chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 03-APR-2014 the patient was vaccinated with ZOSTAVAX (route, dose no., dosage and lot number unknown). On an unknown date in April 2014 the patient experienced ZOSTAVAX (rash/blisters in distal left forearm in c8 dermatomal distribution proximal to the wrist joint). The treatment plan included acyclovir 800 mg, oral tablets, i tab five times daily, during working hours. The outcome of the event was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Significant swelling, tenderness, and redness around the site of injection.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient's medical history included shingles. In "late summer/early fall" of 2013, the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported that 1 week after vaccination, the patient experienced a mild case of shingles. The outcome of shingles was unknown. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a 2 year old patient. On 21-APR-2014 the patient was vaccinated with expired (Oka/Merck) VARIVAX lot # H007170 (Expiry: 22-MAR-2014) (dose, route and frequency were not reported) in error. No adverse effect was reported. No PQC reported. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a pediatric patient of unknown demography. On an unknown date, the patient was vaccinated with GARDASIL in gluteal region. The reporter stated that does the efficacy will be lost because of the wrong site following doses can take are how can get prevention from HPV. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient with currently 38 years old. The patient's current conditions includes; multiple sclerosis and drug allergy to MOTRIN. On an unspecified date in 2011, the patient was vaccinated with two doses of VARIVAX (Merck), (lot number and expiration date unknown), dose, route and anatomical location unspecified. Concomitant therapies included AMPYRA, GILENYA, glatiramer acetate, levofloxacin, MACROBID, ORTHO TRI-CYCLEN, oxybutynin and terconazole. On an unknown date (reported as recently), the patient had titers drawn which showed negative immunity. No treatment was given for the event. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: 4-17-14 Shot site puffy. 4-18-14 Site started to turn red with swelling. 4-19-14 Site still red and swollen. 4-20-14 Went to ER because of redness, swelling and red streak. Told to use cold compress.
Age: 0.57
Sex: F
Vaccine: DTAPIPV, IPV, PNC13, RV5
Symptoms: Incorrect dose administered
Clinical narrative: Gave KINRIX to infant. Due to KINRIX given -> 2 polios given.
Age: 11.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash erythematous, Tremor
Clinical narrative: Mother reported fever of unknown value with wide spread raised red rash decreased appetite fussy shaking of arms & legs but not seizure activity.
Age: 19.0
Sex: F
Vaccine: DT, HEPA, RAB
Symptoms: Cough, Headache, Nasal congestion, Pain, Pyrexia
Clinical narrative: Fever 102. F; nasal congestion, nasal drng, cough; body aches, headache.
Age: 19.0
Sex: F
Vaccine: DT, HEPA, RAB
Symptoms: Rhinorrhoea
Clinical narrative: Fever 102. F; nasal congestion, nasal drng, cough; body aches, headache.
Age: 1.89
Sex: M
Vaccine: DTAP, FLU3, HEPA, IPV, MMR, VARCEL
Symptoms: Hypersensitivity, Rash generalised
Clinical narrative: Mother reports that client broke out in a rash on the face, arms and chest then it went to the back and legs also. Child was taken to ER that same day after mother noticed that he did not respond fast to OTC allergy medication. Dr. at ER was unclear to what was the cause of the rash. Client was treated for allergy at Hospital and released after the rash resolved.
Age: 47.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Disturbance in attention, Dyspnoea, Headache, Immediate post-injection reaction, Injection site erythema
Clinical narrative: C/o headache and attention problems immediately after vaccine. Later that evening, experienced fever (unknown degree), nausea, and difficulty breathing. No medication and did not seek medical attention. Noticed local reaction (redness, golf-ball size) at site).
Age: 47.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Local reaction, Nausea, Pyrexia
Clinical narrative: C/o headache and attention problems immediately after vaccine. Later that evening, experienced fever (unknown degree), nausea, and difficulty breathing. No medication and did not seek medical attention. Noticed local reaction (redness, golf-ball size) at site).
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Skin discolouration
Clinical narrative: After given flu shot, pt waited in waiting room for 5 min then walk to the register with mom to pay.  Mom screamed as pt was started to slide down.  Pharmacy staff with mom help pt back to the waiting room and sat her down. Mom wanted give pt some water but we advised her to wait.  After 5-10 mim, pt started to feel better and was give a little sip of water.  Her color came back, and about another 10 min. pat is better and Mom took her home.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles
Clinical narrative: Developed on outer left thigh that was red, slightly indurated under the skin with 1 single vesicle.  Resolved on own.
