chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 02-MAY-2014 the patient was vaccinated with M-M-R II (lot # was reported as J010933 (invalid), expiration date was reported as 06-SEP-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. Lot number J010933 is an invalid lot number for M-M-R II. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a certified medical assistant via a company representative, refers to unspecified number of less than 10 patients. No information on their medical history, concurrent conditions or concomitant drugs was provided. On an unknown dates, reportedly between 01-MAY-2014 and 01-JUL-2014, the patients were vaccinated with GARDASIL which was improperly stored (lot # J003727, expiration date 07-NOV-2015) (doses, administrations sites and routes unspecified). This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Ear pain, Headache, Myalgia, Pain in jaw, Pyrexia
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. There were no drug reactions/allergies or pertinent medical history. The patient was vaccinated with the first dose of GARDASIL injection (lot# H020901, expired date: 05-JUL-2015, dose and route unspecified) on an unspecified date "a couple of months ago". There was no concomitant therapy. The patient returned to the reporter's office at a later time on the same unspecified date complaining of "severe ear pain, headache, jaw pain, fever and myalgia". The patient was treated with "ear drops for pain, an antibiotic and MOTRIN". The patient had not received any further doses of GARDASIL at that time. The outcome of adverse events was reported as recovered on an unspecified date. The relationship between adverse events and GARDASIL was not reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 1 year old patient. On 07-MAR-2014 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot #, expiration date and route unspecified). accidentally instead of (Oka/Merck) VARIVAX. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative refers to herself (age unspecified). On 13-AUG-2014 (reported as about a week ago) the patient was vaccinated with a dose of ZOSTAVAX (lot # and expiration date, frequency, dose and route were unknown). On an unknown date in August 2014 the patient had severe arm swelling and redness. The patient sought for medical attention by office visit. She was seen by the physician and was diagnosed with cellulitis in August 2014 and was treated by unspecified antibiotics. There was no intervention to prevent serious criteria. The outcome of the events was reported as recovered/resolved (in 2014). Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Joint swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 13 year old female patient of unknown demographics. Patient's current condition and medical history was not reported. On an unknown date, the patient was vaccinated with VAQTA, intramuscular injection (dose, unit, route not reported). No concomitant medication has been reported. ON an unknown date the patient experienced fever and ankle swelling after receiving VAQTA. It was reported that the patient was seen at an unspecified emergency room on an unknown date and had received unspecified treatment and it was not known if the patient was hospitalized. There was no product   quality complaint involved. The outcome of the events fever and ankle swelling was not reported. Causality between the events and VAQTA was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a certified medical assistant, via a company representative, refers to unspecified number of less than 10 patients. No information on their medical history, concurrent conditions or concomitant drugs was provided. On an unknown dates, reportedly between 01-MAY-2014 and 01-JUL-2014, the patients were vaccinated with GARDASIL which was improperly stored (lot # J015378, expiration date 09-APR-2016)(doses, administrations sites and routes unspecified). This is one of several reports from then same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a certified medical assistant, via a company representative, refers to unspecified number of less than 10 patients of unknown age and genders. No information on their medical history, concurrent conditions or concomitant drugs was provided. On an unknown dates, reportedly between 01-MAY-2014 and 01-JUL-2014, the patients were vaccinated with GARDASIL which was improperly stored (lot # J009788, expiration date 17-MAR-2016) (doses, administrations sites and routes unspecified). This is one of several reports from then same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP, MMR, MMR
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 26-APR-1997 the patient was vaccinated with the first dose of M-M-R (route and lot # not reported). On 20-OCT-2001, the patient was vaccinated with the second dose of M-M-R II (route and lot # not reported) and on 20-AUG-2014, the patient received an expired third dose of M-M-R II (lot # reported as H0146948 exp 03-AUG-2014) (route not reported). The nurse reported that the patient received the third dose of M-M-R II because she had negative titers on an unspecified date, after receiving the vaccine. The outcome of negative titers after receiving the vaccine was unknown. Additional information has been requested.
