chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis, Hepatitis B surface antigen positive, Renal function test abnormal, Renal impairment, Underdose
Clinical narrative: This case was reported by a healthcare professional (medical assistant) and described the occurrence of elevated renal function in a 27-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included ENGERIX B ;GlaxoSmithKline;unknown;unknown given on an unspecified date. On 5 January 2013 the subject received 2nd dose of ENGERIX B (.5 ml, unknown route, left arm) and experienced vaccine underdose. The subject received less than the indicated dose for ENGERIX B. On 5 January 2013, less than one month after vaccination with ENGERIX B, the subject experienced elevated renal function. On 4 February 2013, 30 days after vaccination with ENGERIX B, the subject experienced hbsag positive (hepatitis). The medical assistant reported that the subject's "kidney function has been elevated and HBsAg came back positive yesterday [4 February 2013]." This case was assessed as medically serious by GSK. Relevant test results included a positive hepatitis b surface antigen test on 4 February 2013 and nonspecific abnormal results of function study of kidney. At the time of reporting the outcome of the events were unspecified.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Myalgia, Pain, Pruritus
Clinical narrative: 2-1-13 Eve, itching, muscle pain. 2-2-13 Lt upper arm generalized pain#7 with movement at #4 rest. Red inflammation.  2-2-13 pm - hospital. Treated with AUGMENTIN oral -> IV penicillin & Doxycycline, prednisone - Not admitted. To PCP GI Doc - NLT from work.
Age: 39.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Burning sensation, Erythema, Immediate post-injection reaction, Lymph node pain, Lymphadenitis
Clinical narrative: Immediately upon injection of Tdap in the left deltoid, burning and pain shot up my neck. My neck turned red and continued to have a burning sensation. On 1/27/13 I noticed a warm, tender lump in the left side of my neck. My neck continued to be red and continued burning. Urgent care diagnosed me with an inflamed lymph node due to the Tdap injection. The redness and burning has not resolved. The lymph node remains inflamed and tender.
Age: 39.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Mass, Neck mass, Neck pain, Skin warm
Clinical narrative: Immediately upon injection of Tdap in the left deltoid, burning and pain shot up my neck. My neck turned red and continued to have a burning sensation. On 1/27/13 I noticed a warm, tender lump in the left side of my neck. My neck continued to be red and continued burning. Urgent care diagnosed me with an inflamed lymph node due to the Tdap injection. The redness and burning has not resolved. The lymph node remains inflamed and tender.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Injection site erythema, Local swelling, Oedema peripheral
Clinical narrative: Four inch diameter red spot at injection site. Swelling of neck, arm, armpit, and torso on side of injection. Chills. These symptoms lasted four days. Headache: as of today the headache has not gone away. I talked to the pharmacist who told me to take Benadryl which I did. Ibuprofen and Tylenol for the headache.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Four inch diameter red spot at injection site. Swelling of neck, arm, armpit, and torso on side of injection. Chills. These symptoms lasted four days. Headache: as of today the headache has not gone away. I talked to the pharmacist who told me to take Benadryl which I did. Ibuprofen and Tylenol for the headache.
