chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, Muscle contractions involuntary, Muscle spasms, Muscle tightness, Pain
Clinical narrative: Muscle spasms in right hip that traveled down to right foot. Muscle tightness and contractions in abdomen. Very painful. Since I'm pregnant it was alarming.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional referring to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with VAQTA 50/1.0 U/ML intramuscular after being improperly stored at 33F (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the event was unknown. No PQC reported. The case has been linked with the cases (same reporter link) # 1406USA008470, 1406USA008474, 1406USA008476 and 1406USA008477. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, PNC13
Symptoms: Vaccination site swelling
Clinical narrative: Swelling around the vaccination site.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Migraine, Nausea, Photophobia, Staring
Clinical narrative: Glazed eyes, light sensitivity, followed by intense migraine and nausea.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional referring to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX intramuscular after being improperly stored at 33F (for an unspecified amount of time) (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the event was unknown. The case has been linked with the cases (same reporter link) 1406USA008158, 1406USA008474, 1406USA008476 and 1406USA008477. Additional information is not expected.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a pharmacist via a representative refers to a female patient of unknown age. On an unspecified date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, lot# and route not reported) as directed in a arm. Concomitant therapies included influenza virus vaccine (manufacturer unknown) in the opposite arm. "Over 1 year ago", the patients whole arm turned red after administration with PNEUMOVAX 23. The patient sought medication attention via office visit with the primary care physician. PNEUMOVAX 23 was not reintroduced. The patient had no respiratory issues reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional referring to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ after being improperly stored at 33F (for an unspecified amount of time) (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the event was unknown. The case has been linked with the cases (same reporter link) 1406USA008470, 1406USA008474, 1406USA008158 and 1406USA008477. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (merck) injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (merck) was exposed to. No concomitant medications was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exo date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional referring to unspecified patients of unknown age and gender. On an unknown dale the patients were vaccinated with PEDVAX after being improperly stored at 33F. (for an unspecified amount of time) (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the event was unknown. No PQC reported. The case has been linked with the cases(same reporter link) 1406USA008470, 1406USA008474, 1406USA008476 and 1406USA008158. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempts to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional referring to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL intramuscular after being improperly stored at 33F (for an unspecified amount of time, dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the event was unknown. The case has been linked with the cases (same reporter link 1406USA008470, 1406USA008158, 1406USA008476 and 1406USA008477. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Oropharyngeal pain
Clinical narrative: This spontaneous report was received from a male patient of unknown age, The patient's medical history was not reported. On 02-JUN-2014 the patient was vaccinated with ZOSTAVAX. Concomitant medications were not reported. Approximately on 03-JUN-2014 (reported as 1 or 2 days after vaccination), the patient experienced cold symptoms including a sore throat. The outcome of cold symptoms and sore throat was unknown. The causality of cold symptoms including a sore throat was not reported. This case is linked to case # 1406USA008833 (same reporter link). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure to vaccinated person, Nasopharyngitis, Oropharyngeal pain, Secondary transmission
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. The patient's medical history was not reported. On 02-JUN-2014 the patient's husband was vaccinated with ZOSTAVAX. Concomitant medications were not reported. Approximately on 03-JUN-2014 (reported as 1 or 2 days after vaccination), the patient's husband experienced cold symptoms including a sore throat. On an unknown date in June 2014, it was reported that the patient had caught whatever her husband had (secondary transmission). On 09-JUN-2014 (reported as yesterday), the patient had cold symptoms. The outcome of cold symptoms and sore throat was unknown. The causality of cold symptoms including a sore throat was not reported. This case is linked to case # 1406USA005786 (same reporter link). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pyrexia, Tenderness
