chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Body aches, headache, runny nose. By 1:00AM on 10/03/2014 severe chills, fever began.  By 3:00AM fever spiked to 103.  Then later in night sweats began.  Continued on and off for most of 10/03/2014.  Fever gradually decreased. Fever finally hit my normal of 97 by 10/04/2014 at 8:00AM.  Headache remained until 10/05/2014.  Rest of symptoms gone. All OK by 10/06/2014. Only medication taken during this time was Tylenol.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Rhinorrhoea
Clinical narrative: Body aches, headache, runny nose. By 1:00AM on 10/03/2014 severe chills, fever began.  By 3:00AM fever spiked to 103.  Then later in night sweats began.  Continued on and off for most of 10/03/2014.  Fever gradually decreased. Fever finally hit my normal of 97 by 10/04/2014 at 8:00AM.  Headache remained until 10/05/2014.  Rest of symptoms gone. All OK by 10/06/2014. Only medication taken during this time was Tylenol.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Pain, Rash vesicular, Swelling
Clinical narrative: Redness, swelling, pain, induration, erythema, vesicular lesions.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever onset 5 pm Wednesday, Thursday, Friday went to ER and was admitted IV fluids were given.
Age: 41.0
Sex: F
Vaccine: FLU3, FLUC3, FLU3
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Flu shot given high up on my shoulder.  ~36 hrs later had severe shoulder pain, limited mobility.  Increasing pain over the next week.  Inability to do normal tasks, sleep disruption.
Age: 41.0
Sex: F
Vaccine: FLU3, FLUC3, FLU3
Symptoms: Bursitis, Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: Flu shot given high up on my shoulder.  ~36 hrs later had severe shoulder pain, limited mobility.  Increasing pain over the next week.  Inability to do normal tasks, sleep disruption.
Age: 41.0
Sex: F
Vaccine: FLU3, FLUC3, FLU3
Symptoms: Bursitis, Drug administered at inappropriate site, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Flu shot given high up on my shoulder.  ~36 hrs later had severe shoulder pain, limited mobility.  Increasing pain over the next week.  Inability to do normal tasks, sleep disruption.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, itchiness, hardness, and increased temp of 1/2 dollar size region around injection site.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling
Clinical narrative: Patient stated that 30 hours after receiving the shot he started having a reaction in which his upper (mostly) and lower lips swelled towards his jaws.  He stated that he went for a run prior to experiencing the swelling so he thinks that may have exacerbated it.  He took diphenhydramine and about 24 hours after that the swelling reduced to normal.
Age: 34.0
Sex: F
Vaccine: FLUC3
Symptoms: Flushing, Pyrexia
Clinical narrative: Flushed face/ Fever.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Double dose of Varicella on a 1 y/o. 1 shot of MMR-V; 1 shot of Varicella. No signs or symptoms.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Diarrhoea
Clinical narrative: Double dose of Varicella on a 1 y/o. 1 shot of MMR-V; 1 shot of Varicella. No signs or symptoms.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Diarrhea for a few days.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Diarrhoea
Clinical narrative: Diarrhea for a few days.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Lymphadenopathy
Clinical narrative: Swollen lymph nodes especially on the side that flu vaccine administered.  Hard glands.
Age: 1.03
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Pyrexia, Rash generalised, Vaccination site swelling
Clinical narrative: Severe swelling (approx. 5 inches) around the vaccination area. Rash on the bottom have of infants body and high temperature 101.9 for 3 days.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Headache, Nausea, Pain
Clinical narrative: aches and pains, warmness, headache, nausea
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Angiogram, Blood test, Chest X-ray, Dyspnoea, Electrocardiogram
Clinical narrative: Shortness of breath - went to ER
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: SWELLING UNDER THE ARM OF INJECTION SITE. SLOWLY RESOLVED ON ITS OWN WITH NO MEDICAL INTERVENTION. PT STATES THIS HAPPENED ONCE BEFORE A COUPLE YEARS AGO BUT WAS WORSE THE LAST TIME.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint pain, Pain
Clinical narrative: sore joint, pain with range of motion on left shoulder
Age: 14.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Fall, Loss of consciousness, Seizure like phenomena, Syncope, Tremor
Clinical narrative: Subject collapsed during Gym period at school. Appeared to black out momentarily, fell and does not remember doing so. Arms and legs shook while he was down. Appeared to observers as if he were having a seizure. Felt OK, if bewildered, when he came to. Wanted to stay in school. No fever or other reported physical sensations.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Eye movement disorder, Posture abnormal, Tremor
Clinical narrative: Gave patient flu shot. After a few minutes, while patient was sitting in a chair, arms started shaking, eyes were not tracking and head was rolling back. Put patient on floor, called 911, monitored patient until EMT arrived and took patient to hospital.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Nurse administering the influenza vaccine gave it in the patient's IV saline lock instead of IM.   She was unaware of her error, but came out to the nurse's station and mentioned to me (I am the clinical educator for the hospital) that the prefilled vaccine syringe fit perfectly onto the saline lock; she confirmed that she did give it IV.  Patient was monitored, pharmacist contacted, physician notified.  No orders were given by the physician and no adverse effects were noted.