Age: 1.31
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Convulsion, Epilepsy, Intensive care
Clinical narrative: Had a seizure at home then called 911 and the ambulance took her to hospital, where she had a second seizure.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Hypoaesthesia, Induration, Inflammation
Clinical narrative: PATIENT CALLED ON 1/30/13, 2:21PM STATING THAT SHE COULD NOT SLEEP BECAUSE OF HER ARM HAVING TOO MUCH PAIN. WHERE SHE WAS ADMINISTED THE PNEUMONIA VACCINE, YESTERDAY. PATIENT STATED THAT THE PAIN RAN DOWN TO HER FINGER TIPS; IT WAS INFLAMED, HARD, PAINFUL, AND NOT RED. PATIENT WANTED TO KNOW IF THIS WAS NORMAL AND WHAT SHE COULD TAKE. TWO HOURS LATER PATIENT'S DAUGTHER CALLED STATING THAT SHE WAS AT PATIENT'S HOME AND PATIENT CANNOT MOVE HER ARM AND WAS DEFINITELY UNCOMFORTABLE. THE FOLLOWING DAY I CALLED THE PATIENT AFTER THE NURSE PRACTITIONER TOLD ME TO FOLLOW UP WITH HER. PATIENT STATED SHE WAS BETTER AND HAD A LITTLE BIT OF PAIN. AND THE NIGHT OF THE SHOT SHE FELT NUMBNESS AND WAS SCHEDULE THAT SAME DAY TO COME IN TO SEE THE DOCTOR.  WHEN PATIENT CAME IN AND SAW THE MEDICAL DOCTOR THE LEFT ARM WAS SWOLLEN AND IN PAIN-WAS RESOLVING. WAS TENDER AND STARTED TO SWELL UP WITHIN HOURS OF THE PNEUMONIA SHOT PATIENT SELF TREATED WITH TYLENOL. AT THE TIME THAT PT WAS ADMINISTERED THE PNEUMONIA SHOT WE WERE NOT AWARE THAT SHE HAD RECEIVE THE PNEUMONIA SHOT A YEAR AGO (2/2012). AFTER PATIENT LEFT FROM HER PHYSICAL EXAM WE GOT HER IMMUNIZATION RECORDS FROM HER PREVIEWS DOCTOR THAT SHE HAD GOTTEN THE SHOT. DOCTOR'S EXAMS: "LEFT DELTOID INJECTION SITE IS ONLY SLIGHTLY ERYTHEMATOUS <1/2 cm. THERE IS SOME MOTTLED ERYTHEMA LOWER IN THE ARM 7-17 CM ABOVE OLECRANON AND AROUND 1/3 THE CIRCUMFERENCE OF THE ARM- NOT INDURATED. THE LEFT ARM SWELLING 12CM PROXIMAL TO OLECRANON = 40CM CIRCUMFERENCE. THE RIGHT ARM 12 CM PROXIMAL TO OLECRANON = 38 CM MINIMAL IF ANY TENDERNESS. AND NORMAL FOR NEUROLOGY VASCULAR FUNCTION. DOCTOR'S DIAGNOSIS: 995.29 ADVERSE REACTION TO PNEUMONIA (RESOLVING PPV REACTION, DOUBT INFECTION).
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Insomnia, Livedo reticularis, Mobility decreased, Oedema peripheral
Clinical narrative: PATIENT CALLED ON 1/30/13, 2:21PM STATING THAT SHE COULD NOT SLEEP BECAUSE OF HER ARM HAVING TOO MUCH PAIN. WHERE SHE WAS ADMINISTED THE PNEUMONIA VACCINE, YESTERDAY. PATIENT STATED THAT THE PAIN RAN DOWN TO HER FINGER TIPS; IT WAS INFLAMED, HARD, PAINFUL, AND NOT RED. PATIENT WANTED TO KNOW IF THIS WAS NORMAL AND WHAT SHE COULD TAKE. TWO HOURS LATER PATIENT'S DAUGTHER CALLED STATING THAT SHE WAS AT PATIENT'S HOME AND PATIENT CANNOT MOVE HER ARM AND WAS DEFINITELY UNCOMFORTABLE. THE FOLLOWING DAY I CALLED THE PATIENT AFTER THE NURSE PRACTITIONER TOLD ME TO FOLLOW UP WITH HER. PATIENT STATED SHE WAS BETTER AND HAD A LITTLE BIT OF PAIN. AND THE NIGHT OF THE SHOT SHE FELT NUMBNESS AND WAS SCHEDULE THAT SAME DAY TO COME IN TO SEE THE DOCTOR.  WHEN PATIENT CAME IN AND SAW THE MEDICAL DOCTOR THE LEFT ARM WAS SWOLLEN AND IN PAIN-WAS RESOLVING. WAS TENDER AND STARTED TO SWELL UP WITHIN HOURS OF THE PNEUMONIA SHOT PATIENT SELF TREATED WITH TYLENOL. AT THE TIME THAT PT WAS ADMINISTERED THE PNEUMONIA SHOT WE WERE NOT AWARE THAT SHE HAD RECEIVE THE PNEUMONIA SHOT A YEAR AGO (2/2012). AFTER PATIENT LEFT FROM HER PHYSICAL EXAM WE GOT HER IMMUNIZATION RECORDS FROM HER PREVIEWS DOCTOR THAT SHE HAD GOTTEN THE SHOT. DOCTOR'S EXAMS: "LEFT DELTOID INJECTION SITE IS ONLY SLIGHTLY ERYTHEMATOUS <1/2 cm. THERE IS SOME MOTTLED ERYTHEMA LOWER IN THE ARM 7-17 CM ABOVE OLECRANON AND AROUND 1/3 THE CIRCUMFERENCE OF THE ARM- NOT INDURATED. THE LEFT ARM SWELLING 12CM PROXIMAL TO OLECRANON = 40CM CIRCUMFERENCE. THE RIGHT ARM 12 CM PROXIMAL TO OLECRANON = 38 CM MINIMAL IF ANY TENDERNESS. AND NORMAL FOR NEUROLOGY VASCULAR FUNCTION. DOCTOR'S DIAGNOSIS: 995.29 ADVERSE REACTION TO PNEUMONIA (RESOLVING PPV REACTION, DOUBT INFECTION).
