chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug exposure before pregnancy, Hodgkin's disease, Lymphadenopathy, Positron emission tomogram abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 07-MAY-2007, a 34 year old female patient with hyperlipidaemia, recurrent pyelonephritis, a 3 mm LLL (lower left lobe) lung nodule noted of incidental finding on a CT performed on 23-APR-2007, and rhinorrhoea and a history of right ovarian cyst, fibrocystic breast disease, bartholin's cyst, urinary tract infection and no known drug allergies was vaccinated SQ with the first dose of GARDASIL (Lot # 657005/0314U) into her right arm at Obstetrician's visit. The patient had several Obstetricians' visits for unrelated complaints. Primary care physician's records indicated that on 12-JUN-2007, the patient complained of signs and symptoms of cold for 5 weeks, chest pain with palpation, sinus pressure, sinus headache (HA), cough. A repeat CT was done.  On 30-JUL-2007, the patient was diagnosed with migraine, nausea, Gastroesophageal reflux disease (GERD), Urinary tract infection (UTI) and possible endometriosis. On an unspecified date, the patient was diagnosed with allergic rhinitis, and cough. The patient's ears were stuffed and she had facial pain. On the patient's second visit, (date not provided) she complained of acid reflux. On 01-DEC-2007, approximately "one year later", the patient developed a terrible cough that would not go away. The patient thought it was allergies; she also noticed that her lymph nodes were swollen. Subsequently, the patient became pregnant; she could not have any tests done to see what was going on. The patient gave birth to her son in November 2008 and immediately had a chest X-ray, which let to a PET scan and biopsy. The results confirmed the diagnosis of Hodgkin's lymphoma. Diagnostic laboratory tests included: Blood work (results not provided) and H/H 11.1/33 (L). The events of terrible cough, lymph nodes swollen, Hodkins lymphoma, chest pain with palpation, sinus pressure, sinus headache, migraine, nausea, GERD, allergic rhinitis, ears stuffed, face pain and complained of cold were considered to be life threatening events. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released. The original reporting source was not provided. The VAERS ID # was 415775.
Age: 34.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy site unspecified abnormal, Blood test, Chest X-ray abnormal, Chest pain, Condition aggravated
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 07-MAY-2007, a 34 year old female patient with hyperlipidaemia, recurrent pyelonephritis, a 3 mm LLL (lower left lobe) lung nodule noted of incidental finding on a CT performed on 23-APR-2007, and rhinorrhoea and a history of right ovarian cyst, fibrocystic breast disease, bartholin's cyst, urinary tract infection and no known drug allergies was vaccinated SQ with the first dose of GARDASIL (Lot # 657005/0314U) into her right arm at Obstetrician's visit. The patient had several Obstetricians' visits for unrelated complaints. Primary care physician's records indicated that on 12-JUN-2007, the patient complained of signs and symptoms of cold for 5 weeks, chest pain with palpation, sinus pressure, sinus headache (HA), cough. A repeat CT was done.  On 30-JUL-2007, the patient was diagnosed with migraine, nausea, Gastroesophageal reflux disease (GERD), Urinary tract infection (UTI) and possible endometriosis. On an unspecified date, the patient was diagnosed with allergic rhinitis, and cough. The patient's ears were stuffed and she had facial pain. On the patient's second visit, (date not provided) she complained of acid reflux. On 01-DEC-2007, approximately "one year later", the patient developed a terrible cough that would not go away. The patient thought it was allergies; she also noticed that her lymph nodes were swollen. Subsequently, the patient became pregnant; she could not have any tests done to see what was going on. The patient gave birth to her son in November 2008 and immediately had a chest X-ray, which let to a PET scan and biopsy. The results confirmed the diagnosis of Hodgkin's lymphoma. Diagnostic laboratory tests included: Blood work (results not provided) and H/H 11.1/33 (L). The events of terrible cough, lymph nodes swollen, Hodkins lymphoma, chest pain with palpation, sinus pressure, sinus headache, migraine, nausea, GERD, allergic rhinitis, ears stuffed, face pain and complained of cold were considered to be life threatening events. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released. The original reporting source was not provided. The VAERS ID # was 415775.