Clinical narrative: Swollen arm is tender red -> fever. Patient took BENADRYL -> got better.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a consumer (patient's spouse) refers to a 58 year old female patient. No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, frequency, route, lot#, expiry date unspecified) and was told that she did not have to worry about getting shingles. No concomitant medications were reported. On an unspecified date in May 2014 (reported as around two weeks ago), the patient broke out with shingles on her back, on the back sides on her hands, and her stomach. The rash also went around to her face. Reporter said that his wife had to be rushed to Hospital Emergency Room. The patient's physician diagnosed the rash as shingles. No laboratory test were provided. The outcome of event was reported as not recovered. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from 2 registered nurses refers to an 11 year old female patient. The patient had a history of drug reactions described as hives to amoxicillin and penicillin on unspecified dates. On 27-NOV-2013 the patient was vaccinated with the first dose of GARDASIL (lot # J006236, expiration date 25-FEB-2016, dose not reported), intramuscularly in her right deltoid. There was no concomitant therapy. On an unspecified date, the patient's vaccinated arm was sore for an unspecified period of time after vaccination with the first dose of GARDASIL. On an unspecified date, the patient recovered from the adverse event after an unspecified period of time. On 18-JAN-2014, the patient was vaccinated with the second dose of GARDASIL (lot # J010668, expiration date 29-APR-2016, dose not reported), intramuscularly in her left deltoid. On an unspecified date in 2014, the patient's vaccinated arm was sore for an unspecified period of time after vaccination with the second dose of GARDASIL. On an unspecified date in 2014, the patient recovered from the adverse event unspecified period of time. On 03-JUN-2014, the patient was vaccinated with the third dose of GARDASIL (lot # J013324, expiration date 12-FEB-2016, dose not reported), subcutaneously in her right arm. The patient did not seek medical attention. Treatment was not given. No lab performed. It was unspecified if the patient's arm continued to be sore after the dose administered subcutaneously on 03-JUN-2014. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant, M.A.) refers to a patient of unknown age and gender. Pertinent medical history and drug reactions or allergies were not specified. On 09-MAY-2014, the patient was vaccinated with a dose of ROTATEQ, oral (dose number, dose, frequency and lot number were not specified), which was stored outside the temperature ranges specified in the product information (PI) (exact temperatures and dates not specified). Concomitant medications were not specified. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a nurse refers to a female patient of approximately 34 years of age. No relevant medical history of the patient was reported. On an unknown date in June 2007 the patient was vaccinated with M-M-R II, 0.5 ml, subcutaneous (also reported as vaccination) (lot number and expiration dates were not reported), at an other facility. Albumin status was unknown. The patient received the second dose of vaccination on an unknown date in July 2007. No concomitant medications were reported. On an unknown date in 2010 the patient's antibody titers revealed low immunity. The nurse was not able to clarify if the low immunity was to one or all the three antigens. The patient had sought medical attention by visiting the office. There was no product quality complaint (PQC) involved. The outcome of antibody titers revealed low immunity was unknown. The causality of the event was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a female patient of unknown age referring on herself. On an unspecified date, approximately in 2009 (about 5 years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot/batch number, expiration date, dose not reported). On approximately 07-MAY-2014 (beginning about 5 weeks ago), the patient developed shingles. The outcome of shingles at the time of the report was considered as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant, M.A.) refers to a patient of unknown age and gender. Pertinent medical history and drug reactions or allergies were not specified. On 29-MAY-2014, an unspecified patient was vaccinated with a dose of VARIVAX (Merck) (dose number, dose, frequency, route and lot number were not specified), 1 vial, which was exposed to temperature ranges outside of product information (PI) (exact temperatures and dates not specified). Concomitant medications were not specified. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant, M.A.) refers to a patient of unknown age and gender. Pertinent medical history and drug reactions or allergies were not specified. On 29-MAY-2014, an unspecified patient was vaccinated with a dose of PROQUAD (dose number, dose, frequency, route and lot number were not specified), 1 vial, which was exposed to temperature ranges outside of product information (PI) (exact temperatures and dates not specified). Concomitant medications were not specified. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 29-MAY-2014 the patient was vaccinated with unspecified doses of ROTATEQ (dose, route, lot# number not reported) and COMVAX (dose, route, lot# number not reported) that had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 29-MAY-2014 the patient was vaccinated with unspecified dose of RECOMBIVAX HB (dose, route, lot# number not reported) that had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant, M.A.) refers to a patient of unknown age and gender. Pertinent medical history and drug reactions or allergies were not specified. On 09-MAY-2014, the patient was vaccinated with a dose of GARDASIL (dose number, dose, frequency, route and lot number were not specified), 1 vial, which was stored outside the temperature ranges specified in the product information (PI) (exact temperatures and dates not specified). Concomitant medications were not specified. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant, M.A.) refers to a patient of unknown age and gender. Pertinent medical history and drug reactions or allergies were not specified. On 15-MAY-2014, the patient was vaccinated with a dose of ROTATEQ, oral (dose number, dose, frequency and lot number were not specified), 1 vial, which was stored outside the temperature ranges specified in the product information (PI) (exact temperatures and dates not specified). Concomitant medications were not specified. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On an unspecified date in August 2012, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number not provided). No co-suspect or concomitant therapies were reported. On an unspecified date in December 2012, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number not provided). The nurse reported that the patient had not received the 3rd dose in the GARDASIL series. No adverse effect reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Eye movement disorder, Hyperhidrosis, Malaise, Muscle rigidity, Muscle tightness
Clinical narrative: Administered vaccines, pt appears to be fine - made her sit for a moment, within 1-2 min after giving vaccine pt states "I do not feel right". She turned pale and sweaty. I laid her back on exam table called for assistance. Her eyes rolled back in head, fists and arms clenched, twitching and body rigid. Episode lasting 45-60 sec. EMS arrived. VS 9:01 - BP 124/79, (R) 52, (P) 92. EMS sat her up on table, another episode happened lasting about 15 sec. EMS concerned she possibly had a seizure. EMS suggested pt go to hospital for further evaluation. D/C at 9:17 to EMS.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Muscle twitching, Pallor
Clinical narrative: Administered vaccines, pt appears to be fine - made her sit for a moment, within 1-2 min after giving vaccine pt states "I do not feel right". She turned pale and sweaty. I laid her back on exam table called for assistance. Her eyes rolled back in head, fists and arms clenched, twitching and body rigid. Episode lasting 45-60 sec. EMS arrived. VS 9:01 - BP 124/79, (R) 52, (P) 92. EMS sat her up on table, another episode happened lasting about 15 sec. EMS concerned she possibly had a seizure. EMS suggested pt go to hospital for further evaluation. D/C at 9:17 to EMS.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Eye pain, Iritis, Slit-lamp examination
Clinical narrative: Painful red eye, diagnosed with acute or subacute primary iritis.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash
Clinical narrative: Itching throughout whole body, rash on chest.  Used most OTC anti-itching remedies.  None has stopped the itching or cleared the rash.
Age: 0.51
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient (gender unspecified). On 12-JUN-2014, the patient was vaccinated with expired dose of RECOMBIVAX HB vial SD IM 2.5y (strength, dose, frequency, route of administration and anatomical location: not reported) (lot # 1625AA, exp date: 06-JUN-2014). No adverse effects were reported by the reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Day after injection pt developed increased redness, swelling. Denies pain. Swelling improved today. Not hard to touch. C/o itching, denies fever. Advised OTC hydrocortisone cream and BENADRYL, ice, f/u if worse.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 06-JUN-2014, the patient was vaccinated with a dose of ZOSTAVAX (strength reported as 19400 PFU) lot # J013138, expiration date 17-JAN-2015, 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The pharmacist reported that ZOSTAVAX was stored at 40F for 90 days and was administered to a patient on 06-JUN-2014. No adverse effects reported. Additional information has been requested. These is one (1) of two (2) reports from the same reporter (MARRS 1406USA007864 and 1406USA007871).