Age: 0.34
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received an extra HIB vaccine. Was given Pentacel and Hib. No reactions were noted with follow-up.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Laboratory test, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Fever, chills, vomiting, diahrea, severe arm and shoulder pain.  I was given antibiotics and pain meds.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia, Vomiting, X-ray
Clinical narrative: Fever, chills, vomiting, diahrea, severe arm and shoulder pain.  I was given antibiotics and pain meds.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Dysphemia
Clinical narrative: Child began stuttering while speaking. Notified MD office on 10/3, they stated to watch him and it should go away in a couple weeks and not to call attention to it.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: Right thigh at injection site appears like a localized varicella vesicle, large.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Rash, Urticaria
Clinical narrative: Hive like rash on upper forearm. Shoulder and lower arm feel sore. Uncomfortable to raise shoulder.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dry mouth, Gingival bleeding, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Gums started to bleed, eyes very bloodshot and watery, very dry mouth all night, diarrhea in the morning.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: from the injection point to elbow, patient said her arm is swollen, red, and painful. Patient went to the doctor and was told it looked like a reaction many patients experience and that it will get better.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Death, Drug screen
Clinical narrative: Patient Died.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Breath sounds abnormal, Conjunctivitis, Cough, Dyspnoea
Clinical narrative: Within ~ 2 hours post Fluzone vaccine, patient developed marked coughing, SOB, headache, and eventual bilateral conjunctivitis. Came back to clinic 4:40 pm (2 1/2 hours after onset cough) where BP elevated at 127/85, P92, resp 22-24, pulse OX 100%, and harsh expiratory breath sounds without wheezing. Given Benadryl 25 mg po, and 2 nebulizer treatments: one with Albuterol, other with Ipratropium and sent home on Prednisone.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Within ~ 2 hours post Fluzone vaccine, patient developed marked coughing, SOB, headache, and eventual bilateral conjunctivitis. Came back to clinic 4:40 pm (2 1/2 hours after onset cough) where BP elevated at 127/85, P92, resp 22-24, pulse OX 100%, and harsh expiratory breath sounds without wheezing. Given Benadryl 25 mg po, and 2 nebulizer treatments: one with Albuterol, other with Ipratropium and sent home on Prednisone.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site induration, Injection site nodule, Injection site pain, Local swelling
Clinical narrative: I was awakened at 4 AM with severe pain in arm, along with redness, swelling and hot to the touch. I began applying ice packs and taking ibuprofen.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Skin warm
Clinical narrative: I was awakened at 4 AM with severe pain in arm, along with redness, swelling and hot to the touch. I began applying ice packs and taking ibuprofen.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Syncope, Vomiting
Clinical narrative: Dizziness, sweats, faintness and vomiting. After severe vomiting patient went to bed and is resting.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Severe hives for a duration of 3 hours starting on stomach and spread throughout entire torso including back, arms, stomach, difficulty breathing.  Took antihistamine and symptoms subsided.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Chills, Tremor
Clinical narrative: Chills, shaking, loss of balance.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Gastrointestinal disorder
Clinical narrative: This study report as received from a principal investigator refers to an approximately 6 months male patient enrolled in a study for ROTATEQ (study name or protocol was not specified). On an unknown date the patient was vaccinated with ROTATEQ, dose 3 (route, indication and dates unspecified) (also reported as "the patient was in the control group"). On an unknown date in 2014 date the patient experienced a serious adverse event also reported as gastrointestinal problems. "The physician would not elaborate". The physician states the event was already listed in Prescribing Information and he was not sure if it is even reportable. He stated that he was in process of faxing the report to the company. Action take with study therapy was unknown. Patient's outcome was unknown. Upon internal review gastrointestinal problems was considered medically significant, since there was not sufficient information and the event was reported as a serious adverse event (SAE). Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Eyelid oedema, Hypersensitivity, Pruritus
