chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Neck pain, Rash
Clinical narrative: This spontaneous report was received from a physician refers to a 62 year old female patient with drug reaction/allergies to ZOLOFT, CRESTOR, PRAVACHOL, ZOCOR, DIOVAN, AMBIEN, BONIVA, PAXIL, ADVAIR and NASACORT AQ. The patient's medical history included hyperlipidemia, primary insomnia, sinusitis and muscle cramps. On 05-SEP-2009 the patient was vaccinated with ZOSTAVAX 0.65 ml vial, (lot number, expiration date, and route were not reported). Concomitant therapies included omeprazole, CARDIZEM, metronidazole cream, LIVALO, NASONEX, PULMICORT, aspirin, MAXIDE, folic acid, ALLEGRA, XANAX, EVISTA, vitamin D, calcium and CENTRUM multivitamins. The physician informed that on 31-JUL-2014, the patient had a rash on her upper right side of her back. She stated that her neck was hurting and burning. The patient was given a diagnosis of shingles. The patient was prescribed VALTREX and was given an injection of DEPO-MEDROL with lidocaine in the physician's office. The outcome of the event was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy, Breast mass, Ultrasound scan
Clinical narrative: This spontaneous report as received from a female consumer refers to her 23 year old daughter with allergy to amoxicillin. On 04-APR-2014, the patient was vaccinated with the first dose of GARDASIL. On 05-JUN-2014 the patient was vaccinated with the second dose of GARDASIL (lot # J013277, expiration date: 06-AUG-2015, strength unknown, 1 single shot, intramuscular). Concomitant therapies included ZYPREXA and CELEXA (dosage/frequency unknown). In approximately 19-JUN-2014, reported as "2-3 weeks after", the patient discovered lumps in her breasts. The patient sought unspecified medical attentions, two ultrasounds and a biopsy were performed and they were awaiting the results. No adverse effects were reported with the 1st shot of GARDASIL. The outcome of the event was unknown. The relatedness between the therapy with GARDASIL and reported event was not reported. Follow-up information has been received on 19-AUG-2014 from a physician. The patient was vaccinated with the 1st and 2nd dose of GARDASIL (both with lot#: J013277, expiration date: 06-AUG-2015; intramuscular, in left arm) at private doctor's office on 04-APR-2014 and 05-JUN-2014 respectively. Patient's medical conditions included bipolar disease and allergy to penicillin (previously reported also as: amoxicillin). It was reported that the patient noticed a breast lump about the same time as vaccine. She was seen on 19-JUN-2014 and she said that found it almost 2 weeks before (in approximately 05-JUN-2014). She needed breast biopsy, which was performed on 21-JUL-2014. The diagnosis was established as fibroadenoma. Other diagnostic tests included: mammography, ultrasound, pathology report (results not reported). The outcome of the event was unknown. The event was determined to be medically significant by the reporter because it required medical/surgical intervention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy breast abnormal, Breast mass, Fibroadenoma of breast, Mammogram, Pathology test
Clinical narrative: This spontaneous report as received from a female consumer refers to her 23 year old daughter with allergy to amoxicillin. On 04-APR-2014, the patient was vaccinated with the first dose of GARDASIL. On 05-JUN-2014 the patient was vaccinated with the second dose of GARDASIL (lot # J013277, expiration date: 06-AUG-2015, strength unknown, 1 single shot, intramuscular). Concomitant therapies included ZYPREXA and CELEXA (dosage/frequency unknown). In approximately 19-JUN-2014, reported as "2-3 weeks after", the patient discovered lumps in her breasts. The patient sought unspecified medical attentions, two ultrasounds and a biopsy were performed and they were awaiting the results. No adverse effects were reported with the 1st shot of GARDASIL. The outcome of the event was unknown. The relatedness between the therapy with GARDASIL and reported event was not reported. Follow-up information has been received on 19-AUG-2014 from a physician. The patient was vaccinated with the 1st and 2nd dose of GARDASIL (both with lot#: J013277, expiration date: 06-AUG-2015; intramuscular, in left arm) at private doctor's office on 04-APR-2014 and 05-JUN-2014 respectively. Patient's medical conditions included bipolar disease and allergy to penicillin (previously reported also as: amoxicillin). It was reported that the patient noticed a breast lump about the same time as vaccine. She was seen on 19-JUN-2014 and she said that found it almost 2 weeks before (in approximately 05-JUN-2014). She needed breast biopsy, which was performed on 21-JUL-2014. The diagnosis was established as fibroadenoma. Other diagnostic tests included: mammography, ultrasound, pathology report (results not reported). The outcome of the event was unknown. The event was determined to be medically significant by the reporter because it required medical/surgical intervention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ultrasound scan
