chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Patient developed rash at the site of injection 2 days after the vacine was administered. Her doctor gave a triamcinolone to apply to the rash. She also had fever the following day.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: Dyskinesia, Head banging, Neurological symptom, Seizure, Sensory disturbance
Clinical narrative: Patient received 3 vaccines on 12/5/2014 and had full body seizure on 12/6/2014 mid day. Was denied being seen by neurologist because mom mentioned the vaccines. Neurological symptoms continued for months following- including head-banging/spinning- other sensory symptoms- that were no present prior.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site discolouration, Injection site erythema, Injection site reaction, Injection site warmth, Skin tightness
Clinical narrative: Patient came in for 6 months shots. 5 min after injection this nurse notice patients legs turn red from injection site down to toes and circling entire left and right leg. Patients father was holding at the time so I asked him to lay her on the table. This nurse touched infants legs both right and left leg felt warm to touch, tight, and were visible red, purplish with white blanching. This nurse went and found a provider in the facility who came and observed infant. Infant appeared in no distress, was cooing and active. Physician recommend family take infant to ER to be on the safe side for reaction.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Influenza like illness, Injection site pain, Nasopharyngitis
Clinical narrative: Severe flu-like symptoms: shivering, cold sweats, whole body pain, severe pain at injection sight and left arm. Symptoms began approximately 6 hours after injection. My reaction to this second vaccine was much more severe than my reaction to the 1st does, which was more like common cold symptoms. I have literally been confined to bed for 24 hours.   Further note: I have received many vaccinations at this location and vaccine was administered correctly.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Severe flu-like symptoms: shivering, cold sweats, whole body pain, severe pain at injection sight and left arm. Symptoms began approximately 6 hours after injection. My reaction to this second vaccine was much more severe than my reaction to the 1st does, which was more like common cold symptoms. I have literally been confined to bed for 24 hours.   Further note: I have received many vaccinations at this location and vaccine was administered correctly.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pain
Clinical narrative: Chills, headache, fever (Days 1-2), extreme muscle and joint pain (Days 2-4). Still achy. Gradually recovering. This also occurred with the first dose (02/01/19), but I didn't report it.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, headache, fever (Days 1-2), extreme muscle and joint pain (Days 2-4). Still achy. Gradually recovering. This also occurred with the first dose (02/01/19), but I didn't report it.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Pt passed out after receiving vaccination. Pt recovered quickly.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hypoaesthesia, Injection site erythema
Clinical narrative: Patient called and said she received her second dose of the shingles vaccine on 6/3 in her left arm. She states that she woke up the next day with soreness, redness and swelling at the injections site and then felt extremely fatigued with fever, chills and headache. She took an epsom salt bath but not OTC medication. Today she states the swelling is in her entire left arm and even in her bilateral legs more pronounced on the left leg. She states she has a funny feeling of numbness in her left neck down her left arm to her fingers. She denies difficulty breathing. Recommend she visit Urgent care or ER for further evaluation for severe swelling and numbness. Let know could take OTC benadryl but warned of drowsiness. Patient verbalizes understanding and will visit urgent care.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling, Pyrexia
Clinical narrative: Patient called and said she received her second dose of the shingles vaccine on 6/3 in her left arm. She states that she woke up the next day with soreness, redness and swelling at the injections site and then felt extremely fatigued with fever, chills and headache. She took an epsom salt bath but not OTC medication. Today she states the swelling is in her entire left arm and even in her bilateral legs more pronounced on the left leg. She states she has a funny feeling of numbness in her left neck down her left arm to her fingers. She denies difficulty breathing. Recommend she visit Urgent care or ER for further evaluation for severe swelling and numbness. Let know could take OTC benadryl but warned of drowsiness. Patient verbalizes understanding and will visit urgent care.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient said she had fever, body aches, sore arm and was sick for 5 days. Told patient Pharmacist will report to Vaers.
