chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 2 year old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 08-APR-2014, the patient was vaccinated with VARVAX lot#J009165; expiration date: 24-JUL-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reported. Additional information has been requested.
Age: 1.05
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 1 year old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 04-APR-2014, the patient was vaccinated with VARIVAX lot#J009165; expiration date: 24-JUK-2015, (dose, strength and route not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reported. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 20 year old patient. The patient pertinent medical history was not reported. On 09-JUN-20114 the patient was inadvertently vaccinated with pediatric dose of RECOMBIVAX HB. Concomitant medications were not reported. The physician also stated that the dose given on 09-JUN-2014 would be the patient's fourth dose of RECOMBIVAX HB. The physician stated that the patient had the complete series "as an infant" but that the patient's school was requiring a second series to be administered. No information on titers was reported. No adverse effects reported. The outcome of received pediatric dose and dose given on 09-JUN-2014 would be patient's fourth dose of RECOMBIVAX HB was unknown. Additional information is not expected.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: The spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 08-APR-2014, the patient was vaccinated with VARIVAX lot#J009165; expiration date: 24-JUL-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via sales representatives refers to a 20 year old male patient. No information about medical history, concurrent conditions and concomitant medications were reported. Approximately on an unknown date in December 2013 (reported as 7 months ago) the patient was vaccinated with ZOSTAVAX (route and dose not reported). The reported stated that the patient was 20 year old patient and was administered ZOSTAVAX. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist regarding a female patient of unknown age who is her daughter. On a unknown date, the patient was vaccinated with a dose of ZOSTAVAX  (lot# and expiration date not reported). The pharmacist reported that on an unknown date, her daughter experienced similar reaction of reddened area at the injection site which was itchy and later was dark-reddish purple in color when she received ZOSTAVAX. The outcome of similar reaction was unknown. Causality was not reported. This is one of several reports received from the same reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist refers to 5 or 6 patients of unknown age and gender. The pharmacist reported that in the thousands of ZOSTAVAX doses that he had given, he had only seen 5 or 6 injection site reactions. He stated that he did report the first injection site reaction, but he had not reported the subsequent injection site reactions since that initial report. No additional information was provided about these other injection site reactions, and the pharmacist did not have time to discuss these previous injection site reactions further. The outcome of the 5 or 6 injection site reactions was unknown. Causality was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 90 year old female patient. Drug reactions/allergies were reported as none. On 28-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot#J013138, expiration 17-JAN-2015), 0.65 ml, subcutaneously in the left posterior triceps arm. The patient, who received ZOSTAVAX, experienced a reddened area at the injection site "within a few minutes" that was approximately a quarter to a half-dollar sized in diameter. The patient informed the pharmacist on 30-MAY-2014, that the reddened area was itchy and had expanded to 3 inches by 1 inch in size. Today, 02-JUN-2014, the patient informed the pharmacist that her area of redness at her injection site was 8 inches by 3 inches in size, slightly pink, and the original area of redness that was observed on 28-MAY-2014 was now dark-reddish purple in color. The pharmacist did not believe that the area was hard or warm, and he stated that the patient had not reported a fever or malaise. The patient informed him that when the area itches, she applied hydrocortisone cream to the area. The patient had not consulted her healthcare provider regarding the experience. No medical attention was sought. The pharmacist accepted the offer of the VZVIP packet, and VZVIP faxed to the pharmacist. The patient had not recovered from the events. Causality was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Drug hypersensitivity, Hypertension, Injection site anaesthesia, Osteoarthritis, Paraesthesia
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 65 year old female patient with hypertension, osteoarthrosis and lupus. The patient's drug reactions/allergies included codeine, quinine, acetaminophen, VICODIN. On 04-JUN-2014 the patient was vaccinated with a dose of PNEUMOVAX 23, (strength unknown) (lot # J008799, Exp: 15-APR-2016) 0.5 ml, intramuscular in the right arm. The reporter also noted that patient received BOOSTIX in the opposite arm at the same office visit. Concomitant therapies included hydrochlorothiazide, triamterene (manufacture unknown) and baclofen (manufacture unknown). On 05-JUN-2014, the patient experienced numbness and tingling down the right arm where the PNEUMOVAX 23 injection was administered. The patient received icy hot to administer and massage as treatment and contacted medical office for medical attention. No lab diagnostics studies was performed. The outcome of the event was reported as recovering. The causality of the event and PNEUMOVAX 23 was not provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Systemic lupus erythematosus
