chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practitioner nurse referring to a patient of unknown age and gender. On unknown dates the patient was administered the first and second doses of GARDASIL (dose, strength, lot# and route were not reported) series four years apart (inappropriate schedule of vaccine administered). The third dose in the three-dose series had not been administered. No adverse effect was reported. Additional information is not expected because the reporter did not wish to be contacted again for any additional information.
Age: 15.0
Sex: M
Vaccine: MMRV
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 15 year old male patient. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 03-AUG-2015, a 15 year old patient was vaccinated with a dose of PROQUAD (Merck) (strength, dose, route of administration, lot # and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to about 36 infants of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB strength: 2.5/0.5 microgram/ml (lot number K010535 and expiration date 27-AUG-2016, lot number K020216 and expiration date 17-SEP-2016) (dose and route of administration not reported). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Age: 1.39
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 16 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown gender and age. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with doses of VAQTA (lot # J011712 and expiration date 21-SEP-2015) (strength, dose and route were unknown), which were improperly stored. No adverse experiences had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refer to an unspecified number of unspecified patients received of unknown age and gender. The patient's medical history and concurrent conditions and concomitant medications were not specified. On an unknown date, the patients were vaccinated with doses of PROQUAD (Merck), (lot number, expiration date, dose, frequency and route of administration not specified). No adverse effect reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of two reprots received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of unspecified patients received of unknown age and gender. The patient's medical history and concurrent conditions and concomitant medications were not specified. On an unknown date, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (lot number, expiration date, dose, frequency and route of administration not specified). No adverse effect reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash generalised
Clinical narrative: Information has been received from a pharmacist referring to a 54 year old female patient. The patient's medical history included unspecified reaction to penicillin and had rheumatoid arthritis prior to ZOSTAVAX. On 17-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # L003218, expired date 30-APR-2015, dose and route were unspecified). There was no concomitant medication. On 24-JUL-2015, the patient experienced multiple rashes all over her body. The pharmacist reported the patient was diagnosed with shingles on 27-JUL-2015. The patient saw a physician to seek medical attention on an unknown date in 2015. No treatment or lab test was conducted for the patient. At the time of reporting, the patient did not recover from the event. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Exfoliative rash, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 74 year old female patient. The patient has high cholesterol, hypertension, anxiety, history of heart attack, allergy to iodine, trimethoprim, sulfa drugs, statins, tetanus toxoids, had reaction to TDap before and CELEBREX. The patient's medical history included shingles one year ago. On 28-JUL-2015, the patient was vaccinated with ZOSTAVAX lot # KL006382, expiry date 25-MAY-2016. Concomitant therapies included ZOLOFT, SINGLULAIR, LIPITOR, TOPROL XL tablets, VALTREX and hydrochlorothiazide. On 28-JUL-2015, the patient developed an area at the injection site that was red within 30 minutes. Within 24 hours after administration the patient stated that the injection site area became warm, itchy and scaly rash appeared. ON 30-JUL-2015, the patient returned to the pharmacist since the rash was spreading. Pharmacist reported that the area was 1 x 2 diameter and appeared to be getting worse. There was not treatment rendered for the events. No lab test performed. The outcome of the events were unknown. The patient sought medical attention. Additional information has been requested.
