chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient. On an unknown date in March 2007 (also reported as about 7 years ago) the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the patient experienced shingles, it was reported that the patient has continued to get cases of shingles about every two months and has developed shingles in the eye. It was reported that the patient sought medical attention and contacted a pharmacist (details unspecified). The outcome of shingles and shingles in the eye was unknown. The action taken with the therapy with ZOSTAVAX was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 4 month old female patient. On 07-MAR-2014 the patient was vaccinated with a dose of ROTATEQ (lot number: J008507, exp.date: 31-MAR-2015) oral liquid orally (strength and dose not provided). No adverse effect has been observed or reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a office manager (also reported as healthcare worker) refers to patients of unknown age. On an unknown date between 17-FEB-2014 to 21-MAR-2014, the patients were vaccinated with a dose of ROTATEQ, (lot number, expiry date was not reported) which was improperly stored and no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a second dose of VAQTA (dose, route, site of administration, lot #, expiration date not reported). No concomitant medications were reported. The nurse reported that the patient received a second dose of VAQTA 4 days before the recommended 6 months interval (date unspecified). No adverse effect reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 15 years old female patient. The patient had no pertinent medical history, drug reactions or allergies. On 19-NOV-2012, the patient had her first dose of GARDASIL (lot #, expiration date, dose were not reported) injection intramuscularly for human papillomavirus (HPV) prophylaxis. The patient had no other co-suspects or concomitant medications. On 19-NOV-2012 (reported as "today"), the patient was seen at the nurse practitioner's office and had a human chorionic gonadotropin (hCG) urine pregnancy test that was originally negative, subsequently had her first and only dose of GARDASIL administered, then the pregnancy test might have turned positive. The patient might have been in first trimester pregnancy. The patient had last menstrual period (LMP) on an unspecified day in October 2012 (reported as "last month in October 2012"). The estimated date of delivery (EDD) would be on an unspecified date in 2013. No treatment was given to the patient. The patient sought medical attention and went to the nurse practitioner's office. Follow up information has been received from certified registered nurse practitioner on 26-FEB-2014. Reporter provided information that the patient delivered normal infant with no congenital anomaly on an unspecified date in 2013. Delivery type, infant's gender, length or head circumference (HC) were not reported. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a office manager (also reported as healthcare worker) refers to patients of unknown age. On an unknown date between 17-FEB-2014 to 21-MAR-2014, the patients were vaccinated with a dose of PNEUMOVAX 23, (lot number, expiry date was not reported) which was improperly stored and no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a office manager (also reported as healthcare worker) refers to patients of unknown age. On an unknown date between 17-FEB-2014 to 21-MAR-2014, the patients were vaccinated with a dose of GARDASIL, (lot number, expiry date was not reported) which was improperly stored and no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a office manager(also reported as healthcare worker) refers to patients of unknown age. On an unknown date between 17-FEB-2014 to 21-MAR-2014, the patients were vaccinated with a dose of PEDVAXHIB, (lot number, expiry date was not reported) which was improperly stored and no adverse effects were reported. This is one of the several reports received from the same reporter. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL dose 2, intramuscularly. Dose and lot number were not reported. The nurse reported that the second dose of GARDASIL was administered later than recommended. No adverse effects were reported. The outcome of dose was administered later than recommended was unknown. Reporter causality assessment was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a currently 77 years old female consumer reporting on herself without drug reactions or allergies. The patient's medical history included shingles for the first time in approximately 1999 (reported as 15 years ago) and has many outbreaks since then. About 1-2 years ago, the patient was vaccinated with ZOSTAVAX (dose, route, strength, lot number and expiration date were not reported). Secondary therapies were not reported. Concomitant therapies included ZOCOR and pantoprazole. Consumer called in and reported that she has had two outbreaks of shingles, since getting ZOSTAVAX (reported as about 9 month after getting the shot). Patient currently had the rash all over both of her legs and arms, on face and possibly in her ear. At the time of the report, the patient had not recovered from the shingles. The patient did not receive treatment for the shingles. No labs diagnostics studies were performed. It was reported that patient sought medical attention by contact the physician's office. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Pt. developed a rash 3-19-14. 3-22-14. He was seen at urgent care 3-22-14. They did a VZV/HSV w/DFA - skin scraping. Resulted 3-26-14: Positive for varicella zoster. Was reported to state dept of health services 3-27-14.