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 65 year old female patient with hypertension, osteoarthrosis and lupus. The patient's drug reactions/allergies included codeine, quinine, acetaminophen, VICODIN. On 04-JUN-2014 the patient was vaccinated with a dose of PNEUMOVAX 23, (strength unknown) (lot # J008799, Exp: 15-APR-2016) 0.5 ml, intramuscular in the right arm. The reporter also noted that patient received BOOSTIX in the opposite arm at the same office visit. Concomitant therapies included hydrochlorothiazide, triamterene (manufacture unknown) and baclofen (manufacture unknown). On 05-JUN-2014, the patient experienced numbness and tingling down the right arm where the PNEUMOVAX 23 injection was administered. The patient received icy hot to administer and massage as treatment and contacted medical office for medical attention. No lab diagnostics studies was performed. The outcome of the event was reported as recovering. The causality of the event and PNEUMOVAX 23 was not provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 4 year old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 08-APR-2014, the patient was vaccinated with VARIVAX lot#J009165; expiration date: 24-JUL-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 5 years old child. Gender was not reported. Medical history and concurrent conditions were reported. On 09-APR-2014, the patient was vaccinated with VARIVAX lot#J009165; expiration date: 24-JUL-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 18 year old male patient. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on an unknown date (reported as when he was little) the patient was vaccinated with 2 doses of VARIVAX. The reporter also stated that approximately on an unknown date in 2009 (also reported as when he was 13 years old) the patient experienced an episode of shingles. The outcome of shingles is recovered/ resolved on an unknown date. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to two female patients of unknown age. The patient's medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX. Concomitant medications were unspecified. On an unknown date the patients experienced swelling and redness around injection site after receiving ZOSTAVAX. The outcome of swelling and redness around injection site was reported as recovered. The causality was not reported. The patient sought medical attention (spoke to pharmacist). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information has been received from the license practical nurse providing information VARIVAX (Merck) temperature excursion such as affected lot numbers, expiration dates and patient ID. A patient was vaccinated on an unknown date with a dose of VARIVAX (Merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) (lot # J008652, exp date: 10-JUL-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a patient of unknown age and gender. Medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (one single shot, injection, dose, units, route of administration, anatomical location, and lot number was not reported). Concomitant medications were not reported. On and unknown date, the patient developed injection site reaction after receiving ZOSTAVAX. The reporter stated that the nurse gave this vaccine and it was sitting out on the counter and went through a temperature excursion, the office knew about this and administered it anyway. The patient was not happy about this. The outcome of injection site reaction after receiving ZOSTAVAX was not reported. The relatedness between reported events and ZOSTAVAX was not reported. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Arm site redness/swelling "knot under skin" extreme pain.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Constipation, Feeling abnormal, Gastric disorder, Headache
Clinical narrative: Next day, in afternoon, started to feel bad. Blood pressure spiked. Regular BP is 125/80 and 4 reading checks were around 210/120. Took DIOVAN and after 6 hours BP lowered to down to 145. Next day went down further to normal. No rash. On Wednesday, stomach problems started. Couldn't do bowel movement. Finally got better today but still not normal. -Bad headache on Wednesday took TYLENOL.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 6 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 09-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J009165; expiration date: 24-JUL-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. 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 registered nurse refers to a patient of unknown age. On 10-DEC-2012, the patient was vaccinated with the first dose of GARDASIL (dose, lot # not reported). On 10-APR-2013, the patient was vaccinated with the second dose of GARDASIL. On 16-MAY-2013 the patient was vaccinated with the third dose of GARDASIL. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse. The nurse reported on unknown date, multiple unspecified patients were administered GARDASIL there were stored improperly. No adverse effects reported. This is one of several reports from same source. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to approximately 17 year old patient of unknown gender. No information provided regarding medical history and concurrent conditions. On 10-JUN-2014 the 17 year old patient was inadvertently vaccinated with PROQUAD, subcutaneous (dose number, lot#, anatomical location not reported). No concomitant medications reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV2
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's pertinent medical history was not reported. On 22-NOV-2013 the patient was vaccinated with first dose of GARDASIL. On 22-JAN-2014 the patient was vaccinated with second dose of GARDASIL. The patient was then administered CERVARIX inadvertently on 05-JUN-2014. No adverse effects reported. The outcome of the patient was then administered CERVARIX inadvertently was unknown. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 16 years old adolescent. Gender was not reported. Medical history and concurrent conditions were not reported. On 15-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J009165; expiration date: 24-JUL-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to two unspecified patients. The reporter stated that two doses of VARIVAX that were improperly stored at a high temperature of 10F for less than 1 hour, were administered to two unspecified patients on 29-MAY-2014 (one dose, 0.5 ml, subcutaneously, LOT# and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Leukocytoclastic vasculitis, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age with unspecified allergies and no pertinent medical history. On approximately 29-MAY-2014 (reported as about two weeks ago), the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route, lot#, expiry date unspecified). No concomitant medications were reported. On approximately 08-JUN-2014 (reported as 3 or 4 days ago), the patient developed a rash and he was seen by an unspecified primary care physician. The patient was put on oral and injectable steroids, which had little effect on the rash at that time. The physician stated that he had not yet seen the patient, but the patient had a diagnosis of "urticarial vasculitis". No laboratory tests were performed. The outcome of urticarial vasculitis was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: 6/11/14 Fever and chills;  6/14/14 evening-chills, hot, hard, painful red rash anterior, lateral and posterior upper arm at site.  