Age: 1.39
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 16 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 15 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Blister, Erythema
Clinical narrative: Gave pt ZOSTAVAX and FLUARIX QUAD vaccine. 3 days later pt presented with a red patch and blister on her arm. Pt state not warm and did not bother her. Called 2 days later was getting better but still there.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 9 week old female patient. No relevant medical history or concurrent conditions were reported. On 30-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an adolescent male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-APR-2015, the patient who was 16 years old at that time, was vaccinated with his first dose of the GARDASIL series with GARDASIL 9, (dose, route of administratoin, injection site, lot number and expiration date were not reported). The medical assistant reported that on 29-JUL-2015, the patient was administered the second dose of the series with GARDASIL, (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse effects were reported. The outcome of the event of interchange of vaccine products was unknown at the time of the report. The relatedness between the event and suspect therapies was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a female patient of unknown age. No concurrent condition or medical history was reported. On 15-APR-3013, the patient was vaccinated with GARDASIL (dose 1, dose and route of administration not provided). On 29-MAY-2013, the patient was vaccinated with GARDASIL (dose 2, dose and route of administration not provided). No concomitant therapy was reported. The patient had did not experience any adverse effects. The patient was going to receive a third dose of GARDASIL on 29-JUL-2015. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 15 months old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 1.28
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 15 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about medical history and concurrent condition was not reported. On an unknown date since 13-JUL-2015, the patient was administered with RECOMBIVAX HB lot # J013394 with expiration date of 25-AUG-2016 (strength, dose and route unspecified), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about medical history and concurrent condition was not reported. On unknown dates since 13-JUL-2015 the patients were administered with PEDVAXHIB, lot# K025002 with expiration date of 20-JUL-2017, (strength, dose, route and lot number unspecified), which was exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.29
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 15 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old female patient. No relevant medical history or concurrent conditions were reported. On 16-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28 MAY 2016, dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.39
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 16 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a nurse refers to a 20 year old male patient with cardiac murmur. The patient has unknown drug reactions or allergies. There were no concomitant medications. On 16-JUN-2015 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot #K002923, date of expiration 26-FEB-2016 (dose and route unspecified) and dose of RECOMBIVAX HB (lot #, date of expiration, dose and route unspecified). On 07-JUL-2015 the patient developed shingles rash on an unspecified area of the body. The patient sought medical attention, he went to see a physician assistant. On 14-JUL-2015 the patient started VALTREX for the shingles. No laboratory diagnostic studies were performed. The outcome of the event was unknown. The relatedness between the event and (Oka/Merck) VARIVAX and RECOMBIVAX HB was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about medical history and concurrent condition was not reported. On an unknown date since 13 JUL 2015, the patient was administered with VAQTA lot # K012457 with expiration date of 04 JUN 2017 (strength, dose and route unspecified) which were exposed to temperatures outside of the recommended range (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown ages and gender. Information about medical history and concurrent condition was not reported. On unknown dates since 13-JUL-2015 the patients were administered with GARDASIL 9 (lot# L004741 with expiration date of 04-MAR-2017, lot# K026246 with expiration date of 28-JAN-2017) (strength, dose and route unspecified), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about medical history and concurrent condition was not reported. On unknown dates since 13-JUL-2015, the patients were administered with ROTATEQ (lot # K016313 with expiration date of 31 MAY 2016)(strength, dose, route and lot  number unspecified). which were exposed to temperatures outside of the recommended range (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old female patient. No relevant medical history or concurrent conditions were reported. On 30-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports  received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Skin exfoliation
Clinical narrative: Information has been received from a pharmacist referring to a 68 year old female patient with chronic obstructive pulmonary disease (COPD). The patient had no drug reactions or allergies. On 31-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot number reported as 1011434 with expiration date 03-JUL-2016, dose 0.65 ml) subcutaneously. Concomitant therapies included unspecified benzodiazepine, unspecified estrogen vaginal cream, unspecified thyroid medication, omeprazole (manufacturer unknown), unspecified narcotic medication, SPIRIVA and budesonide, SYMBICORT and unspecified antidepressant. The  pharmacist reported that a patient developed a "raised red spot" that was "scaly" and "tender to touch" at the injection site "that evening" on 31-JUL-2015 after receiving ZOSTAVAX. The patient called the pharmacist "yesterday", on 03-AUG-2015 and the pharmacist informed the patient to apply hydrocortisone cream to the injection site. Then "today", on 04-AUG-2015, the patient was seen in the pharmacy. No lab diagnostics studies were performed. At time of the report, outcome of the events was reported as not recovered. The causality was not provided. Additional information has been requested.
