chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: M
Vaccine: HPV4
Symptoms: Condition aggravated, Papilloma, Surgery
Clinical narrative: This spontaneous report as received from a consumer (patient's adoptive mother), refers to a 9 year old male patient with ADHD, HPV, and allergic to penicillin. The patient's medical history included had tonsils taken out, papilloma surgery (every three months since 2007), papilloma and scraping the papilloma off of his vocal cords (every three months since 2007). On 05-SEP-2013 the patient was vaccinated with first dose of GARDASIL (dose unspecified) lot # /expiration: 0459AE 13-DEC-2014. The second dose of GARDASIL (dose unspecified) lot # /expiration: 1860AA 30-SEP-2014, was given on 06-SEP-2012 and the third dose of GARDASIL (dose unspecified) lot # /expiration H014645 27-MAR-2015, was given on 21-JAN-2013. Patient's concomitant medications were not reported. On an unknown date the patient experienced papilloma. On 12-NOV-2012 the patient experienced papilloma surgery (medically significant). The reporter stated that her son had to have surgery every three months since 2007 for scraping the papilloma off of his vocal cords. The reporter stated that the patient's last surgery for the papilloma was on 12-NOV-2012. Since then the patient has not had surgery for this because the papilloma had not grown back for the patient. The reporter stated that the patient every 3-6 months gets a scope down his throat just to make sure the papilloma was not growing back. The reporter thought that the papilloma had not grown back because the patient was receiving GARDASIL vaccine. The reporter reported that the patient was receiving the vaccine, even though the patient was diagnosed with HPV in 2007, to try and see what happens. The reporter also stated that the doctor who performed the papilloma surgeries for the patient had pictures before and after the papilloma surgeries if needed. The outcome of papilloma was reported as recovered/resolved. The outcome of papilloma surgery is unknown. The reporter's causality assessment was not provided. Upon internal review the event papilloma surgery was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling below injection site, 2 days later 2 x 5 cm was bigger.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Swelling face
Clinical narrative: Patient experienced mild swelling under eye. Son said she was disoriented for a few minutes after administration, called ambulance, EMT looked her over and said she is okay.
Age: 1.15
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient assessed by provider - redness noted to left thigh 1'x2', warm to touch - BENADRYL 2.5mL ordered by mouth and tolerated well. Patient observed for 40 minutes after, redness noted, but reduced in size. Allowed to be dismissed. Follow up tomorrow.
Sex: M
Vaccine: DTAPIPV
Symptoms: Extensive swelling of vaccinated limb, Injected limb mobility decreased, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in an child male subject who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown route, unknown deltoid). The lot number was reported as PY3D2 from the reporter; however, based on a safety lot number review, the lot number was updated to PY3DZ. Less than one week after vaccination with KINRIX, the subject experienced injection site cellulitis, injection site tenderness, injection site warmth, injection site redness, extensive swelling of vaccinated limb and was unable to move arm. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. This case was associated to a product complaint. This case was one of 8 cases of injection site reaction reported by the same reporter regarding the same lot of vaccine.
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in an child male subject who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown route, unknown deltoid). The lot number was reported as PY3D2 from the reporter; however, based on a safety lot number review, the lot number was updated to PY3DZ. Less than one week after vaccination with KINRIX, the subject experienced injection site cellulitis, injection site tenderness, injection site warmth, injection site redness, extensive swelling of vaccinated limb and was unable to move arm. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. This case was associated to a product complaint. This case was one of 8 cases of injection site reaction reported by the same reporter regarding the same lot of vaccine.
