chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Axillary pain, Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Tdap (Boostrix) administered on 9-17-14 at 1545. Mom reported on 9-19-14 at 1440 reaction on L arm including itching, warmth, pink, and pain in axilla. Physician exam measured redness and slight warmth mid-lateral LUE about 7x10cm. This was inferior to injection site.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 26-MAR-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J007930, expiration date: 28-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. No further information was reported. In November 2009 the patient was vaccinated with ZOSTAVAX (dose, lot #, expiration date and route were not reported). On 01-AUG-2014 the patient experienced vaccination failure and got shingle. The outcome of the patient got shingle and vaccination failure was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Breast pain, Injection site erythema, Pyrexia, Tenderness
Clinical narrative: 9/27/14 Administer vaccine about 5 pm. 9/30/14 Pt called - area is red -underarm/sore breast and fever 102. 10/1/14 Pt called - arm still tender - redness decreased. 10/3/14 Pt came to pharmacy - redness +- 3 x 4". 10/6/14 Pt called - redness and tenderness gone.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an improperly stored ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 19-MAR-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J007930, expiration date: 28-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 10-APR-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J007930, expiration date: 28-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 04-APR-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J007930, expiration date: 28-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 29-SEP-2014, the patient was vaccinated with an expired dose of M-M-R-II lot # H017437, expiry date: 20-SEP-2014, 0.5 ml, subcutaneous. No adverse effects had been observed or reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Local swelling, Pain, Pyrexia
Clinical narrative: Saturday (10/4) - arm swollen (L), couldn't move it. Seen at urgent care, given MOTRIN. Ice. Sunday (10/5) - high fever, added TYLENOL. Monday (10/6) - fever, swollen arm, pain. Prednisone given at MD visit.
Age: 55.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health care worker refers to a 55 year old male patient. On 23-SEP-2014 the patient was supposed to receive ZOSTAVAX, but was inadvertently vaccinated with VARIVAX (Merck), 0.5 ml, subcutaneous (lot number and expiration date not reported). No concomitant therapy, pertinent medical history, drug reactions or allergies were reported. The patient did not seek medical attention and no treatment was given. No lab diagnostics studies were performed. No adverse effects reported. Additional information is not expected because the reporter refused additional contact.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Abnormal behaviour, Antisocial behaviour, Disturbance in attention, Proctalgia
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 3 year old patient. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB (dose, route, lot# and expiration date were not provided). Mother of the patient reported that after her daughter received RECOMBIVAX HB "she has not been the same, she has become anti-social, shorter attention span, can't focus easily" (onset dates unknown). The patient complained of vaginal, stomach and anal pains (onset date unknown). There was a lot yeast in her vagina and she needed to be bathed multiple times a day. Mother has had to change the patient's diet. Patient sought medical attention. Nystatin was given for the treatment. Patient's mother was not really sure if the patient received RECOMBIVAX HB. The outcomes of all events were reported as not recovered/not resolved. Relatedness between the events and RECOMBIVAX HB was not provided. Additional information is not expected, because there are no contact details.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Vulvovaginal mycotic infection, Vulvovaginal pain
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 3 year old patient. On an unknown date the patient was vaccinated with a dose of RECOMBIVAX HB (dose, route, lot# and expiration date were not provided). Mother of the patient reported that after her daughter received RECOMBIVAX HB "she has not been the same, she has become anti-social, shorter attention span, can't focus easily" (onset dates unknown). The patient complained of vaginal, stomach and anal pains (onset date unknown). There was a lot yeast in her vagina and she needed to be bathed multiple times a day. Mother has had to change the patient's diet. Patient sought medical attention. Nystatin was given for the treatment. Patient's mother was not really sure if the patient received RECOMBIVAX HB. The outcomes of all events were reported as not recovered/not resolved. Relatedness between the events and RECOMBIVAX HB was not provided. Additional information is not expected, because there are no contact details.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 01-APR-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J007930, expiration date: 28-JUN-2015. That may have been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLUX, PPV, TTOX
Symptoms: Injected limb mobility decreased, Injection site swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 49 year old female patient. No current condition was reported. No historical medication was reported. On 01-OCT-2014, the patient was vaccinated with PNEUMOVAX 23, lot number reported K0004542, expiration date- 19-AUG-2015, subcutaneous in the right arm. Patient received PNEUMOVAX 23, subcutaneously along unspecified influenza shot in her right upper arm. Concomitantly patient received Tetanus Toxoid in her left arm on 01-OCT-2014. On 02-OCT-2014, 2 days after onset of therapy the patient experienced pain in her right arm. Patient stated that she can hardly lift her right arm. The swelling is spreading under her arm toward her arm pit. Treatment given for adverse event was reported as no. The outcome of pain in her right arm and swelling is spreading under her arm toward her arm pit was reported as not resolved. No additional information was provided at time of call. No product quality complaint was (PQC) involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Viral rash