Age: 0.78
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Rash generalised, Skin lesion
Clinical narrative: Rash all over body X 3 days, described as: SKIN: raised erythematous circular lesions, some with central clearing covering trunk and extremities.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Enema administration, Intussusception
Clinical narrative: Intussusception.
Age: 50.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain, Diarrhoea, Headache, Nausea
Clinical narrative: Frontal headache, nausea, abdominal cramps, diarrhea.
Age: 0.22
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Convulsion
Clinical narrative: Seizures.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red, hot spot developed around and below the injection site, approximately 3 inches in diameter. Doctor's office said it was normal and not to worry.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Muscle twitching, Pyrexia, Respiratory arrest, Somnolence, Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse, and the patient's mother, refers to a 2 month old male infant with a history of failure to thrive when first born, but now he was eating properly. The patient had no drug reactions or allergies. On 11-APR-2014 the patient was vaccinated with the first "round of vaccinations" with ROTATEQ (lot # J010137; expiration date: 14-MAR-2015) and RECOMBIVAX HB (lot #: reported as "H010050; expiration date: 31-OCT-2014") (doses, routes and frequencies were not reported). The patient was also vaccinated with PENTACEL and PREVNAR. There was no concomitant medication. On 12-APR-2014, the patient was seen at the emergency room (E.R.) of an unspecified hospital, due to vomiting, 100.5 fever (units not specified), extreme drowsiness, twitching and at one point he stopped breathing, according to the patient's mother. The nurse reported that the patient was not admitted to the hospital. No treatment was given for the events. No lab diagnostic studies were performed. The patient sought medical attention through ER visit. At the time of the report, the nurse reported that the patient recovered from most symptoms on an unspecified date in April 2014, but was still experiencing "some drowsiness". Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Gaze palsy, Muscle twitching, Pyrexia, Respiratory arrest, Somnolence
Clinical narrative: This spontaneous report as received from a registered nurse, and the patient's mother, refers to a 2 month old male infant with a history of failure to thrive when first born, but now he was eating properly. The patient had no drug reactions or allergies. On 11-APR-2014 the patient was vaccinated with the first "round of vaccinations" with ROTATEQ (lot # J010137; expiration date: 14-MAR-2015) and RECOMBIVAX HB (lot #: reported as "H010050; expiration date: 31-OCT-2014") (doses, routes and frequencies were not reported). The patient was also vaccinated with PENTACEL and PREVNAR. There was no concomitant medication. On 12-APR-2014, the patient was seen at the emergency room (E.R.) of an unspecified hospital, due to vomiting, 100.5 fever (units not specified), extreme drowsiness, twitching and at one point he stopped breathing, according to the patient's mother. The nurse reported that the patient was not admitted to the hospital. No treatment was given for the events. No lab diagnostic studies were performed. The patient sought medical attention through ER visit. At the time of the report, the nurse reported that the patient recovered from most symptoms on an unspecified date in April 2014, but was still experiencing "some drowsiness". Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse, and the patient's mother, refers to a 2 month old male infant with a history of failure to thrive when first born, but now he was eating properly. The patient had no drug reactions or allergies. On 11-APR-2014 the patient was vaccinated with the first "round of vaccinations" with ROTATEQ (lot # J010137; expiration date: 14-MAR-2015) and RECOMBIVAX HB (lot #: reported as "H010050; expiration date: 31-OCT-2014") (doses, routes and frequencies were not reported). The patient was also vaccinated with PENTACEL and PREVNAR. There was no concomitant medication. On 12-APR-2014, the patient was seen at the emergency room (E.R.) of an unspecified hospital, due to vomiting, 100.5 fever (units not specified), extreme drowsiness, twitching and at one point he stopped breathing, according to the patient's mother. The nurse reported that the patient was not admitted to the hospital. No treatment was given for the events. No lab diagnostic studies were performed. The patient sought medical attention through ER visit. At the time of the report, the nurse reported that the patient recovered from most symptoms on an unspecified date in April 2014, but was still experiencing "some drowsiness". Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature increased, Gaze palsy, Immunisation reaction, Muscle twitching, Respiratory arrest