Sex: F
Vaccine: HEP, MMR, MMR
Symptoms: Antibody test negative, Expired drug administered, Incorrect dose administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 26-APR-1997 the patient was vaccinated with the first dose of M-M-R (route and lot # not reported). On 20-OCT-2001, the patient was vaccinated with the second dose of M-M-R II (route and lot # not reported) and on 20-AUG-2014, the patient received an expired third dose of M-M-R II (lot # reported as H0146948 exp 03-AUG-2014) (route not reported). The nurse reported that the patient received the third dose of M-M-R II because she had negative titers on an unspecified date, after receiving the vaccine. The outcome of negative titers after receiving the vaccine was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. Medical history and and concurrent conditions were not reported with no drug reaction/allergies. Medical history and concurrent conditions were not reported. On 23-AUG-2014, the patient was vaccinated with ZOSTAVAX lot# J011341, expiration date 13-DEC-2014, 0.65 ml, subcutaneous. Concomitant therapies included Plavix, tramadol hydrochloride, acetaminophen, Norco, Klonopin, Lexapro, albuterol sulfate, Spiriva, Elavil, Flexeril, Aricept, Miralax and Singulair. The pharmacist reported reported that on 25-AUG-2014 (also reported as two days after receiving ZOSTAVAX), a patient developed swelling, redness, and itching at the injection site after receiving ZOSTAVAX. At the time of the report the outcome was unknown. Patient did seek medical attention in the pharmacy on 25-AUG-2014. This is one (1) of two (2) reports from the same source (MARRS 1408USA015614 and 1408USA015621). Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. Medical history and and concurrent conditions were not reported with no drug reaction/allergies. Medical history and concurrent conditions were not reported. On 23-AUG-2014, the patient was vaccinated with ZOSTAVAX lot# J011341, expiration date 13-DEC-2014, 0.65 ml, subcutaneous. Concomitant therapies included Plavix, tramadol hydrochloride, acetaminophen, Norco, Klonopin, Lexapro, albuterol sulfate, Spiriva, Elavil, Flexeril, Aricept, Miralax and Singulair. The pharmacist reported reported that on 25-AUG-2014 (also reported as two days after receiving ZOSTAVAX), a patient developed swelling, redness, and itching at the injection site after receiving ZOSTAVAX. At the time of the report the outcome was unknown. Patient did seek medical attention in the pharmacy on 25-AUG-2014. This is one (1) of two (2) reports from the same source (MARRS 1408USA015614 and 1408USA015621). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 62 year old female patient with no drug reaction/allergies. Medical history and concurrent conditions were not reported. On 19-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX lot# J011341, expiration date 13-DEC-2014, 0.65 ml, subcutaneous. Concomitant therapies included hydrochlorothiazide (manufacturer unknown), Lexapro, Mobic, Lisinopril (manufacturer unknown), trazodone hydrochloride and Vistaril. The pharmacist reports that on 21-AUG-2014 (reported as two days after receiving ZOSTAVAX) a patient developed swelling, redness, and itching at the injection site after receiving ZOSTAVAX. The pharmacist states that the patient came into the pharmacy on 22-AUG-2014 to show the pharmacist the symptoms that she developed. At the time of the report the outcome was unknown. The pharmacist patient was seen by the physician on an unspecified date and prescribed unspecified antibiotics as treatment. This is one (a) of two (2) reports from the same source (MARRS 1408USA015614 and 1408USA015621). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 62 year old female patient with no drug reaction/allergies. Medical history and concurrent conditions were not reported. On 19-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX lot# J011341, expiration date 13-DEC-2014, 0.65 ml, subcutaneous. Concomitant therapies included hydrochlorothiazide (manufacturer unknown), Lexapro, Mobic, Lisinopril (manufacturer unknown), trazodone hydrochloride and Vistaril. The pharmacist reports that on 21-AUG-2014 (reported as two days after receiving ZOSTAVAX) a patient developed swelling, redness, and itching at the injection site after receiving ZOSTAVAX. The pharmacist states that the patient came into the pharmacy on 22-AUG-2014 to show the pharmacist the symptoms that she developed. At the time of the report the outcome was unknown. The pharmacist patient was seen by the physician on an unspecified date and prescribed unspecified antibiotics as treatment. This is one (a) of two (2) reports from the same source (MARRS 1408USA015614 and 1408USA015621). Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: This spontaneous report as received from a Radiology technician refers to a 58 year old male patient with erythromycin allergy and penicillin allergy and no pertinent medical history. On 26-AUG-2013 (reported as "yesterday") the patient was vaccinated with RECOMBIVAX HB (lot #, expiration date, dose and route unspecified). Concomitant medication included CRESTOR. On 27-AUG-2014, the patient experienced 3 welts (1 on his right elbow, 1 on his right hand, and 1 on his right wrist) following the administration. No lab diagnostics studies performed. The patient sought medical attention. BENADRYL was administered as treatment. The event outcome was reported as not recovered. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a Radiology technician refers to a 58 year old male patient with erythromycin allergy and penicillin allergy and no pertinent medical history. On 26-AUG-2013 (reported as "yesterday") the patient was vaccinated with RECOMBIVAX HB (lot #, expiration date, dose and route unspecified). Concomitant medication included CRESTOR. On 27-AUG-2014, the patient experienced 3 welts (1 on his right elbow, 1 on his right hand, and 1 on his right wrist) following the administration. No lab diagnostics studies performed. The patient sought medical attention. BENADRYL was administered as treatment. The event outcome was reported as not recovered. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Facial pain, Irritability, Parotitis, Swelling face
