chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from an unspecified non health professional via a company representative refers to a patient of unknown age and gender. It was reported that the patient received 4 doses of GARDASIL (route, dose and lot # not reported) (date unspecified). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a 61 year old female patient. On 15-AUG-2014 the patient was vaccinated with ZOSTAVAX lot # J004311; expiry: 12-JUL-2014, 0.65 ml (millilitres), subcutaneous in the left arm. No concomitant medications were reported. On 15-AUG-2014, the patient was administered with expired vaccine of ZOSTAVAX. The outcome of administered with expired vaccine is unknown. No adverse effects reported. There was no product quality complaint (PQC) involved. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: About 5 minutes after receiving the shot, patient experienced itching and redness around the injection site as well as itching on the scalp. Patient immediately took 50 mg of BENADRYL and itching resolved in 10-15 minutes. Patient to continue with BENADRYL 50 mg every 4-6 hours and follow-up with PCP if necessary.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to a patient of unknown age. On 12-AUG-2014 the patient was vaccinated with ROTATEQ (lot # was not reported). The reported ROTATEQ was exposed to temperatures outside of the proper storage range. No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Bronchospasm, Chest discomfort, Cough, Dysphonia, Eye discharge
Clinical narrative: Less than 40 min after receiving MMR #2 and VZV #2, and KINRIX (DTaP #4, IPV-polio #4) child developed streaming eye, clear rhinorrhea, coughing, "tight" chest - bronchial constriction with wheezing, tongue slightly thickened and thickened voice. Initially given diphenhydramine 25 mg po for watery eyes, then given EPI PEN 0.15 mg for resp. symptoms.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Lacrimation increased, Respiratory disorder, Rhinorrhoea, Tongue disorder, Wheezing
Clinical narrative: Less than 40 min after receiving MMR #2 and VZV #2, and KINRIX (DTaP #4, IPV-polio #4) child developed streaming eye, clear rhinorrhea, coughing, "tight" chest - bronchial constriction with wheezing, tongue slightly thickened and thickened voice. Initially given diphenhydramine 25 mg po for watery eyes, then given EPI PEN 0.15 mg for resp. symptoms.
Age: 0.83
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of RECOMBIVAX HB (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-mintues. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 9 month old patient who on 10-JUN-2014 was vaccinated with improperly stored dose of RECOMBIVAX HB lot#J012567, expiration date 30-JAN-2016 (dose and site of administration not reported). This is one of several reports received from the same reporter. Additional information is not expected.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 4 month old patient of unknown gender who on 09-JUL-2014 was vaccinated with improperly stored dose of ROTATEQ oral, lot#J011344, expiration date 10-MAY-2015 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Oedema, Pain
Clinical narrative: One big red circle around injection site also swollen and fever in it and another red blotch below that one. Severe pain, local pain and edema.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular
Clinical narrative: One big red circle around injection site also swollen and fever in it and another red blotch below that one. Severe pain, local pain and edema.
Age: 75.0
Sex: F
Vaccine: FLUC3, PPV, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: Patient developed a large welt (big raised rash) on arm extending from left shoulder to elbow, (Itching, pain).
