chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Injection site warmth
Clinical narrative: Patient walked into office on 10/17/2015 with parent.  Left upper arm extremely swollen, hard, red and hot to touch. Site painful and itchy.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Feeling hot, Headache, Swelling, Tenderness
Clinical narrative: Headache, tenderness, mild swelling and warmth. MD recommended ice, NSAIDs.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Rash, Rash erythematous
Clinical narrative: Red, painful, raised rash on forehead that spread from eyebrown to hairline. Went to physician next morning diagnosed with shingles. Rash lasted for 2 weeks, treated with antivirals.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Right arm hurting day after flu shot. Went to doctor.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Muscular weakness, Pain in extremity, Restless legs syndrome
Clinical narrative: Leg pain, restless legs, progressive weakness of extremities, neck, difficulty breathing.
Age: 25.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Headache, Papule, Pyrexia
Clinical narrative: Fever, chills, headache, Right arm warm and tender with red papules (largest papule 2.5 cm).
Age: 25.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: Fever, chills, headache, Right arm warm and tender with red papules (largest papule 2.5 cm).
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Musculoskeletal pain
Clinical narrative: Severe neck and shoulder pain, low grade fever, restlessness, headache, dizziness, and no energy.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pyrexia, Restlessness
Clinical narrative: Severe neck and shoulder pain, low grade fever, restlessness, headache, dizziness, and no energy.
Age: 31.0
Sex: F
Vaccine: HEPA, MNQ, TD, TYP, YF
Symptoms: Audiogram abnormal, Culture negative, Deafness neurosensory, Headache, Herpes simplex serology negative
Clinical narrative: Received the following vaccineson 9/18/15 to prepare for a trip: YF, typhoid, hepatitis A, Td, Menactra. On 9/19 and 20 had myalgias, shoulder pain and headaches. Ibuprofen provided relief. On 9/20 had vaginal irritation and on 9/21 developed 5 small vaginal ulcerations scattered bilaterally. By 9/22 the lesions expanded rapidly with ulcerations as large as 1.5 cm. Lesions were painful with deep ulcerations in the center. Saw ob/gyn on 9/22. She was treated with valacyclovir. Cultures were done to test for herpes. Patient reports tests were negative. She does not have a history of genital herpes. In July she had some subtle changes in her hearing on the left side. It had remained stable until 9/21 when she had significant changes in hearing with constant static noise, occasional high pitched noises and muffled quality. She was started on high doses of prednisone and this helped. Hearing started to improve on 9/27. She also experienced periorbital edema. She never had fevers. She developed 3 urticaria on her chest and forearm but no other rashes. No joint pain or swelling.
Age: 31.0
Sex: F
Vaccine: HEPA, MNQ, TD, TYP, YF
Symptoms: Hypoacusis, Musculoskeletal pain, Myalgia, Periorbital oedema, Polymerase chain reaction
Clinical narrative: Received the following vaccineson 9/18/15 to prepare for a trip: YF, typhoid, hepatitis A, Td, Menactra. On 9/19 and 20 had myalgias, shoulder pain and headaches. Ibuprofen provided relief. On 9/20 had vaginal irritation and on 9/21 developed 5 small vaginal ulcerations scattered bilaterally. By 9/22 the lesions expanded rapidly with ulcerations as large as 1.5 cm. Lesions were painful with deep ulcerations in the center. Saw ob/gyn on 9/22. She was treated with valacyclovir. Cultures were done to test for herpes. Patient reports tests were negative. She does not have a history of genital herpes. In July she had some subtle changes in her hearing on the left side. It had remained stable until 9/21 when she had significant changes in hearing with constant static noise, occasional high pitched noises and muffled quality. She was started on high doses of prednisone and this helped. Hearing started to improve on 9/27. She also experienced periorbital edema. She never had fevers. She developed 3 urticaria on her chest and forearm but no other rashes. No joint pain or swelling.
Age: 31.0
Sex: F
Vaccine: HEPA, MNQ, TD, TYP, YF
Symptoms: Skin lesion, Urticaria, Vaginal ulceration, Vulvovaginal discomfort
Clinical narrative: Received the following vaccineson 9/18/15 to prepare for a trip: YF, typhoid, hepatitis A, Td, Menactra. On 9/19 and 20 had myalgias, shoulder pain and headaches. Ibuprofen provided relief. On 9/20 had vaginal irritation and on 9/21 developed 5 small vaginal ulcerations scattered bilaterally. By 9/22 the lesions expanded rapidly with ulcerations as large as 1.5 cm. Lesions were painful with deep ulcerations in the center. Saw ob/gyn on 9/22. She was treated with valacyclovir. Cultures were done to test for herpes. Patient reports tests were negative. She does not have a history of genital herpes. In July she had some subtle changes in her hearing on the left side. It had remained stable until 9/21 when she had significant changes in hearing with constant static noise, occasional high pitched noises and muffled quality. She was started on high doses of prednisone and this helped. Hearing started to improve on 9/27. She also experienced periorbital edema. She never had fevers. She developed 3 urticaria on her chest and forearm but no other rashes. No joint pain or swelling.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: I've always received flu shots with no side effects. This time I encountered lots of itching and bumps initially around my neck. Then my head, upper legs, torso. This occurred roughly 2 days after the shot, but it's been close to 10 days now and still occurs off and on. It's not life threatening but felt it was important to report.
