chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Asthenia, Malaise, Memory impairment, Pain in extremity
Clinical narrative: Patient was seen in ER. C/o pain in right arm. On 10-28-15 she didn't recognize her neighbor. Has prior history of leukemia Also c/o weakness and malaise.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Inflammation, Pain, Peripheral swelling
Clinical narrative: Red swollen arm - started swelling at 9 PM 10/29. By AM 10/30 was red as well - patient is taking acetaminophen. Pain/inflammation is about same as of 10/30/15 at 1:07 PM.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain, Skin warm, Urticaria
Clinical narrative: Patient received PREVNAR 13 10/27/15. On 10/29/15 patient returned to clinic. Pt developed a localized welt (4cm x 5cm) raised, warm, and painful to touch. This appeared 2 days after administration.
Age: 20.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 20-year-old female patient who received FLUARIX quadrivalent (batch number GB749, expiry date 22nd June 2016). On 11th October 2015, the patient received FLUARIX quadrivalent .5 ml. On 11th October 2015, less than a day after receiving FLUARIX quadrivalent, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unchanged. It was unknown if the reporter considered the injection site pain to be related to FLUARIX quadrivalent. Additional details were provided as follows: It had been 12 days from vaccination time that the patient was experiencing injection site pain. No other adverse event was reported.
Age: 20.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 21-year-old female patient who received FLUARIX quadrivalent (batch number GB749, expiry date 22nd June 2016). On 11th October 2015, the patient received FLUARIX quadrivalent .5 ml. On 11th October 2015, less than a day after receiving FLUARIX quadrivalent, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be possibly related to FLUARIX quadrivalent. Additional details were provided as follows: This case was not previously reported to anyone. At the time of reporting, the pain continued on the left deltoid (injection site) of the patient.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Sleep disorder
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a adult female patient who received FLULAVAL quadrivalent (batch number H33J2, expiry date May 2016). On 12th Octobeer 2015, the patient received FLULAVAL quadrivalent. On 12th October 2015, less than a day after receiving FLULAVAL quadrivalent, the patient experienced injection site pain. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to FLULAVAL quadrivalent. Additional details were provided as follows: On 12th October 2015, less than a day after receiving the vaccine, the patient experienced injection site burning (injection site pain). In October 2015, less than a month after receiving the vaccine, the patient subsequently experienced swelling at the injection site (left deltoid). On 22nd October 2015, the patient visited a doctor and was treated with unspecified medication. The pain was keeping the patient awake at night. This case has been linked to 3 other cases US2015150875, US2015150886 and US2015150888, reported by the same reporter. All the patients were concerned about there being an issue with FLULAVAL quadrivalent vaccine and or lot number of the vaccine.
Age: 52.0
Sex: F
Vaccine: FLU3, PNC13, TDAP
Symptoms: Pain in extremity
Clinical narrative: Right arm soreness. Had to see MD and was given Ibuprofen and cyclobenzaprine on 10/16/15 by dr.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: None stated.
Age: 12.0
Sex: F
Vaccine: FLU3, RAB, TYP
Symptoms: Abdominal pain, Headache, Hyperhidrosis, Vomiting
Clinical narrative: Severe HA; vomiting; abdominal pain; diaphoretic.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received FLULAVAL quadrivalent (batch number H33J2, expiry date May 2016). On 13th October 2015, the patient received FLULAVAL quadrivalent. On 13th October 2015, less than a day after receiving FLULAVAL quadrivalent, the patient experienced injection site pain. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to FLULAVAL quadrivalent. Additional details were provided as follows: This case was reported by a other healthcare professional, who herself was the patient. On 13th October 2015, less than a day after receiving the vaccine, the patient experienced injection site burning (injection site pain). In October 2015, less than a month after receiving the vaccine, the patient subsequently experienced swelling at the injection site (left deltoid). The pain was keeping the patient awake at night and some soreness remained. This case has been linked to 3 other cases US2015150874, US2015150886 and US2015150888, reported by the same reporter. All the patients were concerned about there being an issue with FLULAVAL quadrivalent  vaccine and or lot number of the vaccine.
