chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient states she noticed her right arm slightly red on the evening of 10/12/12.  When she woke up on 10/13/12, she states it was bright red, hot and swollen.   Pt. states it was swollen from the upper arm to the elbow.  Pt. used ice packs and took Benadryl.  She states her arm was back to normal on 10/15/12.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Crying, Decreased appetite, Fatigue, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Red, swollen, and extremely tender muscle/skin at site for 4 days.  Low fever.  Prolonged crying and refused to use arm for the rest of the evening.  Tiredness and poor appetite.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Red, swollen, and extremely tender muscle/skin at site for 4 days.  Low fever.  Prolonged crying and refused to use arm for the rest of the evening.  Tiredness and poor appetite.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness & Itchiness to site.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Rash
Clinical narrative: Rash on face, painful joints, chills.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Nausea, Somnolence, Vertigo
Clinical narrative: Vertigo, nausea, extreme fatigue, sleepiness.
Age: 0.35
Sex: M
Vaccine: IPV
Symptoms: Crying, Hypotonia, Hypotonic-hyporesponsive episode, Pallor, Screaming
Clinical narrative: Patient cried/screamed after injection IPV. Then, he became quiet, limp and pale moments after. I (mother) thought he just wore himself out and quickly fell asleep.  I was concerned as I put him in the car, because he did not act this way with other injections. But, I did not realize he was having a reaction. I was not given a VIS, nor was I explained warning signs of rxn. Episode about lasted about 1.5 hrs., with limbs limp, and unresponsive to typical tactile stimulation of limbs. Slowly my son became responsive to touch and verbal stimuli, and regained completely normal behavior by 2 hours. Doctor not notified, as I did not realize S/S of adverse rxn. With some research, I understood he experienced what seemed to be HHE (hypotonic-hyporesponsive episode) w/o apnea. I did notice at the time, his anterior fontanelle was pulsating. I had not noticed this previously.
Age: 0.35
Sex: M
Vaccine: IPV
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient cried/screamed after injection IPV. Then, he became quiet, limp and pale moments after. I (mother) thought he just wore himself out and quickly fell asleep.  I was concerned as I put him in the car, because he did not act this way with other injections. But, I did not realize he was having a reaction. I was not given a VIS, nor was I explained warning signs of rxn. Episode about lasted about 1.5 hrs., with limbs limp, and unresponsive to typical tactile stimulation of limbs. Slowly my son became responsive to touch and verbal stimuli, and regained completely normal behavior by 2 hours. Doctor not notified, as I did not realize S/S of adverse rxn. With some research, I understood he experienced what seemed to be HHE (hypotonic-hyporesponsive episode) w/o apnea. I did notice at the time, his anterior fontanelle was pulsating. I had not noticed this previously.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Cough, Fatigue, Influenza
Clinical narrative: Symptoms began with fever, sneezing, watery eyes and runny nose.  Progressed over the next 7 days to include recurrent fever up to 101, chills, joint pain, fatigue, sinus congestion, sore throat, wheezing, barking cough with mucous, chest congestion. Still contending w/chest/sinus congestion and cough.  The only other time I received a flu vaccine (~1993), I ended up getting the flu.  I will never receive another flu vaccine, it guarantees I get the flu!
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Lacrimation increased, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Symptoms began with fever, sneezing, watery eyes and runny nose.  Progressed over the next 7 days to include recurrent fever up to 101, chills, joint pain, fatigue, sinus congestion, sore throat, wheezing, barking cough with mucous, chest congestion. Still contending w/chest/sinus congestion and cough.  The only other time I received a flu vaccine (~1993), I ended up getting the flu.  I will never receive another flu vaccine, it guarantees I get the flu!
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Sinus congestion, Sneezing, Wheezing
Clinical narrative: Symptoms began with fever, sneezing, watery eyes and runny nose.  Progressed over the next 7 days to include recurrent fever up to 101, chills, joint pain, fatigue, sinus congestion, sore throat, wheezing, barking cough with mucous, chest congestion. Still contending w/chest/sinus congestion and cough.  The only other time I received a flu vaccine (~1993), I ended up getting the flu.  I will never receive another flu vaccine, it guarantees I get the flu!
