chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Eye haemorrhage, Local swelling, Rash, Rash macular, Skin infection
Clinical narrative: This spontaneous report was received from approximately a 71 year old male patient, regarding himself. The patient had no pertinent medical history, drug reactions and allergies. On 29-JUL-2014 the patient was vaccinated with ZOSTAVAX (dose, lot # and other details unspecified). No concomitant therapy was reported. On 30-JUL-2014, the patient experienced big-red blotches on his legs, popped eye vessels and bleeding from his eyes after receiving ZOSTAVAX. The consumer also stated that he was seen and released, the same day (30-JUL-2014), from an unspecified emergency room, on an unspecified date. The consumer stated that, he received treatment for events with antibiotic (unspecified name, dose/frequency and manufacturer), allergy medication (unspecified name, dose/frequency and manufacturer) and steroids (unspecified name, dose/frequency and manufacturer). No product quality complaint was filed. The action taken was assessed as not applicable. The outcome of events was reported as recovered on 13-AUG-2014. The causality was unspecified in the report. Follow-up information was received on 15-SEP-2014 from consumer. The patient's concomitant medications included, acetaminophen (manufacturer unknown) 325 mg tablet, 2 tablets every 6 hours orally for pain-mild 1-3, aspirin 81 mg daily, KEFLEX 500 mg capsule, 1 capsule every 12 hours for 10 days, metoprolol tartrate (manufacturer unknown) 1 tablet every 12 hours, prednisone (manufacturer unknown) 20 mg, 2 tablets daily for 2 days then 1 tablet daily total 5 days and simvastatin (manufacturer unknown) 20 mg, 1 tablet orally at bedtime. On an unknown date in 2014, the patient experienced swelling of hand and infection of skin. The patient was asked to contact primary care physician in order to re-evaluate the condition and overall health of the patient. Approximately on an unknown date in 2014, the patient was laid up for three weeks (disability) because of this bad batch. The outcome of laid up for three weeks, hand swelling and skin infection was unknown. The causality was unknown. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pyrexia
Clinical narrative: Fever of about 104.9, hand where vaccine was adminstered was swollen the size of a golfball
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye pruritus, Gingival pruritus, Injection site pain, Nasal discomfort
Clinical narrative: symptoms came on suddenly and started getting worse and worse, horrible itching inside nose, horrible itching back of throat,pain on injection site, nose started running with clear discharge. I took 1 benadryl 25 mg at 9 PM, took another one 10:30 pm . Still having worsening itching  and I started to cough. Took a 20 mg prednisone at 11PM, took a second 20mg prednisone at 12:53. Now my eyes starting to itch and  my gums are itchy too. If symptoms don't subside I will be taking myself to the ER.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea, Throat irritation
Clinical narrative: symptoms came on suddenly and started getting worse and worse, horrible itching inside nose, horrible itching back of throat,pain on injection site, nose started running with clear discharge. I took 1 benadryl 25 mg at 9 PM, took another one 10:30 pm . Still having worsening itching  and I started to cough. Took a 20 mg prednisone at 11PM, took a second 20mg prednisone at 12:53. Now my eyes starting to itch and  my gums are itchy too. If symptoms don't subside I will be taking myself to the ER.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: papular hives rash on torso spreading down arms and  legs/trunk.
Age: 1.63
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Dtap #4 dose administered to left thigh. Patient complaints of swollen, redness, warm to area starting on late morning patient doesn't complain of pain, active and playful per Mom
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Erythema, Local swelling
Clinical narrative: Swelling, large bruise on arm, redness down shoulder- all more than you would expect from a typical flu shot
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site urticaria, Pruritus
Clinical narrative: After initial dose patient waited 15 minutes. Redness, itching and small hives occurred to bilateral upper arms
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: After initial dose patient waited 15 minutes. Redness, itching and small hives occurred to bilateral upper arms
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via field representative regarding a female patient of unknown age. The caregiver of patient reported to pharmacist regarding the patient. No medical history reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose number and route of administration not specified) (lot number unknown). No concomitant therapy reported. On an unknown date, the patient experienced severe case of ophthalmic zoster above her eye and patient may go blind (disability and medically significant). The outcome of the events were unknown. The causality was unknown. NO PQC was involved. Upon internal review, event patient may go blind was considered medically significant. Additional information has been requested.