Age: 44.0
Sex: M
Vaccine: FLU4, MMR, PPV
Symptoms: Cellulitis, Erythema
Clinical narrative: Pt has cellulitis (L) LE. 16 x 16 cm erythema.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a 24-year-old female patient who received FLULAVAL quadrivalent (batch number 93T79, expiry date 30th June 2016). On 21st October 2015, the patient received FLULAVAL quadrivalent (intramuscular). On 21st October 2015, less than a day after receiving FLULAVAL quadrivalent, the patient experienced injection site redness. On an unknown date, the outcome of the injection site redness was unknown. The reporter considered the injection site redness to be almost certainly related to FLULAVAL quadrivalent. Additional details were received as follows: This case was previously not reported to anyone. The patient received FLULAVAL quadrivalent in right deltoid. The patient experienced injection site redness approximately 3 to 3.5 cm.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Decreased appetite, Injection site induration, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Developed a quarter size welt at site of injection. Home from school hot to touch. Ice pack applied. By 7:30pm, grew to baseball size. Raised and firm. Benadryl given. In am at 6:30 on 10/27/15, measured 4 inches x 4 inches. Was instructed by doctor's office to keep ice on 20 minutes every one hour. By 3pm on 10/27/15, continued to grow in size. Went to Urgent Care. Physician Assistant outlined swelling. Was instructed to start amoxicillin next am if extends below the line. Patient had no appetite that day. Benadryl given at night and continued with ice when able. On 10-28-15, started antibiotics. Swelling measured 7 inches by 7 inches. He did not feel well and stayed home from school. Was home with mom who is a family medicine nurse.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise
Clinical narrative: Developed a quarter size welt at site of injection. Home from school hot to touch. Ice pack applied. By 7:30pm, grew to baseball size. Raised and firm. Benadryl given. In am at 6:30 on 10/27/15, measured 4 inches x 4 inches. Was instructed by doctor's office to keep ice on 20 minutes every one hour. By 3pm on 10/27/15, continued to grow in size. Went to Urgent Care. Physician Assistant outlined swelling. Was instructed to start amoxicillin next am if extends below the line. Patient had no appetite that day. Benadryl given at night and continued with ice when able. On 10-28-15, started antibiotics. Swelling measured 7 inches by 7 inches. He did not feel well and stayed home from school. Was home with mom who is a family medicine nurse.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Pain, Peripheral swelling
Clinical narrative: PATIENT REPORTED MUSCLE PAIN EXTENDING PAST ELBOW, SWELLING OF LEFT ARM AND SAID HER LEFT SIDE (IMMUNIZATION SIDE) ALSO HURT.  NURSE AT DR WAS CALLED AND TOLD PATIENT TO TAKE TYLENOL AND IBUPROFEN FOR SORENESS/PAIN AND TO CALL IF PAIN WORSENED DURING THE DAY.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Shoulder stiffness for last five weeks. Pain in shoulder. Not able to lift shoulder. Unable to sleep at night due to pain.
Age: 5.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Injection site erythema, Injection site rash, Type III immune complex mediated reaction
Clinical narrative: Large, erythematous, oval rash on thigh over injection site. Appears to be arthus reaction.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Discomfort, Injection site erosion, Injection site erythema, Injection site induration
Clinical narrative: Pt calling stating that she is having bad pain in left arm. Pt states that site of injection is warm, hard swollen and painful. Pt states that it was itchy all night. Pt denies SOB, fever. She then went to see Primary Care Doctor 10/30/15 at 10am. Patient reporting severe left arm pain, swelling and itchiness. Started last night. Reports was in GI clinic yesterday and received flu and Pneumovax. One in each arm. Afterwards started noticing swelling and pain in left arm. Became very severe and almost went to ER but could no leave her child at home. Associated with subjective fevers. Review of records received pneumovax on left deltoid. Denies previous reactions to flu shot. First time having the Pneumovax. Denies airway symptoms stridor, or SOB. Very concerned about her symptoms. BP 113/75 mmHg | Pulse 95 | Temp(Src) 98.2 °F (36.8 °C) | Wt 69.9 kg | SpO2 100% Physical Exam  Constitutional: Uncomfortable appearing. Pulmonary/Chest: No respiratory distress. No wheezes or rhonchi. Musculoskeletal: Left upper arm significant swelling and erythema, appears to be one large hive, excoriations noted, warm to touch, tender to touch, radial pulses palpable, full ROM. Assessment and Plan: Patient with significant left arm swelling, erythema and itchiness. Appears to be reaction to pneumovax. No airway involvement. Urticaria adverse reaction to pneumovax. Given subjective fevers and warmth will empirically treat for cellulitis. Benadryl (25mg, 2 capsules every 6 hours as neded for itching), Famotidine 20mg (1 tablet BID) cold packs (PRN) Keflex (250mg, 2 capsules BID x 5 days). Return to clinic in 1 week.