Age: 43.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Employee says her left arm where she had injection became sore after vaccine received that night. Her entire arm has hurt now for 2 wks and difficulty lifting arm above head or dressing herself.  She denies any numbness or tingling unless lays on it for long period of time.  She also denies any fever and site looks normal where injection given and no swelling noted.
Age: 43.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Activities of daily living impaired, Injection site pain, Pain, Pain in extremity
Clinical narrative: Employee says her left arm where she had injection became sore after vaccine received that night. Her entire arm has hurt now for 2 wks and difficulty lifting arm above head or dressing herself.  She denies any numbness or tingling unless lays on it for long period of time.  She also denies any fever and site looks normal where injection given and no swelling noted.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Loss of consciousness, Memory impairment, Tooth fracture
Clinical narrative: About 3-4 minutes after vaccine patient passed out. He was out for less than minute. Came to - didn't remember what just happened and very tired. Also chipped his tooth.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Administered flu shot IM ((L) deltoid) 9/23/15, still experiencing pain in (L) shoulder radiating down/aching down towards () hand. Hurts to lift arm and event in use visited primary care MD and suggested may have hit a nerve when administered.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Platelet count decreased, Pruritus, Pyrexia
Clinical narrative: Pt had fever, severe itching and low platelet count.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Hypoaesthesia, Injection site warmth, Pain, Pain in extremity
Clinical narrative: Pt. presented at walk -in w/(L) arm pain. Upper arm hot to touch, lower arm very cold; pt. stated she was having some tingling and numbness, couldn't move arm without pain. Pt. had temp, of 100.8 degrees. Provider.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Paraesthesia, Peripheral coldness
Clinical narrative: Pt. presented at walk -in w/(L) arm pain. Upper arm hot to touch, lower arm very cold; pt. stated she was having some tingling and numbness, couldn't move arm without pain. Pt. had temp, of 100.8 degrees. Provider.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV9
Symptoms: Abdominal pain upper, Activities of daily living impaired, Asthenia, Blood test, Fatigue
Clinical narrative: This spontaneous report was received from a company representative (patient parent) refers to a 11 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. The patient never had reactions to other unspecified vaccines or flu mists in the past. On 05-OCT-2015, the patient was vaccinated with GARDASIL 9 in the shoulder. Other co suspect therapy included FLUMIST (intranasal (cold). On 06-OCT-2015, 2 days after onset of therapy, the patient experienced headache, low grade fever, stomach ache, debilitating and extreme fatigue. The reporter stated that the main problem was fatigue as the patient was unable to attend school. On an unknown date in October 2015, the patient sought medical attention and was treated with unspecified doses of ibuprofen, ALEVE and TYLENOL all over the counter. On an unknown date in October 2015, the patient has blood work and the results were not reported. On 11-OCT-2015, the patient recovered from headache, low grade fever, stomach ache, debilitating, extreme fatigue and unable to attend school. The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV9
Symptoms: Headache, Pyrexia
Clinical narrative: This spontaneous report was received from a company representative (patient parent) refers to a 11 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. The patient never had reactions to other unspecified vaccines or flu mists in the past. On 05-OCT-2015, the patient was vaccinated with GARDASIL 9 in the shoulder. Other co suspect therapy included FLUMIST (intranasal (cold). On 06-OCT-2015, 2 days after onset of therapy, the patient experienced headache, low grade fever, stomach ache, debilitating and extreme fatigue. The reporter stated that the main problem was fatigue as the patient was unable to attend school. On an unknown date in October 2015, the patient sought medical attention and was treated with unspecified doses of ibuprofen, ALEVE and TYLENOL all over the counter. On an unknown date in October 2015, the patient has blood work and the results were not reported. On 11-OCT-2015, the patient recovered from headache, low grade fever, stomach ache, debilitating, extreme fatigue and unable to attend school. The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site nodule
Clinical narrative: 1 x 2" firm nodule left lat. thigh.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMR, VARCEL
Symptoms: Computerised tomogram head normal, Full blood count, Generalised tonic-clonic seizure, Metabolic function test, Scan with contrast normal
Clinical narrative: PT has tonic clonic seizure within 5 min of immunization lasting for 1 min. Pt was evaluated with CT head to r/o any intracranial mass; which was WNL.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient has extreme tenderness of muscle where injection was administered. She also has a small amount of swelling of deltoid muscle, no redness.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Pruritus
Clinical narrative: Raised, itching lump.