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 09-JUN-2014, the patient was vaccinated with a dose of ZOSTAVAX (strength reported as 19400 PFU) lot # J013138, expiration date 17-JAN-2015, 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The pharmacist reported that ZOSTAVAX was stored at 40F for 90 days and was administered to a patient on 09-JUN-2014. No adverse effects reported. Additional information has been requested. These is one (1) of two (2) reports from the same reporter (MARRS 1406USA007864 and 1406USA007871).
Age: 1.37
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Pyrexia, Rash pruritic, Skin lesion, Varicella post vaccine
Clinical narrative: Clinical presentation of chicken pox started on 6/14/14 - seen in office and diagnosed based on physical exam 6/16/14. (Fever, pruritic vesicles/lesions in different stages in diffuse distribution).
Age: 11.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was inadvertently given ZOSTAVAX vaccine, should have been given varicella. No adverse reactions. Received 0.5 mL not the 0.65 mL.
Age: 11.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was inadvertently given ZOSTAVAX vaccine, should have been given varicella. No adverse reactions. Received 0.5 mL not the 0.65 mL.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No relevant medical history of the patient was reported. On 13-JUN-2014 the patient was vaccinated with RECOMBIVAX HB (dose number, dose, route of administration and lot number were not reported). Expiration date was reported as 02-MAY-2014. No concomitant medications were reported. The patient was administered with a properly stored dose of RECOMBIVAX HB on 13-JUN-2014 that had an expiration date of 02-MAY-2014. No adverse effects were reported. There was no product quality complaint (PQC) involved. The outcome was unknown. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site vesicles
Clinical narrative: 24 hrs after shot administered blister appeared at left leg shot site.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Emotional distress, Pyrexia
Clinical narrative: Inconsolable for multiple hours, fever 101 for more than 48 hours.  Treatment was to continue with Motrin.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Rash generalised, Rash papular, Rhinorrhoea
Clinical narrative: Rash (erythematous papules on neck and then rest of his body, excluding palms and soles) and runny nose. No fever.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Fatigue, Headache, Injection site swelling, Injection site warmth
Clinical narrative: Arm swollen at injection sight (6 days), arm felt hot in the area swollen (3 days), nausea, diarrhea (for 3 days), extreme fatigue and tiredness (6 days) and headache (6 days). The symptoms have improved but have not completely subsided as of 6/18/14. I still feel very tired, nauseated and my arm is still swollen at the injection site on 6/18/14.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Arm swollen at injection sight (6 days), arm felt hot in the area swollen (3 days), nausea, diarrhea (for 3 days), extreme fatigue and tiredness (6 days) and headache (6 days). The symptoms have improved but have not completely subsided as of 6/18/14. I still feel very tired, nauseated and my arm is still swollen at the injection site on 6/18/14.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Face injury, Fall, Injection site rash, Loss of consciousness, Rash
Clinical narrative: Syncope approximately 10 seconds after last immunization given. Fell and hit nose on table next to chair she was sitting in. Lost consciousness for 2 - 3 seconds. Gently lowered patient to floor supporting head and neck. Legs elevated. Monitored vital signs. All remained stable. Ice pack to nose. Small fine rash approximately 3 inches long noted near right axilla. About 10 minutes later developed fine rash and hives on left neck and shoulder area. Mom declined Benadryl as she herself allergic to Benadryl. Hives remained stable and were resolving when EMS arrived. Transported to ER by EMS for further evaluation and treatment as indicated.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Syncope, Urticaria
Clinical narrative: Syncope approximately 10 seconds after last immunization given. Fell and hit nose on table next to chair she was sitting in. Lost consciousness for 2 - 3 seconds. Gently lowered patient to floor supporting head and neck. Legs elevated. Monitored vital signs. All remained stable. Ice pack to nose. Small fine rash approximately 3 inches long noted near right axilla. About 10 minutes later developed fine rash and hives on left neck and shoulder area. Mom declined Benadryl as she herself allergic to Benadryl. Hives remained stable and were resolving when EMS arrived. Transported to ER by EMS for further evaluation and treatment as indicated.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Insomnia, Movement disorder, Myalgia
