chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea, Hypersensitivity, Pruritus generalised, Rash generalised, Urticaria
Clinical narrative: 8/6/2015 pt presents today with widespread hives/itching that he states started on Tues evening after his visit to clinic, where he received a Tdap. States rash started on his scalp, is now on his body, arms, legs. Has been taking BENADRYL 25 mg bid with some relief but cont to itch. Denies SOA, wheezing, chest tightness. 8/7/2015 ED PLAN: switch from BENADRYL to ATARAX: 25-50 mg 3 times a day. Also take prednisone 60 mg a day until rash is gone and then taper it off by 20 mg a day over a week. Add ZANTAC 300 mg a day if still having hives, and rub itching areas with 1% hydrocortisone cream whenever needed, instead of scratching. Ok to use Aveeno anti-itch products as well. Meds given in ED that day: 1253 epi 0.3mg IM given in Right deltoid and prednisone 60mg, BENADRYL 25mg and PEPCID 40mg po given. 1405 epi 0.3mg IM in left deltoid tolerated well. Patient was also seen that evening by local ED for difficulty breathing. 8/10/2015, PC visit. Rash and itching went away yesterday, but resumed today. Continue prednisone 60 mg x 1 wk, then start decreasing by 10 mg every 4 days continue hydroxyzine and ranitidine. 8/19/2015 ADDENDUM spoke with patient Allergic reaction has subsided, last dose of prednisone was yesterday 8/18. Allergy Consult appointment for 9-20-2015. Diphenhydramine 25 mg BID, dexamethasone 8 mg once, prednisone 60mg x 3, 40mgx3, 20mgx3.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Dyspnoea, Hypersensitivity, Pain in extremity
Clinical narrative: Patient is here for labs draw complaining of pain right upper extremity after getting TDAP vaccination yesterday. Patient claims lack night he was having chills and developed shortness of breath on climbing stairs. Denies associated chest pain, palpitation, irregular heart rate, cough, phlegm, pleuritic chest pain. Right arm at injection site: No erythema, no swelling, no tenderness, no discharge noted. Assessment; probable allergic reaction to TDAP, other causes cannot be ruled out.
Age: 69.0
Sex: M
Vaccine: HIBV, MNQ, PPV
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiform.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Patient reports that she developed redness and soreness around the injection site. She also had trouble lifting her arm. This lasted about 2 weeks. Now completely resolved.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Skin reaction
Clinical narrative: Redness noted over the area of the deltoid where DTaP vaccine was administered; edema and warmth present.  Denies signs of pain.  Patient tolerating active and passive ROM of the shoulder left and arm.  Appears to be a local skin reaction to the vaccine. Area of redness is approximately 5cmx4cm.
Age: 18.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Large swollen lump at injection site; red area around injection site; injection site itchy and painful to the touch. Symptoms so far have  lasted 5 days and don't appear to yet be improving. For the Yellow Fever vaccine. Never have had a reaction to a vaccine previously.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Body temperature increased, Cellulitis, Feeling abnormal, Injection site erythema
Clinical narrative: Just was not feeling like my self all day no energy then about 1:00PM my arm started to hurt and it progressively got worst to the point I could hardly move it the pain kept me up all night the next morning I got up to go to work and took my temp I was not feeling good at all and it was 102 and my arm had a raised red spot around the injection site took some Tylenol and called the Doctor they had me go into the office @4:30PM and they told me I had Cellulitis they are treating it with Cephalexin and diphenhydramine.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Just was not feeling like my self all day no energy then about 1:00PM my arm started to hurt and it progressively got worst to the point I could hardly move it the pain kept me up all night the next morning I got up to go to work and took my temp I was not feeling good at all and it was 102 and my arm had a raised red spot around the injection site took some Tylenol and called the Doctor they had me go into the office @4:30PM and they told me I had Cellulitis they are treating it with Cephalexin and diphenhydramine.