Clinical narrative: This spontaneous report as received from a female consumer refers to her 23 year old daughter with allergy to amoxicillin. On 04-APR-2014, the patient was vaccinated with the first dose of GARDASIL. On 05-JUN-2014 the patient was vaccinated with the second dose of GARDASIL (lot # J013277, expiration date: 06-AUG-2015, strength unknown, 1 single shot, intramuscular). Concomitant therapies included ZYPREXA and CELEXA (dosage/frequency unknown). In approximately 19-JUN-2014, reported as "2-3 weeks after", the patient discovered lumps in her breasts. The patient sought unspecified medical attentions, two ultrasounds and a biopsy were performed and they were awaiting the results. No adverse effects were reported with the 1st shot of GARDASIL. The outcome of the event was unknown. The relatedness between the therapy with GARDASIL and reported event was not reported. Follow-up information has been received on 19-AUG-2014 from a physician. The patient was vaccinated with the 1st and 2nd dose of GARDASIL (both with lot#: J013277, expiration date: 06-AUG-2015; intramuscular, in left arm) at private doctor's office on 04-APR-2014 and 05-JUN-2014 respectively. Patient's medical conditions included bipolar disease and allergy to penicillin (previously reported also as: amoxicillin). It was reported that the patient noticed a breast lump about the same time as vaccine. She was seen on 19-JUN-2014 and she said that found it almost 2 weeks before (in approximately 05-JUN-2014). She needed breast biopsy, which was performed on 21-JUL-2014. The diagnosis was established as fibroadenoma. Other diagnostic tests included: mammography, ultrasound, pathology report (results not reported). The outcome of the event was unknown. The event was determined to be medically significant by the reporter because it required medical/surgical intervention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Death
Clinical narrative: This spontaneous report was received from a physician via a company representative referred to a 12 year old female patient. The physician reported she read a report, possibly online, the patient who had a seizure on unknown date after administration of GARDASIL (Lot# unspecified), injection (dose, frequency and route unspecified) on unspecified date. Patient had sought unknown type medical attention, and then died on 31-JUL-2014. Outcome of the event of seizure was not reported. Upon internal review, seizure was considered to be an event of medical significant. Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Balance disorder, Injection site erythema, Injection site pain, Injection site swelling, Motion sickness
Clinical narrative: Soreness at site of shot with body aches, vertigo, balance problems, motion sickness, and clicking in right ear...over two weeks later the injection site is still swollen and red and I continue to have vertigo and clicking sounds in right ear.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Tinnitus, Vertigo
Clinical narrative: Soreness at site of shot with body aches, vertigo, balance problems, motion sickness, and clicking in right ear...over two weeks later the injection site is still swollen and red and I continue to have vertigo and clicking sounds in right ear.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Urticaria
Clinical narrative: Patient had hives, rash, wheals. Patient took Benadryl PO 50mg on 8/19/2014. Patient came into the clinic 8/20/2014, patient was given Zyrtec 10mg Po and Prednisone 60mg PO. Observed for 30 minutes and sent home with Zyrtec 10 mg PO daily x 3 days.
Age: 4.0
Sex: M
Vaccine: DTP
Symptoms: Pyrexia
Clinical narrative: High fever all of a sudden.
Age: 1.31
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 15 month old patient. On 25-JUN-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # J013907, expiration date: 30-OCT-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Inflammation, Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Pt complained of a large, red, swollen, circular rash (70mm light red, 30mm induration) on upper back of left arm where MMR was placed 8/18/14. Pt reported pain, tingly on left arm and hand. Pt denied fever, difficulty breathing, hoarseness, wheezing, fast HR, dizziness. Advised pt to call if she has these symptoms or if current symptoms worsen. Advised pt to take Tylenol/Ibuprofen to reduce inflammation and pain.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Paraesthesia
Clinical narrative: Pt complained of a large, red, swollen, circular rash (70mm light red, 30mm induration) on upper back of left arm where MMR was placed 8/18/14. Pt reported pain, tingly on left arm and hand. Pt denied fever, difficulty breathing, hoarseness, wheezing, fast HR, dizziness. Advised pt to call if she has these symptoms or if current symptoms worsen. Advised pt to take Tylenol/Ibuprofen to reduce inflammation and pain.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Pain
Clinical narrative: Left tricep, induration quater size, flare baseball size, mild pain, length x4 days, no TX.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Bladder catheterisation, Culture urine, Full blood count, Haematochezia, Pyrexia
Clinical narrative: Fever 101.5 rectal, bloody stool.