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old male patient. Nurse stated that patient inadvertently received 3 doses of pediatric VAQTA. First dose of VAQTA was administered on 14-JUN-2010 (dose: 0.5 ml, intramuscularly, lot# reported as AHA VB 362AA expiration date: 23-FEB-2012), second dose was administered on 14-JUN-2011 (dose: 0.5 ml, intramuscularly, lot# reported as: AHA VB481AA expiration date: 05-MAY-2013) and third dose administered on 14-AUG-2014 (dose: 0.5 ml, intramuscularly, lot# J014584, expiration date: 16-JAN-2016). The patient did not seek medical attention. No adverse effects reported. Lot numbers AHA VB362AA and AHA VB481AA are invalid lot numbers for VAQTA. Additional information has been requested.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 5 month old patient of unknown gender who on 09-JUL-2014 was vaccinated with improperly stored dose of ROTATEQ oral for, lot#J011344, expiration date 10-MAY-2015 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
Age: 1.5
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a nurse via the company representative refers to an 18 month old patient of unknown gender. No relevant medical history of the patient was reported. On 14-JUL-2014, the patient was administered with MMR II dose 1 (strength, route and lot number were not reported). On 06-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX dose 1 (strength, route and lot number were not reported). No concomitant medications were reported. It was reported that the doses were given too close together. There were no adverse effects reported. There was no product quality complaint involved. The outcome was unknown. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Blood immunoglobulin E, Erythema, Fatigue, Full blood count, Headache
Clinical narrative: LOCALIZED REDNESS; SWELLING (90mm x 152mm area of induration)@ Rt posterior arm; FEVER UP TO 103.5; NAUSEA; SEVERE HEADACHE; GENERALIZED FATIGUE.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Local swelling, Metabolic function test, Nausea, Pyrexia
Clinical narrative: LOCALIZED REDNESS; SWELLING (90mm x 152mm area of induration)@ Rt posterior arm; FEVER UP TO 103.5; NAUSEA; SEVERE HEADACHE; GENERALIZED FATIGUE.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Red blood cell sedimentation rate
Clinical narrative: LOCALIZED REDNESS; SWELLING (90mm x 152mm area of induration)@ Rt posterior arm; FEVER UP TO 103.5; NAUSEA; SEVERE HEADACHE; GENERALIZED FATIGUE.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: Patient walked out of office into lobby where receptionist noticed he was pale and he reported feeling dizzy and nauseous. He was brought back into an exam room where he laid down on the table. After 10 minutes patients symptoms subsided and he walked left our office on his own.
Sex: F
Vaccine: MEN
Symptoms: Hypersensitivity
Clinical narrative: Initial case received from a consumer on 14 August 2014. A female patient, age not reported, received MENINGOCOCCAL VACCINE on an unspecified date and subsequently experienced " a serious allergic reaction". According to the reporter, the patient would not be able to have a booster injection due to the reaction. Additional information, including symptoms, treatment, and outcome, were not reported. Documents held by sender: None.
Age: 42.0
Sex: M
Vaccine: HEP, MMR, TDAP
Symptoms: Dyspnoea, Injection site swelling, Injection site warmth
Clinical narrative: (R) deltoid warm to touch, swollen. Experienced SOB on 8/13 returned to office on 8/14. Pt states SOB.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Erythema, Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: Right upper arm painful immediately after injection (seemed too high up on arm near shoulder), then redness and pain to hand. Redness spreading. Vaccine site too high. RN supervisor called and will do education - unsure if rxn from vaccine or poor placement.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: This spontaneous report as received from a company representative refers to a female healthcare worker (who is also the patient), age unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX. On an unknown date, the patient experienced a large lump and swelling at the injection site. She sought medical attention via a medical office visit on an unspecified date and was treated with BENADRYL. The outcome of the large lump and swelling at the injection site was reported as recovered/resolved. The healthcare worker considered the large lump and swelling at the injection site to be related to ZOSTAVAX. No information regarding medical history, concomitant medications, or drug allergies was provided. Additional information has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Bacteraemia, Influenza, Lymphocyte count, Lymphopenia, Vaccination failure
Clinical narrative: Initial report received from literature on 12 August 2014. It was reported that 21 patients (age and gender not reported), whose medical history was reported as none and concomitant medication were not reported, had received 0.5 ml of INFLUENZA VACCINE (number of dose, batch number, route and site of vaccination not reported) on an unspecified date. On an unspecified date, all 21 patients confirmed influenza positive infection and the case were reported as vaccination failure case. Design/Method: prospective cohort study was conducted over two influenza seasons (2012-2014) in order to assess seasonal variation in influenza infection. Result: During the study conduct 112 patients were enrolled. Median Absolute lymphocyte count at vaccination was reported as 776 cells/mm3. Sixty-eight percent (65/112) were lymphopenic at vaccination. Twenty-three patients had complete serologic data for influenza season one, and 74% had a sero-response to the vaccine. Median ALC at vaccination was not different among sero-responders versus non-responders. Twenty-nine (32/112) reported symptoms consistent with ILI. Median ALC at vaccination in patients with ILI was 646 11s/mm3 versus 836 cells/mm3 in ILI-negative patients. Twenty-one patients had confirmed influenza positive infection. The median ALC at vaccination for influenza positive patients was 530 cells/mm3. There was no statistically significant difference in median ALC between influenza positive and negative patients who received the vaccine. Clinical complications included (1) inpatient hospitalization for influenza symptoms in 29% (6/21), concurrent bacteremia in 20% (4/21), and delayed chemotherapy in 100% (21/21). Conclusion: Influenza infection remains a significant source of morbidity in children undergoing chemotherapy. Lymphopenia at the time of vaccination did not affect immunogenic response. Correlations between immune response and clinical symptoms could not be assessed during influenza season due to limited complete serologic data. An additional sixty-seven patients (145 totals) have been enrolled in influenza season two, and complete serologic data has been obtained on a majority of Patients. Corrective treatment was not reported. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Rt upper arm swollen, red, hot, pt stated the felt like her skin was stretching.