Clinical narrative: Fussy all night. Next morning (9/1) complained about facial pain and her left side face is swollen. Looks like parotitis.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Skin reaction
Clinical narrative: Large red swell on left leg where vaccine was administered. Few days after the swell the child erupted in a severe skin reaction that spread from thigh to chest. A contact was made with the pediatric office that administered the vaccine. I was advised reaction is normal following vaccination. Child was taken to Emergency evaluation as the reaction persisted and continued to spread. Child was taken again to the pediatrician for evaluation on 8/30/14. Was advised the reaction was due to Dtap vaccine.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Abasia, Asthenia, Back pain, Computerised tomogram, Dizziness
Clinical narrative: Black out, not feeling well, dizzy. Continued to feel lightheaded and spacey and slightly weak for the next 4 days. Had to go to emergency room on 8/24. Admitted and then began decreasing with weakness, numbness, tingling in legs, back, severe shooting pain, could not walk. Stayed in MC, then transferred to another hospital.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Electrocardiogram, Feeling abnormal, Hypoaesthesia, Laboratory test, Loss of consciousness
Clinical narrative: Black out, not feeling well, dizzy. Continued to feel lightheaded and spacey and slightly weak for the next 4 days. Had to go to emergency room on 8/24. Admitted and then began decreasing with weakness, numbness, tingling in legs, back, severe shooting pain, could not walk. Stayed in MC, then transferred to another hospital.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Lumbar puncture, Malaise, Nuclear magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: Black out, not feeling well, dizzy. Continued to feel lightheaded and spacey and slightly weak for the next 4 days. Had to go to emergency room on 8/24. Admitted and then began decreasing with weakness, numbness, tingling in legs, back, severe shooting pain, could not walk. Stayed in MC, then transferred to another hospital.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Abasia, Asthenia, Computerised tomogram, Dizziness, Electrocardiogram
Clinical narrative: Black out, not feeling well, dizzy. Continued to feel lightheaded and spacey and slightly weak for the next 4 days. Had to go to emergency room on 8/24. Admitted and then began decreasing with weakness, numbness, tingling in legs, back, severe shooting pain, could not walk. Stayed in MC, then transferred to another hospital.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Feeling abnormal, Hypoaesthesia, Laboratory test, Loss of consciousness, Lumbar puncture
Clinical narrative: Black out, not feeling well, dizzy. Continued to feel lightheaded and spacey and slightly weak for the next 4 days. Had to go to emergency room on 8/24. Admitted and then began decreasing with weakness, numbness, tingling in legs, back, severe shooting pain, could not walk. Stayed in MC, then transferred to another hospital.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Malaise, Nuclear magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: Black out, not feeling well, dizzy. Continued to feel lightheaded and spacey and slightly weak for the next 4 days. Had to go to emergency room on 8/24. Admitted and then began decreasing with weakness, numbness, tingling in legs, back, severe shooting pain, could not walk. Stayed in MC, then transferred to another hospital.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Extreme pain in left arm, reports hard for her to move arm up or out to side.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Was told she would get a rash 10 days after shot. Fever started on 08/29/14 finally broke 09/01/14. Rash all over body 08/30/14 until... still has.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report as received from a physician via company representative via on-line document (social media) (source unspecified) refers to an 11 or 12 year old female patient. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with GARDASIL (strength, dose, dose number, dose schedule, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. On 27-AUG-2014 the 11 or 12 year old female died after receiving GARDASIL. At the time of this report it was not known if an autopsy were performed. The outcome of the event was reported as fatal. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 15 year old female patient. There was not pertinent medical history. On an unknown date the patient was vaccinated with the second dose of GARDASIL injection, 1 single shot, (lot number, expiration date, route and dosage were not reported). Concomitant therapy was not reported. The physician informed that on an unknown date within a month of receiving the second dose of GARDASIL the patient began experiencing severe shoulder pain. No adverse effects were reported with the first dose. The patient needed physical therapy as treatment for the adverse event, a magnetic resonance imaging (MRI) was performed as diagnostic study. The patient sought an unspecified medical attention for the adverse event. The reporter determined that the shoulder pain was significant disability or incapacity. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Encephalitis, Herpes zoster, Laboratory test, Lumbar puncture, Mental status changes
