chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
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. Concomitant medication and pertinent medical history were not provided. On 19-MAY-2014 the patient was vaccinated with a 0.5ml expired dose of VARIVAX (lot # H009634, expiration date 09-MAY-2014) subcutaneously. No adverse effect was reported. Additional ain formation has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 61 year old female patient with allergy to penicillin (manufacturer unknown). The patient's pertinent medical history was none. On an unspecified date in January 2013, the patient was vaccinated with ZOSTAVAX (Dose/Frequency: "1 single shot") subcutaneous for prevention of shingles. Concomitant medications were unspecified. On an unknown date in February 2014, the patient was diagnosed with shingles. Lab Diagnostics Studies Performed were none. The outcome of shingles was reported as not recovered. The causality was not reported. The patient did not sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received form a Licensed Practical Nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with an expired dose of ZOSTAVAX (route, dose, lot number and exp date were not reported). Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age. On an unknown date, unspecified numbers of patients were with LIQUID PEDVAXHIB (dose, frequency, route of administration and indication were not provided). LIQUID PEDVAXHIB was exposed to 8.8C for 10 days, and then administered to unspecified number of patients on unspecified dates. No concomitants were reported. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further information provided. This report is linked to 1405USA013338 and 1405USA013916 by the same reporter link. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix
Clinical narrative: This spontaneous report as received from a physician refers to a 22 year old female patient with reflux and no known drug reactions/allergies. On unknown dates the patient was vaccinated with three doses of GARDASIL (dose and route was not reported). Concomitant therapies included PRILOSEC. In approximately May 2013, a routine Papanicolaou (PAP) Smear was positive for HPV on an unspecified date a year ago. Physician additionally stated there was "no inflammation". No treatment was given for the patient. No result from a repeat PAP smear obtained on 22-MAY-2014 was available yet. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative and a physician refers to a 63 year old female patient with hydrochlorothiazide allergy and medical history of chickenpox as a child. Patient historical drug included meloxicam, SINGULAIR, XYZAL, bupropion hydrochloride, acetaminophen, LORTAB, ibuprofen and indomethacin. On 11-JAN-2012 the patient was vaccinated with ZOSTAVAX (lot# was reported as 00006496300) in left deltoid (dose and route not reported). Concomitant therapies included LYRICA, BENICAR, NEXIUM, NIFEDICAL XL, PREMARIN, torsemide, meloxicam, PROCARDIA XL, azithromycin and bupropion hydrochloride. There was no rash at the site of injection post-vaccination. On 06-MAY-2014 the patient had painful rash over the right breast around to back, abdomen and flank. Patient also had numerous rash at right upper thorax, back and flank, herpes zoster at right upper thorax and back, right flank with erythematous rash over abdomen and vesicles and dark pigmented lesions. The patient was diagnosed with shingles (The AE onset date was also reported as 03-MAY-2014). The patient didn't have recent VZV exposure to chickenpox or shingles. The patient sough medical attention via office visit on 06-MAY-2014. Since the same day the patient received the following treatment: VALTREX 500mg oral tablet one po tid and ULTRAM 50mg oral tablet one po every 8 hours prn for pain. The outcome of the adverse event was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse. The  reporter reported that an unspecified physician office, VAQTA, RECOMBIVAX and GARDASIL were exposed to 33F for 70 temperature excursions which tolerated 1173 hours out of range. She stated that during this time, these doses may have been administered to an unspecified number of patients. No adverse effects reported. The reporter stated she did not have any patient information. The reporter stated that at a different unspecified physician's office ROTATEQ, VAQTA, RECOMBIVAX and GARDASIL were exposed to 34F for 317 hours (13 days) and then they were exposed to 48F for 63 hours. The reporter stated that these doses may have been administered to an unspecified number of patients. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a Healthcare Worker refers to a currently 46 year old female patient with hypertension, depression and obesity and no known allergies. On an unknown date the patient was vaccinated with MMR II (dose, route, lot # not provided). It was reported that the patient had titers drawn on an unspecified date for proof of immunity of measles, mumps and rubella. The results of the titers were delivered to the physician's office on 30-APR-2014. The mumps titer was 0.85 antibody units per mL. The patient's vaccination history was unknown. No other adverse effect reported. There was no treatment given for the event, no intervention to prevent serious criteria and no PQC involved. The outcome of the event described as: "a patient had drawn on an unspecified date for proof for immunity of MEASLES, MUMPS and RUBELLA. The MUMPS titer was 0.85 antibody units per mL" was unknown. The causality between the upper mentioned event and MMR II was not specified. 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. The reporter reported that at an unspecified physician office, VAQTA, RECOMBIVAX HB and GARDASIL were exposed to 33F for 70 temperature excursions which totaled 1173 hours out of range. She stated that during this time, these doses may have been administered to an unspecified number of patients. No adverse effects reported. The reporter stated she did not have any patient information. The reporter stated that at different unspecified physician's office ROTATEQ, VAQTA, RECOMBIVAX HB and GARDASIL were exposed to 34F for 317 hours (13 days) and then they were exposed to 48F for 63 hours. The reporter stated that these does may have been administered to an unspecified number of patients. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Dyspnoea, Generalised erythema, Joint swelling, Panic attack
Clinical narrative: Reddining of skin from head to toe, difficulty breathing, persistent cough, swelling of joints, panic attack.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Cough, Decreased appetite, Headache, Pyrexia, Respiratory tract congestion
Clinical narrative: Pt received his Anthrax Shot on 19May, and states within an hour, he began to have symptoms. Patient had symptoms of Fever (subjective, x48 hours), anorexia, and headache, congestion, and cough 3-4 days following vaccination. Patient states symptoms have improved, though some lingering sinus issues. Pt did not report event for 8 days.  He states he has gotten HA/anorexia each time he's had the anthrax vaccine (total 4 times).
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Onset one hour after receiving vaccine, experienced severe pain in shoulder and elbow of arm that received immunization; decreased range of motion due to pain; NO swelling or redness present.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV
Symptoms: Rash
Clinical narrative: Sandpaper rash that started on head and neck and spread throughout the whole body.
Age: 0.39
Sex: M
Vaccine: HIBV, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: N/A - pt will need to be revaccinated.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Arthralgia, Groin pain, Imaging procedure, Joint swelling, Nerve block
Clinical narrative: RT hip and groin pain, unable to bear weight. Unable to touch right hip or leg. Swelling and rash to hip region. Patient was placed in the hospital for 3 weeks (6/24/13-6/26-13, 7/8/2013-7/11/2013, 7/23/2013-7/26/2013- 1st hospital) (9/11/20103-9/14/2013- 2nd hospital). Seen a number of physicians for hip and groin pain- had a number of medical images- had a nerve block x2. Did Physical therapy for a number of months- both land and water therapy. Tried HBO therapy.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Rash, Tenderness, Weight bearing difficulty
Clinical narrative: RT hip and groin pain, unable to bear weight. Unable to touch right hip or leg. Swelling and rash to hip region. Patient was placed in the hospital for 3 weeks (6/24/13-6/26-13, 7/8/2013-7/11/2013, 7/23/2013-7/26/2013- 1st hospital) (9/11/20103-9/14/2013- 2nd hospital). Seen a number of physicians for hip and groin pain- had a number of medical images- had a nerve block x2. Did Physical therapy for a number of months- both land and water therapy. Tried HBO therapy.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Aphagia, Barrett's oesophagus, Blood test abnormal, Brain mass, Bursitis