Age: 17.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Minor was recieving vaccines, became lightheaded and had brief syncopal episode lasting approximatiley 30 seconds.  Minor sponteously woke, VSS after episode.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Joint swelling, Swelling
Clinical narrative: Patient came in for 2nd vaccination and described swollen first left knuckle shortly after receiving her 1st dose in March. Patient states she received her shot and took a nap and woke up with redness, swelling, and pain in her first left knuckle. Patient spoke with primary care and stated that md is aware and was not concerned as it was not getting worse. Today, the knuckle still looks bigger. Patient states that she feels pain at times but the swelling has gone down since.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Grip strength decreased, Hypoaesthesia, Paraesthesia
Clinical narrative: The afternoon after receiving the shot he noticed numbness and tingling is the ring and pinky fingers of the arm he received the injection in. The affected fingers have continued to be numb. He has noticed diminished grip strength. He called the doctor after he noticed the symptoms. They told him that it should get better after a few days. It still was not feeling better the Monday after feeling receiving the vaccine, at which time I talked to him. I advised him to see his doctor to be further examined and have not since heard from him.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain in left shoulder and muscles to the point where I could not lift my arm.   This was very different than a normal shot where there may be slight pain at the site.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Dyskinesia, Loss of consciousness
Clinical narrative: stated felt light headed, passed out with jerking of extremities lasted less then a minute. When conscious again, he  asked what happened, no post dictal episode. no somnolence. no incontinence. was able to walk to car unaided, with supervision. heart rate immediately following episode 50 bpm, blood pressure 136/74, pulse ox 100%, within 5 minutes heart rate 68 bpm, blood pressure 130/86 pulse ox 100%,
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: 6/4-generalized body aches, headache, ringing in ears 6/5- at injection site, firm & hot to touch, painful, edema & erythema
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pain, Tinnitus
Clinical narrative: 6/4-generalized body aches, headache, ringing in ears 6/5- at injection site, firm & hot to touch, painful, edema & erythema
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: PATIENT VISITED URGENT CARE WITH SYMPTOMS, WAS TOLD BY MD THAT SHE HAD CELLULITIS
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient called pharmacy on 6/5/2019 and reported developing a shingles rash out break.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Local reaction, Skin warm, Tenderness
Clinical narrative: Local reaction of tenderness, redness, and hot to the touch larger than 10 cm in diameter.  Concerns for cellulitis so a course of Keflex 500mg, tid for 7 days was initiated on 6-5-2019, on the 3rd day post vaccine and 2nd day of the reaction,by her spouse, who is a infectious disease doctor.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, UNK, UNK
Symptoms: Agitation, Fatigue, Flushing, Odynophagia, Oropharyngeal pain
Clinical narrative: Child's throat became so sore to the point child could not intake regular bottled feedings by the 5th day after receiving shots.  Mid grade fevers started immediately the next morning after shots.  Cheeks very flush.  Bed completely soaked after sleep on multiple occasions.  VERY and easily agitated.  Exhausted.  Will sleep for an hour then cry or jolt himself awake.  Then after half an hour of activity starts rubbing  red eyes showing signs of tiredness.  Overnight sleeps for 5 hours then the rest of the night very restless crying himself awake at times.  After nearly 3 weeks of attempting to control the fevers, sore throat, agitation, and tiredness, Dr. decided to start child on an Amoxicillin prescription for one week.  Up until the day of these vaccines, this child was sleeping for two hour stretches at a time during the day, consuming the expected amount of bottled foods for his age and size requirements, HAPPY, nearly sleeping through the night aside from diaper changes or normal feedings with no agitation or crying and was able to stay up for 2-3 hours of playtime/feedings during the day before showing signs of tiredness.  NEVER woke soaking wet and NEVER woke himself crying.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, UNK, UNK