Age: 15.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MNQ, TDAP, VARCEL
Symptoms: Blood pressure decreased, Computerised tomogram normal, Erythema, Head injury, Ligament sprain
Clinical narrative: The patient became nauseous and stood up.  She then had a syncope episode and sustained an injury to right lateral upper side of forehead.  10x10mm closed wound with erythema and edema.  She continued to be unconscious and unresponsive for approximately two minutes.  Two ammonia inhalants were used and patient did not respond.  Emergency responders were called.  Ice pack to forehead placed and vitals within normal limits.  Orientated x 3 after she was responsive (approximately 2 minutes) but stated lack of memory of event.  Also, she denied HA, nausea, SOB, and dizziness.  EMS responded and transferred patient to hospital via ambulance.  On 8/21 2015 spoke with patient's guardian. She stated patient continued with decreased blood pressure yesterday afternoon.  She had an emesis episode and "after vomiting began to feel much better".  She was kept at the hospital overnight for observation and was discharged today.  CT scan and X-ray of head and neck normal but did have a "slight neck sprain".
Age: 15.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness, Nausea, Oedema, Skull X-ray normal, Spinal X-ray normal
Clinical narrative: The patient became nauseous and stood up.  She then had a syncope episode and sustained an injury to right lateral upper side of forehead.  10x10mm closed wound with erythema and edema.  She continued to be unconscious and unresponsive for approximately two minutes.  Two ammonia inhalants were used and patient did not respond.  Emergency responders were called.  Ice pack to forehead placed and vitals within normal limits.  Orientated x 3 after she was responsive (approximately 2 minutes) but stated lack of memory of event.  Also, she denied HA, nausea, SOB, and dizziness.  EMS responded and transferred patient to hospital via ambulance.  On 8/21 2015 spoke with patient's guardian. She stated patient continued with decreased blood pressure yesterday afternoon.  She had an emesis episode and "after vomiting began to feel much better".  She was kept at the hospital overnight for observation and was discharged today.  CT scan and X-ray of head and neck normal but did have a "slight neck sprain".
Age: 15.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MNQ, TDAP, VARCEL
Symptoms: Syncope, Unresponsive to stimuli, Vomiting, Wound
Clinical narrative: The patient became nauseous and stood up.  She then had a syncope episode and sustained an injury to right lateral upper side of forehead.  10x10mm closed wound with erythema and edema.  She continued to be unconscious and unresponsive for approximately two minutes.  Two ammonia inhalants were used and patient did not respond.  Emergency responders were called.  Ice pack to forehead placed and vitals within normal limits.  Orientated x 3 after she was responsive (approximately 2 minutes) but stated lack of memory of event.  Also, she denied HA, nausea, SOB, and dizziness.  EMS responded and transferred patient to hospital via ambulance.  On 8/21 2015 spoke with patient's guardian. She stated patient continued with decreased blood pressure yesterday afternoon.  She had an emesis episode and "after vomiting began to feel much better".  She was kept at the hospital overnight for observation and was discharged today.  CT scan and X-ray of head and neck normal but did have a "slight neck sprain".
