chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Oedema peripheral, Pharyngeal oedema
Clinical narrative: The night after the client received the Zostavax vaccine, she woke up at 4:30 - 5:00 AM with a swollen arm, difficulty breathing and a feeling her throat was swelling.  She took a benadryl and drank some water.  This episode lasted about 20 minutes, she began to feel better and went back to sleep. When she woke up on Wednesday morning about 2 hours later, she felt fine except for some slight swelling in her arm.  She wasn't sure if this was something she needed to tell us or not, and when someone mentioned she should call us and report it, she did.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: Received tdap 5 days ago. Noticed left arm to be red, warm to touch, and itchy about 2 days ago. Area of redness 11.5cm x 5.5cm with induration.
Age: 5.0
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: ADMINISTERED 3RD DOSE OF MMR AND A 3RD DOSE OF HEPATITIS B. NURSE PRESENTED WITH ADDITIONAL VACCINE RECORD AFTER IMMUNIZATIONS GIVEN
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abnormal behaviour, Dizziness, Restlessness
Clinical narrative: Vaccine given at approximately 3:15 pm on 10-1-08.  About 15-20 minutes after injection patient developed mild dizziness, restlessness, sensation that she had to move, and "giggling" (strong urge to laugh).
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure increased, Dyskinesia, Tremor
Clinical narrative: Vaccine given at approximately 3:15 pm on 10-1-08.  About 15-20 minutes after injection patient developed mild dizziness, restlessness, sensation that she had to move, and "giggling" (strong urge to laugh).
Age: 3.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient developed allegic hives in the hours following the administration of Hep A#2 and Varicella #2 (the third allergic-type reaction to that combo in our office this year)
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV4
Symptoms: Blood pressure decreased, Dizziness, Immediate post-injection reaction, Vomiting
Clinical narrative: WITHIN 2 MINS OF INJECTIONS ADMINISTERED PT FELT FAINT, AND VOMITTED B/P WAS CHECKED 80/40. 10 MINS LATER B/P WAS CHECKED 91/71 PATIENT WALKED OUT, NO PROBLEMS
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt developed hives and itching to her torso, arms and legs
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Vomiting
Clinical narrative: 2 hours after vaccine administered, patient turned "ghostly white" per her mother and started vomiting.  She had multiple episodes of vomiting for the next 6 hours.  No diarrhea or fevers to suggest a viral illness.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Migraine
Clinical narrative: Migraine Headache within 12 hours of administration of vaccine.
Age: 55.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Cervical spinal stenosis, Dermatitis contact, Intervertebral disc degeneration, Laboratory test normal
Clinical narrative: This case was reported by a consumer and described the occurrence of neuropathy in an adult female subject who received LYMERIX (GlaxoSmithKline) as part of a clinical trial. A physician or other health care professional has not verified this report. On an unspecified date in 1995 the subject received 2nd dose of LYMERIX. An unspecified amount of time following administration of the 2nd LYMERIX vaccine, the subject experienced neuropathy, electric shock sensation in the right ankle and tingling of the toes. The outcome of these events was not reported. On 17 August 2008, approximately 13 years after the 2nd vaccination with LYMERIX, the subject again experienced neuropathy, electric shock sensation in the right ankle and tingling of the toes. It was reported that MRIs and other miscellaneous testing was performed on the subject (dates and specifics not provided) and all were negative other than arthritis. This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved. Follow up information was received on 29 September 2008 via clinical trial information for this subject. The subject was initially enrolled in protocol 215274/008. She was subsequently enrolled in 215274/013. The subject received LYMERIX vaccine administered on 15 March 1995 and 18 April 1995. The subject did not receive the third dose of LYMERIX. On 18 March 1995, the subject experienced sinus congestion and aches and pains assessed to be possibly related to LYMERIX, which resolved on 24 March 1995. On 13 May 1995, the subject experienced contact dermatitis of the chest assessed to be unrelated to LYMERIX, which resolved on 01 June 1995. On 01 September 2005, the subject experienced neuritis assessed to be unrelated to LYMERIX, which was unresolved at study conclusion. On 22 January 1996, the subject experienced degenerative cervical disc disease and cervical spinal stenosis assessed to be unrelated to LYMERIX, which was unresolved at study conclusion. Treatment included aspirin, Naprosyn, and prednisone. None of the preceding adverse events were assessed to be serious.