Age: 1.59
Sex: M
Vaccine: FLU3, HIBV, PNC13
Symptoms: Cough, Injection site erythema, Irritability, Pyrexia, Rhinorrhoea
Clinical narrative: Fever 101.8, fussy, coughing all night, runny nose, sneezing, redness at injection site.
Age: 1.59
Sex: M
Vaccine: FLU3, HIBV, PNC13
Symptoms: Sneezing
Clinical narrative: Fever 101.8, fussy, coughing all night, runny nose, sneezing, redness at injection site.
Age: 72.0
Sex: F
Vaccine: FLUC3
Symptoms: Ecchymosis, Mobility decreased, Musculoskeletal stiffness, Pain in extremity, Tenderness
Clinical narrative: Stiff anterior, posterior Deltoid, and supraspinatus muscles, very tender, and painful, unable to lift arm. Seen again 10/19/2015, and large ecchymosis of ant. deltoid, softer muscles.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site reaction, Mobility decreased, Muscle spasms, Myalgia
Clinical narrative: Injection site muscle pain, spasm for 2 weeks. Decrease range of motion because of pain, treated with ibuprofen, physical therapy and Medrol dose pack.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Muscle tightness, Pain
Clinical narrative: Diffuse achiness, joint pain, muscles "all locked up".
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Ear pain, Fatigue, Injection site erythema, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: AFTER VACCINE ADMINISTRATION, PATIENT WENT HOME AND SLEPT BECAUSE SHE FELT REALLY TIRED. AFTER SHE WOKE UP FROM HER NAP, HER WHOLE BODY FELT STIFF.  HER LEFT ARM (INJECTION SITE) WAS RED AS A BRICK AND SWOLLEN LIKE A SIZE OF A BASEBALL.  AFTER 1 WEEK, HER UPPER LEFT ARM WAS STILL REALLY RED, BUT SWELLING HAS GONE DOWN.  PATIENT ALSO COMPLAINED OF PAIN IN THE RIGHT EAR.
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Left arm still sore after vaccination - 2 weeks later. Sore when lifting items and lifting arm over shoulder, shoulder pain.
Age: 31.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Myalgia
Clinical narrative: Left arm still sore after vaccination - 2 weeks later. Sore when lifting items and lifting arm over shoulder, shoulder pain.
Age: 28.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Adverse reaction
Clinical narrative: Patient developed a reaction and had to go to the ER where she was told that both shots flu and pneumonia should not be given same time.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Urticaria
Clinical narrative: States hive and redness and itching at site of injection.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Itchy. Was told to take BENADRYL.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Dysphonia, Eye pruritus, Pruritus, Swelling face
Clinical narrative: Itchy face, eyes, hoarseness, face swelling, stomach upset, ? fever.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Oxygen saturation decreased
Clinical narrative: Decrease blood oxygen level.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Body temperature increased
Clinical narrative: Student came to nurses office from lunchroom with c/o stomachache. Axillary temp 101.2. Parent notified, Tylenol given. Parent picked student up and took to family doctor.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Paraesthesia
Clinical narrative: Severe pain upon insertion of the needle, worsening with injection of the quadrivalent flu vaccine. Immediate pain in shoulder afterwards, severe, lasting for several days with loss of range of motion. Persistent pain with some limitation in range of motion and paresthesias along inner aspect of arm, hand and medial three fingers.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth, Musculoskeletal pain
Clinical narrative: Pain in neck, shoulder and right arm. It was also itchy. The next day, the pain continues, hot and swollen. Pain scale is 9 (1-10). On Sunday, the injection site became red, swollen, inflamed, hot, spread about 4-5 inches. Monday, patient reported to the pharmacy. Will see MD on 09/29.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Neck pain, Pain in extremity, Pruritus, Skin warm, Swelling
Clinical narrative: Pain in neck, shoulder and right arm. It was also itchy. The next day, the pain continues, hot and swollen. Pain scale is 9 (1-10). On Sunday, the injection site became red, swollen, inflamed, hot, spread about 4-5 inches. Monday, patient reported to the pharmacy. Will see MD on 09/29.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Body temperature increased, Injection site pain, Nausea, Vomiting
Clinical narrative: Vaccine given 10:30 AM 10/17/15. By 4 pm of same day felt increased tenderness at inject site and widespread joint pains. Later in evening spike temp 101 and vomiting. By 10/19/15 symptoms resolved except waning nausea. Took TYLENOL.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local swelling, Musculoskeletal pain, Neck pain, Rash erythematous
Clinical narrative: Flu shot given 10/13/15. Noticed (R) deltoid was swollen, red and warm on 10/14/15 at 2130. On 10/15/15 at 0530, (R) deltoid was swollen, red, warm, and a raised red rash was descending down the (R) upper arm. Consequent (R) neck and (R) shoulder soreness. Seen by MD on 10/15/15.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Flu shot given 10/13/15. Noticed (R) deltoid was swollen, red and warm on 10/14/15 at 2130. On 10/15/15 at 0530, (R) deltoid was swollen, red, warm, and a raised red rash was descending down the (R) upper arm. Consequent (R) neck and (R) shoulder soreness. Seen by MD on 10/15/15.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: Fever after receiving FLUMIST of 102.0.