Took Benadryl 50mg x1 with slight relief.  Rash continues anterior and lateral with pain 5/10 but getting better.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: 6/11/14 Fever and chills;  6/14/14 evening-chills, hot, hard, painful red rash anterior, lateral and posterior upper arm at site.  Took Benadryl 50mg x1 with slight relief.  Rash continues anterior and lateral with pain 5/10 but getting better.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Patient recieved vaccines at 11:05 AM. Patient was asked to remain in exam room with father for 15 minutes post vaccination. At about 11:10 AM patients father reported to nurses that patient had started vomiting. Patient was asked to sit in chair and was given a cool cloth for comfort. Dr. was made aware and she examined the patient. Patient stated she "felt fine" at 11:20 AM and left the clinic at 11:25 AM in stable condition accompanied by her father.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Feeling abnormal, Feeling hot, Nausea, Retching
Clinical narrative: PATIENT BECAME DIZZY, NAUSEATED, WARM AND FELT LIKE HER ADRENALIN WAS RUSHING ABOUT 10 MINTUES AFTER THE VACCINE WAS GIVEN.  SHE PROCEEDED WITH DRY HEAVES, DIZZINESS CONTINUED.  TRANSPORTED TO THE EMERGENCY ROOM.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Laboratory test normal, Neuralgia, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: Achy pain left brachial arm. (vaccine given in right deltoid).  A week later began to have numbness and tingling in left arm progressing to left leg and then to right arm and leg.  Also sharp shooting nerve pains.  Had brain and cervical spine to r/o any other cause of symptoms.  Has progressively improved but I still have buzzing around feet and ankles and sporadic shooting nerve pain in arms and legs.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Achy pain left brachial arm. (vaccine given in right deltoid).  A week later began to have numbness and tingling in left arm progressing to left leg and then to right arm and leg.  Also sharp shooting nerve pains.  Had brain and cervical spine to r/o any other cause of symptoms.  Has progressively improved but I still have buzzing around feet and ankles and sporadic shooting nerve pain in arms and legs.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling and throbbing on upper right arm with deep intense pain per patient. Pt self treated with Benadryl that night. AM 6/14/2014 awoke with severe headache- rest to treat.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Swelling and throbbing on upper right arm with deep intense pain per patient. Pt self treated with Benadryl that night. AM 6/14/2014 awoke with severe headache- rest to treat.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Burning sensation, Contusion, Injection site pain, Pain
Clinical narrative: Swelling and throbbing on upper right arm with deep intense pain per patient. Pt self treated with Benadryl that night. AM 6/14/2014 awoke with severe headache- rest to treat.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity, Skin discolouration, Tenderness
Clinical narrative: Swelling and throbbing on upper right arm with deep intense pain per patient. Pt self treated with Benadryl that night. AM 6/14/2014 awoke with severe headache- rest to treat.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Infertility male, Insulin resistance, Polycystic ovaries
Clinical narrative: No periods, severe pain in sides, diagnosed with polycystic ovarian syndrome, insulin resistance, infertility.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture, C-reactive protein, Crying, Culture urine, Decreased appetite
Clinical narrative: Non-stop screaming, unconsolable crying, not wanting to eat.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Full blood count, Metabolic function test, Screaming, Urine analysis, X-ray
Clinical narrative: Non-stop screaming, unconsolable crying, not wanting to eat.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse practitioner refers to a patient of unknown age and gender. The nurse practitioner inquired temperature excursion on 22-APR-2014 and there was no adverse event to report. The nurse practitioner reported again on 03-JUN-2014, on 30-MAY-2014 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot # J011882, expiration date 04-JAN-2015, 0.65 ml, subcutaneously) that was exposed to two temperature excursions, -5 C for 26 hours and -10C for 19 hours. No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a 60 year old male consumer. On 09-JUN-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous (dose not reported) when he should have received VARIVAX (Merck). No other concomitant therapies reported. No adverse symptoms reported. The outcome of the events was unknown. The causality of the events was unspecified. There was no PQC reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Rash erythematous, Tenderness
Clinical narrative: Erythematous rash on LUE (painful to touch) nonvesicular.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 10 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 15-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J009165; expiration date: 24-JUL-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 16 years old adolescent. Gender was not reported. Medical history and concurrent conditions were not reported. On 01-MAY-2014, the patient was vaccinated with VARIVAX (Merck) lot # J009165; expiration date: 24-JUL-2015, (dose, strength and route not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Itching, redness, swelling, tenderness et warmth to injection site after PCV23.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and induration at site of injection - (L) deltoid only first noted day after vaccination.
