chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Nerve injury, Pain, Paraesthesia
Clinical narrative: Pt stated that she had a rash that lasted several days. She also had numbing, tingling and shooting pains. Pt states she now has nerve damage. She has seen her family physician who has prescribed her an anti-inflammatory. She is now seeing a Neurologist because she cannot move her arm at times and the sensation is traveling toward her chest.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Pt stated that she had a rash that lasted several days. She also had numbing, tingling and shooting pains. Pt states she now has nerve damage. She has seen her family physician who has prescribed her an anti-inflammatory. She is now seeing a Neurologist because she cannot move her arm at times and the sensation is traveling toward her chest.
Age: 1.5
Sex: F
Vaccine: DTAPH, HIBV
Symptoms: Pain, Pruritus, Rash erythematous, Swelling, Urticaria
Clinical narrative: Itching, raised red rash. Painful and continued to get worse, red, swollen, hive like for three days.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Headache, Pain
Clinical narrative: Watery stools, headache, abdominal cramping, body aches.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac stress test normal, Dyspnoea, Oxygen saturation decreased, Respiratory rate increased
Clinical narrative: Given shot 8:15 - 3 hrs 11:15 later - sx fast breathing & difficult catching breath (accelerated fast) - went to hospital w/ friend - admitted w/ oxygen & NTG-nitroglycerin (O2 level was low) stress test fine - 1 day in hospital.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Activities of daily living impaired, Cellulitis, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Arm very sore, red and swollen extensively over upper arm where injection occurred. Earlier in the day, around 4 pm, I was feeling very tired and my nose was running. The following morning I had a fever over 100 degrees, my arm continued to be very sore, puffed up and red. I was completely exhausted and found difficult to do the simplest of tasks.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia, Rhinorrhoea
Clinical narrative: Arm very sore, red and swollen extensively over upper arm where injection occurred. Earlier in the day, around 4 pm, I was feeling very tired and my nose was running. The following morning I had a fever over 100 degrees, my arm continued to be very sore, puffed up and red. I was completely exhausted and found difficult to do the simplest of tasks.
Age: 67.0
Sex: M
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Rash
Clinical narrative: 2 days following vaccines developed rash starting on right arm - spread to legs/neck over the following week. Saw a physician on 11/16/12 - prescribed Prednisone.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site haematoma, Injection site haemorrhage, Insomnia, Pain in extremity
Clinical narrative: Vaccine given on 11-1-12. On 11-16-12 she stated the arm (right) hurts so badly it keeps her awake & she has to use her left hand (she is right handed). She said the shot was given on upper shoulder & that it bled a lot. She has some bruising. She stated she was allowing time for improvement but it only became worse. On 11-19-12 she went to her doctor. The doctor could see the injection site because of some yellowing around the site. Dr wasn't sure, but thought the joint may have been hit. Dr gave prescription for MOBIC & steroid injection to see if it helps.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Pain, Tenderness
Clinical narrative: Patient describes localized tenderness/pain around deltoid area of arm. States she has difficulty sleeping and wonders if it is nerve pain.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Injection site pain
Clinical narrative: Sore arm where injection was administered - "wasn't feeling like herself."
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Lt arm pain persisting 1 month after injection.
Age: 1.52
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Red bumps all on upper thigh where vaccine was administered right. Bumps are itchy. I have been putting hydrocortisone on it. MD said continue to use with BENADRYL.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: 2-hrs following shot could not lift left arm. I forced myself to move it as much as possible but I felt severe pain, I tried Ibuprofen and no relief. Finally saw nurse practitioner on Tues Nov. 20 and she gave me a steroid shot in right hip and prescribed a pain med LORTAB 7.5. On Thursday, November 1, 2012 at about 1:10 pm at pharmacy. I still cannot lift my left arm without severe pain after 26 days. I saw my internal med doctor's nurse practitioner on November 20th and she gave me a steroid shot, along w/a pain med, LORTAB. Nothing is helping. I am healthy; had no problems at the time of injection; been taking the vaccine twenty years now; never have had any side effects. Please tell me something can be done to help me.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Asthenia, Chills, Dizziness, Injection site pain
Clinical narrative: Queasy in stomach, pain in midriff, became very nauseated, lightheaded and passed out. Violent chills for several hours for remaining of night. Woke up every hour with cycles of chills and pain. Pretty weak next day. Tuesday resumed with normal activities. Pain at injection site minimal. Took ALEVE Sunday and Monday.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Middle insomnia, Nausea
Clinical narrative: Queasy in stomach, pain in midriff, became very nauseated, lightheaded and passed out. Violent chills for several hours for remaining of night. Woke up every hour with cycles of chills and pain. Pretty weak next day. Tuesday resumed with normal activities. Pain at injection site minimal. Took ALEVE Sunday and Monday.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 6 cm area erythema & induration at site of injection.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Pt reports she experienced immediate pain in left deltoid after receiving vaccine. Continues to experience soreness when she raises her left arm since vaccination. Pain is steady getting worse. Decreased ROM in left arm. Scheduled physical therapy appointment.