Age: 34.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cough, Drug exposure before pregnancy, Ear congestion, Facial pain, Gastrooesophageal reflux disease
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 07-MAY-2007, a 34 year old female patient with hyperlipidaemia, recurrent pyelonephritis, a 3 mm LLL (lower left lobe) lung nodule noted of incidental finding on a CT performed on 23-APR-2007, and rhinorrhoea and a history of right ovarian cyst, fibrocystic breast disease, bartholin's cyst, urinary tract infection and no known drug allergies was vaccinated SQ with the first dose of GARDASIL (Lot # 657005/0314U) into her right arm at Obstetrician's visit. The patient had several Obstetricians' visits for unrelated complaints. Primary care physician's records indicated that on 12-JUN-2007, the patient complained of signs and symptoms of cold for 5 weeks, chest pain with palpation, sinus pressure, sinus headache (HA), cough. A repeat CT was done.  On 30-JUL-2007, the patient was diagnosed with migraine, nausea, Gastroesophageal reflux disease (GERD), Urinary tract infection (UTI) and possible endometriosis. On an unspecified date, the patient was diagnosed with allergic rhinitis, and cough. The patient's ears were stuffed and she had facial pain. On the patient's second visit, (date not provided) she complained of acid reflux. On 01-DEC-2007, approximately "one year later", the patient developed a terrible cough that would not go away. The patient thought it was allergies; she also noticed that her lymph nodes were swollen. Subsequently, the patient became pregnant; she could not have any tests done to see what was going on. The patient gave birth to her son in November 2008 and immediately had a chest X-ray, which let to a PET scan and biopsy. The results confirmed the diagnosis of Hodgkin's lymphoma. Diagnostic laboratory tests included: Blood work (results not provided) and H/H 11.1/33 (L). The events of terrible cough, lymph nodes swollen, Hodkins lymphoma, chest pain with palpation, sinus pressure, sinus headache, migraine, nausea, GERD, allergic rhinitis, ears stuffed, face pain and complained of cold were considered to be life threatening events. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released. The original reporting source was not provided. The VAERS ID # was 415775.
Age: 34.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Haematocrit decreased, Haemoglobin normal, Hodgkin's disease, Lymphadenopathy, Migraine
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 07-MAY-2007, a 34 year old female patient with hyperlipidaemia, recurrent pyelonephritis, a 3 mm LLL (lower left lobe) lung nodule noted of incidental finding on a CT performed on 23-APR-2007, and rhinorrhoea and a history of right ovarian cyst, fibrocystic breast disease, bartholin's cyst, urinary tract infection and no known drug allergies was vaccinated SQ with the first dose of GARDASIL (Lot # 657005/0314U) into her right arm at Obstetrician's visit. The patient had several Obstetricians' visits for unrelated complaints. Primary care physician's records indicated that on 12-JUN-2007, the patient complained of signs and symptoms of cold for 5 weeks, chest pain with palpation, sinus pressure, sinus headache (HA), cough. A repeat CT was done.  On 30-JUL-2007, the patient was diagnosed with migraine, nausea, Gastroesophageal reflux disease (GERD), Urinary tract infection (UTI) and possible endometriosis. On an unspecified date, the patient was diagnosed with allergic rhinitis, and cough. The patient's ears were stuffed and she had facial pain. On the patient's second visit, (date not provided) she complained of acid reflux. On 01-DEC-2007, approximately "one year later", the patient developed a terrible cough that would not go away. The patient thought it was allergies; she also noticed that her lymph nodes were swollen. Subsequently, the patient became pregnant; she could not have any tests done to see what was going on. The patient gave birth to her son in November 2008 and immediately had a chest X-ray, which let to a PET scan and biopsy. The results confirmed the diagnosis of Hodgkin's lymphoma. Diagnostic laboratory tests included: Blood work (results not provided) and H/H 11.1/33 (L). The events of terrible cough, lymph nodes swollen, Hodkins lymphoma, chest pain with palpation, sinus pressure, sinus headache, migraine, nausea, GERD, allergic rhinitis, ears stuffed, face pain and complained of cold were considered to be life threatening events. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released. The original reporting source was not provided. The VAERS ID # was 415775.
Age: 34.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nasopharyngitis, Nausea, Palpitations, Positron emission tomogram abnormal, Rhinitis allergic
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 07-MAY-2007, a 34 year old female patient with hyperlipidaemia, recurrent pyelonephritis, a 3 mm LLL (lower left lobe) lung nodule noted of incidental finding on a CT performed on 23-APR-2007, and rhinorrhoea and a history of right ovarian cyst, fibrocystic breast disease, bartholin's cyst, urinary tract infection and no known drug allergies was vaccinated SQ with the first dose of GARDASIL (Lot # 657005/0314U) into her right arm at Obstetrician's visit. The patient had several Obstetricians' visits for unrelated complaints. Primary care physician's records indicated that on 12-JUN-2007, the patient complained of signs and symptoms of cold for 5 weeks, chest pain with palpation, sinus pressure, sinus headache (HA), cough. A repeat CT was done.  On 30-JUL-2007, the patient was diagnosed with migraine, nausea, Gastroesophageal reflux disease (GERD), Urinary tract infection (UTI) and possible endometriosis. On an unspecified date, the patient was diagnosed with allergic rhinitis, and cough. The patient's ears were stuffed and she had facial pain. On the patient's second visit, (date not provided) she complained of acid reflux. On 01-DEC-2007, approximately "one year later", the patient developed a terrible cough that would not go away. The patient thought it was allergies; she also noticed that her lymph nodes were swollen. Subsequently, the patient became pregnant; she could not have any tests done to see what was going on. The patient gave birth to her son in November 2008 and immediately had a chest X-ray, which let to a PET scan and biopsy. The results confirmed the diagnosis of Hodgkin's lymphoma. Diagnostic laboratory tests included: Blood work (results not provided) and H/H 11.1/33 (L). The events of terrible cough, lymph nodes swollen, Hodkins lymphoma, chest pain with palpation, sinus pressure, sinus headache, migraine, nausea, GERD, allergic rhinitis, ears stuffed, face pain and complained of cold were considered to be life threatening events. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released. The original reporting source was not provided. The VAERS ID # was 415775.
