chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Somnolence
Clinical narrative: Drowsiness, dizziness starting within 30 minutes of vaccine and lasting approx 24 hours.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Muscular weakness, Nausea, Somnolence
Clinical narrative: Drowsiness; muscle weakness (legs); nausea; diarrhea; and dizziness starting within 30 minutes of vaccine lasting approximately 36  hours.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Epistaxis, Headache, Pain in extremity
Clinical narrative: The evening of the vaccine reports severe headache and very sore arm. Nose bleed (not severe stopped w/o medical intervention.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye pruritus, Heart rate increased, Ocular hyperaemia
Clinical narrative: Reaction started with itchy and red eyes at 6:30pm.  Sx worsened to include rapid heart rate and breathing difficulties.  She was seen at 11:15pm and given #1 EPI, #2 STEROID, 3# BENADRYL.  Given PREDNISONE 50mg X5 to take home.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Ear discomfort, Erythema, Injection site pain, Malaise, Oedema peripheral
Clinical narrative: On the evening of October 17, 2008, patient and his wife came into the pharmacy for vaccination services. We discussed which vaccinations he needed by attempting to call where they suspected his last PNEUMOVAX vaccination took place. They could not provide that information, and they were not sure when the last PNEUMOVAX vaccination had taken place. It was decided that he would get both the Flu vaccine and PNEUMOVAX that evening. They were administered together the Flu in the left arm and the PNEUMOVAX in the right, at about 5pm. Universal precautions and standard IM injection techniques were used. The patient's wife called me on October 24, 2008, at 11:50a.m. to inform me that the patient had been admitted into the hospital on October 23, 2008, at about noon. She informed me that after leaving the pharmacy the couple had gone to dinner, and around 7:00 on the 17th he was experiencing an ill feeling and pain at the PNEUMOVAX injection site that she described as excruciating pain. They called the phone number provided on the VIS and were informed to take aspirin and apply ice to the injection site. Then at 10:00 p.m. they called the ER and were informed to do the same thing. She informed me that on Monday the swelling and redness on the arm was going down, but that he was having swelling in his legs and his ears were plugged. Their primary doctor started the patient on antibiotics. She informed me that he took the antibiotics and that still Thursday the arm was still swollen, red, and painful and thus, he was ordered to enter the hospital. Upon her request I called the physician and left a message with his staff that I was available for any questions and explained what vaccines were given. This was done at 12:24 p.m. October 24, 2008. I have not been contacted as yet by the doctor. On October 27, 2008, I contacted the wife to inquire on his status, and she informed me that he still had arm pain, but that he was coming home from the hospital that day, she thought.  12/24/08-records received for DOS 10/23-10/27/08-DC DX:Phlebitis, right upper arm. Right shoulder hematoma, deltoid, post vaccination for flu. Decreased range of motion right shoulder, post vaccination for flu. Presented with C/O severe pain in right shoulder consistent with phlebitis and hematoma. Admitted for intravenous antibiotics.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: On the evening of October 17, 2008, patient and his wife came into the pharmacy for vaccination services. We discussed which vaccinations he needed by attempting to call where they suspected his last PNEUMOVAX vaccination took place. They could not provide that information, and they were not sure when the last PNEUMOVAX vaccination had taken place. It was decided that he would get both the Flu vaccine and PNEUMOVAX that evening. They were administered together the Flu in the left arm and the PNEUMOVAX in the right, at about 5pm. Universal precautions and standard IM injection techniques were used. The patient's wife called me on October 24, 2008, at 11:50a.m. to inform me that the patient had been admitted into the hospital on October 23, 2008, at about noon. She informed me that after leaving the pharmacy the couple had gone to dinner, and around 7:00 on the 17th he was experiencing an ill feeling and pain at the PNEUMOVAX injection site that she described as excruciating pain. They called the phone number provided on the VIS and were informed to take aspirin and apply ice to the injection site. Then at 10:00 p.m. they called the ER and were informed to do the same thing. She informed me that on Monday the swelling and redness on the arm was going down, but that he was having swelling in his legs and his ears were plugged. Their primary doctor started the patient on antibiotics. She informed me that he took the antibiotics and that still Thursday the arm was still swollen, red, and painful and thus, he was ordered to enter the hospital. Upon her request I called the physician and left a message with his staff that I was available for any questions and explained what vaccines were given. This was done at 12:24 p.m. October 24, 2008. I have not been contacted as yet by the doctor. On October 27, 2008, I contacted the wife to inquire on his status, and she informed me that he still had arm pain, but that he was coming home from the hospital that day, she thought.  12/24/08-records received for DOS 10/23-10/27/08-DC DX:Phlebitis, right upper arm. Right shoulder hematoma, deltoid, post vaccination for flu. Decreased range of motion right shoulder, post vaccination for flu. Presented with C/O severe pain in right shoulder consistent with phlebitis and hematoma. Admitted for intravenous antibiotics.
