chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Rash macular
Clinical narrative: Patient got red splotches over his face & legs. No rash on trunk. He cried initially then consoled easily. He was given BENADRYL 1mg/kg 25min after vaccines were given & observed.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Urticaria rash on chest and arms. Pt given BENADRYL 250 mg PO x 1.
Age: 63.0
Sex: F
Vaccine: TTOX
Symptoms: Dysphonia, Feeling abnormal, Feeling cold, Injection site erythema, Injection site haematoma
Clinical narrative: Could not get warm.  Raspy voice.  Could not sleep that night. "Funny" feeling in arm - at 6:00 a.m. the next morning, red nodule at injection sight surrounded by very large bruise.  Red lines radiating toward elbow area - swelling from top of shoulder to elbow - feeling as if one banged their elbow - funny feeling in hand - still minor on Monday, March 12.  Arm was cold to touch with splotches.
Age: 63.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site nodule, Injection site streaking, Injection site swelling, Insomnia, Peripheral coldness
Clinical narrative: Could not get warm.  Raspy voice.  Could not sleep that night. "Funny" feeling in arm - at 6:00 a.m. the next morning, red nodule at injection sight surrounded by very large bruise.  Red lines radiating toward elbow area - swelling from top of shoulder to elbow - feeling as if one banged their elbow - funny feeling in hand - still minor on Monday, March 12.  Arm was cold to touch with splotches.
Age: 63.0
Sex: F
Vaccine: TTOX
Symptoms: Rash macular
Clinical narrative: Could not get warm.  Raspy voice.  Could not sleep that night. "Funny" feeling in arm - at 6:00 a.m. the next morning, red nodule at injection sight surrounded by very large bruise.  Red lines radiating toward elbow area - swelling from top of shoulder to elbow - feeling as if one banged their elbow - funny feeling in hand - still minor on Monday, March 12.  Arm was cold to touch with splotches.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: R DELT (WHERE DTAP WAS ADMINISTERED) HAD EDEMA, ERYTHEMA AND WARMTH TO TOUCH. ERYTHEMA HAD A RADIUS OF 50X50 MM.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Chest pain, Cough, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Chest pain next day. Tired, decrease appetite 2 days later. Vomiting, cough, SOB 2 days later.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Vomiting
Clinical narrative: Chest pain next day. Tired, decrease appetite 2 days later. Vomiting, cough, SOB 2 days later.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Rt upper arm red swollen, painful.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Pruritus, Rash
Clinical narrative: Patient was vaccinated on 02-27-2012 without incident or complaints. Reported to the nurse at 7:30 AM for meds. On 03/2/2012 patient complained of "rash, itching and behavior changes". Nurse stated she did not observe any S/S. Health department received letter from the patient on 03/08/2012 with patient's complaint and follow-up began then from HD staff.
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, TDAP
Symptoms: Erythema, Rash, Skin plaque, Urticaria
Clinical narrative: Within approximately 2 1/2 hours the patient presented with erythemetous raised plaques and wheals to face, upper torso, and upper extremities bilaterally. It was then noted by facility staff. The nurse was notified approximately at 12 noon.  Benadryl 50 mg PO was administered. The rash had little improvement. At 17:00 the client was seen at a local emergency room. Decadron and Benadryl were administered by the ER and his diagnosis was Urticaria.  The patient returned back to the facility with an order for Prednisone and Claritin.  The rash cleared within a few hours of returning from the ER. The patient had a follow up appointment with his primary physician on Friday March 9, 2012. At that visit the patient disclosed to the provider he was allergic to vaccines having had a previous reaction. When asked why he did not previously report he stated he did not want to cause trouble. The physician ordered him to complete the prescriptions a per written by the ER and do not administer any further vaccines.
Age: 1.01
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site pallor
Clinical narrative: Mild superficial cellulitis of right thigh approximately 4 cm diameter, blanching, noted 7d after vaccine. Pt started on PO cephalexin, topical BACTROBAN.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Computerised tomogram head, Confusional state, Pain, Syncope
Clinical narrative: Fainting 24 hours later. Elevated BP, mental confusion. Severe localized pain.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MNQ, PPV
Symptoms: Blood culture negative, Cellulitis, Condition aggravated, Erythema, Idiopathic thrombocytopenic purpura
Clinical narrative: Right leg edema, erythema and pain, few hours after vaccines. Fever same day of vaccines. Admitted x 3 days due to cellulitis treated with clindamycin. Pt has chronic ITP refractory to steroids, IVIG and WinRho.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MNQ, PPV
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Right leg edema, erythema and pain, few hours after vaccines. Fever same day of vaccines. Admitted x 3 days due to cellulitis treated with clindamycin. Pt has chronic ITP refractory to steroids, IVIG and WinRho.
Age: 20.0
Sex: M
Vaccine: TD
Symptoms: Dizziness, Pain
Clinical narrative: Light head and very sore.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, HEP, MMR
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient received immunizations on Monday (2/27/12) by Friday (03/2/12) patient had developed a red raised rash at the injection site on her right thigh. Dad said the rash continued to get bigger for a couple of days then stopped growing but was still persistent. It was not itchy or bothersome to patient. Dad was to observe & call if it did not improve. He currently had not contacted us back.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid swollen and tender. Below injection site redness & warmth.
