chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Full blood count normal, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm injection site.
Age: 1.1
Sex: F
Vaccine: IPV, PNC13
Symptoms: Pyrexia
Clinical narrative: Started running a fever on 9/20/12 of 101-102, even with alternating Tylenol and Ibuprofen per recommended schedule. On 9/21/12 at 8:30pm, it was 5.5 hours after prior dose of Ibuprofen- fever spiked to 106 degrees. Gave Ibuprofen and instituted cooling measures, and fever went down to 103 within 1 hour.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Areflexia, Asthenia, CSF protein increased, Cough, Fatigue
Clinical narrative: Came to office 8-13-12 with c/o fatigue, cough, tactile fever, muscle aches (arms & legs) started reportedly 8-8-12 Flu test (Neg) CBC WNL; sister with similar sxs (got GARDASIL on 8-6-12 as well) - came back to office on 8-30-12 with continued weakness; difficulty walking; paraesthesia areflexia exam decreased muscle strength lower ext sent to hospital R/O Guillain Barre syndrome at that time. Just got records from hospital today 9-24-12.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Full blood count normal, Gait disturbance, Immunoglobulin therapy, Influenza virus test negative, Muscular weakness
Clinical narrative: Came to office 8-13-12 with c/o fatigue, cough, tactile fever, muscle aches (arms & legs) started reportedly 8-8-12 Flu test (Neg) CBC WNL; sister with similar sxs (got GARDASIL on 8-6-12 as well) - came back to office on 8-30-12 with continued weakness; difficulty walking; paraesthesia areflexia exam decreased muscle strength lower ext sent to hospital R/O Guillain Barre syndrome at that time. Just got records from hospital today 9-24-12.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Myalgia, Neurological examination, Paraesthesia, Pyrexia
Clinical narrative: Came to office 8-13-12 with c/o fatigue, cough, tactile fever, muscle aches (arms & legs) started reportedly 8-8-12 Flu test (Neg) CBC WNL; sister with similar sxs (got GARDASIL on 8-6-12 as well) - came back to office on 8-30-12 with continued weakness; difficulty walking; paraesthesia areflexia exam decreased muscle strength lower ext sent to hospital R/O Guillain Barre syndrome at that time. Just got records from hospital today 9-24-12.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Heart rate increased
Clinical narrative: WEAKNESS, DIZZINESS, FAST HEART RATE.
Age: 40.0
Sex: M
Vaccine: DTAP
Symptoms: Activities of daily living impaired, Asthenia, Blood creatine phosphokinase increased, Clumsiness, Dysgraphia
Clinical narrative: Suspected Guillain Barre (GBS) per PCP. Wed 8/15  -Morning:  headache / drop in energy / APAP -6PM:  skipped dinner / went to bed -Blazing fever (no APAP).  Groin/Testicle pain/ major aches. -Long/bizarre night.  Thu 8/16 -Morning: Felt AWFUL.  Tough to shower. Groin pain/Testicle pain.  Difficult to walk. Lethargic.  Began feeling grip weakness (brief case carry into work).  Shuffling feet.  Sweating.  Took APAP. -Left work ~1130AM.  Went home and went to bed.  Fever -3PM  drove to another town. -Went out to dinner.  Hard time holding spoon.  Feeling better w/ APAP/Advil.  Fri 8/17 -Stayed on couch all day.  IBU every 4 hours ATC. -Groin pain/testicle pain resolving.  Walking improving. -Both hands progressively weak/numb.  Could not write name.  Hands feel cold.   Sat 8/18 -Morning:  Hands incredibly weak/clumsy.  Could not tie shoes/buttons.  Walking better. -Flex arm/bicep = rippling + can't hold contraction.  All muscles (- face) sore.  Especially midline of forearm. -9AM  went to Emergency Department. -Labs showed elevated CPK (750).  Unable to determine cause.  Checked for Rhabdo/urine. Concluded must be viral.  Received 2L of NS.  MD stated it may take a few days to clear. Left feeling horrible.  Hands immobile (swollen).  Sun 8/19 -Felling a bit better. Still problems with hands  a little more coord (minus swollen)  Mon 8/20 -Back to work.  Could not type/write.  Hands feel cold.  Tue 8/21 - Hand weakness tingling, but less.  Right hand improving over left hand.  -through 8/31, significant hand weakness.  Zapping ulnar nerve (mostly left hand).  Yesterday (9/5) / Today (9/6) -Feeling tingly in 1st/2nd digits  especially left hand.  Can fully type and write name.  Hands feel cold and tingly.  Slight clumsiness in hands.
