chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to her approximately 12 to 15 months old daughter. The patient was vaccinated with a dose of influenza virus vaccine (manufacturer unknown) (lot number, dose and route not reported) and a dose of VARIVAX (Merck) (lot number, dose and route not reported) on 15-OCT-2012. Concomitant medications included: PREVNAR. It was reported that at some point on Tuesday 16-OCT-2012 evening, the patient developed a fever of 104 degrees Fahrenheit. The patient's mother treated her with TYLENOL and ibuprofen. On 17-OCT-2012, by Wednesday morning, the patient's temperature was 99 degrees Fahrenheit. The patient's mother took her to day care on Wednesday 17-OCT-2012 morning and at some point during the morning, the patient developed a rash. The patient's mother took her to the physician for treatment (treatment unspecified by reporter). At the time of the report, the patient's outcome was unknown. The relatedness for fever of 104 degrees Fahrenheit, temperature of 99 degrees Fahrenheit and rash was not reported for Influenza Virus Vaccine (manufacturer unknown) and VARIVAX (Merck). Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood magnesium, Blood potassium, Cardiac flutter, Electrocardiogram abnormal, Headache
Clinical narrative: Blotchiness on arm within a few hours after immz. Fever same night of 102.0 degrees. Fluttering in chest next day. Developed headache. Developed bruising at injection site.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site haematoma, Pyrexia, Rash macular, Ventricular extrasystoles
Clinical narrative: Blotchiness on arm within a few hours after immz. Fever same night of 102.0 degrees. Fluttering in chest next day. Developed headache. Developed bruising at injection site.
Age: 6.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Was given BOOSTRIX when should have been given INFANRIX. No adverse events reported.
Age: 59.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: (R) deltoid area red, and sore. Had low grade temp of 99 degrees during the weekend. Rx KEFLEX 500 mg 1 po QID x 7d. Dx: cellulitis.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient developed a 2 inch x 2 inch rash around injection site within 24 hours of vaccination. Patient self-treated with hydrocortisone cream.
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cellulitis, Erythema, Pain, Pruritus, Swelling
Clinical narrative: Pt. complaining of redness, pain and swelling, also itching increasing over last 3 days. She was Rx'd KEFLEX 500 mg 1 po QID x 7d. Dx: cellulitis.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Lymphadenopathy, Oropharyngeal pain, Pain, Pruritus
Clinical narrative: Body aches, swollen glands, fever, headaches, soreness, sore throat, swelling, itching.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Swelling
Clinical narrative: Body aches, swollen glands, fever, headaches, soreness, sore throat, swelling, itching.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Chest discomfort, Dizziness, Vomiting
Clinical narrative: Vomiting, dizziness, chest tightness.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Lethargy, Pyrexia, Rash
Clinical narrative: Lethargic x 3 d. Fever x 3 d. Rash.
Age: 1.31
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Cellulitis
Clinical narrative: (B) deltoids - cellulitis - antibiotic given x 10 d.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Pain, swelling, redness at injection site. Arm stiffness. Body aches, fatigue.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Pain, swelling, redness at injection site. Arm stiffness. Body aches, fatigue.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Left arm became red & by Thursday wasn't better after 2 days. Pharmacy advised me to go to clinic. Doctor prescribed KEFLEX for injected arm. Red the size of palm of my hand. Very warm.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Pt called 3 days after vaccine saying she felt excessive soreness the day of vaccine and started having numbness/tingling in between fingers of hand she got shot. Pt refused suggestion to see MD.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Injection site erythema, Injection site streaking
Clinical narrative: Reported temperature of 101 degrees 24 hours post vaccine Eased with TYLENOL. Also developed red streaks from injection site (L) Deltoid to elbow which persisted x 4 days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Chills, fever, exhaustion, itching, golf-ball size lump at injection, arm red & itchy the circumference, down to the elbow. R. Alcohol & Cortisone cream, ADVIL.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: Chills, fever, exhaustion, itching, golf-ball size lump at injection, arm red & itchy the circumference, down to the elbow. R. Alcohol & Cortisone cream, ADVIL.
Age: 4.0
Sex: M
Vaccine: FLU3, MMRV
Symptoms: Pyrexia, Rash generalised, Rash maculo-papular
Clinical narrative: Pt presented in office with finite maculopapular rash over face, chest, back, arms and legs. 24 hours post MMR is when rash began as well as fever.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received ZOSTAVAX injection 10/16 in left arm. On 10/19 she returned to the pharmacy & her left elbow was red, warm & swollen. I gave her Diphenhydramine 25 mg & advised her to go to ER if swelling or redness persisted.
