chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patient of unknown age and gender that were vaccinated with a dose of PNEUMOVAX 23 (dose, dose number, lot number, expiration date and route were not reported), that was improperly stored. No adverse effect reported. Medical history and concurrent conditions were not reported. Co-suspect and concomitant therapies were not reported. This is one (1) of eight (8) reports from tje same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot # and expiration date not reported) which was exposed to temperatures outside of recommended condition. No adverse events were reported. The patients did not seek medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Unknown.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Vaccine administered 12/16/14-as of today, 12/181/14, area is very tender, with large area of involvement which is red and inflamed.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Diarrhoea, Nausea, Pyrexia
Clinical narrative: About 15-20 minutes after vaccine patient experienced nausea and diarrhea on second day. Fever occurred in the first couple of days. Patient also had weakness and these lasted for 5 weeks.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: C-reactive protein, Full blood count, Injection site pain, Red blood cell sedimentation rate, X-ray limb
Clinical narrative: Significant pain at the injection site 2 months after flu shot.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Headache, Injection site bruising, Injection site erythema, Injection site induration
Clinical narrative: Noticed this am-site red and size of penny, felt like a bruise/hard, removed sweater this afternoon-site was bigger, reddened, warm to touch, painful with palpation. Reported to clinic-oral temp 99.1 and c/o H/A since yesterday, but has H/A frequently with weather change. Site marked.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Noticed this am-site red and size of penny, felt like a bruise/hard, removed sweater this afternoon-site was bigger, reddened, warm to touch, painful with palpation. Reported to clinic-oral temp 99.1 and c/o H/A since yesterday, but has H/A frequently with weather change. Site marked.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema
Clinical narrative: Erythema on (L) vastus lateralis, approx 5.5 cm in diameter.
Age: 1.42
Sex: F
Vaccine: DTAP, HEPA, PNC13, VARCEL
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: Varicella-like rash at the site of the injection lasting 7-10+ days.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certificate medical assistant (C.M.A.) refers to a multiple unspecified patients of unknown age and gender. On an unknown date multiple unspecified patients were vaccinated with a dose of (Merck) PROQUAD (dose, frequency, lot number and expiration date were not reported) which were improperly stored. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown dates in 2014, unspecified number of patients were vaccinated with GARDASIL (lot number, Expiry Date, dose, route were note reported), that was improperly stored in April 2014. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender that were vaccinated with a dose of ROTATEQ (dose, dose number, lot number and expiration date were not reported), oral, that was improperly stored. No adverse effect reported. Medical history and concurrent conditions were not reported. Co-suspect and concomitant therapies were not reported. This is one (1) of eight (8) reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 3 patients of unknown age and gender. On an unknown date, 3 unspecified patients were administered (Oka/Merck) VARIVAX (dose, route of administration, lot # and expiration date were not reported) that was stored improperly. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a male patient of unknown age. The patient was vaccinated with the first, second and third dose of (Oka/Merck) VARIVAX subcutaneously on 16-APR-2008, 23-OCT-2012 and -07-NOV-2014, respectively (dose and lot number were not reported). Other suspect therapies included the first, second and third dose of MMR II given on 15-OCT-2008, 23-OCT-2012 and 07-NOV-2014, respectively (dose, route and lot number were not reported). There were no known adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health care professional refers to a patient of unknown age and gender. On 19-DEC-2014 the patient was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX, (dose, route, lot number and expiration date not reported). This was purely a medication error. No adverse effect reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Lymphadenopathy
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 65 year old male patient. The patient's medical history included removal of a lymph node from the opposite armpit on 2013 (reported as last year) because it was swollen. The lymph node on that side was found to benign after testing. On 18-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot number reported as K016324, expiration date 24-DEC-2015) (dose and dose number were not reported). Co-suspect and concomitant therapies were not reported. On 20-DEC-2014, patient developed swelling at the site of ZOSTAVAX injection and swelling of a lymph node in the armpit of the same arm that received the ZOSTAVAX injection. At the time of the report the outcome was reported as recovering. Patient sought medical attention on the pharmacy and the pharmacist recommended the patient to used BENADRYL as treatment but not started by the patient yet. No lab diagnostics test were performed. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. On 26-NOV-2014 the patient was vaccinated with a dose of expired MMR II (lot # was not reported) expiration date 20-SEP-2014, dose 0.5 ml, given intramuscular. No concomitant medications were reported. No adverse events were reported. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 30 year old male patient. On 17-NOV-2014, the patient was inadvertently vaccinated with a dose of (Merck) PROQUAD (lot#, expiration date and site of administration were not reported), subcutaneously. No adverse effects were reported. 