chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Dyspnoea, Vomiting
Clinical narrative: Couldn't breathe; chills. Abated at 8:00 PM, violent vomiting began about 9:00 PM. Diarrhea began about 2:00 AM, stopped at 3:00 AM.  Vomiting began again about 2:30 AM.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Dyspnoea, Intensive care, Pneumonitis
Clinical narrative: SOB, cough, pneumonitis. Was admitted and was in critical care for 8 days.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Abdominal pain upper, Chills, Diarrhoea, Headache
Clinical narrative: Chills, body ache, stomach ache, diarrhea, headache, vomiting, ears ringing.  Severe abdominal pain.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Tinnitus, Vomiting
Clinical narrative: Chills, body ache, stomach ache, diarrhea, headache, vomiting, ears ringing.  Severe abdominal pain.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: Patient states he was fine during the day then that evening developed swollen itchy eyes. Patient's eyes feel a little better this morniing. Took Benadryl.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash pruritic, Urticaria
Clinical narrative: Itchy spots on head - hives days later, sores, severe pain on head from base of skull to top of head.  Went to doctor on 9/28 - Dr. prescribed Valacyclovir HCL. Have finished prescription - still itchy - occasional hives.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Patient stated pain started Monday evening, October 5th, and she took Tylenol. Swelling started Tuesday, October 6th, she called pharmacy and was suggested to take Diphenhydramine by R.Ph and see physician if worsens. Patient went to see ARNP on October 7th. She was given a steroid injection and received a prescription for diphenhydramine 25mg po tid for 7 days.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Localized swelling of injection site to left upper arm.  Dr. notified, and was in to see patient.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth, Joint swelling
Clinical narrative: Redness, pain, swollen, site hot to touch, difficulty raising arm, ice pack, elevate arm on pillow, Tylenol, Motrin.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, and pain to Left Deltoid.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Swelling
Clinical narrative: Pt states she received pneumovax at pharmacy 2 days ago in afternoon, states upon waking next morning she felt pain in joints and swelling. No edema at office visit today.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: The shot burned when it went in and the injection site remained consistently sore thereafter. Within days, pain/burning sensation was persistent and shooting pain would occur when I tried moving my shoulder in different directions. Progressively getting worse at 2 weeks post injection and have limited range of motion in my left arm due to shoulder pain (Deltoid).  Difficult with everyday usage, strength impacted and sleep is difficult.  Going into Dr for an evaluation this week.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: The shot burned when it went in and the injection site remained consistently sore thereafter. Within days, pain/burning sensation was persistent and shooting pain would occur when I tried moving my shoulder in different directions. Progressively getting worse at 2 weeks post injection and have limited range of motion in my left arm due to shoulder pain (Deltoid).  Difficult with everyday usage, strength impacted and sleep is difficult.  Going into Dr for an evaluation this week.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: Pt stated she couldn't move (L) arm well or raise above head since flu vaccination 3 wks ago. Pt contacted PMD-was told to take ibuprofen which has helped sx improve.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Discomfort
Clinical narrative: Pt. described nerve discomfort on right hand involving 3 middle fingers. Pt. states feeling much better w/hand exercise with ball.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Pain in extremity
Clinical narrative: The patient states that her arm has been in pain since her injection and that her arm has lost normal function as a result of the injection.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt had fever, pain, swelling and redness at site of injection.
Age: 1.35
Sex: F
Vaccine: DTAP, FLU4, HIBV
Symptoms: Cyanosis, Injection site nodule, Upper respiratory tract infection, Vomiting
Clinical narrative: Seen in office for 15 mo WCE on 9/30/15 and rec'd immunizations. Returned on 10/05/15 with dad who reported "knot in lt thigh" following imm. Also reported pt with vomiting and blue lips x 2 days. Dx with URI. (LT) thigh with 2 cm x 2cm firm nodule; no edema, redness, induration; afebrile. No tx.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 8.0
Sex: F
Vaccine: FLU3, IPV, TD, VARCEL
Symptoms: Dizziness, Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: 10-3-15 101.5 temp, dizzy, rash on left deltoid, hot, firm, red at site of inject seen by Dr. 10-4-15 at 4 AM temp 103.8. No breathing problems. 10-5 low grade fever.