Age: 91.0
Sex: M
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: A tin taste after having vaccine. Went to doctors. The tin taste I have when I eat food of any kind. Still get that horrible taste.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Pruritus, Urticaria
Clinical narrative: Redness inflammation extreme itchiness and hives from axilla to elbow lasting 7-10 days treated w/ antihistamine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Swelling, redness, no pain left arm.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative, refers to an immunocompromised patient of unknown age and gender. On an unspecified date, approximately 5 years ago (estimated as in 2009) the patient was vaccinated with a dose of ZOSTAVAX (dose, indication, lot # and expiration date were not reported). On an unknown date, the patient had been experiencing recurrent shingles flare ups. Outcome of event was not reported. Relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: MU
Symptoms: Laboratory test, Mumps
Clinical narrative: This spontaneous report was received from a Nurse refers to a female patient of unknown age. On an unknown date in December 1970, the patient was vaccinated with MUMPSVAX (dose, route and frequency were not reported). The reporter stated that on an unknown date in 1992, the patient received the vaccination and it was not clear whether she received MMR II or whether she received a single antigen measles vaccine. The reporter stated the only available information about the 1992 administration was the lot number 0809T. On an unknown date, the patient experienced mumps. On an unknown date, the lab samples have been submitted to the CDC. The nurse reported that the labs submitted to the CDC were serum and buccal swabs. The lab results were pending to confirm mumps diagnosis. The patient sought medical attention. The patient was not taking any treatment. The outcome of the event was reported as recovering. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
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 female patient of unknown age. The nurse reported that on an unknown date in 2007, the patient was vaccinated with the first dose of GARDASIL (dose, route and frequency were not reported). On an unknown date in January 2014, the patient was vaccinated with the second dose of GARDASIL (dose, route and frequency were not reported). No adverse effects reported. No further details were provided. Additional information is not expected.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Bedridden, Dyspnoea, Fall, Guillain-Barre syndrome
Clinical narrative: Patient began with balance difficulty 3-4 weeks post-vaccination. Complained of "loss of feeling" in feet about 6 weeks post-vaccination. Difficulty walking followed by falls 8-10 weeks post-vaccination. Presumptive Dx Guillain Barre. Treated for Guillain Barre syndrome with 5 days of IV gamma globulin. Patient did not regain loss of feeling/nerve damage in feet and was bed/wheelchair bound. Rehabilitation and physical therapy for 8+ weeks with little/no improvement. Transferred to long-term care nursing home after no improvement in physical therapy. In addition to loss of feeling waist down, patient is now incontinent.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Incontinence, Lumbar puncture, Nerve injury, Sensory loss
Clinical narrative: Patient began with balance difficulty 3-4 weeks post-vaccination. Complained of "loss of feeling" in feet about 6 weeks post-vaccination. Difficulty walking followed by falls 8-10 weeks post-vaccination. Presumptive Dx Guillain Barre. Treated for Guillain Barre syndrome with 5 days of IV gamma globulin. Patient did not regain loss of feeling/nerve damage in feet and was bed/wheelchair bound. Rehabilitation and physical therapy for 8+ weeks with little/no improvement. Transferred to long-term care nursing home after no improvement in physical therapy. In addition to loss of feeling waist down, patient is now incontinent.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Wheelchair user
Clinical narrative: Patient began with balance difficulty 3-4 weeks post-vaccination. Complained of "loss of feeling" in feet about 6 weeks post-vaccination. Difficulty walking followed by falls 8-10 weeks post-vaccination. Presumptive Dx Guillain Barre. Treated for Guillain Barre syndrome with 5 days of IV gamma globulin. Patient did not regain loss of feeling/nerve damage in feet and was bed/wheelchair bound. Rehabilitation and physical therapy for 8+ weeks with little/no improvement. Transferred to long-term care nursing home after no improvement in physical therapy. In addition to loss of feeling waist down, patient is now incontinent.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Arm swollen and erythematous from shoulder to elbow. Recommended cold compresses, rest, Tylenol as needed. Recheck if worsens.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist who reported that five infant patients between 2 and 10 months of age (gender not provided) were inadvertently administered a third dose of LIQUID PEDVAXHIB (dose, route, frequency and lot # not provided) two months after a second dose. No adverse effects were reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Dizziness, Respiratory arrest, Unresponsive to stimuli, Vomiting
Clinical narrative: Pt became unresponsive 5-10 minutes after receiving both vaccines. Pt's breathing also stopped. Epipen 0.3 mg was administered and pt became responsive again and dizzy. Paramedics were called and arrived then pt began to vomit and was taken to ER by ambulance.
