chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional who stated that ZOSTAVAX and VARIVAX were stored improperly and administered to an unspecified number of patients. No adverse effects were reported. Additional information is not expected since reporter did not want to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a physician referring to a unspecified patients of unknown age. No pertinent medical history and concurrent conditions reported. On an unknown date the unspecified patients were vaccinated with improperly stored GARDASIL injection (dose not reported). No other concomitant therapies reported. The outcome of the event was unknown. No PQC reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a physician referring to a unspecified patients of unknown age. No pertinent medical history and concurrent conditions reported. On an unknown date the unspecified patients were vaccinated with improperly stored liquid PEDVAXHIB intramuscular injection (dose not reported). No other concomitant therapies reported. The outcome of the event was unknown. No PQC reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure before pregnancy, Seroconversion test negative, Serology test
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse, concerning her daughter (age not provided) was currently pregnant and has a history of mild case of chickenpox as child. Approximately five years ago, in 2009, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # and expiration date not provided). Co-suspect therapy and concomitant medications were not provided. The reporter stated that her daughter was currently pregnant, received a dose of (Oka/Merck) VARIVAX prior to nursing school acceptance approximately five years ago (in 2009). Varicella titers were taken and her daughter did not seroconvert after receiving the (Oka/Merck) VARIVAX. At the time of the report, the patients outcome and the relatedness between the event and suspect therapy were unknown. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of "around 25 years old", who was the son of a physician's friend. Medical history and concurrent conditions were not reported. On an unknown date, reported as "many years ago when he was a young child", the patient was vaccinated with 2 doses of (Oka/Merck) VARIVAX. Dose, route, lot number and expiration date were not reported. On an unknown date, "recently", the patient was diagnosed with shingles. The outcome of shingles was not recovered. The friend's son was not a patient of physician. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown current age and gender. Medical history and current conditions were not reported. In approximately 2011 (also reported as at 1 year old) the patient received their first dose of M-M-R II (subcutaneous injection, strength, route, dosage, lot # and expiration date not reported). On 10-JUN-2014 the patient received their second dose of M-M-R II (subcutaneous injection, strength, route, dosage, lot # and expiration date not reported), when the patient was 4 years old. It was reported that the patient inadvertently received a third dose of M-M-R II (subcutaneous injection, strength, route, dosage, lot # and expiration date not reported) on 23-JUL-2014. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
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. On 23-JUL-2014 the patient was vaccinated with RECOMBIVAX HB (dose and lot # were not reported), intramuscular which underwent an unsupported temperature excursion. No adverse effects reported. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 64 year old patient of unknown gender. The patients current conditions or medical history were not reported. On 12-JUN-2014, the patient was administered an expired dose of ZOSTAVAX (dose and route not reported) lot number H019042 expiration date 17-JAN-2014. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. ON an unknown date, the patient was vaccinated with GARDASIL. On an unknown date, the patient complained that there was pain at injection site. The outcome of pain at injection site was unknown. This is one report of several from the same source. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 82 year old patient. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 23-JUL-2014 the patient was vaccinated with expired dose of ZOSTAVAX (strength, route, dose not reported) lot number J0022 with expiry of 21-MAY-2014. Pharmacist stated that registered nurse (RN) at physician office administered vaccine and vaccine date was discovered when nurse was logging information. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Mammogram, Swelling, Tenderness
Clinical narrative: Tenderness and slight swelling in axilla of the arm that injection was given.  Patient also had a mammogram immediately after receiving the vaccination.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Red, swollen, warm to touch in vaccine area.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Right thigh w/10x12cm area if erythema/edema, 2x3cm area of deeper erythema no fluctuance.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Erythema, Fatigue, Local swelling
Clinical narrative: Patient reports felt fatigue right away, has been sleeping about 12-18 hours per night, has slightly raised red swelling 3 inches at widest, and no appetite.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Malaise, Pyrexia, Salivary hypersecretion, Vomiting
Clinical narrative: Symptoms : Fever 101.5°-103.5°F,increased salivation, occasional vomiting, general feeling of malaise lasting over 15 hours  Treatment : Alternating acetaminophen and ibuprofen, increased fluids, lukewarm bath
Age: 34.0
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Fatigue, Headache, Insomnia, Pyrexia
Clinical narrative: In the morning, I was very tired, but still managed to work. After coming back home at night, I was caught by a low fever (99.7 degree), as well as headache, tired feeling, insomnia, and stomach pain.   All the symptoms except headache were relieved after 2 days; then red rashes appeared around my body.   In the first day, I found 14 rashes with one was itchy. More rashes appeared in the second day, which is now, 07/26/2014.
