chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test positive
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 15 month old female patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine strain. On 21-APR-2015, the patient was vaccinated with (Oka/Merck) VARVIAX (lot #K002045, expiry date 10-FEB-2016) 0.5 ml in the left arm. On 20-JUL-2015, three months after vaccination, the patient experienced cough, nasal congestion and maximum body temperatures was 102.0 Fahrenheit. The patient also experienced rash which was blistering and burning, diagnosis was made to herpes zoster. The patient was prescribed acyclovir 200 mg/5ml for the treatment and was given counseling. On 20-JUL-2015, the patient had varicella zoster detected by immune-fluorescent monoclonal antibody staining in spin amplified shell vial culture, no herpes simplex virus (HSV) was isolated in the HSV culture. On the same day, aerobic bacterial culture had no growth in 36-48 hours. An examination was performed including the  scalp (including hair inspection) head (including face), lips but not teeth and gums, neck, chest, abdomen, back, right upper extremity, left upper extremity, and inspection and palpation of digits and nails. Findings all the examinations was normal. The reporter stated that the lesions should be treated within 48 hours of onset with anti-virus therapy. The patient's recovered from the events on an unspecified date in 2015. The reporter did not provide the relatedness of the events with (Oka/Merck) VARIVAX. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse, referring to an unspecified number of patient's of unknown demographics. No medical history nor concurrent conditions were reported. On unknown dates, unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (lot # H021346, expiration date 01-OCT-2015; lot # J008423, expiration date 21-JAN-2016 and lot # K010574, expiration date 08-APR-2017) (strength, dose, route and frequency were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaints were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (dose and route unspecified, lot # reported as L007578 with expiration date of 05-MAR-2017, lot # reported as L003859 with expiration date of 25-FEB-2017). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose and route unspecified, strength reported as 0.5 mcg/0.5 ml, lot # K010535 with expiration date of 27-AUG-2016). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a female patient consumer of unknown age reporting on herself. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (route and lot # not reported) when she was older than 26 years of age. No adverse event was reported. Additional information is not expected as there is no contact information.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 27Aug15-9-10 pm, pt noted inj site warm to touch, pink, and swollen. Parent applied warm compress. 28Aug-increase redness (65 x 105 cm), hot to touch. No fever, aches, chills, chest pain.
Sex: M
Vaccine: HPV4
Symptoms: Arthralgia, Erythema, Gait disturbance, Joint effusion, Joint swelling
Clinical narrative: This spontaneous report was received from a physician and a medical assistant and refers to a male patient of unknown age who was in remission from leukemia. No information about the patient's concomitant medications, drug reactions or allergies was provided. On 19-AUG-2015, the patient was vaccinated with the first dose GARDASIL (dose, route, lot # and expiration date were not reported). On approximately 23-AUG-2015 (reported as "about 4-5 days after GARDASIL administration"), the patient developed joint swelling and pain in his larger joints (specific joints were not named other than knee joints). He sought medical attention and went to an office visit. The physician reported that the patient's joints looked like there was a little bit of fluid build-up and he also noticed red appearance around joint swelling but it was not hot to touch. Physician reported that patient took TYLENOL when he first experienced pain in his joints and most of joint pains subsided after taking TYLENOL but pain in the knee joints persisted and patient experienced difficult time with walking. Outcomes of the events of joint pain, joint swelling and difficulty in walking were reported as not recovered. Relatedness between the events and GARDASIL was not reported. 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 a Registered Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical condition were reported. On unknown dates the patients were vaccinated with GARDASIL lot number not provided, dose, route and anatomical location were not reported, after an interruption of the recommended vaccination schedule for the vaccine. No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Left thigh swelling, rash and pain. Parent gave Ibuprofen and put warm cloth on the thigh. Pt. was seen and sent to ER.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Started with hives on leg that rec'd Hep A. Spread to abdomen and arms. No breathing problems or other issues.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Rash maculo-papular
Clinical narrative: Maculopapular erythematous itchy rash in clusters in the thigh where the VARIVAX was given then spread to abdomen.