Age: 1.32
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, PNC13
Symptoms: Cellulitis, Local reaction, Wound, Wrong drug administered
Clinical narrative: Kinrix ws given instead of Dtap and hib was not administered.  A puncture wound was given to left thigh with already spent vaccine from right thigh; unknown which one.  Child  later developed a large local reaction for which she was seen in ER and dx with cellulitis and started on clindamycin.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large red circle, approx 3 inches in diameter around injection site. Very slightly raised, not itchy, slightly warm to the touch. Pt has remained non-febrile.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Headache, Hot flush, Paraesthesia, Paraesthesia oral
Clinical narrative: Severe headache, tingling in hands/wrist/forearms and around mouth, hot flashes, flushed face. No rash, no wheezing.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Gait disturbance, Pyrexia, Respiration abnormal
Clinical narrative: Patient state he was not feeling sick at time shot was administered. Patient woke up in the middle of the night with chills & fever and could hardly walk - went to the ER - given a nebulizer to help with breathing
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling, Pruritus
Clinical narrative: The patient stated that his arm became very swollen and itched
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Diffuse rash resembling varicella.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth, Local swelling
Clinical narrative: Patient' left arm (the arm in which she got the vaccine)started swelling and progressively got worse. It was swollen, red, and hot to the touch from the shoulder to the elbow. She called her family doctor two days later and was instructed to go to the ER. She went to the ER on 09/11/14 and was told it was a "severe allergic reaction" and was given Benadryl, Solu-medrol, and Pepcid in the ER and was given a prescription for antibiotics.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Eye irritation, Headache, Myalgia, Pyrexia
Clinical narrative: Scratchy throat, muscle aches, and onset of fever 102 degrees. Eyes scratchy and runny. Horrible headache. Took ibuprofen and BENADRYL.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Scratchy throat, muscle aches, and onset of fever 102 degrees. Eyes scratchy and runny. Horrible headache. Took ibuprofen and BENADRYL.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Death, Malaise
Clinical narrative: This spontaneous report as received from a physician (who heard from an unspecified media source) via a company representative refers to a 14 year old female patient. On an unknown date the patient was vaccinated with her first dose of GARDASIL (dose, route, lot number and expiration date not provided). Physician stated that the patient went home, felt a little sick, laid down and died on an unknown date. The outcome of felt a little sick was unknown. Relatedness between the events: felt a little sick and the patient died was not reported. Follow up information was received from a physician via company representative. Physician reported that media source stated that the patient was 12 years old (not 14 years as previously reported). Company representative stated that she found the article on a website and it may have been reported via other media channels. An official cause of death was not mentioned. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patients pertinent medical history was not reported. ON 11-SEP-2014 the patient was vaccinated with improperly stored ZOSTAVAX (reported as 19400 PFU) (Dose/Frequency: Unspecified, Therapy Route: Unspecified) (lot # K000326 and expiry date: 27-FEB-2015). Concomitant medications were not reported. The temperature excursion for the ZOSTAVAX was found to be unsupported by the in-house stability data. No adverse symptoms reported. No product quality complaint (PQC) was filed for ZOSTAVAX. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from nurse pracitioner (mother of patient) refers to a 27 year old female patient. The patient was allergic to codeine (also reported as none). The patient's pertinent medical history was none. On 11-SEP-2014 the patient was vaccinated with GARDASIL (dose/frequency: 0.5 ml) intramuscularly mistakenly instead of unspecified tetanus vaccine when her gestation age was 27 weeks and 3 days (also reported as for vaccination). Concomitant therapies included prenatal vitamins. The patient became pregnant with LMP of approximately 06-MAR-2014 and EDD of approximately 11-DEC-2014. Initial exposure to GARDASIL was at 27 week and 3 days. Lab diagnostic tests performed were done. The patient sought medical attention and no treatment was provided. No adverse effects reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 63 year old female patient who is not pregnant.  