Age: 14.0
Sex: M
Vaccine: FLUN3, MNQ
Symptoms: Immediate post-injection reaction, Vascular headache, Vomiting
Clinical narrative: Vascular headache probably secondary to MENACTRA vaccine. Severe headache onset within minutes of vaccination. Vomited once. Treated with Ibuprofen 800 mg every 4-6 hrs.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Pyrexia, Skin warm
Clinical narrative: Pt called the store on 11/12/08 to report reaction to a PNEUMOVAX vaccination on Monday 11/10/08. Red, hot inflamed area on left arm by axilla (size of a plum), Fever. Went to ER & personal physician on 11/12/08.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: With 17X 2cm erythematous area with mild edema on (L) triceps/biceps region extending to elbow x 3days- Pt Rx ALLEGRA and Naproxen.
Age: 36.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Body temperature, Dizziness, Feeling hot, Heart rate normal, Hyperhidrosis
Clinical narrative: 11-6-08 0920 TWINRIX 1.0 ml vaccine given IM R deltoid lot AHABB128AB, Exp. 7-18-10.  Immediately became pale, c/o whole body feeling warm.  Lightheaded.  BP 30/42 L p.60 T 97.8 degrees. R. 16. No itchiness, no SOB, no rash.  Assisted to cof. 0950 BP 100/60, p.60 6pm.  Respiration nonlabored 12-16.  0935 BP 102/64 p. 60 6pm. O2 per NC @ 2-4 6pm X 5min.  0940-0945.  IM sitting BP 90/60.  Color pink. Skin WID. had some diaphoresis 0950. 1020 feeling fine.
Age: 36.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Immediate post-injection reaction, Pallor
Clinical narrative: 11-6-08 0920 TWINRIX 1.0 ml vaccine given IM R deltoid lot AHABB128AB, Exp. 7-18-10.  Immediately became pale, c/o whole body feeling warm.  Lightheaded.  BP 30/42 L p.60 T 97.8 degrees. R. 16. No itchiness, no SOB, no rash.  Assisted to cof. 0950 BP 100/60, p.60 6pm.  Respiration nonlabored 12-16.  0935 BP 102/64 p. 60 6pm. O2 per NC @ 2-4 6pm X 5min.  0940-0945.  IM sitting BP 90/60.  Color pink. Skin WID. had some diaphoresis 0950. 1020 feeling fine.
Age: 8.0
Sex: M
Vaccine: DTAP, HEPAB, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt was given a TWINRIX instead of correct dosage for age. Misadministration
Age: 54.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Arthralgia, Rash
Clinical narrative: Arthralgia; bilateral knees; hips; hands; 1 week after. Improving 1 week after. Rash over lower abdomen, 2 weeks after. Lasted 2 weeks.
Age: 15.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Erythema, Injection site pruritus, Skin warm, Tenderness
Clinical narrative: 10/13/08 received varicella in LA.  10/14/08 started itching in area of injection - "reddened size of dime". Felt warm and hard. Firm area around injection site - 25 mm. Surrounded by larger reddened area on 10/15/08.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cough, Erythema, Hypersensitivity, Oedema peripheral, Pain
Clinical narrative: He had received a PNEUMOVAX shot on November 5th, in the right arm. yesterday it was red and swollen, he felt achy all over and had a bit of chest congestion and cough. He took ADVIL PM and is noticing that he is better today. I does look like an allergic reaction. He has benefited already from some ADVIL PM he took so I
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pulmonary congestion
Clinical narrative: He had received a PNEUMOVAX shot on November 5th, in the right arm. yesterday it was red and swollen, he felt achy all over and had a bit of chest congestion and cough. He took ADVIL PM and is noticing that he is better today. I does look like an allergic reaction. He has benefited already from some ADVIL PM he took so I
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Area where shot administered (5 in diameter) was red and swollen. Pain experienced down through elbow and into armpit. Patient unable to lift arm above head
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: States arm started having pain, redness very swollen-pain radiating up to shoulders (arm) feverish. Saw PMD- states was allergic reaction- was given Benadryl.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Eye swelling, Oedema peripheral
Clinical narrative: Patient eyes and hands became swollen and red 15-20 minutes after administering the immunizations. Patient given Benadryl .04ml and allergic.
Sex: M
Vaccine: HEPAB
Symptoms: Migraine, Nausea, Neck pain
Clinical narrative: 1 hour after Twinrix - severe migraine headache, neck pain and nausea. Took PERCOCET (is a pharmacist). Duration of symptoms 16 hours. Resolved next day am. Considered ER but did not go.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Large local reaction with 2 cm of induration and 7 cm or erythema
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haematoma, Injection site swelling
Clinical narrative: Immediately upon vaccination, the site bruised and swelling @ 1 cm in diameter and 2-3 mm high.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Child  was inadvertently given the Preservative Free Influenza vaccine for ages 3 - 18 years of age instead of the Preservative Free Influenza vaccine for 6 - 35 months of age. No adverse event occured.
Age: 12.0
Sex: M
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Abdominal pain, Abdominal pain upper, Asthenia, Cough, Eye swelling
Clinical narrative: All-over ache, swollen eyes and throat, stiffness, fatigue, weakness, sweating, croupy cough, congestion (3 days); stomach and abdominal sharp pain, vomiting, low-grade fever (2 days).
Age: 12.0
Sex: M
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Fatigue, Hyperhidrosis, Musculoskeletal stiffness, Pain, Pharyngeal oedema
Clinical narrative: All-over ache, swollen eyes and throat, stiffness, fatigue, weakness, sweating, croupy cough, congestion (3 days); stomach and abdominal sharp pain, vomiting, low-grade fever (2 days).
