chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. ON 08-MAY-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 669646/1703Z, expiry date 09-DEC-2012) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Skin lesion
Clinical narrative: 3.75 cm x 2.75 cm erythematous, induration lesion on upper left thigh, no signs of infection. (1/17/2014) Pt. had received vaccines 48 hours prior (01/15/14). Treatment : Ibuprofen and BENADRYL as prescribed by provider.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from an unknown reporter who is a reporter refers to young girl of unknown age. On an unknown date, the patient was vaccinated with GARDASIL injection (dose, frequency, route, lot #, expiry date unspecified) for an unknown indication. No concomitant medication was reported. On an unknown date, the patient suffered from an unspecified adverse event after use with GARDASIL. There was no product quality complaint. No further AE information was provided. Reporter explained that she was unable to share any of this patient personal information. Action taken with GARDASIL was assessed as not applicable. Outcome of the reported event was unknown. Causality of the reported event was unknown (not applicable). Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune thrombocytopenia, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: Diagnosed with immune thrombocytopenia (ITP) 4 weeks following second GARDASIL dose. Platelet count was 3000 at the time of diagnosis. ITP is now considered chronic. Treatments have included WinRho, IVIG, prednisone and rituximab. Patient is still under treatment.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 07-MAR-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # H012351, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 12-APR-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # H012351, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 31-JUL-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0079AE, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-AUG-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0079AE, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 07-MAY-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 669646/1703Z, expiry date 09-DEC-2012) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 26-JUL-2012, the patient was administered with a dose of VARIVAX (Lot # 670799/0975AA, expiry date 17-JUN-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash vesicular
Clinical narrative: This spontaneous report was received from a consumer (patient husband) refers to a female patient of unknown age. On an unknown date in November 2013, the patient was vaccinated with ZOSTAVAX. Concomitant medications included blood pressure medicines. On an unknown date, the patient experienced chicken pox like rash on face and chest. The patient sought medical attention and spoke to the physician. The patient reported that she noticed three very small rashes on her face that were little bit red which faded away in 2-3 days. Then she got another rash on her chest which also went away in 2-3 days. Patient mentioned these rashes to physician but physician thought that these rashes were not related to ZOSTAVAX. No treatment was given to the events. It was reported that VZVIP packet faxed to physician. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 04-MAY-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 669646/1703Z, expiry date 09-DEC-2012) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender who received the first two doses of GARDASIL injection administered intramuscularly in the gluteal muscle. The first dose of GARDASIL (administered intramuscularly in the gluteal muscle) was administered on 26-JUL-2013 (lot #, expiry date, dose unknown), the second dose of GARDASIL (administered intramuscularly in the gluteal muscle) was administered 26-AUG-2013 (lot #, expiry date, dose unknown) and the third dose of GARDASIL (administered intramuscularly in the deltoid muscle) was administered on 13-JAN-2014 (lot #, expiry date, dose unknown). No adverse event reported. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug administered at inappropriate site
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender who received the first two doses of GARDASIL injection administered intramuscularly in the gluteal muscle. The first dose of GARDASIL (administered intramuscularly in the gluteal muscle) was administered on 26-JUL-2013 (lot #, expiry date, dose unknown), the second dose of GARDASIL (administered intramuscularly in the gluteal muscle) was administered 26-AUG-2013 (lot #, expiry date, dose unknown) and the third dose of GARDASIL (administered intramuscularly in the deltoid muscle) was administered on 13-JAN-2014 (lot #, expiry date, dose unknown). No adverse event reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a patient of unknown age and gender. On unspecified date in December 2013 (also reported as "about a month ago"), the patient was vaccinated with ZOSTAVAX (dose, duration and lot were not reported). On an unknown date, the patient experienced the injection site swelled to "the size of a baseball" and rash on the injection site. The outcome of the injection site swelled to "the size of a baseball" and rash on the injection site was reported as recovered/resolved without treatment "in about two days". Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-APR-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # H012351, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On June 2009 the patient was vaccinated with 1st GARDASIL dose (dose, strength, route, indication and lot number were not provided). The 2nd dose of GARDASIL (dose, strength, route, indication and lot number were not provided) in August 2009. And the 3rd dose of GARDASIL (dose, strength, route, indication and lot number were not provided) on 09-JAN-2014. No adverse events reported. Co-suspect and concomitant therapies were not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 19-APR-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # H012351, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Antinuclear antibody negative, Arthralgia, Blood creatine phosphokinase normal, Blood uric acid normal, Bone pain
Clinical narrative: Left deltoid pain; afterwards generalized joint and bone pain (next day); fatigue and tiredness. No treatment. Second dose of vaccine administered on 08/29/2013.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Bone scan abnormal, C-reactive protein increased, DNA antibody negative, Fatigue, Pain in extremity
Clinical narrative: Left deltoid pain; afterwards generalized joint and bone pain (next day); fatigue and tiredness. No treatment. Second dose of vaccine administered on 08/29/2013.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Red blood cell sedimentation rate increased, Rheumatoid arthritis, Rheumatoid factor negative
Clinical narrative: Left deltoid pain; afterwards generalized joint and bone pain (next day); fatigue and tiredness. No treatment. Second dose of vaccine administered on 08/29/2013.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Left arm began severly itching.  No relief with OTC Benadryl, cortisone cream.  Rash going down arm.  No fever or numbness of arm.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site movement impairment, Injection site pain
Clinical narrative: Right shoulder pain and limited range of motion at present time (2 weeks since vaccination).  Currently awaiting physical therapy appointment.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Fatigue, Headache, Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Left thigh large red swelling and bruised, h/a, tired, neck stiffness.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Musculoskeletal stiffness
Clinical narrative: Left thigh large red swelling and bruised, h/a, tired, neck stiffness.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site haematoma
Clinical narrative: Pt. had a 3 inch erythematous area to (R) upper arm with 0.5 inch hematoma in the center.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV2
Symptoms: Erythema, Local swelling
Clinical narrative: Redness and swollen to the right arm.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature decreased, Bradycardia, Cardiac arrest, Cardiac pacemaker insertion
Clinical narrative: The patient c/o increasing weakness and cephalgia, presented to ED 1/24 with hypotension, hypothermia. Admitted to ICU after cardiac arrest 1/25. Repeat cardiac arrest 1/26 after bradycardia --> asystole. Intubated 1/26 and treated for sepsis with broadspectrum antibiotics, requiring vasopressors. The patient did require permanent pacemaker placement- done 1/29. He continues in ICU in poor condition as of 1/30.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Catheterisation cardiac normal, Endotracheal intubation, Headache, Heart rate decreased, Hypotension
Clinical narrative: The patient c/o increasing weakness and cephalgia, presented to ED 1/24 with hypotension, hypothermia. Admitted to ICU after cardiac arrest 1/25. Repeat cardiac arrest 1/26 after bradycardia --> asystole. Intubated 1/26 and treated for sepsis with broadspectrum antibiotics, requiring vasopressors. The patient did require permanent pacemaker placement- done 1/29. He continues in ICU in poor condition as of 1/30.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypothermia, Intensive care, Platelet count decreased, Sepsis, White blood cell count normal
Clinical narrative: The patient c/o increasing weakness and cephalgia, presented to ED 1/24 with hypotension, hypothermia. Admitted to ICU after cardiac arrest 1/25. Repeat cardiac arrest 1/26 after bradycardia --> asystole. Intubated 1/26 and treated for sepsis with broadspectrum antibiotics, requiring vasopressors. The patient did require permanent pacemaker placement- done 1/29. He continues in ICU in poor condition as of 1/30.