Age: 10.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: 3 hours after HPV #1 and influenza vaccine -> nausea, emesis, diarrhea.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Low grade fever vomiting, diarrhea. Moderate to severe abd cramping, was treated at ER with IV fluids.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Diarrhoea, Dizziness, Hyperhidrosis, Pyrexia
Clinical narrative: Fever, diarrhea, sweating, cough, dizzy, fainting spell. Symptoms started 6 hours after administration - stopped 14 hours later. Unsure it may be a virus going around.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Fever, diarrhea, sweating, cough, dizzy, fainting spell. Symptoms started 6 hours after administration - stopped 14 hours later. Unsure it may be a virus going around.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Aphonia, Blood test, Contusion, Dysphonia, Dyspnoea
Clinical narrative: Told vaccine was administered incorrectly, given subcutaneous instead of intramuscular. Arm site red and it hurt. Puffy to touch; 1 inch in height and 2 inches long. Lasted over a week by 9/30 still red, dark bruise still on arm today. Pain subsided by 9/23. On 9/25 fever started and ended in 1 hour by night at 6:30 pm lost voice and hoarseness began. Had some trouble breathing, like wheezing, like wet breathing. Seen at 9/28 at clinic by nurse for hoarseness was told nurse at station had laryngitis so that is probably why not feeling well. Still today voice is not at 100%. Pt mentions nurse denied her the VAERS form to report the problems she is experiencing.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling, Laryngitis
Clinical narrative: Told vaccine was administered incorrectly, given subcutaneous instead of intramuscular. Arm site red and it hurt. Puffy to touch; 1 inch in height and 2 inches long. Lasted over a week by 9/30 still red, dark bruise still on arm today. Pain subsided by 9/23. On 9/25 fever started and ended in 1 hour by night at 6:30 pm lost voice and hoarseness began. Had some trouble breathing, like wheezing, like wet breathing. Seen at 9/28 at clinic by nurse for hoarseness was told nurse at station had laryngitis so that is probably why not feeling well. Still today voice is not at 100%. Pt mentions nurse denied her the VAERS form to report the problems she is experiencing.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Malaise, Pyrexia, Respiration abnormal, Wheezing
Clinical narrative: Told vaccine was administered incorrectly, given subcutaneous instead of intramuscular. Arm site red and it hurt. Puffy to touch; 1 inch in height and 2 inches long. Lasted over a week by 9/30 still red, dark bruise still on arm today. Pain subsided by 9/23. On 9/25 fever started and ended in 1 hour by night at 6:30 pm lost voice and hoarseness began. Had some trouble breathing, like wheezing, like wet breathing. Seen at 9/28 at clinic by nurse for hoarseness was told nurse at station had laryngitis so that is probably why not feeling well. Still today voice is not at 100%. Pt mentions nurse denied her the VAERS form to report the problems she is experiencing.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Balance disorder, Feeling hot, Hypersensitivity, Injection site erythema
Clinical narrative: Pt was given HPV immunization (1st dose) and advised to wait 20 min in lobby; pt began to feel "hot all over my body and inside my head". Pt became unstable on chair and had to be supported; a large red area appeared at injection site. Pt was escorted back to exam room where he was immediately evaluated by Dr., pt was administered 10mL of Q-DRYL to stop allergic reaction symptoms. Pt. remained in exam room for 20 min more and Dr. re-evaluated pt a final time and then allowed pt to leave clinic as his condition had stabilized.
Age: 48.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Erythema, Myalgia, Painful respiration, Skin lesion, Swelling
Clinical narrative: Muscle soreness shoulder, chest and neck. Increased pain with deep breathing. Red raised lesions neck, chest, back all on (L) side.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Amylase, Parotitis
Clinical narrative: Acute parotitis - (R) gland.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: She received PNEUMOVAX on her left deltoid (IM) started to have swollen left upper arm and fever max 101.0 next day. She came back to our clinic for follow up on 10/15/12. Her left upper arm had 13 x 17 cm erythematous mildly swelling with 6 x 5 cm light colored ecchymosis. Mildly tender to prep.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash under (R) arm & (R) breast.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Induration, Skin warm
Clinical narrative: Cellulitis. Red warm hard 10 cm x 10 cm area redness increased about 2cm - 4cm over next 12 hours.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Insomnia, Restless legs syndrome
Clinical narrative: Pt reported to pharmacy on 10/16/12 to report possible adverse reaction to flu shot. Pt said about 4 hours after immunization, she experienced restless leg symptoms and pain in her hips that cause difficulty sleeping. These symptoms lasted about 4 days but gradually improved. Pt reported no injection site reaction at all. Pt did not seek medical attention.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Chills, Injection site rash, Myalgia
Clinical narrative: T 102 degrees, chills and muscle aches in bil lower extremities. Rash on injection site.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Periarthritis
Clinical narrative: Patient describes "frozen shoulder". Has shoulder pain and limited mobility 2 weeks post immunization. Pt says she has MD appt.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swollen, red, warm - started approx 14 hrs after injection - lasted til visit 24 hr after injection.
