chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Walking aid user
Clinical narrative: My husband, is retired, after 31 years of public service. He walked 7 miles every day, up and down the steps, and in every kind of weather, plus dogs. Most days he would come home soaked to the skin and cold, and for years he never got so much as the sniffles. My husband was a saint to his many patrons on his daily route, and a teddy bear that talked to me. Later after he retired, he sailed right thru his heart by-pass and prostate cancer, and he remained very active since he tends to be practical and upbeat in all circumstances. He has always credited  his flu shots with the reason my husband remained untouched by the illnesses most people would talk about, making the rounds thru the years. I noticed when the next day after the flu shot he said he somehow did not feel good. The next morning he said he felt lousy and dizzy, and he had a temperature, and a stomach ache. He is not a complainer, and I was baffled, so I called the clinic. To my surprise they wanted patient to come in that very afternoon. I'm reading the newspaper when an ambulance pulls up and five big neck attendants walked to the back with a stretcher. I thought someone back there is in trouble. MD came to the waiting area and told me not to be alarmed, but she was sending patient to the hospital. She did not want me to drive him to the hospital since she wanted him to be monitored on oxygen, and a IV started, during the trip. Patient got out of the hospital nine days later. I expected him to be on the mend and be his old cheerful self, but weeks went by then months went by, and he was never the same person. The main result was an unfathomable and unrelenting decline in strength and stamina, not recovered, faster than general aging could account for. He put himself into physical therapy but even that finally proved to be too much for him, even using a cane. My husband turned quiet and now can barely move or lift his feet, without fatigue. My husband never took another flu shot. Some previous flu shots dates: 10-24-2011, 9-29-2010, 10-30-2009, 11-3-2008, 11-19-01, 11-9-1999.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Hypoaesthesia, Lumbar puncture, Muscular weakness, Nerve conduction studies
Clinical narrative: Leg weakness, numbness, loss of feeling, nerve damage, falls. Weakness began within a couple weeks of receiving 3rd dose of HPV vaccine. 1st dose given with FLUMIST.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nerve injury, Nuclear magnetic resonance imaging, Sensory loss
Clinical narrative: Leg weakness, numbness, loss of feeling, nerve damage, falls. Weakness began within a couple weeks of receiving 3rd dose of HPV vaccine. 1st dose given with FLUMIST.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to a 62 year old male patient with allergy to oxycodone and PERCOCET. Pertinent medical history was not reported. On 19-SEP-2012, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot number were not reported). Concomitant medication was not reported. On 20-SEP-2012, the day after the vaccination, the patient experienced redness and warmth at injection site. The patient sought medical attention and was treated with KEFLEX for 7 days, an injection of dexamethasone and nonsteroidal anti-inflammatory drugs as needed. On an unknown date, the patient recovered from redness and warmth at injection site. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with ROTATEQ (lot#, dose unknown) oral. The reporter reported that ROTATEQ were exposed to a lowest temperature of 32F for a total of 1 hour over "four different occasions" and the improperly stored ROTATEQ were administered to an unspecified amount of patients. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date in 2014 the unspecified number of patients were vaccinated with ROTATEQ. Concomitant medications were not reported. It was reported that the ROTATEQ vaccine was exposed to 11 degree celsius (C) for 84.5 hours, and then for -2.5C for 47 hours in January 2014. These doses of ROTATEQ are administered consistently throughout the period of January 2014 to May 2014. No adverse effects were reported. The outcome of administered vaccine exposed to 11c for 84.5 hours and then for -2.5c for 47 hours and no adverse effects was unknown. This case was linked to 1406USA000152, 1406USA000392, 1406USA000393 and 1406USA000395 (same reporter link). Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Presents with red area on inner (L) leg at injection site of MMRV given 1 week ago 5/23/14, Center is raised and white w/darker red at edge of center. Pink surrounding area warm to touch and itchy. Pain last night but denies today after shot was pink area has gotten worse since 5/2.14. Afebrile, active, behaving normal. Redness about 60 mm across. Advised treat symptoms and monitor for infection, fever etc. Spoke w/mother 6/2/14, redness, swelling, heat all decreased, child behaves normal, afebrile.