Age: 34.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: In the morning, I was very tired, but still managed to work. After coming back home at night, I was caught by a low fever (99.7 degree), as well as headache, tired feeling, insomnia, and stomach pain.   All the symptoms except headache were relieved after 2 days; then red rashes appeared around my body.   In the first day, I found 14 rashes with one was itchy. More rashes appeared in the second day, which is now, 07/26/2014.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Bronchitis, Cough, Diarrhoea, Myalgia
Clinical narrative: Initial all over muscle aches and fever. Next morning a large painful blister in the back of my throat. Then urgent diarrhea. This progressed to wheezing and a cough and what appears to be bronchitis.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Wheezing
Clinical narrative: Initial all over muscle aches and fever. Next morning a large painful blister in the back of my throat. Then urgent diarrhea. This progressed to wheezing and a cough and what appears to be bronchitis.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a registered nurse refers to an adult patient of unknown age. On an unknown date the patient was inadvertently vaccinated with only one pediatric dose of RECOMBIVAX HB injection (lot # not reported), intramuscular, instead of two pediatric doses, resulting in a less than full dose. No adverse effects. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Full blood count, Metabolic function test, Urticaria
Clinical narrative: This spontaneous report as received from medical assistant refers to a 66 year old female patient. Concomitant therapies included SINGULAIR. No information about concurrent conditions and medical history was reported. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dose strength not reported). The reporter stated that one month later after the patient was vaccinated with a dose of ZOSTAVAX patient developed exercised induced hives. The medical assistant stated the patient was seen in the office on 16-JUL-2014 and a comprehensive metabolic and complete blood count (CBC) were completed and the results were unknown (also reported as however "we haven't gotten the results back "yet"). The reporter also stated that the hives aren't always present, appears when the patient exercises, last for however long and then eventually go away, but comes back when the patient exercises again. The outcome of exercised induced hives is unknown. No product quality complaint has involved. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pruritus generalised, Rash generalised
Clinical narrative: Itching all over, broke out in bumps all over, didn't feel well. Patient took BENADRYL as advised by us and primary care provider. Also used OTC hydrocortisone cream for itching.
Age: 49.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Brachial plexopathy, Hypoaesthesia, Pain, Swelling face
Clinical narrative: Excruciating pain and burning sensation in the left arm felt in the evening of the administrated injection. I was unable to move my arm after the administration, and my finger became numb. The pain continued and I took pain relievers. This continued for a week, so I visited my primary physician, who recommended IBUPROFEN and Percocet. She diagnosed brachial neuritis. The medication didn't help so I went back to the doctor, and she put me on oxycodone with a referral to the neurologist. After the neurologist examined me, he diagnosed brachial neuritis and recommended an EMG and MRI. He also referred me to physical therapy. Meanwhile my primary physician ordered blood test and she put me on morphine tabs for the constant severe pain that I felt. I continued to see the doctor back and forth every week, as they continued to increase my medication regarding the severe pain that I felt, after the injection. I still have severe pain, and continue to take various medications recommended by my physician.