Age: 64.0
Sex: M
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Anaphylactic shock, Respiratory arrest
Clinical narrative: Pt became unresponsive 5-10 minutes after receiving both vaccines. Pt's breathing also stopped. Epipen 0.3 mg was administered and pt became responsive again and dizzy. Paramedics were called and arrived then pt began to vomit and was taken to ER by ambulance.
Age: 28.0
Sex: M
Vaccine: TDAP, TYP, UNK
Symptoms: Blood test, Chest X-ray, Chills, Headache, Influenza virus test
Clinical narrative: At 10:00 patient started to experience severe headache/malaise.  patient was seen by military sick call and given Motrin 800mg.  Patient was experiencing fever at this time of 99.2.  Patient states he took the Motrin as prescribed.  At approxmiately 4:00PM the patient arrived home and was experiencing body chills and suffered an event of syncope.  Patient stated he woke up an hour later and went inside his home and took oral temperature (103.5) patient then called Change of command -patient advised to take Tylenol 650mg.  15 minutes later fever was still 103.5.  Patient was advised to call 911.  Patient was seen at hospital.
Age: 28.0
Sex: M
Vaccine: TDAP, TYP, UNK
Symptoms: Malaise, Pyrexia, Syncope, Urine analysis
Clinical narrative: At 10:00 patient started to experience severe headache/malaise.  patient was seen by military sick call and given Motrin 800mg.  Patient was experiencing fever at this time of 99.2.  Patient states he took the Motrin as prescribed.  At approxmiately 4:00PM the patient arrived home and was experiencing body chills and suffered an event of syncope.  Patient stated he woke up an hour later and went inside his home and took oral temperature (103.5) patient then called Change of command -patient advised to take Tylenol 650mg.  15 minutes later fever was still 103.5.  Patient was advised to call 911.  Patient was seen at hospital.
Age: 0.66
Sex: F
Vaccine: FLUX
Symptoms: Hypotonia, Laboratory test abnormal, Myelitis transverse
Clinical narrative: She started to become floppy with 24 hours.  We took her to the doctor and she went completely limp 24 hours after that.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site infection, Staphylococcal infection
Clinical narrative: Patient presented a prescription from her Dr. for bactroban ointment and said Dr. told her she had a staff infection. The infection was in the same area as vaccine was given.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Condition aggravated, Haematochezia
Clinical narrative: Blood-tinged stool (specks) started 2 days after receiving routine 2 month old vaccines, including Rotarix (RV1).  By 3/27/14 (today), still present.  No vomiting, no current-jelly stools, feeding well, no pain or fussiness, otherwise normal exam. Clinically not acting like intussusception -- just blood-specked stools.  (This could very well be cows-milk sensitivity, so will restrict cow and soy products from mom's diet [nursing] and change to elemental formula.)
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Headache, Herpes zoster, Nausea
Clinical narrative: Extreme swelling, itching, redness, hot; fever body aches, headache (2 weeks) shingles, nausea. (Pharmacy stated that 58% of patients have same "Rare" adverse effects but Merck considers "rare" or "uncommon") if I would have known (as many have online) I would have considered more carefully.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: Extreme swelling, itching, redness, hot; fever body aches, headache (2 weeks) shingles, nausea. (Pharmacy stated that 58% of patients have same "Rare" adverse effects but Merck considers "rare" or "uncommon") if I would have known (as many have online) I would have considered more carefully.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Eye pain, Migraine, Pyrexia
Clinical narrative: Severe migraine, fever, chills, couldn't open left eye without extreme pain to the point of almost passing out.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis, Chills, Injection site swelling, Kidney infection, Pyrexia
Clinical narrative: Cellulitis  pt was treated with antibiotics...fever chills swelling at injection site...pt also had kidney infection at time of cellulitis.