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Mobility decreased
Clinical narrative: Very painful during pain administration, continuation of pain to date, limited range of motion to date, painful upon palpation to date, inability to lift normally to date.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Hyperacusis, Nausea, Somnolence, Vertigo
Clinical narrative: Vertigo, nausea, fatigue, sleepiness, sounds extremely loud.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Edema and erythema at site of injection - 4 mm x 7 mm of induration.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Concussion, Fall, Head injury, Headache, Swelling face
Clinical narrative: Patient received flu vaccine (he was standing by mom while seeing his younger sibling receive the flu shot) and shortly fell to floor resulting with a bump on side of forehead. He was conscious the entire time answering all questions being asked of him and placed ice pack on bump immediately. (Swelling went down before he was pushed in motor chair to car). He also had some water. He said his head hurt and parents took him to visit dr right away. We offered to call ambulance, however they said it was not necessary. I followed up with mom at 11:30 and then 12:30. They had just left dr office and dr said he had a concussion to only give Tylenol and refrain from sports this week, but that he would be ok. Dr. said he had fainting episode due to possibly watching brother get vaccine administered. Mom said he would be fine and I told her I would continue following up with her throughout the week.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient received flu vaccine (he was standing by mom while seeing his younger sibling receive the flu shot) and shortly fell to floor resulting with a bump on side of forehead. He was conscious the entire time answering all questions being asked of him and placed ice pack on bump immediately. (Swelling went down before he was pushed in motor chair to car). He also had some water. He said his head hurt and parents took him to visit dr right away. We offered to call ambulance, however they said it was not necessary. I followed up with mom at 11:30 and then 12:30. They had just left dr office and dr said he had a concussion to only give Tylenol and refrain from sports this week, but that he would be ok. Dr. said he had fainting episode due to possibly watching brother get vaccine administered. Mom said he would be fine and I told her I would continue following up with her throughout the week.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Woke up itching and saw hives all over, reported no breathing difficulties.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Myalgia, Oedema peripheral, Skin warm
Clinical narrative: Patient states the evening of the day she got her flu shot, her left arm became swollen, red, hot to touch.  Swelling went from the injection site down to her elbow.  Reports having muscle aches up the left side of her neck.  Patient reported these symptoms on 10-29-2012 and states she has an appointment to see her physician today in the afternoon.  Patient has been taking Tylenol and applying ice pack alternating with heating pad to her injection site to left deltoid.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itching noticed about 2 hours after the vaccine. Cleared up some with Claritin. Pretty much gone the next day.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Case reported upper arm to elbow becoming increasingly itchy with a welty rash. Peaked 10/27; Worsened with hot shower, improved with application of hydrocortisone cream.  Resolving today, but still present (10/29). Reported to School Nurse, who directed this teacher to call RN at Public Health Department.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blood culture negative, Blood glucose normal, Full blood count normal, Grand mal convulsion
Clinical narrative: Tonic Clonic Seizure Activity.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site warmth
Clinical narrative: RED CIRCULAR BRUISE AROUND INJECTION SHOT, IT WAS HOT ON 10/28/12. BUT NOT AT 1:10PM ON 10/29/12.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Immediate arm pain, from shoulder to wrist. At one month out, pain is severe in shoulder and exists into the elbow. Saw primary physician, 10/29/2012.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy, rashy hives about two hours after the vaccine.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Dizziness, Heart rate irregular, Hypotension, Mydriasis
Clinical narrative: Paleness, dizziness, blurring of vision, sleepiness, weakness & loss of strength in extremities, dilated pupils, low BP, & irregular heart rate & rhythm.  Laid pt down, used ammonia salts as inhalant, gave juice and bite of cheese, cold cloth (pt not diaphoretic) & continued to take VS.  Third party called 911 to get EMTs here.  Worked with pt for approximately 40 min before EMTs arrived.  EMTs called because of pt continued to have loss of strength in extremities and sleepiness.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pallor, Somnolence, Vision blurred
Clinical narrative: Paleness, dizziness, blurring of vision, sleepiness, weakness & loss of strength in extremities, dilated pupils, low BP, & irregular heart rate & rhythm.  Laid pt down, used ammonia salts as inhalant, gave juice and bite of cheese, cold cloth (pt not diaphoretic) & continued to take VS.  Third party called 911 to get EMTs here.  Worked with pt for approximately 40 min before EMTs arrived.  EMTs called because of pt continued to have loss of strength in extremities and sleepiness.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Pain
Clinical narrative: Severe fatigue and body aches.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: I had a small reaction to the shot some redness and swelling and a slight fever and chill. However, the there are clusters of small red bumps at the site of where the shot was given. Please advise.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: I had a small reaction to the shot some redness and swelling and a slight fever and chill. However, the there are clusters of small red bumps at the site of where the shot was given. Please advise.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chills, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Started with chills and then severe body aches to were I felt almost stiff. It was painful to move.  Dizziness, slight headache. This last through the night of 10/22 until mid noon of 10/23. By mid day all I was having were sweat break outs and my body was just sore. I called my PPI in the morning and was prescibed Atarax. Missed two days of work.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Started with chills and then severe body aches to were I felt almost stiff. It was painful to move.  Dizziness, slight headache. This last through the night of 10/22 until mid noon of 10/23. By mid day all I was having were sweat break outs and my body was just sore. I called my PPI in the morning and was prescibed Atarax. Missed two days of work.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Urticaria
Clinical narrative: 24 hours after injection, rash appeared at injection site. Looked like hives, spread to both arms, legs and belly. Did not treat.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Chest discomfort, Chills, Conjunctivitis infective, Flushing, Headache
Clinical narrative: Flushed face, tight chest, throat irritation.  Then followed by pink eye 1 hour later, then later chills/fever, general malaise and headache. Next morning only headache and general malaise.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Malaise, Pyrexia, Throat irritation
Clinical narrative: Flushed face, tight chest, throat irritation.  Then followed by pink eye 1 hour later, then later chills/fever, general malaise and headache. Next morning only headache and general malaise.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Felt like she had a tetanus shot.  Her arm is still hurting very bad even though she was administered the shot over 30 days ago.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, swelling, burning during injection.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath approximately one hour after receiving flu shot.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypoaesthesia, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported experiencing numbness and tingling in left hand of the arm in which vaccine was administered, starting approximately 2 days after vaccine administration. There was redness and swelling extending to below the elbow in the left arm and itching extending down entire arm. Patient was seen at an urgent care facility and received a methylprednisolone dose pack 3 days after vaccination. Swelling and redness then reduced on days four and five following vaccination. Five days after administration, patient reported that the numbness and tingling was also being experienced in the right hand.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Paraesthesia
Clinical narrative: Patient reported experiencing numbness and tingling in left hand of the arm in which vaccine was administered, starting approximately 2 days after vaccine administration. There was redness and swelling extending to below the elbow in the left arm and itching extending down entire arm. Patient was seen at an urgent care facility and received a methylprednisolone dose pack 3 days after vaccination. Swelling and redness then reduced on days four and five following vaccination. Five days after administration, patient reported that the numbness and tingling was also being experienced in the right hand.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Dizziness, Fatigue, Nausea
Clinical narrative: Nausea, abdominal cramping, fatigue, dizziness.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: 4-5 hours post vaccine patient began experiencing nausea. Nausea has lasted 13 day. Vomited times one.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised, Urine analysis
Clinical narrative: Faint erythematous rash, started on the chest, spread to face and arms and back. More around eyes.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Rash began to be appear on Left arm at site of vaccination 10/24/12 evening, then rash continued past elbow the next morning with itching.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Dyspnoea, Wheezing
Clinical narrative: Pt stated that she had flu vaccine around 10:30am. Patient returned to clinic at 1:15pm and complained of SOB, wheezing, hoarsness. Pt has history of asthma. Pt took asthma medication prior to returning to clinic. Pt decided to call her physician. Pt returned to clinic for the 3rd time at 2:15PM and stated that her doctor advised her to take Benadryl. Benadryl 100mg was given by PHN. 15 minutes after receiving Benadryl patient stated feeling much better.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Injection site erythema, Injection site oedema
Clinical narrative: Upper arm at injection site very red from elbow to shoulder, no pain, minimal edema. After a few days it resolved. Also c/o liquid stool for 3 days after vaccination.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site reaction, Oedema peripheral, Pain in extremity, Rash macular
Clinical narrative: Arm was almost unmoveable, extremely painful and swollen and red blotches around injection site. Could hardly use arm.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Local reaction, Pain, Rash
Clinical narrative: Rah, red, hot, painful, localized.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Insomnia, Pain in extremity
Clinical narrative: Swelling, red and hot w extreme soreness around injection site. Upper arm backside constant pain, difficult to sleep. Took several days to resolve.
Age: 0.35
Sex: M
Vaccine: HEP, HIBV, IPV, PER, RV1
Symptoms: Abdominal pain upper, Asthenia, Body temperature decreased, Cold sweat, Crying
Clinical narrative: Rotarix caused symptoms for 9 days which were inconsolable crying, severe stomach pain, extremely loud gurgling from bowls, diarrhea, vomiting, fever 100*-104*, loss of appetite, restless sleep, weakness and at the end cold sweats temp down to 96*. I know Rotarix caused these symptoms because I did not give him the second dose and all other vaccines were repeated without these issues reoccurring.
Age: 0.35
Sex: M
Vaccine: HEP, HIBV, IPV, PER, RV1
Symptoms: Decreased appetite, Diarrhoea, Gastrointestinal sounds abnormal, Poor quality sleep, Pyrexia
Clinical narrative: Rotarix caused symptoms for 9 days which were inconsolable crying, severe stomach pain, extremely loud gurgling from bowls, diarrhea, vomiting, fever 100*-104*, loss of appetite, restless sleep, weakness and at the end cold sweats temp down to 96*. I know Rotarix caused these symptoms because I did not give him the second dose and all other vaccines were repeated without these issues reoccurring.
Age: 0.35
Sex: M
Vaccine: HEP, HIBV, IPV, PER, RV1
Symptoms: Vomiting
Clinical narrative: Rotarix caused symptoms for 9 days which were inconsolable crying, severe stomach pain, extremely loud gurgling from bowls, diarrhea, vomiting, fever 100*-104*, loss of appetite, restless sleep, weakness and at the end cold sweats temp down to 96*. I know Rotarix caused these symptoms because I did not give him the second dose and all other vaccines were repeated without these issues reoccurring.
Age: 3.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Dysphemia
Clinical narrative: A couple of days after he was given the flu shot he started stuttering.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Fatigue, Myalgia, Oral herpes, Pruritus
Clinical narrative: Hand tremors in morning, later in the day fever, post nasal drip, muscle pain, backache, general extreme fatigue. 10/29 symptoms persisting, with added scratchy throat, itchy ears and a cold sore eruption on lower lip.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Throat irritation, Tremor, Upper-airway cough syndrome
Clinical narrative: Hand tremors in morning, later in the day fever, post nasal drip, muscle pain, backache, general extreme fatigue. 10/29 symptoms persisting, with added scratchy throat, itchy ears and a cold sore eruption on lower lip.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 years old male patient with penicillin allergy. The patient was vaccinated with the first dose of PNEUMOVAX23 intramuscularly in approximately 2009 ("about three years ago"). It was reported that the patient was administered another dose of PNEUMOVAX23 intramuscularly as well as a flu vaccine (manufacturer unknown) on 10-OCT-2012. The lot# of PNEUMOVAX23 was reported as H010661, expired date 02-FEB-2014. Concomitant medications included an antidepressant. It was reported that "same evening of 10-OCT-2012 the patient was treated in an emergency room for cellulitis." The present patient status was recovered. The date the patient recovered was unknown. No treatment information was reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a physician refers to a female patient in her 70's who was a cardiac patient. The patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (lot number not reported) "early last week" approximately on 16-OCT-2012. On the same date, the patient was also given an unspecified flu vaccine in the opposite arm. No concomitant medications were reported. "Early last week" approximately on 16-OCT-2012 the patient experienced anaphylactic reaction. She went to an unspecified hospital where she was given epinephrine and was admitted for 24 hours and then released. The hospital report stated that this might have been a reaction to neomycin, but only because that was mentioned in the prescribing information. The outcome of the event was reported as recovered/resolved. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Allergy to vaccine
Clinical narrative: Please see enclosed documentation: 3 x inpatient. Dx by Occ Health Dr 9/21/12- enclosed. Allergist 10/22/12 - enclosed. Vaccine mandatory per hospital policy w/o Dr note.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Computerised tomogram, Disorientation, Dizziness, Dysgraphia
Clinical narrative: Legs swelling, trouble writing, disoriented and can't find words, trouble with speech, unsteady gait, dizziness.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Electroencephalogram, Gait disturbance, Nuclear magnetic resonance imaging, Oedema peripheral, Speech disorder
Clinical narrative: Legs swelling, trouble writing, disoriented and can't find words, trouble with speech, unsteady gait, dizziness.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site pain
Clinical narrative: Hematoma / pain at injection site. Ice to area.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema of eyelid, Eyelid oedema, Eyelids pruritus, Urticaria
Clinical narrative: 20 minutes after receiving vaccine - eyelids began to swell and become urticaria within 2 hrs - eyelids red, puff, very itchy. Pt took 2 AC PEPCID - response was decreased swelling, redness and itching. 10/19/12 pt seen at employee health, slight swelling and redness of lids remains. Lids itchy.
Age: 59.0
Sex: F
Vaccine: FLUN3
Symptoms: Chest X-ray abnormal, Granulocyte count, Headache, Lymphocyte count increased, Malaise
Clinical narrative: 10/19/12 Headache muscle aches. 10/22/12 Felt run down. 10/23/12 Fever 100 degrees F. 10/25/12 Palpitations, fever 101.5. Went to ED. CXR, labs. Started on antibiotics for bilateral pneumonia.
Age: 59.0
Sex: F
Vaccine: FLUN3
Symptoms: Myalgia, Palpitations, Pneumonia, Pyrexia, White blood cell count increased
Clinical narrative: 10/19/12 Headache muscle aches. 10/22/12 Felt run down. 10/23/12 Fever 100 degrees F. 10/25/12 Palpitations, fever 101.5. Went to ED. CXR, labs. Started on antibiotics for bilateral pneumonia.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Glossodynia, Palpitations, Pyrexia, Swollen tongue
Clinical narrative: Tongue became swollen and painful, heart raced, reports fever - but did not take temperature. Did not seek medical treatment.
Age: 13.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Ear pain, Urinary tract infection, VIIth nerve paralysis
Clinical narrative: 2 week hx right facial paralysis. Preceded by URI symptoms and mild right ear pain. Flu, Hep A & HPV shots 1-2 weeks prior to symptoms. Previous flu shots, Hep A & HPV without problems. Wears glasses. Bell's Palsy handout given. Eye care/protection discussed, VAERS given. F/U no improvement referral - Neurology.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, swelling, erythema at site of injection - approximately 2 hrs following vaccination.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: 8 cm raised, erythematous, warm tender over left deltoid injection site. Treated with antibiotic.
Age: 35.0
Sex: U
Vaccine: FLU3
Symptoms: Dizziness, Electrocardiogram normal, Musculoskeletal pain, Obstructive airways disorder, Pain
Clinical narrative: Shooting pains within minutes across shoulder. Dizziness, lightheaded, airway tight - transferred to E.D.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Contracted a case of shingles about 6 days later, lasted about 3 weeks.
Age: 1.25
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Irritability, Local reaction, Vaccination complication
Clinical narrative: Soon after vaccination developed warm red area at site of MMR and VARIVAX shots. Child fussy no hives. Borders marked in ink; observed for 30 min. no increase in size of red area. Local vaccine reaction.
Age: 8.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Cyanosis, Nausea, Pallor
Clinical narrative: Patient came out in the hallway and sat by the garbage can. I told him to go sit in the room with it. Nurse went in and said he was pale with blue lips. She laid him down, put his arm above his head. He was on his right side. After a minute or so his color started returning and nausea went away.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Headache, Hypoacusis
Clinical narrative: 6 pm day of vaccine dizzy poor hearing rt. ear felt dull in front of head.
Age: 4.0
Sex: M
Vaccine: FLUN3, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: 10/29/12 I spoke with Mom, broke out in hives evening of 10/26. Had rec'd MMR #2, VARIVAX #2 and Flu earlier in the day. No resp. s/sx.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Throat irritation
Clinical narrative: Over period of 3 days c/o "scratchy" throat -> chest tightness -> chest pain - seen in ED 10/26/12 - obs x 24 hrs.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Injection site pain, Pain in extremity, Peripheral coldness
Clinical narrative: Received Flu vaccine on 10/25/12 at 4 pm. Fri. 10/26 some pain at site, by Sat. AM 10/27 entire arm aches, armpit aches, no swollen nodes or knots. Has taken Ibuprofen. No bruising at site, arm feels cooler to touch than other arm.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Malaise, Pain
Clinical narrative: Chills, malaise, sweating, aches, shooting pains.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: On day of vaccination: unable to lift arm 2 hours after shot persisted for 24 hours. Past 2 weeks constant ache.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: Received flu shot at flu clinic in AM. Noticed reaction 10 pm 10/27/12 - reddened area 60 x 65 mm noted firm, sore, warm to touch. No other s/s.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Erythema, Local reaction, Mass, Pruritus
Clinical narrative: Client called 5 days after vaccinating to indicate she experienced local rx within 1 hr of getting vaccinated - red itchy lump -> progressed to size of 1/2 dollar hot to touch - lasted few days. Also within hrs of vaccine developed wheeze/cough. Persisted x 5 days. Unsure if correlates with vaccinating as has sick grandchildren exposure. PCP notified.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Wheezing
Clinical narrative: Client called 5 days after vaccinating to indicate she experienced local rx within 1 hr of getting vaccinated - red itchy lump -> progressed to size of 1/2 dollar hot to touch - lasted few days. Also within hrs of vaccine developed wheeze/cough. Persisted x 5 days. Unsure if correlates with vaccinating as has sick grandchildren exposure. PCP notified.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Fall, Pallor, Syncope
Clinical narrative: He fainted fell out of chair was pale, lasted for maybe a minute. Woke up when on floor. We elevated legs put coat under his head. He kept saying "how did I end up on the floor". I got Dr. and he checked his breathing and heart asked how he felt.