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Swelling, Tenderness, Vaccination complication
Clinical narrative: PATIENT CALLED ON 1/30/13, 2:21PM STATING THAT SHE COULD NOT SLEEP BECAUSE OF HER ARM HAVING TOO MUCH PAIN. WHERE SHE WAS ADMINISTED THE PNEUMONIA VACCINE, YESTERDAY. PATIENT STATED THAT THE PAIN RAN DOWN TO HER FINGER TIPS; IT WAS INFLAMED, HARD, PAINFUL, AND NOT RED. PATIENT WANTED TO KNOW IF THIS WAS NORMAL AND WHAT SHE COULD TAKE. TWO HOURS LATER PATIENT'S DAUGTHER CALLED STATING THAT SHE WAS AT PATIENT'S HOME AND PATIENT CANNOT MOVE HER ARM AND WAS DEFINITELY UNCOMFORTABLE. THE FOLLOWING DAY I CALLED THE PATIENT AFTER THE NURSE PRACTITIONER TOLD ME TO FOLLOW UP WITH HER. PATIENT STATED SHE WAS BETTER AND HAD A LITTLE BIT OF PAIN. AND THE NIGHT OF THE SHOT SHE FELT NUMBNESS AND WAS SCHEDULE THAT SAME DAY TO COME IN TO SEE THE DOCTOR.  WHEN PATIENT CAME IN AND SAW THE MEDICAL DOCTOR THE LEFT ARM WAS SWOLLEN AND IN PAIN-WAS RESOLVING. WAS TENDER AND STARTED TO SWELL UP WITHIN HOURS OF THE PNEUMONIA SHOT PATIENT SELF TREATED WITH TYLENOL. AT THE TIME THAT PT WAS ADMINISTERED THE PNEUMONIA SHOT WE WERE NOT AWARE THAT SHE HAD RECEIVE THE PNEUMONIA SHOT A YEAR AGO (2/2012). AFTER PATIENT LEFT FROM HER PHYSICAL EXAM WE GOT HER IMMUNIZATION RECORDS FROM HER PREVIEWS DOCTOR THAT SHE HAD GOTTEN THE SHOT. DOCTOR'S EXAMS: "LEFT DELTOID INJECTION SITE IS ONLY SLIGHTLY ERYTHEMATOUS <1/2 cm. THERE IS SOME MOTTLED ERYTHEMA LOWER IN THE ARM 7-17 CM ABOVE OLECRANON AND AROUND 1/3 THE CIRCUMFERENCE OF THE ARM- NOT INDURATED. THE LEFT ARM SWELLING 12CM PROXIMAL TO OLECRANON = 40CM CIRCUMFERENCE. THE RIGHT ARM 12 CM PROXIMAL TO OLECRANON = 38 CM MINIMAL IF ANY TENDERNESS. AND NORMAL FOR NEUROLOGY VASCULAR FUNCTION. DOCTOR'S DIAGNOSIS: 995.29 ADVERSE REACTION TO PNEUMONIA (RESOLVING PPV REACTION, DOUBT INFECTION).
