chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Underdose
Clinical narrative: This non-serious medically confirmed report (initial receipt 13-Oct-2014) concerns a female patient. On the 13-Oct-2014, the patient received AFLURIA multi-dose vial (batch number not reported) for the prevention of influenza. The patient believed that during the administration, she did not receive all of the vaccine dosage because she felt the back of her arm and her skin felt wet. The patient was fine. Outcome was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Injection site extravasation, No adverse event, Underdose
Clinical narrative: This non-serious medically confirmed report (initial receipt 10-OCT-2014) concerns a larger female patient. On the 10-OCT-2014, the patient received AFLURIA (batch number T57706) .5 ml annually via a one inch needed intramuscularly. After administering the vaccine, some of the AFLURIA did not go in completely and discharged down the patient's arm. The reporter stated this was not due to a defect of the syringe. The patient was fine. Outcome was not reported. Batch record review for lot T57706 noted: All deviations relating to the seed lot, MPH, formulated bulk vaccine and finished product lot T57706 were received and all results were satisfactory with no out-of specification results reported. Trend analysis of the product attributes were the focus of this investigation (HA content, TDOC, ovalbumin, endotoxin and protein by nitrogen) was performed, and all of these attributes were within statistically-derived process control limits. In conclusion, there were no batch related issues identified that may have  caused the adverse events reported.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This non-serious medically confirmed report (initial receipt 10-Oct-2014) concerns a male patient. On the 10-Oct-2014, the patient received AFLURIA (batch number R56508) 0.5mL annually via the intramuscular route for the prevention of influenza. The vaccine was expired on the 30-Jun-2014. It was believed that the patient was fine and had left the facility. Outcome was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This non-serious medically confirmed report (initial receipt 10-OCT-2014) concerns a female patient. On the 10-OCT-2014, the patient received AFLURIA (batch number not reported) 0.5 ml annually via the intramuscular route. The vaccine was expired on the 30-JUN-2014. It was believed that the patient was fine and had left the facility. Outcome was not reported.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error, No adverse event
Clinical narrative: This non-serious medically confirmed report (initial receipt 10-OCT-2014) concerns a 84 year old female patient. No additional medical history was provided. Concomitant medications were not known. It was unknown whether the patient had received and tolerated the influenza vaccine in the past. On the 10-OCT-2014, the patient received AFLURIA (batch number T58106) 0.5 ml once. The vaccine was received via the subcutaneous route in the abdomen, a medication error. No adverse reactions were reported. Outcome was reported as recovered. Reporter comments: The reporter stated that the case was non-serious and a medication error.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 06-OCT-2014) concerns a female patient. On an unknown date, the patient received an unspecified flu vaccine (manufacturer and batch number not provided). On an unknown date, following the flu vaccine administration, the patient experienced pain and swelling at the injection site. The patient was doing fine. Outcome was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: This non-serious consumer report (initial receipt 06-OCT-2014) concerns a female patient. On an unknown date, the patient received an unspecified flu shot. On an unknown date, the patient experienced a negative reaction to the unspecified flu shot. She also reported that she also had an unspecified reaction to an unspecified "smallpox vaccine". Outcome was not reported.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This non-serious medically confirmed report (initial receipt 09-OCT-2014) concerns a 55 year old female patient who had no known relevant medical history. On the 09-OCT-2014, the patient received AFLURIA (batch number R52006m expiry date 19-JUN-2014) 0.5 ml via the intramuscular route. The patient inadvertently was administered the dose of expired AFLURIA. No adverse reaction had been reported. Outcome was recovered. Reporter comments: The reported stated the case to be non-serious.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report (initial receipt: 08-OCT-2014) concerns a 14-year-old male patient. On 05-OCT-2014, the patient received AFLURIA (batch number not reported). On an unspecified date after vaccination, the patient's arm was more swollen than usual at the injection site. The patient may have been allergy to one of AFLURIA's ingredients. Outcome was not reported.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Injection site erythema, Injection site swelling
Clinical narrative: (1) Hardness under the injection site/four inch large (red, swollen and) hardness under the injection site (LLT: Injection site induration, PT: injection site (induration), 10/05/2014 to, Outcome is Not Recovered/Not Resolved. (2) Redness at the injection site/four inch large red (swollen and hardness) under the injection site (LLT: Injection site redness, PT: Injection site erythema), 10/05/2014 to, Outcome is Not Recovered/Not Resolved. (3) Swelling at the injection site/ Four inch large (red) swollen (and hardness) under the injection site (LLT: Injection site swelling, PT: Injection site swelling), 10/05/2014 to, Outcome is not Recovered/Not Resolved.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: This medically confirmed regulatory report (initial receipt 02-Dec-2014) concerns a 60 year-old female patient. On 02-Oct-2014, the patient received intramuscular AFLURIA, (batch number 09949211A) in the left arm. On 02-Oct-2014, approximately 1 hour after receiving the Influenza vaccination, the patient felt an aching sensation in her left hand below her thumb. The ache was constant and when she lifts things, the ache radiated to her left wrist area. No visible or apparent inflammation upon inspection. The outcome was not reported. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 07-OCT-2014) concerns a 2-year old patient. On 07-OCT-2014, the patient received AFLURIA (batch number T51108) at a dose of 0.5 ml once via intramuscular route (under 5 administration). The patient did not experience any adverse reaction as a consequence of receiving the vaccine. The outcome was reported as recovered. Reporter's comments: The reporter assessed the case as non-serious and also stated an "off-label use".
