chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Inflammation, Skin lesion
Clinical narrative: This spontaneous report was received from a healthcare worker via company representative refers to a male patient of unknown age. On 12-DEC-2013, the patient was vaccinated with ZOSTAVAX lot # J006827 (dose, route and frequency were not reported). Concomitant therapies included PROVENTIL. On an unknown date, the patient experienced a rather large rash after receiving ZOSTAVAX. The reporter stated that the rash was below chest on left side and extended around to flank area. The physician was interested in collecting specimen from rash. The patient sought medical attention and saw the physician in office. On an unknown date, isolate collected from the patient. The patient was treated with ZOVIRAX tablets and ointment. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising, Injection site nodule
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age (reported as a teenager). On an unknown date in January 2014 the patient was vaccinated with GARDASIL dose 1, intramuscular (lot number and expiration date was not provided). On an unknown date in 2014, after the administration of GARDASIL the patient experienced reaction at the injection site described as a knot and bruising. Patient sought medical attention at an emergency room where she was treated with "steroid shot". The outcome of the events was reported as recovered/resolved. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to two patients of unknown age and gender. No medical history or concurrent conditions reported. On 11-APR-2014, both patients were inadvertently vaccinated with MMR II (dose, strength and lot number not provided). Co-suspect or concomitant therapies were not reported. The reporter stated that MMR II vaccine had been improperly stored. At the time of the report, the outcome of the event was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction, Skin warm
Clinical narrative: Noticed redness, soreness and swelling at injection site less than 24 hrs after receiving vaccine. Warm and tender to touch. Localized rxn. No changes in LOC. No SOB/resp distress. No rash noted.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Noticed redness, soreness and swelling at injection site less than 24 hrs after receiving vaccine. Warm and tender to touch. Localized rxn. No changes in LOC. No SOB/resp distress. No rash noted.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Pt received rash from head to toe several days after getting the ZOSTAVAX shot.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Cellulitis, Erythema, Excoriation, Papule, Pruritus
Clinical narrative: Varicella-zoster virus: > 50 2-3mm red papules on back of neck, trunk, arms in varynig stages. Also, 1x3 cm abrasion on (L) elbow with yellow crust, cellulitis treated with KEFLEX. Itching began a few days ago. Rash 4/14/14. T. 98.0 degrees F temp.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Varicella-zoster virus: > 50 2-3mm red papules on back of neck, trunk, arms in varynig stages. Also, 1x3 cm abrasion on (L) elbow with yellow crust, cellulitis treated with KEFLEX. Itching began a few days ago. Rash 4/14/14. T. 98.0 degrees F temp.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site swelling
Clinical narrative: Dizziness after immunization treated w/BENADRYL cookies and juice. Swelling and redness at the injection site treated with Azithromycin.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Joint swelling, Musculoskeletal pain
Clinical narrative: Pain and swelling in left shoulder noticed 6:00 am 4/13/14. Redness from injection site to elbow noticed 5.00 pm 4/15/14. Treated with hot compresses.
Age: 42.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Patient received Tdap vaccine in (R) deltoid on 3/11/14. She states her deltoid was swollen and red and stated she thinks she had a reaction to the Tdap vaccine.