Age: 8.0
Sex: F
Vaccine: FLU3, IPV, TD, VARCEL
Symptoms: Pyrexia
Clinical narrative: 10-3-15 101.5 temp, dizzy, rash on left deltoid, hot, firm, red at site of inject seen by Dr. 10-4-15 at 4 AM temp 103.8. No breathing problems. 10-5 low grade fever.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised
Clinical narrative: ALL OVER BODY ITCHING.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Immediate post-injection reaction, Lung disorder, Nausea, Neck pain
Clinical narrative: Tightness in lungs immediately. Slight wheezing, stomach churning, pt turned bright red, Throat felt tight. Neck pain developed and hour later. Gave 25mg of diphenhydramine orally immediately.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness, Wheezing
Clinical narrative: Tightness in lungs immediately. Slight wheezing, stomach churning, pt turned bright red, Throat felt tight. Neck pain developed and hour later. Gave 25mg of diphenhydramine orally immediately.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Flank pain, Neck pain, Pain
Clinical narrative: Sudden Pain in neck. Thought it would go away next day but it did not. Took Advil, which didn't really help. Pain in left side, hurts to move. Shot administered on left side.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: Localized red, raised area 10 cm with hardness present.  Recommend warm packs.
Age: 70.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Nodule, Skin warm
Clinical narrative: Patient said that she had no side effects after immunization. Started having a knot on arm and warmth radiating down it 13 days later.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Headache, Pruritus, Throat irritation
Clinical narrative: ITCHY THROAT AND ARMS, SUDDEN ONSET OF HEADACHE, ANXIETY.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: "Began a numb feeling in my right ear".
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Pruritus
Clinical narrative: Initially patient felt itching and after 24 hrs post injection she developed localized redness with mininal swelling, tiny blister on injection site.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Urticaria
Clinical narrative: ALL OVER HIVES, ALL OVER FLUSHING. PATIENT TOOK ALLEGRA AT 11:20am.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: INJECTION SITE BECAME RED, INFLAMED AND WAS PAINFUL.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt complains of pain and swelling in right deltoid. Right deltoid site is red, slightly swollen and pt states it is painful to touch.  Pt has full range of motion in right shoulder without pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt developed redness, swelling, itching, and pain at injection site. Pt went to Dr on 10/5 and was prescribed antibiotic for cellulitis. Symptoms continued to progress but as of 10/7 symptoms have begun to improve.
Age: 76.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Dizziness, Dysstasia, Fatigue, Headache
Clinical narrative: Generalized weakness, fever, body shaking, fatigue, unable to stand, headache, dizziness and nausea.
Age: 76.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Generalized weakness, fever, body shaking, fatigue, unable to stand, headache, dizziness and nausea.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: The 2nd day after the shingles shot, the injection area started to become very itchy, red and hot, not pain. Pt is allergic to thimerosal, flu shot spot is fine.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Patient complained of congestion (chest) site pain and bruising. Slight fever.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Hyperhidrosis, Pain
Clinical narrative: Felt tired, did not want to get out of bed for 5 days after shot. Felt sweaty and achy but did not take temperature.
Age: 73.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Musculoskeletal disorder
Clinical narrative: Patient describes loss of function in left arm since PREVNAR vaccine; patient has trouble lifting arm and reaching.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Pt came in at 18:13 experiencing a red rash on his face. He stated he had the flu shot at 14:45 then at 15:20 he started feeling a rash on his face and itching. Pt came in and rash had spread to his chest. No other symptoms occurred.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: According to parent on forecast pt was due for rotavirus. Pt at the age of 27 weeks was given ROTARIX. Informed provider of the action and stated pt was past the age range of receiving ROTARIX. No reaction at the time of vaccine given.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Musculoskeletal pain
Clinical narrative: Patient experiencing extreme shoulder and back pain shortly after vaccine was administered. She is following up with her PCP.