Age: 1.05
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Herpes zoster, Injection site rash
Clinical narrative: Zoster (shingles) rash on right arm (same arm where she got the vaccine seven months earlier. Patient is otherwise asymptomatic and is expected to recover.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Rash
Clinical narrative: Noticed a rash forming in groin area on the evening of the vaccine. Progressively became worse and slightly spread for the next four days. On the fifth day it began to clear.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Genital rash, Rash
Clinical narrative: Rash on neck, torso and genital/leg area. Given prednisone, loratidine and betamethasone valerate oint.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersensitivity, Injection site erythema, Rash erythematous, Rash generalised
Clinical narrative: The patient described a local injection site red reaction after the vaccine, and then a fine red itchy bumpy rash that started on her legs and spread to most of her body over the next week or so.  She was seen by Dr. on 3/01 and evaluated.  He felt the rash was most likely an allergic reaction to the vaccine.  He concurred with the patient's assesment of the injection site reaction and rash.  The patient also reported low-grade headache but no fever or chills or other symptoms.  He did not feel the rash was a varicella-type rash.  He prescribed OTC diphenhydramine 25-50 mg every 4 hours as needed and cool baths.  As of 3/12/12, the patient reports improvement but still a rash on arms.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: The patient described a local injection site red reaction after the vaccine, and then a fine red itchy bumpy rash that started on her legs and spread to most of her body over the next week or so.  She was seen by Dr. on 3/01 and evaluated.  He felt the rash was most likely an allergic reaction to the vaccine.  He concurred with the patient's assesment of the injection site reaction and rash.  The patient also reported low-grade headache but no fever or chills or other symptoms.  He did not feel the rash was a varicella-type rash.  He prescribed OTC diphenhydramine 25-50 mg every 4 hours as needed and cool baths.  As of 3/12/12, the patient reports improvement but still a rash on arms.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Dysgeusia, Erythema, Fatigue, Myalgia, Oropharyngeal pain
Clinical narrative: Metallic taste in mouth lasted an hour, then bad sore throat, rhinorrhea, myalgias, fatigue and urticaria, few scattered red papules, lives alone, no one had similar sx, sx resolved 24-36 hours and then noted arm sore, was sl tired and achy but otherwise sx resolved.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Papule, Rhinorrhoea, Urticaria
Clinical narrative: Metallic taste in mouth lasted an hour, then bad sore throat, rhinorrhea, myalgias, fatigue and urticaria, few scattered red papules, lives alone, no one had similar sx, sx resolved 24-36 hours and then noted arm sore, was sl tired and achy but otherwise sx resolved.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Grandmother/legal guardian called clinic 3/12/12 approx 1:30pm. Stated the patient c/o dizziness since last evening. Denies sinus, inner ear or other symptoms. Denies new food, medication, drug or alcohol usage. Bp per grandmother is 101/59 and respirations normal. Instructed to call personal physican for appt or advice and informed that she could take Benadryl 1 dose tonight at bedtime with MD okay and that VAERS would be done and to expect contact. Informed that unlikely it is related to vaccine at this late time post vaccination but, to stay in touch.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: After shot, pain was abnormally high. Unable to make fist. Arm was sore. Pain went up through next. Pain in arm for 3 days. From Hep C shot, first round.
Age: 9.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Red rash on shoulder, armpit and leg, fever. Treated with Calamine lotion and ibuprofen.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Feeling hot, Heat rash, Panic attack, Rash macular
Clinical narrative: Panic attack, felt like I couldn't breathe, Hot, got rash, but not like Shingles. Had Shingle shot 4 days before. Has lasted over 4 months, but is fading.
Age: 0.19
Sex: F
Vaccine: DTAP, DTPIPV, HIBV, RVX
Symptoms: Decreased eye contact, Screaming, Staring, Unresponsive to stimuli
Clinical narrative: Patient screamed uncontrollably non stop for over 4 hours. The next day she did not make eye contact. Patient was staring blankly and "glazed" over. She was unresponsive to any noise or movement in front of her. This lasted for 4 days.
Age: 1.42
Sex: F
Vaccine: DTAPHEPBIP, FLUX, HEP, PPV
Symptoms: Convulsion, Otitis media acute, Productive cough, Pyrexia
Clinical narrative: Developed a fever, then had a seizure and was taken by ambulence to the emergency room. When I evaluated her again on 2/8/12, she had complaints of 1 week of a productive cough and evidence of acute otitis media on exam.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Insomnia, Irritability, Somnolence
Clinical narrative: Dad reports sleepiness immediately following vaccines. He then reports him being very irritable and refusing to go to sleep that night. The following morning he that he was at his usual activity level.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Patient seen in office.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Syncope
Clinical narrative: Fainted and fall down after 5 minutes of vaccination (GARDASIL).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Rash
Clinical narrative: Woke this am with rash on back. Now on back, neck, arms, chest bad.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Fatigue, Feeling abnormal, Injection site pain, Swelling
Clinical narrative: Pt received Tdap on 3/8/12 as part of her annual exam. A few hours after vaccine administered she began to feel "fuzzy" and was tired. On 3/9/12 she woke up & (L) axillary was swollen & painful. (L) deltoid was also painful. No rash or fever.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Screaming, Tremor
Clinical narrative: Screaming and shaking fits.