Age: 1.84
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Pyrexia, Rash, Skin lesion, Varicella post vaccine
Clinical narrative: Varicella disease - fever (subjective low grade) x 2 days then rash multiple stage lesions.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, refers to a 20 year old female patient. No pertinent medical history was reported. On 11-APR-2014, reported as today, the patient was vaccinated with MMR II, (lot # 0686AE; Exp. Date: 02-APR-2014), Dose: 0.5 ml, subcutaneous injection in the left arm. Co-suspect or concomitant therapies were not reported. The reporter nurse stated that patient was vaccinated with expired MMR II vaccine. No adverse effects reported.At the time of the report, the outcome of the event was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a health care worker refers to a female patient of unknown age. The patients pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 31-MAR-2014 the patient was vaccinated with GARDASIL lot # J013324, expire date 12-FEB-2016, intramuscular. No concomitant medications were reported. On 31-MAR-2014, few minutes after the therapy the patient fainted. The sought medical attention was not reported. After few minutes (31-MAR-2014) the patient recovered from the adverse event fainted. It was reported that the lot check was requested. This is one of the two report received from the same reporter link (1404USA008325). Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pallor, Vomiting
Clinical narrative: Within 2 minutes of receiving vaccines, patient went into restroom, turned pale and vomited. Patient returned to room rested 15-20 min, drank water BP 120/66. Ambulated out of office under care of her mother, color improved and feeling fine.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: 4/3/13 - Pt received ZOSTAVAX, lt upper arm SQ. 4/7/14 - Pt seen for rash to his lt wrist and forearm. Reports rash appeared after vaccine.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: Body aches/chills. Sore arm.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager (medical assistant) refers to a patient of unknown age and gender. On 18-DEC-2013 the patient was vaccinated with the first dose of oral ROTATEQ. The oral ROTATEQ was improperly stored. It was exposed to temperature of 32F for 32 minutes on 02-DEC-2013, then 32F for 24 minutes on 03-DEC-2013, then on the same day 03-DEC-2013 at 31F for 8 minutes, then 33 F for 19 minutes on 04-DEC-2013, then 33 F for 34 minutes on 17-DEC-2013. No adverse effects reported. This is one of four 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 was received from a licensed practitioner nurse and refers to a unspecified number of patient of unspecified demographics. On an unknown date the patients were vaccinated with GARDASIL dose 2. Nurse stated that a client was vaccinated with a second dose of GARDASIL 6 months after the first dose. Nurse stated that they were a large practice and they have clients that occasionally come in late for the GARDASIL vaccination. No adverse effects were reported. On an unknown date the patient experienced a client was vaccinated with a second dose of GARDASIL 6 months after the first dose and no adverse effects reported. Additional information is not expected. No new follow-up information was received. The case will not be voided because there are another unspecified patients mentioned, who received delayed doses of GARDASIL.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to two patients of unknown age and gender. On an unknown date, the patients were vaccinated with GARDASIL (dose, frequency, route, lot# and expired date were not reported). Concomitant therapy was not reported. The patients were vaccinated with improperly stored GARDASIL. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of unknown demography. The nurse reported that on 08-APR-2014, the patient was administered with expired dose of ZOSTAVAX Lot # 0068AE (Expiration: 03-APR-2013) (dose and frequency were not reported). No adverse effect reported. No further information provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Pruritus generalised
Clinical narrative: This spontaneous report as received from a 60 year old female consumer refers to herself with allergy to penicillin and no pertinent medical history. On 20-MAR-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported) as preventive vaccine. There was no concomitant medication. The patient stated that her husband was diagnosed with shingles on 22-MAR-2014 prior to her receiving the vaccine on 28-MAR-2014. On the evening of 31-MAR-2014, the patient began feeling "tingling all over the body like needles". The patient also stated she had a "warm sensation and redness" at injection site on 31-MAR-2014. The patient did not have a rash and had not been diagnosed with shingles. No further symptoms provided by the patient. She informed the doctor via office visit of these symptoms. To date, no treatment had been given. No lab diagnostics studies were performed. At the time of report, the outcome of the events was reported as not recovered. Additional information has been recovered.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Paraesthesia
Clinical narrative: This spontaneous report as received from a 60 year old female consumer refers to herself with allergy to penicillin and no pertinent medical history. On 20-MAR-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported) as preventive vaccine. There was no concomitant medication. The patient stated that her husband was diagnosed with shingles on 22-MAR-2014 prior to her receiving the vaccine on 28-MAR-2014. On the evening of 31-MAR-2014, the patient began feeling "tingling all over the body like needles". The patient also stated she had a "warm sensation and redness" at injection site on 31-MAR-2014. The patient did not have a rash and had not been diagnosed with shingles. No further symptoms provided by the patient. She informed the doctor via office visit of these symptoms. To date, no treatment had been given. No lab diagnostics studies were performed. At the time of report, the outcome of the events was reported as not recovered. Additional information has been recovered.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, CSF protein increased, CSF protein normal, CSF white blood cell count negative, Cytogenetic analysis normal
Clinical narrative: Initially, loss of sensation of touch; progression to severe hand, forearm pain; developent of involuntary muscle spasms; falls associated with and without headache; neurological decline; hospitalized 5 days; treated with 5 days IVIG; symptom management with medications; persistent mobility and balance problems.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Headache, Immunoglobulin therapy, Muscle spasms, Nervous system disorder
Clinical narrative: Initially, loss of sensation of touch; progression to severe hand, forearm pain; developent of involuntary muscle spasms; falls associated with and without headache; neurological decline; hospitalized 5 days; treated with 5 days IVIG; symptom management with medications; persistent mobility and balance problems.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Neuropathy peripheral, Pain in extremity, Sensory loss
Clinical narrative: Initially, loss of sensation of touch; progression to severe hand, forearm pain; developent of involuntary muscle spasms; falls associated with and without headache; neurological decline; hospitalized 5 days; treated with 5 days IVIG; symptom management with medications; persistent mobility and balance problems.
