chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown age. On 25-AUG-2014 the patient was vaccinated with ROTATEQ vial, lot # K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 26-AUG-2014, it was reported that the patient was rex posed to temperatures outside of the proper storage range. No adverse effect reported. The outcome of were exposed to temperatures outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date those patients were vaccinated with an improperly stored GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown age. On 26-AUG-2014 the patient was vaccinated with ROTATEQ vial, lot # K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 26-AUG-2014, it was reported that the patient was exposed to temperatures outside of the proper storage range. No adverse effect reported. The outcome of were exposed to temperatures outside of the proper storage range and no adverse effect is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source.  Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old male patient. The patient did not have any pertinent medical history and his drug reactions and allergies included an unspecified allergic reaction to an unspecified formulation of penicillin. On 29-APR-2014, the patient was vaccinated with the dose of ZOSTAVAX (dose: 0.65 ml, lot number J011550, expiration date: 19-DEC-2014) subcutaneous in the left arm. Concomitant therapies included CIALIS, Tramadol hydrochloride, ANDROGEL, and TORBADEX. On 08-OCT-2014, the patient experienced hardness under the skin and itching near the deltoid muscle of his left arm. The patient did not seek for medical attention and did not receive any treatment. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered at the time of the report. The relatedness between the hardness under the skin and itching near the deltoid muscle of his left arm and ZOSTAVAX were not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown age. On 26-AUG-2014 the patient was vaccinated with ROTATEQ vial, lot # K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 26-AUG-2014, it was reported that the patient was exposed to temperatures outside of the proper storage range. No adverse effect reported. The outcome of were exposed to temperatures outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source.  Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of approximately 63 years old. Current conditions and medical history was not reported. On 03-OCT-2014, the patient was vaccinated with ZOSTAVAX vial, subcutaneous (dose and frequency were not reported). Concomitant medication were not reported. On 07-OCT-2014, patient came into the pharmacy and presented with a non-vesicular rash at injection site on an unknown date in October 2014. The pharmacist described the rash as red and approximately 1 and half inches in diameter around the injection site. The pharmacist advised the patient to put ice on the injection site. The outcome of the events was reported as not recovered. Causality assessment was not reported. Patient sought medical attention by visiting the pharmacy on 07-OCT-2014. Product quality complaint was not reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Injection site pain, Injection site pruritus, Scab
Clinical narrative: This spontaneous report as received from a 75 year old female retired healthcare worker (certified medical assistant) reporting on herself. the patient's drug reactions/allergies included flu-like symptoms with antihistamines and sulfa drugs. The patient had no pertinent medical history. On approximately 10-SEP-2014, reported as approximately 3-4 weeks ago, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number not reported). There was no concomitant medication. On approximately 12-SEP-2014, within approximately 2 days of administration of ZOSTAVAX, the patient developed pain and itchiness at site. At some point over the past 2-3 weeks (unspecified date in September 2014), she developed a full blown case, not mild at all of shingles with multiple blisters which has been scabbed over. There was no treatment given for the adverse event. No laboratory tests were performed. The patient did not seek medical attention. All of the patient's symptoms have resolved (unspecified date approximately in October 2014). The patient also reported that the facility where she was vaccinated was given a "bad batch" of ZOSTAVAX. The relatedness between adverse event and ZOSTAVAX was not reported. Additional information is not expected because the patient wants no follow-up.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (at another office) via other health professional (registered nurse) refers to a patient of unknown age and demographics. Current conditions and medical history was not reported. On 07-OCT-2014, the patient was vaccinated with RECOMBIVAX HB 10 microgram per milliliter. Concomitant medications were  not reported. On 07-OCT-2014, the patient received an expired dose of RECOMBIVAX HB (lot number H014029 and expiry date 07-SEP-2014). No symptoms reported. Product quality complaint was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Electrocardiogram normal, Headache, Myalgia
