chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Axillary pain
Clinical narrative: Came in noon 1/31/13 c/o sore spot in (L) armpit, same arm for shot. I saw no redness or edema or felt warmth of fever. Has no other complaints, noticed this soreness in morning 1/30/13. Instructed to watch, use a warm cloth, take ibuprofen, if concerned or increases to seek medical care. Ask client to update me.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Maternal exposure before pregnancy
Clinical narrative: Initial report received from a healthcare professional on 01 October 2012. A 29-year-old female patient had received first intramuscular (IM) dose of FLUZONE vaccine (Lot number UH716AA) in left deltoid on 20 September 2012. The last menstrual period date was unknown and the expected date of delivery is in 2013. At the time of report the patient did not experience any adverse event. The patient health during pregnancy and risk factors was unknown. The patient medical history and previous pregnancy details were unknown. Follow-up information was received 05 February 2013 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been upgraded from nonserious to serious. According to the reporter, the patient had a miscarriage and was actually not pregnant at the time of vaccination (date of conception and date of last menstrual period were not reported). The patient's outcome was not reported. List of documents held by sender: None.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site urticaria, Injection site warmth
Clinical narrative: Initial report received from a healthcare professional on 19 October 2012. A 23-year-old female patient had received a dose of FLUZONE intradermal (Batch number UT4468BA) in the right deltoid on 17 October 2012. The patient had allergy to Sulfa and no other history of medical conditions. Concomitant medications were not reported. On 18 October 2012 one day after vaccination, the patient experienced large welt, redness, warm to touch, hard area at injection site of right arm and fever. It was reported that the symptoms of redness, warm to touch, hard and welt area were worse on 19 October 2012. The laboratory investigations and treatment medications were not reported. The patient's outcome was not recovered. Follow-up information was received on 01 February 2013 from a health care professional. Based upon new information received, it was determined this case now meets seriousness criteria and has been upgraded from non-serious to serious. According to the reporter, per the patient she received an antibiotic to treat her diagnosis of cellulitis. No further information was provided at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 19 October 2012. A 23-year-old female patient had received a dose of FLUZONE intradermal (Batch number UT4468BA) in the right deltoid on 17 October 2012. The patient had allergy to Sulfa and no other history of medical conditions. Concomitant medications were not reported. On 18 October 2012 one day after vaccination, the patient experienced large welt, redness, warm to touch, hard area at injection site of right arm and fever. It was reported that the symptoms of redness, warm to touch, hard and welt area were worse on 19 October 2012. The laboratory investigations and treatment medications were not reported. The patient's outcome was not recovered. Follow-up information was received on 01 February 2013 from a health care professional. Based upon new information received, it was determined this case now meets seriousness criteria and has been upgraded from non-serious to serious. According to the reporter, per the patient she received an antibiotic to treat her diagnosis of cellulitis. No further information was provided at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Erythema, Spleen disorder, Swelling
Clinical narrative: Patient was given a MENACTRA inj in (L) deltoid. There were no signs & symptoms when she exited clinic. Client called 2/7/2013 - stating she had a red raised reaction size of quarter. She called her physician & he instructed her to contact us.
Age: 26.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Erythema, Laboratory test, Spleen disorder, Swelling
Clinical narrative: Patient was given a MENACTRA inj in (L) deltoid. There were no signs & symptoms when she exited clinic. Client called 2/7/2013 - stating she had a red raised reaction size of quarter. She called her physician & he instructed her to contact us.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Initial report received from a healthcare professional on 30 October 2012. A 38-year-old female patient, whose medical history included hypothyroidism and concomitant medications were not reported, had received an intradermal dose of FLUZONE ID (lot number: UT4471AA) in left deltoid on 29 September 2012. The patient had no illness at the time of vaccination. The patient had no known allergies. The patient had received numerous flu vaccines. On 30 September 2012, 1 day after vaccination, the patient had experienced left upper arm to shoulder redness, sore and hot to touch. Laboratory investigations and corrective medications were not reported. The patient's outcome was not recovered. Follow-up information was received from a healthcare professional on 01 February 2013. Based upon follow-up information this case has been upgraded to serious. The patient required Prednisone 20mg two tablets daily for 5 days in order to treat reaction. Outcome remained not recovered. Documents held by sender: none.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Severe pain upper left arm 12-03 to 12-07-2012 cannot lie on (L) arm or apply pressure. Severe pain has subsided to constant soreness like a bad bruise - certain movements increase pain.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Feeling cold, Injected limb mobility decreased, Insomnia, Pain in extremity
Clinical narrative: This spontaneous consumer report (initial receipt 29-Jan-2013) concerns a 61 year old male patient. Concomitant medications included vitamins. On 14-Jan-2013, the patient received AFLURIA (batch P51208) in his right shoulder. On 14-Jan-2013, he noticed a cool sensation going 3-4 inches down his arm. During the same evening he couldn't move arm and needed the assistance from his left arm to accommodate his daily routine. He also had problems sleeping at night time. Two weeks later, the patient's arm is still sore. He states that it is annoying and very disturbing that this pain is still present. The event outcome is not yet recovered.
