chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: HIBV, MNQ, PNC13
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Patient stated after the injection she felt light headed and a little dizzy. She felt numbness down her neck to her left arm.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On 16-JUL-2015 the patient was vaccinated with improperly stored ZOSTAVAX (route, dose unspecified). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 1.31
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Pyrexia, Weight bearing difficulty
Clinical narrative: 103 fever at 1:00am 07/08/15 could not bare weight on legs or walk on night of 7/7/15 after receiving vaccines. Did not start bearing weight until 07/09/15.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: Localized itch at site of injection, reported by patient immediately after receiving injection. Had patient remain seated in waiting area. Rechecked her in about 15 minutes. Site was a little red (patient skin tan and red already) and small bump "slightly itchy". Called patient several times 7/17/15, no answer.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and heat at injection site received 10 day course of cephalexin.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cyst, Injection site erythema, Injection site swelling
Clinical narrative: Received Tdap right deltoid 7/13/15, 7/14/15 noticed swelling and redness to right deltoid, MD diagnosed with antigenic cyst and given KEFLEX 250 mg.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Patient received vaccine 7/8/15, did not experience any adverse effects until 7/10/15 in the morning. Patient noticed burning and swelling at the injection site, tenderness to touch. Red lump and rash, with spreading infection the size of a softball. Started antibiotics.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Shingles vaccine 7/10/2015, Lt. deltoid. Today site is red, indurated, warm to touch and "itchy". Induration 5 x 7 cm. Redness 10 x 12 cm.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Rash
Clinical narrative: Left shoulder pain and rash. Difficulty lifting arm.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Burn oral cavity, Dizziness, Dysgeusia, Nausea
Clinical narrative: 8 days nauseous every 4 hrs or so, dizzy then too, roof of mouth behind teeth burned, metallic taste in mouth, couldn't taste drinks normally, fever on and off.  I've had a few days clear now so I think it's over. I asked for Tdap so could be around new baby in family-looks like gave me something else. One place form says Tdap other place DTP DTaP wonder if not wrong one for adults since no one else had reaction in family and I usually don't. Confusing form from pharmacy (just now looking at it).
Age: 49.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 3 x 4 in. area on left tricep from MMR vaccine given 7/10/15 red, slightly swollen, tender and itchy.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to one of two patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-JAN-2015, the patient was vaccinated with improperly stored GARDASIL injection (lot # K006960, expiry date 19-FEB-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse experiences were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Pruritus, Urticaria
Clinical narrative: Pt woke up itching.  Had hives and swollen eyes.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Injection site rash, Rash
Clinical narrative: Pt first developed rash day after injection 7/15/15 around site of injection, then entire arm turned red.  Pt called clinic 7/20/15 stating rash spread to back and chest and was raised with blisters.  Pt was then brought back to clinic on 7/21/15 and assessed by provider.  Pt diagnosed with shingles at that time and treated for this diagnosis.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Joint contracture, Seizure like phenomena, Syncope
Clinical narrative: Child was sitting on the exam table and was given the Tdap vaccine.  Immediately had a syncopal episode then presented with seizure -like activity for approximately 7 seconds. Hand/wrists contracted.  Child awoke - was oriented x3.  No loss of bladder function nor drooling from the mouth. Mom was instructed to take to the emergency room if any further activity noted and to make an appointment with his primary doctor. Mom verbalized understanding.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 60 year old female patient. The patient had a concurrent condition of hypertension, hypothyroidism and hypercholesterolemia and codeine allergy. On 07-JUL-2015, the patient was vaccinated with ZOSTAVAX lot # L006382, expiry date 25-MAY-2016, 0.65 ml, subcutaneous in the left deltoid. Concomitant therapies included hydrochlorothiazide, levothyroxine sodium and simvastatin. On 09-JUL-2015, the patient noticed a large, red, warm, swollen area at her injection site. The patient went to the pharmacy the previous night to show the injection site adverse experiences to the pharmacist. The pharmacist stated that it looked like she developed a rash. He described the effected area's size as most of her deltoid area and it was pretty large. The patient had not notified her primary healthcare provider. There was no treatment rendered for the events. The outcome of the events were reported as not recovered/not resolved. The patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a female patient of unknown age. On 16-NOV-2014 (also reported as 16-NOV-2015) the patient was vaccinated with VARIVAX (Merck) (dose, route, lot # unspecified). No concomitant medications were reported. The patient became pregnant. The LMP and EDD was not known. It was reported that the patient was now pregnant, about 2.5 weeks after was vaccinated with VARIVAX (Merck) on 16-NOV-2014 (vaccine exposure during pregnancy). The reporter stated that the patient has not experienced any adverse effects. No further information provided. The pregnancy outcome was pending. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 48 years old nurse referring to herself with no drug allergy/reaction. She was not pregnant. The patient experienced chicken pox with she was 13 years old. On an unspecified date in 2013 (reported as "approximately 2 years ago")) the patient was vaccinated with a dose of ZOSTAVAX (concentration, dose, frequency and route were unknown). Concomitant therapy included ZOLOFT. On an unspecified date in April 2015 (reported as "approximately 3 months ago"), the patient developed 3 "spots/clusters" of shingles. On an unspecified date in June 2015 (reported as "approximately 1 month ago") the patient developed 3 to 5 "spots/crushes" of shingles. The patient currently has 2 areas of "spots/clusters" of shingles. The patient had made appointment to see her Primary Care Physician for treatment. VZVIP packet was not sent as Reporter/Patient was going to discuss with her Primary Physician first. No lab was performed and no treatment was given. The action taken was not applicable. 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 nurse refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patient were vaccinated with an unspecified number of improperly stored doses of MMR II (strength, dose, route of administration, lot# and expiration date were not reported). No information on patients concomitant medications was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports 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 healthcare worker refers to a patient of unknown age and gender. On 23-JUN-2015 the patient was vaccinated with oral, ROTATEQ (dose was not reported, route of vaccination defaulted to oral, lot # K016314 with expiration date: 05-JUN-2016) which was improperly stored. No adverse symptoms reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site rash, Skin test positive
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 15 year old female patient. The patient's pertinent medical history included angioedema and the patient was allergic to thimerosal and presented with popular rashes for unspecified vaccines. On 04-JUN-2012, the patient was vaccinated with 0.5 ml VAQTA (lot# 1168AA and expiry date: 20-JUN-2014) intramuscular for prevention of hepatitis A. Concomitant therapies included EPIPEN. On 08-JUN-2012 the patient experienced rash around the injection site. The patient sought medical attention and was treated with BENADRYL. The outcome of the event was unknown. The relatedness of the event with the VAQTA was not reported. No product quality complaint (PQC) was reported for VAQTA. 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 physician refers to unspecified number of patients of unknown age and gender. Patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown dates, unspecified number of patients were vaccinated with a dose of improperly stored MMR II (lot number, Expiry date, dose and route were not reported). No adverse effects were 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 multiple unspecified patients of unknown age and gender. On an unknown date the patient was vaccinated with RECOMBIVAX HB, that was stored improperly (dosage, lot# and route of administration not provided). No adverse event effects reported. Additional information is not expected, as the reporter did not wish to be contacted. Additional information is not expected, as the reporter did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown ages and genders. On an unknown dates in 2015 (reported as: since 20-MAY-2015), the patients were vaccinated with improperly stored PROQUAD (Merck) subcutaneous injection, lot # K021547, expiration date: 06-MAY-2016 (Dose not provided). No adverse effects reported. This is one of two reports received from the same reproter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were inadvertently vaccinated with improperly stored MMR II injection (Dose, lot number, albumin status and route not provided). A total of 39 doses were administered. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patient were inadvertently vaccinated with improperly stored GARDASIL injection (Dose, lot number and route not provided). A total of 32 doses were administered. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTP, OPV
Symptoms: Blood glucose increased, Blood test, Glycosylated haemoglobin, Hypotonia, Urinary incontinence
Clinical narrative: Patient had been losing muscle mass and weight and had trouble controlling his bladder. A visit to his pediatrician found his blood sugar to be over 800mg. He was immediately hospitalized.
Age: 5.0
Sex: M
Vaccine: DTP, OPV
Symptoms: Weight decreased, X-ray
Clinical narrative: Patient had been losing muscle mass and weight and had trouble controlling his bladder. A visit to his pediatrician found his blood sugar to be over 800mg. He was immediately hospitalized.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased
Clinical narrative: Mother came to Health Department reporting temp of 104.  Mother talked with physician's office by phone while in Health Department.
