chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 60 year old female patient. Medical history was not reported. On 08-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date was unknown) (reported as age). Concomitant therapies included SYNTHROID, PAXIL and AMBIEN and unspecified hormone. On 10-APR-2014, the patient developed an area around the site where ZOSTAVAX was administered was hot, painful, red and swollen up the size of an egg. Lab results were not reported. Steroids and antibiotic were given as a treatment for the event. On 17-APR-2014, the outcome of the events were reported as recovered. The patient sought medical attention. 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 Licensed Practical Nurse (L.P.N.) refers to a patient of unknown gender and age. The patient was respectively vaccinated with the first, second and third dose of GARDASIL, injection (dose and lot numbers not reported) intramuscular on the following dates: 03-MAY-2012, 22-SEP-2012nad 24-NOV-2012. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report received from a healthcare worker refers to patients of unspecified demographics. On 05-MAY-2014, excursion occurred 14 of 33.8 Fahrenheit (F) (rounded to 34 F) for 8.31 minutes affecting GARDASIL (lot number J006236, expiry date 25-FEB-2016). It was reported that the excursion product was supported. On 05-MAY-2014, the unspecified number of patients were administered GARDASIL (dose unspecified) post excursion. Concomitant therapy was unspecified. No product quality complaint was involved. No adverse effects noted by any patient. The outcome of the event was unknown. No additional information was available. This is one of the several reports from same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 years child patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. On an unknown date the patient was vaccinated with ZOSTAVAX (therapy dates, route not reported). The reporter stated that on an unknown date the liquid shot out of the injection site on to her hands, while reconstituting vial of ZOSTAVAX (therapy dates, route, indication not reported). The nurse immediately washed her hands and had no side effects. A product quality complaint was filed to document vial pressure irregularity. The outcome of the event reported is unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report received from healthcare worker refers to patients of unspecified demographics. On 05-MAY-2014, excursion occurred 14 of 33.8 Fahrenheit (F) (rounded to 34 F) for 8.31 minutes affecting RECOMBIVAX HB (lot number J010335, expiry date 17-DEC-2015). It was reported that the excursion products were supported. Approximately on an unknown date in May 2014, the unspecified number of patients were administered RECOMBIVAX HB (dose unspecified). Concomitant therapy was unspecified. No product quality compliant was involved. No adverse effects noted by any patient. The outcome of event was unknown. No additional information was available. This is one of the several reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report received from healthcare worker refers to patients of unspecified demographics. On 05-MAY-2014, excursion occurred 14 of 33.8 Fahrenheit (F) (rounded to 34 F) for 8.31 minutes affecting PEDVAXHIB (lot number J014279, expiry date 16-SEP-2016). It was reported that the excursion products were supported. Approximately on an unknown date in May 2014, the patients were vaccinated with PEDVAXHIB (lot number J014279, expiry date 16-SEP-2016) (dose unspecified) for vaccination post excursion. Concomitant therapy was unspecified. No product quality complaint was involved. No adverse effects noted by any patient. The outcome of event was unknown. No additional information was available. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report received from healthcare worker refers to patients of unspecified demographics. On 05-MAY-2014, excursion occurred 14 of 33.8 Fahrenheit (F) (rounded to 34 F) for 8.31 minutes affecting VAQTA (Lot number K000578, expiry date 21-SEP-2015). It was reported that the excursion products were supported. Approximately on an unknown date in May 2014, the unspecified number of patients were administered VAQTA, (dose unspecified) (Lot number K000578, expiry date 21-SEP-2015). Concomitant therapy was unspecified. No product quality compliant was involved. No adverse effects noted by any patient. The outcome of event was unknown. No additional information was available. This is one of the several reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report received from healthcare worker refers to patients of unspecified demographics. On 05-MAY-2014, excursion occurred 14 of 33.8 Fahrenheit (F) (rounded to 34 F) for 8.31 minutes affecting ROTATEQ (lot number J011334, expiry date 13-MAY-2015). It was reported that the excursion products were supported. On 05-MAY-2014, the patients were vaccinated with ROTATEQ (lot number J011334, expiry date 13-MAY-2015) (dose unspecified) for vaccination post excursion. Concomitant therapy was unspecified. No product quality compliant was involved. No adverse effects noted by any patient. The outcome of event was unknown. No additional information was available. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Swelling face
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The physician stated that the patient has mental conditions and is a poor historian, and that her list of allergies is extensive, but that only some of them have been confirmed by healthcare professionals. On an unknown date the patient was vaccinated with RECOMBIVAX HB and the patient experienced mild facial swelling and the patient was given ZYRTEC and the swelling did not resolve. The reporter also stated that swelling was not severe enough to give her steroids and the patient visited two unspecified emergency departments at unspecified hospitals but was not admitted. On an unknown date the patient was seen by an unspecified allergist and the allergist determine that patient is not allergic to latex in RECOMBIVAX HB but some other unknown allergen. The outcome of mild facial swelling was reported as recovered/resolved on an unknown date. The outcome of patient is not allergic to latex in RECOMBIVAX HB but some other unknown allergen is unknown. No product quality complaint was involved. Additional information has been requested.
