chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site pruritus, Injection site rash, Vaccination complication
Clinical narrative: Puritic rash and itching noted on L arm around injection site. Later on 10/18 R arm started itching and rash was noticed. When I awoke on 10/19 my body was covered in a puritic rash and had severe itching. Nothing changed in my routines- no food changes, no body care changes, no laundry detergent changes. Itching and rash worsened, left work to go to MD at 12noon on 10/19. MD stated likely an allergic reaction to the flu shot. Methylprednisolone dose pack and Benedryl started on 10/19. Rash and itching still present on 10/20, but significantly reduced.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site rash, Swelling face
Clinical narrative: Injection site rash with localized facial swelling.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: REDNESS AT SITE OF IMMUNIZATION AND ITCHING ACCORDING TO PATIENT.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chills, Malaise, Pyrexia, Urine analysis
Clinical narrative: Chills, rigors, fever to 101.4 degrees, malaise.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Mom reports swelling and pain at the injection site. Also a low grade fever. Symptoms lasted one day per mom, and swelling is now going down.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Asthma, Cough, Immediate post-injection reaction, Nasopharyngitis, Pyrexia
Clinical narrative: She immediately got cold symptoms, high fever, wheezing, asthma attacks, throwing up from coughing so hard during attacks EVERY night, a full body rash. Took her back several times and the cdc told me to go to a different dr and they started her with albuterol, bensonide, tylenol/advil, prednisolone, and an asthma allergy medicine. One year later and we still cant get her asthma under control. Shes stopped breathing a couple times from asthma attacks and still throws up at night.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Rash generalised, Vomiting, Wheezing
Clinical narrative: She immediately got cold symptoms, high fever, wheezing, asthma attacks, throwing up from coughing so hard during attacks EVERY night, a full body rash. Took her back several times and the cdc told me to go to a different dr and they started her with albuterol, bensonide, tylenol/advil, prednisolone, and an asthma allergy medicine. One year later and we still cant get her asthma under control. Shes stopped breathing a couple times from asthma attacks and still throws up at night.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Injection site erythema, Pruritus, Rash
Clinical narrative: Day of no reported problems. 2nd day-Developed itching-2 hives/rash on face, at base of thumb and red patch below injection site. Felt light-headed so rested all day and used Benadryl cream to alleviate itching (not used at injection site). 3rd day-top side of inj arm from top of arm to wrist was slightly redder than normal-underneath side of arm ok. As of 10/20/16, symptoms are slowly subsiding.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Day of no reported problems. 2nd day-Developed itching-2 hives/rash on face, at base of thumb and red patch below injection site. Felt light-headed so rested all day and used Benadryl cream to alleviate itching (not used at injection site). 3rd day-top side of inj arm from top of arm to wrist was slightly redder than normal-underneath side of arm ok. As of 10/20/16, symptoms are slowly subsiding.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: BRUISING AND SWELLING ON THE INJECTION SITE.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: PT STATES THAT THE AFTERNOON OF HER HIGH DOSE FLUZONE VACCINE, THAT HER LEFT ARM WAS VERY PAINFUL AND SHE COULD NOT RAISE IT FOR ABOUT 24 HOURS. NO TREATMENT, NEVER CALLED PCP OR HEALTH DEPT TO REPORT.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Client reports swelling, redness, heat in upper part of Left arm after Pneumo vax 23.  Denied seeing PMD re: reaction. Client fully recovered per report and denies any lasting symptoms or effects.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: WARMTH, REDNESS, SWELLING AT THE INJECTION SITE.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Flank pain, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Left thumb began throbbing, sore to the touch, "arthritic pain" type of feeling. Within two days, Left arm and side (beginning under arm, radiating down) began hurting. Could not lay on her side or raise her arm, even currently (2 weeks later).