Age: 12.0
Sex: M
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Pyrexia, Respiratory tract congestion, Vomiting
Clinical narrative: All-over ache, swollen eyes and throat, stiffness, fatigue, weakness, sweating, croupy cough, congestion (3 days); stomach and abdominal sharp pain, vomiting, low-grade fever (2 days).
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: An hour after receiving the vaccination, patient complained of symptoms.  Patient felt dizzy.  Tongue felt heavy and throat swollen a little.  She went to clinic where she received a benadryl shot and steroid shot.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Cough, Dizziness, Induration, Injected limb mobility decreased, Injection site pruritus
Clinical narrative: 80MM DIAMETER WHEAL WITH 20MM INDURATION NOTED ON 11-14-2008.  ARM TENDER, SLIGHTLY SWOLLEN, AND VERY WARM TO TOUCH.  CHILD REPORTED INCREASED DIZZINESS AND THE DEVELOPMENT OF A COUGH WITHIN A FEW HOURS OF RECEIVING IMMUNIZATIONS.  THE COUGH AND DIZZINESS RESOLVED BY 11-13-2008.  BY 11-14-2008, CHILD REPORTED AN INABILITY TO ABDUCT LIMB ("HEAVINESS" AND PAIN).  CHILD WAS GIVEN TYLENOL FOR PAIN AND BENADRYL FOR ITCHINESS AT INJECTION SITE.  WAS SEEN IN URGENT CARE FOR MEDICAL ATTENTION ON 11-14-2008.  BY MONDAY, 11-17-2008, CHILD'S ARM WAS LESS RED, LESS TENDER.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Oedema peripheral, Pain in extremity, Sensation of heaviness, Skin warm, Tenderness
Clinical narrative: 80MM DIAMETER WHEAL WITH 20MM INDURATION NOTED ON 11-14-2008.  ARM TENDER, SLIGHTLY SWOLLEN, AND VERY WARM TO TOUCH.  CHILD REPORTED INCREASED DIZZINESS AND THE DEVELOPMENT OF A COUGH WITHIN A FEW HOURS OF RECEIVING IMMUNIZATIONS.  THE COUGH AND DIZZINESS RESOLVED BY 11-13-2008.  BY 11-14-2008, CHILD REPORTED AN INABILITY TO ABDUCT LIMB ("HEAVINESS" AND PAIN).  CHILD WAS GIVEN TYLENOL FOR PAIN AND BENADRYL FOR ITCHINESS AT INJECTION SITE.  WAS SEEN IN URGENT CARE FOR MEDICAL ATTENTION ON 11-14-2008.  BY MONDAY, 11-17-2008, CHILD'S ARM WAS LESS RED, LESS TENDER.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: 80MM DIAMETER WHEAL WITH 20MM INDURATION NOTED ON 11-14-2008.  ARM TENDER, SLIGHTLY SWOLLEN, AND VERY WARM TO TOUCH.  CHILD REPORTED INCREASED DIZZINESS AND THE DEVELOPMENT OF A COUGH WITHIN A FEW HOURS OF RECEIVING IMMUNIZATIONS.  THE COUGH AND DIZZINESS RESOLVED BY 11-13-2008.  BY 11-14-2008, CHILD REPORTED AN INABILITY TO ABDUCT LIMB ("HEAVINESS" AND PAIN).  CHILD WAS GIVEN TYLENOL FOR PAIN AND BENADRYL FOR ITCHINESS AT INJECTION SITE.  WAS SEEN IN URGENT CARE FOR MEDICAL ATTENTION ON 11-14-2008.  BY MONDAY, 11-17-2008, CHILD'S ARM WAS LESS RED, LESS TENDER.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Chills, Cough, Dizziness
Clinical narrative: FRIDAY NIGHT STARTED WITH SEVERE BURNING SENSATION IN THROAT.SATURDAY:WEAK, WHOLE BODY ACHINESS, CHILLS. SUNDAY: FATIGUE EASILY, CHEST IS TIGHT, COUGHING, EARACHES, SINUS PAIN ON L SIDE. MONDAY: STILL FEELS WEAK, THROAT STILL SORE& BURNING,CHEST IS TIGHT, SINUS PAIN, CHILLS, A BIT DIZZY AT TIMES.i FAXED A NOTE TO MY PHYSICIAN SINCE THEIR LINE IS BUSY. i DON'T HAVE THE INFO ON THE VACCINE.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Fatigue, Pain, Sinus headache, Throat irritation
Clinical narrative: FRIDAY NIGHT STARTED WITH SEVERE BURNING SENSATION IN THROAT.SATURDAY:WEAK, WHOLE BODY ACHINESS, CHILLS. SUNDAY: FATIGUE EASILY, CHEST IS TIGHT, COUGHING, EARACHES, SINUS PAIN ON L SIDE. MONDAY: STILL FEELS WEAK, THROAT STILL SORE& BURNING,CHEST IS TIGHT, SINUS PAIN, CHILLS, A BIT DIZZY AT TIMES.i FAXED A NOTE TO MY PHYSICIAN SINCE THEIR LINE IS BUSY. i DON'T HAVE THE INFO ON THE VACCINE.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Gastroenteritis
Clinical narrative: Patient with history of Acute Gastroenteritis 1/12/09-hospital records received for DOS 5/2-5/9/08-DC DX: Gastroenteritis. Urinary tract infection. Presented with C/O vomiting.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Developed facial shingles three days after flu shot and primary physician requested reporting via the VAERS.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Erythema, Infection, Oedema peripheral, Skin warm
Clinical narrative: Swollen red warm arm,arm infection.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor, Urticaria
Clinical narrative: Began to feel shaky on two hours after the shot which was given on 10.29.08 - broke out in hives later that nite and have been breaking out ever since the shot - will be seeing my MD on 11.18.08 as this condition has been ongoing since I received the shot.