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in an child male subject who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown route, unknown deltoid). The lot number was reported as PY3D2 from the reporter; however, based on a safety lot number review, the lot number was updated to PY3DZ. Less than one week after vaccination with KINRIX, the subject experienced injection site cellulitis, injection site warmth, injection site blisters, injection site redness, swelling injection site. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. This case was associated to a product complaint. This case was one of 8 cases of injection site reaction reported from the same reporter regarding the same lot of vaccine.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in an child male subject who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown route, unknown deltoid). The lot number was reported as PY3D2 from the reporter; however, based on a safety lot number review, the lot number was updated to PY3DZ. Less than one week after vaccination with KINRIX, the subject experienced injection site cellulitis, injection site warmth, injection site blisters, injection site redness, swelling injection site. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. This case was associated to a product complaint. This case was one of 8 cases of injection site reaction reported from the same reporter regarding the same lot of vaccine.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown route, unknown deltoid). At an unspecified time after vaccination with KINRIX, the subject experienced injection site cellulitis, injection site swelling, injection site warmth and injection site redness. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. This case was associated to a product complaint. This case was one of 8 cases of injection site reaction reported by the same reporter regarding the same lot of vaccine.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Insomnia, Pain, Sensory disturbance, Tinnitus
Clinical narrative: Client states since he rec'd Hep B on 3/24/14 he has experienced (1) beating in (R) ear and rt side of head and at (R) leg (2) RUE "feels out of place" "sharp pains", difficulty sleeping. Denied experienced prior to receiving Hep B and TYLENOL PRN had provided short relief.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Cold sweat, Dizziness, Feeling of body temperature change
Clinical narrative: Within 30 minutes of receiving the influenza vaccine and with BENADRYL on board, developed a severe migraine HA, tightness of the jaw, hot/cold flashes, arthralgia, weakness, lightheadedness, tunnel vision, clammy skin, facial flushing.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Migraine, Muscle tightness, Tunnel vision
Clinical narrative: Within 30 minutes of receiving the influenza vaccine and with BENADRYL on board, developed a severe migraine HA, tightness of the jaw, hot/cold flashes, arthralgia, weakness, lightheadedness, tunnel vision, clammy skin, facial flushing.
Age: 26.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Abdominal discomfort, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: 2 hours after receiving vaccines felt very tired, slept for 3 hours then had H/A, cough, congestion, upset stomach with mild diarrhea, general aches.
Age: 26.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Pain, Respiratory tract congestion, Somnolence
Clinical narrative: 2 hours after receiving vaccines felt very tired, slept for 3 hours then had H/A, cough, congestion, upset stomach with mild diarrhea, general aches.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Arthritis, Synovitis
Clinical narrative: Arthritis with synovitis starting 3 days after vaccine. Waxing and waning but persists 6 months after incident.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Extreme pain at instant of injection at site on upper left shoulder. Pain down to fingers for about two days. Decreased to upper arm for days after. Still pain in upper arm 18 days later. Slight fever 2-3 days 9-3 - 9-5. Used hot water and Naprosen for pain. Still aching and tingling in hand/fingers as of 9-27-13.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Activities of daily living impaired, Erythema, Immediate post-injection reaction, Injected limb mobility decreased, Injection site induration
Clinical narrative: Information was received from a 50 year old male patient, with an allergy to codeine. The patient's medical history included: broke left leg in 4 places in motorcycle accident. On 06-OCT-2013, while he was a patient in the hospital being treated for cellulitis of the left leg, the patient was vaccinated with PNEUMOVAX 23 injection (lot #J00786, expiration date 25-SEP-2014) in the left arm. Concomitant medications included unspecified antibiotics. The PNEUMOVAX 23 vaccine was administered to him on either the first or second day of his 4 day hospitalization. Immediately after receiving the vaccine, the patient developed a stiffness in his left arm from the shoulder to the elbow. That part of his arm hardened like "granite." Since then, the patient has lost range of motion in that arm, cannot carry anything with it, lean on it, or use it to put on clothing. The pain feels like "an ice pick going into it." He also developed red sores on his face, hairline, arms, legs, and buttocks. The sores itched and hurt but were never diagnosed. They were, however, treated with a topical steroid, fluocinolone (manufacturer unknown). The patient sought medical attention at a doctor visit. His present status was reported as not recovered. His hospitalization was not prolonged due to the events. Additional information was received from the 50 year old male patient. He reported that on 06-OCT-2013, as soon as he received the PNEUMOVAX 23, his left arm turned granite hard/rock hard from the shoulder to his elbow. Since that time, he reported that his arm is not hard like that any longer, but he has lost full range of motion in the arm. He gets ongoing and sharp shooting pain in the arm. The patient reports it is hard for him to do simple tasks like put on his coat, use his arm to support himself getting out of bed. "All of this happened as soon as I received the shot and it hasn't subsided." He also reports open sores on his face, legs, arms, buttock, and head in his hairline. The patient stated: "This also occurred when I received the vaccine and the doctor's just stood there and looked at me as if I was a lab rat. As if I was contagious and they didn't want to get near me." Lot # J00786 is an invalid lot number for PNEUMOVAX 23. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Musculoskeletal stiffness, Pain, Pain in extremity, Pruritus