Age: 49.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood test, Burning sensation, Electromyogram, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Excruciating pain and burning sensation in the left arm felt in the evening of the administrated injection. I was unable to move my arm after the administration, and my finger became numb. The pain continued and I took pain relievers. This continued for a week, so I visited my primary physician, who recommended IBUPROFEN and Percocet. She diagnosed brachial neuritis. The medication didn't help so I went back to the doctor, and she put me on oxycodone with a referral to the neurologist. After the neurologist examined me, he diagnosed brachial neuritis and recommended an EMG and MRI. He also referred me to physical therapy. Meanwhile my primary physician ordered blood test and she put me on morphine tabs for the constant severe pain that I felt. I continued to see the doctor back and forth every week, as they continued to increase my medication regarding the severe pain that I felt, after the injection. I still have severe pain, and continue to take various medications recommended by my physician.
Age: 49.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Radiculitis brachial
Clinical narrative: Excruciating pain and burning sensation in the left arm felt in the evening of the administrated injection. I was unable to move my arm after the administration, and my finger became numb. The pain continued and I took pain relievers. This continued for a week, so I visited my primary physician, who recommended IBUPROFEN and Percocet. She diagnosed brachial neuritis. The medication didn't help so I went back to the doctor, and she put me on oxycodone with a referral to the neurologist. After the neurologist examined me, he diagnosed brachial neuritis and recommended an EMG and MRI. He also referred me to physical therapy. Meanwhile my primary physician ordered blood test and she put me on morphine tabs for the constant severe pain that I felt. I continued to see the doctor back and forth every week, as they continued to increase my medication regarding the severe pain that I felt, after the injection. I still have severe pain, and continue to take various medications recommended by my physician.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old female patient. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 19-JUL-2014 the patient was vaccinated with ZOSTAVAX lot # J013137, expiration date 17-JAN-2015, dose 1, dose 0.65 ml, route subcutaneous, right after the patient developed irritability, redness, warmth and itching at the injection site. It was also reported that the patient visited pharmacy on 21-JUL-2014 and stated that the events are still present. The outcome of irritability, redness, warmth and itching at the injection site was reported as not recovered/not resolved. No product quality complaint was involved. This is one of the several reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Irritability
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old female patient. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 19-JUL-2014 the patient was vaccinated with ZOSTAVAX lot # J013137, expiration date 17-JAN-2015, dose 1, dose 0.65 ml, route subcutaneous, right after the patient developed irritability, redness, warmth and itching at the injection site. It was also reported that the patient visited pharmacy on 21-JUL-2014 and stated that the events are still present. The outcome of irritability, redness, warmth and itching at the injection site was reported as not recovered/not resolved. No product quality complaint was involved. This is one of the several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dehydration, Dizziness, Syncope
Clinical narrative: Syncope and dehydration. Pt was light headed following vaccination. Had pt sit in the lobby for 20 minutes following the shot. Called EMS to ensure he did not need medical attention. Blood pressure was fine, EMS stated that pt was dehydrated. Gave pt a bottle of water and he sat in lobby for an additional 20 minutes. Pt signed a waiver from EMS stating that he did not need medical treatment. He felt better and went home.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Decreased appetite, Dizziness, Mobility decreased, Nausea
Clinical narrative: WITHIN 24 HOURS OF VACCINATION, PATIENT WAS EXPERIENCING DIZZINESS, ITCHING, AND NAUSEA. AS OF 7/27/14, SYMPTOMS HAVE PROGRESSED TO BILATERAL RASH ON STOMACH, WORSENING ARTHRITIS PAIN (PATIENT CAN BARELY MOVE), DIZZINESS, NAUSEA, LOSS OF APPETITE, ITCHING, PAIN.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash
Clinical narrative: WITHIN 24 HOURS OF VACCINATION, PATIENT WAS EXPERIENCING DIZZINESS, ITCHING, AND NAUSEA. AS OF 7/27/14, SYMPTOMS HAVE PROGRESSED TO BILATERAL RASH ON STOMACH, WORSENING ARTHRITIS PAIN (PATIENT CAN BARELY MOVE), DIZZINESS, NAUSEA, LOSS OF APPETITE, ITCHING, PAIN.