Clinical narrative: Case number PHEH2014US019824, is an initial spontaneous report from a consumer received on 01 Oct 2014. This report refers to a 41-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on from 28 Sep 2014. On 29 Sep 2014, she experienced life threatening allergy. She stated that her eyes, nose, head, neck and face were affected. She had itching in the face, face was red, eyes began to swell shut and it was hard to breathe. She called 911 and she went to the hospital (emergency room) on 30 Sep 2014. She was in the emergency department from 08:30 to 09:30. About 24 hours before the reaction, she received FLUVIRIN. Treatment was rendered with EPIPEN and in the hospital she was given other drugs (unspecified). She stated that, nobody told her the reaction was related to flu shot but nothing else in her life had changed. She informed that, she was told to carry an EPIPEN with her everywhere now. She did not spend the night in the hospital. The final outcome of the events was unknown. Seriousness was reported as life threatening and causality was not reported. She reported that, she does not have a primary physician. No additional details available.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHEH2014US019697 is an initial spontaneous report received from a physician on 30 Sep 2014. This report refers to a 31 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with a FLUVIRIN (batch number: not reported) intramuscularly in Oct 2010. On an unknown date after vaccination in Oct 2010, she experienced anaphylactic reaction. The outcome of the event was unknown. The causality and seriousness were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Cellulitis
Clinical narrative: Case number PHEH2014US019868 is an initial spontaneous report received from a consumer on 22 Sep 2014. This report refers to a female patient of unknown age. Her medical history and concomitant medication were not reported. Her current condition included egg allergy. She was vaccinated with an influenza (flu) vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after vaccination, she experienced cellulitis. The outcome, causality and seriousness were not reported.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Feeling abnormal, Headache, Vision blurred
Clinical narrative: Patient returned saying he "felt funny." Had blurred vision and problems focusing eyes. Had headache and couldn't catch breath. No swelling of throat/tongue. Called 911. They did pulse ox (>99) and gave O2. Then transported patient.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old patient of unknown gender. On 25-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose, strength not reported, lot # 003597, exp. date: 12-MAR-2015). No adverse effect reported (also reported that the patient did not report shingles symptoms). It was reported that the freezer temperature was -15 degrees C prior receiving the ZOSTAVAX. On 11-JUL-2014 the ZOSTAVAX was received. The temperature of the freezer was not recorded through 25-SEP-2014, when it was -9.2 degrees C. There were no power outages. The reporter asked what she should do. This is one of four reports from the same source. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: ANTH
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Chronic fatigue syndrome, Fatigue
Clinical narrative: Patient reports she received 5 of the 6-shot vaccine series in 2002. After the 2nd or 3rd dose she began to develop aching in the muscles and joints. The symptoms continued and she evolved to experiencing pain in the upper and lower back, hips, SI joints, and neck, as well as fatigue interfering with functioning, and unrefreshing sleep. She reports she was evaluated by rheumatology in 2011 and diagnosed with fibromyalgia. In the course of this evaluation multiple other conditions were ruled out including autoimmune disease, ankylosing spondylitis, psoriatic arthritis (employee has psoriasis), and Ehlers Danlos syndrome (which is in her family history). Fibromyalgia syndrome continues today. Patient also meets the 2012 International case Definition for Chronic Fatigue Syndrome.