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Meniere's disease, Tinnitus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Meniere's disease aggravated in a adult female patient who received FLUARIX QUADRIVALENT (batch number 2F5P4, expiry date 30th June 2016). Concurrent medical conditions included Meniere's disease. On an unknown date, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced Meniere's disease aggravated (serious criteria GSK medically significant and other: as per reporter) and ringing in ears. On an unknown date, the outcome of the Meniere's disease aggravated and ringing in ears were unknown. The reporter considered the Meniere's disease aggravated to be almost certainly related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the ringing in ears to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The reporter stated that patient received the FLUARIX vaccine and believed that the vaccine flared up the Meniere's disease. The sales rep reported that the patient developed ringing in ears after vaccination with FLUARIX.
Age: 79.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Diagnosed with Guillain Barre syndrome. Paralyzed from neck down. Couple of weeks after flu-shot.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular
Clinical narrative: She has a splotchy rash that comes and goes. BENADRYL cream made it worse. Rash was better on 10-19-15. Rash is not around the site and is not head to toe. It has appeared on hip, neck, and arm. Mom called pediatrician and pediatrician reported it was normal and she could have symptoms for 5 days after administration.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had redness, swelling and itchiness at the injection site (right arm).
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Body temperature increased
Clinical narrative: Patient arrived to nurses office with c/o stomachache. Axillary temp 101.1. Informed dad, Tylenol given. Dad picked student up and took her to family doctor.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Muscle spasms
Clinical narrative: Arm and hand spasms.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: Began with feeling "flush", followed by headache, fever 100.6, shakes, malaise, nausea. No local reaction.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Began with feeling "flush", followed by headache, fever 100.6, shakes, malaise, nausea. No local reaction.
Age: 29.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Abdominal pain, Chills, Diarrhoea, Hyperhidrosis, Pain
Clinical narrative: Began feeling body aches and abdominal pain evening of 10/15/15. When woke up on 10/16/15 she c/o body aches, diarrhea, sweating, chills, low grade fever and vomiting.  Also reported jaw pain on 10/16/15.  Symptoms continued for couple days.  Continues with body aches and jaw soreness.
Age: 29.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Pain in jaw, Pyrexia, Vomiting
Clinical narrative: Began feeling body aches and abdominal pain evening of 10/15/15. When woke up on 10/16/15 she c/o body aches, diarrhea, sweating, chills, low grade fever and vomiting.  Also reported jaw pain on 10/16/15.  Symptoms continued for couple days.  Continues with body aches and jaw soreness.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Rash, Rash pruritic
Clinical narrative: States had itchy, raised rash starting on right shoulder, then progressed to upper back, back of neck, then other shoulder. States used hydrocortisone cream.
Age: 1.65
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 59.0
Sex: F
Vaccine: FLUR3
Symptoms: Asthenia, Bone pain, Fatigue, Lymphadenopathy, Myalgia
Clinical narrative: Muscle and bone aches, skin with burning feeling Saturday 10/17/15.  Extreme fatigue, swollen lymph nodes, low grade fever.  Sunday 10/18/15, skin started to feel itchy and burning subsided. still with aches, swollen nodes, feverish, weakness.  Monday 10/19/15,  Weakness some itchiness, aches, swollen glands and headache. 10/20/15, symptoms decreased and able to go to work, still with swollen glands, weakness, fatigue, aches.
Age: 59.0
Sex: F
Vaccine: FLUR3
Symptoms: Pain, Pruritus, Pyrexia, Skin burning sensation
Clinical narrative: Muscle and bone aches, skin with burning feeling Saturday 10/17/15.  Extreme fatigue, swollen lymph nodes, low grade fever.  Sunday 10/18/15, skin started to feel itchy and burning subsided. still with aches, swollen nodes, feverish, weakness.  Monday 10/19/15,  Weakness some itchiness, aches, swollen glands and headache. 10/20/15, symptoms decreased and able to go to work, still with swollen glands, weakness, fatigue, aches.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PT. RECEIVED 2 FLU VACCINES IN SAME SEASON ON 9/10/15 & 10/15/15.  PT. WAS ASKED PRIOR TO VACCINATION IF SHE HAD GOTTEN VACCINE THIS YEAR?  PT. STATED NO.  SHE DIDN'T REMEMBER GETTING VACCINE OVER 4 WEEKS AGO.  THIS PT. DID NOT HAVE ANY SYMPTOMS OR COMPLICATIONS @ TIME OF VISIT AND HAS NOT REPORTED ANY TO DATE.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Rash, Rash pruritic, Rhinorrhoea
Clinical narrative: Itching rash on back of knees, spread to left of trunk. Feeling "worn out". Nasal drainage. Better 10/20/2015.
