chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: This spontaneous report as received from a consumer's wife refers to a 57 year old male patient with medical history of high blood pressure, migraines and with none drug reactions or allergies. On 22-MAY-2014 the patient was vaccinated with ZOSTAVAX (in the right arm, dose, units, route of administration, lot number, expiration date were not reported). Concomitant therapies included dopamine hydrochloride, FLOMAX, aspirin and unspecified medication for blood pressure. On 01-JUN-2014 the patient subsequently developed a red, blotchy, itchy rash over the entire trunk of his body. The reporter stated that the rash disappeared sometime within that week and then reappeared again on 16-JUN-2014. None lab diagnostic studies were performed. The patient sought medical attention. The patient received treatment with prednisone (reported as presidone)and BENADYRL. The outcome of reported adverse effects was reported as recovered on an unspecified date in June 2014. The relatedness between reported events and ZOSTAVAX was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age (the pharmacist's mother). On an unknown date (reported as many years ago), the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not provided) in the arm. On an unknown date, the patient experienced redness and swelling on her arm at the injection site after receiving ZOSTAVAX. The outcome of redness and swelling at the injection site was unknown. The relatedness between the events and the vaccination with ZOSTAVAX was unknown. This is one of several report from the same source. Additional information is not expected because the pharmacist did not want to provide any additional information.
Age: 1.7
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Pertussis, Polymerase chain reaction
Clinical narrative: This is one case out of a cumulative total of 230 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 25 July 2014. These 230 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 25 July 2014 from the Investigator participating in a post-marketing study under reference number M5A16. A case of pertussis disease in a four-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) database. The subject had received 3 doses of PENTACEL (dose one lot number not reported; dose two lot number C3421AA, dose 3 lot number C3599AA) on 07 January 2010, 20 April 2010, and 15 July 2010, (routes and site of administration not reported). She also received a dose of DAPTACEL, (lot number C3192AA) on 06 June 2011. The subject developed a cough on 05 July 2014, approximately three years after the last dose, and on 06 July 2014 developed a paroxysmal cough. A chest x-ray was negative; PCR test results were not reported. Corrective treatment included azithromycin for 5 days beginning 09 July 2014. The subject was not hospitalized. At the time of final contact on 21 July 2014 the subject's cough had been ongoing for 16 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per the protocol. Documents held by sender: None.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unknown number of patients, unknown age and gender. medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of (Oka/Merck) PROQUAD (dose, frequency, strength and route were not reported) (lot number J010160 valid for V221, expiration date 23-FEB-2015. Co-suspect and concomitant therapies were not reported. The nurse reported that in her facility got a new thermometer system on 13-MAY-2014, and according to the thermometer, (Oka/Merck) PROQUAD was exposed to temperatures above the recommended storage temperature on multiple occasions. At this time, it was not known whether or not the excursions were supported because data was insufficient to evaluate. the nurse stated that she was certain that doses of (Oka/Merck) PROQUAD had been administered to patients since these excursions were recorded. No adverse effects have been experienced. The reporter considered the events to be not related (Oka/Merck) PROQUAD. This case is linked to case numbers 1407USA001030 and 1407USA006119 via same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified amount of patients were administered (Oka/Merck) VARIVAX (dose, route, lot# and expiration date were not reported) that underwent a temperature excursion. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 66 years old female patient. The pharmacist reported that, on an unknown date (reported as "as a child"), the patient received varicella virus vaccine live (manufacturer unknown) (reported as an unspecified chickenpox vaccine) (dose, route of administration, lot # and expiration date were not provided). On an unknown date (reported as "some time after"), the patient developed a swollen arm. The pharmacist stated that at the time of the report the patient no longer had a swollen arm as this reaction occurred a long time ago. The relatedness between the event and the vaccination with varicella virus vaccine live (manufacturer unknown) was unknown. Additional information has been requested.