Age: 15.0
Sex: M
Vaccine: FLUN4, HEPA, HPV9
Symptoms: Abdominal pain upper, Dizziness, Head injury, Syncope
Clinical narrative: Patient complained of stomach ache and felt dizzy after leaving clinic - stepped out of elevator and fainted - hit back of head on floor - episode lasted < 5 min - occurred at 10:40AM. Patient taken to ER for evaluation by EMS.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site paraesthesia, Injection site swelling, Injection site warmth
Clinical narrative: Inj. site sensitivity, red, swollen, hot to touch, hard, size of a nickel.
Age: 84.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Malaise, Vomiting
Clinical narrative: Vomiting. Fatigue. Not feeling well. He got these sx the night he received this vaccine.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Aphonia, Cough, Upper-airway cough syndrome
Clinical narrative: Chronic cough, lost of voice and post nasal drip.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Bradycardia, Electrocardiogram abnormal, Full blood count, Metabolic function test, Presyncope
Clinical narrative: Vaccine given IM in left deltoid -> "instantaneous" syncope or near-syncope. Pt guided down to lie on exam table. VS, O2 Sat - monitored for 50 minutes. Pt alert and able to respond appropriately to questioning. Bradycardia: 44/m -> low 50's. Finally 911 called, and pt taken to Hosp ER where he was monitored x 2 hr and given IV fluids before being discharged.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Syncope
Clinical narrative: Vaccine given IM in left deltoid -> "instantaneous" syncope or near-syncope. Pt guided down to lie on exam table. VS, O2 Sat - monitored for 50 minutes. Pt alert and able to respond appropriately to questioning. Bradycardia: 44/m -> low 50's. Finally 911 called, and pt taken to Hosp ER where he was monitored x 2 hr and given IV fluids before being discharged.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Blood pressure increased, Dizziness, Eye movement disorder, Heart rate decreased, Immediate post-injection reaction
Clinical narrative: Vaccine given IM in left deltoid -> "instantaneous" syncope or near-syncope. Pt guided down to lie on exam table. VS, O2 Sat - monitored for 50 minutes. Pt alert and able to respond appropriately to questioning. Bradycardia: 44/m -> low 50's. Finally 911 called, and pt taken to Hosp ER where he was monitored x 2 hr and given IV fluids before being discharged.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Pallor
Clinical narrative: Vaccine given IM in left deltoid -> "instantaneous" syncope or near-syncope. Pt guided down to lie on exam table. VS, O2 Sat - monitored for 50 minutes. Pt alert and able to respond appropriately to questioning. Bradycardia: 44/m -> low 50's. Finally 911 called, and pt taken to Hosp ER where he was monitored x 2 hr and given IV fluids before being discharged.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Ocular hyperaemia
Clinical narrative: Pt. returned to clinic several hours after vaccine adm. Left deltoid swelling, hard and warm to the touch. Some redness around eye orbits. No SOB/palpitations. Pt. transferred to ED by ambulance.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: Large whelp, approx 2 inches in diameter at injection site.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Condition aggravated, External ear pain, Neck pain, VIIth nerve paralysis
Clinical narrative: Patient started feeling pain in upper back, neck, and behind ears on 10-1-15 around 3:00PM. Woke up on Saturday 10-3-15 with face drawn to one side. Patient went to Emergency Room on Monday 10-5-15 and diagnosed with Bell's Palsy.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 10-1-15 pt noticed 0.5 inch red circular area to (L). Upper arm's warm to touch - not at injection site.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to multiple unspecified patients of unknown age and gender. The patients concurrent conditions and medical history were not reported. The healthcare worker reported that on an unknown date, multiple different unspecified patients received a dose of improperly stored VARIVAX (Merck) lot # L001326; expiry date: 13-JAN-2017 (dose and route not reported). No adverse effects were reported. No further information was provided. This case is one of the several reports from the same reporter. Additional inormation has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to 2 unspecified patient of unknown age and gender. The patients concurrent conditions and medical history were not reported. The healthcare worker reported that on 22-SEP-2015, 2 different unspecified patients were vaccinated with an improperly stored, VARIVAX (Merck) lot # L006386; expiry date: 25-FEB-2017 (dose and route not reported). No adverse effects were reported. No further information was provided. This case is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist regarding a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration were not reported). On an unspecified date in 2008 (reported as 7 years ago), the patient had post ZOSTAVAX shingles. The patient's outcome was unknown. The relatedness between the event and the therapy with ZOSTAVAX was not provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: DTP, VARZOS
Symptoms: Erythema, Headache, Injection site induration, Peripheral swelling, Rash pustular
Clinical narrative: Per patient voice message my arm swelled up and turned red in an area the size of a large orange and when pressed at the site of the shot the tissue felt very hard. Soon after small pustules formed similar to those of chicken pox. I also got a very bad headache.