Clinical narrative: This spontaneous report as received from a registered nurse, and the patient's mother, refers to a 2 month old male infant with a history of failure to thrive when first born, but now he was eating properly. The patient had no drug reactions or allergies. On 11-APR-2014 the patient was vaccinated with the first "round of vaccinations" with ROTATEQ (lot # J010137; expiration date: 14-MAR-2015) and RECOMBIVAX HB (lot #: reported as "H010050; expiration date: 31-OCT-2014") (doses, routes and frequencies were not reported). The patient was also vaccinated with PENTACEL and PREVNAR. There was no concomitant medication. On 12-APR-2014, the patient was seen at the emergency room (E.R.) of an unspecified hospital, due to vomiting, 100.5 fever (units not specified), extreme drowsiness, twitching and at one point he stopped breathing, according to the patient's mother. The nurse reported that the patient was not admitted to the hospital. No treatment was given for the events. No lab diagnostic studies were performed. The patient sought medical attention through ER visit. At the time of the report, the nurse reported that the patient recovered from most symptoms on an unspecified date in April 2014, but was still experiencing "some drowsiness". Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Somnolence, Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse, and the patient's mother, refers to a 2 month old male infant with a history of failure to thrive when first born, but now he was eating properly. The patient had no drug reactions or allergies. On 11-APR-2014 the patient was vaccinated with the first "round of vaccinations" with ROTATEQ (lot # J010137; expiration date: 14-MAR-2015) and RECOMBIVAX HB (lot #: reported as "H010050; expiration date: 31-OCT-2014") (doses, routes and frequencies were not reported). The patient was also vaccinated with PENTACEL and PREVNAR. There was no concomitant medication. On 12-APR-2014, the patient was seen at the emergency room (E.R.) of an unspecified hospital, due to vomiting, 100.5 fever (units not specified), extreme drowsiness, twitching and at one point he stopped breathing, according to the patient's mother. The nurse reported that the patient was not admitted to the hospital. No treatment was given for the events. No lab diagnostic studies were performed. The patient sought medical attention through ER visit. At the time of the report, the nurse reported that the patient recovered from most symptoms on an unspecified date in April 2014, but was still experiencing "some drowsiness". Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Cough, Dizziness, Dysphonia, Pallor, Throat tightness
Clinical narrative: Pt received HPV and MENACTRA. 15-20 mins later c/o tight feeling in throat, developed cough, became pale and dizzy. Treated w/ 50mg BENADRYL, 60mg Prednisone, 0.3mg Epi, albuterol neb then transferred to ER via EMS.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: -Severe shoulder pain, difficulty moving/rotating arm since receiving the vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pallor, Rash, Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Approximately 3 days after receiving PROQUAD and KINRIX she developed an itchy maculopapular erythematous (blanching) rash initially on her sides, progressively spread to all of trunk, face and extremities. Very itchy.
Age: 19.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Pruritus, Rash, Skin warm
Clinical narrative: 1 week after vaccination administered, pt reports she noticed pruritus bilateral thighs with erythematous, warm, diffuse raised rash. Lower legs bilaterally with same rash, onset 4-2 - 4-3-14. She applied hydrocortisone cream without relief. She was seen in Health Services 4-14-14. Treated w/ loratadine 10mg and tepid bath with improvement.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a consumer, as part of a marketing research program conducted by Market Research Agency, refers to her granddaughter a female patient of unknown age. On an unknown date, the patient was vaccinated with VARIVAX (route, lot number and expiration date not reported). There was no concomitant medication reported. On an unknown date, the patient experienced Chickenpox. Consumer's granddaughter received routine vaccination with VARIVAX and then developed a moderate case of the chickenpox. The outcome of Chickenpox was reported as recovered/resolved in 2003 (approximately). The relatedness between adverse event and VARIVAX was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac ablation, Chest discomfort, Computerised tomogram normal, Demyelination, Dyspnoea
Clinical narrative: Went to ER on 2/12/14 for worsening heart palpitations. Noted to have freq. PVC's, chest tightness and SOB. On morning of 2/13/14 pt had RLE weakness and Bil. UE weakness. Transferred to another hosp. for cardiac ablation procedure. Brace on RLE due to foot drag/drop. Home RN and PT. Possible GBS.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Echocardiogram normal, Lumbar puncture normal, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Orthosis user
Clinical narrative: Went to ER on 2/12/14 for worsening heart palpitations. Noted to have freq. PVC's, chest tightness and SOB. On morning of 2/13/14 pt had RLE weakness and Bil. UE weakness. Transferred to another hosp. for cardiac ablation procedure. Brace on RLE due to foot drag/drop. Home RN and PT. Possible GBS.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Peroneal nerve palsy, Ventricular extrasystoles