Age: 0.11
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Dr. grabbed KINRIX instead of Hep B. We are unaware of any adverse reactions just to report wrong vaccine given.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: This spontaneous report as received from a physician refers to a 53 year old female patient with irritable bowel syndrome, skeletal back problems and no known allergies. On 28-JUN-2014, the patient was vaccinated at an unspecified pharmacy with a dose of ZOSTAVAX injection in the left arm (dose, route of administration, lot#, expiry date unspecified). Concomitant therapies included diazepam (manufacturer unknown), gabapentin, cyclobenzaprine hydrochloride, AMITIZA, pantoprazole and montelukast sodium (manufacturer unknown). On an unspecified date in 2014, the patient experienced erythema, itching, and mild acute swelling, 3 centimeters in diameter, at the injection site and also localized myalgia. There was no compartment syndrome. The patient sought medical attention - she was in the emergency room at the time of report (on 02-JUL-2014) and received the treatment: DECADRON, 4mg (route of administration unspecified). The physician stated that the patient would not be hospitalized. The outcome of events was reported as not recovered. The relatedness between events and ZOSTAVAX was not reported. Additional information is not expected as the physician did not wish any contact.
Sex: U
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unspecified date of approximately 2013 (reported as about a year ago) the patient was vaccinated with first dose of GARDASIL (dose and lot number not reported). On an unspecified date of approximately 2013, after receiving the GARDASIL the patient developed fever. The physician also reports the patient received the first dose of GARDASIL the patient developed fever. The physician also reports the patient received the first dose of GARDASIL about a year ago, and had not received the second dose yet. There was no product quality complaint (PQC). The outcome and causality of fever was unknown. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 59 year old female patient. On an unknown date, the patient was vaccinated at unspecified pharmacy with a dose of ZOSTAVAX 1 injection (dose, dose number, lot/batch number, exp. date not reported) subcutaneous. On an unspecified date, immediately after vaccination, the patient experienced hard lump that was itchy and painful to scratch at the injection site. There was no treatment given for the events. The patient did not seek medical attention. The outcome of event was reported as recovered/resolved, all symptoms cleared up after 5 days (date unspecified). The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient in her 60's. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, 1 injection (dose, dose number, lot/batch number, exp. date not reported) subcutaneous. On an unspecified date, immediately after vaccination, the patient experienced hard lump that was itchy and painful to scratch at the injection site. There was no treatment given for the events. The patient did not seek medical attention. The outcome of event was reported as recovered/resolved, all symptoms cleared up after 5 days (date unspecified). The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 59 year old female patient. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, 1 injection (dose, dose number, lot/batch number, exp. date not reported) subcutaneous. On an unspecified date, immediately after vaccination, the patient experienced hard lump that was itchy and painful to scratch at the injection site. There was not treatment give for the events. The patient did not seek medical attention. The outcome of event was reported as recovered/resolved, all symptoms cleared up after 5 days (date unspecified). The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: TYP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, light fever, mild vomiting after 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via other pharmacists refers to an unspecified number of patients of an unknown age and gender. On an unknown dates, an unspecified number of patients were vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not provided). The pharmacist reported that she had heard from other pharmacists that they have seen, on an unknown dates, injection site reactions. The outcome of swelling and redness at the injection site was unknown. The relatedness between the events and the vaccination with ZOSTAVAX was unknown. This is one of several report from the same source. Additional information is not expected because the pharmacist did not want to provide any additional information.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. The nurse reported that an unknown number of doses of RECOMBIVAX HB (pediatric/adolescent formulation) 0.5 ml, intramuscularly (lot number not reported) that were exposed to temperature below 32 Fahrenheit had been administered. No adverse effect was reported. Concomitant medications were not specified. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from same reporter. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Immunization site post aspect RA. Round 6x6 cm slightly raised, erythemic, warm to the touch. Tender upon palpitation, it is indurated (at size of half/silver dollar coin), and local itching no SOB, CP, ETC.