Age: 67.0
Sex: F
Vaccine: DTP, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Per patient voice message my arm swelled up and turned red in an area the size of a large orange and when pressed at the site of the shot the tissue felt very hard. Soon after small pustules formed similar to those of chicken pox. I also got a very bad headache.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash. Hydroxyzine.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swelling and pain in left hand approximately 1 hour after vaccine given.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unspecified date, in 2015, reported as "since the first execution, which occurred on an unspecified date in August 2015", the patients were vaccinated with unspecified doses of PNEUMOVAX 23 lot # K008410 and expiration date 26-FEB-2016, (route of administration and anatomical location were not reported); the doses were exposed to temperatures outside of the recommended range. There were no concomitant medications reported. No adverse experiences had been reported. There was no product quality issue involved. This is one case of several cases 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 has been received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. Some doses of GARDASIL, (Lot # K011562, exp. date 08-APR-2017 and Lot # reported as L005560, exp. date 18-DEC-2016), (strength, route of administration and dose were not provided), which were exposed to temperatures outside of the recommended range, have been administered to unspecified patients on unspecified dates since 28-AUG-2015. No adverse experience had been reported. No product quality complaint (PQC) was involved. 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 was received from a licensed vocational nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unspecified dates, in 2015, reported as "since the first execution, which occurred on an unspecified date in August 2015", the patients were vaccinated with unspecified doses of (Oka/Merck) VARIVAX (route of administration, anatomical location, lot number and expiration date were not reported); the doses were exposed to temperature outside of the recommended range. There were no concomitant medications reported. No adverse experiences had been reported. There was no product quality issue involved. This is one case of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On an unknown date the patient was vaccinated with a dose of an improperly stored ZOSTAVAX (lot#, dose, route not reported). Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received form a Registered Nurse concerning an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. Some doses of PNEUMOVAX 23, (Lot # L003227,exp. date 13-oCT-2016), (strength, route of administration and dose were not provided), which were exposed to temperatures outside of the recommended range, have been administered to unspecified patients on unspecified dates since 28-AUG-2015. No adverse experience had been reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.1
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse referring to a 1 month old infant of unknown gender. The patient's concurrent conditions and medical history were not reported. On 11-SEP-2015, the patient was intended to receive an unspecified hepatitis B vaccine, was inadvertently administered VAQTA (dose, strength, lot # and route were not reported). No adverse effects reported. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unspecified dates, in 2015, reported as "since the first execution, which occurred on an unspecified date in August 2015", the patients were vaccinated with unspecified doses of VAQTA (route of administration, anatomical location, lot number and expiration date were not reported); the doses were exposed to temperatures outside of the recommended range. There were no concomitant medications reported. No adverse experiences had been reported. There was no product quality issue involved. This is one case of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unspecified dates, in 2015, reported as "since the first execution, which occurred on an unspecified date in August 2015", the patients were vaccinated with unspecified dose of oral, ROTATEQ, (lot number and expiration date were not reported); the doses were exposed to temperatures outside of the recommended range. There were no concomitant medications reported. No adverse experiences had been reported. There was no product quality issue involved. This is one case of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unspecified dates, in 2015, reported as "since the first execution, which occurred on an unspecified date in August 2015", the patients were vaccinated with unspecified doses of GARDASIL (route of administration, anatomical location, lot number and expiration date were not reported); the doses were exposed to temperatures outside of the recommended range. There were no concomitant medications reported. No adverse experiences had been reported. There was no product quality issue involved. This is one case of several cases