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. The patient had allergies to meperidine, naloxone, opium alkaloids, propoxyphene, methadone and morphine derivatives. The patient's medical history included shingles. Many years ago the patient was vaccinated with one dose of ZOSTAVAX (dose, route, lot# and expiration date were unknown) from an unspecified healthcare provider. The reason why she received ZOSTAVAX was because she had a history of shingles so her physician thought the ZOSTAVAX would prevent further cases of shingles. After receiving ZOSTAVAX the patient developed two separate cases of shingles. The first case occurred a year after receiving ZOSTAVAX. The patient was recovered from that case. The second case occurred at an unspecified time after vaccination. The patient was recovered from that case. Unspecified treatments were given for the adverse events. The patient sought medical attention by unspecified contact with physician. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient. There was no pertinent medical history and no drug reactions or allergies. On 07-DEC-2014, the patient was vaccinated with ZOSTAVAX lot # J013138 expiry date 17-JAN-2015 (dose and route not reported). Concomitant therapies included levothyroxine sodium (manufacturer unknown), LAMICTAL and MYRBETRIQ. It was reported that the patient stopped taking VALTREX prior to the administration of ZOSTAVAX. Pharmacist reported patient inquired of she could continue taking VALTREX again since patient "felt like a herpes outbreak is about to happen (on an unknown date in December 2014). No lab diagnostics performed. At the time of the report, action taken regarding therapy with ZOSTAVAX was not reported. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 1.05
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. On 15-DEC-2014, the patient was inadvertently vaccinated with an expired dose of VAQTA lot # 0672AE, expiration date reported as 07-DEC-2014, one dose (reported as 1 dose), 0.5 ml dose, intramuscular (dose number was not reported). No adverse effects were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown ages and genders. On an unknown date the unknown number of patients were vaccinated with a dose of VARIVAX (Merck) (lot #, expiration date, strength, dose and frequency were not reported) which were improperly stored. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Age: 1.11
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: A spontaneous report was received from a healthcare worker concerning a 13 month old child (gender not reported) who on 01-DEC-2014 received an expired dose of MMR II (lot number reported as H020257; expiration 08-NOV-2014). No adverse experience was observed. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On 10-DEC-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot #, expiration date, dose, route and site of administration were not reported). No adverse effects was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse via company representative refers to an 82 year old female patient. There were not pertinent medical history, drug reaction or allergies. On 20-OCT-2014 the patient was vaccinated with ZOSTAVVAX (dosage and route were not reported) lot # K007548, expiration date: 23-AUG-2015, for vaccination. Concomitant therapies included vitamin d (unspecified)(Manufacturer unknown). The practical nurse informed that on 23-OCT-2014, the patient developed the shingles a few days after being vaccinated. There was not treatment given for the adverse event. There were not laboratories diagnostics performed. The patient sought medical attention by a physician visit. The outcome of the event was reported as recovering. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report as received from a 63 year old male dentist who was also the patient and was reporting on himself. The patient's current condition was hypertension and kidney stones. It was reported that the patient did not suffer from any drug allergy. On 14-DEC-2014 the patient was vaccinated with ZOSTAVAX (reported as dose: 0.654 ml, in the left forearm, route of administration, lot number and expiration date were not reported). Concomitant therapy included vitamin supplements and unspecified medication for prevention of accumulation of uric acid. On 15-DEC-2014, on Monday, the day after receiving ZOSTAVAX, the patient noticed redness at his injection site when he removed his Band-Aid. At first the patient thought that he was having an allergic reaction to the Band-Aid but during that day of 15-DEC-2014, he noticed that the area of redness expanded until it was about the diameter of a baseball. The patient sought medical attention (consulted the physician at another urgent care clinic). The patient was prescribed KEFLEX and BENADRYL (manufacturers unspecified). The patient stated that the area continued to get larger. On approximately 17-DEC-2014, reported as today, the area of redness has expanded to about twice the size that it was on Monday, 15-DEC-2014, but it seemed to be less red. The patient stated that the area was itchy and warm (started in approximately December 2014) and noticed a low-grade fever of 99.5F (in approximately December 2014). The patient believed that he was recovering, and was not developing a rash. No lab diagnostic was performed for adverse events. The outcome of the adverse events was reported as recovering. The relatedness between ZOSTAVAX and the events was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via direct contact, Product quality issue
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date, pressure issue with ZOSTAVAX cause medication to get in the patient's eye. The patient sought medical attention- was at doctor's office at the time of the event. Product quality complaint (PQC) was involved. Additional information is not expected as there is no reporter or physician contact details available.