Symptoms: Poor quality sleep, Pyrexia, Sleep disorder
Clinical narrative: Child's throat became so sore to the point child could not intake regular bottled feedings by the 5th day after receiving shots.  Mid grade fevers started immediately the next morning after shots.  Cheeks very flush.  Bed completely soaked after sleep on multiple occasions.  VERY and easily agitated.  Exhausted.  Will sleep for an hour then cry or jolt himself awake.  Then after half an hour of activity starts rubbing  red eyes showing signs of tiredness.  Overnight sleeps for 5 hours then the rest of the night very restless crying himself awake at times.  After nearly 3 weeks of attempting to control the fevers, sore throat, agitation, and tiredness, Dr. decided to start child on an Amoxicillin prescription for one week.  Up until the day of these vaccines, this child was sleeping for two hour stretches at a time during the day, consuming the expected amount of bottled foods for his age and size requirements, HAPPY, nearly sleeping through the night aside from diaper changes or normal feedings with no agitation or crying and was able to stay up for 2-3 hours of playtime/feedings during the day before showing signs of tiredness.  NEVER woke soaking wet and NEVER woke himself crying.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: The RN administered first of two vaccine shots in left shoulder of my son.  He was not even aware that the shot had been administered until the RN set that needle down, picked up the other one, and went to his other side for shot #2.  About 5-10, no more than 30 seconds later, he began feeling faint, woozy, nauseated.  The RN quickly repositioned my son on the table to lean back some while we lifted his legs, which I took over as the RN went to get the doc.  Dr. came in, examined vitals as I recall and mentioned, I think, that son's BP had dropped some, but within a few minutes his color came back, nausea dissipated, I was able to lower his legs, and eventually we left.  No additional noticeable reactions since then, tho monitoring.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Musculoskeletal pain, Neck pain
Clinical narrative: reported experiencing pain in shoulders, neck and base of skull and dizziness for more than 2 weeks after injection.  She had been taking ibuprofen but getting little relief.  Patient will contact her primacy care provider.
Age: 54.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Arthritis, Hypoaesthesia, Injected limb mobility decreased, Pain in extremity, X-ray abnormal
Clinical narrative: Patient has had pain in the arm since the injections on 4/1/2019 (pain that never went away).  Her dr has done a x-ray (showed  "filling up with arthritis" according to patient) and has a MRI scheduled for 6/20/19.  Complains on loss of mobility and feeling in the arm since the injection (she stated the shingrix specifically).
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Approximately 5 x 15 cm erythematous, warm reaction around the injection site on the right shoulder. Tylenol, and ibuprofen. RTC if worsening or changing symptoms, if experiencing fevers, or if no improvement over the next 5 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Injection site reaction, Muscular weakness
Clinical narrative: severe muscle ache and muscle weakness (left arm above elbow) headache; tiredness; slight fever -- all at the same time.  Muscle ache and slight headache  lasted about 30 hours
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: severe muscle ache and muscle weakness (left arm above elbow) headache; tiredness; slight fever -- all at the same time.  Muscle ache and slight headache  lasted about 30 hours
Age: 31.0
Sex: M
Vaccine: HEPAB, PPV, TDAP
Symptoms: Feeling cold, Hyperhidrosis, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Redness, swelling, and pain at injection sites on left arm. Patient feels cold and sweating every 15 minutes. Movement restriction on left arm.
