chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unknown number of patients with unknown age and gender. On unknown dates the patients were vaccinated with GARDASIL lot # J015378, expiration date: 09-APR-2016 (strength, dosage, frequency and route unknown). There was temperature excursion during vaccine storage. The patient was vaccinated at private doctor's clinic/hospital with public funds. The manufacturer was contacted. Vaccine was stable and no adverse event was observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unknown number of patients with unknown age and gender. On unknown dates the patients were vaccinated with GARDASIL lot # J008423, expiration date: 21-JAN-2016(strength, dosage, frequency and route unknown). There was temperature excursion during vaccine storage. The patient was vaccinated at private doctor's clinic/hospital with public funds. The manufacturer was contacted. Vaccine was stable and no adverse event was observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unknown number of patients with unknown age and gender. On unknown dates the patients were vaccinated with GARDASIL lot # K003520, expiration date: 20-NOV-2016(strength, dosage, frequency and route unknown). There was temperature excursion during vaccine storage. The patient was vaccinated at private doctor's clinic/hospital with public funds. The manufacturer was contacted. Vaccine was stable and no adverse event was observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unknown number of patients unkonwn age and gender. On unknown date the patients were vaccinated with GARDASIL lot # J002641, expiration date: 10-DEC-2015 (strength, dosage, frequency and route unknown). There was temperature excursion during vaccine storage. The manufacturer was contacted. Vaccine was stable and no adverse event was observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a physician refers to a 1 year old patient. On 02-SEP-2014 the patient was vaccinated with VARIVAX (Merck) (1 shot, lot # K002048, exp 10-FEB-2016, Injection in the left thigh). Concomitant therapies included VAQTA. On an unknown date (in September 2014) the patient experienced varicella-like blister at injection site. No treatment was given. The outcome of varicella-like blister at injection site was reported as recovered/resolved. 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 registered nurse refers to a patient of unknown gender, age range reported as 4(units not reported). On 04-NOV-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot number K005180, expiration date 10-APR-2016 (dose, dose number, route and frequency were not reported) which was improperly stored. No adverse effects were reported. The patient did not seek medical attention. No product quality complaint (PQC) involved. The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown gender, age range reported as 16 (units not reported). On 04-NOV-2014, the patient was vaccinated with a dose of (oka/Merck) VARIVAX lot number K005180, expiration date 10-APR-2016 (dose, dose number, route and frequency were not reported) which was improperly stored. No adverse effects were reported. The patient did not seek medical attention. No product quality complaint (PQC) involved. The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown gender, age range reported as 10 (units not reported). On 04-NOV-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot number K005180, expiration date 10-APR-2016 (dose, dose number, route and frequency were not reported) which was improperly stored. No adverse effects were reported. The patient did not seek medical attention. No product quality complaint (PQC) involved. The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown gender, age range reported as 11 (units not reported). On 04-NOV-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot number K005180, expiration date 10-APR-2016 (dose, dose number, route and frequency were not reported) which was improperly stored. No adverse effects were reported. The patient did not seek medical attention. No product quality complaint (PQC) involved. The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown gender, age range reported as 9 (units not reported). On 04-NOV-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot number K005180, expiration date 10-APR-2016 (dose, dose number, route and frequency were not reported) which was improperly stored. No adverse effects were reported. The patient did not seek medical attention. No product quality complaint (PQC) involved. The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient (age range reported as 14, units not reported) of unknown gender. On 06-NOV-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot number K005180, expiration date 10-APR-2016 (dose, dose number and route were not reported) which was improperly stored. No adverse effects were reported. The patient did not seek medical attention. No product quality complaint (PQC) involved. The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown gender, age range reported as 5 (units not reported). On 07-NOV-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot number K005180, expiration date 10-APR-2016 (dose, dose number, route and frequency were not reported) that was improperly stored. No adverse effects were reported. The patient did not seek medical attention. No product quality complaint (PQC) involved. The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 21.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 21 year old patient of unknown gender. The nurse stated, that a 21 year old patient received his first dose of RECOMBIVAX HB (dose, units, route of administration, anatomical location, lot number was not reported) in 1994 (exact date unspecified). On 17-NOV-2014 (reported as today), the patient inadvertently received a pediatric formulation of RECOMBIVAX HB (second dose, strength reported as: 2.5 mcg/0.5 ml, route of administration, anatomical location, lot number was not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPAB
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a physician and described the occurrence of possible overdose in an adult subject of unspecified gender who was vaccinated with TWINRIX (GlaxoSmithKline). The medical Doctor's office requested TWINRIX dose 2 and TWINRIX Accelerated dose 2. Follow up information received on 17th October 2014: The patient details were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional on 14-NOV-2014 refers to unspecified patients. On unknown dates the patients were vaccinated with doses of VARIVAX (Merck) (lot #, expiration date and route unspecified) which had been exposed to temperature excursions that were supported, since the first temperature excursion on 28-OCT-2014. No adverse experiences had been observed or reported. This is one of several reports received from same source. Additional information has been requested.