Clinical narrative: Went to ER on 2/12/14 for worsening heart palpitations. Noted to have freq. PVC's, chest tightness and SOB. On morning of 2/13/14 pt had RLE weakness and Bil. UE weakness. Transferred to another hosp. for cardiac ablation procedure. Brace on RLE due to foot drag/drop. Home RN and PT. Possible GBS.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hair growth abnormal
Clinical narrative: This spontaneous report as received from a physician from a nurse via company representative refers to a 14 year old female patient. On 13-MAY-2013 (also reported as "13-MAY-2014", "first dose on May 2013"), the patient was vaccinated with the first dose of GARDASIL, in June 2013, the patient was vaccinated with the second dose of GARDASIL and in December 2013, dose 3 of GARDASIL (lot# and dose unspecified). On 11-APR-2014 the patient developed facial hair after completing three doses of GARDASIL. The outcome of the event was unknown. The mother of the patient called in to seek medical attention. No treatment was given for the event. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Full blood count normal, Headache, Influenza virus test negative, Pyrexia, Streptococcus test negative
Clinical narrative: Child developed fever to 105.2 (temporal) and headache the day following vaccine administration.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Back pain, Blood pressure abnormal, Constipation, Fatigue
Clinical narrative: Unable to walk, lower back pain, constipation, September to present. Unstable blood pressure, fever, fatigue.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Unable to walk, lower back pain, constipation, September to present. Unstable blood pressure, fever, fatigue.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: 2 cm erythematous wheal at the injection site on the R deltoid. Slight warmth.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pneumonia, Pyrexia
Clinical narrative: Pt presented with fever to 101 degree-103. Dx'd with clinical pneumonia and treated. Did not keep f/up or get testing done.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure to communicable disease, Rash erythematous
Clinical narrative: Patient received ZOSTAVAX 4/17/14 and came to pharmacy 4/19/14 with 3" long red rash. Noticed 4/19. Not itchy or scaly. Took BENADRYL 4/19 and by 4/21 rash gone. Was around son w/ shingles 4/20/14.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from an immunization coordinator via a company representative, refers to a 17 year old female patient. No medical history or concurrent conditions were provided. On 15-APR-2014, the patient was vaccinated with GARDASIL INJ (dose, route and lot number not provided). No co-suspect or concomitant therapies were provided. The reporter stated that on the same visit, on 15-APR-2014, the patient received 2 doses of GARDASIL in different arms. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a male patient of unknown age reporting on himself. Pertinent medical history, drug reaction or allergies were not reported. On 21-APR-2014, the patient was vaccinated with an improperly stored dose of GARDASIL dose 1 (lot# was not reported) by his physician. Concomitant therapy was not reported. The patient reported that he stored GARDASIL in his refrigerator at 28 F overnight. No adverse effects reported. 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 nurse concerning multiple patients. Medical history and concurrent conditions were not reported. On an unknown date, patients were vaccinated with RECOMBIVAX HB (dose, strength, route, lot number and expiration date were not reported. Secondary and concomitant therapies were not reported. Nurse reported that one of their health care providers has stored vaccines incorrectly from November 2013 to 03-MAR-2014. Multiple patients, ages pediatrics up to less 18 years of age, were vaccinated with improperly stored vaccines. No adverse event was reported on the original call. This is one of 5 reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 6 year old male patient with no pertinent medical history and no drug reactions or allergies. On 21-APR-2014, the patient was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (lot # reported as J009989, expiration date 12-AUG-2015) subcutaneously. There was no concomitant medication. The nurse reported that on 22-APR-2014, the patient experienced generalized rash after receiving VARIVAX (Merck). The patient did not receive treatment for the adverse event. There were no Lab diagnosis or studies performed. The outcome of generalized rash was unknown. 