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 a patient of unknown age and gender (patient identifier: 7715394). On an unspecified date the unspecified patient were administered RECOMBIVAX HB (Lot# H010380, expired date: 18-NOV-2014) dose, frequency, route and location unspecified was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects reported. This is one of several reports received from the same reproter. Additional information has been requested.
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 a patient of unknown age and gender (patient identifier: 7751316). On an unspecified date the unspecified patient was administered RECOMBIVAX HB  (Lot# H010380, expired date: 18-NOV-2014) dose, frequency, route and location unspecified was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
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 a patient of unknown age and gender (patient identifier: 7715627). On an unspecified date the unspecified patient was administered RECOMBIVAX HB (Lot # H010380, expired date: 18-NOV-2014) dose, frequency, route and location unspecified was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
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 a patient of unknown age and gender (patient identifier: 7716594). On an unspecified date the unspecified patient was administered RECOMBIVAX HB (Lot# H010380, expired date: 18-NOV-2014) dose, frequency, route and location unspecified was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
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 a patient of unknown age and gender (patient identifier: 7613962). On an unspecified date the unspecified patient was administered RECOMBIVAX HB (Lot# H010380, expired date: 18-NOV-2014) dose, frequency, route and location unspecified was stored improperly (first exposed to 9C for 30 minutes and then exposed 8.3C for 1 hour). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report was received on 07 May 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. This is one case in a series of 228 pertussis cases received during the surveillance period from 01 January 2010 to 07 May 2014 respectively (routes and sites of administration not reported). Two days after the last dose, on 29. A case of pertussis disease in a six month old, female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS). The subject's vaccine history included three doses of PENTACEL received on 05 December 2013, 29 January 2014 and 27 March 2014, the subject developed a catarrhal illness. Nine days later, the subject developed a cough and a paroxysmal cough with whoop. The subject also experienced apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 10 April 2014. Chest x-ray findings were negative for pneumonia. Corrective treatment included Azithromycin stated on 11 April 2014 for five days. The subject was not hospitalized. At the time of final contact on 05 May 2014, the subject's cough had stopped after 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report was received on 07 May 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. This is one case in a series of 228 pertussis cases received during the surveillance period from 01 January 2010 to 07 May 2014 respectively (routes and sites of administration not reported). Two days after the last dose, on 29. A case of pertussis disease in a six month old, female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS). The subject's vaccine history included three doses of PENTACEL received on 05 December 2013, 29 January 2014 and 27 March 2014, the subject developed a catarrhal illness. Nine days later, the subject developed a cough and a paroxysmal cough with whoop. The subject also experienced apnea and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 10 April 2014. Chest x-ray findings were negative for pneumonia. Corrective treatment included Azithromycin stated on 11 April 2014 for five days. The subject was not hospitalized. At the time of final contact on 05 May 2014, the subject's cough had stopped after 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unkonwn age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on an unknown date the patient was vaccinated with VARIVAX (Merck) (route therapy dates not reported) that was stored improperly. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information is not expected.