Age: 2.0
Sex: M
Vaccine: DTAP, PNC
Symptoms: Childhood disintegrative disorder, Crying, Decreased interest, Disturbance in attention, Feeling abnormal
Clinical narrative: The location of the vaccination (right arm) became very hard, like large cyst. Patient began crying and expressed pain (boo-boo) on his right arm. Patient knows enough words to be able to communicate with my wife what was wrong. When she looked at the injection spot, it was very swollen and painful for patient. The cyst remained for more than a week (hasn't disappeared completely yet). We called the doctor's office and informed him of the reaction. Patient also received a vaccination in his left arm. Since the vaccination, patient has seemed to have a harder time concentrating and being attentive. I know that may sound absurd considering he's a 2 year old, but before the vaccination patient has been able to identify all numbers 0-9, all the letters of the alphabet and at least 15 different states on a Map (sometimes as many as 20). Since the vaccinations, patient has digressed in his ability & desire to identify the states. He also seems to space out more.
Age: 2.0
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site cyst, Injection site pain, Injection site swelling, Vaccination site induration
Clinical narrative: The location of the vaccination (right arm) became very hard, like large cyst. Patient began crying and expressed pain (boo-boo) on his right arm. Patient knows enough words to be able to communicate with my wife what was wrong. When she looked at the injection spot, it was very swollen and painful for patient. The cyst remained for more than a week (hasn't disappeared completely yet). We called the doctor's office and informed him of the reaction. Patient also received a vaccination in his left arm. Since the vaccination, patient has seemed to have a harder time concentrating and being attentive. I know that may sound absurd considering he's a 2 year old, but before the vaccination patient has been able to identify all numbers 0-9, all the letters of the alphabet and at least 15 different states on a Map (sometimes as many as 20). Since the vaccinations, patient has digressed in his ability & desire to identify the states. He also seems to space out more.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinusitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 82 year old female patient. On 13-JAN-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous. Concomitant therapies included simvastatin (manufacturer unknown), levothyroxine sodium (manufacturer unknown), potassium chloride (manufacturer unknown), hydrochlorothiazide, MAXZIDE and meclizine. On an unspecified date, in January 2014, the patient experienced a sinus infection after receiving ZOSTAVAX. Patient sought physician for sinus infection on 24-JAN-2014. The outcome of sinus infection was not reported. Patient received Prednisone and LEVAQUIN as treatment for the adverse event. The relationship between ZOSTAVAX and the event was not reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. In 2008 the patient was vaccinated with a first and second dose of GARDASIL at the proper schedule. Dose, route and lot number were not reported. No co-suspect and concomitant therapies were reported. On 23-JAN-2014, the patient went to the office for the 3rd dose of GARDASIL. Dose, route and lot number were not reported. No adverse effect reported. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Electromyogram abnormal, Eyelid ptosis, Fatigue, Motor dysfunction
Clinical narrative: Fatigue, loss of use of fine motor skills, variable ptosis, EMG results and neurology determined CIDP. Developed rash w/in days of vaccination.
Age: 3.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Nuclear magnetic resonance imaging, Rash
Clinical narrative: Fatigue, loss of use of fine motor skills, variable ptosis, EMG results and neurology determined CIDP. Developed rash w/in days of vaccination.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Unevaluable event
Clinical narrative: NONE.