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle contractions involuntary, Pain in extremity, Paraesthesia
Clinical narrative: Tingling in legs, arms and face on same side as vaccine beginning soon after administration, pain in hand. These worsened with time, and fasciculation of the lower lip on same side developed within 24 hours.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Haematochezia
Clinical narrative: Bloody stool day after and again on 10/18/2016. Mom reported dime size blood in stool.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Fatigue, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Patient was in for appointment with a primary care provider and received the HPV, meningococcal, and the flu vaccines during that appointment. Patient was sitting on the patient couch in the exam room and became pale, diaphoretic, and fainted approximately 1 minute after being given the HPV vaccine. The patient had already received the meningococcal and influenza injectable vaccines a minute prior to receiving the HPV vaccine. The nursing staff and primary care provider responded to the nurse call for assistance within seconds and the patient was already starting to say a few words and was still seated on the couch in the exam room. Patient's father was also present. Patient did not sustain and injuries. Blood pressure was 149/80, pulse 82 with initial assessment at the time of the fainting episode. Patient was assisted to lie down and elevated feet above level of heart. Patient was observed, provided oral fluids and allowed to rest in a supine position over the next hour, patient was able to progress to a sitting position and stand briefly. He was able to drink 2 (6 ounce) cans of apple juice and 3 (8 ounce) cups of water without difficulty. The patient was alert and oriented, with normal color and feeling better, but still very tired out upon discharge to home with father. Patient's vital signs were stable at 118/79 (blood pressure) and 87 (pulse). Patient was escorted by wheelchair with nurse to his father's car and was dismissed to the care of his father. The patient's primary care provider was notified of the patient's stable condition at the time of discharge from the clinic to home. The patient's primary provider was notified of the emergency response actions taken.  The emergency response actions taken were discussed with the family members present at the event.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Patient complaining of radiating pain starting from back of the arm to the neck.
Age: 0.33
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RVX
Symptoms: Abnormal behaviour, Acoustic stimulation tests normal, Aphasia, Decreased eye contact, Hypertonia
Clinical narrative: Stopped all cooing and mimicking. Complete loss of vocalization. Decreased eye contact. Lump on left leg. Mild fever.
Age: 0.33
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RVX
Symptoms: Injection site mass, Pyrexia
Clinical narrative: Stopped all cooing and mimicking. Complete loss of vocalization. Decreased eye contact. Lump on left leg. Mild fever.
Age: 81.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, Redness, mild pain.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling, Sleep disorder
Clinical narrative: Patient's arm was red and swollen.  Hurt the evening of injection. Patient couldn't sleep.  Patient has limited arm movement. Painful, swollen, and red.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Pt. c/o redness and edema of left upper arm starting today. Site feels warm to touch. Left arm is site of Prevnar injection, administered on 10/14/16. Denies insect bites. Denies being outdoors and states she wears long sleeved shirts. Denies scratching area. Pt. reports placing Lidoderm patch on affected area on Saturday morning for arm pain, removed it on Monday and replaced it with a new one. She removed that patch today which is when she noticed erythema of left upper arm. Diagnosis Cellulitis left upper arm. Treatment: Sulfamethoxazole trimethoprim 800-160mg oral 1 tab q12 hours x 14 days. Follow up office visit scheduled 10/21/16.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Cellulitis, Injection site pain
Clinical narrative: Pt. c/o redness and edema of left upper arm starting today. Site feels warm to touch. Left arm is site of Prevnar injection, administered on 10/14/16. Denies insect bites. Denies being outdoors and states she wears long sleeved shirts. Denies scratching area. Pt. reports placing Lidoderm patch on affected area on Saturday morning for arm pain, removed it on Monday and replaced it with a new one. She removed that patch today which is when she noticed erythema of left upper arm. Diagnosis Cellulitis left upper arm. Treatment: Sulfamethoxazole trimethoprim 800-160mg oral 1 tab q12 hours x 14 days. Follow up office visit scheduled 10/21/16.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Redness, Swelling, Feverish, Large area on arm.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: All over body itchy rash; recommended Benadryl PO and present to clinic if no relief.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, warmth to injection site= 4CM, headache, body aches and localized injection site pain and itching.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Pain
Clinical narrative: Redness, swelling, warmth to injection site= 4CM, headache, body aches and localized injection site pain and itching.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Irritability, Papule, Pyrexia, Urticaria
Clinical narrative: Fever to 100.9 (axillary), erythematous wheals and papules on chest, arms, legs, back, patient fussy.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Local swelling, Swelling face, Urticaria
Clinical narrative: Woke up with hives and welt-like swelling on both sides of face and neck, one hive on wrist.