Age: 18.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Abdominal discomfort, Asthenia, Blood glucose normal, Blood pressure decreased, Dyskinesia
Clinical narrative: THE PATIENT FAINTED AND WAS HAVING JERKING MOVEMENTS APPROXIMATELY 10 SECONDS AFTER GIVING HER THE MENINGOCOCCAL VACCINE. I USED AMMONIA TO BRING HER BACK. SHE WAS EXPERIENCING STOMACH UPSET AND I HAD TO CALL THE RESCUE WHEN THEY ARRIVED ABOUT 20 MIN LATER THE PATIENT BLOOD PRESSURE WAS 50 ALL THE OTHER VITAL SIGNS WERE GOOD. IT TOOK THE PATIENT ABOUT 1 HOUR TO FEEL STRONG ENOUGH TO WALK AND HAVE HER GRAND MOTHER PICK HER UP.
Age: 18.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Syncope
Clinical narrative: THE PATIENT FAINTED AND WAS HAVING JERKING MOVEMENTS APPROXIMATELY 10 SECONDS AFTER GIVING HER THE MENINGOCOCCAL VACCINE. I USED AMMONIA TO BRING HER BACK. SHE WAS EXPERIENCING STOMACH UPSET AND I HAD TO CALL THE RESCUE WHEN THEY ARRIVED ABOUT 20 MIN LATER THE PATIENT BLOOD PRESSURE WAS 50 ALL THE OTHER VITAL SIGNS WERE GOOD. IT TOOK THE PATIENT ABOUT 1 HOUR TO FEEL STRONG ENOUGH TO WALK AND HAVE HER GRAND MOTHER PICK HER UP.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT REPORTS REDNESS/SWELLING AT INJECTION SITE. APPROXIMATELY THE SIZE OF QUARTER AS OF 10/19/2015.  PATIENT STATES FEELS WARM TO TOUCH AND FIRM IN RED AREA.   NO HIVES. NO FEVER. NO PUS.
Age: 0.61
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Confusional state, Conversion disorder, Cough, Crying, Disorientation
Clinical narrative: Hysterical, high pitched crying which was inconsolable for 3 hours.  Additional was having difficulty catching breath due to extreme crying and appeared disoriented, dazed, glazed and confused for 3+ hours during crying episode.  Swelling and redness at injection site for 3 days following injection.  Swelling of soft spot near base of head (near neck) for 3 days following injection.  Irritability, fussiness, congestion and cough for 4+ days following injection.
Age: 0.61
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Dyspnoea, Feeling abnormal, Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Hysterical, high pitched crying which was inconsolable for 3 hours.  Additional was having difficulty catching breath due to extreme crying and appeared disoriented, dazed, glazed and confused for 3+ hours during crying episode.  Swelling and redness at injection site for 3 days following injection.  Swelling of soft spot near base of head (near neck) for 3 days following injection.  Irritability, fussiness, congestion and cough for 4+ days following injection.
Age: 0.61
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Respiratory tract congestion, Swelling
Clinical narrative: Hysterical, high pitched crying which was inconsolable for 3 hours.  Additional was having difficulty catching breath due to extreme crying and appeared disoriented, dazed, glazed and confused for 3+ hours during crying episode.  Swelling and redness at injection site for 3 days following injection.  Swelling of soft spot near base of head (near neck) for 3 days following injection.  Irritability, fussiness, congestion and cough for 4+ days following injection.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warmth experienced around bicept, radiating 180 degrees from bicept around to tricept, 4-6 inch diameter.
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Contusion, Erythema, Facial pain, Local swelling, Musculoskeletal stiffness
Clinical narrative: Received Rabies immunology & vaccine. Right side of face red & swollen. Cold compress & told to take BENADRYL I was told mild reaction continue on with vaccine, received 2nd dose on 6/12/15 went to ER 6/14/15 neck stiffness & complete left side had little swelling was prescribed prednisone, oxycodone, & Flexeril. 6/15/2015 back to ER severe pain, neck, face & hand & legs very swollen. Admitted to Hospital. Stay was 2 days. Back to  Hospital 3 days discharged. Back to Hospital on 6/20/2015 swelling & bruising. Readmitted to Hospital for four days, discharged to Rehabilitation.
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Neck pain, Pain, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Received Rabies immunology & vaccine. Right side of face red & swollen. Cold compress & told to take BENADRYL I was told mild reaction continue on with vaccine, received 2nd dose on 6/12/15 went to ER 6/14/15 neck stiffness & complete left side had little swelling was prescribed prednisone, oxycodone, & Flexeril. 6/15/2015 back to ER severe pain, neck, face & hand & legs very swollen. Admitted to Hospital. Stay was 2 days. Back to  Hospital 3 days discharged. Back to Hospital on 6/20/2015 swelling & bruising. Readmitted to Hospital for four days, discharged to Rehabilitation.
