provided, reconstituted in a vial of GARDASIL (instead of the sterile diluent, reported as a first dose) (Lot # reported as K009482, expiration date not provided), subcutaneously in the left upper arm, on 16-MAR-2015 at 11:30 a.m. It was mentioned that the patient did not seek medical attention. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender who on 20-APR-2015 was vaccinated with an expired dose of PNEUMOVAX 23, expiration date on 21-FEB-2015 (dose, route, lot # were not provided). No adverse effects reported. Additional information has been requested.
Age: 1.14
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a 13 month old patient. Current condition and medical history were not reported. On 23-MAR-2015 the patient received (Oka/Merck) VARIVAX 0.5 ml, subcutaneous (lot # K005426, expiry date: 15-APR-2016) or VAQTA 0.5 ml, intramuscular (lot # K009506, expiry date: 22-SEP-2016), that were improperly stored. Concomitant medications were not reported. No adverse effects were reported. Outcome of the event, incorrect product storage was unknown. Reporting health professional considered the event to be not related to (Oka/Merck) VARIVAX or VAQTA. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a 19 month old patient. Current condition and medical histsory were not reported. On 27-MAR-2015 the patient received VAQTA 05 ml, intramuscular (lot # K009506, expiry date: 22-SEP-2016), that were improperrly stored. Concomitant medications were not reported. No adverse effects were reported. Outcome of the event, incorrec product storage was unknown. Reporting health professional considered the event to be not related to VAQTA. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from healthcare professional refers to a patient of unknown age and gender. On 21-APR-2015 the patient was vaccinated with RECOMBIVAX HB (dose, route of administration and lot # were not reported). It was reported that this vaccine had been improperly stored. No adverse effects reported. Additional information has been requested.
Age: 35.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Product label confusion, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 35 year old patient. Medical history and concurrent conditions were not reported. On 16-APR-2015, the patient was vaccinated with ZOSTAVAX 19400 PFU, dose, route, lot number and expiration date were not reported. Other suspect therapies included (Oka/Merck) VARIVAX dose, route, lot number and expiration date were not reported. On 16-APR-2015, the patient inadvertently received one dose of (Oka/Merck) VARIVAX and one dose of ZOSTAVAX at same visit. Label confusion was not addressed at time of call. No adverse effects were noted. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site pain
Clinical narrative: Shoulder discomfort and sight pain at sight of tetanus injection given x3 weeks (L) arm. No fever, no redness at sight.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 23-APR-2015, the patient was vaccinated with a 0.5 ml improperly stored dose of PROQUAD (Merck) (lot # reported as L002213 exp date 21-JUL-2016) subcutaneously. No adverse events were reported. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: 25 chickenpox.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site urticaria, Rash generalised, Urticaria
Clinical narrative: Pain and itchiness at site of injection which I was told is normal. Then slowly hives started forming at site of injection and slowly spread down that arm. Over the next week hives spread to other arm. Over the course of 3 weeks rash slowly made it's way all over my body. I told my doctor who said it was probably just pregnancy hormones and not related to vaccine but went to a dermatologist who said if it was due to pregnancy hormones, then itch would be relieved by the prescribed cream. The cream did nothing to help. I eventually took Allegra and wiped witch hazel to help itching. Hives went away on their own after about 6 weeks.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Dyspnoea, Nasopharyngitis, Pyrexia, Respiratory tract congestion
Clinical narrative: Came down with cold and fever and heightened congestion.  Am having trouble breathing.  Spent all day in bed 4/22/2015.  Was better 4/23/2015 and 4/24/2015 in the AM but developed fever in the afternoon again.  Saturday morning woke up at 3:00am drenched in cold sweat.  Had to get out of bed as it is all wet.  Am now trying to see if illness is due to pneumonia shot.
Age: 1.28
Sex: F
Vaccine: DTAP, MMR
Symptoms: Activated partial thromboplastin time normal, Basophil count increased, Basophil percentage increased, Blood lactate dehydrogenase increased, Blood test
Clinical narrative: Patient reported to the ED after eruption of purpuric rash. Found to have platelet count of 23 and developed moderate neutropenia to an ANC of 910. Clinically well. No treatment. Within 12 hours the platelet count rose to 43,000 and the ANC rose to 2100. Thought to be immune thrombocytopenic purpura with atypical feature of neutropenia.
Age: 1.28
Sex: F
Vaccine: DTAP, MMR
Symptoms: Blood uric acid normal, Eosinophil count normal, Eosinophil percentage increased, Haematocrit normal, Haemoglobin normal
Clinical narrative: Patient reported to the ED after eruption of purpuric rash. Found to have platelet count of 23 and developed moderate neutropenia to an ANC of 910. Clinically well. No treatment. Within 12 hours the platelet count rose to 43,000 and the ANC rose to 2100. Thought to be immune thrombocytopenic purpura with atypical feature of neutropenia.
Age: 1.28
Sex: F
Vaccine: DTAP, MMR
Symptoms: Immune thrombocytopenic purpura, International normalised ratio normal, Lymphocyte count increased, Lymphocyte percentage increased, Mean cell haemoglobin concentration normal
Clinical narrative: Patient reported to the ED after eruption of purpuric rash. Found to have platelet count of 23 and developed moderate neutropenia to an ANC of 910. Clinically well. No treatment. Within 12 hours the platelet count rose to 43,000 and the ANC rose to 2100. Thought to be immune thrombocytopenic purpura with atypical feature of neutropenia.
Age: 1.28
Sex: F
Vaccine: DTAP, MMR
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte count increased, Monocyte percentage increased
Clinical narrative: Patient reported to the ED after eruption of purpuric rash. Found to have platelet count of 23 and developed moderate neutropenia to an ANC of 910. Clinically well. No treatment. Within 12 hours the platelet count rose to 43,000 and the ANC rose to 2100. Thought to be immune thrombocytopenic purpura with atypical feature of neutropenia.
Age: 1.28
Sex: F
Vaccine: DTAP, MMR
Symptoms: Neutropenia, Neutrophil count decreased, Neutrophil percentage decreased, Platelet count decreased, Prothrombin time normal
Clinical narrative: Patient reported to the ED after eruption of purpuric rash. Found to have platelet count of 23 and developed moderate neutropenia to an ANC of 910. Clinically well. No treatment. Within 12 hours the platelet count rose to 43,000 and the ANC rose to 2100. Thought to be immune thrombocytopenic purpura with atypical feature of neutropenia.
Age: 1.28
Sex: F
Vaccine: DTAP, MMR
Symptoms: Purpura, Red blood cell count normal, Red blood cell morphology normal, Red cell distribution width normal, White blood cell count normal
Clinical narrative: Patient reported to the ED after eruption of purpuric rash. Found to have platelet count of 23 and developed moderate neutropenia to an ANC of 910. Clinically well. No treatment. Within 12 hours the platelet count rose to 43,000 and the ANC rose to 2100. Thought to be immune thrombocytopenic purpura with atypical feature of neutropenia.