Age: 55.0
Sex: F
Vaccine: LYME
Symptoms: Neuritis, Neuropathy peripheral, Nuclear magnetic resonance imaging normal, Pain, Paraesthesia
Clinical narrative: This case was reported by a consumer and described the occurrence of neuropathy in an adult female subject who received LYMERIX (GlaxoSmithKline) as part of a clinical trial. A physician or other health care professional has not verified this report. On an unspecified date in 1995 the subject received 2nd dose of LYMERIX. An unspecified amount of time following administration of the 2nd LYMERIX vaccine, the subject experienced neuropathy, electric shock sensation in the right ankle and tingling of the toes. The outcome of these events was not reported. On 17 August 2008, approximately 13 years after the 2nd vaccination with LYMERIX, the subject again experienced neuropathy, electric shock sensation in the right ankle and tingling of the toes. It was reported that MRIs and other miscellaneous testing was performed on the subject (dates and specifics not provided) and all were negative other than arthritis. This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved. Follow up information was received on 29 September 2008 via clinical trial information for this subject. The subject was initially enrolled in protocol 215274/008. She was subsequently enrolled in 215274/013. The subject received LYMERIX vaccine administered on 15 March 1995 and 18 April 1995. The subject did not receive the third dose of LYMERIX. On 18 March 1995, the subject experienced sinus congestion and aches and pains assessed to be possibly related to LYMERIX, which resolved on 24 March 1995. On 13 May 1995, the subject experienced contact dermatitis of the chest assessed to be unrelated to LYMERIX, which resolved on 01 June 1995. On 01 September 2005, the subject experienced neuritis assessed to be unrelated to LYMERIX, which was unresolved at study conclusion. On 22 January 1996, the subject experienced degenerative cervical disc disease and cervical spinal stenosis assessed to be unrelated to LYMERIX, which was unresolved at study conclusion. Treatment included aspirin, Naprosyn, and prednisone. None of the preceding adverse events were assessed to be serious.
Age: 55.0
Sex: F
Vaccine: LYME
Symptoms: Sinus congestion
Clinical narrative: This case was reported by a consumer and described the occurrence of neuropathy in an adult female subject who received LYMERIX (GlaxoSmithKline) as part of a clinical trial. A physician or other health care professional has not verified this report. On an unspecified date in 1995 the subject received 2nd dose of LYMERIX. An unspecified amount of time following administration of the 2nd LYMERIX vaccine, the subject experienced neuropathy, electric shock sensation in the right ankle and tingling of the toes. The outcome of these events was not reported. On 17 August 2008, approximately 13 years after the 2nd vaccination with LYMERIX, the subject again experienced neuropathy, electric shock sensation in the right ankle and tingling of the toes. It was reported that MRIs and other miscellaneous testing was performed on the subject (dates and specifics not provided) and all were negative other than arthritis. This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved. Follow up information was received on 29 September 2008 via clinical trial information for this subject. The subject was initially enrolled in protocol 215274/008. She was subsequently enrolled in 215274/013. The subject received LYMERIX vaccine administered on 15 March 1995 and 18 April 1995. The subject did not receive the third dose of LYMERIX. On 18 March 1995, the subject experienced sinus congestion and aches and pains assessed to be possibly related to LYMERIX, which resolved on 24 March 1995. On 13 May 1995, the subject experienced contact dermatitis of the chest assessed to be unrelated to LYMERIX, which resolved on 01 June 1995. On 01 September 2005, the subject experienced neuritis assessed to be unrelated to LYMERIX, which was unresolved at study conclusion. On 22 January 1996, the subject experienced degenerative cervical disc disease and cervical spinal stenosis assessed to be unrelated to LYMERIX, which was unresolved at study conclusion. Treatment included aspirin, Naprosyn, and prednisone. None of the preceding adverse events were assessed to be serious.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cyanosis, Full blood count, Hypersomnia, Intensive care, Oral intake reduced
Clinical narrative: Slept 22 hrs after imms - no intake - decreased output. Seen at 11:30 9/30/08 - awake, alert, took 3 oz formula. Took another 3 oz about 3 hrs later and had another wet diaper - At 4:30 p 9/30/08 baby began having circumoral cyanosis and was seen in ER. Admitted to PICU.  10/16/2008 MR received for DOS 9/30-10/1/2008 with D/C DX: Gastroesophageal Reflux. Pt presented with excessive sleeping, decreased po intake, pallor and purple lips. Had 2 episode of vomiting and decreased wet diapers. Initial PE WNL but pt had a witnessed O2 sat drop to 52% with HR decrease to 90's. Pt was pale with oral cyanosis. Admitted for ALTE, hypoxia and cyanosis. Pt did well on smaller more frequent feed and meds. D/C on reflux precautions.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Oxygen saturation, Urine analysis, Urine output decreased
Clinical narrative: Slept 22 hrs after imms - no intake - decreased output. Seen at 11:30 9/30/08 - awake, alert, took 3 oz formula. Took another 3 oz about 3 hrs later and had another wet diaper - At 4:30 p 9/30/08 baby began having circumoral cyanosis and was seen in ER. Admitted to PICU.  10/16/2008 MR received for DOS 9/30-10/1/2008 with D/C DX: Gastroesophageal Reflux. Pt presented with excessive sleeping, decreased po intake, pallor and purple lips. Had 2 episode of vomiting and decreased wet diapers. Initial PE WNL but pt had a witnessed O2 sat drop to 52% with HR decrease to 90's. Pt was pale with oral cyanosis. Admitted for ALTE, hypoxia and cyanosis. Pt did well on smaller more frequent feed and meds. D/C on reflux precautions.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Full blood count, Injection site swelling, Irritability, Oedema peripheral
Clinical narrative: -extreme irritability; crying; legs swelling; rash purpura
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Purpura, X-ray
Clinical narrative: -extreme irritability; crying; legs swelling; rash purpura
Age: 52.0
Sex: U
Vaccine: FLU3, PPV, TD
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Approximately 6 hours after immunization, got fever, headache, myalgias, laminating pain, red, hot, swollen injection site of Pneumo.