Clinical narrative: Severe generalized soreness of muscles and joints, impairing movement due to pain, extreme headache, extreme fatigue. Unable to sleep night after administration due to soreness, focused pain to bilateral calves, heating pad applied with little relief, 600mg of Ibuprofen around the clock seemed to take edge off. Symptoms remain an issue. Worst is subsiding.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Severe generalized soreness of muscles and joints, impairing movement due to pain, extreme headache, extreme fatigue. Unable to sleep night after administration due to soreness, focused pain to bilateral calves, heating pad applied with little relief, 600mg of Ibuprofen around the clock seemed to take edge off. Symptoms remain an issue. Worst is subsiding.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Febrile convulsion, Pyrexia, Somnolence, Vomiting
Clinical narrative: Pt. seen in clinic, received 6 month well child vaccines. Later in evening, pt. had fever of 101.0 degree F with forehead thermometer, while dad holding him. Started to have a febrile seizure (couple of mns.) then vomited up formula, baby was groggy but response afterwards. Fever went down to 98.5 degrees F and baby is back to normal by next morning.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Diarrhoea, Pyrexia, Rash, Vomiting
Clinical narrative: Fever began day after vaccines. She then had vomiting and diarrhea on and off for 7-10 days. She came to see us 2 weeks later when she developed a rash. Fever lasted 3 days.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to 3 unspecified patients of unknown age and gender. Medical history or concurrent conditions were not reported. On an unspecified date in June 2014, reported as last week, the patients were vaccinated with VARIVAX (Merck), dose 0.5 ml, subcutaneous (lot # reported as: J004204; Exp. Date: 12-APR-2015) and (lot # reported as: J008443; Exp. Date: J008443) (strength and dose number not provided). The VARIVAX (Merck) was exposed to 81F for 72 hours. The reporter did not have specified administration dates. It was unclear which patient received which lot. No adverse effects were reported. PQC (product quality complaint) not involved. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Blister, Injection site abscess, Injection site erythema, Injection site vesicles
Clinical narrative: Redness/blister (fluid filled) 24 hours later on thighs at shot site LLT - progressed over next 24 hours - abscessed. 1 shot administered 2 blisters/2 areas.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Fever occurred 8-9 days after vaccine admin. w/ no other symptoms.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Asthenia, Decreased appetite, Dizziness, Feeling hot, Influenza like illness
Clinical narrative: Notes from 6/12 phone note with pt: Started not feeling well approximately 9 pm, felt "lazy", feverish with body aches. Both arms "really hurt" couldn't raise (R) arm due to pain and at site of injection (R) arm was burning. Felt extremely weak - this has continued. Has had flu-like symptoms - body felt hot. By 6/11 she was able to raise her (R) arm up but caused pain to do so. 6/12 still feeling lightheaded and weak, no appetite. 6/13 weak, lethargic but sl. better from 6/12. Still is getting some pain in (R) arm intermittently. Declined follow up OV.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Lethargy, Malaise, Pain
Clinical narrative: Notes from 6/12 phone note with pt: Started not feeling well approximately 9 pm, felt "lazy", feverish with body aches. Both arms "really hurt" couldn't raise (R) arm due to pain and at site of injection (R) arm was burning. Felt extremely weak - this has continued. Has had flu-like symptoms - body felt hot. By 6/11 she was able to raise her (R) arm up but caused pain to do so. 6/12 still feeling lightheaded and weak, no appetite. 6/13 weak, lethargic but sl. better from 6/12. Still is getting some pain in (R) arm intermittently. Declined follow up OV.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Notes from 6/12 phone note with pt: Started not feeling well approximately 9 pm, felt "lazy", feverish with body aches. Both arms "really hurt" couldn't raise (R) arm due to pain and at site of injection (R) arm was burning. Felt extremely weak - this has continued. Has had flu-like symptoms - body felt hot. By 6/11 she was able to raise her (R) arm up but caused pain to do so. 6/12 still feeling lightheaded and weak, no appetite. 6/13 weak, lethargic but sl. better from 6/12. Still is getting some pain in (R) arm intermittently. Declined follow up OV.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives on legs, back, and under left arm 3 hrs. after getting GARDASIL vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Injection site swelling, Pain