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Pt calling stating that she is having bad pain in left arm. Pt states that site of injection is warm, hard swollen and painful. Pt states that it was itchy all night. Pt denies SOB, fever. She then went to see Primary Care Doctor 10/30/15 at 10am. Patient reporting severe left arm pain, swelling and itchiness. Started last night. Reports was in GI clinic yesterday and received flu and Pneumovax. One in each arm. Afterwards started noticing swelling and pain in left arm. Became very severe and almost went to ER but could no leave her child at home. Associated with subjective fevers. Review of records received pneumovax on left deltoid. Denies previous reactions to flu shot. First time having the Pneumovax. Denies airway symptoms stridor, or SOB. Very concerned about her symptoms. BP 113/75 mmHg | Pulse 95 | Temp(Src) 98.2 °F (36.8 °C) | Wt 69.9 kg | SpO2 100% Physical Exam  Constitutional: Uncomfortable appearing. Pulmonary/Chest: No respiratory distress. No wheezes or rhonchi. Musculoskeletal: Left upper arm significant swelling and erythema, appears to be one large hive, excoriations noted, warm to touch, tender to touch, radial pulses palpable, full ROM. Assessment and Plan: Patient with significant left arm swelling, erythema and itchiness. Appears to be reaction to pneumovax. No airway involvement. Urticaria adverse reaction to pneumovax. Given subjective fevers and warmth will empirically treat for cellulitis. Benadryl (25mg, 2 capsules every 6 hours as neded for itching), Famotidine 20mg (1 tablet BID) cold packs (PRN) Keflex (250mg, 2 capsules BID x 5 days). Return to clinic in 1 week.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Pt calling stating that she is having bad pain in left arm. Pt states that site of injection is warm, hard swollen and painful. Pt states that it was itchy all night. Pt denies SOB, fever. She then went to see Primary Care Doctor 10/30/15 at 10am. Patient reporting severe left arm pain, swelling and itchiness. Started last night. Reports was in GI clinic yesterday and received flu and Pneumovax. One in each arm. Afterwards started noticing swelling and pain in left arm. Became very severe and almost went to ER but could no leave her child at home. Associated with subjective fevers. Review of records received pneumovax on left deltoid. Denies previous reactions to flu shot. First time having the Pneumovax. Denies airway symptoms stridor, or SOB. Very concerned about her symptoms. BP 113/75 mmHg | Pulse 95 | Temp(Src) 98.2 °F (36.8 °C) | Wt 69.9 kg | SpO2 100% Physical Exam  Constitutional: Uncomfortable appearing. Pulmonary/Chest: No respiratory distress. No wheezes or rhonchi. Musculoskeletal: Left upper arm significant swelling and erythema, appears to be one large hive, excoriations noted, warm to touch, tender to touch, radial pulses palpable, full ROM. Assessment and Plan: Patient with significant left arm swelling, erythema and itchiness. Appears to be reaction to pneumovax. No airway involvement. Urticaria adverse reaction to pneumovax. Given subjective fevers and warmth will empirically treat for cellulitis. Benadryl (25mg, 2 capsules every 6 hours as neded for itching), Famotidine 20mg (1 tablet BID) cold packs (PRN) Keflex (250mg, 2 capsules BID x 5 days). Return to clinic in 1 week.
Age: 1.18
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site swelling
Clinical narrative: SWOLLEN RIGHT THIGH WITH NO REDNESS OR FEVER.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Pt said she experienced shortness of breath and took a Benadryl tablet.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain, Swelling
Clinical narrative: Swelling, pain and difficulty moving arm.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Dx of Cellulitis per MD. Treated with Clindamycin 300mg tid.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Body temperature increased, Cough, Feeling cold, Headache
Clinical narrative: Starting coughing feeling like throat was closing up, thought I was having an asthma attack, took 2 puffs of inhaler went to bed, at 1:25am starting feeling freezing cold, achy all over took temperature it was 100.9 noticed face was swelling and eyes had turned red. My lips were swelling as well as extremities. Headache as well as body aches and itchy feeling all over.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Ocular hyperaemia, Pain, Peripheral swelling, Pruritus generalised
Clinical narrative: Starting coughing feeling like throat was closing up, thought I was having an asthma attack, took 2 puffs of inhaler went to bed, at 1:25am starting feeling freezing cold, achy all over took temperature it was 100.9 noticed face was swelling and eyes had turned red. My lips were swelling as well as extremities. Headache as well as body aches and itchy feeling all over.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Throat tightness
Clinical narrative: Starting coughing feeling like throat was closing up, thought I was having an asthma attack, took 2 puffs of inhaler went to bed, at 1:25am starting feeling freezing cold, achy all over took temperature it was 100.9 noticed face was swelling and eyes had turned red. My lips were swelling as well as extremities. Headache as well as body aches and itchy feeling all over.