Age: 43.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Immunization site post aspect RA. Round 6x6 cm slightly raised, erythemic, warm to the touch. Tender upon palpitation, it is indurated (at size of half/silver dollar coin), and local itching no SOB, CP, ETC.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 20 year old male patient. On 23-JUL-2013 the patient was vaccinated with a fourth dose of GARDASIL (0.5 ml, intramuscular, in the left arm, lot number was not reported). The reporter stated that this error occurred when they were converting paper charts to electronic records. Vaccinations dates of the previous vaccinations with GARDASIL were not reported. The reporter stated that the patient did not experience any adverse effect due to the extra dose of GARDASIL. This is one of several reports from the same reporter. Additional information is not expected because the reported doesn't want to be contacted.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 year old male patient. On 21-FEB-2014 the patient was vaccinated with a fourth dose of GARDASIL (0.5 ml, intramuscular, in the left arm, lot number was not reported). The reporter stated this error occurred when they were converting paper charts to electronic records. Vaccinations dates of the previous vaccinations with GARDASIL were not reported. The reporter stated that the patient did not experience any adverse effect due to the extra dose of GARDASIL. This is one of several reports from the same reporter. Additional information is not expected because the reported doesn't want to be contacted.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a female consumer of unknown age and refers to herself. On an unknown date (reported as several years ago) the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose, lot # and expiration date not provided). On unspecified date the patient developed little fluid filled blisters on buttocks that itched, burned and hurt. The patient was treated with unspecified antibiotic. It was reported that patient did not seek medical attention. The outcome of the events was unknown. Relatedness between events and ZOSTAVAX was not reported. Additional information is not expected, no reporter's contact details were provided.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 year old male patient. On 24-AUG-2012 the patient was vaccinated with a fourth dose of GARDASIL (0.5 ml, intramuscular, in the left arm, lot number was not reported). The reporter stated that this error occurred when they were converting paper charts to electronic records. Vaccinations dates of the previous vaccinations with GARDASIL were not reported. The reporter stated that the patient did not experienced any adverse effect due to the extra dose of GARDASIL. This is one of several reports from the same reporter. Additional information is not expected because the reporter doesn't want to be contacted.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Rash, Swelling
Clinical narrative: This spontaneous report as received from an approximately 60 years old male consumer refers to himself. On unspecified date in December 2013 the patient was vaccinated with ZOSTAVAX (does, route of administration, lot # and expiration date were not provided). Concomitant therapies included CRESTOR and metformin. Patient has no drug reactions/allergies. The patient stated that he experienced itchiness, a rash, redness, swelling and a little pain on 09-JUL-2014 (also reported as 6 months after administration of ZOSTAVAX. There was no treatment given for adverse events and no lab diagnostic were performed. The patient did not seek medical attention. The patient also reported that before receiving ZOSTAVAX he had been diagnosed with the shingles in unspecified number of times. The outcome of itchiness, little pain, swelling, redness and rash was reported as not recovered/not resolved. Relatedness between itchiness, little pain, swelling, redness, rash and ZOSTAVAX 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 as received from a nurse refers to a patient of unknown age. No infromation about medical history, concurrent conditions and concomitant were reported. The reporter stated that the patient was vaccinated with first dose of GARDASIL (dose strength, route not reproted) on 17-OCT-2013, the 2nd dose of GARDASIL on 07-JAN-2014. It was reproted that patient was seen in the office on 28-JUL-2014 and was getting 3rd dose of GARDASIL. No adverse effects reproted. The outcome of events reported is unknown. No product quality complaint was involved. Addtional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, mild erythema of injection site, developing 24-48 hours after injection.