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US021767 is an initial spontaneous report received from a pharmacist on 16 OCT 2013. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The reporter stated that she had heard other pharmacist say that they administered FLUCELVAX 2013/2014 (batch number not reported) to a patient under 18 years of age on an unknown date.  No adverse event was reported following the maladministration.
Age: 11.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US021419 is an initial spontaneous report received frrom a pharmacist on 10 Oct 2013. This report refers to an 11-year-old female patient. She was vaccinated with FLUCELVAX, (batch number: unknown) intramuscularly on 09 Oct 2013. No adverse event was reported following medication error (inappropriate age at vaccine administration).
Age: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US020559 is an initial spontaneous report received from a pharmacist on 30 SEP 2013. This report refers to a 14-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly on 28 SEP 2013. No adverse event was reported following this medication error.
Sex: U
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US024169 is an initial spontaneous report received from a health care professional on 07 NOV 2013. This report refers to multiple patients. Past medical history and concomitant medication were not reported. These patients were vaccinated with FLUCELVAX (batch number: 006021A and expiry date: JUN 2014) on unknown dates, which was out of recommended temperature range with the maximum temperature of 10.9 C for 2 days. No adverse event was reported following this administration error.
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US021116 is an initial spontaneous report received from a medical assistant on 08 OCT 2013: This report refers to a 16-year-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: 006021A) intramuscularly on 07 OCT 2013. No adverse event was reported following this administration error.
Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US024171 is an initial spontaneous report received from a pharmacist on 15 Nov 2013: This report refers to a 15-year-old female patient who was inadvertently vaccinated with FLUCELVAX, (batch number: 009021A) intramuscularly on 14 Nov 2013. No adverse event was reported following this administration error.
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US021576 is an initial spontaneous report received from a health care professional on 14 OCT 2013. This report refers to a patient of an unknown gender who was under the age of 18. On 12 OCT 2013, the patient received FLUCELVAX 2013/2014 (batch number unknown). No adverse event was reported following medication error (inappropriate age at vaccine administered).
Age: 9.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US024163, is an initial spontaneous report received from a pharmacist on 18 Nov 2013. This case refers to a 09-years old male child patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX, (batch number: 010021A) intramuscularly on 16 Nov 2013. No adverse event was reported following this administration error.
Age: 17.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US023646 is an initial spontaneous report received from a pharmacist on 28 OCT 2013. This report refers to a 17-year-old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. The pharmacist reported that this patient under 18 years of age received FLUCELVAX 2013/2014 (batch number not reported) on 26 OCT 2013. No adverse event was reported following the maladministration.
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US023614 is an initial spontaneous report received from a pharmacist on 28 OCT 2013. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The pharmacist reported that she suspected that a patient under 18 years of age received FLUCELVAX 2013/2014 (batch number: 006011A, expiry date: JUN 2014) three weeks ago (vaccination date was not reported). No adverse event was reported following the maladministration.
Age: 14.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US023237 is an initial spontaneous report received from a pharmacist on 04 NOV 2013. This case refers to a 14-year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 004011A) intramuscularly on 03 NOV 2013. No adverse event was reported following this administration error.
