chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Fall, Pallor
Clinical narrative: After administering 2 IM injections, Typhoid and Hepatitis A, the patient appeared to faint. He slumped to his right and landed on his mom's lap. His eyes were opening and closing for 3-5 seconds. He was easily arouseable and once the brief episode passed, he was alert and oriented to person, place and time. He did not appear to be in any respiratory or cardiac distress. He did appear slightly pale. Legs lifted to accommodate blood flow to head, water and snack given. He verbalized he was OK, but just did not remember what happened. Mom denies any health problems, allergies, medicatoins or previous reaction like this to a vaccine. He does admit to not eating breakfast. He recovered quickly and left with his mom after 20 minutes. Support and reassurance provided.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: PROVIDER ON CALL RECEIVED PHONE CALL AFTER HOURS ON 06/02/2016 FROM MOTHER. MOTHER STATED PATIENT HAD AN AREA ON LEFT DELTOID THAT WAS RED, SWOLLEN HOT TO TOUCH & TENDER. PROVIDER ON CALL SENT THEM TO URGENT CARE FOR EVALUATION & TREATMENT.
Age: 47.0
Sex: M
Vaccine: MMR
Symptoms: Pain, Rash papular
Clinical narrative: 7-10 days after injection reported body aches, followed by a red raised palpular rash.
Age: 19.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Purulent discharge, Rash pustular, Sunburn
Clinical narrative: Patient fell asleep outside without shirt on. Sustained second degree sunburn to over 50% of left arm. Patient was 11 days post smallpox administration into deltoid of limb. Also exhibited numerous sites of white pustules to lower limb beginning at elbow and extending distally over medial lateral aspect of same appeared intact with moderate amount of pus in each. No sites like this above elbow.
Age: 0.61
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site nodule, Staphylococcal infection
Clinical narrative: DEVELOPED KNOTS UNDER IMMUNIZATION SITE, AND IS BEING TREATED FOR STAPH INFECTION.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Hyporesponsive to stimuli, Pallor, Vomiting
Clinical narrative: Mom reports patient vomited and became pale and less responsive than normal. Entire event lasted a few minutes, and he recovered to normal level of consciousness spontaneously.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Blood glucose normal, Seizure, Syncope
Clinical narrative: Patient was given vaccine in right deltoid shortly after that lab tech started to draw blood on left arm. As tech was finishing drawing final tube patient fainted and than began to seize. Reaction could be a result of anxiety and not eating or drinking anything that morning.
Age: 20.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Peripheral swelling
Clinical narrative: Patient reports severe arm swelling and pain on upper arm that the injection was administered. Patient has tried ibuprofen and Benadryl with no symptom improvement.
Age: 1.03
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Autism spectrum disorder, Constipation, Decreased eye contact, Dyskinesia, Food allergy
Clinical narrative: Soreness and swelling at the injection sight followed by a mild fever the evening of the vaccine. As early as the next day she began stimming: arm flapping, rocking, bouncing. She started refusing eye contact, ignored speech, and her babbling stopped. By her next well visit, our pediatrician raised concerns over missed milestones and recommended us to an in home therapeutic program to test for possible Autism Spectrum Disorder. Her sensory issues increased: mouthing, sensitive to many types of touch, sensitivity to noises. She suffers from chronic constipation. Her verbal ability is extremely diminished and primarily relys on "scripting" (memorization of movies/scripts) to express herself. Has OCD tendencies and food sensitivities. She obtained an educational diagnosis of ASD in July 2013, and an official medical diagnosis in 2015. She is expected to require assistance and therapeutic treatment for the duration of her life.