Age: 1.6
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Autism, Coordination abnormal, Incorrect dose administered, Mobility decreased, Motor dysfunction
Clinical narrative: Slow regression in movement, coordination, and motor functioning. Later diagnosed with high functioning autism. I distinctly remember the office being in a transition with medical records going to a more computerized system. I believe my son was  1. Had a bad reaction to the vaccine. 2. Was given the MMR vaccination twice.
Age: 1.6
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Slow regression in movement, coordination, and motor functioning. Later diagnosed with high functioning autism. I distinctly remember the office being in a transition with medical records going to a more computerized system. I believe my son was  1. Had a bad reaction to the vaccine. 2. Was given the MMR vaccination twice.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Induration, Rash erythematous, Skin warm
Clinical narrative: Red circle rash 3 inch in diameter, hot to the touch & hard.
Age: 1.81
Sex: F
Vaccine: HEPA
Symptoms: Lethargy, Rash macular, Urticaria
Clinical narrative: Red blotchy irregular shaped welts all over entire body: arms, hands, legs, feet, ears, cheeks. Lethargic. Administered Benadryl as instructed by pediatrician. No results were found. Administered oral steroids in afternoon and, now 5 hrs later still no change in symptoms.
Age: 0.76
Sex: F
Vaccine: HEP
Symptoms: Injection site rash
Clinical narrative: Very mild rash at the injection site and approx. 1 inch around the injection site.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Macule, Skin reaction
Clinical narrative: Localized skin reaction:  erythematous macule.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood culture, Body temperature increased, Chest X-ray normal, Febrile convulsion, Lumbar puncture normal
Clinical narrative: Pt was taken to ER 5 days after MMR vaccine via ambulance for febrile seizure. Temperature in ER was 105.4 rectally.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urine analysis normal, White blood cell count increased
Clinical narrative: Pt was taken to ER 5 days after MMR vaccine via ambulance for febrile seizure. Temperature in ER was 105.4 rectally.
Age: 37.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site swelling, Local swelling, Pyrexia
Clinical narrative: Left arm swelling from deltoid to forearm with redness and fever.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. there was no pertinent medical history, current conditions reported. On an unknown date the patient was vaccinated with LIQUID PEDVAXHIB, (dose, frequency, lot#, route not reported). No concomitant medications reported. On an unknown date medication error was reported were doses of LIQUID PEDVAXHIB were exposed to highest temperature of 53F for 21 hours. The healthcare worker does not know whether or not any of these improperly stored doses were administered to any patients since these excursions occurred. This case is linked to 140USA012856, 1403USA012857, 1403USA012858, 1403USA012859, 1403USA005464 (same reporter link) Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. There were no pertinent medical history, current conditions reported. It was unknown the patient was vaccinated with PNEUMOVAX 23, (dose, frequency, lot#, route not reported). No concomitant medications reported. On an unknown date medication error was reported were doses of PNEUMOVAX 23 were exposed to highest temperature of 53F for 21 hours. The healthcare worker does not know whether or not any of these improperly stored doses were administered to any patients since these excursions occurred. This case is linked to 1403USA012856, 1403USA012857, 1403USA012858, 1403USA005464, 1403USA012860 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This sponaneous rerpot as received from a pharmacist refers to a patient of unknown age and gender. On 24-SEP-2014 the patient was vaccianted with RECOMBIVAX HB dose 1, 1 ml, intramuscular and was administered second dose on 24-MAR-2014. No adverse effects were reported. Additonal information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site rash, Rash
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative refers to a 67 year old female patient. Pertinent medical history, drug reactions or allergies were not reported. On 18-MAR-2014, the patient was vaccinated with ZOSTAVAX (dose, route and lot # were not reported). Concomitant therapies included SYNTHROID. On 19-MAR-2041, the patient developed a rash at the injection site, spreading to the chest and neck area and had trouble breathing after receiving ZOSTAVAX. The patient was sent to the hospital and refused all medical treatment with the exception of a high dose of BENADRYL and was released from the hospital within 45 minutes. It was reported that the patient was not admitted into the hospital. At the time of the report, the patient had a little bit of a rash but was now feeling better, reported as recovering. Causality was not reported. Additional information has been requested.