Sex: U
Vaccine: PNC
Symptoms: Granulomatosis with polyangiitis
Clinical narrative: This is a spontaneous report from a contactable pharmacist based on information received by Pfizer from Merck & Co., Inc. (manufacturer control number 00219802). A patient of unspecified age, ethnicity and gender received PREVNAR (lot number and expiration date unspecified), via an unspecified route of administration on an unspecified date as single dose for immunization. The patients medical history and concomitant medications were not reported. The patient experienced Wegener's disease on an unspecified date. Details were as follows: pharmacist reported that a patient who received a dose of PREVNAR "about a year ago" was diagnosed with Wegener's disease on an unspecified date after receiving the vaccine. No further information provided. The action taken with pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) was not applicable. The outcome of Wegener's disease was unknown. No follow-up attempts are possible. No further information is expected. Company clinical evaluation comments Current information is limited for full medical assessment, especially lack of complete medical history and concomitant medications. Based on the information available, the reported event of Wegener's disease more likely represents an inter-current medical condition that is unlikely related to the vaccination with PREVENAR. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Sender's Comments: Current information is limited for full medical assessment, especially lack of complete medical history and concomitant medications. Based on the information available, the reported event of Wegener's disease more likely represents an inter-current medical condition that is unlikely related to the vaccination with PREVENAR. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Body ache, vomiting, fever 103.4.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Myalgia, Pain in extremity
Clinical narrative: Sharp pain in upper arm muscle, back, and lower arm multiple times per day. Pain continues to last and has not lessened in severity. Visited doctor, who recommended 800mg ibuprofen per day. Pain not relieved at this time.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: I woke up with pain in my left upper arm and saw a three inch circular pink/red rash where my shingles shot was given. Also, have had a slight head ache since the shot.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Dysgeusia, Hypertension, Paraesthesia oral, Sensory disturbance
Clinical narrative: Approximately 30 minutes post vaccination, patient experienced metallic taste in mouth. Complained of tongue feeling strange, limbs feeling strange.  Vital signs:  tachycardia, mildly hypertensive. (102-108 BPM, 138/90).  Glucose 100.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia
Clinical narrative: Approximately 30 minutes post vaccination, patient experienced metallic taste in mouth. Complained of tongue feeling strange, limbs feeling strange.  Vital signs:  tachycardia, mildly hypertensive. (102-108 BPM, 138/90).  Glucose 100.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Drug administered at inappropriate site, Inflammation
Clinical narrative: PATIENT RECEIVED TWO INJECTIONS IN ONE ARM AND ARM BECAME INFLAMED.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Limb discomfort, Pain in extremity
Clinical narrative: RED AREA APPROX 2X2 INCHES STARTS ABOUT 4 INCHES BELOW INJECTION SITE; PAIN AND DISCOMFORT IN ARM. RECOMMENDED ICE PACK AND BENADRYL.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash, patient went to Dr and got steroid shot and steroid pack.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling, Skin reaction
Clinical narrative: ARM GIVEN IN BECAME RED, SOMEWHAT SWOLLEN, AND PAINFUL TO THE TOUCH. PATIENT DID NOT CALL THE PHARMACY UNTIL 10-20-16. PATIENT STATED SHE DID NOT SEEK TREATMENT BECAUSE SHE THOUGHT IT WOULD GO AWAY. AND ONLY REPORTED IT TO THE PHARMACY BECAUSE SHE FORGOT SHE HAD 5 LYMPH NODES REMOVED FROM THAT SIDE OF HER BODY AND THINKS THAT'S WHAT LED TO THIS REACTION. I TOLD HER TO USE BENADRYL, ICE TO THE AFFECTED AREA AND TYLENOL FOR ANY PAIN ASSOCIATED WITH IT.
Age: 77.0
Sex: F
Vaccine: MEA, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Below the injection site- redness, slightly raised, itching.  taking benadryl, cool compress, benadryl cream topically.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain at site of injection some mark possible welting.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt with right upper arm red, swollen and hot, mom noticed arm last night iced it but came in until this afternoon. PAC recommended to continue with ice, Benadryl and Ibuprofen as needed, f/u if no improvement of symptoms.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersomnia, Somnolence
Clinical narrative: Profound sleepiness. Fell asleep and slept for several hours. NOT usual for me. Dangerous if I had been driving or at work.
Age: 30.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Nausea, Pain, Swelling, Vomiting
Clinical narrative: Swelling, severe pain, chills, nausea, copious vomiting.