Clinical narrative: Mother reports child broke out in a rash within 48 hours of receiving MMR, Varicella and Hep A vaccines administered at another providers office, seen on 9/23/2014 - rash appears viral, no treatment given.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Pt came to pharmacy complaining of sore and bruised (R) upper arm (site of injection). Pt is in pain over a week.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. The patient's current conditions included diabetes, hypertension. On 18-NOV-2013, the patient was vaccinated with ZOSTAVAX (lot # J000427, expiry: 10-APR-2014) (0.65 ml, subcutaneous). Concomitant therapies included FLUZONE received on 18-NOV-2013 and unspecified oral medications for hypertension and diabetes. On an unknown date in September 2014 (reported as early September 2014), the patient experienced shingles. Patient received treatment with unspecified antiviral medication. No product quality complaint was involved. The outcome of shingles was unknown. The relatedness of the event shingles with the therapy ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 14-MAY-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J006955, expiration date: 07-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 28-MAY-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J006955, expiration date: 07-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several report received from the same reporter. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Left arm sore; cannot lift arm shoulder height; seeing MD Friday 10/10/14.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: After vaccine administered, patient felt warm. Next day: swelling around injection site, itchy, red.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUN4, IPV, VARCEL
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Rash/swelling started on Thursday 10/2/14. Redness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient. No medical history, drug reactions or allergies were reported. On 01-OCT-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous, (lot # reported as K009769 expiration date 09-OCT-2015) (dose not reported). There was no concomitant medication. ON 01-OCT-2014, since receipt of the vaccine, the patient experienced that the area in which she received the vaccine was red, raised and a little warm and it was about 1.5 inches in diameter. The patient sought medical attention she visited pharmacy. No lab diagnostic studies were performed. At the time of the report the outcome of the events was reported as not recovered. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLUC3, VARZOS
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Pain, Tremor
Clinical narrative: Patient reported that about 1 hour after vaccine, he had dizziness, sweating, shaking, weakness and aches. It took almost 24 hours to feel back to normal.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 08-JUL-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 67 year old female patient. On 09-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX vial 19400 PFU (Lot number not provided), 0.65 ml, subcutaneous. The pharmacist reported that as the patient was leaving the store on 09-SEP-2014, the injection site started itching intensely. She stated that the patient reported that the injection site was hot to the touch, raised, and sore, and that the patient had been fatigued since she received the dose on 09-SEP-2014. No treatment was given for the patient's adverse events. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Nausea, Pain in extremity
Clinical narrative: In 24hrs - sore arm, tired, queasy. In 48hrs - severe diarrhea, continued tiredness.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient is complaining of a rash. She was going to try BENADRYL. Told her to see her doctor.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Blood electrolytes normal, Contusion, Dehydration, Flushing, Vomiting
Clinical narrative: Given Flu vaccine then 30 min later with reported emesis x 3, flushing. No prev issues, seen at ED for care. Electrolytes WNL. Bolus fluid discharged with no further issues. Noted 4 x 5 cm bruise (L) arm. 60yo female presents with complaints of vomiting after receiving a Flu vaccine this morning while at work. Symptoms started within 30 minutes of the injection. Now feeling better. No CP/SOB. Denies abd pain. Vitals stable. Patient awake and alert, clinically dehydrated. Heart regular and lungs clear. Abd soft and nontender. Neuro intact. Will fluid hydrate and medicate with IV ZOFRAN while checking a BMP. Diagnostic studies pending.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 18-MAR-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J007930, expiration date: 28-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II would had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Pruritus
Clinical narrative: Pt. reported on 10/6/14 that approx. 1 hour after she rec. flu vaccine on 10/2/14 she developed redness and itching along jawline and ears. Pt went home after work and took BENADRYL. All symptoms resolved.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Hypersensitivity, Hypoaesthesia, Injection site erythema
Clinical narrative: Within 24 hrs, injection sites become red, hot and a rash appeared. Arm became painful to left - within the 2nd 24 hrs this pt's inner bicep began to turn blotchy red and now is full blown red, hot to touch and numb. Pt went to ER for treatment. Dx Cellulitis. Pt was + allergic rxn. Cephalexin 500 g QID x 7d and BENADRYL 25 g Q6H prn.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Injection site warmth, Pain, Pain in extremity, Rash macular
Clinical narrative: Within 24 hrs, injection sites become red, hot and a rash appeared. Arm became painful to left - within the 2nd 24 hrs this pt's inner bicep began to turn blotchy red and now is full blown red, hot to touch and numb. Pt went to ER for treatment. Dx Cellulitis. Pt was + allergic rxn. Cephalexin 500 g QID x 7d and BENADRYL 25 g Q6H prn.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Within 24 hrs, injection sites become red, hot and a rash appeared. Arm became painful to left - within the 2nd 24 hrs this pt's inner bicep began to turn blotchy red and now is full blown red, hot to touch and numb. Pt went to ER for treatment. Dx Cellulitis. Pt was + allergic rxn. Cephalexin 500 g QID x 7d and BENADRYL 25 g Q6H prn.