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Diarrhoea, Gastrointestinal disorder, Headache, Hypersensitivity, Immune system disorder
Clinical narrative: Allergies, memory issues, headaches, rashes, immune issues, gastro issues.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Memory impairment, Rash
Clinical narrative: Allergies, memory issues, headaches, rashes, immune issues, gastro issues.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Erythema
Clinical narrative: Redness lines 2.5 each vaccine (B) arms.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a physician refers to an 18 years old male patient. The patient was vaccinated with an adult dose of VAQTA (Lot # not reported) on an unspecified date. The physician reported that the patient weighted greater than 180 lbs. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 60 years old female patient with allergy to sulfa. On 20-JAN-2013, the patient was vaccinated subcutaneously with a 0.65 ml dose live ZOSTAVAX lot # (H019035), Exp date: 17-JAN-2014 for shingles. No other co-suspects were reported. The patient had no relevant concomitant medications. The patient's relevant past drug history was unknown. The patient stated that on 21-JAN-2013, the patient noted a local reaction at and around the injection site on the left arm. This reaction included swelling, redness and warmth. The area was further described as a dark red spot about the size of a quarter. There was hardness at the injection site. The area of swelling, redness and warmth extends out from this dark red spot about 5 inches. Relevant lab was unknown. As of 23-JAN-2013, the patient no longer took the live ZOSTAVAX. As of 23-JAN-2013, the patient continued to experience the swelling, redness and warmth at and around the injection site. No treatment information was reported. The relatedness for the event was unknown for live ZOSTAVAX. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dengue fever, Malaise, Tonsillitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to her 18 year old daughter. The patient was vaccinated (route not reported) with dose 1 GARDASIL (lotnumber and expiry date not reported) on unspecified dates. No other co-suspects were reported. Concomitant medications included: hormonal contraceptives (unspecified) . The pharmacist reported that her daughter later developed tonsillitis and the Dengue fever on 21-DEC-2012. The pharmacist also reported that her daughter was supposed to receive the third dose of GARDASIL on 07-JAN-2013, but she was still sick so she didn't receive it. The event was treated was TYLENOL. Unspecified lab work was performed. The outcome of tonsillitis, Dengue fever and was still sick was reported as recovering/resolving. The outcome of supposed to receive the third dose of GARASIL on 07-jan-2013 is unknown. The relatedness for tonsillitis, was still sick, supposed to receive the third dose of GARDASIL on 07-jan-2013 and Dengue fever is unknown for GARDASIL. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Dyspnoea, Pruritus, Swelling, Urticaria
Clinical narrative: Hives. Shortness of breath. Chest pain. Itching. Swelling. Sent to ER immediately.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: None stated.
Age: 49.0
Sex: F
Vaccine: TTOX
Symptoms: Asthenia, Crying, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: I woke feeling groggy, fuzzy, fatigued with a slight headache.  As the day progressed I developed a migraine and pain/weakness all over my body.  I had difficulty walking, moving, lifting, etc.  By afternoon I was in so much pain I was crying and even laying still I hurt in every cell of my body. Once home I was administered epson salt soaks for my feet x3 and bath, a variety of homeopathic remedies, herbal detox tea, herbal cream/tinctures for pain and lots of water.
Age: 49.0
Sex: F
Vaccine: TTOX
Symptoms: Headache, Migraine, Mobility decreased, Pain, Somnolence
Clinical narrative: I woke feeling groggy, fuzzy, fatigued with a slight headache.  As the day progressed I developed a migraine and pain/weakness all over my body.  I had difficulty walking, moving, lifting, etc.  By afternoon I was in so much pain I was crying and even laying still I hurt in every cell of my body. Once home I was administered epson salt soaks for my feet x3 and bath, a variety of homeopathic remedies, herbal detox tea, herbal cream/tinctures for pain and lots of water.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEP, MMRV
Symptoms: Computerised tomogram normal, Febrile convulsion, Influenza virus test negative, Pyrexia
Clinical narrative: Fever of 103.3 and resulting febrile seizure.