Clinical narrative: Information was received from a 50 year old male patient, with an allergy to codeine. The patient's medical history included: broke left leg in 4 places in motorcycle accident. On 06-OCT-2013, while he was a patient in the hospital being treated for cellulitis of the left leg, the patient was vaccinated with PNEUMOVAX 23 injection (lot #J00786, expiration date 25-SEP-2014) in the left arm. Concomitant medications included unspecified antibiotics. The PNEUMOVAX 23 vaccine was administered to him on either the first or second day of his 4 day hospitalization. Immediately after receiving the vaccine, the patient developed a stiffness in his left arm from the shoulder to the elbow. That part of his arm hardened like "granite." Since then, the patient has lost range of motion in that arm, cannot carry anything with it, lean on it, or use it to put on clothing. The pain feels like "an ice pick going into it." He also developed red sores on his face, hairline, arms, legs, and buttocks. The sores itched and hurt but were never diagnosed. They were, however, treated with a topical steroid, fluocinolone (manufacturer unknown). The patient sought medical attention at a doctor visit. His present status was reported as not recovered. His hospitalization was not prolonged due to the events. Additional information was received from the 50 year old male patient. He reported that on 06-OCT-2013, as soon as he received the PNEUMOVAX 23, his left arm turned granite hard/rock hard from the shoulder to his elbow. Since that time, he reported that his arm is not hard like that any longer, but he has lost full range of motion in the arm. He gets ongoing and sharp shooting pain in the arm. The patient reports it is hard for him to do simple tasks like put on his coat, use his arm to support himself getting out of bed. "All of this happened as soon as I received the shot and it hasn't subsided." He also reports open sores on his face, legs, arms, buttock, and head in his hairline. The patient stated: "This also occurred when I received the vaccine and the doctor's just stood there and looked at me as if I was a lab rat. As if I was contagious and they didn't want to get near me." Lot # J00786 is an invalid lot number for PNEUMOVAX 23. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Skin ulcer
Clinical narrative: Information was received from a 50 year old male patient, with an allergy to codeine. The patient's medical history included: broke left leg in 4 places in motorcycle accident. On 06-OCT-2013, while he was a patient in the hospital being treated for cellulitis of the left leg, the patient was vaccinated with PNEUMOVAX 23 injection (lot #J00786, expiration date 25-SEP-2014) in the left arm. Concomitant medications included unspecified antibiotics. The PNEUMOVAX 23 vaccine was administered to him on either the first or second day of his 4 day hospitalization. Immediately after receiving the vaccine, the patient developed a stiffness in his left arm from the shoulder to the elbow. That part of his arm hardened like "granite." Since then, the patient has lost range of motion in that arm, cannot carry anything with it, lean on it, or use it to put on clothing. The pain feels like "an ice pick going into it." He also developed red sores on his face, hairline, arms, legs, and buttocks. The sores itched and hurt but were never diagnosed. They were, however, treated with a topical steroid, fluocinolone (manufacturer unknown). The patient sought medical attention at a doctor visit. His present status was reported as not recovered. His hospitalization was not prolonged due to the events. Additional information was received from the 50 year old male patient. He reported that on 06-OCT-2013, as soon as he received the PNEUMOVAX 23, his left arm turned granite hard/rock hard from the shoulder to his elbow. Since that time, he reported that his arm is not hard like that any longer, but he has lost full range of motion in the arm. He gets ongoing and sharp shooting pain in the arm. The patient reports it is hard for him to do simple tasks like put on his coat, use his arm to support himself getting out of bed. "All of this happened as soon as I received the shot and it hasn't subsided." He also reports open sores on his face, legs, arms, buttock, and head in his hairline. The patient stated: "This also occurred when I received the vaccine and the doctor's just stood there and looked at me as if I was a lab rat. As if I was contagious and they didn't want to get near me." Lot # J00786 is an invalid lot number for PNEUMOVAX 23. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Asthenia, Fatigue, Headache, Myalgia
Clinical narrative: Severe head pain, sore muscles, weak and tired.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Gastrostomy, Laboratory test normal, Lumbar puncture normal, Muscular weakness, Myelitis transverse
Clinical narrative: Arm weakness, progressed over days to total quadraplegia, diagnosed with likely transverse myelitis, with excess gray matter involvement compared to typical transverse myelitis. Involved spine from C2 to T12.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Quadriplegia, Tracheostomy
Clinical narrative: Arm weakness, progressed over days to total quadraplegia, diagnosed with likely transverse myelitis, with excess gray matter involvement compared to typical transverse myelitis. Involved spine from C2 to T12.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Paralysis
Clinical narrative: Arm weakness, progressed over days to total quadraplegia, diagnosed with likely transverse myelitis, with excess gray matter involvement compared to typical transverse myelitis. Involved spine from C2 to T12.