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 nurse concerning multiple patients. Medical history and concurrent conditions were not reported. On an unknown date, patients were vaccinated with VARIVAX (dose, strength, route, lot number and expiration date were not reported). Secondary and concomitant therapies were not reported. Nurse reported that one of their health care providers has stored vaccines incorrectly from November 2013 to 03-MAR-2014. Multiple patients, ages pediatrics up to less 18 years of age, were vaccinated with improperly stored vaccines. No adverse event was reported on the original call. This is one of 5 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse concerning multiple patients. Medical history and concurrent conditions were not reported. On an unknown date, patients were vaccinated with GARDASIL (dose, strength, route, lot number and expiration date were not reported). Secondary and concomitant therapies were not reported. Nurse reported that one of their health care providers has stored vaccines incorrectly from November 2013 to 03-MAR-2014. Multiple patients, ages pediatrics up to less 18 years of age, were vaccinated with improperly stored vaccines. No adverse event was reported on the original call. This is one of 5 reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse via a company representative refers to a 65 year old female patient. Patient non pregnant. On 09-APR-2014 the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # H006529, expiration date 09-MAR-2013) route not reported. There was no concomitant medication reported. No specific adverse experience was reported. It was also reported that patient did not seek for medical attention. No treatment was given. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse concerning multiple patients. Medical history and concurrent conditions were not reported. On an unknown date, patients were vaccinated with M-M-R II (dose, strength, route, lot number and expiration date were not reported). Secondary and concomitant therapies were not reported. Nurse reported that one of their health care providers has stored vaccines incorrectly from November 2013 to 03-MAR-2014. Multiple patients, ages pediatrics up to less 18 years of age, were vaccinated with improperly stored vaccines. No adverse event was reported on the original call. This is one of 5 reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Muscle twitching, Pyrexia, Respiratory arrest, Somnolence, Vomiting
Clinical narrative: A two month-old male patient with a history of failure to thrive had received the following vaccines on 11 April 2014: an intramuscular right thigh injection of PENTACEL, lot number C4640AA; an intramuscular left thigh injection of PREVNAR, lot number H00004; an intramuscular injection of Hepatitis B, lot number H010050 and an oral dose of Rota virus, lot number J010137 and a day later on 12 April 2014 developed a temperature of 100.5, vomiting, drowsy and difficult to awake. The Mom reported the child stopped breathing, then started again, had an episode of one leg twitching, one eye rolled back and one eye went to the side. The patient was taken to the emergency room, assessed and released. Diagnosis was immunization reaction. No further information was provided at the time of the report. Outcome was reported as recovered. Documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Gaze palsy, Muscle twitching, Pyrexia, Respiratory arrest, Somnolence
Clinical narrative: A two month-old male patient with a history of failure to thrive had received the following vaccines on 11 April 2014: an intramuscular right thigh injection of PENTACEL, lot number C4640AA; an intramuscular left thigh injection of PREVNAR, lot number H00004; an intramuscular injection of Hepatitis B, lot number H010050 and an oral dose of Rota virus, lot number J010137 and a day later on 12 April 2014 developed a temperature of 100.5, vomiting, drowsy and difficult to awake. The Mom reported the child stopped breathing, then started again, had an episode of one leg twitching, one eye rolled back and one eye went to the side. The patient was taken to the emergency room, assessed and released. Diagnosis was immunization reaction. No further information was provided at the time of the report. Outcome was reported as recovered. Documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: A two month-old male patient with a history of failure to thrive had received the following vaccines on 11 April 2014: an intramuscular right thigh injection of PENTACEL, lot number C4640AA; an intramuscular left thigh injection of PREVNAR, lot number H00004; an intramuscular injection of Hepatitis B, lot number H010050 and an oral dose of Rota virus, lot number J010137 and a day later on 12 April 2014 developed a temperature of 100.5, vomiting, drowsy and difficult to awake. The Mom reported the child stopped breathing, then started again, had an episode of one leg twitching, one eye rolled back and one eye went to the side. The patient was taken to the emergency room, assessed and released. Diagnosis was immunization reaction. No further information was provided at the time of the report. Outcome was reported as recovered. Documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature increased, Gaze palsy, Immunisation reaction, Muscle twitching, Respiratory arrest
Clinical narrative: A two month-old male patient with a history of failure to thrive had received the following vaccines on 11 April 2014: an intramuscular right thigh injection of PENTACEL, lot number C4640AA; an intramuscular left thigh injection of PREVNAR, lot number H00004; an intramuscular injection of Hepatitis B, lot number H010050 and an oral dose of Rota virus, lot number J010137 and a day later on 12 April 2014 developed a temperature of 100.5, vomiting, drowsy and difficult to awake. The Mom reported the child stopped breathing, then started again, had an episode of one leg twitching, one eye rolled back and one eye went to the side. The patient was taken to the emergency room, assessed and released. Diagnosis was immunization reaction. No further information was provided at the time of the report. Outcome was reported as recovered. Documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Somnolence, Vomiting