Age: 40.0
Sex: M
Vaccine: DTAP
Symptoms: Feeling abnormal, Gait disturbance, Grip strength decreased, Groin pain, Guillain-Barre syndrome
Clinical narrative: Suspected Guillain Barre (GBS) per PCP. Wed 8/15  -Morning:  headache / drop in energy / APAP -6PM:  skipped dinner / went to bed -Blazing fever (no APAP).  Groin/Testicle pain/ major aches. -Long/bizarre night.  Thu 8/16 -Morning: Felt AWFUL.  Tough to shower. Groin pain/Testicle pain.  Difficult to walk. Lethargic.  Began feeling grip weakness (brief case carry into work).  Shuffling feet.  Sweating.  Took APAP. -Left work ~1130AM.  Went home and went to bed.  Fever -3PM  drove to another town. -Went out to dinner.  Hard time holding spoon.  Feeling better w/ APAP/Advil.  Fri 8/17 -Stayed on couch all day.  IBU every 4 hours ATC. -Groin pain/testicle pain resolving.  Walking improving. -Both hands progressively weak/numb.  Could not write name.  Hands feel cold.   Sat 8/18 -Morning:  Hands incredibly weak/clumsy.  Could not tie shoes/buttons.  Walking better. -Flex arm/bicep = rippling + can't hold contraction.  All muscles (- face) sore.  Especially midline of forearm. -9AM  went to Emergency Department. -Labs showed elevated CPK (750).  Unable to determine cause.  Checked for Rhabdo/urine. Concluded must be viral.  Received 2L of NS.  MD stated it may take a few days to clear. Left feeling horrible.  Hands immobile (swollen).  Sun 8/19 -Felling a bit better. Still problems with hands  a little more coord (minus swollen)  Mon 8/20 -Back to work.  Could not type/write.  Hands feel cold.  Tue 8/21 - Hand weakness tingling, but less.  Right hand improving over left hand.  -through 8/31, significant hand weakness.  Zapping ulnar nerve (mostly left hand).  Yesterday (9/5) / Today (9/6) -Feeling tingly in 1st/2nd digits  especially left hand.  Can fully type and write name.  Hands feel cold and tingly.  Slight clumsiness in hands.
Age: 40.0
Sex: M
Vaccine: DTAP
Symptoms: Headache, Hyperhidrosis, Hypoaesthesia, Laboratory test, Lethargy
Clinical narrative: Suspected Guillain Barre (GBS) per PCP. Wed 8/15  -Morning:  headache / drop in energy / APAP -6PM:  skipped dinner / went to bed -Blazing fever (no APAP).  Groin/Testicle pain/ major aches. -Long/bizarre night.  Thu 8/16 -Morning: Felt AWFUL.  Tough to shower. Groin pain/Testicle pain.  Difficult to walk. Lethargic.  Began feeling grip weakness (brief case carry into work).  Shuffling feet.  Sweating.  Took APAP. -Left work ~1130AM.  Went home and went to bed.  Fever -3PM  drove to another town. -Went out to dinner.  Hard time holding spoon.  Feeling better w/ APAP/Advil.  Fri 8/17 -Stayed on couch all day.  IBU every 4 hours ATC. -Groin pain/testicle pain resolving.  Walking improving. -Both hands progressively weak/numb.  Could not write name.  Hands feel cold.   Sat 8/18 -Morning:  Hands incredibly weak/clumsy.  Could not tie shoes/buttons.  Walking better. -Flex arm/bicep = rippling + can't hold contraction.  All muscles (- face) sore.  Especially midline of forearm. -9AM  went to Emergency Department. -Labs showed elevated CPK (750).  Unable to determine cause.  Checked for Rhabdo/urine. Concluded must be viral.  Received 2L of NS.  MD stated it may take a few days to clear. Left feeling horrible.  Hands immobile (swollen).  Sun 8/19 -Felling a bit better. Still problems with hands  a little more coord (minus swollen)  Mon 8/20 -Back to work.  Could not type/write.  Hands feel cold.  Tue 8/21 - Hand weakness tingling, but less.  Right hand improving over left hand.  -through 8/31, significant hand weakness.  Zapping ulnar nerve (mostly left hand).  Yesterday (9/5) / Today (9/6) -Feeling tingly in 1st/2nd digits  especially left hand.  Can fully type and write name.  Hands feel cold and tingly.  Slight clumsiness in hands.
Age: 40.0
Sex: M
Vaccine: DTAP
Symptoms: Mobility decreased, Muscular weakness, Myalgia, Oedema peripheral, Pain
Clinical narrative: Suspected Guillain Barre (GBS) per PCP. Wed 8/15  -Morning:  headache / drop in energy / APAP -6PM:  skipped dinner / went to bed -Blazing fever (no APAP).  Groin/Testicle pain/ major aches. -Long/bizarre night.  Thu 8/16 -Morning: Felt AWFUL.  Tough to shower. Groin pain/Testicle pain.  Difficult to walk. Lethargic.  Began feeling grip weakness (brief case carry into work).  Shuffling feet.  Sweating.  Took APAP. -Left work ~1130AM.  Went home and went to bed.  Fever -3PM  drove to another town. -Went out to dinner.  Hard time holding spoon.  Feeling better w/ APAP/Advil.  Fri 8/17 -Stayed on couch all day.  IBU every 4 hours ATC. -Groin pain/testicle pain resolving.  Walking improving. -Both hands progressively weak/numb.  Could not write name.  Hands feel cold.   Sat 8/18 -Morning:  Hands incredibly weak/clumsy.  Could not tie shoes/buttons.  Walking better. -Flex arm/bicep = rippling + can't hold contraction.  All muscles (- face) sore.  Especially midline of forearm. -9AM  went to Emergency Department. -Labs showed elevated CPK (750).  Unable to determine cause.  Checked for Rhabdo/urine. Concluded must be viral.  Received 2L of NS.  MD stated it may take a few days to clear. Left feeling horrible.  Hands immobile (swollen).  Sun 8/19 -Felling a bit better. Still problems with hands  a little more coord (minus swollen)  Mon 8/20 -Back to work.  Could not type/write.  Hands feel cold.  Tue 8/21 - Hand weakness tingling, but less.  Right hand improving over left hand.  -through 8/31, significant hand weakness.  Zapping ulnar nerve (mostly left hand).  Yesterday (9/5) / Today (9/6) -Feeling tingly in 1st/2nd digits  especially left hand.  Can fully type and write name.  Hands feel cold and tingly.  Slight clumsiness in hands.