from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via field representative refers to two female patients of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date in 2015 (also reported as in the past month), the patient was vaccinated with ZOSTAVAX, (dose, frequency and route of administration not provided). On an unknown date in 2015 (also reported as in the past month), both patients experienced injection site swelling and redness after receiving ZOSTAVAX. No treatment was given for adverse events. Therapy with ZOSTAVAX was continued. The outcome of events was unknown. Causality assessment was not provided. No product quality complaint (PQC) was filed. Follow up information has been received on 02-OCT-2015 from a pharmacist via phone call referring to the approximately 60 year old female patient. Lot# of ZOSTAVAX was L012475 and expiration date was unknown at the time of reporting. The reporter confirmed the patient experienced injection site erythema and injection site swelling and both the events were resolved in about 2-3 days. The reporter also stated one of the reported female patients stated that the injection site "looked bad" but there was "no pain or itching" at the injection site. This is one of two reports received from the same reporter. Additional information has been requested. Patient information, event information and narrative were updated.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 1 year old patient of an unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) unknown route and strength (lot # K015970 with expiration date 23-SEP-2016 or lot # K021847 with expiration date 03-NOV-2016 or lot # L001335 with expiration date of 13-JAN-2017) which were exposed to temperatures outside of the recommended range. There was no adverse events reported. The reporter could not break out which specific lot number of vaccine was administered to the patient. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 4 year old patient of an unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) unknown route and strength (lot # K015970 with expiration date 23-SEP-2016 or lot # K021847 with expiration date 03-NOV-2016 or lot # L001335 with expiration date of 13-JAN-2017) which were exposed to temperatures outside of the recommended range. There was no adverse event reported. The reporter could not break out which specific lot number of vaccine was administered to the patient. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 55 year old female patient. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 05-OCT-2015 the patient was subcutaneously vaccinated with 0.5 ml of PROQUAD (Merck) in the right arm. No concomitant medications were reported. Reporting nurse stated that the patient was supposed to be vaccinated with M-M-R II and VARIVAX (Merck), but due staff error the patient was administered with PROQUAD (Merck). No adverse effects were reported at this time. Additional information is not expected as the reporter did not wish further contact.
Age: 0.2
Sex: U
Vaccine: HEPA
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 2 month old patient of unspecified gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 05-OCT-2015 the patient was vaccinated with dose 1 of VAQTA (strength, dose, frequency, route, lot #, expiry date unspecified). No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 05-OCT-2015, the patient was vaccinated with expired dose of ZOSTAVAX (lot# K009198, expiration date 05-SEP-2015, dose, route of administration and anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with a improperly stored doses of GARDASIL 9 (lot# not reported). This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 1 year old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX unknown route and strength (lot # K015970 with expiration date 23-SEP-2016 or lot # K021847 with expiration date 03-NOV-2016 or lot # L001335 with expiration date of 13-JAN-2017) which were exposed to temperatures outside of the recommended range. There was no adverse event reported. The reporter could not break out which specific lot number of vaccine was administered to the patient. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 4 year old patient of an unknown gender. The patient's pertinent medical history, drug reactions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) unknown route and strength (lot # K015970 with expiration date 23-SEP-2016 or lot # K021847 with expiration date 03-NOV-2016 or lot # L001335 with expiration date of 13-JAN-2017) which were exposed to temperatures outside of the recommended range. There was no adverse event reported. The reporter could not break out which specific lot number of vaccine was administered to the patient. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Varicella