On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose not reported, subcutaneously). Concomitant medications were not reported. Pharmacist stated that on an unspecified date the patient developed shingles 7-10 days after the administration of ZOSTAVAX. The patient did not seek medical attention. Outcome of the event was reported as recovering. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site anaesthesia, Injection site pain, Insomnia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old male patient. The patient's medical history included dysphonia. On 07-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (Dose/Frequency: Unspecified, Therapy Route: Unspecified). Concomitant therapies included BOTOX. Approximately on 08-SEP-2014 (reported as 24 hours after the dose was given), the patient experienced severe pain at the injection site which prevented him from sleeping. The patient also experienced numbness which was unilateral from his neck, down his left arm. The patient had previous dose of PNEUMOVAX 23 approximately in 2012 (reported as 2 years ago). Approximately in 2012 (reported as about 2 years ago) the patient had pneumonia. In May 2014 (reported as May of this year), the patient had a cardiac stent placed. The pharmacist stated that the patient has been taking ibuprofen and using cold compresses to address the injection site pain but it has not brought him relief. The patient sought medical attention and no lab diagnostic tests were performed. The outcome of pneumonia and cardiac stent placed was unknown. The outcome of severe pain at the injection site which prevented him from sleeping and numbness which is unilateral from his neck, down his left arm was reported as not recovered. The causality of the events was not reported. No product quality complaint (PQC) was filed for PNEUMOVAX 23. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: This spontaneous report as received from a other health professional refers to a 63 year old female patient. The patient had a history of unknown reaction to codeine and penicillin. On an unknown date the patient was vaccinated with ZOSTAVAX. Concomitant therapies included aspirin, ascorbic acid, RESTASIS, OS-CAL CALCIUM CARBONATE, vitamins (unspecified), lisinopril (unknown manufacturer) and estradiol (unknown manufacturer). ON 11-SEP-2014 the patient experienced redness at the injection site and fever. The patient sought medical attention by calling the physician's office. As treatment over the counter BENADRYL was taken and ice was put over the reaction site. The outcome of redness at the injection site and fever was reported as recovering/resolving. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Hyperhidrosis, Hyporesponsive to stimuli
Clinical narrative: After administering immunizations client became diaphoretic and when asked if he was okay he nodded yes X1 then was not responding well. Clt with difficulty understanding english and speaking as well as he is a foreign exchange student. Client's fellow foreign exchange student did translate and client answered him appropriately. Ice was applied to clt's back of head and HR 64 was lowered to the floor for precautionary reasons and was doing well then to a wheelchair and was able to get out of the wheelchair go around the car and get into the car and was joking around with his fellow student. Patient when returned home did share with his host mother that he had this same reaction from previous vaccinations.
Sex: M
Vaccine: TDAP
Symptoms: Abscess sterile
Clinical narrative: A male patient (date of birth not reported) had received on 19 August 2014 a subcutaneous administration of ADACEL (lot number and site of administration not reported) and an unspecified amount of time later on the same date, experienced a sterile abscess. The patient's medical history and concomitant medications were not reported. Treatments were not reported. No further information was provided at the time of the report. Outcome was unknown. Documents held by sender: none.
Age: 1.03
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative and refers to a 15 month old patient of unknown gender. On 04-APR-2014 the patient was vaccinated with (oka/merck) VARIVAX (dose, units, route of administration, anatomical location were not reported, lot # J008170, expiration date: 02-JUL-2015). On 14-JUL-2014 the symptoms of chickenpox occurred (described as spots and fever). The outcome of event was reported as not recovered. The relatedness between event and (oka/merck) VARIVAX was not reported. Follow-up information has been received from a medical assistant. The reporter stated a VAERS (Vaccine Adverse Event Reporting System) report had been filed and additional information regarding patient was available at that time. The reporter also stated if any additional information becomes available she may fax that information. This is one of several reports from the same reporter. Additional information is not expected because address was correctly entered but the correspondence was returned.