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Expired drug administered, Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report as received from a health care worker (certified medical assistant) refers to a 5 year old male patient with none pertinent medical history and none drug reactions/allergies. On unknown date the patient was vaccinated with first dose of (Oka-Merck) PROQUAD (dose, lot # and expiration date not provided). On 21-JUL-2014 the patient was vaccinated with second 0.5 ml dose of expired PROQUAD (lot # J000199, exp. 08-JUL-2014) subcutaneously. There were none concomitant medication. Healthcare worker reported that patient's mother stated that on 21-JUL-2014 patient experienced a hard red knot at injection site with pain, swelling and a low grade temperature. TYLENOL and cold compressed was ordered as a treatment. There were no lab tests performed. The outcome of hard red knot at injection site with pain, swelling and a low grade temperature was unknown. Relatedness between events and (Oka-Merck) PROQUAD was not reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a health care worker (certified medical assistant) refers to a 5 year old male patient with none pertinent medical history and none drug reactions/allergies. On unknown date the patient was vaccinated with first dose of (Oka-Merck) PROQUAD (dose, lot # and expiration date not provided). On 21-JUL-2014 the patient was vaccinated with second 0.5 ml dose of expired PROQUAD (lot # J000199, exp. 08-JUL-2014) subcutaneously. There were none concomitant medication. Healthcare worker reported that patient's mother stated that on 21-JUL-2014 patient experienced a hard red knot at injection site with pain, swelling and a low grade temperature. TYLENOL and cold compressed was ordered as a treatment. There were no lab tests performed. The outcome of hard red knot at injection site with pain, swelling and a low grade temperature was unknown. Relatedness between events and (Oka-Merck) PROQUAD was not reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Dysgeusia, Migraine, Musculoskeletal stiffness, Nausea, Throat irritation
Clinical narrative: Nausea 20 minutes after vaccine. Migraine headache 30 minutes after vaccine. Neck stiffness. Metallic taste in mouth and itching in back of throat approx 60 minutes after vaccine. BENADRYL 50 mg IM, TORADOL 60 mg IM and ZOFRAN 8 mg PO given to good effect. Observed approx 2 hours.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 7/24/14 - warmth, redness, and swelling approximately 50mm in diameter at injection site, slight itching, and tender to touch. (Redness and swelling have completely resolved 7/30/14).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt. received ZOSTAVAX (shingles) vaccine 07/07/2014 Rt upper arm 0.65 ml SQ. Returned 7/9/14 with approx. 5 inches in diameter of erythema and 3 inches induration area of medial aspect proximal to elbow. Pt. returned 7/10 showing approx. 25% improvement.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-JUL-2014, the patient received improperly stored RECOMBIVAX HB, 2.5 mcg/0.5 ml (dose, route of administration, lot # and expiration date were not provided). No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Vaccination site swelling
Clinical narrative: Patient reported swelling at sight of vaccine on 7/21. Patient then went to ER. Patient diagnosed with cellulitis and prescribed KEFLEX.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Blisters and erythematous, patch on the injection site. Left thigh where VAQTA (Hep B) was given.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Pyrexia, Swelling
Clinical narrative: Pt developed cellulitis in (R) arm with fever and swelling. D/C w/ KEFLEX and BACTRIM. Sx have resolved.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Convulsion
Clinical narrative: Mother called approximately 15 minutes after child received immunizations, to report that child had a "seizure". Child quickly gained consciousness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pruritus, Swelling
Clinical narrative: Swelling, hot, itchy for 5 days.
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Cerebrovascular accident, Influenza like illness, Injection site pain, Somnolence
Clinical narrative: This is a spontaneous report from a contactable consumer reported for himself. A male patient of unknown age and ethnicity received on an unknown date PREVENAR 13 at single dose. Relevant medical history and concomitant medications were unknown. Vaccines given on the same day and vaccines taken within the last four weeks were unknown. Illness at the time of vaccination was unknown. On an unknown date he experienced soreness at the injection point, felt very sleepy, had joint aches, joint pain, felt like he got flu and stroke. Relevant lab was unknown. At the time of the report he had not recovered from the above mentioned events.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Injection site swelling
Clinical narrative: (R) leg swelling started about 24 hrs after vaccination - Patient was also noted to be limping. (R) thigh swelling persisted at time of evaluation. No longer limping.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Anxiety, Dizziness, Loss of consciousness