Age: 1.54
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash generalised, Urticaria
Clinical narrative: Wheal (hive)-Uriticatial on extremities-Buttocks-Trunk with erythematous and pruritis. Timing of rash is not suggestive of anaphylactic reaction. No previous history of reaction to vaccine. Physical appearance is consistent with allergic reaction. Caladryl lotion and Benadryl PO. Referral to Allergy Clinic and be tested for further allergic reactions.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Asthenia, Fatigue, Headache, Loss of consciousness, Nausea
Clinical narrative: His vision turned black and his knees became weak. He felt nauseated and began to lose consciousness. He hung is head down until he could see. He made his way to his mother's bedroom leaning against the wall as his vision continued to be black. His mother laid in bed with him for 2 hours. He began to see white "streaks" across his vision. That lasted all day. He was tired and weak. He complained of a headache (5/10) and nausea throughout the day.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Visual impairment
Clinical narrative: His vision turned black and his knees became weak. He felt nauseated and began to lose consciousness. He hung is head down until he could see. He made his way to his mother's bedroom leaning against the wall as his vision continued to be black. His mother laid in bed with him for 2 hours. He began to see white "streaks" across his vision. That lasted all day. He was tired and weak. He complained of a headache (5/10) and nausea throughout the day.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Blood test, Condition aggravated, Muscle spasms, Rash vesicular
Clinical narrative: 4 days post-vaccination, patient began to develop circular varicella-like rash on right leg and experienced muscle cramping. Rash is contained to small area on right leg and 24 hours later cramping was subsiding; rash was still present.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swelling, redness tenderness.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Discomfort, Dry mouth, Hypersensitivity, Immediate post-injection reaction, Oropharyngeal pain
Clinical narrative: Patient received her first HPV vaccine today and immediately described  discomfort in her jaw and glands in neck. Patient also described a "filter" in front of her eyes as well as noises in her ears. When patient stated that her mouth was dry and her throat was "tight" and sore, nurse sent family to emergency room 6 minutes away. Patient did not state that she could not breathe but did not want to take any unnecessary chances. At emergency room, doctor diagnosed patient with an systemic allergic histamine reaction. Patient had started to feel somewhat better while being assessed by doctor. Once patient was treated with Benadryl, patient's condition resolved.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Throat tightness, Tinnitus, Visual impairment
Clinical narrative: Patient received her first HPV vaccine today and immediately described  discomfort in her jaw and glands in neck. Patient also described a "filter" in front of her eyes as well as noises in her ears. When patient stated that her mouth was dry and her throat was "tight" and sore, nurse sent family to emergency room 6 minutes away. Patient did not state that she could not breathe but did not want to take any unnecessary chances. At emergency room, doctor diagnosed patient with an systemic allergic histamine reaction. Patient had started to feel somewhat better while being assessed by doctor. Once patient was treated with Benadryl, patient's condition resolved.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Pain
Clinical narrative: Redness over left arm which is spreading. Mild pain. CEFTRIAXONE 1 GRAM INJ RECON SOLN, LIDOCAINE HCL 10 MG/ML (1%) INJ SOLN, CEPHALEXIN 500 MG ORAL CAP.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cellulitis, Injection site infection
Clinical narrative: Redness over left arm which is spreading. Mild pain. CEFTRIAXONE 1 GRAM INJ RECON SOLN, LIDOCAINE HCL 10 MG/ML (1%) INJ SOLN, CEPHALEXIN 500 MG ORAL CAP.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: Worsening redness and pain over right arm since injection. She is allergic to cephalosporins and PCN. If no improvement and spreading then rec her to go to ER. Also rec follow up visit in clinic on Thursday. Plan: SULFAMETHOXAZOLE-TRIMETHOPRIM 800-160 MG ORAL TAB.
Age: 72.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Worsening redness and pain over right arm since injection. She is allergic to cephalosporins and PCN. If no improvement and spreading then rec her to go to ER. Also rec follow up visit in clinic on Thursday. Plan: SULFAMETHOXAZOLE-TRIMETHOPRIM 800-160 MG ORAL TAB.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Patient presented back to pharmacy around 5 hours after receiving immunization with itching, erythema and urticaria around the neck and shoulders; no angioedema; no bronchospasm or shortness of breath. Patient reported self-administration of Diphenhydramine 50mg around 10 minutes prior to presenting to pharmacy with reaction. She reports having food allergies, but not to eggs, and she always carries an EpiPen with her at all times for that reason and is trained on how to use it. She reports getting the flu shot yearly since age 10 and has never experienced an adverse event. Two hours prior to reporting to pharmacy with reaction, the patient had some watermelon and other things to eat so we are not completely sure of what caused the reaction. Around 30 minutes after reporting to the pharmacy with reaction, patients hives were gradually subsiding and improvement noticed.