Age: 18.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Human chorionic gonadotropin positive, Maternal exposure during pregnancy, No adverse event
Clinical narrative: No adverse event -> positive pregnancy.
Age: 31.0
Sex: U
Vaccine: FLU3, HEPA, TYP
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: No adverse events reported by client. TUBERSOL (PPD solution) .5cc administered IM in right deltoid.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Rash
Clinical narrative: Pt received vaccine (FLUZONE) on 10/19 - woke up on 10/20/12 with puffiness in eyes and body rash to both upper extremities, upper chest. Treated with BENADRYL every six hours.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Swelling
Clinical narrative: On 10-19-12 pt received FLUZONE vaccine to (L) deltoid. 12 hours later began facial itching and swelling radiating to trunk. Treated with BENADRYL every six hours.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Rash
Clinical narrative: Patient developed rash and sore muscle pain below deltoid muscle between elbow to area near armpit height. Pain exist for 6 days after vaccine administered. Not other treatment to date.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Encephalitis, Encephalopathy
Clinical narrative: Encephalitis/encephalopathy symptoms requiring hospitalization.
Age: 32.0
Sex: M
Vaccine: FLU3, HEPA, TYP
Symptoms: No adverse event
Clinical narrative: No adverse events reported by client. Tubersol (PPD solution) .5 cc administered IM in left deltoid.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site induration, Injection site swelling, Ultrasound scan abnormal
Clinical narrative: Immediately after Tdap injection by staff, noted swelling and induration at site. Area was 4 x 5 cm on (L) upper arm with slight violaceous discoloration at site.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: X-ray
Clinical narrative: Immediately after Tdap injection by staff, noted swelling and induration at site. Area was 4 x 5 cm on (L) upper arm with slight violaceous discoloration at site.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Anxiety, Depression, Insomnia, Nausea
Clinical narrative: This spontaneous report as received from a physician (Local Reference Number#US12-056809) refers to a female patient of unknown age who was a junior in high school with no past medical history of note. The patient was vaccinated with first dose of GARDASIL (Lot #, dose, route unspecified) in August 2012. She had tolerated vaccines in the past without incident. Until recently, she took no medications but had been prescribed ABILIFY and CELEXA in recent weeks. The patient experienced nausea, insomnia, anxiety and depression starting within 24 hours of receiving her first dose of GARDASIL in August 2012. This was followed within a short time (weeks) by the onset of visual disturbance (blurry vision) which had persisted. A work-up by ophthalmology including MRI had not revealed any abnormalities. Physician did mention that his daughter might be having twitching of the extra ocular muscles, causing her to squint to be able to focus her vision. Patient had missed a fair amount of school which exacerbates her anxiety and depression. No treatment information was reported. The outcome of visual disturbance (blurry vision) was reported as not recovered/not resolved. The outcome of all the other events were unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Vision blurred, Visual impairment
Clinical narrative: This spontaneous report as received from a physician (Local Reference Number#US12-056809) refers to a female patient of unknown age who was a junior in high school with no past medical history of note. The patient was vaccinated with first dose of GARDASIL (Lot #, dose, route unspecified) in August 2012. She had tolerated vaccines in the past without incident. Until recently, she took no medications but had been prescribed ABILIFY and CELEXA in recent weeks. The patient experienced nausea, insomnia, anxiety and depression starting within 24 hours of receiving her first dose of GARDASIL in August 2012. This was followed within a short time (weeks) by the onset of visual disturbance (blurry vision) which had persisted. A work-up by ophthalmology including MRI had not revealed any abnormalities. Physician did mention that his daughter might be having twitching of the extra ocular muscles, causing her to squint to be able to focus her vision. Patient had missed a fair amount of school which exacerbates her anxiety and depression. No treatment information was reported. The outcome of visual disturbance (blurry vision) was reported as not recovered/not resolved. The outcome of all the other events were unknown. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: 39 y/o referred to VHC by Dr./OCC HEALTH for report of LLR 24 hrs s/p receipt of Tdap placed on 14NOV12, as part of required Annual FFD exam, as firefighter. No other vaccines received on same day or w/in 30 days prior to Tdap. No viral or GI illness endorsed w/in 30 days prior to receipt of Tdap. Per DEERS, last Td was on (06APR05). Employee states that the Tdap really burned on administration (L deltoid). Denied shooting pain to fingers, no tingling, no paresthesias, numbness or weakness of LUE or left hand. He woke up the next morning (15NOV12) with a hard, painful lump, about 3 inches in diameter, at Tdap injection site (L deltoid). No fever, no significant erythema or warmth at the injection site. He had difficulty sleeping x 2 nights (14-15th NOV12) due to pain in LUE- could not sleep on left side. Self-treated with ibuprofen 600-800 mg q6-8h WF (only took x 2 days). The localized induration & pain made it hard to lift 4 lb bunker jackets with his left arm at work. On 16NOV12 he had a f/u appt with Dr. at OCC HEALTH FOR Part II of his Annual FFD Exam and indicated the indurated, painful area on his left deltoid to Dr., who referred pt to VHC for documentation of adverse event following immunization. Note: patient rated localized pain (L) deltoid as "8"/10, impeding him from executing his job safely due to difficulty lifting with left arm. Excused from work x 1 day. Pt also c/o of redness of his eyes- bilat (sclera) since receipt of Tdap; wife noticed redness around 24 hours. No drainage. No irritation / gritty sensation eyes- just red (bilat)- didn't sleep much x 2 nights. Redness seems to be resolving on its own.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Insomnia, Ocular hyperaemia, Pain in extremity
Clinical narrative: 39 y/o referred to VHC by Dr./OCC HEALTH for report of LLR 24 hrs s/p receipt of Tdap placed on 14NOV12, as part of required Annual FFD exam, as firefighter. No other vaccines received on same day or w/in 30 days prior to Tdap. No viral or GI illness endorsed w/in 30 days prior to receipt of Tdap. Per DEERS, last Td was on (06APR05). Employee states that the Tdap really burned on administration (L deltoid). Denied shooting pain to fingers, no tingling, no paresthesias, numbness or weakness of LUE or left hand. He woke up the next morning (15NOV12) with a hard, painful lump, about 3 inches in diameter, at Tdap injection site (L deltoid). No fever, no significant erythema or warmth at the injection site. He had difficulty sleeping x 2 nights (14-15th NOV12) due to pain in LUE- could not sleep on left side. Self-treated with ibuprofen 600-800 mg q6-8h WF (only took x 2 days). The localized induration & pain made it hard to lift 4 lb bunker jackets with his left arm at work. On 16NOV12 he had a f/u appt with Dr. at OCC HEALTH FOR Part II of his Annual FFD Exam and indicated the indurated, painful area on his left deltoid to Dr., who referred pt to VHC for documentation of adverse event following immunization. Note: patient rated localized pain (L) deltoid as "8"/10, impeding him from executing his job safely due to difficulty lifting with left arm. Excused from work x 1 day. Pt also c/o of redness of his eyes- bilat (sclera) since receipt of Tdap; wife noticed redness around 24 hours. No drainage. No irritation / gritty sensation eyes- just red (bilat)- didn't sleep much x 2 nights. Redness seems to be resolving on its own.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Day after vaccine was administered arm surrounding injection was red & swollen, and itchy.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pruritus, Rash, Varicella
Clinical narrative: Varicella - Rash - itchiness. Treated symptomatically with.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Vesiculopapular rash on body. No treatment.
Age: 29.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Cough, Dysphagia, Pharyngeal oedema
Clinical narrative: 29 y/o F dependent spouse with history of atopy referred by Dr./OCC HEALTH to healthcare center for evaluation & documentation of onset of swelling of throat with difficulty swallowing & coughing paroxysms about 4 to 5.5 hrs s/p receipt of Tdap (LUE) & IM Seasonal Influenza (RUE) on 16NOV12. These immunizations were required in order for her to volunteer.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Local reaction
Clinical narrative: Raised knot with erythema & itching - local reaction left leg.