Age: 30.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: White blood cell count increased
Clinical narrative: Swelling, severe pain, chills, nausea, copious vomiting.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Cough, Nausea, Tachycardia, Throat irritation
Clinical narrative: Received a flu vaccination 30 September/Friday and then within several hours began with itching sensation in his throat, coughing and nausea. He reported to the medical group clinic and was found to be tachycardic and presumed to be an early anaphylaxis. He was given epinephrine 0.3 mg IM with significant improvement. 911 was contacted and patient was transported to local ED. In the ED he was primarily observed to be stable and discharged home on oral steroids.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient was complaining of a little soreness at the site on left arm and no redness until the third to fourth day after the immunization. It started to become red and swollen. That is when she went to her primary care physician. Her doctor gave her Keflex, thinking it was an infection and told her after she takes it, if the redness is still spreading that she was to go to the emergency room. Patient only took for three doses and noticed the redness was still spreading and was warm to hot to the touch so she went to the emergency room. She reported that she had no fever, no headaches, but she did feel a bit tired, had a decreased appetite, and mild soreness at the site of the immunization. The redness was raised and blotchy at the site.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Rash macular
Clinical narrative: Patient was complaining of a little soreness at the site on left arm and no redness until the third to fourth day after the immunization. It started to become red and swollen. That is when she went to her primary care physician. Her doctor gave her Keflex, thinking it was an infection and told her after she takes it, if the redness is still spreading that she was to go to the emergency room. Patient only took for three doses and noticed the redness was still spreading and was warm to hot to the touch so she went to the emergency room. She reported that she had no fever, no headaches, but she did feel a bit tired, had a decreased appetite, and mild soreness at the site of the immunization. The redness was raised and blotchy at the site.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hyperhidrosis
Clinical narrative: Pt had weakness and sweating shortly after vaccination with Afluria PF 2016-17.  Ambulance called, most symptoms resolved prior to EMT arrival, pt declined hospital care.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Crying, Decreased appetite
Clinical narrative: After the patient received the Rotavirus oral vaccine, the onset of symptoms started within 6 hours. His abdomen was swollen and solid upon touch. His stomach was rumbling with gas bubbles. He cried none stop for more then 3 hours, and did not want to eat. He vomited all his milk that he would drink, because his stomach was filled with so much gas. The hospital did an x-ray and saw his belly full of tightly condense colic gas. These colic episodes lasted for 3-4 days.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Flatulence, Gastrointestinal sounds abnormal, Vomiting, X-ray abnormal
Clinical narrative: After the patient received the Rotavirus oral vaccine, the onset of symptoms started within 6 hours. His abdomen was swollen and solid upon touch. His stomach was rumbling with gas bubbles. He cried none stop for more then 3 hours, and did not want to eat. He vomited all his milk that he would drink, because his stomach was filled with so much gas. The hospital did an x-ray and saw his belly full of tightly condense colic gas. These colic episodes lasted for 3-4 days.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: PERMANENT SORE ARM--HAS BEEN A MONTH OR SO SINCE GETTING THE VACCINE AND THE ARM IS STILL SORE.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Goitre
Clinical narrative: A GOITER APPEARED BY THE ARMPIT.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Neck pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm red area size of a large dollar, swollen, warm, sore and moving into neck area.
Age: 53.0
Sex: F
Vaccine: MMRV
Symptoms: Musculoskeletal pain, Pain in extremity, Tenderness
Clinical narrative: Sore arm, shoulder and collar bone very tender.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Dizziness, Headache, Nausea, Phonophobia
Clinical narrative: After waking up, had bitemporal headache, nausea, lightheadedness, and abdominal pain.  Associated with photophobia and phonophobia.  No fever or emesis.  Reports had similar symptoms plus fever and emesis after first gardasil shot as well.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Photophobia, Pyrexia, Vomiting
Clinical narrative: After waking up, had bitemporal headache, nausea, lightheadedness, and abdominal pain.  Associated with photophobia and phonophobia.  No fever or emesis.  Reports had similar symptoms plus fever and emesis after first gardasil shot as well.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Condition aggravated, Eczema
Clinical narrative: Extensive widespread flare up of eczema covering back and torso and spreading to proximal regions of extremities. This became noticeable by 6 hours after I received the flu vaccine injection and is continuing to increase and spread ten days later. I have been prescribed and am taking 60 mg prednisone (started on 10/19/16) and 1500 mg Cell Cept.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Eye haemorrhage, Hyperhidrosis, Ocular hyperaemia
Clinical narrative: FEELING LIGHT HEADED. RED EYE. STARTED TO SWEAT. CHECKED HER BLOOD PRESSURE THREE TIMES. SHE STATED SHE HAD NOT EATEN AND DID NOT TAKE HER BLOOD PRESSURE MEDICATIONS. 1ST BP. 180/30, 2ND. 211/181 3RD/ 241 /111 PULSE 66/
Age: 78.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Dizziness
Clinical narrative: PATIENT REPORTED FEELING LIGHT HEADED.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Heart rate increased, Injection site erythema, Mobility decreased, Nausea
Clinical narrative: She could not even lift her arm and had limited mobility- Redness at the site occurred and it grew to about 5 inch in diameter. She experienced a rapid heart rate, fever, and nausea. On 10/19/16 the rash grew to almost her elbow and was hot to the touch - she is currently on antibiotics and was diagnosed with cellulitis - fever is gone but rash is still there.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash, Skin warm
Clinical narrative: She could not even lift her arm and had limited mobility- Redness at the site occurred and it grew to about 5 inch in diameter. She experienced a rapid heart rate, fever, and nausea. On 10/19/16 the rash grew to almost her elbow and was hot to the touch - she is currently on antibiotics and was diagnosed with cellulitis - fever is gone but rash is still there.