Clinical narrative: Parent called 6/13/14 to report child woke up to a red, swollen, "baseball" size lump on right thigh. No c/o shortness of breath or wheezing. Afebrile. Spoke with parent today 6/18/14 still has "bruise" to right thigh, doing well. Did not develop rash had slight fever and c/o it "hurting" treated with ice and ibuprofen.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Parent called 6/13/14 to report child woke up to a red, swollen, "baseball" size lump on right thigh. No c/o shortness of breath or wheezing. Afebrile. Spoke with parent today 6/18/14 still has "bruise" to right thigh, doing well. Did not develop rash had slight fever and c/o it "hurting" treated with ice and ibuprofen.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's current conditions or medical history were not reported. The patient received the first dose of GARDASIL series on: on 30-JAN-2014, second dose on -3-APR-2014 and third dose on 11-JUN-2014, (0.5 ml intramuscular injection, not numbers and expiration dates not reported). No adverse effects reported. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: PT REMAINED CONSCIOUS, BECAME PALE AND DIAPHORETIC. NO S/SX OF RESP. DISTRESS, NO CHEST PAIN. Pt remained in sitting position. Pt denied any allergies prior to vaccine, and did not indicate taking any medications.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: FEVER, SORE THROAT, RASH.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Injection site induration, Injection site mass, Injection site pain
Clinical narrative: HARD LUMP IN ARM WHERE SHOT WAS GIVEN, SORE TO TOUCH.  BEEN BOTHERING HER PAST WEEK.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Ear pain, Rash
Clinical narrative: EAR ACHE, RASH ON CHEST, BACK OF LEGS, ARMS.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Lip swelling, Local swelling, Pruritus, Rash
Clinical narrative: Intense itching (pruritis) of hands, red rash on palms, swelling of right hand, swelling of lip. Two days later, on 6/18/2014 hives and diarrhea develop.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Intense itching (pruritis) of hands, red rash on palms, swelling of right hand, swelling of lip. Two days later, on 6/18/2014 hives and diarrhea develop.
Age: 48.0
Sex: M
Vaccine: MMR
Symptoms: Pain, Rash
Clinical narrative: RASH/ACHES
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Laboratory test abnormal, Polymerase chain reaction, Rash morbilliform
Clinical narrative: RASH THAT LOOKED LIKE MEASLES, NO FEVER/NO OTHER SYMPTOMS.
Age: 1.86
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: RASH (ALL OVER) LOW GRADE FEVER.
Age: 22.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash, Swelling face
Clinical narrative: Rash to neck and chest and face was puffy per patient. States she "took a Benadryl and symptoms faded." Right arm at injection site was red, swollen, and tender all the way to elbow. Swelling and redness worse on 06/13/14. Pt reported to health department. No rash or puffiness noted to face, neck or chest area. Right arm with redness, swelling, measured 48mm. Pt c/o tenderness. Told pt to put cool compress to area and take Motrin, if not allergies to Motrin. If swelling, redness worsens to report to doctor by 06/14/14. Call health department week of 06/16/14 to follow-up.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Rash, Urticaria
Clinical narrative: RASH ON FACE, HIVES ON LEGS, TUMMY ACHE.
Age: 1.25
Sex: F
Vaccine: DTAP, PNC13, VARCEL
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: Patient developed rash on 06/03/2014, at first family thought it was bug bites, but quickly spread over body and appeared very classic like chickenpox. She had between 50-75 pox over body with majority on lower trunk/genital area.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Anticonvulsant drug level therapeutic, Dyskinesia, Full blood count normal, Metabolic function test normal, Somnolence
Clinical narrative: Patient was sleepy, took a nap and woke up with abnormal movements and had an event where she stared off into space for 15 minutes and was very still.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Staring, Urine analysis normal
Clinical narrative: Patient was sleepy, took a nap and woke up with abnormal movements and had an event where she stared off into space for 15 minutes and was very still.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: PT HAD SWELLING OF INJECTION SITE, SLIGHT FEVER, NAUSEA.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Pain, Pain in extremity, Sensation of heaviness
Clinical narrative: Body Aches: heaviness and pain in legs and back.