Age: 45.0
Sex: F
Vaccine: ANTH
Symptoms: Fibromyalgia, Myalgia, Neck pain, Poor quality sleep
Clinical narrative: Patient reports she received 5 of the 6-shot vaccine series in 2002. After the 2nd or 3rd dose she began to develop aching in the muscles and joints. The symptoms continued and she evolved to experiencing pain in the upper and lower back, hips, SI joints, and neck, as well as fatigue interfering with functioning, and unrefreshing sleep. She reports she was evaluated by rheumatology in 2011 and diagnosed with fibromyalgia. In the course of this evaluation multiple other conditions were ruled out including autoimmune disease, ankylosing spondylitis, psoriatic arthritis (employee has psoriasis), and Ehlers Danlos syndrome (which is in her family history). Fibromyalgia syndrome continues today. Patient also meets the 2012 International case Definition for Chronic Fatigue Syndrome.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with an unspecified dose of ZOSTAVAX. On an unknown date the patient experienced swelling at the injection site on the back of her arm. Patient sought medical attention (unknown type). No PQC (product complaint was involved. The outcome of swelling at the injection site was unknown. The relatedness between ZOSTAVAX and the event was not reported. This is one of several reports from the same source. Additional information is not expected because the pharmacist did not give the consent for follow-up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, 8 doses of improperly stored ROTATEQ, orally (dose and lot number were not reported) had been administered to an unspecified number of patients. The temperature excursions were found to be supported excursions with in-house stability data. No adverse symptoms were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker 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, 26 doses of improperly stored LIQUID PEDVAXHIB injection (dose, route and lot number were not reported) had been administered to an unspecified number of patients. The temperature excursions were found to be supported excursion with in-house stability data. No adverse symptoms were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, (medical assistant (M.A.), also reported as registered nurse (RN)) refers to a patient of unkonwn age and gender. Medical history and drug reactions or allergies were not specified. On 08-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) injection, lot number K007158, expiration date 12-NOV-2015, 0.5 ml once, subcutaneously, that was stored at 42.9 (also reported as 73) degrees Fahrenheit for 744 hours (temperature excursion date reported as 25-AUG-2014). No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, (medical assistant (M.A.), also reported as registered nurse (RN)) refers to a patient of unknown age and gender. Medical history and drug reactions or allergies were not specified. On 26-AUG-2014, the patient was vaccinated with a dose of PROQUAD (Merck) injection, lot number K007158, expiration date 12-NOV-2015, 0.5 ml once, subcutaneously, that was stored at 42.9 (also reported as 73) degrees Fahrenheit for 744 hours (temperature excursion date reported as 25-AUG-2014). No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, (medical assistant (M.A.), also reported as registered nurse (RN)) refers to a patient of unknown age and gender. Medical history and drug reactions or allergies were not specified. On 25-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) injection, lot number K007158, expiration date 12-NOV-2015, 0.5 ml once, subcutaneously, that was stored at 42.9 (also reported as 73) degrees Fahrenheit for 744 hours (temperature excursion reported as 25-AUG-2014). No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, (medical assistant (M.A.), also reported as registered nurse (RN)) refers to a patient of unkonwn age and gender. Medical history and drug reactions or allergies were not specified. On 02-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) injection, lot number K007158, expiration date 12-NOV-2015, 0.5 ml once, subcutaneously, that was stored at 42.9 (also reported as 73) degrees Fahrenheit for 744 hours (temperature excursion date reported as 25-AUG-2014). No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 15 month old patient of unknown gender. On 22-SEP-2014, the patient was routinely vaccinated with PROQUAD (Merck). Lot number reported as J0000140 is an invalid lot number for PROQUAD (Merck). The patient received PROQUAD (Merck) which had expired, expiration date was reported as 04-JUL-2014. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, (medical assistant (M.A.), also reported as registered nurse (RN)) refers to a patient of unknown age and gender. Medical history and drug reactions or allergies were not specified. On 25-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) injection, lot number K007158, expiration date 12-NOV-2015, 0.5 ml once, subcutaneously, that was stored at 42.9 (also reported as 73) degrees Fahrenheit for 744 hours (temperature excursion date reported as 25-AUG-2014). No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to own child (age and gender not reported). On an unknown date at the age of 2, 4 and 15 month the patient was vaccinated with a first, second and third doses of PEDVAXHIB (dose, route, lot numbers not reported). On an unknown date the patient received the fourth dose of PEDVAXHIB (at the age of 3 year and 4 months). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health worker referring to a patient of unknown age and gender. The reporter reported that improperly stored PNEUMOVAX 23 (lot# unspecified) (1 dose) was administered to the patient on unspecified date (frequency and route unspecified). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The reporter reported that improperly stored VAQTA (Lot# unspecified) (2 doses) were administrated to unspecific number of patients (dose, frequency and route unspecified). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unkown age and gender. The reproter reported that improperly stored GARDASIL (Lot# unspecified) (1 dose) was administered to the patient on unknown date (route and frequency unspecified). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 years old patient of unknown gender. On 06-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose, strength not reported, lot # K003597, exp. date: 12-MAR-2015). No adverse effect reported (also reported that the patient did not report shingles symptoms). It was reported that the freezer temperature was -15 degrees C prior receiving the ZOSTAVAX. On 11-JUL-2014 the ZOSTAVAX was received. The temperature of the freezer was not recorded through 25-SEP-2014, when it was -9.2 degrees C. There was no power outages. The patient did not report shingles symptoms. The reporter asked what she should do. This is one of four reports from the same source. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Abnormal behaviour, Eczema, Proctalgia