Age: 1.02
Sex: F
Vaccine: MEN, MMR
Symptoms: Hyperaesthesia, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Sore and swollen at injection site. Sensitive to the touch. Fever of 101.7 F (rectal) at 5:30AM. administered 3.75 mL acetaminophen oral suspension at 5:30 AM. Fever reduced to 100.7 F (rectal) by 8:30AM. Administered 3.75 mL acetaminophen oral suspension 9:45AM.
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, MNQ, TDAP
Symptoms: Dizziness, Headache, Myalgia
Clinical narrative: Dizziness, lightheaded, eye muscles hurt, headache.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site streaking, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: 6 days later--low grade fever, body aches, 2 areas of streaking redness on the arm--one at injection site and one newer area about 2 inches away from the site along scar from prior joint replacement surgery. + Lymphadenopathy. I have given patient a prescription for prednisone, but am watching for cellulitis as well.
Age: 2.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 2 year old patient. On 25-JUL-2014 the patient was vaccinated with MMR II (HSA, lot # J011332, EXP date: 13-SEP-2015, dose and route not reported) and a dose of (oka/merck) VARIVAX (lot # J013907, expiration date: 30-OCT-2015, dose and route not reported), both vaccines were stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 1.51
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 18 month old patient. On 23-JUN-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # J013907, expiration date: 30-OCT-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 12.0
Sex: U
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Chest discomfort, Incomplete course of vaccination, Muscle spasms, Pruritus, Swollen tongue
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old patient (gender unknown). On approximately 11-AUG-2014 (also reported as this past Monday) the patient was vaccinated with GARDASIL standard dose, first shot in series, lot # K001631 (route of administration not reported). On the same date, the patient also received MENACTRA (manufacturer unknown). On 11-AUG-2014, the patient experienced muscle spasms, tightness in chest, swollen tongue and itchy dace after receiving GARDASIL. The physician recommended the patient not to receive any further doses in the series. The patient was given treatment with BENADRYL (therapy route unspecified). The adverse events improved. The patients present status was reported as recovered (date unspecified). It was reported that the patient sought medical attention but unspecified how. The causality for the event was unknown. No product quality issue (PQC) had been reported. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Chest discomfort, Muscle spasms, Pruritus, Swollen tongue
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old patient (gender unknown). On approximately 11-AUG-2014 (also reported as this past Monday) the patient was vaccinated with GARDASIL standard dose, first shot in series, lot # K001631 (route of administration not reported). On the same date, the patient also received MENACTRA (manufacturer unknown). On 11-AUG-2014, the patient experienced muscle spasms, tightness in chest, swollen tongue and itchy dace after receiving GARDASIL. The physician recommended the patient not to receive any further doses in the series. The patient was given treatment with BENADRYL (therapy route unspecified). The adverse events improved. The patients present status was reported as recovered (date unspecified). It was reported that the patient sought medical attention but unspecified how. The causality for the event was unknown. No product quality issue (PQC) had been reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient. On 23-JUL-2014 the patient was vaccinated with (oka/merck) VARIVAX (lot # J014229, EXP 08-NOV-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.47
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Expired drug administered, No adverse event, Off label use
Clinical narrative: This spontaneous report was received from a physician refers to an infant patient of unknown age. On an unknown date, the patient was inadvertently vaccinated with adult dose of RECOMBIVAX HB (10 MCG/ML) (dose, route and frequency were not reported). No adverse effect reported. No further information was provided. Follow up information has been received from the physician refers to a 6 month old male patient. On 25-JUL-2014 at 12:00 PM the patient was vaccinated with the first dose of RECOMBIVAX HB (lot# H010965, expire date 01-JUN-2014) in the right arm (dose and route not reported). Concomitant therapies included PREVNAR 13 and PENTACEL. No adverse events. Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product quality issue, Wrong technique in drug usage process
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown age and gender. Medical history was not reported. On 07-JUL-2014 the patient was vaccinated with ZOSTAVAX 1 vial of 1, almost 0.6 ml, lot number, expiration date and route were not reported. Concomitant therapy was not reported. The pharmacist informed that on 07-JUL-2014, she reconstituted ZOSTAVAX with sterile water diluent and ZOSTAVAX vial which resulted in an under filled vial of almost 0.6 instead of the required 0.65. The vaccination was still given to the patient. No adverse symptoms were reported. The patient did not seek medical attention. Follow up information was received from the pharmacist which reported that the 74 year old male patient received full ZOSTAVAX dose. The under dose was diluent only. A PQC was filed. This is one of several reports from the same source. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: Single hive at the administration site. Lasted 7-10 days. No lingering effects at this time.