Age: 14.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, VARCEL
Symptoms: Blood glucose normal, Dizziness, Fall, Visual impairment
Clinical narrative: After vaccines given and pt out of treatment room she saw black spots, told her mom she was going to pass out and had controlled fall to ground. All VS WNL and quickly recovered.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Local reaction
Clinical narrative: Local inflammatory reaction for approx 2-weeks, improving, suspect sensitivity to component of immunization.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Fatigue, Feeling abnormal, Hallucination, Moaning, Pyrexia
Clinical narrative: Mom reports before bed gave respiratory treatment because child was starting to get sick with wheezing. Fever became very high where child was hallucinating, moaning, shaking, kicking his legs and flailing. His hands and feet were very hot. Mom gave ibuprofen and it did seem to calm him down to the point he was able to rest some. In the morning he continued to act very tired like he does not feel good.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Restlessness, Skin warm, Tremor, Wheezing
Clinical narrative: Mom reports before bed gave respiratory treatment because child was starting to get sick with wheezing. Fever became very high where child was hallucinating, moaning, shaking, kicking his legs and flailing. His hands and feet were very hot. Mom gave ibuprofen and it did seem to calm him down to the point he was able to rest some. In the morning he continued to act very tired like he does not feel good.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Injection site reaction, Muscle twitching
Clinical narrative: Twitching of upper arm right and left thigh.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Oedema peripheral
Clinical narrative: Swelling (slight) in arm after 4-5 hrs. Used ice/overnight. Swelling to elbow in AM after approximately 18 hrs.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: Misadministration. Pt was given a 2nd dose of ZOSTAVAX 1st dose was 6/24/10.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pruritus, Swelling, Urticaria
Clinical narrative: Urticaria, pruritus & pain, swelling.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site red, swollen, painful. Pt will contact PCP.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Warmth, pain, red area at site of injection armpit pain 12 hrs after injection cool compress at site of injection.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lip swelling, Oropharyngeal discomfort
Clinical narrative: Patient's lower lip swelled. Described throat pressure. Remained conscious. EPIPEN given x1 dose - EMT arrived - pt transported to hospital for eval.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lip swelling
Clinical narrative: Patient's lower lip swelled. Described throat pressure. Remained conscious. EPIPEN given x1 dose - EMT arrived - pt transported to hospital for eval.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Pt called complaining of slight fever, red arm and raised bump. Pt came into store following morning and arm was barely red and no swelling. Pt went to MD and  they gave her antibiotics.
Age: 85.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt. called to report she received a shingles vaccine (L) SQ and Flu vaccine (L) IM on 10/15/12 at HD. Now has redness about 3 inch x 3 inch area, with sm. amt of swelling and erythema at site of shingles injection. Also, sl. tenderness to touch. No skin breakdown, drainage or fever. Advised to watch area for s/s of worsening and use ice and Ibuprofen for comfort.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Pain, swelling redness, warm to touch at injection site; itching.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pigmentation disorder, Rash
Clinical narrative: "Rash since May - child" mother believes started after second GARDASIL. Hypopigmented circular areas noted to bilateral arms and legs - child saw dr on 10-16-12.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Multiple sclerosis, Periarthritis
Clinical narrative: Vaccine given 2010 - developed MS inflammatory joints w/in 2 weeks.  Resulted frozen shoulder x 1 yr. 11/21/11 - vaccine 2011 - developed MS inflammation w/in 2 weeks - continued for almost 4 months. Then mostly resolved still residual (R) hip knee.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Pt got lightheaded and almost passed out after administration of her GARDASIL #2 injection.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Approximately 15 min after flu vax. felt like a bee sting with sharp pain down arm, up to neck, then intermittent. No numbness/tingling.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Localised infection, Oedema peripheral
Clinical narrative: Pt got pneumonia shot on Friday called on weekend saying redness/swelling in (L) arm/streaks going down arm. Pt went to ER and was diagnosed with "infection" in (L) arm" and given IV antibiotics. Pt left with 1 week worth oral ATB's and follow/up with MD in 1 week.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Unevaluable event
Clinical narrative: Immunizations drawn up by staff, then staff members went in together and gave all injection.