Clinical narrative: Patient presented to office for MENACTRA and ADACEL. Vaccines given pt very anxious Perma. Pt rested in room for 10 min prior to standing. Proceeded to check out and became light headed and passed out at approx 15:50 PM. She was in our office for a total of 40 min post vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: First noticed symptoms evening of vaccine - raised red patch of skin at injection site - burning and irritating to touch. About 3 inches in diameter. Area grew to this size over a 2 day period then she presented to pharmacy. Has not tried any treatments.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Muscle spasms
Clinical narrative: 12 and a half m teen seen for routine physical. Patient riding in car after receiving HPV (Merck) developed low back muscle spasm. See copy of of visit and append information.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Eczema, Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report as received from a dermatologist concerning a 20 year old female patient. Relevant medical history was not reported. The patient did not have any allergies. On 18-JUL-2014 the patient was vaccinated with first dose of GARDASIL (dose, route and frequency not provided). The patient had no concomitant medications. On 19-JUL-2014, 2 days after onset of therapy the patient developed a rash. The reporter saw the patient on 23-JUL-2014 and described the rash as unspecified systemic eczema. The patient's unspecified primary care physician initially prescribed an unspecified antihistamine on an unspecified date which did not seem to affect the rash. The dermatologist stated that the rash was on the patient's face, neck, trunk and extremities. The rash was very itchy. The dermatologist prescribed an injection of CELESTONE, an unspecified topical steroid and BENADRYL for the patient on 23-JUL-2014. The patient sought medical attention. The outcome of events was reported as not recovered/not resolved. The causality of the event with GARDASIL was not reported. Product quality issue was not involved. Upon internal review the events eczema, rash on the patient's face, neck, trunk and extremities and itchy rash was considered medically significant. Additional information has been requested.
Age: 1.33
Sex: F
Vaccine: MMRV
Symptoms: Local reaction, Rash, Rash erythematous
Clinical narrative: Patient had local reaction red and white bumps 2 min after administration - given P.O. BENADRYL.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to "at least 4 unspecified patients" (age and gender: unknown). On an unknown date the patients were vaccinated with 0.5 ml of (Oka/Merck) VARIVAX, subcutaneously (dose, frequency, anatomical location: unknown) (lot#, exp date: unspecified) which underwent an unspecified temperature excursion. No adverse effect was reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Vaccination site bruising, Vaccination site swelling
Clinical narrative: Redness, swelling, blisters at vaccination site 2 days after vaccine.
Age: 0.51
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a physician regarding a patient of unknown age and gender. The patient's medical history, drug allergies or allergies were not provided. On 28-JUL-2014, the patient was vaccinated with a dose of VARIVAX (Merck), (0.5 ml, subcutaneous, Lot number reported as J012816, expiration date not reported), that had been improperly stored. No adverse effects reported. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Local swelling, Pain
Clinical narrative: This spontaneous report as received from a physician via field representative regarding himself. The patients age, concurrent conditions and relevant medical history was not reported. On an unspecified date in June 2014 (reported as one month back) the patient was vaccinated with ZOSTAVAX (dose, frequency, and route unspecified). The physician who was the patient reported that after being vaccinated his arm swoll up really really bad and it stun and burned for a week. The field representative stated that the patient was fully recovered now. The causality of the events with ZOSTAVAX was not reported. Product quality issue was not involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age. Medical history and concomitant medications were not reported. On 12-MAY-2014 the patient was vaccinated with VARIVAX (Merck) (lot # J006957) in the left arm. Concomitant medications were not reported. The patient was administered vaccines stored at inappropriate temperature (out of range temp logs and the vaccines that have been administered to patients). The outcome was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age. The patient medical history and historical conditions were not reported. On 15-MAY-2014, the patient was vaccinated with (Oka-Merck) PROQUAD (lot # J009885 and expiration date 12-FEB-2015) subcutaneous, in the left arm (deltoid). These were their out of range temp logs and vaccines that have been administered to different patients and no adverse event. The outcome of out of range temp logs and vaccines that have been administered to different patients and no adverse event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, MNQ, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Error was discovered when vaccines were to be entered into the computer system.  