Age: 1.04
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a 12 month old patient. On 17-JUL-2014 the patient was vaccinated with M-M-R II (HSA, lot # J015503, EXP 05-DEC-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a 2 year old patient. On 17-JUL-2014 the patient was vaccinated with M-M-R II (HSA, lot # J015503, EXP 05-DEC-2015 dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, Injection site pain
Clinical narrative: This spontaneous report as received from a consumer refers to her 12 year old daughter with psoriasis and sulfa medications allergy. On 13-AUG-2009, the patient was vaccinated with her first dose of GARDASIL, on 16-OCT-2009 with the second dose and on 19-AUG-2010 with the third dose (doses, lot# and routes of administration were not reported). On 12-AUG-2014, the patient received 4th dose of GARDASIL inadvertently (dose, lot# and route of administration was not reported). Concomitant therapies included triamcinolone ointment. In approximately August 2014, reported as "soon after receiving 4th dose" the patient experienced soreness at the injection site. The patient sought medical attention by calling the office. No treatment was given. No lab diagnostics studies were performed. The patient present status was reported as recovering. The reporter states also, that the patient might have experienced soreness at the injection site on an unknown date with the other doses, as well. The outcome of soreness at the injection site on an unknown date with the other doses was not reported. Relatedness between soreness at the injection site and therapy with GARDASIL was not provided. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Hypokinesia, Myalgia
Clinical narrative: Joint and muscular pain.  Difficulty moving freely.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Local reaction, Mobility decreased, Myalgia
Clinical narrative: Joint and muscular pain.  Difficulty moving freely.
Age: 0.96
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site rash, Injection site swelling
Clinical narrative: Pt right leg became red and swollen with a 2x2 knot with about 4-5 bumps after 7 days of receiving her varicella vaccine. Mom states the redness, swelling, knot and bumps have gotten better and are almost gone now.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Blood culture negative, CSF culture negative, CSF glucose decreased, CSF protein increased, CSF white blood cell count increased
Clinical narrative: Patient presented with fever and decrease activity. She was found to have pleocytosis in CSF and is being currently treated for meningitis. Today is Hospital day #2.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Culture urine negative, Decreased activity, Enterovirus test negative, Gram stain negative, Meningitis
Clinical narrative: Patient presented with fever and decrease activity. She was found to have pleocytosis in CSF and is being currently treated for meningitis. Today is Hospital day #2.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pleocytosis, Polymerase chain reaction, Pyrexia, Red blood cells CSF positive
Clinical narrative: Patient presented with fever and decrease activity. She was found to have pleocytosis in CSF and is being currently treated for meningitis. Today is Hospital day #2.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical hisotry of the patients was reported. On unspecified dates the multiple unspecified patients were vaccianted with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reproted. It was unspecified whether the patients had sought any medical attention. There was no product quality complaint involved. Follow up infromation has been received from office manager, who stated she may call back or fax infromation as it become available. Also, reported that M-M-R II was not mentioned in the original call, but did experience a temperature excursion. No further infromation was available at that time. Follow-up infromation as received from office manager refers to a 4 years old patient. On 03-JUN-2014 the patient was vaccianted with a dose of improperly stored M-M-R II HSA (lot # reported as J013315, expiration date 18-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of the several reports from the same source. Additional infromation has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 08-AUG-2014 the patient was vaccinated with a dose of expired ZOSTAVAX (lot # H019998, expiration date 02-FEB-2014, dose not reported). Concomitant medications were not provided. The physician came on the phone and stated the expired ZOSTAVAX had no previous temperature excursions. No adverse symptoms were reported. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 12 month old patient. On 30-JUN-2014 the patient was vaccinated with a dose of M-M-R II (HSA, lot # J011332, EXP date: 13-SEP-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