Clinical narrative: This spontaneous report as received from a physician refers to a 75 year old male patient with high blood pressure, alcohol use and bipolar. The patient had none drug reactions/allergies. On 17-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported) for "interested in getting vaccinated". Concomitant therapies included lisinopril (manufacturer unknown), lithium, paroxetine and naltrexone hydrochloride (manufacturer unknown). The physician reported that the patient received a dose of ZOSTAVAX on 17-JUL-2014 and "within a week" developed shingles on an unspecified date in July 2014. The physician reported on 08-AUG-2014 the patient was admitted to hospital with "altered mental status". The physician stated the patient was diagnosed with meningoencephalitis. While in the hospital, the patient started acyclovir therapy and had "a lumbar puncture and several other laboratory tests" (result not provided). The patient was discharged from the hospital on 18-AUG-2014 and was in an unspecified Rehabilitation Center because he hadn't fully recovered. The physician considered this AE was life threatening and caused significant disability because the patient hadn't fully recovered. The outcome of shingles was unknown. Upon internal review, meningoencephalitis was considered as medical significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nuclear magnetic resonance imaging normal
Clinical narrative: This spontaneous report as received from a physician refers to a 18 year old female patient with no known allergies. The patient's medical history included syncope episodes. On 25-JUL-2014, the patient was vaccinated with the first 0.5 ml dose of GARDASIL (lot # J009788, exp 17-MAR-2016) intramuscularly in the left arm. There were no concomitant medications. The physician reported that on an unknown date in approximately July 2014 post vaccination, the patient experienced violent headaches and dizziness. The patient went for doctor visit on 30-JUL-2014 with complaints of violent headache, dizziness but no fever. The patient was sent for Nuclear magnetic resonance imaging (MRI) which showed normal results. The patient was sent to neurologist consult, the diagnosis was headaches with unknown etiology. The patient was treated with EXCEDRIN and MOTRIN. At the time of the report, the patient had not recovered. Headaches with unknown etiology was considered to be disabling and medically significant by the physician because the patient went to MRI and neurologist consult. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report was received from a consumer who read an article on the internet refers to a 12 year old female patient. No medical history reported. On an unknown date, same day or day after they took her home the patient was vaccinated with GARDASIL (dose number and route of administration unknown) (lot number unknown). No concomitant therapies reported. On 19-AUG-2014 the patient went to bed and didn't wake up (death). The patient died on 19-AUG-2014. The cause of death according to the consumer was reported as GARDASIL. The causality was unknown. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Antibody test negative, Drug administered to patient of inappropriate age, Herpes zoster, Splenectomy
Clinical narrative: This spontaneous report was received from a nurse via a company representative refers to a female patient in her 30's. The patient recently was vaccinated with PROQUAD (Merck) dose 1 (dose, lot # and route of administration were not reported). On an unknown date, the patient developed shingles after receiving PROQUAD (Merck). On unknown date, the patient had a splenectomy and presented no titers, so an infectious disease physician recommended the patient receive the first dose of PROQUAD (Merck) and then a second dose at late time, however, at the time of this report the patient had received one dose of PROQUAD (Merck). The patient sought medical attention. The outcome of the events was unknown. Upon internal review, the event of patient had a splenectomy was determined to be medically significant. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt c/o swelling at injection site (size of football) (left arm) and pain level 20 from scale 1-10 with no relief from TYLENOL or ice packs. Advised pt to go to ER/urgent care for follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site papule
Clinical narrative: Redness and a small patule at injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash, Rash vesicular, Scab