Age: 5.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 5 year old patient. The patient's pertinent medical history was not reported. On 20-APR-2010 the patient was vaccinated with ZOSTAVAX plague-forming units (PFU). On 12-MAY-2014, patient received ZOSTAVAX instead of a second dose of VARIVAX (Merck). No adverse symptoms reported. The outcome of patient received ZOSTAVAX instead of a second dose of VARIVAX (Merck) and no adverse symptoms reported was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Local swelling
Clinical narrative: C/o minor upper arm swelling and low grade temp of 100.3-100.4 degrees.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscle injury, Pain, X-ray normal
Clinical narrative: Sore arm where injection was given since Sept. 14th 2013. X-ray negative. Physical therapy for 30 days, no improvement. Was told deltoid muscle damaged. Still hurts when I move arm a certain way. Return to orthopedic Dr. on 5-21-14.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Received MMR on 4/14/14. Over time the area developed large knot that increasingly got bigger. For about 2 weeks the (L) back of upper arm where MMR was administered has gotten red, warm to touch, tender and painful. She has no fever at time.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Large local reaction with greater than 10 cm redness, firm area, no pustule.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Ataxia
Clinical narrative: Ataxic after vaccines. (same day). Mostly resolved now.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Faeces discoloured
Clinical narrative: Chest heaviness and green stool.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Local reaction
Clinical narrative: >2 in painful, swollen, local reaction to Tdap to left arm.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood urine present, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Parents stated patient had fever x2 days starting on 05/07/2014 reaching 40 C. They returned to the clinic on 05/07/2014 for another test and informed the RN. RN took the patient's temperature and it was 98.4. Recommended for parents to seek medical attention for evaluation. The parents stated they then administered anti-pyretics but it did not relieve the fever. On the 3rd day after the shot, they noticed blood in his urine and took him to the emergency room. There, the patient was given IV fluids and anti-pyretics. They then transferred him to another hopsital and was admitted on 05/08/2014 for 2 days. They also complained that the patient's left arm where Tdap was administered was "red and swollen."
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, DTAP, HEPA, HPVX, MEN
Symptoms: Erythema, Injection site erythema, Injection site rash, Injection site warmth, Local reaction
Clinical narrative: RECEIVED 11 YO SHOTS DURING SCHOOL CLINIC ON 5-12-14. STARTED HAVING RED WARM SPOTS AT THE SITES ON BOTH ARMS IN THE EVENING ON 5-13-14. ON 5-14-14 EVEN MORE SWOLLEN, RED, HOT, SORE AND ITCHY.  SEEN AT MD OFFICE ON 5-14-14 6:20AM. DR RECOMMENDED IBUPROFEN, ZYRTEC AND BENADRYL ALLERGY. DR DOCUMENTED "UNLIKELY CELLULITIS, MORE LIKELY LOCAL REACTION, BENADRYL AND WATCH CLOSELY-IF FEVER, VOMITING, RASH, RAPIDLY SWELLING, ANY PUS AT SITE OF SHOTS ETC CALL IMMEDIATELY OR GO TO HOSP, WILL REPORT RXN TO VAERS".
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, DTAP, HEPA, HPVX, MEN
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: RECEIVED 11 YO SHOTS DURING SCHOOL CLINIC ON 5-12-14. STARTED HAVING RED WARM SPOTS AT THE SITES ON BOTH ARMS IN THE EVENING ON 5-13-14. ON 5-14-14 EVEN MORE SWOLLEN, RED, HOT, SORE AND ITCHY.  SEEN AT MD OFFICE ON 5-14-14 6:20AM. DR RECOMMENDED IBUPROFEN, ZYRTEC AND BENADRYL ALLERGY. DR DOCUMENTED "UNLIKELY CELLULITIS, MORE LIKELY LOCAL REACTION, BENADRYL AND WATCH CLOSELY-IF FEVER, VOMITING, RASH, RAPIDLY SWELLING, ANY PUS AT SITE OF SHOTS ETC CALL IMMEDIATELY OR GO TO HOSP, WILL REPORT RXN TO VAERS".
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, DTAP, HEPA, HPVX, MEN
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: RECEIVED 11 YO SHOTS DURING SCHOOL CLINIC ON 5-12-14. STARTED HAVING RED WARM SPOTS AT THE SITES ON BOTH ARMS IN THE EVENING ON 5-13-14. ON 5-14-14 EVEN MORE SWOLLEN, RED, HOT, SORE AND ITCHY.  SEEN AT MD OFFICE ON 5-14-14 6:20AM. DR RECOMMENDED IBUPROFEN, ZYRTEC AND BENADRYL ALLERGY. DR DOCUMENTED "UNLIKELY CELLULITIS, MORE LIKELY LOCAL REACTION, BENADRYL AND WATCH CLOSELY-IF FEVER, VOMITING, RASH, RAPIDLY SWELLING, ANY PUS AT SITE OF SHOTS ETC CALL IMMEDIATELY OR GO TO HOSP, WILL REPORT RXN TO VAERS".