Age: 5.0
Sex: M
Vaccine: HEPAB
Symptoms: Wrong drug administered
Clinical narrative: (None reported) - wrong vaccine administered.
Age: 1.51
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen, right outer thigh. (Localized). No fever accompanied. Hydroxyzine 10mg/5mL (3.5 mL every 6 hours). Prednisolone 15mg/5mL (10mL x 5 days).
Age: 76.0
Sex: F
Vaccine: DT
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Provider ordered Td. RN administered DT. No fever or prolonged injection site pain.
Age: 1.01
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Pyrexia
Clinical narrative: 5 days after vaccine (Tuesday 6/3/14) at 7 am T= about 102 pt developed fever and no other significant symptoms. Clinical work up was negative and pt still with temp 101.2 6/6/14 in afternoon. Pt has follow up next week.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Broke out in rash 5 days ago started on back and spread to stomach; seen immediate care 06/08 and this office 06/09 Dx: shingles.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Given 6/4/14. Seen 6/6/14 - area 7 cm x 7 cm, red, swollen, warm to touch, itching. Per PA - cool compresses and BENADRYL.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: After receiving shingles vaccine I came down with painful case of shingles. Started to spread over neck, shoulder and on back. Went to Doctor confirmed it was shingles and gave me valacyclovir HCl 500 mg 1 tablet 3 x day. Improved slowly over next week or 2 weeks less painful with movement.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received vaccine on 6/5/14 at 3:13 pm. Woke up on 6/6/14 with injection site red and swollen. Patient applied ice and took oral antihistamines. Area measured 6 inches long by 2 inches wide. Redness and swelling improved with home treatment.
Age: 67.0
Sex: F
Vaccine: DT
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Provider ordered Td, RN administered DT. No fever or prolonged injection site pain.
Age: 1.81
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Rash, fever one week after vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Hypersomnia
Clinical narrative: 6/04/14 2:00 PM mom called to say child got up about 7:00 AM today, ate breakfast, then went back to bed at 10:00 AM and slept for next 4 hrs so soundly she didn't hear environmental noises she normally would hear. Aroused, but promptly went to sleep; this uncharacteristic for her. After 5 hrs, she awoke and began to act normally. 6/05/14 Phone call to mom -> acting normally. Child afebrile per mom's history.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 02-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J003700; expiration date: 27-MAR-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 32.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 32 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 18-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J003700; expiration date: 27-MAR-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 42.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 42 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 17-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J003700; expiration date: 27-MAR-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 26.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 26 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 16-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot # J003700; expiration date: 27-MAR-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 08-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J003700; expiration date: 27-MAR-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 59.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 59 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 11-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J003700; expiration date: 27-MAR-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 43.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 43 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 24-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J003700; expiration date: 27-MAR-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 49.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 49 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 25-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J003700; expiration date: 27-MAR-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 9 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 01-MAY-2014, the patient was vaccinated with VARIVAX (Merck) lot #J003700; expiration date: 27-MAR-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin burning sensation
Clinical narrative: This spontaneous report as received from a consumer refers to an approximately 83 year old female patient with arthritis and sulfa allergy. Medical history included aorta aneurysm and pacemaker. In October 2013 (also reported as 10-JAN-2013) the patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported), one time vaccination injection. Concomitant medications included "3 unspecified blood pressure medications". Since January 201 the patient has had experienced a burning sensation that stings on buttocks cheeks after the ZOSTAVAX. On an unknown date the patient sought for medical attention. The patient reported that her physician prescribed fungus ointment, yeast pills and lacane patch. "None of these has been effective". No lab diagnostics studies were performed. At the time of the report the patient had not recovered from burning sensation that stings on buttock cheeks. Relationship between burning sensation that stings on buttocks cheeks and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 25.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 25 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 04-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J005416; expiration date: 02-MAY-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Rash
Clinical narrative: Rash.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation
Clinical narrative: Pt had BOOSTRIX on 6/10 and ZOSTAVAX on 6/12. Pt came into pharmacy 6/16 3:10 pm to show us large inflamed area on left arm. Area appeared lower than IM site and more to front of arm than SQ site. Pt advised to go to MD to have it looked at.