Age: 10.0
Sex: M
Vaccine: MNQ, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Myositis
Clinical narrative: Myositis of (R) arm. Warm, tender and red at injection site. Clindamycin 450 mg IV Q 6 hrs.
Sex: F
Vaccine: HPV4
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. On an unspecified date years ago, an anonymous patient (demographics unknown) received all 3 shots of the GARDASIL, route "injection", (indication, dose, frequency, lot# and expired date were not reported). Concomitant therapy was not reported. After the patient received the 3rd shot of GARDASIL, she developed a nodule at the injection site. No adverse events were reported in regards to the 1st and 2nd shot of GARDASIL. The outcome of adverse event was not reported. The relationship between adverse event and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's pertinent medical history was not reported. On 11-APR-2014 the patient was inadvertently vaccinated with ROTATEQ (lot # H017721) (Dose: 2 ml) orally which was expired on 01-APR-2014. No adverse effects reported. The outcome was unknown. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Asthma, Herpes zoster, Immunodeficiency, Leukaemia in remission, Pain
Clinical narrative: Herpes zoster in one-dose varicella vaccine recipient. Painful rash on hand and arm on left side. Rash was ongoing, but starting to crust at the time of interview which was 4/1/14. Unknown treatment. Patient is immunocompromised. Hospitalized 3/26/14-4/7/14. Admit diagnosis (related): Acute lymphoid leukemia, without mention of having achieved remission (204.00); Chronic rhinitis; Herpes zoster without mention of complication; Other specified counseling; Transfusion reaction, unspecified; Unspecified asthma (493.90); Unspecified leukemia in remission; Unspecified rehabilitation procedure; Vaccination not carried out for other reason.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Polymerase chain reaction, Rash, Rhinitis, Scab, Transfusion reaction
Clinical narrative: Herpes zoster in one-dose varicella vaccine recipient. Painful rash on hand and arm on left side. Rash was ongoing, but starting to crust at the time of interview which was 4/1/14. Unknown treatment. Patient is immunocompromised. Hospitalized 3/26/14-4/7/14. Admit diagnosis (related): Acute lymphoid leukemia, without mention of having achieved remission (204.00); Chronic rhinitis; Herpes zoster without mention of complication; Other specified counseling; Transfusion reaction, unspecified; Unspecified asthma (493.90); Unspecified leukemia in remission; Unspecified rehabilitation procedure; Vaccination not carried out for other reason.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Varicella virus test positive
Clinical narrative: Herpes zoster in one-dose varicella vaccine recipient. Painful rash on hand and arm on left side. Rash was ongoing, but starting to crust at the time of interview which was 4/1/14. Unknown treatment. Patient is immunocompromised. Hospitalized 3/26/14-4/7/14. Admit diagnosis (related): Acute lymphoid leukemia, without mention of having achieved remission (204.00); Chronic rhinitis; Herpes zoster without mention of complication; Other specified counseling; Transfusion reaction, unspecified; Unspecified asthma (493.90); Unspecified leukemia in remission; Unspecified rehabilitation procedure; Vaccination not carried out for other reason.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from the physician assistant via the company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route unknown). On an unknown date after vaccination the patient developed a rash and shingles. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to a patient of unspecified demographics. On 25-MAR-2014, the patient received an expired dose of PNEUMOVAX 23 injection, dose unspecified, (lot # H01661, expiry date 02-FEB-2014), intramuscularly. Concomitant therapy was unspecified. The healthcare worker stated that the patient would probably be revaccinated. No adverse effects reported. No product quality complaint was involved. The outcome of patient received an expired dose of PNEUMOVAX was unknown. No further information was provided. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 27 year old female patient. On 10-APR-2014, the patient received first dose of MMR II, dose 0.5 milliliter (ml), intramuscular, (lot # 0680AE, expiry date 02-APR-2014) which was expired. Concomitant therapy was unspecified. No adverse effects reported. No product quality complained was involved. The outcome of expired vaccine administered and MMR vaccinated intramuscularly was unknown. No further information has been provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site reaction, Injection site vesicles, Neuralgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with no medical history and drug reaction/allergy. On 04-APR-2014 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous. Concomitant vaccine included BOOSTRIX. On 04-APR-2014 the patient experienced red lump at injection site where ZOSTAVAX was given. On 07-APR-2014, the patient developed nerve pain and blister at injection site. The patient contacted pharmacist and put ice and heat on blister. There was no laboratory test performed. The outcome of the events were reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist student refers to a patient of unknown age and gender. On 04-APR-2014, the patient was inadvertently administered with a dose of VARIVAX (Merck), lot # 671029/1065AA, expiration date 05-JUL-2013, 0.5 ml, subcutaneous that had expired in July 2013. No adverse effects were reported. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: Muscle pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Local swelling