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 59 year old non-pregnant female patient with high blood pressure. On approximately 31-JUL-2014 (about two weeks ago) the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX, (lot #, expiration date unspecified), subcutaneous. Concomitant medication included blood pressure medications. In 2014 the patient developed disorganized, bilateral rash on arms, neck and face. The pharmacist stated that the patient reported itching and pain with the rash, and that the lesions crust when they resolved. The patient had sought medical attention. The pharmacist stated that the patient was prescribed a "steroid cream" by her physician, but it had not brought the patient relief. The pharmacist stated "I think it looks like chicken pox". She stated that the patient reported having no history of chickenpox. The event outcome was reported as not recovered. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 59 year old non-pregnant female patient with high blood pressure. On approximately 31-JUL-2014 (about two weeks ago) the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX, (lot #, expiration date unspecified), subcutaneous. Concomitant medication included blood pressure medications. In 2014 the patient developed disorganized, bilateral rash on arms, neck and face. The pharmacist stated that the patient reported itching and pain with the rash, and that the lesions crust when they resolved. The patient had sought medical attention. The pharmacist stated that the patient was prescribed a "steroid cream" by her physician, but it had not brought the patient relief. The pharmacist stated "I think it looks like chicken pox". She stated that the patient reported having no history of chickenpox. The event outcome was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to an adult patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 25-AUG-2014 the patient was vaccinated with (Oka/Merck) PROQUAD (strength, route not reported) lot # K007798 instead of M-M-R II. The reporter also stated that PROQUAD that was administered to the patient was improperly stored. No symptoms reported. The outcome of events reported as unknown. No product quality complaint was involved. 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 health care worker refers to a patient of unknown demographics. On 28-AUG-2014, the patient was vaccinated with M-M-R II (route, dose unspecified) lot # H015826, expiry date: 24-AUG-2014. No concomitant therapies were reported. ON 28-AUG-2014 the patient inadvertently received an expired dose of M-M-R II which was expired on 24-AUG-2014. No adverse event was reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 65 year old female patient. The patient's medical history included diabetes. In approximately February 2013 (also reported as about a year and a half ago) the patient was vaccinated with ZOSTAVAX (dose, lot # unknown) via injection. No concomitant medication was reported. In August 2014 (also reported as in the last week and a half) the patient experienced shingles. The patient sought medical attention. The patient was treated with Acyclovir antiviral. The physician reported there was no progression and deemed it a mile case. The outcome of shingles was reported as recovering. There was no intervention to prevent serious criteria. Product quality complaint was not reported. Causality of shingles with ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 18-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23, (lot # J009827, expiration date 10-AUG-2014), 0.5 ml, intramuscular. No adverse effects reported. Additional information has been requested.
Age: 0.62
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 7 month old male patient. On 26-AUG-2014 the patient was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscular in the right lower thigh. ON 26-AUG-2014, the patient was administered PNEUMOVAX23 instead of PREVNAR13. It was due to staff error. No adverse effects were reported. The outcome of events was unknown. Product quality complaint was not reported. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Seroconversion test negative
Clinical narrative: This spontaneous report was received from a physician refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAXHB (dose, lot # and route of administration were not reported). On an unknown date the patients failed to seroconvert to hepatitis B. The outcome of the event was unknown. Additional information is not expected due to the reporter did not want to be contacted again.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Pallor, Vomiting
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a 14 year old male patient. Patient's concurrent conditions and relevant medical history was unknown. On 28-AUG-2014 the patient was vaccinated with third dose of GARDASIL (dose unspecified) (lot number: K00902). Concomitant medications were not reported. On 28-AUG-2014, after receiving the third dose of GARDASIL, the patient experienced vomiting, light-headedness and paleness. The patient sought medical attention by visiting the office. Start date of therapy with GARDASIL was reported as 28-AUG-2014. The outcome of vomiting, light-headedness and paleness was reported as recovered/resolved on 28-AUG-2014. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 14 year old female patient. On 20-DEC-2012 the patient was vaccinated with GARDASIL (dosing regimen unspecified) dose 3. It was reported that nurse states on 20-DEC-2012 a patient was vaccinated with the third dose of GARDASIL too early. Patient was vaccinated with GARDASIL first dose 22-AUG-2012, second dose 25-OCT-2012 and the third dose of GARDASIL on 20-DEC-2012. Nurse states patient vaccinated at another facility. No adverse effects reported. The outcome of patient was vaccinated with the third dose of GARDASIL too early and no adverse effects reported is unknown. No product complaint involved. This is one of several reports received from the same source. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 15 year old female patient. On 20-DEC-2012 the patient was vaccinated with GARDASIL (dosing regimen unspecified) dose 3. It was reported that nurse states on 20-DEC-2012 a patient was vaccinated with the third dose of GARDASIL too early. Patient was vaccinated with GARDASIL first dose 22-AUG-2012, second dose 25-OCT-2012 and the third dose of GARDASIL on 20-DEC-2012. Nurse states patient vaccinated at another health care facility. No adverse effects reported. The outcome of patient was vaccinated with the third dose of GARDASIL too early and no adverse effects reported is unknown. No product quality complaint involved. This is one of several reports received from the same source. Additional information is not expected.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 years old patient of unknown gender. On 26-AUG-2014, the patient was vaccinated with expired PROQUAD (merck), injection, 0.5 milliliter (ml) once, subcutaneously. Concomitant medications were not reported. No adverse effects were reported. Patient did not seek medical attention. The outcome of events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash, Injection site reaction, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient with no drug allergies. No pertinent medical history and concurrent conditions were reported. In approximately 2014, reported as "a month ago or longer"  the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, route of administration and lot # not reported). No concomitant medication was reported. On an unknown date in 2014, the patient experienced warm, raised rash around the injection site shortly after vaccination. On an unknown date in 2014, reported as "within a couple of days" the rash went away but the patient developed a shingle near the injection site. On an unknown date in 2014, reported as "within a couple of days", the shingle went away again and the patient developed another shingle (unspecified date in 2014). Within one week of the vaccination (unspecified date in 2014), the patient recovered from all symptoms including warm raised rash around the injection site and shingle near the injection site. No treatment was given to the patient. No lab diagnostics studies were performed. Relatedness between warm, raised rash around the injection site and shingle and therapy with ZOSTAVAX was not provided. 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 pharmacist refers to a patient of unknown age and gender. On 15-AUG-2014 the patient was inadvertently vaccinated an expired dose of M-M-R II (0.5 ml, subcutaneous, lot # H014977, expiration date: 09-AUG-2014). Dose was supported. No adverse experience reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to unspecified number of patients of unknown age. On unknown dates the patients were vaccinated with (Oka/Merck) VARIVAX (lot # and expiration date, route and dose were unknown) which were exposed to unspecified temperatures above 5F on unspecified dates. The specified temperatures and dates of the excursions were not specified, and it was not known whether or not the temperature excursions would be supported. No adverse effects had been reported or observed. This is one of two reports from the same reporter. (there were totally approximately 50 unspecified patient involved in the two reports). 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 refers to a patient of unknown demographics. On 26-AUG-2014 the patient was vaccinated with PNEUMOVAX23, intramuscular (dosing regimen/lot # unspecified). Concomitant therapy was not reported. On 26-AUG-2014 the pharmacist reported that she inadvertently administered PNEUMOVAX23 which had expired on 10-AUG-2014. No adverse effects reported. There was no product quality complaint involved. The outcome of she inadvertently administered PNEUMOVAX23 which had expired on 10-AUG-2014 was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 5 year old female patient with asthma, seasonal allergies and no past drug history. On 05-AUG-2014 the patient was in error vaccinated with ZOSTAVAX (dose, units, route of administration, anatomical location, lot number, expiration date were not reported). Concomitant therapies included ALBJTEROL nebulizer as needed. It was unknown if any relevant tests were performed. The reporter stated that the patient received ZOSTAVAX instead of (Oka/Merck) VARIVAX.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 12 year old female patient. On 20-DEC-2013 the patient was vaccinated with GARDASIL (dosing regimen unspecified) dose 3. It was reported that nurse states on 20-DEC-2013 a patient was vaccinated with the third dose of GARDASIL too early. Patient was vaccinated with GARDASIL first dose 28-AUG-2013, second dose 25-OCT-2013 and the third dose of GARDASIL on 20-DEC-2013. Nurse states clients were vaccinated at another health care facility. No adverse effects reported. The outcome of patient was vaccinated with the third dose of GARDASIL too early and no adverse effects reported is unknown. No product quality complaint involved. This is one of several reports received from the same source. Additional information is not expected.