Age: 22.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, no pain, pruritus of both arms at injection sites.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Cold sweat, Feeling abnormal, Immediate post-injection reaction
Clinical narrative: Immediately after receiving HPV vaccine pt stated tongue felt funny & got clammy. He was always able to talk & drink water pulse 62 BP 110/70 again P - 64 BP 110/80. Patient observed for 15 minutes, symptoms subsided & pt left clinic.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was intramuscularly vaccinated with the first dose of 0.5 ml GARDASIL (lot number not provided) on an unspecified date, a second dose of GARDASIL 4 months later and a third dose of GARDASIL 2 months after the second dose. No other co-suspects were reported. NO concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 5 cm in diameter, red, warm touch on the (L) thigh.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who refers to a patient of unknown age and gender. It was reported that the patient received first dose of GARDASIL on 01-DEC-2011 (dose, route and lot# not reported) and a second dose of GARDASIL (dose, route and lot# not reported) on 20-NOV-2012. No adverse effects reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician who refers to a 22 year old female patient. It was reported that the patient received her first dose of GARDASIL (dose, route and lot # not reported) in November 2012 (reported as "a year ago") and on 20-NOV-2012 the patient received intramuscularly her second 0.5 ml dose of GARDASIL (lot # reported as 0629AE, exp. 16-DEC-2014). No adverse reactions reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dyspnoea, Fatigue, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Received Tdap vaccine IM (L) deltoid 11/14/12 lump at injection site on 11/15/2012 and not feeling well. Felt achy, short of breath and tired. Small red area at injection site 11/19/12. 11/20/12 Increased redness, swelling, warmth and pain at injection site. Seen emergency room for IV antibiotics.
Age: 62.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site swelling, Injection site warmth, Malaise, Pain
Clinical narrative: Received Tdap vaccine IM (L) deltoid 11/14/12 lump at injection site on 11/15/2012 and not feeling well. Felt achy, short of breath and tired. Small red area at injection site 11/19/12. 11/20/12 Increased redness, swelling, warmth and pain at injection site. Seen emergency room for IV antibiotics.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site.
Age: 56.0
Sex: M
Vaccine: HIBV, MNQ, PPV
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea started 3 days after vaccines, lasted 3 days but after 2 wk. has occ. diarrhea.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Pt received a VARIVAX on 10/29/12 & was dx'd with chicken pox on 11/21/12.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: ADACEL & MENACTRA administered right arm 11/21/12. Patient returned on 11/23/12 with dx. cellulitis right upper arm.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Spinal X-ray, Tenderness, Urine analysis
Clinical narrative: Came to urgent care on 11/24 with chief complaint of right sided lower back pain that is tender to palpation. Given ketorolac 30mg IM x 1 dose & sent home with ketorolac 5mg po Q6 hours prn pain. Returned to urgent care on 11/25/12. X-ray obtained. Patient had 8/10 radiating pain. Was given diazepam 2mg po x 1. Sent home to continue ketorolac, apply heat, & stretch the muscle.
Age: 51.0
Sex: F
Vaccine: HEPAB
Symptoms: Erythema, Pain, Pruritus, Rash, Urticaria
Clinical narrative: 0845 - Pain behind left ear. 1010 - Red arms. 1030 - Red face, itching - hives with bumps on arms, back, face.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Headache, Muscular weakness, Nausea, Pain
Clinical narrative: Received vaccine 11/13/12. Had tender right arm on 11/14/12. Felt weak in arm. Had temp of 102, nausea, headaches, body aches at same time. Still tender in arm, but improved by 11/19/12.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Received vaccine 11/13/12. Had tender right arm on 11/14/12. Felt weak in arm. Had temp of 102, nausea, headaches, body aches at same time. Still tender in arm, but improved by 11/19/12.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site swelling, Local reaction, Pruritus
Clinical narrative: Dev. swelling at injection site next morning. By 24 hrs, golfball size, by 72 hrs softball size, red, sl. itching. Took BENADRYL 25mg PO x 3, TYL x 1. Diagnosis is: delayed local reaction.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Culture urine negative, Eye pain, Nausea, Pyrexia, Sinusitis
Clinical narrative: Fever, vomiting, nausea, Lt eye pain, sinusitis.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: Fever, vomiting, nausea, Lt eye pain, sinusitis.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on inner calves of both legs appeared Sunday morning, after Thursday afternoon vaccination.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Myalgia, Serum sickness
Clinical narrative: C/O myalgias of back, chest, legs & arms c/o arthralgias of PIP joints of fingers, bil knees, sx began the evening of 11/12. Suspect serum sickness from Tdap. Patient has since recovered.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Rash