Clinical narrative: Allergic reaction to Zostavax within 1 day.  Arm was very swollen and red.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient with no pertinent medical history and no drug reactions or allergies. On 31-MAR-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # J011828, expiry date 26-DEC-2014, 0.65 ml, subcutaneous (anatomical location not specified). Concomitant therapies included CYMBALTA and HEATHER. On approximately 01-APR-2014, reported as 24 hours after injection, the patient called the pharmacy to report that she experienced itching, redness and pain at the injection site. The patient reported that the itching, redness and pain had spread to her elbow and she was seen in the ER of an unspecified hospital, but was not admitted. An unspecified ER physician diagnosed her with an allergic reaction and possible cellulitis. The patient was given BENADRYL OTC, prednisone and an unspecified steroid injection and was prescribed KEFLEX. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient with no pertinent medical history and no drug reactions or allergies. On 31-MAR-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # J011828, expiry date 26-DEC-2014, 0.65 ml, subcutaneous (anatomical location not specified). Concomitant therapies included CYMBALTA and HEATHER. On approximately 01-APR-2014, reported as 24 hours after injection, the patient called the pharmacy to report that she experienced itching, redness and pain at the injection site. The patient reported that the itching, redness and pain had spread to her elbow and she was seen in the ER of an unspecified hospital, but was not admitted. An unspecified ER physician diagnosed her with an allergic reaction and possible cellulitis. The patient was given BENADRYL OTC, prednisone and an unspecified steroid injection and was prescribed KEFLEX. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Rash, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient with no pertinent medical history and no drug reactions or allergies. On 31-MAR-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # J011828, expiry date 26-DEC-2014, 0.65 ml, subcutaneous (anatomical location not specified). Concomitant therapies included CYMBALTA and HEATHER. On approximately 01-APR-2014, reported as 24 hours after injection, the patient called the pharmacy to report that she experienced itching, redness and pain at the injection site. The patient reported that the itching, redness and pain had spread to her elbow and she was seen in the ER of an unspecified hospital, but was not admitted. An unspecified ER physician diagnosed her with an allergic reaction and possible cellulitis. The patient was given BENADRYL OTC, prednisone and an unspecified steroid injection and was prescribed KEFLEX. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a technologist (other health care professional) refers to unknown number of patients of unknown age. On an unknown date the unknown number of patients were vaccinated with VARIVAX (Dose: 0.5 milliliter (ml)), subcutaneous. The reporting technologist reported on an unknown date the unknown number of patients received VARIVAX that had multiple excursions. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Gait disturbance, Guillain-Barre syndrome
Clinical narrative: This spontaneous report as received from a medical assistant via a field employee refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the third dose of GARDASIL, injection (lot#, expiry and dose not reported) at a hospital and had difficulty walking afterward. The patient was diagnosed with Guillain Barre Syndrome. The patient sought an unspecified medical attention. Unspecified treatment was given for adverse events. The outcome of the events was unknown. Upon internal review, Guillain Barre Syndrome was considered as medically significant. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Injection site haematoma
Clinical narrative: Hematoma (L) thigh. Treatment: TYLENOL 1.25ml q 4-6 hrs and warm compresses 3-4x day for 10-15 minutes.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Injection site erythema, Local reaction
Clinical narrative: Large localized area of erythema near injection site.  Appears to be local allergic reaction.
Age: 0.5
Sex: M
Vaccine: IPV
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: On 4/11/14 Mom called our office around 4:49 pm saying child was having little swelling and little redness on left thigh where child received Polio vaccine. Patient was crying. Dr advised TYLENOL for any pain but to have child seen if swelling increased or pain noted.
Age: 40.0
Sex: M
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Rash, Varicella
Clinical narrative: Developed chicken pox rash on 4-12-14. Removed from work.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Warm, swollen, painful left deltoid. Clindamycin for 10 days given reported given by MA. States was diagnosed with cellulitis.