Age: 1.03
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Hyperacusis, Hyperaesthesia, Injection site pain, Injection site swelling, Obsessive-compulsive disorder
Clinical narrative: Soreness and swelling at the injection sight followed by a mild fever the evening of the vaccine. As early as the next day she began stimming: arm flapping, rocking, bouncing. She started refusing eye contact, ignored speech, and her babbling stopped. By her next well visit, our pediatrician raised concerns over missed milestones and recommended us to an in home therapeutic program to test for possible Autism Spectrum Disorder. Her sensory issues increased: mouthing, sensitive to many types of touch, sensitivity to noises. She suffers from chronic constipation. Her verbal ability is extremely diminished and primarily relys on "scripting" (memorization of movies/scripts) to express herself. Has OCD tendencies and food sensitivities. She obtained an educational diagnosis of ASD in July 2013, and an official medical diagnosis in 2015. She is expected to require assistance and therapeutic treatment for the duration of her life.
Age: 1.03
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Pyrexia, Sensory disturbance, Speech disorder, Unresponsive to stimuli
Clinical narrative: Soreness and swelling at the injection sight followed by a mild fever the evening of the vaccine. As early as the next day she began stimming: arm flapping, rocking, bouncing. She started refusing eye contact, ignored speech, and her babbling stopped. By her next well visit, our pediatrician raised concerns over missed milestones and recommended us to an in home therapeutic program to test for possible Autism Spectrum Disorder. Her sensory issues increased: mouthing, sensitive to many types of touch, sensitivity to noises. She suffers from chronic constipation. Her verbal ability is extremely diminished and primarily relys on "scripting" (memorization of movies/scripts) to express herself. Has OCD tendencies and food sensitivities. She obtained an educational diagnosis of ASD in July 2013, and an official medical diagnosis in 2015. She is expected to require assistance and therapeutic treatment for the duration of her life.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Neuralgic amyotrophy, Pain in extremity, X-ray
Clinical narrative: She started complaining that her arm and hand hurt and she could not use her hand. She saw Dr at after-hours clinic the next day, Dr 3 days later, then orthopedics specialist and neurology specialist that finally diagnosed Parsonage-Turner Syndrome caused by vaccines. Referred to pediatric rheumatologist for on going treatment.
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Muscular weakness, Pain, Tremor, Vertigo
Clinical narrative: Violent chills/shaking. Vertigo. Very sore and weak muscles.
Age: 72.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Developed redness on left arm and itching and swelling next day.
Age: 0.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event noted at this time.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Myoclonus, Pyrexia
Clinical narrative: Myoclonic jerking, fever' treated with ibuprofen in office when patient returned.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Musculoskeletal pain
Clinical narrative: Patient states he has sore left shoulder, needs assistance to dress.  Vaccine administered to RIGHT arm.
Age: 52.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Skin warm, Staphylococcal infection, Swelling
Clinical narrative: Started out warm and swollen but kept increasing in diameter and got hot to touch. Went to ER and was empirically diagnosed with Staph infection.
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Feeling hot, Urticaria
Clinical narrative: REDNESS, HEAT, WELTS. PT INSTRUCTED TO TAKE BENADRYL AND SEEK MEDICAL ATTENTION IF WORSENING.
Age: 73.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site abscess, Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Patient was given Prevnar 13 IM in left arm on 5/30/16. Patient reported to pharmacy a red itchy rash around left arm injection site on 6/3/16. Patient was seen by physician later in the day on 6/3/16 who provided treatment.  Patient was given Zostavax SQ in right arm on 5/30/16. Patient reported to pharmacy a warm ring around right arm injection site on 6/3/16. Patient was seen by physician later in the day on 6/3/16 who provided treatment.
Age: 1.59
Sex: M
Vaccine: TDAP
Symptoms: Abnormal behaviour, Pyrexia, Unresponsive to stimuli
Clinical narrative: High fever, laying around. Fee days was acting a little different. Before vaccination was responding to name more.
Age: 5.0
Sex: M
Vaccine: DTPIPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives, fever.