Age: 3.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative and refers to a 3 year old patient of unknown gender. On an unknown date the patient was vaccinated with (oka/merck) VARIVAX (dose, units, route of administration, anatomical location, lot number were not reported). On 14-JUL-2014 the symptoms of chickenpox occurred (described as spots and fever) which was diagnosed as chickenpox (diagnosed on 21-JUL-2014). On 21-JUL-2014 the patient sought medical attention. The outcome of event was reported as not recovered. The relatedness between event and (oka/merck) VARIVAX was not reported. Follow-up information has been received from a medical assistant. The reporter stated a VAERS (Vaccine Adverse Event Reporting System) report had been filed and additional information regarding patient was available at that time. The reporter also stated if any additional information becomes available she may fax that information. This is one of several reports from the same reporter. Additional information is not expected because address was correctly entered but the correspondence was returned.
Age: 3.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Pyrexia, Rash, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative and refers to a 3 year old patient of unknown gender. On an unknown date the patient was vaccinated with (oka/merck) VARIVAX (dose, units, route of administration, anatomical location, lot number were not reported). On 14-JUL-2014 the symptoms of chickenpox occurred (described as spots and fever) which was diagnosed as chickenpox (diagnosed on 21-JUL-2014). On 21-JUL-2014 the patient sought medical attention. The outcome of event was reported as not recovered. The relatedness between event and (oka/merck) VARIVAX was not reported. Follow-up information has been received from a medical assistant. The reporter stated a VAERS (Vaccine Adverse Event Reporting System) report had been filed and additional information regarding patient was available at that time. The reporter also stated if any additional information becomes available she may fax that information. This is one of several reports from the same reporter. Additional information is not expected because address was correctly entered but the correspondence was returned.
Age: 1.52
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative and refers to a 3 year old patient of unspecified gender. Vaccination history included: On 04-FEB-2011 DTaP-IPV-Hib (manufacturer unknown). On 04-FEB-2011, 31-MAR-2011 and 29-JUN-2011 Hep B (manufacturer unknown). On 31-MAR-2011, 29-JUN-2011 and 07-JUN-2012 PCV-13 (manufacturer unknown). On 29-MAR-2012 MMR (manufacturer unknown). On 29-MAR-2012 second dose Hep A (manufacturer unknown). On 29-MAR-2012 Influenza injectable (manufacturer unknown). On 07-JUN-2012 the patient was vaccinated with (oka/merck) VARIVAX 0.5 ml (subcutaneous, in the right thigh (reported as RT) lot number was not reported). On an unknown date the patient experienced chickenpox/chickenpox describes as spots and fever. The outcome of event was reported as not recovered/not resolved. The relatedness between event and (oka/merck) VARIVAX was not reported. This is one of several reports from the same reporter. Additional information is not expected because address was correctly entered but the correspondence was returned.
Age: 1.52
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Pyrexia, Rash, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative and refers to a 3 year old patient of unspecified gender. Vaccination history included: On 04-FEB-2011 DTaP-IPV-Hib (manufacturer unknown). On 04-FEB-2011, 31-MAR-2011 and 29-JUN-2011 Hep B (manufacturer unknown). On 31-MAR-2011, 29-JUN-2011 and 07-JUN-2012 PCV-13 (manufacturer unknown). On 29-MAR-2012 MMR (manufacturer unknown). On 29-MAR-2012 second dose Hep A (manufacturer unknown). On 29-MAR-2012 Influenza injectable (manufacturer unknown). On 07-JUN-2012 the patient was vaccinated with (oka/merck) VARIVAX 0.5 ml (subcutaneous, in the right thigh (reported as RT) lot number was not reported). On an unknown date the patient experienced chickenpox/chickenpox describes as spots and fever. The outcome of event was reported as not recovered/not resolved. The relatedness between event and (oka/merck) VARIVAX was not reported. This is one of several reports from the same reporter. Additional information is not expected because address was correctly entered but the correspondence was returned.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: loud ringing in right ear, went to sleep then awoken by loud ringing and unable to hear out of right ear
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Erythema, Fatigue, Injection site vesicles, Local swelling, Pyrexia
Clinical narrative: Left arm red swollen arm with low grade fever and tiredness. Swelling increased and blisters at injection site. MD visit 9/17/14.
Age: 12.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Crying, Dizziness, Ear pain, Electrocardiogram normal, Fall
Clinical narrative: 30 minutes after the Tdap shot my daughter felt very dizzy and experienced a very bad headache. Upon sitting up, she passed out after seeing black dots and then everything went black. She fell sideways, and then when she "came to" she was screaming that her ears were very painful from the ringing in her ears. She was crying and then started shaking all over her body. The doctor called 911 and had her taken by ambulance to the hospital where they did tests. All the tests came back normal and the findings were that it was all caused by the Tdap shot.