Age: 70.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 70 year old patient (gender unknown). Pertinent medical history or current conditions were not reported. On 24-MAR-2014, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # H013847, expiry date: 15-MAR-2014, 0.5 ml, intramuscular. No adverse effect reported. 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 physician refers to an unknown number of patients of unknown age. On an unknown date, the unknown number of patients might have been vaccinated with doses of GARDASIL (lot # not reported) that were improperly stored. It was reported that the doses of GARDASIL were exposed to temperatures of 33F for 120 hours. No adverse effect reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: Infection at site - given antibiotic. Redness and swelling.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a female patient of unknown age. On 26-SEP-2013, the patient was vaccinated with first dose of GARDASIL (dose, route and frequency were not reported). It was reported that the patient still not received second dose of GARDASIL. No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Erythema migrans, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: Immediately after administration of Tdap, experienced left neck stiffness and tightness that lasted for 4 days. Gradually less stiff/tight over time. Continues intermittent "tightness" with neck rotation to the left side. Also stated "bulls eye" rash noted on left neck the day after vaccine administration.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Rash vesicular
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a 21 year old female patient with codeine allergy. the patient's medical history included positive PPD skin test (Tuberculin test), chicken pox and negative titers for varicella. On 04-MAR-2014 the patient was vaccinated with VARIVAX (Merck) (lot # reported as J013507, exp 31-OCT-2015) dose and route not reported). There was no concomitant therapy. The healthcare worker reported on an unspecified date in March 2014 the patient developed a vesicular rash after being vaccinated with VARIVAX (Merck). The reporter stated the patient received vaccinated with VARIVAX (Merck) because she was showing negative titers for varicella despite having had the chicken pox and the patient needed clearance for nursing school. the outcome of vesicular rash was reported as recovering. The patient sought medical attention by office visit. it was reported there was no lab diagnostics studies performed. 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 health department nurse refers to an unknown number of patients of unknown ages and genders. On unknown dates the patients were vaccinated with VARIVAX (Merck) injection which underwent a supported temperature excursion, but was outside the recommended temperature provided in the prescribing information, intramuscular (lot #, expiry date and dose unknown). No adverse effects reported. Additional information has been requested.
Age: 54.0
Sex: U
Vaccine: ANTH, FLUX, HEP, HEPA, IPV, MMR, SMALL, TYP, VARCEL, YF, ANTH, FLUX, HEP, HEPA, IPV, MMR, SMALL, TYP, VARCEL, YF
Symptoms: Abdominal discomfort, Arthralgia, Back pain, Bursitis, Cervical spinal stenosis
Clinical narrative: Muscles pain, back pains, legs, shoulder, fingers, upset stomach, joints hurt so much.
Age: 54.0
Sex: U
Vaccine: ANTH, FLUX, HEP, HEPA, IPV, MMR, SMALL, TYP, VARCEL, YF, ANTH, FLUX, HEP, HEPA, IPV, MMR, SMALL, TYP, VARCEL, YF
Symptoms: Musculoskeletal pain, Myalgia, Pain in extremity, Tendon injury, Tendonitis
Clinical narrative: Muscles pain, back pains, legs, shoulder, fingers, upset stomach, joints hurt so much.
Sex: U
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Limb discomfort, Musculoskeletal pain, Neuralgia, Pain in extremity
Clinical narrative: This spontaneous report as received from a patient of unknown age refers to herself/himself. On 10-JAN-2014 at 4:45 pm the patient was vaccinated with ZOSTAVAX Shingles Shot (route, dose and lot # were unknown). On 11-JAN-2014 3:00 the patient woke up to pain at the injection site and deeper into the muscle. The next few weeks it progressively got worse so the patient went back to her/his doctor complaining of nerve pain. That was almost 3 months ago (approximately in December 2013) and the patient was an suffering horrible in pain. The patient had 3 Magnetic Resonance Imaging (MRI)s to determine the problem, now on heavy painkillers where it was hard to focus at work, therefore, the patient's job was suffering. The patient had lost 12 lbs and had a host of side-effects from the drugs, including a minor car accident. The patient was in constant pain in right shoulder and suffer from terrible head and neck aches. The patient could not clean her/his house, could barely take care of her/his animals, could not cook for herself/himself any longer, could not garden or walk or do any of the things she/he once enjoyed. The patient's life was falling apart and it was all due to that preventive ZOSTAVAX Shingles Shot. The outcome of events was unknown. Additional information has been requested.