Age: 40.0
Sex: M
Vaccine: DTAP
Symptoms: Paraesthesia, Peripheral coldness, Pyrexia, Testicular pain, Urine analysis
Clinical narrative: Suspected Guillain Barre (GBS) per PCP. Wed 8/15  -Morning:  headache / drop in energy / APAP -6PM:  skipped dinner / went to bed -Blazing fever (no APAP).  Groin/Testicle pain/ major aches. -Long/bizarre night.  Thu 8/16 -Morning: Felt AWFUL.  Tough to shower. Groin pain/Testicle pain.  Difficult to walk. Lethargic.  Began feeling grip weakness (brief case carry into work).  Shuffling feet.  Sweating.  Took APAP. -Left work ~1130AM.  Went home and went to bed.  Fever -3PM  drove to another town. -Went out to dinner.  Hard time holding spoon.  Feeling better w/ APAP/Advil.  Fri 8/17 -Stayed on couch all day.  IBU every 4 hours ATC. -Groin pain/testicle pain resolving.  Walking improving. -Both hands progressively weak/numb.  Could not write name.  Hands feel cold.   Sat 8/18 -Morning:  Hands incredibly weak/clumsy.  Could not tie shoes/buttons.  Walking better. -Flex arm/bicep = rippling + can't hold contraction.  All muscles (- face) sore.  Especially midline of forearm. -9AM  went to Emergency Department. -Labs showed elevated CPK (750).  Unable to determine cause.  Checked for Rhabdo/urine. Concluded must be viral.  Received 2L of NS.  MD stated it may take a few days to clear. Left feeling horrible.  Hands immobile (swollen).  Sun 8/19 -Felling a bit better. Still problems with hands  a little more coord (minus swollen)  Mon 8/20 -Back to work.  Could not type/write.  Hands feel cold.  Tue 8/21 - Hand weakness tingling, but less.  Right hand improving over left hand.  -through 8/31, significant hand weakness.  Zapping ulnar nerve (mostly left hand).  Yesterday (9/5) / Today (9/6) -Feeling tingly in 1st/2nd digits  especially left hand.  Can fully type and write name.  Hands feel cold and tingly.  Slight clumsiness in hands.
Age: 1.01
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site rash, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Child developed red maculopapular rash on face and trunk, and left thigh. Resolved over 15 minutes, no breathing problems, patient was alert and playful.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Postictal state
Clinical narrative: Post-icteral symptoms, trouble breathing, IV placed. Patient now doing better.
Age: 1.01
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site rash, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: After vaccines child developed red maculopapular rash on face, trunk and left thigh. Resolved over 15 minutes, no breathing problems. Alert and playful.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Chest pain, Dizziness, Feeling abnormal, Injection site erythema
Clinical narrative: Vomiting, fever of 103-104, nausea, severe body aches, extreme pain/swelling/redness where the shot was given (upper right arm), closing of my airway, swollen tongue. I could not move when I woke up from a nap. My son age 13 had to help me sit up and walk me to the rest room. I could not move. I was severely dizzy and vomiting (dry heaves). I thought I was dying and everything seemed like a cloud.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Laboratory test, Mobility decreased, Nausea
Clinical narrative: Vomiting, fever of 103-104, nausea, severe body aches, extreme pain/swelling/redness where the shot was given (upper right arm), closing of my airway, swollen tongue. I could not move when I woke up from a nap. My son age 13 had to help me sit up and walk me to the rest room. I could not move. I was severely dizzy and vomiting (dry heaves). I thought I was dying and everything seemed like a cloud.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Retching, Swollen tongue, Upper airway obstruction
Clinical narrative: Vomiting, fever of 103-104, nausea, severe body aches, extreme pain/swelling/redness where the shot was given (upper right arm), closing of my airway, swollen tongue. I could not move when I woke up from a nap. My son age 13 had to help me sit up and walk me to the rest room. I could not move. I was severely dizzy and vomiting (dry heaves). I thought I was dying and everything seemed like a cloud.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Vomiting, fever of 103-104, nausea, severe body aches, extreme pain/swelling/redness where the shot was given (upper right arm), closing of my airway, swollen tongue. I could not move when I woke up from a nap. My son age 13 had to help me sit up and walk me to the rest room. I could not move. I was severely dizzy and vomiting (dry heaves). I thought I was dying and everything seemed like a cloud.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Severe pain and swelling, redness, possible cellulitis. Had to go to ER in the evening. Now finishing anti-biotics.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PPV, RV5
Symptoms: Abdominal pain upper, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Stomach cramps, vomiting, diarrhea, fever. Diarrhea for 7 days. Vomiting for 1 days. Stomach cramps for 3 days. Fever for 2 days.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Rash
Clinical narrative: Terrible abdominal pain on left side prior to rash onset.