Age: 61.0
Sex: F
Vaccine: FLUC3, VARZOS
Symptoms: Dermatitis, Musculoskeletal pain, Rash erythematous
Clinical narrative: I noticed discomfort in the area below my right shoulder blade while driving home from work.  After arriving home, I discovered a red rash in that area. Subsequent to calling pharmacy and then going to an urgent care center (where I was diagnosed with a non-specific dermatitis), I applied Cortaid to the rash at bedtime.  The rash had slightly subsided as of 10/30/15 A.M.
Age: 61.0
Sex: F
Vaccine: FLUC3, VARZOS
Symptoms: Rash
Clinical narrative: I noticed discomfort in the area below my right shoulder blade while driving home from work.  After arriving home, I discovered a red rash in that area. Subsequent to calling pharmacy and then going to an urgent care center (where I was diagnosed with a non-specific dermatitis), I applied Cortaid to the rash at bedtime.  The rash had slightly subsided as of 10/30/15 A.M.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Injection site reaction, swelling, erythema, myalgia, fever/chills.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Left shoulder arthralgia. States "Feels like rotator cuff injury." Stated cannot raise arm above shoulder and cannot reach and grab items has to use other arm.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose increased
Clinical narrative: INCREASED BLOOD GLUCOSE.  NORMALLY RUNS AROUND 95.  READINGS DAY AFTER VACCINE WERE 172 AND 184.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Haemorrhage, Injection site swelling, Intensive care, Platelet count decreased, Vaccination complication
Clinical narrative: Patient received Fluvirin at the pharmacy on 10/1/15 and waited approximately 10 minutes in the waiting room before going home. The pharmacists recommend all patients to stay in the pharmacy for 10 to 15 minutes after receiving any vaccines to ensure that patients don't experience any immediate reaction after vaccination. After going home, he claims there was a bulge at the injection site. He called the pharmacy approximately an hour later and pharmacist informed him that injection site reactions are reported side effects of the vaccine and that he can try to use a cold compress to see if it provides any relief. Pharmacist informed patient to monitor the situation and to contact a medical professional if the condition worsens or does not improve. Patient did not contact the pharmacy after at this time. On 10/30/15, the patient comes back to the pharmacy to inform pharmacist that he has been hospitalized in the ICU for 20 days and was in physical therapy for 10 days due to an unexplained severe reaction to the flu vaccine. According to the patient, he began bleeding within hours of the vaccine and was brought to the hospital by a friend after consulting with a physician. He stated that his platelet levels were very low and that the hospital had to provide intensive care. He stated that none of the physicians treating him could explain why his body had this trigger reaction since he has previously received flu vaccines year after year in the past with no adverse reaction. He has recovered as of 10/30/15.
Age: 64.0
Sex: M
Vaccine: FLUC3
Symptoms: Injection site pain
Clinical narrative: LEFT ARM/SHOULDER PAIN.  INITIALLY HURT "PRETTY SEVERE FOR ABOUT A WEEK", THEN SEEMED GET BETTER OVER THE NEXT TWO WEEKS, AND NOW IS BACK TO HURTING "PRETTY SEVERE" AS OF 10/30/2015.
Age: 1.24
Sex: M
Vaccine: FLU4, UNK
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Father of patient noticed hives on left upper arm and bilateral thighs. Patient was seen by provider and was given 2.5 mL of Benadryl.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Bruising on site of administration.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Patient reported bruising on site of admistration.
Age: 18.0
Sex: M
Vaccine: HPV4, PPV
Symptoms: Arthralgia, Burning sensation, Chills, Dizziness, Injection site bruising
Clinical narrative: Arm severely tender to the touch, joint pain, muscle pain, chills, fever 103.6, dizziness, neck pain, burning in back. Brought to doctor on  (10/29/2015) the doctor doesn't know what it is. It has been 4 days now (10/30/2015) he is still with fever and body pain, bruised, raised and hotter than body at injection site on left arm, it is still on going.
Age: 18.0
Sex: M
Vaccine: HPV4, PPV
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Neck pain, Pain
Clinical narrative: Arm severely tender to the touch, joint pain, muscle pain, chills, fever 103.6, dizziness, neck pain, burning in back. Brought to doctor on  (10/29/2015) the doctor doesn't know what it is. It has been 4 days now (10/30/2015) he is still with fever and body pain, bruised, raised and hotter than body at injection site on left arm, it is still on going.
Age: 18.0
Sex: M
Vaccine: HPV4, PPV
Symptoms: Pyrexia, Tenderness
Clinical narrative: Arm severely tender to the touch, joint pain, muscle pain, chills, fever 103.6, dizziness, neck pain, burning in back. Brought to doctor on  (10/29/2015) the doctor doesn't know what it is. It has been 4 days now (10/30/2015) he is still with fever and body pain, bruised, raised and hotter than body at injection site on left arm, it is still on going.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Lethargy, Presyncope, Vomiting
Clinical narrative: Pt became lethargic, vomited appeared vasovagal response to flu shot administration.