Age: 52.0
Sex: U
Vaccine: FLU3, PPV, TD
Symptoms: Pain, Pyrexia
Clinical narrative: Approximately 6 hours after immunization, got fever, headache, myalgias, laminating pain, red, hot, swollen injection site of Pneumo.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Confusional state, Diarrhoea, Dizziness, Nausea, Tremor
Clinical narrative: Nausea, vomiting, diarrhea, trembling, confusion, feeling as if going to pass out.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, trembling, confusion, feeling as if going to pass out.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site urticaria
Clinical narrative: Hives at the site of injection-small covering a quarter size area around injection site. Pt took BENADRYL-2 hrs later- Rash is not bigger-also seen by PMD by then.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Local reaction
Clinical narrative: Local reaction 3 x 3 cm red, rash, not warm, not indurated, not painful.  Treated with Benadryl.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: approx. 2.5 x 2.5 area of slight erythema warmness, slight induration on the (R) deltoid area, warm compress on the affected area ADVIL 200 mg cap 2 caps every 6 hours prn
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Underdose
Clinical narrative: Patient was receiving FLUVIRIN 0.5ml, IM injection.  Patient pulled away and only got partial injection.  The rest dripped down her arm.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: On 9-18-08 had flu vac around 3pm. Between 5 and 7 pm he became very achy, especially in lges-no temp noted-gradually at better our 2-3 days
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Convulsion, Otitis media, Pyrexia, Tremor
Clinical narrative: At 2 AM on day following vaccinations, patient had seizure with shaking of arms and legs, eyes open, lasting 10 minutes.  Parents called 911.  Went to Emergency Room - had fever.  Diagnosed with Otitis Media.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Fall, Immediate post-injection reaction, Tooth injury
Clinical narrative: Pt. received MCV-4 and HPV. Stood up after receiving vaccines and fell forward. Pt. hit mouth and last part of tooth. Pt. taken to E.R. and released.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Oedema peripheral
Clinical narrative: (L) deltoid area red swollen area 110 mm x 70 mm with induration
Age: 63.0
Sex: F
Vaccine: FLUX, MNQ, PPV
Symptoms: Splenectomy
Clinical narrative: Pt had MENACTRA and PNEUMOVAX administered here 9/10/08 (Flu shot given by another Dr). Had splenectomy 9/26/08. While in hospital patient experienced arm paralysis. Also received Hep B at health clinic. 12/1/08-records received for DOS 9/24-9/30/08-DC DX: Thrombocytopenia. Splenomegaly. Myelofibrosis. Admitted due to enlarged spleen, thrombocytopenia caused by myelofibrosis syndrome diagnosed July 2008. Splenectomy. Received influenzae vaccination pre operatively, pneumonia vaccination and meningitis vaccination. Ventilator for atelectasis. Developed right sided weakness in arm after surgery weakness. Similar weakness as part of multiple sclerosis diagnosed 10 years ago. Impression: could have an exacerbation of previously weak point that can happen after stressful circumstances such as surgery or new multiple sclerosis plaque
Age: 3.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Wrong drug administered
Clinical narrative: Patient was given GARDASIL injection by error.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Immunisation reaction, Paraesthesia
Clinical narrative: Patient experienced parasthesia to hands, face, and lower extremities (Left leg and foot). MD evaluation suggested that employee had a reaction to flu shot. Prescribed steroid (liquid) 2 tablespoons x 2 days
Age: 37.0
Sex: F
Vaccine: FLUN3, SMALL
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Culture wound, Erythema, Full blood count normal
Clinical narrative: fever, headache, swelling left arm, axillary, cervical, clavicular lymphadenopathy 8 days post receipt primary SPV and FLUMIST. Tmax 104.0 on 9/22/2008; headache severity progressed to 9/10 9/23/2008; 3 satellite lesions around SPV site, date first noted unknown; 2 possible autoinoc lesions: noticed over right thumb pad 9/20/2008; noticed between right 4th/5th toe 9/23/2008; small round macule noted on upper lip 9/24/2008; seen in ER 9/22; followed up at another hospital 9/23. 9/26/2008 bilateral wrist and finger swelling/pain; single erythematous macule over left 1st and right 5th MCP joint. As of 10/1/2008 symptoms resolved. Symptoms: Joint pain, Isolated, swelling, lesions, macule, lesions, macule, lesions, pustule, fever, headache, general, lesions, pustule, lesions, pustule.
Age: 37.0
Sex: F
Vaccine: FLUN3, SMALL
Symptoms: Headache, Lymphadenopathy, Metabolic function test, Oedema peripheral, Pain in extremity
Clinical narrative: fever, headache, swelling left arm, axillary, cervical, clavicular lymphadenopathy 8 days post receipt primary SPV and FLUMIST. Tmax 104.0 on 9/22/2008; headache severity progressed to 9/10 9/23/2008; 3 satellite lesions around SPV site, date first noted unknown; 2 possible autoinoc lesions: noticed over right thumb pad 9/20/2008; noticed between right 4th/5th toe 9/23/2008; small round macule noted on upper lip 9/24/2008; seen in ER 9/22; followed up at another hospital 9/23. 9/26/2008 bilateral wrist and finger swelling/pain; single erythematous macule over left 1st and right 5th MCP joint. As of 10/1/2008 symptoms resolved. Symptoms: Joint pain, Isolated, swelling, lesions, macule, lesions, macule, lesions, pustule, fever, headache, general, lesions, pustule, lesions, pustule.