Age: 16.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: Soreness after vaccine given. Patient woke up in pain which was not relieved by ice or TYLENOL. Left deltoid is tender and swollen.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant regarding an unspecified number of patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with a dose of improperly stored GARDASIL, lot number K023432, expiration date 18-JUN-2016, lot number K008931, expiration date 04-MAR-2017 and lot number reported as L013190, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). There was no concomitant medication reported. No adverse effects reported. This is one of several reports from the same source. Lot number L013190 is an invalid lot number for GARDASIL. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chest X-ray, Differential white blood cell count, Full blood count, Headache
Clinical narrative: Flu like symptoms, myalgias, arthralgias, fever of 104, headache. Recovered in 10 days. Had blood work and chest x-ray.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Myalgia, Pyrexia, Urine analysis
Clinical narrative: Flu like symptoms, myalgias, arthralgias, fever of 104, headache. Recovered in 10 days. Had blood work and chest x-ray.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 11-AUG-2015 the patient was vaccinated with a dose of improperly stored VAQTA (0.5 ml, lot # was reported as K010195, expiration date was reported as 15-JAN-2016, dose in series was not reported) intramuscularly. Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: 8/28/15 Mom called office to state right arm was red, swollen, hard oval area the size of mom's palm of her hand. 1st noticed 7pm 8/27/15 took BENADRYL and TYLENOL with mild relief.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Decreased appetite, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Redness, rash, warm feeling from injection site. Prickly feeling. No energy for a few days. Less appetite.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Paraesthesia
Clinical narrative: Redness, rash, warm feeling from injection site. Prickly feeling. No energy for a few days. Less appetite.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site warmth
Clinical narrative: Injection site hot/red, headache, low grade temp 98.4; 1 1/2 inches in diameter.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Decreased appetite, Erythema
Clinical narrative: The symptom began 2 days ago. No fever his appetite was down. His arm was redder yesterday but today it increase in size now involving most of the external part of the lower arm. 3" oval area.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Blood test normal, Foaming at mouth, Seizure
Clinical narrative: Around 430AM woke up asking for a drink of water. When he didn't drink the water mom saw he was having an active seizure. Had white pasty stuff around his mouth. Uncle call 911. No idea how long it lasted. When ambulance staff transported child to ER they placed ice packs around him. Child was given purple liquid in ER parent not sure what it was. Given TYLENOL for at home.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site haemorrhage, Peripheral swelling
Clinical narrative: Patient arm was swollen and red after flu shot. There was some bleeding at time of injection. As of 8/24-patient feels better and no swelling at injection site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a healthcare worker refers to her mother: a 66 years old female patient with high blood pressure and allergies to penicillin and unspecified medications that contain sulfur. On 22-AUG-2015, the patient was vaccinated with ZOSTAVAX injection, 0.65 ml, subcutaneous (lot# and expiration date were not reported) for shingles prevention. Concomitant medication included unspecified high blood pressure medications. On an unspecified date in August 2015 (reported as "after receiving ZOSTAVAX"), the patient developed redness and itching at the injection site. The outcome of the adverse events was reported as not recovered. No lab diagnostics studies were performed, and no treatment was given for the adverse events. The patient did not seek medical attention. The causality between the adverse events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Fatigue, Hypophagia, Mobility decreased
Clinical narrative: The 2nd and 3rd day after vaccination I experienced fatigue so severe I could not move. The 4th day I experienced absolute anorexia. I didn't eat at all.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling abnormal, Headache, Limb discomfort, Malaise, Pain in extremity
Clinical narrative: The next day: fever, legs shaking, malaise; unable to eat; severe headache; dazed; arm very sore and heavy.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Tremor
Clinical narrative: The next day: fever, legs shaking, malaise; unable to eat; severe headache; dazed; arm very sore and heavy.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Pt experienced redness and swelling at injection site 2 days following administration. Treated with diphenhydramine and rash started resolving.
Age: 1.04
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to female patient of approximately 1 year old. No information on concurrent conditions and medical history was reported. On 09-JUL-2015 the patient was vaccinated with improperly stored MMR II (unknown strength, route and dose) lot # K007107 with an expiry date of 16-MAY-2016, stored at improper temperature (<46 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: (L) arm swelling and redness. Gradually started swelling.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (dose and route unspecified, lot # L010596 with expiration date of 06-APR-2017, lot # K016966 with expiration date of 06-APR-2017, lot # K016966 with expiration date of 10-MAY-2017). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Pt had a syncopal episode shortly after receiving vaccinations. Pt received vaccines at 1505, syncopal episode at 1515 on 8/14/15. Elevated feet, cool compress, pt responded to treatment.