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a male patient of unknown age and gender. No concurrent condition and medical history were not reported. On 02-JUL-2015, the patient was inadvertently administered a dose of PNEUMOVAX 23 intramuscular (dose #, strength, and lot # were not provided), which expired on 02-MAY-2015. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and genders. Approximately in July 2015, the patients were vaccinated with PROQUAD doses that were improperly stored (Lot number and expiration date unknown) dose and route of vaccination were unknown. No symptoms reported. No other details. This is one of two reports from the same reporter (1507USA004335). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician referring to a patient of unknown gender and age. No concurrent condition, medical history and concomitant medication were reported. On 13-JUL-2015 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dosage and route were not reported), who was supposed to receive ZOSTAVAX. At the time of the report, there was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: The initial spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were inadvertently vaccinated with improperly stored RECOMBIVAX HB injection (Dose, lot number and route not provided). A total of 5 doses were administered. No adverse events were 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 initial spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were inadvertently vaccinated with improperly stored oral, ROTATEQ, oral liquid (Dose, lot number and route not provided). A total of 25 doses were administered. No adverse events were 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 fro a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 23-JUN-2015 was vaccinated with a dose of oral, ROTATEQ (lot # K016313) (dose and route not reported) that was 87 hours temperature excursion. This lot was received on 08-APR-2015. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Angioedema, Eyelid oedema
Clinical narrative: Angioedema & swelling of eyelids 30 minutes after shot.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. Patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown dates, unspecified number of patients were vaccinated with a dose of improperly stored GARDASIL (lot number, Expiry date, dose and route were not reported). No adverse effects were 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 licensed practical nurse refers to an unspecified number of patients of unknown age and gender. There was no information about concomitant medications and pertinent medical history reported. On an unknown date, the unspecified number of patients was vaccinated with unspecified doses of improperly stored (Oka/Merck) VARIVAX lot # J013905, expiry date 30-OCT-2015 and lot # K021932, expiry date 10-NOV-2016 (route was not reported). No adverse effects were 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 Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history and concomitant medications reported. On an unknown date, the patients were vaccinated with improperly stored oral, ROTATEQ orally (dose, lot# and expiration date were not reported). There were no adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Chest pain, Dyspnoea
Clinical narrative: This spontaneous report was received from a registered nurse via company representative referring to a 21 year old female patient. Patient's medical history and concurrent conditions were not reported. On 22-JUN-2015, the patient was vaccinated with the 3rd dose of GARDASIL (lot # and expiry date not reported. Other co-suspect or concomitant medications were not reported. The Nurse reported that the patient experienced anxiety, chest pains and difficulty breathing after receiving her 3rd and final dose of GARDASIL on 22-JUN-2015. The nurse reported that sometime after the patient received her first two doses but before her final third dose the patient read numerous horror stories about side effects regarding GARDASIL. The physician and the nurse spent time talking to the patient as she was extremely anxious about getting the injection. After the patient calmed down she was administered her final dose of GARDASIL. They waited for 20 minutes before releasing the patient from the clinic. Twenty minutes later the patient called the clinic and said she thought she was having a heart attack. She complained of chest pain then said she couldn't catch her breath. The nurse said the patient was speaking just fine over the phone and referred to the Doctor for advice to see if an Emergency Room visit was necessary. The patient was advised to return to the clinic which she did. The physician examined her vitals and determined the patient was fine (no treatment was given). The office had had no contact with the patient since then so they are assuming she was no longer experiencing and adverse effects, but at the reporting time, the outcome of the event was uncertain. 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 Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history and concomitant medications reported. On an unknown date, the patients were vaccinated with improperly stored M-M-R II (dose, route of administration, lot# and expiration date were not reported). There were no adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 18 year old female patient. The patient's pertinent medical history included depression and acne. The patient had no prior history of drug reactions or allergies. On 23-DEC-2014, the patient was vaccinated with the first dose of GARDASIL (lot# K009482, expiry date 06-MAR-2017) (dose and route of administration were not reported). She experienced no adverse effects after she received this first dose. On 26-JUN-2015, the patient was vaccinated with the second dose of GARDASIL (lot# L018286, expiry date 13-APR-2017) intramuscularly in the left deltoid (dose was not reported). Concomitant therapies included WELLBUTRIN, EFFEXOR XR and SEASONALE for contraception. On 26-JUN-2015, 3 hours after vaccination, the patient experienced hives at the injection site. She experienced the hives "on and off" until 08-JUL-2015, when she sought medical attention by being examined by physician. At that time, she had not fully recovered from the event. No treatment was given for the event and no lab diagnostic studies were performed. At the time of this report, the patient did not receive her third dose of GARDASIL. The outcome of the event was unknown. The relatedness between GARDASIL and the event was not provided. 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 healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 23-JUN-2015 was vaccinated with a dose of oral, ROTATEQ (lot # K016313) (dose and route not reported) that was 87 hours temperature excursion. This lot was received on 08-APR-2015. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender who on unknown dates were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, route, lot # and expiration date were not provided). No adverse experiences were 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 nurse refers to an unspecified number of patients of unknown age and gender who on unknown dates were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, route, lot # and expiration date were not provided). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.78
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 9 month old given Kinrix. Kinrix is dosed for 4 years and older.