Age: 37.0
Sex: F
Vaccine: FLUN3, SMALL
Symptoms: Pyrexia, Rash macular, Rash pustular, Skin lesion
Clinical narrative: fever, headache, swelling left arm, axillary, cervical, clavicular lymphadenopathy 8 days post receipt primary SPV and FLUMIST. Tmax 104.0 on 9/22/2008; headache severity progressed to 9/10 9/23/2008; 3 satellite lesions around SPV site, date first noted unknown; 2 possible autoinoc lesions: noticed over right thumb pad 9/20/2008; noticed between right 4th/5th toe 9/23/2008; small round macule noted on upper lip 9/24/2008; seen in ER 9/22; followed up at another hospital 9/23. 9/26/2008 bilateral wrist and finger swelling/pain; single erythematous macule over left 1st and right 5th MCP joint. As of 10/1/2008 symptoms resolved. Symptoms: Joint pain, Isolated, swelling, lesions, macule, lesions, macule, lesions, pustule, fever, headache, general, lesions, pustule, lesions, pustule.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Lip swelling, Pyrexia, Urticaria
Clinical narrative: 9/25/08 40 hours after receiving DTaP vaccine pt developed swelling of lips and hives. Hives and lip swelling recurred x 2d. Pt developed fever 9/24/08-9/26/08 Tmax 103 F. Pt did not have GI or respiratory sx with hives/lip swelling.
Age: 0.5
Sex: M
Vaccine: HIBV, PNC
Symptoms: Mass
Clinical narrative: little lump on L thigh
Age: 12.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Headache, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling to injection site with headache for 48 hours after IZ is given.
Age: 1.1
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Lymphadenopathy, Pyrexia, Rash generalised
Clinical narrative: Red rash over entire body. Onset 1 wk after 1 yr old vaccines. Low grade fever. Enlarged lymph node in neck x 1 mo.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Gait disturbance, Nausea, Nystagmus, Photophobia
Clinical narrative: vertigo 48 hours after administration of ENGERIX B with dizziness, unsteady gait, nystagmus, nausea, photophobia. VS WNL. Similar but milder reaction after 1st dose of Hep B.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Vertigo
Clinical narrative: vertigo 48 hours after administration of ENGERIX B with dizziness, unsteady gait, nystagmus, nausea, photophobia. VS WNL. Similar but milder reaction after 1st dose of Hep B.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction - red, swollen, warm to touch RA size baseball: ice, cool compress, warm compress, hydrocortisone 1% top. Motrin for discomfort. Pt also with low grade fever.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Injection site reaction - red, swollen, warm to touch RA size baseball: ice, cool compress, warm compress, hydrocortisone 1% top. Motrin for discomfort. Pt also with low grade fever.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pain in extremity
Clinical narrative: L upper arm pain - onset the evening of MMR injection, no redness. Tx'd with Naprosyn / Vicodin. Achy, deep arm pain persists 9/30/08
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Appendicectomy, Computerised tomogram normal, Dehydration, Haematochezia
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 3 month old male who on 02-FEB-2007 was vaccinated PO with the second dose of ROTATEQ (lot # 654392/0578F). Concomitant suspect vaccine therapy included the second IM dose of PEDVAXHIB (lot #654676/1084F) in the left leg. Other concomitant vaccine therapy included the second IM dose of PEDIARIX (lot # AC21B084CA) in the left leg and the second IM dose of PREVNAR (lot # B08683A) in the right leg. On 30-MAR-2007 the patient experienced vomiting for 5 days and dehydration. The patient was admitted to the hospital. A CT scan revealed reg scan and the patient was transferred for surgical evaluation and had an open reduction on 03-APR-2007. Medical records revealed that the patient experienced abdominal pain, vomiting times 6 days; irritability; bloody, mucousy stool times 1 day. The patient was admitted to the hospital on 02-APR-2007 and discharged on 05-APR-2007, the hospitalization was considered to be prolonged. The final diagnosis was intussusception that was surgically reduced and appendectomy. The outcome was not reported. The reporter considered abdominal pain, dehydration, haematochezia, mucousy stools, intussusception, and vomiting to be serious and life-threatening. Lot check results for lot # 654392/0578F: A standard lot check investigation was performed. 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 # is 292254. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Irritability, Mucous stools, Surgery, Vomiting
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 3 month old male who on 02-FEB-2007 was vaccinated PO with the second dose of ROTATEQ (lot # 654392/0578F). Concomitant suspect vaccine therapy included the second IM dose of PEDVAXHIB (lot #654676/1084F) in the left leg. Other concomitant vaccine therapy included the second IM dose of PEDIARIX (lot # AC21B084CA) in the left leg and the second IM dose of PREVNAR (lot # B08683A) in the right leg. On 30-MAR-2007 the patient experienced vomiting for 5 days and dehydration. The patient was admitted to the hospital. A CT scan revealed reg scan and the patient was transferred for surgical evaluation and had an open reduction on 03-APR-2007. Medical records revealed that the patient experienced abdominal pain, vomiting times 6 days; irritability; bloody, mucousy stool times 1 day. The patient was admitted to the hospital on 02-APR-2007 and discharged on 05-APR-2007, the hospitalization was considered to be prolonged. The final diagnosis was intussusception that was surgically reduced and appendectomy. The outcome was not reported. The reporter considered abdominal pain, dehydration, haematochezia, mucousy stools, intussusception, and vomiting to be serious and life-threatening. Lot check results for lot # 654392/0578F: A standard lot check investigation was performed. 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 # is 292254. No further information is available.