Age: 46.0
Sex: F
Vaccine: PNC13
Symptoms: Circumstance or information capable of leading to medication error, Immediate post-injection reaction, Injection site pain, Underdose
Clinical narrative: The patient had experienced a pain due to the needle stick, she felt the pain as soon as the needle got in touch with her skin she started complaining about it as the needle was introduced into the muscle, she started moving her hand, even though I tried to calm her down and confort her as this normal and she may feel a little sore due to the needle, but she continue to act uncomfortable, and the second I started to inject the medicine, she was hurt so bad and this was hapening the second I was injecting, she didn't stop moving that I decided to stop the administration of the vaccine giving the fact that the medicine may be the one giving her the pain, she received half of the dose of Prevnar 13.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Confusional state, Dizziness, Dyspnoea, Fatigue, Injection site erythema
Clinical narrative: Extreme fatigue, confusion, dizziness, huge swelling and redness at injection site, labored breathing (SOB); Rest, plenty of fluids, self(home) treatment of OTC Benadryl, utilized an inhaler (Pro-air); also doctor's visit with NP (on 03/28/16) to ensure no vitamin B12 deficiency & even requested injection due to the fatigue, SOB, and confusion but NP suggested labs initially. Labs displayed no B12 deficiency. Received vaccination due to WC injury (lacerated digit).
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Vitamin B12 normal, X-ray
Clinical narrative: Extreme fatigue, confusion, dizziness, huge swelling and redness at injection site, labored breathing (SOB); Rest, plenty of fluids, self(home) treatment of OTC Benadryl, utilized an inhaler (Pro-air); also doctor's visit with NP (on 03/28/16) to ensure no vitamin B12 deficiency & even requested injection due to the fatigue, SOB, and confusion but NP suggested labs initially. Labs displayed no B12 deficiency. Received vaccination due to WC injury (lacerated digit).
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Severe pain in shoulder and difficulty moving arm. Forcing to move the arm with pain, range of motion was still limited. Lasted for 72 hours.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Itching rash on the body.
Age: 0.25
Sex: F
Vaccine: DTPIHI
Symptoms: Abnormal behaviour, Injection site erythema, Injection site induration, Injection site pain, Psychomotor hyperactivity
Clinical narrative: He had a high fever of 103, and a hard spot at the place of injection.
Age: 0.25
Sex: F
Vaccine: DTPIHI
Symptoms: Pyrexia
Clinical narrative: He had a high fever of 103, and a hard spot at the place of injection.
Age: 41.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Burning sensation, Peripheral swelling, Pruritus
Clinical narrative: Patient notified the pharmacy to tell us that her arm was swollen, burning, and itching. Pharmacist counseled pt to place cold compress on the arm and to take a pain/fever reliever such as ibuprofen. Told the patient seek medical attention if symptoms become worse or if she experiences oral swelling inside or outside the mouth, trouble swallowing, or rash beyond the the injection site.  The pharmacist would follow-up with pt in the morning.
Sex: M
Vaccine: HEPAB
Symptoms: Joint injury, Radiculitis brachial
Clinical narrative: This case was reported by a consumer and described the occurrence of brachial neuritis in a adult male patient who received TWINRIX adult (batch number B457F, expiry date unknown). On 27th September 2013, the patient received TWINRIX adult. On an unknown date, an unknown time after receiving TWINRIX adult, the patient experienced brachial neuritis (serious criteria disability) and injury to shoulder nos. On an unknown date, the outcome of the brachial neuritis and injury to shoulder nos were unknown. It was unknown if the reporter considered the brachial neuritis and injury to shoulder nos to be related to TWINRIX adult. Additional details were provided as follows: The age at vaccination was not reported. The patient's right arm was injured due to vaccination with TWINRIX adult. The patient experienced shoulder injury related to vaccine administration (SIRVA) and brachial neuritis. The patient was possibly permanently disabled.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Abscess, Cellulitis