Age: 23.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 23 year old patient of an unknown gender. Medical history and concurrent conditions were not provided. The reporter stated that the patient was administered 5 doses of GARDASIL on the following dates: On 26-AUG-2008, first dose of GARDASIL (dose, route, lot number and expiry date were not reported). On 03-NOV-2008, second dose of GARDASIL (dose, route, lot number and expiry date were not reported). On 03-SEP-2013, third dose of GARDASIL (dose, route, lot number and expiry date were not reported). On 09-JUN-2014, fourth dose of GARDASIL (dose, route, lot number and expiry date were not reported). On 30-OCT-2014, fifth dose of GARDASIL (dose, route, lot number and expiry date were not reported). No adverse effect reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 28-AUG-2014, the patient received VARIVAX (Merck) lot number J014400, expiration date: 13-NOV-2015 (dose and route were not provided), which was improperly stored on 05-AUG-2014 at 11:18 am for 3 hours 10 minutes. Other suspect and concomitant therapies were not reported. No adverse symptoms were reported. The temperature excursion for the VARIVAX (Merck) was supported with in-house stability data. 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 was received from a registered nurse concerning a patient of an unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 20-AUG-2014, the patient received (Oka/Merck) VARIVAX lot number J014400, expiration date: 13-NOV-2015 (dose and route were not provided), which was improperly stored on 05-AUG-2015 at 11:18 am for 3 hours 10 minutes. Other suspect and concomitant therapies were not reported. No adverse symptoms were reported. The temperature excursion for the (Oka/Merck) VARIVAX was supported with in-house stability data. 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: This spontaneous report as received from a health care worker refers to an unknown number of patients with unknown demographics. Approximately on an unknown date in the year 2014, unknown number of RECOMBIVAX HB vaccines undergone temperature excursion and improperly stored had been administered to an unknown number of patients. No adverse effects were reported. No additional information was provided. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, multiple unspecified patients were vaccinated with GARDASIL (dose, dose number, route, anatomical location, lot number and expiration date were unspecified), after the vaccines were exposed to temperatures from outside of recommended condition. No adverse events were reported. No concomitant therapies were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to unspecified number patients of unknown age. On an unknown date the patients were vaccinated with VAQTA (lot# was not reported). Nurse reported the vaccine administered were improperly stored. No adverse events were reported. This is one of the reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of VAQTA (lot number, expiration date, dose, route were not reported) and a dose of LIQUID PEDVAXHIB (lot number, expiration date, dose, route were not reported) that were improperly stored. No adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Body temperature increased, Hyperhidrosis, Nausea
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 12 year old male patient. Medical history was not reported. On 02-SEP-2014 the patient was vaccinated with the first dose of GARDASIL and on 03-NOV-2014 the patient was vaccinated with the second GARDASIL injection, intramuscular, lot # K009811, expiration date 19-JUN-2016. Concomitant therapy was not reported. The physician informed that on 04-NOV-2014 the patient had a temperature of 100, sweating and nausea after receiving GARDASIL. The patient sought medical attention by a call. The outcome of the events was unknown. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Amylase, Blood test, C-reactive protein, Diarrhoea, Differential white blood cell count
Clinical narrative: Skin hot - flushed pale, diarrhea, swollen glands, brain on fire.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Flushing, Full blood count, Head discomfort, Lymphadenopathy, Metabolic function test
Clinical narrative: Skin hot - flushed pale, diarrhea, swollen glands, brain on fire.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Pallor, Red blood cell sedimentation rate, Skin warm
Clinical narrative: Skin hot - flushed pale, diarrhea, swollen glands, brain on fire.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Insomnia, Neck pain, Nuclear magnetic resonance imaging brain normal
Clinical narrative: He received anthrax #2 on 24 Jan '03 and #3 on 8 Feb '03. No other vaccines were given simultaneously. He does not recall similar immediate adverse events after these doses. However, he does recall developing new onset headaches during the 4 week period when he received these vaccines. He states he sought treatment several times at the clinic and "lived on ibuprofen". He continues to work even though the headaches were severe and occurred daily for the next year. They interfered with sleep and were "the worse pain I ever experienced." Although there are no medical records for review from this time period there are documented ibuprofen and oxycodone prescriptions from 27 Mar '03. The patient received anthrax #4 on 26 July '04. He doesn't recall any increase in headaches with this dose but he was taking NAPROXYN prescribed on 24 July '04 for continued head and neck pain. He has had for headache prophylaxis which was ineffective. He does recall that the anthrax vaccination he received on 10 Sep '09 triggered worsening headaches for 4-5 weeks, beginning on the day he received the shot.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a raised, red, hot to the touch, 3 inch diameter area where the shot was given 2 days after receiving the vaccine. Patient took ZYRTEC, BENADRYL and ZANTAC to treat the area.