Age: 17.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Narcolepsy, Sleep study abnormal, Somnolence
Clinical narrative: Gradual diagnosis of increasing drowsiness first noted by parents June, 2010 and steadily worsening over next 1-2 years finally with diagnoses of classic narcolepsy after sleep testing in 1/2013.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Dizziness, Pallor
Clinical narrative: HPV#2 and varicella vaccines given and within a few minutes he became light headed and his face became pale. Had him lie down, have a drink and a snack. B/P initially 88/60 and back up to 110/68 after resting for 15 minutes. Entire event lasted 15 minutes.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: .8 cm area of erythema, warmth tenderness and swelling at injection site
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Ear infection viral, Hearing aid user, Nuclear magnetic resonance imaging, Tinnitus
Clinical narrative: Began to have buzzing and ringing in right ear.  Few days later saw Dr. who said it was probably a viral infection in ear.  Wants to rule out relation to flu shot. Saw ENT, MRI done.  Now wears hearing aid.  Was given PO Steroids with no improvement.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Breath holding, Chills, Crying, Immediate post-injection reaction, Pyrexia
Clinical narrative: Immediate cry after vaccine administration, held breath, chills vs shaking, arms & legs lasted about 10 mins. Shaking stopped when arms or legs are held. Fever of 102 around 1:00 p.m.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Tremor
Clinical narrative: Immediate cry after vaccine administration, held breath, chills vs shaking, arms & legs lasted about 10 mins. Shaking stopped when arms or legs are held. Fever of 102 around 1:00 p.m.
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain, Skin warm
Clinical narrative: Swelling of arm, pain, and red warm area.
Age: 51.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: Severe chills, arm pain, aches.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cerebral haemorrhage, Lethargy, Spinal cord haemorrhage, Vomiting projectile
Clinical narrative: Lethargic, projectile vomiting, bleeding on brain/spine.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: CSF cell count normal, CSF glucose normal, CSF protein increased, Headache, Influenza A virus test negative
Clinical narrative: Pt complained of headache, light sensitivity, neck stiffness, body aches, nausea and fever starting on 4Feb.  Pt was given 1GM Rocephin, Zofran and Tylenol.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Influenza B virus test, Influenza virus test negative, Laboratory test normal, Musculoskeletal stiffness, Nausea
Clinical narrative: Pt complained of headache, light sensitivity, neck stiffness, body aches, nausea and fever starting on 4Feb.  Pt was given 1GM Rocephin, Zofran and Tylenol.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Pain, Photophobia, Pyrexia, Streptococcus test negative
Clinical narrative: Pt complained of headache, light sensitivity, neck stiffness, body aches, nausea and fever starting on 4Feb.  Pt was given 1GM Rocephin, Zofran and Tylenol.
Age: 4.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Vomiting
Clinical narrative: Vomit.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain (R) upper arm.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis, Erythema, Skin swelling
Clinical narrative: Redness, inflamed swollen skin.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Erythema, Pain
Clinical narrative: Positive erythema 3 1/2 cm x 3 1/2 cm x 2 days pain to area - Tx with ice packs, ADVIL for pain.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Full blood count normal, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Fever 101.6 per pt/aches - took one 325 mg TYLENOL T = 97.6 in office arm swollen/erythematous & extremely tender normal CBC.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Fever 101.6 per pt/aches - took one 325 mg TYLENOL T = 97.6 in office arm swollen/erythematous & extremely tender normal CBC.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Patient received injection and has since experienced difficulty moving her left arm. Still experiencing soreness.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Mild swelling, redness and itching at site.
Age: 54.0
Sex: F
Vaccine: FLU3, HEPA, TDAP, TYP
Symptoms: Chest pain, Chills, Dyspnoea, Electrocardiogram normal, Headache
Clinical narrative: 01/12 - midday 01/13: Flu like symptoms/chills (1.5 days). Stayed in bed self-treated with ibuprofen. 01/14 - 01/15: Improvement of symptoms to light headache. 01/17: Per patient, difficulty breathing, intense chest pain, headache, blocked airways, taken by husband to ER (3 hours) pt left AMA - pt felt uncared fore. Pt was given promethazine with codeine. Sx's resolved 01/20.