Age: 70.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Blister, Infection, Rash, Swelling
Clinical narrative: Patient states that there was a swollen rash the next day, was seen by MD and sent home. 2 days later, patient came back and reported blisters, spread to stomach. MD treated patient for infection and asked them to notify us of the adverse event.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, MEN
Symptoms: Axillary pain, Chest discomfort, Chest pain, Cough, Dyspnoea
Clinical narrative: Complaints of chest tightness, pain, shortness of breath starting evening/night the vaccination was given. Stated more pain the deeper the breathe. Treatment: I gave him 200mg of ibuprofen. Complaint: 8/20/2015 7:00 AM Soreness and pain under left arm.  Stated he felt a "something" at site of pain. Treatment: I felt under his arm and felt slightly enlarged nodes and  there was tenderness. Applied warm compress and acetaminophen. 8/20/2015 7:00 PM - Chest pain still the same. He felt as if he were coming down with a cold, and he started coughing.  Treatment: Administered Motrin and Mucinex cold/cough.   8/21/2015 7:00 AM - Awakened to no relief from chest pain, left under arm still sore. Treatment: I took him to the health department where shot was administered, explained to nurse symptoms. I was informed the symptoms were not side affects to immunizations administered to child. I scheduled an appointment for him with PCP for 8/22/2015.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, MEN
Symptoms: Lymph node pain, Lymphadenopathy, Nasopharyngitis, Painful respiration
Clinical narrative: Complaints of chest tightness, pain, shortness of breath starting evening/night the vaccination was given. Stated more pain the deeper the breathe. Treatment: I gave him 200mg of ibuprofen. Complaint: 8/20/2015 7:00 AM Soreness and pain under left arm.  Stated he felt a "something" at site of pain. Treatment: I felt under his arm and felt slightly enlarged nodes and  there was tenderness. Applied warm compress and acetaminophen. 8/20/2015 7:00 PM - Chest pain still the same. He felt as if he were coming down with a cold, and he started coughing.  Treatment: Administered Motrin and Mucinex cold/cough.   8/21/2015 7:00 AM - Awakened to no relief from chest pain, left under arm still sore. Treatment: I took him to the health department where shot was administered, explained to nurse symptoms. I was informed the symptoms were not side affects to immunizations administered to child. I scheduled an appointment for him with PCP for 8/22/2015.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient has reported redness, swelling, and itching at injection site.  She was informed to use a cold compress to help alleviate symptoms and to use generic Benadryl if itching is too bothersome.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Constipation, Crying, Discomfort
Clinical narrative: Severe crying, discomfort, constipation.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a female patient of unknown age. The patient received the first dose of GARDASIL on 02-APR-2015 and second dose on 02-JUN-2015 (both doses were not reported) and finished the series with GARDASIL 9 (lot # K026247, expiration date 28-JAN-2017, dose was not reported) which was determined on 03-AUG-2015 (Interchange of vaccine products and Inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a female patient of unknown age. On an unknown date the patient who was 4 weeks pregnant was vaccinated with GARDASIL injection of 1 vial (route, dose, frequency, lot batch number unspecified). Last menstrual period date (LMP) and estimated delivery date (EDD) were unknown. The pregnancy outcome was pending. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history and concurrent condition were not reported. On unknown dates the patients received improperly stored oral, ROTATEQ (dose, frequency and route were unknown, lot# K016263, expiration date 26-JUN-2016; lot# K012432, expiration date 20-MAY-2016). No concomitant medication was reported. No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant therapies. On 06-AUG-2015, the patient was inadvertently vaccinated with a dose of PROQUAD (Merck) lot # K025765, expiration date 08-JUN-2016 (dose, frequency, route of administration not specified) and a dose of VARIVAX (Merck) (dose, frequency, route of administration, lot # and expiration date not specified) during the same office visit. There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered medical assistant referring to an unspecified number of patients of unknown age and gender. On an unknown date in 2015, the patients were vaccinated with improperly stored oral, ROTATEQ (dose and strength were not reported, lot# reported as K023157). The temperature was possible out of range by 2 degrees to 3 degrees for short periods of time over a couple of days in April 2015. No adverse events were reported. This case is one of several cases received from the same source. Additional information has been requested. This case was initially received on 28-MAY-2015 and reported in 1505USA015812. 1505USA015812 has been deleted upon the follow up information received on 01-JUL-2015, in which the medical assistant stated no incorrect product storage happened. Now, case was re-created due to new follow up information was received from the medical assistant on 13-AUG-2015 and incorrect product storage was confirmed.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 16 year old female patient. There was no concomitant medication, medical history or known drug reactions/allergies. The patient had received her the first dose of VARIVAX (Merck) on 01-FEB-2000 (lot #, en expiration date, dose, frequency, route of administration and indication were not reported). On 29-JUL-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # K026384, an expiration date: 15-DEC-2015), the second 0.5 ml dose, subcutaneously. The healthcare worker reported, that the injection site became red and swollen on 30-JUL-2015, after receiving improperly stored VARIVAX (Merck). The patient was treated for the events with BENADRYL and BACTRIM. The patient sought medical attention and was seen in the office. The outcome of the events was unknown. The relatedness between the events and VARIVAX (Merck) was not reported by the reporter. This is one of the several reports received from the reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unknown age and gender. There was no patients' concomitant medications pertinent medical history, drug reactions and allergies reported. On an unknown dates, the patients were vaccinated with ZOSTAVAX 0.65 ml (lot #, expiration date, site of vaccination were not reported) subcutaneously. On an unknown dates, the patients experienced redness, swelling, warmth and pain at the injection site. No lab diagnostics studies were performed. The patients sought medical attention, visited pharmacy and received BENADRYL as a treatment. The outcome of the events was reported as resolved (dates, unspecified). The relatedness between the events and ZOSTAVAX were not reported. Follow-up information has been received from the pharmacist on 09-JUL-2015. On 08-JUL-2015, a phone call was placed to the pharmacist. The pharmacist stated that she had no additional information to report. She provided all the information she had when she called in the adverse event. She also stated that she made the call due to the increase in the number of patients that experienced an adverse events at the injection site. She stated that no additional adverse event had been reported since then. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled follow up information has been received. Narrative was updated.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Rash, Swelling face
Clinical narrative: Patient experienced rash and facial swelling.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Fatigue, Rash, Skin lesion, Somnolence
Clinical narrative: 62 yo female who received influenza immunization for the 1st time in Oct. or Nov., 2007 and since then has suffered with profound fatigue, somnolence and scalp lesions. Dizziness and giddiness, rash, oth nonspecific skin eruption.
Age: 26.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Broke out in rash both lower arms approx 4 hours following injection.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Skin warm
Clinical narrative: 4.5 cm W 5.5 cm H > erythema, mildly warm, no induration. No systemic symptoms.