Clinical narrative: I was laying in my bed in my dorm and I was suddenly overcome with intense chest pain and difficulty breathing. I immediately used my nebulizer thinking that I was just having an asthma attack. After waiting for about 45 minutes and receiving no relief from the medication I asked my roommate to drive me to the hospital. When I get to the hospital I could barely breath and was unable to find a position to sit/stand/lay in that wasn't excruciatingly painful. The doctors eventually diagnosed me with costal chondritis. I spent the next 5-6 months in and out of the doctors office and the hospital as various different infections attacked different parts of my body (stomach, kidneys, lungs, skin, and eventually my mouth and throat resulting in ulcers so bad I was hospitalized because I could not eat or drink due to the pain. I also have non-epileptic seizures.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Chest pain, Computerised tomogram abnormal, Convulsion, Costochondritis, Dyspnoea
Clinical narrative: I was laying in my bed in my dorm and I was suddenly overcome with intense chest pain and difficulty breathing. I immediately used my nebulizer thinking that I was just having an asthma attack. After waiting for about 45 minutes and receiving no relief from the medication I asked my roommate to drive me to the hospital. When I get to the hospital I could barely breath and was unable to find a position to sit/stand/lay in that wasn't excruciatingly painful. The doctors eventually diagnosed me with costal chondritis. I spent the next 5-6 months in and out of the doctors office and the hospital as various different infections attacked different parts of my body (stomach, kidneys, lungs, skin, and eventually my mouth and throat resulting in ulcers so bad I was hospitalized because I could not eat or drink due to the pain. I also have non-epileptic seizures.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Electroencephalogram abnormal, Endoscopy abnormal, Fibromyalgia, Hepatic mass, Infection
Clinical narrative: I was laying in my bed in my dorm and I was suddenly overcome with intense chest pain and difficulty breathing. I immediately used my nebulizer thinking that I was just having an asthma attack. After waiting for about 45 minutes and receiving no relief from the medication I asked my roommate to drive me to the hospital. When I get to the hospital I could barely breath and was unable to find a position to sit/stand/lay in that wasn't excruciatingly painful. The doctors eventually diagnosed me with costal chondritis. I spent the next 5-6 months in and out of the doctors office and the hospital as various different infections attacked different parts of my body (stomach, kidneys, lungs, skin, and eventually my mouth and throat resulting in ulcers so bad I was hospitalized because I could not eat or drink due to the pain. I also have non-epileptic seizures.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Mixed connective tissue disease, Mouth ulceration, Nuclear magnetic resonance imaging abnormal, Pain, Polymyositis
Clinical narrative: I was laying in my bed in my dorm and I was suddenly overcome with intense chest pain and difficulty breathing. I immediately used my nebulizer thinking that I was just having an asthma attack. After waiting for about 45 minutes and receiving no relief from the medication I asked my roommate to drive me to the hospital. When I get to the hospital I could barely breath and was unable to find a position to sit/stand/lay in that wasn't excruciatingly painful. The doctors eventually diagnosed me with costal chondritis. I spent the next 5-6 months in and out of the doctors office and the hospital as various different infections attacked different parts of my body (stomach, kidneys, lungs, skin, and eventually my mouth and throat resulting in ulcers so bad I was hospitalized because I could not eat or drink due to the pain. I also have non-epileptic seizures.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Scleroderma, Sleep study abnormal, Systemic lupus erythematosus, Ulcer, X-ray abnormal
Clinical narrative: I was laying in my bed in my dorm and I was suddenly overcome with intense chest pain and difficulty breathing. I immediately used my nebulizer thinking that I was just having an asthma attack. After waiting for about 45 minutes and receiving no relief from the medication I asked my roommate to drive me to the hospital. When I get to the hospital I could barely breath and was unable to find a position to sit/stand/lay in that wasn't excruciatingly painful. The doctors eventually diagnosed me with costal chondritis. I spent the next 5-6 months in and out of the doctors office and the hospital as various different infections attacked different parts of my body (stomach, kidneys, lungs, skin, and eventually my mouth and throat resulting in ulcers so bad I was hospitalized because I could not eat or drink due to the pain. I also have non-epileptic seizures.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: No adverse reactions while patient was in the clinic after administration.