Menactra vaccine (MCV4) was given instead of PCV13 vaccine. Mom was contacted and states the baby was fine and no adverse effects were noted.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. The patient medical history and historical conditions were not reported. On an unknown date, the patient was vaccinated with LIQUID PEDVAXHIB (lot # was not reported) intramuscular, in the left arm (deltoid). Concomitant medications was not reported. These were their out of range temp logs and vaccines that have been administered to different patients and no adverse event. The outcome of out of range temp logs and vaccines that have been administered to different patients and no adverse event was unknown. The reporter considered out of range temp logs and vaccines that have been administered to different patients and no adverse event to be related to LIQUID PEDVAXHIB. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, C-reactive protein increased, Cellulitis, Clostridium difficile colitis, Decreased appetite
Clinical narrative: Mom stated she noted a local reaction on the arm injection was given. It was 1/2 inch below the actual injection site. Mom took patient on the 17th to the ER because of a fever. Hospital started patient on clindamycin. On the 18th reaction was twice a big in size and took him again to ER and was at that time admitted. And started IV antibiotics and till this day patient is still admitted.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea, Erythema, Joint range of motion decreased, Local reaction, Nausea
Clinical narrative: Mom stated she noted a local reaction on the arm injection was given. It was 1/2 inch below the actual injection site. Mom took patient on the 17th to the ER because of a fever. Hospital started patient on clindamycin. On the 18th reaction was twice a big in size and took him again to ER and was at that time admitted. And started IV antibiotics and till this day patient is still admitted.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Oropharyngeal pain, Pyrexia, Tenderness, Ultrasound scan abnormal, White blood cell count increased
Clinical narrative: Mom stated she noted a local reaction on the arm injection was given. It was 1/2 inch below the actual injection site. Mom took patient on the 17th to the ER because of a fever. Hospital started patient on clindamycin. On the 18th reaction was twice a big in size and took him again to ER and was at that time admitted. And started IV antibiotics and till this day patient is still admitted.
Age: 35.0
Sex: M
Vaccine: JEV1, RAB, TYP, YF
Symptoms: Vaccination site swelling
Clinical narrative: Bump size of tennis ball on vaccination site.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Cold sweat, Heart rate increased, Hyperhidrosis, Nausea, Palpitations
Clinical narrative: Pt began to feel nausea, palpatations and diaphoretic. Pt was given water and told to lay down on exam table. Blood pressure was taken, normal. Pulse was rapid and patient was clammy.
Age: 24.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Nodule, Swelling face
Clinical narrative: Complains of bilateral knots behind her ear and a small red swollen spot on the left side of face by ear.
Age: 49.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Back pain, Injected limb mobility decreased, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Severe pain in arm, neck, back. But the arm area where shots were given pain goes up to shoulder, I can't sleep on that side, can't reach for anything with that arm. Pain is getting so bad.
Age: 49.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Sleep disorder, X-ray normal
Clinical narrative: Severe pain in arm, neck, back. But the arm area where shots were given pain goes up to shoulder, I can't sleep on that side, can't reach for anything with that arm. Pain is getting so bad.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: At appt 7/30/14 it was noted that client was approx 6 weeks pregnant at date of #2 HPV vaccine 10/7/13.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Onset of symptoms: last night very slight but worse this am and through today. Symptoms: fever, with a tmax of 102 taken orally, pain/tenderness around injection site, redness, approximately quarter size around injection site and swelling around injection site. Severity: severe. Treatment of reaction: Tylenol and Motrin for fever and pain. Past reactions to immunizations: No. Current medications: None. Protocol(s) referenced: none.
Age: 12.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Left arm swollen up, and pain.
Age: 0.84
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Dermatitis, Erythema, Rash, Rash pustular, Viral skin infection
Clinical narrative: Skin redness, bumps and pustules on her legs. Child was brought to ED. Pt was discharged with diagnosis dermatitis of viral origin and to use calamine lotions for itching and Tylenol or Motrin for any pain or fever.