Age: 1.05
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: High temperature 104.8 axillary.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Arterial haemorrhage, Chills, Chromatopsia, Decreased appetite, Feeling cold
Clinical narrative: Nov. 9th, approximately 6 hours after receiving a senior citizens dosage flu shot: uncontrollable shivering, loss of appetite. Went to bed shivering - continued approx. 2 hours. Next day noticed spot in right eye. Spot changed color. Went to see M.D. on Nov. 15th. Diagnosed bleeding artery in retina. Second opinion Nov. 16 from another M.D. agrees with first Dr. & prescribed eye drops. Bleeding stopped by Dec. 15 on exam by Dr. Feb 17, Dr concurs, right eye will have permanent spot, could be due to Flu shot. Wed. Nov 9, 2011 - While shopping stopped at Pharmacy for a flu shot. Got a "Senior Dosage" shot about noon. Felt cold about 5:00 PM and began shivering about 6:00 PM. Couldn't eat my dinner - not hungry. Had two glasses of wine. Began violent shivering and went to bed. No apparent fever. Shivering stopped about 8:00PM. - Slept till 6:00 AM. Thur. Nov 10 - First noticed bright gold spot when both my eyes were closed. Thought it might be a migraine aura, to which I'm prone, but then noticed when I closed my left eye a purple dot, kind of maple leaf or badge shape appeared slightly higher than center vision when looking straight ahead. When I'd raise my line of vision the dot would move up. This condition stayed the same all day and evening. Fri. Nov 11 - 6:00 AM Same spot appears when left eye closes. Left at 8:30 for dove hunting trip - drove 160 miles - spot doesn't effect my driving. - Symptoms stayed the same all day. Sat. Nov 12 - 6:00 AM Missed several shots at dove as target was blotted out by the purple dot. Particularly noticeable as I close my left eye when aiming. Rain storm on way home made it difficult to see, but was not much effected by the dot. Sun Nov 13 - No spot apparent for a few minutes, but then it came back. Same symptoms all day: close left eye=dot appears slightly above center of line of vision. Mon Nov 14 - Same all day - got appointment to see Dr. Tues Nov 15 - Examination by Dr - wants to do more tests Weds.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Retinal haemorrhage, Visual impairment
Clinical narrative: Nov. 9th, approximately 6 hours after receiving a senior citizens dosage flu shot: uncontrollable shivering, loss of appetite. Went to bed shivering - continued approx. 2 hours. Next day noticed spot in right eye. Spot changed color. Went to see M.D. on Nov. 15th. Diagnosed bleeding artery in retina. Second opinion Nov. 16 from another M.D. agrees with first Dr. & prescribed eye drops. Bleeding stopped by Dec. 15 on exam by Dr. Feb 17, Dr concurs, right eye will have permanent spot, could be due to Flu shot. Wed. Nov 9, 2011 - While shopping stopped at Pharmacy for a flu shot. Got a "Senior Dosage" shot about noon. Felt cold about 5:00 PM and began shivering about 6:00 PM. Couldn't eat my dinner - not hungry. Had two glasses of wine. Began violent shivering and went to bed. No apparent fever. Shivering stopped about 8:00PM. - Slept till 6:00 AM. Thur. Nov 10 - First noticed bright gold spot when both my eyes were closed. Thought it might be a migraine aura, to which I'm prone, but then noticed when I closed my left eye a purple dot, kind of maple leaf or badge shape appeared slightly higher than center vision when looking straight ahead. When I'd raise my line of vision the dot would move up. This condition stayed the same all day and evening. Fri. Nov 11 - 6:00 AM Same spot appears when left eye closes. Left at 8:30 for dove hunting trip - drove 160 miles - spot doesn't effect my driving. - Symptoms stayed the same all day. Sat. Nov 12 - 6:00 AM Missed several shots at dove as target was blotted out by the purple dot. Particularly noticeable as I close my left eye when aiming. Rain storm on way home made it difficult to see, but was not much effected by the dot. Sun Nov 13 - No spot apparent for a few minutes, but then it came back. Same symptoms all day: close left eye=dot appears slightly above center of line of vision. Mon Nov 14 - Same all day - got appointment to see Dr. Tues Nov 15 - Examination by Dr - wants to do more tests Weds.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Injection site pain, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Initial report received from a health care professional on 25/Jul/2005. An 18-year-old female patient, had received a first dose of MENACTRA, lot number U1657AA in the left arm and a second of TUBERSOL 5 TU, lot number C2079AA, intra-dermally in the right forearm on 20/Jul/2005 at 3:00 pm. One day later, she developed a fever, generalized body aches and chills. In addition, her left arm was swollen from her wrist to her elbow and she had pain underneath her arm at the shoulder joint. She had developed a tiny node at the left axilla, which was tender. At the site of the MENACTRA injection, she developed swelling and pain. She was seen by a physician on 22/Jul/2005 and was treated with TYLENOL and MOTRIN. The impression was that the patient had a "reaction to MENACTRA". As per the reporter, it is unknown whether the patient recovered from these events.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Musculoskeletal pain, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Initial report received from a health care professional on 25/Jul/2005. An 18-year-old female patient, had received a first dose of MENACTRA, lot number U1657AA in the left arm and a second of TUBERSOL 5 TU, lot number C2079AA, intra-dermally in the right forearm on 20/Jul/2005 at 3:00 pm. One day later, she developed a fever, generalized body aches and chills. In addition, her left arm was swollen from her wrist to her elbow and she had pain underneath her arm at the shoulder joint. She had developed a tiny node at the left axilla, which was tender. At the site of the MENACTRA injection, she developed swelling and pain. She was seen by a physician on 22/Jul/2005 and was treated with TYLENOL and MOTRIN. The impression was that the patient had a "reaction to MENACTRA". As per the reporter, it is unknown whether the patient recovered from these events.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Arthritis, Joint range of motion decreased, Joint warmth, Tenosynovitis