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date in 2014 the unspecified number of patients were vaccinated with VAQTA. Concomitant medications were not reported. It was reported that the VAQTA vaccine was exposed to 11 degree Celsius (C) for 84.5 hours, and then for -2.5C for 47 hours in January 2014. These doses of VAQTA are administered consistently throughout the period of January 2014 to May 2014. No adverse effects were reported. The outcome of administered vaccine exposed to 11C for 84.5 hours and then for -2.5C for 47 hours and no adverse effects was unknown. This case was linked to 1406USA000152, 1406USA000392, 1406USA000393 and 1406USA000394 (same reporter link). Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Immunizations given in office 5/27/14. Mom reports redness to (lt) arm began next day. (+) H.A. and low grade temp began ever of 5/27/14. Temp 102F 5/28/14. Seen in office for reaction on 5/29/14 9 cm x 1 1/2 cm area redness (lt) arm, no edema. Tx - BENADRYL; Return increased fever/redness.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Severe local reaction - induration and erythema 18cm x 15cm.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: K.D. immunizations given 05/27/14 in office. Seen in office 05/29/14 for s/s -> (Lt) arm with edema, warmth and erythema beginning next day (5/28/14). Tx with KEFLEX (250/5) x 10 days; Ibuprofen - PRN.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain
Clinical narrative: 24 hours post vaccination, patient had itchiness, redness, and pain at the vaccination site. Took some TYLENOL and it seemed to help.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Abdominal pain, Blood culture negative, Culture urine negative, Intussusception, Pyrexia
Clinical narrative: 2 mo check up and vaccines given - 5/20/14. Fever next day to 102 and seen in ED. Cultures drawn and sent home. Better 5/22 and 5/23. 5/24 -> Fever returned with significantly increased abd pain. 5/25 -> Sent to ED and admitted. Abd ultrasound showed small bowel intussusception that resolved during US. Sent home next day and has improved.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: 2 mo check up and vaccines given - 5/20/14. Fever next day to 102 and seen in ED. Cultures drawn and sent home. Better 5/22 and 5/23. 5/24 -> Fever returned with significantly increased abd pain. 5/25 -> Sent to ED and admitted. Abd ultrasound showed small bowel intussusception that resolved during US. Sent home next day and has improved.
Age: 45.0
Sex: F
Vaccine: ANTH
Symptoms: Abdominal discomfort, Cold sweat, Headache, Influenza like illness, Nausea
Clinical narrative: Patient received Anthrax vaccine on 5/18/14. Experienced cold sweats, nausea and headache. Also stated an upset stomach. Went to hospital ER on 5-19-14. Was treated for flu like symptoms and released. Given TYLENOL, ibuprofen and ZOFRAN.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Redness, swelling, small rash.
Age: 0.44
Sex: F
Vaccine: PNC13
Symptoms: Hypopnoea, Lethargy, Respiratory rate decreased, Somnolence
Clinical narrative: Patient went to sleep in the car on the drive home from physician's office. Her breath during sleep became extremely slow and shallow, worrying her mother that she would stop breathing. Mother tried to wake patient by saying her name, speaking loudly, and clapping her hands. Patient opened her eyes after approximately two minutes of attempts to wake her, but continued to appear extremely lethargic. Upon arrival home, the patient appeared alert and happy for 30 minutes, then fell asleep again. During this sleep her breath became very slow and shallow yet again, so parents stayed next to her to watch for additional symptoms while she slept. After three hours of deep sleep, patient awoke but acted lethargic for the rest of the evening. Was normal the following day and no additional treatment was needed.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Rash macular
Clinical narrative: Splotchy red raised areas with an outer red ring. Painful. These symptoms appeared less angry after I was up for awhile. Pain still present and only if touched. I just wondered if I should ever have the injection again.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: RIGHT LEG ALL SWOLLEN - NO PAIN - ONLY SWELLING. RIGHT LEG MEASURED 10 1/2 INCHES ABOVE KNEE, UPPER THIGH RIGHT 12 1/4. COMPARING TO LEFT 9 1/2 ABOVE KNEE AND UPPER THIGH 11 1/4.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Fever up to 101, vomiting, & rash for about 3wks.