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a male patient of unknown age. In September 2014 (exact date unspecified) the patient was vaccinated with the first dose and in October 2014 (exact date unspecified) the patient was vaccinated with the second dose of GARDASIL (dose, units, route of administration, anatomical location, lot number were not reported) that were exposed to out of range temperatures before they were administered. No adverse effects were reported. Additional information is not expected because there is no contact information to do a follow-up with.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown gender and age. Patient's pertinent medical history and drug allergies were not reported. On 19-DEC-2014 the patient was vaccinated with VARIVAX (Merck), .5 ml, once, subcutaneous. Concomitant medications were not reported. On an unknown date it was reported that the adult patient was vaccinated with VARIVAX (Merck) instead of ZOSTAVAX. No adverse effect was reported. Outcome of the event was not reported. No product quality complaint (PQC) was reported. Reporter considered the event as not related to therapy with VARIVAX. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a anonymous multiple patients of unknown age and gender. On unspecified date COMVAX (lot #, expiration date, strength and dose were not reported) was administered to multiple anonymous patients post supported temperature excursion. No concomitant medications were reported. No adverse effects reported by any patients. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with RECOMBIVAX (dose, lot number, expiration date were not reported) that were stored improperly. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a patient in 60s (gender unknown). On an unknown date the patient was vaccinated with ZOSTAVAX (lot # and expiry date not specified), for the prevention of shingles. No concomitant medications are reported. On an unknown date after receiving ZOSTAVAX the patient developed a mild case of shingles. The patient sought medical attention. The outcome of the reported event was unknown. The causality was also unknown. No Product quality complaint (PQC) was involved. Additional information is not expected as the physician did not give permission to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 25-NOV-2014 the patient was vaccinated with a dose of ROTATEQ (oral dose, frequency, lot number and expiration date were not reported) which had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old patient of unknown gender. On 16-DEC-2014 the patient was inadvertently received/vaccinated with a dose of ZOSTAVAX ((dose, dose number, administration site and route not reported), instead of VARIVAX dose. No adverse effects were noted. The outcome of event was unknown. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Skin warm
Clinical narrative: This spontaneous report was received from a nurse refers to a 52 year old female patient with drug reaction/ allergic to codeine. On 10-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX (strength and dose were not reported). subcutaneous in the left arm. Concomitant therapies included LIPITOR, COLACE and loratadine (manufacturer unknown). On 11-DEC-2014, the patient experienced hard lump and redness that was 2-3 inches at the injection site and her arm was warm to the touch. The nurse reported by 14-DEC-2014, the reaction had completely resolved. On 16-DEC-2014, the redness reappeared. The nurse reported redness was back it spans 6 inches by 2 inches and spreads every day. Also reported, that her arm was hot to the touch now approximately on 19-DEC-2014. No Product Quality Complaint (PQC) was involved. Treatment was not taken by the patient. The outcome of events was reported as not recovered/not resolved. Causality was not assessed by the reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 15-DEC-2014, the patient was vaccinated with an expired dose of MMR II injection (lot # H009781 with expiry date 15-MAY-2014; strength, dose, route of administration unspecified). No concomitant medications were reported. No adverse effect were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 26-NOV-2014, the patient was vaccinated with a dose of M-M-R II (subcutaneous, dose, frequency, lot number and expiration date were not reported) which had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient with unknown age and gender. On an unknown date the patient received a dose of improperly stored ZOSTAVAX (1 dose). No adverse effects reported. It was not specified if the patient sought for medical attention. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates in 2014 (reported as "between 06-SEP-2014 and 18-DEC-2014), unspecified number of patients were vaccinated with a dose of RECOMBIVAX HB (lot number, Expiry Date, dose, frequency, route were not reported) for prophylaxis that underwent multiple temperature excursions. It was unknown if any of those doses were supported. No adverse experiences were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to his wife, a female patient of unknown age. No concurrent conditions or medical history were provided. On 19-DEC-2014, the patient was vaccinated with an improperly stored dose of ZOSTAVAX injection (strength, dose, route of administration, lot# and expiry date unspecified). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 17 year old patient of unknown gender. On 15-DEC-2014, the patient was inadvertently vaccinated with a dose of (Merck) PROQUAD (dose, lot number, expiration date were not provided). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified number of patient's of unknown demographics. No current condition was reported. No historical medication was reported. On 01-JUN-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported). Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. All product's had been administered. No adverse effects reported by any patients. Nurse was compiling lot and expiration date information and would call back for further evaluation. No PQC was involved. The outcome of excursion of 6 F since 01-JUN-2013 and products were not sorted in an overall average support range of -58 degree F and 5 degree F was unknown. No other information was provided. This case is linked to MARRS # 1412USA010657 and MARRS # 1412USA010450 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's medical history was not reported. On 18-DEC-2014, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (frequency, anatomical location, route of administration and lot # were not provided) which expired on 12-JUL-2014. No adverse event was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 years old female patient. Patient's medical history was unspecified. No drug reactions or allergies were reported. On 28-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose: 0.65 ml, frequency and anatomical location were not provided, subcutaneously) (lot # K007548, expiration date: 23-AUG-2015). Concomitant therapies included losartan potassium (manufacturer unknown), SYNTHROID and estrogens, PREMARIN vaginal cream. In approximately 2014 also reported as "after a couple of weeks" after receiving ZOSTAVAX, the patient experienced "three outbreaks of fever blisters on her lips". The patient sought medical attention (she saw pharmacist). Acyclovir was given as treatment for adverse event. No diagnostic tests were performed. No product quality complaint (PQC) was involved. The outcome of "three outbreaks of fever blisters on her lips" was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 24-NOV-2014, the patient was vaccinated with a dose of M-M-R II (subcutaneous, dose, frequency, lot number and expiration date were not reported) which had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Licensed Practical Nurse refers to unspecified number of patient's of unknown demographics. No current condition was reported. No historical medication was reported, On 01-JUN-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported). Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. All products had been administered. No adverse effects reported by any patients. Nurse was compiling lot and expiration date information and would call back for further evaluation. No PQC was involved. The outcome of excursion of 6 F since 01-JUN-2013 and products were not stored in an overall average support range of -58 degree F and 5 degree F was unknown. No other information was provided. This case is linked to MARRS # 1412USA010657 and MARRS # 1412USA010658 via same reporter link. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a female pharmacist of unknown age refers to herself. On an approximately 20-NOV-2014 reported as about two weeks ago the pharmacist was administering a dose of ZOSTAVAX (dose, route and lot number were not reported) to patient but during administration approximately on 20-NOV-2014 some of the ZOSTAVAX got on her hand. The pharmacist reported that on 01-DEC-2014 she developed a shingles like rash and pain at the rash site. The pharmacist was seen by an unspecified physician on 04-DEC-2014, and was diagnosed with shingles. The pharmacist reported that her physician prescribed VALTREX and Lidocaine cream for treatment. The patient's outcome was not reported. The relatedness between ZOSTAVAX and the patient's events was not reported. This report is one of 2 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On 10-DEC-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot #, expiration date, dose, route and site of administration were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patients. On unknown dates the patients were vaccinated with doses of improperly stored doses of ROTATEQ (lot #, expiration date and dose unspecified), oral. No adverse events were reported. No additional information was available at that time. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with unspecified number of improperly stored GARDASIL (dose, route of administration, lot number and expiration date were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a 71 year old female patient. On 24-NOV-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # K009876, expiration date reported as 19-MAR-2016 (dose, dose number and route of vaccination were not reported) for prevention of pneumonia. It was reported that after receiving a PNEUMOVAX 23 vaccine, the patient presented at the clinic with injection site redness and surrounding area feeling "hot" and the patient was diagnosed with cellulitis (onset date reported as 25-NOV-2014). The event was treated with an unspecified antibiotics. The outcome of the event was unknown. The patient sought medical attention by visiting the clinic. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 18-DEC-2014 the patient was inadvertently vaccinated with ZOSTAVAX lot # J014851, which expired on 24-OCT-2014 (via subcutaneous route of administration, dose and anatomical location were not reported). It was reported that this dose was supported. No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates in 2014 (reported as "between 06-SEP-2014 and 18-DEC-2014"), unspecified number of patients were vaccinated with a dose of GARDASIL (lot number, expiry date, dose, frequency, route were not reported) that underwent multiple temperature excursions. It was unknown if any of those doses were supported. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an 11 year old female patient. On 16-DEC-2014 the patient was vaccinated with VAQTA (dosing regimen unspecified). No concomitant therapy was reported. On 16-DEC-2014 the patient inadvertently received adult doses of VAQTA, instead of pediatric doses. Nurse reports that the two patients are sisters. No adverse effect reported and there was no product quality complaint involved. The outcome of "inadvertently received adult doses of VAQTA" was unknown. This case is linked to: 1412USA010040 (same reporter). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified amount of patients. The reporter stated that on an unknown date the patients were vaccinated with improperly stored GARDASIL (dose, dosage schedule, route, lot number and expiry date not provided). There was no concomitant medication reported. No adverse effects were reported at the time of the report. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: A spontaneous report was received from a registered nurse regarding an unspecified number of patients who received improperly stored GARDASIL, VAQTA, RECOMBIVAX HB and ROTATEQ between 26-NOV-2014 and 01-DEC-2014. No adverse symptoms were reported. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of GARDASIL (dose, lot number, expiration date were not reported) that were stored improperly. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a other healthcare professional refers to a 16 week old patient of unknown gender. On 18-DEC-2014 the patient was vaccinated with ROTATEQ dose 1, oral (strength, dose and lot # was not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown dates in 2014, unspecified number of patients were vaccinated with a dose of ROTATEQ, (lot number, Expiry Date, dose were not reported), route default to oral, that was improperly stored in April 2014. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. The nurse reported that the patient, who, on 11-DEC-2013, received his first dose of GARDASIL 0.5ml, intramuscular (lot # and expiration date were not provided), was in the office on 19-DEC-2014 to receive his second dose of GARDASIL 0.5ml intramuscular (lot # and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to unspecified patients of unknown age and gender. On an unknown date in 2014 (also reported as since 2014) the patient was vaccinated with PEDVAXHIB (lot number and expiry date unknown) (dosing regimen and frequency unknown) which was exposed to temperatures below the recommended range. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with PEDVAXHIB was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with PEDVAXHIB was unknown. No product quality issue was reported. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from licensed practical nurse refers to unspecified number of patients of unknown demographics. No current condition was reported. No historical medication was reported. On 01-JUN-2013, the patient was vaccinated with PROQUAD (dose strength and route was not reported). Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. All products had been administered. No adverse effects reported by any patients. Nurse was compiling lot and expiration date information and would call back for further evaluation. No PQC was involved. The outcome of excursion of 6F since 01-JUN-2013 and products were not stored in an overall average support range of -58 degree F and 5 degree F was unknown. No further information was provided. This case is linked to MARRS # 1412USA010657 and MARRS # 1412USA010450 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Drug effect decreased
Clinical narrative: This spontaneous report as received from a pharmacist, as part of a marketing research program, refers to an unknown number of patient(s) of unknown age and gender. On an unknown date the patient(s) were vaccinated with PNEUMOVAX 23 (lot#, expiry date, dose and route were not provided). On an unknown date the patient(s) experienced, PNEUMOVAX 23 less potent than other. The outcome of the event was unknown. Additional information is not expected because the reporter is not willing for the pharmaceutical company's safety team to contact to discuss further.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an adult patient of unknown age and gender. On 18-DEC-2014 the patient was vaccinated with a single pediatric dose of RECOMBIVAX HB (first dose, 0.5 ml, intramuscular, lot number was not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse concerning an unspecified number of patients (demographics not provided). On unknown dates, 10 doses of improperly stored VARIVAX (dosages and routes of administration, lot numbers and expiration dates were not provided) were administered to an unspecified number of patients. No adverse symptoms were reported. The temperature excursion for VARIVAX was found to be supported with in-house stability data. This is one of several reports received from the same reporter. Follow up information has been received from a registered nurse on 19-DEC-2014 during a phone call. The nurse was able to provide lot numbers, expiration dates, number of doses affected by the temperature excursion and remaining doses. The nurse provided that the approximate ages of the patients who received the vaccinations were 1 year old and 4 years old. Additional walk-in patients who received the vaccinations, were older from other countries. There have been no adverse events reported since administration of the vaccinations and there was no need for revaccination. On an unknown dates, an unspecified number of patient received improperly stored doses of VARIVAX lot # reported as K002928, expiration date: 26-FEB-2016. The nurse also reported that 20 doses of vaccine with lot # reported as K002928 were affected and 20 doses were remaining. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 01-DEC-2014 the patient was vaccinated with a dose of ROTATEQ (oral dose, frequency, lot number and expiration date were not reported) which had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. Medical histories, current conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (route, lot number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patients of unknown age and gender. On an unknown date GARDASIL (dose, route and site of administration were not reported) vaccines have been administered to multiple patients post supported excursions. No adverse effects reported by any patients. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Fatigue, Nausea, Pyrexia
Clinical narrative: Fevers, tiredness, nausea and weakness.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: ARM pain.   Significant pain in deltoid muscle of arm, still continuing now for 2 months after injection.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Mobility decreased, Pain in extremity
Clinical narrative: Soreness in left arm that got progressively worse to the point where I could not use it.  Extremely painful.  Episode of dizziness which could have been due to incense during Christmas Eve church service.  After putting my head between my knees, it passed.  After almost 24 hours, the pain is getting better, but my arm is still very sore and painful.
Age: 57.0
Sex: M
Vaccine: DTAP
Symptoms: Chills, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Fever; Chills; Spot swollen; Redness; Pain; Took Ibuprofen, acetaminophen and Azithromycin.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: My daughter got Sanofi Pasteur's intradermal flu vaccine as part of a pilot program.  She hated it.  She got an itchy rash that lasted for days. They gave participants a survey immediately after the shot, before she was aware of this reaction.  So she could not give accurate feedback.  They were only interested in positive feedback.  They also "bribed" participants with a gift card.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Injection site movement impairment, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Woke from his nap and complained of his leg hurting. Could not bend it at the knee on the leg of the injection site, thigh was swollen and hot to the touch. Developed a low grade fever (101) on 12/25/14 at noon.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Intense stomach cramps that continue for the following days, diarrhea, severe stomach cramps with any food intake.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Blindness transient, Chills, Deafness transitory, Decreased appetite, Dizziness
Clinical narrative: Dizziness, nausea, temporary hearing loss, temporary loss of vision(black out), fever, chills, soreness, loss of appetite.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Loss of consciousness, Nausea, Pain, Pyrexia
Clinical narrative: Dizziness, nausea, temporary hearing loss, temporary loss of vision(black out), fever, chills, soreness, loss of appetite.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Abdominal discomfort, Constipation, Cough, Crying, Haematochezia
Clinical narrative: After receiving the Pentacel Vaccination, the patient began experiencing stomach upsets, constipation and vomiting, mucous and blood in stool, and extreme crying. The patient could no longer sleep on his back or lying down, and would wake up frequently crying in pain. The patient started nursing more frequently, sleeping sporadically and wheezing frequently.  The patient also appeared to have a case of whooping cough, and was brought in at around 3 months of age but the doctor refused to believe it, and instead gave patient a test for rsv which came out negative.  The patient was breastfed and an elimination diet was started by the patient's mother, after the symptoms did not go away.  Some relief was experienced after several potential allergens were eliminated but the patient at 15 months is still suffering from gastrointestinal distress, and having difficulty sleeping.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Increased appetite, Insomnia, Mucous stools, Pain, Respiratory syncytial virus test negative
Clinical narrative: After receiving the Pentacel Vaccination, the patient began experiencing stomach upsets, constipation and vomiting, mucous and blood in stool, and extreme crying. The patient could no longer sleep on his back or lying down, and would wake up frequently crying in pain. The patient started nursing more frequently, sleeping sporadically and wheezing frequently.  The patient also appeared to have a case of whooping cough, and was brought in at around 3 months of age but the doctor refused to believe it, and instead gave patient a test for rsv which came out negative.  The patient was breastfed and an elimination diet was started by the patient's mother, after the symptoms did not go away.  Some relief was experienced after several potential allergens were eliminated but the patient at 15 months is still suffering from gastrointestinal distress, and having difficulty sleeping.