Age: 24.0
Sex: F
Vaccine: ANTH, MMR, TYP
Symptoms: Injection site swelling, Injection site warmth, Sensory loss, Skin tightness
Clinical narrative: Patient presented with left arm swollen from shoulder down to elbow, hot to touch, and patient stated loss of sensation in fingers and it was tight.  Dr. prescribed Prednisone 60mg for 7 days and Lidex 0.05% ointment-apply to the area bid-tid.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Noticed shoulder was hurting where the injection was given when pt woke up.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Muscular weakness, Pain in extremity
Clinical narrative: Extreme soreness, no range of motion in my arm.  Can't lift anything.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Pt presents left arm swelling red tender after flu shot on Monday (2 days ago). Mother has been icing area with sig reduction in swelling. Mother states that yesterday patient was complaining of severe pain, and was not using arm as much. Pain has improved, and she is using arm more now, but area remains indurated and warm to touch. She was also reports that the area did itch.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt presents left arm swelling red tender after flu shot on Monday (2 days ago). Mother has been icing area with sig reduction in swelling. Mother states that yesterday patient was complaining of severe pain, and was not using arm as much. Pain has improved, and she is using arm more now, but area remains indurated and warm to touch. She was also reports that the area did itch.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Skin irritation
Clinical narrative: Pt presented to clinic with rash on his back and some irritation on arm left side.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis post ZOSTAVAX administration. PCP was seen and Cephalexin 500 was prescribed.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Chest X-ray, Crying
Clinical narrative: Crying for 9 hours after vaccines. Started 1 hour after vaccines given.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Disturbance in attention, Feeling abnormal, Headache, Immediate post-injection reaction
Clinical narrative: Started "feeling very bad" immediately after injection given. Reports to have pounding headache, couldn't focus on school on Wednesday, went home and slept all afternoon. Same symptoms noted today Thursday 1/23.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Injection site reaction, Menstrual disorder, Nuclear magnetic resonance imaging brain abnormal, Pituitary enlargement
Clinical narrative: Started "feeling very bad" immediately after injection given. Reports to have pounding headache, couldn't focus on school on Wednesday, went home and slept all afternoon. Same symptoms noted today Thursday 1/23.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vertigo
Clinical narrative: Started "feeling very bad" immediately after injection given. Reports to have pounding headache, couldn't focus on school on Wednesday, went home and slept all afternoon. Same symptoms noted today Thursday 1/23.
Age: 0.36
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV1
Symptoms: Decreased appetite, Insomnia, Screaming
Clinical narrative: Screaming, 6-8 hour stretches. Didn't eat - 9+ hour stretches, sometimes only 5-7 oz. in 24 hrs. Didn't sleep - less than 4 hrs in 24 hrs. Lasted 12 days w/ 2 mo. vacc and 9 w/ 4 mo. vacc.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Swollen arm from shoulder to elbow. Red and warm to the touch. Told patient to see family Dr.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Pruritus, Rash
Clinical narrative: Rec'd FLUMIST 1/9/14 - mother states developed rash on back, groin, stomach, chest, arms, axilla with itch 2 days after. Resolved after oral antihistamine. No rash since.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Local swelling, Musculoskeletal disorder, Nuclear magnetic resonance imaging
Clinical narrative: Pain during admin of shot and when needle was pulled out. Swelling at site of shot, a lot of pain. Loss of use of arm due to pain and swelling. Frozen shoulder, chronic tendonitis and swelling, loss of use of arm.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Periarthritis, Tendonitis
Clinical narrative: Pain during admin of shot and when needle was pulled out. Swelling at site of shot, a lot of pain. Loss of use of arm due to pain and swelling. Frozen shoulder, chronic tendonitis and swelling, loss of use of arm.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site rash, Injection site swelling, Rash
Clinical narrative: Mother stated that the patient had rash on his left arm where the patient received his 11 year shot. Rash was from his upper arm to his left elbow. Localized rash according to mother. Mother applied ice to the site for the swelling and administer BENADRYL. Mother stated that the patient rash clear up by 1-20-14.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: October 19, 2013 I received the vaccine in my left arm had pain went back to hospital the following week was told it could hurt up to 28 days waited but pain increased so went to my doctor the letter from her is attached.
Age: 10.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Pallor
Clinical narrative: Within approximately 5 minutes post vaccination during wait period - client c/os dizziness and lightheadedness and pale. Mom carried child to exam table and we placed him in Trendelenburg position, gave cool clothes and a glass of H2O to drink - color returned within minutes, however remained in this position approximately 10 minutes before departure from our facility.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Pt. with dime size erythema spot at site of MMRV approx. 24 hours after injection, no warmth, no discharge at site. (+) compress and bacitracin recommended.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to 2 patients of unknown age. On an unknown date the patients were vaccinated with VARIVAX (Merck). It was reported that two unspecified patients, in their 60's (years of age), received VARIVAX, instead of ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
Age: 0.23
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death
Clinical narrative: None stated.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown demography. On an unknown date, an unspecified number of patients were administered the second dose in the GARDASIL series more than 2 months after the first dose of GARDASIL (0.5 ml) intramuscular. No adverse event was reported by the reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Rash, Rash erythematous
Clinical narrative: Vaccine was administered on 01-13-14. Next day (01/14, 01/15) patient had soreness in arm. On Saturday 01/18 patient broke up in rash (red little needle-prick-like bumps) from waist down. On Sunday 01/19 rash spread to chest and patient went to the ER. Patient today 1-29-14 is reporting that after a course of prednisone she is doing well and rash has vanished.