Age: 1.29
Sex: F
Vaccine: DTAP, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Rash starting 4/5/14 - not yet resolved. Fever starting 4/14/14.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Nausea, Pain in extremity
Clinical narrative: 4 hrs later got dizzy, nausea, stomach ache, got diarrhea, went on liquid diet and took 2 TYLENOL, lasted 24 hrs, ate light for 2 days, arm was sore for the week.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: VIIth nerve paralysis
Clinical narrative: Received flu shot and five days later had to go to doctors office where I was diagnosed with Bells Palsy. Gave me anti-inflammatories and steroids to help correct. Symptoms lasted 12 days, with a total of 3 office visits.
Age: 5.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old female patient. On 27-MAR-2014 the patient was inadvertently vaccinated with ZOSTAVAX (Lot number J012660, expiration date: 10-JAN-2015), 0.65 ml in the right arm (route not reported) instead of PROQUAD (Merck). Staff error only. This would be the second dose of varicella. Nurse stated that no adverse effects had been reported. This is one of two reports from the same source. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: This spontaneous report was received from a registered nurse, refers to a 64 year old male patient (reporter's husband). No pertinent medical history or concurrent conditions. No drug reactions or allergies. Around the end of January 2014 or beginning of February 2014, the patient was vaccinated with ZOSTAVAX for prevent shingles (Dose, strength, route and lot number were not provided). No concomitant therapies. On 12-APR-2014, patient developed facial nerve paralysis. on 13-APR-2014, patient was taken to a hospital and was diagnosed with Bell's palsy. The patient was not admitted to the hospital. On the same date, the patient was put on treatment with prednisone and valacyclovir (manufacturer unknown). At the time of the report, the patient's status was not recovered. The causal relationship between ZOSTAVAX and the event was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old female patient. On 27-MAR-2014 the patient was inadvertently vaccinated with ZOSTAVAX (Lot number reported as J012660, expiration date: 10-JAN-2015), 0.65 ml in the right arm( route not reported) instead of PROQUAD (Merck). Staff error only. This would be the second dose of varicella. Nurse stated that no adverse effects had been reported. This is one of two reports from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health care worker refers to a 12 month old patient. On 11-APR-2014 the patient was vaccinated with M-M-R II and PROQUAD (Merck) instead of M-M-R II and VARIVAX (Merck). No adverse effects reported. No product complaint was discovered. No product confusion just medication error was reported. The outcome was unknown. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site rash, Injection site swelling, Pain
Clinical narrative: Patient states she developed chills with achiness all over within 48 hrs. of receiving vaccine. Patient also developed redness and swelling at the injection site on left deltoid. Patient seen on 4/14/14 and left arm still red from shoulder to elbow, slightly raised rash. Patient denied pain and not hot to touch.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia, Muscular weakness, Myelitis transverse, Paraesthesia
Clinical narrative: Contracted transverse myelitis. 2 months motor sensor problems, 4 months numbness, tingling, weakness right shoulder and arm and torso.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Sensorimotor disorder
Clinical narrative: Contracted transverse myelitis. 2 months motor sensor problems, 4 months numbness, tingling, weakness right shoulder and arm and torso.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Local swelling
Clinical narrative: Pt stated that arm is swollen and red, there is also a round puffy circle around the area of injection.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Blood culture positive, Chest X-ray normal, Culture urine positive, Febrile convulsion, Full blood count normal
Clinical narrative: Febrile seizure 4/13/14. Evaluated in emergency department.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Influenza virus test negative, Metabolic function test normal, Respiratory syncytial virus test negative, Urine analysis normal
Clinical narrative: Febrile seizure 4/13/14. Evaluated in emergency department.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Circumstance or information capable of leading to medication error, Injection site injury, Scratch, Syringe issue
Clinical narrative: Upon administration plunger came out of vaccine device, child moved suddenly causing needle to withdraw and superficial scrape against child upper LT thigh leaving 3cm arc scratch on thigh which required first aid and readmin of vaccine.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Bruxism, Chest X-ray, Convulsion, Cough, Cyanosis
Clinical narrative: Started runny nose, cough day after vaccines. Then turned blue, had seizure. Went to ER. 1-year-oild male presents following a generalized seizure. Mom states that the child was well yesterday and went for a routine checkup. He had his 12 month vaccinations. This morning he had a runny nose which mom states he has had for most of is life. She states he developed a cough and decreased appetite that were new symptoms today. No rash. No vomiting or diarrhea. No ill contacts. Mom states that he was sitting and suddenly developed a clenched jaw and blue discoloration around his mouth, he then "stopped breathing" and started shaking all over. Mom states she ran over to her neighbor's house with him and they blew into his nose and mouth and he then started crying and breathing. She states that while he was shaking his body seemed very stiff but then after he started crying his body seemed limp. She reports that she did not notice a fever until after it was checked here. He has never had a seizure before. There is a strong family history of seizures. Mom states that multiple children in the family have had seizures. She is unsure if they were febrile seizures. No treated Temp 101.9.