chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Eye movement disorder, Head injury, Tremor
Clinical narrative: Patient received her Menactra today at 9:15am. She was sitting on that examining table on room 26. A few seconds after she received her vaccine in her left arm and right after I had placed the bandaid, the patient, who had been leaning against her mother up to this point, flipped back onto the table and hit the back of her head agianst the wall. Almost at the same time her head and arms started shaking and her eyes rolled back in her head. The patient started sliding off the table and we laid her down on the floor. I turned toward the door to call the other nurses to get the attending doctor and when I turned back, the patient was standing upright and asked what had happened. Vital signs were normal and O2sats were 99%. Patient was evaluated by Dr., remained resting in room 26 and was released after 45 minutes.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Dizziness, Ear discomfort, Tinnitus
Clinical narrative: PATIENT STATES IT FELT LIKE COTTON WAS IN HER EARS AND SHE FELT LIKE BOTH EARS WERE RINGING. SHE ALSO STATED SHE FELT DIZZY.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Musculoskeletal pain
Clinical narrative: ARM AND SHOULDER ACHED WHEN RAISED. RED BLOTCH ABOUT A QUARTER INCH BELOW INJECTION SITE. SWELLING WITH FEVER IN BLOTCH AREA.  BLOTCH SPREAD LARGER OVER THE FOLLOWING TWO DAYS AND IS STILL TENDER.  TODAY IS THE THIRD DAY POST VACINE AND THE BLOTCH IS LARGER.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Rash macular
Clinical narrative: ARM AND SHOULDER ACHED WHEN RAISED. RED BLOTCH ABOUT A QUARTER INCH BELOW INJECTION SITE. SWELLING WITH FEVER IN BLOTCH AREA.  BLOTCH SPREAD LARGER OVER THE FOLLOWING TWO DAYS AND IS STILL TENDER.  TODAY IS THE THIRD DAY POST VACINE AND THE BLOTCH IS LARGER.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Dyspnoea
Clinical narrative: Chills, weakness, exhaustion, lack of appetite, dizziness, shortness of breath, pain and hot at injection site.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Injection site pain, Injection site warmth
Clinical narrative: Chills, weakness, exhaustion, lack of appetite, dizziness, shortness of breath, pain and hot at injection site.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Confusional state, Dehydration, Disorientation, Erythema, Peripheral swelling
Clinical narrative: Patient had a high fever (103.5) and right arm became red and swelled. High dose flu and Pneumovax was given in right arm.  Boostrix given in left arm. Over the next few days (Tuesday and Wednesday), patient became disoriented, confused, dehydrated, and fever remained.  Patient was admitted to hospital on Thursday with the same symptoms, and had an elevated white blood count, with a possibly infection in right arm.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Patient had a high fever (103.5) and right arm became red and swelled. High dose flu and Pneumovax was given in right arm.  Boostrix given in left arm. Over the next few days (Tuesday and Wednesday), patient became disoriented, confused, dehydrated, and fever remained.  Patient was admitted to hospital on Thursday with the same symptoms, and had an elevated white blood count, with a possibly infection in right arm.