Age: 31.0
Sex: M
Vaccine: HEPAB, PPV, TDAP
Symptoms: Injection site swelling
Clinical narrative: Redness, swelling, and pain at injection sites on left arm. Patient feels cold and sweating every 15 minutes. Movement restriction on left arm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Influenza like illness, Peripheral swelling
Clinical narrative: Shingrix Vaccine was administered on 06/03/19. Patient stopped by the pharmacy to report that she developed swelling on her left hand about 4-5 inches below the vaccine site on 06/04/19. it was red, warm to the touch, painful and had been expanding in size. she also reported having had Flu-like symptoms. she was advised to see her Dr. She later stated that she had gone to an Urgent care where she was diagnosed with cellulitis, for which was being treated
Age: 13.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Left arm (Bicep) Red & swollen Fever up to 102' since 6/4/19. Body aches.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Ageusia, Facial paralysis, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Patient was administered the second Menactra dose a week ago. Two days later the right side of his face began to feel numb. His mother noted that his mouth was sagging towards the left side at rest. Patient also lost his sense of taste on the right side of the mouth. He was subsequently diagnosed with Bell's Palsy and prescribed oral steroids and an unrecalled antibiotic. He has two more days left on the oral steroid.UNABLE TO RAISE THE RIGHT EYEBROW; MOUTH IS SYMMETRICAL AT REST BUT DEVIATES TOWARDS THE LEFT SIDE WHEN ASKED TO SMILE; RIGHT BUCCAL MUCOSA, RIGHT UPPER AND LOWER GINGIVA AND HARD PALATE IS NUMB, RIGHT SIDE OF THE LIPS IS NUMB. Advised to complete course of oral steroids.Call in 7 days if no improvement.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Joint swelling, Lip swelling, Swollen tongue, Tachycardia
Clinical narrative: Tachycardia Ankle Swelling swollen Lips tongue shortness of breath
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Dysphagia, Dyspnoea, Rash
Clinical narrative: Patient/employee reported on 6/3/19 that on 6/1/19 she began developing rash on neck, chest & torso (mid) - when further questioned she reported some SOB & difficulty swallowing - she went to ER for eval & tx. Per her report received Benadryl/PO & rash began to resolve within 1 hr. No further difficulty with SOB or swallowing.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Influenza like illness, Injection site pain, Swelling
Clinical narrative: patient reported flu like symptoms, pain at the injection site, swelling, numbness in arm and was wearing a sling
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Swelling
Clinical narrative: sore arm, bump, hard to lift arm after several months. if she messages area she can lift arm
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Urticaria; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 696062). Information was received regarding a 11-year-old male patient. The patient's concurrent conditions included asthma and allergies to eggs, hydroxyzine, ibuprofen, lentils, peanut butter. The patient's medical history included eczema. Information on the patient's prior vaccinations and other medications was not reported. On 22-MAY-2017, at 03:00, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 2, intramuscularly in the right arm for prophylaxis (dosage unspecified). The patient left the clinic with the parent and on the way home, the patient noticed hives on legs and arms (urticarial). The patient returned to clinic and the registered nurse (RN) gave 25 mg of diphenhydramine hydrochloride (BENADRYL) orally at 3:30. The patient did not have difficulty breathing or other symptoms. The outcome of urticaria was reported as recovered in May 2017. The causality assessment was not reported.  Lot number M04199D is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  Follow-up information was obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 696062) on 15-APR-2019. The primary reporter was a licensed vocational nurse. The patient had no illness at time of vaccination. The time of the vaccination was reported as 15:00 and the onset of the event as 15:10 on 22-MAY-2017.  Follow-up information was received from the nurse on 28-MAY-2019. The nurse stated that she had no recollection of submitting an adverse event report to the FDA, regarding the specified patient. No further information was provided.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Anticoagulation drug level, Asthenia, Blood gases, Blood magnesium, Blood pressure immeasurable