Age: 4.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Laboratory test, Lumbar puncture, Pain, Paraesthesia
Clinical narrative: Developed generalized weakness, tingling in lower extremities and finger tips, bodyaches the evening of the day she received Tdap.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Musculoskeletal stiffness, Pain, Peripheral swelling, Pruritus
Clinical narrative: 10/16/14 soreness, 10.17.14 itchy, red stripe up her arm, swollen. 10/18/14-> ER - swollen, neck stiff, redness, red stripe up arm to shoulder area.
Age: 88.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: Patient already received ZOSTAVAX vaccine on 4/12/2011. Since was so long ago his profile didn't even list the record of the shot.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 16-OCT-2014, the patients were vaccinated with improperly stored GARDASIL, 0.5 ml, intramuscular (strength, frequency and lot number not provided). Co-suspect or concomitant therapies were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unknown number of patients with unknown demographics. Approximately on an unknown date in the year 2014, unknown number of GARDASIL vaccines undergone temperature excursion and improperly stored which had been administered to an unknown number of patients. No adverse effects were reported. No additional information was provided. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 16-OCT-2014, the patients were vaccinated with improperly stored VAQTA, 0.5 ml, intramuscular. Co-suspect or concomitant therapies were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Cold sweat, Fatigue, Headache, Somnolence
Clinical narrative: Presented the same as my salicylate reactions, headache, claminess, fatigue, upset stomach, somnolence. I fell asleep twice. I am wondering if it contains salicylate.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant on 07-NOV-2014 refers to a patient of unknown age and gender. On 07-NOV-2014 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # 0384AE, expiration date: 02-NOV-2014 strength, dose and route were unknown) injection. No adverse effects were noted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Embolism venous
Clinical narrative: Information has been received from the authors of an article, concerning 3 female patients who on an unknown date were vaccinated with a dose of Quadrivalent HPV (manufacturer unknown). On an unknown date in the "1-7" day period following Quadrivalent HPV (manufacturer unknown) patients were identified with venous thromboembolism. Patient's outcomes were not reported. Methods: authors conducted a self-controlled case series analysis of venous thromboembolism (VTE) in six healthcare delivery systems. They identified potential VTEs among vaccinated women using coded inpatient and outpatient diagnoses from 2008 through 2011, and then manually reviewed them to confirm the diagnosis and collect risk factor (e.g., hormonal contraceptive, trauma, pregnancy) data. Study physicians adjudicated ambiguous cases. Observation time for each confirmed case was divided into exposed periods (7, 14, 28, 42, and 60 days following HPV4) and unexposed periods (the remainder of the observation period). They calculated the risk of VTE by dividing the incidence in exposure periods by the incidence in unexposed periods. Results: Authors identified 153 confirmed VTE cases in females 9-26 years of age who were exposed to HPV4 (manufacturer unknown) during the study period. Three VTE cases were identified in the 1-7 day period following HPV4 (manufacturer unknown) and the estimated relative risk in this period was 1.51 (95% confidence interval (Cl): 0.48-4.76). The risk estimate decreased with increasing exposure window length; the relative risk in the 1-60 day period following HPV4 (manufacturer unknown) was 0.95 (95% Cl: 0.55-1.62). In the 1-7 day exposure period the risk of VTE associated with HPV4 (manufacturer unknown) among hormonal contraceptive users was 0.88 (95% Cl: 0.12-6.35) compared to 2.44 (95% Cl: 0.59-10.12) among non-users. Conclusions: Authors did not observe a statistically significant increased risk of VTE in the 60 days following HPV4 (manufacturer unknown) exposure in young women. Statistical power was limited for examining potential effect modification by hormonal contraceptive use. The authors considered that venous thromboembolism was related to Quadrivalent HPV (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. This report is linked to MARRS 1410USA015758, same literature report. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: Pr (R) arm reacted with red spots around injected area. Pt was given BENADRYL 10 mg per dr.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Body temperature increased, Chills, Headache, Injection site erythema
Clinical narrative: 100 degree F - 2 days; Extreme muscle and joint pain - 2 days; Headache/chills - 2 days; Slight nauseas - 3 days; Photosensitivity - 3 days; Widespread redness around injection sight -4 days and continuing.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Nausea, Photosensitivity reaction
Clinical narrative: 100 degree F - 2 days; Extreme muscle and joint pain - 2 days; Headache/chills - 2 days; Slight nauseas - 3 days; Photosensitivity - 3 days; Widespread redness around injection sight -4 days and continuing.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients in their 30's of unknown gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with ZOSTAVAX 19400 PFU. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. No adverse events were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Left arm redness, pain and swelling/hot to touch - next day reaction. Treat with KEFLEX.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: 11 x 4 cm area erythema. Warmth tenderness. Antibiotic and follow up 11/10/14.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Vomiting, stomach, cramps, diarrhea, itching, red swollen at injection site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Vomiting, stomach, cramps, diarrhea, itching, red swollen at injection site.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia, Skin discolouration
Clinical narrative: Injection given on Tuesday afternoon. Fever started three hours later, reached 101.5 degrees F. Upper arm injection site turned red. It was hot and very sore. Doctor prescribed antibiotics on Thursday. Fever subsisded on Friday morning. Arm still discolored a week later.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Erythema, Nodule, Pain, Pruritus
Clinical narrative: Redness, rash, itchy, SOB, pain, knot in arm
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Redness, rash, itchy, SOB, pain, knot in arm
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Pain in extremity, Rash erythematous
Clinical narrative: No reaction on Friday, date of vaccination. Saturday 11-8-14 site slightly red rash size of quarter. Sunday 11-9-14-rash larger, redder and warm to touch. Monday rash 1 1/2" x 3" red, warm to touch, some arm pain but very tolerable. Rash 3 x 5 cm by provider.
Age: 0.21
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Hypophagia, Infantile spitting up, Irritability, Pyrexia, Vomiting
Clinical narrative: Decreased eating on oz per feeding. Increased fussiness. Increased spitting up/vomiting. Fever.
Age: 0.38
Sex: F
Vaccine: HIBV, PPV, RVX
Symptoms: Decreased appetite, Infantile spitting up, Irritability, Pyrexia, Vomiting
Clinical narrative: Decreased eating in oz per feeding. Increased fussiness. Increased spitting up/vomiting. Fever.