Clinical narrative: Approximately 24 hrs. after receiving a ZOSTAVAX vaccination, the patient developed anterior chest pain, diffuse myalgias and mild headache. No reaction at injection site. No cough, diarrhea, nausea, vomiting, fever, chills. Symptoms spontaneously resolved mid-afternoon on 10/10/14.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with VAQTA (dose, route of administration, lot # and expiry date were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Chills, Herpes zoster, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a 82 ear old male patient refers to himself. Patient pertinent medical history included hart arrhythmia, hypertension and pacemaker. On unknown date, in approximately 2011 (reported as "about three years ago") the patient was vaccinated with ZOSTAVAX (dose reported as 1  injection, route of administration, site of administration and lot number were not reported). Concomitant therapies included MULTAQ, Warfarin, HYTRIN, VISTEK and pravastatin sodium. Patient stated that even though he was vaccinated with ZOSTAVAX in approximately 2011 (date unspecified);  about three years ago) he experienced a mild outbreak of the shingles "a few years ago" (date unspecified) and mot currently on 06-OCT-2014 "about a week ago". He still has the rash (at the tie of report 13-OCT-2014) and it was blistering. The shingles started with the patient having the chills; the rash is on side of his body, he was experiencing an itch and a "shooting pain" on and off. Cold compressions and hydrocortisone cream were reported as treatment given for adverse events. Patient did not seek medical attention. The outcome of vaccination failure and mild outbreak of the shingles (occurred on unknown date) was unknown. The outcome and mild outbreak of shingles (occurred on 06-OCT-2014) was reported as not recovered. Relatedness between events and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Vaccination failure
Clinical narrative: This spontaneous report as received from a 82 ear old male patient refers to himself. Patient pertinent medical history included hart arrhythmia, hypertension and pacemaker. On unknown date, in approximately 2011 (reported as "about three years ago") the patient was vaccinated with ZOSTAVAX (dose reported as 1  injection, route of administration, site of administration and lot number were not reported). Concomitant therapies included MULTAQ, Warfarin, HYTRIN, VISTEK and pravastatin sodium. Patient stated that even though he was vaccinated with ZOSTAVAX in approximately 2011 (date unspecified);  about three years ago) he experienced a mild outbreak of the shingles "a few years ago" (date unspecified) and mot currently on 06-OCT-2014 "about a week ago". He still has the rash (at the tie of report 13-OCT-2014) and it was blistering. The shingles started with the patient having the chills; the rash is on side of his body, he was experiencing an itch and a "shooting pain" on and off. Cold compressions and hydrocortisone cream were reported as treatment given for adverse events. Patient did not seek medical attention. The outcome of vaccination failure and mild outbreak of the shingles (occurred on unknown date) was unknown. The outcome and mild outbreak of shingles (occurred on 06-OCT-2014) was reported as not recovered. Relatedness between events and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients. The patients medical history and current conditions were not reported. It was reported that an unspecified number of patients have received improperly stored doses of LIQUID PEDVAXHIB (strength, dose and frequency not reported) on 15-OCT-2014. No symptoms reported. Product quality complaint was not reported. The outcome of the event is unknown. Thi sis one of the two reports received from the same reporter and linked to case # 1410USA008573. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, concerning a male patient of unknown age. Medical history and concurrent conditions were not reported. On 08-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX, 1 DF (reported as single shot), therapy route reported as injection. Co-suspect and concomitant therapies were not reported. The pharmacist reported that on 08-OCT-2014, "immediately" after receiving ZOSTAVAX a patient had a fever, and a very red arm (erythema). At the time of the report the outcome was unknown. Patient was told to take TYLENOL as treatment. The patient did not seek medical attention or performed lab diagnostics tet. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient, who received KINRIX (batch number 23MJ7, expiry date 22nd October 2015). On 12rth September 2014, the patient received KINRIX (intramuscular0. On an unknown date, an unknown time after receiving KINRIX patient experienced inappropriate age of vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to KINRIX.  Additional details: the KINRIX was administered accidentally. No AEs were reported as a result of the maladministration. This was one of the 2 reports sent by the same reporter.
Age: 0.35
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received KINRIX (batch number PY3DZ, expiry date 31st May 2016). On 22nd August 2014, the patient received KINRIX (intramuscular) .5 ml. On 22nd August 2014, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the appropriate age at vaccine administration to be related to KINRIX. Additional details: No other AE's were noted with the maladministration.