Age: 14.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US023212 is an initial spontaneous report received from a consumer on 04 Nov 2013. This case refers to a 14-year-old unknown gender patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX, (batch number: not reported) at dose of 0.5 ml on an unknown date. No adverse event was reported following this administration error.
Age: 12.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US023211 is an initial spontaneous report received from a consumer on 04 NOV 2013. This case refers to a 12-year-old unknown gender patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: not reported) at dose of 0.5 ml on an unknown date. No adverse event was reported following this administration error.
Age: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US023210 is an initial spontaneous report received from a pharmacist on 04-NOV-2013. This case refers to a 15-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 006011A and expiry date: JUN 2014) at dose of 0.5 ml intramuscularly on 01 NOV 2013. No adverse event was reported following this administration error.
Age: 9.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US022856 is an initial spontaneous report from the pharmacist received on 29 OCT 2013. This report refers to a 09-year-old male patient who was accidentally vaccinated with FLUCELVAX (batch number: 006011A) intramuscularly on 28 OCT 2013. No adverse event reported following this medication error (inappropriate age of vaccine administration).
Age: 14.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US022744 is an initial spontaneous report received from a pharmacist on 28 OCT 2013 and a follow up report from the pharmacist received on 28 OCT 2013. This report refers to a 14-year old patient of an unknown gender. The patient was vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) intramuscularly on 26 OCT 2013. No more information was available. No adverse event reported following this medication error (inappropriate age of vaccine administration). Follow up report from the pharmacist received on 28 OCT 2013. The age of the patient was updated. The report type changed from other to spontaneous report.
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, Hypersensitivity
Clinical narrative: Case number PHEH2013US024193 is an initial spontaneous report received from a consumer via a claim examiner on 18 Nov 2013: This report refers to a 16-year-old female patient. She was vaccinated with FLUCELVAX, (batch number: 0040011A and expiry date: Jun 2014) on 11 Oct 2013 and experienced allergic reaction on an undetermined date. No further information about outcome, seriousness and causality was reported.
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US022682 is an initial incomplete case received from a physician on 26 OCT 2013. This report refers to two children aged 14 and 17 years (unknown gender). These two patients were vaccinated with FLUCELVAX 2013/2014 (batch number unknown) intramuscularly on 26 OCT 2013, which was indicated for 18 years and older. No adverse event was reported following medication error (inappropriate age at vaccine administration).
Age: 12.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US022650 is an initial spontaneous report received from a pharmacist on 28 OCT 2013. This report refers to a 12-year-old female patient who was vaccinated with FLUCELVAX 2013/2014 (batch number: 006011A) intramuscularly on 26 OCT 2013. No adverse event was reported following medication error (inappropriate age at vaccine administration).
Sex: U
Vaccine: FLUC3
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2013US022534 is an initial spontaneous report received from a pharmacist on 16 OCT 2013. This report refers to multiple patients whose identifiers were not reported. The pharmacist reported that he was getting lot of patient complaints of pain at the injection site for FLUCELVAX 2013/2014 (batch number: 006011A, expiry date: JUN 2014) compared to last year's FLUVIRIN 2012/2013. The pharmacist reported that 50% of cases reported that the vaccination  hurt. The event outcome was not reported. No further information was provided.