Age: 81.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Diarrhoea, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Abdominal distress (first 1-2 days) followed by serious diarrhea (7 days; at reporting, symptoms are waning but have not abated)                  (Pain at injection site and severe swelling up to shoulder for 2 days also noted)               (General malaise for 2 days)
Age: 81.0
Sex: F
Vaccine: FLUX
Symptoms: Oedema peripheral
Clinical narrative: Abdominal distress (first 1-2 days) followed by serious diarrhea (7 days; at reporting, symptoms are waning but have not abated)                  (Pain at injection site and severe swelling up to shoulder for 2 days also noted)               (General malaise for 2 days)
Age: 1.0
Sex: F
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Rash developed 10 days after injection
Age: 26.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Burning sensation, Pain in extremity, Rash, Sensation of heaviness, Sleep disorder
Clinical narrative: CLIENT STATED THAT THE FIRST TWO DAYS AFTER THE FLU SHOT, SHE HAD "A RASH AND MY ARM FELT HEAVY.  THERE WAS SOME PAIN, BUT NOT ALOT."  SHE THEN GOES ON TO SAY THAT THE THIRD DAY AFTER THE FLU SHOT SHE HAD A SHARP BURNING PAIN THAT RADIATED UP HER RIGHT NECK AND DOWN HER RIGHT ARM.  SHE SAID THAT SHE TOOK TYLENOL, USED THE COLD COMPRESSES, TOOK HOT SHOWERS, BUT DID NOT GET ANY RELIEF AND CANNOT SLEEP.  SHE DID NOT TAKE HER TEMPERATURE SO SHE IS NOT AWARE OF A FEVER.  SHE CALLED OUR OFFICE BEFORE GOING TO SEE A DOCTOR.  ENCOURAGED HER TO SEE HER PRIMARY CARE PHYSICIAN. SHE SAID THAT SHE DOES NOT HAVE ONE SHE WOULD HAVE TO GO TO THE ER.  2/5/09 Received ER medical records of 11/21/2008. FINAL DX: cervicalgia; pain in limb Records reveal  patient experienced right side neck & shoulder pain x several weeks.  Exam noted sever muscle spasm of right posterior neck & severe soft tissue tenderness of right upper neck.  Tx w/steroids & pain meds.  Phone f/u revealed patient improved on 11/24/08.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: FLULAVAL given 1 minute after my wife, 33 days ago.Pain in my left arm where shot was given. After two days had passed I was in excruiating pain, so much so that I went back to doctor. Since that time I have had and MRI of my shoulder and arm. I have been on steriods, darvocet, percoset, had xrays of my shoulder and arm via an orthopedic doctor. Manufacturer offered NO help whatsoever. No my hand is in a splint.Have had physcial therapy for week and still in pain. what to do? and why?
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Ear discomfort, Immediate post-injection reaction, Injection site erythema, Injection site induration
Clinical narrative: I experienced plugged up ears all day starting within minutes of shot & sharp pain through my right knee and into my thigh for a few hours on that day. Increased soreness, hardness, and redness of area of shot over weekend. Today it is starting to spread out - but less sore, hard, and red... starting to itch. Too busy to get checked out - so I did not do it. I have never had any reaction to these shots before.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site pruritus, No reaction on previous exposure to drug, Pain in extremity
Clinical narrative: I experienced plugged up ears all day starting within minutes of shot & sharp pain through my right knee and into my thigh for a few hours on that day. Increased soreness, hardness, and redness of area of shot over weekend. Today it is starting to spread out - but less sore, hard, and red... starting to itch. Too busy to get checked out - so I did not do it. I have never had any reaction to these shots before.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Impetigo, Rash, Staphylococcal infection
Clinical narrative: 11/06/2008 received FluMist at Flu Clinic/Exercise.  11/11/08-noticed slight rash on rt. side of upper lip, during weekend spread to outer left side of nostril. MOC took child to clinic on 11/17/08, rash dx. as staph infection (impetigo) given medication and instructions to stop spread, also told to report it to Public Health.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hyperaesthesia, Lymphadenopathy, Pyrexia, Vomiting
Clinical narrative: GENERALIZED HYPERSENSITIVITY TO TOUCH LASTING ONE DAY; VOMITING LASTING ONE DAY; FEVER LASTING TWO DAYS; SWOLLEN LYMPH NODES LASTING FOUR DAYS
Age: 44.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Chills, fever; swelling/redness/tenderness to outer aspect of upper L arm immediately after injection, on third day of symptoms when seen by PCP.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: red 2" diameter, warm to touch, hard knot at injection site, began on 11/15/2008.  Patient did not take any OTC meds
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Ageusia, Facial palsy
Clinical narrative: Four days following administration of Fluarix, Lot Number AFLUA380CA, Expiration 6/30/09, I came down with facial palsy on the same side of the body (right) as the injection.  The palsy started with loss of taste sensation, moving through the mouth and up to the eye, resulting in partial paralysis by the following afternoon (complete paralysis of the mouth).  Current course of treatment is Prednisone and Zovirax in addition to Chinese herbs. 1/14/09 Reviwed ER medical records of 11/13/2008. FINAL DX: Bell's palsy Records reveal patient experienced gradual right sided facial numbness, inability to close right eye, droop right mouth, loss of right nasolabial fold x 1 day.  Tx w/antiviral & steroid meds.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pruritus, Skin burning sensation, Urticaria
Clinical narrative: The morning after receiving the flu shot I had 2 hard red welts on my lower left back, the same side as the shot. 2 days later the same 2 hard welts appeared on my left ankle. 2-3 days later they moved to my left neck. 2-3 days later they moved to my lower left back. 2-3 later they moved to my left arm. 11/14 one welt moved to my right jaw. 11/16 one welt moved to my right upper arm. The welts are about 1 1/2" long to 1" wide. Always just 2. They start out as a hard lump, then get bright red start burning & have a slight itch. The welts that were on my ankle have left the bone at that area very sore.