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cough, Dyspnoea, Pharyngeal oedema, Swelling face
Clinical narrative: PATIENT REPORTED EXCESSIVE COUGHING, WITH SOME THROAT/FACE SWELLING AND SHORTNESS OF BREATH. INSTRUCTED TO GO TO URGENT CARE OR EMERGENCY ROOM TO SEEK TREATMENT. UPON EXAMINATION WAS GIVEN NAPROXEN, SENT HOME, AND SYMPTOMS RESOLVED AROUND MIDNIGHT THAT NIGHT. PATIENT RECEIVED FLUZONE HD AND ZOSTAVAX VACCINES.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient complained of redness, swelling, intense tenderness to touch at injections site, also redness, tenderness and rash on the inside of arm (opposite of the injection site), also fever of 99.2F, and aches.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pyrexia, Rash
Clinical narrative: Patient complained of redness, swelling, intense tenderness to touch at injections site, also redness, tenderness and rash on the inside of arm (opposite of the injection site), also fever of 99.2F, and aches.
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: Altered state of consciousness, Arthralgia, Dizziness, Fatigue, Injection site pain
Clinical narrative: Tired and sore at injection site:  same day 10/19/2016: Tired, dizzy, feeling like passing out next day  Still sore at injection site and increasingly sore on arms and legs. 10/20/2016: Tired, sore at injection site, increasingly sore arms and legs, pain in right hip when walking.
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: Pain in extremity
Clinical narrative: Tired and sore at injection site:  same day 10/19/2016: Tired, dizzy, feeling like passing out next day  Still sore at injection site and increasingly sore on arms and legs. 10/20/2016: Tired, sore at injection site, increasingly sore arms and legs, pain in right hip when walking.
Age: 72.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Amnesia, Cerebrovascular accident, Dizziness, Headache
Clinical narrative: Pt had remicade tx and felt like he was having a stroke - dizziness, headache, memory loss - same sx as last stroke.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Sore, red, swollen at injection site. Chills, malaise.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Loss of consciousness, Nausea
Clinical narrative: Case number PHEH2016US026739, is an initial spontaneous report received from a consumer on 13 Oct 2016. This report refers to a 41 years old female patient. Medical history and concomitant medications were not reported. Current conditions included allergies to sulfa, cipro and amoxicillin. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 162001) at a dose of 0.5 ml intramuscularly on 13 Oct 2016. On the same day 2 hours after vaccination, the patient passed out for 10 minutes. It was reported that, she also felt clammy and nauseous when it happened. The outcome of the event passed out was unknown and of other events was not reported. The seriousness of the event passed out was reported as non serious by the consumer and of other events was not reported. The causality of the events was not reported. The seriousness assessment of the event loss of consciousness was upgraded to medically significant based on the Novartis Important Medical Event list.
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Skin discolouration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a 87-year-old female patient who received FLUARIX QUADRIVALENT. Previously administered products included Flu vaccine (without issue). Concurrent medical conditions included blood cholesterol increased. Concomitant products included ADVAIR, azelastine, Aspirin, CLARITIN, omeprazole and Pravastatin. On 3rd October 2016, the patient received the 1st dose of FLUARIX QUADRIVALENT .5 ml. On 6th October 2016, 3 days after receiving FLUARIX QUADRIVALENT, the patient experienced cellulitis (serious criteria GSK medically significant), erythema, skin discoloration, swelling and pain in arm. The patient was treated with Antibiotic. On an unknown date, the outcome of the cellulitis, erythema, skin discoloration, swelling and pain in arm were recovering/resolving. The reporter considered the cellulitis, erythema, skin discoloration, swelling and pain in arm to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: This case was previously reported to a doctor. The patient received previous flu vaccine in the past without any issue. The patient received the suspect vaccine in her left arm. On 6th October 2016, the patient developed swelling, which was like fluid filled, red, and sore area about 4 inches below the injection site, but not directly under it. The patient stated that it was black and blue and sore, but she denies hitting her arm or the injection itself being uncomfortable. The patient stated she did go back to the pharmacy and was also seen at an urgent care, who prescribed an antibiotic for concern of a potential cellulitis developing. The patient noted it does appear to be improving at this point. The patient did not know what else could be the cause of events besides the vaccine.