Age: 1.15
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a health professional refers to a 13 month old patient. On 10-JUL-2014 the patient was vaccinated with M-M-R II  HSA (lot #H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 month old patient. On 25-JUL-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date 25-JUN-2014) 0.5 ml, subcutaneously , which was expired. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 15 month old patient. On 09-JUL-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date 25-JUN-2014) 0.5 ml, subcutaneously , which was expired. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product label issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to 10 adults of unknown age. Since July 2014 the adults were inadvertently vaccinated with 10 doses of pediatric RECOMBIVAX HB, 5mcg/0.5ml, 0.5ml,  once, route unspecified. Pharmacist reported that she made this error in part due to the lack "PEDIATRIC" wording on labeling. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients were vaccinated with improperly stored doses of ROTATEQ (lot#, expiration date, strength, dose and route not reported). No symptoms reported. The improperly stored doses were administered 27-AUG-2014 and 28-AUG-2014. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot #, expiration date, strength, dose and route not reported). No symptoms reported. The improperly stored doses were administered 27-AUG-2014 and 28-AUG-2014. It was unspecified if the patient sought medical attention.This is one of several reports received from the same source. 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 nurse refers to  an unspecified number of patients of unknown age and gender. The patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot #, expiration date, strength, dose and route not reported). No symptoms reported. The improperly stored doses were administered 27-AUG-2014 and 28-AUG-2014. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to  an unspecified number of patients of unknown age and gender. The patients were vaccinated with improperly stored doses of M-M-R II (lot #, expiration date, strength, dose and route not reported). No symptoms reported. The improperly stored doses were administered 27-AUG-2014 and 28-AUG-2014. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and unknown gender. On 25-APR-2014 the patient was vaccinated with the first dose of GARDASIL, (strength and lot# unknown) injection, 0.5 ml, intramuscularly. The patient's dosing schedule of GARDASIL completed as followed: second dose 29-AUG-2012 and third dose 07-NOV-2012. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy refers to an unspecified number of patients of unknown age and gender. In approximately August 2014, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # not reported) that were exposed to temperatures out of range and were evaluated and supported on 15-AUG-2014 and since then administered to patients. No adverse effects were reported. This is one of several reports received from the same source. 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 pharmacy technician refers to an unspecified number of patients of unknown age and gender. In approximately August 2014, the patients were vaccinated with doses of PROQUAD (Merck) (lot # not reported) that were exposed to temperatures out of range and were evaluated and supported on 15-AUG-2014 and since then administered to patients. No adverse effects were reported.This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored GARDASIL (dose, route and lot were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected, because is not possible contact the physician.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 25-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 (strength, dose, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse effects were noted. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an adult female patient, of unknown age. Medical  history and concurrent conditions were not reported. Nurse reported that patient got in December 2013 her first dose of RECOMBIVAX HB (dose, strength, route and lot number were not reported) and came to get her second dose of RECOMBIVAX  HB on 25-AUG-2014 (reported as today). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 16-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 expiration date: 10-AUG-2014 (dose, lot # and route of administration were not reported). It was unknown if the patient had been received another dose of PNEUMOVAX23 at the time of this report. Additional information is not expected due to the reporter declined to provide any additional information for this report.
Age: 1.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer refers to his 1 year old female daughter. Patient did not had any pertinent medical history drug reactions or allergies. On 22-AUG-2014, the patient was vaccinated with ZOSTAVAX, 0.5 ml/once, in her leg (reported as needle on top of thigh") (strength, route and lot number were not reported). Concomitant therapies included nystatin and cephalexin. The patient's father reported that patient was supposed to received (Oka/Merck) VARIVAX but was given ZOSTAVAX instead. The patient's father confirmed that the patient received 0.5 ml of ZOSTAVAX. Patient's father stated that patient "looked to be normal". Patient did not received treatment for the adverse events. No labs diagnostics studies were performed. The patient did not seek medical attention. Additional information has been requested.