Age: 37.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Wrong drug administered
Clinical narrative: Pediatric/Adolescent Hepatitis A given instead of adult dose
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Pain, Pyrexia, X-ray limb
Clinical narrative: Patient is experiencing left shoulder pain which she feels is in result of her flu vaccine adminsitered on 10/27/08. She stated 2 hours after the injection she started noticing a burning type pain and a low grade fever. She was also unable to reach behind her head. No swelling or redness was present. She had been seen by Dr. on 11/10/08. A left shoulder xray was obtained. Agreed upon recommendation - physical therapy for the shoulder per Dr. dictation.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large amount of swelling and redness at site of injection, lasting several hours after administration.  No treatment.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling, Pain in extremity, Staphylococcal infection, Tenderness
Clinical narrative: After the vaccination, my arm was sore but I expected this.  Two days after the vaccination, there was swelling around the injection site and the arm continued to be sore.  Three days after the vaccination, the swelling around the injection site worsened, so I went back to the clinic.  The doctor on duty identified it as a staph infection and prescribed Azithromycin.  He told me to take two immediately, then continue to take 1 per day for 6 days.  The arm continued to ache for about a week.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Lymphadenopathy, Pain, Tenderness
Clinical narrative: Patient arrived at the pharmacy 2 days after vaccine administration with swollen lymph nodes in the clavicular area.  She described feeling general ache on the night of vaccine administration.  The day after, vaccination, she described seeing the enlarged lymph node in the clavicle area.  Patient was followed up the day later and also described having tenderness and pain in her axillary area as well.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased activity, Pallor, Pharyngeal oedema, Pyrexia
Clinical narrative: Child received influenza vaccine at approximately 1:30 p.m. on 11/14/08, about 1/2 hour after administration, father called to report that child was "out of it", looked pale, doesn't want to do anything.  Nurse advised parent to lay child down, elevate legs/feet and use cold cloth or ice pack.  Father advised by nurse that if he continues to have problems to take the child to the ER, since child does not have a primary physician.  11/17/08 Follow-up call to parents by RN, mom reports child was taken to ER, his temperature was 102-103, he very pale and a "swollen throat", Mom states child started to "come around" after ER gave medication (mother unaware what medication was given), and child was sent home.  Child today is having no problems. Information given to mom regarding VAERS and vaccine compensation program.  Advised mother this would be reported by this office to VAERS.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large amount of swelling and redness at site of injection (left arm) lasting several hours after administration.  No treatment.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Receive vaccination in left deltoid on Saturday 11/15/08. Began having redness and swelling early Monday morning, 11/17/08.  Went to doctor that afternoon to get it checked.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Asthenia, Choking, Cyanosis, Pyrexia, Vomiting
Clinical narrative: Administered the DTaP, IPV, and Hib vaccines around 10:15am. Mom called back early to mid afternoon describing that patient had a fever, went limp, lips were dusky, then vomited and choked a bit. Came back to my office within an hour of this episode. Appeared fine. Sent to ER for acute life threatening.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: This patient developed a warm, red, hard knot at the area of injection which had lasted for 5 days.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abasia, Injection site erythema, Injection site warmth, Myalgia, Pyrexia
Clinical narrative: ADMINISTERED IN LEFT THIGH MUSCLE. REPORTED FEVER OF 103DEGREES FOR 2 DAYS. SMALL RED AREA AT INJECTION SIGHT, 2 INCHES AWAY WAS FEVERISH AREA SIZE OF SMALL ORANGE. MUSCLE SORENESS TO THE POINT OF BEING UNABLE TO WALK ON LEG FOR 3 DAYS. ALL SYMPTOMS RESOLVED ON THEIR ON OWN IN 6 DAYS. USED TYLENOL AND HEAT/COLD FOR COMFORT AND FEVER.