Age: 1.03
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to male patient of approximately 1 year old. No information on concurrent conditions and medical history was reported. On 26-JUN-2015 the patient was vaccinated with improperly stored M-M-R II (unknown strength, route and dose) lot # K007107 with an expiry date of 16-MAY-2016, stored at improper temperature (< 46 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Chills, Pain of skin, Pyrexia
Clinical narrative: 12 hrs after TRUMENBA -> fever, chills, skin pain without rash.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 05-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017, dose, route and site of administration were not reported). The vaccine was exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (dose unspecified, oral, lot # L000569 with expiration date of 13-JUL-2016, lot # K019372 with expiration date of 13-JUL-2016, lot # L000434 with expiration date of 10-JUL-2016). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to five patients of unknown demographics. Pertinent medical history and concomitant therapies were not reported. The nurse reported that patients received improperly stored PROQUAD (Merck) (lot # L008353, expiry date 11-SEP-2016, 0.5ml, subcutaneously). Four doses were administered on 17-AUG-2015 and one dose was administered on 20-AUG-2015. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to female patient of approximately 1 year old. No information on concurrent conditions and medical history was reported. On 13-JUL-2015 the patient was vaccinated with improperly stored MMR II (unknown strength, route and dose) lot # K004949 with an expiry date of 04-APR-2016, stored at improper temperature (<46 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with improper stored RECOMBIVAX HB (dose, route and lot number not provided) for routine vaccination. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Fatigue, Myalgia, Pneumonia
Clinical narrative: Pt is a physician. Received PNEUMOVAX around 2002 with no problem. Within a couple of days developed full blown symptoms of pneumonia. Symptoms included chills, fever, muscle pain, muscle aches, productive cough, loss of appetite, weight loss and fatigue. No chest x-ray done, no doctor visit but spoke to nurse who told him to give it a couple of days. Doctor prescribed no medication but took over the count cough syrup, Guaifenesin. Checked in with his physician friends and concluded that it was a severe immunological reaction to the vaccine. 6 weeks after just beginning to feel normal again.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Productive cough, Pyrexia, Vaccination complication, Weight decreased
Clinical narrative: Pt is a physician. Received PNEUMOVAX around 2002 with no problem. Within a couple of days developed full blown symptoms of pneumonia. Symptoms included chills, fever, muscle pain, muscle aches, productive cough, loss of appetite, weight loss and fatigue. No chest x-ray done, no doctor visit but spoke to nurse who told him to give it a couple of days. Doctor prescribed no medication but took over the count cough syrup, Guaifenesin. Checked in with his physician friends and concluded that it was a severe immunological reaction to the vaccine. 6 weeks after just beginning to feel normal again.
Age: 1.11
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to male patient of approximately 1 year old. No information on concurrent conditions and medical history was reported. On 08-JUL-2015 the patient was vaccinated with improperly stored MMR II (unknown strength, route and dose) lot # K007107 with an expiry date of 16-MAY-2016, stored at improper temperature (<46 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 25-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not provided). On 27-AUG-2015, the patient presented at the pharmacy with a prescription of MEDROL DOSEPAK. The reason for MEDROL DOSEPAK was needed was unknown. The outcome of the unspecified adverse event was unknown. Additional information has been requested.
Age: 1.11
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to male patient of approximately 1 year old. No information on concurrent conditions and medical history was reported. On 22-JUL-2015 the patient was vaccinated with improperly stored MMR II (unknown strength, route and dose) lot # K004949 with an expiry date of 04-APR-2016, stored at improper temperature (47.5 degrees). Concomitant medications were not reported. No adverse effects were reproted. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a male patient of approximately 1 year old. No information on concurrent conditions and medical history was reported. On 14-JUL-2015 the patient was vaccinated with improperly stored MMR II (unknown strength, route and dose) lot # K004949 with an expiry date of 04-APR-2016, stored at improper temperature (<46 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to female patient of approximately 1 year old. No information on concurrent conditions and medical history was reported. On 13-JUL-2015 the patient was vaccinated with improperly stored MMR II (unknown strength, route and dose) lot # K004949 with an expiry date of 04-APR-2016, stored at improper temperature (<46 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt complained of feeling extremely painful at the injection site. And he felt hurt moving the injection arm. 98.6 degrees F. He was advised to take ALEVE to relieve the pain. The event was reported approximately 15-20 min after the injection.