Age: 18.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Oedema, Panic attack, Pyrexia
Clinical narrative: The patient experienced fever, edema and hot in the left arm which started on 11/6/13, at night. Four days later, he woke up in the middle of the night with a panic attack that he attributed to the vaccine. He called a doctor who recommended that he take 2 tablets of hydroxyzine. The left arm recovered but the edema moved to the forearm. Then, all symptoms disappeared.
Age: 0.66
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Condition aggravated, Dyspnoea, Echocardiogram abnormal, Endotracheal intubation, Hypophagia
Clinical narrative: Approximately 3 days after receiving vaccines, patient experienced increased work of breathing and decreased po intake. Patient was intubated for respiratory distress.
Age: 0.66
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pericardial effusion, Respiratory distress
Clinical narrative: Approximately 3 days after receiving vaccines, patient experienced increased work of breathing and decreased po intake. Patient was intubated for respiratory distress.
Age: 1.01
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 2 cm firm red swelling in (L) thigh at site of Varicella and Hep A vaccines 7 days after vaccines given.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Patient's elderly mother reported event to me about a week and a half after reaction of arm swelling at injection site - for which she visited PCP on 5/2. I contacted patient, but she did not return phone call.
Age: 53.0
Sex: F
Vaccine: HEPA, IPV
Symptoms: Dizziness, Hypoaesthesia, Increased upper airway secretion, Pharyngeal oedema
Clinical narrative: Numbness of shoulder 5 min or less from injection, throat swollen 30 minutes later, drainage in throat, dizziness 5 min or less from injection.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: C/O rash on neck, face, forearm.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: A round circle the diameter of a 50 cent piece where the vaccine was administered. It is still there this day, although faded.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient reported silver dollar sized red, itchy area at injection site.
Age: 15.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Rash
Clinical narrative: This patient was consulted with over the phone in February. At the time he said he developed a rash that did not go away. However on follow-up for VAERS we have not been able to reach after multiple attempts.
Age: 15.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Drug administered to patient of inappropriate age, Rash
Clinical narrative: This patient was consulted with over the phone in February. At the time he said he developed a rash that did not go away. However on follow-up for VAERS we have not been able to reach after multiple attempts.
Age: 1.38
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Periorbital oedema, Polymerase chain reaction, Pyrexia, Rash
Clinical narrative: On 5/29/14 approx. 9:30PM pt presented to ED with c/o fever and mild peri orbital edema.  Pt was given Benadryl and prednisone to treat the peri orbital edema.  On 5/31/14 pt developed a rash in the am.  Pt presents to office for evaluation today (6/2/14) and was diagnosed with chicken pox.  Pt has between 50 - 249 lesions present on her body.  Vesicle lesion was unroofed and specimen obtained to confirm the diagnosis.
Age: 1.38
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Skin lesion, Varicella, Varicella virus test
Clinical narrative: On 5/29/14 approx. 9:30PM pt presented to ED with c/o fever and mild peri orbital edema.  Pt was given Benadryl and prednisone to treat the peri orbital edema.  On 5/31/14 pt developed a rash in the am.  Pt presents to office for evaluation today (6/2/14) and was diagnosed with chicken pox.  Pt has between 50 - 249 lesions present on her body.  Vesicle lesion was unroofed and specimen obtained to confirm the diagnosis.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Pain
Clinical narrative: Chills, body aches, severe headache, tiredness temp 100.4 - 102.  Lasted 36 hours.  Tiredness, headache lasted 48.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pain, Rash pruritic
Clinical narrative: 3-4 inch area around the injection site became very red and warm to touch, and an itchy & painful rash appeared on both arms, scalp and forehead that was exposed to about 30 minutes of sunlight. Treated with anti-itch cream.