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, DTAP, HEPA, HPVX, MEN
Symptoms: Erythema, Injection site erythema, Injection site rash, Injection site warmth, Local reaction
Clinical narrative: Developed substantial swelling in both arms where shots were administered.  Both arms continue to remain swollen, very warm to the touch and sensitive to touch.  The size redness and swelling on both arms was about the diameter of a softball.  As of today 5/15, there was no improvement.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, DTAP, HEPA, HPVX, MEN
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Developed substantial swelling in both arms where shots were administered.  Both arms continue to remain swollen, very warm to the touch and sensitive to touch.  The size redness and swelling on both arms was about the diameter of a softball.  As of today 5/15, there was no improvement.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, DTAP, HEPA, HPVX, MEN
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Developed substantial swelling in both arms where shots were administered.  Both arms continue to remain swollen, very warm to the touch and sensitive to touch.  The size redness and swelling on both arms was about the diameter of a softball.  As of today 5/15, there was no improvement.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Movement disorder, Muscular weakness, Pain
Clinical narrative: Severe pain, unable to move my arm, muscle weakness.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, swelling in the left arm up to the elbow.
Age: 0.92
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 11 month old patient of unknown gender. On 08-OCT-2013 the patient was vaccinated with M-M-R II (lot# and expiration date not provided) (dose not reported). No adverse effects were reported.  Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Headache, Papule, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Onset 5/8 of headache and fever, a few red sports. First spot appeared on hand. No fever on subsequent days but new spots appearing 5/9, 5/10. Exam 5/10: Several papules on face, several on trunk, one on hand, one on wrist, one on buttocks. Many scabbed.
Age: 1.3
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Scab
Clinical narrative: Onset 5/8 of headache and fever, a few red sports. First spot appeared on hand. No fever on subsequent days but new spots appearing 5/9, 5/10. Exam 5/10: Several papules on face, several on trunk, one on hand, one on wrist, one on buttocks. Many scabbed.
Age: 10.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Local swelling, Pain in extremity
Clinical narrative: Mother called and stated child with left arm swelling and pain. Mother applied cold compress w/ ice to site. Redness, edema and tenderness on site.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Pain, swelling and erythema with injection site, diffuse body aches and fever.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Eye swelling, Pyrexia, Rash
Clinical narrative: Low grade fever, swelling around eyes and rash. No trmt, reassurance.
Age: 62.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site mass
Clinical narrative: Lumps at site of injection on both arms.
Age: 11.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, warmth and swelling. Warmth remained, swelling and redness increased to aprox 4"diameter between shoulder and elbow.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Injection site nodule, Nodule, Swelling
Clinical narrative: Patient came back to office on 5/15/2014 reported after playing basketball on 5/12/2014 had noticed a knot where Varicella vaccine was given.  On 5/15/2014 at office visit, reported redness, swelling and knot. 3cm induration and 6cm redness. Doctor gave prescription of Augementin to treat.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 7 patients of unkonwn age and gender. On an unknown date, since 27-FEB-2014, the 7 patients were vaccinated with ZOSTAVAX (route, lot number and expiration date not reported) (7 doses) that were previously exposed to 16 F for 13.5 hours. The pharmacist stated that she had not been informed of any adverse experiences for these 7 patients. On 12-MAY-2014, the pharmacist reported that four doses of ZOSTAVAX (route, lot number and expiration date not reported) that were exposed to 16F for 13.5 hours were exposed to an additional 12 hours at a highest temperature of 36F. At the time of the report, the four doses of ZOSTAVAX that were exposed to the additional time out of range have not been administered to any patients. Additional information has been requested.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Convulsion, Pyrexia
Clinical narrative: Child had immunizations and later that day had a 20 minute seizure followed by a fever of 100.8. He was hospitalized overnight.
Age: 1.07
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and then rash.
Age: 0.27
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash around mouth, about a week later spread to chest and back.