Age: 31.0
Sex: M
Vaccine: MMR
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: Pt. RTC on 10/18/12 for MMR #2 to meet college requirement. States after MMR on 8/28/12 had high fever and increased HR next day. States sx's had resolved by end of day. Dr order to hold MMR #2.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Labored breathing, weak, fast heart rate, dizziness lasting about 1 min at 9PM night after receiving shot. No treatment needed.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: On 2nd day after shot I got hives in evening next day gone then came back in that evening goes away at daylight and came back the next 6 days.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood test abnormal, Cellulitis, Chills, Injection site erythema, Injection site swelling
Clinical narrative: Patient started with chills and fever, started 7pm Thursday 9.20.12. Noted the area was swollen and red and felt hot/warm to the touch on 9/20 in the PM. Went to see MD on 9/21 and blood work was done for infection. Cellulitis was diagnoses.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Patient started with chills and fever, started 7pm Thursday 9.20.12. Noted the area was swollen and red and felt hot/warm to the touch on 9/20 in the PM. Went to see MD on 9/21 and blood work was done for infection. Cellulitis was diagnoses.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Large redness, warm to touch.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pain in extremity, Swelling
Clinical narrative: Pt had reaction 24 hrs after injection of redness, pain, swelling. Redness - size of baseball. Pain - shoulder to elbow. Tx: Cool compress/ADVIL or TYLENOL.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Golf ball size lump at injection site. Warm to touch. Small painful lump in pt arm pike cool compresses.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Skin reaction
Clinical narrative: Right deltoid - localized skin reaction 4 x 4 cm induration and erythema. Tx - BENADRYL DM, ice. Pt seen on 10/19/12 after calling in to report reaction.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersomnia
Clinical narrative: Pt slept for 37 hours straight after vaccine.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Decreased appetite, Erythema, Malaise, Pain in extremity, Toothache
Clinical narrative: Vaccine FLUVIRIN and PNEUMOVAX given on 10/16 in upper left arm 1 inch apart. Patient returned 10/19 said she had been sick and could barely eat. She complained of legs and teeth hurting. She had a large red area on left arm.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Left arm, upper, outer aspect with swollen, warm tender area of induration 5 cm x 4 cm. Mildly pruritic. No vesicles. No pustules. No (L) axillary nodes -  Meds 1) XYZAL 5 mgm po qhs for 7 - 10 nights 2) BACTRIM DS tabs 1 po BID x 10 days.
Age: 37.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Ecchymosis, Erythema, Feeling hot, Local swelling, Pain
Clinical narrative: 7 x 7 cm area of redness, heat, swelling, with increased swelling in center. 2 x 1.5 cm ecchymotic area. C/O pain, pruritus.
Age: 37.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Pruritus
Clinical narrative: 7 x 7 cm area of redness, heat, swelling, with increased swelling in center. 2 x 1.5 cm ecchymotic area. C/O pain, pruritus.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Fatigue, Lymphadenopathy, Myalgia, Skin lesion
Clinical narrative: Employee developed fatigue, muscle pain and lymphadenopathy 9 days after vaccination. 2 lesions - chin, (L) great toe pustular.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Erythema, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: C/O pain (Lt) delt. at time of injection. C/O "burning, arthritic" pain beginning that evening and continuing. Has redness approx 10 cm x 25 cm. Temp 99.1 (tymp.).
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth, Restlessness
Clinical narrative: Mother states patient's arm started swelling 1 hr after vaccines. Pt had low grade temp. This a.m. mom states arm is swollen, red, & hot to the touch where vaccine was given. Also states pt was restless last night.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: Patient came in 10/3/12 with swollen, tight red (L) upper arm area with raised skin temperature at area. PAC prescribed SEPTRA susp. and children's ibuprofen.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Skin warm
Clinical narrative: Patient returned day after immunization showing swelling of upper left arm. Swelling was present from upper deltoid down to elbow (approx 4"-6"). Skin was hot to the touch. Patient made office appt. with PCP for 10-19-12. Taking BENADRYL and Ibuprofen until MD appt (In Left Arm).