Sex: M
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a clinical medical assistant refers to a male patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On 30-SEP-2014, reported as "yesterday", the patient was vaccinated with ROTATEQ dose 2, 2 ml, oral (lot # was not reported). The medical assistant stated that the administered dose of ROTATEQ was improperly stored. No adverse effects reported. No treatment was given. This is one of two cases from the same reporter. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's current or medical history were not reported. On 10-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX vial injection, 0.65 ml (route, anatomical location, lot number and expiration date not reported). On an unspecified date in September 2014, the patient experienced pain and welt at the injection site, the patient returned to the pharmacy on 29-SEP-2014 and stated that she still had pain and welt at the injection site. Outcome of the events was unknown at the time of the report. Additional information is not expected as the reporter did not wanted follow up contact.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. On 29-SEP-2014 the patient was inadvertently vaccinated with an expired dose of ROTATEQ oral, Lot # J004874, expiration date: 26-SEP-2014 (dose was not reported (also reported as "no dose administered")). No adverse effects were reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Mononucleosis heterophile test
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 15 year old female patient. The patient had no pertinent medical history or current conditions and no drug reactions or allergies. At the moment of this report, patient was not pregnant. On an unspecified date in August 2014, the patient was vaccinated with the first dose of GARDASIL (intramuscular injection, dose 1, 0.5 ml, intramuscularly, batch/lot # and expiration date not reported). There were no concomitant medications. Since an unspecified date in August 2014, after being vaccinated, the patient experienced less energy, more fatigue than normal, some dizziness and some shortness of breath. The patient sought medical attention. The physician reported that he had completed many unspecified blood tests like "mono and thyroid" believing "there was something viral going on"; at the moment of this report some unspecified tests were pending while others "looked good" (exact results, tests and dates were not provided). As treatment for shortness of breath, PROAIR and QVAR were prescribed on an unspecified date in September 2014 (also reported as since last week). The outcome of shortness of breath was reported as recovering/resolving due to the prescribed treatment. The outcome of the other events was reported as not recovered/not resolved. The reporting physician did not provide causality assessment for the events. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Thyroid function test
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 15 year old female patient. The patient had no pertinent medical history or current conditions and no drug reactions or allergies. At the moment of this report, patient was not pregnant. On an unspecified date in August 2014, the patient was vaccinated with the first dose of GARDASIL (intramuscular injection, dose 1, 0.5 ml, intramuscularly, batch/lot # and expiration date not reported). There were no concomitant medications. Since an unspecified date in August 2014, after being vaccinated, the patient experienced less energy, more fatigue than normal, some dizziness and some shortness of breath. The patient sought medical attention. The physician reported that he had completed many unspecified blood tests like "mono and thyroid" believing "there was something viral going on"; at the moment of this report some unspecified tests were pending while others "looked good" (exact results, tests and dates were not provided). As treatment for shortness of breath, PROAIR and QVAR were prescribed on an unspecified date in September 2014 (also reported as since last week). The outcome of shortness of breath was reported as recovering/resolving due to the prescribed treatment. The outcome of the other events was reported as not recovered/not resolved. The reporting physician did not provide causality assessment for the events. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 29-SEP-2014, the patient was vaccinated with an expired opened dose of PNEUMOVAX23 lot # J009827, expiry date: 10-AUG-2014 (dose and route were not reported). The pharmacist also stated that from 10-AUG-2014 through 10-SEP-2014, the opened vial of PNEUMOVAX23 was previously exposed to 70F. No adverse symptoms reported. This is one of three cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 29-SEP-2014, the patient was vaccinated with an expired opened dose of PNEUMOVAX 23 lot # J009827, expiry date: 10-AUG-2014 (dose and route were not reported). The pharmacist also stated that from 10-AUG-2014 through 10-SEP-2014, the opened vial of PNEUMOVAX 23 was previously exposed to 70F. No adverse symptoms reported. This is one of three cases from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Pt found to be pregnant after receiving FLUMIST.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Neck pain, Pain in extremity, Swelling
Clinical narrative: Initially (L) deltoid soreness progressing over 3d to intense (L) axillary pain/swelling and pain at base of neck. Exam: No cellulitis. Tender 4-10 mm lymph nodes at (L) base of neck, supraclavicular chain and (L) axilla.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood test, Peripheral swelling, Skin warm, Vaccination complication