Clinical narrative: This spontaneous report as received from other health professional refers to a 64 years old female patient. On 08-NOV-2012 at 09:45 AM, the patient was vaccinated with the first dose of ZOSTAVAX lot number reported as aCoeH013938AC subcutaneously (dose and exp. date were not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 09-NOV-2012 at 17:00 PM, the patient experienced red burning sensation on upper chest and right arm that created into a rash about 10 inches diameter. Treatment information was not reported. At the time of report, the patient's outcome was unknown. The relatedness for the patient's events was not reported for ZOSTAVAX. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant (C.M.A.) who refers to a patient of unknown age and gender. It was reported that the patient was vaccinated with an expired dose of ZOSTAVAX (dose, and route not reported) (lot # 671190/1270AA, exp 05-NOV-2012) on 20-NOV-2012. No adverse symptoms reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (dose, route not reported), (lot# reported as H012579, exp. 28-SEP-2012) on 29-OCT-2012. On an unknown date, after receiving ZOSTAVAX, the patient developed "a red spot at the injection site". The patient only spoke with the pharmacist. At the time of the report patient's state was reported as not recovered. Additional information is not expected.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Condition aggravated, Herpes zoster, Nasopharyngitis, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 47 years old female patient with prevent shingles. The patient was vaccinated with ZOSTAVAX on SEP-2011. No other co-suspects were reported. No concomitant medications were reported. On NOV-2011 the patient experienced shingles outbreaks 6 times since being vaccinated. The patient reported each time it is progressively more painful. The patient reported that before the outbreaks she had cold type symptoms, ran a fever, and got a feeling similar to burning in her legs. The patient also experienced eyesight is diminished and she wears sunglasses due to the sensitivity to light. Treatment information was with antivirals. The outcome of shingles outbreaks, sensitivity to light and eyesight diminished is unknown. The relatedness for shingles outbreaks, sensitivity to light and eyesight diminish is unknown for ZOSTAVAX. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Photophobia, Pyrexia, Visual acuity reduced
Clinical narrative: This spontaneous report as received from a consumer refers to a 47 years old female patient with prevent shingles. The patient was vaccinated with ZOSTAVAX on SEP-2011. No other co-suspects were reported. No concomitant medications were reported. On NOV-2011 the patient experienced shingles outbreaks 6 times since being vaccinated. The patient reported each time it is progressively more painful. The patient reported that before the outbreaks she had cold type symptoms, ran a fever, and got a feeling similar to burning in her legs. The patient also experienced eyesight is diminished and she wears sunglasses due to the sensitivity to light. Treatment information was with antivirals. The outcome of shingles outbreaks, sensitivity to light and eyesight diminished is unknown. The relatedness for shingles outbreaks, sensitivity to light and eyesight diminish is unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Initial information has been received from a registered pharmacist concerning a patient with unspecified age, gender, pertinent medical and drug reactions/allergies, who on 14-NOV-2012, was vaccinated subcutaneously with ZOSTAVAX (lot 1160AA exp date 18-OCT-2012) expired vaccine (dose was not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. No treatment information and lab diagnostic studies performed were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient was vaccinated with ZOSTAVAX 4 years ago. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced incorrect storage of drug. No treatment information was reported. The outcome of incorrect storage of drug is unknown. Incorrect storage of drug is not related to ZOSTAVAX. No adverse effect reported. No other information provided. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Herpes zoster, Nasopharyngitis, Neuralgia
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 years old female patient with prevent shingles. The patient was vaccinated with dose 1 ZOSTAVAX on 18-AUG-2011. No other co-suspects were reported. Concomitant medications included levothyroxine sodium and CEPHALEX. On 10-NOV-2012 the patient experienced shingles, 451 days after onset of therapy. The patient experienced a band at waist on left front and around to the back side also. The blisters occurred on the 12-NOV-2012, and she is still experiencing the pain in nerve endings around the waist line. The patient also felt she was developing a head cold around 15-NOV-2012 along with a low grade fever that lasted through 17-NOV-2012. The patient was diagnosed with shingles at a walk-in clinic on 17-NOV-2012. The patient was treated with antiviral, Valacyclovir. The outcome of shingles is unknown. The relatedness for shingles is unknown for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 years old female patient with prevent shingles. The patient was vaccinated with dose 1 ZOSTAVAX on 18-AUG-2011. No other co-suspects were reported. Concomitant medications included levothyroxine sodium and CEPHALEX. On 10-NOV-2012 the patient experienced shingles, 451 days after onset of therapy. The patient experienced a band at waist on left front and around to the back side also. The blisters occurred on the 12-NOV-2012, and she is still experiencing the pain in nerve endings around the waist line. The patient also felt she was developing a head cold around 15-NOV-2012 along with a low grade fever that lasted through 17-NOV-2012. The patient was diagnosed with shingles at a walk-in clinic on 17-NOV-2012. The patient was treated with antiviral, Valacyclovir. The outcome of shingles is unknown. The relatedness for shingles is unknown for ZOSTAVAX. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pyrexia, Varicella, White blood cell count increased