Age: 25.0
Sex: M
Vaccine: HEP, MMR, TDAP
Symptoms: Guillain-Barre syndrome, Muscular weakness, Sensory loss, Tenderness
Clinical narrative: Weakness and tenderness in legs, feeling loss, 7 day hospital treatment, medication, physical therapy still trying to recover now in 2015.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: CSF test normal, Chills, Computerised tomogram head normal, Dizziness, Headache
Clinical narrative: 38 y/o male who received his 3rd anthrax vaccine high in his right upper arm on 24 APR 2015. That was the only vaccine he received that day. He experienced almost immediate pain near his right shoulder and in his upper arm. The pain was significant. He reports pain intensity was initially 8/10 and later, 5-6/10 using a pain scale of 0 (= no pain) to 10 (= worst pain ever experienced). The pain hurt to the point patient significantly limited use of his right arm x 24 hours. He reports pain increased with movement and from clothing touching the affected area. His pain resolved within 2-3 days, without recurrence. Patient denies recent RUE trauma or injury, but did have right rotator cuff repair in 2010. He denies RUE numbness or weakness. The first day post-vaccination, patient also reports tenderness and swelling surrounding vaccination site (<2" area), which lasted 2-3 days. He denies redness and warmth at vaccination site, but does report a pea-sized knot around that time that resolved at 2 days. Patient denies similar reactions following previous anthrax vaccines. Patient experienced the onset of a headache within 4 hours of vaccine receipt. Patient self-treated with ALEVE with little resolution, but he was able to sleep through the night. The following morning, he woke up with a headache. He self-treated with ALEVE that day and was able to carry out his ADLs and work duties, and sleep through the night. The next morning, patient again awoke with a headache accompanied by blurred vision, stiff neck, fever (maximum temperature was 100 degrees F) and chills, and lightheadedness. He denies photophobia, nausea and vomiting, but experienced phonophobia. Patient sought evaluation at a local emergency room. [Name and location of ER and hospital where admitted is unknown to reporter]. He was treated with IV fluids and pain medication, with no significant decrease in his headache. After an evaluation to rule out meningitis was begun, he was admitted for observation and treatment for 3 days. He had a normal head CT and normal CSF analysis post-lumbar puncture. His headache resolved after treatment with TORADOL. All of patient's symptoms subsided by time of discharge. Patient has been symptom-free for about 3 months.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: 38 y/o male who received his 3rd anthrax vaccine high in his right upper arm on 24 APR 2015. That was the only vaccine he received that day. He experienced almost immediate pain near his right shoulder and in his upper arm. The pain was significant. He reports pain intensity was initially 8/10 and later, 5-6/10 using a pain scale of 0 (= no pain) to 10 (= worst pain ever experienced). The pain hurt to the point patient significantly limited use of his right arm x 24 hours. He reports pain increased with movement and from clothing touching the affected area. His pain resolved within 2-3 days, without recurrence. Patient denies recent RUE trauma or injury, but did have right rotator cuff repair in 2010. He denies RUE numbness or weakness. The first day post-vaccination, patient also reports tenderness and swelling surrounding vaccination site (<2" area), which lasted 2-3 days. He denies redness and warmth at vaccination site, but does report a pea-sized knot around that time that resolved at 2 days. Patient denies similar reactions following previous anthrax vaccines. Patient experienced the onset of a headache within 4 hours of vaccine receipt. Patient self-treated with ALEVE with little resolution, but he was able to sleep through the night. The following morning, he woke up with a headache. He self-treated with ALEVE that day and was able to carry out his ADLs and work duties, and sleep through the night. The next morning, patient again awoke with a headache accompanied by blurred vision, stiff neck, fever (maximum temperature was 100 degrees F) and chills, and lightheadedness. He denies photophobia, nausea and vomiting, but experienced phonophobia. Patient sought evaluation at a local emergency room. [Name and location of ER and hospital where admitted is unknown to reporter]. He was treated with IV fluids and pain medication, with no significant decrease in his headache. After an evaluation to rule out meningitis was begun, he was admitted for observation and treatment for 3 days. He had a normal head CT and normal CSF analysis post-lumbar puncture. His headache resolved after treatment with TORADOL. All of patient's symptoms subsided by time of discharge. Patient has been symptom-free for about 3 months.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Phonophobia, Pyrexia, Vaccination site nodule, Vaccination site pain, Vaccination site swelling