Clinical narrative: Patient states he was severely fatigued the following day. He visited his physician due to fatigue and was sent to hospital. Patient states he was diagnosed with atrial fibrillation. Patient states his physicians did not indicate his diagnoses was due to him receiving the vaccine, but patient states he had no prior history of A-fib.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood thyroid stimulating hormone, Brain natriuretic peptide, Chest X-ray, Differential white blood cell count, Dyspnoea
Clinical narrative: Patient states he was severely fatigued the following day. He visited his physician due to fatigue and was sent to hospital. Patient states he was diagnosed with atrial fibrillation. Patient states his physicians did not indicate his diagnoses was due to him receiving the vaccine, but patient states he had no prior history of A-fib.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Echocardiogram, Electrocardiogram, Fatigue, Full blood count, Gait inability
Clinical narrative: Patient states he was severely fatigued the following day. He visited his physician due to fatigue and was sent to hospital. Patient states he was diagnosed with atrial fibrillation. Patient states his physicians did not indicate his diagnoses was due to him receiving the vaccine, but patient states he had no prior history of A-fib.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test, Lipids, Metabolic function test, Nausea, Platelet count
Clinical narrative: Patient states he was severely fatigued the following day. He visited his physician due to fatigue and was sent to hospital. Patient states he was diagnosed with atrial fibrillation. Patient states his physicians did not indicate his diagnoses was due to him receiving the vaccine, but patient states he had no prior history of A-fib.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Thyroxine free
Clinical narrative: Patient states he was severely fatigued the following day. He visited his physician due to fatigue and was sent to hospital. Patient states he was diagnosed with atrial fibrillation. Patient states his physicians did not indicate his diagnoses was due to him receiving the vaccine, but patient states he had no prior history of A-fib.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation, Fatigue
Clinical narrative: Patient states he was severely fatigued the following day. He visited his physician due to fatigue and was sent to hospital. Patient states he was diagnosed with atrial fibrillation. Patient states his physicians did not indicate his diagnoses was due to him receiving the vaccine, but patient states he had no prior history of A-fib.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Incorrect route of product administration, Injected limb mobility decreased, Pain in extremity
Clinical narrative: PATIENT STATED IMMUNIZATION WAS GIVEN IN JOINT INSTEAD OF MUSCLE AND CANNOT LIFT ARM
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Product administered at inappropriate site
Clinical narrative: PATIENT STATED IMMUNIZATION WAS GIVEN IN JOINT INSTEAD OF MUSCLE AND CANNOT LIFT ARM
Age: 74.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Incorrect route of product administration, Injected limb mobility decreased, Pain in extremity
Clinical narrative: PATIENT STATED IMMUNIZATION WAS GIVEN IN JOINT INSTEAD OF MUSCLE AND CANNOT LIFT ARM
Age: 74.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Product administered at inappropriate site
Clinical narrative: PATIENT STATED IMMUNIZATION WAS GIVEN IN JOINT INSTEAD OF MUSCLE AND CANNOT LIFT ARM
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever of 100.4 and muscle aches. Also head ache.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Slight fever Severe chills Severe body aches Fatigue Dull headache  I took a non-aspirin otc pain reliever. Symptoms lasted approximately 2 days.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenitis
Clinical narrative: adenitis of the left supraclavicular lymph node. Ice area. Use Tylenol/Ibuprofen for pain and swelling. And go to PCP. Complete workers compensation paperwork.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Mobility decreased, Myalgia
Clinical narrative: -significant muscle pain (all over body), started about 1 day after administration and lasted about 15 days, ibuprofen taken to help with the pain and improve mobility -moderate fatigue, started about 1 day after administration and lasted a few days
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; on 28-MAY-2019, 1 dose of properly stored VAQTA (expiration date 27-MAY-2019) was administered to a child; This spontaneous report was received from a medical assistant and refers to a child patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions or allergies was not provided.    On 28-MAY-2019, the patient was vaccinated with a properly stored but expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 dosage form, lot # R010954, expiration date 27-MAY-2019 (strength, route and anatomical location were not provided) for prophylaxis. No adverse effects were reported.