Age: 26.0
Sex: U
Vaccine: FLU4
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: Vaccination site on Right deltoid a circle of erythema the size of a half dollar. Area is warm, firm, tender. Vaccination 10/17/2016 - Redness noted that evening.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Induration, Injection site induration, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Significant swelling in left arm from proximal shoulder to below left elbow, indurated, warm, non tender. Treated with 12 day steroid course.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Significant swelling in left arm from proximal shoulder to below left elbow, indurated, warm, non tender. Treated with 12 day steroid course.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Injection site reaction, Local reaction, Local swelling
Clinical narrative: Within 24 hrs post vaccine, developed local redness and swelling, seen by outside physician on 10/19/16, dx'd w/cellulitis, given ROCEPHIN injection, and KEFLEX 500mg bid x 10 days. On 10/20/16 site of local reaction measures 5"x6" across (R) upper arm.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: Pt felt pain in right shoulder at time of vaccination and has continuously had pain in right shoulder since then to present.
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram, Feeling jittery, Palpitations
Clinical narrative: Received vaccine 10/11/16 - felt jittery and had heart palpations. Went to urgent card on 10/18/16.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Large bruising from right under site of administration down arm approx. 1 inch above elbow. Bruise began 10/7/16 and is still present as of today 10/19/16.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Hyperhidrosis
Clinical narrative: I administered the vaccine, around 30 seconds later his wife tells me he's having trouble breathing. He is red and appears to be sweating. I have 911 called and prepared EPI pen. Pt then begins to recover and is ok by the time EMS arrives.
Age: 50.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypotension, Injection site swelling, Malaise, Pain, Peripheral swelling
Clinical narrative: This spontaneous report received from a medical assistant refers to a 50-year old female patient. The patient had no pertinent medical history but was allergic to CYMBALTA. The patient's concomitant medications included MOBIC, FLONASE, VENTOLIN, ZANTAC, methotrexate (manufacturer unknown), RESTASIS, amitriptyline hydrochloride (manufacturer unknown), PLAQUENIL and estradiol (manufacturer unknown). On 13-Oct-2016, the patient received a dose of PNEUMOVAX 23 intramuscular injection (lot number: M027552; Expiry date: 04-FEB-2018) 0.5 ml in the right arm. On 14-OCT-2016, the patient began feeling achy and was not well. The patient went to the emergency room on 15-OCT-2016 because she was getting worse-her blood pressure got very low, she had a 103 F fever and her right arm, by the injection site and the whole upper arm was swollen. The medical assistant stated that the patient was admitted to a medical center on 17-OCT-2016, as she was not getting any better and did not know why it took so long to admit her. The outcome of the events was reported as not recovered. Causality assessment was not provided. The reporter considered the events to be serious due to hospitalization. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report received from a medical assistant refers to a 50-year old female patient. The patient had no pertinent medical history but was allergic to CYMBALTA. The patient's concomitant medications included MOBIC, FLONASE, VENTOLIN, ZANTAC, methotrexate (manufacturer unknown), RESTASIS, amitriptyline hydrochloride (manufacturer unknown), PLAQUENIL and estradiol (manufacturer unknown). On 13-Oct-2016, the patient received a dose of PNEUMOVAX 23 intramuscular injection (lot number: M027552; Expiry date: 04-FEB-2018) 0.5 ml in the right arm. On 14-OCT-2016, the patient began feeling achy and was not well. The patient went to the emergency room on 15-OCT-2016 because she was getting worse-her blood pressure got very low, she had a 103 F fever and her right arm, by the injection site and the whole upper arm was swollen. The medical assistant stated that the patient was admitted to a medical center on 17-OCT-2016, as she was not getting any better and did not know why it took so long to admit her. The outcome of the events was reported as not recovered. Causality assessment was not provided. The reporter considered the events to be serious due to hospitalization. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypotension, Injection site swelling, Malaise, Pain, Pyrexia