Age: 1.77
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Injection site rash, Rash, Streptococcus test negative
Clinical narrative: Patient started with a rash 3 days after injection started on (L) thigh, then spread all over torso and extremities. No other symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. In December 2013, "about month ago", the patient was vaccinated with ZOSTAVAX. Dose and lot number were not reported. No co-suspect and concurrent therapies were reported. The pharmacist reported that the patient developed an injection site reaction with redness and swelling (approximately in December 2013) and one month later, the injection site was still swollen. At the time of this report the outcome was not recovered. The causality was not reported. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Flu vaccine given 1/20/14, pt states next day woke up left arm very painful difficulty lifting arm, left rib cage area painful - she went to ER 1/20/14.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Hyperaesthesia, Pruritus, Rash, Rash macular
Clinical narrative: Intense itching, hypersensitive skin, macular rash on middle of back and left groin. Diagnosis: shingles on 01/17/2014 started famvistatin.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pain, Rash pruritic, Rash vesicular
Clinical narrative: Pox-like bumps all over, especially near joints--hands, knees feet. Itchy and painful. Fingers swollen.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Sensation of heaviness, Skin warm
Clinical narrative: Pt received pneumonia and flu vaccine in left arm. Pt reported of swollen, redness, heaviness, warmth on arm. The swollen area is not at the injection site.
Age: 23.0
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 24 year old patient. On 28-JAN-2014, the patient was vaccinated with expired GARDASIL, .5 ml, 0636AA as lot number and expiry date was 11-AUG-2013 intramuscular in the left deltoid. No adverse effect was reported. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: FLUN4, MMR
Symptoms: Incorrect route of drug administration, Mobility decreased, Pain in extremity
Clinical narrative: 27 y/o male called c/o sore arm after MMR vaccine states arm sore all over and hard to move MMR given IM instead of Subque. Initial call 1-17-14 recheck on Tuesday 1-21 states much better 3rd MMR in 1 yr due to losing record (he did not tell RN that at IZ visit).
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Swollen arm down to elbow. Sore red stiff.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: After vaccination received small blisters 1 and 1/2 to 2 inches in diameter, resolved in 3 to 4 days, no treatment.
Age: 27.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. received Varicella vaccine #1 in (L) arm, SC on 1/29/14. Awoke on 1/30/14 with 4.5cm long x 2.5 cm wide red, swollen, itchy area at inj. site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Patient presented 5 days post vaccine c/o sudden onset of vertigo not sure if related.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 51 year old female patient. On 21-JAN-2014, the patient was vaccinated with ZOSTAVAX Lot No: J011213 (Expiry: 14-NOV-2014) dose 1, subcutaneous. On an unknown date in January 2014, the patient experienced cold sore on her lip. The patient sought medical attention and called the pharmacy. The patient was prescribed with VALTREX. The outcome of the event cold sore on her lip was reported as recovering. This case was linked to the case 1401USA014220 (same reporter link). Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes simplex
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient's medical history included herpes simplex. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose and frequency was not reported). On an unknown date, the patient experienced 5 herpes simplex outbreaks in the 3 months after the administration of ZOSTAVAX. The outcome of 5 herpes simplex outbreaks in the 3 months was unknown. The reporter did not provide the causality between the event and the suspect drug. This case was linked to the case 1401USA013866 (same reporter link). Additional information is not expected.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pruritus, Skin hyperpigmentation
Clinical narrative: Local itching, soreness, hyperpigmentation.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Asthenia, Dizziness, Erythema, Fatigue, Hyperhidrosis