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 a patient of unknown demographics. No current condition was reported. No historical drug was reported. On 13-AUG-2014 the patient was vaccinated with (oka/merck) VARIVAX (dose strength and route of administration was not reported). No concomitant medication was reported. On 13-AUG-2014, the patient received the dose of (oka/merck) VARIVAX that was exposed to temperatures outside proper storage range. No adverse effects were reported. The outcome of received a dose of (oka/merck) VARIVAX that was exposed to temperatures outside proper storage was unknown. No PQC was involved. This is one of the several reports. 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 a patient of unknown demographics. No current condition was reported. No historical drug was reported. On 08-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route of administration was not reported). No concomitant medications was reported. On 08-AUG-2014, patient received the dose of (Oka/Merck) VARIVAX that was exposed to temperatures outside proper storage range. No adverse effect was reported. The outcome of received a dose of (Oka/Merck) VARIVAX that was exposed to temperatures outside proper storage was unknown. No PQC was involved. This is one of the several reports. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with 4th dose of GARDASIL (lot, expiration date, dose, route were not provided). No adverse effects were reported. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Explorative laparotomy, Gastrointestinal surgery, Intussusception
Clinical narrative: Patient had intussusception 6/22/14 and had exploratory laparotomy surgery on 6/23/14.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient. On 26-JUN-2014 the patient was vaccinated with a dose of MMR II (HSA, lot # J011332, EXP date: 13-SEP-2015, dose and route not reported) and a dose of (oka/merck) VARIVAX (lot # J014229, expiration date: 08-NOV-2015, dose and route not reported), both vaccines were stored improperly. There was no adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. No current condition was reported. No medical history was reported. On 16-AUG-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported). No concomitant medication was reported. On 19-AUG-2014, patient reported to pharmacist that on an unspecified date in August 2014, he experienced that an area at the site of ZOSTAVAX administration was red. The outcome of an area at the site of ZOSTAVAX administration was red was reported as not resolved. No PQC was involved. The causality between adverse event an area at the site of ZOSTAVAX administration was red and ZOSTAVAX was unknown. This is one of the several reports. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. No current condition was reported. The patient's medical history included cancer survival. On 16-AUG-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported). No concomitant medication was reported. On 19-AUG-2014, patient reported to pharmacist that on an unspecified date in August 2014, she experienced that an area at the site of ZOSTAVAX administration was red and warm. The outcome of an area at the site of ZOSTAVAX administration was red and warm was reported as not resolved. No PQC was involved. The causality between event an area at the site of ZOSTAVAX administration was red and warm and ZOSTAVAX was unknown. This is one of the several reports. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to an unknown number of patients of unknown age and gender. There were no pertinent medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with ROTATEQ (dose, lot# not reported). No concomitant medications reported. On an unknown date an unknown number os patients were in advertently administered ROTATEQ that had been improperly stored and no adverse effects reported. This report is one of two linked reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to an unknown number of patients of unknown age and gender. There were no pertinent medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with GARDASIL (dose, route, lot# not reported). No concomitant medications reported. On an unkonwn date an unknown number of patients were inadvertently administered GARDASIL that had been improperly stored and no adverse effects reported. This report is one of two linked reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning a patient of unknown age and gender. On 13-AUG-2014, the patient was vaccinated with ROTATEQ lot number given as J002975, expiry: 02-AUG-2014, oral, dose unknown. It was reported that the nurse inadvertently administered an expired ROTATEQ on 13-AUG-2014. The date of expiry of the vaccine administered was reported as 02-AUG-2014. No adverse events were reported. Lot number J002975 is an invalid lot number for ROTATEQ. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. On 18-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 injection form-STR, lot #, unknown, expiry date, 11-JUL-2014 (other details unspecified). No concomitant therapy was reported. On 18-AUG-2014 the patient received an expired dose of PNEUMOVAX 23. No adverse events were reported. No product quality complaint was filed. The patient did not seek medical attention. The action taken was assessed as not applicable. The outcome of event was not reported. The causality was assessed as not related to the therapy with PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous reports as received from a registered nurse refers to a unspecified number of patients. Reporter stated she had no patient data available. On an unknown date the patients were vaccinated with LIQUID PEDVAXHIB, 0.5 ml, (dose unspecified in series), intramuscularly. Lot number or expiry data were not available (no dates were expired). On unknown dates the patients received doses of LIQUID PEDVAXHIB which were exposed to 9C degree for 360 hours. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to 6 unspecified patients of unknown age. Nurse reported that on 13-AUG-2014, the 6 unspecified patients inadvertently received expired dose of MMR II (lot# H014648, expiration date 03-AUG-2014). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. Information regarding concurrent conditions and pertinent medical history was not provided. Between 13-AUG-2014 and 15-AUG-2014, an unspecified number of patients had been administered PNEUMOVAX23 (dose, route and frequency were not provided), which was improperly stored and not supported. Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a unspecified number of patients. Reporter stated she had no patient data available. On an unknown date the patients were vaccinated with M-M-R II 0.5 ml, (dose unspecified in series) subcutaneously. Lot number or expiry data were not available (no dates were expired). On an unknown dates the patients received doses of M-M-R II which were exposed to 9C degree for 360 hours. No adverse effect reported. This is one of several reports received from the same reporter. Additional infuriation has been requested.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 15 month old patient. On 03-JUL-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # J013907, expiration date: 30-OCT-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
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 a patient of unknown demographics. No current condition was reported. No historical drug was reported. On 19-AUG-2014 the patient was vaccinated with (oka/merck) VARIVAX (dose strength and route of administration was not reported). No concomitant medication was reported. On 19-AUG-2014, the patient received the dose of  (oka/merck) VARIVAX that was exposed to temperatures outside proper storage range. No adverse effect was reported. The outcome of received a dose of (oka/merck) VARIVAX that was exposed to temperatures outside proper storage was unknown. No PQC was involved. This is one of the several reports. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a unspecified number of patients. Reporter stated she had no patient data available. On an unknown date the patients were vaccinated with GARDASIL, 0.5 ml, (dose unspecified in series) once, intramuscularly. Lot number or expiry data were not available (no dates were expired). On unknown dates the patients received doses of GARDASIL which were exposed to 9C degree for 360 hours. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient. On 24-JUN-2014 the patient was vaccinated with a dose of MMR II (lot # J011332, EXP date: 13-SEP-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There were no pertinent medical history and concurrent conditions reported. On an unknown date an unspecified number of patients were vaccinated with ROTATEQ (dose, frequency, lot#, expiry date and indication were not reported), which was stored improperly for a period of 25 days. No adverse effect was reported. It was unspecified if the patient sought medical attention. It was reported that unknown number of patients were also administered ROTATEQ that had been involved in the previously AE due to improper storage for 25 days. It was recently discovered that the ROTATEQ has been stored in the same refrigerator with RECOMBIVAX23 during low temperature excursion. This report is one of four linked reports from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain, Blood count abnormal, Blood test abnormal, Computerised tomogram abdomen abnormal, Gait disturbance
Clinical narrative: Chronic abdominal pain - very sharp - hard to walk.  Went to ER diagnosed with infection and poor blood count, although previously considered good.  Diagnois:  intestinal infection.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Gastrointestinal infection, Infection
Clinical narrative: Chronic abdominal pain - very sharp - hard to walk.  Went to ER diagnosed with infection and poor blood count, although previously considered good.  Diagnois:  intestinal infection.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Chronic abdominal pain - very sharp - hard to walk.  Went to ER diagnosed with infection and poor blood count, although previously considered good.  Diagnois:  intestinal infection.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain, Blood count abnormal, Blood test abnormal, Computerised tomogram abdomen abnormal, Gait disturbance
Clinical narrative: Stomach cramping, vomiting. Went to ER.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Gastrointestinal infection, Infection
Clinical narrative: Stomach cramping, vomiting. Went to ER.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Stomach cramping, vomiting. Went to ER.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pharyngeal oedema, Throat tightness