Sex: U
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Headache, Impaired work ability, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report as received from a patient of unknown age refers to herself/himself. On 10-JAN-2014 at 4:45 pm the patient was vaccinated with ZOSTAVAX Shingles Shot (route, dose and lot # were unknown). On 11-JAN-2014 3:00 the patient woke up to pain at the injection site and deeper into the muscle. The next few weeks it progressively got worse so the patient went back to her/his doctor complaining of nerve pain. That was almost 3 months ago (approximately in December 2013) and the patient was an suffering horrible in pain. The patient had 3 Magnetic Resonance Imaging (MRI)s to determine the problem, now on heavy painkillers where it was hard to focus at work, therefore, the patient's job was suffering. The patient had lost 12 lbs and had a host of side-effects from the drugs, including a minor car accident. The patient was in constant pain in right shoulder and suffer from terrible head and neck aches. The patient could not clean her/his house, could barely take care of her/his animals, could not cook for herself/himself any longer, could not garden or walk or do any of the things she/he once enjoyed. The patient's life was falling apart and it was all due to that preventive ZOSTAVAX Shingles Shot. The outcome of events was unknown. Additional information has been requested.
Sex: U
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Myalgia, Neck pain, Neuralgia, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report as received from a patient of unknown age refers to herself/himself. On 10-JAN-2014 at 4:45 pm the patient was vaccinated with ZOSTAVAX Shingles Shot (route, dose and lot # were unknown). On 11-JAN-2014 3:00 the patient woke up to pain at the injection site and deeper into the muscle. The next few weeks it progressively got worse so the patient went back to her/his doctor complaining of nerve pain. That was almost 3 months ago (approximately in December 2013) and the patient was an suffering horrible in pain. The patient had 3 Magnetic Resonance Imaging (MRI)s to determine the problem, now on heavy painkillers where it was hard to focus at work, therefore, the patient's job was suffering. The patient had lost 12 lbs and had a host of side-effects from the drugs, including a minor car accident. The patient was in constant pain in right shoulder and suffer from terrible head and neck aches. The patient could not clean her/his house, could barely take care of her/his animals, could not cook for herself/himself any longer, could not garden or walk or do any of the things she/he once enjoyed. The patient's life was falling apart and it was all due to that preventive ZOSTAVAX Shingles Shot. The outcome of events was unknown. Additional information has been requested.
Sex: U
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Road traffic accident, Weight decreased
Clinical narrative: This spontaneous report as received from a patient of unknown age refers to herself/himself. On 10-JAN-2014 at 4:45 pm the patient was vaccinated with ZOSTAVAX Shingles Shot (route, dose and lot # were unknown). On 11-JAN-2014 3:00 the patient woke up to pain at the injection site and deeper into the muscle. The next few weeks it progressively got worse so the patient went back to her/his doctor complaining of nerve pain. That was almost 3 months ago (approximately in December 2013) and the patient was an suffering horrible in pain. The patient had 3 Magnetic Resonance Imaging (MRI)s to determine the problem, now on heavy painkillers where it was hard to focus at work, therefore, the patient's job was suffering. The patient had lost 12 lbs and had a host of side-effects from the drugs, including a minor car accident. The patient was in constant pain in right shoulder and suffer from terrible head and neck aches. The patient could not clean her/his house, could barely take care of her/his animals, could not cook for herself/himself any longer, could not garden or walk or do any of the things she/he once enjoyed. The patient's life was falling apart and it was all due to that preventive ZOSTAVAX Shingles Shot. The outcome of events was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Injected limb mobility decreased, Injection site pain, Nasal congestion, Pallor
Clinical narrative: The child was calm and quiet during the administering of shots, she had 4 shots, then the nurse said something about giving her bandaids and got out the band aids and applied them, then the child lifted her head from where it was leaning on my shoulder and immediately started vomiting violently. I stood her up and she started vomiting again this time it was coming out of both her mouth and nose at the same time and she had a panicked expression on her face like she was having trouble breathing at which point I demanded the doctor come back into the room. We sat her down on the patient table and started cleaning her up, after sitting calmly for about 5 minutes I removed her clothes, and they brought me a paper gown and we dressed her, I then took her down from the table to stand and she vomited again. I cleaned her up again, we took her into another room changed her and had her sit for 15-20 minutes then we stood her up again more slowly and waited about 2 minutes, then had her walk around for a moment and she seemed ok, we went to leave and in the elevator she vomited again. During the entire time period from when she started vomiting she was very pale. I took her home gave her a bath, dressed her she complained that her arms hurt her where the shots had been given to the point of not wanting to move her arms. At bedtime she had difficulty because she couldn't lay on her sides, the next day she had her color back in her face, felt better and while her arms were sore to the touch they didnt bother her as long as noone touched her, the following day after that she said the pain in her arms were gone. Now this may be unrelated but the following Monday 3/24/14 (5 days after the shots) she vomited 3 times and has had a runny/stuffy/sneezy nose since.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rhinorrhoea, Sneezing, Vomiting