Sex: U
Vaccine: FLUC3
Symptoms: Injection site pain, No adverse event
Clinical narrative: Case number PHEH2013US021620, is an initial spontaneous report received from a pharmacist on 15 OCT 2013. This case refers to a multiple patients. Past medical history and concomitant medications were not reported. These patients were vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on an unspecified date, reporter believes FLUCELVAX causes more local adverse reactions than FLUVIRIN. These patients were complained of pain at injection site. No adverse event was reported following this administration error.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown gender and age. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX23 (strength, dose, route, lot# and expiration date unknown), which were improperly stored. No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: FLUC3
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2013US020863, is an initial spontaneous report received from a pharmacist on 02 OCT 2013. This case refers to a multiple patients. Past medical history and concomitant medication were not reported. These patients were vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) intramuscularly on an unspecified dates. Reporter stated that almost of her patients complain of pain upon injection of FLUCELVAX into her patient's deltoid. Reporter also stated that, this does not occur when using FLUVIRIN. No more information was provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner refers to an unspecified number of unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored GARDASIL (lot #, expiry date was not reported). No adverse event was reported. The outcome of the events were not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dyskinesia, Loss of consciousness, Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 13 year old male patient. Concurrent condition and medical history were not reported. On an unknown date, the patient was vaccinated with a dose GARDASIL (lot number, expiration date, dose and route were not provided). Concomitant medications were unspecified. On an unknown date, the patient experienced dyskinesia reported as "jerky movement" and syncope reported as "passed out temporarily". The patient did not seek medical attention. The outcome of dyskinesia and loss of consciousness was reported as recovered/resolved on an unspecified date. The reporter did not assess the relatedness of GARDASIL to the events. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were inadvertently vaccinated with oral, ROTATEQ (dose, route and lot# were not reported) that had been improperly stored. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients pf unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were inadvertently vaccinated with RECOMBIVX HB (dose, route and lot# were not reported) that had been improperly stored. No adverse effects reported, No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 21-APR-2015, the patient was vaccinated with a dose of PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports 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 was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 24-SEP-2014, the patient was vaccinated with an improperly stored dose of VAQTA (Lot No. K 001792 Expiration date: 22-OCT-2015) (dose, route, and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 13-AUG-2014, the patient was vaccinated with the first dose of an improperly stored GARDASIL (Lot No. J010668 Expiration date: 29-APR-2016). Then, on 15-OCT-2014 received the second dose of an improperly stored GARDASIL (lot no. J010668 Expiration date: 29-APR-2016) (doses, routes and anatomical locations of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 31-MAR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 03-APR-2015, the patient was vaccinated with a dose RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Anxiety, Dizziness, Dry mouth, Dyspnoea, Paraesthesia
Clinical narrative: Pt called stated he had tingling in hands & behind knees, dry mouth, anxiety, light headed, SOB. Sx started 2-3 hours after vaccine was given. Pt states he has never had a rxn to a shot. Says he has asthma & has had SOB off and on far about a month. Use of inhaler improved SOB. Pt will go see MD if sx continue or get worse. Pt unsure if sx related to shot or if it is anxiety or asthma attack.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash generalised, Seizure
Clinical narrative: Pt had a fever of 103.8 on 7-17-15 and a seizure in the early morning on 7-18-15. Full body rash.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local swelling
Clinical narrative: Large area of swollen redness appeared 2 days after getting vaccinated. Was given acetaminophen 325 mg, to take 1 tab Q 6 hours and ice packs to apply TID.
Age: 0.73
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Irritability, Lethargy, Rash erythematous, Rosacea, Tremor
Clinical narrative: Pt. mom called MD evening of 6/15 reports "involuntary shaking" x "few seconds" followed by "lethargy". T: 100 degrees. Same episode of shaking for a few seconds again on 6/16. Pt generally fussy and T 100 degrees until 6/18. Rash on neck noted 6/18 and increased rash on face and trunk and arms. Rash "rosacea-like" (pink M-P rash) seen by MD 6/19.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site hypoaesthesia, Pain in extremity
Clinical narrative: Patient's arm was really sore for a week (also and she said her arm felt numb at the site of injection) and she couldn't lift the arm for few days. She had to go to the ER where she was told the needle might have hit the blood vessel.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: One day after injection site became red and swollen. ? of cellulitis so pt was started on antibiotics. On 7/14/15 site was better and pt was advised to stop antibiotics.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: Received vaccine 7/24/15. Reports local reaction 7/25/15 AM. Seen by Dr. on 7/27/15 with large area erythema, warmth and reddened skin. Rx'd antibiotic and oral steroid. Severe local reaction diagnosed.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Fatigue, Speech disorder
Clinical narrative: Mother stated that pt came home after receiving vaccines and that he complained of being tired and was talking slow. Pt had red blotches on his face also. Patient went to E.R. and received steroids and BENADRYL.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Computerised tomogram head normal, Head injury, Laceration, Suture insertion, Syncope
Clinical narrative: Patient had a syncope episode and hit head on floor causing laceration of chin requiring 4 sutures and follow up head CT (normal results).