Clinical narrative: This spontaneous report was received from a licensed practical nurse, who is also the patient, 39 or 40 years old female patient. Concurrent conditions included antiphospholipid syndrome, ankylosing spondylitis, juvenile idiopathic arthritis, autoimmune thyroiditis, Sjogren's syndrome, and albumin urine. Additionally, the patient's medical history included a hysterectomy and a disability due to a fractured hip in 2003 and osteopenia; the patient had been in a wheelchair. On an unspecified date in 2006, the patient was vaccinated with PNEUMOVAX 23 (dose number, route of administrations, anatomical location, and lot # and expiration date not reported). Concomitant therapies included aspirin (manufacturer unknown) and SYNTHROID. After vaccination, also approximately in 2006 (reported as "believed this occurred in 2006") the patient developed an abscess which ended up in a cellulitis (location was unspecified), consequently, the patient was hospitalized for 4 or 5 days. At the reporting time, the outcome of abscess and cellulitis was unknown. The causal relationship between vaccination with PNEUMOVAX 23 and the events was not reported. Upon internal review the event of cellulitis was considered medically significant. Subsequently, the patient experienced adverse events while on therapy with lisinopril (manufacturer unknown) (captured in MARRS # 1606USA000913). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Cellulitis of upper left arm; first appeared 05/02/2016 and patient saw MD on 05/10/2016. Treated with cephalexin 500 mg 3 x daily x 10 days. Affected area from elbow to shoulder.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Pt. received vaccine at 10 AM. Came back in the store later to tell me that he got nauseous and did vomit after he went home within 1 hr. of vaccine.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB, TDAP
Symptoms: Dyskinesia, Immediate post-injection reaction
Clinical narrative: Per Dr, three immunizations were given to patient on 06/02/2016 at 10:45am, Tdap and TRUMENBA given in Left deltoid IM given one inch apart. Hep A was given in Right deltoid IM. After injection of Hep A patient, who was in a sitting position, stated that she would like to lay down. As I was still at her side I assisted her to a prone position on the exam table. Patient immediately has jerking motion of arms and legs which consisted of 10-15 jerking motions. Patient closed eyes for 2-3 seconds. Patient was not left alone at bedside and a call for doctor assist was given. Patient stopped jerking motions and was orientated to person and place and stated she thought she had fallen asleep. 10-15 seconds time elapsed from start to end of jerking motions. Time elapsed from start of injections to end of jerking episode was 3 minutes. Upon end of episode of jerking motions Dr arrived for evaluation of patient. Please note, patient has previously had MENACTRA vaccination on 08/03/2015 with no adverse event. Today, on 06/02/16 patient was given TRUMENBA vaccination to complete series.
Age: 47.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea and diarrhea after oral typhoid.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Dyspnoea, Eye irritation, Pyrexia, Vomiting
Clinical narrative: Patient developed fever, vomiting, eyes burning, joint pains, shortness of breath.
Age: 23.0
Sex: M
Vaccine: HPV9
Symptoms: Cyanosis, Eye movement disorder, Muscle twitching, Mydriasis, Pallor
Clinical narrative: (1-2 mins) total - pupils dilated, eyes rolled back, tremors/twitches for 1 min then stopped. Patient's face pale, lips somewhat blue, breathing, unresponsive to sound, then patient woke up, conscious and responsive, vital signs stable, patient safety maintained.