Sex: M
Vaccine: HEPAB
Symptoms: Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a male patient who received TWINRIX. In August 2015, the patient received TWINRIX. In August 2015, less than a week after receiving TWINRIX, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was not recovered/not resolved. It was unknown if the reporter considered the tiredness to be related to TWINRIX. Additional details were provided as follows: The patient reported that he had a TWINRIX vaccine, about a week before reporting and he has been tired since then. The patient did not want to provide any further details on this report.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Nausea, Pain
Clinical narrative: This is a prospective pregnancy case. This female subject was enrolled in a study. The subject received Flu Seasonal QIV on 12th August 2015. Previously administered products included FLUARIX (trivalent received in the past and the patient did not experience any problems). In August 2015, less than a week after receiving Flu Seasonal QIV, the subject developed nausea (Non-serious). Additional event(s) included general body pain in August 2015 and vaccine exposure during pregnancy. The outcome of nausea was unknown. The outcome(s) of the additional event(s) included general body pain (unknown) and vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the nausea and general body pain to be related to Flu Seasonal QIV. Additional details were provided as follows: On Wednesday, 12th August 2015, the patient received FLUARIX while she was pregnant. In August 2015, less than a week after receiving FLUARIX, the patient experience nausea and body aches (general body pain). The patient seemed to suggest that she received the FLUARIX quadrivalent instead of the trivalent like in years but this could not be clarified. The patient was wondering if the events were normal or not. The caller was from a pharmacy but it was unknown whether she was a pharmacist or technician. The call was dropped before additional details could be gathered, including the contact information.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 09-AUG-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016154 with exp. 24-SEP-2016), (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 17-JUL-2015, the patient was vaccinated with an improperly stored dose of MMR II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding on a 2 month old patient of unknown gender and no medical history or concurrent conditions informed. On 02-JUL-2015 the patient was vaccinated with inappropriate stored ROTATEQ (lot # K000487, expiration date: 27-SEP-2015) (route, anatomical localization, dose and frequency were not reported). Concomitant therapies were not provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 17-JUL-2015, the patient was vaccinated with an improperly stored doses of MMR II lot # K016154 with exp. 24-SEP-2016, (route and dose were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 7 year old patient of unknown gender. Medical history and concurrent condition were not reported. On 17-AUG-2015, the patient was vaccinated with a dose of GARDASIL 9 (lot number, expiration date and dose were not reported), intramuscular. Concomitant medication was not reported. It was unknown if the patient sought medical attention. No adverse experience was reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 17-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 17-JUL-2015, the patient was vaccinated with an improperly stored M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 6 month old patient. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot number, expiration date, dose, strength and route of administration were not reported). On an unknown date, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot number, expiration date, dose, strength and route of administration were not reported). On an unknown date, the patient was vaccinated with the third dose of RECOMBIVAX HB (lot number, expiration date, dose, strength and route of administration were not reported). On an unknown date, the patient was vaccinated with the fourth dose of RECOMBIVAX HB (lot number, expiration date, dose, strength and route of administration were not reported). No adverse effect was reported. 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 Medical Assistant refers to a patient of unknown age and gender. On 07-JUL-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot # L000454, expiry date 06-JAN-2017 (route and dose were not provided. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a healthcare worker refers to two no pregnant female patients of unknown ages. The patient's concurrent conditions, medical history and allergies were not reported. On an unknown date, the two patients were vaccinated whether with doses of GARDASIL or GARDASIL 9, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Concomitant therapies were not reported. ON an unknown date, after the vaccination, the two patients experienced syncope described as "patients fainted". The patients sought medical attention through office visit on an unknown date. Treatment was not given for the adverse event, and it was unspecified if laboratory diagnostics studies were performed.  The outcome of syncope was reported as recovered on an unknown date. The relatedness between syncope and therapy with GARDASIL and GARDASIL 9 was not reported. 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 Medical Assistant refers to a patient of unknown age and gender. On 27-JUL-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot # L000454, expiry date 06-JAN-2017 (route and dose not provided). No adverse effect reported. 