Age: 54.0
Sex: F
Vaccine: FLU3, HEPA, TDAP, TYP
Symptoms: Influenza like illness
Clinical narrative: 01/12 - midday 01/13: Flu like symptoms/chills (1.5 days). Stayed in bed self-treated with ibuprofen. 01/14 - 01/15: Improvement of symptoms to light headache. 01/17: Per patient, difficulty breathing, intense chest pain, headache, blocked airways, taken by husband to ER (3 hours) pt left AMA - pt felt uncared fore. Pt was given promethazine with codeine. Sx's resolved 01/20.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a 13 years old female patient. On an unknown date, the patient was vaccinated with GARDASIL (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The patient after was administered GARDASIL developed a fever. The patient was treated with antibiotics. The outcome of the event was reported as recovered/resolved. The relatedness for the event was unknown for GARDASIL. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmcist via a representative refers to a 65 to 70 years old female patient. On unknown date, the patient was vaccinated with ZOSTAVAX. The pharmacist reported that the female patient (anonymous) who reported injection site redness and swelling within a 24 hour period. The patient had sought medical attention since he returned to pharmacy for consultation. The relatedness for all the events was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a representative refers to a 65 to 70 years old male patient. On unknown date, the patient was vaccinated with ZOSTAVAX. The pharmacist reported that the male patient reported injection site redness and swelling within a 24 hour period. The patient sought medical attention since he returned to pharmacy for consultation. The relatedness for all the events was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (652965/0622F) ZOSTAVAX on 20-NOV-2006. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a office manager to a 11 years old female patient. The patient was vaccinated with the first dose of GARDASIL (lot# 0636AE) on 21-JAN-2013. No other co-suspects were reported. Concomitant medications included Influenza Virus Vaccine (manufacture unknown) and meningococcal vaccine (manufacture unknown). On 21-JAN-2013 the patient experienced fainted after the administration. The office called the paramedics and the patient was sent to the emergency room at an unspecified hospital for an unspecified duration. No treatment information was reported. The outcome of fainted was unknown. The relatedness for fainted was unknown for GARDASIL. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: This spontaneous report as received from a registered nurse. The nurse was also an 11 years old male patient aunt. The patient was given his third dose of GARDASIL (injection; 0.5ml) on 23-JAN-2013 (the dates of the first 2 vaccinations were unspecified). On 27-JAN-2013, the patient developed "hand print sized red spots all over his body and smaller spots on his face." He was brought to the emergency room (ER) of an unspecified hospital but the representative did not know if the patient was admitted. No other vaccines were given at the time of this vaccination. There was no AE with the first 2 doses of GARDASIL. BENADRYL was given for AE. The outcome of events was unknown. The patient was sought medical attention. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report as received from a regulatory authority refers to a patient of unknown age. The patient was vaccinated with lot # (656609/0015U) ZOSTAVAX on 23-APR-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (656412/1476F) ZOSTAVAX on 17-APR-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report refers to a patient of unknown age. The patient was vaccinated with lot # (657676/0619U) ZOSTAVAX on 12-OCT-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report refers to a patient of unknown age. The patient was vaccinated with lot # (659406/0298X) ZOSTAVAX on 09-JUN-2008. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. the relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report refers to a patient of unknown age. The patient was vaccinated with lot # (656606/0033U) ZOSTAVAX on 17-APR-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report refers to a patient of unknown age. The patient was vaccinated with lot # (657676/0619U) ZOSTAVAX on 13-JUN-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report refers to a patient of unknown age. The patient was vaccinated with lot # (658208/0886U) live ZOSTAVAX on 10-OCT-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for live ZOSTAVAX. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (656609/0015U) ZOSTAVAX on 19-MAR-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (656412/1476F) ZOSTAVAX on 11-SEP-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (656412/1476F) ZOSTAVAX on 13-MAR-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (652965/0622F) ZOSTAVAX on 29-NOV-2006. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (652965/0622F) ZOSTAVAX on 23-OCT-2006. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (656609/0015U) ZOSTAVAX on 01-APR-2008. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (656609/0015U) ZOSTAVAX on 27-SEP-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (652965/0622F) ZOSTAVAX on 29-NOV-2006. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report refers to a patient of unknown age. The patient was vaccinated with lot # (657676/0619U) ZOSTAVAX on 02-OCT-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report refers to a patient of unknown age. The patient was vaccinated with lot # (658208/0886U) ZOSTAVAX on 17-SEP-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (659406/0298X) ZOSTAVAX on 23-MAY-2008. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report refers to a patient of unknown age. The patient was vaccinated with lot # (658208/0886U) ZOSTAVAX on 09-JUL-2008. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report refers to a patient of unknown age. The patient was vaccinated with lot # (657676/0619U) ZOSTAVAX on 25-JUL-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report refers to a patient of unknown age. The patient was vaccinated with lot # (658208/0886U) ZOSTAVAX on 08-JUL-2008. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (657676/0619U) ZOSTAVAX on 22-JUN-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Arthralgia, Body temperature increased, Influenza like illness, Injection site abscess, Injection site cellulitis
Clinical narrative: Case number PHHY2011US94430 is an initial spontaneous report derived from Vaccine Adverse Event Reporting System website (VAERS ID: 433298) on 27 Oct 2011. This case refers to a 65-year-old male patient. His medical history included of hypertension, emphysema, hyperlipidaemia, was ex-smoker and alcohol user. Concomitant therapy included DIOVAN HCT, BYSTOLIC, ADVAIR, CRESTOR and aspirin. He was vaccinated with PNEUMOVAX 23 in 2005 for the first time. On 31 Oct 2008, he was vaccinated for the second time with PNEUMOVAX 23. On 28 Sep 2010, this patient was vaccinated with FLUVIRIN (batch number: 111807P1, expiry date: 30 Apr 2011) into his left deltoid, PNEUMOVAX 23 (other manufacturer, batch number: 667913/1021Z, expiry date: 27 Feb 2012) intramuscularly into his left deltoid and ADACEL vaccine (other manufacturer, batch number: unknown) into his right deltoid. The next day he had flu like symptoms, including nausea, joint and muscular pain that lasted for 24 hours without fever but did not look at his arm. He noticed his arm swelling for the first time on 30 Sep 2010, and it was painful to the touch. He was seen by his physician the same day with swollen left upper arm area and had a slight elevation in temperature of 99F. Assessment included cellulitis and abscess of upper arm. He was advised to elevate and rest his arm, take ibuprofen 400-600 mg every 6 hours as necessary for pain or fever and BENADRYL that night and be re-checked in 2 days. The physician suggested him to take off from work the following day, but he did not want to. He was also prescribed OMNICEF 300 mg one capsule twice daily for 10 days. It was reported that he had recovered by 05 Oct 2010. The physician felt it was probably a reaction to the PNEUMOVAX 23. Batch review report (reference number 133291) received from quality assurance department on 21 Nov 2011: Based on the document review, it was stated that the concerned FLUVIRIN batch number 111807P1 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from QA department received on 21 Nov 2011: Updated the batch review report.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site swelling, Myalgia, Nausea, Oedema peripheral, Pain in extremity
Clinical narrative: Case number PHHY2011US94430 is an initial spontaneous report derived from Vaccine Adverse Event Reporting System website (VAERS ID: 433298) on 27 Oct 2011. This case refers to a 65-year-old male patient. His medical history included of hypertension, emphysema, hyperlipidaemia, was ex-smoker and alcohol user. Concomitant therapy included DIOVAN HCT, BYSTOLIC, ADVAIR, CRESTOR and aspirin. He was vaccinated with PNEUMOVAX 23 in 2005 for the first time. On 31 Oct 2008, he was vaccinated for the second time with PNEUMOVAX 23. On 28 Sep 2010, this patient was vaccinated with FLUVIRIN (batch number: 111807P1, expiry date: 30 Apr 2011) into his left deltoid, PNEUMOVAX 23 (other manufacturer, batch number: 667913/1021Z, expiry date: 27 Feb 2012) intramuscularly into his left deltoid and ADACEL vaccine (other manufacturer, batch number: unknown) into his right deltoid. The next day he had flu like symptoms, including nausea, joint and muscular pain that lasted for 24 hours without fever but did not look at his arm. He noticed his arm swelling for the first time on 30 Sep 2010, and it was painful to the touch. He was seen by his physician the same day with swollen left upper arm area and had a slight elevation in temperature of 99F. Assessment included cellulitis and abscess of upper arm. He was advised to elevate and rest his arm, take ibuprofen 400-600 mg every 6 hours as necessary for pain or fever and BENADRYL that night and be re-checked in 2 days. The physician suggested him to take off from work the following day, but he did not want to. He was also prescribed OMNICEF 300 mg one capsule twice daily for 10 days. It was reported that he had recovered by 05 Oct 2010. The physician felt it was probably a reaction to the PNEUMOVAX 23. Batch review report (reference number 133291) received from quality assurance department on 21 Nov 2011: Based on the document review, it was stated that the concerned FLUVIRIN batch number 111807P1 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from QA department received on 21 Nov 2011: Updated the batch review report.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Autopsy, Death, Livedo reticularis, Peripheral coldness, Pulse absent