Age: 34.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Sinus headache, Urinary tract infection
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 07-MAY-2007, a 34 year old female patient with hyperlipidaemia, recurrent pyelonephritis, a 3 mm LLL (lower left lobe) lung nodule noted of incidental finding on a CT performed on 23-APR-2007, and rhinorrhoea and a history of right ovarian cyst, fibrocystic breast disease, bartholin's cyst, urinary tract infection and no known drug allergies was vaccinated SQ with the first dose of GARDASIL (Lot # 657005/0314U) into her right arm at Obstetrician's visit. The patient had several Obstetricians' visits for unrelated complaints. Primary care physician's records indicated that on 12-JUN-2007, the patient complained of signs and symptoms of cold for 5 weeks, chest pain with palpation, sinus pressure, sinus headache (HA), cough. A repeat CT was done.  On 30-JUL-2007, the patient was diagnosed with migraine, nausea, Gastroesophageal reflux disease (GERD), Urinary tract infection (UTI) and possible endometriosis. On an unspecified date, the patient was diagnosed with allergic rhinitis, and cough. The patient's ears were stuffed and she had facial pain. On the patient's second visit, (date not provided) she complained of acid reflux. On 01-DEC-2007, approximately "one year later", the patient developed a terrible cough that would not go away. The patient thought it was allergies; she also noticed that her lymph nodes were swollen. Subsequently, the patient became pregnant; she could not have any tests done to see what was going on. The patient gave birth to her son in November 2008 and immediately had a chest X-ray, which let to a PET scan and biopsy. The results confirmed the diagnosis of Hodgkin's lymphoma. Diagnostic laboratory tests included: Blood work (results not provided) and H/H 11.1/33 (L). The events of terrible cough, lymph nodes swollen, Hodkins lymphoma, chest pain with palpation, sinus pressure, sinus headache, migraine, nausea, GERD, allergic rhinitis, ears stuffed, face pain and complained of cold were considered to be life threatening events. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released. The original reporting source was not provided. The VAERS ID # was 415775.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Information has been received from an 87 years old female consumer reporting herself with no known drug reactions or allergies and no pertinent medical history reported, who on 28-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) by unknown route (lot number unspecified). Concomitant therapy included NEURONTIN. It was reported that 2 days later (on 30-JAN-2011), the consumer got a rash on her hands, her hands got numb and tingly, she was in pain especially at night and she could not grasp anything, she could hardly open a door. The consumer was hospitalized for 2 days (date unspecified). No treatment was given for the adverse event. No labs were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Grip strength decreased, Hypoaesthesia, Pain, Paraesthesia, Rash
Clinical narrative: Information has been received from an 87 years old female consumer reporting herself with no known drug reactions or allergies and no pertinent medical history reported, who on 28-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) by unknown route (lot number unspecified). Concomitant therapy included NEURONTIN. It was reported that 2 days later (on 30-JAN-2011), the consumer got a rash on her hands, her hands got numb and tingly, she was in pain especially at night and she could not grasp anything, she could hardly open a door. The consumer was hospitalized for 2 days (date unspecified). No treatment was given for the adverse event. No labs were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Patient reported swelling at injection site on the day following vaccine administration.  She further states that her arm is sore and that her mobility is now impaired.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Mobility decreased, Pain in extremity
Clinical narrative: Patient reported swelling at injection site on the day following vaccine administration.  She further states that her arm is sore and that her mobility is now impaired.
Age: 71.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness, Vertigo
Clinical narrative: Severe vertigo, beginning at 6:00 AM on awakening.  Lasting severe for 2 days. Becoming less severe over the course of one week. Still experience slight dizziness.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: Reported itching and 4x4mm vesicular blister after 3rd Hep B vaccine one day after injection. Upper arm slightly pink, no itching/tenderness. Treat with hydrocortisol topically or oral BENADRYL.
Age: 41.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Pain
Clinical narrative: INITIAL PAIN AND SORENESS OF INJECTION MOVED TO MODERATE TO SEVERE PAIN THROUGHOUT ENTIRE UPPER ARM WHERE INJECTION WAS GIVEN. THE PAIN IS CONTINUING AND IS NOT RESOLVING EVEN AFTER TAKING IBUPROFEN FOR PAIN. IT IS VERY DIFFICULT TO LIFT MY ARM WITHOUT SEVERE PAIN.
Age: 50.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Body temperature, Pain in extremity
Clinical narrative: Ran a temp, very sore arm. Left arm has remained sore for months now. It seems to be from the area the shot was in.