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Left arm: little soreness, little itch, swelling at injection site approx 2 inches wd.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Erythema, Fatigue, Pruritus
Clinical narrative: 24 hours after administration patient developed redness, warmth, itching and a bullae measuring 1 x 2 cm. Clear fluid. No induration. Did experience chills and fatigue for first 24 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: 24 hours after administration patient developed redness, warmth, itching and a bullae measuring 1 x 2 cm. Clear fluid. No induration. Did experience chills and fatigue for first 24 hours.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Heart rate increased, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Became diaphoretic within 2-3 minutes one episode of vomiting. Nausea, vomiting, diaphoresis resolved in approximately 5 min. Elevated BP and HR -> 150/70 HR 100 128/68 HR 95. Resolved with rest and hydration approximately 20 min.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Rash macular, Vaccination complication
Clinical narrative: Reaction to MCV4. 2 red swollen areas (R) upper arm 6.7 cm slightly erythematous-splotchy region (R) upper arm.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Arthralgia, Erythema, Headache, Joint swelling, Joint warmth
Clinical narrative: 6/24/15-late afternoon itching, swollen, red. 6/25/15-woke up in morning and was the size of a baseball, fever and headache. 6/26/15-went to the hospital, swollen and red to pt. elbow, hot to touch and very painful.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Pruritus, Pyrexia, Swelling
Clinical narrative: 6/24/15-late afternoon itching, swollen, red. 6/25/15-woke up in morning and was the size of a baseball, fever and headache. 6/26/15-went to the hospital, swollen and red to pt. elbow, hot to touch and very painful.
Age: 7.0
Sex: F
Vaccine: JEV1
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 7-14-15 Japanese encephalitis vaccine administered 7-15-15 Mom calls reporting sore legs and fever 100.3 F.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pallor, Staring, Syncope
Clinical narrative: Pt very calm and did not cry during immunizations. Gave MMR and VARIVAX left thigh. After 2-3 min getting off table had syncope <5 sec. Appeared pale and glazed over but awake. Vitals normal. Returned to baseline 10 minutes later and acting normally. Drank water and ate crackers.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Swelling face
Clinical narrative: Face became swollen, headache, burning feeling around torso.
Age: 78.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Pruritus, Skin warm, Urticaria
Clinical narrative: On 7-11-15 noticed a half dollar sized welt on arm that received vaccine. Has since grown to most of upper forearm. Warm to touch and itching is evident.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Chest X-ray, Culture, Pyrexia
Clinical narrative: Moderate fever prior to fever spiking on day of diagnosis; fever went from 102 to 106 on Friday, April 10.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Localized red rash around site of injection.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner refers to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 02-JUL-2015 the patient was inadvertently administered with improperly stored, MMR II, lot # K007107 (dose, route, therapy type not reported). No adverse effects reported. No product quality complaint reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 30-MAR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates the patients were vaccinated with doses of improperly stored PROQUAD lot # K007158, expiration date 12-NOV-2015 (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 07-APR-2015, the patient was vaccinated with a dose of oral, ROTATEQ lot # K011663 (route and dose were not reported) which was exposed to temperature outside of the recommended range during 12 hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: Pt called advice line on 3/31/15 to report event from 2/11/15 PREVNAR vaccine which he stated last 10 days. No medical intervention needed. Pt used ice with response. Rash, urticaria, pruritus and swelling at site.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 22-MAY-2015, the patient was vaccinated with an improperly stored dose of VAQTA (Lot No. K001792 Expiration date: 22-OCT-2015) (dose, route, and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were inadvertently vaccinated with PEDVAXHIB (dose, route and lot# were not reported) that had been improperly stored. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Gait disturbance, Injection site pain, Myalgia
Clinical narrative: Received injection. Normal sore injection site. The next day and following five days increasing muscle and severe joint pain. So much pain in hip joints bilaterally could barely walk. I am a registered nurse, retired, and do not exaggerate. Truly extreme joint pain. Would rate an 8 on a scale of 1 to 10. I called doctor and because I take almost no meds. I simply reported the reaction. No breathing or anaphylactic type reaction. In fact it was a delayed reaction. It slowly receded about day six and seven. I was very concerned and amazed at the severity of the joint and muscle pain.