Age: 12.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Headache, Loss of consciousness, Tinnitus, Tremor, Urine analysis normal
Clinical narrative: 30 minutes after the Tdap shot my daughter felt very dizzy and experienced a very bad headache. Upon sitting up, she passed out after seeing black dots and then everything went black. She fell sideways, and then when she "came to" she was screaming that her ears were very painful from the ringing in her ears. She was crying and then started shaking all over her body. The doctor called 911 and had her taken by ambulance to the hospital where they did tests. All the tests came back normal and the findings were that it was all caused by the Tdap shot.
Age: 12.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Visual impairment
Clinical narrative: 30 minutes after the Tdap shot my daughter felt very dizzy and experienced a very bad headache. Upon sitting up, she passed out after seeing black dots and then everything went black. She fell sideways, and then when she "came to" she was screaming that her ears were very painful from the ringing in her ears. She was crying and then started shaking all over her body. The doctor called 911 and had her taken by ambulance to the hospital where they did tests. All the tests came back normal and the findings were that it was all caused by the Tdap shot.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Dizziness, Fatigue, Impaired driving ability
Clinical narrative: Dizziness, Weak, Fatigue - could not drive and called out sick from work.  It was an effort to brush teeth.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Relates that around 1700 09/17/14 her L arm began to ache from the injection site all the way down her L arm to the L wrist. Them related that was awoke at midnight on 09/18/14 running a fever of 100.9 and arthralgia in all joints. Relates that all symptoms had resolved by the time she woke up the morning of 09/18/14.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 02-SEP-2014 the patient received a dose of MMR II (dose, route not reported, lot # J009706, expiration date 15-AUG-2015) exposed to temperatures outside of the proper storage range. Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 04-SEP-2014 the patient was vaccinated with an expired dose of M-M-R II lot # H015833, expiration date: 24-AUG-2014, 0.5 ml, subcutaneous. No adverse effects were reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Personality change, Therapeutic response unexpected
Clinical narrative: This spontaneous report as received from aunt and caregiver of the patient refers to a 20 year old female patient (age reported as "20", unit approximated to years from the context of the source document). The patient was mildly autistic, she was diagnosed at the age of 7 (units not provided). Patient's historical drugs included an unspecified chicken pox vaccine which the patient received as a child (date unspecified). The patient's medical history included being extremely withdrawn. On unknown dates, reported as 4-5 years ago, also reported as at the age of 15 or 16, the patient was vaccinated with the three dose regimen of GARDASIL route reported as injection (dose, anatomical location and lot numbers were not reported). Concomitant medications were not specified. On an unknown date, reported as within a few days of the first GARDASIL dose, the patient became much more social and affectionate, whereas before she was extremely withdrawn. The medical attention had been sought, the reporter mentioned the event to the healthcare professional (HCP). The outcome of became much more social and affectionate, whereas before she was extremely withdrawn was unknown. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via field employee refers to a 17 year old male patient. On an unknown date the patient was vaccinated with (oka/merck) VARIVAX (dose, frequency, route of administration unknown). Pertinent medical history and concomitant medications were unspecified by the reporter. The reporter stated that on an unknown date the patient was diagnosed with his second case of shingles after receiving (oka/merck) VARIVAX. The patient visited office on an unspecified date. The outcome of shingles was unknown. The causality was unknown. No further adverse event information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from Employee, refers to a patient of unknown age and gender. No pertinent medical history reported. On an unknown date, approximately in September 2013 (a year ago) the patient received GARDASIL 1st dose (route, lot# were not reported) and on 12-SEP-2014, the patient received the 2nd dose of GARDASIL. Concomitant medications were unspecified by reporter. No adverse effects reported. No Product Quality Complaint (PQC) was involved. The reporter considered incorrect schedule to be not related to GARDASIL. The employee had attempted to conference the nurse, in order to report the adverse event however it was unsuccessful. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Myalgia, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 65 year old male patient. On 06-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, lot/batch number, expiration date and route were not reported). On 06-SEP-2014 (reported as since receiving ZOSTAVAX), the patient experienced severe reaction clarified as arthralgia, myalgia, diarrhea and fever with temperature 101 to 102F. There was no treatment given for the events. The patient sought medical attention. The outcome of the events was not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. 