Age: 0.51
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Irritability, Pyrexia, Vomiting
Clinical narrative: Today at 230 pm, fever 101, decreased by 3 pm. Slightly fussy, vomited yesterday.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (R) arm hot, red, tender, swollen. Rx given: Triamcinolone 0.1% oint, KEFLEX suspension 1 1/2 tsp po BID x 10 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 3/25/11 2:43 pm. 1) Rt posterior arm-2 cm area of induration & warmth & erythema - 1 cm - tender to touch - Cephalexin 250mg/5ml 1 tsp - 4xdly for 7 days to be checked 3/28/11. 2) Lt anterior thigh - erythema & tenderness of 2 cm above injection site - no induration.
Age: 0.89
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Diffuse hives 3/23 - 3/25 worse 3/24 - 3/25 treated with ORAPRED.
Age: 3.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Contusion, Ecchymosis, Face oedema, Petechiae, Rash
Clinical narrative: Received (Hib/PREVNAR/HepA) immunizations on 3/14. On 3/18 reported 48 hour history of rash and bruising. Seen on 3/19 facial edema, ecchymotic/petechial rash noted. He was otherwise happy and not toxic.
Age: 1.08
Sex: M
Vaccine: 6VAX-F
Symptoms: Contusion, Injection site erythema, Injection site induration, Injection site urticaria, Injection site warmth
Clinical narrative: Red spots on chest. Red hot hard welt about 1.5 inches on right thigh.  Bruising left and right thigh.
Age: 1.08
Sex: M
Vaccine: 6VAX-F
Symptoms: Rash erythematous
Clinical narrative: Red spots on chest. Red hot hard welt about 1.5 inches on right thigh.  Bruising left and right thigh.
Age: 16.0
Sex: U
Vaccine: HPVX
Symptoms: Rash, Urticaria
Clinical narrative: Welts, rashes.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, IPV, MMRV, PNC
Symptoms: Henoch-Schonlein purpura, Oedema, Oedema peripheral, Rash
Clinical narrative: RASH ON LEGS 3 DAYS AFTER VACCINES CONSISTENT WITH HSP ALSO SOME EDEMA ABOVE RIGHT KNEE AND OF RIGHT ANKLE
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: rt leg swelling, redness, heat at injection site; taken to local ed and placed on augmentin; developed diarrhea; seen in clinic on 3/31/11, antibiotic stopped and placed on loratidine, instructed to use warm compresses at site; returned to office 4/1/11 improving
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test, Blood immunoglobulin M, Pruritus, Rash macular, Rash papular
Clinical narrative: SKIN LESIONS ALL OVER THE BODY WITH ITCHING.  NO OTHER SYMPTOMS.  ERYTHEMATOUS MACULAR, PAPULAR AND PUSTULAR LESIONS ALL OVER THE TRUNK.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pustular, Skin lesion
Clinical narrative: SKIN LESIONS ALL OVER THE BODY WITH ITCHING.  NO OTHER SYMPTOMS.  ERYTHEMATOUS MACULAR, PAPULAR AND PUSTULAR LESIONS ALL OVER THE TRUNK.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Case received from a Healthcare Professional on 13 October 2010 under the local number 10-0721. Several patients (not specified) developed cellulites on an unspecified date after receiving a dose of ADACEL (batch number, route and site of administration not reported) on an unspecified date. Patient's outcome were not reported. Follow-up information was received 13 January 2011 from a health care professional. The reporter provided patient identifiers for one of the previously reported "several" patients who experienced the event of cellulitis. The patient was identified as a 51-year-old male who had received ADACEL (lot number, route and site of administration not reported) on 05 October 2010. According to the reporter, the patient recovered (date not reported). No further information was provided at the time of the report. Follow-up information was received 24 March 2011 from a health care professional who confirmed a total of two patients (previously reported as several patients) had experienced adverse events after receiving ADACEL. The reporter provided information pertaining to the second previously unidentified patient (captured in case number 2011-01693). Based upon new information received, it was determined the event experienced by the patient in this case now meets seriousness criteria, and this case has been upgraded from nonserious to serious. The patient had received an intramuscular left deltoid injection of ADACEL, lot number U3281CA (sanofi pasteur Ltd. lot number C3354) on 05 October 2010. On 13 October 2010, approximately one week post vaccination, the patient developed cellulitis of the left upper arm and was evaluated by their physician that same day. KEFLEX 500 mg was prescribed and the patient recovered within one week (date not available). The patient had no medical history, no concurrent illness and he had not been taking any concomitant medications. Several months later, the patient had been seen for a well visit at which time he had no complaints. No additional information was provided at the time of the report. The reporter for this case is the same as for case number 2011-01693. Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Redness, swelling, tender, itching.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pallor, Syncope
Clinical narrative: Vaccines administered, pt. became pale, fainted, within 3 minutes of final immunization. Laid pt. down on exam table, applied cool compresses.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Asthenia, Gaze palsy, Hyperhidrosis, Hypopnoea, Hypotonia
Clinical narrative: In parent's arms awake then became pale sweaty very shallow breathing as if faint. Eyes starting rolling back "like a doll". Limp very weak lasted <1 min then fine. Seen by EMS shortly after fine. Saw me next day of exam. HHE self limited no sequelae.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pallor
Clinical narrative: In parent's arms awake then became pale sweaty very shallow breathing as if faint. Eyes starting rolling back "like a doll". Limp very weak lasted <1 min then fine. Seen by EMS shortly after fine. Saw me next day of exam. HHE self limited no sequelae.