Age: 53.0
Sex: M
Vaccine: HPV9
Symptoms: Anogenital warts, Vaccination failure
Clinical narrative: genital warts have now returned; but the genital warts have now returned; This spontaneous report was received from a pharmacist referring to a 53 years old male patient. The patient's concurrent conditions included type 2 diabetes mellitus, hypertension, hyperlipidaemia and human immunodeficiency virus (HIV) infection (reported as HIV). The patient's medical history included human papillomavirus (HPV) with genital warts, resulting in prior surgeries. Concomitant therapies included testosterone(ANDROGEL), hydroxyzine (reported as hydrozyzine), duloxetine hydrochloride(CYMBALTA), cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide fumarate(GENVOYA), lisinopril and metformin hydrochloride, sitagliptin phosphate(JANUMET).  In 2018 (reported as last year), at the age of 53 years old, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) series (strength, dose, lot # and expiration date were not reported) intramuscularly for prophylaxis (indication reported as HPV). The last dose was being administered on 02-AUG-2018. In 2018 (reported during the two months following the last dose of the series), the patient did not have any outbreaks but the genital warts had now returned, which might require another surgery. Treatment was not given. None lab diagnostics or studies was performed. The patient sought medical attention.  The outcome of anogenital warts and vaccination failure was reported as not recovered. The causality assessment was not provided by the reporter.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, No adverse event, Rubella antibody negative
Clinical narrative: patient had a blood work drawn and it showed no immunity for measles, mumps, and rubella; no adverse effects reported; This spontaneous report was received from a registered nurse and refers to herself, a female patient of unknown age with hyperlipidaemia, seasonal allergy and food allergy. Concomitant therapies included sterile diluent, unspecified thyroid medication, unspecified cholesterol medication and unspecified seasonal allergy medication.      On an unknown date (also reported as "unknown vaccination history with MMR II"), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), via an unknown route of administration, for prevention of measles, mumps, rubella (strength, dose, frequency, lot number and expiration date were not provided).     On an unknown date, the patient had a blood work-titer drawn for  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and it showed no immunity for measles, mumps, and rubella (measles antibody negative). No adverse effect reported.      At the time of reporting, the outcome of measles antibody negative was unknown, however it was reported that the patient was stable.     The causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the reported measles antibody negative was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 09-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034394, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA001826: US-009507513-1906USA001827: US-009507513-1906USA001828: US-009507513-1906USA001829: US-009507513-1906USA001830: US-009507513-1906USA001831: US-009507513-1906USA001832: US-009507513-1906USA001833: US-009507513-1906USA001834: US-009507513-1906USA001835: US-009507513-1906USA001836: US-009507513-1906USA001837: US-009507513-1906USA001838: US-009507513-1906USA001839: US-009507513-1906USA001840: US-009507513-1906USA001841: US-009507513-1906USA001842: US-009507513-1906USA001843: US-009507513-1906USA001844: US-009507513-1906USA001845: US-009507513-1906USA001846: US-009507513-1906USA001847: US-009507513-1906USA001848: US-009507513-1906USA001849:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Improperly stored PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender.    The patient's medical history and concurrent conditions were unknown.  On 31-MAY-2019, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S002497 Exp.date: 23-JUL-2020) of dose 1.5 milliliter through subcutaneous route for prophylaxis (product storage error). The patient's concomitant medication included sterile diluent.  The vaccine was exposed to a temperature of -4.3 C for a time frame of 3 hours and 21 minutes. There was no previous temperature excursion. No adverse events was reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; a patient was administered PNEUMOVAX 23 - Temperature AND Time frame; This spontaneous report has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, pertinent medical history, concomitant medication, drug reactions or allergies.  On 31-MAY-2019, the patient received an unspecified dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot #R034248 and expiration date 07-AUG-2020 for prophylaxis (dose and route of administration were not reported) which was improperly stored. No adverse effects were reported.  It was reported that on an unspecified date, the vaccine was exposed to a temperature above 47 Fahrenheit degrees/9 Celsius degrees for 7 hours. The registered nurse reported that there was no previous temperature excursion. The call was not placed because of a Digital Data logger report.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored PROQUAD was administered to patient; No adverse effect reported; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On 30-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 milliliter per subcutaneous route, lot # S002501 expiration date 23-JUL-2020.  No adverse effect was reported.  Digital Data Logger registered a temperature excursion of 18.3 Fahrenheit degrees along 8 hours and 47 minutes.