Age: 7.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Fever with body aches, vomiting.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 4 days after receiving my shingles shot my wife developed shingles. She had the shingles shot herself Jan. 26, 2009 and we believe this shot gave my wife shingles.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR
Symptoms: Abasia, Drug ineffective, Pain in extremity, Rash morbilliform, Synovitis
Clinical narrative: Measles-like rash; antihistamine (no effect). Stopped walking, leg pain.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR
Symptoms: X-ray normal
Clinical narrative: Measles-like rash; antihistamine (no effect). Stopped walking, leg pain.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR
Symptoms: Rash morbilliform
Clinical narrative: Measles-like rash, antihistamine (no effect).
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Mobility decreased, Myalgia, Tremor
Clinical narrative: Patient describe severe muscle pain, limiting mobility. Also chills and shaking.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: 2d after vaccine area became red, indurated and itchy. No warmth or tenderness.
Age: 67.0
Sex: F
Vaccine: FLUC3, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Rash on chest and upper arms.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Insomnia, Joint crepitation, Musculoskeletal pain
Clinical narrative: Night of "shot" severe pain negated sleep and the following night. The day after it was administered, could not lift that arm. Six days later, still painful with crepitus in my shoulder. 8/15 - still pain in arm/shoulder. Pain is severe at times. Husband has to help me get shirts on and off.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Night of "shot" severe pain negated sleep and the following night. The day after it was administered, could not lift that arm. Six days later, still painful with crepitus in my shoulder. 8/15 - still pain in arm/shoulder. Pain is severe at times. Husband has to help me get shirts on and off.
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt had the immunization on 08/06/2014 next day pt woke up with (L) leg swollen. Symptoms was swollen, painful, and feeling hot on the area that I gave the DTaP and Polio vaccine.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Decreased appetite, Injection site rash, Pyrexia, Rash erythematous, Somnolence
Clinical narrative: Mother reports infant was "sleepy" most of the afternoon after immunizations. Developed fever to 103.8 that night and had poor appetite / nursing throughout the night. Appetite improved within 8 hours. Fever continued, 101-102 with Tylenol, for approx 24 hours. The day after immunizations, she developed "large red bumps" at all 3 injection sites, that lasted approx 3 days. Residual "bumps under the skin" persisted for approx 1 month afterward.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Electromyogram normal, Injection site pain, Musculoskeletal stiffness, Nuclear magnetic resonance imaging abnormal
Clinical narrative: More than usual pain at site of injection, which was very high in arm, that got worse throughout the day reaching extreme pain and stiffness with any movement.  Pain and weakness with movement has persisted since shot administration.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: More than usual pain at site of injection, which was very high in arm, that got worse throughout the day reaching extreme pain and stiffness with any movement.  Pain and weakness with movement has persisted since shot administration.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It ws reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported.  It was unspecified whether the patient had sought any medical attention. There was  no product quality complaint involved.   Follow up information has been received from office manager, who stated she may call back for fax information as it become available. Also , reported that M-M-R II was not mentioned int he original call, but did experience a temperature excursion. No further information was available at that time.   Follow up information as received from office manager refers to a 4 years old patient. On 13-JUN-2014 the patient was vaccinated with a dose of improperly   stored M-M-R II (lot # J012818, expiration date 10-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of several reports from the same source. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Cold sweat, Joint stiffness, Migraine, Musculoskeletal stiffness
Clinical narrative: Stiff neck, migrane, stiff joint in the left hand, cold sweats.