Age: 1.12
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates the patients were vaccinated with VAQTA (lot #, expiration date, dose and route not reported), which were improperly stored. No adverse effects were reported. Follow up information has been received on 07-JUL-2015. This report refers to a 13-month-old patient of unknown gender who on 05-JUN-2015, was vaccinated with improperly stored VAQTA lot # K018181, expiration date: 04-JUN-2017 (dose and route of administration were not provided). This is one of several reports received from the same source. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 15 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 month old female patient. No relevant medical history or concurrent conditions were reported. On 01-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 9 week old female patient. No relevant medical history or concurrent conditions were reported. On 015-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Clonus, Eye movement disorder, Fall, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immediately after receiving GARDASIL (HPV) IM vaccine at (R) upper extremity which was preceded by the Hepatitis A IM vaccine at (L) upper extremity, this patient developed loss of consciousness and subsequent fall to the floor, his head protected by LPN. He proceeded to have clonic head and neck movements and rolling of eyes, simulating a brief seizure episode. This episode lasted approximately 5 secs. Patient placed in supine position with legs elevated with resulting gain of consciousness. He was observed for 30 minutes and then discharged home.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Seizure
Clinical narrative: Immediately after receiving GARDASIL (HPV) IM vaccine at (R) upper extremity which was preceded by the Hepatitis A IM vaccine at (L) upper extremity, this patient developed loss of consciousness and subsequent fall to the floor, his head protected by LPN. He proceeded to have clonic head and neck movements and rolling of eyes, simulating a brief seizure episode. This episode lasted approximately 5 secs. Patient placed in supine position with legs elevated with resulting gain of consciousness. He was observed for 30 minutes and then discharged home.
Age: 16.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of drug administration
Clinical narrative: Measles, Mumps and Rubella vaccine MMR II administered intramuscular instead of subcutaneously. Called and spoke with CDC and states does count.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Redness to the right arm.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old male patient. No relevant medical history or concurrent conditions were reported. On 10-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322.  Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 month old female patient. No relevant medical history or concurrent conditions were reported. On 12-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter.Original report is MARRS#1507USA011233.  Additional information has been requested.
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Antibody test negative, Hepatitis B antibody negative, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 20 year old female patient. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route and lot # not reported). Other suspect therapies included (Oka/Merck) VARIVAX (dose, route and lot # not reported) and RECOMBIVAX HB (dose, route and lot # not reported) both given on an unspecified date. On an unknown date, the patient had a blood test and results showed low titers for measles, mumps, rubella, varicella and hepatitis B. At the time of the report, the patient's outcome was unknown. Additional information is not expected as the reporter did not wish further contact.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Injected limb mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Erythema multiforme and swelling, increased warmth, and decreased range of motion of left arm. Ceftriaxone mg once, azithromycin mg other.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Body temperature increased, Injection site bruising, Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: T 99.1, no other constitutional symptoms 8cm x 8 1/2cm localized reaction centered on VARIVAX injection with minimal bruising at KINRIX site. Evaluated 17:25 8/5; 52 hours after. Patient received vaccinations on Monday. The shot injection site has a large red area around it. Patient complains of itching in area. Patient's mother states that the area is getting better. Patient's mother has not given any medications. Patient received KINRIX and Varicella in the affected leg.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Local reaction
Clinical narrative: T 99.1, no other constitutional symptoms 8cm x 8 1/2cm localized reaction centered on VARIVAX injection with minimal bruising at KINRIX site. Evaluated 17:25 8/5; 52 hours after. Patient received vaccinations on Monday. The shot injection site has a large red area around it. Patient complains of itching in area. Patient's mother states that the area is getting better. Patient's mother has not given any medications. Patient received KINRIX and Varicella in the affected leg.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 20-JUL-2015 the patient was vaccinated with an expired dose of RECOMBIVAX HB lot # 0385AE with expiration date of 08-NOV-2014, (dose, strength and route unknown). Concomitant medication was not reported. No symptom was reported. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old female patient. No relevant medical history or concurrent conditions were reported. On 08-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.45
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Body temperature increased
Clinical narrative: Mother reported child had temp >107 and was taken to ER. ER doctor said of all previous vaccines given it was most likely the DTaP. Mom refuses to let child receive another DTaP.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever of 101.6 degrees F at 0400 the day after 2 month vaccines. Fever resolved after TYLENOL and did not reoccur.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old male patient. No relevant medical history or concurrent conditions were reported. On 18-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS1507USA011322.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Full blood count normal, Rash
Clinical narrative: Rash, patient also came back on 7/29/15 with another rash on face. Original rash was on legs.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncope after vaccination.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 24-JUL-2015, the patient was inadvertently vaccinated with an expired dose of M-M-R II lot # J008534, expiration date on 12-JUL-2015 (strength, dose, anatomical location and route of administration were not provided). There was not a product quality complain involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a consumer, concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot # K020215 expiration date: 15-MAY-2016) (dose, route and anatomical location of administration were not reported). On an unknown date, the patient experienced pain at the injection site. The outcome of the injection site pain was unknown. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 month old female patient. No relevant medical history or concurrent conditions were reported. On 03-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322.  Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 month old female patient. No relevant medical history or concurrent conditions were reported. On 17-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 03-AUG-2015, the patient was vaccinated with one dose of improperly stored (Oka/Merck) VARIVAX (lot # was reported as L004653, expire date 11-FEB-2017, (dose, dose# and route not provided) (incorrect product storage). No adverse effect was reported.