Age: 20.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Dizziness, Malaise, Syncope, Tachycardia
Clinical narrative: Patient received Flumist for the first time. Began feeling ill, weak and lightheaded then had syncopal episode in a friend's car. Taken to acute care clinic and found to be tachycardic; developed hives/urticaria w/o dyspnea. Administered IV methylprednisolone, diphenhydramine, and ranitidine with complete resolution of symptoms.
Age: 20.0
Sex: F
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: Patient received Flumist for the first time. Began feeling ill, weak and lightheaded then had syncopal episode in a friend's car. Taken to acute care clinic and found to be tachycardic; developed hives/urticaria w/o dyspnea. Administered IV methylprednisolone, diphenhydramine, and ranitidine with complete resolution of symptoms.
Age: 53.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None. Report completed because pt age was out of range of appropriate age for medication.
Age: 40.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Full blood count abnormal, Inflammation, Injection site erythema, Leukocytosis, Myalgia
Clinical narrative: Muscle soreness, inflammation, and erythema at site of injection, fevers and leukocytosis.
Age: 40.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Rash
Clinical narrative: Muscle soreness, inflammation, and erythema at site of injection, fevers and leukocytosis.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: No adverse events.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome - reported to my by his parents one year later when they came to our office to have travel vaccinations.  Patient treated at Hospital in 2011 (September).
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Body temperature increased, Decreased appetite, Headache, Nasal congestion
Clinical narrative: Weakness no energy on day one, day two extreme sore throat, day three aching day 4 nausea vomiting, sore throat, aching, temperature over 100, weakness, no appetite, headache, nasal congestion - symptoms are still continuing now.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Oropharyngeal pain, Pain, Vomiting
Clinical narrative: Weakness no energy on day one, day two extreme sore throat, day three aching day 4 nausea vomiting, sore throat, aching, temperature over 100, weakness, no appetite, headache, nasal congestion - symptoms are still continuing now.
Age: 52.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blister, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site. 5 blisters. Applied cold pack.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Patient developed a large rash around the injection site as well as a fever. Patient treated in the hospital and given a prescription for a steroid cream and released. Fever had gone away but rash still present as of 9/24/12.
Age: 39.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Activities of daily living impaired, Feeling of body temperature change, Headache, Influenza like illness, Injection site pain
Clinical narrative: Woke up in the middle of the night with throbbing pain in the Lt upper arm. Took Ibuprofen and returned to bed. Woke up again between 6:00 AM - 7:00 AM with flu-like symptoms. In less than an hour, took more Ibuprofen for the headache and body aches. She than began to experience bouts of hot and cold episodes that worsened. This lasted until 11:00 PM Sunday night. Was in bed the entire day on Saturday and did not physically get up from bed until late Sunday night.
Age: 39.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Middle insomnia, Pain
Clinical narrative: Woke up in the middle of the night with throbbing pain in the Lt upper arm. Took Ibuprofen and returned to bed. Woke up again between 6:00 AM - 7:00 AM with flu-like symptoms. In less than an hour, took more Ibuprofen for the headache and body aches. She than began to experience bouts of hot and cold episodes that worsened. This lasted until 11:00 PM Sunday night. Was in bed the entire day on Saturday and did not physically get up from bed until late Sunday night.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy, Chronic inflammatory demyelinating polyradiculoneuropathy, Electroencephalogram, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Pt. was extremely weak in his upper and lower extremities. He had a 3 day IVig treatment and was diagnosed with Gillian Barre Syndrome. The event continued to happen over and over. We spent many nights in the hospital. He has since then been diagnosed with chronic Gillian Barre Syndrome aka CIDP. We go to the day medicine clinic 100 miles away every month for an IV treatment. I had no idea I could report this to anyone until last week. I had met someone with a similar scenario.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Pt. was extremely weak in his upper and lower extremities. He had a 3 day IVig treatment and was diagnosed with Gillian Barre Syndrome. The event continued to happen over and over. We spent many nights in the hospital. He has since then been diagnosed with chronic Gillian Barre Syndrome aka CIDP. We go to the day medicine clinic 100 miles away every month for an IV treatment. I had no idea I could report this to anyone until last week. I had met someone with a similar scenario.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Facial pain, Trigeminal neuralgia
Clinical narrative: New onset of severe facial pain on ipsilateral side as injection site -  right side. Diagnosed as Trigeminal Neuralgia by Veteran's Affairs ED by two providers. Refered to Neuro. Treated medically.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Obtained both Tdap & PNEUMOVAX 9/10/12. Reports hard, hot lump upper lateral (R) arm, swelling, pain. Redness/swelling moving inferiorly. Rx: OTC ZYRTEC as directed on bottle; warm packs to site qid.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site warmth
Clinical narrative: Obtained both Tdap & PNEUMOVAX 9/10/12. Reports hard, hot lump upper lateral (R) arm, swelling, pain. Redness/swelling moving inferiorly. Rx: OTC ZYRTEC as directed on bottle; warm packs to site qid.
