chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: FLUX
Symptoms: Mechanical ventilation, Paralysis, Wheelchair user
Clinical narrative: Case number PHEH2014US022798 is an initial spontaneous report received from a consumer on 10 Nov 2014. This report refers to a 10 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal Influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that 3 days after vaccination, she was paralyzed. She was then on oxygen and was confined to a wheelchair. The event outcome was unknown. The seriousness of paralysis was not reported, but the event was upgraded as medically significant based on the information available on NVS-IME list and NVx key event list. The causality of the event was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: Case number PHEH2014US022792, is an initial spontaneous report received from a consumer on 10 Nov 2014. This report refers to a female patient of unknown age. Reporter used to write a newspaper column and one woman responded to a column about flu vaccine. She was vaccinated with influenza vaccine (manufacturer and batch number unknown) on an unknown date. The woman "almost died" from the flu shot. Outcome of the event, seriousness and causality assessment was not reported. Seriousness assessment of almost died was upgraded based on information available in the source documents. No additional details available.
Sex: U
Vaccine: RV5
Symptoms: Gastritis
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ROTATEQ, orally (dose, dose number and lot# not reported). On an unknown date, 5 days after the vaccination the patient was hospitalized with the diagnosis of gastritis. The outcome of event was unknown. The causality was not reported. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient broke out in a red, raised, itchy rash on the same day he received the flu vaccine (10/24/14). He tried topical cortisone cream and topical triple antibiotic ointment without relief. Methylprednisolone 125 mg once, prednisone taper (20 --> 10 --> 5 mg) mg every day.
Age: 23.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Flushing, Incorrect route of drug administration, Pyrexia, Tachycardia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of tachycardia in a female patient who received BOOSTRIX (batch number 3HY32, expiry date 8th November 2016). Concurrent medical conditions included hospitalization (The patient was already in the hospital on the day of adverse events). Concomitant products included Influenza vaccine, COLACE, ketorolac, simethicone, Lactated Ringers and NORCO. On 4th November 2014, the patient received BOOSTRIX (intravenous) 1 ml. In November 2014, Less than a month after receiving BOOSTRIX, the patient experienced tachycardia (serious criteria clinically significant/intervention required), fever and flushing. On an unknown date, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the tachycardia, fever, flushing and inappropriate route of vaccination were unknown. It was unknown if the reporter considered the tachycardia, fever, flushing and inappropriate route of vaccination to be related to BOOSTRIX. Additional information received: The patient was inadvertently administered BOOSTRIX intravenously and subsequently spiked a body temperature of 105 Deg. F, and some tachycardia (heart rate was 120 bpm) and flushing.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: C-reactive protein normal, Full blood count normal, Metabolic function test normal, Neck pain, Spinal X-ray normal
Clinical narrative: FLUMIST given 10/16/14 about 2 pm, patient awoke with severe neck pain 10/17/14 seen in ER->torticollis dx.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Streptococcus test negative, Torticollis
Clinical narrative: FLUMIST given 10/16/14 about 2 pm, patient awoke with severe neck pain 10/17/14 seen in ER->torticollis dx.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Pt states they have developed cellulitis.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Patient c/o vaccination evolving into systemic sx: fatigue, chills, headache, nausea, arthralgia.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Swelling face, Urticaria
Clinical narrative: Swollen left side of face after receiving intranasal FLUMIST. Treatment, amoxicillin and prednisone.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Full blood count, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left upper arm swollen, slightly red and tender. Patient unable to lift arm up.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: White blood cell count increased
Clinical narrative: Left upper arm swollen, slightly red and tender. Patient unable to lift arm up.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Feeling cold, Feeling hot, Muscle contractions involuntary, Muscle spasms
Clinical narrative: I awakened around midnight feeling very warm but chilled at the same time. I had rhythmic muscle contractions followed by relaxation. Not painful spasms but they were continuous and slowly abated. I took TYLENOL, slept and better in the am. Fatigued though.