Age: 23.0
Sex: M
Vaccine: HPV9
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: (1-2 mins) total - pupils dilated, eyes rolled back, tremors/twitches for 1 min then stopped. Patient's face pale, lips somewhat blue, breathing, unresponsive to sound, then patient woke up, conscious and responsive, vital signs stable, patient safety maintained.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to multiple unspecified patient of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of ZOSTAVAX reported lot # M003486 with expiration date of 27-MAR-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was also reported by the Licensed Practical Nurse, that the vaccine was exposed to a temperature excursion of -7 degrees C for a time of 411 minutes. No additional temperature excursion was reported. Data logger was stated. Furthermore, no adverse events were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to unspecified multiple patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On 29-MAR-2016, 05-MAY-2016 and 06-MAY-2016, the patients were vaccinated with an improperly stored dose of ROTATEQ (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. The Licensed Practical Nurse stated, that the first vaccine administered had a lot # of L013192 with an expiration date of 19-JAN-2017 and it was exposed to a temperature excursion of 23.4 degrees C for 2 hours and 4 minutes. Moreover, the other two vaccines administered, since the beginning of the cumulative excursion, had a lot number of L033545 with an expiration date of 30-MAR-2017 and were exposed to a temperature excursion of 23.4 degrees C for 3842 minutes (64.03 hours). Data logger and no previous exposures were reported. Furthermore, no adverse effect was stated and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to 18 patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of PEDVAXHIB lot # L038501 with expiration date of 16-JUN-2018; lot # L051122 with expiration date of 12-OCT-2018 and lot # M001813 with expiration date of 14-OCT-2018 (anatomical route of vaccination and dose number were not provided). It was stated by the reporter, that the vaccine was exposed to a temperature excursion of 9 degrees C for 35 minutes. The vaccine has not been exposed to any previous temperature excursion and a data logger was stated. Furthermore, no adverse events were reported due to PEDVAXHIB and no product quality issue was involved. This is one of several reports received from the same reporter. 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 Licensed Practical Nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated an improperly stored dose of VAQTA (anatomical route of vaccination, dose number, lot number and expiration date were not provided). The patient's concomitant medications were not reported. It was stated by the Licensed Practical Nurse that the patients did not suffer from any adverse event, furthermore, no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a unspecified multiple patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L009155 with expiration date of 29-OCT-2016, lot # L044917 with expiration date of 05-OCT-2018 and lot # L044707 with expiration date of 16-OCT-2018 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was also reported by the Licensed Practical Nurse, that the vaccine was exposed to a temperature excursion of 23.4 degrees C for a time of 3842 minutes. Data logger was stated. Furthermore, no adverse events were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to multiple unspecified patient of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # M005286 with expiration date of -8-OCT-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was also reported by the Licensed Practical Nurse, that the vaccine was exposed to a temperature excursion of 23.4 degrees C for a time of 2329 minutes. No additional temperature excursion was reported. Data logger was stated. Furthermore, no adverse events were reported and no product quality issues was involved. This is one of 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 was received from a Licensed Practical Nurse referring to multiple unspecified patient of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of VARIVAX lot # K015969 with expiration date of 23-SEP-2016 and lot # L017142 with expiration date of 13-MAY-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was also reported by the Licensed Practical Nurse, that the vaccine was exposed to a temperature excursion of -7 degrees C for a time of 2213 minutes. NO additional temperature excursion was reported. Data logger was stated. Furthermore, no adverse events were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Abnormal faeces, Alanine aminotransferase increased, Aspartate aminotransferase increased, Body temperature increased, Dehydration
Clinical narrative: Pneumococcal vaccine left bicep in AM Monday May 23, 2016. In PM May 23, 2016 she developed watery non-bloody diarrhea, occurring several times hourly, and which had a "strange odor". This continued through the night, she had some relief on Tuesday but resumed severe watery diarrhea Wednesday. She presented to my office Thursday AM, May 26, having had a fairly benign morning, with respect to bowel movements. She reported that her right flank was "achy", but denied overt abdominal pain or tenesmus. No vomiting, but she was nauseous, poss sec. to the large volume fluid intake. On day 2, she had a temp of 100.7, but was o/w afebrile. No contacts with similar symptoms.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Flank pain, Full blood count normal, Liver function test increased, Monocyte count increased