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 years old female patient with prevention of shingles. The patient was vaccinated with ZOSTAVAX on 05-NOV-2012. No other co-suspects were reported. Concomitant medications included carbidopa, glipizide, hydrochlorothiazide, SYNTHROID, ascorbic acid, vitamin D (unspecified) (vitamin D (unspecified)), vitamin E (vitamin E) and biotin. On 15-NOV-2012 the patient experienced chickenpox, 11 days after onset of therapy. Patient reported blisters appearing on forehead that burned that worsened when they were touched. The patient was also running a low grade fever. The patient's doctor stated she had the chickenpox but did not do any cultures of the area. Blood work showed a high WBC. A medication was prescribed but the pharmacy refused to fill the script saying it was not chickenpox. No treatment information was reported. The outcome of chickenpox is unknown. The relatedness for chickenpox is unknown for ZOSTAVAX. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an 81 years old female patient. The patient's medical history included drug reactions/allergies to penicillin, sulfa, cephalosporins and tramadol hydrochloride. The patient also had a lymphoma 4 years ago, for which she was not currently receiving any treatment or medication. On 08-OCT-2012 the patient was vaccinated with ZOSTAVAX (vial 19400). Information regarding dose, dose number, route and lot number was not provided. No other co-suspects were reported. Concomitant medications included: ZOMETA. Two weeks after receiving ZOSTAVAX (approximately 22-OCT-2012) the patient experienced shingles. The patient had sought medical attention (office visit). No relevant tests were performed. The patient received VALTREX as treatment for the event. On 07-NOV-2012 the patient recovered from the event. A reporter causality for shingles was not provided for ZOSTAVAX. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash, Rash erythematous, Tenderness, Urticaria
Clinical narrative: This spontaneous report as received from a 62 years old female consumer refers to herself with drug allergy to penicillin and drug allergy to aspirin. The patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided) on 19-SEP-2012. No other co-suspects were reported. Concomitant medications included lisinopril (manufacturer unknown) and vitamin D (unspecified). On 20-SEP-2012 the patient had an adverse reaction to ZOSTAVAX. There was an injection site reaction that was similar to a "welt." The rash was sore to the touch and was a deep red. The rash lasted for about 1.5 weeks. The rash was only on her arm and was about three inches wide. The rash was about 4-5 inches long. The patient did not seek medical attention and not treatment was given for the adverse events. There were no laboratory diagnostics studies performed. The outcome of the rash was sore to the touch and was a deep red, the rash was only on her arm and an injection site reaction that was similar to a "welt" was reported as recovered/resolved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site nodule, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. No medical history or concurrent conditions were reported. The patient was vaccinated intramuscular with 0.5 ml of lot # (1071AA, expiration date 20-MAR-2013) PNEUMOVAX 23 on 18-OCT-2012. No other co-suspects were reported. There were no concomitant medications. It was reported that the patient developed a "knot" at injection site, "shortly" after vaccination in October 2012. Furthermore, the patient was "now" complaining of warmth and itching at the injection site (reported on 01-NOV-2012). The patient sought medical attention by calling the pharmacy. The event was treated with compresses placed at the injection site. No lab test was done. The outcome the events was reported as not recovered/not resolved. The reporter relatedness for "knot" at injection site, itching and warmth at the injection site is unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 17 weeks old patient. The reporter reported that the patient was received first dose, oral, of ROTATEQ (lot # was unknown) on 15-OCT-2012 when the patient was 17 weeks old. No adverse effect reported. This is one of the two reports from the same source. The other report was captured in MARRS # 1211USA008789. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 17 weeks old patient. The reporter reported that the patient was received first dose of ROTATEQ, oral (lot # was unknown) on 15-OCT-2012 when they were 17 weeks old. No adverse effect reported. This is one of the two reports from the same source. The other report was captured in MARRS # 1211USA010105. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 33 years old female patient with amyotrophic lateral sclerosis (ALS). The patient had no drug allergy. The patient was vaccinated with the first and only dose of PNEUMOVAX23 (lot# reported as 0225AE; expired date: 03-JUN-2013) subcutaneously on 19-NOV-2012. No other co-suspects were reported. Concomitant medications included influenza virus vaccine (manufacture unknown), CELEXA, baclofen, lorazepam and "NUEDEXTA". The physician's assistant noted the patient "developed fever, chills, vomiting, as well as redness and swelling at the injection site on 20-NOV-2012." No treatment was given. The present patient status was not recovered. No lab tests were performed. The patient had sought medical attention via calling the office. This same practice had another adverse event with the same lot number and expiration date of PNEUMOVAX23. MARRS# 1211USA009807. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Electroencephalogram abnormal, Grand mal convulsion, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain
Clinical narrative: Patient received FLUZONE on 11/13/12. Suffered generalized tonic-clonic seizure 11/18/12. Hospitalized; work-up includes abnormal EEG, but etiology remains unclear - clinically well since - no prior h/o seizures.