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 as received from a Medical Assistant refers to a patient of unknown age and gender. On 29-JUL-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot number L000454, expiry date 06-JAN-2017 (dose and route were not reported). No adverse effect reported. 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 as received from a Medical Assistant refers to a patient of unknown age and gender. On 29-JUL-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot # L000454, expiry date 06-JAN-2017 (dose and route were not reported). No adverse effect reported. 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 as received from a Medical Assistant refers to an unspecified patients of unknown age and gender. On an unknown dates, the unspecified patients were vaccinated with doses of improperly stored ROTATEQ oral (dose was not reported) lot # K016263, expiry date 26-JUN-2016. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. There was not reported medical history or concurrent conditions. On 01-JUN-2015, the patient received improperly stored M-M-R II lot number reported K005574 (dose, strength and route were unknown, expiration date: not reported), with no adverse effects. There was no concomitant therapies reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Patient presented with red, swollen, puffy under arm where vaccine (ZOSTAVAX) was administered. I (staff Rph) received OTC treatment with antihistamine and hydrocortisone cream.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient is experiencing pain and limited mobility in the shoulder.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative and refers to a several unspecified patients of unknown ages and genders. Historical condition for all the unspecified patients included shingles before vaccination. On an unknown date, the several unspecified patients were vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot # and expiration date were not informed). After they were vaccinated, then they developed shingles on unspecified dates. No product quality complaint was involved. At the time of the report, the outcome of shingles was unknown. The relatedness of the adverse event and suspect therapy was not provided. Additional information is not expected because the physician cannot be contacted.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: Patient was hospitalized for pneumonia 2 days after receiving PREVNAR vaccine.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Erythema, Injection site pain, Pyrexia, Skin lesion
Clinical narrative: Patient mother states patient had been febrile, her arm where injection was given is painful, a satellite appearing blister/red lesion has appeared a few cm down from injection site.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: L delt slightly swollen, red and warm. Tdap and MENVEO given IM 3 days prior. Advised cool compress. Noted in chart and RTC if not  improved x2-3d.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Vaccination complication
Clinical narrative: (L) shoulder swelling adverse vaccine reaction. Ice pack, TYLENOL/MOTRIN x pain 98 degrees.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. On 11-AUG-2015 the patient was vaccinated with a dose of PEDVAXHIB injection (lot # K019701, expiration date 17-JUL-2017, dose and route were not reported) and a dose of PENTACEL (lot #, dose and route were not reported). No adverse effects reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity, Tendonitis
Clinical narrative: Patient reported pain in left arm that started the evening after receiving vaccine. FLUZONE HD. Patient seen doctor 7 days after vaccine administration on 8-20-15. Dr ruled pain to be caused by tendonitis.
Sex: U
Vaccine: HEP, HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on 30-JUL-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Aphasia, Eye movement disorder, Hyperhidrosis, Pallor, Posture abnormal
Clinical narrative: 5 MINUTES AFTER INJECTION, PATIENT NOTED TO SIGH AND LEAN HIS HEAD BACK.  PALLOR NOTED WITH EYES ROLLING TO BACK OF HEAD.  PATIENT UNABLE TO VERBALLY RESPOND FOR APPROXIMATELY 1 1/2 MINUTES.  DIAPHORETIC.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Oropharyngeal pain, Pyrexia, Sinus congestion
Clinical narrative: Sore throat, fever, sinus congestion, cough.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Blindness transient, Computerised tomogram, Concussion, Dizziness, Eye movement disorder
Clinical narrative: Approximately 8 minutes after patient received his Vaccine we were waiting to check out at the office desk when he said he was feeling dizzy, I turned towards him and reached for him but his eyes were rolling upwards and he fell straight backwards before I could catch him striking his head on the floor, patient went into a full body including arms, legs and head seizure that lasted about 8-10 seconds.  He was unconscious and would not respond to voice or touch.  He became completely soaked in sweat and his skin was hot to the touch. He was unresponsive for approximately 4 to 5 minutes, not responding to smelling salts, sternal rubs, voice prompts.  When he was moved to a treatment room in the office he began to come around but instantly stated he could not see anything.  His eyes were opened but he was rapidly scanning the entire room saying he could not see, he could hear myself and the doctor but could not see us in the room.  His vision problem stayed the same until after the EMS crew had arrived, began treatment and loaded him in the Ambulance which was probably around 10 minutes or more.  At the emergency room he had a CT scan where they determined patient had a concussion from striking his head.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Fall, Head injury, Hyperhidrosis, Laboratory test, Loss of consciousness