Clinical narrative: 38 y/o male who received his 3rd anthrax vaccine high in his right upper arm on 24 APR 2015. That was the only vaccine he received that day. He experienced almost immediate pain near his right shoulder and in his upper arm. The pain was significant. He reports pain intensity was initially 8/10 and later, 5-6/10 using a pain scale of 0 (= no pain) to 10 (= worst pain ever experienced). The pain hurt to the point patient significantly limited use of his right arm x 24 hours. He reports pain increased with movement and from clothing touching the affected area. His pain resolved within 2-3 days, without recurrence. Patient denies recent RUE trauma or injury, but did have right rotator cuff repair in 2010. He denies RUE numbness or weakness. The first day post-vaccination, patient also reports tenderness and swelling surrounding vaccination site (<2" area), which lasted 2-3 days. He denies redness and warmth at vaccination site, but does report a pea-sized knot around that time that resolved at 2 days. Patient denies similar reactions following previous anthrax vaccines. Patient experienced the onset of a headache within 4 hours of vaccine receipt. Patient self-treated with ALEVE with little resolution, but he was able to sleep through the night. The following morning, he woke up with a headache. He self-treated with ALEVE that day and was able to carry out his ADLs and work duties, and sleep through the night. The next morning, patient again awoke with a headache accompanied by blurred vision, stiff neck, fever (maximum temperature was 100 degrees F) and chills, and lightheadedness. He denies photophobia, nausea and vomiting, but experienced phonophobia. Patient sought evaluation at a local emergency room. [Name and location of ER and hospital where admitted is unknown to reporter]. He was treated with IV fluids and pain medication, with no significant decrease in his headache. After an evaluation to rule out meningitis was begun, he was admitted for observation and treatment for 3 days. He had a normal head CT and normal CSF analysis post-lumbar puncture. His headache resolved after treatment with TORADOL. All of patient's symptoms subsided by time of discharge. Patient has been symptom-free for about 3 months.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Vision blurred
Clinical narrative: 38 y/o male who received his 3rd anthrax vaccine high in his right upper arm on 24 APR 2015. That was the only vaccine he received that day. He experienced almost immediate pain near his right shoulder and in his upper arm. The pain was significant. He reports pain intensity was initially 8/10 and later, 5-6/10 using a pain scale of 0 (= no pain) to 10 (= worst pain ever experienced). The pain hurt to the point patient significantly limited use of his right arm x 24 hours. He reports pain increased with movement and from clothing touching the affected area. His pain resolved within 2-3 days, without recurrence. Patient denies recent RUE trauma or injury, but did have right rotator cuff repair in 2010. He denies RUE numbness or weakness. The first day post-vaccination, patient also reports tenderness and swelling surrounding vaccination site (<2" area), which lasted 2-3 days. He denies redness and warmth at vaccination site, but does report a pea-sized knot around that time that resolved at 2 days. Patient denies similar reactions following previous anthrax vaccines. Patient experienced the onset of a headache within 4 hours of vaccine receipt. Patient self-treated with ALEVE with little resolution, but he was able to sleep through the night. The following morning, he woke up with a headache. He self-treated with ALEVE that day and was able to carry out his ADLs and work duties, and sleep through the night. The next morning, patient again awoke with a headache accompanied by blurred vision, stiff neck, fever (maximum temperature was 100 degrees F) and chills, and lightheadedness. He denies photophobia, nausea and vomiting, but experienced phonophobia. Patient sought evaluation at a local emergency room. [Name and location of ER and hospital where admitted is unknown to reporter]. He was treated with IV fluids and pain medication, with no significant decrease in his headache. After an evaluation to rule out meningitis was begun, he was admitted for observation and treatment for 3 days. He had a normal head CT and normal CSF analysis post-lumbar puncture. His headache resolved after treatment with TORADOL. All of patient's symptoms subsided by time of discharge. Patient has been symptom-free for about 3 months.
Sex: F
Vaccine: HEP
Symptoms: Abscess drainage, Computerised tomogram, Drain placement, Enterocolitis, Gastrooesophageal reflux disease
Clinical narrative: Child presented on 7/30 (age 27 d) with vomiting -> GERD, FPIES and new onset painful lump right thigh. Ultrasound -> ?hematoma. Follow up 8/5 -> marked induration, pain -> ER (abscess drained MRSA).
Sex: F
Vaccine: HEP
Symptoms: Incisional drainage, Induration, Injection site mass, Injection site pain, Pain
Clinical narrative: Child presented on 7/30 (age 27 d) with vomiting -> GERD, FPIES and new onset painful lump right thigh. Ultrasound -> ?hematoma. Follow up 8/5 -> marked induration, pain -> ER (abscess drained MRSA).
Sex: F
Vaccine: HEP
Symptoms: Staphylococcal infection, Ultrasound scan, Vomiting, X-ray
Clinical narrative: Child presented on 7/30 (age 27 d) with vomiting -> GERD, FPIES and new onset painful lump right thigh. Ultrasound -> ?hematoma. Follow up 8/5 -> marked induration, pain -> ER (abscess drained MRSA).