Age: 27.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Balance disorder, Blood test normal, Borrelia test positive, Chills
Clinical narrative: Stiff neck, migrane, stiff joint in the left hand, cold sweats.
Age: 27.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Dizziness, Headache, Injection site pain, Local swelling, Mobility decreased
Clinical narrative: Stiff neck, migrane, stiff joint in the left hand, cold sweats.
Age: 27.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Myalgia, Neck pain, Night sweats, Oropharyngeal pain, Pyrexia
Clinical narrative: Stiff neck, migrane, stiff joint in the left hand, cold sweats.
Age: 0.26
Sex: F
Vaccine: HEP, PPV
Symptoms: Abdominal pain, Crying, Pyrexia, Vomiting
Clinical narrative: 6 to 7 days of continuous colic-like symptoms; vomiting, crying, fever.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's mother reported her son's right arm where he got his vaccine on 08/13/2014 got swollen and reddened on 08/14/2014. She reported the swelling went down on 08/18/2014. It was reddened in a 3 cm size area around the site of injection of the right arm. She was encouraged to ice the area and report any other signs or more swelling or redness. No fever.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a first dose of GARDASIL (dose: 0.5 ml, intramuscularly, lot # and expiration date not reported). Three weeks later (date unknown) the patient was vaccinated with a second dose of GARDASIL (dose: 0.5 ml, intramuscularly, lot# and expiration date not reported). No adverse effects reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEP, HPV4, VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: "Started fri 8/15 started off as a light ring and progressively has gotten more red measured in office at a 50 mm welt/wheel by 23mm has gotten smaller in appearance since Fri 8/15.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Abdominal discomfort, Decreased appetite, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Stomach upset, nausea, loss of appetitie (unable to eat for 1 day), fever (temp not known by mother), sweating at night/early morning, dizziness. Neck pain - woke patient in early morning hours. S/s reported to occur for past 2 days. Patient experienced dizziness and faint-like episode (No syncope) day of vaccine.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Neck pain, Pyrexia
Clinical narrative: Stomach upset, nausea, loss of appetitie (unable to eat for 1 day), fever (temp not known by mother), sweating at night/early morning, dizziness. Neck pain - woke patient in early morning hours. S/s reported to occur for past 2 days. Patient experienced dizziness and faint-like episode (No syncope) day of vaccine.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Cough, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Mother reports fever, rash, cough, runny node. Similar symptoms after last vaccines 3/19/14 but mom attributed to "cold". Recurred this time - so reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Urticaria
Clinical narrative: Rash on legs and torso and wheals measuring 5-8 cm on both legs and she had a few on her arms and one on her face.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Hypotonia, Pallor, Syncope
Clinical narrative: After administered vaccinations sitting in chair - became limp - pale- fainted - assisted onto floor by nurse and mom - v/s taken - propped up legs - 93  and B/P 98/66 P66 93.8 and 100/60 P60 - color returning to normal, can hear when nurse spoke to him - knows name - where he is at - sat up 94 100/68 P60 sat up in chair - soon assisted to waiting area.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site of injection - raised bump. Little redness. Referred to MD told to use cold compress and take BENADRYL.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 15-AUG-2014, the patient was vaccinated with expired dose of PNEUMOVAX23  injection (lot # J006921, expiry date: 09-AUG-2014) inadvertently, dose 1, 0.5 ml. On 15-AUG-2014, 1 day after onset of therapy the patient experienced expired vaccine used. The outcome of expired vaccine used in unknown. The reporter considered expired vaccine used to be not related PNEUMOVAX23. Dose was supported. No adverse experience reported. No product quality complaint. No further information provided. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from registered nurse via field representative refers to a 80 year old female patient, who is a mother of the reporter. The patient's pertinent medical history included with diabetes and hypertension. Approximately on an unknown date of 2009, reported as about 5 years ago the patient was vaccinated with ZOSTAVAX (dose, frequency, lot#, route not reported). No concomitant medications reported. Approximately on JUNE-2014, reported as about a month ago, the patient started getting pain and currently has a case of shingles that almost looks like poison ivy. The outcome of shingles that almost looks like poison ivy and started getting pain about a month ago were unknown. The field representative had minimal information therefore many drop down fields are unspecified by reporter. Additional information is not expected.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Clostridium test negative, Culture negative, Frequent bowel movements, Haematochezia, White blood cells stool positive