Age: 54.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pruritus generalised, Seizure, Throat irritation
Clinical narrative: Itching all over. Throat itching. Symptoms getting worse over the next 5-10 minutes. Patient had a seizure about 20 minutes after vaccination administration.
Age: 54.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pruritus generalised, Seizure, Throat irritation, Throat tightness
Clinical narrative: Itching all over. Throat itching. Symptoms getting worse over the next 5-10 minutes. Patient had a seizure about 20 minutes after vaccination administration.
Age: 70.0
Sex: M
Vaccine: YF
Symptoms: Cellulitis, Erythema, Joint swelling, Skin warm
Clinical narrative: Left knee swollen, red, warm to touch.  Went to ER on 10/25/2015.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Eye pain, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: On the night of receiving the vaccine, patient experienced tightness in her chest which was relieved after taking a couple of puffs of ventolin inhaler. During the course of the night symptoms included freesing, shaking, painful eye sockets, headache, major sweat and painful skin all over. She felt better by noon of next day.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pain of skin, Tremor
Clinical narrative: On the night of receiving the vaccine, patient experienced tightness in her chest which was relieved after taking a couple of puffs of ventolin inhaler. During the course of the night symptoms included freesing, shaking, painful eye sockets, headache, major sweat and painful skin all over. She felt better by noon of next day.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: HEADACHE, DIZZINESS, NAUSEA FOR 2 DAYS THEN LARGE AREA OF REDNESS, SWELLING, SLIGHT TENDERNESS BOTH ARMS MORE ON RIGHT THAN LEFT WHERE SHOTS WAS GIVEN; GETTING BETTER AFTER 3RD DAY.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Nausea
Clinical narrative: HEADACHE, DIZZINESS, NAUSEA FOR 2 DAYS THEN LARGE AREA OF REDNESS, SWELLING, SLIGHT TENDERNESS BOTH ARMS MORE ON RIGHT THAN LEFT WHERE SHOTS WAS GIVEN; GETTING BETTER AFTER 3RD DAY.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Rash, Skin exfoliation
Clinical narrative: SWELLING INITIALLY ARM SIZE AND SPREAD DOWN TO TRICEPS AND DISAPPERED. NOW THE RASH APPEARS DRY AND PEELING OFF. ROUGHLY THE SIZE OF FIST.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: The patient complained of limited ROM and soreness at the site of injection. Treatment consisted of a Medrol steroid pack and cyclobenzaprine. Physician outlook was for the soreness to dissipate within the next 4-6 weeks.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site. 5x5.5 area redness/swelling. Left arm 9in in diameter. Right arm 7.5in in diameter for comparison. Kinrix was given at that site. No other vaccines given in that arm.
Age: 38.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: Arm became very sore, unable to lift or straighten arm. Has remained sore for over a month.  Able to stretch out as of a couple days ago, but it is still very painful (5/10 when trying to lift arm). Some numbness in the middle of the night.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING AROUND AND ON SITE OF INJECTING. RED, RASIED SKIN, 8 INCHES LONG, AND WARM TO THE TOUCH.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose, Feeling cold, Heart rate increased, Nausea, Presyncope
Clinical narrative: Near-faint episode (occasionally occurs already with this patient) at 11:30PM on 10/29/15. Low blood sugar of 70mg/dL at 12:30AM. Ate a snack. Felt cold at 1:10AM. Checked oral temperature twice at 1:30AM, with reading of 95.0 degrees F both times. Blood sugar normal of 110mg/dL at this time. Felt he had a high heart rate and nausea. He took vitamin C and his missed thyroid dose at 1:30 (missed dose earlier in day, was going to wait until normal scheduled time, but took it when he saw his temperature. Felt less cold around 2:00AM but did not recheck temperature. Upon waking, normal body temperature but still nauseous. Still slightly nauseous at time of reporting to administering pharmacist at 5:30PM on 10/30/15.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Dizziness, Hypersensitivity, Injection site rash, Pyrexia
Clinical narrative: Patient experienced allergic reaction (rash at and around injection site, extending down arm almost to elbow) on right arm, fever, chills, and dizziness. Patient took acetaminophen to control fever and chills. Symptoms resolved on 10/30/15.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site red and swelling.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site swelling, Peripheral swelling, Pharyngeal oedema, Pyrexia
Clinical narrative: Fever, chills, swollen throat and arm at immunization site.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever 101 degrees F, chills, myalgia.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Patient reported cellulitis after co-administration of Pneumovax-23 and Fluvirin '15-'16.  She had to go to urgent care to obtain antibiotics and is fine now.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Condition aggravated, Cough, Dyspnoea, Erythema
Clinical narrative: Chills-hard coughing-loud wheezing-throat tight-short of breath-very difficult breathing-skin red lumpy and very itchy at shot sight for 3 weeks- still itchy for another week-sleeping sitting up.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site mass, Injection site pruritus, Sleep disorder, Throat tightness, Wheezing
Clinical narrative: Chills-hard coughing-loud wheezing-throat tight-short of breath-very difficult breathing-skin red lumpy and very itchy at shot sight for 3 weeks- still itchy for another week-sleeping sitting up.