Age: 59.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: Facial swelling, itching - face, neck itching, erythema neck et face.
Age: 1.78
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Gaze palsy, Posture abnormal, Pyrexia, Somnolence
Clinical narrative: Mother reports 8 hrs. following immunizations that pt. was sleepy with rolling eyes and sticking her tongue out, along with fever. The next night pt. had leg up in the air and mother had difficult time pulling it down. (Mother did give Acetaminophen the first night).
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Nodule, Urticaria
Clinical narrative: Seen at Medical Center on 3/25/2011. Mother stated pt. had hives on face and a large knot/welt on legs. (1 inch below injection site). Pt. was given BENADRYL and Prednisone. Pt. doing much better today.
Age: 48.0
Sex: F
Vaccine: DTAP
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Severe pain, then swelling that began to worsen and redness to site. Swelling and redness from injection site to elbow. Elbow felt numb and throbbing. Red stripes noted above elbow. Elevated blood pressure and pounding head that started on 3-31-11.
Age: 24.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discolouration, Injection site pruritus, Pyrexia
Clinical narrative: Mother reported child with itching over injection site on Saturday afternoon following varicella vaccine injection on Friday morning 3/25/11. Mother states fever 99.8 but no respiratory symptoms. Small dark ring over injection site - taken to ER - given BENADRYL - increased reaction over site on Sunday taken ER - given AUGMENTIN & BENADRYL.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: rash on chest, then on back the next am
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Blister, Rash, Scab, Varicella virus test
Clinical narrative: Rash 2 weeks after Varicella vaccine (1/27/11); seen on 2/24/11; 2 pinpoint scabs on lower abdomen; 1 pinpoint scabs on buttocks; 1:3mm vesicle on left middle finger; 2:3mm vesicles on rt palm (1 vesicle) rt thumb (1 vesicle)
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Blister, Rash, Scab, Varicella virus test
Clinical narrative: Rash 2 weeks after Varicella vaccine (1/27/11);seen 2/24/11: 2 pinpoint scabs on lower abdomen; 1 pinpoint scab on buttocks; 1:3mm vesicle on left middle finger; 2:3mm vesicles on rt palm (1 vesicle) rt thumb (1 vesicle)
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: local redness and swelling on her right deltoid
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Activities of daily living impaired, Discomfort, Erythema, Skin warm, Swelling
Clinical narrative: 4/1/11 - 3.5 inch moderate erythema with minimal puffiness. Slightly warm to touch. She said discomfort is "enough to make me miss a party". No other s/s. Gave ice pack for comfort at intervals. Mom said will use TYLENOL & BENADRYL.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: As per Dr pt needs Hep B titers, 3rd dose was given before date. Also she does not give HIB after 2 years old.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Rash, Scab
Clinical narrative: PATIENT PRESENTED TO THE PHARMACY WITH A SHINGLE TYPE RASH UNDER HER LEFT BREAST AND CIRCLING TO HER BACK ON 4/1/11.  SHE HAD SOME LESIONS THAT WERE RED AND SCABBED OVER.  SHE SAID THAT SHE HAD SOME PAIN AND ITCHING INITIALLY BUT FELT BETTER NOW, EXCEPT AT NIGHT WHEN SHE WAS LYING DOWN, WITHOUT A BRASSIERE.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: PATIENT PRESENTED TO THE PHARMACY WITH A SHINGLE TYPE RASH UNDER HER LEFT BREAST AND CIRCLING TO HER BACK ON 4/1/11.  SHE HAD SOME LESIONS THAT WERE RED AND SCABBED OVER.  SHE SAID THAT SHE HAD SOME PAIN AND ITCHING INITIALLY BUT FELT BETTER NOW, EXCEPT AT NIGHT WHEN SHE WAS LYING DOWN, WITHOUT A BRASSIERE.
Age: 42.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid area where shot was given there was a hard, raised, warm to touch area.   Area was the size of a softball.  Client did not run a temperature.  Area was not red. Improvment in 3-4 days.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Mass, Skin warm, Swelling
Clinical narrative: HARD LUMP, 4.5 x4.5 CM, ERYTHEMA HOT SWELLING, T-MAX 37.1.  TREATING PT WITH BACTRIM DOUBLE STRENGTH 1 TABLET PO x 10 DAYS. ICE AND HEAT. AND FU APPT WITH ARNP.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: LARGE RED, HOT INDURATED AREA TO LT UPPER THIGH 60mm x 50mm
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: Symptoms started 03/31/11 and escalated till patient saw MD on 04/01/11- MD prescribed BENADRYL- itching; swelling; red; hard like bee sting.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site vesicles
Clinical narrative: Large area (shoulder to elbow) red, edematous with vesicles at injection site (VARIVAX-SQ). Treatment: BENADRYL 25mg po q day, ice, Acyclovir ointment.