Clinical narrative: Received Rota vaccine on 8/7/14. That night started having frequent stools about 12 x/day. By 8/10/14 had visible blood in stools. 8/19/14 bloody stools resolved stool cultures sent.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a Healthcare worker refers to a patient of unknown age. On 15-AUG-2014, the patient was vaccinated with experienced ZOSTAVAX (lot # J001700, expiry date: 08-MAY-2014) vial .65 ml, subcutaneously. Concomitant medication was unspecified. There was no PQC. Outcome of the reported event was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Immunology test abnormal
Clinical narrative: This spontaneous report was received from a consumer regarding his surrogate (female patient) of unknown age. On an unknown date (reported as many years ago) the patient was vaccinated with (Oka/Merck) VARIVAX, one dose. In 2014 (reported as recently) the patient was found to be non-immune to varicella virus. Consumer wanted to know if the surrogate could receive (Oka/Merck) VARIVAX before she becomes pregnant. The outcome of the event was unknown. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Age: 0.38
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), wihch were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 4 month old patient of unknown gender who on 23-JUL-2014 was vaccinated with improperly stored dose of ROTATEQ oral, lot#J011344, expiration date 10-MAY-2015 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to an 11 year old patient. On 19-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J002319, expiration date 23-FEB-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Wrong technique in drug usage process
Clinical narrative: On 8/15/14 one of our clinic nurses noted an extra MENVEO diluent in the box. 4 doses of this vaccine were given 8/14 by 3 different nurses. On 8/15 research was done on times vaccines were given as to know the 4 clients who may have rec'd powder only. This client was one of the four. No nurse working 8/14 could 100% recall whether they gave the vaccine in error (possibly using sterile diluent rather than diluent supplied to give it for example). All four client were notified by supervisor and recommended to revaccinate as soon as possible at no cost to them. Plan is to now band all vaccines together that come with a separate diluent and double check meds before given as to prevent this error in the future.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injected limb mobility decreased
Clinical narrative: She received both vaccines in the same arm and days later she stated she could not move her arm. She saw her PCP and states she feels better.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Pt received FLUVIRIN on 8/8/14 and called 8/19/14 stating her left arm at site of injection is very painful and hurts to lift it (her (L) arm). Informed patient to ice the site of inject, take APAP for pain and follow up w/MD in day or 2.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The nurse reported that an unspecified patient received a dose of M-M-R II (dose, route and lot number were not reported) yesterday, 11-AUG-2014, that was exposed to temperatures outside of the proper storage range. No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient. On 07-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX lot # J012377, expiration date 03-OCT-2015, dose and route not reported and MMR II (lot # J003785, expiration date 28-MAR-2015, dose and route not reported) which were stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Increased appetite, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unkonwn age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 5 month old patient of unknown gender who on 10-JUN-2014 was vaccinated with improperly stored dose of ROTATEQ oral, lot# J010131, expiration date 11-MAR-2015 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old female patient. The patient's medical history, past drug history, or concomitant medications were unknown. On 15-AUG-2014 the patient was vaccinated with a dose of expired PNEUMOVAX23 (lot # J009827, exp. date: 10-AUG-2014, 0.5 ml, injection, site and route of administration not reported). The patient did not have any relevant laboratory data or tests. As of 15-AUG-2014, it was unknown if the patient would continue to receive PNEUMOVAX23, and the outcome of receiving an expired vaccine was reported as unknown. Additional information has been requested.
Age: 1.87
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 22 month old patient. On 15-MAY-2014 the patient was vaccinated with MMR II (lot # J013315, expiration date 17-OCT-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Hypersensitivity, Local reaction
Clinical narrative: Local allergic reaction, treated with 7 days of KEFLEX to cover the possibility of infection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Eye movement disorder, Loss of consciousness, Musculoskeletal stiffness, Pallor, Seizure like phenomena
Clinical narrative: Upper extremity (arms) stiffness, eyes rolled back, paleness, loss of consciousness, lasting for about 5 seconds. Seizure like event was witnessed by staff physician.