Clinical narrative: Approximately 8 minutes after patient received his Vaccine we were waiting to check out at the office desk when he said he was feeling dizzy, I turned towards him and reached for him but his eyes were rolling upwards and he fell straight backwards before I could catch him striking his head on the floor, patient went into a full body including arms, legs and head seizure that lasted about 8-10 seconds.  He was unconscious and would not respond to voice or touch.  He became completely soaked in sweat and his skin was hot to the touch. He was unresponsive for approximately 4 to 5 minutes, not responding to smelling salts, sternal rubs, voice prompts.  When he was moved to a treatment room in the office he began to come around but instantly stated he could not see anything.  His eyes were opened but he was rapidly scanning the entire room saying he could not see, he could hear myself and the doctor but could not see us in the room.  His vision problem stayed the same until after the EMS crew had arrived, began treatment and loaded him in the Ambulance which was probably around 10 minutes or more.  At the emergency room he had a CT scan where they determined patient had a concussion from striking his head.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Seizure, Skin warm, Unresponsive to stimuli
Clinical narrative: Approximately 8 minutes after patient received his Vaccine we were waiting to check out at the office desk when he said he was feeling dizzy, I turned towards him and reached for him but his eyes were rolling upwards and he fell straight backwards before I could catch him striking his head on the floor, patient went into a full body including arms, legs and head seizure that lasted about 8-10 seconds.  He was unconscious and would not respond to voice or touch.  He became completely soaked in sweat and his skin was hot to the touch. He was unresponsive for approximately 4 to 5 minutes, not responding to smelling salts, sternal rubs, voice prompts.  When he was moved to a treatment room in the office he began to come around but instantly stated he could not see anything.  His eyes were opened but he was rapidly scanning the entire room saying he could not see, he could hear myself and the doctor but could not see us in the room.  His vision problem stayed the same until after the EMS crew had arrived, began treatment and loaded him in the Ambulance which was probably around 10 minutes or more.  At the emergency room he had a CT scan where they determined patient had a concussion from striking his head.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: Rash, hives; red bumps; itching.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Skin exfoliation, Skin fissures
Clinical narrative: 4 days after injection pt got red bumps on abdomen and right arm, 1 week later her hands started itching, peeling and cracking, Dr prescribed triamcinolone cream, 8/22/15 suggested hydrocortisone cream and aquaphor, at follow up call pt said doing better.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Joint stiffness
Clinical narrative: Patient describes numbess, and a feeling of rigidity in the jaw.
Age: 29.0
Sex: F
Vaccine: HEPA, MNQ, PPV
Symptoms: Headache, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Received PNEUMOVAX 23 8-18-15 2pm - noticed evening swelling of arm, tenderness H/A, fever 101.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a 2 patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose and route of administration not provided). No concomitant therapy was reported. On an unknown date, the patient experienced shingles, one year after receiving ZOSTAVAX. The outcome of the event was unknown. The causality assessment was not reported. No product quality issue was involved. 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 licensed practical nurse (LPN) refers to an unspecified number of unspecified patients of unknown age and gender. Medical history and drug allergies were not reported. On unknown dates, the patients were vaccinated with doses of  improperly stored ROTATEQ (lot # K005397, expiration date 29-FEB-2016, route of administration default to oral, dose and frequency were not reported). 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.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. The nurse reported that on 31-JUL-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. 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 as received from a licensed practical nurse (LPN) refers to an unspecified number of unspecified patients of unknown age and gender. Medical history and drug allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA (lot # L004742, expiration date 18-AUG-2016, route of administration, dose and frequency were not reported). No adverse effects were reported. Product quality complaint (CPC) was not 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 as received from a registered nurse (RN) refers to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On 20-AUG-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # L012038, expiration date 07-APR-2017, dose and route of administration were not provided). The patient's concomitant medication was not provided. No adverse events were reported. Product quality complaint (PQC) was not involved. 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 nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # K020181, expiration date: 24-JUN-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.