Clinical narrative: Patient approached the pharmacy counter approximately 20 minutes after vaccine was administered (~11:30 AM) and stated that her throat felt tight and swollen since just a few seconds after vaccine was administered (this was not reported to the pharmacist at the time of administration) and that it still was feeling that way, not getting any better but not getting any worse.  She stated she had no difficulty breathing but some trouble swallowing, and was feeling, "a little dizzy."  Pharmacy personnel had her sit down in front of the pharmacy counter, took her blood pressure and pulse (BP 128/72, pulse 72), store personnel called for EMS backup assistance, and pharmacist contacted MD that issued the prescription order to administer the vaccine, to advise her of the situation.  Dr. felt that the patient was having a possible allergic reaction to the vaccine and that she should be assessed in the emergency room or by the EMS.  The EMS arrived at 11:50AM, further assessed patient (R = 18, sat = 92%), and advised that she should be transported to the ER for observation/further assessment in case the reaction worsened.  Patient refused transport to the ER at 11:50AM, stating that her symptoms were not getting any worse at that time.  The EMTs facilitated the patient speaking with Dr. ER, who also suggested that she be transported and evaluated at the ER.  She refused transport again at 12:02 PM. Pharmacy Manager, called Dr. back at 12:09 PM to advise her of the patient's decision to refuse treatment.  Also called the patient at home at 5:07 PM to ask how the patient was feeling, and her husband reported that she, "still feels swollen," but was out running errands at that time.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown demographics. On 12-AUG-2014 the patient was vaccinated with GARDASIL dose 3, intramuscular. On 12-AUG-2014 the patient had a medication error. Nurse reported that a patient received dose one and two of GARDASIL on unspecified dates in 2012. Nurse reported that patient received dose three of GARDASIL on 12-AUG-2014. No adverse effects reported. No further information provided. Outcome was unknown. There was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported. It was unspecified whether the patient had sought any medical attention. There was no product quality complaint involved. Follow up information has been received from office manager, who stated she may call back or fax information as it becomes available. Also, reported that MMR II was not mentioned in the original call, but did experience a temperature excursion. No further information was available at that time. Follow-up information as received from office manager refers to a 2 years old patient. On 02-JUN-2014 the patient was vaccinated with a dose of improperly stored MMR II (lot # reported as J013315, expiration date 18-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of several reports from the same source. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 23 month old patient. On 20-JUN-2014, the patient was vaccinated with a dose of (oka/merck) VARIVAX (lot # J013907, expiration date: 30-OCT-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 5 year old patient. On 25-JUL-2014 the patient was vaccinated (oka/merck) VARIVAX (lot # J014229, EXP 08-NOV-2015 dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient. On 26-JUN-2014 the patient was vaccinated with a dose of M-M-R II (HSA, lot # J011332, EXP date: 13-SEP-2015, dose and route not reported) and a dose of (Oka/Merck) VARIVAX (lot # J013907, expiration date: 30-OCT-2015, dose and route not reported), both vaccines were stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's demographics were unknown. There was no information on pertinent medical history and drug reactions or allergies. On 19-AUG-2014, the patient was vaccinated with expired dose of PNEUMOVAX23 injection N/A 10 standard package syringe of 1 (dose 0.5 ml(milliliter), Product lot # H022172, Expiry date: 16-AUG-2014) subcutaneously. No adverse effects reported. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
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 unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The registered nurse who was able to provide lot numbers and expiration dates for PROQUAD (Merck) (lot # K005644; expiration date: 17-OCT-2015) 10 doses were available, none were administered and PROQUAD (Merck) (lot # J008157; expiration date 08-JAN-2015) 10 doses were available, 7 were administered. Additionally the reporter provided lot numbers and expiration dates for another vaccination vaccine VARIVAX (Merck) (MARRS #1408USA0066440). Both vaccinations went through a temperature excursion. As of this time no adverse experiences had been reported to the health department of those patients who were administered the out of range vaccinations. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 8-19-2014 at 8:30am mom noticed redness and swelling to injection sites and warmth to area as well. Later that night redness was increasing in size with same previous symptoms mom brought patient to clinic where patient was diagnosed with cellulitis and was started on antibiotics (clindamycin).
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Decreased appetite, Fatigue, Hypoaesthesia
Clinical narrative: This spontaneous report as received from a physician refers to his wife, a 74 year old female patient. The patient had no drug reactions or allergies. On 23-JUL-2014 the patient was vaccinated with ZOSTAVAX, (0.65 ml, subcutaneous; anatomical location, dose number and lot number unknown) for vaccination. Concomitant therapies included NEURONTIN, oxycodone and another unspecified narcotic. Approximately on 26-JUL-2014 (reported as: 3 days later) the patient experienced numbness in the right ear, numbness in both hands, a burning sensation in both ankles, decreased appetite and fatigue. The patient sought medical attention and received treatment with prednisone (manufacturer unknown). No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. Additional information has been requested.