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash
Clinical narrative: Student was administered FLUMIST at 1:30 pm. Student was sent back to Health Center with rash to face. Examined by PA, NAD. BENADRYL given. Parents notified observed x 30 min.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Hives on chest developed 6 hrs after vaccine. Injection site red, swollen, size of silver dollar. Patient treated w/ antihistamines.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Throat tightness
Clinical narrative: Patient felt fine. She received shot. We visited, she left. Within 30 to 50 min, she felt faint, dizziness, constricted throat but only mildly. Continued to monitor her and she was not better. Sent her to urgent care Dr. He gave a shot of BENADRYL.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Fall, Nervousness, Syncope
Clinical narrative: The patient was given a PPD, Hb test, Flu shot and lastly a GARDASIL injection. About 1 min. later she fainted and fell off the table and seconds later was awake and shaky. Laid down and given juice.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Head injury, Syncope
Clinical narrative: At 5:30 pm, I gave pt. Influenza vaccine, after about 5 minutes pt. started walking and fainted and hitting her head on floor. Pt. was out for about 10-15 seconds. We checked B/P, pulse, glucose, all was WNL. Pt. had a bump on back of head, put ice pack. Pt. to f/u in 1 day.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Redness, arm swelling. Temp elevated - 39.1 degree C. Gave TYLENOL for fever.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, swelling, pain at injection site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Slightly pink (R) upper arm tender slightly swollen covering 50% of mid upper arm.
Age: 53.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Feeling hot, Headache, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Sore throat, achiness, congestion, headache, hot at night, symptoms disappeared 10-23-12. Patient took BENADRYL and ADVIL for symptoms. Redness and soreness/rash x1 day rt upper arm injection site.
Age: 53.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Oropharyngeal pain, Pain, Respiratory tract congestion
Clinical narrative: Sore throat, achiness, congestion, headache, hot at night, symptoms disappeared 10-23-12. Patient took BENADRYL and ADVIL for symptoms. Redness and soreness/rash x1 day rt upper arm injection site.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Nausea, Pallor, Paraesthesia, Sensory disturbance
Clinical narrative: C/O dizziness, nausea, BP 92/54, then more dizzy, pale (lying down) - C/o vibration in arms - tingling B/L arms & (R) side face tingling. Cold compress, orange juice given BP 100/62, 98/64. Seen by PA. Feels better 4:45 pm. Informed to go to ER verbalized understanding.
Age: 0.17
Sex: F
Vaccine: HIBV, PNC13, RV1
Symptoms: Diarrhoea, Faeces discoloured, Haematochezia, Stool analysis abnormal
Clinical narrative: 8/22/12 - Received vaccines - HIB, PCV-13 and ROTARIX -> stools that PM became green, looser and had blood. Maternal milk free diet, ZANTAC, GI ref.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fear, Hyperhidrosis, Malaise
Clinical narrative: Extreme chills and rigors for greater than 1 hour followed by profuse sweating. Rxn occurred aprox. 36 hours after vaccination. General malaise for next 24 hours after rxn. T not taken during rxn secondary fear of breaking glass thermometer.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction
Clinical narrative: Local reactions: soreness, erythema, induration at site of injection.
Age: 44.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Incorrect dose administered, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Patient's wife reported that patient had a fever of 101.3 on Saturday and on his left arm there was a 4 in band going around his arm (width) site of administration, red and warm to touch. Pt took TYLENOL.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Pt present to Rx and asked me to look at injection site - oval inflamed area with red border about 1 1/2 - 2" in diameter - center was not as red. Instructed pt to see md after reviewing, side effects with her.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Injection site swelling
Clinical narrative: 10/20/12 no fever, swelling of right arm (feel like a rock) painful on day 1. 10/21/12 swelling and redness spread throughout the upper arm.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Ear pain, Hyperhidrosis, Pallor
Clinical narrative: Father ran in approximately 10 min. after vaccine administered saying she could not breathe. I found patient to be pale, sweating, and complaining of ear pain also. 911 was called and I administered one EPIPEN.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Electrocardiogram normal, Injection site pain
Clinical narrative: Patient has significant pain in (R) deltoid. She reports pneumonia vaccine and ZOSTAVAX were given there Sept 28, 2012 at health center.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Rash
Clinical narrative: Rash - face, neck, arms. Diarrhea.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient stopped by the pharmacy and complained of pain in her right arm (not at the site of injection) - but around it. Pain is worse when lift her arm while bending.