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Headache, Hyperhidrosis, Induration
Clinical narrative: 10/7 at 0500 severe nausea, diaphoresis, arm burning from shoulder tip to elbow. At 0630 con't nausea, diaphoresis, burning arm, no redness, induration 10 x 12 cm. At 0745 nausea, burning to forearm, induration from shoulder to elbow, hot to touch, no redness, left hand numb, headache starting. Took BENADRYL 50mg. At 2100 slight nausea, arm very painful but able to lift arm now, all joints ache, headache. 10/8 next AM. Slight nausea, mild headache, all joints ache, arm hurts, induration decreased 1/2 size. 10/9-10/11 no nausea, arm very sore, no headache, mild joint pain. Unable to work 10/7 due to reaction.
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Skin burning sensation, Skin warm
Clinical narrative: 10/7 at 0500 severe nausea, diaphoresis, arm burning from shoulder tip to elbow. At 0630 con't nausea, diaphoresis, burning arm, no redness, induration 10 x 12 cm. At 0745 nausea, burning to forearm, induration from shoulder to elbow, hot to touch, no redness, left hand numb, headache starting. Took BENADRYL 50mg. At 2100 slight nausea, arm very painful but able to lift arm now, all joints ache, headache. 10/8 next AM. Slight nausea, mild headache, all joints ache, arm hurts, induration decreased 1/2 size. 10/9-10/11 no nausea, arm very sore, no headache, mild joint pain. Unable to work 10/7 due to reaction.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 3.5" x 2" area of erythema, swelling, tenderness and warm involving area of shot and extending distally. Began 24 hr after vaccine. Did start on cephalexin for possible infection. Rec'd heat compress, ibuprofen and BENADRYL.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Facial pain, Fatigue, Headache, Pyrexia
Clinical narrative: Fever-over 100 degrees/chills/severe headache and face pain/extreme fatigue/slept from 1:30 p.m. Thurs. until 6:30 p.m. Friday/went to bathroom in between and drank water only/took one pill Friday a.m. and vomited.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Fever-over 100 degrees/chills/severe headache and face pain/extreme fatigue/slept from 1:30 p.m. Thurs. until 6:30 p.m. Friday/went to bathroom in between and drank water only/took one pill Friday a.m. and vomited.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Lip swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: Red whelps on arms, legs, stomach. Swelling of lips and lower face. Severe itching.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Eczema, Eye swelling, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid red, warm, swollen; eyes (bilaterally) swollen; wheezing; eczema.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Left deltoid red, warm, swollen; eyes (bilaterally) swollen; wheezing; eczema.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Blood test, Diplegia, Mobility decreased
Clinical narrative: 2 days after the Flu shot - I called not get out of bed by myself, nor could I lift myself from toilet. Husband lifted me up - my shoulders and arms were paralyzed.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever of 101.2 degrees F.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Back pain, Drug administration error, Injected limb mobility decreased, Injection site pain
Clinical narrative: Hurt horribly. Plunger stuck in arm. She hurt me getting it out. Arm very sore that day and worse as time progressed. By Oct 2 and 3 I couldn't raise my arm to dress. Hurt so bad. Now burning pain starting and radiating to back, neck and down arm.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Hurt horribly. Plunger stuck in arm. She hurt me getting it out. Arm very sore that day and worse as time progressed. By Oct 2 and 3 I couldn't raise my arm to dress. Hurt so bad. Now burning pain starting and radiating to back, neck and down arm.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Herpes zoster, Immune system disorder, Induration, Local swelling
Clinical narrative: I reacted by my arm swelling up, getting really red and hard, Dr said it also attacked my immune system which triggered shingles. ER Dr said that.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chest pain, Vaccine positive rechallenge
Clinical narrative: Approx 3-4 hrs after vaccine injection, I get a burning/pain sensation from my waist up thru my chest. Last about 2-3 hrs. This has happened every time I have gotten the vaccine for about the last 5 yrs. No treatment.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Dizziness after several days.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Middle insomnia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient states approx 1 week after Flu shot she began experiencing stiffness in left arm that would be painful at times and wake her at night. The stiffness is intermittent and does not happen all the time.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Patient received PNEUMOVAX in right deltoid 10/31/14. Reported painful administration and extreme soreness in muscle persistent for 5 or more days. Patient cannot use right arm without severe pain, and had trouble lifting arm at all. Left arm unaffected by FLUVIRIN.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Patient experienced pain and excessive swelling in left arm.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal
Clinical narrative: 20 minutes after receiving flu shot, patient says she's feeling funny and asked for paramedics. She refused to leave with paramedics and stated she'll go to hospital with her husband.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Muscle rigidity, Posture abnormal, Snoring
Clinical narrative: S/p injection, pt was being in for med about shot; pt ready to leave and all of a sudden slumped in chair, his head drooped to the left, she snored briefly with his eyes open. His wife assisted, asked him to sit up, he struggled then went rigid and briefly seized. Went to ER via EMTs.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Local reaction, Vaccination complication
Clinical narrative: Severe local reaction right arm from ZOSTAVAX.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema
Clinical narrative: 7.5 cm x 6.5 cm circular erythematous cellulitis to right upper arm.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Local swelling
Clinical narrative: Swollen arm (> 2 times its size).