Age: 1.03
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blood test, Contusion, Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: My son legs bruised. His legs and arms had several bruises the size of a quarter. He had petichiae all over his body, His platelets drop. And continue dropping still.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Disturbance in attention, Feeling abnormal, Paraesthesia
Clinical narrative: Felt very loopy, tingling in legs, acting like under influence, hard time focusing, very silly.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Disorientation, Dizziness, Nausea, Ocular hyperaemia, Syncope
Clinical narrative: Pt. felt lightheaded about 8 minutes later after vaccines were received (varicella #2 and a TB test), when she was back out in the front office paying. She fainted out of her chair. We kept her lying on the ground and she was concious quickly, but disoriented and didn't realize she fainted. The mucosal membranes of her eyes were reddened for about 5 minutes then cleared up. She was alert and oriented x3 within a couple of minutes, was given juice and crackers and BP taken right away, which was 108/70. She stated she normally runs around 128/80. She stated some nausea. She was moved to a couch to rest. Continuous BP's were 98/64, 96/72, 90/70. Pt. had a previous Varicella at an earlier age with no reaction. She is allergic to sulfa meds and stated a previous sensitivity to anesthesia in the past. Pt. rested for about 70 minutes before leaving with her mother. Was taken to the doctor for evaluation right after leaving our facility. BP was still in 90's over 70 and she still stated nausea. The physician she saw requested and received an ingredient list from us for the vaccine and TB solution.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Developed fever to 102, and marked tenderness and erythema of right upper arm, around vaccination site. Fever has lasted up to time of report (7/30/2014-8:00 PM), but is slowly improving.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Epistaxis, Hyperhidrosis, Vomiting
Clinical narrative: Leaving office after vaccine, became diaphoretic and vomited, had brief nosebleed.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Headache, Hypoaesthesia, Peroneal nerve palsy, Pyrexia
Clinical narrative: Patient complained of headache and feeling faint. Also had numbness to one side of leg and complained of foot drop. Had a fever. Was seen the next day. No further symptoms.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Pruritus generalised
Clinical narrative: Itchiness everywhere; feeling weak 2 hours post vaccine; redness (size of baseball) around injection area.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Blood test normal, Bradycardia, Cold sweat, Heart rate decreased, Opisthotonus
Clinical narrative: After her vaccines, I was holding her and looking through a goodie bag she received. Approximately two minutes into that, she tensed up and started to squirm and bend backward. I picked her up and called for the nurse. We laid her on the bed on her right side, facing us. They checked her heart rate and blood pressure. Her heart rate dropped to 58 or below. (That was when the nurse decided to tell me her blood showed she was anemic.) She stayed in this state for about 10 minutes, wheezing and speechless with her eyes open, until she came to. My daughter then told me she had a dream but didn't remember what it was. She didn't remember anything after she "fainted". (So the nurses said.) During her spell, she was clammy and pale. After all was said and done, they did another blood test; a small prick on her toe. It came back normal. Not anemic at all. I failed to ask how anemic the first test showed she was, but obviously not enough to stop them from vaccinating her.... They called this a "NEAR syncopal episode with bradycardia". We were referred to go to the hospital tomorrow for a 2 minute EKG. She seems to be doing 100% better.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pallor, Presyncope, Syncope, Tension, Wheezing
Clinical narrative: After her vaccines, I was holding her and looking through a goodie bag she received. Approximately two minutes into that, she tensed up and started to squirm and bend backward. I picked her up and called for the nurse. We laid her on the bed on her right side, facing us. They checked her heart rate and blood pressure. Her heart rate dropped to 58 or below. (That was when the nurse decided to tell me her blood showed she was anemic.) She stayed in this state for about 10 minutes, wheezing and speechless with her eyes open, until she came to. My daughter then told me she had a dream but didn't remember what it was. She didn't remember anything after she "fainted". (So the nurses said.) During her spell, she was clammy and pale. After all was said and done, they did another blood test; a small prick on her toe. It came back normal. Not anemic at all. I failed to ask how anemic the first test showed she was, but obviously not enough to stop them from vaccinating her.... They called this a "NEAR syncopal episode with bradycardia". We were referred to go to the hospital tomorrow for a 2 minute EKG. She seems to be doing 100% better.