Age: 36.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Crying, Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain left arm (TDAP injection site). Decreased ROM of left shoulder. Unable to lift arm above shoulder. Strength 2/5. Pain scale 10/10. Patient crying in pain. 0 swelling; 0 erythema; 0 rash; no signs of infection.
Age: 26.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: Onset of fever 102F, continued subjective fevers x 4 days, measles-like rash started 6/16/14 on chest and spread to face, then arms, then legs.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Hives
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Foetal disorder, Injection site swelling, Nausea, Pain
Clinical narrative: Pt had localized pain and swelling to inj site, high fever, nausea and vomiting, became very tachycardic as did the baby (pt was 31 weeks preg).
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Tachycardia, Vomiting
Clinical narrative: Pt had localized pain and swelling to inj site, high fever, nausea and vomiting, became very tachycardic as did the baby (pt was 31 weeks preg).
Age: 18.0
Sex: F
Vaccine: HPV4, YF
Symptoms: Erythema, Local swelling, Nausea, Pruritus
Clinical narrative: Swelling (mild to moderate), redness, and itching to both hands -- nausea onset about 30 minutes after vaccine administration, but resolved after a short period of time; instructed patient to take 50mg (2 OTC tablets) of Benadryl and I will check back with her in 45-60 minutes, she also will mark where redness extends on her arm and we will compare in 45-60 minutes; a visit to urgent care may be needed if benadryl does not control/limit extension of reaction.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Increasing pain L shoulder not able to move upward. Required pain meds, steroids, physical therapy, MRI Neurolgy consult.
Age: 20.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Dizziness, Erythema, Hyperhidrosis
Clinical narrative: WITHIN ONE MINUTE OF RECEIVING VACCINES, PATIENT FELT DIZZY AND FELT FAINT. SHE WAS SWEATING PROFUSELY AND HER FACE WAS RED. WITHIN 5-10 MINUTES OF RECEIVING THE VACCINES, HER SYMPTOMS SUBSIDED.
Age: 28.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Painful at injection site since the administration of the vaccine. Itching noticed 6/17/2014. Noticed painful, red, swollen area that continues to itch on 06/18/2014.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased appetite, Hypersomnia, Injection site erythema, Injection site swelling, Middle insomnia
Clinical narrative: Mother states that infant fell asleep around 10 PM on 06/17/14, woke up at 12 midnight screaming and didn't fall back asleep till 2 AM. Woke up around 5 AM on 06/18/14 with a rash on abdomen and had a fever around 100.2; mother states fever has not got any higher than 100.5, that infant hasn't had an appetite all day and has been sleeping a lot through out the day. Injection site was red and swollen.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Rash, Screaming
Clinical narrative: Mother states that infant fell asleep around 10 PM on 06/17/14, woke up at 12 midnight screaming and didn't fall back asleep till 2 AM. Woke up around 5 AM on 06/18/14 with a rash on abdomen and had a fever around 100.2; mother states fever has not got any higher than 100.5, that infant hasn't had an appetite all day and has been sleeping a lot through out the day. Injection site was red and swollen.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Developed redness and warmth over the injection site which was the right triceps area.She took one half of an over-the-counter children's Benadryl which had minimal effectiveness for her. She has not experienced any troubles with breathing. No other specific constitutional symptoms
Age: 1.21
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Allergy test negative, Basophil count decreased, Basophil percentage decreased, Blood lead normal, C-reactive protein normal