Clinical narrative: Initial report was received from a consumer who is also the patient on 29 October 2010. A 56 year-old female with a history of left breast cancer, right hand pain and weakness with overuse and allergies to penicillin (PCN), morphine and thimerosal, had received a first dose intramuscular right deltoid injection of ADACEL (lot number not reported) and an intradermal right forearm injection of TUBERSOL 5 TU (lot number not reported) on 13 October 2010 and "three days later", experienced pain in both her thumb joints. She reported her left thumb pain has decrease by "75%" however her right thumb pain continues and is also stiff and weak. No further information was available at the time of the report. The patient's out was not recovered. Follow-up information received from a health care professional on 13 January 2011 reported that the patient had no illness at the time of vaccination. The patient had received greater than 16 previous doses of TUBERSOL in the past. The patient had a sensitivity reaction to the (dose 1) H1N1 vaccine, CSL 00249611A at age 56-years. The patient received ADACEL, sanofi pasteur Ltd. lot number C3448AA and TUBERSOL 5 TU, sanofi pasteur Ltd. lot number C3510AA. On 16 October 2010, the patient developed bilateral thumb joints that were very painful, hot, inflamed and difficult to move. She began taking NSAIDS with minimal pain relief and continued taking NSAIDS throughout the week. On 26 October 2010, she reported to the Occupational Health nurse via phone that her pain in the left thumb joint began to subside somewhat but had no change in the right thumb joint. On 29 October 2010, the patient spoke with a representative of sanofi pasteur that stated that "underlying condition can experience a "flare-up" from ADACEL." On the 12 November 2010, the patient updated the Occupational Health Service (OHS) via e-mail. The patient was treated with NAPROSYN, and started using a thumb immobilizer on 13 November 2010. She also received occupational therapy (OT). The patient had been wearing the thumb immobilizer around the clock except to shower with no improvement noted in the right thumb joint. The left thumb joint has become aggravated from increased use. The etiology of the event was reported as unknown and adverse reaction. The diagnosis was "tenosynovitis secondary to T-DAP vac". The patient has not recovered and remains under medical care. Follow-up information was received from the health care professional on 16 March 2011. Since reporting the adverse event, the patient had 5 appointments with an occupational physician, and 12 occupational therapy sessions. She continued to use kinesio tape to help alleviate tenosynovitis in her right thumb and hand. Her last therapy session was 23 February 2011, and last doctor's appointment was 01 March 2011; no further appointments were scheduled. No diagnostic test were ordered. The event is still ongoing at the time of the report. Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: Initial report was received from a consumer who is also the patient on 29 October 2010. A 56 year-old female with a history of left breast cancer, right hand pain and weakness with overuse and allergies to penicillin (PCN), morphine and thimerosal, had received a first dose intramuscular right deltoid injection of ADACEL (lot number not reported) and an intradermal right forearm injection of TUBERSOL 5 TU (lot number not reported) on 13 October 2010 and "three days later", experienced pain in both her thumb joints. She reported her left thumb pain has decrease by "75%" however her right thumb pain continues and is also stiff and weak. No further information was available at the time of the report. The patient's out was not recovered. Follow-up information received from a health care professional on 13 January 2011 reported that the patient had no illness at the time of vaccination. The patient had received greater than 16 previous doses of TUBERSOL in the past. The patient had a sensitivity reaction to the (dose 1) H1N1 vaccine, CSL 00249611A at age 56-years. The patient received ADACEL, sanofi pasteur Ltd. lot number C3448AA and TUBERSOL 5 TU, sanofi pasteur Ltd. lot number C3510AA. On 16 October 2010, the patient developed bilateral thumb joints that were very painful, hot, inflamed and difficult to move. She began taking NSAIDS with minimal pain relief and continued taking NSAIDS throughout the week. On 26 October 2010, she reported to the Occupational Health nurse via phone that her pain in the left thumb joint began to subside somewhat but had no change in the right thumb joint. On 29 October 2010, the patient spoke with a representative of sanofi pasteur that stated that "underlying condition can experience a "flare-up" from ADACEL." On the 12 November 2010, the patient updated the Occupational Health Service (OHS) via e-mail. The patient was treated with NAPROSYN, and started using a thumb immobilizer on 13 November 2010. She also received occupational therapy (OT). The patient had been wearing the thumb immobilizer around the clock except to shower with no improvement noted in the right thumb joint. The left thumb joint has become aggravated from increased use. The etiology of the event was reported as unknown and adverse reaction. The diagnosis was "tenosynovitis secondary to T-DAP vac". The patient has not recovered and remains under medical care. Follow-up information was received from the health care professional on 16 March 2011. Since reporting the adverse event, the patient had 5 appointments with an occupational physician, and 12 occupational therapy sessions. She continued to use kinesio tape to help alleviate tenosynovitis in her right thumb and hand. Her last therapy session was 23 February 2011, and last doctor's appointment was 01 March 2011; no further appointments were scheduled. No diagnostic test were ordered. The event is still ongoing at the time of the report. Documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Back pain, Nausea, Pain
