chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Unknown number of improperly stored RECOMBIVAX HB (dose, route, lot # not reported) were administered to patients. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Lower respiratory tract infection
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old female patient with a history of chest colds and a long standing order of prednisone. On 09-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous in the right arm (dose number, lot/batch number and expiration date were not reported)(indication reported as vaccination) concomitant with a dose of an unspecified flu vaccine in the left arm. In approximately September 2014, the patient experienced chest cold. The event was treated with prednisone 60 mg. The reporter also asked about steroid use in relation to ZOSTAVAX. The outcome of chest cold was reported as not recovered/not resolved. The reporter considered chest cold to be not related to ZOSTAVAX (reported as had anything to do with the chest cold). Additional information is not expected as no consent for contact was given.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 21-AUG-2014 the patient was vaccinated with expired dose of M-M-R II (HSA, lot # H014647, expiration date 03-AUG-2014) (dose, route unspecified). No symptoms reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to 2 patients of unknown age. Physician reported that two employees at his office inadvertently received the dialysis dose of RECOMBIVAX HB (route, dose and indication not reported) twice on unspecified dates. No adverse effects were reported. Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Blood test normal, Chills, Dyspnoea, Headache, Hyperhidrosis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 45 year old female patient with allergy to sulfa. The patient's medical history included Mycobacterium avium complex (MAC) infection. The patient's past drug included SULFA. On 25-AUG-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K004148, expiration date: 10-MAY-2015, 0.5 ml, intramuscular in the right upper arm for vaccination). On 25-AUG-2014, the patient experienced adverse effects. By evening of 25-AUG-2014 the patient had body aches, headache, sweats, chills, shortness of breath, fever, right arm swelling. The patient also vomited once. On 26-AUG-2014, the patient sought medical attention by going to the emergency room of a different hospital. Blood work drawn (unspecified date in August 2014) was normal. The patient was diagnosed as severe allergic reaction to PNEUMOVAX 23. It was specified what type of treatment was given and the patient was not hospitalized. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Local swelling, Pain, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 45 year old female patient with allergy to sulfa. The patient's medical history included Mycobacterium avium complex (MAC) infection. The patient's past drug included SULFA. On 25-AUG-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K004148, expiration date: 10-MAY-2015, 0.5 ml, intramuscular in the right upper arm for vaccination). On 25-AUG-2014, the patient experienced adverse effects. By evening of 25-AUG-2014 the patient had body aches, headache, sweats, chills, shortness of breath, fever, right arm swelling. The patient also vomited once. On 26-AUG-2014, the patient sought medical attention by going to the emergency room of a different hospital. Blood work drawn (unspecified date in August 2014) was normal. The patient was diagnosed as severe allergic reaction to PNEUMOVAX 23. It was specified what type of treatment was given and the patient was not hospitalized. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, 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 in November 2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, lot number and route not provided) and the patient received a possible second dose of PNEUMOVAX 23 (0.5ml, lot number unknown, intramuscularly) on 15-SEP-2014. No adverse effect reported. There was no product quality issue involved. Additional information has been requested.