Age: 25.0
Sex: F
Vaccine: HPVX, PPV
Symptoms: Asthenia, Chills, Dizziness, Headache, Injection site pain
Clinical narrative: Headache, chills, weakness, myalgia, light headedness, nausea, severe pain and swelling around injection site starting May 23 PM and lasting until May 25 AM.  Hives around injection site starting May 24 AM and lasting until May 25 PM.  Took Benadryl, ibuprofen, acetaminophen.
Age: 25.0
Sex: F
Vaccine: HPVX, PPV
Symptoms: Injection site swelling, Injection site urticaria, Myalgia, Nausea
Clinical narrative: Headache, chills, weakness, myalgia, light headedness, nausea, severe pain and swelling around injection site starting May 23 PM and lasting until May 25 AM.  Hives around injection site starting May 24 AM and lasting until May 25 PM.  Took Benadryl, ibuprofen, acetaminophen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema multiforme, Rash
Clinical narrative: 7 days after administration of vaccines patient developed rash consistent with erythema multiforme.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Activities of daily living impaired, Hypersensitivity, Insomnia, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: The first night it began hurting (as expected), and I woke early, unable to sleep due to the pain in my shoulder.  I took 2 ibuprofen and was able to sleep a few more hours.  The pain did improve in the next couple of days, but it has not gotten better since and actually is more limited 9 days post injection than over the weekend.  (Ibuprofen and heat helps temporarily, but it continues to return.) By 5/27/2014, functional range of motion is limited to approximately 80-90 degrees of flexion and abduction, and daily activities are painful or very difficult including such things as brushing/washing hair, doing laundry, reaching for items on cupboard shelves, turning off alarm clock, etc.  Saw nurse practitioner on 5/28/2014, x-rays and exam performed--diagnosed with allergic reaction-frozen shoulder and referred to orthopedic doctor for next-day appointment on 5/29/2014.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Periarthritis, X-ray limb abnormal
Clinical narrative: The first night it began hurting (as expected), and I woke early, unable to sleep due to the pain in my shoulder.  I took 2 ibuprofen and was able to sleep a few more hours.  The pain did improve in the next couple of days, but it has not gotten better since and actually is more limited 9 days post injection than over the weekend.  (Ibuprofen and heat helps temporarily, but it continues to return.) By 5/27/2014, functional range of motion is limited to approximately 80-90 degrees of flexion and abduction, and daily activities are painful or very difficult including such things as brushing/washing hair, doing laundry, reaching for items on cupboard shelves, turning off alarm clock, etc.  Saw nurse practitioner on 5/28/2014, x-rays and exam performed--diagnosed with allergic reaction-frozen shoulder and referred to orthopedic doctor for next-day appointment on 5/29/2014.