Clinical narrative: Initial report received on 22 June 2011 from a healthcare professional. A cluster of 3 unidentified patients had received an intramuscular injection of ADACEL (lot number C3727BA) on an unspecified date in June 2011. At an unspecified amount of time later, the patient called the physicians office to report symptoms after vaccination of body aches, back pain, and nausea. No diagnostic tests or laboratory data were provided. Recovery status was unknown. Follow-up information was received 15 July 2011 from a health care professional who provided patient identifying information for one of the three previously unidentified patients. Two patients remain unidentified. A fourth identified patient (captured in case 2011-03707) also received ADACEL, lot number C3727BA which had previously been reported as receiving a different ADACEL lot number of U3491CA (sanofi pasteur Ltd, lot number C3637). This case pertains to one of the cluster of four patients and has been identified as a 21-year-old female who received an intramuscular injection of ADACEL, lot number C3727BA and an intradermal "right" injection (site not reported) of TUBERSOL (Mantoux), lot number C3375AB on 21 June 2011. She had no illness at the time of vaccination. According to the reporter, the events began on the day of vaccination and required an emergency room or doctor's visit. Outcome was recovered. Documents held by sender: None. The reporter for this case is the same as for case 2011-03707.
Age: 1.53
Sex: M
Vaccine: DTAPH, HEPA, PPV
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever as high as 104.3 f lasting for more than 5 days. Severe fussiness.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Screaming
Clinical narrative: Screamed for 48 hours after two month vaccines.
Age: 1.08
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: By Sunday 3-11-12 patient had a 6 1/2 cm x 4 cm red, warm raised lump where injection was given. PCV-13 is what was given in that thigh that he reacted to (R thigh).
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Day after last vaccine 3rd dose of GARDASIL pt developed itchy pink bump above bikini line, under umbilicus, and at inner thigh. Resolved. 3/8/12 Rt hip area.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Day after last vaccine 3rd dose of GARDASIL pt developed itchy pink bump above bikini line, under umbilicus, and at inner thigh. Resolved. 3/8/12 Rt hip area.
Age: 22.0
Sex: M
Vaccine: HPV4, TYP, HPV4, TYP
Symptoms: Rash papular
Clinical narrative: Erythematous 1.5cm well circumscribed papules - trunk, posteriorly/anteriorly. Non-pruritic, non-painful. Given steroid cream (1%) and diphenhydramine.
Age: 22.0
Sex: M
Vaccine: HPV4, TYP, HPV4, TYP
Symptoms: Rash, Rash papular
Clinical narrative: Erythematous 1.5cm well circumscribed papules - trunk, posteriorly/anteriorly. Non-pruritic, non-painful. Given steroid cream (1%) and diphenhydramine.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Tenderness, Urticaria
Clinical narrative: Pt stated she had a large welt on her arm, tenderness throughout entire body, decreased appetite & sluggishness & went to ER. Welt has gone down slightly.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Asthenia, Gene mutation identification test positive, Loss of consciousness, Methylenetetrahydrofolate reductase polymorphism
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a 14 year old female patient with family history of a blood clotting disorder and MTHFR gene abnormality who on an unknown date, was vaccinated with the first dose of GARDASIL (lot# 0298AA, expiration date: 21-JUN-2013) (dose and route were not reported). The patient did not receive any concomitant medication. Two days later, on 07-DEC-2011, the patient fainted. The nurse practitioner stated that before the patient was placed on hormonal contraceptives (unspecified) on 05-DEC-2011, she had laboratory test drawn, to test for blood clotting abnormalities. The patient was diagnosed with MTHFR gene abnormality. The patient was hospitalized in an unknown hospital for an unspecified period of time. The Nurse practitioner stated that the patient's mother reported that on an unknown date, the patient had taken her first dose of birth control medication and the day after the patient fainted at school. The patient was taken to the hospital. Then the patient was transferred to another hospital. The patient again was transferred to another hospital. The patient's mother reported that it was determined that the patient's MTHFR gene abnormality was not related to the patient's fainting. It was also reported that on an unknown date the patient had weakness and she had just "started to walk again". At the time of the report patient's outcome was unknown. Follow up information was received from the nurse practitioner concerning a 14 year old female student with no pre-existing allergies, birth defects or medical conditions (previously reported as having a history of blood clotting disorder and MTHFR gene abnormality) and no illness at the time of vaccination who on 05-DEC-2011 at 16:00, was vaccinated in the left deltoid with the first dose of GARDASIL (lot# 0298AA, expiration date: 21-JUN-2013) (dose and route were not reported). The nurse reported that at the time of injection no problems occurred. Seven days later, on 12-DEC-2011, the mother called and said that on 12-DEC-2011 at 13:00, the patient had passed out at school and was taken to ER (previously reported also as on 07-DEC-2011). The patient was hospitalized off and on since the event because of neurological deficit, low extremities (LE) weakness, foot drop and inability to walk. At the time of the report, the patient had not recovered. Passed out, neurological deficit, low extremities (LE) weakness, foot drop and inability to walk were considered by the nurse to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Nervous system disorder, Peroneal nerve palsy, Syncope