Age: 0.62
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal pain, Barium enema, Enema administration, Intussusception, Ultrasound abdomen
Clinical narrative: Abdominal pain 5/31/14 -> went to ER. Diagnosed with intussusception of colon. Corrected by barium enema.
Sex: M
Vaccine: HPV4
Symptoms: Grand mal convulsion
Clinical narrative: This spontaneous report as received from a mother via company representative refers to a male child patient of unknown age. The field representative states a Local TV news show on 28-MAY-2014 referenced GARDASIL safety concerns. The representative investigated the information on 29-MAY-2014 and found an article, on the website. The article includes adverse event information from a mother, reporting her two children (related sibling case 1406USA000479). On an unknown date the patient was vaccinated with GARDASIL (lot number and dose not reported). No other concomitant medications were reported. On an unknown date the patient experienced grand mal seizure (medically significant) after administration of GARDASIL. No product quality issue involved. The outcome of grand mal seizure is unknown. The causality of grand mal seizure is not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date in 2014 the unspecified number of patients were vaccinated with LIQUID PEDVAXHIB. concomitant medications were not reported. It was reported that the LIQUID PEDVAXHIB vaccine was exposed to 11 degree celsius (C) for 84.5 hours, and then for -2.5C for 47 hours in January 2014. These doses of LIQUID PEDVAXHIB are administered consistently throughout the period of January 2014 to May 2014. No adverse effect were reported. The outcome of administered vaccine exposed to 11C for 84.5 hours and then for -2.5c for 47 hours and no adverse effects was unknown. This case was linked to 1406USA000152, 1406USA000392, 1406USA000394 and 1406USA000395 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date in 2014 the unspecified number of patients were vaccinated with M-M-R II. Concomitant medications were not reported. It was reported that the M-M-R II vaccine was exposed to 11 degree celsius (C) for 84.5 hours, and then for -2.5C for 47 hours in January 2014. These doses of M-M-R II are administered consistently throughout the period of January 2014 to May 2014. No adverse effects was unknown. This case was linked to 1405USA000152, 1406USA000393, 1406USA000394 and 1406USA000395 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists refers to a patient of unknown age. On 25-APR-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX, lot # J013451, expiration date 24-JAN-2014 (dose and route not reported) with worst case exposure of 34F for 506 hours, Dates of excursions: 06-MAR-2014 to 25-APR-2014. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On 29-MAY-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous (dosing regimen unspecified). Other suspect therapies included: approximately on an unknown date in May (also reported as 2 weeks ago), PNEUMOVAX23 subcutaneous (dosing regimen unspecified). No concomitant therapy was reported. Approximately on 29-MAY-2014 the patient experienced a small spot of erythema at the ZOSTAVAX injection site after the injection of ZOSTAVAX and medication error was reported that patient received PNEUMOVAX23 2 weeks ago, and then received ZOSTAVAX on 29-MAY-2014. There was no product quality complaint (PQC) involved. The patient's present status was unspecified. No further data was provided by the caller at the time of the call. The outcome of a small spot of erythema at the ZOSTAVAX injection site and patient received PNEUMOVAX23 2 weeks ago, and then received ZOSTAVAX on 29-MAY-2014 is unknown. Causality of the event small spot of erythema at the ZOSTAVAX injection site after the injection of ZOSTAVAX was not provided. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Pt showed up 2 days after receiving the MENACTRA vaccine with a swollen, edematous, erythematous, and warm left upper arm where vaccine was given. Treated with BENADRYL, warm compresses, and Clindamycin.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists refers to a patient of unknown age and gender. On 22-APR-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX, lot # J013451, expiration date 24-JAN-2014 (dose and route not reported) with worst case exposure of 34F for 458 hours, Dates of excursions: 06-MAR-2014 to 22-APR-2014. No adverse effects were reported. This is one pf several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (L.V.N) refers to an unspecified number of patients of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route, lot# and expiration date unknown). On an unknown date the patients received a second or third dose GARDASIL late, due to patients not showing up for appointments. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists refers to a patient of unknown age and gender. On 21-APR-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX, lot # J013451, expiration date 24-JAN-2014 (dose and route not reported) with worst case exposure of 34F for 434 hours, Dates of excursion: 06-MAR-2014 to 21-APR-2014. No adverse effects were reported. This is one of several reports received from the same source. 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 licensed vocational nurse (L.V.N) refers to some patients of unknown age. On an unknown date the patients were vaccinated with Hepatitis A vaccine (manufacturer unknown) dose 1 (dose, route, lot# and expiration date unknown). On an unknown date the patients received their booster dose of hepatitis A vaccine, (manufacturer unknown) too early. No adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists refers to a patient of unknown age and gender. On 21-FEB-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX, lot # J007854, expiration date 28-SEP-2014 (dose and route not reported) that was exposed to 28F for 432 hours, Dates of excursions: 01-FEB-2014 to 21-FEB-2014. No adverse effects were reported. This is one several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists refers to a patient of unknown age and gender. On 20-FEB-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX, lot # J007854, expiration date 28-SEP-2014 (dose and route not reported) that was exposed to 28F for 408 hours, Dates of excursions: 01-FEB-2014 to 20-FEB-2014. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists refers to a patient of unknown age and gender. On 28-FEB-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX, lot # J007854, expiration date 28-SEP-2014 (dose and route not reported) that was exposed to 38F for 576 hours, dates of excursions: 01-FEB-2014 to 28-FEB-2014. No adverse effects were reported. This is one of several reports received from the same source. 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 two pharmacists refers to a patient of unknown age and gender. On 20-MAR-2014 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck), lot # J008229, expiration date 12-JUL-2015 (dose and route not reported) with worst case exposure of 39F for 588 hours, but must be used within one month. On 04-MAY-2014, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck), lot # J008229, expiration date 12-JUL-2015 (dose and route not reported) that exposed to 39F for 1154 hours, Dates of excursions: 01-FEB-2014 to 04-MAY-2014. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's medical history was not reported. On 23-MAY-2014 the patient was inadvertently vaccinated with a less than complete dose of ZOSTAVAX (subcutaneous, lot#, expiration date, anatomical location not reported) due to leakage from the needle. Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Malaise, Measles post vaccine
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Patient's medical history and concurrent condition was not reported. On an unknown date in April, those unspecified number of patient's who were exposed with an active case of measles were administered a dose of M-M-R II vaccine, with the dose of 0.5 ml, subcutaneous, in less than 72 hours after exposure to measles. On unspecified dates within a week or so of exposure, those patients developed measles which was described as those patients got sicker than patient's who were exposed to the measles and were not vaccinated. PQC was not involved. The outcome of the events was unknown. Reporter's causality assessment was not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Prostatic specific antigen increased
Clinical narrative: This spontaneous report as received from a healthcare student refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route and lot# unknown). On an unknown date the patient experienced developed elevated prostatic specific antigen (PSA) levels. The outcome of the event was unknown. The causality of the event and with ZOSTAVAX was unknown. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a health care worker refers to a 19 year old patient with no drug reaction, allergies and no concomitant medication reported. On unknown date the patient was vaccinated with GARDASIL. The patient had the first dose of GARDASIL at 16 years of age (in approximately 2011) and was at age 19 years of age to receive the second dose of GARDASIL (dose 2, 0.5 ml, intramuscular) today (on 14-MAY-2014). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 4 years old female patient with no illness at the time of vaccination. On 27-MAR-2014, in the morning, the patient was vaccinated in the left posterior upper arm with a dose of VARIVAX (dose, route were not reported, lot: J007952, expiry date: 27-JUN-2015) that was improperly stored. The freezer temperature was 7.3 F for 1 hour, 12 minutes. No known adverse reaction was reported. This is one of three reports from the same reporter. Additional information is not expected.