Age: 0.55
Sex: F
Vaccine: DTAP, HEP, IPV, RVX
Symptoms: Hypophagia, Infantile spitting up, Irritability, Pyrexia, Vomiting
Clinical narrative: Decreased eating per feeding. Increase fussiness. Increased spitting up/vomiting. Fever.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Anxiety, Asthenia, Blood test normal, Confusional state, Crying
Clinical narrative: Immediate: Swollen, red, hotness on arm, slight elevated fever undiagnosed red patches on chest and back, and several small warts under right arm and scattered about. Weeks following: Lack of energy and concentration, confusion, fatigue in legs and arms...no pain just funny tired feeling. Episode of vertigo (never had before). Nausea, weakness (visit to doctor to inquire-blood work taken-). Sudden panic attack, fear. Severe anxiety episodes. Depression, had thoughts of suicide...called emergency pediatrician # and hotline. (2nd doctor visit) psychiatric help recommended. He is presently getting therapy, no medication is being taken. I have a 12 year old boy who only 2 months ago received the first of 3 HPV shot. His arm was swollen, red and tender to the touch and he felt a bit sluggish and had a slight fever, which I was told was ok and normal, however shortly after he started to feel fatigue, weakness and pain in legs and arms and getting small patches on skin that looked like eczema as well as small warts under his arm, he also experienced nausea and as time went on he had a episode of vertigo like effect. It all seemed odd so I brought him back to doctor and they said all was ok, they said blood work looked good! Within days after that appt he started to have severe anxiety, fear, and depression. My son was a happy, smart boy who got great grades and enjoyed school and learning and now he hardly has a will to live! The depression is so severe and he has no idea what happened to him. He keeps saying he wants his old self back and cries all the time, feels scared and isolated. I try to comfort him but he can't shake it. I have so much guilt for allowing him to get this shot! I am now getting him therapy and looking into holistic health to try to reverse these effects. I am praying that they can be reversed and he can go on living like he used to. My gut was telling me not to get the 2nd and 3rd shots and then I began to do research which I am now facing my worst fear that he has some permanent irreversible damage.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Depression, Disturbance in attention, Erythema, Fatigue, Fear
Clinical narrative: Immediate: Swollen, red, hotness on arm, slight elevated fever undiagnosed red patches on chest and back, and several small warts under right arm and scattered about. Weeks following: Lack of energy and concentration, confusion, fatigue in legs and arms...no pain just funny tired feeling. Episode of vertigo (never had before). Nausea, weakness (visit to doctor to inquire-blood work taken-). Sudden panic attack, fear. Severe anxiety episodes. Depression, had thoughts of suicide...called emergency pediatrician # and hotline. (2nd doctor visit) psychiatric help recommended. He is presently getting therapy, no medication is being taken. I have a 12 year old boy who only 2 months ago received the first of 3 HPV shot. His arm was swollen, red and tender to the touch and he felt a bit sluggish and had a slight fever, which I was told was ok and normal, however shortly after he started to feel fatigue, weakness and pain in legs and arms and getting small patches on skin that looked like eczema as well as small warts under his arm, he also experienced nausea and as time went on he had a episode of vertigo like effect. It all seemed odd so I brought him back to doctor and they said all was ok, they said blood work looked good! Within days after that appt he started to have severe anxiety, fear, and depression. My son was a happy, smart boy who got great grades and enjoyed school and learning and now he hardly has a will to live! The depression is so severe and he has no idea what happened to him. He keeps saying he wants his old self back and cries all the time, feels scared and isolated. I try to comfort him but he can't shake it. I have so much guilt for allowing him to get this shot! I am now getting him therapy and looking into holistic health to try to reverse these effects. I am praying that they can be reversed and he can go on living like he used to. My gut was telling me not to get the 2nd and 3rd shots and then I began to do research which I am now facing my worst fear that he has some permanent irreversible damage.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Feeling abnormal, Immediate post-injection reaction, Local swelling, Nausea, Pain in extremity