Age: 12.0
Sex: F
Vaccine: FLU3, FLU3, FLUN3
Symptoms: Syringe issue, Urticaria
Clinical narrative: Patient was been given in the (L) arm when the vaccine ejected out of the junction between needle and syringe and sprayed the patient on the back. She developed urticarial patches on her back within shins. She was given oral BENADRYL tab and reaction subsided. Duration to subside unknown as patient left the clinic.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Hot flush, Injection site swelling, Lymphadenopathy, Pain, Tenderness
Clinical narrative: Lymphadenopathy, swelling at site, pain, tenderness, hot flashes.
Age: 0.18
Sex: M
Vaccine: HEP, RV5
Symptoms: Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: Patient seen in office for c/o blood in stool with mucus 8 days after vaccine administered. Lab confirmed one positive hemoccult on 9-13-12. No medications ordered.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Pyrexia
Clinical narrative: Redness, inflammation, fever - started day after receiving vaccine. Patient put ice packs on it and took some ibuprofen as well. Was doing fine 2 days later.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Local swelling, Pruritus, Pyrexia
Clinical narrative: See attached. Received FLUZONE Pres-Free injection on August 28, 2012, in the left deltoid area. On Tues, August 29 had quarter size swollen area, with about half dollar size red area, low grade fever of 100.5. Wed, August 30 woke up with hives everywhere. Neck and face were bright red just about purple looking. Started taking BENADRYL when that did not work was told to try Cetirizine came to see dr on August 31, he had her stop the Cetirizine and put her on Hydroxyzine 50 mg three times a day. After two days on medication hives resolved. Then on Sept 10 the itching started again. She was in to see dr on Sept 11, and was treated with Hydroxyzine 50 mg again. Patient stated that 24hrs after being on Hydroxyzine hives and itching gone. See it to follow up with allergist.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: See attached. Received FLUZONE Pres-Free injection on August 28, 2012, in the left deltoid area. On Tues, August 29 had quarter size swollen area, with about half dollar size red area, low grade fever of 100.5. Wed, August 30 woke up with hives everywhere. Neck and face were bright red just about purple looking. Started taking BENADRYL when that did not work was told to try Cetirizine came to see dr on August 31, he had her stop the Cetirizine and put her on Hydroxyzine 50 mg three times a day. After two days on medication hives resolved. Then on Sept 10 the itching started again. She was in to see dr on Sept 11, and was treated with Hydroxyzine 50 mg again. Patient stated that 24hrs after being on Hydroxyzine hives and itching gone. See it to follow up with allergist.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of pain during injection in a 78-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 11 September 2012 the subject received 1st dose of BOOSTRIX (.5 ml, unknown, right arm). On 11 September 2012, immediately after vaccination with BOOSTRIX, the subject experienced excruciating pain that began as soon as the vaccine was administered [pain during injection] and that has worsened. The pain and swelling affected her left arm from the shoulder down to her elbow [spreading pain], requiring the subject wear an arm sling. Because of the excruciating pain from shoulder to elbow necessitating the subject had to wear a sling. The healthcare professional considered the events were disabling. At the time of reporting the pain during injection, spreading pain and swelling were worse.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Dyspnoea, Erythema, Extensive swelling of vaccinated limb
Clinical narrative: Thursday, September 13, 2012, at 8:30 a.m., at the direction of my employer, I reported to my scheduled appointment with a Pharmacy where I received a Health Screening. Since I have had both the flu and pneumonia in the past, I spoke with the Pharmacist and requested both the flu and pneumonia shots. I received the flu shot in my left arm and the pneumonia shot in my right. I was told to "work" my arms and that would lessen the pain and prevent them from "stiffening up". I spent the rest of the day doing housework. My left arm was feeling fine, but my right arm was intensely painful. As time went by and my right arm, shoulder, chest and back were now red, hot and swollen, I realized I was not getting any better, but, I just thought I was not "working" it enough. By evening, my right arm was four times its size. I was freezing cold, shaking uncontrollably, putting on warmer clothing and turning up the heat in my home. I had no idea that I was not only getting worse but, by now, I was having trouble breathing and was in serious trouble. At approximately 8 p.m., I telephoned my Mother, who sent my daughter to transport me to the Emergency Department where I was seen immediately by the physician on duty. Upon my arrival in the emergency room, I was given two shots, (one for pain and one for inflammation) one in each hip and was told my pneumonia shot had been administered improperly. The shot needed to be given into the muscle of my arm. Instead, when person gave me the shot, she placed it into the fatty tissue of my right arm. Upon leaving the Emergency Department, I was given two prescriptions: Ketorolac Tablets, an anti-inflammatory drug and Oxycodone, for pain. And, as of this date, have not been able to return to work.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling cold, Oedema peripheral, Pain in extremity, Skin warm, Tremor