Clinical narrative: When the pt. was seen for her 1 year checkup on 2/1/12 she did not receive her 12 month vaccinations. The mother of the patient reported concerns regarding intermittent fevers, intermittent diarrhea and an abdominal "lesion" (which was later diagnosed as 2 epigastric hernias and an umbilical hernia). A review of the EMR indicates several notations of intermittent fevers, diarrhea and various rashes prior to the 1 year checkup. The pt. was seen again on 4/5/12 for a red, papular rash on her arms and face, a cough and congestion. She was diagnosed with eczema and an URI. The pt. received her MMR, HepA and Varicella vaccinations on 4/18/12. At her 15 month checkup on 5/1/12 it was noted that the pt. had macular blanching lesions scattered on her entire body and papular lesions scattered on her body with some in the scalp and an isolated dime sized brown/orange lesion on her forearm with a positive Darier sign (the Mother of the pt. confirms that this solitary brownish lesion was first noted when the child was 6 months of age). She was diagnosed with a viral exanthema most likely related to the MMR, referred to Allergy/Immunology for the history of intermittent fevers and Dermatology. The HIB #4 and PREVNAR #4 vaccinations were deferred. Labs for Hgb, Lead and Pediatric Airborne Allergy Panel were wnl. On 5/2/12 the Mother of the pt. reported that the infant's rash had changed and now was purple spots that looked like bruising. Upon questioning dark lesions were noted on the oral mucosa. According to the EMR the infant was seen at a ER and her platelets were noted to be 4. Peds Hematology-Oncology was consulted and the infant was transferred to hospital for admission. Labs were: ESR 25, CRP wnl, PT 13.2, INR 1.01L, and CBC with diff wnl except: HCT 31.7. Platelets NT, Neutrophils 1.3L and Monocytes 1.3H. The infant received IVIG without adverse event and was discharged at the Mothers request on 5/3/12.Repeat platelet count on 5/10/12 was 422 and on 5/17/12 was 289. No further episodes of ITP have been noted.
Age: 1.21
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Contusion, Eosinophil count normal, Eosinophil percentage, Haematocrit decreased, Haemoglobin normal
Clinical narrative: When the pt. was seen for her 1 year checkup on 2/1/12 she did not receive her 12 month vaccinations. The mother of the patient reported concerns regarding intermittent fevers, intermittent diarrhea and an abdominal "lesion" (which was later diagnosed as 2 epigastric hernias and an umbilical hernia). A review of the EMR indicates several notations of intermittent fevers, diarrhea and various rashes prior to the 1 year checkup. The pt. was seen again on 4/5/12 for a red, papular rash on her arms and face, a cough and congestion. She was diagnosed with eczema and an URI. The pt. received her MMR, HepA and Varicella vaccinations on 4/18/12. At her 15 month checkup on 5/1/12 it was noted that the pt. had macular blanching lesions scattered on her entire body and papular lesions scattered on her body with some in the scalp and an isolated dime sized brown/orange lesion on her forearm with a positive Darier sign (the Mother of the pt. confirms that this solitary brownish lesion was first noted when the child was 6 months of age). She was diagnosed with a viral exanthema most likely related to the MMR, referred to Allergy/Immunology for the history of intermittent fevers and Dermatology. The HIB #4 and PREVNAR #4 vaccinations were deferred. Labs for Hgb, Lead and Pediatric Airborne Allergy Panel were wnl. On 5/2/12 the Mother of the pt. reported that the infant's rash had changed and now was purple spots that looked like bruising. Upon questioning dark lesions were noted on the oral mucosa. According to the EMR the infant was seen at a ER and her platelets were noted to be 4. Peds Hematology-Oncology was consulted and the infant was transferred to hospital for admission. Labs were: ESR 25, CRP wnl, PT 13.2, INR 1.01L, and CBC with diff wnl except: HCT 31.7. Platelets NT, Neutrophils 1.3L and Monocytes 1.3H. The infant received IVIG without adverse event and was discharged at the Mothers request on 5/3/12.Repeat platelet count on 5/10/12 was 422 and on 5/17/12 was 289. No further episodes of ITP have been noted.