Clinical narrative: Immediate: Swollen, red, hotness on arm, slight elevated fever undiagnosed red patches on chest and back, and several small warts under right arm and scattered about. Weeks following: Lack of energy and concentration, confusion, fatigue in legs and arms...no pain just funny tired feeling. Episode of vertigo (never had before). Nausea, weakness (visit to doctor to inquire-blood work taken-). Sudden panic attack, fear. Severe anxiety episodes. Depression, had thoughts of suicide...called emergency pediatrician # and hotline. (2nd doctor visit) psychiatric help recommended. He is presently getting therapy, no medication is being taken. I have a 12 year old boy who only 2 months ago received the first of 3 HPV shot. His arm was swollen, red and tender to the touch and he felt a bit sluggish and had a slight fever, which I was told was ok and normal, however shortly after he started to feel fatigue, weakness and pain in legs and arms and getting small patches on skin that looked like eczema as well as small warts under his arm, he also experienced nausea and as time went on he had a episode of vertigo like effect. It all seemed odd so I brought him back to doctor and they said all was ok, they said blood work looked good! Within days after that appt he started to have severe anxiety, fear, and depression. My son was a happy, smart boy who got great grades and enjoyed school and learning and now he hardly has a will to live! The depression is so severe and he has no idea what happened to him. He keeps saying he wants his old self back and cries all the time, feels scared and isolated. I try to comfort him but he can't shake it. I have so much guilt for allowing him to get this shot! I am now getting him therapy and looking into holistic health to try to reverse these effects. I am praying that they can be reversed and he can go on living like he used to. My gut was telling me not to get the 2nd and 3rd shots and then I began to do research which I am now facing my worst fear that he has some permanent irreversible damage.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Panic attack, Pyrexia, Rash, Rash erythematous, Skin papilloma
Clinical narrative: Immediate: Swollen, red, hotness on arm, slight elevated fever undiagnosed red patches on chest and back, and several small warts under right arm and scattered about. Weeks following: Lack of energy and concentration, confusion, fatigue in legs and arms...no pain just funny tired feeling. Episode of vertigo (never had before). Nausea, weakness (visit to doctor to inquire-blood work taken-). Sudden panic attack, fear. Severe anxiety episodes. Depression, had thoughts of suicide...called emergency pediatrician # and hotline. (2nd doctor visit) psychiatric help recommended. He is presently getting therapy, no medication is being taken. I have a 12 year old boy who only 2 months ago received the first of 3 HPV shot. His arm was swollen, red and tender to the touch and he felt a bit sluggish and had a slight fever, which I was told was ok and normal, however shortly after he started to feel fatigue, weakness and pain in legs and arms and getting small patches on skin that looked like eczema as well as small warts under his arm, he also experienced nausea and as time went on he had a episode of vertigo like effect. It all seemed odd so I brought him back to doctor and they said all was ok, they said blood work looked good! Within days after that appt he started to have severe anxiety, fear, and depression. My son was a happy, smart boy who got great grades and enjoyed school and learning and now he hardly has a will to live! The depression is so severe and he has no idea what happened to him. He keeps saying he wants his old self back and cries all the time, feels scared and isolated. I try to comfort him but he can't shake it. I have so much guilt for allowing him to get this shot! I am now getting him therapy and looking into holistic health to try to reverse these effects. I am praying that they can be reversed and he can go on living like he used to. My gut was telling me not to get the 2nd and 3rd shots and then I began to do research which I am now facing my worst fear that he has some permanent irreversible damage.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Skin warm, Sluggishness, Suicidal ideation, Tenderness, Vertigo