Age: 1.16
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Maculopapular rash on back.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Flu shot given 8-27-15. Reported red, slightly raised bump, size of softball at injection site today 8-28-15 at 10 AM. Symptoms ongoing as of 10 AM 8-28-15.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 28-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot# K026242, expiration date 28-JAN-2017, dose, route and site of administration were not reported). The vaccine was exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: Gave pt 2nd dose of rotavirus today before mom explained baby had already had immunizations today. Only told me when I saw marks on legs. Mom and I had previously communicated in English and she seemed to understand and responded with appropriate answers. I did ask all screening questions beforehand-mom did not tell me child had already had immunizations today. Mom, speaks Nepali. Computers were not behaving!
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored GARDASIL lot # K001631 and lot # J011272 (dose was not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report was received from an other health care professional refers to a 52 year old female patient who works in women's service. The patient's concurrent conditions included sulfa allergy, penicillin (PCN) allergy, ciprofloxacin allergy, osteoporosis and dyslipidemia. The patient's medical history was not reported. On 29-JUN-2015, at 10:40am, the patient was vaccinated with the first dose of ZOSTAVAX, subcutaneous injection in the left arm, lot # L006382 (expiration date was not provided). There were not concomitant medications reported. On 30-JUN-2015, at unspecified time pm, the patient experienced erythema, cellulitis, pain and edema in her left arm and was diagnosed with cellulitis. The patient sought medical attention and received treatment for the adverse events with oral unspecified antibiotics. At the time of the report the outcome of cellulitis was recovering/resolving. The reporter did not assess the relatedness of cellulitis with ZOSTAVAX. Additional information has been requested.
Age: 54.0
Sex: U
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: Information has been received from the author of a literature, title as stated below. This literature marketed report as received from the authors refers to a 54 male patients of unknown age with HIV infection which diagnosed in 12 patients before vaccination and in 42 after vaccination. On an unknown date, the patients were vaccinated with a dose of hepatitis b vaccine (manufacturer unknown) (Lot numbers, expiration dates, dose and route were not provided). Concomitant medication included combination antiretroviral therapy (cART). On an unspecified date, the patients experienced vaccination failure reported as vaccine non-respondent. The reporter stated that to assess and quantify the effect of hepatitis b vaccine (manufacturer unknown) response on CD4 lymphocytes reconstitution after cART initiation, all available CD4 counts for participants from cART initiation to one year post-cART were analyzed. The outcome of vaccination failure was unknown at the time of the report. The reporter considered vaccination failure to be related to Hepatitis B Vaccine (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports from the same literature. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a physician (also reported as consumer) refers to a 57 year old male patient. The patient's concurrent conditions and medical history were not reported. On an unknown date in 2012, the patient was vaccinated with ZOSTAVAX for prophylaxis subsequent to his mother having shingles. On an unknown date in 2012, 12 hours after vaccination the patient developed T4-T6 dermatomal pain and the duration of pain was unknown, but it was being described as Sine Herpete. The outcome and causality of the event was not reported. Additional information is not expected as the contact details were not reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse, referring to an unspecified number of patients of unknown demographics. No medical history nor concurrent conditions were reported. On unknown dates, unspecified number of patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L002419, expiration date 23-JUL-2015; lot # L005293, expiration date 17-AUG-2016; lot # reported as L008353, expiration date 11-SEP-2016 and lot # reported as L010142, expiration date 24-SEP-2016) (strength, dose, route and frequency were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaints were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 26 year old female patient. Concurrent conditions and medical history were not reported. The nurse stated that on an unspecified date in 2007, the patient received a dose, which was assumed, of GARDASIL (Lot number, expiration date, dose and route were not provided). On 20-JUL-2015, the patient was vaccinated with a dose of GARDASIL 9 (Lot # K023432 is not valid for GARDASIL 9, expiration date 18-JUN-2016) (Dose and route were not provided). Concomitant medication were not reported. The patient had not experienced any adverse effects. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response, Vaccination failure