Age: 0.01
Sex: M
Vaccine: HBHEPB
Symptoms: Dyspnoea, Nasal congestion
Clinical narrative: Irregular breathing...patient was fine the first two day after he was born, no usual breathing. Right before we left the hospital they gave him the hepatitis vaccine with out consent and within a few hours I noticed he was breathing very funny. I took him to the doctor, they said he looked ok. Just to monitor his breathing. He had several issues with his nose being stuffed and they told me to get a humidifier to help with his breathing. Within a month or so his respiratory issues seemed to have cleared up. (he would breathe ok then suddenly breathe very heavy it went in intervals it continued for several weeks after he received the shot)
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain
Clinical narrative: 3 hours after receiving the flu shot (inactivated influenza vaccine 2008-09) I was stricken with the most severe back pain I've ever felt, except for when I had back surgery ~3 years ago. It felt like a disc in my lower back approx. L4 or L5 had slipped half a notch and I experienced exruciating pain. It was all I could do to drive home and go to bed, laying face down until morning. I slowly recovered over the next 3 days.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Facial palsy
Clinical narrative: Left facial paralysis with onset 11/16/08.  Diagnosed with Bell's palsy on 11/17/08. HEENT: Fundi nl. TM's and ears clear. no vessicles. OP clear. nares patent.  neuro:      A & O; CN 2-12 nl except for 7th cranial nerve: L forehead weak,  can't raise L eyebrow, can't close L eye; L side of mouth drooping; sensation to  light touch nl all ext; strength 5/5 all ext; muscle tone and bulk nl.  coordination nl to past point, rapid alternating movements; gait nl; DTR's symmetric and non-pathologic all extremities; romberg negative; babinski negative; no clonus.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 40-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 12 November 2008 at 10:10, the subject received a dose of FLULAVAL (.5 ml, unknown, right arm). On 12 November 2008, immediately after vaccination with FLULAVAL, the subject experienced swelling injection site, injection site redness, injection site pain. On 12 November 2008 at 10:20, the subject experienced dizziness, and panic sensation. The subject was treated with Epinephrine. On 12 November 2008 at 11:20, the subject experienced trouble breathing and throat tightness. The healthcare professional reported the subject received FLULAVAL at a flu vaccine clinic held at a job site at 10:10 and immediately experienced swelling, redness, and pain at the injection site. The subject was monitored for five to ten minutes and then felt panicked and dizzy. The subject then received epinephrine 0.5mL, felt better and went back to work. One hour later the subject returned complaining that she was having trouble breathing and her throat was tightening. She was then given a second dose of epinephrine (0.3mL). She did not respond to the epinephrine so she was given another 0.3mL dose. The subject did respond and stated she felt fine. She was advised to go to the emergency room, but the subject felt she did not need to and she therefore, did not go to the ER. The reporter stated these adverse events resolved between 12-12:30 pm. The healthcare professional considered the events were clinically significant (or requiring intervention). On 12 November 2008, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Panic reaction, Throat tightness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 40-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 12 November 2008 at 10:10, the subject received a dose of FLULAVAL (.5 ml, unknown, right arm). On 12 November 2008, immediately after vaccination with FLULAVAL, the subject experienced swelling injection site, injection site redness, injection site pain. On 12 November 2008 at 10:20, the subject experienced dizziness, and panic sensation. The subject was treated with Epinephrine. On 12 November 2008 at 11:20, the subject experienced trouble breathing and throat tightness. The healthcare professional reported the subject received FLULAVAL at a flu vaccine clinic held at a job site at 10:10 and immediately experienced swelling, redness, and pain at the injection site. The subject was monitored for five to ten minutes and then felt panicked and dizzy. The subject then received epinephrine 0.5mL, felt better and went back to work. One hour later the subject returned complaining that she was having trouble breathing and her throat was tightening. She was then given a second dose of epinephrine (0.3mL). She did not respond to the epinephrine so she was given another 0.3mL dose. The subject did respond and stated she felt fine. She was advised to go to the emergency room, but the subject felt she did not need to and she therefore, did not go to the ER. The reporter stated these adverse events resolved between 12-12:30 pm. The healthcare professional considered the events were clinically significant (or requiring intervention). On 12 November 2008, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL.
Age: 40.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site irritation, Injection site pain, Pharmaceutical product complaint
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of stinging at the injection site in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX. At an unspecified time after vaccination with TWINRIX, the subject experienced stinging and burning at the injection site. This was also reported to be a product complaint as the reporter felt the events were related to a quality issue with the TWINRIX injection. The outcome of the events was unspecified. It was reported that 10 subjects (including this one) experienced burning and stinging at the injection site following administration of TWINRIX from the same lot. Linked case include: A0752087A, A0752088A, A0752089A, A0752090A, A0752091A, A0752092A, A0752093A, A0752094A and A0752095A. Follow-up information was received on 04 November 2008, by a physician and described the occurrence of injection site stinging in a 39-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject had no adverse events were reported with previous vaccinations. On an unspecified date, the subject received 2nd dose of TWINRIX (unknown). On 03 October 2008, at an unspecified time after vaccination with TWINRIX, the subject experienced injection site stinging, injection site burning and TWINRIX AHABB128AB batch has problem. The physician considered the case as medically serious. On 03 October 2008, the events were resolved. The physician considered the events were related to vaccination with TWINRIX.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: 10/20/08 FLUVIRIN given. 11/17/08 patient complains of tingling, burning sensation on left arm. Not constant, on and off.  (vaccine in left arm).