Age: 7.0
Sex: F
Vaccine: HEPA, HIBV, IPV, MMRV, TDAP
Symptoms: Erythema, Induration
Clinical narrative: 7x10cm area of erythema w/2x3cm area of induration centrally
Age: 30.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner via sales representative refers to a 30 year (reported as patient in her 30's) old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (therapy start dates, strength, route was not reported). The reporter stated that on an unknown date the patient broke out with shingles after receipt of the vaccine. The outcome of broke out with shingles is unknown. No product quality complaint was involved. 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 nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On unspecified dates, these unspecified patients were vaccinated with LIQUID PEDVAXHIB, (injection, lot#, dose, route and frequency were not provided) that were improperly stored outside the recommended storage temperatures in the product insert. No adverse effects reported. No product quality complaint (PQC). The outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to a 22 year old patient. The patients pertinent medical history included dialysis, hypertension, end stage renal disease. No known allergies were reported to drugs. Concomitant therapies included amlodipine, ferric sulfate, LISINOPRIL (manufacturer unknown), OMEPRAZOLE (manufacturer unknown), albuterol and TYLENOL. On 19-MAY-2014 the patient was vaccinated with PNEUMOVAX23 lot # J013555 expiration date 02-MAY-2015, dose 0.5 ml, route intramuscular in the deltoid of right arm. Approximately on an unknown date in MAY 2014 (reported as with in 24 hours) the patient developed redness, warm to touch, swelling at the injection site of right arm. The nurse stated comfort measures of warm compress was recommended to patient and follow up with his health care provider. The outcome of redness, warm to touch, swelling at the injection site or right arm was reported as not recovered/not resolved. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patients of unknown demographics. No information about medical history, concurrent conditions and concomitant medications ware reported. The reporter stated that unknown number of patients were vaccinated with VAQTA (dose strength, route not reported) that had been improperly stored. Approximately on an unknown date in July 2014 (reported as between 09-JUL-2014 and 16-JUL-2014). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patients of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that unknown number of patients were vaccinated with ROTATEQ route oral (dose strength not reported) that had been improperly stored. Approximately on an unknown date in July 2014 (reported as between 09-JUL-2014 and 16-JUL-2014). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patients of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that unknown number of patients were vaccinated with RECOMBIVAX HB (dose, strength, route not reported) that had been improperly stored. Approximately on an unknown date in July 2014 (reported as between 09-JUL-2014 and 16-JUL-2014). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patients of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that unknown number of patients were vaccinated with PNEUMOVAX23 (dose, strength, route not reported) that had been improperly stored. Approximately on an unknown date in July 2014 (reported as between 09-JUL-2014 and 16-JUL-2014). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of the several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 4 year old child of unknown gender. Medical history and concurrent conditions were not reported. On 04-MAR-2014, the patient was vaccinated an improperly stored dose of VARIVAX (lot # J008443, expiration date 09-JUL-2015), 0.5 ml, subcutaneous (strength and indication not reported). No adverse events were reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. This case has been linked with case 1407USA003655, 1407USA005531, and 1407USA011075. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients (no patient's information were provided). On unknown date the patients were vaccinated with GARDASIL, that were improperly stored outside the recommended temperature storage range. No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On unspecified dates, these unspecified patients were vaccinated with ROTATEQ (oral, lot #, dose and frequency were unknown), that were improperly stored outside the recommended storage temperatures in the product insert. No adverse effects reported. No product quality complaint (PQC). The outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Nausea, Paraesthesia
Clinical narrative: Around 12:00 pm patient got home and complained left arm was numb and tingling (blood drawn in left arm). Pt moved it around and sx resolved. After playing outside until about 1:00 pm, patient came inside to tell mom tongue was numb and she was talking funny. Mom sat her down gave juice and toast and sx resolved. Then horrible headache followed, mom gave TYLENOL. Patient then became nauseous. Mom called us, we advised BENADRYL. 30 minutes following BENADRYL pt felt better. Slight headache lingered.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Speech disorder
Clinical narrative: Around 12:00 pm patient got home and complained left arm was numb and tingling (blood drawn in left arm). Pt moved it around and sx resolved. After playing outside until about 1:00 pm, patient came inside to tell mom tongue was numb and she was talking funny. Mom sat her down gave juice and toast and sx resolved. Then horrible headache followed, mom gave TYLENOL. Patient then became nauseous. Mom called us, we advised BENADRYL. 30 minutes following BENADRYL pt felt better. Slight headache lingered.