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information on patient's medical history or concurrent conditions provided. On 20-JUL-2015, the patient was inadvertently vaccinated with (Oka/Merck) VARIVAX subcutaneous injection (dose, lot # and expiration date were not reported) instead of the intended ZOSTAVAX. No information on patient's concomitant medication was provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 18-MAY-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 159 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of unknown age and gender. On 06-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72  hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 65 year old female patient. The patient's pertinent medical history included a previously diagnosed of diabetes (unspecified date). The patient had no known drug reactions or allergies. On 07-JUL-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot # L002310; expiration date: July 2016) (dose and route not provided). On the same day, the patient was also vaccinated with a dose of PREVNAR (dose, route and lot # not provided). Concomitant medications included unspecified medications. No adverse event was reported. There were no laboratory tests or diagnostic studies performed. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a medical assistant on behalf of the mother's patient, referring to a 15 year old male patient. Concurrent condition, drug or allergic reactions and medical history were not reported. On 18-JUL-2014, the patient was vaccinated with the first dose of GARDASIL (lot # K007828; expiration date 02-MAR-2017), (dose was not provided) intramuscular, the second dose was on 10-NOV-2014 (dose, route of administration, lot number and expiration date were not reported) and the third dose was on 08-JUL-2015, 0.5 ml (route of administration, lot number and expiration date were not reported). On 08-JUL-2015, after receiving the third dose of GARDASIL the patient experienced headache. The patient received medical attention calling the physician and treated the headache with ADVIL. Lab diagnostic studies were not performed. The outcome of headache was reported as recovered/resolved on 09-JUL-2015. This case is one of two adverse events cases reported by this Healthcare worker. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 07-MAY-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 46 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to an unspecified number of patients (gender and sex were nor specified). No concurrent or medical history was reported. On unspecified dates were administered unspecified number of improperly stored doses of Oral, ROTATEQ (lot number K006455 - expiration date 10-FEB-2016 and lot number K004468 - expiration date 08-DEC-2016), (dose, route, frequency and anatomical location were unknown). No adverse event was reported. No further information was provided. No product quality complaint was reported. This is one of several cases received from the same source (MARRS numbers 1507USA010114, 1507USA010881, 1507USA010882, 1507USA010884). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about concomitant medication, pertinent medical history, drug reactions and allergies reported. On unknown date, the patients were vaccinated with improperly stored GARDASIL (lot#, expiration date, dose, frequency, route and site of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of MMR II (lot # K016153 with expiration date 24-SEP-2016 and lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. There was no information about concomitant medication, pertinent medication history, drug reactions and allergies reported. On unknown date, the patients were vaccinated with improperly stored VAQTA (lot#, expiration date, dose, frequency, indication, route and site of administration were not reported). No adverse events were reported. 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 registered nurse refers to unspecified number of patients of unknown age and gender. There was information about concomitant medication, pertinent medical history, drug reactions and allergies reported. On unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot#, expiration date, dose, frequency, indication, route and site of administration were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner refer to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 02-JUL-2015 the patient was inadvertently administered with improperly stored, MMR II, lot # K007107 (dose, route, therapy type not reported). No adverse effects reported. No product quality compliant reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. There was no information about concomitant medication, pertinent medical history, drug reactions and allergies reported. On unknown date, the patients were vaccinated with improperly stored ROTATEQ orally (lot#, expiration date, dose, frequency, indication were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 13-APR-2015, the patient was vaccinated with a dose of PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to an unspecified number of unspecified patients. No concurrent or medical history was reported. On unspecified dates were administrated unspecified number of improperly stored doses of MMR II (lot number J006137 - expiration date 24-MAY-2015 and lot number K008814 - expiration date 19-JUN-2016), dose, route, frequency and anatomical location were unknown. No adverse event was reported. No further information was provided. No product quality complaint was reported. This is one of several cases received from the same source. (MARRS numbers 1507USA010114, 1507USA010881, 1507USA010882, 1507USA010883). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 14-AUG-2014, the patient was vaccinated with the first dose of GARDASIL (Lot No. J006850 Expiration date: 31-MAR-2016 this lot was not improperly stored). Then, on 16-OCT-2014, the patient received the second dose of an improperly stored GARDASIL (Lot No. 010668 Expiration date: 29-APR-2016) and on 27-FEB-2015, received the third dose of an improperly stored GARDASIL (Lot No. J010668 Expiration date: 29-APR-2016) (doses, routes and anatomical locations of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.