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: This medically confirmed report (initial receipt: 01-Nov-2012) concerns an elderly female patient. Concomitant medications include sulfa, phenobarbital and DEMEROL. In 2011, the patient received an influenza vaccine (manufacturer, brand name and batch no. were not specified). The patient's throat started to close up and she had difficulty breathing. She was treated at the emergency room and released. The outcome for the events was recovered. Case correction (14-Nov-2012): Case upgraded to serious.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Heart rate increased, Pyrexia, Swelling face, Swollen tongue
Clinical narrative: This consumer report (initial receipt: 15-Nov-2012) concerns a 50-year-old female patient, who had a medical history of 'deliac disease' (celiac disease). On 12-Nov-2012 the patient received AFLURIA (batch number was not provided) injection. On 12-Nov-2012, hours later, the patient's face and tongue swelled. Her heart rate increased. She suffered a headache, had a high fever and continuously kept throwing up. The patient did not seek medical attention. No lab diagnostic study was performed.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: This consumer report (initial receipt: 15-Nov-2012) concerns a 50-year-old female patient, who had a medical history of 'deliac disease' (celiac disease). On 12-Nov-2012 the patient received AFLURIA (batch number was not provided) injection. On 12-Nov-2012, hours later, the patient's face and tongue swelled. Her heart rate increased. She suffered a headache, had a high fever and continuously kept throwing up. The patient did not seek medical attention. No lab diagnostic study was performed.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Autopsy, Death, Glioblastoma multiforme, Hyporeflexia, Immunoglobulin therapy
Clinical narrative: This literature report (initial receipt: 13-Nov-2012) concerns a 49-year-old male patient. The patient had a recent history of viral infection status post flu vaccination (manufacturer, brand name and batch number were not provided). On an unknown date (post viral infection) the patient presented with a 2-week history of bilateral lower extremity weakness and paresthesias starting at the level of the axilla. He was evaluated by Neurology and initially diagnosed with transverse myelitis. He underwent intravenous immunoglobulin and steroid treatment without improvement. The patient's physical examination revealed 3/5 proximal and 5/5 distal muscle strength in the lower extremities, deep tendon reflexes were 2/4 with no upper motor neuron signs visualized. He was medically stabilized and transferred to inpatient rehabilitation facility. Ten days post admission, the patient experienced acute motor loss (0/5) in bilateral lower extremities and worsening paresthesias, now involving bilateral upper extremities. At 10 days post admission, imaging revealed C7 to T2 diffuse cord expansion and an oval-shaped focus of intramedullary enhancement. Prior to the completion of his medical work-up, the patient passed away due to unclear causes. Death was most likely related to respiratory compromise. Post mortem autopsy results showed histopathological diagnosis of primary glioblastoma multiforme of the spinal cord. Reporter's comment: This is a rare documented case of primary spinal glioblastoma multiforme in an adult patient. Mean survival time after onset is between 6-16 months. The major cause of death is leptomeningeal spread and cerebral metastasis. Cervical glioblastoma multiforme may have an even poorer outcome because of early involvement of the phrenic nerve nucleus and vasomotor centers.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Metastases to meninges, Motor dysfunction, Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging spinal cord abnormal
Clinical narrative: This literature report (initial receipt: 13-Nov-2012) concerns a 49-year-old male patient. The patient had a recent history of viral infection status post flu vaccination (manufacturer, brand name and batch number were not provided). On an unknown date (post viral infection) the patient presented with a 2-week history of bilateral lower extremity weakness and paresthesias starting at the level of the axilla. He was evaluated by Neurology and initially diagnosed with transverse myelitis. He underwent intravenous immunoglobulin and steroid treatment without improvement. The patient's physical examination revealed 3/5 proximal and 5/5 distal muscle strength in the lower extremities, deep tendon reflexes were 2/4 with no upper motor neuron signs visualized. He was medically stabilized and transferred to inpatient rehabilitation facility. Ten days post admission, the patient experienced acute motor loss (0/5) in bilateral lower extremities and worsening paresthesias, now involving bilateral upper extremities. At 10 days post admission, imaging revealed C7 to T2 diffuse cord expansion and an oval-shaped focus of intramedullary enhancement. Prior to the completion of his medical work-up, the patient passed away due to unclear causes. Death was most likely related to respiratory compromise. Post mortem autopsy results showed histopathological diagnosis of primary glioblastoma multiforme of the spinal cord. Reporter's comment: This is a rare documented case of primary spinal glioblastoma multiforme in an adult patient. Mean survival time after onset is between 6-16 months. The major cause of death is leptomeningeal spread and cerebral metastasis. Cervical glioblastoma multiforme may have an even poorer outcome because of early involvement of the phrenic nerve nucleus and vasomotor centers.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Paraesthesia, Respiratory disorder, Viral infection