Age: 0.44
Sex: M
Vaccine: HEPA, MMR
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was in the office for an annual well child check with immunization update - father did not have yellow immunization card nor any previous records with him.  Medical Assistant accidentally gave patient a Hepatitis A vaccine as well as a MMR vaccine - patient is only 5 months old.  Too soon for these vaccines to be given.
Age: 38.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood pressure increased, Chest discomfort, Chest pain, Heart rate increased, Urticaria
Clinical narrative: Hives, burning sensation in chest, tightness, difficulty breathing, rapid heart rate, high blood pressure.
Age: 38.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Asthenia, Dyspnoea, Pharyngeal oedema, Urticaria
Clinical narrative: Hives, burning sensation in chest, tightness, difficulty breathing, rapid heart rate, high blood pressure.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Burning sensation, Cardiac disorder, Cellulitis, Coagulopathy
Clinical narrative: Severe burning in arm, severe redness, spreading discomfort, forming blisters.  Was diagnosed with cellulitis because of this shot.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Condition aggravated, Discomfort, Erythema
Clinical narrative: Severe burning in arm, severe redness, spreading discomfort, forming blisters.  Was diagnosed with cellulitis because of this shot.
Age: 1.76
Sex: F
Vaccine: FLUX
Symptoms: Seizure
Clinical narrative: Seizure.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Mobility decreased, Pain in extremity
Clinical narrative: Arm pain, not at injection site. Not constant but continues to happen two weeks later. Weakness, difficulty raising arm over head.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Local arm reaction with erythema and induration.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: 11:00 AM Arm began hurting at the Fluarix Quad injection site and down arm. 11:20 AM Had difficulty raising my arm or using it for anything. Sleeping has been very difficult for 21 days.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt's complaining she cant raise (L) arm and has c/o soreness and itching on upper (L) arm. Pt is able to move fingers, has sl amt of swelling on upper (L) arm. (L) arm sl warm to touch, no redness noted. Has a circular raised area midway on (L) forearm approx 4 inches down from shoulder. Circular raised area measuring approx 2 inches x 2 inches Informed pt to see MD.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Local swelling
Clinical narrative: Pt's complaining she cant raise (L) arm and has c/o soreness and itching on upper (L) arm. Pt is able to move fingers, has sl amt of swelling on upper (L) arm. (L) arm sl warm to touch, no redness noted. Has a circular raised area midway on (L) forearm approx 4 inches down from shoulder. Circular raised area measuring approx 2 inches x 2 inches Informed pt to see MD.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash erythematous, Rash macular, Skin warm, Swelling
Clinical narrative: Patient had red, blotchy rash that was slightly swollen and warm to the touch.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Areflexia, Asthenia, Guillain-Barre syndrome, Lumbar puncture abnormal, Paraesthesia
Clinical narrative: On 9/18/15 started with tingling in feet then a few days later tingling in hand. Saw MD and was given ELAVIL then progressive weakness and absent reflexes in hands and legs then saw neurologist.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea
Clinical narrative: Patient feels nauseous and dizzy.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Breast pain, Rash
Clinical narrative: C/O rash with pain (R) side breast area to back. Has a relative who is pregnant. No ins. No PCP - Advised to avoid pregnant person and FU ASAP. States sx started "arounf the same time she had the flu shot and TST done.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pt complaining of pain level of 2 (1-10 pain scale) said it hurts when she sleeps on it or touch it. Pain occurs infrequently, but noticeable since administration on 10/9/15.