Clinical narrative: The child was calm and quiet during the administering of shots, she had 4 shots, then the nurse said something about giving her bandaids and got out the band aids and applied them, then the child lifted her head from where it was leaning on my shoulder and immediately started vomiting violently. I stood her up and she started vomiting again this time it was coming out of both her mouth and nose at the same time and she had a panicked expression on her face like she was having trouble breathing at which point I demanded the doctor come back into the room. We sat her down on the patient table and started cleaning her up, after sitting calmly for about 5 minutes I removed her clothes, and they brought me a paper gown and we dressed her, I then took her down from the table to stand and she vomited again. I cleaned her up again, we took her into another room changed her and had her sit for 15-20 minutes then we stood her up again more slowly and waited about 2 minutes, then had her walk around for a moment and she seemed ok, we went to leave and in the elevator she vomited again. During the entire time period from when she started vomiting she was very pale. I took her home gave her a bath, dressed her she complained that her arms hurt her where the shots had been given to the point of not wanting to move her arms. At bedtime she had difficulty because she couldn't lay on her sides, the next day she had her color back in her face, felt better and while her arms were sore to the touch they didnt bother her as long as noone touched her, the following day after that she said the pain in her arms were gone. Now this may be unrelated but the following Monday 3/24/14 (5 days after the shots) she vomited 3 times and has had a runny/stuffy/sneezy nose since.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Loss of consciousness, Tonic clonic movements
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 11 year old female patient, the daughter of the co worker (pharmacist). Patient's medical history was not reported. On 18-MAR-2014 the patient was vaccinated with GARDASIL (dose and frequency unknown). Patient's concomitant medications were unknown. On 18-MAR-2014 the patient experienced a seizure (medically significant), lost consciousness (medically significant) and tonic clonic movements (medically significant) after receiving GARDASIL. It was reported that the girl recovered within an hour of receiving the dose at her physician's office, but the girl was sitting on her mother's lap when she received the dose. The girl's mother reported that she demonstrated tonic-clonic movements for an unspecified brief period of time after she received the dose, and the mother lowered her daughter to the floor after she lost consciousness. The reporter states that soon after the girl was lowered to the floor, she regained consciousness. The girl was fully recovered within an hour, and she had no residual effects. The outcome the events were reported as recovered/resolved. The reporters causality assessment were not provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anti-ganglioside antibody negative, Areflexia, Diplopia, Electromyogram abnormal, Facial paresis
Clinical narrative: Teen presented 3/18 with facial weakness, diplopia, and tingly progressed with a descending weakness areflexia felt consistent with Miller Fisher syndrome - a Guillain Barre variant. Received IVIG x 5 days with improvement in facial palsies, but persistent weakness, sensory changes.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Immunoglobulin therapy, Laboratory test, Lumbar puncture normal, Metabolic function test, Miller Fisher syndrome
Clinical narrative: Teen presented 3/18 with facial weakness, diplopia, and tingly progressed with a descending weakness areflexia felt consistent with Miller Fisher syndrome - a Guillain Barre variant. Received IVIG x 5 days with improvement in facial palsies, but persistent weakness, sensory changes.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Paraesthesia, Sensory disturbance, VIIth nerve paralysis
Clinical narrative: Teen presented 3/18 with facial weakness, diplopia, and tingly progressed with a descending weakness areflexia felt consistent with Miller Fisher syndrome - a Guillain Barre variant. Received IVIG x 5 days with improvement in facial palsies, but persistent weakness, sensory changes.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling, Pain in extremity, Pyrexia