Age: 0.34
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received KINRIX (batch number 23MJ7, expiry date 22nd October 2015). On 15th September 2014, the patient received KINRIX (intramuscular). On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to KINRIX. Additional details: KINRIX was accidentally administered. No AEs reported as a result of maladministration. This was 1 of the 2 reports received from the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a male consumer of unknown age reporting of himself. Concomitant medications, medical history, drug reactions and allergies were not reported. On an unknown date, reported as (couple of years ago), the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). On an unknown date, reported as (couple of months ago), the patient developed shingles. The patient received an unspecified treatment. It was unknown if the patient sought medical attention. The outcome of developed shingles was unknown. Additional information is not expected, because the reporter details were not provided.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site induration
Clinical narrative: Fever 102F, 7 cm induration/erythema at vaccination site (rt deltoid) - ice, ibuprofen, Tylenol, Benadryl, ABX.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown age. On 16-SEP-2014 the patient was vaccinated with ROTATEQ, lot # K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 16-SEP-2014, it was reported that the patient was exposed to temperature outside of the proper storage range. No adverse effect reported. The outcome of were exposed to temperature outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Incorrect route of drug administration, Injection site swelling, Rash, Urticaria
Clinical narrative: This spontaneous report was received from a consumer referring to his 78 year old female wife with congestive obstructive pulmonary disease (COPD), allergy to FLEXERIL, allergy to codeine, allergy to hydralazine, allergy to procardia, allergy to Darvocet, hypertension, spinal stenosis, allergy to iodine and allergy to quine sulfate. On 04-OCT-2014, the patient was vaccinated with a dose ZOSTAVAX (dose number, lot number and expiration date were not reported), 1 DF (reported as 1 vaccine), intramuscular route (reported as under the muscle) in the right arm. Concomitant included several different medications to treat blood pressure and other ailments. Husband reported that on 05-SEP-2014, his wife received the ZOSTAVAX vaccine and experienced rash and hives, swelling at the injection site. At the time of the report the outcome was unknown. Blood work were performed on an unknown date. Results were not reported. The husband reported his wife performed blood work every six months. Patient did not sought medical attention. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Mobility decreased, Pain, Rash erythematous, Swelling
Clinical narrative: 8-21-14 Fri PM Started with severe pain that evening, inability to move arm due to pain, then red rash, accompanied by heat and swelling Sat. am. Pt. seen and put on antibiotic KEFLEX 500 mg three times daily from superior with ER-seen in office again 8-26-14-rash had move down arm pt sx better. Pt doing fine now.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a sergeant refers to a 24 years female patient without pertinent medical history, drug reactions or allergies. On 09-OCT-2014 the patient was vaccinated with VARIVAX (Merck), intramuscular, 1 single shot, lot # reported as J012379, expiration date reported as: 03-OCT-2015 (dose was not reported). There were not concomitant medications. On 09-OCT-2014 the patient received VARIVAX (Merck) per requirements but she was pregnant with last menstrual period (LMP) of 29-MAY-2014 and estimated date of delivery (EDD) of 05-MAR-2015. Initial exposure to VARIVAX (Merck) was at 19 week(s). The pregnancy outcome was outcome pending. It was reported that the patient sought medical attention on unknown date. She did not receive any treatment. There were not laboratory diagnostics studies performed. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL (strength, dose and frequency not reported) (route, lot# and expiration date not provided). It was reported that GARDASIL was exposed to a supported temperature excursion on 06-OCT-2014 and had been administered to unspecified patients on unspecified dates since the excursion on 06-OCT-2014. No adverse effects had been observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. The pharmacist states that in all years he has been administering ZOSTAVAX he "has seen only one case in which a patient reported a case of shingles after receiving ZOSTAVAX". Pharmacist reported that the situation occurred in an unknown date in approximately 2009 ("four or five years ago"). Pharmacist remembered that