Clinical narrative: Within one hour of receiving injection my arm became quite sore and started to itch and swell. Approx. 4 hours later arm was very swollen and slightly red and very tender. During the night while up to use the bathroom I became very diaphoretic and light headed. The next day the swelling extended nearly to my elbow, into my axilla and up under the clavicle and I continued to feel weak and fatigued. The swelling and redness continued through December 8 and then subsided gradually over the next several days.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Local swelling, Pain in extremity, Pruritus, Swelling
Clinical narrative: Within one hour of receiving injection my arm became quite sore and started to itch and swell. Approx. 4 hours later arm was very swollen and slightly red and very tender. During the night while up to use the bathroom I became very diaphoretic and light headed. The next day the swelling extended nearly to my elbow, into my axilla and up under the clavicle and I continued to feel weak and fatigued. The swelling and redness continued through December 8 and then subsided gradually over the next several days.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Dizziness, Erythema, Hyperhidrosis, Local swelling, Malaise
Clinical narrative: Within one hour of receiving injection my arm became quite sore and started to itch and swell. Approx. 4 hours later arm was very swollen and slightly red and very tender. During the night while up to use the bathroom I became very diaphoretic and light headed. The next day the swelling extended nearly to my elbow, into my axilla and up under the clavicle and I continued to feel weak and fatigued. The swelling and redness continued through December 8 and then subsided gradually over the next several days.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3, PPV
Symptoms: Pain, Pain in extremity, Pruritus, Swelling, Tenderness
Clinical narrative: Within one hour of receiving injection my arm became quite sore and started to itch and swell. Approx. 4 hours later arm was very swollen and slightly red and very tender. During the night while up to use the bathroom I became very diaphoretic and light headed. The next day the swelling extended nearly to my elbow, into my axilla and up under the clavicle and I continued to feel weak and fatigued. The swelling and redness continued through December 8 and then subsided gradually over the next several days.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: MOTHER VOICES PATIENT NOTED WITH LARGE HIVE TO HAND AND UPON FURTHER ASSESSMENT NOTED HIVES TO BACK AND BILATERAL POSTERIOR LEGS. MOTHER DOSED CHILD WITH BENADRYL PO. APPROXIMATELY 1 HOUR LATER HIVES HAD DISAPPERED.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: I began noticing that my arm was achy.  A soreness.  I thought it would go away in a few days.  A month went by and it hurt so bad that I went to dr.  They prescribed some strong ibuprofen and suggested I do some physical therapy.  Ibuprofen did not help the pain.  I did not do the therapy.  It lasted about 3 1/2 months before I began to feel better.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Fatigue, Hypoaesthesia, Injection site discolouration, Joint swelling
Clinical narrative: Felt extremely tired and sore. As time went on, becoming lethargic. Large purple area formed at the injection site.  Arm began to swell. That night just wanted to sleep.  Next morning noticed that the arm, shoulder, shoulder blade, chest, and kneck all swollen.  Very painful to move and extreme pain in lower back.  Numbness and shooting pain in arm. Emergency room on 1/26/2014.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Lethargy, Local swelling, Pain, Pain in extremity
Clinical narrative: Felt extremely tired and sore. As time went on, becoming lethargic. Large purple area formed at the injection site.  Arm began to swell. That night just wanted to sleep.  Next morning noticed that the arm, shoulder, shoulder blade, chest, and kneck all swollen.  Very painful to move and extreme pain in lower back.  Numbness and shooting pain in arm. Emergency room on 1/26/2014.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: PATIENT HAD HPV VACCINE ON 01/14/2014. PATIENT STATES RASHES ALL OVER BODY BEGINNING ON 01/15/2014. PATIENT TOOK BENADRYL AT HOME 01/15/2014. PATIENT CAME 01/29/2014, BENADRYL 50MG IM GIVEN. TREATMENT PLAN INCLUDES: RANITIDINE 150MG PO BID, BENADRYL 50 EVERY 6HRS AS NEEDED. IF PATIENT EXPERIENCE SHORTNESS OF BREATH GO TO ER.