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Swelling face
Clinical narrative: Received Rabies immunology & vaccine. Right side of face red & swollen. Cold compress & told to take BENADRYL I was told mild reaction continue on with vaccine, received 2nd dose on 6/12/15 went to ER 6/14/15 neck stiffness & complete left side had little swelling was prescribed prednisone, oxycodone, & Flexeril. 6/15/2015 back to ER severe pain, neck, face & hand & legs very swollen. Admitted to Hospital. Stay was 2 days. Back to  Hospital 3 days discharged. Back to Hospital on 6/20/2015 swelling & bruising. Readmitted to Hospital for four days, discharged to Rehabilitation.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt has a red, hot, itchy spot where the shot was given.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site inflammation, Pain
Clinical narrative: Inflammation at site of injection. Pain.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Loss of consciousness, Syncope
Clinical narrative: After receiving the FLUZONE HD, patient started to slide down the chair. She look like she was fainting, but it then seemed like she might have had a seizure. Patient regained consciousness quickly and 911 was called. Her HR was high at 120 then down to 89 then 74. BP=89/154 when ambulance got there. She was released from ER. She is doing well. Normal per ER.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injected limb mobility decreased, Injection site reaction, Pain in extremity
Clinical narrative: Pt. came in to report to our pharmacy manager that her arm was extremely sore after her shot. Couldn't lift it. She saw her MD on 10/13/15 - he diagnosed shoulder bursitis from receiving injection into the bursa which will require 4 weeks of physical therapy.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Conjunctivitis, Cough, Pharyngeal oedema, Urticaria
Clinical narrative: Hives of face, cough, conjunctivitis, edema throat (Prednisone).
Age: 53.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Balance disorder, Discomfort, Metabolic function test normal, Pain, Paraesthesia
Clinical narrative: Began day after injection/administration. Shooting pains throughout her body, feeling of heaviness, fever x4 days. Heaviness lasted x4 days, and then felt off balance x2 weeks. Feeling of tingling in her feet.
Age: 53.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pyrexia, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: Began day after injection/administration. Shooting pains throughout her body, feeling of heaviness, fever x4 days. Heaviness lasted x4 days, and then felt off balance x2 weeks. Feeling of tingling in her feet.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Headache, Migraine, Musculoskeletal pain
Clinical narrative: Headache, migraine, severe pains upper back and shoulders beginning during night and continuing for 5 days.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Heart rate irregular, Visual acuity reduced
Clinical narrative: Exact time not remembered. Tightness in chest, difficulty catching breath, irregular heart rate on day 2, plus poor vision on day 2. Fluvirin 90658 0.5mL
Age: 0.3
Sex: F
Vaccine: DTAP, IPV
Symptoms: Diarrhoea, Injection site swelling, Insomnia, Lethargy, Pyrexia
Clinical narrative: Projectile vomiting for 4 days. Diarrhea. Extreme Swelling at Injection Site. Fever of 103 to 105. Lethargy. Difficulty Sleeping.
Age: 0.3
Sex: F
Vaccine: DTAP, IPV
Symptoms: Vomiting projectile
Clinical narrative: Projectile vomiting for 4 days. Diarrhea. Extreme Swelling at Injection Site. Fever of 103 to 105. Lethargy. Difficulty Sleeping.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Hyperacusis, Tinnitus
Clinical narrative: Ear ache, sounds amplified and sound robotic, ringing and rumbling in ears.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Migraine, Musculoskeletal pain
Clinical narrative: Severe migraine with pains in upper back and shoulders lasting 4 days.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's flu shot was given in her left deltoid.  She came in on 10/13/2015 with her left upper arm swollen. I measured the left arm against the right arm. The left upper arm measured 16 1/2 inches in diameter while the right measured 13 3/4 inches.  The redness measured 4" X 3".  She said that she was seeing her PCP on 10/14/2015.  I told her to ask about the flu reaction and see what he thought about the reaction to the influenza vaccine.  She called me back on 10/14/2015 and said her PCP said for her to not take anymore flu vaccinations.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Allergy to vaccine, Anaphylactic shock, Blood pressure abnormal, Erythema, Oxygen saturation decreased
Clinical narrative: Within minutes of receiving his MMR and Chicken Pox Vaccines, patient turned red, itchy, and started sneezing.  He then started to swell in his face and went into anaphylactic shock. His oxygen level started to drop and his blood pressue was off as well.  He was given 2 doses Benadryl and finally given the EPI PEN.  He was then given an oxygen mask with a breathing treatment. (This is the SECOND time patient received these vaccines but had no reaction the first time).  He was monitored at the pediatricians office for a couple of hours then we were instructed to take him to the hospital for overnight observation.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Sneezing, Swelling face
Clinical narrative: Within minutes of receiving his MMR and Chicken Pox Vaccines, patient turned red, itchy, and started sneezing.  He then started to swell in his face and went into anaphylactic shock. His oxygen level started to drop and his blood pressue was off as well.  He was given 2 doses Benadryl and finally given the EPI PEN.  He was then given an oxygen mask with a breathing treatment. (This is the SECOND time patient received these vaccines but had no reaction the first time).  He was monitored at the pediatricians office for a couple of hours then we were instructed to take him to the hospital for overnight observation.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient is unable to lift her left arm above her elbow.  She cannot lay on it and hasn't since the administered date. Hasn't seeked medical attention yet.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Erythema, Lymph node pain, Lymphadenopathy, Swelling
Clinical narrative: Swelling and redness with pain in Axilla occured 2-3 days after vaccine.  Then developed a painful enlarged lymph node.  Gradually resolved over the week.