the patient developed a mild rash around her neck and on the back of her head. Patient did not receive treatment and patient reported to the pharmacist that she was "glad that she received the vaccine", her healthcare provider had told her that if she had not received ZOSTAVAX, her case of shingles "could have been much worse". Pharmacist reported that the patient developed this shingles-like rash "months after receiving the vaccine" and pharmacist believed that the patient made a full recovery on an unknown date. This is one of two reports from the same source. Additional information is not expected since the reporter stated that this was all information he can remember about this scenario and he would not be able to provide any other information in the future since he cannot remember the patient's name and it was so long ago.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 83 female patient. Patient with drug reactions/allergies: CIPRO (unspecified reaction). On 27-AUG-2012 the patient was vaccinated with ZOSTAVAX 19400 PFU (dose 0.65 ml, lot number 0467AE, expiration date 04-APR-2013) subcutaneous. There was no concomitant medication reported. On an unknown date the patient experienced what might possibly be a case of shingles. The pharmacist did not observe the patient's skin of discuss the symptoms with patient in any details. The patient sought for medical attention and was prescribed famciclovir on 30-SEP-2014. The pharmacist reported that the patient returned to the pharmacy on 14-OCT-2014 (today) to report that her condition did not improve after her course of famciclovir. It was reported that the patient had not consulted with her prescriber physician about the fact that the famciclovir did not help her "rash" resolved at the time of this report. The outcome of the event was not recovered. This is one of two reports from the same source. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Culture throat positive, Nausea, Pharyngitis streptococcal, Pyrexia, Streptococcus test positive
Clinical narrative: This spontaneous report as received from a pharmacist refers to her son, a 17 year old male patient with acne. On 11-AUG-2014 the patient was vaccinated with the first dose of GARDASIL (Intramuscular injection, dose 1, intramuscular, batch/lot # reported as K008621, expiration date reported as 04-MAR-2017, anatomical location not reported). Later, on 14-OCT-2014, the patient was vaccinated with the second dose of GARDASIL (Intramuscular injection, dose 2, intramuscular, batch/lot # reported as K008621, expiration date reported on 04-MAR-2017, anatomical location not reported). Concomitant therapies included clindamycin. The reporter informed that on 15-OCT-2014, the patient developed nausea and fever of 103F. It was also reported that after a throat culture performed on the same date, he was diagnosed with "strep". The patient sought medical attention, was given TYLENOL and ZOFRAN on 15-OCT-2014, and as treatment for the strep throat, he was prescribed OMNICEF. The outcome for nausea was recovering (reported as "nausea is better"). The outcome for fever was not recovered (reported as "still had fever"). The outcome for strep throat was not reported. Causality was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, since 17-SEP-2014, unspecified number of M-M-R II doses (dose, route and lot number not provided) had been administered to patients, (exact dates not specified). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, since 17-SEP-2014, unspecified number of GARDASIL doses (dose, route and lot number not provided) had been administered to patients. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Mouth ulceration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age with a history of frequent "mouth ulcers". Concomitant medication, drug reactions and allergies were not reported. On 21-SEP-2014, the patient was vaccinated with ZOSTAVAX subcutaneous, 0.65 ml, lot # K000996 expiry date 13-MAR-2015. On approximately 21-SEP-2014, reported that since the patient received ZOSTAVAX had had some mouth ulcers appeared. The patient received unspecified treatment. The patient sought medical attention call to pharmacy. The outcome of had some mouth ulcers appear was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with M-M-R II dose, route of administration, lot# and expiry date were not reported that were improperly stored. No adverse symptoms was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ (dose, route of administration: default as oral, lot# and expiry date were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous  report as received from a registered nurse refers to an unspecified number of patients unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX HB (dose, route of administration, lot# and expiry date were not