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Hypotonia, Laboratory test, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Started runny nose, cough day after vaccines. Then turned blue, had seizure. Went to ER. 1-year-oild male presents following a generalized seizure. Mom states that the child was well yesterday and went for a routine checkup. He had his 12 month vaccinations. This morning he had a runny nose which mom states he has had for most of is life. She states he developed a cough and decreased appetite that were new symptoms today. No rash. No vomiting or diarrhea. No ill contacts. Mom states that he was sitting and suddenly developed a clenched jaw and blue discoloration around his mouth, he then "stopped breathing" and started shaking all over. Mom states she ran over to her neighbor's house with him and they blew into his nose and mouth and he then started crying and breathing. She states that while he was shaking his body seemed very stiff but then after he started crying his body seemed limp. She reports that she did not notice a fever until after it was checked here. He has never had a seizure before. There is a strong family history of seizures. Mom states that multiple children in the family have had seizures. She is unsure if they were febrile seizures. No treated Temp 101.9.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Respiratory arrest, Rhinorrhoea, Tremor
Clinical narrative: Started runny nose, cough day after vaccines. Then turned blue, had seizure. Went to ER. 1-year-oild male presents following a generalized seizure. Mom states that the child was well yesterday and went for a routine checkup. He had his 12 month vaccinations. This morning he had a runny nose which mom states he has had for most of is life. She states he developed a cough and decreased appetite that were new symptoms today. No rash. No vomiting or diarrhea. No ill contacts. Mom states that he was sitting and suddenly developed a clenched jaw and blue discoloration around his mouth, he then "stopped breathing" and started shaking all over. Mom states she ran over to her neighbor's house with him and they blew into his nose and mouth and he then started crying and breathing. She states that while he was shaking his body seemed very stiff but then after he started crying his body seemed limp. She reports that she did not notice a fever until after it was checked here. He has never had a seizure before. There is a strong family history of seizures. Mom states that multiple children in the family have had seizures. She is unsure if they were febrile seizures. No treated Temp 101.9.
Age: 48.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received meningococcal vaccine (MCV4 Menactra by Sanofi-Pasteur) on Wednesday, 4-09-014 around 5:15 in the afternoon.  Patient stated that the injection site was sore for about 2-3 days, and on Saturday, 4-12-14 around 8:00 pm, he noticed that his arm was getting red in the left arm area where the injection was given.  He said the next day the reddened area became larger and by Tuesday, 04/15/16 when he presented to the clinic for evaluation, the area had grown to extend to just below the mid arm but above the elbow.  Patient was advised to take Benadryl in which he did, and he reported today, 4/16/14 that after taking the Benadryl, the reddened area was almost gone.  He stated that he never had pain nor fever with the redness.  The area was slightly raised, but the redness was evenly distributed with no rash.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Dizziness, Feeling abnormal, Hypoaesthesia oral
Clinical narrative: After approval of provider's order was obtained and facility verified no contraindications to immunizations, SOP followed and vaccinations administered.  Patient showed no immediate adverse reactions and was directed to sit in waiting area at front of clinic for 20min.  After 10min, patient had c/o 'weird numbness' on the left side of mouth.  When inquiries into 'weird' feeling he was having were made, it was found that the patient's buccal area felt 'like when you get the needles at the dentist.'  At that time he also reported being 'kind of lightheaded.'  His feet were elevated, an cold compress was applied to neck, vitals done, and the supervising provider was called over to evaluate.  A series of checks to gauge the area and severity of numbness was done.  The numbness was localized to left buccal area, d/t c/o 'dizziness' the patient was escorted back to the nurses area and placed in modified Trendelenburg position with cold compress to back of neck.  Vitals were obtained and WNL for the patient.  Patient remained monitored until 1222PM.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Gait disturbance, Hypersensitivity, Local swelling, Pain in extremity
Clinical narrative: Client was monitored 15 minutes post-vaccination.  Tolerates without difficulty.  Client leaves with  mother and returns approximately 15  minutes later.  Mother enters the clinic and states that her daughter cannot walk.  Nurse assesses client in car.  Client denies shortness of breath, dizziness.  States that both legs hurt terribly and she can barely walk.  Legs warm to touch.  Client was able to move them but was in tears.  Encouraged mother to take client to emergency room to have her assessed.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Skin warm, Vaccination complication
Clinical narrative: Client was monitored 15 minutes post-vaccination.  Tolerates without difficulty.  Client leaves with  mother and returns approximately 15  minutes later.  Mother enters the clinic and states that her daughter cannot walk.  Nurse assesses client in car.  Client denies shortness of breath, dizziness.  States that both legs hurt terribly and she can barely walk.  Legs warm to touch.  Client was able to move them but was in tears.  Encouraged mother to take client to emergency room to have her assessed.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Chest X-ray normal, Fall, Rash erythematous, Rhonchi, Upper respiratory tract infection
Clinical narrative: Rash with redness and pustules surrounding vaccinia vaccination site after falling onto left shoulder while playing football.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination site pustule, Vaccination site reaction
Clinical narrative: Rash with redness and pustules surrounding vaccinia vaccination site after falling onto left shoulder while playing football.