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a 14 year old female patient with family history of a blood clotting disorder and MTHFR gene abnormality who on an unknown date, was vaccinated with the first dose of GARDASIL (lot# 0298AA, expiration date: 21-JUN-2013) (dose and route were not reported). The patient did not receive any concomitant medication. Two days later, on 07-DEC-2011, the patient fainted. The nurse practitioner stated that before the patient was placed on hormonal contraceptives (unspecified) on 05-DEC-2011, she had laboratory test drawn, to test for blood clotting abnormalities. The patient was diagnosed with MTHFR gene abnormality. The patient was hospitalized in an unknown hospital for an unspecified period of time. The Nurse practitioner stated that the patient's mother reported that on an unknown date, the patient had taken her first dose of birth control medication and the day after the patient fainted at school. The patient was taken to the hospital. Then the patient was transferred to another hospital. The patient again was transferred to another hospital. The patient's mother reported that it was determined that the patient's MTHFR gene abnormality was not related to the patient's fainting. It was also reported that on an unknown date the patient had weakness and she had just "started to walk again". At the time of the report patient's outcome was unknown. Follow up information was received from the nurse practitioner concerning a 14 year old female student with no pre-existing allergies, birth defects or medical conditions (previously reported as having a history of blood clotting disorder and MTHFR gene abnormality) and no illness at the time of vaccination who on 05-DEC-2011 at 16:00, was vaccinated in the left deltoid with the first dose of GARDASIL (lot# 0298AA, expiration date: 21-JUN-2013) (dose and route were not reported). The nurse reported that at the time of injection no problems occurred. Seven days later, on 12-DEC-2011, the mother called and said that on 12-DEC-2011 at 13:00, the patient had passed out at school and was taken to ER (previously reported also as on 07-DEC-2011). The patient was hospitalized off and on since the event because of neurological deficit, low extremities (LE) weakness, foot drop and inability to walk. At the time of the report, the patient had not recovered. Passed out, neurological deficit, low extremities (LE) weakness, foot drop and inability to walk were considered by the nurse to be disabling. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Death, Expired drug administered
Clinical narrative: Information has been received from a pharmacist. This pharmacist reports similar events for 2 patients. This was the first of 2 reports. This pharmacist reports she gave PNEUMOVAX 23, 1 injection, to a female patient, age unknown, about 3 hours ago, on 01-MAR-2012, and the PNEUMOVAX 23 expired on 25-FEB-2012. On unspecified date, the patient died. It was unknown if there was any relevant medical history, relevant concomitant medications, or relevant past drug history. It was unknown if there was any relevant laboratory tests. Additional information has been requested. This is one of several reports from the same source.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Clonus, Electrocardiogram normal
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who on 24-JAN-2012, was vaccinated with the first dose of GARDASIL (lot number, dose and route not reported). The physician reported that on 24-JAN-2012, the patient called the office later in the day with symptoms described as "mild clonus". On an unspecified date, the patient had an electrocardiogram which was normal. The patient was reported to be admitted to the hospital on 29-FEB-2012 because the she was still having symptoms. At the time of the report, the patient's mild clonus persisted. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture, Pneumonia streptococcal
Clinical narrative: Information has been received from a registered pharmacist concerning a 69 year old female patient with cancer (diagnosed on an unspecified date) in chemotherapy treatment and drug reactions allergies to allopurinol and cilastatin sodium (+) imipenem (MSD, WAES 1203USA01127) who on 22-MAR-2011 was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (Lot # reported as 1480Z, Exp. 14-AUG-2012) (route not reported). It was unknown if the patient received other doses of PNEUMOVAX 23 in the past. The registered pharmacist reported that he received a phone call from a doctor stating that the patient now had strep pneumonia. The patient had blood transfusion in the past 6 months. The patient was recently in the hospital, for possible sepsis and after a few days was discharged on 21-FEB-2012. On an unspecified date blood cultures and possibly sputum test were performed (results not provided). At the time of the report, the patient had not recovered from possible sepsis and strep pneumonia. At the time of the report, the patient's outcome for had a blood transfusion was unknown. Additional information has been requested.