Age: 1.12
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Erythema, Induration, Pyrexia
Clinical narrative: Redness, fever, induration size of nickel. Pt given BENADRYL oral and ims to continue to give q 6 hrs see MD if no improvement.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Agitation, Flushing, Pruritus, Rash macular
Clinical narrative: Approximately one hour after receiving 5y vaccines, developed itching, agitation, and red blotchy/flushed skin; No breathing difficulties or vomiting.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient developed rash along waistline. Pt went to the dermatologist and was told it was shingles.
Age: 49.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever, redness and soreness on right upper arm.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Headache
Clinical narrative: Developed bad headache on 2-5-13.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Laboratory test, Rash maculovesicular, Varicella
Clinical narrative: Rec. shingles vac. Jan.4, 2013 macular/vesicular eruptions approx 1/21/13 Definitive Dx: Chicken pox at hospital ER. Cellulitis down legs.
Sex: M
Vaccine: VARCEL
Symptoms: Blindness, Necrotising herpetic retinopathy, Polymerase chain reaction, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age with common variable immune deficiency. On an unknown date, the patient was vaccinated with a dose of (Merck) VARIVAX (Lot # not reported). The physician reported that on an unknown date, the patient developed progressive outer retinal necrosis (PORN), from which he subsequently went blind. The outcome of went blind and progressive outer retinal necrosis was unknown. Upon internal review PORN and blindness were considered to be important medical events. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swollen area running between the 2 injection sites on (L) thigh - appeared 7 days after vaccination. Treated with cool compresses. Did not feel deep - likely no muscular involvement.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Patient reports the day vaccine was administered prior to administration she had mild nausea and diarrhea. Rabies vaccines was administered 1/31/13 at 10:30AM. On 2/1/13 about 4pm developed itching of feet, hands, torso and jaw. Noted "large welts" "hives" on torso. Redness of feet and hands. Took BENADRY. Resolved in about 30 minutes.
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to many male patients of unknown age. On an unknown date, the patients were vaccinated with a dose of GARDASIL (lot number, expiry date, dose and route were not reported). The nurse reported that on an unknown date, many male patient have passed out while on GARDASIL. Action taken with GARDASIL was unknown. The outcome of passed out was unknown. Upon internal review, the event passed out was considered as medically significant. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness & swelling to LT DT hot to touch. Ice to LDT 4x a day.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Urticaria
Clinical narrative: Patient developed red, 2 inch wide welp half-way around arm and under arm into lymph node area on the side of the body the shot was administered (left). Patient experienced soreness, which was resolving within a week of the shot. He notified his doctor 3 days after the shot.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea/vomiting the day after the vaccine administered but patient did inform me of the event until 1/20/13, almost 3 months later & the hospital wouldn't release any info on her stay b/c they stated, "I'm not HIPPA certified".
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Parotitis
Clinical narrative: Right-sided parotitis; referred to ENT for further evaluation and management on 2/12/2013.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Nervous system disorder, Neurological examination abnormal, Paraesthesia
Clinical narrative: Numbness and tingling. First thought to be Guillain Barre.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: COMPLAINED OF PAIN AND TINGLING IN LEFT ARM POST FLU SHOT.  SYMPTOMS DID NOT BEGIN UNTIL SEVERAL DAYS TO A WEEK AFTER SHE RECEIVED THE SHOT.