Clinical narrative: This literature report (initial receipt: 13-Nov-2012) concerns a 49-year-old male patient. The patient had a recent history of viral infection status post flu vaccination (manufacturer, brand name and batch number were not provided). On an unknown date (post viral infection) the patient presented with a 2-week history of bilateral lower extremity weakness and paresthesias starting at the level of the axilla. He was evaluated by Neurology and initially diagnosed with transverse myelitis. He underwent intravenous immunoglobulin and steroid treatment without improvement. The patient's physical examination revealed 3/5 proximal and 5/5 distal muscle strength in the lower extremities, deep tendon reflexes were 2/4 with no upper motor neuron signs visualized. He was medically stabilized and transferred to inpatient rehabilitation facility. Ten days post admission, the patient experienced acute motor loss (0/5) in bilateral lower extremities and worsening paresthesias, now involving bilateral upper extremities. At 10 days post admission, imaging revealed C7 to T2 diffuse cord expansion and an oval-shaped focus of intramedullary enhancement. Prior to the completion of his medical work-up, the patient passed away due to unclear causes. Death was most likely related to respiratory compromise. Post mortem autopsy results showed histopathological diagnosis of primary glioblastoma multiforme of the spinal cord. Reporter's comment: This is a rare documented case of primary spinal glioblastoma multiforme in an adult patient. Mean survival time after onset is between 6-16 months. The major cause of death is leptomeningeal spread and cerebral metastasis. Cervical glioblastoma multiforme may have an even poorer outcome because of early involvement of the phrenic nerve nucleus and vasomotor centers.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blood test, Paraesthesia, Varicella
Clinical narrative: This consumer report (initial receipt: 12-Nov-2012) concerns a female patient, who had a medical history of osteoarthritis and had unusual pain in her arm muscles, in areas that she had not had experienced pain before. On 20-Oct-2012 the patient received a flu vaccination (manufacturer, brand name and lot number were not provided). On 26-Oct-2012 the patient received her ZOSTAVAX injection once subcutaneously. On 26-Oct-2012 (7 days after receiving flu vaccine), the patient walked to the parking lot and had the sensation that she was being electrocuted. The sensation lasted for about 4 -5 minutes. As soon as she got home she called the pharmacist who gave her the ZOSTAVAX vaccination. The pharmacist told her to see her physician. Her physician drew unspecified blood samples. Two days after receiving the ZOSTAVAX (28-Oct-2012; 9 days after receiving flu vaccine), the patient had an outbreak of chickenpox. The event outcome was recovering.
Age: 28.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Herpes simplex, Herpes zoster, Oral herpes, Pain
Clinical narrative: This literature report (initial receipt: 13-Nov-2012) concerns a 28-year-old male patient, who had a history of varicella as a child. The patient was in excellent health until about 2 weeks prior when he received an influenza vaccine (manufacturer, brand name and batch number were not provided). The following day (after vaccination), the patient noted the development of a cold sore on his lip. He was treated with over the counter medications. About 1 week later, he developed a burning-like pain across the mid-back and then noted a rash. The patient was referred for a painful rash. Examination revealed a rash consistent with herpes zoster, just lateral to the midline of the back, at the level of T9. The remained of the examination was normal. The rash had subsequently resolved. However, the patient continued to have pain and was started on gabapentin and provided with a TENs unit, which helped to resolve the pain. Reporter's comment: There is no known case in the literature of the influenza vaccine leading to shingles. In this patient, the influenza vaccine appears to have reactivated the latent HSV-1 & HSV-3 viruses.
Age: 28.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: This literature report (initial receipt: 13-Nov-2012) concerns a 28-year-old male patient, who had a history of varicella as a child. The patient was in excellent health until about 2 weeks prior when he received an influenza vaccine (manufacturer, brand name and batch number were not provided). The following day (after vaccination), the patient noted the development of a cold sore on his lip. He was treated with over the counter medications. About 1 week later, he developed a burning-like pain across the mid-back and then noted a rash. The patient was referred for a painful rash. Examination revealed a rash consistent with herpes zoster, just lateral to the midline of the back, at the level of T9. The remained of the examination was normal. The rash had subsequently resolved. However, the patient continued to have pain and was started on gabapentin and provided with a TENs unit, which helped to resolve the pain. Reporter's comment: There is no known case in the literature of the influenza vaccine leading to shingles. In this patient, the influenza vaccine appears to have reactivated the latent HSV-1 & HSV-3 viruses.