Clinical narrative: Monday night 9/22/14 Rt arm swell up Tuesday got worse warm to the touch went to ER given IV antibiotics discharged on 10 day high dose oral antibiotic, went back Wed IV saline fluids originally diagnosed as cellulitis then when f/u they felt it resolved too quickly and they don't think it was cellulitis but a bad rxn to shots given together same day same arm.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pain, Pruritus
Clinical narrative: Red and swollen 3" x 4" (size), some itching and pain. Clobetasol propionate cream.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. medical history was not reported. The nurse informed that on 25-JUN-2014 the patient was vaccinated with M-M-R II (strength, doses and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly exposed since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 39 year old female patient. Medical history and concurrent conditions were not reported. On 29-SEP-2014, the patient was vaccinated with a dose of M-M-R II (dose number, lot number and expiration date were not reported), 0.5 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The pharmacist reported that the patient received expired M-M-R II vaccine (Exp. August, 2014, lot unspecified) on 29-SEP-2014. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 22-JUL-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 19-JUN-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of a improperly stored ZOSTAVAX (lot # K007177, expiration date 21-AUG-2015) (dose and route were not reported). Concomitant therapies were not reported. No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 02-JUL-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly stored since February 2014. The thermometer batteyr ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temeprature the M-M-R II could had been exposed was 70F. Also stated that was no way to detemrine waht the exact temperature was at any given time after 01-FEB-2014 since the batteyr in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Fatigue, Headache, Myalgia, Otitis media, Pyrexia
Clinical narrative: Patient received FLUMIST on Friday, then had 2 days of fever, fatigue, muscle aches. Patient reports headache during the fever. Mom took to urgent doc and dx with OM, given amoxicillin.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Ocular hyperaemia, Pharyngeal oedema
Clinical narrative: Swollen throat. Difficulty breathing. Bright red eyes.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 18-JUL-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 18-JUN-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J008720, expiration date: 26-JUL-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site reaction, Injection site vesicles, Scab
Clinical narrative: Red blister on right anterior thigh began on 9/26/14. Following by crusting area approx 1/4 inch to redness on the outside to total size of 1/2 inch. Redness on outside begain on 10/5/14.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse who refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 17-JUL-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from another health professional refers to an unspecified number of patients of unknown age and gender. Between 03-SEP-2014 and 30-SEP-2014 the patients were vaccinated with an improperly stored dose (Oka/Merck) PROQUAD lot # K005117, expiration date: 29-OCT-2015, lot #K007797, expiration date: 29-NOV-2015 (dose, lot# and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pruritus, Urticaria
Clinical narrative: Pt noted itching immediately after vaccine, the next day large indurated area 4 x 5 cm. Hives experienced the next day. Resolved with OTC CLARITIN.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injection site pruritus, Tachycardia, Urticaria
Clinical narrative: Within 30 sec. pt described itching at site, then tachycardia, then hives and weakness before leaving office treated with injectable steroids and antihistamine.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager regarding unspecified number of patients of unknown age and gender. There was no information on pertinent medical history and drug reaction or allergies. The reporter reported that an unknown date in 2014 an unspecified number of patients was vaccinated with RECOMBIVAX HB (strength, dose, frequency, product lot#, expiry date not reported) that was improperly stored since 09-MAY-2014. This was not supported. No adverse effects reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager regarding unspecified number of patients of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. The reporter reported that on an unknown date in 2014 an unspecified number of patients was vaccinated with VAQTA (strength, dose, frequency, product lot#, and expiry date not reported) that was improperly stored since 09-MAY-2014. This was not supported. No adverse effects reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Swelling in left arm where shot was administered. Swelling from wrist to shoulder - swelling started being noticed on 10/03/2014 - still swollen on 10/06/2014.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot
Clinical narrative: Hot, dizzy light headed.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Rxn to HPV. Bump at injection site started growing that night, pain and swelling present at visit 10/2/14. Temp 98 F. Erythematous halo around both vaccines, mildly tender but not exquisitely so 8.5 x 7. BENADRYL given.