Age: 61.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Chest discomfort, Dyspnoea, Swelling
Clinical narrative: Swelling, SOB, chest tightness same evening of receiving the vaccine worst the next morning. Took ALLERGAN and applied cortisone. Recovered.
Age: 22.0
Sex: M
Vaccine: FLUC3
Symptoms: Dizziness, Nausea
Clinical narrative: FLUCELVAX administered, approx. 15 min later pt. complained about nausea, lightheadedness. I put pt. in safe area on floor. He recovered within 10 min. without further issues.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity, Tenderness
Clinical narrative: Extreme soreness/pain in the upper arm/shoulder beginning evening after shot. Patient could only raise arm a few inches w/out pain; couldn't roll over on it or lay on it during the night. TYLENOL and Ice helped a little.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Extreme soreness/pain in the upper arm/shoulder beginning evening after shot. Patient could only raise arm a few inches w/out pain; couldn't roll over on it or lay on it during the night. TYLENOL and Ice helped a little.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Lumbar puncture, Myelitis transverse, Nuclear magnetic resonance imaging spinal
Clinical narrative: Case number PHHY2013US146995 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 511521) website on 16 Dec 2013 with a follow up information received from the health authority on 24 Jul 2014. This report refers to a 57-year-old female patient. Her medical history was not reported. Her concomitant medications were levothyroxine, allopurinol, simvastatin, lisinopril and bupropion. She was vaccinated with FLUVIRIN (batch number: 130920) intramuscularly in the left arm on 14 Oct 2013. She was hospitalized for 5 days for acute transverse myelitis due to flu shot from 31 Oct 2013 to 05 Nov 2013. She underwent magnetic resonance imaging (MRI) of cervical and thoracic spine, computerized tomogram (CT) of head and lumbar puncture (results unknown). Outcome of the event was reported as unknown. The event was reported as serious. The causality of the events was not reported. Follow up information received from the health authority on 24 Jul 2014: Updated suspect vaccine, batch number, route and site of vaccination, number of days of hospitalization, reported seriousness and outcome.
Age: 1.54
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Bacterial infection, Injection site erythema, Wound drainage
Clinical narrative: Localized erythema on RIGHT thigh at site of injection, progressing to worsening erythema with discharge concerning for secondary bacterial infection.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Anxiety, Drug administered to patient of inappropriate age, Herpes zoster, Infection susceptibility increased
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a 48 year old female, who was vaccinated with ZOSTAVAX (dosage and route of administration not provided). On 18-JUL-2013, while at the pharmacy, a pharmacist encouraged the patient to receive an injection of ZOSTAVAX. He did not provide the patient with any information regarding the vaccination and subsequently administered the vaccination without screening the patient or obtaining signed consent. He knew or should have known that the patient has an immunodeficiency from radiation treatment for her breast cancer and that she was not in the recommended age bracket of age 60 or over. He injected the patient with a vaccine that was unreasonably likely to cause her great harm. At the time of the injection, the patient experienced severe pain in her arm at the injection site. Days later, the arm was swollen and she felt excruciating pain. The patient called the pharmacist who assured her that there was no chance she had contracted shingles. She subsequently visited her primary doctor regarding the pain and informed him of the vaccination. Her doctor was shocked to learn that she had been given a ZOSTAVAX as she was clearly not a suitable candidate, and he informed her that she was infected with shingles as a result of the ZOSTAVAX. The patient now suffers from shingles with outbreaks manifesting as large, unsightly rashes which bring