Age: 0.75
Sex: M
Vaccine: UNK
Symptoms: Rash generalised
Clinical narrative: Per parent child developed generalized rash 2 days after receiving vaccination. No fevers, no other symptoms. Otherwise child well. Rash resolving within 4 days.
Age: 1.06
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Hyperaesthesia, Irritability, Rash erythematous, Vaccination site reaction
Clinical narrative: Small patch of red, raised, rashy, sensitive skin on right thigh (outer) at point of vaccination administration. Very fussy for several days.
Age: 1.56
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized redness, swelling: hot left upper thigh 9 cm x 7.5 cm. Cool compresses & MOTRIN care.
Age: 27.0
Sex: M
Vaccine: VARCEL
Symptoms: Malaise, Pain, Pruritus, Rash maculo-papular
Clinical narrative: Less than 50 maculo-pap rashes - over body - more upper & more centripetal, body ache, malaise, itch on 16th day post vaccination.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Head injury, Hypotonia, Localised oedema, Syncope
Clinical narrative: Approximately 5 min after pt received IM immunizations (x5) pt was ambulating to d/c area with mother at side & pt went limp of muscle tone with syncopal episode apparent. Pt (L) forehead hit chart holder box. Red without edema to forehead. PT VSS during occurrence. Pt's mother refused transport or transfer to hospital for eval. Pt ambulated out to POV with mother at side & escorted by clinic staff (x2). Pt A & O x 3 at time of leaving clinic.
Age: 7.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Muscle spasms, Muscular weakness
Clinical narrative: Mother of patient came to Health Department on 03/31/2011. Stating her son had numbness in legs progressing to belly button, cramps in legs and legs giving out 4-6 wks after H1N1 vaccine was given. Mother stated she felt like it was growing pains. She took child to see physician 01/2011. Then seen specialist 02/2011. Mother states physician feels like it is Charcot Marie Tooth Disease. EMG being done 05/16/11. Mother wonders if it could be GBS.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Pt developed redness, swelling extending above injection & streaking down to elbow. Seen in ED tx with Clindamycin 300 mg QID.
Sex: M
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: Refusal of vaccine sign on 03/28/11. Hep B, MMR, Varicella, Hep A.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No symptoms. Pt given adult dose 1mL instead of ped dose - 0.5mL.
Age: 85.0
Sex: M
Vaccine: FLUX
Symptoms: Productive cough, Pulmonary congestion
Clinical narrative: CONGESTION IN LUNGS COUGHING UP THICK SECRETIONS EVER SINCE
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Formication, Pain, Pruritus generalised
Clinical narrative: Body aches, took Tylenol. Itching, skin crawling, entire body, not at injection site, took Benadryl.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Non-Hodgkin's lymphoma, Testicular operation, Testicular swelling
Clinical narrative: Right testicle enlarged.  Contacted doctors office for appointment.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Gastrointestinal tube insertion, Guillain-Barre syndrome, Headache, Hypoaesthesia
Clinical narrative: Severe headaches/back of the head lower part by neck.  Also felt tingling and numbness in legs. Went to primary care physician on 10/21/2010 because of severe pain and numbness in legs and constant headache.  Physician instructed the patient to go to emergency room if symptoms persisted or if they got worse.  Next morning was in emergency room at 6 in the morning.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Intensive care, Mechanical ventilation, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Severe headaches/back of the head lower part by neck.  Also felt tingling and numbness in legs. Went to primary care physician on 10/21/2010 because of severe pain and numbness in legs and constant headache.  Physician instructed the patient to go to emergency room if symptoms persisted or if they got worse.  Next morning was in emergency room at 6 in the morning.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Paralysis, Pulmonary oedema, Tracheostomy, Wheelchair user
Clinical narrative: Severe headaches/back of the head lower part by neck.  Also felt tingling and numbness in legs. Went to primary care physician on 10/21/2010 because of severe pain and numbness in legs and constant headache.  Physician instructed the patient to go to emergency room if symptoms persisted or if they got worse.  Next morning was in emergency room at 6 in the morning.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Cellulitis, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Noticed that arm where injection was given was itchy & hurt & that's when she noticed a red rash. Went to school nurse & was given an ice pack. Area hot to touch & swollen, so I gave Benadryl @ 4:00 PM & continued ice packs. Painful so gave Tylenol before bed. Then woke up 4/2/11 with a "bullseye" rash, swelling & hard underneath, & still hot to touch. Took to dr's office & was started on Keflex for cellulitis.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Injection site warmth, Rash erythematous
Clinical narrative: Noticed that arm where injection was given was itchy & hurt & that's when she noticed a red rash. Went to school nurse & was given an ice pack. Area hot to touch & swollen, so I gave Benadryl @ 4:00 PM & continued ice packs. Painful so gave Tylenol before bed. Then woke up 4/2/11 with a "bullseye" rash, swelling & hard underneath, & still hot to touch. Took to dr's office & was started on Keflex for cellulitis.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: This 11 year old male patient received meningococcal polysaccharide vaccine (MCV4) 0.5 mL and Tetanus, Diphtheria, and Pertussis (Tdap) vaccine 0.5 mL on 08Dec2010 in his left arm. The patient's relevant medical history includes no prior allergic reaction to MCV4 or Tdap. The patient's relevant past drug history includes no history of reactions to immunizations in the past. In the evening of 08Dec2010, the patient had tactile fever. The patient awoke on 09Dec2010 with some swelling and erythema. On 10Dec2010, significant swelling and erythema (5 cm area) around site of immunizations were present. He complained of pain and itching. The patient was treated with Benadryl and with Augmentin for possible infection. The patient's physician was notified. The patient recovered.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Pyrexia, Swelling
Clinical narrative: This 11 year old male patient received meningococcal polysaccharide vaccine (MCV4) 0.5 mL and Tetanus, Diphtheria, and Pertussis (Tdap) vaccine 0.5 mL on 08Dec2010 in his left arm. The patient's relevant medical history includes no prior allergic reaction to MCV4 or Tdap. The patient's relevant past drug history includes no history of reactions to immunizations in the past. In the evening of 08Dec2010, the patient had tactile fever. The patient awoke on 09Dec2010 with some swelling and erythema. On 10Dec2010, significant swelling and erythema (5 cm area) around site of immunizations were present. He complained of pain and itching. The patient was treated with Benadryl and with Augmentin for possible infection. The patient's physician was notified. The patient recovered.