reported) that improperly stored. No adverse symptoms was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiry were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient concurrent conditions and medical history were not reported. On 16-SEP-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: This spontaneous report was received from a 55 year old female consumer referring on herself. Patient's pertinent medical history includes asthma and cancer. On 15-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # not reported). The patient stated that she used other unspecified medications (unspecified names, doses/frequencies and manufacturers). No lab diagnostics studies were performed. On 16-OCT-2014, the patient experienced swollen and painful lymph nodes, under the arm and on the collar bone, after receiving PNEUMOVAX23. The outcome of swollen and painful lymph nodes 23 was reported as not recovered/not resolved. The patient didn't seek medical attention and didn't receive any treatment for the adverse event. Additional information is not expected.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Pain, Rash macular, Swelling
Clinical narrative: Pain day received vaccine and since, 10/13 swelling and increased pain, 10/16 red blotches, heat. Triamcincolone cream, Prednisone, Zofran, OTC - Benadry; Zyrtec; Famotidine, Tylenol. Referred to allergist for allergy testing.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients. The patients medical history and current conditions were not reported. It was reported that an unspecified number of patients have received improperly stored doses of GARDASIL (strength, dose and frequency not reported) on 15-OCT-2014. No symptoms reported. Product quality complaint was not reported. The outcome of the event is unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (dose, route of administration, lot# and expiry date were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 25-AUG-2014 the patient was vaccinated with a dose of VARIVAX (Merck) (dose, units, route of administration, lot# and expiration date were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. On an unspecified date in October 2014 (also reported as a week and a half ago) the patient was vaccinated with ZOSTAVAX (route, dose, frequency and lot # not reported). It was reported that the patient developed dermatomal rash "that looked like shingles" on an unspecified date in October 2014. The outcome of the event and relatedness between the event and ZOSTAVAX were not reported. There was no treatment given for the event. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-SEP-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 12-OCT-2014 the patient was vaccinated with expired PNEUMOVAX 23 lot number J004332, expiration date: 26-SEP-2014 dose, frequency and route of administration were not reported. No adverse events were noted. Additional information is not expected, as caller declined follow-up to this report, and there was no permission to contact physician.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Radiation skin injury, Rash macular, Skin warm
Clinical narrative: This spontaneous report as received from a 60 year old female patient, who was also a nurse refers to herself. The patient's pertinent medical history included Multiple Sclerosis (MS). On 13-OCT-2014, the patient was vaccinated with ZOSTAVAX lot # J008802, expiration date: 19-OCT-2014 (also reported as 17-OCT-2014) 1 injection (dose and route of administration were not reported). Other suspect therapy included AVONEX (dose, route of administration and indication was not reported) which was taking weekly, since an unknown date, before being injected with ZOSTAVAX. Concomitant therapies included COREG, MOBIC, ZYRTEC, LASIX, PRILOSEC and SEPTRA DS (one dose on 12-OCT-2014 and one dose on 13-OCT-2014). On 14-OCT-2014, the patient experience an outbreak that looked more like a bright red radiation burn. The area was hot to the touch and it was very smooth, not raised. The outbreak stings. The red area extended from her knee to her ankle. she also had red blotches sporadically in her inner thigh area on both legs. There was no treatment given for the adverse events. Action taken with AVONEX was unknown. The outcome of the events was unknown. The relatedness between the events and the ZOSTAVAX was unknown. The relatedness between the events and the therapy with AVONEX was also unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Drooling, Faecal incontinence, Febrile convulsion, Musculoskeletal stiffness, Pyrexia
Clinical narrative: 8/15/14-started running low grade fever Friday evening. Saturday normal playful self with temp of 99.5 went stiff drooling BM + also went to Emergency Dept in another city and Dx with febrile seizure, ran temperature 8/18/14 rash started 8/18/14.