Age: 0.58
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Rash generalised, Swelling face
Clinical narrative: Pt received flu vaccine at 4:15pm and at 5:15pm mom noticed that pt had facial swelling and a rash all over his body, mom called afterhours service and was advised to take pt to the Emergency Room immediately, mom took pt to the ER and mom noticed while en route to the ER that pt developed difficulty breathing, pt was taken back upon arrival and received IV Solumedrol, Pepcid and Benadryl. Patient was sent home with prescriptions for Benadryl and Orapred.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: C-reactive protein, C-reactive protein increased, Chest X-ray normal, Dyspnoea, Monocyte count increased
Clinical narrative: Patient went to the ER for breathing difficulty. ER stated he had myocarditis.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Myocarditis, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Patient went to the ER for breathing difficulty. ER stated he had myocarditis.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Arteriogram coronary normal, Blood creatine phosphokinase MB increased, C-reactive protein increased, Catheterisation cardiac, Chest X-ray normal
Clinical narrative: Patient went to the ER for breathing difficulty. ER stated he had myocarditis.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chest pain, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Exercise test
Clinical narrative: Patient went to the ER for breathing difficulty. ER stated he had myocarditis.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Heart rate increased, Pain, Painful respiration, Red blood cell sedimentation rate increased, Troponin I increased
Clinical narrative: Patient went to the ER for breathing difficulty. ER stated he had myocarditis.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Ventricular hypertrophy
Clinical narrative: Patient went to the ER for breathing difficulty. ER stated he had myocarditis.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: C-reactive protein, Chest X-ray normal, Dyspnoea, Monocyte count increased, Myocarditis
Clinical narrative: Patient went to the ER for breathing difficulty. ER stated he had myocarditis.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Patient went to the ER for breathing difficulty. ER stated he had myocarditis.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis, Pericarditis, Troponin I increased
Clinical narrative: Patient went to the ER for breathing difficulty. ER stated he had myocarditis.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Parent reports migraine headache developed within hours of HPV#3. Headache persists 8 days after vaccine. He has returned to the office three times for evaluation of the headache.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Injection site warmth, Paraesthesia
Clinical narrative: Felt prickly & hot from inside - out. 'I just want to itch it but I know I shouldn't'.  Site is at injcetion site; 3" x 2 3/4" raised, bright red, warm/hot to touch. Denies any other S/S. Reports placing Hydrocortizone Cr. on it.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Asthenia, Decreased appetite, Dizziness, Fall, Fatigue
Clinical narrative: Fever up to 103.2 even with fever reducers, red swollen injection site, soreness of leg, fussiness, tiredness, poor appetite, dizziness, weakness, falling over, slight lethargy, restless sleeping. All symptoms resolved within 48 hours except the swelling and redness of the injection limb are still there.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Irritability, Lethargy, Pain in extremity
Clinical narrative: Fever up to 103.2 even with fever reducers, red swollen injection site, soreness of leg, fussiness, tiredness, poor appetite, dizziness, weakness, falling over, slight lethargy, restless sleeping. All symptoms resolved within 48 hours except the swelling and redness of the injection limb are still there.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Poor quality sleep, Pyrexia
Clinical narrative: Fever up to 103.2 even with fever reducers, red swollen injection site, soreness of leg, fussiness, tiredness, poor appetite, dizziness, weakness, falling over, slight lethargy, restless sleeping. All symptoms resolved within 48 hours except the swelling and redness of the injection limb are still there.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Pyrexia
Clinical narrative: High fever.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Erythema and pain at site of injection.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Severe headache 2 1/2 hours after immunization followed by fever, dizziness, unusual fatigue, drowsiness, itching, some trouble breathing, attempted vomiting.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Headache, Lumbar puncture normal, Pruritus, Pyrexia, Somnolence