Clinical narrative: This spontaneous report received from a medical assistant refers to a 50-year old female patient. The patient had no pertinent medical history but was allergic to CYMBALTA. The patient's concomitant medications included MOBIC, FLONASE, VENTOLIN, ZANTAC, methotrexate (manufacturer unknown), RESTASIS, amitriptyline hydrochloride (manufacturer unknown), PLAQUENIL and estradiol (manufacturer unknown). On 13-Oct-2016, the patient received a dose of PNEUMOVAX 23 intramuscular injection (lot number: M027552; Expiry date: 04-FEB-2018) 0.5 ml in the right arm. On 14-OCT-2016, the patient began feeling achy and was not well. The patient went to the emergency room on 15-OCT-2016 because she was getting worse-her blood pressure got very low, she had a 103 F fever and her right arm, by the injection site and the whole upper arm was swollen. The medical assistant stated that the patient was admitted to a medical center on 17-OCT-2016, as she was not getting any better and did not know why it took so long to admit her. The outcome of the events was reported as not recovered. Causality assessment was not provided. The reporter considered the events to be serious due to hospitalization. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypotension, Injection site swelling, Malaise, Pain, Peripheral swelling
Clinical narrative: This spontaneous report received from a medical assistant refers to a 50-year old female patient. The patient had no pertinent medical history but was allergic to CYMBALTA. The patient's concomitant medications included MOBIC, FLONASE, VENTOLIN, ZANTAC, methotrexate (manufacturer unknown), RESTASIS, amitriptyline hydrochloride (manufacturer unknown), PLAQUENIL and estradiol (manufacturer unknown). On 13-OCT-2016, the patient received a dose of PNEUMOVAX 23 intramuscular injection (lot number: M027552; Expiry date: 04-FEB-2018) 0.5 ml in the right arm. On 14-OCT-2016, the patient began feeling achy and was not well. The patient went to the emergency room on 15-OCT-2016 because she was getting worse-her blood pressure got very low, she had a 103 F fever and her right arm, by the injection site and the whole upper arm was swollen. The medical assistant stated that the patient was admitted to a medical center on 17-OCT-2016, as she was not getting any better and did not know why it took so long to admit her. The outcome of the events was reported as not recovered. Causality assessment was not provided. The reporter considered the events to be serious due to hospitalization. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report received from a medical assistant refers to a 50-year old female patient. The patient had no pertinent medical history but was allergic to CYMBALTA. The patient's concomitant medications included MOBIC, FLONASE, VENTOLIN, ZANTAC, methotrexate (manufacturer unknown), RESTASIS, amitriptyline hydrochloride (manufacturer unknown), PLAQUENIL and estradiol (manufacturer unknown). On 13-OCT-2016, the patient received a dose of PNEUMOVAX 23 intramuscular injection (lot number: M027552; Expiry date: 04-FEB-2018) 0.5 ml in the right arm. On 14-OCT-2016, the patient began feeling achy and was not well. The patient went to the emergency room on 15-OCT-2016 because she was getting worse-her blood pressure got very low, she had a 103 F fever and her right arm, by the injection site and the whole upper arm was swollen. The medical assistant stated that the patient was admitted to a medical center on 17-OCT-2016, as she was not getting any better and did not know why it took so long to admit her. The outcome of the events was reported as not recovered. Causality assessment was not provided. The reporter considered the events to be serious due to hospitalization. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypotension, Injection site swelling, Malaise, Pain, Pyrexia
Clinical narrative: This spontaneous report received from a medical assistant refers to a 50-year old female patient. The patient had no pertinent medical history but was allergic to CYMBALTA. The patient's concomitant medications included MOBIC, FLONASE, VENTOLIN, ZANTAC, methotrexate (manufacturer unknown), RESTASIS, amitriptyline hydrochloride (manufacturer unknown), PLAQUENIL and estradiol (manufacturer unknown). On 13-OCT-2016, the patient received a dose of PNEUMOVAX 23 intramuscular injection (lot number: M027552; Expiry date: 04-FEB-2018) 0.5 ml in the right arm. On 14-OCT-2016, the patient began feeling achy and was not well. The patient went to the emergency room on 15-OCT-2016 because she was getting worse-her blood pressure got very low, she had a 103 F fever and her right arm, by the injection site and the whole upper arm was swollen. The medical assistant stated that the patient was admitted to a medical center on 17-OCT-2016, as she was not getting any better and did not know why it took so long to admit her. The outcome of the events was reported as not recovered. Causality assessment was not provided. The reporter considered the events to be serious due to hospitalization. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Anaphylactic reaction, Injection site pruritus, Rash, Sneezing
Clinical narrative: Anaphylaxis within 5 minutes of vaccine. Itchy at local site. Within 15 minutes developed diffuse rash, sneezing. Sent to Emergency Room received epinephrine, BENADRYL, SINGULAIR, IVF.
Age: 18.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Chills, Injection site pain, Injection site rash, Pain
Clinical narrative: Rash (R) deltoid injection site area. Pain at injection site, chills, body aches.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Swollen tongue
Clinical narrative: R eye swollen on Tuesday night after shot, resolved. Tongue swollen, which started Wednesday night, ongoing.