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old patient. The pharmacist reported patient received a dose of PNEUMOVAX 23 on 30-AUG-2014 that had expired on 09-AUG-2014. The pharmacist was not able to provide the lot number of the dose of PNEUMOVAX 23 because the documentation was missing at the time of this report, however, she was certain that the dates she provided are accurate. The dose of PNEUMOVAX 23 had not been exposed to any temperature excursions. The patient had not experienced any adverse effects. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 2 patients of unknown age and gender. On an unknown date those patients were vaccinated with PNEUMOVAX 23 (dose, units, route of administration, anatomical location, lot number were not reported) after being stored improperly. No adverse effects reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from the medical assistant stating that a 65 year old patient of unknown gender was vaccinated on 16-SEP-2014 with PNEUMOVAX 23 (lot# J005068 and expiration date: 18-JAN-2015, dose, route of administration and anatomical position was unknown) which experienced a temperature excursion. Pertinent medical history and concomitant medications were unspecified by reporter. The outcome of the events was unknown. There was no additional information available with the reporter. This is one of the several reports from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist reported that unspecified number of patients received RECOMBIVAX HB which was stored improperly. No adverse effects reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Myalgia, Pain in extremity, Rash, Skin warm
Clinical narrative: Reports adverse reaction to Pneumonia vaccine he received 5-22-14. Day 1, redness, sore upper arm. Day 2, entire upper arm red, sore and hot. Muscle aches developed. Starting to feel better today, symptoms improving, stated, I just wanted to report the adverse reaction. Took the day off work today. Myalgia and rash.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Rash
Clinical narrative: Leg weakness and rash.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Generalizes hives.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 16-year-old female patient, who was allergic to amoxicillin and pollen and had no illness at time of vaccination. The reported informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 23-JAN-2014 at 3:50 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Parents declined to revaccinate. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown (recovery date was written though, as 22-APR-2014). This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 4 year old female patient who was overweight and with none drug reactions or allergies. On 30-SEP-2014 the patient was intradermally vaccinated with (Oka-Merck) PROQUAD (0.5 ml, in the arm, route of administration, lot number were not reported). On 30-SEP-2014 the patient developed a small 'welt' at the site of the injection. The reporter stated that the patient was also scheduled to receive a PPD tuberculosis skin test at the visit. This products had been drawn up into syringes and the physician thought she had the syringe for the a tuberculin PPD in her hand but it was actually (Oka-Merck) PROQUAD. The actual PPD was administered in the opposite arm intradermally. The outcome of the event was not reported. The relatedness between event and (Oka-Merck) PROQUAD was not reported. 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. In approximately 2014 (exact dates not reported) unspecified number of patients were vaccinated with ZOSTAVAX, (subdermal, dose, anatomical location, lot#, expiration date not reported) that had been improperly exposed to -9 Celsius degrees since 01-MAY-2014. Concomitant medications were not reported. No adverse effects were reported. 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. In approximately 2014 (exact dates not reported) unspecified number of patients were vaccinated with (Merck) VARIVAX, (subdermal, dose, anatomical location, lot#, expiration date not reported) that had been improperly exposed to -9 Celsius degrees since 01-MAY-2014. Concomitant medications 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: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt reported rapid heartbeat, was achy, fever, swollen, red hot to the touch at injection site, very sore and achy.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Pt reported rapid heartbeat, was achy, fever, swollen, red hot to the touch at injection site, very sore and achy.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Pyrexia, Rash, Rash erythematous
Clinical narrative: Broke out in rash on abd, hands, arms, neck. Very itchy, red spots-small blisters. Lasted approx 1 week with low grade fever. Few on legs. No treatment.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Laboratory test normal, Memory impairment
Clinical narrative: This spontaneous report was received from a currently 79 year old male patient refering himself. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, units, route of administration, anatomical location, lot number were not reported). On an unknown date, reported as some time afterwards, the patient developed shingles and mentioned that has experienced blisters and forgetfulness. On an unknown date, lung test (unspecified) was performed and showed everything was negative. The patient sought medical attention (unspecified). The outcome of events was not reported. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date the patients were vaccinated with improperly stored (Merck) VARIVAX (lot#, dose, route and frequency were not provided).  No adverse effect was reported. This is one of several reports received from the same source. 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 an unknown number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX (19400, PFU, lot#, dose, route and frequency were not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Axillary pain, Local swelling, Nausea, Pain in extremity