Age: 46.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Patient temp was elevated to 100.1. Injection area was reddened and swollen to the size of an orange. This lasted all of Saturday and Sunday. She started to take Benadryl, but did not help. She presented to the clinic today. Examining doctor advised her to use ice on affected area, and to take Tylenol for the discomfort.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received duplicate vaccine, no effect at time of vaccine.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Feeling abnormal, Hypoaesthesia, Hypoaesthesia oral, Speech disorder
Clinical narrative: Felt yucky in the afternoon stated that his mouth felt numb and the next morning he said he felt very tired and noticed his whole jaw was numb and noticed he couldn't talk good and his lip was sagging. He went to ER.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: VIIth nerve paralysis
Clinical narrative: Felt yucky in the afternoon stated that his mouth felt numb and the next morning he said he felt very tired and noticed his whole jaw was numb and noticed he couldn't talk good and his lip was sagging. He went to ER.
Age: 66.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Right arm extremely sore unable to lift for almost two weeks and constant ache and pain.  Sleep interrupted.  Using heating pad and taking ibuprofen.
Age: 47.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Circumoral oedema, Lip swelling, Pruritus
Clinical narrative: In the evening patient stated she felt itching to arms and had swelling to lips and around mouth.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Pallor
Clinical narrative: Employee complained of being hot, sweaty, and lightheaded.  Donor was given an ice pack and gatorade.  Temperature was 98.6F before and after being given the vaccine.  BP and pulse remained stable and within normal limits at all times.  Appeared pale and diaphoretic.  Symptoms lasted for 35 minutes before being recommended to go to the ER for more treatment.  Symptoms stayed the same and did not worsen or get better.  Employee called at 4:30 PM at ER and stated she was beginning to feel normal but had not yet been seen by a physician.
Age: 15.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Abasia, Dizziness, Fatigue, Hypersomnia, Immediate post-injection reaction
Clinical narrative: Since first shot, she had sinus problems and tired progressively getting worse.  After second dosage, she started sleeping 18 to 20 hours a day, passed out and lost feeling in her legs and arms, unable to walk and had 3 IVIG treatments, 72 hour steroid blast, shock testing and sleep study, spinal tap, 12 days in the hospital and more to come.
Age: 15.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Immunoglobulin therapy, Laboratory test normal, Loss of consciousness, Lumbar puncture, Malaise
Clinical narrative: Since first shot, she had sinus problems and tired progressively getting worse.  After second dosage, she started sleeping 18 to 20 hours a day, passed out and lost feeling in her legs and arms, unable to walk and had 3 IVIG treatments, 72 hour steroid blast, shock testing and sleep study, spinal tap, 12 days in the hospital and more to come.
Age: 15.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Sensory loss, Sinusitis, Sleep study
Clinical narrative: Since first shot, she had sinus problems and tired progressively getting worse.  After second dosage, she started sleeping 18 to 20 hours a day, passed out and lost feeling in her legs and arms, unable to walk and had 3 IVIG treatments, 72 hour steroid blast, shock testing and sleep study, spinal tap, 12 days in the hospital and more to come.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Chest X-ray normal, Chills, Cough, Dyspnoea, Ear pain
Clinical narrative: Cough, bodyaches, shortness of breath, ear pain, fever, chills, nausea and vomiting.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Cough, bodyaches, shortness of breath, ear pain, fever, chills, nausea and vomiting.