Age: 0.28
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not reported. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 3 month old patient of unknown gender who on 09-JUL-2014 was vaccinated with improperly stored dose of ROTATEQ oral, lot# K004468, expiration date 08-DEC-2015 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Erythema, Headache, Local swelling, Malaise
Clinical narrative: No reaction day of shot. Next day arm and shoulder very swollen, red, hot to touch. Then became ill with abdominal pain, headache and nausea. Symptoms lasted all that day. No other symptoms. Patient took ADVIL for headache and rubbed BENADRYL on left upper arm. Duration 3 days.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Skin warm
Clinical narrative: No reaction day of shot. Next day arm and shoulder very swollen, red, hot to touch. Then became ill with abdominal pain, headache and nausea. Symptoms lasted all that day. No other symptoms. Patient took ADVIL for headache and rubbed BENADRYL on left upper arm. Duration 3 days.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Face injury, Fall, Hypotonia, Syncope
Clinical narrative: Dad declined HPV. VIS given to dad, he will think about it for next visit. After vaccines were given at aprox 9:58 client became faint. Her body became limp and she slid forward from a sitting position from her chair to the floor. I called for help and I slid down to the floor to break her fall from hitting the desk. She rolled over glazed the right side of cheek. I grabbed an ice bag from the drawer and applied it to the back of her neck and on for the right side of face. Feet were elevated up to chair and soft clothing placed under her head. Client became alert and responsive in less than 10 seconds it was right after she went to the floor. B/P 110/70 Pulse 80 Resp 20. 10:05 AM pupils reactive alert and oriented. No bumps or bruises noted. 10:10 Slowly got her up to chair. Gave her a cup of orange juice she drank 100% and tolerated it well. Dad called the mom to let her know what happened. They said they will take her to PMD for precaution. I encouraged dad to watch for signs or symptom nausea, blurred vision or headache. And call PMD if any noted. Client denies any discomfort, blurred vision or nausea. Departed clinic at 10:15. Voices no other c/o. We will call dad later today for follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a Company Representative, who reported on behalf of Medical Assistant refers to patients of various ages, (3 yr old, 12 month old, and an 8 year old, and 2 other age unknown,) gender unknown who received VARIVAX. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX lot # J008170, expiration date 20-JUL-2015, subcutaneous Chicken Pox vaccine. On an unknown date, the patients experienced chickenpox described as spots and fever and with a diagnoses of chickenpox after administration of the Chickenpox vaccine. The outcome of chickenpox described as spots and fever was reported as Not Recovered/Not Resolved. No further information was provided. Follow up information: Representative received a second call from the Medical Assistant. A fourth patient 8 years old, presented to office today with, "a few spots" and no fever. Patient was diagnosed with Chicken Pox. he clarified that this patient had received two separate VARIVAX injections on unspecified dates. He indicated that he believed VARIVAX may have had same expiration date of previously reported patients. No further information was provided.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 9 week old patient of unknown gender who on 09-JUL-2014 was vaccinated with improperly stored dose of ROTATEQ oral, lot# K004468, expiration date 08-DEC-2015 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: 6 inch x 8 inch area of erythema and edema to right upper arm post vaccination. Mother reports erythema today is improved since yesterday. Area warm to touch, mildly tender and pruritic. Erythema suggests moderate to severe allergic response/possible cellulitis. No systemic symptoms of allergic reaction, patient stable at time of assessment on 8/18/2014 at 4:56 PM. Referred to urgent care for evaluation.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site warmth
Clinical narrative: 6 inch x 8 inch area of erythema and edema to right upper arm post vaccination. Mother reports erythema today is improved since yesterday. Area warm to touch, mildly tender and pruritic. Erythema suggests moderate to severe allergic response/possible cellulitis. No systemic symptoms of allergic reaction, patient stable at time of assessment on 8/18/2014 at 4:56 PM. Referred to urgent care for evaluation.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Began 8/9/14 with a slight bump and redness at the site of the varicella injection. Had fever (101.4) and chills early in the morning 08/10/14 (12 - 4 am). Redness and swelling spread from site of injection (upper outer right arm) down toward elbow and up toward shoulder. Arm hurt. Saw a physician 8/12/2014. Treated with Bactrim DS and Tylenol. 8/19/2014 - Symptoms completely resolved.