Age: 0.77
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Incorrect product formulation administered
Clinical narrative: During routine chart audits found that Lot number for HIB was invalid. Later determined that lot number belonged to diluent that was part of our stock. Unable to determine if child received actual vaccine.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Allergy to vaccine, Erythema, Injection site pain, Injection site urticaria
Clinical narrative: He complained of the injection site being sore for 2 days, then on day 3 a red spot under the injection site appeared. On day 5 following the vaccine (July 1, 2015) there was a large circle of hives all the way around the injection site. I informed the doctor's office and was asked to bring him in because a rash isn't normal. The Dr said it was hives and that my son is allergic to something in the DTaP vaccine.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Irritability, Pyrexia
Clinical narrative: First few days after vaccine high fever and irritable. 7/20/15 Redness, swelling at site (LLT). 7/21/15 Vesicular cluster at site (LLT).
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain, Pain in extremity, Rash, Rash erythematous, Vomiting
Clinical narrative: Vomited soon after shot. At home-shower. Red rash neck-tummy. Child complained-tummy pain, (R) arm pain. Few bumps on chest.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL lot # K005881, K006960 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 27-APR-2015 was vaccinated with a dose of GARDASIL (lot # K006960) (dose and route not reported) that was 24 hours temperature excursion. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 06-MAY-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent an unknown number of excursion hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender who on unknown dates were vaccinated with improperly stored doses of ZOSTAVAX (dose, route, lot # and expiration date were not provided). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pt said she had soreness, redness and itching at injection site.  The red area was about a 3 inch circle.
Age: 1.27
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Seizure
Clinical narrative: Patient developed a fever the evening of 6/25 following the vaccine administration earlier that day. He continued with a fever on 6/26. We were awakened in the middle on the night (6/26 into 6/27) to patient convulsing. We called 911 and he was taken to the hospital where they confirmed that he had suffered a seizure.
Age: 91.0
Sex: M
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Painful upper arm, cannot lift arm up without using other arm.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Chills, Erythema, Headache, Lymphadenopathy
Clinical narrative: DONOR WOKE UP MORNING OF 7/16/15 WITH TINGLING IN HANDS AND FEET. TWO DAYS AFTER INTIAL SYMPTOMS DONOR HAD SWOLLEN GLANDS. ON 7/20/15 DONOR HAD FEVER, CHILLS, STOMACH ACHE, TINGLING, HEADACHE, AND A SWOLLEN RED ARM. ALL SYMPTOMS FROM 7/20/15 CONTINUE TODAY.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Peripheral swelling, Pyrexia
Clinical narrative: DONOR WOKE UP MORNING OF 7/16/15 WITH TINGLING IN HANDS AND FEET. TWO DAYS AFTER INTIAL SYMPTOMS DONOR HAD SWOLLEN GLANDS. ON 7/20/15 DONOR HAD FEVER, CHILLS, STOMACH ACHE, TINGLING, HEADACHE, AND A SWOLLEN RED ARM. ALL SYMPTOMS FROM 7/20/15 CONTINUE TODAY.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-FEB-2015, the patient was vaccinated with a dose of MMR II (dose, injection site, route of administration, lot number and expiration date were not reported). It was also reported that the patient received two consecutive doses of MMR II, (dose, injection site, route of administration, lot number and expiration were not reported) on 16-MAR-2015 and 26-MAY-2015, respectively. No adverse symptoms were reported. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative, Varicella virus test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 26 year old male patient with asthma, anxiety and penicillin allergy. On 09-JAN-2015 and 11-MAR-2015, the patient was vaccinated with respectively with the first second dose of (Oka/Merck) VARIVAX (lot #, expiration date, dose and route were not provided) and with MMR II (lot #, expiration date, dose and route were not provided). Concomitant therapies included ATIVAN. On 30-JUN-2015, the patient's antibody titers to measles, mumps, rubella and varicella were negative. The outcome of varicella virus test negative, mumps antibody test negative, rubella antibody negative and measles antibody negative was unknown. The causality between the events and (Oka/Merck) VARIVAX and MMR II was not provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history and concomitant medications reported. On an unknown date, patients were vaccinated with improperly stored PEDVAXHIB (dose, route of administration, lot# and expiration date were not reported). There were no adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history and concomitant medications reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL (dose, route of administration, lot# and expiration date were not reported). There were no adverse symptoms 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 was received from a physician refers to a patient of unknown demographics. Patient's relevant medical history, concurrent conditions and drug reactions/allergies were unspecified. On 17-JUL-2015 the patient was vaccinated with a dose of an improperly stored VARIVAX (Merck) (strength, dose/frequency, lot # unspecified). Concomitant therapy was unspecified. No adverse experience was 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 physician refers to unspecified number of patients of unknown age and gender. Patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown dates, unspecified number of patients were vaccinated with a dose of improperly stored oral, ROTATEQ, (lot number, Expiry date and dose were not reported). No adverse effects were 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 physician refers to unspecified number of patients of unknown age and gender. Patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown dates, unspecified number of patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (lot number, Expiry date, dose and route were not reported). No adverse effects were 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 physician refers to unspecified number of patients of unknown age and gender. Patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown dates, unspecified number of patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot number, Expiry date, dose and route were reported). No adverse effects were 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 healthcare worker refers to a patient of unknown age and gender. On 06-JUL-2015 the patient was vaccinated with oral, ROTATEQ (dose was not reported, route of vaccination defaulted to oral, lot # K016314 with expiration date: 05-JUN-2016) which was improperly stored. This is one of several reports 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 healthcare worker refers to a patient of unknown age and gender. On 23-JUN-2015 the patient was vaccinated with ROTATEQ (dose was not reported, route of vaccination defaulted to oral, lot # K013661 with expiration date: 26-MAY-2016), which was improperly stored. No adverse symptoms reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. There was no information about concomitant medication and pertinent medical history reported. On an unknown date, the unspecified number of patients was vaccinated with unspecified doses of improperly stored PROQUAD (route was not reported) lot # K025759, expiry date 08-JUN-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 06-JUN-2015 was vaccinated with an improperly stored of GARDASIL lot #K006960 as (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent an unknown an unknown number of excursion hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated for oral, ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administration were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 15-MAY-2015 was vaccinated with a dose of oral, ROTATEQ (lot # K016313) (dose and route not reported) that was 87 hours temperature excursion. This lot was received on 08-APR-2015. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Debridement, Dyspnoea, Palpitations, Vaccination site cellulitis
Clinical narrative: Patient developed cellulitis to his left arm smallpox vaccination site, 9 days post vaccination, with IV antibiotics administered in the Emergency Department and subsequent wound debridement, twice, at a Wound Care Center, during follow up. He also developed chest pain, palpitations and shortness of breath, especially with exertion, 3-4 weeks after vaccination date. He has not been evaluated for this and still has residual chest pain.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Probable cellulitis at the Left deltoid injection site of Tdap vaccine administered 7/15/15.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Formation of rash at and around injection site (Left deltoid / upper arm).
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Syncope. Monitored.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Dysphagia, Dyspnoea, Heart rate increased, Hyperhidrosis, Pain in extremity
Clinical narrative: Trouble breathing, swallowing, pain in chest raised heart rate sweating.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Headache, Oropharyngeal pain, Pyrexia, Streptococcal infection
Clinical narrative: Patient is on day 4 of a high fever.  His fever has been between 102.6 and 103.7 daily.  On day one (7/18) he started complaining of a head ache, day two (7/19) he started complaining of a sore throat.  On day three (7/20) he was tested for and diagnosed with Streptococcus.  He  has now been on antibiotics for 24 hours.  Today is 7/21.
Age: 0.16
Sex: M
Vaccine: DTAP, RV5
Symptoms: Irritability, Muscle twitching
Clinical narrative: Rhythmic Head twitch to the left. Accompanied by hand twitching. Patient was still alert and responding however VERY fussy. The event lasted nearly an hour.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cyanosis, Pallor, Vomiting
Clinical narrative: Patient returned to office approx. 30 min after receiving vaccines. Pt. had vomited, pale color and blue lips. BP taken 98/60 POX 98%, clear lungs, heart RRR 72. Pt. given apple juice, blow by O2. Felt better and released home stable.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Fever, redness and swelling of arm, patient used BENADRYL cream, OTC pain medication and ice as needed.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site urticaria, Local reaction, Urticaria
Clinical narrative: Large local reaction with urticaria surrounding injection site. BENADRYL 12.5 mg PO and cold compress given. Pt observed for 30 minutes and normal vitals. Smaller urticarial rash after 20 minutes.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash.