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 nurse refers to a patient of unknown age and gender. On 10-SEP-2014 the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # J009827, expiry date: 10-AUG-2014 (reported as 14-AUG-2014), intramuscular, dose and frequency unknown). Pertinent medical history and concomitant medications were unspecified by reporter. No known adverse effects reported. The outcome of the events was unknown. Patient present status was reported as other: no known adverse effects. No further information provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Skin discolouration, Swelling, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 08-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # J009689, expiry date: 29-JAN-2015, dose/frequency: as recommended in the prescribing information, intramuscular). Pertinent medical history and concomitant medications were unspecified by reporter. On 09-SEP-2014, the patient experienced hives, pain, swelling and pinkless below the injection site and difficulty raising her arm after receiving PNEUMOVAX 23. The patient did not seek any medical attention. The outcome of the events was unknown. The causality was unknown. No further adverse event information was provided. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative and refers to a 8 year old patient of unknown gender. On an unknown dates the patient was vaccinated with a first and second dose of VARIVAX (Merck) (doses, units, routes of administration, anatomical locations, lot numbers were not reported). On 22-JUL-2014 the symptoms of chickenpox occurred (described as spots and no fever) and was diagnosed with chickenpox. The outcome of event was reported as not recovered. The relatedness between event and VARIVAX (Merck) was not reported. Follow-up information has been received from a medical assistant. The reporter stated a VAERS (Vaccine Adverse Event Reporting System) report has been filled and additional information regarding patient was available at that time. The reporter also stated if any additional information becomes available she may fax that information. This is one of several reports from the same reporter. Additional information is not expected because address was correctly entered but the correspondence was returned.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to one or two patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, improperly stored ZOSTAVAX doses (dose number, dose, route, anatomical location and lot number were not reported) were administered to one or two patients. No adverse effects were reported. Concomitant medications were not specified. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown demographics (captured in MARRS# 1409USA002329). Pertinent medical history, drug reactions or allergies were not reported. On unspecified dates, those patients were inadvertently administrated PROQUAD (Merck), that had been improperly stored (strength, dose, dose schedule, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse effects reported. Follow up information received on 19-AUG-2014. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received from a registered nurse refers to a 6 year old male patient. On 07-AUG-2014, the patient was vaccinated with the second dose of PROQUAD (Merck) injection (lot # K004860 with expiry date: 04-OCT-2015) given subcutaneously in the left arm, and with a dose of KINRIX intramuscularly in the right arm (lot# EP2A3). This is one of several reports from the same source. Additional information is not expected as all required correspondence was scheduled.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. The patient was allergic to sulfa drugs. On 04-SEP-2014 the patient was vaccinated with ZOSTAVAX 0.65 milliliter, lot # K003599 and expiry date of 13-MAR-2015, subcutaneous. Concomitant medications include blood pressure and cholesterol medicines. On an unknown date in September 2014, the patient experienced itching and redness around the injection site after receiving ZOSTAVAX. On 13-SEP-2014, the patient asked the pharmacist how long injection site reaction usually lasts and complained that she was still experiencing itching and redness around injection site. The patient was treated with BENADRYL. No lab tests were performed. The patient sought medical attention by calling the physician. The outcome of itching and redness around injection site was reported as not recovered/not resolved. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 26 year old male patient with attention deficit/hyperactive disorder. The patient had no drug reactions or allergies. On 31-JUL-2014 the patient was vaccinated with the first dose of GARDASIL (lot # K001500, expiration date 06-NOV-2016, dose 0.5 ml, intramuscular in the left arm). Concomitant therapies included ADDERALL. On 01-AUG-2014 the patient experienced extensive swelling and bruising of the entire left upper arm. The upper arm swelling was to "3 times its normal size". The swelling and bruising resolved on 07-AUG-2014 without requiring medical treatment. The medical assistant added that the patient would not be administered any further doses of GARDASIL. No lab diagnostics studies were performed. The patient had sought medical attention via calling the office. It was reported that the patient was given the last dose on 31-JUL-2014. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Myalgia, Swelling
Clinical narrative: PT CALLED 9/17 TO REPORT RED CIRCLE AROUND INJECTION SITE AND MUSCLE TENDERNESS.  PT PRESENTED 9/18 WITH REDNESS EXTENDING TO ELBOW AND SLIGHT SWELLING BUT STATED TENDERNESS WAS BETTER. PT ALSO RECEIVED FLUVIRIN IM THE SAME DAY AS PNEUMOVAX SQ