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pruritus, Vomiting
Clinical narrative: Patient received PNEUMOVAX 23 and FLUZONE HD in her left arm on 11-4-14. Patient came to pharmacy on 11-14-14 (Yes, 10 days later) and stated the night of the shots she was red x 7 days, vomiting x 4 days, and now itching. Told patient to take BENADRYL for itching.
Age: 16.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Dyskinesia, Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: Immediately after injection pt became pale passed out slight jerking noted. Pt laid down cool comp. applied. Dr called in pt then became more alert and aware and oriented. Pt rested for 1/2 hr. Monitored and check by Dr then was able to leave office.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Pain, Pain in extremity
Clinical narrative: Pt received IM shot on 10/25. On 10/26, reported pain shooting/radiating down arm. On 11/15, subsequently reported shooting pain for 2 days following shot, then severe arm then 24 hours of flu symptoms. After 3 days, all sx resolved.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received vaccine on 11-13-14. Came in on 11-15-14 with red swollen area on upper lateral arm. Gave BENADRYL, and told her to follow-up. On 11-16-14 looked a little better.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a female patient of unknown age who was not pregnant. On an unknown date the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous (strength and lot # were not reported). Concomitant therapies included Influenza virus vaccine (unspecified). On an unknown date the patient experienced bump on patient's arm at the injection site after receiving ZOSTAVAX. Patient did not seek medical attention. She did not receive any treatment for the adverse event. The outcome of bump on patient's arm at the injection site was reported as recovered/resolved on unknown date. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Laboratory test normal, Migraine, Paraesthesia
Clinical narrative: Debilitating migraines in a 10-year old lasting for a week after receiving LAIV along with tingling in hands and feet.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypotension, Paraesthesia, Pruritus
Clinical narrative: Approximately 10 to 20 minutes after receiving flu vaccine, patient complained of numbness, tingling, and pruritus to upper extremities; blood pressure was measured and was low (hypotensive). He was placed on O2 and given 400 ml NS but this did not provide much improvement. Patient remained awake, alert, and oriented x 3. Respirations were event an unlabored. MD was called; orders for epinephrine 1 mg provided and recommendation for patient to go to ER. Patient refused epinephrine but agreed to go to ER. Patient was transported to ER by transport.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Tachycardia
Clinical narrative: Debilitating headache within 1-1/2 hours of administration of FLUARIX injection, lasting approximately 36 hours. Tachycardia within 15 minutes, dizziness, lasting approximately 12 hours.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Had a injection to prevent Shingles. Three days later developed a rash on my back which later spread to my stomach. Returned to my MD 8 days after receiving the injection for diagnosis. Diagnosis was Shingles. Prescribed Valacyclovir, 1GM 2 x daily for 7 days. No sign of Shingles prior to getting vaccinated.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Pt claims she has been sneezing and has had runny nose. Started about 1 week after shot. Explained to pt she may be having allergies or cold, but she thinks it might be b/c of flu shot.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Dysstasia, Muscular weakness
Clinical narrative: 12 hours after flu vaccine, developed weakness in legs-unable to stand pt fell-transported to ER-admitted to ER. Symptoms resolved-discharged 10/29.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Speech disorder
Clinical narrative: Patient presented to ER with difficulty speaking on 6/24/14 arriving at 10:53 and transferred to Neuro at 1754. No other information available after transfer.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Oedema, Skin warm
Clinical narrative: (L) arm, below deltoid with 10cm area of erythema slight warm and edematous, not particularly tender.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Pain in arm (left) day 2 was swollen no longer swollen, no redness. Pain continues.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema, Nodule, Skin warm
Clinical narrative: Patient had a red puffy "knot" that spread to her elbow as well. It was warm to the touch and partially resembled a bruise.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Full blood count normal, Infection, Injection site inflammation