Age: 0.34
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 month old male patient. No relevant medical history or concurrent conditions were reported. On 25-JUN-2015, the patient was inadvertently vaccinated with improperly stored oral, ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported). No adverse effects were reported. This is one of several reports receive from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 9 week old male patient. No relevant medical history or concurrent conditions were reported. On 24-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322.  Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 9 week old female patient. No relevant medical history or concurrent conditions were reported. On 25-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322.  Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old male patient. No relevant medical history or concurrent conditions were reported. On 29-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322.  Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 5 month old female patient. No relevant medical history or concurrent conditions were reported. On 06-JUL-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322.  Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 3 month old male patient. No relevant medical history or concurrent conditions were reported. On 01-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322.  Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Fever, myalgia. Localized skin rashes & swelling at injection site.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Musculoskeletal disorder, Vaccination complication
Clinical narrative: Initial case was received by a consumer on 18 March 2013. A two-year-old female patient, with past medical history not reported, received an injection of FLUZONE, sanofi pasteur Inc., lot number U4482BA, (route, site, side and dose in series not reported) on 05 September 2012 (reported as on or about 05 September 2012). On 07 September 2012, two days post vaccination, the patient was admitted to the hospital after losing all functioning of her lower extremities. According to reporter, the patient has lost permanent function of her lower extremities following her flu shot, believed as due to "Guillain Barre Syndrome" and the adverse reactions (unspecified) to the flu shot. Laboratory or diagnostic testing and treatments were not reported. The patient's outcome was not recovered. Documents held by sender: None.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site reaction, Skin exfoliation
Clinical narrative: Initial report received from a Healthcare professional on 07 December 2012. An 86-year-old female patient, whose concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (lot number-U4491AA and site of administration was not reported) on 30 August 2012. It was reported that the patient illness at time of vaccination was none and had no known allergies. On 20 August 2012 i.e. on same day patient had 3/4 inch flaking red brown spot at injection site that persist till the day of report. Corrective treatments were not reported. Relevant diagnostic test/laboratory data were not reported. At the time of this report the event outcome of patients was unknown, Documents held by sender: None. Follow-up information received from health care professional on 08 April 2013. The patient received vaccine on an unspecified time (in PM) in left deltoid. The patient did not receive any concomitant medications. As of 08 April 2013, the patient had recovered from events.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is a cluster case of three patients (same reporter, event, product and product batch number). Initial report received from a healthcare professional on 20 SEPTEMBER 2012. 3 patients with no reported medical history and concomitant medications received FLUZONE (batch number UH745AA) intramuscularly in the deltoid region on 18 SEPTEMBER 2012. The patients had received doses of FLUZONE in past. On 20 SEPTEMBER 2012, all the patients had redness, swelling, warmth and pain at injection site. The patients were treated with BENADRYL and ice. Lab investigations were not reported. At the time of this report, the patient's outcome was unknown. Documents held by sender: None.  Follow up information received from the healthcare professional on 19 NOVEMBER 2012. Initially this case was a cluster case of 3 patients (same reporter, event, product and product batch number). As per follow-up information patient identifiers were updated, hence this case is a part of cluster of 3 cases and is lined to AER2012-11090 and 2012-11096.  A 52-year-old female patient , after vaccination, developed red, raised 4 inch area, itchy on 19 SEPTEMBER 2012. The patient had no illness at the time of vaccination. The patient's concomitant medications and pre-existing laboratory investigations were reported as not applicable. On an unspecified date, the patient had recovered.