Age: 0.58
Sex: M
Vaccine: HEP, HIBV, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given KINRIX which is contraindicated for children under 4 years old.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Pain where shot was given, headache, tiredness, chills, body aches, sore joints, swollen glands.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Pain where shot was given, headache, tiredness, chills, body aches, sore joints, swollen glands.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash maculo-papular
Clinical narrative: Diffuse maculopapular rash - onset < 24 hours after vaccine.
Age: 1.57
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Dry skin, Injection site reaction, Rash, Rash erythematous, Skin warm
Clinical narrative: Parents brought child to clinic presenting with a rough, slightly raised, red rash on left thigh at injection site of DTaP vaccine. Had moderate amounts of red dots throughout both legs, and small amount on abdomen and back. Child was alert, playful, warm to touch. Parents denied fever, loss of appetite, N/V. Advised to go pediatrician as soon as possible. Did not have one, so gave them copy of community clinic.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker concerning an unknown number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of PNEUMOVAX 23 (dose, frequency, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare worker reported that on an unknown date, an improperly stored PNEUMOVAX 23 may have all been administered. The healthcare worker that she would call back once she knows for sure which vaccines had been administered. The healthcare worker reported that the PNEUMOVAX 23 was exposed to a temperature of 1.5C for 25 minutes. No adverse effect reported. Additional information has been requested. These are one (1) of five (5) reports from the same reporter. (MARSS 1405USA012173, 1406USA000568, 1406USA000569, 1406USA000570 and 1406USA000571).
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker concerning an unknown number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of ROTATEQ (dose, frequency, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare worker reported that on an unknown date, an improperly stored ROTATEQ may have all been administered. The healthcare worker reported that the ROTATEQ were exposed to a temperature of 1.5C for 25 minutes. No adverse effect reported. Additional information has been requested. There are one (1) of five (5) reports from the same reporter. (MARSS 1405USA012173, 1406USA000568, 1406USA000569, 1406USA000570 and 1406USA000571).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness
Clinical narrative: Within 5 minutes of ZOSTAVAX, pt became lightheaded and felt weak. BP remained normal, pt not diaphoretic. Fluids, food and 20 min of rest resolved symptoms.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker concerning an unknown number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of VAQTA (dose, frequency, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare worker reported that on an unknown date, an improperly stored VAQTA may have all been administered. The healthcare worker that she would call back once she knows for sure which vaccines had been administered. The healthcare worker reported that the VAQTA was exposed to a temperature of 1.5C for 25 minutes. No adverse effect reported. Additional information has been requested. These are one (1) of five (5) reports from the same reporter. (MARSS 1405USA012173, 1406USA000568, 1406USA000569, 1406USA000570 and 1406USA000571).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker concerning an unknown number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of GARDASIL (dose, frequency, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare worker reported that on an unknown date, an improperly stored GARDASIL may have all been administered. The healthcare worker that she would call back once she knows for sure which vaccine had been administered. The healthcare worker reported that the GARDASIL were exposed to a temperature of 1.5C for 25 minutes. No adverse effect reported. These is one (1) of five (5) reported from the same reporter. (MARRS 1405USA012173, 1406USA000568, 1406USA000568, 1406USA000569, 1406USA000570 and 1406USA000571). 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 healthcare worker concerning an unknown number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of RECOMBIVAX HB (dose, frequency, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare worker reported that on an unknown date, an improperly stored RECOMBIVAX HB may have all been administered. The healthcare worker that she would call back once she knows for sure which vaccines had been administered. The healthcare worker reported that the RECOMBIVAX HB was exposed to a temperature of 1.5C for 25 minutes. NO adverse effect reported. Additional information has been requested. This is one (1) of five (5) reports from the same reporter. (MARRS 1405USA012173, 1406USA000568, 1406USA000569, 1406USA000570 and 1406USA000571).
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: LA hot to touch with redness 6cm swelling.