Clinical narrative: Information has been received from a pharmacist referring to a 34 years old unpregnant female patient. There were no pertinent medical history or drug reaction/allergies of the patient. On 21-SEP-2015 the patient received her first dose of VARIVAX (Merck) (dose, lot# and expiration date were not reported) subcutaneously. There was no concomitant medication. After receiving the VARIVAX (Merck) the patient experienced a varicella like rash on unspecified areas of her body on an unspecified date in 2015. The patient visited her unspecified physician on an unspecified date in 2015 who diagnosed the patient with chickenpox. The patient was not prescribed any treatment for the rash. The outcome of the event was reported as recovering. The causality was not reported. Additional information is not expected as there is no consent to contact any healthcare professional.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age and gender. There was no information about the patient's medical history and concurrent condition. On unknown dates between July 2015 and 11-SEP-2015, these patients were vaccinated with improperly stored oral, ROTATEQ (lot # K016314, expiration date: 05-JUN-2016 or lot # L004466, expiration date: 02-AUG-2016, strength, dose unknown) orally. There was no information about concomitant therapy. No adverse effects were 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: Information has been received from a Licensed Vocational Nurse referring to multiple patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L001335 with expired date 13-JAN-2017; lot# L006386 with expired date 25-FEB-2017; lot# L018002 with expired date 19-MAY-2015; lot# L001333 with expired date 13-JAN-2017; lot# L015047 with expired date 19-APR-2017; dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. Some doses of VAQTA, (Lot # L007559, exp. date 01-JUN-2017), (strength, route of administration and dose were not provided), which were exposed to temperatures outside of the recommended range, have been administered to unspecified patients on unspecified dates since 28-AUG-2015. No adverse experience had been reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. Some doses of PEDVAXHIB, (Lot # K015464, exp. date 09-JUL-2017 and Lot # K008680, exp. date 11-MAR-2017), (strength, route of administration and dose were not provided), which were exposed to temperatures outside of the recommended range, have been administered to unspecified patients on unspecified dates since 28-AUG-2015. No adverse experience had been reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. Some doses of RECOMBIVAX HB, (Lot # L007558, exp. date 10-OCT-2016 and Lot # K026666, exp. date 22-OCT-2016), (strength, route of administration and dose were not provided), which were exposed to temperature outside of the recommended range, have been administered to unspecified patients on unspecified dates since 28-AUG-2015. No adverse experience had been improved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with a improperly stored doses of VAQTA (lot# not reported). This is one of several reports received from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product
Clinical narrative: This spontaneous report was received from a pharmacist via poison and drug center (Manufacturer# US15-045398) on 29-SEP-2015 and refers to a 63 year old female patient. There was no information about patient's concurrent conditions and medical history reported (no chronic health issues as hypertension or diabetes mellitus). On 13-OCT-2014, the patient was vaccinated with the first dose of ZOSTAVAX (lot#, expiration date, dose, site and route of administration were not reported). On 26-SEP-2015, the patient was inadvertently vaccinated with the second dose of ZOSTAVAX 0.65 ml (lot# L020482, expiration date 02-SEP-2016, anatomical location was not reported) intramuscularly. Concomitant therapies included Tdap, influenza virus vaccine inactivated (unspecified), gabapentin, propranolol (manufacturer unknown), paroxetine, levothyroxine (manufacturer unknown), lamotrigine, fenofibrate and triazolam. No unwanted events and no lab work were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with a improperly stored doses of RECOMBIVAX HB (lot# not 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 pharmacists refers to an unspecified patient of unknown age and gender. No information on concurrent conditions and medical history was reported. No previous drug reactions or allergies were reported. On 29-SEP-2015, the patient were vaccinated with improperly stored RECOMBIVAX HB (strength, dose, route and frequency were not reported) lot # K021444 with an expiry date of 17-SEP-2016. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacy manager referring to a number of unspecified patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # J007952, expiration date: 27-JUN-2015, first dose on 26-AUG-2014 and last dose on 05-MAY-2015; lot # J014960, expiration date: 26-NOV-2015, first dose on 07-AUG-2014 and last dose on 25-AUG-2014; lot # K002917, expiration date: 26-FEB-2016, first dose on 27-AUG-2014 and last dose on 13-JUL-2015; lot # L005298, expiration date: 17-FEB-2017, first dose on 21-JUL-2015 and last dose on 02-SEP-2015; lot # K005427, expiration date: 15-APR-2016, first dose on 08-JUL-2015 and last dose on 28-AUG-2015; lot # reported as L003856, expiration date: 05-FEB-2017, first dose and last dose both on 18-AUG-2015; strength, dose and route unknown). The VARIVAX (Merck) was stored in a clinic freezer which had operated for 13 months with excursions above 5 degree Fahrenheit for 10-20 minutes three times a day. These temperature variations continued until the problem was discovered on 04-SEP-2015. At that time all VARIVAX (Merck) was sequestered and new vaccines ordered. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Information has been received from a Certified Medical Assistant (healthcare provider) via a company representative referring to two unspecified female patient of unknown age. Information about patient's concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with unspecified doses of GARDASIL 9 (lot#, dose, route not provided, for vaccination). On unspecified dates the patients experienced light headed and dizzy. The patients had sought medical attention via an unspecified office visit. The outcome of the event was reported as recovered on an unknown date. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. on 05-SEP-2014 the patient was vaccinated with RECOMBIVAX HB, (dose 1, route-unspecified) followed by the second dose on 06-OCT-2014. It was reported that the patient had not received the third dose yet but was planning to get it on 30-OCT-2015 (inappropriate schedule of drug administration). No adverse effects were reported. No product quality complaint (PQC) was involved. The outcome of the events is unknown. The reporter considered the events to be not related to RECOMBIVAX HB. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Malaise
Clinical narrative: This spontaneous report as received from a 60 year old female nurse regarding herself. The patient's concurrent conditions included diabetes and high blood pressure. On 20-SEP-2015, the patient was vaccinated with 0.65 ml of ZOSTAVAX subcutaneously for prevention of shingles. The patient also received a dose of unspecified influenza virus vaccine. Concomitant medications included many unspecified medications. On 23-SEP-2015, the patient started to develop a rash with little bumps on her left arm around the injection site which was described as oval in shape measuring 12 centimeter (cm) long and 5 cm wide. The rash was reported as red in color and warm to touch. There was a larger and lighter color around the rash which had begun to subside on 24-SEP-2015 but was yet sore to touch. The patient felt feverish as though she was falling sick. The Varicella-zoster virus packet was declined. The patient did not sought medical attention and no treatment was provided for the events. The outcome of falling sick, injection site pain and feeling feverish was unknown. The outcome of the injection site reactions reported for the main rash were recovering at the time of this report. The relatedness of the events with suspect therapies was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a 60 year old female nurse regarding herself. The patient's concurrent conditions included diabetes and high blood pressure. On 20-SEP-2015, the patient was vaccinated with 0.65 ml of ZOSTAVAX subcutaneously for prevention of shingles. The patient also received a dose of unspecified influenza virus vaccine. Concomitant medications included many unspecified medications. On 23-SEP-2015, the patient started to develop a rash with little bumps on her left arm around the injection site which was described as oval in shape measuring 12 centimeter (cm) long and 5 cm wide. The rash was reported as red in color and warm to touch. There was a larger and lighter color around the rash which had begun to subside on 24-SEP-2015 but was yet sore to touch. The patient felt feverish as though she was falling sick. The Varicella-zoster virus packet was declined. The patient did not sought medical attention and no treatment was provided for the events. The outcome of falling sick, injection site pain and feeling feverish was unknown. The outcome of the injection site reactions reported for the main rash were recovering at the time of this report. The relatedness of the events with suspect therapies was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. Doses of PROQUAD (Merck) lot # L026728, expiry date 15-JAN-2017 or lot # L019996, expiry date 02-FEB-2016 (routes and sites of administration, doses were not reported) which were exposed to temperatures outside of the recommended range, have been administered to unspecified patients on unspecified dates since 24-SEP-2015 - the date of the excursion. Other suspect therapies included VARIVAX (Merck). No adverse experience has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's current conditions, medical history and concomitant medications were not reported. On 22-OCT-2014, the patient was vaccinated with ZOSTAVAX 0.65 ml subcutaneously (strength, lot number and expiry date were not reported). On 23-SEP-2015, the patient received a second dose of ZOSTAVAX 0.65 ml subcutaneously (lot number L000461 and expiry date 08-MAR-2016). No adverse effects were reported. No further information was provided. Additional information has been requested.