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Burning sensation, Fatigue, Hypersensitivity, Injection site erythema
Clinical narrative: In the same arm as shot my arm pit lymph nodes swelled to size of tennis ball, burning, pain, joint pain, then by the next day more swelling in arm pit to my chest and breast, then up my clavicle, neck and throat. Even more pain and extreme exhaustion then the injection site turned red and swelled. I ended up in urgent care where they put me on antihistamine, Pepcid, steroids, and ibuprofen. I was told I was having a severe allergic reaction to the flu vaccine, and to never take it again.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling, Local swelling, Lymphadenopathy, Pain, Pharyngeal oedema
Clinical narrative: In the same arm as shot my arm pit lymph nodes swelled to size of tennis ball, burning, pain, joint pain, then by the next day more swelling in arm pit to my chest and breast, then up my clavicle, neck and throat. Even more pain and extreme exhaustion then the injection site turned red and swelled. I ended up in urgent care where they put me on antihistamine, Pepcid, steroids, and ibuprofen. I was told I was having a severe allergic reaction to the flu vaccine, and to never take it again.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: In the same arm as shot my arm pit lymph nodes swelled to size of tennis ball, burning, pain, joint pain, then by the next day more swelling in arm pit to my chest and breast, then up my clavicle, neck and throat. Even more pain and extreme exhaustion then the injection site turned red and swelled. I ended up in urgent care where they put me on antihistamine, Pepcid, steroids, and ibuprofen. I was told I was having a severe allergic reaction to the flu vaccine, and to never take it again.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Patient experienced swelling, redness and itching with a diameter of approximately 6-8 inches.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Patient began running high fever and shaking with chills (described as tremors. fever reached 103 was brought down to 101 with APAP. By 10:30am the next day fever was gone.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 27-AUG-2014 the patient received a dose of M-M-R II (dose, route not reported, lot # J009706, expiration date 15-AUG-2015) exposed to temperatures outside of the proper storage range. Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 21 year old female patient. The patient's medical history was not reported. Approximately in 2007 (reported as when she was 14 years of age) the patient was vaccinated with first dose of GARDASIL (dosage/frequency was unknown, Therapy Route: Unspecified). Concomitant medications were not reported. The healthcare worker reported that the patient would like to receive remaining doses of GARDASIL (reported as INJ 120 Y) approximately in 2014 (reported as now at 21 years of age). No adverse symptoms were reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Age: 1.26
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to two patient of unknown age. On 28-AUG-2014 the patients were vaccinated expired doses of M-M-R II (lot # H014647, expiration date 03-AUG-2014) (dose, route unspecified). No symptoms reported. This is one of several reports received from same source.  Follow up information has been received. This spontaneous report refers to one of the two patients who were twins. On 21-AUG-2014 the patients were vaccinated with expired doses of M-M-R II (dose, route, therapy type unspecified). This is one of the several reports from the same reporter. 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 nurse refers to a patient of unknown age and gender. On 27-AUG-2014 the patient received a dose od M-M-R II (dose, route not reported, lot # J009706, expiration date 15-AUG-2015) exposed to temperatures outside of the proper storage range. Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 9/10/14 Student came into clinic to show immunization nurse (R) arm where received MMR et arm was sore, red, warm to touch at site. 5 cm x 3.5 cm reddened area. Area marked with marker and hydrocortisone cream applied. Use ice on and off next 2 hours et return to clinic to see provider as needed. 9/11/14 pt. returned to clinic to see provider and diagnosis of cellulitis of (R) upper arm. Given doxycycline 100mg caps (1 cap. BID x 7 days PO). Antihistamine, ice on and off. To return to clinic as needed.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Noticed 1 welt on my arm after it started to itch. Took Band-Aid off and had my husband draw a circle around the welt. This morning upon waking up it was red and very hot. Having some pain down into my hand. Weakness.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Noticed 1 welt on my arm after it started to itch. Took Band-Aid off and had my husband draw a circle around the welt. This morning upon waking up it was red and very hot. Having some pain down into my hand. Weakness.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Swelling and redness of left arm after PNEUMOVAX administration. Patient self treated with BENADRYL and TYLENOL. Swelling began to subside after 3 days.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cold sweat, Injection site pain, Pain in extremity
Clinical narrative: Pain from neck to wrist in arm flu shot was given. Onset 2 hours after vaccination. Skin also felt clammy. Lasted 6-7 hours. Treatment w/ BUFFERIN (OTC).