Clinical narrative: Severe headache 2 1/2 hours after immunization followed by fever, dizziness, unusual fatigue, drowsiness, itching, some trouble breathing, attempted vomiting.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Urine analysis normal, Vomiting
Clinical narrative: Severe headache 2 1/2 hours after immunization followed by fever, dizziness, unusual fatigue, drowsiness, itching, some trouble breathing, attempted vomiting.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Severe headache 2 1/2 hours after immunization followed by fever, dizziness, unusual fatigue, drowsiness, itching, some trouble breathing, attempted vomiting.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Erythema at the site of injection in thigh. Left thigh 9x7cm; right thigh 6x4cm.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Rash
Clinical narrative: Patient got rash.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Rash
Clinical narrative: RASH.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Alopecia, Chest X-ray normal, Chest pain, Chills, Fatigue
Clinical narrative: Fatigue, body aches, chills, hair loss, chest pain.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Immunoglobulins normal, Pain, X-ray limb normal
Clinical narrative: Fatigue, body aches, chills, hair loss, chest pain.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Abdominal pain upper, Cough, Erythema, Eyelid oedema, Gait disturbance
Clinical narrative: SEVERE STOMACH PAINS RED FACE PUPPY EYES CAN'T WALK WITHOUT ASSISTANCE HORRIBLE PERSISTANT COUCHING ALLERGIC REACTION FAINT BREATHING AMBULANCE WAS CALLED WENT TO ER.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Hypersensitivity, Hypopnoea
Clinical narrative: SEVERE STOMACH PAINS RED FACE PUPPY EYES CAN'T WALK WITHOUT ASSISTANCE HORRIBLE PERSISTANT COUCHING ALLERGIC REACTION FAINT BREATHING AMBULANCE WAS CALLED WENT TO ER.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Feeling hot, Heat exhaustion, Lymphadenopathy, Myalgia
Clinical narrative: Swollen lymph nodes in armpit of injection side. Swelling, heat, tenderness, pain radiating into muscle over breast, cannot put arm down due to axillary pain.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Tenderness
Clinical narrative: Swollen lymph nodes in armpit of injection side. Swelling, heat, tenderness, pain radiating into muscle over breast, cannot put arm down due to axillary pain.
Age: 1.26
Sex: M
Vaccine: HIBV, MMR
Symptoms: Blood glucose normal, Febrile convulsion, Pyrexia
Clinical narrative: Abrupt onset of febrile seizures; 911 called and pt transported to ER.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site rash, Rash erythematous, Rash papular
Clinical narrative: 3 mo. old received vaccine at 10:30 - went home - gave infant MOTRIN - at 2:30 feeding infant and noticed pimple like rash (small papular, erythematous) on (R) thigh - Later on rash spread to arms and legs.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: < 24 hrs after administering 2nd dose varicella, experienced itching and swelling, redness, 4" x 4".
Age: 8.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Injection site discharge
Clinical narrative: Pt states that arm became blistered and the liquid came out of the injection site.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Erythema, Papule
Clinical narrative: Erythematous papules vesicle. Cetirizine for 4-5 day advised.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site irritation, Pain
Clinical narrative: Mom called and reported (R) arm red and irritated. Mom said you could not touch due to pain. Referred to PCP. PCP reported mild irritation.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Arms became itchy the day after immunization. Small raised bumps appear on both arms the evening after. 3-4 on each arm but no sign of fever or headache.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Nausea, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Per pt's dtr, pt's arm was swollen; tingling in arm radiating to shoulder and back; pain in (R) hand; body ache and nausea.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Aggression, Agitation
Clinical narrative: 2 weeks after MMR vaccine, parent, teacher and other adults noticed major behavioral changes in patient. Noticed to be non-compliant, major tantrums, family agitation and meltdown at school, home and restaurant.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old female patient with pre-existing rash. On 17-MAR-2014 the patient was vaccinated with ZOSTAVAX dose 1, 0.65 ml (lot number reported as J013135, expiration date 17-JAN-2015) route was not provided. Concomitant therapies included BUSPAR, DITROPAN, XANAX and trazodone hydrochloride. The pharmacist reported that the patient saw an unspecified physician on 18-MAR-2014 in regards to the pre-existing rash and was prescribed prednisone for treatment. The pharmacist stated that did not know if the rash got any worse as just know it was there before the patient was vaccinated with the dose of ZOSTAVAX. At the time of the report, the patient outcome was not unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unkonwn demographics. The patient's current conditions or medical history were not reported. On 27-MAR-2014, the patient was inadvertently administered a dose of ROTATEQ suspension 2, 2 ml oral lot number reported as H016881 that had expired on 22-MAR-2014. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Herpes zoster disseminated, Skin reaction