Age: 58.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 58 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 11-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J005416; expiration date: 02-MAY-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 42.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 42 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 18-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J005416; expiration date: 02-MAY-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.49
Sex: M
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was inadvertently vaccinated with ROTATEQ (route, dose and lot # were unknown) which was improperly stored. No adverse effects reported. The temperature range was: 30 Fahrenheit (F) for 360 hours. Follow up information for this spontaneous report has been received from the medical assistant concerning a 5 month old male patient. None pre-existing allergies, birth defects and medical conditions reported. On 03-APR-2014, at an unknown time in the afternoon (PM), the patient was inadvertently vaccinated with ROTATEQ lot # J001257, expiration date: 27-AUG-2014 (dose and route not reported) which was improperly stored. None illness at time of vaccination reported. It was reported that vaccines for children program (VFC) field representative came out and the fridge/freezer temperatures were out of range. The temperature was too low. It had a combination unit which was faulting. The fridge and freezer were replaced and was approved by VFC. Plan of action was taken care of and resolved. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness around injection site.
Age: 44.0
Sex: F
Vaccine: TYP, YF
Symptoms: Injection site inflammation, Injection site pain, Injection site reaction, Pruritus, Rash
Clinical narrative: Pt complained of hypersensitivity-like reactions (rash, hives, urticaria, pruritus) and injection site reaction (pain, inflammation at site).
Age: 44.0
Sex: F
Vaccine: TYP, YF
Symptoms: Urticaria
Clinical narrative: Pt complained of hypersensitivity-like reactions (rash, hives, urticaria, pruritus) and injection site reaction (pain, inflammation at site).
Age: 25.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 25 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 21-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J005416; expiration date: 02-MAY-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Patient called to report "breaking out in chicken pox" on both arms after ZOSTAVAX - at least 40 spots on arms only.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dysgeusia, Injection site erythema, Injection site pain, Pruritus
Clinical narrative: Redness, pain at injection sight, diffuse itching, metallic taste in mouth. Resolving spontaneously with topical anti-histamine cream.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability
Clinical narrative: Increased, unconsolable fussiness.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Heart rate increased, Syncope
Clinical narrative: Pt fainted after receiving HPV vaccine for 20 sec. drop in BP 60/38 - Rise in pulse 110 BP 82/58 P. 67 BP 110/68 P: 80. Controlled SpO2/Pulse/BP for 30 min. Gave orange juice. Pt claims not to have eaten - possibly related.
Sex: F
Vaccine: DTAP
Symptoms: Loss of consciousness
Clinical narrative: Initial case received from a healthcare professional on 11 June 2014. A female infant, with no reported medical history, received a third dose of DAPTACEL (lot number C4617AA) on an unspecified date. The patient's mother reported that one hour post-vaccination, the patient experienced loss of consciousness lasting approximately 10 minutes. The event subsequently recovered. No additional information was reported. Documents held by sender: None.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Joint range of motion decreased
Clinical narrative: Red, warm, swollen (R) upper arm. Fever, chills, body ache and pain. Adverse event documented 1 day after received injection. Now same sx with limited arm motion - strength.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Red, warm, swollen (R) upper arm. Fever, chills, body ache and pain. Adverse event documented 1 day after received injection. Now same sx with limited arm motion - strength.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 01-APR-2014, the patient was vaccinated with (Oka/Merck) VARIVAX lot #J005416; expiration date: 02-MAY-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with (Oka/Merck) VARIVAX that was exposed to 43.1 F for 29 hours on 03-MAR02014. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse refers to an unspecified number of patients (no demographics provided). No medical history or concurrent conditions were reported. On an unspecified date, the patients were vaccinated with GARDASIL (dose, rout, strength and lot number were not provided). No co-suspect or concomitant therapies were reported. On an unspecified date, GARDASIL was administered to an unspecified number of patients after being exposed to 34F for a cumulative time of 18 hours over two excursions, and then to 47F for 9 hours. The reported did not have any patient information. No adverse effects reported. This is one of two reports from the same source. Additional information is not expected.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 71 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 15-APR-2014, the patient was vaccinated with ZOSTAVAX lot # J007208; expiration date: 20-SEP-2014, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with ZOSTAVAX that was exposed to 43.1 F for 29 hours on 03-MAR-2014. This is one of four reports from the same reporter. Additional information has been requested.
Age: 41.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 41 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 03-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J005416; expiration date: 02-MAY-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.