Clinical narrative: Information has been received from the author of a literature. This literature marketed report as received from the authors refers to 14 male patients of unknown age with Human Immunodeficiency Virus HIV infection which was diagnosed in 2 patients before vaccination and in 12 after vaccination. On an unknown date, the patients were vaccinated with a dose of HepB vaccine (recombinant) (manufacturer unknown) (Lot numbers, expiration date, dose and route were not provided). Concomitant medication included combination antiretroviral therapy (cART). On an unspecified date, the patients experienced vaccination failure reported as "vaccine non-responder". The reporter stated that to assess and quantify the effect of HepB vaccine (recombinant) (manufacturer unknown) response on CD4 lymphocytes (CD4) reconstitution after cART initiation, all available CD4 counts for participants from cART initiation to one year post-cART were analyzed. The outcome of vaccination failure was unknown at the time of the report. The reporter considered vaccination failure to be related to HepB vaccine (Recombinant) (manufacturer unknown). This is one of several reports from the same literature. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: Information has been received from the author of a literature. This literature marketed report as received from the authors refers to 46 male patients of unknown age with Human Immunodeficiency Virus HIV infection which was diagnosed in 5 patients before vaccination and in 41 after vaccination. On an unknown date, the patients were vaccinated with a dose of HepB vaccine (recombinant) (manufacturer unknown) (Lot numbers, expiration date, dose and route were not provided). Concomitant medication included combination antiretroviral therapy (cART). On an unspecified date, the patients experienced vaccination failure reported as "vaccine non-responder". The reporter stated that to assess and quantify the effect of HepB vaccine (recombinant) (manufacturer unknown) response on CD4 lymphocytes (CD4) reconstitution after cART initiation, all available CD4 counts for participants from cART initiation to one year post-cART were analyzed. The outcome of vaccination failure was unknown at the time of the report. The reporter considered vaccination failure to be related to HepB vaccine (Recombinant) (manufacturer unknown). This is one of several reports from the same literature. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A spontaneous report has been received from a Physician concerning a two years old male patient. Patient relevant history, concurrent diseases and concomitant drugs were not provided. The patient had been receiving nasal FLUENZ, started on an unknown date. The patient had been administered with FLUENZ TETRA 36 hours beyond the expiry date. The physician unintentionally administered the vaccine to patient which was expired on 31-DEC-2014. He removed it from fridge and was not used to the new year. Action taken with FLUENZA TETRA, intranasal was unknown. The reporter considered the event to be non serious. Follow-up of insignificant information received by AstraZeneca/MedImmune 12-Jan-2015 received from physician via spontaneous report:No new information added.Narrative updated.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swollen at the site of injection. On 8/27/15, condition was diagnosed as cellulitis by the physician and was given cephalexin(500mg QID x 10days and sulfamethoxazole-TMP 160/800 BID x 10 days. Upon phone call on 8/29/15 to patient, she indicated "arm is getting much better and redness is going away". Instructed patient to complete antibiotic therapy.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Paraesthesia oral, Vaccination complication
Clinical narrative: Patient reports tingling in both arms and legs and tingling in the tongue. Her physician prescribed prednisone 10mg.
Age: 1.25
Sex: M
Vaccine: HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Hives on both thighs.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure increased, Rash, Swelling face
Clinical narrative: Rash on arm, trunk and neck area, swelling in facial area, elevated blood pressure. Patient went to PCP and received blood pressure medication.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Patients states that on Friday her arm swelled up and itched.  By Saturday the swelling had gone down but still itched.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site swelling, Pruritus
Clinical narrative: Patients states that on Friday her arm swelled up and itched.  By Saturday the swelling had gone down but still itched.
Age: 72.0
Sex: M
Vaccine: RAB
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itchiness. First shot for rabies was given to me on August 4th. A day later I felt itchy and and noticed a rash on my arms and legs. The first 3 shots were given to me at emergency room.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Decreased appetite, Irritability, Laboratory test, Lethargy, Pyrexia
Clinical narrative: High rectal temperature of 104.3, rash all over face, stomach and back. Lethargic, lack of appetite, cranky, fever.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Rash
Clinical narrative: High rectal temperature of 104.3, rash all over face, stomach and back. Lethargic, lack of appetite, cranky, fever.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Eyelid oedema, Pruritus, Rash papular, Skin disorder, Urticaria papular
Clinical narrative: Severe papular rash, worse on face, head and neck. Papular urticaria on extremities, anticubicals, backs of knees. Pruritus. Benadryl PO, hydrocortisone cream. Felt like a severe sunburn, skin leathery, eyes swollen closed.
Age: 67.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Injected limb mobility decreased, Myalgia
Clinical narrative: Severe muscle/joint pain in left arm/elbow since 6/11/2015. Limitation of left arm movement and use. Reported to pharmacy and PA at practice. No treatment sought since told symptoms would abate within 40 days according to Pfizer. Symptoms remain to date (8/29/2015).