Clinical narrative: Thursday, September 13, 2012, at 8:30 a.m., at the direction of my employer, I reported to my scheduled appointment with a Pharmacy where I received a Health Screening. Since I have had both the flu and pneumonia in the past, I spoke with the Pharmacist and requested both the flu and pneumonia shots. I received the flu shot in my left arm and the pneumonia shot in my right. I was told to "work" my arms and that would lessen the pain and prevent them from "stiffening up". I spent the rest of the day doing housework. My left arm was feeling fine, but my right arm was intensely painful. As time went by and my right arm, shoulder, chest and back were now red, hot and swollen, I realized I was not getting any better, but, I just thought I was not "working" it enough. By evening, my right arm was four times its size. I was freezing cold, shaking uncontrollably, putting on warmer clothing and turning up the heat in my home. I had no idea that I was not only getting worse but, by now, I was having trouble breathing and was in serious trouble. At approximately 8 p.m., I telephoned my Mother, who sent my daughter to transport me to the Emergency Department where I was seen immediately by the physician on duty. Upon my arrival in the emergency room, I was given two shots, (one for pain and one for inflammation) one in each hip and was told my pneumonia shot had been administered improperly. The shot needed to be given into the muscle of my arm. Instead, when person gave me the shot, she placed it into the fatty tissue of my right arm. Upon leaving the Emergency Department, I was given two prescriptions: Ketorolac Tablets, an anti-inflammatory drug and Oxycodone, for pain. And, as of this date, have not been able to return to work.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal distension, Blood culture, Culture urine negative, Dyspnoea, Haemoglobin normal
Clinical narrative: < 24 hours s/p vaccine, pt had hypersalivation, abd distention, irritability, diff with breathing secondary to increased saliva. Resolved with BM 28 hours later.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Metabolic function test, Salivary hypersecretion, White blood cell count increased
Clinical narrative: < 24 hours s/p vaccine, pt had hypersalivation, abd distention, irritability, diff with breathing secondary to increased saliva. Resolved with BM 28 hours later.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Abnormal behaviour, Culture, Diarrhoea, Eating disorder, Haematochezia
Clinical narrative: Patient had extreme fussiness and large blowout stools post rotavirus vaccine. She had some specks of blood in it too and was seen in the ER and a culture was taken. No fever, lots of increased sleeping, some pallor. Today mom and date note she is acting more like herself and stooling more normally and her eating has improved.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Hypersomnia, Irritability, Pallor
Clinical narrative: Patient had extreme fussiness and large blowout stools post rotavirus vaccine. She had some specks of blood in it too and was seen in the ER and a culture was taken. No fever, lots of increased sleeping, some pallor. Today mom and date note she is acting more like herself and stooling more normally and her eating has improved.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Cold sweat, Dizziness, Feeling hot, Injection site erythema
Clinical narrative: Client received flu shot on AM of 9/19/12, started having cold sweat within 1 hr, then felt hot & "like he was going to pass out". Drove home. Called daughter, took temp, in evening when he called prompt care. Temp was 103 degrees. C/O body aches the next day. Flu shot given in RD. C/o redness & swelling at site the night of vaccine.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Pain
Clinical narrative: Client received flu shot on AM of 9/19/12, started having cold sweat within 1 hr, then felt hot & "like he was going to pass out". Drove home. Called daughter, took temp, in evening when he called prompt care. Temp was 103 degrees. C/O body aches the next day. Flu shot given in RD. C/o redness & swelling at site the night of vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: At site redness appeared day 4 = approximately 3 cm diameter smooth, no opening, slightly firm 'to touch'.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Haematoma, Myalgia
Clinical narrative: Hematoma located several inches lower than where shot was given. Hematoma extended to approx 1/2 of pts arm. Pt has muscle pain extending to her elbows.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Axillary pain, Injection site reaction, Lymphadenopathy, Musculoskeletal chest pain, Myalgia
Clinical narrative: 1st day muscle aches around injection area (L. arm) later moving lower left arm muscle pain. 2nd day aches in left arm pit and left rib cage. Felt like I had a ball in my arm pit. The pain was steady. Clinic advise treatment by ice packs. Used ice packs for three days.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Cough, Injection site pruritus, Injection site swelling, Wheezing
Clinical narrative: Swelling and itching at injection site; wheezing and coughing; mild anaphylaxis. Self treatment with rescue inhaler and BENADRYL symptoms subsided after treatment. No previous history of flu shot reactions.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Syncope
Clinical narrative: Five minutes after shots administered, client fainted at reception desk. He did not sustain any.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis on (L) arm injection site of immunizations 8/23/2012 - date of Imm KINRIX (DTaP & IPV) (L) deltoid IM MMR & Varicella (L) upper arm SQ.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Headache, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Vaccine rec'd for shingles protection on 9/11/12 at 1 pm. Band aid to area. By evening day 1 - bright red rash - shape to match regular single band aid appeared. Removed - sore at site. Day 2 evening - arm area swollen, bright red rash, hot to touch/ice applied. Day 3 - back of arm still swollen, hot to touch red bright rash same area, now surrounded by a circular rash going out 3-4 more inches all around it. Headache. Day 4 - off work sick- nauseated, headache, swollen, hot, extended rash continued, painful. Day 5 - outer rash diminishing, swelling down, ongoing band aid size rash, bright rash continued, no further nausea or headache. Not hot to touch. Day 6: Slightly less red - still visible at full out line of band aid area, swelling gone. Slightly painful to touch only. Not hot to touch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise, Nausea, Rash erythematous