Sex: U
Vaccine: MMR
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a pediatric patient of unknown age. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route and lot # not reported). The healthcare worker reported that on an unknown date, the patient experienced unspecified type of reaction after receiving M-M-R II. The patient's mother did not want to give M-M-R II to her younger child because her older child (patient for this AE) experienced some type of adverse effects after receiving M-M-R II. The outcome of unspecified type of reaction was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, concerning an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (dose, strength, lot number were not reported), intramuscular. Co-suspect and concomitant therapies were not reported. The register nurse reported that an unknown number of patients had received VARIVAX (Merck) since 19-MAY-2014, that had went through a supported temperature excursion. No adverse effects reported. Additional information has been requested. These case is one (1) of two (2) reports from the same reporter. (MARRS 1405USA015715 and 1406USA000619).
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, concerning an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, strength, lot number and lot number were not reported), intramuscular route. Co-suspect and concomitant therapies were not reported. The register nurse reported that an unknown number of patients had received ZOSTAVAX since 19-MAY-2014, that had went through a supported temperature excursion. No adverse effects reported. Additional information has been requested. These case is one (1) of two (2) reports from the same reporter. (MARRS 1405USA015715 and 1406USA000619).
Age: 1.03
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old female patient. On 13-MAR-2014, the patient was vaccinated with a 0.5 ml dose of VAQTA (Lot # J011385, expiration date 10-MAR-2016) intramuscularly. The nurse reported that the patient previously received a dose of hepatitis A virus vaccine (manufacturer unknown) (dose, route and lot # not reported) in another country on 01-MAR-2014. No adverse effects were reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Presyncope
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative, concerning a 16 year old female patient. Medical history and concurrent conditions were not reported. On 28-MAY-2014, the patient was vaccinated with the first dose of GARDASIL (strength, lot number and expiration date were not reported), intramuscular route, 0.5 ml. Co-suspect and concomitant therapies were not reported. On 29-MAY-2014, the patient experienced pre-syncope, consisting of lightheadedness, which remains unresolved. At the time of the report the outcome was not recovered. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chills, Pyrexia, Tremor
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a 71 year old male patient with penicillin allergy. On 14-MAY-2014 the patient was vaccinated with ZOSTAVAX lot # J013137, 0.65 ml, subcutaneous. Concomitant therapies included digoxin. In the evening of 14-MAY-2014, the patient experienced a fever of 103 degrees F. He also experienced an increase in blood pressure, chills and shaking that lasted for 2 days. The patient visited the pharmacy to sought medical attention. There was no treatment given for the events. At reporting time, his blood pressure was back to normal and there were no chills and no shaking increase in blood pressure. His temperature was 100 degrees F. The patient's present status was reported as recovering. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Malaise, Rash, Urticaria
Clinical narrative: This spontaneous report as received from the patient's husband via Poison and Drug Center refers to a 60 year old female patient. The patient's past medical history, past drug history, and concomitant medications were all unknown. On 19-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX, injection (dose, lot# and site not reported). On 23-MAY-2014, the patient began not feeling well, with an overall feeling of lethargy. She also developed a raised rash with welts under one of her eyes and a similar rash that run in a two-inch long line down the back of her neck. It was unknown if any relevant labs were performed. As of 24-MAY-2014, the husband reported he would be notifying his wife's physician of this reaction. The outcome of the events was unknown. It was not reported if the events were related to ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 years old female patient with no pertinent medical history and no drug reactions or allergies. The reporter stated that she held a ZOSTAVAX clinic, on 02-MAY-2014, patient was administered with ZOSTAVAX lot number K000456, expiration date-15-DEC-2014, dose single dose, route SQ. On an unknown date in May 2014, patient the patient developed redness, swelling and induration at injection site. The pharmacist stated she became aware of the adverse events the patient was experiencing on the weekend (03-MAY-2014 and 04-MAY-2014). The vaccine clinic took place at a high school. Vaccine recipient was teacher. The pharmacist spoke to the school nurse on Monday 05-MAY-2014. The school nurse shared with the pharmacist that the adverse experiences, the teacher was experiencing, was resolving. There was no hospitalization. No specific treatments mentioned. The pharmacist shared the initials, gender and age of each ZOSTAVAX vaccine recipient. All vaccine recipients were women. The pharmacist learned from school nurse that one of the patient experiences of redness spread to over 5 inches from injection site, the pharmacist unable to identify which patient. Patient sought medical attention (called pharmacy). The patient did not receive treatment for the adverse event. There was no Lab diagnosis or studies performed. The outcome of redness, swelling and induration at injection site was recovering. No product quality complaint was involved. This is one of 9 reports from the same source. Additional information has been requested.