Age: 21.0
Sex: M
Vaccine: HPV4
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Pt c/o of chest caving in. Pt also have difficulty breathing and chest tightness.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Patient has dark red patch approx. 1x3 inches surrounded by a lighter pink area. Patient said everything felt fine all day on Friday, but noticed the redness and soreness Saturday morning. Pain at the touch and pain internally radiating down to the elbow. No fever or other symptoms.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Dizziness, Headache, Nausea
Clinical narrative: Severe body aches, fevers, chills, nausea, dizziness, weakness, severe headache, vision trails beginning 24 hours after injection and continuing for the next 48 hrs.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Visual impairment
Clinical narrative: Severe body aches, fevers, chills, nausea, dizziness, weakness, severe headache, vision trails beginning 24 hours after injection and continuing for the next 48 hrs.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture, C-reactive protein, Culture urine, Diarrhoea, Full blood count
Clinical narrative: Fever up to 104.0, generalized rash, vomiting and diarrhea, red eyes. Diagnosed with Kawasaki Disease.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Kawasaki's disease, Metabolic function test, Ocular hyperaemia, Pyrexia, Rash generalised
Clinical narrative: Fever up to 104.0, generalized rash, vomiting and diarrhea, red eyes. Diagnosed with Kawasaki Disease.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Red blood cell sedimentation rate, Urine analysis, Vomiting
Clinical narrative: Fever up to 104.0, generalized rash, vomiting and diarrhea, red eyes. Diagnosed with Kawasaki Disease.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Pt presented to ER with rash (bilateral) on arms and legs, chest, back, and neck. BP 131/73, Temp 98, Pulse 85, Resp 18.  Pt given Solu-Medrol 125mg IV, Pepcid 20mg IV, and Benadryl 25mg IV.  Discharged at 7:10 PM.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Ultrasound scan, Vaccination site cellulitis
Clinical narrative: Redness and swelling at site of vaccine, tx for cellulitis at vaccine site.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling cold, Headache, Hypoaesthesia, Pain in jaw, Paraesthesia
Clinical narrative: Numbness/tingling right side jaw pain, headache, cold sensation, facial puffiness, tightness in periorbital region.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Skin tightness, Swelling face
Clinical narrative: Numbness/tingling right side jaw pain, headache, cold sensation, facial puffiness, tightness in periorbital region.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt stated her arm got really red and swollen from sight to her elbow on (L) arm sub q.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncope with questionable seizure activity, transported to medical center.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Fatigue, Irritability, Rash
Clinical narrative: Rash started upper body the evening of 2/11/13 - spread to face, torso, arms & legs including palms by 2/12/13. Fussy and tired.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Laboratory test abnormal, Maternal exposure during pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: This prospective pregnancy case was reported by a physician and described the occurrence of vaccine exposure during pregnancy in a 24-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) during pregnancy. Concurrent medical conditions included anxiety, depression and menstrual bleeding that occurred two days prior to this report. Concurrent medications included Prenatal vitamins. On 17 January 2013 at 16:20 the subject received 1st dose of FLULAVAL (.5 ml, unknown, right arm). Her last menstrual period (LMP) was on 07 December 2012 and estimated date of delivery (calculated based on LMP) was on 14 September 2012. The subject was exposed to FLULAVAL during the first trimester. On 17 January 2013 at the time of vaccination with FLULAVAL, the subject experienced vaccine exposure during pregnancy. The pregnancy was ongoing. Follow up received on 8 February 2013 from physician. The physician documented that the conception was normal with no in-vitro fertilization. On 14 January 2013, the subject was evaluated by her OB/GYN due to spotting and cramping and "was being monitored for threatened abortion." The subject reported to the OB/GYN that one day prior to vaccination (16 January 2013), the vaginal bleeding had increased. Per the physician, the gestation at the time of the intramuscular vaccination on 17 January 2013 was 5 weeks and 6 days. On 23 January 2013, an "ultrasound and lab test revealed that she had spontaneously aborted." The gestational age at the time of the event was calculated to be 6 weeks and 6 days. The physician did not consider this case as serious. GSK has determined this case is serious.
Age: 1.07
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site swelling, Injection site warmth
Clinical narrative: On - 2-1-13 child received immunizations & immediately reacted with swelling and heat to injection site provider had cold packs applied & gave TYLENOL. Swelling to (R) quad.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Crying, Irritability, Poor quality sleep, Screaming, Sleep disorder
Clinical narrative: Hives for weeks requiring Benadryl, worsening of food allergies as patient was hiving from eating many things she had previously been able to tolerate, irritability such as inability to sit in car seat for any length of time without screaming and crying which is completely uncharacteristic, disrupted sleep with waking and screaming for no apparent reason, crying and irritable every day for unknown reason which is totally uncharacteristic of child.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria, Viral infection
Clinical narrative: Hives for weeks requiring Benadryl, worsening of food allergies as patient was hiving from eating many things she had previously been able to tolerate, irritability such as inability to sit in car seat for any length of time without screaming and crying which is completely uncharacteristic, disrupted sleep with waking and screaming for no apparent reason, crying and irritable every day for unknown reason which is totally uncharacteristic of child.
Age: 29.0
Sex: M
Vaccine: JEV1
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: I was given the same vaccination within a one week span when the next required dose was 28 days from the initial dose given.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Miller Fisher syndrome
Clinical narrative: Guillain Barre syndrome, Miller Fisher variant. Treated with IVIG at Medical Center.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Paraesthesia, Swelling
Clinical narrative: Small hives noticed a day before were getting bigger, slightly more painful.  Red raised areas spread around upper left chest, left side, under left arm (near injection area) and along upper left back. These areas had been tingly and sore at time as they are in the area of August 2012 open heart surgery.  On 2/12/13 the doctor's PA diagnosed shingles and prescribed Valacyclovir.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Small hives noticed a day before were getting bigger, slightly more painful.  Red raised areas spread around upper left chest, left side, under left arm (near injection area) and along upper left back. These areas had been tingly and sore at time as they are in the area of August 2012 open heart surgery.  On 2/12/13 the doctor's PA diagnosed shingles and prescribed Valacyclovir.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Pain, Skin warm
Clinical narrative: Next day pt calls with 3" x 5" area on arm that is hot, red, swollen, painful. Treating with Tylenol and ice.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Body temperature increased, Crying, Headache, Pain in extremity
Clinical narrative: Vaccine was administered 2/6/13 - mom states child wake up crying 2/7/13 c/o headache, pains in her arms and legs with a temp of 102F. 2/8/13 mom called and stated child fully recovered - no fevers or sx's.
Age: 1.52
Sex: M
Vaccine: HEPA
Symptoms: Body temperature increased, Convulsion
Clinical narrative: Temperature elevated- as high as 103.9. Had seizure at 102.9- and was taken by ambulance to ER. Just observed, given TYLENOL & ibuprofen. Sent home. Returned next PM for high temp-ordered ZITHROMAX & oral steroid (to ER).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 7cm x 9 1/2 cm area of erythema (R) upper arm; No pus or pain.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Muscular weakness, Pain
Clinical narrative: On 9/11/2012, pt received a tetanus shot Left Deltoid at 4pm and by 7pm had pain. By 3:45 on 09/12/12 has muscle weakness and SOB.
Age: 60.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Axillary pain, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Area of shot site red, swollen, & warm to touch.  Pain in armpit when lifting arm.  Onset @6:00pm, worst @8:00pm.  Swelling, redness, & pain decreased by 8:00 am on 02/11/2013.
Age: 1.03
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: T-cell lymphoma, Varicella post vaccine
Clinical narrative: Received vaccines on 08/20/12.  Admitted to Hospital on 09/04/12, chicken pox diagnosed while at hospital.  Was diagnosed with T-cell Lymphoma during hospital stay. Still had "bumps" on body as of 11/19/12.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster in 2 dose varicella vaccine recipient.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure abnormal, Dizziness, Tunnel vision
Clinical narrative: Patient had dizziness and tunnel vision-felt faint. 911 was called.  EMT checked vitals, decided she was stable and left. PT stayed with nurse until BP returned to normal and nurse advised taking the rest of the day off and calling 911 if she experiences any other issues.  PT indicated she hasn't had a flu shot since she was 8 yrs old and does often feel faint when having blood drawn or receiving shots.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: Soreness at injection site, red/raised bumps at injection site; fever; severe headaches. Headaches continue.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: SWELLING AND ITCHING AT SITE OF INJECTION.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Thigh swelling and redness.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Customer Safety Compromised: Pregnant. Vaccine was administered to a pregnant participant. Participant was informed to advise OB/GYN of vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Acne, Cellulitis, Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: Received immunizations on 9/13/12. Woke up next morning RT arm was red and itching.  9/15/12 RT arm was swollen to twice the normal size from shoulder to elbow with dimpling.  Pimple like lesion at injection site.  Went to ER, diagnosed with cellulitis and started on antibiotics.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Received immunizations on 9/13/12. Woke up next morning RT arm was red and itching.  9/15/12 RT arm was swollen to twice the normal size from shoulder to elbow with dimpling.  Pimple like lesion at injection site.  Went to ER, diagnosed with cellulitis and started on antibiotics.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Participant had trouble breathing after being vaccinated. Participant says she has asthma and COPD. Participant was fine after taking inhaler and resting.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Erythema, Injection site swelling, Nausea, Pain
Clinical narrative: Patient noticed body aches, chills, localized redness and swelling at injection site, nausea, fever of 103F.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Patient noticed body aches, chills, localized redness and swelling at injection site, nausea, fever of 103F.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Cough, Dermatitis, Rash, Rash macular
Clinical narrative: Within 15min of vaccine administration Mother noted cough, followed by facial rash. Review of notes remarkable for rash described as macular rather than urticarial rash on the face, which subsequently spread to chest and back. Diphenhydramine and Prelone given without resolution of sxs. Epinephrine administered with prompt resolution of dermatitis and cough. Temperature increased to 100F from initial of 98.7. Child observed for several hours with NO recurrence of sxs. Sa02 notably normal (99-100 on RA), with normal oral/throat/respiratory/pulmonary examination. No angioedema reported. No GI sxs reported.
Age: 36.0
Sex: M
Vaccine: TYP
Symptoms: Asthenia, Body temperature increased, Fatigue
Clinical narrative: Pt took first dose of oral Typhoid 2/9/13. Had temps remainder of weekend up to 101 degrees F. C/o "horrible fatigue and weakness.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling, Vomiting
Clinical narrative: Vomiting, swollen & red.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Influenza like illness, Lip swelling, Malaise, Oropharyngeal pain
Clinical narrative: Pt called 5 hours after receiving shot complaining severe sore throat, swollen eyes, & swollen lips. Pt was seen in ER & given BENADRYL. Pt also had severe flu-like sx (fever, body aches, malaise) for few days after receiving shot. Per last phone conversation, 4 days after shot, pt felt better.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Pt called 5 hours after receiving shot complaining severe sore throat, swollen eyes, & swollen lips. Pt was seen in ER & given BENADRYL. Pt also had severe flu-like sx (fever, body aches, malaise) for few days after receiving shot. Per last phone conversation, 4 days after shot, pt felt better.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ, VARCEL
Symptoms: Erythema
Clinical narrative: 5:30 pm Red - quarter size. Gave BENADRYL and ice. 10:00 am Lg fist size or softball size more BENADRYL and ice/heat. Less red same size more same then gone.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site induration, Injection site nodule, Injection site pain, Pyrexia
Clinical narrative: 4 centimeter indurated, mildly tender, non-erythematous nodule on right deltoid fever 102.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Tension headache, Tinnitus
Clinical narrative: Ringing in ears, lightheaded "head feels tight" No reports of respiratory distress. Mother called at 2:50 pm pt informed to go to ER if resp distress occurs.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticarial lesions over trunk & extremities with severe itching. No respiratory issues. Vital signs were stable. Was given SOLUMEDROL 20mg IM and observed for - 30mts. Lesions began to fade; Itching resolved. Called mom about 2 hours later and all the lesions were gone.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site mass, Injection site pain, Pain, Pyrexia, Rash
Clinical narrative: Fever, pain at injection site rash, body aches golf ball size lump to injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 5 1/2 cm x 10 cm  area of erythema (R) upper arm; No pus or pain.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to an approximately 51-year-old female patient (reported as over 50 years). Patient had a history of shingles. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). The patient developed shingles after receiving a dose of ZOSTAVAX on an unknown date. The patient recovered on an unknown date. It was unspecified whether lab diagnostic studies were performed or whether patient sought medical attention. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient had none pertinent medical history. The patient had none drug allergies. On 18-JAN-2013 the patient was vaccinated subcutaneously with live ZOSTAVAX (lot # H016762, expiry date 11-DEC-2013). Concomitant medication was reported as none. "At some point the following week", in approximately January 2013, the patient developed a rash which was hot and red and two to three inches wide. The rash disappeared for a few days and had reappeared at the time of reporting as little red bumps but was not irritating. The patient sought for medical attention by calling the reporting pharmacist. No treatment was given. Lab diagnostics studies performed were reported as none. The outcome was reported as not recovered. Additional information is not expected.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 82-year-old male patient. On an unknown date in December 2010 The patient was vaccinated with a dose of ZOSTAVAX (lot# and expiration date not reported) subcutaneously. While on ZOSTAVAX the patient developed shingles on 28-JAN-2013. The patient was prescribed VALTREX. It was unspecified whether lab diagnostic studies were performed. The patient sought medical attention for the event. The outcome of "shingles' was unknown at the time of this report. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of live ZOSTAVAX (lot # H011048, expiration date 05-SEP-2013, route not reported) which was placed in refrigerator for 6 days. No adverse effects reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient. This patient had no allergies. On 25-JAN-2013 the patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (lot # h020000, expiry date 02-FEB-2014). Whether the patient had any concomitant medications was unspecified. She returned to the pharmacist on 28-JAN-2013 concerning a reddened area around the injection site, about the size of a palm which was hot and raised. This patient had been using a topical hydrocortisone cream, with no relief. The patient had not yet seen her doctor. The outcome was unknown. Pharmacist requested a lot check of ZOSTAVAX (lot # h020000, expiry date 02-FEB-2014). The pharmacist also reported another patient who received ZOSTAVAX and develop similar injection site reactions. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient. The patient was allergic to anti-inflammatory drugs and opioid analogue derivatives. On 29-JAN-2013 the patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (lot # h020000, expiry date 02-FEB-2014). The patient was on unspecified pain medications and unspecified cholesterol medications. The patient developed a reddened area about the size "of a palm" around injection site that was hot and raised. She came back to see the pharmacist on 01-FEB-2013 concerning the reaction. The patient had not seen her physician at the time of reporting. The outcome was unknown. Pharmacist requested a lot check of ZOSTAVAX (lot # h020000, expiry date 02-FEB-2014). The pharmacist also reported another patient who received ZOSTAVAX and develop similar injection site reactions. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a reporter (details unspecified) refers to a 12 year old female patient. The patient had no medical history. On 30-OCT-2012, the patient was vaccinated with a second dose of GARDASIL 0.5 milliliter (ml), intramuscular. No concomitant medications were taken. On 12-NOV-2012 (reported as day 12 of second dose), the patient experienced headache, vomiting and fever. No laboratory test was performed. The outcome of headache, vomiting and fever was unknown. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient with drug hypersensitivity of Red dye, morphine, opiods, codeine, SULFA, COMPAZINE, fluoroquinolones, BENADRYL, SUDAFED. The patient had no pertinent medical history. On 04-FEB-2013 the patient was vaccinated with ZOSTAVAX (lot number reported as H019092) (dose and injection site were not reported) subcutaneously. On 06-FEB-2013 the patient experienced an injection site reaction that consisted of a "raised, red welt that was bigger than a quarter, but not hot, around the injection site". Treatment short course of prednisone was given for adverse events. The action taken and outcome of the adverse events was not provided. The patient had a phone call for medical attention. This one of two reports received from the same patient. MARRS number" 1302USA004670. Additional information is not expected.
Age: 0.9
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 10 month old patient. On 23-AUG-2012 the patient was vaccinated subcutaneously with 0.5 ml dose of VARIVAX (lot# not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to patients of unknown age and gender. Approximately on an unknown date in 2012 the patient was vaccinated with a dose of RECOMBIVAX HB (lot#, expiration date and route not reported). Improperly stored RECOMBIVAX HB had been administered to an unknown number of patients. The dates RECOMBIVAX HB were improperly stored were between 30-JUN-2012 to 24-JUL-2012 (exact dates of administration were unspecified). No adverse event reported. The office did not wish follow-up for a safety report. No other information to report. This is one of the several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to patients of unknown age and gender. Approximately on an unknown date in 2012 the patient was vaccinated with a dose of GARDASIL (lot #, expiration date and route not reported). Improperly stored GARDASIL had been administered to an unknown number of patients. The dates GARDASIL were improperly stored were between 30-JUN-2012 to 24-JUL-2012 (exact dates of administration were unspecified). No adverse event reported. The office did not wish follow-up for a safety report. No other information to report. This is one of several reports from the same source. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Glaucoma, Hepatic steatosis, Herpes zoster, Neuralgia
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 70 year old female patient with osteopenia, hypertension and desipramine allergy. The patient's medical history included fatty liver and glaucoma. On 02-MAR-2010, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # not reported). Concomitant therapies included lisinopril, milk thistle and WELCHOL. On 26-JAN-2013, the patient experienced shingles which manifested as one blistered area and as nerve pain radiating around and towards the back of the patient. Treatment included VALTREX and NEURONTIN. No laboratory diagnostic tests were performed. Patient sought medical attention (unspecified). The outcome of shingles was reported as recovering. The causality of shingles for ZOSTAVAX was unknown. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: This spontaneous report as received from a physician refers to an 11 year old female patient without pertinent medical history or drug reactions/allergies. On 01-FEB-2013 the patient was vaccinated with first dose of GARDASIL (dose unknown, lot# reported as H014282, expired date: 09-APR-2014). Concomitant therapies included MENACTRA and DAPTACEL given at the same visit on 01-FEB-2013 at separate sites. In February, 2013 the patient developed a swollen, slightly warm, red rash at the injection site of the first dose of GARDASIL. The patient's mother called the office on 03-FEB-2013 to report the rash, but the exact time frame development of the rash was unspecified. The physician instructed the patient to take BENADRYL or CLARITIN and ibuprofen or TYLENOL. There was no lab diagnostics studies performed. At the time of reporting, the status of the patient was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Hypoaesthesia, Injection site anaesthesia
Clinical narrative: Initial report received from a healthcare professional on 18 January 2013. An 18-year-old female patient, with no illness at the time of vaccination and had no known allergies, had received an intramuscular dose 2 of MENACTRA vaccine (lot number U4292AA) in left arm, on 18 January 2013. On 18 January 2013, the patient experienced numbness from injection site in left arm down to left hand. Laboratory investigations and corrective treatment were not reported. The patient's outcome was not recovered. Documents held by sender: None.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse in a doctor office refers to a 69 years old female patient. On 04-FEB-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # reported as H018441, exp. date 28-FEB-2014). On 05-FEB-2013 the patient came to the office with redness and swelling at the site of injection. It was unknown if medical treatment was prescribed. The outcome of the events was reported as recovering. The relatedness for the events was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 65 year old male patient without pertinent medical history. The patient had no drug reactions or allergies. The patient was vaccinated with one dose of ZOSTAVAX (lot number, dose, route and indication were not reported) at an unspecified facility, on an unspecified date within the past two weeks. No other co-suspects were reported. There was no concomitant medication. The patient visited the office for medical attention on 08-FEB-2013, with a generalized varicella-like rash. There was no treatment given for adverse event. There was no laboratory diagnostics study performed. Action taken was not provided. The patient was not recovered at the time of report. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 05-FEB-2013, the patient was vaccinated with GARDASIL (dose, route and lot not reported). The physician stated that while she was injecting the GARDASIL, she noticed a leak from the syringe. After inspecting the syringe, she noticed a crack in the syringe. Physician reported that the patient might had only received a partial dose of GARDASIL. No adverse event symptoms reported. The reporter considered the event was not related to GARDASIL. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 62 year old female patient regarding herself. No medical history or drug allergies were reported. On 04-FEB-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported). No concomitant medications were reported. On 05-FEB-2013, the patient experienced the following injection site reactions after receiving ZOSTAVAX: redness, swelling and the skin was warm to the touch. The outcome of injection site reactions was reported as not recovered. No treatment was received. No laboratory diagnostics tests were performed. No medical attention was sought. The causality of injection site reactions for ZOSTAVAX was unknown. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Initial information has been received from a physician via field representative concerning a 65 years old female patient with an unspecified pertinent medical history or drug reactions/allergies. On an unspecified date in 2010, the patient was vaccinated with a 0.65 ml (one) dose of ZOSTAVAX (route and lot number were not reported). No other suspect medications were reported. No concomitant medications were reported. On 04-FEB-2013 the patient "got shingles". The patient was treated with acyclovir. Laboratory studies were not reported. The patient sought medical attention by visiting office. The patient outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with amoxicillin allergy and no pertinent medical history. The patient was vaccinated with a dose of PNEUMOVAX23 (lot # not reported) 0.5 mL intramuscular on 29-JAN-2013. No other co-suspects were reported. There were no concomitant medications. On 31-JAN-2013 the patient developed cellulitis, after PNEUMOVAX23 was administered. No Lab diagnostics were performed. There was no treatment given for the event. The outcome of cellulitis was reported as recovering/resolving. The patient contacted the pharmacist. The relatedness for cellulitis was unknown for PNEUMOVAX23. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a 17 year old female patient who on an unknown date, was vaccinated with first dose of RECOMBIVAX HB (Lot # and route not provided). On an unknown date, was vaccinated with second dose of RECOMBIVAX HB (Lot # and route not provided). On an unknown date, was vaccinated with third dose of RECOMBIVAX HB (Lot # and route not provided). No concomitant medications were reported. The nurse stated that on unspecified date, a patient who received three doses of RECOMBIVAX HB as an infant, has been determined to have negative antibody titers to hepatitis B. The patient did not receive any treatment for adverse event. The patient sought medical attention. The outcome of anti-hbs antibody negative was unknown. The relatedness adverse event was unknown for RECOMBIVAX HB. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect drug dosage form administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an adult patient (gender unknown). On 05-FEB-2013, the patient was vaccinated with RECOMBIVAX HB, 40 mcg, intramuscular (lot number not reported). Concomitant medication was not reported. It was reported that the patient who was not a dialysis patient received the dialysis formulation of RECOMBIVAX HB and the patient did not experience any known symptoms. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 08-FEB-2013, the patient was administered an expired dose of live ZOSTAVAX (lot#165744; exp., date: 21-JAN-2013) (dose and route not reported). The outcome of the event was not provided. The relatedness of the event with live ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug interaction
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient reported that on 29-JAN-2013, the patient was vaccinated with ZOSTAVAX (dose, route and lot not reported) and was at the time of the phone call being prescribed ENEBREL (manufacturer unknown). The outcome of the event was unknown. The reporter considered that the event was not related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 08-JAN-2013, the patient was inadvertently vaccinated intramuscularly with a 1 ml dose of RECOMBIVAX HB (Lot # 0482Z) that had expired on 03-DEC-2012. No adverse effects reported. The outcome of the event was unknown. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 29 year old female patient. No pertinent medical history, drug reactions or allergies. In 1984, the patient was vaccinated with the first dose of M-M-R II (lot#, dose and route not reported). On 31-JAN-2013, the patient was vaccinated with a second dose of M-M-R II (subcutaneous injection) 0.5 ml (lot# H011907; exp. date: 03-JUL-2014). Concomitant medications included SPRINTEC. On 02-FEB-2013, the patient developed pre-auricular and post-auricular lymphadenopathy. No treatment was given. The patient was scheduled to be evaluated on 07-FEB-2013. The outcome of the event was reported as not recovered. The relatedness of the event with M-M-R II was not provided. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 65 year old male patient with elevated blood pressure and penicillin allergy. On an unknown date, the patient was vaccinated with live ZOSTAVAX, 0.65 ml, subcutaneously (lot number not provided). Concomitant therapies included beclomethasone diproprionate, blood pressure medication, acid reflux medication and antibiotic (unspecified). On an unknown date, the patient experienced a cold sore approximately 5 days, exact date unspecified, after receiving live ZOSTAVAX. The patient was not intervened to prevent serious criteria. At the time of the report, the outcome of cold sore was unknown. The event of cold sore was unknown related to live ZOSTAVAX.