Clinical narrative: Pain and swelling left arm, fever.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist who stated that a nurse called him and said she had administered expired ROTATEQ, 2ml oral (lot#H015682), to an infant today (21-MAR-2014). The expiration date was 18-MAR-2014. No adverse effects were noted to the infant. No treatment was given for the infant. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. There was no pertinent medical history, current conditions reported. It was unknown the patient was vaccinated with GARDASIL, (dose, frequency, lot #, route not reported). No concomitant medications reported. On an unknown date medication error was reported were doses GSRDASIL were exposed to highest temperature of 53F for 21 hours. The healthcare worker does not know whether or not any of these improperly stored doses were administered to any patients since these excursions occurred. This case is linked to 1403USA012856, 1403USA012857, 1403USA012859, 1403USA005464, 1403USA012860 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. There was no pertinent medical history, current conditions reported. It was unknown the patient was vaccinated with VAQTA, (dose, frequency, lot#, route not reported). No concomitant medications reported. On an unknown date medication error was reported were doses of VAQTA were exposed to highest temperature of 53F for 21 hours. The healthcare worker does not know whether or not any of these improperly stored doses were administered to any patients since these excursions occurred. This case is linked to 1403USA012856, 1403USA012858, 1403USA012859, 1403USA005464 1403USA012860 (same reporter link). Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 5 year old female patient. On 25-MAR-2014 the patient was vaccinated with a dose of GARDASIL (route, dose, frequency and lot # were unknown). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Lip blister, Paraesthesia, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 15-MAR-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry date, route, dose, strength and indication not reported). The pharmacist reported that the unspecified patient experienced blisters on lower lip, itching and tingling after receiving ZOSTAVAX. The patient was advised by pharmacist to take CLARITIN and patient applied BENADRYL topically to blisters. The patient informed pharmacist that she experienced a huge redness and rash around injection site on 18-MAR-2014. The pharmacist asked if patient should see her unspecified physician. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy abnormal, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an unspecified number of non pregnant female patients of unknown age (reported also as girls). On an unknown date, the patients were vaccinated with GARDASIL (injection, dose, lot # and expiration date not reported). On an unknown date, the patients had Pap smears (papniculaou smears) and Colposcopies (also reported as treatment) performed with abnormal results. The patient had HPV (Human Papilloma Virus ) DNA (deoxyribonucleic acid) capture tewsts performed with no results provided (date unspecified). There was also reported that colposcopy was intervention to prevent serious criteria. The patients sought medical attention by office visit (date unspecified). The outcome of the events was not reported. The relatedness between the events and GARDASIL was not reported. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient (physician's wife) "in her 40's" (currently "in her 50's"). On unknown dates, when the patient was "in her 20's", she received two doses of VARIVAX (Merck) (dose, route and lot numbers not reported), respectively. On an unknown date, when the patient was "in her 40's", she was diagnosed with shingles. The outcome of shingles was reported as recovered/resolved (date unspecified). Relatedness between shingles and VARIVAX (Merck) was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
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 18-MAR-2014, the patient was vaccinated with expired dose of ZOSTAVAX (lot # reported as H0199996, dose not reported). No adverse events were reported. Patient's outcome was not reported. No PQC (Product Quality Complaint) was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin exfoliation
Clinical narrative: This spontaneous report as received via company representative from female physician assistant refers to herself (age unknown). The patient's medical history included eczema. On an unknown date (when she turned 60) the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration and lot # were not provided). The physician assistant reported that 3 months later she developed rash on her hand and her skin was peeling off. The patient saw her healthcare provider who placed her on unspecified antibiotics which didn't work. The patient then saw 3 unspecified dermatologists who could not figure out what it was. The patient reported that the rash went away completely after a year. The outcome of her skin was peeling off was unknown. Relatedness between rash on her hand, her skin was peeling off and ZOSTAVAX was unknown. Additional information has been requested.
Age: 47.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 47 years old patient (gender unknown). On 25-MAR-2014 the patient was vaccinated with PNEUMOVAX 23, injection, lot # H014196, expiry date 19-MAR-2014, dose (unknown), frequency (unknown), route of administration (unknown). No concomitants were reported. On 25-MAR-2014, the patient received an expired dose of PNEUMOVAX 23. No adverse effect has been observed or reported. Action taken with respect to PNEUMOVAX 23 was not applicable. No product quality complaint was involved. Outcome of events was unknown. Additional information has been requested.