Clinical narrative: This spontaneous report as received from a physician, via market research (TPSI), refers to a immunosuppressed female patient in her 80's with leukemia. In December 2013 or January 2014, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medications were not reported. On an unknown date the patient experienced skin reaction that clinically looked to be disseminated zoster. The outcome of skin reaction and disseminated zoster was reported as recovered/resolved. On an unknown date patient underwent biopsy of skin lesion: results not provided. The relationship between ZOSTAVAX and the events was not reported. Physician suspected that immunosuppression and concomitant leukemia were the reason for skin reaction. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient, aged 6 month and 4 days, of unkonwn gender. No medical history concurrent conditions were provided. On 24-MAR-2014, the patient was vaccinated with a first dose of ROTATEQ (lot number, dose and route not provided). No co-suspect or concomitant therapies were provided. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. No medical history or concurrent conditions were provided. On 28-MAR-2014, the patient was vaccinated with MMR II INK (lot # 0496AE; expiration date 07-MAR-2014), 0.5 ml, subcutaneously. No co-suspect or concomitant therapies were provided. The reporter stated that the patient was inadvertently administered with MMR II that had expired. No adverse events reported. Additional information is not expected.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swelling and slight redness in the morning the next day after the shot, with time there selling got worse and it became more and more red, it also became very tender. The size of the swelling and redness progress. Saw doctor around 2 PM, patient was prescribed Hydroxyine HCL. The following day on 04/05/2014 still no change.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Abnormal behaviour, Educational problem, Fear, Obsessive thoughts, Psychomotor hyperactivity
Clinical narrative: Racing thoughts, rapid and complex motor tics, heightened state of fear, obsessive thoughts, licking of objects in the home as well licking of people at school, inability to remain in a location for even a minute at a time, running around and flailing of his limbs, running into people, inappropriately touching people, rapid and constant touching of objects for no purpose, complex motor tics with his arms and legs, periodic growling vocal tic, and an inability to execute simple academic tasks. Symptoms came on rapidly in the early morning hours of 2/21/14 and have progressively worsened.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Tachyphrenia, Tic
Clinical narrative: Racing thoughts, rapid and complex motor tics, heightened state of fear, obsessive thoughts, licking of objects in the home as well licking of people at school, inability to remain in a location for even a minute at a time, running around and flailing of his limbs, running into people, inappropriately touching people, rapid and constant touching of objects for no purpose, complex motor tics with his arms and legs, periodic growling vocal tic, and an inability to execute simple academic tasks. Symptoms came on rapidly in the early morning hours of 2/21/14 and have progressively worsened.
Age: 2.0
Sex: M
Vaccine: DTAP, DTAPIPVHIB, DTIPV, HBHEPB, MMRV
Symptoms: Balance disorder, Blood test, Computerised tomogram, Convulsion, Disorientation
Clinical narrative: He started with a high fever that ended up with a siezure since the seizure he has complained of constant pain ans severe headaches with vomiting and light sensitivity he is not speaking as well as he did prior and is disoriented and unbalanced constantly and he has ran a constant low grade fever since the shots.
Age: 2.0
Sex: M
Vaccine: DTAP, DTAPIPVHIB, DTIPV, HBHEPB, MMRV
Symptoms: Headache, Pain, Photophobia, Pyrexia, Speech disorder
Clinical narrative: He started with a high fever that ended up with a siezure since the seizure he has complained of constant pain ans severe headaches with vomiting and light sensitivity he is not speaking as well as he did prior and is disoriented and unbalanced constantly and he has ran a constant low grade fever since the shots.