Age: 26.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Headache, Injection site erythema, Lymph node pain, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Aching in Left Shoulder with stiffness. Erythema around injection site radiating upward toward shoulder/deltoid area. Headache, lymphnode pain. Counseled to go to emergency room if s/s worsened.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Feeling cold, Headache, Vomiting
Clinical narrative: Diarrhea, vomiting, headache, felt cold but did not check for a fever.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Crying, Diet refusal
Clinical narrative: Uncontrolled crying from 8:30 PM to 12 midnight. Would not eat from 8:30 PM to 2 AM. Would suck but quit nursing as soon as milk flowed as if it hurt to swallow?
Age: 1.03
Sex: M
Vaccine: HEPA, PPV, VARCEL
Symptoms: Herpes zoster, Pain, Polymerase chain reaction, Rash, Varicella virus test positive
Clinical narrative: Herpes zoster in one dose varicella vaccine recipient. Painful rash in one dermatome, lasted less than 4 weeks. Treated with Valtrex. Visited Emergency Department on 2/16/14.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Feeling abnormal, Vomiting
Clinical narrative: "I threw up and am not feeling good."  She bagan gasping for air.  Was administered epinephrine 1:1000 (1mg/cc), 0.5cc given in arm. Taken directly to ER, as she was all ready at the hospital.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test, Chest discomfort, Eye swelling, Throat tightness
Clinical narrative: 2 hours after shot, throat began closing, tightness in chest, eyes swollen.  Went to dr, he drew blood to check for egg allergy.  He started her on Zyrtec.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Myelitis transverse, Pain in extremity
Clinical narrative: Sudden pain and weakness in arms, hands and legs.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cough, Drooling, Pruritus, Urticaria
Clinical narrative: Driving home from the Pediatrician's office, patient began coughing, drooling, and scratching her ears.  By the time we got home (2:45 PM), she was covered in hives.  We went to the ER.
Age: 49.0
Sex: M
Vaccine: ANTH, VARCEL
Symptoms: Epistaxis, Hypertension, Tachycardia
Clinical narrative: Tachycardia, nose bleed, and hypertension.
Age: 41.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Asthenia, Dizziness, Hallucination, Hypertension, Tachycardia
Clinical narrative: Dizziness, weakness, hallucinations, hypertension and tachycardia.
Age: 53.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Malaise
Clinical narrative: Headache, generalized malaise, symptoms worsened, hypertachea.
Age: 49.0
Sex: M
Vaccine: ANTH, VARCEL
Symptoms: Hallucination, Headache, Hypertension, Pyrexia, Tachycardia
Clinical narrative: Tachycardia, hallucination, headache, fever, and hypertension.
Age: 50.0
Sex: M
Vaccine: ANTH, VARCEL
Symptoms: Cardiac stress test, Chest pain, Headache, Hypertension, Tachycardia
Clinical narrative: Chest Pain, hypertension, headache and tachycardia.
Age: 72.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site swelling, Local swelling, Pain in extremity, Pruritus
Clinical narrative: Patient came into clinic on 4/16, left arm was mildly swollen with extreme erythema, hot to touch, swollen past elbow and into armpit. Very painful and itching.