Clinical narrative: Vaccine rec'd for shingles protection on 9/11/12 at 1 pm. Band aid to area. By evening day 1 - bright red rash - shape to match regular single band aid appeared. Removed - sore at site. Day 2 evening - arm area swollen, bright red rash, hot to touch/ice applied. Day 3 - back of arm still swollen, hot to touch red bright rash same area, now surrounded by a circular rash going out 3-4 more inches all around it. Headache. Day 4 - off work sick- nauseated, headache, swollen, hot, extended rash continued, painful. Day 5 - outer rash diminishing, swelling down, ongoing band aid size rash, bright rash continued, no further nausea or headache. Not hot to touch. Day 6: Slightly less red - still visible at full out line of band aid area, swelling gone. Slightly painful to touch only. Not hot to touch.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hypoaesthesia, Pain in extremity, Pyrexia
Clinical narrative: Severe (L) UE pain/numbness, which radiated to entire trunk. Fever 102.4 degrees po.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Injection site pain, Musculoskeletal stiffness, Nausea, Neck pain
Clinical narrative: Pt complained of nausea, vertigo, diarrhea, tinnitus, stiffness and pain on (L) side of neck & at site.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus, Vertigo
Clinical narrative: Pt complained of nausea, vertigo, diarrhea, tinnitus, stiffness and pain on (L) side of neck & at site.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Muscle spasms, Neck pain, Pain in extremity
Clinical narrative: Started with sore arm. Soreness continued to go up neck & into back & patient had severe muscle spasms. Had ER visit.
Age: 84.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Body temperature increased, Glossodynia
Clinical narrative: Tongue - sore on tip. Lips - looks like chicken pox. Temperature - low grade. Noticed 9/19/12.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Tinnitus, Vertigo
Clinical narrative: Vertigo, nausea, headache, tinnitis, chills.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Patient had redness & swelling at the injection site. She went to the ER and was diagnosed with cellulitis.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: AM after injections patient's arm was sore, red and warm to the touch. Symptoms worsened over time and she sought help at a medical walk in clinic where she was prescribed a MEDROL Dose pak and Cephalexin 500mg t.i.d x 10 days.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: ZOSTAVAX given twice 8/15/12 & 9/24/12.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Localized pain and redness at the injection site on left deltoid stating about 24 hours after injection. 1" size hard lump at injection site. Patient cannot lie on side without pain.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Injection site erythema, Injection site inflammation, Pain
Clinical narrative: - Body aches (8/10). - Fever, chills. - Injection site redness, inflammation. - Loss of appetite. - Pt seems better today, 9-24-12.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: - Body aches (8/10). - Fever, chills. - Injection site redness, inflammation. - Loss of appetite. - Pt seems better today, 9-24-12.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Fall, Laceration, Suture insertion, Syncope
Clinical narrative: Patient fainted few minutes after the shot (felt dizzy), fell on the floor sustained laceration on the forehead and broke front tooth. Examined patient PR 102 O2 Sat 98%-99% chest clear bs. Heart no murmur sent to ER for further evaluation & suturing of laceration.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Tooth fracture
Clinical narrative: Patient fainted few minutes after the shot (felt dizzy), fell on the floor sustained laceration on the forehead and broke front tooth. Examined patient PR 102 O2 Sat 98%-99% chest clear bs. Heart no murmur sent to ER for further evaluation & suturing of laceration.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction, Back pain, Blood pressure decreased, Dizziness, Dyspnoea
Clinical narrative: Anaphylaxis approximately 3 minutes after administering PNEUMOVAX 23, 0.5 mL IM in left deltoid. Pt became dizzy and stated could not breathe. Had lower right back pain and started to have labored breathing and went pale. Blood pressure dropped patient stooped forward. Administered 0.3 mg EPIPEN within 5 mins - 911 called.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pallor
Clinical narrative: Anaphylaxis approximately 3 minutes after administering PNEUMOVAX 23, 0.5 mL IM in left deltoid. Pt became dizzy and stated could not breathe. Had lower right back pain and started to have labored breathing and went pale. Blood pressure dropped patient stooped forward. Administered 0.3 mg EPIPEN within 5 mins - 911 called.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Patient called the pharmacy indicating that her arm was swollen all the way to the elbow after receiving the vaccine.  The site was red, swollen and warm.  She was advised to go to the doctor and the doctor suggested that she uses BENADRYL and put ice.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Induration, Nodule
Clinical narrative: Pt called to complain of hard red knot the next day (which has subsided), then headache, and chills beginning on 9-20-2012. Pt is self-treating headache with OTC medications; 9/24 pt stated husband has similar symptoms so probably picked up a virus.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: About 4h after injection she started with progressively worsening erythema and swelling that spread by next day from injection site to entire arm (L) side - area started decreasing swelling and redness by 9/20/12 - Erythema, swelling, increased local temperature from entire upper 1/3 of (L) arm - more noticeable on distal 1/3 of arm.