Clinical narrative: This spontaneous report was received from a 59 year old female patient reporting on herself. Pertinent medical history was not reported. Patient had an allergy to "biophosphate", penicillin and DERMABOND. Concomitant therapies included lisinopril (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). On 10-SEP-2014 the patient was vaccinated with one shot of ZOSTAVAX into the arm. It was reported that roughly 18 hours after the vaccination, the patient developed by noon on 11-SEP-2014 severe nausea and pain in the upper abdomen that lasted 3-4 hours and then stopped. Right after that, a rash "extending from elbow into armpit" appeared on her injection arm. Patient described it as a foot long, red and itchy with swelling and pain in arm and armpit radiating to her side. The rash had become as of 15-SEP-2014 a much smaller reaction with itchiness and redness but no pain. There was no lab diagnostics studies performed. Product Quality Complaint (PQC) was not involved. The patient sought medical attention and she went to the pharmacy. She received the treatment for the adverse events, she took ZYRTEC. The outcomes of the severe nausea and pain in the upper abdomen were reported as recovered/resolved (on 11-SEP-2014). The outcome of rash "with pain" was recovered/resolved as of 15-SEP-2014. The outcomes of rash "a foot long, red and itchy with swelling" was reported as recovering (reported as "rash had become as of 15-SEP-2014 a much smaller reaction with itchiness and redness"). The causality between the ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report was received from a 59 year old female patient reporting on herself. Pertinent medical history was not reported. Patient had an allergy to "biophosphate", penicillin and DERMABOND. Concomitant therapies included lisinopril (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). On 10-SEP-2014 the patient was vaccinated with one shot of ZOSTAVAX into the arm. It was reported that roughly 18 hours after the vaccination, the patient developed by noon on 11-SEP-2014 severe nausea and pain in the upper abdomen that lasted 3-4 hours and then stopped. Right after that, a rash "extending from elbow into armpit" appeared on her injection arm. Patient described it as a foot long, red and itchy with swelling and pain in arm and armpit radiating to her side. The rash had become as of 15-SEP-2014 a much smaller reaction with itchiness and redness but no pain. There was no lab diagnostics studies performed. Product Quality Complaint (PQC) was not involved. The patient sought medical attention and she went to the pharmacy. She received the treatment for the adverse events, she took ZYRTEC. The outcomes of the severe nausea and pain in the upper abdomen were reported as recovered/resolved (on 11-SEP-2014). The outcome of rash "with pain" was recovered/resolved as of 15-SEP-2014. The outcomes of rash "a foot long, red and itchy with swelling" was reported as recovering (reported as "rash had become as of 15-SEP-2014 a much smaller reaction with itchiness and redness"). The causality between the ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site induration, Vaccination site warmth
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a 57 year old male patient. On an unknown date the patient was vaccinated with ZOSTAVAX (0.65 ml/single dose, subcutaneous in the arm, lot number was not reported). On an unknown date, 24 hours after vaccination, the patient experienced hard, indurated, warm area around the vaccination site in an unspecified arm while using ZOSTAVAX. The patient was treated with doxycycline. The patient sought medical attention via visiting physician. The outcome of events was reported recovering (reported as the adverse reactions had improved). The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. On an unknown date, the patient was vaccinated with ZOSTAVAX dose, lot number, expiration date not reported. On an unknown date, the patient experienced injection site reactions, including pain, itching, redness and swelling. The patient reported a headache a few times too (dates unspecified). On an unknown date, the patient recovered from all events. Relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected, no contact details for physician and consumer were available.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to approximately 10 patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On an unknown date, approximately 10 patients were vaccination with improperly stored PROQUAD (dose, anatomical location, route of administration, lot#, expiration date not reported). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected since there is no consent for follow-up.
Age: 1.53
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Local reaction
Clinical narrative: Pt developed local reaction two days after vaccination.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On 01-OCT-2014 the patient was vaccinated with an expired RECOMBIVAX HB (expiration date: 07-SEP-2014, lot#, dose, units, route of administration, anatomical location were not reported). The reporter stated the RECOMBIVAX HB did not have any previous temperature excursions. RECOMBIVAX HB was supported with post-expiry data. No adverse symptoms reported. 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 registered nurse refers to approximately 5 patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On an unknown date, approximately 5 patients were vaccinated with improperly stored ZOSTAVAX (dose, anatomical location, route of administration, lot#, expiration date not reported). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected since there is no consent for follow-up.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 13 year old male patient. Patient's concurrent conditions and relevant medical history was reported as none. Drug reactions/allergies were none. On an unknown date in March 2014, the patient was vaccinated with GARDASIL (lot number, dose and route unspecified). Concomitant medications were none. On unknown date in April 2014 (reported as a month later) the patient experienced warts on knees and hands on the same side as injection which hurt. The patient sought medical attention by consulting doctor and dermatologist. Patient was treated with cryotherapy and unspecified acid. The outcome of warts on knees and hands was reported as recovering/resolving. The causality of the events with GARDASIL was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a physician's assistant via company representative refers to a 61 year old female patient. On 23-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX lot # J004310, expiration date 12-JUL-2014, 0.65 ml dose, subcutaneous. It was reported that the patient experienced shingles a year after receiving ZOSTAVAX (adverse event onset date reported as 07-JUL-2014). On 07-JUL-2014, the patient saw physician for a rash on the right arm and was treated with bacitracin. On 22-JUL-2014, the patient was seen by the nurse practitioner and received VALTREX. On 01-AUG-2014, the patient saw physician for follow-up and received calamine lotion. On 15-SEP-2014, the patient was seen by nurse practitioner for a spot in same area where the rash had been on the right arm, and no treatment was given. The outcome of event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: FLUC3, VARCEL
Symptoms: Rash
Clinical narrative: Has breakthrough rash, less than ten (10) noted non-draining lesions.