Clinical narrative: Pneumococcal vaccine left bicep in AM Monday May 23, 2016. In PM May 23, 2016 she developed watery non-bloody diarrhea, occurring several times hourly, and which had a "strange odor". This continued through the night, she had some relief on Tuesday but resumed severe watery diarrhea Wednesday. She presented to my office Thursday AM, May 26, having had a fairly benign morning, with respect to bowel movements. She reported that her right flank was "achy", but denied overt abdominal pain or tenesmus. No vomiting, but she was nauseous, poss sec. to the large volume fluid intake. On day 2, she had a temp of 100.7, but was o/w afebrile. No contacts with similar symptoms.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Polycythaemia, White blood cell count normal
Clinical narrative: Pneumococcal vaccine left bicep in AM Monday May 23, 2016. In PM May 23, 2016 she developed watery non-bloody diarrhea, occurring several times hourly, and which had a "strange odor". This continued through the night, she had some relief on Tuesday but resumed severe watery diarrhea Wednesday. She presented to my office Thursday AM, May 26, having had a fairly benign morning, with respect to bowel movements. She reported that her right flank was "achy", but denied overt abdominal pain or tenesmus. No vomiting, but she was nauseous, poss sec. to the large volume fluid intake. On day 2, she had a temp of 100.7, but was o/w afebrile. No contacts with similar symptoms.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Chest discomfort, Oropharyngeal pain, Pyrexia, Sputum discoloured
Clinical narrative: Sore throat, chest tightening, green phlegm - on 5/23/16. Weak, tempt, fever - 5/25/16.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to unspecified multiple patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On 21-MAR-2016 and 11-MAY-2016, the patients were vaccinated with an improperly stored dose of M-M-R II (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. The Licensed Practical Nurse stated, that the first and second vaccine administered had a lot # K011317 with an expiration date of 13-AUG-2016. The first vaccine had an exposure at the time of 20.8 C for 18 minutes, while the second vaccine was exposed to a temperature excursion of 23.4 C for 3842 minutes (64.03 hours) with cumulative exposure. Moreover, data logger and no previous exposures were reported. Furthermore, no adverse effect was stated and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Allergy to vaccine, Erythema, Pruritus, Swelling
Clinical narrative: This spontaneous report concerning a 33 year old female patient was received from the patient herself via Pfizer Inc. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (Manufacturer unknown) (the dose, dosage number, route of administration, anatomical location, lot # and expiration date were not reported). No concomitant medications were reported. Subsequently, on 10-APR-2002, the patient experienced swelling, itching and redness, as a result of an allergy to Hepatitis B Vaccine (Recombinant) (Manufacturer unknown). At the time of reporting, the outcome of the events were unknown. The patient considered swelling, itching and redness to be related to Hepatitis B Vaccine (Recombinant) (Manufacturer unknown) while being silent on the relationship with the allergy. This is one of the three reports concerning the same patient (US-009507513-1606USA001646) (US-00907513-1606USA001647). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Menstruation delayed
Clinical narrative: Pt. had missed/delayed menstrual period by more than a week.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: Received HAV vaccine 6/2/16 3 PM, went overnight to grandmothers home and woke up with rash "bumps" to legs and arms with c/o itching. Mom brought child to ER and doctor stated had allergic reaction. RX steroids.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Hypersensitivity, Rash
Clinical narrative: Received HAV and HPV9 vaccines on 6-2-16 at 3PM, went overnight to grandmother's home and woke up with rash "bumps". Mom brought child to ER and doctor stated had allergic reaction. Rx steroids.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Hyperhidrosis, Hypotension, Vision blurred
Clinical narrative: Chills, blurry vision, sweats, low BP. Pt. was given juice and told to elevate feet. Vitals were checked.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a patient of unknown age and gender. The patient's current conditions, medical history and concomitant medications were not reported. On 31-MAY-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB injection (lot # L042835, expiry date 09-AUG-2018, therapy type digital data logger, temperature 32.8 F and time frame 20 hours). No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Dizziness, Pallor, Paraesthesia, Skin warm, Unresponsive to stimuli