Age: 15.0
Sex: F
Vaccine: HEP, HPV4, IPV, MMR
Symptoms: Dizziness, Pallor
Clinical narrative: Patient was given the following vaccines: Hep B pediatric, MMR, Polio, and HPV.  After vaccination, patient began to look pale in color and complained of feeling faint, but did not faint. Patient was advised to put her head down between her legs and given water and a snack.  Patient left after 15 minutes after verbalizing feeling better.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a 71 year old female patient with high blood pressure and thyroid issues. On 31-MAR-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # J008434, Exp date 11-OCT-2014, subcutaneous, 1 single shot. Concomitant medication included MOBIC. There were not drug reactions or allergies. On 02-APR-2014, the patient experienced back pain which were mistaken for kidney stones. On unknown date the patient was hospitalized and diagnosed with shingles. There was a significant disability or incapacity considered by the reporter. The hospitalization duration was unknown. On unknown date the patient sought medical attention and received VALTREX and unspecified pain medication for the treatment of the back pain and shingles. The outcome of back pain and patient was diagnosed with shingles was reported as recovering/resolving. Additional information has been requested.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal discomfort, Abnormal behaviour, Anger, Childhood disintegrative disorder, Crying
Clinical narrative: HE HAD A FEVER. AFTER THE SHOTS HE HAD A BLANK LOOK IN HIS EYES IMMEDIATELY. HE STOPPED HOLDING HIS BOTTLE AND FORGOT HOW TO HOLD HIS BOTTLE. HIS MILESTONES STOP BEING MET AFTER THOSE SHOTS OCCURRED. HE COULDN'T SIT UP AT ALL HE WAS SAYING MOM, MOMMA, DAD, DADDAH. BEFORE THE SHOTS TOOK PLACE. HE COULDN'T CRAWL ON TIME AND WALK ON TIME. WHEN CALLING HIS NAME HE DIDN'T RESPOND TO US. HE USE TO RESPOND TO HIS NAME. HE HAD BECAME REALLY ANGRY AND GRUMPY ALL THE TIME HE CRIED FOR HOURS ON IN WHEN HE WOULD SLEEP HE WOULD WAKE UP FROM NIGHT TERROR'S EVERYDAY AND NIGHT. HE DIDN'T LIKE US HE DIDN'T TRUST US WE COULDN'T GET HIM TO SHOW ANY TYPE OF AFFECTION TOWARDS US AT ALL. YOU WOULD HAVE THOUGHT THAT HE WAS BEING ABUSED THIS IS THE FIRST TIME I EVER WITNESS A CHILD THAT DON'T HUG AND KISS AND LOVE HIS PARENTS AND IN RETURN LET US DO THOSE THINGS BACK!''...HE HAD STOMACH ISSUES FOOD WOULDN'T STAY DOWN TO LONG. HE DOES NOT KNOW HOW TO EAT WE HAVE TO FEED HIM EVERYTHING THROUGH A BABY BOTTLE.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Eating disorder, Gastric disorder, Pyrexia, Staring, Unresponsive to stimuli
Clinical narrative: HE HAD A FEVER. AFTER THE SHOTS HE HAD A BLANK LOOK IN HIS EYES IMMEDIATELY. HE STOPPED HOLDING HIS BOTTLE AND FORGOT HOW TO HOLD HIS BOTTLE. HIS MILESTONES STOP BEING MET AFTER THOSE SHOTS OCCURRED. HE COULDN'T SIT UP AT ALL HE WAS SAYING MOM, MOMMA, DAD, DADDAH. BEFORE THE SHOTS TOOK PLACE. HE COULDN'T CRAWL ON TIME AND WALK ON TIME. WHEN CALLING HIS NAME HE DIDN'T RESPOND TO US. HE USE TO RESPOND TO HIS NAME. HE HAD BECAME REALLY ANGRY AND GRUMPY ALL THE TIME HE CRIED FOR HOURS ON IN WHEN HE WOULD SLEEP HE WOULD WAKE UP FROM NIGHT TERROR'S EVERYDAY AND NIGHT. HE DIDN'T LIKE US HE DIDN'T TRUST US WE COULDN'T GET HIM TO SHOW ANY TYPE OF AFFECTION TOWARDS US AT ALL. YOU WOULD HAVE THOUGHT THAT HE WAS BEING ABUSED THIS IS THE FIRST TIME I EVER WITNESS A CHILD THAT DON'T HUG AND KISS AND LOVE HIS PARENTS AND IN RETURN LET US DO THOSE THINGS BACK!''...HE HAD STOMACH ISSUES FOOD WOULDN'T STAY DOWN TO LONG. HE DOES NOT KNOW HOW TO EAT WE HAVE TO FEED HIM EVERYTHING THROUGH A BABY BOTTLE.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Aphasia, Confusional state, Dysarthria, Loss of consciousness, Speech disorder
Clinical narrative: About a half hour or so after patient rec'd her shot she passed out in the lobby. She was out for about 7 seconds. From hitting her head so hard on the floor she did have a concussion.  The Dr thought she probably passed out because of her missing breakfast (9AM appt) and also from stressing and being anxious about getting a shot.  We were kept at the office for about 45 min had some juice and cheese and crackers and she seemed much better. About an hour to an hour and a half after the shot she started getting seriously confused, couldn't remember simple things like how to unbuckle her seat belt, locking the door etc and her speech was very slurred and she couldn't makes complete sentences or produce understand able thoughts.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Rash pruritic
Clinical narrative: Pruritic rash of upper arm and chest.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 13-MAY-2014, the patient was inadvertently vaccinated with an expired dose of ROTATEQ, oral, (lot # not provided) expiry date: 01-APR-2014. Concomitant therapy was not reported. No adverse effects reported. It was reported that the expired vaccine was supported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness
Clinical narrative: This spontaneous report as received from a 63 year old female consumer with high cholesterol and contrast media allergy (reported as allergic to IVP dye) referring to herself. The reporter also stated that she is extremely sensitive to sound and that she has had physical therapy because her doctor thought she had crystals in the inner ear. The patient reported she has 90% hearing loss in the left ear. The patient reported that the inner ear problem started before receiving ZOSTAVAX. On 29-DEC-2013 the patient was vaccinated with ZOSTAVAX, (Dose, route, anatomical location, lot number and expiration date not reported). Concomitant therapies included ZETIA (10 mg, once daily, oral tablets) (duration unspecified), TRICOR (145 mg, once daily) (duration unspecified), aspirin (81 mg, once daily) (duration unspecified), calcium (unspecified), Multi-vitamins (manufacturer unknown), loratadine (manufacturer unknown) and OMEGA-3 MARINE TRIGLYCERIDES (900 mg once daily,oral) (duration and frequency unspecified). On an unknown date the patient have been dizzy and developed chills after receiving the ZOSTAVAX. The patient sought medical attention saw the doctor. The outcome of the events was reported as not recovered/not resolved. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Fatigue, Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old patient (gender unspecified). On 02-APR-2014 (yesterday), the patient received a dose of PROQUAD injection, dose and frequency was unspecified (lot number J006568, expiry date 30-NOV-2014) that might have been administered intravascular. Concomitant medication was unspecified. The patient was evaluated at unspecified emergency room for precautionary reasons. No adverse effect reported. No product quality complaint was involved. The outcome of received a dose of PROQUAD that might have been administered intravascular was unknown. No other information was available. Follow up information has been received from the nurse via questionnaire concerning the 5 year old male patient (previously reported as 4 year old) with no known drug reactions or allergies and no illness at time of vaccination who on 02-APR-2014 at approximately 15:15, was vaccinated with PROQUAD in the right upper arm and KINRIX (Lot # AL20B267CA) in the left deltoid intramuscularly. The nurse reported that on 02-APR-2014 at 15:45, the patient seemed extremely tired. The patient's mother was upset and took him to ER at 16:00. ER called poison control center where they told he maybe more likely to get one of the diseased in the next 3-4 weeks. The nurse stated that there were no other concerns except KINRIX site arm above elbow that was red and swollen for the next 5 days. There were no Lad diagnosis or studies performed. It was planned to getting titres before considering revaccination. On 02-APR-2014, the patient recovered from seemed extremely tired. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history and drug reactions were not reported. The healthcare worker reported that the patient received a dose of GARDASIL in 2009 (reported as 5 years ago) and also on 21-MAR-2014. No known adverse effects. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Diarrhoea, Dizziness, Dysuria, Erythema
Clinical narrative: Pt. report left arm stiffness, swelling, redness, lump, itchy at site of injection on the morning following administration. She c/o lightheadedness, nausea, vomiting and diarrhea - constant episodes beginning day after injection until 2 days later when had physician visit. Left arm swollen, warm, hard and red.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. report left arm stiffness, swelling, redness, lump, itchy at site of injection on the morning following administration. She c/o lightheadedness, nausea, vomiting and diarrhea - constant episodes beginning day after injection until 2 days later when had physician visit. Left arm swollen, warm, hard and red.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling, Musculoskeletal stiffness, Nausea, Pain in extremity, Pollakiuria
Clinical narrative: Pt. report left arm stiffness, swelling, redness, lump, itchy at site of injection on the morning following administration. She c/o lightheadedness, nausea, vomiting and diarrhea - constant episodes beginning day after injection until 2 days later when had physician visit. Left arm swollen, warm, hard and red.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Vaccination complication, Vomiting
Clinical narrative: Pt. report left arm stiffness, swelling, redness, lump, itchy at site of injection on the morning following administration. She c/o lightheadedness, nausea, vomiting and diarrhea - constant episodes beginning day after injection until 2 days later when had physician visit. Left arm swollen, warm, hard and red.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTPPHIB, PPV, RVX
Symptoms: Blood culture, Full blood count, Injection site erythema, Injection site rash, Injection site reaction