Age: 1.13
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified number of patient of unknown age and gender. Licensed nurse reported that since 17-JUL-2014, improperly stored (Merck) VARIVAX (dose, strength, route and lot number were not reported) was dispensed to patients. No adverse effects were noted. Follow up information has been received from Licensed Practical Nurse. Nurse did not have the information (patient identifiers, lot number, expiration date or dates of vaccine administration) available. Follow up information has been received from Licensed Practical Nurse referring to a 13 month old patient of unknown gender. On 26-SEP-2014 the patient was vaccinated with improperly stored (Merck) VARIVAX lot # J013905, expiration date 30-OCT-2015. This is one of several reports received from the same reporter. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient. On 13-SEP-2014 the patient was vaccinated with ZOSTAVAX lot # K003601, subcutaneous. It was reported that in September 2014, the patient experienced that the injection site was swelling and there was a 1 to 1.5 inch long red streak over the injection site. There was no additional symptoms. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 14-year old male patient, who had no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 13-FEB-2014. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Parents were informed and declined to revaccinate. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 1.31
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified number of patient of unknown age and gender. Licensed nurse reported that since 17-JUL-2014, improperly stored (Merck) VARIVAX (dose, strength, route and lot number were not reported) was dispensed to patients. No adverse effects were noted. Follow up information has been received from Licensed Practical Nurse. Nurse did not have the information (patient identifiers, lot number, expiration date or dates of vaccine administration) available. Follow up information has been received from Licensed Practical Nurse referring to a 15 month old patient of unknown gender. On 04-SEP-2014 the patient was vaccinated with improperly stored (Merck) VARIVAX lot # J013905, expiration date 30-OCT-2015. This is one of several reports received from the same reporter. Additional information is not expected because all follow ups requested to complete the case were received.
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 13-MAY-2014 the patient was vaccinated with MMR 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 MMR 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-FEB-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J006953, 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 MMR 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: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified number of patient of unknown age and gender. Licensed nurse reported that since 17-JUL-2014, improperly stored (Merck) VARIVAX (dose, strength, route and lot number were not reported) was dispensed to patients. No adverse effects were noted. Follow up information has been received from Licensed Practical Nurse. Nurse did not have the information (patient identifiers, lot number, expiration date or dates of vaccine administration) available. Follow up information has been received from Licensed Practical Nurse referring to a 5 year old patient of unknown gender. On 18-AUG-2014 the patient was vaccinated with improperly stored (Merck) VARIVAX lot # J013905, expiration date 30-OCT-2015. This is one of several reports received from the same reporter. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 1.05
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified number of patient of unknown age and gender. Licensed nurse reported that since 17-JUL-2014, improperly stored (Merck) VARIVAX (dose, strength, route and lot number were not reported) was dispensed to patients. No adverse effects were noted. Follow up information has been received from Licensed Practical Nurse. Nurse did not have the information (patient identifiers, lot number, expiration date or dates of vaccine administration) available. Follow up information has been received from Licensed Practical Nurse referring to a 12 month old patient of unknown gender. On 19-AUG-2014 the patient was vaccinated with improperly stored (Merck) VARIVAX lot # J013905, expiration date 30-OCT-2015. This is one of several reports received from the same reporter. Additional information is not expected because all follow ups requested to complete the case were received.