Age: 70.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient stated he couldn't move his right shoulder or arm in the air.  Able to move his fingers.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: No true adverse event. Realized I'd misread her DOB and gave her a 3+ prefilled preservative free flu shot instead of a 6-35 months shot.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site hypoaesthesia, Injection site joint pain, Injection site pain
Clinical narrative: Nurse said she was having a problem with the syringe plunger while the needle was already in my left shoulder.  After a few seconds, she finally was able to get the fluid injected.  Immediately I felt a numbing pain in my left shoulder.  A few hours later, I could not lift my left arm above shoulder level and my whole shoulder was very painful, especially the shoulder joints.  On 10/11/2015 I went to Dr. at Immediate Care, because my left arm started getting numb, lame and tingly.  The shoulder was still sore.  She prescribed 3-4 Advils three times per day and and referred me to a neurologist.  Today, 10/21/2015 the pain in my shoulder is still severe and I have limited range of motion.  It seems to be getting worse, rather than better.  I have had 2 physical therapy treatments, which so far have not yet helped.  I have made an appointment to see someone on Monday (10/26/2015) and hope to get an MRI of my shoulder and get referred to an orthopedic surgeon.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Syringe issue
Clinical narrative: Nurse said she was having a problem with the syringe plunger while the needle was already in my left shoulder.  After a few seconds, she finally was able to get the fluid injected.  Immediately I felt a numbing pain in my left shoulder.  A few hours later, I could not lift my left arm above shoulder level and my whole shoulder was very painful, especially the shoulder joints.  On 10/11/2015 I went to Dr. at Immediate Care, because my left arm started getting numb, lame and tingly.  The shoulder was still sore.  She prescribed 3-4 Advils three times per day and and referred me to a neurologist.  Today, 10/21/2015 the pain in my shoulder is still severe and I have limited range of motion.  It seems to be getting worse, rather than better.  I have had 2 physical therapy treatments, which so far have not yet helped.  I have made an appointment to see someone on Monday (10/26/2015) and hope to get an MRI of my shoulder and get referred to an orthopedic surgeon.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt explained she had aching in arm near injection site. States pain lasted a few days (approx. 3) and subsided. Claims now the pain has returned and arm is difficult to move.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pneumonia, Pyrexia, Respiratory tract congestion, Respiratory tract infection
Clinical narrative: Initial chest congestion with some SOB began 12 hours after vaccine. Approximately 24-36 hours patient began running a fever of 99.9-100.  Fever continued for 2 days.  Patient was seen again at doctors office on 10/12/2015 and Chest X-ray confirmed patient developed pneumonia in the lower right lobe, presumably as a complication of respiratory infection.  Oral antibiotics and a tapered dose of Prednisone were prescribed along with nebulizer treatments of Ipatropium bromide/albutol for wheezing.  Patient recovering at home.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Initial chest congestion with some SOB began 12 hours after vaccine. Approximately 24-36 hours patient began running a fever of 99.9-100.  Fever continued for 2 days.  Patient was seen again at doctors office on 10/12/2015 and Chest X-ray confirmed patient developed pneumonia in the lower right lobe, presumably as a complication of respiratory infection.  Oral antibiotics and a tapered dose of Prednisone were prescribed along with nebulizer treatments of Ipatropium bromide/albutol for wheezing.  Patient recovering at home.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Dyskinesia, Injection site pain, Muscular weakness, Opisthotonus, Unresponsive to stimuli
Clinical narrative: My son recieved a DTaP and a hep B vaccine from the physician. As we were leaving the facility within five minutes following receiving the shot I stood at the receptionist desk checking out and saw my son laying on  the ground. I ran to him. His back was arched his head tilted back and both feet rising and lowering creating a banging back and forth. He was not responsive. I called for help three times yelling loudly. Staff finally came and ran from one end of the building to the other before putting him on an empty exam room table. Vitals were taken and within 2 to 4 minutes he came around. He steadily improved over the course of the next hour. The physician cleared him to leave. He complains of arm soreness and left leg weakness 24 hours following incident.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Developed a redness around vaccine site a few days after injection.  The reaction is resolving on its own.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis reported by patient and ER physician. Cephalexin was prescribed by the ER physician.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Eye pruritus, Wheezing
Clinical narrative: Itchy eyes, cough, wheezing. He was already on Allegra for two days for runny nose at home. So no hives.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysgeusia, Lacrimation increased, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Metallic taste in mouth, started to cough, red eyes and watery drainage, sore throat.  Saw acute care and they told them to use Benadryl and other otc products.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Immediate post-injection reaction, Induration, Pain, Tenderness
Clinical narrative: Immediate soreness, ~5x6 cm area of erythema, induration, exquisite tenderness to palpation.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 44-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 93T79, expiry date 30th June 2016). On 7th October 2015, the patient received FLULAVAL QUADRIVALENT .5 ml. On 7th October 2015, 2 hrs after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site erythema, injection site itching and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site warmth were recovering/resolving. The reporter considered the injection site erythema, injection site itching and injection site warmth to be probably related to FLULAVAL QUADRIVALENT. Additional details provided were as follows: This case was not previously reported to anyone. The patient received FLULAVAL QUADRIVALENT vaccine in her right deltoid. Same day, approximately 2 hours after vaccination, the patient experienced a warm and redness of 9 by 9 cm of area with itching below the injection site. No additional details were available.
Sex: U
Vaccine: FLU4
Symptoms: Eye swelling
Clinical narrative: This case was received by a pharmacist via call center representative and described the occurrence of periorbital swelling in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced periorbital swelling. On an unknown date, the outcome of the periorbital swelling was unknown. It was unknown if the reporter considered the periorbital swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The health care professional had a patient who was complaining about periorbital swelling after receiving flu shot. Only information the health care professional had, was the symptom the patient was complaining to have.