Age: 72.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: CSF test normal, Cytomegalovirus test, Enterovirus test negative, Full blood count normal, Headache
Clinical narrative: On 7/27 patient woke up with a mild headache that persisted for a few days along with some neck soreness. On 7/30 he woke up with ride facial paralysis and came into the ED. An LP was done. CSF came back normal. Enterovirus is negative, HSV and CMV are still pending. All other results were within normal limits (Chem 7, CBC). MRI was normal. Patient discharged with a likely diagnosis of Bells Palsy and given a prescription for a steroid and antiviral.
Age: 72.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Herpes simplex serology, Laboratory test normal, Neck pain, Nuclear magnetic resonance imaging normal, VIIth nerve paralysis
Clinical narrative: On 7/27 patient woke up with a mild headache that persisted for a few days along with some neck soreness. On 7/30 he woke up with ride facial paralysis and came into the ED. An LP was done. CSF came back normal. Enterovirus is negative, HSV and CMV are still pending. All other results were within normal limits (Chem 7, CBC). MRI was normal. Patient discharged with a likely diagnosis of Bells Palsy and given a prescription for a steroid and antiviral.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation
Clinical narrative: Local upper arm inflammation.
Age: 11.0
Sex: F
Vaccine: HIBV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report sa received from other health professional refers to a female patient of unknown age. Medical history and concomitant medications were not reported. On 05-MAY-2014, the patient was vaccinated with LIQUID PEDVAXHIB (U4423HD) (manufacturer also reported as Sanofi Pasteur) in the left arm. Concomitant medications were not reported. The patient was administered vaccines stored at inappropriate temperature (out of range temp logs). The outcome was unknown. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: ROTARIX administered IM vs Orally.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: No adverse events and treatment.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Full blood count, Headache, Heart rate increased, Lipids
Clinical narrative: Pt had not been feeling well 2-3 days previous to vaccine and has hx of asthma. However, approx. 4-5 hrs after vaccine pt developed increased HR, SOB and feeling that throat was closing. Also had HA and nausea. Treated with VENTOLIN and BENADRYL. (+) improvement noted within 1 hr. Feeling better on 7/30/14.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Serum ferritin, Throat tightness
Clinical narrative: Pt had not been feeling well 2-3 days previous to vaccine and has hx of asthma. However, approx. 4-5 hrs after vaccine pt developed increased HR, SOB and feeling that throat was closing. Also had HA and nausea. Treated with VENTOLIN and BENADRYL. (+) improvement noted within 1 hr. Feeling better on 7/30/14.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Nervousness, Pallor, Syncope
Clinical narrative: Patient had a syncopal episode following his immunizations. Complaining of not being able to see well and feeling dizzy before he passed out. He came to very quickly but was very pale. Patient felt "kind of shaky" before end and after passing out. Observed pt 30 min after and was doing well.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Visual impairment
Clinical narrative: Patient had a syncopal episode following his immunizations. Complaining of not being able to see well and feeling dizzy before he passed out. He came to very quickly but was very pale. Patient felt "kind of shaky" before end and after passing out. Observed pt 30 min after and was doing well.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Right upper thigh, baseball size raised red area noted approx. 48 hrs. pt received PROQUAD immunization. No warmth or pain accompanied area: afebrile.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Dry throat, Dysphagia, Dysphonia
Clinical narrative: Immediately -> pain at injection site, burning at injection site, dry throat, hoarseness, slight difficulty in swallowing, tightness in throat. Following with stomach upset, lightheadedness.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Throat tightness
Clinical narrative: Immediately -> pain at injection site, burning at injection site, dry throat, hoarseness, slight difficulty in swallowing, tightness in throat. Following with stomach upset, lightheadedness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Reddened area measuring approx 5 by 3 inches with reddened warm area in center that is slightly raised measuring approximately 1 1/2 by 1 1/2 inches.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient report slight pain and rash at site. Then on 7/28 the same rash on legs., very itchy. Doctor told her it is "probably" the ZOSTAVAX. Rash described as "puffy, red and itchy".
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 15 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with PROQUAD (Merck). Dose, route, lot number and expiration date were not reported. No adverse effects were reported. Additional information has been requested.