Clinical narrative: Immediate: Swollen, red, hotness on arm, slight elevated fever undiagnosed red patches on chest and back, and several small warts under right arm and scattered about. Weeks following: Lack of energy and concentration, confusion, fatigue in legs and arms...no pain just funny tired feeling. Episode of vertigo (never had before). Nausea, weakness (visit to doctor to inquire-blood work taken-). Sudden panic attack, fear. Severe anxiety episodes. Depression, had thoughts of suicide...called emergency pediatrician # and hotline. (2nd doctor visit) psychiatric help recommended. He is presently getting therapy, no medication is being taken. I have a 12 year old boy who only 2 months ago received the first of 3 HPV shot. His arm was swollen, red and tender to the touch and he felt a bit sluggish and had a slight fever, which I was told was ok and normal, however shortly after he started to feel fatigue, weakness and pain in legs and arms and getting small patches on skin that looked like eczema as well as small warts under his arm, he also experienced nausea and as time went on he had a episode of vertigo like effect. It all seemed odd so I brought him back to doctor and they said all was ok, they said blood work looked good! Within days after that appt he started to have severe anxiety, fear, and depression. My son was a happy, smart boy who got great grades and enjoyed school and learning and now he hardly has a will to live! The depression is so severe and he has no idea what happened to him. He keeps saying he wants his old self back and cries all the time, feels scared and isolated. I try to comfort him but he can't shake it. I have so much guilt for allowing him to get this shot! I am now getting him therapy and looking into holistic health to try to reverse these effects. I am praying that they can be reversed and he can go on living like he used to. My gut was telling me not to get the 2nd and 3rd shots and then I began to do research which I am now facing my worst fear that he has some permanent irreversible damage.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unkonwn date, multiple unspecified patients were vaccinated with RECOMBIVAX HB (dose, dose number, route, anatomical location, lot number and expiration were unspecified), after the vaccines were exposed to temperatures from outside of recommended condition. No adverse events were reported. No concomitant therapies were reported. The outcome of the events was unknown. 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 as received from a health care worker refers to an unknown number of patients with unknown demographics. Approximately on an unknown date in the year 2014, unknown number of PEDVAX HIB vaccines undergone temperature excursion and improperly stored had been administered to an unknown number of patients. No adverse effects were reported. No additional information was provided. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, multiple unspecified patients were vaccinated with COMVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified), after the vaccines were exposed to temperatures from outside of recommended condition. No adverse events were reported. No concomitant therapies were reported. The outcome of the events was unknown. 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 was received from a registered nurse concerning a patient of an unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 18-AUG-2014, the patient received VARIVAX (Merck) lot number J014400, expiration date: 13-NOV-2015 (dose and route were not provided), which was improperly stored on 05-AUG-2014 at 11:18 am for 3 hours 10 minutes. Other suspect and concomitant therapies were not reported. No adverse symptoms were reported. The temperature excursion for the VARIVAX (Merck) was supported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, 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 current conditions or medical history were not reported. On 06-NOV-2014, the patient was vaccinated with an expired dose of RECOMBIVAX HB injection 10 Y (dose and route not reported) lot number J014312, expiration date 07-SEP-2014. The patient had not demonstrated or reported any adverse effects. Additional information has been requested.