Age: 0.4
Sex: M
Vaccine: DTAP, FLU3, IPV, PNC, RV5
Symptoms: Abdominal X-ray, Barium enema abnormal, Bowel movement irregularity, Enema administration, Explorative laparotomy
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 5 month old male with no previous medical history who on 04-DEC-2007 was vaccinated PO with the third dose of ROTATEQ (lot # 656659/0942). Concomitant vaccine therapy included the third IM dose of DAPTACEL (lot # C2749AA) in the left leg, the first IM dose of FLUZONE (lot # UT2456EA) in the right leg, the third IM dose of PREVNAR (lot # B540168) in the right leg and the third IM dose of IPOL (lot # A0169) in the left leg. There were no other concomitant medications. On 17-DEC-2007, the patient had vomiting and decreased urine output. On 18-DEC-2008, the patient did not have a bowel movement for two days. The patient had a two view abdominal which showed dilated loops of small bowel obstruction and an upper GI which revealed no malrotation and free fluid, favoring intussusception in right mid abdomen. The patient was admitted to the hospital and diagnosed with intussusception. On 19-DEC-2007, after the patient had two hydrostatic enemas that were unable to completely reduce the intussusception, the patient had an exploratory laparotomy and reduction of the intussusception. The patient was discharged from the hospital on 22-DEC-2008, the outcome was not reported. The reporter considered intussusception, bowel movement irregularity, urine output decreased and vomiting to be life-threatening. Lot check results for lot # 656659/0942U: A standard lot check investigation was performed. 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 and was released. The original reporting source was not provided. The VAERS ID # is 300429. No further information is available.
Age: 0.4
Sex: M
Vaccine: DTAP, FLU3, IPV, PNC, RV5
Symptoms: Intussusception, Small intestinal obstruction, Urine output decreased, Vomiting, X-ray abnormal
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 5 month old male with no previous medical history who on 04-DEC-2007 was vaccinated PO with the third dose of ROTATEQ (lot # 656659/0942). Concomitant vaccine therapy included the third IM dose of DAPTACEL (lot # C2749AA) in the left leg, the first IM dose of FLUZONE (lot # UT2456EA) in the right leg, the third IM dose of PREVNAR (lot # B540168) in the right leg and the third IM dose of IPOL (lot # A0169) in the left leg. There were no other concomitant medications. On 17-DEC-2007, the patient had vomiting and decreased urine output. On 18-DEC-2008, the patient did not have a bowel movement for two days. The patient had a two view abdominal which showed dilated loops of small bowel obstruction and an upper GI which revealed no malrotation and free fluid, favoring intussusception in right mid abdomen. The patient was admitted to the hospital and diagnosed with intussusception. On 19-DEC-2007, after the patient had two hydrostatic enemas that were unable to completely reduce the intussusception, the patient had an exploratory laparotomy and reduction of the intussusception. The patient was discharged from the hospital on 22-DEC-2008, the outcome was not reported. The reporter considered intussusception, bowel movement irregularity, urine output decreased and vomiting to be life-threatening. Lot check results for lot # 656659/0942U: A standard lot check investigation was performed. 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 and was released. The original reporting source was not provided. The VAERS ID # is 300429. No further information is available.