terrible pain. The pain interferes with every aspect of her daily life. Plus the shingles infection makes the patient more susceptible to infection and threatens to hinder her recovery should her cancer ever return. The patient must also take VALTREX for the rest of her life to alleviate the symptoms of shingles. The negligence resulted in serious and extensive residual disabilities and permanent damages to the patient including but not limited to: extreme physical pain, large unsightly rashes, anxiety, apprehension, and nausea from the medication she must take to combat the shingles. There is no cure for shingles and the patient must endure the virus for the rest of her life. Shingles, anxiety/apprehension and nausea were considered to be disabling. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Local swelling, Nausea, Pain, Rash
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a 48 year old female, who was vaccinated with ZOSTAVAX (dosage and route of administration not provided). On 18-JUL-2013, while at the pharmacy, a pharmacist encouraged the patient to receive an injection of ZOSTAVAX. He did not provide the patient with any information regarding the vaccination and subsequently administered the vaccination without screening the patient or obtaining signed consent. He knew or should have known that the patient has an immunodeficiency from radiation treatment for her breast cancer and that she was not in the recommended age bracket of age 60 or over. He injected the patient with a vaccine that was unreasonably likely to cause her great harm. At the time of the injection, the patient experienced severe pain in her arm at the injection site. Days later, the arm was swollen and she felt excruciating pain. The patient called the pharmacist who assured her that there was no chance she had contracted shingles. She subsequently visited her primary doctor regarding the pain and informed him of the vaccination. Her doctor was shocked to learn that she had been given a ZOSTAVAX as she was clearly not a suitable candidate, and he informed her that she was infected with shingles as a result of the ZOSTAVAX. The patient now suffers from shingles with outbreaks manifesting as large, unsightly rashes which bring terrible pain. The pain interferes with every aspect of her daily life. Plus the shingles infection makes the patient more susceptible to infection and threatens to hinder her recovery should her cancer ever return. The patient must also take VALTREX for the rest of her life to alleviate the symptoms of shingles. The negligence resulted in serious and extensive residual disabilities and permanent damages to the patient including but not limited to: extreme physical pain, large unsightly rashes, anxiety, apprehension, and nausea from the medication she must take to combat the shingles. There is no cure for shingles and the patient must endure the virus for the rest of her life. Shingles, anxiety/apprehension and nausea were considered to be disabling. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Had Tdap for physical 7/21/14 2 days ago on 7/26 developed erythema, raised blotchy hive like 7 x 9 cm at injection site right deltoid. Advised BENADRYL, PEPCID f/u if not improved.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: Lightheaded, headache, vomiting.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Mild fever and rash starting on chest and extended to back, neck, and face
Age: 51.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Rash generalised, Rash pruritic, Urticaria
Clinical narrative: itchy rash/hives on Left side of face & neck & abd. received Hep A (Right deltoid) & Tdap (Left deltoid) immunizations on Wednesday, 7/16/14 & on Saturday 7/19/14 am noticed rash with intense itching on face . states has been taking benadryl & using hydrocortisone cream to alleviate. On 7/24/14 patient seen again and rash/hives have now developed on Left thigh & buttock.  Referred to dermatologist and was seen on same day (7/24/14).  Was told by dermatologist that hives could possibly be due to one or both immunizations.  Was prescribed Hydrozyzine Hcl 25mg tab, Triamcinolone 0.1% cream & Cetirizine Hcl 10mg tab.