Age: 34.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large red area, warm to touch, no pain, within 24 hours (R) delt.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth started about 15 minutes aftr the shot was administered 8/19/15 until around 2 am on 8/20/15. Note: Has never had this taste before other than when she started toTOPAMAX in 2008. Tasted lasted a few months after TOPAMAX.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Duplicate of injection given in error.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Erythema, Pain of skin, Rash
Clinical narrative: About 2 inch square rash, red, burning sensation, tender skin, still getting worse after 1 week.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Rec'd vaccines 8/18/15 at WCE. C/O (Rt) arm/deltoid edema and erythema starting 8/19/15. Seen for same 8/19/15 at 1115 AM. Stated redness had increased since 8/18/15. > 4 x 4 cm area pink with warmth. No streaking; afebrile. TX > cold compresses-ibuprofen, BENADRYL.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Skin warm
Clinical narrative: Rec'd vaccines 8/17/15 at WCE. C/O (Lt) arm with redness and warmth on exam at 8/19/15 O.V. -> 2.5 x 3" area erythema (Lt) shoulder with mild warmth and tenderness. No induration; no fever. TX with PRN ibuprofen/warm compress.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Seizure
Clinical narrative: Patient had mild seizure immediately after being given Tdap vaccine. Seizure lasted about 30 seconds and then she was ok and rested at pharmacy for about 30 minutes before leaving with her mother. Told mom to take her to MD afterward.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Body temperature increased, Diarrhoea, Malaise, Nausea
Clinical narrative: Pt received Tdap at 10 AM 8/18/15 and by 4:00 pm had stomach pain. The next day 8/19/15 the pt woke with nausea and vomited accompanied by diarrhea and a temp of 99.8 that rose to 101.3 by midday. Pt still feels ill today 8/20/15 nauseous with stomach pain, afebrile.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Pt received Tdap at 10 AM 8/18/15 and by 4:00 pm had stomach pain. The next day 8/19/15 the pt woke with nausea and vomited accompanied by diarrhea and a temp of 99.8 that rose to 101.3 by midday. Pt still feels ill today 8/20/15 nauseous with stomach pain, afebrile.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Localized swelling, redness and itching. MEDROL pack, PEPCID 2 mg, Loratadine 10 mg, and hydrocortisone cream prescribed.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Syncope
Clinical narrative: After receiving 3 vaccinations (KINRIX, MMR, Varicella) pt fainted. Pt revived on her own. Provided cool cloth and water. Parent told to f/u with PCP.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Occult blood positive
Clinical narrative: (+) occult stool 24 hrs post immz 8/11/15. (-) occult stool 72 hrs post immz 8/13/15. (-)  visual stools with blood 48 hr post immz 8/12/15.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Medical history and concurrent condition was not reported. On unknown dates the patient were vaccinated with oral, ROTATEQ lot # K023534 with expiration date of 22-MAY-2016 and K011948 with expiration date of 07-JUN-2016; strength, dosage, frequency and route unspecified), which were exposed to temperatures outside of the recommended range(incorrect product storage). No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Chills, Tinnitus, Wheezing
Clinical narrative: Within 24 hours of ADACEL administration developed wheezing, weakness, chills, increase of chronic tinnitus.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose, Cyanosis, Fatigue, Full blood count, Hypoglycaemia
Clinical narrative: After 15 min pt had a seizure. Last 1-3 mn. Pt hx hypoglycemia ate fruit snack 10 min before sz. Had blue lips and secretion EMS evaluated blu 147-Told to come to office. Pt has vomit and acting tired.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Laboratory test, Salivary hypersecretion, Seizure, Vomiting
Clinical narrative: After 15 min pt had a seizure. Last 1-3 mn. Pt hx hypoglycemia ate fruit snack 10 min before sz. Had blue lips and secretion EMS evaluated blu 147-Told to come to office. Pt has vomit and acting tired.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site hypersensitivity
Clinical narrative: Patient with localized allergic type reaction at injection site. Redness approx 5cm in diameter. Has improved with MOTRIN and cool compresses.