Clinical narrative: Evening of 5/5/14 developed fever of 102, fussy and mom noted red lesion just below bandaid on Rt thigh. PCV13 given Rt thigh 5/5/14. On exam erythema - tons flat warm rash confluent about size of quarter, injection site not inflamed.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTPPHIB, PPV, RVX
Symptoms: Injection site warmth, Irritability, Pyrexia, Skin lesion
Clinical narrative: Evening of 5/5/14 developed fever of 102, fussy and mom noted red lesion just below bandaid on Rt thigh. PCV13 given Rt thigh 5/5/14. On exam erythema - tons flat warm rash confluent about size of quarter, injection site not inflamed.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTPPHIB, PPV, RVX
Symptoms: Injection site cellulitis
Clinical narrative: Evening of 5/5/14 developed fever of 102, fussy and mom noted red lesion just below bandaid on Rt thigh. PCV13 given Rt thigh 5/5/14. On exam erythema - tons flat warm rash confluent about size of quarter, injection site not inflamed.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration
Clinical narrative: Worsening redness 6 cm wide with induration and hot LUE.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Patient broke out in a rash that covered her whole body and face. Mom said only place that did not have rash was back of knees and forehead. Rash described as itchy - very bumpy individual spots. May have been fluid filled. Rash lasted until Monday. No fever.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Arthrogram, Crying, Injection site pain, Joint injection, Joint range of motion decreased
Clinical narrative: Case number PHHY2012US099048 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 463138) on 01 Nov 2012 with a follow up information from the quality assurance department (reference number: 209248) on 14 May 2014. This report refers to 64-year-old female patient. The patient's medical history included migraine (on the day of vaccination) and drug intolerances to Imitrex, percocet and codeine. Concomitant medications included Maxalt, trazodone and Advair. She was vaccinated with FLUVIRIN (batch number: 11074P) intramuscularly in left arm on 19 Oct 2011. The patient reported that the shot did not hurt at the time of vaccination, but was mildly tender in the next day. On 21 Oct 2011, 2 days after the vaccination, the patient experienced gradual worsening of a sharp pain deep in her left arm at the injection site. She had decreased range of motion (ROM), and had a very sharp pain with certain movements. After the pain occurred, it took a while for it to settle back down. She stated that, with certain movements, it was actually so painful that it brought tears to her eyes. The area was not red, swollen, or warm. The patient immediately cried out in pain when nurse pressed on the exact area in which she got the flu shot. She was diagnosed with impingement syndrome of the left shoulder, adhesive capsulitis of the left shoulder, and neuropathic pain at the injection site on an unspecified date. She had two cortisone injections into the joint and was treated with gabapentin for neuropathic pain. The MRI arthrogram and shoulder x-ray were done (results were not reported). The outcome of events were reported as condition unchanged as of 24 Aug 2012. The causality of the events was not reported. Upon follow up information received from the quality assurance department (reference number: 209248) on 14 May 2014. Based on the document review, it was reported that the FLUVIRIN (batch number: 11074P) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 14 May 2014: Batch summary updated.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Nuclear magnetic resonance imaging, Pain, Periarthritis, Rotator cuff syndrome
Clinical narrative: Case number PHHY2012US099048 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 463138) on 01 Nov 2012 with a follow up information from the quality assurance department (reference number: 209248) on 14 May 2014. This report refers to 64-year-old female patient. The patient's medical history included migraine (on the day of vaccination) and drug intolerances to Imitrex, percocet and codeine. Concomitant medications included Maxalt, trazodone and Advair. She was vaccinated with FLUVIRIN (batch number: 11074P) intramuscularly in left arm on 19 Oct 2011. The patient reported that the shot did not hurt at the time of vaccination, but was mildly tender in the next day. On 21 Oct 2011, 2 days after the vaccination, the patient experienced gradual worsening of a sharp pain deep in her left arm at the injection site. She had decreased range of motion (ROM), and had a very sharp pain with certain movements. After the pain occurred, it took a while for it to settle back down. She stated that, with certain movements, it was actually so painful that it brought tears to her eyes. The area was not red, swollen, or warm. The patient immediately cried out in pain when nurse pressed on the exact area in which she got the flu shot. She was diagnosed with impingement syndrome of the left shoulder, adhesive capsulitis of the left shoulder, and neuropathic pain at the injection site on an unspecified date. She had two cortisone injections into the joint and was treated with gabapentin for neuropathic pain. The MRI arthrogram and shoulder x-ray were done (results were not reported). The outcome of events were reported as condition unchanged as of 24 Aug 2012. The causality of the events was not reported. Upon follow up information received from the quality assurance department (reference number: 209248) on 14 May 2014. Based on the document review, it was reported that the FLUVIRIN (batch number: 11074P) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 14 May 2014: Batch summary updated.