Age: 14.0
Sex: M
Vaccine: HEP, HEPA, MEN, TDAP
Symptoms: Alanine aminotransferase increased, Antibody test abnormal, Aspartate aminotransferase increased, Blood test abnormal, Coeliac disease
Clinical narrative: I began to get a rash on my side, this was later diagnosed as shingles. I began to feel increasingly sick, and for many years my doctors told me I'm ok and there was no correlation to vaccine. In December 2011 I was diagnosed type 1 diabetic.
Age: 14.0
Sex: M
Vaccine: HEP, HEPA, MEN, TDAP
Symptoms: Herpes zoster, Inappropriate schedule of drug administration, Liver disorder, Malaise, Rash
Clinical narrative: I began to get a rash on my side, this was later diagnosed as shingles. I began to feel increasingly sick, and for many years my doctors told me I'm ok and there was no correlation to vaccine. In December 2011 I was diagnosed type 1 diabetic.
Age: 14.0
Sex: M
Vaccine: HEP, HEPA, MEN, TDAP
Symptoms: Type 1 diabetes mellitus
Clinical narrative: I began to get a rash on my side, this was later diagnosed as shingles. I began to feel increasingly sick, and for many years my doctors told me I'm ok and there was no correlation to vaccine. In December 2011 I was diagnosed type 1 diabetic.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Visual impairment
Clinical narrative: Pt. complained of dizziness, vision change.  Pt. became diaphoretic.  Blood Pressure was 99/68, Heart Rate was 68, SpO2 98% Respirations 16.  Pt. given ice pack to place under arm pit.  Pt. monitored for an additional 20-30 minutes and he left the clinic in stable condition with all signs and symptoms described above resolved.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Deafness bilateral
Clinical narrative: Loss of hearing right ear, intermittent loss of hearing left ear lasting approx. 6 months.
Age: 1.18
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Expired drug administered
Clinical narrative: Expired MMR given. Expired 08/10/2014.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Differential white blood cell count, Full blood count, Rash erythematous, Red blood cell sedimentation rate
Clinical narrative: Joint pain, red dots all over body which were more around feet and pelvic area.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Urine analysis
Clinical narrative: Joint pain, red dots all over body which were more around feet and pelvic area.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired drug administered
Clinical narrative: Expired vaccine was administered. No physical reaction. Required another visit and revaccination.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: This morning, father noted redness and swelling of the right thigh and stated, "looks like a mosquito bite". He also stated, "he complains of pain once in a while but walks without difficulty. No itching, no fever noted. Denies any other signs and symptoms. Father called clinic to report this incident.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Body temperature increased, Convulsion, Grand mal convulsion
Clinical narrative: 9 sz for 45 mins - DIAZEPAM rectally and midazolam intranasally. 1st sz lasted for 5 mins - had 9 sz total over the course of 4 hrs. Was kept overnight.
Age: 1.02
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: At about 11:20 am patient received PROQUAD vaccine and about 11:30 am started showing reaction on rt thigh. Redness, induration of 40 mm x 30 mm, warm to touch. BENADRYL (4.5mlk given) at 11:35am.
Age: 67.0
Sex: F
Vaccine: FLUC3, PPV, VARZOS
Symptoms: Chills, Malaise
Clinical narrative: Chills, not feeling well, felt like she was getting sick lasted 2-3 days.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Pt. on both HPV developed 1 hour numbness and decreased strength in arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Both arms redness, swelling.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Erythema, Feeling abnormal, Injection site erythema, Injection site vesicles
Clinical narrative: Mom stated that pt had developed blister on 8-14-14 with redness or swelling and didn't feel good all day. On 8-15-14 Mom brought pt into clinic and right upper arm was red with quarter size blister that had popped and several smaller blisters next to it. Mom said pt did feel better and that arm looked much better on 8-15-14.