Age: 2.0
Sex: M
Vaccine: DTAP, DTAPIPVHIB, DTIPV, HBHEPB, MMRV
Symptoms: Vomiting
Clinical narrative: He started with a high fever that ended up with a siezure since the seizure he has complained of constant pain ans severe headaches with vomiting and light sensitivity he is not speaking as well as he did prior and is disoriented and unbalanced constantly and he has ran a constant low grade fever since the shots.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Aphagia, Chills, Diarrhoea, Headache, Nausea
Clinical narrative: Patient states after receiving the Hepatits B vaccine she began to have a headache. She states she that around 12:00 AM on 04/04/2014 she started to have episodes of nausea & vomiting, chills, & diarrhea. She states she has not been able to eat since getting the vaccine.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Patient states after receiving the Hepatits B vaccine she began to have a headache. She states she that around 12:00 AM on 04/04/2014 she started to have episodes of nausea & vomiting, chills, & diarrhea. She states she has not been able to eat since getting the vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Pruritus generalised
Clinical narrative: Generalized pruritis, parasthesias or "electrical tingling" in extremities and face. No visible rash.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Paraesthesia
Clinical narrative: Generalized pruritis, parasthesias or "electrical tingling" in extremities and face. No visible rash.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Chest X-ray normal, Computerised tomogram normal, Dizziness, Electrocardiogram normal
Clinical narrative: Numbness tingling started in left forearm then left foot progressed into left leg and eventually into right arm and legs and both feet. Prickly sensations, blurred vision, dizziness.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging normal, Paraesthesia, Vision blurred
Clinical narrative: Numbness tingling started in left forearm then left foot progressed into left leg and eventually into right arm and legs and both feet. Prickly sensations, blurred vision, dizziness.
Age: 11.0
Sex: F
Vaccine: HPVX, MNQ, TDAP
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site swelling, Injection site warmth
Clinical narrative: Patient's leg where shot was administered was bloody and the wound area continued to redden and swell to more than 5.5 x 5.5 inches [warm to touch].  Multiple trips and calls to the doctor includes now antibiotics, antihistamine and monitoring.
Sex: U
Vaccine: HEP, TD
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Feeling hot, Induration, Swelling, Vaccination site cellulitis
Clinical narrative: Cellulitis at vaccination site, erythema, swelling, warmth, induration.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Extreme pain in arm. Unable to move arm without extreme pain.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Dizziness, Fatigue, Injection site erythema
Clinical narrative: Patient stated she felt lightheaded and dizzy. Had her sit down. NO problems breathing, NO swelling of tongue, No hives. A little redness around site of injection. She said she felt very tired. She was getting very anxious.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Cold sweat, Feeling cold, Injection site pain, Injection site rash
Clinical narrative: Cold chill, 102 temp, night sweats. During the following day large rash going down from needle point to bicep approximately 3"x5" and very tender. Cold sweats the following night and rash larger and tender.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Night sweats
Clinical narrative: Cold chill, 102 temp, night sweats. During the following day large rash going down from needle point to bicep approximately 3"x5" and very tender. Cold sweats the following night and rash larger and tender.
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: Musculoskeletal disorder, Pain, Radiculitis brachial, Tendonitis, X-ray
Clinical narrative: Shoulder never got better from vaccine.  Pain spread and continued to get worse.  Treatments so far -- Prescriptions: cyclobenzaprine 5 mg tablet, Prednisone 20 mg tablet, Hydrocone 5-325 tablet, Gabapentin 300 mg capsules and ibuprofen.  Others: physical therapy and acupuncture.  Pain continues.  Waiting for appointment with neurologist.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Alopecia, Appendicitis
Clinical narrative: Severe stomach pains on 07/17/13 which subsided for a while and would come and go until severe pains 8/27/2013 and appendicitis on 8/28/2013. Also has experienced hair loss since Sept 2013.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age concerning her daughter. Patient's medical history and other drug allergic reactions were not reported. On an unknown date of February, the patient was vaccinated with recalled GARDASIL (strength, dose number, dose unit, route, lot number and expiry date unknown). On an unknown date patient still had a sore arm. Legal issue involved and adverse event sent to legal. The outcome of received the recalled GARDASIL vaccine in February and still had a sore arm was unknown. The reporter did not provide the causality of sore arm to GARDASIL. No further information was reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Cold sweat, Dizziness, Hyperhidrosis, Hypotension