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to an 8 year old male patient with no drug reactions or allergies. No concurrent conditions or medical history were provided. It was reported that, on an unspecified dates, the patient had received 2 doses of RECOMBIVAX HB injections (doses, routes of administration, indication, lot# and expiry date unspecified for both shots). No concomitant medications were reported. The reporter stated, that after receiving RECOMBIVAX HB (specific dates unknown), the patient had complained of anal and stomach pains and eczema flare ups. The mother reported she had to change patient's diet and "he just doesn't seem to be the same child." The patient sought medical attention and was treated with nystatin (dosage/frequency unknown). The outcome of the events was reported as not recovered. The relatedness between the events and RECOMBIVAX HB was not reported. During the call, the reporter became unable to confirm if the patient received RECOMBIVAX HB. Additional information is not expected as there is no patient and physician's contact information and we could not do follow up with them.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Redness 5 in x 4 in area, warm to touch, arm can be moved, area is just sore.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 10-FEB-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J006955, expiration date: 07-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLUN4
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: Full body hives with extreme itch. Lips puffy.} Rapid onset. No respiratory difficulty.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event, Product reconstitution issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 17-SEP-2014 expired sterile diluent (MSD) (lot #: G012930, expiration date March 2014) was used to reconstitute ZOSTAVAX and was administered to a patient (dose, dose number, route, anatomical location, lot number and expiration date were unspecified).  No adverse effects reported. No concomitant therapies were reported. The outcome of the events was unknown. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient informed employer that arm, shoulder, and back hurt.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt. received shingles shot on 9/16 and then developed shingles.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On 19-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (dose: 0.5 ml, subcutaneous, lot#, expiration date, anatomical location not reported) that had been exposed to a temperature of 10 degrees Fahrenheit (F) for possibly 15 hours. Concomitant medications were not reported. No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a male patient of unknown age (the reporting nurse's husband). The patient's pertinent medical history was not provided. On an unspecified date in approximately 2013 (reported as last year), the patient was vaccinated with ZOSTAVAX (route of administration, lot number and expiration date were not reported). No concomitant medication was provided. On an unknown date, the patient experienced chicken pox. The reporter stated that the pox was on the patient's head and "in his beard". The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Pt went home laid down after waking up could not move legs, nap lasted 3 hrs. Had to use the help of his wife and son to move him to where ever he had to go. This lasted all night according to his wife. Better in the morning. Recovered next day.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea, Fatigue, Hyperhidrosis, Tachycardia, Tongue disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 27 year old male patient. On 20-AUG-2014 the patient was vaccinated with RECOMBIVAX HB lot # K003533 and expiration date 07-FEB-2016, intramuscular, (dose not reported). On 20-AUG-2014, the patient experienced tachycardia, unspecified bumps under his tongue, shortness of breath, sweating and tiredness after receipt of the vaccine. The patient's symptoms began the day of vaccination and lasted 9 days. The patient did not seek medical attention. The outcome of the events was reported as recovered on 30-AUG-2014. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Influenza like illness, Local swelling
Clinical narrative: Severe flu-like symptoms next 3 days after shot. Arm severely red and swollen next several days requiring trip to urgent care and treatment with Ibuprofen 800mg.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 years old patient of unknown gender. On 07-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX, (dose not reported, lot # K003597, exp. date: 12-MAR-2015). No adverse effect reported (also reported that the patient did not report shingles symptoms). It was reported that the freezer temperature was -15 degrees C prior receiving the ZOSTAVAX. On 11-JUL-2014 the ZOSTAVAX was received. The temperature of the freezer was not recorded through 25-SEP-2014, when it was -9.2 degrees C. There were no power outages. The patient did not report shingles symptoms. The reporter asked what she should do. This is one of four reports from the same source. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Throat tightness
Clinical narrative: Asthma-like cough/throat constriction - attempted CHLORASEPTIC spray to treat. Dyspnea/tightness in chest.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an expired dose of ZOSTAVAX, lot # J007211 and expiration date 20-SEP-2014, (dose and route not reported). No adverse effects were reported. Additional information has been requested.