Clinical narrative: I had the shingles vaccine at pharmacy on 11/5-11/6 started with a reaction at the injection site, ended up at Urgent Care by Thursday eve because it was spreading was put on 500mg of Cephalexin 3 times a day they drew a circle around the inflamed area. Went to my PC on Friday because it was spreading quick was given an injection of ROCEPHIN new inflamed area marked, appt made for Urgent Care on Saturday (Urgent Care Dr. stated vaccine given too low, her nurse agreed. PC Dr. also states in wrong place, her nurse agrees) went to appt at Urgent Care was told to go right to Hospital ER. Comment at new Urgent Care "why was the vaccine given there?". Went to ER got IV of ROCEPHIN had to return next day (24 hours later) for another IV of ROCEPHIN along with the continuation of Cephalexin antibiotics original visit gave me. Sunday finally some relief from this raging infection. Now just continuing on oral antibiotics. Again in ER was told by numerous hospital staff that vaccine was not given where it should be???
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: After receiving a flu shot (FLUZONE HD INJ [SANO] Qty: 1ML) I experienced pain in my left shoulder. Shot administered on Oct. 17, 2014. The pain abated but has returned as of Nov. 5, 2014. Pain is restricting movement of my left arm to the vertical when I try to extend. No problem with my hand/fingers/etc.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, RV5
Symptoms: Haematochezia, Mucous stools, Vomiting
Clinical narrative: Mucous in stools, vomited once, had one stool w/ blood in it.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site mass, Lip swelling, Oral discomfort, Oral pruritus, Rash
Clinical narrative: On Friday, October 31, 2014, the medical center was administrating flu shots. I received the flu shot that Friday afternoon with no immediate symptoms. Starting Saturday, I developed a rash around my mouth, a lump at the injection site, and my lips swelled to three times their size. This reoccurred Sunday and Monday with swelling, rash, itching and burning around my mouth area. The nurse reported the incident to Employee health. After several days the symptoms have lessened.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Headache, Herpes zoster, Rash, Vision blurred
Clinical narrative: Received FLUZONE QUADRIVALENT Adult vaccine on 10/20/14. From 10/21-10/23 patient experienced headache, tiredness and difficulty with vision focus. On 10/24 rash appeared on one side of face. Rash worsened over 10/25 and 10/26. On 10/27 patient visited dermatologist and was diagnosed with shingles.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Burning sensation, Discomfort, Lymph node pain, Lymphadenopathy
Clinical narrative: Next morning woke up with pain and discomfort on armpit as if pulled a muscle. It got worse over time. Then burning sensation started. Performed a tactile test and noticed nodules where the size of golf balls and tender to touch. No adverse event on immunization site. Went to doctor and lymph nodes size of apple and eventually increased to size of grapefruit. It is painful and tender to touch. Took ibuprofen and using cold/heat packs to see if it gets better. No improvement so far. Has taken flu shot yearly with no problems until this year.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Nodule, Tenderness
Clinical narrative: Next morning woke up with pain and discomfort on armpit as if pulled a muscle. It got worse over time. Then burning sensation started. Performed a tactile test and noticed nodules where the size of golf balls and tender to touch. No adverse event on immunization site. Went to doctor and lymph nodes size of apple and eventually increased to size of grapefruit. It is painful and tender to touch. Took ibuprofen and using cold/heat packs to see if it gets better. No improvement so far. Has taken flu shot yearly with no problems until this year.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Disorientation, Muscular weakness, Pyrexia
Clinical narrative: Fever, disorientation, lower body weakness.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Acoustic stimulation tests, Deafness unilateral
Clinical narrative: Complete hearing loss in right ear. Has improved slightly. Being treated w/DEBROX and prednisone.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Multiple sclerosis relapse, Respiratory disorder
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. The patient's medical history included multiple sclerosis. On an unspecified date in September 2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, dose# and route unspecified). On an unspecified date in 2014, after receiving the vaccine, the patient experienced a flare up of her multiple sclerosis. The patient sought medical attention via contacting pharmacist. The outcome of the event "a flare up of her multiple sclerosis" was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Multiple sclerosis relapse
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. The patient's medical history included multiple sclerosis. On an unspecified date in September 2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, dose# and route unspecified). On an unspecified date in 2014, after receiving the vaccine, the patient experienced a flare up of her multiple sclerosis. The patient sought medical attention via contacting pharmacist. The outcome of the event "a flare up of her multiple sclerosis" was unknown. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warmth, itching surrounding injection site-no swollen lips, no difficulty breathing, no hives-pt given rx: diphenhydramine parents given ER precautions.