Age: 41.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site urticaria
Clinical narrative: 20x15 cm. hive in Rt. upper arm consisted with immunization rx.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Erythema, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Pt states had red, swollen, sore right arm from elbow to armpit - fever and was achey, Tried heat and made arm burn. Is on Naprosyn antibiotic already from other
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Pt states had red, swollen, sore right arm from elbow to armpit - fever and was achey, Tried heat and made arm burn. Is on Naprosyn antibiotic already from other
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pta developed erythema, induration and mild tenderness around site of injection. Will observe now. Cool soaks. Recheck day to day if worsening.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Body temperature increased, Headache, Muscle rigidity, Neck pain
Clinical narrative: Flumist given 11/2/08.  Developed HA 11/10.  Neck pain, nuchal rigidity 11/13.  Afebrile.  Head MRI negative.  HA resolved 11/14, neck pain resolved 11/16.  Abd pain 11/16, V x2.  No D.  Temperature 99.2.  No P.O., abd pain severe - ER.  P.E. sig. for afebrile, RUQ abd pain to palp, severe leg pain to palp.  CXR negative.  WBC = 19K with 90% polys.  U/A positive ketones only.  Pain resolved with NSO4 and IVF.  Today (11/17) without do.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Nodule, Nuclear magnetic resonance imaging normal, Urine analysis abnormal, White blood cell count increased
Clinical narrative: Flumist given 11/2/08.  Developed HA 11/10.  Neck pain, nuchal rigidity 11/13.  Afebrile.  Head MRI negative.  HA resolved 11/14, neck pain resolved 11/16.  Abd pain 11/16, V x2.  No D.  Temperature 99.2.  No P.O., abd pain severe - ER.  P.E. sig. for afebrile, RUQ abd pain to palp, severe leg pain to palp.  CXR negative.  WBC = 19K with 90% polys.  U/A positive ketones only.  Pain resolved with NSO4 and IVF.  Today (11/17) without do.
Age: 2.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Allergy to vaccine, Erythema, Induration, Oedema peripheral, Skin warm
Clinical narrative: Swollen Rt thigh, hot to touch: red, erythema and firm.
Age: 2.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Tenderness
Clinical narrative: Swollen Rt thigh, hot to touch: red, erythema and firm.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Skin warm, Tenderness, X-ray abnormal
Clinical narrative: Pt developed area of tenderness 2 days later. Redness, slight warmth - tenderness to area. Tx Doxycycline dose 150mg Tid x 7 days. DIFLUCAN 150mg po Qdx8
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash papular
Clinical narrative: Papular, pruritis rash on (B) arms and legs
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Asthenia, Frequent bowel movements, Malaise, Vomiting projectile
Clinical narrative: Had flu shot on Wed - felt fine; Thurs. sick all day - stomach pain, projectile vomiting X 2 and 5 bowel movements (4 solid and 1 liquid) Fri. felt "weak as a kitten"
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Myalgia, Pain in extremity
Clinical narrative: Patient says arm hurts to move up and away from body and has had ever since vaccination. Patient has not been seen by MD yet. I encouraged her to go to the doctor to get it check out. No outward signs or symptoms just the muscle pain.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Electrocardiogram abnormal, Laboratory test, Ultrasound scan normal, Ventricular extrasystoles
Clinical narrative: Began throwing PVC's on 10/5/08 sent to ER, EKG done, labwork, CXR sent home from ER with abnormal EKG saw cardiologist 10/9/08. US of heart normal.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Convulsion
Clinical narrative: Pt received 1st dose of GARDASIL. Pt began seizing in approx 3-4 seconds after receiving GARDASIL vaccine.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Hypertension, Nausea
Clinical narrative: 45 minutes after AFLURIA complained of feeling hot and nauseated. RN checked vitals: BP 144/100 pulse 72 skin warm and dry. Appears fine. Was talking on telephone when RN arrived for assessment. Voicemail left at pt's home 11/14.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Discomfort, Injection site erythema
Clinical narrative: Patient returned to flu clinic about 2 hours after injection of flu vaccine, complaining of discomfort and increased temperature. Per RN assessment, revealed mild redness around site.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal pain, Neck pain
Clinical narrative: Swelling at site of FLUZONE shot. Pain in deltoid, shoulder, and neck. Area warm per RN.
Age: 3.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Erythema, Induration
Clinical narrative: Has 7X3 cms Erythema, induration X 2days. No fever. Warm compress, po AUGMENTIN 400 PO BIOX 10
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: Pt called stating he had fever 102 and RT arm was sore and very red. Advised to come to office to see Doctor. Prescribed Augmentin for possible Cellulitis, Benadryl and Tylenol. 11/17/08 pt is doing better reaction less red at this time.
Age: 0.6
Sex: F
Vaccine: HIBV, PNC
Symptoms: Erythema, Oedema peripheral, Swelling
Clinical narrative: With first short, (R) leg swelled and turned red same day, lasted about 2 days; with third short, red, softball-sized area within 24 hrs; resolved after 48 hrs without concern.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea
Clinical narrative: Pt c/o SOB, back pain about 3-5 min after vaccine given. Pt given 50 mg Benadryl IV, 80mg depo-medrol IM, and HH Neb with xopenex.