Age: 0.65
Sex: M
Vaccine: RV5
Symptoms: Abdominal X-ray, Abdominal discomfort, Computerised tomogram abnormal, Emotional distress, Intestinal obstruction
Clinical narrative: Information has been received from a physician and medical assistant concerning a 14 month old male patient with no drug reactions or allergies who was vaccinated with the first, the second and the third dose of ROTATEQ, orally, (dose not reported) on 24-MAR-2011 (lot number 669073/1525Z), 03-MAY-2011 (lot number 668899/1075Z), and 19-JUL-2011 (lot number 669565/0064AA), respectively. Concomitant therapy included FLAGYL. Physician reported that the patient experienced "bowel perforation" and was hospitalized from 12-FEB-2012 through 21-FEB-2012 / 23-FEB-2012 (physician was unsure of the exact discharge date) during which "he underwent bowel resection". Medical assistant reported that on 05-FEB-2012 (a week prior to the 12-FEB-2012, also reported as hospital admission date), the patient experienced a fever (only a symptom) and on 12-FEB-2012, the patient's symptoms included pain, distress, lethargy and vomiting. It was reported that on approximately 12-FEB-2012, an abdominal x-ray followed by CT scan (computed axial tomography) confirmed the bowel perforation. Physician stated that on 06-MAR-2012, the patient was readmitted to the hospital with a "bowel obstruction" and at the time of report was still on hospital. Medical assistant reported that starting on 07-MAR-2012, the patient was getting his colon flushed every 12 hours. The patient's outcome was not recovered at the time of report. Therapy treatment included "many meds given during hospitalization". The patient's outcome was not recovered at the time of report. "Bowel perforation", an indication for "underwent bowel resection" was considered to be other important medical event by physician (intervention to prevent serious criteria). "Bowel perforation" / "underwent bowel resection" and "bowel obstruction" were considered to be life-threatening and disabling by physician. A priority LOT check has been initiated. Additional information has been requested. The patient was hospitalized from 12-FEB-2012 through 21-FEB-2012 / 23-FEB-2012 (physician was unsure of the exact discharge date). Subsequently, on 06-MAR-2012, the patient was readmitted to another Hospital, and "was still confined to hospital" at the time of report.
Age: 0.65
Sex: M
Vaccine: RV5
Symptoms: Intestinal perforation, Intestinal resection, Lethargy, Pain, Pyrexia
Clinical narrative: Information has been received from a physician and medical assistant concerning a 14 month old male patient with no drug reactions or allergies who was vaccinated with the first, the second and the third dose of ROTATEQ, orally, (dose not reported) on 24-MAR-2011 (lot number 669073/1525Z), 03-MAY-2011 (lot number 668899/1075Z), and 19-JUL-2011 (lot number 669565/0064AA), respectively. Concomitant therapy included FLAGYL. Physician reported that the patient experienced "bowel perforation" and was hospitalized from 12-FEB-2012 through 21-FEB-2012 / 23-FEB-2012 (physician was unsure of the exact discharge date) during which "he underwent bowel resection". Medical assistant reported that on 05-FEB-2012 (a week prior to the 12-FEB-2012, also reported as hospital admission date), the patient experienced a fever (only a symptom) and on 12-FEB-2012, the patient's symptoms included pain, distress, lethargy and vomiting. It was reported that on approximately 12-FEB-2012, an abdominal x-ray followed by CT scan (computed axial tomography) confirmed the bowel perforation. Physician stated that on 06-MAR-2012, the patient was readmitted to the hospital with a "bowel obstruction" and at the time of report was still on hospital. Medical assistant reported that starting on 07-MAR-2012, the patient was getting his colon flushed every 12 hours. The patient's outcome was not recovered at the time of report. Therapy treatment included "many meds given during hospitalization". The patient's outcome was not recovered at the time of report. "Bowel perforation", an indication for "underwent bowel resection" was considered to be other important medical event by physician (intervention to prevent serious criteria). "Bowel perforation" / "underwent bowel resection" and "bowel obstruction" were considered to be life-threatening and disabling by physician. A priority LOT check has been initiated. Additional information has been requested. The patient was hospitalized from 12-FEB-2012 through 21-FEB-2012 / 23-FEB-2012 (physician was unsure of the exact discharge date). Subsequently, on 06-MAR-2012, the patient was readmitted to another Hospital, and "was still confined to hospital" at the time of report.