Age: 1.32
Sex: M
Vaccine: HEP, HIBV, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: (Left Lat Thigh) redness, swelling, hard area on July 17, 2015. Hib vaccine given on 7-16-2015 states mom here at HC. Mom came to clinic 7-21-2015 with son/grandma. Dr did look at site. Our clinic was closed 7-17-2015. Swelling decreased on Monday, redness noted close at site with hard lump.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Pt stated she noticed one week after being vaccinated an area of redness at injection site. Area has irregular borders and measures 3cm w x 2.5 cm l. Advised to take ADVIL 200 mg 1 tab po Q 4-6 hrs and apply Hydrocortisone 1% cream BID.
Age: 28.0
Sex: M
Vaccine: MMR, TYP
Symptoms: Cold sweat, Dyspnoea, Flushing, Hypotension, Injection site pruritus
Clinical narrative: C/O itching at MMR injection site; flushed; eyes became red; c/o difficulty breathing; emesis x 3; warm and clammy; hypotensive.
Age: 28.0
Sex: M
Vaccine: MMR, TYP
Symptoms: Ocular hyperaemia, Skin warm, Vomiting
Clinical narrative: C/O itching at MMR injection site; flushed; eyes became red; c/o difficulty breathing; emesis x 3; warm and clammy; hypotensive.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Immediate post-injection reaction, Seizure
Clinical narrative: Seizure immediately after administration of MENACTRA injection. Duration of 30 seconds-1 minute.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Anxiety, Asthenia, Confusional state, Feeling abnormal, Immediate post-injection reaction
Clinical narrative: Immediately after HPV4 was administered today around 11:00 am, client fainted and convulsed for approximately 5 seconds. She immediately recovered consciousness and appeared confused for a short period. She indicated that she felt like being in a dark roller coaster tunnel with her little sister screaming. She complained of weakness, anxiety and for a few minutes she also expresses feeling strange as an impending doom feeling. BP and HT were taken WNL and patient was observed for approximately one hour until she fully recovered. Patient went home verbalizing that feels well and she appeared fine just like before injection, happy and playing with her little sister. It is very important to note that her brother received a second HPV4 dose an hour later and surprisingly a very similar reaction occurred. Adverse event also completed for her brother.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Seizure, Syncope
Clinical narrative: Immediately after HPV4 was administered today around 11:00 am, client fainted and convulsed for approximately 5 seconds. She immediately recovered consciousness and appeared confused for a short period. She indicated that she felt like being in a dark roller coaster tunnel with her little sister screaming. She complained of weakness, anxiety and for a few minutes she also expresses feeling strange as an impending doom feeling. BP and HT were taken WNL and patient was observed for approximately one hour until she fully recovered. Patient went home verbalizing that feels well and she appeared fine just like before injection, happy and playing with her little sister. It is very important to note that her brother received a second HPV4 dose an hour later and surprisingly a very similar reaction occurred. Adverse event also completed for her brother.
Age: 12.0
Sex: M
Vaccine: HEP, HPV4
Symptoms: Confusional state, Injection site pain, Pain in extremity, Seizure, Syncope
Clinical narrative: Immediately after GARDASIL was administered today around 12:30 PM, client fainted and convulsed for approximately 3 seconds. He immediately recovered consciousness and appeared confused for a very short time. Questions about name, time and place were asked which he accurately answered. He complained of pain at the site of injections and lower extremities. BP and HR were taken WNL and patient was observed for approximately 1/2 hour. Patient went home verbalizing that he feels well and he appeared fine just like before injection. It is very important to note that his sister received a 3 dose of GARDASIL and hour earlier and surprisingly the same reaction occurred. Adverse event also completed for her.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous reprot was received from a 54 year female consumer reporting on herself as part of a market research program. Patient's medical and concurrent conditions were not reported. In summer of 2014 (in approximately June 2014), the patient was vaccinated with a dose of ZOSTAVAX (route, site, lot # and expiry date not reported). The patient reported that after she was vaccinated, she experienced very minor soreness at injection site. After approximately 12 hours of onset of soreness at the injection site the patient took over the counter inflammatory. The outcome of injection site pain was reported as recovered/resolved within 48 hours. The reporter considered injection site pain to be related to ZOSTAVAX. Additional information is not expected.