Sex: U
Vaccine: RV5, HIBV, HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 27-OCT-2014, an unspecified number of patients were vaccinated with improperly stored PEDVAXHIB lot # J016186, expiration date: 24-OCT-2016 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5, HIBV, HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 27-OCT-2014, an unspecified number of patients were vaccinated with improperly stored PEDVAXHIB lot # J016186, expiration date: 24-OCT-2016 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown demographics. In 2014 (exact date unspecified), those patients were vaccinated with an improperly stored for 8 days from 24-OCT-2014 through 31-OCT-2014 PNEUMOVAX 23 (dose, route of administration, anatomical location, lot number were not reported). No adverse effects reported. This is one of several reports 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 as recived from a nurse practitioner refers to a patient of unknown age and gender. On 10-NOV-2014 the patient received improperly stored RECOMBIVAX HB (lot#, dose, route not reported, strength 10mcg/1.0ml). Concomitant medications were not provided. No adverse symptoms were reported. The temperature excursion with RECOMBIVAX HB was found to be supported with in-house stability data. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On an unspecified day in 2004 the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date, dose and route of administration were not reported). On an unspecified day in August 2014 the patient was vaccinated with the second dose of GARDASIL (lot #, expiration date, dose and route of administration were not reported). On 04-NOV-2014 the patient was vaccinated with the third dose of GARDASIL (lot #, expiration date, dose and route of administration were not reported). The reporter stated that "the 3rd dose was only separated by 10 1/2 weeks from the second dose". No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown demographics. In 2014 (exact date unspecified), those patients were vaccinated with an improperly stored for 8 days from 24-OCT-2014 through 31-OCT-2014 GARDASIL (dose, route of administration, anatomical location, lot number were not reported). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. On 06-NOV-2014, the patient was vaccinated with (Oka/Merck) VARIVAX vaccine 0.5 ml, subcutaneous (lot # and expiry date not reported). No concomitant medication was reported. It was reported that the patient received the (Oka/Merck) VARIVAX vaccine which on an unknown date underwent a supported temperature excursion. No adverse experience reported. The outcomes of the events were unknown. A product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Lichen planus
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 60 year old female patient with pertinent medical history of seizures. The patient had no drug allergies or reactions. On 28-JUN-2014 the patient was vaccinated with 1 single shot of ZOSTAVAX, subcutaneous injection. On an unknown date, approximately on 05-JUL-2014 (reported as "1 week after administration") the patient presented with Lichen Planus, one spot on each wrist, which had since spread to other parts of her body. The patient sought medical attention. The treatment included CLOBETASOL and two unspecified steroid injections (dosages, frequencies and routes of administration unknown). On an unkonwn date there was unspecified biopsy performed. No results were reported. The outcome of Lichen Planus was reported as not recovered. The relatedness between the adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The nurse reported an unspecified number of patients received improperly stored GARDASIL (lot#, dosage and route unknown) on an unspecified date. No adverse effects reported. This is one of several reports received 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 as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Between 16-OCT-2014 and 06-NOV-2014 the patients were vaccinated with improperly stored dose of ROTATEQ oral (dose and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the unspecified amount of clients were vaccinated with improperly stored VAQTA (lot# and expiration date not provided) (dose not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unkonwn age and gender. On 20-SEP-2014 the patient was vaccinated with improperly stored dose of PNEUMOVAX 23, 0.5 ml, intramuscular (lot number not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number patients of unknown age and gender. On an unknown date of 2014 (reproted as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from a physician concerning a patient (age range reported as 13-18, units not reported) of unknown gender. On 10-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016); dose number, dose and route were not reported). This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Diarrhoea, Discomfort, Vomiting