Clinical narrative: A two month-old male patient with a history of failure to thrive had received the following vaccines on 11 April 2014: an intramuscular right thigh injection of PENTACEL, lot number C4640AA; an intramuscular left thigh injection of PREVNAR, lot number H00004; an intramuscular injection of Hepatitis B, lot number H010050 and an oral dose of Rota virus, lot number J010137 and a day later on 12 April 2014 developed a temperature of 100.5, vomiting, drowsy and difficult to awake. The Mom reported the child stopped breathing, then started again, had an episode of one leg twitching, one eye rolled back and one eye went to the side. The patient was taken to the emergency room, assessed and released. Diagnosis was immunization reaction. No further information was provided at the time of the report. Outcome was reported as recovered. Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Induration, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Started complaining of arm pain by 4 pm. Swelling by 6pm. On the 23rd when he came home from school his arm was red, hot, hard, swollen, painful. This morning it remains with the same symptoms and appears more swollen.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Swelling
Clinical narrative: Started complaining of arm pain by 4 pm. Swelling by 6pm. On the 23rd when he came home from school his arm was red, hot, hard, swollen, painful. This morning it remains with the same symptoms and appears more swollen.
Age: 29.0
Sex: F
Vaccine: DTOX
Symptoms: Arthralgia, Arthropathy, Joint lock, Joint range of motion decreased, Laboratory test
Clinical narrative: I began having joint issues.  My fingers were locking up in closed position. My ankle joint, my elbow and my knee and jaw also began catching occasionally most predominately on the right side at the beginning then started on the left side about six months later it only lasted a short time then it resolved. I still have issues with my right ankle with loss of ROM and some joint pain.
Age: 29.0
Sex: F
Vaccine: DTOX
Symptoms: Rheumatoid arthritis
Clinical narrative: I began having joint issues.  My fingers were locking up in closed position. My ankle joint, my elbow and my knee and jaw also began catching occasionally most predominately on the right side at the beginning then started on the left side about six months later it only lasted a short time then it resolved. I still have issues with my right ankle with loss of ROM and some joint pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Eczema, Pruritus, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a 62 years-old female patient. On 25-OCT-2013, the patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX lot # J004268, expiration date 12-JUL-2014. On an unspecified date, approximately in October 2013 (since she received ZOSTAVAX), the patient experienced, intermittent red speckles and constant itchiness since she received ZOSTAVAX. No lab diagnostics studies were performed. The patient was seen by her unspecified family physician who referred her to an unspecified dermatologist who told her that she had eczema, however the patient did not have these symptoms prior to receiving ZOSTAVAX. Further, the patient did not feel that the prescribed unspecified eczema cream was helpful, so she used calamine lotion for itch relief. VZVIP packet sent. The outcome of the events was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Headache, Mobility decreased, Myalgia, Somnolence
Clinical narrative: Dull headache, daily. Fatigue, daily, ongoing. Sleepiness, daily, ongoing. Limited arm movement, daily, ongoing. Deltoid muscle pain, daily, ongoing. Treatment: As per Dr.: antihistamines, OTC pain relievers.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to an unknown number of patients of unknown age and gender. The healthcare worker reported that the unknown number of patients might had received with a dose of RECOMBIVAX HB (lot#, expiration date, dose and strength not reported) that was exposed to a high temperature of 47 degrees F., 7 different times since January 2014, 5 minutes for each excursion, for a total of 35 minutes. No adverse effect reported. It was unspecified if the patient sought medical attention. This is one of four reports received from the same source. 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 registered nurse refers to a patient of unknown age and gender. There were no pertinent medical history, drug reactions/allergies were reported. On 21-APR-2014 the patient was vaccinated with ROTATEQ lot # H013539, 2 ml, oral expire date reported as 28-MAR-2014 (dose number not reported). No concomitant medications were reported. On 21-APR-2014, the patient was inadvertently administered ROTATEQ lot# H013539 on 21-APR-2014 that had expired on 28-MAR-2014 and experienced no adverse effect. Additional information has been requested.