Age: 67.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Musculoskeletal disorder, Myalgia
Clinical narrative: Severe muscle/joint pain in left arm/elbow since 6/11/2015. Limitation of left arm movement and use. Reported to pharmacy and PA at practice. No treatment sought since told symptoms would abate within 40 days according to Pfizer. Symptoms remain to date (8/29/2015).
Age: 67.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Injected limb mobility decreased, Myalgia
Clinical narrative: Muscle pain occurring in injection arm starting a few days after injection. Pt reported limited use of arm and worsening pain with stress. Patient reported issue to PCP after a few weeks. Patient primary concerns are treatment/resolution of pain, and she wants to know if she is able to get other immunizations without similar issue.
Age: 67.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Musculoskeletal disorder, Myalgia
Clinical narrative: Muscle pain occurring in injection arm starting a few days after injection. Pt reported limited use of arm and worsening pain with stress. Patient reported issue to PCP after a few weeks. Patient primary concerns are treatment/resolution of pain, and she wants to know if she is able to get other immunizations without similar issue.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-AUG-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (0.5 ml, intramuscularly, in the right arm, lot # K004542, expiration date 19-AUG-2015). No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. Recently on an unknown date in 2015, the patient was vaccinated with ZOSTAVAX (dose and route of administration not provided) for vaccination. No concomitant therapy was reported. On an unknown date in 2015, after the vaccination, the patient experienced injection site reaction that was red and inflamed (more inflamed than she normally sees). The pharmacist referred the patient to the physician. The reporter noted that the reaction subsided on an unknown date. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 14-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, dose and frequency were not reported) lot # L008355, expiration date 11-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. Some doses of (Oka/Merck) VARIVAX lot# reported as L003777, exp. 04-FEB-2017, lot# K006132, exp. 29-APR-2016 and lot# reported as L002216, exp. 21-JAN-2017 (doses were not reported), which were exposed to temperatures outside of the recommended range, have been adminsitered to unspecified patients on unspecified dates since 14-AUG-2015. No adverse experience has been reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 21-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, dose, and frequency were not reported) lot # L008355, expiration date 11-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 03-AUG-2015 (also reported as 03-AUG-2016), the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017, dose, frequency, route and site of administration were not reported). The vaccine was exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown dates, the patient were vaccinated with an improperly stored doses of LIQUID PEDVAXHIB (dose and route were not reported, lot # K016965, expiration date 20-JUL-2017). There was no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. No patients' medical history or current condition were reported. In August 2015, reported as on 04-AUG-2015, through 26-AUG-2015, an unspecified number of unspecified patients were administered an unspecified number of improperly stored PEDVAXHIB (dose, route of administration were not reported) (lot number: K025002, expiry date: 20-JUL-2017 and lot number: K025005, expiry date: 21-JUL-2017). No concomitant therapy was reported. No adverse effect or experience was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about patients' concomitant therapies, concurrent conditions or medical histories provided. On an unknown dates, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # L005299, expiration date 17-FEB-2017 or lot # L007225, expiration date 03-MAR-2017, route and dose were not reported) that were exposed to temperatures outside of the recommended range. There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of ROTATEQ (route oral, dose not reported, lot# K010323 with expiration date 10-MAY-2016 or lot#K017576 with expiration date 12-JUN-2016). There was no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a field representative refers to a patient of unknown age and gender. There was no information about patient's concomitant therapies, concurrent conditions or medical history provided. In approximately 2009 (reported as "about six years ago"), the patient was vaccinated with a dose of ZOSTAVAX injection (dose, lot # and expiration date not specified). In approximately 2009, the patient's arm swelled up. The time of swelling relative to receiving ZOSTAVAX was unspecified. The outcome of the swelling arm and relatedness between the event and ZOSTAVAX was unspecified. The outcome of swelling arm relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 2 unspecified patients of unknown age and gender. The patients concurrent conditions, medical history and concomitant therapies were not reported. On unspecified dates, two doses of PROQUAD (Merck) (dose and route of administration were not provided; either from lot # L007231 with expiry date on 09-MAR-2016 or from lot # L017140 with expiry date on 13-NOV-2016), that had been improperly stored were inadvertently administered to unspecified patients. No adverse effects were reported. Additional information has been requested.