Age: 1.34
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: fever of 102 Tylenol
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Decreased appetite, Diarrhoea, Vomiting
Clinical narrative: Diarrhea and loss of appetite began eight hours after polio immunization and continued for 36 hours after immunization.  Patient vomited 48 hours after immunization.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Axillary pain, Lymphadenitis, Lymphadenopathy, Neck pain
Clinical narrative: Very acute lymphadenitis- Left axillary and cervical painful lymphadenopathy
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Chills, Fatigue, Headache, Joint stiffness
Clinical narrative: Chills, Fever, backache, very tired, headache, joint stiffness
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Chills, Fever, backache, very tired, headache, joint stiffness
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Crying, Dizziness, Fall, Thermal burn
Clinical narrative: PATIENT WAS GIVEN TDAP, HPV IN RT ARM AND MENVEO IN LEFT ARM. NURSE WAS GETTING READY TO GIVE VARICELLA IN L ARM WHRN HE STOOD UP SAID WAS DIZZY AND SISTER TOLD HIM TO LIE DOWN.  HE FELL TO THE FLOOR GETTING A CARPET BURN TO RT CHEEKBONE AREA. WHEN I GOT TO HIM HE WAS CRYING.  I ASKED IF HURT ANYWHERE HE REPLIED NO. I ASKED IF HAD BREAKFAST AND SISTER SAID GO-GURT. I SAT HIM UP GAVE HIM SOME O.J AND ANOTHER NURSE BROUGHT COOL COMPRESS FOR FACE. HE WAS HELPED TO CHAIR AND OBSERVED FOR 15 MINUTES. I WALKED OUT TO CAR WITH PATIENT AND SISTER AND ADVISED NO SOCCER GAME TODAY AND TO TAKE TO DR. FOR EVAL OF FACE.  I GAVE SISTER MY PHONE NUMBER TO CALL ME OF ANY REPORT FURTHER.  AS OF TODAY 4/3/11 NO PHONE CALL RECEIVED.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Crying, Dizziness, Excoriation, Fall
Clinical narrative: PATIENT WAS GIVEN TDAP, HPV IN RT ARM AND MENVEO IN LEFT ARM. NURSE WAS GETTING READY TO GIVE VARICELLA IN L ARM WHRN HE STOOD UP SAID WAS DIZZY AND SISTER TOLD HIM TO LIE DOWN.  HE FELL TO THE FLOOR GETTING A CARPET BURN TO RT CHEEKBONE AREA. WHEN I GOT TO HIM HE WAS CRYING.  I ASKED IF HURT ANYWHERE HE REPLIED NO. I ASKED IF HAD BREAKFAST AND SISTER SAID GO-GURT. I SAT HIM UP GAVE HIM SOME O.J AND ANOTHER NURSE BROUGHT COOL COMPRESS FOR FACE. HE WAS HELPED TO CHAIR AND OBSERVED FOR 15 MINUTES. I WALKED OUT TO CAR WITH PATIENT AND SISTER AND ADVISED NO SOCCER GAME TODAY AND TO TAKE TO DR. FOR EVAL OF FACE.  I GAVE SISTER MY PHONE NUMBER TO CALL ME OF ANY REPORT FURTHER.  AS OF TODAY 4/3/11 NO PHONE CALL RECEIVED.