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Influenza virus test negative, Injection site erythema
Clinical narrative: 9-10 Sudden onset headache, chills, fever 101; 9-11 Fever 100.2, extreme fatigue; 9-12 Fever 100.2. Clinic visit. Started antibiotics. 9-13 Much better. Pt also reports hot, red left arm from shoulder to elbow from 9-9 to 9-15.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: 9-10 Sudden onset headache, chills, fever 101; 9-11 Fever 100.2, extreme fatigue; 9-12 Fever 100.2. Clinic visit. Started antibiotics. 9-13 Much better. Pt also reports hot, red left arm from shoulder to elbow from 9-9 to 9-15.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Bursal fluid accumulation, Dizziness, Drug administered at inappropriate site, Injected limb mobility decreased
Clinical narrative: I received the flu shot vaccine on 10/22/13 around 0800 in my left arm. The flu shot was administered by a facility employee. I noticed she gave the shot very high in the arm, and I remember this being odd because she asked me to roll up my cap sleeve shirt before she gave me the shot. My shoulder was very sore the remainder of the day. The following morning (10/23/14) I woke up in extreme pain and with extremely limited mobility in my left arm/shoulder. The pain was so bad while trying to put my clothes on, I got light-headed and felt I was going to pass out and had to lay back down. I assumed the pain would go away, but over the next several weeks the pain kept getting worse and the mobility in my left arm/shoulder became more and more limited. On 11/8/13 I called a local orthopedic office to schedule an appointment. This office specializes in upper extremity orthopedics and I had previously seen them about an unrelated hand issue. I scheduled an appointment to see Dr. on 11/12/13. On 11/12/13, Dr. checked my left arm/shoulder and recommended orthopedic therapy (OT) 1-2 times per week onsite for 3 weeks and he wanted to see me for a follow-up on 12/5/13. I had my OT evaluation on 11/18/13 and did an OT session following the evaluation. I was also given OT to do at home between onsite OT sessions, which I did as instructed. I had additional onsite OT sessions on 11/21/13, 11/25/13, 12/2/13, 12/5/13, 12/12/13. I continued OT daily at home during and after the onsite OT sessions. During the 12/5/13 follow-up appointment with Dr. he administered a cortisone shot since the pain in my arm was still so strong and my mobility was still extremely limited. Dr. hoped that cortisone shot would take care of the problem and he instructed me to call back if the shoulder didn't get better. After receiving the cortisone shot, the pain was much better, but the mobility was still limited. Around the end of January the pain began coming back so I called the doctor and set up an appointment to see Dr. on 3/13/14. During the 3/13/14 appointment Dr. checked my shoulder again (still in pain and still limited mobility) and then administered another cortisone shot. Dr. said to call if the pain/limited mobility continued and if so we would do an MRI at that time. The pain continued along with the limited mobility so dr. sent me for an MRI on 7/10/14. I went back to see Dr. on 7/17/14 to review the MRI results which showed fluid in my bursa. Essentially there is nothing else that can be done to ease my pain or increase my mobility unless I want to get yet another cortisone shot. My shoulder mobility is still very limited. It even hurts to sleep on my left shoulder at night. When I reach certain directions she shoulder pops and shoots extreme pain down the arm. I am still doing OT at home as of 9/17/14 while I am writing this.