Age: 79.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 79 years old patient of unknown gender. On 19-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose, strength not reported, lot # 003597, exp. date: 12-MAR-2015). No adverse effect reported (also reported that the patient did not report shingles symptoms). It was reported that the freezer temperature -15 degrees C prior receiving the ZOSTAVAX. On 11-JUL-2014 the ZOSTAVAX was received. The temperature of the freezer was not recorded through 25-SEP-2014, when it was -9.2 degrees C. There were no power outages. The patient did not report shingles symptoms. The reporter asked what she should do. This is one of four reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 25-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose, route, lot# and expiration date were not reported). No adverse effects were noted. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 71 year old male patient with high blood pressure, diabetes and gout. On an unknown date, in December 2010, the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported). Concomitant therapies included allopurinol (manufacturer unknown), lisinopril (+) hydrochlorothiazide (manufacturer unknown) and metformin (manufacturer unknown). On 12-SEP-2014 the patient developed shingles. The patient sought medical attention. On 15-SEP-2014, the patient started VALTREX. At the time of the report the outcome of shingles was reported as recovering. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pyrexia
Clinical narrative: 9/18/14 - vaccine given in left arm. 9/21 - very painful shoulder and severe loss of motion. Could not extend left arm up, out, to the side, across body or to the back. Low grade temp then up to 101 degrees F. 9/22, 23, 24 - 1 tablet ALEVE each day. Arm mobility returned slowly shoulder pain gone by 9/27.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a female patient reporting in herself. The patient's age was not provided. The patient's pertinent medical history, concurrent conditions, drug reactions and allergies were not reported. The patient received GARDASIL in three doses. On unspecified date, in March 2014, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, anatomical location, lot# and exp. date were not reported). The second dose was administered on an unspecified date, in July 2014, (dose, route of administration, anatomical location, lot# and exp. date were not reported). The patient received the last dose of GARDASIL on an unspecified date in September 2014, (dose, route of administration, anatomical location, lot# and exp. date were not reported). No additional information was provided. Additional information is not expected because no contact information is available.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: A little itchy when went to bed 10/1/14. Woke up very, very itchy, on right side, right arm, arm pit, breast, shoulder, up neck and right side of scalp and ear. Took 25 mg of BENADRYL 9:30 am 10/2. T 99.1 - rx dr.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Red inflamed around injection site and itchy.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Dizziness, Pallor, Vomiting
Clinical narrative: Within 5 min of administration to (R) glut (Quadrivalent IM Flu), pt c/o feeling dizzy. Seated pt - c/o stomach ache, then vomited. (+) pale -> recovered, VSS after 25-30 min. Sips of water.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Infection, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Right thigh swelling and redness. Local reaction vs. infection. Rx KEFLEX.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Right arm turned red, swollen, painful for over 2 1/2 weeks.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Tic
Clinical narrative: Three days after vaccines patient experienced frequent numerous verbal and motor tics. Had no prior history.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, swelling and discomfort of left arm from 3 cm distal to injection site to elbow area marked. Patient advised to take Benadryl 50 mg !6 hrs and present to ER if redness moves out side of pen lined area. Pt presented to ER later same day. Prednisone 20 mg QD x 5 days.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (9/30/14) (11:40AM): Vaccines (HIB) and (PREVNAR) was administered to L antero-lateral thigh area, within 10-15 seconds post, redness and swelling (mild -moderate) noted to L forearm and L lower leg. Dr. immediately assessed client. Client observed 2 hours in clinic (1340) client re-assessed by Dr. No swelling or redness to extremities. Vital signs normal.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood alcohol, Blood creatine phosphokinase MB, Blood gases, Dizziness, Dyspnoea
Clinical narrative: Swelling of injection site, decreased ROM, pain, advancing to SOB and dizziness. Pt. c/o rt arm s/s as above.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Joint range of motion decreased, Myoglobin blood, Pain, Troponin I
Clinical narrative: Swelling of injection site, decreased ROM, pain, advancing to SOB and dizziness. Pt. c/o rt arm s/s as above.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: VIIth nerve paralysis
Clinical narrative: Facial droop noted evening after receiving vaccines (9/23/14).