Age: 0.57
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a medical assistant refers to a male patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The medical assistant also stated that one of the unspecified patients first received a dose of ENGERIX B, which is not going to be counted due to the improper storage, then received a dose of RECOMBIVAX HB, then received another dose of ENGERIX B and will be receiving another dose of RECOMBIVAX HB so that he actually completes a full hepatitis B series. The outcome of the event reported is unknown. This case is linked to the case 1405USA004386 via same reporter link. Follow up information had been received from the certified medical assistant refers to the 6 month old male patient. The patient received a first dose of ENGERIX B at an unspecified hospital on an unspecified date; it was reported the vaccine was stored improperly, reported as "too cold". The certified medical assistant was instructed by GlaxoSmithKline to revaccinate the patient. The patient was vaccinated with RECOMBIVAX HB on 22-NOV-2013 and 19-MAY-2014 (lot numbers and expiration dates unavailable at this time) and the patient was due to receive his third dose of RECOMBIVAX HB at his 9 month appointment (date unspecified) at the time of report. The reporter also stated the office did not have any storage issues with RECOMBIVAX HB. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Feeling hot, Nodule, Pain, Pruritus
Clinical narrative: Mild fever - few hours. Soreness - 5/24 - 5/26. Itching - 5/27 - 5/30. Small knot - 5/26 - 5/30. Swelling 22 x 32 mm w/ redness, warmth.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Swelling
Clinical narrative: Mild fever - few hours. Soreness - 5/24 - 5/26. Itching - 5/27 - 5/30. Small knot - 5/26 - 5/30. Swelling 22 x 32 mm w/ redness, warmth.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Reported red, swollen, hot, itchy at site 515p on 6/1/14.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Reddened area 1" x 1" size at VARIVAX injection site right thigh.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Induration, Local swelling
Clinical narrative: Red, raised swelling and hard to touch, warm skin. Dr. at a unrelated appt. -> said cellulitis and put her on antibiotics.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Administered vaccines, within 5 minutes after, patient fainted for about 15 seconds before coming to.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Left deltoid swelling/induration (5x9 cm).
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Groin pain, Muscle strain
Clinical narrative: Groin pain. Saw pediatrician 6/2/14 - muscle strain.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Dizziness, Local swelling, Mobility decreased, Pain, Vomiting
Clinical narrative: Pt called and complains of vomiting, dizziness, arm swelling and pain of the right side, can't pick up arm.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Neuritis
Clinical narrative: Site of injection overnight developed swelling, redness and warm to touch. Some neuritis.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral coldness
Clinical narrative: Pt reported to me Sat 5/31/14 at 9:05AM. Says 1-2 weeks after receiving vaccine he suffers total numbness in lower extremity waist down, lasts 15 minutes to 1/2 hour. Stabbing pains in feet, frozen. Occurs every day, last 15 min - 1 hr. Feels like standing on ice. Toes frozen. Normal for another 2-3 hours.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness at lt injection site and hot.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Catheterisation cardiac, Chest X-ray, Chills, Computerised tomogram, General physical health deterioration
Clinical narrative: I returned to the doctors office a day or so later with headache, swelling and discoloration at injection site, fever, chills, severe pain in left arm where injection was given.  The dr sent me for a chest x-ray the same day as my return visit.  Then told me that I had pneumonia.  Was given injections and had 3 return visits that week. Over the next couple of months I noticed an increase in respiratory problems. In September was told that I have several respiratory diseases.  Have been declining in health rapidly.  Now even when I just set up or stand my SpO2 declines into the upper  70 or low 80.