Age: 57.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: Initial report received from a healthcare professional on 18 SEPTEMBER 2012. A 57-year-old patient of unspecified gender, whose -pre-existing illness and illness at time of vaccination was unknown, received an intramuscular dose of FLUZONE (lot number: UH717AA, expiry date: 08/30/2013) in right deltoid on 24 AUGUST 2012. On 25 AUGUST 2012, the patient had numbness and tingling at the injection site on right arm. Corrective treatment was not reported. The outcome of numbness and tingling at the injection site was reported as persisting. List of documents held by the  sender: none.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 02 October 2012. A 66-year-old male patient with no relevant medical history and concomitant medications was not reported; had received a first intramuscular dose of FLUZONE HD in left arm on 25 September 2012 at 2.45 pm (Lot number U4498BA). On 25 September 2012 in evening, the patient had fever and muscle aches. She also experienced dizziness and sweating with fever in next day early "am". At the time of report laboratory investigations and corrective measures were not reported. The patient's outcome was recovered on an unspecified date. Documents held by sender: None.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Rash, Skin warm
Clinical narrative: This case is a part of 3 cluster cases and is linked to case number 2012-08840 and 2012-1190 (same reporter, adverse events after FLUZONE batch number: UH745AA). Summary narrative including initial information received on 20 September 2012 and follow-up information received on 19 November 2012 from healthcare professional. A 54-year-old female patient, whose concomitant medications were not reported and had received doses of FLUZONE in past and illness at the time of vaccination was none, had received an intramuscular dose of FLUZONE, batch number: UH745AA, on deltoid on 18 September 2012 afternoon. On 18 September 2012 evening, after vaccination, the patient experienced entire arm red with raised rash, warm to touch and ache. The laboratory investigations were not reported and the patient was treated with BENADRYL. 4 days later on an unspecified date, the patient had recovered. Documents held by sender: None.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Initial reporter received from a healthcare professional on 10 October 2012. An 88-year-old male patient, whose concomitant medications and medical history were not reported, had received intramuscular FLUZONE HD vaccine (Lot number U4490AA) in left arm on 27 September 2012. The illness at the time of vaccination was reported as soreness in arm. On 27 September 2012 after few hours of vaccination, the patient had swelling in arm. The patient came back the next day the arm does not seen to swollen anymore but patient had pain/soreness in arm 2-3 days after the vaccine. Corrective treatment was not reported. The patient's outcome was recovered on unspecified date. List of documents held by the sender: None.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dysphagia, Dysphonia, Dyspnoea, Electrocardiogram normal
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 04 October 2012. A 66-year-old female patient received an intramuscular injection dose of FLUZONE HIGH-DOSE, sanofi pasteur Inc., (lot number not reported) on 25 September 2012. On the same day, 25 September 2012, the patient developed chest pains, shortness of breath, throat swelling, difficulty swallowing and hypotension with blood pressure (BP) 84/50. The patient was taken to the emergency department (ED) and treated with Prednisone and BENADRYL. The patient claims she went into shock and was hospitalized for two days and released from the hospital. The patient stated her electrocardiogram "(EKG) was ok", on date not specified. The patient denied allergies and claimed to be in good health. She denied any illness at time of vaccination and denied any other vaccinations within prior four weeks of vaccination. The patient's outcome was reported as recovered on unspecified date (and also reported as unknown). Follow-up information was received from the consumer, who was also the patient, on 16 November 2012. The patient had influenza vaccinations every year for the last six years and never had an allergic reaction. The patient never received FLUZONE HIGH-DOSE in previous years. The patient received the vaccine at 3:30 PM on 25 September 2012 and the symptoms began within three hours of vaccination. The patient was admitted to the hospital from 25 September 2012 to 27 September 2012. She was released when she was able to talk (with hoarseness), swallow and breathe. The patient had a follow-up with an internist on 02 October 2012 and an ear, nose, and throat (ENT) doctor on 05 October 2012. It was suggested that the patient wait several weeks before being prescribed swallow test and the patient opted to wait for further tests. As of the day of the report, swallowing was normal, breathing was normal and the patient had a full recovery. Documents held by sender: None.