Age: 1.12
Sex: F
Vaccine: FLUX, HEPA, HIBV, PPV
Symptoms: Acne, Rash
Clinical narrative: 21st-pimple looking bumps, apply hydrocortisone cream. 23-took her to Dr-told not to apply anything. 27-rash has spread into patches of small bumps and was given antibiotic cream. 30th-cream hasn't helped, rash worsened. Started steroid/antifungal cream.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Extreme soreness in upper left arm at injection site. Pain has gotten worse over the past few weeks. Pain when reaching above head, sleeping on arm, using muscle on arm.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Blood potassium decreased, Diarrhoea, Electrocardiogram normal, Muscle twitching
Clinical narrative: 1/23/14 Vaccine given. 1/20/14 Consult for headache and H. pylori - started clarithromycin and NEXIUM 1/23 - started Amoxicillin 1/20/14. 1/25/14 Started diarrhea and twitching of muscles. 1/27/14 To emergency low potassium (3.0 mEq/L).
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Muscle twitching
Clinical narrative: Clinic appt 5PM. Vaccines administered ROTARIX, PREVNAR 13, PEDIARIX, Hib. Presented to Urgent Care at 7:50 PM, "crying for 2-3 hrs after receiving his immunizations" per parents. Parents state "head twitching while crying". Assessment at Urgent Care normal exam, easily consolable.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: Redness, swelling, some tenderness (R) upper arm (size 12 x 12cm). No relation to injection site.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Capillary fragility, Dry skin, Joint swelling, Local swelling
Clinical narrative: Two days after flu vaccine pt had left hand-wrist and hand swelling with some broken capillaries. Pt now has dryness of skin over that area. No swelling or redness at site.
Age: 12.0
Sex: F
Vaccine: HEP, HPV4, IPV
Symptoms: Dizziness, Dizziness postural, Headache
Clinical narrative: At about 6:00 pm started to feel very dizzy. States had to lay down and started to get "bad" headaches, states felt like she would pass out if she stood up. Called PMD next day. Felt better 10/10/2007, but still a little dizzy. By 10/11/07 symptoms resolved.
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: MMRV given instead of single MMR. Per parent has had no reaction in past 24 hrs.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Back pain, Vaccination complication
Clinical narrative: Reported by mother to PHN: patient had lower back pain with stomach ache within 2 hours of vaccine administration. Lower back pain progressively worse and parent took daughter to local hospital ER. Doctor diagnosed attributed the symptoms as side effects of the GARDASIL. ED doctor prescribed relaxant med; Symptoms relieved and gone by 3rd day. Had no reaction from 1st HPV given.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Seizure like phenomena
Clinical narrative: Seizure-like side effect about 10:15 (5 min) after vaccine was given. Pt was laid down and observed in knee-chest position for 15 - 20 min.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Pt states had pain in arm around injection site from the time she received the vaccine. Pt states pain has worsened and is now radiating down to her forearm. Pt states also now having difficulty lifting arm.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Redness and swelling to injection site (left arm) measuring 3 1/2 inches by 2 1/4 inches. Rash and discharge was also noticed on the injection site. Measurement became larger ( 4 1/2 " X 3 1/2 " ) on 30 Jan 2014.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction, Pruritus, Skin ulcer
Clinical narrative: Patient reports that several days after shot she began to have a shingles outbreak at the site of injection. The infection has spread and has progressed to open sores and itchiness.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Heart rate increased, Pyrexia
Clinical narrative: High fever (40 C), headache, fatigue, increased heart rate (122).
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large reddened and swollen area around injection site, warm to touch, large portion of back of arm improving slightly over the last few days.
Age: 30.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain at injection with radiation down to forearm. Patient seen in office again on 12/19/2013, given NSAIDS and hydrocodone/APAP to use as needed for pain.