Sex: M
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: The patient was hospitalized after receiving the GARDASIL 9 vaccination; Information has been received from a consumer referring to a 11-year-old male patient via a vaccine representative. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported.    On an unknown date, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis.         The reporter, as the patient's aunt, reported that the patient was hospitalized after receiving the HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). The outcome of the hospitalization was unknown.  The reporter did not provide causal relationship between the hospitalization and the vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; administered improperly stored doses of VARIVAX; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 31-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R035223, expiration date 04-DEC-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of -11.4 degrees Celsius (C) for 9 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA001815: US-009507513-1906USA001816:
Sex: F
Vaccine: HPV9
Symptoms: Chest pain
Clinical narrative: The patient experienced severe chest pains and was taken to the emergency room; This spontaneous report was received from a nurse practitioner concerning  to a 39 year old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On 20-MAR-2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported).        On 22-MAR-2019, (reported as within 3 days of the injection) the patient experienced severe chest pains and was taken to the emergency room.   The outcome of chest pain was unknown.   The nurse did not think the chest pain was related to  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE EFFECT; Patient received the first and second doses of gardasil 9 on unspecified dates when she was 19-year-old and at 24-year-old was on the office for the third dose of gardasil 9.; This spontaneous report was received from a medical assistant and refers to a 24-year-old patient, gender was not reported. Patient's concurrent conditions, medical history, concomitant medications, drug allergies or reactions were not reported.     On an unspecified date in 2014 (reported as when the patient was 19-year-old), the patient was vaccinated with first and second dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and on 04-JUN-2019, the patient went for the third dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, administration route, lot number and expiration date was not provided) for prophylaxis. (inappropriate schedule of product administration). No adverse events were reported. At the reporting time, the event outcome was unknown.
Sex: M
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: developed warts on his hand on an unspecified date following administration of GARDASIL 9; Information has been received from a physician via a field representative through a message on the voicemail, referring to a male patient of unknown age. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  In 2018 (reported as "sometime last year"), the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot#, expiration date, strength, frequency and route were unknown) for prophylaxis.         On an unknown date, the patient developed warts on his hand on an unspecified date following administration of the suspect vaccine. The outcome of the event was unknown. The patient visited physician who did not think the warts were related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), so the patient was administered his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot#, expiration date, strength, frequency and route were unknown) for prophylaxis on a unknown date.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA001599:
Sex: F
Vaccine: HPV9
Symptoms: Inadequate aseptic technique in use of product, Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: swelling, redness and pain at an unspecified injection site\infection at the injection site; first injection that occured on an unspecified date in 2016; This spontaneous report was received from a physician refers to a 12-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were unknown.  On an unknown date in 2016, the patient had her first vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis. On 30-MAY-2019, the patient was vaccinated with second dose (inappropriate schedule of product administration) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis.  On 31-MAY-2019, the patient developed swelling, redness and pain at an unspecified injection site. The patient's mother took the patient to the urgent care center who sent them to the emergency room for a possible infection. The emergency room diagnosed the patient with an infection at the injection site (vaccination site infection) and started the patient on unspecified oral antibiotics. The Emergency Room told the patient's mother that the infection was a result of a "dirty clinic" using "dirty needles". The Mother reportedly spoke directly with the physician on 03-JUN-2019, about the conversation she had at the emergency room. The mother stated that, the patient did not had this reaction with the first injection of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). As of 3-JUN-2019, the patient is feeling much better with no redness, swelling or pain. The outcome of vaccination site infection was reported as recovered/resolved. Causality assessment of the event vaccination site infection in relation to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; Patient received an expired dose of VAQTA; This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 04-JUN-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) injection (dose and frequency were not reported) (lot # R007388, expiry date: 27-MAY-2019) intramuscularly for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; administered improperly stored doses of VARIVAX; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 31-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R035223, expiration date 04-DEC-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of -11.4 degrees Celsius (C) for 9 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA001214: US-009507513-1906USA001816:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; administered improperly stored doses of VARIVAX; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 31-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034392, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of -11.4 degrees Celsius (C) for 9 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA001815: US-009507513-1906USA001214:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 14-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034394, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA000180:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 14-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034394, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 17-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034394, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 20-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034394, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 21-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034394, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 21-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034394, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.  ; Sender's Comments:  US-009507513-1906USA000180:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 24-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034394, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.  ; Sender's Comments:  US-009507513-1906USA000180:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 28-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034394, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180: