chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Severely ill infant with onset of vomiting on 9/29/2012 with fever x 2 days. Abdomen dilated, pale skin, capillary refill greater than 3 seconds. Fire Rescue called to scene taken to Medical Center and then transferred to Pediatric Intensive Care Unit at another Medical center. Underwent laparotomy. Found to have purulent peritonitis with no identifiable intestinal leak, no intussusception. Peritoneal fluid culture was M.R.S.A (Patient is slowly improving in PEDIATRIC INTENSIVE CARE as of today 10/04/2012). Family members at home have history of M.R.S.A infections.
Age: 0.2
Sex: F
Vaccine: DTPPHIB, MMR, RVX
Symptoms: Crying, Drooling, Moaning, Mucous stools, Pyrexia
Clinical narrative: Fever, non stoppable crying and moaning for few hours before falling asleep. Next morning - change of stool to mucus like, episodes of shrill crying for few following days, excessive drooling and change of "speech" from distinct throaty sounds to only bubble blowing.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever of 104 degrees, Heart rate of 165BPM, febrile seizures lasting minutes at a time intermittently.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood glucose increased, Blood potassium decreased, Choking, Cough, Dyspnoea
Clinical narrative: At 2:45 patient began to have a barky cough.  Then seemed to have trouble breathing and seemed like he was choking on mucus.  Then had episode of clear emesis.  Mother called clinic at 3:15 and was told to take him to urgent care immediately.  At about 3:30 while driving in care he became unresponsive in car seat.  Did not open eyes to having name called or leg shaken by mother.  He had normal skin color.  She pulled over and called EMS.  When ambulance arrived he was slightly responsive, pink, but not interactive.  He was given oxygen and a Duoneb treatment.  Became more responsive while getting neb.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Neutrophil percentage increased, Unresponsive to stimuli, Vomiting, White blood cell count increased
Clinical narrative: At 2:45 patient began to have a barky cough.  Then seemed to have trouble breathing and seemed like he was choking on mucus.  Then had episode of clear emesis.  Mother called clinic at 3:15 and was told to take him to urgent care immediately.  At about 3:30 while driving in care he became unresponsive in car seat.  Did not open eyes to having name called or leg shaken by mother.  He had normal skin color.  She pulled over and called EMS.  When ambulance arrived he was slightly responsive, pink, but not interactive.  He was given oxygen and a Duoneb treatment.  Became more responsive while getting neb.
Age: 84.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Swollen, painful arm, instructed patient to take Motrin and use an ice pack for comfort.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUX, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Severe redness, and swelling of the whole thigh/leg area.  Painful to touch and leg is fevering/hot to touch.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Pain in extremity
Clinical narrative: Pt left store without incident. Shortly Pt felt pain in left leg then pain in back. In evening Pt went to ER and was admitted - six days in hosp was trx to rehab.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Very fatigued, chills, headache, muscle aches few hours after receiving vaccine.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, local erythema, pain.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein amniotic fluid normal, Face presentation, Maternal exposure during pregnancy, Prolonged labour, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient who on 26-OCT-2011, was vaccinated IM with a 0.5 ml dose of GARDASIL (Lot #668262/0841AA, expiration date: 08-APR-2013). The patient did not know that she was pregnant at the time of vaccination. No adverse effect was known. The patient visited doctor's office. At the time of the report, the patient's outcome was unknown. The patient's last menstrual period was 30-SEP-2011 and estimated delivery date would be 06-JUL-2012. Follow up information was received from a physician concerning an 18 year old female patient with a history of one pregnancy and 0 full term deliveries who on 26-OCT-2011, was vaccinated IM with the second 0.5 ml dose of GARDASIL (Lot # 668262/0841AA, expiration date: 08-APR-2013). On 20-JAN-2012, ultrasound was performed - result reported as 14617 - consistent with dates. At the time of the report, the patient's outcome was unknown. Follow-up information was received regarding the patient who on 19-JUL-2012 at 41.5 weeks gave birth to a full term female (7 lbs., 9oz) infant. Apgar scores were 7 and 8. It was reported that the patient experienced failure to progress/occiput posterior. The infant was reported as being normal with no congenital anomalies, abnormalities or other complications. It was also reported that the patient did not use any other medications during her pregnancy. Obstetric information included a negative/normal QUAD screen on 03-FEB-2012. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Eye swelling, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 9/28/12 Pt developed facial swelling, runny eyes, swollen eyes, and a "funny sensation" to her nose after received Dtap, IPOL, MMR vaccines. Went to ER. 10/1/12 Later in day - mom reports (L) upper arm swelling, redness, pain 2" x 2" = cellulitis per walk in MD.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Lacrimation increased, Nasal discomfort, Swelling face
Clinical narrative: 9/28/12 Pt developed facial swelling, runny eyes, swollen eyes, and a "funny sensation" to her nose after received Dtap, IPOL, MMR vaccines. Went to ER. 10/1/12 Later in day - mom reports (L) upper arm swelling, redness, pain 2" x 2" = cellulitis per walk in MD.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Rash
Clinical narrative: Rash/blisters on hands & feet.
Age: 44.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Urticaria
Clinical narrative: Urticaria up & down arm and (L) side of face. No SOB/wheezing. Tx with topical ice (+) CLARITIN 10mg symptoms improved in 30 minutes.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB, FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Lt leg with 3 separate erythema rash - raised - (1) -> 10cm x 12cm (Lt buttocks) (2) -> 10 cm x 20 cm (vastus lateralis) (3) 15 cm x 30 cm (vastus lateralis).
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Pt reported swelling of the tongue at night, was seen in office on 10/4/12 for tongue and facial swelling. Loratadine was prescribed.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Adverse event, Swelling face, Swollen tongue
Clinical narrative: Pt reported swelling of the tongue at night, was seen in office on 10/4/12 for tongue and facial swelling. Loratadine was prescribed.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Heart rate increased, Injection site pruritus, Nervousness
Clinical narrative: 10 min after Flu shot. Pt. began to feel "hot, dizzy and shaky". Itching at vaccination site. Pt symptoms intermittent with same intensity and rapid HR.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: 0.5 cc PPD given IM instead of PNEUMOVAX. No reaction.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Paraesthesia oral
Clinical narrative: Tongue tingling, headache, dizziness.
Age: 27.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, Injection site warmth, Urticaria
Clinical narrative: Hives on upper body and pain and fever in right arm at injection site a few hours after injections. Patient went to Hospital ER later the same day and to another ER day after injections. Was told to take CLARITIN and Ibuprofen by second ER.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Received Flu vaccine Hx of sensitivity to eggs. C/O itching and pruritus after vaccine.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Feeling hot, Tremor
Clinical narrative: Patient started shaking uncontrollably, became very hot and had explosive diarrhea. Symptoms lasted approximately 3 hours.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: Hives, itching, rash, fever, SOB.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Injected limb mobility decreased, Injection site haematoma
Clinical narrative: Pt came in & showed bruise on upper left shoulder c/c difficulty raising & moving the arm. Complaint of shoulder bone pain. RPh on duty recommended warm moist head and BENGAY when not using heat.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Injection site pain, Maternal exposure during pregnancy, Pain, Pyrexia
Clinical narrative: The evening after vaccine administration, pt felt feverish, total body aches, pain at injection site on (L) upper arm. Also sinus congestion, cough - still having these symptoms 8 days later. 15 weeks pregnant.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Sinus congestion
Clinical narrative: The evening after vaccine administration, pt felt feverish, total body aches, pain at injection site on (L) upper arm. Also sinus congestion, cough - still having these symptoms 8 days later. 15 weeks pregnant.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Blood pressure increased, Diarrhoea, Eye pain, Feeling hot
Clinical narrative: About 1 hour post flu shot administration, patient experienced hot sensation starting from injection site radiating throughout the rest of the body. Other symptoms included blurry vision, eye pain, severe headache, nausea, upset stomach, diarrhea. BP elevated to 174/105.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site warmth, Nausea, Vision blurred
Clinical narrative: About 1 hour post flu shot administration, patient experienced hot sensation starting from injection site radiating throughout the rest of the body. Other symptoms included blurry vision, eye pain, severe headache, nausea, upset stomach, diarrhea. BP elevated to 174/105.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient had a ZOSTAVAX vaccine & is complaining of itching & redness around site.
Age: 21.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Injection site pruritus, Injection site urticaria, Rash pruritic, Urticaria
Clinical narrative: Pt describes itchy hive-like rash on his left arm around area of injections beginning on same day of injection. Itchy hive like rash spread to left side of his trunk over next few days. Pt denies SOB or any difficulty breathing at any time.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema
Clinical narrative: Large, 2 inch diameter (approximately equal to 2 x 2) bruising with red line (approximately equal to 1 1/2 cm) extending 3 inches down arm. No soreness reported / no pain or discomfort.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation
Clinical narrative: Approx 1 inch below injection site the patients arm became red & inflamed approximately the size of a baseball. The inflammation subsided after 48 hours.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Fatigue, Myalgia, Somnolence
Clinical narrative: Employee called Emp Health with request for exemption from mandatory influenza vaccine due to symptoms experienced with last year's vaccination. A review of encounter with another provider indicated employee complained of developing extreme sleepiness, fatigue, myalgia & temp of 99.4 degrees within hours of receiving vaccine. Symptoms resolved within 2 days.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Fatigue, Malaise, Nausea
Clinical narrative: Approximately 3 hours after receiving flu injection I felt very tired & by 6:30 P.M. felt ill & went to bed with fever, chills, some diarrhea & nausea. Felt somewhat better when I got up at 6:30 A.M. but, went back to bed & slept from 10:30 AM - 11:30 P.M. Took me another day to start feeling better. Next year I plan to stay with the regular flu shot!
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Approximately 3 hours after receiving flu injection I felt very tired & by 6:30 P.M. felt ill & went to bed with fever, chills, some diarrhea & nausea. Felt somewhat better when I got up at 6:30 A.M. but, went back to bed & slept from 10:30 AM - 11:30 P.M. Took me another day to start feeling better. Next year I plan to stay with the regular flu shot!
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Pharyngeal hypoaesthesia, Pruritus generalised, Vomiting
Clinical narrative: All started within 15 min patient started itching all over body throat went numb, started coughing with vomiting trouble breathing - pt was seen and ordered & given SOLU-MEDROL 40mg IM and was kept in office 1 hr before she was taken home feeling better.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: Sore throat, persistent cough, needed to use hand held nebulized asthma medicine.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Muscle tightness, Myalgia
Clinical narrative: Pt stated that she had right jaw/muscle tightening & pain.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Pt states that following am, noticed arm was red, hot and swollen. Showed his mother around 930 pm that night. MOC called clinic around 440ish on 10/4/12 and info clinic of reaction. Had pt RTC. Redness has gone down and swelling is gone. Pt adv to use ice compress.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 10-02-12 started w/symptoms, pain in (lt) deltoid, fever 100.7 degree F, hot arm, swollen, & headache x 3 days. On exam warm , red, induration area at injection site measuring 19 x 10 cm.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: 10-02-12 started w/symptoms, pain in (lt) deltoid, fever 100.7 degree F, hot arm, swollen, & headache x 3 days. On exam warm , red, induration area at injection site measuring 19 x 10 cm.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Severe chills after vaccine (1.5 hrs) lasting 8 hrs. Fever of 102.5 degrees F that would not resolve, next morning at 99.6.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac monitoring, Chest pain, Mental status changes, Throat tightness
Clinical narrative: 31 year old female received FLUVAC -Lot: AFLUA6898A; Exp: 06/26/2013-. Approximately 15 minutes later, the patient experienced throat tightness, chest pain, and exhibited altered mental status. 0.3 mg of EPIPEN was administered.  Patient was transferred to ER and given 50 mg of diphenhydramine PO, 60 mg of prednisone PO, and monitored with pulse ox and cardiac monitoring. Patient remained in ER for 6 hours before being discharged home by medical personnel.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: Pt given flu shot 9-28-12, lot number: Company: Novartis NDC 66521-0115-02 had temp at site of injection with contusion, skin discoloration, redness, soft tissue swelling Lt deltoid at site of injection on evening of 9/28/12. Tx with ice and warm packs until seen 10/1/12. Pt with hx of brain tumor, surgery, chemotherapy that was completed <1 yr ago.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Rash, Vaccination failure
Clinical narrative: We paid a great price for me to get the shingles shot in 2010. It is supposed to prevent or lighten the case if you do get it. I started with pain in the upper back, progressed to a very painful rash, and now after 6 weeks of misery I am finally recovering. And I did visit my doctor to confirm that I had shingles. I feel that the shot does not work that well. If they allow it to continue to be used at least the price should not be so exorbitant.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Throat tightness
Clinical narrative: Pt complained of cough 10 min after vaccine, then felt throat closing at 15 min. Was given BENADRYL.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Adverse event, Cough, Throat tightness
Clinical narrative: Pt complained of cough 10 min after vaccine, then felt throat closing at 15 min. Was given BENADRYL.
Age: 68.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Chest discomfort, Dyspnoea, Pallor, Paraesthesia oral
Clinical narrative: Pt became gray in the face within 20 minutes after receiving FLUZONE HD and ZOSTAVAX. He reported tingling lips and chest tightness. I inquired about calling his PCP, to which he agreed. I contacted Dr, to whom patient spoke briefly. Dr advised me to activate EMS Protocol, administer EPIPEN 0.3 mg IM, and call 911. Pt reported easier breathing after administration of EPIPEN. EMS arrived within 5 minutes and pt was transported to local ER.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain in extremity, Poor quality sleep
Clinical narrative: 2 days after vaccine given - whole (L) arm was painful from shoulder to fingers 8 (1-10). TYLENOL X-strength muscle cream. Heating - helped some. Did not sleep well x 4 nights. Pain continued for 4 days.
Age: 38.0
Sex: F
Vaccine: FLU3, MNQ, PPV
Symptoms: Dizziness, Oedema peripheral, Pyrexia
Clinical narrative: Went to ER. Dizzy, fever 104.3 degrees F. Arm swollen to the size of softball.
Age: 1.02
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Swelling, Urticaria
Clinical narrative: Immediately after receiving varicella (VARIVAX) vaccine, child developed one hive (urticarial) surrounded by redness and swelling 1.5 cm x 3 cm. Cold pack applied. Waited in office 40 minutes. Hive resolved. No other symptoms. Heart and lungs asculated with stethoscope- within normal limits.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, FLUN3, HEP, MMR, PNC13, VARCEL
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Immediately after receiving Varicella (VARIVAX) vaccine, child developed 1 hive (urticaria) surrounded by redness & swelling 1.5 cm x 3 cm. Cold pack applied. Waited in office 45 minutes. Hive resolved. No other symptoms. Heart & lungs auscultated with stethoscope - within normal limits.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Pruritus
Clinical narrative: Received flu vaccine and itching. Sensitivity to eggs.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling at injection site (L) deltoid.
Age: 7.0
Sex: M
Vaccine: FLUN3, HEP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Pallor, Syncope
Clinical narrative: Immediately after receiving vaccines, while sitting on chair, became faint, leaned forward at mother's instruction, I supported him as he collapsed, I slowly lowered him to floor. He regained conscious, responded to mother's voice & moved over to put his head in her lap on floor. Very pale. After resting 10 minutes, drank 6 oz fruit punch, felt better, after 20 minutes got up & walked out with mother. Pulse WNL.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. The patient was vaccinated intramuscularly with a 0.5 ml dose 2 of GARDASIL (lot # not reported) on an unspecified date. The nurse reported that the patient was 1 month late for her second dose of vaccine. No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a pharmacist, concerning a 4 month patient of unknown sex. On 26-SEP-2012, the patient was vaccinated with a dose of MMR II (dose, and route were not reported). No symptoms were reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner (NP), concerning a 17 year old male patient. The patient had no pertinent medical history and no known drug allergies. On 23-AUG-2012, the patient was vaccinated intramuscularly with one single dose of GARDASIL (dose and frequency were not reported) (lot #: 1537AA, expiration date not reported). There were no concomitant medications. On 24-AUG-2012, after receiving his first dose of GARDASIL, the patient developed urticaria or hives on extremities and on the trunk. The patient went to the E.R. to seek medical attention and was released. BENADRYL was given as treatment for the event. No lab diagnostic studies were performed. At the time of the report, in 2012, the patient had recovered from the urticaria or hives. The relatedness for urticaria or hives and therapy with GARDASIL was unknown. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist regarding to a 83 years old female patient. Two weeks ago, approximately on 07 September 2012, the patient was vaccinated with 0.65 ml dose of ZOSTAVAX, subcutaneous in the right arm. No other co-suspects were reported. No concomitant medications were reported. In September 2012 "now" the patient had shingles at the area around the injection site. The patient was treated with ZOVIRAX and sought medical attention, called pharmacy. The patient's outcome was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated SC, with a does of 0.65 ml ZOSTAVAX (lot number not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced swelling at the injection site and went to the hospital. It was unknown what treatment was received and whether the patient was admitted or not. The outcome of the patient was unknown. Additional information is not expected.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Immediate post-injection reaction, Pain in extremity, Respiratory tract congestion
Clinical narrative: This spontaneous report as received from a consumer refers to her husband, a 51 years old male patient with insulin-dependent type 1 diabetic and aspirin allergies. The patient was vaccinated with lot # (667912/0933Z exp date 25-FEB-2012), 0.5 ml PNEUMOVAX 23 (IM or SubQ) for routine vaccination on 05-SEP-2012 2:30 pm. Concomitant medications included insulin, BENICAR and LIPITOR. After vaccination, on 05-SEP-2012, the patient immediately had severe arm pain, followed by severe chest congestion and coughing that occurred 12 hours after. The patient did not seek medical attention, (2) extra strength TYLENOL was given for the adverse events. None lab diagnostics was performed, the adverse events were not improved. The outcome of severe chest congestion, coughing that occurred 12 hours after and severe arm pain was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with an expired dose of MMR II (lot #: 667431/1008Z, expired date: 28-JUL-2012) (route, dose not reported) on 20-AUG-2012. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age. The patient was vaccinated a dose of GARDASIL (lot number not reported) on 18-SEP-2012. Other suspect therapies included CERVARIX vaccinated on 25-MAY-2011. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 years old female patient. The patient was vaccinated SC, with a dose of ZOSTAVAX (lot number reported as "H011331", expired date 08-SEP-2013) in the morning of 24-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 24-SEP-2012 the patient saw her physician in the afternoon and was diagnosed with shingles. The physician prescribed VALTREX for the patient. Appointment had been scheduled. The outcome of shingles was unknown. Additional information has been requested.
Sex: F
Vaccine: DTAP, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare student refers to a female patient of unknown demographics. On an unspecified date, the patient might have been vaccinated with dose 2 ZOSTAVAX who came into the pharmacy to receive diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (unspecified). The reporter did not known which vaccine was administered. The administration date of the first ZOSTAVAX was unknown and the possible second dose of ZOSTAVAX or diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid was unknown. No concomitant medications were reported. No adverse symptoms were reported. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a newborn baby on unknown age and gender, who was vaccinated with doses of RECOMBIVAX HB (lot # and doses not reported) on 31-AUG-2012 and 06-SEP-2012. No adverse symptoms reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 years old female patient, who on 21-SEP-2012 (today) was vaccinated with expired dose of (Merck) VARIVAX 0.5 ml subcutaneously at left upper arm (Lot # reported as H011553, Exp: 14-JUN-2011 - in validation process). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a nurse who reported that an unknown number of doses of MMR II were exposed to 47 degree F. for 24 hours, which may have been administered. No adverse effects reported. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Heart rate increased, Pruritus generalised, Rash, Rash generalised
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13 months old male patient without pertinent medical history and without drug reaction. The patient was vaccinated with the first dose of 0.5 ml MMR II (lot number 0288AE, expiration date 03-JAN-2014) subcutaneously on 10-AUG-2012. No other co-suspects were reported. Concomitant medications included: VENTOLIN nebulizer treatment. On 22-SEP-2012 the patient started vomiting when awake and on 24-SEP-2012 had circular small patches on his cheeks and on 25-SEP-2012 had a full body rash and itching from face to feet, no fever but elevated pulse and temperature. Medical assistant noted the physician suspects it may be signs and symptoms of possible rubella but not confirmed. No treatment was given for adverse event. No diagnosis studies were performed. The outcome of adverse event was reported as not recovered. The patient contacted physician for seek medical attention. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13 months old male patient without pertinent medical history and without drug reaction. The patient was vaccinated with the first dose of 0.5 ml MMR II (lot number 0288AE, expiration date 03-JAN-2014) subcutaneously on 10-AUG-2012. No other co-suspects were reported. Concomitant medications included: VENTOLIN nebulizer treatment. On 22-SEP-2012 the patient started vomiting when awake and on 24-SEP-2012 had circular small patches on his cheeks and on 25-SEP-2012 had a full body rash and itching from face to feet, no fever but elevated pulse and temperature. Medical assistant noted the physician suspects it may be signs and symptoms of possible rubella but not confirmed. No treatment was given for adverse event. No diagnosis studies were performed. The outcome of adverse event was reported as not recovered. The patient contacted physician for seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a register nurse refers to a patient of unknown age. The patient was vaccinated IM with lot # (666121/0597Z) dose 2, 0.5 ml expired GARDASIL (expired date was 19-AUG-2012) on 28-AUG-2012. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a female patient, not pregnant, of unknown age. On an unknown date the patient was vaccinated intramuscularly with a first dose of GARDASIL (dose and lot # were not reported). On an unknown date, while on therapy with GARDASIL, the patient fainted. The patient sought unspecified medical attention. No treatment was given for reported adverse event. The outcome of the fainted was reported as recovered (date unspecified). It was also the that adverse event improved on therapy. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropod bite, Pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to a 72 years old female patient with penicillin allergy. Pertinent medical history included: "thyroid, cholesterol and estrogent". The patient was vaccinated with ZOSTAVAX (lot# unspecified) subcutaneously on 24-SEP-2012. No other co-suspects were reported. Concomitant medications included levothyroxine sodium, simvastatin, estradiol, and XANAX. On 24-SEP-2012 the patient started with itching along her right side by her little finger on right side. Then it moved to right arm, to her back, and on her knee. She described it as a bug bite, about the size of a dime. She would consult her physician. No treatment was given. The outcome of itching was unknown. No lab test was performed. 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 physician refers to unspecified patients of unknown age. The reporter stated that in the past, unknown number of patients came into the office to receive the second dose of GARDASIL (lot#unknown) later than the recommended schedule. He did not have a specific patient. No adverse effect reported. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patients had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: No adverse event, Syringe issue
Clinical narrative: Information has been received from a nurse practitioner who on 10-AUG-2012 reported that due to a malfunction of RECOMBIVAX HB (lot # H010380, expiration date 18-NOV-2014) 5 mcg/0.5ml and VAQTA (lot # 0669AE, expiration date 07-DEC-2014) 25u/0.5ml pediatric dose syringes, an unspecified number of patients had received doses of the vaccine when the syringe plunger came out of the barrel. The reporter did not have any specific patient information available at the time of this initial report, since she reported a product quality complaint. The reporter described the following: "When the person administering the vaccine introduced the needle into the patient's muscle and attempted to aspirate the plunger in order to check for placement of the needle in the patient's muscle rather than in the patient's blood vessel, the plunger plastic rod disconnected from the rubber stopper and came entirely out of the syringe barrel. One administrator may have removed the syringe from the needle and attached a new syringe to the needle that was inserted into the patient in order to administer a dose of the vaccine". The reporter was not certain of these events, nor was she certain of the number of patients effected by this syringe malfunction that she reported. The reporter stated that to her knowledge, none of the patients had demonstrated or reported any adverse effects. No additional information is currently available. On 15-AUG-2012, the reporter stated that 3 VAQTA and 2 RECOMBIVAX HB syringes malfunctioned during patient care of previously noted unspecified patients. No further information was provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a medical student regarding a 21 year old female patient. The patient was vaccinated with GARDASIL on 07-NOV-2008 (1st dose) with lot number 0572x, 2nd dose in 12-JAN-2009 with lot number 0570x and 3rd dose in 26-MAY-2009 with lot number 1312x. No concomitant medications were reported. On 14-SEP-2012, the patient had a HPV smear result which was positive after 3 doses being administered. The outcome of the event was reported as not recovered. The patient did not seek medical attention. Additional information is expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site haemorrhage
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 60 years old female patient. On 12-SEP-2012, the patient was vaccinated subcutaneously with dose 1, 0.65 ml ZOSTAVAX lot # (972930/0598AE). No concomitant medications were reported. On 12-SEP-2012, the patient experienced significant bleeding and bruising at the injection site. The bleeding lasted a few seconds and the bruising was "quarter sized". No treatment information was reported. The outcome of significant bleeding and bruising at the injection site was unknown. The relatedness for significant bleeding and bruising at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 51 years old female patient. The patient was vaccinated in unspecified arm with 0.65 ml ZOSTAVAX (lot number 672675/0068AE, expiration date 12-SEP-2013) subcutaneously on 06-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. In approximately September 2012 the patient experienced a "huge water blister the size of a lemon, at the injection site". The outcome of adverse event was reported as recovered. The patient called for office medical attention. Additional information has been requested. This is one of several reports received from the same source.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist regarding two patient's of unknown age and gender with no pertinent medical history. On an unknown date, the patient's were vaccinated with a dose of ZOSTAVAX, 0.65 ml subcutaneous injection (lot number not reported). No concomitant medications were reported. Subsequently the patient's received ZOSTAVAX and broke out with shingles within 2 months. No treatment information was reported. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a registered nurse refers to a female patient of unknown age. It was reported that the patient noted on an medical history questionnaire that she had an unspecified reaction to an unspecified pneumonia vaccine (manufacturer unknown) on an unspecified date that possibly may have been PNEUMOVAX 23 (dose, route and lot # not reported). The outcome was not reported. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Urticaria
Clinical narrative: This spontaneous report as received from a mother refers to her 18 years old daughter. The patient was vaccinated with the first dose of GARDASIL (lot# unknown) intramuscular on 07-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 07-AUG-2012 the patient experienced pain at the injection site and broke out with hives. It was unknown that if the patient had sought medical attention. The outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant via company representative refers to a patient of unknown age and gender. On 25-JUL-2012 the patient was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (dose, route and lot# not reported). It was reported that on 25-SEP-2012 the patient was vaccinated intramuscularly with an expired a second 0.5 ml dose of GARDASIL lot # (666121/1778Y, expiration date 19-AUG-2012). It was reported that the patient was not experiencing any known symptoms. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with lot # (667418/0978Z), .5 ml PNEUMOVAX23 on 01-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced expired drug administered. No treatment information was reported. The outcome of expired drug administered is unknown. Expired drug administered is not related to PNEUMOVAX23. (Additional information has been requested. Additional information is not expected.)
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information was received from a healthcare worker concerning four patients who between 05-SEP-3012 through 19-SEP-2012 were vaccinated with a dose of PNEUMOVAX 23 (Lot # H013581, expiration 03-MAY-2014). The reporter stated 4 patients received PNEUMOVAX 23 from the same lot and all patients reported having redness, soreness, pain, swelling, and warmth at the injection site on the day following administration of the vaccine. All 4 patients had sought medical attention. Treatment was "ice". All of the patients were recovering at the time of the report. No further information was provided. Additional information was requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Incorrect route of drug administration, Injection site pain
Clinical narrative: Information has been received from a 66 year old male patient who in January 2012 was vaccinated with a dose of ZOSTAVAX (Merck). His concomitant medications were CELEBREX and LIPITOR. He stated that the nurse practitioner did not give the vaccine as a subcutaneously injection, but rather as intramuscular injection. His major concern was about efficacy. The patient experienced little site pain tenderness which subsided after a few days. Quarterly blood work was performed (result not provided). No further information is available.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information was received from a healthcare worker who reported that on 20-AUG-2012 an 83 year old female with a previous history of vaccination with PNEUMOVAX 23 (2006), was vaccinated with a dose of PNEUMOVAX 23 (Lot# H009826, expiration 11-FEB-2014). On 21-AUG-2012, the patient called the office reporting that the arm that the PNEUMOVAX 23 was administered developed an injection site reaction where the arm had become red, swollen, and warm to the touch from the shoulder to the wrist. Treatment given was specified as ADVIL and cold compresses. The patient was reported as recovered on an unspecified date. This is one of two reports of similar adverse events (1209USA02926). Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information was received from a pharmacist regarding a 73 year old female who developed an injection site reaction following a vaccination with PNEUMOVAX 0.5 ml intramuscularly in her left arm on 18SEP2012. The pharmacist reported the patient received AFLURIA concomitantly in the same arm (separate sites, separated by about two inches). On 19SEP2012 the patient had an injection site reaction at the site of the PNEUMOVAX 23 described as a red, swollen, warm to touch, softball sized area (slightly irregular in shape). At the time of this report, the patient had not recovered. The pharmacist reported that the patient had received a previous vaccination with PNEUMOVAX 23 (date of previous vaccination unspecified some time prior to the patient's 65th birthday), without any reported problem. The pharmacist reported that the patient had received influenza vaccine (dates and manufacture unspecified) in previous years without problems. No other information was reported. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a nurse regarding a 6 year old male patient who was vaccinated with a first dose of VAQTA on 29-JAN-2009 (Lot number not reported). The patient was vaccinated with a second dose of VAQTA on 16-JUL-2009 which was 11 days early. No adverse effects were reported. No further information is expected as the nurse declined to provide contact information for follow up.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash pruritic
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 79 years old male patient. On 24-AUG-2012, the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported). Nurse practitioner stated that on 24-AUG-2012, the patient received ZOSTAVAX and had a pruritic rash that the patient had for the last 4 days. The patient was seen in the office and saw tiny fluid filled vesicles. The patient had no pain, no fever, and no chills. At the time of the report, the patient's outcome was unknown. The relatedness for patient events were unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient was vaccinated with VARIVAX (Merck) on 02-OCT-2012. Dose, route, frequency and lot number were not provided. No other co-suspects were reported. No concomitant medications were reported. On 02-OCT-2012 the patient was mistakenly vaccinated with VARIVAX (Merck) rather than Zoster vaccine live. No adverse event reported. The outcome was unknown. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 75 years old female patient with none drug allergies and reactions. The patient's medical history included "thyroid and blood pressure". The patient was vaccinated intramuscularly in right arm with a 0.5 ml dose of PNEUMOVAX23 (lot# reported as H010515 exp. 13-FEB-2014) on 26-SEP-2012 (it was reported that the patient did not receive the vaccine after age 65 years). Concomitant medications included: FLUVIRIN given in left arm. On 26-SEP-2012 the patient's right arm swelled that evening and traveled down the arm. The swelling was from the injection site down to the inner elbow and was warm to the touch. The patient would be following up with the physician (at the time of the report the patient had her husband visit pharmacist). No treatment was given for adverse events. The outcome of adverse events was not recovered. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 75 years old female patient with none drug allergies and reactions. The patient's medical history included "thyroid and blood pressure". The patient was vaccinated intramuscularly in right arm with a 0.5 ml dose of PNEUMOVAX23 (lot# reported as H010515 exp. 13-FEB-2014) on 26-SEP-2012 (it was reported that the patient did not receive the vaccine after age 65 years). Concomitant medications included: FLUVIRIN given in left arm. On 26-SEP-2012 the patient's right arm swelled that evening and traveled down the arm. The swelling was from the injection site down to the inner elbow and was warm to the touch. The patient would be following up with the physician (at the time of the report the patient had her husband visit pharmacist). No treatment was given for adverse events. The outcome of adverse events was not recovered. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender with unknown medical history or drug reactions/allergies. On 13-OCT-2004, the patient was vaccinated with COMVAX. On 15-DEC-2004, the patient received a second dose of COMVAX. The doses and routes were not provided. Other suspect therapies included PEDIARIX which was administered on 11-AUG-2004. No concomitant medications were reported. The patient's outcome was unknown. The patient was not experiencing any known symptoms. 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 registered nurse refers to a female patient of unknown age. The patient was vaccinated with first dose of GARDASIL (lot number not reported)on 25-JUL-2005. The patient was vaccinated with second dose of GARDASIL (lot number not reported)in June 2010. The patient was in office today, on 26-SEP-2012, to possibly receive the third dose to complete the series. No other co-suspects were reported. No concomitant medications were reported. Nurse asked release date of GARDASIL on market and believed that the date of first dose might be erroneous. No adverse effects reported. It was unknown if the patient had sought medical attention. Additional information has been requested.