Age: 0.4
Sex: F
Vaccine: MMR, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Vomiting lasting one day.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to a patient of unknown age and gender. No pertinent medical history of the patient was reported. On 20-MAY-2014, the patient was vaccinated with MMR II, 0.5 ml, subcutaneously (Lot # h010137; expiration date 17-MAY-2014). No concomitant medications were reported. It was reported that the patient received an expired lot of MMR II on 20-MAY-2014. No adverse effect reported. The outcome was unknown. The reporter reported that one more patient has received vaccination with expired lot of MMR II. This case is linked to MARRS # 1405USA013975 via the same reporter link. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patient were vaccinated with a dose of GARDASIL (dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients' identifiers were obtained. This report concerns one of the patients. On 25-MAR-2014 at 14:15, the 23 year old female patient was vaccinated with the first dose of GARDASIL (lot # J005661, exp. 26-SEP-2014) into left deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20; Feb 17, 20/20; Mar 20 26/40. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.8
Sex: F
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 10 month old female patient. Pertinent medical history, concomitant medication, drug reactions and allergies were not provided. On an unknown date, the patient was vaccinated with a first dose of VARIVAX (dose, route of administration, lot number and expiration date were not reported). No adverse symptoms were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Memory impairment
Clinical narrative: This spontaneous report was received from a male patient of unknown age. The patient's medical history included prior heart attack (dates unspecified). Patient stated that he also previously had an allergic reaction to an unspecified medication, but he did not recall the details  of the reaction or what medication had caused it or what was the manufacturer. On an unknown date (reported as "5 or more years ago") the patient was vaccinated with ZOSTAVAX ("one shot", therapy route "injection", lot number unspecified by the reporter). Concomitant medications included: many unspecified medications, including unspecified pain medicine (manufacturers unspecified). Patient reported that, beginning "about 6 or 7 months after" having received ZOSTAVAX, he has had recurring shingles-like spots which have been in the region of his "back and rear" and "mostly on his left side". He has gotten one or two spots in this area of his body "every 3 or 4 weeks" ever since the first onset. He currently has a spot. Patient sought medical attention and his physician diagnosed these spots as "shingles". An unspecified salve was given to the patient as a treatment for the adverse event. The patient reported also having difficulty remembering things. None lab tests were performed. The outcomes of having difficulty remembering things were unknown and not recovered from shingles. The relationship between the ZOSTAVAX and the events was not provided. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old male patient with heart disease and none drug reactions/allergies. On 12-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # J003808, expiration date 03-JUL-2014) (dose and route unknown). Concomitant therapies included hydrochlorothiazide (manufacturer unknown) and CRESTOR. On approximately 08-MAY-2014 (reported as "about 2 weeks ago"), the patient experienced shingles. The patient saw the physician assistant for medical attention. Capsaicin cream and lidocaine patch were given for the treatment of the events. The outcome of the events was unknown. Reporter's causality of therapy to adverse event was not provided. 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 a patient of unknown age and gender. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 09-MAY-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS #1405USA008203, 1405USA0082972, 1405USA008973, 1405USA008974, 1405USA008975, 1405USA008976, 1405USA008977, 1405USA008978, 1405USA008979, 1405USA008981, 1405USA008982). Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients' identifiers were obtained. This report concerns one of the patients. On 10-MAR-2014 at 10:00, the 23 year old female patient was vaccinated with the first dose of GARDASIL (lot # J005661, exp. 26-SEP-2014) into right deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20; Feb 17, 26/20. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to a patient of unknown age and gender. No pertinent medical history of the patient was reported. On 21-MAY-2014 the patient was vaccinated with M-M-R II, 0.5 ml, subcutaneous (Lot # H010137; expiration date 17-MAY-2014). No concomitant medications were reported. It was reported that the patient received an expired lot of M-M-R II on 21-MAY-2014. No adverse effect reported. The outcome was unknown. The reporter reported that one more patient had received vaccination with expired M-M-R II on 20-MAY-2014. This case is linked to MARRS # 1405USA011648 via the same reporter link. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients' identifiers were obtained. This report concerns one of the patients. On 07-MAR-2014, the 19 year old (reported as 20 year old) female patient was vaccinated with the first dose of GARDASIL (lot # H020848, exp. 03-APR-2015) into left deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20; Feb 17, 26/20. This is one of several reports received from the same source. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients identifiers were obtained. This report concerns one of the patients. On 25-MAR-2014 at 14:00, the 20 year old female patient was vaccinated with the first dose of GARDASIL (lot # J005661, exp. 26-SEP-2014) into left deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20; Feb 17, 20/20; Mar 20, 26/40. This is one of several reports received from the same source. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, lot # and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patient or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients' identifiers were obtained. This report concerns one of the patients. On 17-MAR-2014 at 09:15, the 20 year old female patient was vaccinated with the first dose of GARDASIL (lot # H020848, exp. 03-APR-2015) into right deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14. 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20; Feb 17,26/20. This is one of several reports received from the same source. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patient were vaccinated with a dose of GARDASIL (dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patient's identifiers were obtained. This report concerns one of the patients. On 13-MAR-2014 at 17:00, the 25 year old female patient was vaccinated with the first dose of GARDASIL (lot # H020848, exp. 03-APR-2015) into right deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20; Feb 17, 26/20. This is one of several reports received from the same source. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients' identifiers were obtained. This report concerns one of the patients. On 11-MAR-2014 at 10:00, the 23 year old female patient was vaccinated with the first dose of GARDASIL (lot # J005661, exp. 26-SEP-2014) into right deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26/; Jan 09, 36/22; Jan 11, 26/40/; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20; Feb 17,26/20. 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, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age. On an unknown date, unspecified numbers of patients were vaccinated with GARDASIL INJ, (dose, frequency, route of administration and indication were not provided). GARDASIL was exposed to 8.8C for 10 days, and then administered to unspecified numbers of patients on unspecified dates. No concomitants were reported. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further information provided. This report is linked to 1405USA013915 and 1405USA013916 by the same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age. On an unknown date, unspecified numbers of patients were with RECOMBIVAX HB (dose, frequency, route of administration and indication were not provided). RECOMBIVAX HB was exposed to 8.8C for 10 days, and then administered to unspecified number of patients on unspecified dates. No concomitants were reported. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further information provided. This report is linked to 1405USA013338 and 1405USA013915 by the same reporter link. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 or 60 year old female patient. The patient's medical history and drug reactions were not provided. The pharmacist reported that the patient who received a dose of ZOSTAVAX (lot#, dose, route unknown) on 12-MAY-2014, developed a rash on her torso and back, and was diagnosed with shingles by an unspecified physician via an office visit. Outcome of the event was reported as not recovered and reporter's causality of therapy to the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse. The reporter reported that at an unspecified physician office, VAQTA, RECOMBIVAX and GARDASIL were exposed to 33F for 70 temperature excursion tolerated 1173 hours out of range. She stated that during this time, these doses may have been administered to an unspecified number of patients. No adverse effects reported. The reporter stated she did not have any patient information. The reporter stated that at a different unspecified physician's office ROTATEQ, VAQTA, RECOMBIVAX and GARDASIL were exposed to 34F for 317 hours (13 days) and then they were exposed to 48F for 63 hours. The reporter stated that these doses may have been administered to an unspecified number of patients. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse. The reporter reported that at an unspecified physician office, VAQTA, RECOMBIVAX and GARDASIL were exposed to 33F for 70 temperature excursions which totaled 1173 hours out of range. She stated that during this time, these doses may have been administered to an unspecified number of patients. No adverse effects reported. The reporter stated she did not have any patient information. The reporter stated that at a different unspecified physician's office ROTATEQ, VAQTA, RECOMBIVAX and GARDASIL were exposed to 34F for 317 hours (13 days) and then they were exposed to 48F for 63 hours. The reporter stated that these doses may have been administered to an unspecified number of patients. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to approximate 270 (reported as "90-93 percent of 300") patients of unknown age and gender. The company representative reported that these patients who were assumed to received the M-M-R II (lot#, dose, route not reported) were infected with mumps. Outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse. The reporter reported than at an unspecified physician office, VAQTA, RECOMBIVAX and GARDASIL were exposed to 33F for 70 temperature excursions which totaled 1173 hours out of range. She stated that during this time, these doses may have been administered to an unspecified number of patients. No adverse effects reported. The reporter stated she did not have any patient information. The reporter stated that at a different unspecified physician's office ROTATEQ, VAQTA, RECOMBIVAX and GARDASIL were exposed to 34F for 317 hours (13 days) and then they were exposed to 48F for 63 hours. The reporter stated that these doses may have been administered to an unspecified number of patients. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse. The reporter reported that at an unspecified physician office, VAQTA, RECOMBIVAX HB and GARDASIL were exposed to 33F for 70 temperature excursions which totaled 1173 hours out of range. She stated that during this time, these doses may have been administered to an unspecified number of patients. No adverse effects reported. The reporter stated she did not have any patient information. The reporter stated that at a different unspecified physician's office ROTATEQ, VAQTA, RECOMBIVAX HB and GARDASIL were exposed to 34F for 317 hours (13 days) and then they were exposed to 48F for 63 hours. The reporter stated that these doses may have been administered to an unspecified number of patients. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse. The reporter reported that at an unspecified physician office, VAQTA, RECOMBIVAX HB and GARDASIL were exposed to 33F for 70 temperature excursions which totaled 1173 hours out of range. She stated that during this time, these doses may have been administered to an unspecified number of patients. No adverse effects reported. The reporter stated she did not have any patient information. The reporter stated that at a different unspecified physician's office ROTATEQ, VAQTA, RECOMBIVAX HB and GARDASIL were exposed to 34F for 317 hours (13 days) and then they were exposed to 48F for 63 hours. The reporter stated that these doses may have been administered to an unspecified number of patients. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse. The reporter reported than at an unspecified physician office, VAQTA, RECOMBIVAX and GARDASIL were exposed to 33F for 70 temperature excursions which totaled 1173 hours out of range. She stated that during this time, these doses may have been administered to an unspecified number of patients. No adverse effects reported. The reporter stated she did not have any patient information. The reporter stated that at a different unspecified physician's office ROTATEQ, VAQTA, RECOMBIVAX and GARDASIL were exposed to 34F for 317 hours (13 days) and then they were exposed to 48F for 63 hours. The reporter stated that these doses may have been administered to an unspecified number of patients. No adverse effects 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 registered nurse refers to a patient of unknown age and gender. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 14-APR-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA008203, 1405USA0082972, 1405USA008973, 1405USA008974, 1405USA008975, 1405USA008976, 1405USA008977, 1405USA008978, 1405USA008980, 1405USA008981, 1405USA008982). Additional information has been requested.
Age: 22.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients' identifiers were obtained. This report concerns one of the patients. On 06-MAR-2014 at 16:20, the 22 year old patient (gender not provided) was vaccinated with the first dose of GARDASIL (lot # J005661, exp. 26-SEP-2014) into left deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 17, 26/20; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.99
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 11 month old patient of unknown gender. No information on medical history, concurrent conditions or concomitant drugs was provided. On 05-FEB-2010, a few days prior to the patient's first birthday, the patient was vaccinated with M-M-R II, VARIVAX (Merck) and VAQTA. No lot#, expiration dates, doses, routes and sites of administration were reported for either of the vaccines. There was no adverse effect. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 2 month old patient of unknown gender. On 19-MAR-2014 the patient was vaccinated with ROTATEQ, lot # J003465, expiration date 04-AUG-2014 (dose not reported, dose in series unspecified) that was improperly stored at 52F on 15-JAN-2014 for 1 hour and at 33F on 19-MAR-2014 for 35 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 5 year old patient of unknown gender. On 02-APR-2014 the patient was vaccinated with (Oka/Merck) VARIVAX, lot # J006114, expiration date 19-MAY-2015, 0.5 ml once, subcutaneous (dose in series unspecified) that was improperly stored at 11.5F due to defrost cycling for an unspecified time frame. No adverse effects were reported. This is one of several reports received from the same source. 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 healthcare worker refers to a 4 year old patient of unknown gender. On 15-APR-2014 the patient was vaccinated with VARIVAX (Merck), lot # J006114, expiration date 19-MAY-2015, 0.5 ml once, subcutaneous (dose in series unspecified) that was improperly stored at 11.5F due to defrost cycling for an unspecified time frame. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.