Age: 87.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria, pruritus.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Lt arm swollen, red. c/o itching; started the evening of shots 10/26/12. BENADRYL tid for 5 days.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Laboratory test, Vomiting
Clinical narrative: Painful red 3 inch circle left upper arm & vomiting.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt states she has pain in shoulder radiating down arm & describes it as soreness. Pt thinks this was caused by flu shot she received. Pt states soreness developed after vaccination and has not gone away or improved.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus
Clinical narrative: Patient called to say next day woke up w/ 2 inch red, hard knot where shot was & said it itches too. I told her to use ice & BENADRYL if worsens to call her Dr.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Fatigue, Injection site pain, Pain, Skin warm
Clinical narrative: 10/25/12 - c/o pain at injection site - continued x 3 days, "hurts to move arm". Hot to touch and burned. Felt tired and ached all over her body for 3 days after injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dyspnoea, Erythema, Pain
Clinical narrative: (L) deltoid area 3 x 4" area bright redness, then faint redness around area 7 x 6" & going bilateral side of arm 15 x 7. No induration. Pt had (+) pain, burning (+) shortness of breath. Seen today.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Clerical did not pull current record, thought client was new. Did not know Tdap given 8-15-07, so gave one 10-2-12.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Clerical did not pull chart (that showed Hep B x 3) Thought client knew and she stated she needed Hep B #3. Gave Hep B 10-11-12.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives over trunk, arms, neck. Took BENADRYL over the counter.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Polymyalgia Rheumatica prednisone 15 mg/d - started 10/9/12.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling, Thermal burn
Clinical narrative: Red sore puffed looks like burned hot to touch.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Feeling abnormal, Myalgia, Pain, Pyrexia
Clinical narrative: On the evening of the day vaccine was given, pt started to feel bad with muscle aches, fever, pain, and back ache. Saw Dr. on 10/29/12 and given Rx's for pain and sleep meds. Problem persists at this time. Pt also has pain in same place she had shingles 30 mins ago back of shoulder radiating down arm.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reported swelling and redness in left arm that stretches from administration site to elbow and wraps around arm. Patient's primary physician was not in, nurse advised to go to ER then informed us.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Blood pressure increased, Heart rate increased, Injection site erythema, Pyrexia, Urticaria
Clinical narrative: 6 x 7" red welted, swollen area at vaccine site, fever, increased B/P, increased pulse x 4 days.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Vaccination site reaction
Clinical narrative: 6 x 7" red welted, swollen area at vaccine site, fever, increased B/P, increased pulse x 4 days.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: 10/26/12: Patient's left arm is swollen and painful touch after receiving PNEUMOVAX 24 hours earlier. 10/28/12: Arm still swollen and tender - pt via doctor is to take IBU for pain/swelling. He says it feels better everyday.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site of PNEUMOVAX - was prescribed doxycycline 100 mg for cellulitis.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus, Swelling face
Clinical narrative: Received vaccine 30 m later became SOB, itchy and face swelled, 911 called transported to ER received BENADRYL and Prednisone. She is ok per TC 10/24/12.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site of PNEUMOVAX - Doctor prescribed Doxycycline 100mg.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site nodule, Injection site swelling, Lymphadenopathy, Nausea
Clinical narrative: High fever, chills, nausea, (R) arm (pneumococcal given) swollen, had a knot at injection site and under arm, lymph node at neck swollen, treated w/ ice pack and TYLENOL, and BENADRYL. MD prescribed antibiotic and steroid.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nodule, Pyrexia
Clinical narrative: High fever, chills, nausea, (R) arm (pneumococcal given) swollen, had a knot at injection site and under arm, lymph node at neck swollen, treated w/ ice pack and TYLENOL, and BENADRYL. MD prescribed antibiotic and steroid.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Gave ZOSTAVAX 0.5 mL (L) arm. Client not 60 years of age.
Age: 46.0
Sex: F
Vaccine: FLUN3
Symptoms: Paraesthesia oral, Throat tightness
Clinical narrative: 3:45 plus or minus nasal mist administered at high school flu clinic, 4:00 pt. re-entered after leaving stating, "throat feels thick, tongue, lips are tingling". Pt. sat down, no apparent distress. 4:05 took 50mg PO BENADRYL. 4:25 left feeling better with inst. to go to ER PRN.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Red, hot, swollen arm down to elbow. Recommended ice and BENADRYL - if not improved within a few hours, contact physician. Tx w/ ice and BENADRYL - improved next day.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Culture, Injection site discharge, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Began with redness, swelling 10/27/12 - purulent discharge noted 10/28/12 - indistinct bordered area of warmth and redness on (L) upper thigh w/ tender palpable subcutaneous swelling approx. size of egg - drained by palpation about 8 cc purulent discharge. Mupirocen applied and sterile gauze and Rx for cephalexin 10/29/12.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Began with redness, swelling 10/27/12 - purulent discharge noted 10/28/12 - indistinct bordered area of warmth and redness on (L) upper thigh w/ tender palpable subcutaneous swelling approx. size of egg - drained by palpation about 8 cc purulent discharge. Mupirocen applied and sterile gauze and Rx for cephalexin 10/29/12.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Nausea, Neck pain, Oedema peripheral
Clinical narrative: Swelling and pain of the arm and neck, redness on the arm and surrounding tissues. Nausea and vomiting once in the morning. Was given a steroid shot by the MD on 10/25/12.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Swelling and pain of the arm and neck, redness on the arm and surrounding tissues. Nausea and vomiting once in the morning. Was given a steroid shot by the MD on 10/25/12.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pallor
Clinical narrative: Pt. got extremely lightheaded and pale. Pt stated at the point of almost passing out. Scared of needles. No trouble breathing, heart rate normal. Pt. wanted to lay down with an ice pack. Called EMS - pt. was released w/ no hospitalization.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Rash 20 min after administration. Parents treated with BENADRYL and resolved. Rash over arms legs and hands only.
Age: 98.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Local swelling, Pain
Clinical narrative: Vaccine administered 10/26/12 (R) deltoid. Adverse reaction noted 10/27/12; Resident noted with localized swelling redness & heat. Resident c/o soreness - no changes in vital signs noted. Dr ordered: KEFLEX 250 mg PO q 6 hours x 10 days. BENADRYL 25 mg po q 6 hours x 24. BENADRYL 25 mg po q 6 hours - prn after 24 hours.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Rash - generalized, all over body for over 2 weeks.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: HA, slight nausea, Lt deltoid swollen, pain, 3 cm red, warm 101412 tried ice to reduce swell, warmth, pain decreased. 20 min ice then itch w/in 3 cm red area BENADRYL x 3 das w/ itch subsiding 101412 itch only at injection site if rubbed ie when applying lotion over area.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Nausea
Clinical narrative: HA, slight nausea, Lt deltoid swollen, pain, 3 cm red, warm 101412 tried ice to reduce swell, warmth, pain decreased. 20 min ice then itch w/in 3 cm red area BENADRYL x 3 das w/ itch subsiding 101412 itch only at injection site if rubbed ie when applying lotion over area.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt. had flu shot 10/27. Came into store 10/29 to show me red arm. Redness about 3" wide, 4" long near injection site. Pt. reported it was hot and itchy. I recommended ice and topical diphenhydramine. Pt. told me she is allergic to thimerosal.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised, Urticaria
Clinical narrative: Pt c/o hives / rash on arms, legs, torso and feet approximately 2 days after receiving vaccine. Treated with oral steroids and resolved.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Pt. reported itching, red raised areas (L) and (R) wrists inner (L) and (R) thighs.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. The patient was vaccinated with a dose of GARDASIL (lot # 672652/0022AE; expiry date 28-SEP-2014) on 15-0CT-2012. Route was unknown. No other co-suspects were reported. No concomitant medications were reported. On 15-OCT-2012 the patient received GARDASIL that was improperly stored at 28 f for 8.5 hours. No adverse effect was reported. This is 1 of 2 cases from the same source (other case number 1210USA013616). Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with GARDASIL (lot # unknown) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The physician stated he had a patient who experienced an adverse event while taken GARDASIL on an unknown date. It was unknown that if the patient had sought medical attention. The outcome was unknown. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 45 years old female patient. The patient was inadvertently vaccinated with PROQUAD (lot number, dose, route not reported) instead of MMR II on 22-OCT-2012. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 27 years old female patient who was not pregnant with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated intramuscularly with her first and only dose of GARDASIL (lot # 0121AE, expiration date 29-SEP-2014) on 30-MAY-2012. There were not concomitant medications. On 25-OCT-2012 the patient experienced a red, raised rash with one bump at the injection site. The patient called the reporting nurse practitioner for medical attention. No treatment was given. No laboratory diagnostics studies were performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age who in May 2012 was vaccinated with the first dose of GARDASIL and the second dose of GARDASIL on an unspecified date in her pediatrician's office. The second dose was given "late" but the date was unknown. The patient was in the office "today" on 25-OCT-2012 to receive the third dose of GARDASIL. No adverse effects reported. The outcome for the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL on 06-SEP-2011. No other co-suspects were reported. No concomitant medications were reported. On 01-OCT-2012 the patient was in the office to receive dose 2 of GARDASIL which was late. No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age (gender unspecified). On 14-SEP-2012, the patient was vaccinated with dose 1 ROTATEQ (Lot# and route not reported). No concomitant medications were reported. On 28-SEP-2012, the patient was vaccinated with second dose of ROTATEQ (Lot# and route not reported). No adverse symptoms were reported. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Arthralgia, Gait disturbance, Immune system disorder, Joint effusion, Joint injury
Clinical narrative: This spontaneous report as received from a consumer refers to her 22 years old male son with no pertinent medical history and no drug reactions/ allergies. The patient was intramuscularly vaccinated with the first, second and third dose of 0.5 ml GARDASIL on 12-JUN-2010, 20-AUG-2010 and 07-JAN-2011. No other co-suspects were reported. Concomitant medications included prednisone, sulfasalazine and ORENCIA. In February 2011 the patient experiencing joint pain. The pain started in his elbow, which filled with fluid. He was now immunocompromised. The pain had spread to all his joints and was being treated now as though he had rheumatoid arthritis, even though he did not meet all the criteria for that diagnosis. Some days he can hardly walk. His left hip was now damaged. He had failed treatments with ENBREL and REMICADE already. The patient had sought medical attention via seen health care professional. X-Rays and MRI were performed with no results reported. The outcome of joint pain started in his elbow, which filled with fluid, immunocompromised, his left hip is now damaged, rheumatoid arthritis, hardly walk and joint pain started in his elbow and spread to all his joints was reported as not recovered/not resolved. Additional information is not expected.
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Rheumatoid arthritis, X-ray
Clinical narrative: This spontaneous report as received from a consumer refers to her 22 years old male son with no pertinent medical history and no drug reactions/ allergies. The patient was intramuscularly vaccinated with the first, second and third dose of 0.5 ml GARDASIL on 12-JUN-2010, 20-AUG-2010 and 07-JAN-2011. No other co-suspects were reported. Concomitant medications included prednisone, sulfasalazine and ORENCIA. In February 2011 the patient experiencing joint pain. The pain started in his elbow, which filled with fluid. He was now immunocompromised. The pain had spread to all his joints and was being treated now as though he had rheumatoid arthritis, even though he did not meet all the criteria for that diagnosis. Some days he can hardly walk. His left hip was now damaged. He had failed treatments with ENBREL and REMICADE already. The patient had sought medical attention via seen health care professional. X-Rays and MRI were performed with no results reported. The outcome of joint pain started in his elbow, which filled with fluid, immunocompromised, his left hip is now damaged, rheumatoid arthritis, hardly walk and joint pain started in his elbow and spread to all his joints was reported as not recovered/not resolved. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient was vaccinated with first dose of GARDASIL (Lot number and route was not reported)approximately in 2010 (reported as unspecified date 2 years ago)and the second dose of GARDASIL on approximately 18-SEP-2012(Lot number and route was not reported)(reported as about 2 weeks ago). Concomitant medications were not reported. No adverse effects were reported. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a male patient of unknown age. The patient was vaccinated with dose 1 GARDASIL in 2011 (dose, route, site of administration and lot # not reported). The reporter stated that in 2012, the patient received the second dose of GARDASIL (dose, route, site of administration and lot # not reported) well outside the recommended interval between the first and second dose. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a female patient of unknown age. The patient was vaccinated with dose 1 GARDASIL in 2011 (dose, route, site of administration and lot # not reported). The reporter stated that in 2012, the patient received the second dose of GARDASIL (dose, route, site of administration and lot # not reported) well outside the recommended interval between the first and second dose. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.