Clinical narrative: Case number PHHY2012US110961 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 466130) on 04 Dec 2012 with a follow up report received from the Quality Assurance department (QA reference number: 210084) on 02 Apr 2014. This case refers to 61-year-old female patient. Concomitant medications included lisinopril, hydrochlorothiazide and lumigan eye drops. The patient was vaccinated with FLUVIRIN (batch number : 1204521) intramuscularly in left arm on 24 Sep 2012. On 24 Sep 2012, five minutes after receiving the flu shot, the patient was found sitting slumped and mumbling in chair. The patient was conscious but not responding to questions. After some time, the patient was responsive to questioning and was coherent. The patient experienced upset stomach and was dizzy (had to use bathroom). She was sweating and clammy. The paramedics stated that her blood pressure was low at sitting and standing position and determined patient needed to go to emergency room for further evaluation. The outcome of events was reported as condition unchanged as of 24 Sep 2012. The causality of the events was not reported. Based on the review performed, this product batch (1204521) was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report received from the Quality Assurance department (QA reference number: 210084) on 02 Apr 2014: The batch review report was updated.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Posture abnormal, Speech disorder, Unresponsive to stimuli
Clinical narrative: Case number PHHY2012US110961 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 466130) on 04 Dec 2012 with a follow up report received from the Quality Assurance department (QA reference number: 210084) on 02 Apr 2014. This case refers to 61-year-old female patient. Concomitant medications included lisinopril, hydrochlorothiazide and lumigan eye drops. The patient was vaccinated with FLUVIRIN (batch number : 1204521) intramuscularly in left arm on 24 Sep 2012. On 24 Sep 2012, five minutes after receiving the flu shot, the patient was found sitting slumped and mumbling in chair. The patient was conscious but not responding to questions. After some time, the patient was responsive to questioning and was coherent. The patient experienced upset stomach and was dizzy (had to use bathroom). She was sweating and clammy. The paramedics stated that her blood pressure was low at sitting and standing position and determined patient needed to go to emergency room for further evaluation. The outcome of events was reported as condition unchanged as of 24 Sep 2012. The causality of the events was not reported. Based on the review performed, this product batch (1204521) was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report received from the Quality Assurance department (QA reference number: 210084) on 02 Apr 2014: The batch review report was updated.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Heart rate increased, Hypertension
Clinical narrative: Case number PHHY2012US110984 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 466911) web site on 04 Dec 2012 with a follow up received from the Quality Assurance department (QA reference number: 210118) on 01 Apr 2014. This report refers to a 61-years-old female patient. Her medical history chronic obstructive pulmonary disease (COPD) and bipolar disorder. Her concomitant medications were Celebrex, lithium, bupropion, diazepam, albuterol, Spiriva, levothyroxine and Vicodin ES. She was vaccinated with FLUVIRIN (batch number: 1204521) intramuscularly on to left arm on 25 Sep 2012. On the same day at 12:05 pm, she had shortness of breath. She used Ventolin HFA inhaler. At 12:20 pm, she reported dizziness. Her blood pressure was checked and it was 167/85 (units not reported). Her pulse rate was 82 (units not reported). At 12:30 pm, she experienced itching, chest tightness, throat swelling and closing. She called to emergency and administered 0.3 mg autoinjector Epipen. Emergency medical service arrived and administered diphenhydramine and took her to hospital. She went to emergency room. The event outcome was reported as complete recovery as of 29 Sep 2012. Based on the batch review performed, it was concluded that FLUVIRIN batch 1204521 was manufactured in accordance with the approved internal procedures and is in compliance with the cGMP requirements. Follow up report received from the Quality Assurance department (QA reference number: 210118) on 01 Apr 2014: The batch review report was updated.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pruritus, Throat tightness
Clinical narrative: Case number PHHY2012US110984 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 466911) web site on 04 Dec 2012 with a follow up received from the Quality Assurance department (QA reference number: 210118) on 01 Apr 2014. This report refers to a 61-years-old female patient. Her medical history chronic obstructive pulmonary disease (COPD) and bipolar disorder. Her concomitant medications were Celebrex, lithium, bupropion, diazepam, albuterol, Spiriva, levothyroxine and Vicodin ES. She was vaccinated with FLUVIRIN (batch number: 1204521) intramuscularly on to left arm on 25 Sep 2012. On the same day at 12:05 pm, she had shortness of breath. She used Ventolin HFA inhaler. At 12:20 pm, she reported dizziness. Her blood pressure was checked and it was 167/85 (units not reported). Her pulse rate was 82 (units not reported). At 12:30 pm, she experienced itching, chest tightness, throat swelling and closing. She called to emergency and administered 0.3 mg autoinjector Epipen. Emergency medical service arrived and administered diphenhydramine and took her to hospital. She went to emergency room. The event outcome was reported as complete recovery as of 29 Sep 2012. Based on the batch review performed, it was concluded that FLUVIRIN batch 1204521 was manufactured in accordance with the approved internal procedures and is in compliance with the cGMP requirements. Follow up report received from the Quality Assurance department (QA reference number: 210118) on 01 Apr 2014: The batch review report was updated.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)