Age: 0.15
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt received Hep B vaccine on 9/08/2014, first dose. Pt. received a second dose of Hep B on 9/26/2014.
Age: 0.15
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Pt received Hep B vaccine on 9/08/2014, first dose. Pt. received a second dose of Hep B on 9/26/2014.
Age: 0.15
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt received Hep B vaccine on 09-08-2014, 1st dose. Pt received a second dose of Hep B on 09/26/2014.
Age: 0.15
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Pt received Hep B vaccine on 09-08-2014, 1st dose. Pt received a second dose of Hep B on 09/26/2014.
Sex: U
Vaccine: VARCEL
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 of unknown age and gender. Between 03-SEP-2014 and 30-SEP-2014 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # J004160, expiration date: 05-APR-2015 (dose, lot# and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: VIIth nerve paralysis
Clinical narrative: "Incident" or symptoms occurred 6 day after receiving FLUZONE Quadrivalent vaccination. Diagnosed as Bell's Palsy. Patient given Rx for steroids and antivirals and Abx.
Age: 54.0
Sex: F
Vaccine: FLU3, TYP
Symptoms: Pain in extremity
Clinical narrative: Arm pain.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on legs and arms.
Age: 11.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an 11 year old patient on unknown gender. On 10-NOV-2004 the patient was vaccinated with the first dose VAQTA (dose 0.5 ml, lot# and expiration date were unknown) intramuscular. On 23-JUN-2014, the patient was vaccinated with the second dose of VAQTA (dose 0.5 ml, lot# and expiration date were unknown) intramuscular. No adverse effects were reported. The physician would contact CDC (regarding dosage interval) so no patient details or lot information offered. The reporter stated first dose VAQTA administered at another unspecified facility. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 36 year old female patient. On 01-OCT-2014 the patient was vaccinated with GARDASIL, (lot # unspecified) 0.5 ml, intramuscular in right deltoid. The patient had never been sexually active, but would like to received GARDASIL because she was going to get married. No adverse effects reported. Nurse states due to Health Insurance Portability and Accountability Act of 1996 (HIPPA), she did not want this AE report to go to Merck's vendors, but to a health agency like the FDA was okay. Nurse stated the patient gave her consent to report this to Merck. Additional information is not expected as there was no consent to contact physician.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: Fever, redness, pain and fever.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager regarding unspecified number of patients of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. The reporter reported that on an unknown date in 2014 an unspecified number of patients was vaccinated with GARDASIL (strength, dose, frequency, product lot #, expiry date not reported) that was improperly stored since 09-MAY-2014. This was not supported. No adverse effects reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Joint swelling, Pain, Paraesthesia
Clinical narrative: Rashes, Itching, Red Induration, Tingling, Joint swollen ( Lt hand) and pain.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rashes, Itching, Red Induration, Tingling, Joint swollen ( Lt hand) and pain.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 38 year old female patient with no pertinent medical history. The patient was allergy to penicillin and sulfa. On 08-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (strength not reported), lot # K009107, expiration date: 21-JAN-2016, 0.5 ml, intramuscular in the right arm. Other suspect therapies included FLUVIRIN, vaccinated on 08-SEP-2014 in her right arm about 1 inch apart with PNEUMOVAX 23. There was no concomitant therapy. Since 08-SEP-2014, the patient experienced excruciating arm pain, lack of ability to move her arm and a few red spots on her arm at the site of PNEUMOVAX 23 administration. On 10-SEP-2014, the patient sought medical attention from pharmacist over the phone. The patient reported to pharmacist that she had treated her symptoms with BENADRYL and ice. Lab tests were not performed. Patient stated to pharmacist on 10-SEP-2014 that red spots were improving and she still had pain in her right arm and lack of ability to move her right arm on 10-SEP-2014. The pharmacist requested a lot check of PNEUMOVAX 23 with a lot number K009107 and expiration date: 21-JAN-2016. Additional information has been requested.