Age: 1.07
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Pt. rec'd 12 mo immunizations at WCE on 5/22/14. Nurse noted mild redness at LA site following MMR administration and reported to Dr. Pt assessed and Dr conferred with ID per phone and with red book. Observed x 30 min post vaccine. No systemic s/s - approximately 4cm x 3 1/2cm lt pink area decreased. Referred to allergy.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Headache, Hyperhidrosis, Pallor, Tinnitus
Clinical narrative: Pt stated she ate and was feeling well. She received HPV, MENACTRA, and Tdap. After the vaccines she stated she felt well. Denied dizziness, lighthead or any other symptom. She stood up and nurse and her father escorted her to waiting room so she could wait 15 min. Pt stated she was lighthead, dizzy, ringing in ear, visual disturbances. She was guided to ground. Her blood pressure was 88/56. She was pale, diaphoretic. She was given cool rag and fan. She was given a cool drink of water. At 2:37 vision got better. At 2:37 she was guided to an exam table to lay down. She ate and was cooled off at 2:45. Blood pressure was 116/76. Her only complaints were a headache. At 3:00 she denied any symptoms. At 3:07 her father stated that since she was feeling better, he was going to take her home.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Visual impairment
Clinical narrative: Pt stated she ate and was feeling well. She received HPV, MENACTRA, and Tdap. After the vaccines she stated she felt well. Denied dizziness, lighthead or any other symptom. She stood up and nurse and her father escorted her to waiting room so she could wait 15 min. Pt stated she was lighthead, dizzy, ringing in ear, visual disturbances. She was guided to ground. Her blood pressure was 88/56. She was pale, diaphoretic. She was given cool rag and fan. She was given a cool drink of water. At 2:37 vision got better. At 2:37 she was guided to an exam table to lay down. She ate and was cooled off at 2:45. Blood pressure was 116/76. Her only complaints were a headache. At 3:00 she denied any symptoms. At 3:07 her father stated that since she was feeling better, he was going to take her home.
Age: 57.0
Sex: F
Vaccine: FLUC3
Symptoms: Arthralgia, Asthenia, Decreased appetite, Headache, Pain
Clinical narrative: headache, joint pain, body aches, loss of energy, heart palpitations, loss of appetite
Age: 57.0
Sex: F
Vaccine: FLUC3
Symptoms: Palpitations
Clinical narrative: headache, joint pain, body aches, loss of energy, heart palpitations, loss of appetite
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 year old female patient. No information about medical history and concomitant medications were reported. The reporter stated that patient has a rash since an unspecified date prior 6to the administration of ZOSTAVAX was vaccinated with ZOSTAVAX lot #J011339 expiration date 13-DEC-2014, dose 0.65 ml, route subcutaneous, on 14-JUL-2014. On 16-JUL-2014, the patient was diagnosed with shingles. The outcome of shingles was reported as recovering/resolving. Patient sought medical attention at physician's office on an unspecified date and was prescribed FAMVIR. No product quality complaint was involved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 63 year old female patient. Patient got the first dose of RECOMBIVAX HB in 2009 (reported as "5 years ago"), and the second dose of RECOMBIVAX HB (1.0 ml, intramuscular, right deltoid) on 14-JUL-2014 (reported as "today"). No adverse effects reported. Additional information is not expected.
Age: 58.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 58 year old patient of unknown gender. Concomitant medication and pertinent medical history were not provided. On 19-MAY-2014 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot #, dose, route and frequency were not provided) instead of ZOSTAVAX in error. The error was not a result of medication confusion, but an error of the staff in the practice in which the patient was vaccinated. The patient had not reported or demonstrated any adverse effects.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and unknown gender. The patients medical history and current conditions were not reported. On 17-JUL-2014 the patient was vaccinated with improperly stored M-M-R II (albumin status/therapy type: unknown) (dose/frequency, route of administration were not reported) (lot # J000202, expiry date: 19-JAN-2015). Concomitant medications were not reported. No adverse effects were reported. No product quality complaint (PQC) was reported for M-M-R II. The case is linked to 1407USA009063, 1407USA012208, 1407USA012207 and  1407USA012206 (same reporter link).Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and unknown gender. The patients medical history and current conditions were not reported. On 05-JUN-2014 the patient was vaccinated with improperly stored M-M-R II (albumin status/therapy type: unknown) (dose/frequency, route of administration were not reported) (lot # J000202, expiry date: 19-JAN-2015). Concomitant medications were not reported. No adverse effects were reported. No product quality complaint (PQC) was reported for M-M-R II. This case is linked to 1407USA012205, 1407USA012206, 1407USA012207 and 1407USA012208 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and unknown gender. The patient's medical history and current conditions were not reported. Since 03-JUN-2014, the unspecified number of patients were vaccinated with improperly stored GARDASIL (dose/frequency, route of administration were not reported). Concomitant medications were not reported. No adverse effects were reported. No product quality complaint (PQC) was reported for GARDASIL. This case is linked to 1407USA009063, 1407USA012208, 1407USA012207 and 1407USA012205 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and unknown gender. The patients medical history and current conditions were not reported. Since 03-JUN-2014, the unspecified number of patients were vaccinated with improperly stored ROTATEQ (dose/frequency, route of administration were not reported). Concomitant medications were not reported. No adverse effects were reported. No product quality complaint (PQC) was reported for ROTATEQ. This case is linked to 1407USA0009063, 1407USA012205, 1407USA012206, 1407USA012208. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant refers to a unspecified number of patients of unknown age and unknown gender. The patients medical history and current conditions were not reported. Since 03-JUN-2014, the unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB (dose/frequency, route of administration were not reported). Concomitant medications were not reported. No adverse effects were reported. No product quality complaint (PQC) was reported for RECOMBIVAX HB. This case is linked to 1407USA009063, 1407USA012207, 1407USA012206 and 1407USA012205 (same reporter link). Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: This spontaneous report as received from a healthcare worker via consumer (the patient's mother) refers to a 2 year old female patient with allergy to milk. No other patient's pertinent medical history was provided. On 09-JUL-2014, the patient received first dose of (Oka/Merck) VARIVAX 0.5ml, subcutaneous (lot number and expiration date were not reported). No concomitant medications were provided. In approximately July 2014 (reported as beginning over the weekend), the patient developed high fever and blister like rash. It was clarified that blistery rash was not at injection site. the events remained ongoing. The relatedness between the events and the vaccination with (Oka/Merck) VARIVAX was unknown. The patient did not seek medical attention. No treatment was given for adverse events. Additional information is not expected because we cannot contact with the physician.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician and office manager via Company Representative refers to a patient of unknown age and gender. In approximately June 2014, reported as a month ago, the patient was vaccinated with (Oka/Merck) VARIVAX injection, 1 single shot instead of ZOSTAVAX (dose, route and lot # not reported). The patient did not seek any medical attention. It was reported that therapy with (Oka/Merck) VARIVAX was continued. The patient's outcome was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a "roughly" 65 years old female patient with allergy to RITUXAN and no pertinent medical history. On an unknown date, the patient was vaccinated with a dose of PCV (manufacturer unknown, PNEUMOVAX could not be ruled out) (dose, route and lot# number not provided). Other suspect therapies included influenza virus vaccine (unspecified) (dose, route and lot# number not provided) administered on an unknown date. On an unknown date, the patient developed severe swelling in her arm. The outcome of severe swelling in her arm was reported as recovered on an unspecified date. Causality between the event and suspect therapies was not provided. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On unknown dates the patient was vaccinated with first and second dose of M-M-R II (lot #, expiration date, dose and route not reported). No concomitant medications were reported. Then on an unknown date the patient had a blood titer performed. The titer was negative for immunity to mumps. There was not treatment given. The patient's present status was unspecified. The relatedness between "titer was negative" and M-M-R II was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to an unspecified number of patients of unknown age. On an unknown date, patients were vaccinated with a dose of (Oka/Merck) VARIVAX (lot #, expiration date, dose, route, indication not reported) that had arrived "without dry ice", indicated that the vaccine might have gone through an excursion. The reporter did not specify the exact temperature of the shipment. No adverse experience reported. Additional information is not expected due to the reporter did not wish to provide any information.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 2 patients of unknown age and gender. On an unknown date, the 2 patients was vaccinated with RECOMBIVAX HB (dose, and lot # not reported) which was improperly stored, intramuscularly. The 2 patients received an intramuscular dose in accordance with the prescribing information. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.