Age: 72.0
Sex: F
Vaccine: DTAP
Symptoms: Skin warm
Clinical narrative: Patient came into clinic on 4/16, left arm was mildly swollen with extreme erythema, hot to touch, swollen past elbow and into armpit. Very painful and itching.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Cough, Dizziness, Dysgeusia, Dysphagia
Clinical narrative: Very bitter/metallic taste in mouth, flushing, nausea, severe abdominal cramps, tongue/lip numbness, burning in back of throat, difficulty swallowing, coughing, headache, jitters, shaking, dizziness.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Feeling jittery, Flushing, Headache, Hypoaesthesia oral, Nausea
Clinical narrative: Very bitter/metallic taste in mouth, flushing, nausea, severe abdominal cramps, tongue/lip numbness, burning in back of throat, difficulty swallowing, coughing, headache, jitters, shaking, dizziness.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Throat irritation, Tremor
Clinical narrative: Very bitter/metallic taste in mouth, flushing, nausea, severe abdominal cramps, tongue/lip numbness, burning in back of throat, difficulty swallowing, coughing, headache, jitters, shaking, dizziness.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Redness, itching, pain, warm to touch, grew from 1" to near 6" radius - red center surrounded by raised pink circle; getting larger daily.  Saw my doctor on 4/16/14 - drew blood for varicella titers & recommended Benedryl & Advil.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching, pain, warm to touch, grew from 1" to near 6" radius - red center surrounded by raised pink circle; getting larger daily.  Saw my doctor on 4/16/14 - drew blood for varicella titers & recommended Benedryl & Advil.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Pt developed an itchy, red swelling amid site of injection the day after vaccinated. The swelling got bigger everyday up to 6" wide now. Pt is currently treating with BENADRYL and ADVIL for pain. Pt has also gone to a doctor. MD is ordering a titer.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt developed an itchy, red swelling amid site of injection the day after vaccinated. The swelling got bigger everyday up to 6" wide now. Pt is currently treating with BENADRYL and ADVIL for pain. Pt has also gone to a doctor. MD is ordering a titer.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site urticaria, Irritability
Clinical narrative: Hives on leg below immunization site. Extreme irritability for 2 days.
Age: 1.34
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Diarrhoea, Injection site movement impairment, Injection site pain, Muscle rigidity, Pain
Clinical narrative: Baby developed high fever.  Baby had severe pain in leg where shot was administerd.  Baby cannot bend leg.  Baby's whole body is rigid.  Baby had diarrhea and vomiting.  Baby is in a lot of pain.
Age: 1.34
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: Baby developed high fever.  Baby had severe pain in leg where shot was administerd.  Baby cannot bend leg.  Baby's whole body is rigid.  Baby had diarrhea and vomiting.  Baby is in a lot of pain.
Age: 33.0
Sex: F
Vaccine: DTAP, HEP
Symptoms: Chills, Dizziness, Dizziness postural, Fatigue, Hyperhidrosis
Clinical narrative: Bump and a lot of pain at injection site, lots of sweating, fevers and chills, neck and muscle pain, achy everywhere, extreme exhaustion, dizzy when I stand or sit up.
Age: 33.0
Sex: F
Vaccine: DTAP, HEP
Symptoms: Injection site pain, Injection site swelling, Myalgia, Neck pain, Pain
Clinical narrative: Bump and a lot of pain at injection site, lots of sweating, fevers and chills, neck and muscle pain, achy everywhere, extreme exhaustion, dizzy when I stand or sit up.
Age: 33.0
Sex: F
Vaccine: DTAP, HEP
Symptoms: Pyrexia
Clinical narrative: Bump and a lot of pain at injection site, lots of sweating, fevers and chills, neck and muscle pain, achy everywhere, extreme exhaustion, dizzy when I stand or sit up.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash generalised
Clinical narrative: Patient developed a severe case of zoster on her lower extremity, then a disseminated rash.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Balance disorder, Guillain-Barre syndrome
Clinical narrative: GBS. Started 12/1/11 with weakness and balance problems. Recurrent episodes still occur presently.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Bacterial test negative, Computerised tomogram normal, Convulsion, Electroencephalogram abnormal, Febrile convulsion
Clinical narrative: On 4/1 and 3/31 T 102+. On 4/2/14 T 103+ and one arm twitching, witnessed by EMS and ER. Given ATIVAN/fosphenytoin and observed. Recurrence focal and generalized sz with (+) EEG findings until put on phenobarbital. All viral and bacterial cultures (-), HSV negative. MRI - diffuse changes c/w seizures. Dx Complex Febrile Sz - focal status epilepticus.