Age: 15.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Asthenia, Balance disorder, Dyspnoea, Pain in extremity, Tremor
Clinical narrative: Received HPV and FLUMIST on 10/19/12. Later in the day felt knees were weak, legs and ankles felt "wobbly", legs were shaking "tremors". Pain down lower legs. When lying, breathing bothered her.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain
Clinical narrative: Shooting pains around injection site for one year, requiring pain meds, Gabapentin.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Got zoster inj 10/17 - redness swelling at site that day then 2d later swelling 20 cm round with redness warm to touch could be latex allergy did not inform staff x 2.
Age: 87.0
Sex: U
Vaccine: FLU3
Symptoms: Pain, Skin discolouration, Swelling
Clinical narrative: Black - blue. Swollen. Painful. Applied ice.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth, Pain, Pain in extremity, Pruritus
Clinical narrative: Patient received a pneumonia vaccine on 10/19/12 and later that evening her (R) arm started itching and swelling. The area of injection was red and warm to touch. Patient states her arm was sore to touch and movement.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Patient received a pneumonia vaccine on 10/19/12 and later that evening her (R) arm started itching and swelling. The area of injection was red and warm to touch. Patient states her arm was sore to touch and movement.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Tenderness
Clinical narrative: Patient reports that soreness/tenderness did not occur until 4 days after the injection. Throbbing pain/tender between deltoid and elbow. No visible reaction.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain upper, No adverse event, Throat irritation
Clinical narrative: This spontaneous report as received from a consumer refers to her son, a 18 years old male patient with allergy for sulfa drugs. The patient's medical history included wisdom teeth removal. The patient was vaccinated with dose 1, 0.5 ml GARDASIL intramuscularly (IM) in March 2012, as part of a 3 dose series of injections. Lot number was not reported. The patient used no concomitant medications. After the first 2 injections the patient did not experience any adverse event. On 28-SEP-2012 the patient received the third and final dose of GARDASIL 0.5 ml IM (lot # not reported). On 02-OCT-2012, after the third injection, the patient developed pain in his upper right abdomen. He also mentioned his throat was bothering him and he did not want to eat because of the irritation. The reporter had not spoken to the patient's doctor yet, but planned to do so. No treatment was provided for the events. At the time of report the patient had not recovered. The relatedness for the events was not reported for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker. The reporter informed that an unknown number of patients (no details provided) had been vaccinated with improperly stored GARDASIL (lot number, dose, dose number and route not reported). The vaccines were exposed to 30 degrees Fahrenheit for 15 hours. No adverse effect reported. This case is linked to case reports 1210USA010300 and 1210USA010301 (same reporter; same medication error reported for other vaccines). Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Pharyngeal oedema
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of age 25 years. The patient had no drug reactions or allergies. The patient was vaccinated with dose 1, 0.5 ml GARDASIL given intramuscularly (the lot number and expiry date not reported) on 02-MAR-2012. The second dose (dose, route and frequency, lot number and expiry date was not reported) was given on 03-MAY-2012 and the third dose (route dose and frequency not reported) (lot number reported as #0022AE and expiry date reported as 28-SEP-2014) was given on 11-SEP-2012. No other co-suspects were reported. The concomitant medications included an unspecified birth control pill. On 11-SEP-2012 the patient experienced swollen throat, nausea and dizziness after receiving the third dose of vaccine. The patient took BENADRYL and the events resolved within an hour on 11-SEP-2012. The patient sought medical attention and called the physician's office. The relatedness for swollen throat, nausea and dizziness is unknown for GARDASIL. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients were vaccinated with a dose of GARDASIL (lot number not specified). Route was unknown. The reporter stated that up to 10 patients had received improperly stored vaccines during the time period of 17-SEP-2012 through 02-OCT-2012. Vaccines involved were MMR II, VAQTA, RECOMBIVAX HB and GARDASIL. No symptoms were reported. This is one of multiple reports from the same source (other case IDs 1210USA009229, 1210USA009230 and 1210USA009231). Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This report was received from a registered nurse refers to a male patient of unknown age who was in a non-Merck investigator-initiated study. On an unspecified date, in August 2012, the patient was vaccinated with a dose of GARDASIL (lot number 660393/0067X) (dose and route not reported) that was expired 20-OCT-2012. No adverse effects had been observed or reported. Due to the nature of the study, the reporter declined to provided any patient identifiers. She would like to know if the patent should be revaccinated. Reporter called back on 16-OCT-2012 to stated that there was no additional information to provide, and she was not comfortable faxing these forms back. She requested that no additional follow-up forms or letters were sent to the office of this matter. This is one of several reports that received from the same source. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This report was received from a registered nurse refers to a male patient of unknown age who was in a non-merck investigator-initiated study. On an unspecified date, in August 2012, the patient was vaccinated with a doses of GARDASIL (lot number 660393/0067X) (dose and route not reported) that was expired 20-OCT-2010. No adverse effects had been observed or replied. Due to the nature of the study, the reporter declined to provided any patient identifiers. She would like to know if the patient should be revaccinated. Reporter called back on 16-OCT-2012 to stated that there was no additional information to provide, and she was not comfortable faxing these forms back. She requested that no additional follow-up forms or letters were sent to the office on this matter. This is one of several reports that recovered from the same source. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This report was received from a registered nurse refers to a male patient of unknown age who was in a non-merck investigator-initiated study. On an unspecified date, in August 2012, the patient was vaccinated with a doses of GARDASIL (lot number 660393/0067X) (dose and route not reported) that was expired 20-OCT-2010. No adverse effects had been observed or reported. Due to the nature of the study, the reporter declined to provide any patient identifiers. She would like to know if the patient should be revaccinated. Reporter called back on 16-OCT-2012 to stated that there was no additional information to provide, and she was not comfortable faxing these forms back. She requested that no additional follow-up forms or letters were sent to the office on this matter. This is one of several reports that received from the same source. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, Oral administration complication, Regurgitation, Underdose
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 2 months old female patient. The patient was vaccinated with an expired dose of lot # (669523/1556Z: exp date 12-SEP-2012) ROTATEQ on 18-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 18-OCT-2012 the patient experienced regurgitated most of the dose during administration. No treatment was given for the event. It was unknown of the patient sought medical attention. The outcome of regurgitated most of the dose during administration was unknown. The relatedness for the reported event was not provided for ROTATEQ. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Musculoskeletal discomfort
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient had a knee replacement in the past. On 15-OCT-2012 the patient was vaccinated with a single dose of ZOSTAVAX (lot # reported as H012523, expiration date reported as 09-OCT-2013). The patient had experienced discomfort in that knee since administration of ZOSTAVAX. The patient sought medical attention by calling the pharmacy. No treatment was given. Lab diagnostics studies performed were reported as none. The outcome was reported as not recovered. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker. The reporter informed that an unknown number of patients (no details provided) had been vaccinated with improperly stored RECOMBIVAX HB (lot number, dose, dose number and route not reported). The vaccines were exposed to 30 degrees Fahrenheit for 15 hours. No adverse effect reported. This case is linked to case reports 1210USA001182 and 1210USA010301 (same reporter; same medication error reported for other vaccines). Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Fatigue, Herpes zoster, Muscular weakness, Pain in extremity
Clinical narrative: This spontaneous report as received from a 71 years old female consumer refers to herself. The patient had none pertinent medical history. The patient had none drug allergies. On 12-OCT-2012 the patient was vaccinated with ZOSTAVAX (lot # reported as H012521, expiration date reported as 09-OCT-2013). Concomitant medications included calcium, vitamin D and unspecified organic treatments. It was reported that the patient believed that she might be coming down with a case of shingles. The patient explained that "2 days ago", on 16-OCT-2012 she had a little break out at the corner of her mouth, and "yesterday", on 17-OCT-2012 she developed 3 very itchy dots in 3 inch areas on her chest. "This morning", on 18-OCT-2012, on her left upper arm she developed an itchy patch in about a 3x3 inch patch that was pink, and has turned red at the time of reporting. It was subsequently reported that the patient also explained that she had additional symptoms including chest pain and pain that went down her left arm that had occurred in the last few days as well as tiredness and weakness inside her thighs that began "today", on 19-OCT-2012. The patient did not seek medical attention. She took a couple of aspirin to treat these symptoms. The patient also mentioned that she was taking BENADRYL to stop her initial reaction with the itchy patches on her chest. After taking BENADRYL the itching has stopped. Treatment given for the adverse events also included: lavender essential oil and OLUX FOAM. Lab diagnostics studies performed were reported as none. The adverse events did not improve. The outcome was reported as not recovered. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a 71 years old female consumer refers to herself. The patient had none pertinent medical history. The patient had none drug allergies. On 12-OCT-2012 the patient was vaccinated with ZOSTAVAX (lot # reported as H012521, expiration date reported as 09-OCT-2013). Concomitant medications included calcium, vitamin D and unspecified organic treatments. It was reported that the patient believed that she might be coming down with a case of shingles. The patient explained that "2 days ago", on 16-OCT-2012 she had a little break out at the corner of her mouth, and "yesterday", on 17-OCT-2012 she developed 3 very itchy dots in 3 inch areas on her chest. "This morning", on 18-OCT-2012, on her left upper arm she developed an itchy patch in about a 3x3 inch patch that was pink, and has turned red at the time of reporting. It was subsequently reported that the patient also explained that she had additional symptoms including chest pain and pain that went down her left arm that had occurred in the last few days as well as tiredness and weakness inside her thighs that began "today", on 19-OCT-2012. The patient did not seek medical attention. She took a couple of aspirin to treat these symptoms. The patient also mentioned that she was taking BENADRYL to stop her initial reaction with the itchy patches on her chest. After taking BENADRYL the itching has stopped. Treatment given for the adverse events also included: lavender essential oil and OLUX FOAM. Lab diagnostics studies performed were reported as none. The adverse events did not improve. The outcome was reported as not recovered. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner (A.P.N.) via a company representative refers to an over 80 year old male patient with leukemia. On an unknown date the patient was vaccinated subcutaneously with ZOSTAVAX (lot # not reported). It was reported that while on ZOSTAVAX, the patient developed shingles. It was unspecified whether the patient sought for medication. The outcome was unknown. Additional information is not expected.
Age: 29.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a male patient who on an unknown date was vaccinated with a dose of PNEUMOVAX23, intramuscular (dose not provided) (lot # 0709AE, expiration date on 04-JAN-2014). On an unknown date, the patient came down with fever and rash around injection site with color of scarlet red. No treatment was given for the events. The patient spoke to pharmacist. At the time of the report, the outcome of the events was unknown. A lot check investigation was initiated. This is one of several reports received from the same source. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a 72 years old male physician regarding himself. The patient had an allergy to suture that was used in surgery many years ago but was no longer being used. The patient's medical history included a couple of hernia operations at least 10 years ago. On an unknown date 15 years ago (approximately October 1997), the patient was vaccinated with 3 doses of RECOMBIVAX HB (lot# and route not reported). No concomitant medications were reported. In the past week on an unknown date in approximately September 2012, the patient had 2 titers done by 2 different laboratories that were negative for hepatitis B. He had titers done 5-6 years ago and the titers were fine. No treatment information was reported. The patient sought medical attention (unspecified). The outcome of the event was unknown. The relatedness for the event was unknown for RECOMBIVAX HB. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient was vaccinated with dose 1 RECOMBIVAX HB (lot # not reported) dose and route not reported on 18-SEP-2012. No concomitant medications were reported. On 25-SEP-2012 was vaccinated with dose 2 RECOMBIVAX HB (lot # not reported) dose and routes not reported and on 09-0CT-2012 was vaccinated with dose 3 RECOMBIVAX HB (lot # not reported) dose and route not reported. No adverse symptoms reported. No further information provided. Additional information is not expected.
Age: 64.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 years old male patient with diabetes, neuropathy, high cholesterol, high blood pressure, gout and allergy to DEMEROL. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # 672676/0069AE; expiry date 03-APR-2013) on 02-OCT-2012. No other co-suspects were reported. Concomitant medications included tramadol hydrochloride, losartan potassium (manufacturer unknown), JANUVIA, CRESTOR, PLAVIX, COREG, gabapentin, morphine, allopurinol and FLUVIRIN. On 05-OCT-2012 the patient developed pain at the injection site. The patient sought medical attention; he spoke to the pharmacist. No treatment was provided for the event. No laboratory tests were performed. At the time of report the patient was recovering. The relatedness for pain at the injection site was not reported for ZOSTAVAX. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure, No adverse event, Product quality issue, Syringe issue
Clinical narrative: This spontaneous report was received from a male pharmacy student of unknown age refers to him self. It was reported, that on 18-OCT-2012 while attempting to withdrawn a dose of reconstituted ZOSTAVAX (lot # not reported) from the vial, the vaccine leaked all over his hands from the needle insertion site. No adverse effect reported. PQC has been already involved. Additional information has been requested.