Age: 1.95
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of extra dose administered in a 23-month-old male patient who received HAVRIX pediatric (batch number AHAVB286BA, expiry date 21st March 2006). Previously administered products included HAVRIX pediatric. On 2nd September 2009, the patient received the 3rd dose of HAVRIX pediatric. On an unknown date, an unknown time after receiving HAVRIX pediatric, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. It was unknown if the reporter considered the extra dose administered to be related to HAVRIX pediatric. Investigator comments: HAVRIX given to a child on 05 November 2008, 29 April 2009 and 02 September 2009. State registry and EMR now flagging Hep A dose needed.
Age: 18.0
Sex: F
Vaccine: MEN, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive, Tuberculin test
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 18 year old female patient with no pertinent medical history, drug reactions or allergies. The reporter stated, that on 13-SEP-2012 a patient received a dose of VARIVAX (Merck) (lot# reported as: H007450 with expiry date: 27-MAR-2014) and later, on an unknown date in 2-12 she was pregnant. On 13-SEP-2012 the patient also received an unspecified meningococcal vaccine (manufacturer unspecified). The patient became pregnant with LMP (last menstrual period) of 01-AUG-2012 and EDD (estimated delivery date) of 08-MAY-2013. Initial exposure to VARIVAX (Merck) was at 6 week. The pregnancy outcome was not reported. There was no treatment given for the adverse event. In 2012 (exact date unspecified) pregnancy test was done and the patient was pregnant. On 13-SEP-2012, PPD (tuberculosis skin tests) was performed, results not provided. The patient sought unspecified medical attention. No further information is available. Additional information is not expected because the reported did not have more information. Concomitant was added. Laboratory studies were corrected. Information regarding pregnancy information were corrected. Narrative was updated. Closing statement was changed.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a pharmacist via field representative on 10-NOV-2014 refers to a 67 years old female patient. On 31-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, lot# and route were unknown). The pharmacist reported that a patient was diagnosed with shingles after receiving ZOSTAVAX. The pharmacist reported that the patient had abdominal pain which "felt like she pulled a muscle", and then the patient noticed the rash. The patient was diagnosed with shingles by her physician on an unknown date of 2014. The patient was in a lot of pain. The patient was treated with oral antiviral therapy, antiviral ointment and pain meds. On 10-NOV-2014 saw unspecified physician for seeking medical attention. The outcome of event was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to patient of unknown age and gender. On an unknown date, the patient was vaccinated on the same day with two doses of M-M-R II (dose, dose numbers, lot/batch number, expiration date, route and frequency were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of an unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 09-AUG-2014, the patient received VARIVAX (Merck) lot number J014400, expiration date: 13-NOV-2015 (dose and route were not provided), which was improperly stored on 05-AUG-2014 at 11:18 am for 3 hours 10 minutes. Other suspect and concomitant therapies were not reported. No adverse symptoms were reported. The temperature excursion for the VARIVAX (Merck) was supported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unknown number of patients with unknown demographics. Approximately on an unknown date in the year 2014, unknown number of PNEUMOVAX 23 vaccines undergone temperature excursion and improperly stored had been administered to an unknown number of patients. No adverse effects were reported. No additional information was provided. No product quality complaint was involved. Additional information has been requested.