Age: 10.0
Sex: F
Vaccine: FLU3, HPV4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Developed pain, redness, and swelling at L deltoid injection site. Worsening over 48 hours.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Blood test abnormal, Cheilitis, Chest X-ray, Diarrhoea, Echocardiogram
Clinical narrative: Patient started running a high fever the day after his shots of 102.6.  we went to the emergency room and were admitted to another hosptial.  He later started showing more symptoms, including a rash over his whole body, red eyes, red lips, vomiting and diarrhea.  he was transferred to a third hospital where he was diagnosed and treated for Kawasaki Disease.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Electrocardiogram, Kawasaki's disease, Ocular hyperaemia, Pyrexia, Rash generalised
Clinical narrative: Patient started running a high fever the day after his shots of 102.6.  we went to the emergency room and were admitted to another hosptial.  He later started showing more symptoms, including a rash over his whole body, red eyes, red lips, vomiting and diarrhea.  he was transferred to a third hospital where he was diagnosed and treated for Kawasaki Disease.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Vomiting
Clinical narrative: Patient started running a high fever the day after his shots of 102.6.  we went to the emergency room and were admitted to another hosptial.  He later started showing more symptoms, including a rash over his whole body, red eyes, red lips, vomiting and diarrhea.  he was transferred to a third hospital where he was diagnosed and treated for Kawasaki Disease.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Apnoea, Contusion, Convulsion, Crying, Cyanosis
Clinical narrative: Patient received HPV, TDaP, & Varicella in the left arm, and Hepatitis A, and Meningitis vaccines in the right arm. Immediately after vaccine administration patient was alert and oriented and talking. Approximately 2 minutes later patient fell out of chair hitting head on floor. Patient began seizing and posturing, I rolled her onto her side and stayed with her. Called for help. Patient had period of apnea and cyanosis followed by spontaneous breathing. A second seizure happened immediately afterward followed by a second period of apnea and cyanosis. Patient spontaneously began to breathe again and began to cry. She was aware of her surroundings- "a doctor's office". Patient had head injury with swelling and bruising on forehead from hitting the floor. Ice pack applied to head injury. Oriented to person, place, and time. Juice box given to patient for fluids. Patient's grandfather was present at the time of event and called mother on cell phone to update her. Advised patient and her family to go to emergency room or primary care provider immediately.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Fall, Head injury, Posturing, Respiration abnormal, Swelling face
Clinical narrative: Patient received HPV, TDaP, & Varicella in the left arm, and Hepatitis A, and Meningitis vaccines in the right arm. Immediately after vaccine administration patient was alert and oriented and talking. Approximately 2 minutes later patient fell out of chair hitting head on floor. Patient began seizing and posturing, I rolled her onto her side and stayed with her. Called for help. Patient had period of apnea and cyanosis followed by spontaneous breathing. A second seizure happened immediately afterward followed by a second period of apnea and cyanosis. Patient spontaneously began to breathe again and began to cry. She was aware of her surroundings- "a doctor's office". Patient had head injury with swelling and bruising on forehead from hitting the floor. Ice pack applied to head injury. Oriented to person, place, and time. Juice box given to patient for fluids. Patient's grandfather was present at the time of event and called mother on cell phone to update her. Advised patient and her family to go to emergency room or primary care provider immediately.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a consumer refers to herself as a female patient of unknown age. On an unknown date in January 2014 (also reported as about 2 weeks ago), the patient was vaccinated with VARIVAX (Merck) injection (dose and frequency was not reported) and then the patient discovered that she was 17 weeks and 2 days pregnant. No adverse event reported. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Rash all over body.
Age: 58.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 58.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypotension, Pain in extremity
Clinical narrative: None stated.
Age: 40.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Rash
Clinical narrative: Case number PHEH2014US001797 is an initial spontaneous report received from a pharmacist on 22 Jan 2014: This report refers to an adult male patient. He was vaccinated with FLUCELVAX (batch number: 004031A) intramuscularly on 09 Jan 2014 and then developed a rash that spread over his entire body two to three days later. He came to the pharmacy to report his symptoms on 14 Jan 2014. Reporter did not know what caused the rash. No further information about outcome and seriousness was reported.