Clinical narrative: Vomiting multiple times with watery stools up to 7 times a day. Pt also with crying and apparent discomfort.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a 19 year old female patient regarding herself. The patient had no relevant medical history. Her relevant past history was unknown. On 23-FEB-2013, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot #, expiry, dose, route were unknown). The patient did not take any concomitant medication. On an unknown date, the patient experienced exposure in utero. On an unknown date in 2013, a week or so after receiving (Oka/Merck) VARIVAX she had a positive urine pregnancy test. No other relevant laboratory testing was performed. The LMP (last menstrual period) and EDD (estimated date of delivery) were not known. The pregnancy outcome was pending. The outcome of exposure in utero was unknown. Follow-up information has been received from a registered nurse on 06-NOV-2014. The reporter stated that the patient was never seen in the office for her pregnancy. The patient had an appointment schedule for 08-APR-2013. The appointment was canceled with no reason given, and not rescheduled. The pregnancy outcome was unknown. The outcome of exposure in utero was recovered/resolved on an unknown date, approximately in 2013. Additional information is not expected, because there was no more information available.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 21-OCT-2014, an unspecified number of patients were vaccinated with improperly stored PEDVAXHIB lot # J014279, expiration date: 16-SEP-2016 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. The patient's pertinent medical history was not reported. Approximately on an unknown date and month in 2013 (reported as about a year ago) the patient was vaccinated with ZOSTAVAX (strength, dose and frequency not reported). Other co-suspects and concomitant medication were not reported. On an unknown date the patient experienced sharp stabbing pain on her right side of her body and abdomen. The outcome of experiencing sharp stabbing pain on her right side of her body and abdomen is unknown. Causality was unspecified by the reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site swelling, Pyrexia
Clinical narrative: Per patient: "I received the PNEUMOVAX 23 vaccination at the office. I subsequently had a very adverse reaction to it causing cellulitis to that arm as well as a very high temp (103.7) causing admission to ER. Also rather large bump on arm at injection site."
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to unspecified patients of unknown age and gender. On an unknown dates the patients were vaccinated with a dose of ROTATEQ (orally, doses and lot numbers not reported) that were improperly stored. No adverse symptoms reported. The temperature excursions with these vaccines were found to be supported with in-house stability data. This is one of several reports from the same source. 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 nurse practitioner refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. The nurse practitioner informed that since 24-OCT-2014 the patients were vaccinated with improperly stored of VARIVAX (Merck) injection (lot number, expiration date, dosage and route were not reported). No adverse effected were noted. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. The nurse practitioner informed that since 24-OCT-2014 the patients were vaccinated with improperly stored (Merck) PROQUAD injection (lot number, expiration date, dosage and route were not reported). No adverse effected were noted. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to unspecified patients of unknown age and gender. On an unknown dates the patients were vaccinated with a doses VAQTA (doses, route and lot numbers were not reported) that were improperly stored. No adverse symptoms reported. The temperature excursions with these vaccines were found to be supported with in-house instability data. This is one of several reports from the same source. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site rash, Lymphadenopathy
Clinical narrative: Red rash around injection site approx 2" x 3" in size. Swollen lymph node (axilla). Dr stated pt has cellulitis. Presented day after immunization. Pt treated with cephalexin x 7 days.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report was received from patient's father concerning his daughter, a female patient of unknown age. Patient's concurrent conditions and relevant medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. On an unknown date the patient experienced complete hair loss after receiving GARDASIL. The outcome of complete hair loss was unknown. The causality of the events with GARDASIL was not reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Pt experience severe muscle pain 14 hours post vaccination. 3am in morning until 6pm next day. Vaccination adm 1pm 11/14/14. Pt stated no redness, swelling or bruising. Pt took MOTRIN and applied ice.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to unspecified patients of unknown age and gender. On an unknown dates the patients were vaccinated with a doses of MMR II (dose, route and lot# were not provided) that were improperly stored. No adverse symptoms reported. The temperature excursions with these vaccines were found to be supported with in-house stability data. This is one of several reports from the same source. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Malaise
Clinical narrative: Began with generalized body achiness, fever, malaise, developed erythema and induration at site and involving forearm.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Began with generalized body achiness, fever, malaise, developed erythema and induration at site and involving forearm.