Age: 16.0
Sex: M
Vaccine: FLUN4, HPV9
Symptoms: Dizziness, Dyskinesia, Tremor, Xanthopsia
Clinical narrative: Pt had onset of sxs to include dizzy/tremors/"jerkiness"/"yellow vision" x 30 minutes. All started within 2-12 hours after vaccine.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Extra dose administered
Clinical narrative: Client received FLUMIST on 10-22-15 from Dr, and received FLUMIST at school on 10-28-15.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Extra dose administered
Clinical narrative: Client received FLUMIST one at Dr office, and received FLUMIST at school.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Extra dose administered
Clinical narrative: Client received FLUMIST on 10/16/15 at Dr office, and received FLUMIST at school on 10-28-15.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Injection site reaction, Pain, Rash erythematous
Clinical narrative: Patient at clinic today presenting with 7 x 10 cm asymmetrical erythematous rash on left anterior thigh. Rash appeared 1 day after receiving flu vaccine. Vaccine was given in left thigh on 10/28/2015. Patient having pain and limping when walking. Patient prescribed cephalexin 250/5 7.5 ml every 12 hours for 10 days and cold compress to affected area. ER precautions given to mom.
Sex: U
Vaccine: FLU4
Symptoms: Adverse event
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of adverse event in a patient who received FLULAVAL quadrivalent (batch number 3L9LD, expiry date 16th June 2016). In 2015, the patient received FLUARIX quadrivalent. On an unknown date, an unknown time after receiving FLUARIX quadrivalent, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to FLUARIX quadrivalent. Additional details were provided as follows: The office reported 3 separate adverse events for the vaccine. The nurse reported 2 of the adverse events via fax to VAERS but did not report the 3rd event because of some type of non-traditional treatment. This case has been linked to other 2 cases (US2015151594 and US201511595), reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Adverse event
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of adverse event in a patient who received FLUARIX quadrivalent (batch number 3L9LD, expiry date 16th June 2016). In 2015, the patient received FLUARIX quadrivalent. On an unknown date, an unknown time after receiving FLUARIX quadrivalent, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to FLUARIX quadrivalent. Additional details were received as follows: The office reported 3 separate adverse events for the vaccine. The nurse reported 2 of the adverse events via fax to VAERS but did not report the 3rd event because of some type of non-traditional treatment. This case was linked with case US2015151593 and US2015151594, reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Adverse event
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of adverse event in a patient who received FLUARIX quadrivalent (batch number 3L9Ld, expiry date 16th June 2016). In 2015, the patient received FLUARIX quadrivalent. On an unkonwn date, an unkonwn time after receiving FLUARIX quadrivalent, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. Additional detials were provided as follows: The office reported 3 separate adverse events for the vaccine. The nurse reported 2 of the adverse events via fax to VAERS but did not report the 3rd event because of some type of non-traditional treatment. This case has been link to 2 other cases (US2015151593 and US2015151595), reported by the same reporter.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Computerised tomogram, Headache
Clinical narrative: Started out with mild headache ar front of head continued to get worse and by 6:00 pm on 10/16/2015 so intense, debilitating, told by primary care doctor to go to nearest emergency room, which I did.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Redness, skin rash, swelling. BENADRYL and hydrocortisone.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient called 11-30 to report pain at time of injection and now 2 days later a red spot lower on arm that the injection site.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Pt. arm still hurts, keeps up at night and trouble with movement.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, swelling to (L) deltoid. Treatment: BENADRYL, steroids f/u if no improvement.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: Hot spot at injection.
Age: 61.0
Sex: M
Vaccine: MMR
Symptoms: Chills, Cold sweat, Cough, Feeling hot, Nasal congestion
Clinical narrative: Rash - trunk, face, arms, neck. Rash was pruritic, chills, dry cough, hot/cold sweats, nasal congestion/runny nose, red eyes. TX: Recommended OTC BENADRYL or CLARITIN/antihistamine.
Age: 61.0
Sex: M
Vaccine: MMR
Symptoms: Ocular hyperaemia, Rash pruritic, Rhinorrhoea
Clinical narrative: Rash - trunk, face, arms, neck. Rash was pruritic, chills, dry cough, hot/cold sweats, nasal congestion/runny nose, red eyes. TX: Recommended OTC BENADRYL or CLARITIN/antihistamine.
Age: 11.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt. recevied Tdap in error. Was due to received TD.
Age: 2.0
Sex: M
Vaccine: HEP, HEPA, PNC13, VARCEL
Symptoms: Crying, Gait disturbance, Injection site rash, Peroneal nerve palsy, Skin warm
Clinical narrative: Mother observed her son sitting and crying on 10-14-15, and noticed a rash on his (R) anterior thigh area, which she pointed to today. Father states on 10/23/15 he noticed his son having problems walking, and his (R) foot was turned in, and then two days ago they felt his head and he was hot like a fever, TYLENOL given.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Arm got edematous from elbow to shoulder. Hot. Painful.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Angioedema
Clinical narrative: Angioedema of the lips.