Clinical narrative: Case number PHHY2011US113808 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 435354) website on 30 Dec 2011 with a follow-up received from Quality assurance department (reference number: 140343) on 30 Jan 2013: This report refers to a 54-year-old male patient. His medical history included hypertension and type I diabetes and he had no other illnesses. He was vaccinated with FLUVIRIN (batch number: 1100201) intramuscularly in to the right arm on 31 Aug 2011. On 07 Sep 2011 at 12.30 p.m. he laid down for a nap and he offered no complaints at that time. At 2 p.m. his wife found him unresponsive with no pulse and no respiratory effort. His skin was cold and mottled. His wife began chest compressions but did not get a pulse first responders and she also worked on patient and transferred him to a hospital where he was pronounced dead at 2.08 p.m. on 07 Sep 2011. Post mortem results were still pending and no additional information was provided. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN (batch number: 1100201) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirement. Follow-up received from the Quality assurance department on 30 Jan 2013: Updated batch review report.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory arrest, Unresponsive to stimuli
Clinical narrative: Case number PHHY2011US113808 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 435354) website on 30 Dec 2011 with a follow-up received from Quality assurance department (reference number: 140343) on 30 Jan 2013: This report refers to a 54-year-old male patient. His medical history included hypertension and type I diabetes and he had no other illnesses. He was vaccinated with FLUVIRIN (batch number: 1100201) intramuscularly in to the right arm on 31 Aug 2011. On 07 Sep 2011 at 12.30 p.m. he laid down for a nap and he offered no complaints at that time. At 2 p.m. his wife found him unresponsive with no pulse and no respiratory effort. His skin was cold and mottled. His wife began chest compressions but did not get a pulse first responders and she also worked on patient and transferred him to a hospital where he was pronounced dead at 2.08 p.m. on 07 Sep 2011. Post mortem results were still pending and no additional information was provided. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN (batch number: 1100201) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirement. Follow-up received from the Quality assurance department on 30 Jan 2013: Updated batch review report.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Initial case received 29 January 2013 from a healthcare professional, (physician). A 60 year old male patient, with no reported medical history or concomitant medications, received a FLUZONE vaccination, in the left arm on 17 January 2013, batch number and route were not reported. On 18 January 2013 the patient developed numbness and drooping of the right side of the face and was seen by the reporter on 21 January 2013. The patient was examined again on 29 January 2013 and the symptoms remained the same. A steroid dose pack, details not reported, was prescribed on 21 January 2013 with no changes in the condition noted. Laboratory tests and treatment details were not reported. No further details were available at the time of this report. The patient outcome was reported as not recovered. Documents held by sender: None.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: Initial case received 29 January 2013 from a healthcare professional, (physician). A 60 year old male patient, with no reported medical history or concomitant medications, received a FLUZONE vaccination, in the left arm on 17 January 2013, batch number and route were not reported. On 18 January 2013 the patient developed numbness and drooping of the right side of the face and was seen by the reporter on 21 January 2013. The patient was examined again on 29 January 2013 and the symptoms remained the same. A steroid dose pack, details not reported, was prescribed on 21 January 2013 with no changes in the condition noted. Laboratory tests and treatment details were not reported. No further details were available at the time of this report. The patient outcome was reported as not recovered. Documents held by sender: None.
Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Computerised tomogram abdomen abnormal, Intussusception, Surgery, Volvulus
Clinical narrative: This spontaneous report as received from a physician refers to a two and a half month old female patient. The patient was vaccinated with first dose of ROTATEQ (lot number not reported) orally on 29-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. A few weeks later, in approximately January 2013, the patient was diagnosed and treated for intussusception. The patient was operated on at medical center and part of the patient's bowel was removed because of the AE. The patient had done a CAT scan on an unspecified date. The patient was improved after the operation and recovered on an unspecified date. The relatedness for the event was unknown for ROTATEQ. The reporter felt the events was intervention to prevent serious criteria. Additional information has been requested.