Age: 0.3
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant and refers to a 4 month old patient of unknown gender. On 13-NOV-2014 the patient was accidentally vaccinated with VARIVAX (Merck) (0.5 ml, subcutaneous, anatomical location, lot number were not reported). No adverse effect reported. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Red, swollen, itchy arm for > 2 weeks.
Sex: U
Vaccine: HPV4
Symptoms: Drug ineffective
Clinical narrative: This spontaneous report as received from a other health professional via a company representative refers to an unspecified article which stated that the types of GARDASIL protects against are not a prevalent in a certain population and thus GARDASIL may not be as effective in said population. The outcome of lack of efficacy of GARDASIL in a certain population was unknown. The causality between GARDASIL and the events was unknown. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and it refers to a 54 year old male patient. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 04-NOV-2014, the patient was vaccinated with expired VARIVAX (Merck) lot # H018448, exp.date: 09-OCT-2014, 0.5 ml, subcutaneously in the left arm. No adverse effects were reported. The outcome of the event was unknown. Additional information is not expected, the reporter does not wish to be contacted.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: (R) arm swelling, itching, pain, redness. Given antibiotic.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Pain, Paraesthesia
Clinical narrative: Pt. experienced pain originally just with lifting and backwards motion and tingling sensation. Pt. received prednisone therapy, which helped, but pain returned post therapy. Pain is now present (at injection site) with all motion; primary CNP is referring her to musculoskeletal specialist and further testing.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient got itchy red rash 2 days after vaccine which has continued to todays date. 11/17/14- says it is improving now.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 3 unspecified patients of unknown age. On 04-NOV-2014 (also reported as yesterday), the patients were vaccinated with ZOSTAVAX, (dose frequency, route of administration and indication were not provided), that were exposed to temperatures outside of the proper storage range. No concomitant were reported. No adverse effect reported. Outcome of events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date of 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Oka/Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 17-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 23-OCT-2014, an unspecified number of patients were vaccinated with improperly stored PEDVAXHIB lot # J014279, expiration date: 16-SEP-2016 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Malaise
Clinical narrative: This spontaneous report as received from a male physician (via a company representative) on unknown age regarding himself. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneous (lot and dose not reported), for previous of shingles. Concomitant medication was not reported. On an unknown date about two years after he was vaccinated, the patient experienced a mild case of shingles. Shingles appeared on his forehead. The physician explained that he woke up one morning and was not feeling well. His wife noticed spots on his forehead. No other symptoms were reported. The outcome of shingles and was not feeling well was reported as recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Malaise, Rash
Clinical narrative: This spontaneous report as received from a male physician (via a company representative) on unknown age regarding himself. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneous (lot and dose not reported), for previous of shingles. Concomitant medication was not reported. On an unknown date about two years after he was vaccinated, the patient experienced a mild case of shingles. Shingles appeared on his forehead. The physician explained that he woke up one morning and was not feeling well. His wife noticed spots on his forehead. No other symptoms were reported. The outcome of shingles and was not feeling well was reported as recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse on 13-NOV-2014 refers  to 2 unspecified patients. In November 2014 (either 11-NOV-2014 or 12-NOV-2014, the exact date was unknown) the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot #, expiration date and route unspecified). No adverse symptoms reported. The temperature excursions for (Oka/Merck) VARIVAX was a supported excursion with long term stability data. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history was unknown. The reporter stated that expired RECOMBIVAX HB 2.5 micrograms/0.5 ml (lot # 0384AE, expiry date: 02-NOV-2014, dose and route of administration was unknown) was inadvertently administered to the patient on 03-NOV-2014. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.