Age: 77.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Rash, achy, pruritic at PREVNAR 13 injection site 1 week after administration. Diffuse redness over right delt. warm. Redness extends to anterior right side of chest.
Age: 77.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Rash
Clinical narrative: Rash, achy, pruritic at PREVNAR 13 injection site 1 week after administration. Diffuse redness over right delt. warm. Redness extends to anterior right side of chest.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Pyrexia
Clinical narrative: Pt reports she developed fever approx 4 hrs after receiving vaccine. Fever/fatigue lasted approximately 24 hrs.
Age: 1.78
Sex: F
Vaccine: HEPA
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiformed rash patient was given steroids.
Age: 39.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: When woke up 8/12/15 it was red and warm to touch and tender. 8/13/15 larger area of redness tender warm to touch. Area 2 x 1 1/2 inches of redness with swelling. Pt instructed to take anti-inflammatory and not warm compresses to area and seek medical advice if it gets worse.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Employee presents to dept. 48 hours after Tdap to report redness around injection site that is slightly raised. No pain or illness symptoms.
Age: 0.44
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Received PENTACEL, PREVNAR 13 and ROTATEQ 5/12/15. Developed fever of 104 degrees, rash and slight fussiness the following day that lasted 2 days. Parents reported symptoms to office on 8/4/15. Pt was taken to ER on 5/13/15. Advised to give TYLENOL. Pt recovered fully.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker, certificated medical assistant (CMA) who reported that multiple unspecified patients received doses of improperly stored VAQTA (lot # L009445 expiration date 01-JUN-2017, dose, frequency and route were not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In approximately August 2015 (reported as since 06-AUG-2015), the patients had been administered doses of improperly stored oral, ROTATEQ lot # K010222, expiration date reported as 12-MAY-2016 (dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. It was not reported medical history or concurrent conditions. On 27-MAY-2015, the patient received improperly stored M-M-R II (dose, strength and route were unknown, lot number reported K021952, expiration date: 10-NOV-2015), with no adverse effects. There was no concomitant therapies described. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse regarding on a patient of unknown age and gender. Patient's medical history or concurrent conditions were not reported. On an unknown date, the patient received improperly stored with RECOMBIVAX HB lot #K020216, expiration date 17-SEP-2016 (dose, strength and route were unknown). There were no concomitant therapies reported. No adverse effects were reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a 7 week old patient of unknown gender. On 16-OCT-2014 the patient was 7 weeks old and was vaccinated with first dose of LIQUID PEDVAXHIB injection (dose, route, frequency unspecified). On 26-JAN-2015 the patient was 4 months old and was vaccinated with second dose of LIQUID PEDVAXHIB injection (dose, route, frequency unspecified). No adverse experience reported. No further information provided. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Transient ischaemic attack
Clinical narrative: This spontaneous report as received from a pharmacist via a field employee refers to a male patient of about 70 years of age. The patient's current condition included heart disease. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot number not reported). On the same date, 40 minutes after the injection the patient experienced a minor transient ischaemic attack (TIA). On an unspecified date, the patient recovered from transient ischaemic attack. No further details was provided. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender.  In approximately August 2015 (reported as since 06-AUG-2015), the patients had been administered doses of improperly stored GARDASIL lot # K011562, expiration date reported as 08-APR-2017 (dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In approximately August 2015 (reported as since 06-AUG-2015), the patient had been administered doses of improperly doses RECOMBIVAX HB lot # K014548, expiration date reported as 27-AUG-2016 (dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In approximately August 2015 (reported as since 05-AUG-2015), the patients had been administered doses of improperly stored VAQTA lot # K018182, expiration date reported as 12-FEB-2017, lot # L002717, expiration date reported as 02-JUN-2017 (dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker, certificated medical assistant (CMA) who reported that multiple unspecified patients received doses of improperly stored GARDASIL injection (lot # J003727 expiration date 07-NOV-2015 and lot # K009482 expiration date 06-MAR-2017, dose, frequency and route were not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Registered Nurse referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 03-AUGG-2015, the patient was vaccinated wiht improperly stored dose of VAQTA 25/0.5 lot # K012457, expiration date: 04-JUN-2017, dose, route, frequency and anatomical location were unknown. No adverse symptoms reported. No product quality complaint was reported. This is one of several cases received from the same source (MARRS numbers: 1508USA003819, 1508USA005118, 1508USA005119, 1508USA005120, 1508USA005121, 1508USA005122, 1508USA005123, 1508USA005124, 1508USA005125). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 17-AUG-2015 the patient was vaccinated with VAQTA (dose, strength and frequency were not reported, lot # J005680, expiration date: 02-AUG-2015) (expired product administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In approximately August 2015 (reported as since 06-AUG-2015), the patients has been administered doses of improperly stored GARDASIL 9 lot # K026247, expiration date reported as 29-JAN-2017 (dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In approximately August 2015 (reported as since 06-AUG-2015), the patient had been adminsitered doses of improperly stored PNEUMOVAX23 lot # K007262, expiration date reported as 25-NOV-2015 (dose, route and site of administration wer enot reported). No adverse effects were reported. This is one of several reports  from the same reporter. Additional informatino has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with improperly stored PEDVAXHIB lot K026533, expiration date: 07-AUG-2017, (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 year old female patient. The patient was not pregnant. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was vaccinated with a dose of either GARDASIL or GARDASIL 9 injection (strength, dose, route of administration, lot# and expiry date were not reported). The reporter could not specify which dose it was in the vaccination series or whether the product used was GARDASIL or GARDASIL 9. There were no concomitant therapies reported. On an unknown date, the patient experienced vomiting. The patient sought medical attention (office visit on an unspecified date) and received treatment with soda. There was no product quality complaint (PQC) involved. The outcome of the event was reported as recovered on an unspecified date. The relatedness between GARDASIL or GARDASIL 9 and the event was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates the patient were vaccinated with improperly stored GARDASIL lot # K011562, expiration date: 08-APR-2017, (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional referring to multiple patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA, (Lot# K007791, expiration date: 22-AUG-2016; Lot# K010812, expiration date: 12-FEB-2017), dose and route of administration were not provided. No adverse effect reported. This service request was first opened on 30-JUN-2015, when a pharmacist called to report a vaccine temperature excursion but any adverse event was reported at that time. However, this adverse event was reported on 11-AUG-2015, during a call back by this healthcare worker. This is one of several reports received from the same source. The lot# K010812 is not valid for VAQTA. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker, medical assistant who reported that on unspecified dates, an unspecified number of unspecified patients received doses of improperly stored RECOMBIVAX HB (therapy type unknown, Lot numbers, expiration dates, dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker, certificated medical assistant  (CMA) who reported that multiple unspecified patients received doses of improperly stored oral, ROTATEQ (lot # K010224 expiration date 13-MAY-2016, dose, frequency and route were not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on 04-FEB-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist referring to a patient of unkonwn age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry date, dose and route were unspecified). On an unknown date the patient developed a case of Shingles on an unspecified date following the administration of ZOSTAVAX. The outcome of the event was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker, medical assistant who reported that on unspecified dates, an unspecified number of unspecified patients received doses of improperly stored oral, ROTATEQ (Lot numbers, expiration dates, dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pain of skin
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. On an unknown date, the patient experienced pain in a dermatome other than the dermatome that ZOSTAVAX was administered, 12 hours following ZOSTAVAX administration. The outcome of adverse event was unknown. The relatedness between adverse event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified number of patients of unknown age and gender. Pertinent medical history and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L013068, expiry date 14-APR-2017, dose and route of administration not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions and medical history were reported. The week of 03-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (Lot # reported as L00374, expiration date, route and dose were not provided) as routine pre-employment Vaccinations. Concomitant medications were not provided. On an unknown date in August 2015, the patient experienced injection site redness and itching. The patient did not seek for medical attention. No treatment was given for the event. The outcome of injection site redness and itching was reported as recovered on an unspecified date in August 2015. The reporter did not assess the relatedness of (Oka/Merck) VARIVAX to the events. Lot # L00374 is Not valid as provided for (Oka/Merck) VARIVAX. This is one of several reports from the same source. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old male patient. On 10-AUG-2015, the patient was vaccinated with ZOSTAVAX lot # L012475, expiration date: 16-JUL-2016, subcutaneously in his right arm. On 10-AUG-2015, after receiving ZOSTAVAX, the patient experienced itching on his left arm and down the left side of his body. The patient sought medical attention: called the pharmacist. At the time of the report the patient did not recover from the event. Relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # K026246, expiration date: 28-JAN-2017) dose and route were not reported. No adverse symptoms reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on 24-FEB-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 18 year old patient of unspecified gender. On 04-AUG-2015, the patient was vaccinated with first dose of GARDASIL 9 (lot number: L001312 and expiry date: 24-FEB-2017) and on 06-AUG-2015, the patient was vaccinated with second dose of GARDASIL 9 in error (lot number: L001312 and expiry date: 24-FEB-2017). The patient did not report any adverse effects. The outcome of inappropriate schedule of drug administration was unknown. No product quality complaint (PQC) was filed. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot # K026533, expiration date: 07-AUG-2017 and lot# K026532, expiration date: 07-AUG-2017) dose and route were not reported. No adverse symptoms reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP, HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. The nurse reported that on 26-MAR-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K009953, expiry date 03-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist, as part of a marketing research program, refers to a 65 year old female patient. There was no concurrent condition and medical history of the patient. On an unknown date in August 2014 (also reported as "11-AUG-2015"), the patient was vaccinated with a dose of ZOSTAVAX (administration, lot number and expiration date were not provided). No concomitant therapies were reported. On an unspecified date in August 2015, the patient experienced herpes zoster (shingles), for which she was currently taking some unknown medications as treatment. There were no diagnostic laboratory tests performed. At the time of the report the outcome of herpes zoster was reported as recovering. The reporter did not provide a causality relationship assessment between the event and therapy with ZOSTAVAX. Additional information is not expected, since there was no consent to contact the physician to discuss further.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse regarding on a patient of unknown age and gender. Patient's medical history or concurrent conditions were not reported. On an unknown date, the patient received improperly stored dose of GARDASIL lot # K010574, expiration date 08-APR-2017 (dose, strength and route were unknown). There was no concomitant therapies reported. No adverse effects were reported. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown age and gender, who were vaccinated since 03-JUN-2015 with an improperly stored (Oka/Merck) VARIVAX (lot number, expiration date, route, doses, dose number were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (dose and route were not reported) lot # J015378, expiry date 09-APR-2016. There was no concomitant medication provided. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, refers to unspecified patients of unknown ages and genders. Concomitant condition and medical history were not reported. On unspecified dates, the patients were vaccinated with doses of GARDASIL injection, lot # K006960, expiration date on 19-FEB-2017 (strength, dose #, dose, anatomical and route of administration were not reported), which were exposed to temperatures outside of the recommended range. There was not concomitant medication reported. Product quality complaint was not involved. No adverse experience has been reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. The patient started the GARDASIL (lot#, dose and route not provided) series "over 2 years ago" (in approximately 2013) and had not received the third dose yet. Patient was in the office (on 18-AUG-2015) to receive the third dose (inappropriate schedule of drug administration). No adverse effects reported. It was also reported that the patient sought for medical attention. The outcome of the event was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unknown number of patients of unknown age and gender. No concurrent condition or medical history was reported. It was reported that since 24-JUL-2015, the patients were vaccinated with improperly stored doses of M-M-R II (lot # J014876, Exp. 21-NOV-2015, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (dose, strength, frequency and route were not reported) lot # L009209, expiration date 17-SEP-2016; lot # L016395, expiration date 08-NOV-2016. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, strength, frequency and route were not reported) lot # J014406, expiration date 13-NOV-2015; lot # L013063, expiration date 14-APR-2017; lot # L001324, expiration date 13-JAN-2017; lot # L004655, expiration date 11-FEB-2017. No adverse effect reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient reports fever, chills, achy 5 hrs after vaccination, abrupt onset and cessation sx lasted approx. 1 hr. Arm soreness for 3 days. Occurred with both injections, but less after second.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Pt reports chills and nausea a few hrs after vaccination of dose #2 - abrupt onset and cessation lasted 1 hr. Also mild fever. Sx less severe with dose #2. Arm sore for 3 days.