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 15-APR-2014 the patient was vaccinated with MMR 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 MMR 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: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified number of patient of unknown age and gender. Licensed nurse reported that since 17-JUL-2014, improperly stored (Merck) VARIVAX (dose, strength, route and lot number were not reported) was dispensed to patients. No adverse effects were noted. Follow up information has been received from Licensed Practical Nurse. Nurse did not have the information (patient identifiers, lot number, expiration date or dates of vaccine administration) available. Follow up information has been received from Licensed Practical Nurse referring to a 12 month old patient of unknown gender. On 24-SEP-2014 the patient was vaccinated with improperly stored (Merck) VARIVAX lot # J013905, expiration date 30-OCT-2015. This is one of several reports received from the same reporter. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 1.35
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified number of patient of unknown age and gender. Licensed nurse reported that since 17-JUL-2014, improperly stored (Merck) VARIVAX (dose, strength, route and lot number were not reported) was dispensed to patients. No adverse effects were noted. Follow up information has been received from Licensed Practical Nurse. Nurse did not have the information (patient identifiers, lot number, expiration date or dates of vaccine administration) available. Follow up information has been received from Licensed Practical Nurse referring to a 16 month old patient of unknown gender. On 29-SEP-2014 the patient was vaccinated with improperly stored (Merck) VARIVAX lot # J013905, expiration date 30-OCT-2015. This is one of several reports received from the same reporter. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 16-year-old female patient, who had no known drug allergies had no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported, on 10-FEB-2014 at 5:00 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Parents were informed and declined to revaccinated. No adverse event was reported for the patient. The outcome was reported by the reporter as recovered. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 17-year old female patient, who was allergic to nickel and no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 13-JAN-2014 at 3:00 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Parents were informed, patient was revaccinated at no charge on an unspecified date. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
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 05-JUN-2014 the patient was vaccinated with MMR 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 MMR 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 07-MAR-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J006953, 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 MMR 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 10-JUN-2014 the patient was vaccinated with MMR 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 MMR 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: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 13-year old female patient, with no known drug allergies and no illness at time of vaccination. The reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot# J008423,e expiration date 21-JAN-2016, in the right arm, route not reported), on 04-FEB-2014 at 3:40 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Parents were informed and were going to revaccinate at no charge. The reporter wrote date of recovery as 27-APR-2014 but did not specify if revaccination occurred. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a physician refers to his medical assistant a female patient of unknown age with asthma. Drug reactions and allergies were unspecified by the reporter. On an unknown date, the patient received twice doses of (Merck) VARIVAX "nonresponder". On an unknown date, the patient performed viral titer and the results showed titer negative each time (date unspecified). The outcome of the patient received (Merck) VARIVAX twice on unspecified dates and titer were negative each time and patient was a VARIVAX "nonresponder" was unknown. Additional information has been requested.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from the registered nurse regarding 1 day old female patient who on 17-JUL-2014 at 04:15 AM was vaccinated with an improperly stored first dose of RECOMBIVAX HB (lot # J012520, expiration date 30-JAN-2016) intramuscularly. The reporter stated that, on unspecified dates, vaccine storage temperature dropped to 0-1 degree in 18 different episodes, and that according to minimum and maximum, all recorded temperatures were supposed to be between 2-8 degrees. This is one of several reports received from the same source. Additional information is not expected because all follow up information was received.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempt to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report refers to a 15-year-old patient of unspecified gender. It was unkonwn if the patient had any allergies, conditions or illnesses at the time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the second dose of GARDASIL (intramuscular injection, batch/lot# J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 04-FEB-2014 at 4:00 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 4:00 PM). The patient was going to return to revaccinate at no charge. No adverse event was reported for the patient. Outcome was not reported by the reporter, although date of recovery was written as 27-MAR-2014. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified number of patient of unknown age and gender. Licensed nurse reported that since 17-JUL-2014, improperly stored (Merck) VARIVAX (dose, strength, route and lot number were not reported) was dispensed to patients. No adverse effects were noted. Follow up information has been received from Licensed Practical Nurse. Nurse did not have the information (patient identifiers, lot number, expiration date or dates of vaccine administration) available. Follow up information has been received from Licensed Practical Nurse referring to a 6 year old patient of unknown gender. On 19-AUG-2014 the patient was vaccinated with improperly stored (Merck) VARIVAX lot # J013905, expiration date 30-OCT-2015. This is one of several reports received from the same reporter. Additional information is not expected because all follow ups requested to complete the case were received.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that the patient inadvertently was administered of more than one dose of ZOSTAVAX (dose, routes and lot numbers not provided). First dose was given "last year", approximately in 2013, and second dose was given September 2014 (exact dates not specified). No adverse effects were reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Left arm extremely painful, pain traveling to wrist and hand. Recommended contact dr at clinic. No temperature.