Age: 1.07
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Herpes zoster, Injection site reaction, Skin infection, Viral rash
Clinical narrative: This spontaneous report as received from a physician via company representative and also through a VZV identification program questionnaire refers to a 13 month old female patient. The patient did not have recent varicella zoster virus exposure or shingles. The patient had no known drug reactions or allergies. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. On 17-MAR-2014, the patient was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, subcutaneous, lot # reported J007953, expiration date 27-JUN-2015. On 19-MAR-2014, 2 days after VARIVAX (Merck) vaccination, the patient experienced diarrhea. On 20-MAR-2014, the patient experienced rash generalized on trunk and extremities, also reported as viral rash on her trunk and herpes zoster left anterior thigh at injection site also reported as a zoster like rash developed at injection site approximately the size of a half dollar coin. The physician treated the injection site as a skin infection with an unspecified antibiotic. On 20-MAR-2014, the patient's maximum temperature reported was 101 degrees. On 31-MAR-2014, 14 days after VARIVAX (Merck) vaccination, the patient experienced vesicles erythematous base. There were no laboratory diagnostics studies performed. The patient sought medical attention. Office would be submitting samples to Varicella Zoster Virus Identification Program. Physician stated that the diarrhea and viral rash cleared after fourteen days on 02-APR-2014 and 03-APR-2014 respectively. The outcome of vesicles erythematous base, diarrhea, herpes zoster left anterior thigh at injection site and rash generalized on trunk and extremities was reported as recovered. 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 healthcare worker refers to an unknown number of patients of unknown age and gender. The healthcare worker reported that the unknown number of patients might had received with a dose of ROTATEQ (lot#, expiration date, dose and strength not reported) that was exposed to a high temperature of 47 degrees F., 7 different times since January 2014, 5 minutes for each excursion, for a total of 35 minutes. No adverse effect reported. It was unspecified if the patient sought medical attention. This is one of four reports received from the same source. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Culture stool negative, Diarrhoea, Rotavirus infection, Rotavirus test positive
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 9 week old male patient. On 05-MAR-2014, the patient was vaccinated with ROTATEQ (Lot# J008752, expiry date 26-NOV-2015) series of 2 ml, oral. On 11-MAR-2014, the patient experienced diarrhea. The patient mother was instructed to take the stool sample to the lab by the physician. On 13-MAR-2014, the stool sample was taken to the lab. On 15-MAR-2014, the result of the stool culture was negative. The result for stool sample for rotavirus was positive. On 15-MAR-2014, the patient was diagnosed with rotavirus by the physician. 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: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to an unknown number of patients of unknown age and gender. The healthcare worker reported that the unknown number of patients might had received with a dose of PEDVAXHIB (lot#, expiration date, dose and strength not reported) that was exposed to a high temperature of 47 degrees F., 7 different times since January 2014, 5 minutes for each excursion, for a total of 35 minutes. No adverse effect reported. It was unspecified if the patient sought medical attention. This is one of four reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to an unknown number of patients of unknown age and gender. The healthcare worker reported that the unknown number of patients might had received a dose of VAQTA (lot#, expiration date, dose and strength not reported) that was exposed to a high temperature of 47 degrees F., 7 different times since January 2014, 5 times for each excursion, for a total of 35 minutes. No adverse effect reported. It was unspecified if the patient sought medical attention. This is one of four reports from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Scab
Clinical narrative: This spontaneous report as received from a pharmacist (also reported as non-healthcare professional) refers to a 62 year old female patient. On 09-APR-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # J012660, expiry date 10-JAN-2015, once, in the left arm (dose and route not reported). The patient's relevant concomitant medication and past drug history were unknown. The patient had no history of injection site reactions. On 09-APR-2014 (also reported as on an unknown date, following the injection), the patient experienced golf-ball sized area at the injection site that is red and crusty and arm itches from the elbow to the armpit. It was unknown if there was relevant laboratory data. It was unknown if the patient would receive another injection of ZOSTAVAX. At the time of the report, the patient continued to experience golf-ball sized area at the injection site that is red and crusty and arm itching from the elbow to the armpit. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients with unspecified demographics. Approximately in 2014 (reported as unspecified dates since 13-FEB-2014 and prior to 14-APR-2014), the patients were administered doses of GARDASIL injection which were improperly stored. Concomitant therapy was unspecified. No adverse events were reported. No product quality complaint was involved. Therapy with GARDASIL was continued. The outcome of improperly stored GARDASIL administered was unknown. No further information was provided. This case is linked with MARRS # 1404USA008845 and MARRS # 1404USA011761 as same reporter link. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients with unspecified demographics. Approximately in 2014 (reported as unspecified dates since 13-FEB-2014 and prior to 14-APR-2014), the patients were administered doses of PNEUMOVAX 23 which were improperly stored. Concomitant therapy was unspecified. No adverse events were reported. No product quality complaint was involved. The outcome of improperly stored PNEUMOVAX 23 vaccine administered was unknown. No further information was provided. This case is linked with MARRS # 1404USA011760 and MARRS # 1404USA008845 as same reporter link. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Chest pain, Electrocardiogram normal, Middle insomnia, Troponin I increased
Clinical narrative: A male patient, medical history not reported developed chest pain considered moderate in severity, 10 days after he received an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) on 24 March 2014 and concomitantly an injection of Typhoid Vaccine, manufacturer not reported, (lot number, route, site and side not reported) on 24 March 2014. On 03 April 2014, 10 days post vaccination, the subject reported at visit 2, that he experienced two episodes of chest pain, first lasting several hours waking him from sleep and the following episode lasting about 45 minutes to an hour. Both improved with hot showers. He did not take any medications or seek medication attention. An EKG and Troponin I (<0.10 ng/mL) were normal on 08 April 2014. The subject was referred appropriately for care. The subject recovered on 05 April 2014. According to the reporter the event of chest pain was considered other important medical event and possibly related to the trial product. Documents held by sender: None.
Sex: M
Vaccine: HEPAB, SMALL, TYP
Symptoms: Dizziness, Electrocardiogram normal, Haemolysis
Clinical narrative: This study case was received from the investigator in a trial on 15 April 2014. A male subject with no reported past medical history had received on 24 March 2014: ACAM2000 (lot number, route and site of administration not reported), Typhoid vaccine (lot number, route and site of administration not reported) and TWINRIX (manufacturer, lot number, route and site of administration not reported) and 7 days later was found to have on 31 March 2014, lightheadedness. The subject had no associated chest pain or shortness of breath. ECG was normal and Troponin I level was not performed due to hemolysis on 08 April 2014. The subject did not seek medical attention. No further information was available at the time of the report. The subject's outcome was recovered. According to the investigator, the event of lightheadedness was considered an other important event and possibly related to vaccination.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients with unspecified demographics. Approximately in 2014 (reported as unspecified dates since 13-FEB-2014 and prior to 14-APR-2014), the patients were administered doses of RECOMBIVAX HB injection 10, which were improperly stored. Concomitant therapy was unspecified. No adverse events were reported. No product quality complaint was involved. Therapy with RECOMBIVAX HB injection 10 was continued. The outcome of improperly stored RECOMBIVAX HB vaccine administered was unknown. No further information was provided. This case is linked with MARRS # 1404USA011760 and MARRS # 1404USA011761 as same reporter link. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza A virus test positive, Influenza B virus test
Clinical narrative: Case received on 15 April 2014 from a healthcare professional (physician). A 41 year old female was vaccinated intradermally with FLUZONE Intradermal batch UT4721BA, site not reported on 23 October 2013. The patient denied being ill at the time of vaccination. The patient has a history of diabetes type 2 and hyperlipidemia. On 11 April 2014, the patient had a rapid flu test for A and B only and tested positive for influenza A with a Rapid Test. It is unknown if the A strain is H1N1. The patient is being treated with TAMIFLU. The patient outcome is not recovered. This reporter also reported another adverse event which is captured in case number 2014SA049822 same product and same reporter. Documents held by sender: None.
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Urticaria
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a female patient of unknown age. On 03-APR-2014 the patient was vaccinated with a does of PNEUMOVAX 23 (lot#J011714, expiration date 20-FEB-2015), 0.5 ml, intramuscular. On an unknown date, in approximately April 2014, the patient experienced welts and rash at the injection site. The patient called her office and was suggested to use ice compresses and ibuprofen. No lab tests were performed. The outcome of welts and rash at the injection site was reported as recovering/resolving. The medical assistant was requesting a lot check. This is one of several reports received from the same source. Additional information has been requested.