Clinical narrative: Very warm to touch, pale, dizziness, tingling of finger, non responsive for 15-20 sec.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to 7 patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with M-M-R II lot # K022284 with expiration date of 12-NOV-2016; lot # L003858 with expiration date of 05-FEB-2017; lot # L015280 with expiration date of 30-APR-2017 and lot # L034731 with expiration date of 09-SEP-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was stated by the reporter, that the vaccine was exposed to a temperature excursion of 9 degrees C for 35 minutes. The vaccine has not been exposed to any previous temperature excursion and a data logger was stated. Furthermore, no adverse events were reported due to M-M-R II vaccination and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 lot # L016428 with expiration date of 30-JUL-2017; lot # L018351 with expiration date of 11-AUG-2017; lot # L048237 with expiration date of 08-MAY-2017 and lot # L026602 with expiration date of 19-OCT-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was stated by the reporter, that the vaccine was exposed to a temperature excursion of 9 degrees C for 35 minutes. The vaccine has not been exposed to any previous temperature excursion and a data logger was stated. Furthermore, no adverse events were reported due to GARDASIL 9 and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) concerning a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 01-JUN-2016, the patient was vaccinated with improperly stored VARIVAX (Lot # L045956; Expiration date 17-NOV-2017), (dose and route of administration were not reported). It was reported that the vaccine was exposed to a temperature of 50 F for 26 hour. There was no previous temperature excursion, data logger or product quality complaint involved. No adverse symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Feeling abnormal, Rash generalised
Clinical narrative: This spontaneous report concerning a female patient of an unknown age, and was received from the patient's mother, who was part of a patient support program. The patient's concurrent conditions, medical history and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. On an unknown date, the patient experienced a rash generalized described as "her entire body broke up," and she felt terrible for several weeks (feeling abnormal). The patient's mother stated that "it was really scary." The outcome of feeling abnormal and rash generalized was unknown. The relatedness between rash generalized and feeling abnormal, and therapy with M-M-R II was not reported. Additional information is not expected, as the reporter did not consent for further follow up.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M010475, expiration date: 01-SEP-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 0.5 degrees Celsius for 7 hours and 46 minutes. Additionally, it was also stated that separate doses from the same lot (lot # M010475, expiration date: 01-SEP-2017) of PROQUAD were exposed to a temperature excursion of 0.5 degrees Celsius for 4 hours. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site reaction, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a 57 year old female patient, who was reporting on herself. Her concurrent conditions included an allergy to PEPTO-BISMOL. However, information regarding her medical history was not reported. On 25-MAY-2016, the patient was vaccinated with a dose of ZOSTAVAX 1 shot, subcutaneously (lot # and expiration date were not reported). Her concomitant therapies included an unspecified diuretic. On 30-MAY-2016, the patient woke up itching, having a burning skin rash which was primarily located on her chest and went up to her lower neck. It was also reported that she had a patch on her arm which she stated as an injection site reaction, but it was mostly raised bumps on her arm. Therefore, the patient took some antihistamines to help her sleep, and put hydrocortisone cream on to alleviate the pain but did not visited her doctor yet, regarding the issue. No laboratory diagnostic studies were performed and no product quality complaint was involved. At the time of reporting the outcome of all above mentioned events was reported as not recovered. Additionally, the relatedness between the events and the suspect therapy was not provided by the reporter. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Syncope
Clinical narrative: Syncope. Patient transported to hospital via ambulance.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Parent notice swelling and redness to injection sites that evening. Took patient to ER following day. There impression was Rt tricep local site reaction status post vaccines. Treatment ibuprofen, ice and also warm compress.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Emotional distress, Irritability, Opisthotonus, Pyrexia
Clinical narrative: Child seen 5/25 for routine WCC visit. Had hx of fever 101. At time of visit fever was 99; 6 hours after vaccines, child had fever 103, arching back, irritable and difficult to console. Was sent to ED. Was batter on arrival to ER per ER notes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of left lower limb. Treatment - Children's BENADRYL 125 mg/5ml; 3 ml po q6-8 hrs prn; KEFLEX suspension 250mg/5ml po tid 7 days; TYLENOL 160ml/5ml, 5ml po q4-6 hrs prn.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt presented with swelling and redness at the injection site approximately 2" wide. Pt said it was hot and itchy. She noticed it was red right away but was full blown this AM. Advised pt to take BENADRYL and let MD know if it gets worse or doesn't improve.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Received ZOSTAVAX (L) upper arm sub-q on 6/1/16. Presents on 6/3/16 with area of erythema, tenderness approx. 4 1/2" x 3" at injection site. Treated with KEFLEX 500 mg one TID x 10 days.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Diarrhoea, Haematochezia, Nausea, Rash, Vomiting