Age: 0.4
Sex: M
Vaccine: DTAP, FLU3, IPV, PNC, RV5
Symptoms: X-ray with contrast upper gastrointestinal tract
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act concerning a 5 month old male with no previous medical history who on 04-DEC-2007 was vaccinated PO with the third dose of ROTATEQ (lot # 656659/0942). Concomitant vaccine therapy included the third IM dose of DAPTACEL (lot # C2749AA) in the left leg, the first IM dose of FLUZONE (lot # UT2456EA) in the right leg, the third IM dose of PREVNAR (lot # B540168) in the right leg and the third IM dose of IPOL (lot # A0169) in the left leg. There were no other concomitant medications. On 17-DEC-2007, the patient had vomiting and decreased urine output. On 18-DEC-2008, the patient did not have a bowel movement for two days. The patient had a two view abdominal which showed dilated loops of small bowel obstruction and an upper GI which revealed no malrotation and free fluid, favoring intussusception in right mid abdomen. The patient was admitted to the hospital and diagnosed with intussusception. On 19-DEC-2007, after the patient had two hydrostatic enemas that were unable to completely reduce the intussusception, the patient had an exploratory laparotomy and reduction of the intussusception. The patient was discharged from the hospital on 22-DEC-2008, the outcome was not reported. The reporter considered intussusception, bowel movement irregularity, urine output decreased and vomiting to be life-threatening. Lot check results for lot # 656659/0942U: A standard lot check investigation was performed. 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 and was released. The original reporting source was not provided. The VAERS ID # is 300429. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Urticaria, Vomiting
Clinical narrative: BY EVENING OF DATE OF ADMINISTRATION OF HER FIRST DOSE OF GARDASIL, PATIENT BROKE OUT IN A "RAISED, RED, ITCHY RASH ALLOVER". 2 DAYS LATER SHE BECAME NAUSEATED WITH VOMITING. BY THE 4TH DAY SHE'D DEVELOPED A LOW-GRADE FEVER IN ADDITION TO THE CONTINUATION OF THE OTHER SYMPTOMS. HER TEMP. WASN'T VERIFIED. HER STEP-MOM CALLED THE HEALTH DEPT. TO ASK IF HER SYMPTOMS COULD BE A RESULT OF THE INJECTION OF GARDISIL. RECOMMENDED THEY SEE A DOCTOR DUE TO THE PRESENCE OF FEVER/RASH ILLNESS, WHICH THEY DID. THE PROVIDER TOLD THEM THAT PATIENT HAD AN ALLERGIC REACTION TO THE GARDASIL VACCINE AND TREATED THE SYMPTOMS.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypersensitivity, Nausea, Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: BY EVENING OF DATE OF ADMINISTRATION OF HER FIRST DOSE OF GARDASIL, PATIENT BROKE OUT IN A "RAISED, RED, ITCHY RASH ALLOVER". 2 DAYS LATER SHE BECAME NAUSEATED WITH VOMITING. BY THE 4TH DAY SHE'D DEVELOPED A LOW-GRADE FEVER IN ADDITION TO THE CONTINUATION OF THE OTHER SYMPTOMS. HER TEMP. WASN'T VERIFIED. HER STEP-MOM CALLED THE HEALTH DEPT. TO ASK IF HER SYMPTOMS COULD BE A RESULT OF THE INJECTION OF GARDISIL. RECOMMENDED THEY SEE A DOCTOR DUE TO THE PRESENCE OF FEVER/RASH ILLNESS, WHICH THEY DID. THE PROVIDER TOLD THEM THAT PATIENT HAD AN ALLERGIC REACTION TO THE GARDASIL VACCINE AND TREATED THE SYMPTOMS.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vomiting
Clinical narrative: BY EVENING OF DATE OF ADMINISTRATION OF HER FIRST DOSE OF GARDASIL, PATIENT BROKE OUT IN A "RAISED, RED, ITCHY RASH ALLOVER". 2 DAYS LATER SHE BECAME NAUSEATED WITH VOMITING. BY THE 4TH DAY SHE'D DEVELOPED A LOW-GRADE FEVER IN ADDITION TO THE CONTINUATION OF THE OTHER SYMPTOMS. HER TEMP. WASN'T VERIFIED. HER STEP-MOM CALLED THE HEALTH DEPT. TO ASK IF HER SYMPTOMS COULD BE A RESULT OF THE INJECTION OF GARDISIL. RECOMMENDED THEY SEE A DOCTOR DUE TO THE PRESENCE OF FEVER/RASH ILLNESS, WHICH THEY DID. THE PROVIDER TOLD THEM THAT PATIENT HAD AN ALLERGIC REACTION TO THE GARDASIL VACCINE AND TREATED THE SYMPTOMS.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Anorexia, Diarrhoea, Headache, Hyperhidrosis, Pain
Clinical narrative: Patient started three hours after the Flu Mist was administered with fever of 101.5, body aches, diarrhea, sweats, headache and loss of appetite.  It lasted 36 hours.  The fever returned to normal, but the diarrhea and body aches still persist almost 72 hours later.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: Patient started three hours after the Flu Mist was administered with fever of 101.5, body aches, diarrhea, sweats, headache and loss of appetite.  It lasted 36 hours.  The fever returned to normal, but the diarrhea and body aches still persist almost 72 hours later.
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL. Concomitant therapy included VARIVAX (Oka/Merck). It was reported that the patient experienced an adverse reaction following vaccination with GARDASIL. The reporter stated that the patient had an adverse reaction (possible seizure) when VARIVAX (Oka/Merck) was administered concomitantly with GARDASIL. The details of the adverse reaction were not provided, thought it may have been a seizure. On an unspecified date, the patient recovered. It was unknown if the patient sought medical attention or not. Upon internal review, seizure was considered to be other important medical event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on an unknown date, was vaccinated with GARDASIL. After receiving the vaccine, the patient experienced seizure. The patient was in the physician's office when the adverse event occurred. An electroencephalography (EEG) was performed (results were not provided). Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.   10/10/08 Reviewed vax records & office note of 8/4/08 when patient seen for recheck of axillary cyst & states EEG abnormal.  No other records available. 10/14/08 Reviewed neuro medical records of 9/9/08. FINAL DX: complex partial seizure disorder w/secondary generalization Records reveal patient experienced seizure symptoms since 7/2007 each lasting appro 5-10 min.  Starts w/eye deviation, progressed to LOC & tonic-clonic activity followed by confusion.  Tx w/antiseizure meds.