Age: 1.1
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: 8/15/14-started running low grade fever Friday evening. Saturday normal playful self with temp of 99.5 went stiff drooling BM + also went to Emergency Dept in another city and Dx with febrile seizure, ran temperature 8/18/14 rash started 8/18/14.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date those patients were vaccinated with an improperly stored M-M-R II (therapy type, dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown age. On 09-SEP-2014 the patient was vaccinated with ROTATEQ Vial, lot # K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 09-SEP-2014, it was reported that the patient was exposed to temperature outside of the proper storage range. No adverse effect reported. The outcome of were exposed to temperature outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous reports as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with M-M-R II (strength, dose and frequency not reported) (route, lot# and expiration date not provided). It was reported that M-M-R II was exposed to a supported temperature excursion on 06-OCT-2014 and had been administered to unspecified patients on unspecified dates since the excursion on 06-OCT-2014. No adverse effects had been observed or reported. This is one of several reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown age. On 02-SEP-2014 the patient was vaccinated with ROTATEQ Vial, lot # K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 02-SEP-2014, it was reported that the patient was exposed to temperatures outside of the proper storage range. No adverse effect reported. The outcome of were exposed to temperatures outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy concerning a female patient who was vaccinated with ZOSTAVAX (date of administration not provided) and sustained an adverse reaction to the vaccine (not further specified) on 24DEC2012. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 27-AUG-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Follow-up information has been received from certified medical assistant who stated she did not have any further information available at that time. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown age. On 12-SEP-2014 the patient was vaccinated with ROTATEQ Vial, lot # K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 12-SEP-2014, it was reported that the patient was exposed to temperature outside of the proper storage range. No adverse effect reported. The outcome of were exposed to temperature outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: Discomfort, Injection site joint movement impairment, Injection site pain, Pain, Quality of life decreased
Clinical narrative: Patient is a 58-year-old female who works as a child day care worker. Patient received government-mandated TWINRIX vaccine on 3 April 2014 as part of her employment. Patient notes she received this vaccine high on the left shoulder (approximately 1 inch below the acromion process) and shortly after vaccination develop significant discomfort/pain within hours of vaccination which has since persisted for several months. She denies any systemic symptoms such as hives, or other dermatitis, lip swelling, tongue swelling, throat tightness, or any airway or vascular compromise. She denies any diffuse arthralgias or myalgias. However, she does endorse chronic left shoulder pain and somewhat limited range of motion of her left arm. She states this pain is lifestyle limiting and prevents her from sleeping on her left side. She states the pain has minimally improved. She describes the pain as a chronic aching pain, and estimates it severity is 5/10. She denies any previous shoulder injuries or orthopedic problems. She is otherwise in good health with no other chronic medical problems. She does not take any medications. She does describe occasional doses of ibuprofen to help with her shoulder pain with little relief. She denies any other symptoms or complications. She specifically denies any left shoulder/arm weakness or paresthesias. She denies any local site reactions other that mid swelling for a couple of days after vaccination.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown age. On 09-SEP-2014 the patient was vaccinated with ROTATEQ vial, lot # K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 09-SEP-2014, it was reported that the patient was exposed to temperature outside of the proper storage range. No adverse effect reported. The outcome of were exposed to temperature outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a 54 year old female patient reporting of herself with allergie and pain. No pertinent medical history and no drug reactions. Concomitant medications, included unspecified medicine for allergy and unspecified pain medicine. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot were not reported). On an unknown date, the patient developed round the insertion site ( red 4 inches all around). Unspecified treatment was given and no laboratory diagnostic test were performed. It was unknown if the patient sought medical attention. The outcome of developed around the insertion site ( 4 red inches all around) was unknown. Additional information is not expected because there is not contact patient information.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: 10-16-14 - Baseball size whelp on L arm where shot administered, red, not and raised.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The reporter stated that a booster dose of VAQTA (dose, strength, frequency, site and route of administration not reported) was administered to a patient too close to the first dose of VAQTA. Patient received his first dose of VAQTA on 14-JUL-2014 and a booster dose was administered on 10-OCT-2014. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 03-SEP-2014 the patient was vaccinated with VARIVAX (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. Follow-up information has been received from certified medical assistant who stated she did not have any further information available at that time. This is one of several reports from the same reporter. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 32 year old male patient. No pertinent medical history was reported. On 08-OCT-2014, the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # H022172 and expiration date was 16-AUG-2014) dose 0.5 ml, intramuscular, in the right arm. On an unknown date approximately in 2014, the patient experienced soreness and hotness at the injection site of an unspecified arm after also being administered FLUVIRIN (Novartis) in his right arm and diphtheria toxoid, form an unspecified physician and was prescribed an unspecified antibiotic. The outcome od event soreness and hotness at the injection site of an unspecified arm was reported as recovering/resolving. Causality for the event soreness and hotness at the injection site of an unspecified arm was not provided by the reporter. This is one of the two reports from the same source. This case was linked to MARRS# 141USA008927. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with VAQTA (strength, dose and frequency not reported) (route, lot# and expiration date not provided). It was reported that VAQTA was exposed to a supported temperature excursion on 06-OCT-2014 and had been administered to unspecified patients on unspecified dates since the excursion on 06-OCT-2014. No adverse effects had been observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.