Age: 72.0
Sex: U
Vaccine: PNC13
Symptoms: Infection
Clinical narrative: Upper lt. arm became infected on 10-10-15. Sent to ER on 10-14. On 10-16 infected to elbow sent to ER.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Erythema, Pain, Pain in extremity
Clinical narrative: (L) arm swollen, red, hot, itchy, sore. Temp 100.2. Chills and body aches swelling and redness has continued for a week and its still red.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: (L) arm swollen, red, hot, itchy, sore. Temp 100.2. Chills and body aches swelling and redness has continued for a week and its still red.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Pain, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: I received a shingles shot on Oct 14, at 8:00 a.m. By 5 pm my arm was swollen and hard and developed a rash 5 3/4 inches by 2 3/4 inches. During the night the pain was shooting down the arm - keeping me awake. I went back to the clinic and was informed that very rarely the shot causes shingles. Was told to use BENADRYL Allergy pills and BENADRYL cream to calm symptoms. The rash and symptoms were present for 10 days, and are now disappearing.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: I received a shingles shot on Oct 14, at 8:00 a.m. By 5 pm my arm was swollen and hard and developed a rash 5 3/4 inches by 2 3/4 inches. During the night the pain was shooting down the arm - keeping me awake. I went back to the clinic and was informed that very rarely the shot causes shingles. Was told to use BENADRYL Allergy pills and BENADRYL cream to calm symptoms. The rash and symptoms were present for 10 days, and are now disappearing.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site vesicles, Vaccination complication
Clinical narrative: Pt received ZOSTAVAX at pharmacy on 10/19/15. Came to office 10/23/15 complaining of reaction to shingles vaccine. Area on back of (L) arm approximately 2-3" above elbow noted have red 1/2 dollars size area w/2  fluid filled blisters inside. Edema noted around red area. Area is painful. Rx BACTRIM DS x 7 days.
Age: 49.0
Sex: U
Vaccine: UNK
Symptoms: Chills, Discomfort, Hyperhidrosis, Influenza, Nausea
Clinical narrative: Within 24 hours after injection suffered flu symptoms fever, nausea, chills, sweating, aches, pain, general discomfort, congestion.
Age: 49.0
Sex: U
Vaccine: UNK
Symptoms: Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Within 24 hours after injection suffered flu symptoms fever, nausea, chills, sweating, aches, pain, general discomfort, congestion.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral, Rash
Clinical narrative: Hearing loss right ear. Rash with acyclovir 200mg oral capsules for 10 days.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Lymphangitis, Pain
Clinical narrative: Inflamed lymph nodes in armpit area, pain and redness at injection site, body aches.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Swollen red rash 3 inches by 1.5 inches left tricep area.
Age: 1.08
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Expired product administered
Clinical narrative: Patient administered KINRIX with exp. 10-19-15 on 10-29-15. Parent notified and will plan to revaccinate in 1 month at next check-up. Child underage for vaccine. CDC contacted.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Itch, redness, rash measured 7 x 6.5 cm (Provider prescribed ZANTAC and KENALOG) 10-29-15.
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Patient complained of not being able to move her arm and the pain was extreme. With a fever of 102 degrees. The next morning fever of 100 degrees F but still has problems with moving her arm and fingers. Pain is getting better but still has problems moving her arm.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On an unspecified date between 03-AUG-2015 and 24-AUG-2015, the patient was vaccinated with the second dose in the PROQUAD (Merck) immunization series that was improperly stored (Lot # L007230, expiration date: 03-SEP-2016) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored oral, ROTATEQ (lot # L004466, exp. 02-AUG-2016, dose and route of administration not provided). No concomitant therapy was reported. No symptoms were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 27-OCT-2015 the patient was vaccinated with improperly stored ZOSTAVAX (lot # L0212039, expiry: 07-JUL-2016) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects are reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to 2 patients of unknown age and gender. No concurrent condition or medical history was reported. On 24-OCT-2015, the patients were vaccinated with ZOSTAVAX (lot # L025000, dose and route of administration not provided) which were exposed to temperatures outside of the recommended range. No concomitant therapy was reported. No adverse effect were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored MMR II (lot # K024035, dose and route of administration not proivded). No concomitant therapy was reported. No symptoms were reported. The outcome of the event was unknown. No produt quality issuse was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. No pertinent or historical conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose and route unknown). There was no concomitant medication reported. On an unknown date, the patient had a "terrible itch on scalp and back" and was later diagnosis with shingles after ZOSTAVAX. The outcome of shingles was unknown. Causality between shingles and ZOSTAVAX was not reported. Additional information has been requested.