Sex: F
Vaccine: HPV4
Symptoms: Central nervous system lesion, Cerebrovascular accident, Computerised tomogram abnormal
Clinical narrative: Information has been received from a physician concerning a female friend of the physician's patient who was vaccinated with a dose of GARDASIL.  Subsequently the patient was diagnosed as having had a stroke.  A computed axial tomography scan of the brain revealed an unspecified lesion or mass.  The patient's outcome was unknown.  It was unspecified if the patient sought medical attention or not.  Upon internal review, stroke was determined to be an other important medical event.  No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Condition aggravated, Convulsion, Fatigue, Gaze palsy
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female who faints easily and with a history of seizures after car accident in 2004, and issues with a shot given in the past, but unknown what drug or vaccine, or unknown what type of reaction who on 23-SEP-2008 was vaccinated with the first dose of GARDASIL (Lot # 661044/0548X), 0.5 ml, intramuscularly, into the left deltoid. There was no concomitant medication. The registered nurse reported that 5 minutes post vaccination the patient experienced an adverse event. The nurse reported that the patient said that she did not feel good. The patient had seizure activity, some shaking, her eyes rolled back into her head, she passed out, and had loss of urine. When the client came to she experienced nausea and vomiting. Her pulse was weak, but her airway was open. The nurse reported that the patient was given oral fluids, crackers and was monitored. One hour later the patient's blood pressure was 110/72. Prior to administering the GARDASIL vaccine a unsuccessful blood draw was attempted on client, but after vaccination another blood drawn was taken. A cat scan was performed with negative results. At the time of the report a EEG was scheduled. The patient sought medical attention at internist office. At the time of the report the registered nurse called the patient and she said that she was "tired but was feeling much better today". Upon internal review, seizure was considered to be an other important medical event. Additional information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Loss of consciousness, Malaise, Nausea, Pulse pressure decreased
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female who faints easily and with a history of seizures after car accident in 2004, and issues with a shot given in the past, but unknown what drug or vaccine, or unknown what type of reaction who on 23-SEP-2008 was vaccinated with the first dose of GARDASIL (Lot # 661044/0548X), 0.5 ml, intramuscularly, into the left deltoid. There was no concomitant medication. The registered nurse reported that 5 minutes post vaccination the patient experienced an adverse event. The nurse reported that the patient said that she did not feel good. The patient had seizure activity, some shaking, her eyes rolled back into her head, she passed out, and had loss of urine. When the client came to she experienced nausea and vomiting. Her pulse was weak, but her airway was open. The nurse reported that the patient was given oral fluids, crackers and was monitored. One hour later the patient's blood pressure was 110/72. Prior to administering the GARDASIL vaccine a unsuccessful blood draw was attempted on client, but after vaccination another blood drawn was taken. A cat scan was performed with negative results. At the time of the report a EEG was scheduled. The patient sought medical attention at internist office. At the time of the report the registered nurse called the patient and she said that she was "tired but was feeling much better today". Upon internal review, seizure was considered to be an other important medical event. Additional information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor, Urinary incontinence, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female who faints easily and with a history of seizures after car accident in 2004, and issues with a shot given in the past, but unknown what drug or vaccine, or unknown what type of reaction who on 23-SEP-2008 was vaccinated with the first dose of GARDASIL (Lot # 661044/0548X), 0.5 ml, intramuscularly, into the left deltoid. There was no concomitant medication. The registered nurse reported that 5 minutes post vaccination the patient experienced an adverse event. The nurse reported that the patient said that she did not feel good. The patient had seizure activity, some shaking, her eyes rolled back into her head, she passed out, and had loss of urine. When the client came to she experienced nausea and vomiting. Her pulse was weak, but her airway was open. The nurse reported that the patient was given oral fluids, crackers and was monitored. One hour later the patient's blood pressure was 110/72. Prior to administering the GARDASIL vaccine a unsuccessful blood draw was attempted on client, but after vaccination another blood drawn was taken. A cat scan was performed with negative results. At the time of the report a EEG was scheduled. The patient sought medical attention at internist office. At the time of the report the registered nurse called the patient and she said that she was "tired but was feeling much better today". Upon internal review, seizure was considered to be an other important medical event. Additional information is expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Laboratory test, Ultrasound scan abnormal
Clinical narrative: Information has been received from a 24 year old female who in February 2008 received her first dose of GARDASIL (lot # not provided) and on 02-Apr-2008 received the second dose of GARDASIL (lot # not provided) without knowing she was pregnant.  The patient had no medical history or concurrent condition.  Concomitant therapy included vitamins (unspecified).  The patient's LMP was reported as 07-MAR-2008.  The patient was scheduled to be due in December however when she went in for a Ultra Sound on 17-Sep-2008 the baby had no heart beat and was dead.  The patient delivered the baby on 18-Sep-2008 and was hospitalized for 12 hours after giving birth.  Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old male who in December 2007, was vaccinated with ZOSTAVAX (Oka/Merck).  In December 2007, after being vaccinated, the patient experienced hearing loss.  The patient's hearing loss persisted.  Upon internal review, the patient's hearing loss was considered to be an other important medical event.  The patient sought medical attention by seeing the physician.  Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Abasia, Aphasia, Gastrointestinal disorder, Nervous system disorder
Clinical narrative: Information has been received from a consumer regarding a case in litigation concerning her daughter (now nearing 3 years of age) who was born healthy and who was vaccinated with a dose of MMR II (date and dose not reported).  It was reported that after being vaccinated the patient developed an unspecified central nervous system disorder and digestive tract disorder and has lost the ability to walk and to talk.  The reporter felt that central nervous system disorder, digestive tract disorder, loss of ability to walk and loss of ability to talk were related to therapy with MMR II.  Upon internal review loss of ability to walk and to talk were considered to be disabling.  The outcome at the time of the report was unknown.  No further information is available.