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: Chills that night headache, nausea, diarrhea, body aches, fever at 102 overnight. Next day fever decreased to 101. ADVIL taken every 4 hours symptoms resolved 2 days later.
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Chills that night headache, nausea, diarrhea, body aches, fever at 102 overnight. Next day fever decreased to 101. ADVIL taken every 4 hours symptoms resolved 2 days later.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Vaccines administered 9/19/12 rash developed 9/20/12. Hives - neck, axilla, trunk , leg, left chest wall post.
Age: 11.0
Sex: M
Vaccine: FLUN3, MNQ, TDAP
Symptoms: Fatigue, Headache, Neck pain
Clinical narrative: Tdap, MENACTRA, FLUMIST administered approx 930am. Developed HA, neck pain, and extreme fatigue within 1-2 hours. Returned to our office 1 pm, taken to ER by ambulance. Treated with IV fluids. Recovered by 6 pm.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Wide spread rash which started at injection site. 9-24-12 - Followed up with pt. rash is resolving today with BENADRYL and hydrocortisone cream.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness & warmth to injection sites on (L) arm. No fever, no hives.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Reaction began 9/91/12 am. Pink/red circle around inj site about 2 in diameter. 2 other red circles in same location. (Rt) deltoid.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Needle issue, Syringe issue
Clinical narrative: Retractable injectable 1 inch syringe & needle malfunction - vaccines spilled over instead in the muscle. Revaccinated patient with a new dose.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Blood glucose normal, Nausea
Clinical narrative: Returned to clinical with complains of nausea and weakness began on hour after administration of vaccine. Feeling better when left clinic.
Age: 72.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Chest pain, Eructation
Clinical narrative: Burning pain in chest one day after receiving flu vaccine; located in substernal area; belching.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Administration 9/19/12. All is OK, pt comes in on 9/21/12 reporting a swollen arm hot and tender to touch. We were attempting to present her to clinic but she went to ER.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Arthralgia, Blood test abnormal, Chills, Gait disturbance
Clinical narrative: Became very ill within the (hrs.) vaccine. Became almost paralyzed, chills & fever, aches & pain every muscle & joint - difficult to walk or do any activities.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Paralysis, Pyrexia, Rheumatoid arthritis
Clinical narrative: Became very ill within the (hrs.) vaccine. Became almost paralyzed, chills & fever, aches & pain every muscle & joint - difficult to walk or do any activities.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Swollen tongue, Vomiting
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 years old female patient with a medical history of acne and no known drug reactions and allergies. On 10-SEP-2012, the patient was vaccinated with, 0.5 ml GARDASIL Lot # 0518AE Exp: 21-NOV-2014. Concomitant medications included: clindamycin. The medical assistant stated that on 10-SEP-2012, the patient experienced nausea, vomiting and tongue swelling after being given a first dose of GARDASIL Lot # 0518AE on 10-SEP-2012 at 3:30 pm. She noted that the patient developed tongue swelling a few hours later at 8 pm and was put on treatment with BENADRYL. Laboratory and diagnostics were not performed. The patient sought medical attention. The medical assistant stated that the patient's symptoms subsided and patient was recovered by the next day on 11-SEP-2012. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a consumer refers to her 14 years old daughter. The patient was vaccinated with the second dose of GARDASIL (Lot number and expire date unspecified) intramuscularly on an unknown date. The patient had no pertinent medical history or drug reactions/allergies. No other co-suspects and concomitant medications were received. The consumer reported that on 13-SEP-2012 a lymph node under her daughter's left arm pit had became swollen and her daughter also had headaches where the pain occurred when she looked to the left or right especially. The patient had her first vaccination with no trouble. The reaction mentioned in this report was the patient's second vaccination. No treatment was received. No lab diagnostics were performed. The outcome was reported as not recovered/not resolved at the time of reporting. The patient didn't sought medical attention. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 12 years old female patient. The patient was vaccinated with three dose series of GARDASIL (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that since on an unknown date, the patient had been having menstrual bleeding for three continuous weeks, which had been heavy at times. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL, second dose of CERVARIX and third dose of GARDASIL. No adverse effects reported. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a patient's mother, consumer refers to her son of unknown age. The patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot number, route, site not reported) on 23-JUL-2012. He received his second dose at nearly 6 weeks after first dose, approximately on 03-SEP-2012, instead of 2 months. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a female patient of unknown age. On unspecified dates, the patient was vaccinated with the first and second doses of GARDASIL (Dose, route and frequency were not reported) (lot # not reported), and on an unspecified date, "one month early", the patient received intramuscularly the third 0.5 ml dose of GARDASIL (lot # not reported). No adverse effect was reported. Additional information has been requested.