Age: 1.0
Sex: M
Vaccine: HEP
Symptoms: Rash generalised
Clinical narrative: Rash developed on body
Age: 22.0
Sex: M
Vaccine: HEPA, SMALL, FLUN3, HEPA, SMALL, VARCEL
Symptoms: Cardiac enzymes, Cardiac imaging procedure, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: H-406-005: A Phase IV Enhanced Safety Surveillance Study of ACAM2000.  Subject #: 5000107.  This study case was received from the investigator in the above mentioned trial on 29 March 2011.  A 22 year-old male subject with no significant medical history was found to have unspecified disease of pericardium, non-specific myocarditis, and other and unspecified acute myocarditis 9, 10 and 23 days (respectively), after he received on 21 September 2010 an injection of ACAM2000 (lot number, route and site of administration not reported); HEP A Adult (manufacturer name, lot number, route and site of administration not reported); intranasal INFLUENZA (manufacturer name, lot number not reported); and VARICELLA (manufacturer Merck, lot number route and site of administration not reported).  Relevant laboratory data included: on 01 October 2010 an abnormal Troponin I with the highest recorded value of 01.89, a normal electrocardiogram (ECG) on 02 October 2010, normal MRI of the heart on 02 October 2010, and a normal echocardiogram on 04 October 2010.  Lumbar puncture and MRI of brain and spinal cord were not performed.  Treatments were not reported.  The subject's outcome was not reported.  Additional information will be requested from the investigator.  Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.  Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: HEPA, SMALL, FLUN3, HEPA, SMALL, VARCEL
Symptoms: Myocarditis, Troponin increased
Clinical narrative: H-406-005: A Phase IV Enhanced Safety Surveillance Study of ACAM2000.  Subject #: 5000107.  This study case was received from the investigator in the above mentioned trial on 29 March 2011.  A 22 year-old male subject with no significant medical history was found to have unspecified disease of pericardium, non-specific myocarditis, and other and unspecified acute myocarditis 9, 10 and 23 days (respectively), after he received on 21 September 2010 an injection of ACAM2000 (lot number, route and site of administration not reported); HEP A Adult (manufacturer name, lot number, route and site of administration not reported); intranasal INFLUENZA (manufacturer name, lot number not reported); and VARICELLA (manufacturer Merck, lot number route and site of administration not reported).  Relevant laboratory data included: on 01 October 2010 an abnormal Troponin I with the highest recorded value of 01.89, a normal electrocardiogram (ECG) on 02 October 2010, normal MRI of the heart on 02 October 2010, and a normal echocardiogram on 04 October 2010.  Lumbar puncture and MRI of brain and spinal cord were not performed.  Treatments were not reported.  The subject's outcome was not reported.  Additional information will be requested from the investigator.  Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.  Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: HEPA, SMALL, FLUN3, HEPA, SMALL, VARCEL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Nuclear magnetic resonance imaging normal, Pericardial disease
Clinical narrative: H-406-005: A Phase IV Enhanced Safety Surveillance Study of ACAM2000.  Subject #: 5000107.  This study case was received from the investigator in the above mentioned trial on 29 March 2011.  A 22 year-old male subject with no significant medical history was found to have unspecified disease of pericardium, non-specific myocarditis, and other and unspecified acute myocarditis 9, 10 and 23 days (respectively), after he received on 21 September 2010 an injection of ACAM2000 (lot number, route and site of administration not reported); HEP A Adult (manufacturer name, lot number, route and site of administration not reported); intranasal INFLUENZA (manufacturer name, lot number not reported); and VARICELLA (manufacturer Merck, lot number route and site of administration not reported).  Relevant laboratory data included: on 01 October 2010 an abnormal Troponin I with the highest recorded value of 01.89, a normal electrocardiogram (ECG) on 02 October 2010, normal MRI of the heart on 02 October 2010, and a normal echocardiogram on 04 October 2010.  Lumbar puncture and MRI of brain and spinal cord were not performed.  Treatments were not reported.  The subject's outcome was not reported.  Additional information will be requested from the investigator.  Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.  Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: HEPA, SMALL, FLUN3, HEPA, SMALL, VARCEL
Symptoms: Troponin I increased
Clinical narrative: H-406-005: A Phase IV Enhanced Safety Surveillance Study of ACAM2000.  Subject #: 5000107.  This study case was received from the investigator in the above mentioned trial on 29 March 2011.  A 22 year-old male subject with no significant medical history was found to have unspecified disease of pericardium, non-specific myocarditis, and other and unspecified acute myocarditis 9, 10 and 23 days (respectively), after he received on 21 September 2010 an injection of ACAM2000 (lot number, route and site of administration not reported); HEP A Adult (manufacturer name, lot number, route and site of administration not reported); intranasal INFLUENZA (manufacturer name, lot number not reported); and VARICELLA (manufacturer Merck, lot number route and site of administration not reported).  Relevant laboratory data included: on 01 October 2010 an abnormal Troponin I with the highest recorded value of 01.89, a normal electrocardiogram (ECG) on 02 October 2010, normal MRI of the heart on 02 October 2010, and a normal echocardiogram on 04 October 2010.  Lumbar puncture and MRI of brain and spinal cord were not performed.  Treatments were not reported.  The subject's outcome was not reported.  Additional information will be requested from the investigator.  Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.  Documents held by sender: none.