Age: 1.1
Sex: F
Vaccine: PNC
Symptoms: Abnormal behaviour, Autopsy, Blood culture positive, Body temperature increased, Chest X-ray abnormal
Clinical narrative: Information regarding PREVNAR was received from a pediatrician regarding a 16-month-old female patient who experienced Invasive Pneumococcal Disease - drug ineffective, pneumococcal bacteremia and sepsis. The patient died. The patient received the fourth dose on 16-Apr-2008.  No significant medical history. Concomitant medications were not reported. The patient was seen at the doctor's office on 17-Aug-2008. She was fussy and clingy and had a temperature. The child returned to the office on 19-Aug-2008, at which time, she was afebrile and tachypnic. The physician sent her to the ER for diagnostic tests (see test results) and treatment. The child died in the ER. It was determined that the patient experienced Invasive Pneumococcal Disease - drug ineffective on 17-Aug-2008, pneumococcal bacteremia, and sepsis on 19-Aug-2008. The physician stated that IPD was due to serotype 33F, which was not covered by PREVNAR. An autopsy was performed, however results were not available. No additional information was available at the time of this report. The cause of death was reported as sepsis and pneumococcal infection and the autopsy cause of death was not reported. Body temperature (results: fever) was done on 17-Aug-2008. On 19-Aug-2008 test results were: body temperature (results: afebrile); chest x-ray (results: revealed pneumonia); and blood culture (results: revealed S. pneumoniae; Serotype 33F).  10/17/08 Autopsy report states COD as acute lobar pneumonia complicating CHF following viral myocarditis.  10/17/08 Reviewed autopsy report, death certificate & extensive hospital & PCP medical records received for coroner.  Records reveal patient experienced fever & difficulty breathing x 2 days.  Seen by PCP & sent for admission.  Tx w/IV antibiotics.  Became tachypneic, tachycardic & intubated for impending respiratory failure.  Developed bradycardia.  CPR & transcutaneous pacing initiated.  Transported to higher level of care for PICU.  Upon arrival, had blood in ETT & was acidotic & despite continued resuscitative efforts expired. FINDINGS at Autopsy: severe viral myocarditis w/marked patchy myofibrillar nectosis; chronic lymphocytic bronchitis; acute bilateral pan-lobar pneumonia; acute passive visceral congestion; pleural & pericardial effusions; ascites; mild focal lymphocytic meningeal infiltrates; early neuronal anoxic changes; acute splenitis.
Age: 1.1
Sex: F
Vaccine: PNC
Symptoms: Death, Drug ineffective, Irritability, Pneumococcal bacteraemia, Pneumococcal infection
Clinical narrative: Information regarding PREVNAR was received from a pediatrician regarding a 16-month-old female patient who experienced Invasive Pneumococcal Disease - drug ineffective, pneumococcal bacteremia and sepsis. The patient died. The patient received the fourth dose on 16-Apr-2008.  No significant medical history. Concomitant medications were not reported. The patient was seen at the doctor's office on 17-Aug-2008. She was fussy and clingy and had a temperature. The child returned to the office on 19-Aug-2008, at which time, she was afebrile and tachypnic. The physician sent her to the ER for diagnostic tests (see test results) and treatment. The child died in the ER. It was determined that the patient experienced Invasive Pneumococcal Disease - drug ineffective on 17-Aug-2008, pneumococcal bacteremia, and sepsis on 19-Aug-2008. The physician stated that IPD was due to serotype 33F, which was not covered by PREVNAR. An autopsy was performed, however results were not available. No additional information was available at the time of this report. The cause of death was reported as sepsis and pneumococcal infection and the autopsy cause of death was not reported. Body temperature (results: fever) was done on 17-Aug-2008. On 19-Aug-2008 test results were: body temperature (results: afebrile); chest x-ray (results: revealed pneumonia); and blood culture (results: revealed S. pneumoniae; Serotype 33F).  10/17/08 Autopsy report states COD as acute lobar pneumonia complicating CHF following viral myocarditis.  10/17/08 Reviewed autopsy report, death certificate & extensive hospital & PCP medical records received for coroner.  Records reveal patient experienced fever & difficulty breathing x 2 days.  Seen by PCP & sent for admission.  Tx w/IV antibiotics.  Became tachypneic, tachycardic & intubated for impending respiratory failure.  Developed bradycardia.  CPR & transcutaneous pacing initiated.  Transported to higher level of care for PICU.  Upon arrival, had blood in ETT & was acidotic & despite continued resuscitative efforts expired. FINDINGS at Autopsy: severe viral myocarditis w/marked patchy myofibrillar nectosis; chronic lymphocytic bronchitis; acute bilateral pan-lobar pneumonia; acute passive visceral congestion; pleural & pericardial effusions; ascites; mild focal lymphocytic meningeal infiltrates; early neuronal anoxic changes; acute splenitis.