Clinical narrative: 1/2 hr after injection, rash to chest and arms. 6-8 hrs after injection nausea and vomiting. 1-2 days after injection, mild diarrhea and blood in stool.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Injection site erythema, Irritability
Clinical narrative: Pt seen at clinic 6/2/16 for 10:15 am. appt. Vaccines admin. per protocol. 16:30 Mom called reported pt cried most of the afternoon with limited breaks for feeding and approx. 30 min nap. 16:45 pt arrived at clinic, presented fussy, crying, afebrile, localized erythematous reactions bilateral anterior thighs at inj. sites. TYLENOL administered 17:13, cold compresses applied. Pt settled by 17:35. 6/3 pt vst @ 8:30 am. bilateral erythematous reactions completely resolved. Baby calm.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (dose and route were not reported) lot # L033707, expiration date 18-MAY-2017. It was reported that the vaccine was exposed to 29 Fahrenheit degrees for 96 hours. No adverse experience has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 month old patient of unknown gender. Pertinent medical history and drug reactions/allergies were not reported. On 12-FEB-2016 during an office visit, the patient might have been vaccinated with a dose of GARDASIL 9 lot # L013429, expiration date: 21-JUL-2017 (dose and route were not reported) inadvertently (Inappropriate schedule of drug administration). Concomitant drug was not reported. The reporter stated that it could not be determined if the patient did indeed receive the vaccination or if it was a documentation error. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to multiple unspecified patients of unknown gender and ages. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were inadvertently administered with ROTATEQ (lot # L033693, expiry date: 31-MAY-2017) that had been improperly stored at a temperature of 34.5 F for 5 hours. The outcome of the excursion was reported as supported. No adverse effects were reported. The outcome of the events was unknown. Additional information had been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown age and gender. No current of historical conditions were reported. On 17-MAY-2016 the patient was vaccinated with PEDVAXHIB (lot # L051122, expired date of 12-OCT-2018, dose and route unknown). The vaccines were improperly stored under 9.1 Celsius degree for 30 minutes. No previous temperature excursion. Data logger was involved. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to multiple unspecified patients of unknown gender and ages. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were inadvertently administered with GARDASIL 9 (lot # L016429, expiry date: 09-AUG-2017; lot # L018351, expiry date: 11-AUG-2017) that had not been improperly stored at a temperature of 34.5 F for 5 hours. The outcome of the excursion was reported as supported. No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (dose and route were not reported) lot # L037339, expiration date 09-FEB-2018. It was reported that the vaccine was exposed to 29 Fahrenheit degrees for 96 hours. No adverse experience has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (dose and route were not reported) lot # L044917, expiration date 05-OCT-2018. It was reported that the vaccine was exposed to 29 Fahrenheit degrees for 96 hours. No adverse experience has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Muscle disorder
Clinical narrative: Information has been received from a female consumer via a vendor refers to a female patient of unknown age enrolled in a market research. Concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, route, lot# and expiration date were not reported). Concomitant drug was not reported. Within a few months on an unknown date, the patient began to have muscular problem and she was not able to be the athlete she once was. The causality and outcome of the event were unknown. Additional information is not expected as there was no consent for follow up.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This solicited report as received from a physician and another unspecified reporter as a part of a market research program refers to an approximately 12 year old female patient. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. On an unknown date, the patient experienced a lot of pain at the injection site. The outcome of the event was reported as recovering/resolving. The reporting physician considered the event to be non-serious and related to the vaccination with GARDASIL. 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 licensed practical nurse and refers to seven patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # L023232, expiry date 25-FEB-2017 (dose, route of administration and anatomical location were not specified). On an unknown date, the administered doses of VAQTA underwent temperature excursion at 1.2 Celsius degrees for 54 minutes. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.