Age: 78.0
Sex: M
Vaccine: PPV, TD
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Swelling at injection site and fever-contact patient for more info.
Age: 1.5
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Rash maculo-papular
Clinical narrative: 5-7 days after receiving vaccine, generalized macular papular rash.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal X-ray, Abdominal pain upper, Haemoglobin, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Stomach pain - immediate localized erythema - L upper arm, started same day given.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Neutrophil count, Platelet disorder, White blood cell count
Clinical narrative: Stomach pain - immediate localized erythema - L upper arm, started same day given.
Age: 75.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, pain, itching at site date after injection, slowly subsided.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Child developed a rash after )a few hours) receiving the seasonal Flu shot at school. Was given BENADRYL by the school nurse. Went to private Dr after school. Is back in school.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Patient developed welts at injection site.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 46-year-old female patient who received FLUARIX QUADRIVALENT (batch number 7FF3N, expiry date 30th June 2017. This case was associated with a product complaint. Concomitant products included FAMVIR. On 11th October 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) 0.5 ml. On 12th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced site swelling, injection site warmth and injection site erythema. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema and pharmaceutical product complaint were unknown. The reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT on right deltoid and experienced swelling, redness, and warm to touch feeling at injection site. The patient required the emergency room visit. Filing related QA since health care professional felt as though events could be due to a specific lot. This case has been linked with case US2016150970 as reported by same reporter.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Product quality issue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 42-year-old female patient who received FLUARIX QUADRIVALENT (batch number 7FF3N, expiry date 30th June 2017). This case was associated with a product complaint. Concomitant products included ZADITOR Eye Drops. On 10th October 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) 0.5 ml. On 11th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling, injection site warmth and injection site erythema. On an unknown date, the patient experienced pharmaceutical product complaint. The patient was treated with sulphamethoxazole, BACTRIM. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema and pharmaceutical product complaint were unknown. The reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient experienced swelling, redness, and warm to touch feeling at injection site. The patient required the emergency room visit. It was reported that the related QA was filed since health care professional felt as though events could be due to a specific lot. The patient went to doctor and was prescribed BACTRIM. The health care professional confirmed no infection was present. This case has been linked with case US2016150857 as reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of tingling of extremity, numbness of upper extremities and muscle pain. On an unknown date, the outcome of the tingling of extremity and muscle pain were unknown and the outcome of the numbness of upper extremities was not recovered/not resolved. It was unknown if the reporter considered the tingling of extremity, numbness of upper extremities and muscle pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reporter. The patient received FLUARIX QUADRIVALENT in her left deltoid and experienced tingling, numbness, muscle pain on left arm. The batch number of the vaccine was unknown. No other information was provided by the reporter.
Age: 70.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Soon after (day after) injection, redness, swelling, subjective fever.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Body temperature increased, Drug administered at inappropriate site, Erythema, Pain, Skin warm
Clinical narrative: Had both Flu and PPSV 23 given in lf arm in 24hrs, has had swelling, warmth, redness, pain, low grade temp.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Swelling
Clinical narrative: Had both Flu and PPSV 23 given in lf arm in 24hrs, has had swelling, warmth, redness, pain, low grade temp.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to the touch.
Age: 61.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Joint swelling, Neutrophil count increased, Rheumatoid factor positive, White blood cell count increased
Clinical narrative: Swelling of joints in entire body. Patient reports high levels of RA in test.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Urticaria
Clinical narrative: Pt developed rash at injection site and hives on heads and neck. She visited her dermatologist and took an antihistamine. Reaction resolved.
Age: 1.0
Sex: F
Vaccine: FLU4, HIBV, PNC13
Symptoms: Breath holding, Chest X-ray normal, Crying, Dyspnoea, Eye movement disorder
Clinical narrative: RN gave vaccines in left thigh. Pt held her breath. RN blew in face to get her to breathe. Pt took large gasp then went limp, with eyes deviating, not breathing for approx 3 seconds. Took breath and had another episode. Kept crying after. Vs WNL. Monitored pt for 1.75hrs.
Age: 1.0
Sex: F
Vaccine: FLU4, HIBV, PNC13
Symptoms: Hypotonia
Clinical narrative: RN gave vaccines in left thigh. Pt held her breath. RN blew in face to get her to breathe. Pt took large gasp then went limp, with eyes deviating, not breathing for approx 3 seconds. Took breath and had another episode. Kept crying after. Vs WNL. Monitored pt for 1.75hrs.