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray limb
Clinical narrative: Case number PHHY2012US099048 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 463138) on 01 Nov 2012 with a follow up information from the quality assurance department (reference number: 209248) on 14 May 2014. This report refers to 64-year-old female patient. The patient's medical history included migraine (on the day of vaccination) and drug intolerances to Imitrex, percocet and codeine. Concomitant medications included Maxalt, trazodone and Advair. She was vaccinated with FLUVIRIN (batch number: 11074P) intramuscularly in left arm on 19 Oct 2011. The patient reported that the shot did not hurt at the time of vaccination, but was mildly tender in the next day. On 21 Oct 2011, 2 days after the vaccination, the patient experienced gradual worsening of a sharp pain deep in her left arm at the injection site. She had decreased range of motion (ROM), and had a very sharp pain with certain movements. After the pain occurred, it took a while for it to settle back down. She stated that, with certain movements, it was actually so painful that it brought tears to her eyes. The area was not red, swollen, or warm. The patient immediately cried out in pain when nurse pressed on the exact area in which she got the flu shot. She was diagnosed with impingement syndrome of the left shoulder, adhesive capsulitis of the left shoulder, and neuropathic pain at the injection site on an unspecified date. She had two cortisone injections into the joint and was treated with gabapentin for neuropathic pain. The MRI arthrogram and shoulder x-ray were done (results were not reported). The outcome of events were reported as condition unchanged as of 24 Aug 2012. The causality of the events was not reported. Upon follow up information received from the quality assurance department (reference number: 209248) on 14 May 2014. Based on the document review, it was reported that the FLUVIRIN (batch number: 11074P) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 14 May 2014: Batch summary updated.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dysphagia
Clinical narrative: Case number PHHY2013US000558 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 469636) on 02 Jan 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 209061) on 14 May 2014. This report refers to a 53-year-old male patient. The patient was vaccinated with FLUVIRIN (batch number: 1205201) on right arm on 10 Oct 2012. After vaccination, the patient left prior to 15 minute wait. When he got to his car he felt dizzy and trouble swallowing. Returned inside to notify of symptoms. Immediately assessed, emergency service (EMS) called, EPIPEN 0.3mg given intramuscularly into left thigh. The patient was taken to emergency room for evaluation and treated by EMS. Outcome of the events were reported as condition unchanged as of 15 Oct 2012. Seriousness and causality of the events were not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1205201) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 209061) on 14 May 2014: Updated batch review report.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Head injury, Syncope
Clinical narrative: Case number PHHY2013US000581 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 469664) on 02 Jan 2013 with follow-up received on 14 May 2014. This case refers to a 59-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1204401) intramuscularly in her left arm on 12 Oct 2012. On 13 Oct 2012, she suddenly collapsed and hit back of her head hard. She had an emergency doctor visit due to these events. She had lab work and CT scan which were deemed to be normal. The final outcome was reported as condition unchanged as of 15 Oct 2012. The seriousness and causality were not reported. No other information was available. Based on the investigation performed by the QA department, it was confirmed that FLUVIRIN batch number 1204401 was manufactured in accordance with the effective company procedure and was in compliance with corporate quality requirements. Non-significant follow-up received from QA department on 07 Feb 2013: Updated QA reference number as 209078. Follow-up received from QA department on 14 May 2014: Updated batch review report.