Age: 63.0
Sex: F
Vaccine: TD
Symptoms: Muscle swelling, Pain, Pyrexia, Skin warm
Clinical narrative: Fever to 101.2.  deltoid muscle swollen, hot to touch and painful.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Edema, warmth, tenderness at the injection site one hour post PNEUMOVAX.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Dizziness, Nausea, Pain, Pyrexia
Clinical narrative: Initial information was received on 14 November 2008 from a health care professional.  A 13 year old male patient with a history of an irregular heart rate, wheezing and seasonal allergies received an intramuscular left deltoid injection of MANACTRA (U2817AA) on 13 November 2008 at 13:15 PM.  Within hours the patient complained of a headache, nausea, dizziness and a fever.  The patient was not recovered at the time of vaccination.  List of Documents held by Sender: None.
Age: 13.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Initial information was received on 14 November 2008 from a health care professional.  A 13 year old male patient with a history of an irregular heart rate, wheezing and seasonal allergies received an intramuscular left deltoid injection of MANACTRA (U2817AA) on 13 November 2008 at 13:15 PM.  Within hours the patient complained of a headache, nausea, dizziness and a fever.  The patient was not recovered at the time of vaccination.  List of Documents held by Sender: None.
Age: 3.0
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Infantile spitting up, Underdose
Clinical narrative: Information has been received from a medical assistant concerning a 2 month old female infant who on 29-JUL-2008 was vaccinated orally with a first 2ml dose of ROTATEQ.  Concomitant therapy on that same day included TYLENOL.  It was reported that infant spit all of the vaccine out of her mouth.  It was noted that the infant was given TYLENOL prior to the vaccination.  It was also noted that the infant probably did not like the taste of the vaccine.  Medical attention was sought at the office.  At the time of the report, the patient's status was unknown.  There was no product quality complaint involved.   Follow-up information has been received from a medical assistant concerning a 41 month old female patient (previously reported as 2 month old) who on 29-JUL-2008 was vaccinated with a first dose of ROTATEQ.  There was no illness at the time of vaccination.  It was reported that the patient spit out the majority of the vaccine.  At the time of the report, the patient's status was unknown.  Additional information is not expected.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Infantile spitting up, Regurgitation, Vomiting
Clinical narrative: Information has been received from a physician concerning an 8 week old white female with no allergies or pertinent medical history who on 01-OCT-2008 was vaccinated po with a 2ml second dose of ROTATEQ.  There was no concomitant medication.  The physician reported that the patient immediately spit up what appeared to be entire dose of ROTATEQ as well as the milk just given.  The physician stated they could see the ROTATEQ in the milk.  Unspecified medical attention was given in the physician's office.  No laboratory diagnosis were done.  A product quality  complaint was not involved.  Follow up information was received on 21-OCT-2008.  The patient was reported to be 16 weeks old.  It was reported the patient experienced emesis on "08-OCT-2008".  The patient vomited up ROTATEQ and formula immediately after dose.  The patient recovered the same day.  Additional information has been requested. 12/03/08 This is in follow-up to report(s) previously submitted on 11/14/2008. In formation has been received from a physician concerning an 8 week old female with no allergies or pertinent medical history who on 01-OCT-2008 was vaccinated po with a 2 ml second dose of ROTATEQ. There was no concomitant medication. The physician reported that the patient immediately spit up what appeared to be the entire dose of ROTATEQ as well as the milk just given. The physician stated they could see the ROTATEQ in the milk. Unspecified medical attention was given in the physician's office. No laboratory diagnostics were done. A product quality complaint was not involved. Follow-up information was received on 21-OCT-2008. The patient was reported to be 16 weeks old. It was reported the patient experienced emesis on "08-OCT-2008". The patient vomited up ROTATEQ and formula immediately after dose. The patient recovered the same day. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Infantile spitting up, Underdose
Clinical narrative: This is in follow-up to report(s) previously submitted on 11/14/2008. Information has been received from a health professional concerning a 16 week old female with no allergies or pertinent medical history who was vaccinated on 30-SEP-2008 with second dose of ROTATEQ. It was reported the child spit out an unknown amount of ROTATEQ while it was being administered. The child's first dose of ROTATEQ was administered at 2 months of age. Unspecified medical attention was given in the physician's office. No laboratory diagnostics were done. A product quality complaint was not involved. Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This is in follow-up to report(s) previously submitted on 11/14/2008. Information has been received from a physician concerning a 16 week old female with no allergic or pertinent medical history who on 29-SEP-2008 was vaccinated po with a first dose of ROTATEQ.  There was no concomitant medication.  The physician mentioned a patient inadvertently received first dose at 4 months of age.  No adverse effects reported.  No laboratory diagnostics were done.  A product quality complaint was not involved.  Follow-up information was received on 29-OCT-2008.  The patient was given ROTATEQ at 4 months and 5 days of age.  At the time of this report, there were no known consequences.  No further information is expected.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse concerning her 6 month old female daughter with no allergies or pertinent medical history who on an unspecified date was vaccinated by mouth with a first dose of ROTATEQ. There was no concomitant medication. The nurse reported her daughter was administered her first dose of ROTATEQ at 6 months of age. No adverse effect was reported. No laboratory diagnostics were done. A product quality complaint was not involved. No additional informational information was provided.