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Red spot, rash (?) on face, neck and swollen (started 2012 and 2013 not seriously).
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Elevated temp. Left arm swollen and red from shoudler to elbow. Warm to touch with a large  knot. Mom instruction to follow-ujp with family physician. Instruction to use ice on area until seen by Dr. Mom called Dr - Dr stated to come in if swelling not gone in seven days - Swelling gone 10-1-14.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Pain, Pruritus
Clinical narrative: Pt had Tdap 9-15-14. Started experiencing upper arm swelling and itching beginning 9-17. Continued to swell and itch. Went to walk in clinic 9-21-14 due to pain with swelling and itch. Instructed to take Benadryl given Prednisone. Came in to our office 9-2still swollen and red, instructed to start Prednisone 9-29-14. Pt still c/o slight itch. No other sx.
Age: 0.25
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Flu vaccine given to 3 month infant at flu clinic -> MD notified after administered and mom called offc. No adverse reactions at this time.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth, Vaccination complication
Clinical narrative: 9/26 (R) elbow with swelling and redness (R) elbow after receiving flu vaccine (R) del on 9/24 - no recent injury, (R) elbow warm to touch no tenderness good ROM - tx prednisone 20mg qd x 5 days. Dx allergic rea to flu vaccine. No future flu shots. Monitor.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pruritus, Skin warm, Tenderness
Clinical narrative: Left shoulder reaction 45 mm in diameter, slightly raised, itchy, tender to touch, warm to touch.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Nausea, Pain
Clinical narrative: Nausea, vomiting, diarrhea, sweating, chills, fever, body aches - lasting 30+ hours.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, sweating, chills, fever, body aches - lasting 30+ hours.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dry skin, Erythema, Pruritus, Rash, Skin exfoliation
Clinical narrative: Neck rash, face itchy and red. Peeling and skin and very dry. Started 4 days after vaccine approximately 9/8/14.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site pain, Local swelling
Clinical narrative: Approximately 30 seconds after vaccine administration the patient's arm bruised (11 inch diameter) and swelled (1/2 inch raised). The patient did experience any other symptoms. Approximately 4 hours later the patient returned and some swelling had gone down and stated it was sore at the injection site but no other problems.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Pruritus
Clinical narrative: Rash 2  inch diameter around injecitn site. 2 small spots on back and arm. Dr treating for itch. Cover area. If more develop return to Dr.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: Pt. came in to show us her arm which appeared red and tender to the touch. Pt. stated it was very swollen the previous day. We followed up 9/12/14 pt was much better.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abdominal pain lower, Pyrexia
Clinical narrative: Received Hep A and HPV vaccine on 8/27/14. Developed fever and RLQ pain 4 days after. Went to ED to rule out acute abdome.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 1355 - Vaccine administered. 1413 - Itching and redness at injection site. 1417 - Epinephrine administered. 1428 - EMS transported to ER. 1530 - Given BENADRYL at ER and discharged.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Rash, Skin warm
Clinical narrative: Left arm swelled, red, hot, rash like area that ws 5 inches by 4 inches.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Cellulits on the arm,  is observe red and hot
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Red, swollen, painful and warm to the touch 5 days after being given.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 17-MAR-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J007930, expiration date:28-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to within recommended storage temperature since then. The highest temperature the M-M-R II could have been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Dyspnoea, Headache
Clinical narrative: Patient told physician she had headache, shortness of breath and diarrhea after flu shot.
Age: 1.5
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Erythema multiforme, Rash
Clinical narrative: Rash involving buttocks and legs 1 day after vaccine administration. Erythema multiforme minor.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: "Burning" rash in straight line R side of abdomen. DX: Shingles
Sex: M
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a clinical medical assistant refers to a male patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On 30-SEP-2014, reported as "yesterday", the patient was vaccinated with ROTATEQ dose 2, 2 ml, oral (lot # was not reported). The medical assistant stated that the administered dose of ROTATEQ was improperly stored. No adverse effects reported. No treatment was given. This is one of two cases from the same reproter. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Mom states back of L arm looked slightly red 10-2-14 but on 10-3-14. she stated the back of his L arm was red from his elbow to  his shoulder. Dr's office said redness was 7" x 7", not to touch, but no fever and no pain. Dr put pt on Keflex 250 mg TID x 1 week and mom says today it is 90% better. This was in area Varicella was given.