Age: 0.65
Sex: M
Vaccine: RV5
Symptoms: Vomiting, X-ray abnormal
Clinical narrative: Information has been received from a physician and medical assistant concerning a 14 month old male patient with no drug reactions or allergies who was vaccinated with the first, the second and the third dose of ROTATEQ, orally, (dose not reported) on 24-MAR-2011 (lot number 669073/1525Z), 03-MAY-2011 (lot number 668899/1075Z), and 19-JUL-2011 (lot number 669565/0064AA), respectively. Concomitant therapy included FLAGYL. Physician reported that the patient experienced "bowel perforation" and was hospitalized from 12-FEB-2012 through 21-FEB-2012 / 23-FEB-2012 (physician was unsure of the exact discharge date) during which "he underwent bowel resection". Medical assistant reported that on 05-FEB-2012 (a week prior to the 12-FEB-2012, also reported as hospital admission date), the patient experienced a fever (only a symptom) and on 12-FEB-2012, the patient's symptoms included pain, distress, lethargy and vomiting. It was reported that on approximately 12-FEB-2012, an abdominal x-ray followed by CT scan (computed axial tomography) confirmed the bowel perforation. Physician stated that on 06-MAR-2012, the patient was readmitted to the hospital with a "bowel obstruction" and at the time of report was still on hospital. Medical assistant reported that starting on 07-MAR-2012, the patient was getting his colon flushed every 12 hours. The patient's outcome was not recovered at the time of report. Therapy treatment included "many meds given during hospitalization". The patient's outcome was not recovered at the time of report. "Bowel perforation", an indication for "underwent bowel resection" was considered to be other important medical event by physician (intervention to prevent serious criteria). "Bowel perforation" / "underwent bowel resection" and "bowel obstruction" were considered to be life-threatening and disabling by physician. A priority LOT check has been initiated. Additional information has been requested. The patient was hospitalized from 12-FEB-2012 through 21-FEB-2012 / 23-FEB-2012 (physician was unsure of the exact discharge date). Subsequently, on 06-MAR-2012, the patient was readmitted to another Hospital, and "was still confined to hospital" at the time of report.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Eye swelling, Lip swelling, Pruritus, Urticaria, Vomiting
Clinical narrative: Vomiting within 10-15 mins. Developed hives over entire body. Mid lip swelling & eye swelling intense itching was given 2 tsp ORAPRED 2 1/2 tsp BENADRYL & monitored for 1 1/2 hrs.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest X-ray abnormal, Lobar pneumonia, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: 3/2/12 chest congestion body aches, fever. 3-2-12 CXR PA & LAT right middle lobe pneumonia.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Streptococcus test, Urticaria
Clinical narrative: Urticarial rash in less < 8 hrs after administration of MMR, varicella & Hep A vaccines, responding to antihistamines. No other allergies hygiene identified.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 03/10/2012 mild other mother reports injection site was hot/swollen with a hard spot 2.5 inches in diameter.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Diffuse swelling that is nontender, nonerythematous and no warmth on left upper arm.
Age: 9.0
Sex: F
Vaccine: TD
Symptoms: Rash, Rash pruritic
Clinical narrative: 9 year old female with acute onset of a itchy rash of her right arm the day she received a Td for a puncture wound of her foot. Her Td was given 3/6/2012. Rash treated with Hydrocortisone cream and oral BENADRYL at home. Pt seen in office 3/12/2012 & treated with 5-day course of Prednisone.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Injection site erythema, Injection site warmth
Clinical narrative: Received Tdap vaccine in (L) deltoid on 12/19/11 & also a Tb skin test on (L) lower arm same day. Later that day (L) upper arm red & hot to touch by 1730 SOB, tightness in chest, nausea 1745 used my son's PROVENTIL inhaler 2 puffs & repeated q 4-6hrs. x 4 days. Body aches, fatigue, pillow orthopnea. Also used SINGULAIR, ALLEGRA & ZYRTEC: face looked sunburned & peeled.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Orthopnoea, Pain, Skin exfoliation, Sunburn
Clinical narrative: Received Tdap vaccine in (L) deltoid on 12/19/11 & also a Tb skin test on (L) lower arm same day. Later that day (L) upper arm red & hot to touch by 1730 SOB, tightness in chest, nausea 1745 used my son's PROVENTIL inhaler 2 puffs & repeated q 4-6hrs. x 4 days. Body aches, fatigue, pillow orthopnea. Also used SINGULAIR, ALLEGRA & ZYRTEC: face looked sunburned & peeled.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Arthropod bite, Hypersensitivity, Rash, Vaccination complication
Clinical narrative: On 11/15/11 at 09:35 patient received flu vaccine, on 11/16/11 reported to employee wellness with rash to neck & what appeared to be flea or insect bites all over her legs. Sent to occupational health MD. He treated an allergic reaction to flu vaccine.
Age: 1.02
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pallor
Clinical narrative: 2.5cm x 2cm blanching redness with mild swelling on right anterolateral thigh.
Sex: F
Vaccine: DTP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Initial report received from a consumer on 22 July 2011. A female patient born 03 December 1987 received as a child in 1985 an injection of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE, manufacturer and lot number unknown The patient experienced a bad fever of >101 and redness and swelling on thigh that the vaccine was administered. The outcome was reported as unknown. Follow-up information was received on 12 September 2011 from a consumer who is also the patient. The patient's birth weight was reported as 9 lb 12 oz and she has three siblings The patient has received DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE in 1988 (previously reported as 1989) According to the patient, she recently received the TDaP vaccine and did not have an adverse event "with the acellular pertussis vaccine, as she did with the whole cell pertussis vaccine in 1988 " No further information was available at the time of the report Outcome remained recovered. Documents held by sender: None.