chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Eye movement disorder, Skin warm, Unresponsive to stimuli
Clinical narrative: Patient began having chills, patient's mother noticed she was burning up. Patient went non  responsive for approximately 1 minute during which her eyes rolled back. Epinephrine was not administered due to patient becoming responsive with no difficulties breathing. EMS was called and patient left under her own power. Patient declined EMS transport to hospital.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Rash
Clinical narrative: Severe rash left axilla, right and left groin. Treated with IV prednisone and pain medicine. Hospitalized overnight beginning 48 hrs after vaccine administration.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Computerised tomogram, Eyelid function disorder, Facial paralysis
Clinical narrative: 6 hours after receiving my flu shot developed left sided facial paralysis, mouth drooping, unable to close my eye. Diagnosed the next morning with Bells Palsy by Dr at Urgent Care.
Age: 0.33
Sex: M
Vaccine: IPV, PNC13, UNK
Symptoms: Blood culture negative, CSF culture negative, Computerised tomogram head normal, Crying, Culture urine negative
Clinical narrative: PATIENT DEVELOPED EPISODES OF INCONSOLABLE CRYING WHERE HIS EYES ARE CLOSED SHUT AND THERE IS SPONTANEOUS MOVEMENTS OF THE EXTREMITIES. PER FAMILY, BABY WAS UNRESPONSIVE TO VERBAL STIMULI AND ONE OR TWO TIMES HAD RIGHTWARD DEVIATION OF THE EYES OR THE EYES WERE ROLLED BACK. EPISODES OCCUR MORE FREQUENTLY DURING THE DAY AND RARELY AT NIGHT. BABY HAD NO POSTICTAL STATE. RETURNS TO NEUROLOGICAL BASELINE AFTER THE EPISODE RESOLVES. EPISODES LAST MAX 10 MINUTES. BABY ABLE TO TOLERATE FEEDS AND NO CHANGES IN STOOL OR URINE OUTPUT. BABY HAD A FEVER ON 10/5/17 BUT NONE WHILE ADMITTED SINCE 10/7/17.
Age: 0.33
Sex: M
Vaccine: IPV, PNC13, UNK
Symptoms: Dyskinesia, Electroencephalogram, Eye movement disorder, Eyelid oedema, Gaze palsy
Clinical narrative: PATIENT DEVELOPED EPISODES OF INCONSOLABLE CRYING WHERE HIS EYES ARE CLOSED SHUT AND THERE IS SPONTANEOUS MOVEMENTS OF THE EXTREMITIES. PER FAMILY, BABY WAS UNRESPONSIVE TO VERBAL STIMULI AND ONE OR TWO TIMES HAD RIGHTWARD DEVIATION OF THE EYES OR THE EYES WERE ROLLED BACK. EPISODES OCCUR MORE FREQUENTLY DURING THE DAY AND RARELY AT NIGHT. BABY HAD NO POSTICTAL STATE. RETURNS TO NEUROLOGICAL BASELINE AFTER THE EPISODE RESOLVES. EPISODES LAST MAX 10 MINUTES. BABY ABLE TO TOLERATE FEEDS AND NO CHANGES IN STOOL OR URINE OUTPUT. BABY HAD A FEVER ON 10/5/17 BUT NONE WHILE ADMITTED SINCE 10/7/17.
Age: 0.33
Sex: M
Vaccine: IPV, PNC13, UNK
Symptoms: Pyrexia, Skeletal survey normal, Ultrasound abdomen normal, Unresponsive to stimuli, White blood cell count normal
Clinical narrative: PATIENT DEVELOPED EPISODES OF INCONSOLABLE CRYING WHERE HIS EYES ARE CLOSED SHUT AND THERE IS SPONTANEOUS MOVEMENTS OF THE EXTREMITIES. PER FAMILY, BABY WAS UNRESPONSIVE TO VERBAL STIMULI AND ONE OR TWO TIMES HAD RIGHTWARD DEVIATION OF THE EYES OR THE EYES WERE ROLLED BACK. EPISODES OCCUR MORE FREQUENTLY DURING THE DAY AND RARELY AT NIGHT. BABY HAD NO POSTICTAL STATE. RETURNS TO NEUROLOGICAL BASELINE AFTER THE EPISODE RESOLVES. EPISODES LAST MAX 10 MINUTES. BABY ABLE TO TOLERATE FEEDS AND NO CHANGES IN STOOL OR URINE OUTPUT. BABY HAD A FEVER ON 10/5/17 BUT NONE WHILE ADMITTED SINCE 10/7/17.
Age: 1.42
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Rash erythematous
Clinical narrative: Decreased appetite and red spots on body.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Eye contusion, Full blood count, Platelet count normal
Clinical narrative: Received shot on 09/29/17, on 10/01/17 had black right eye, on 10/02/17 had left black eye around 3:00pm. Came into work and other associates noticed his left eye was black.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: The patient had an injection site reaction (itchy, pink rash/welt), the patient got a script for KEFLEX as she thought it was cellulitis. Her arm is now fine.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Pain at site.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient fainted immediately upon receiving vaccine and then woke up immediately. 911 was called and paramedics came to take vital signs, etc. They determined the patient was anxious from seeing the needle and fainted. Pt has had no reaction to a vaccine in the past. Pt was allowed to go home with his father and did not need to be transported to the hospital.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Myalgia
Clinical narrative: MUSCLE ACHES, SORENESS, AND TENDER AT INJECTION SITE.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Herpes zoster, Inflammation, Labyrinthitis, Neuralgia
Clinical narrative: Developed painful, itchy rash on right side of abdomen (across rib cage) approximately 10 days after receiving flu vaccination. Rash became more inflamed, painful, and spread. Sought medical attention within 2 days. Dermatologist confirmed the rash as shingles.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash, Rash pruritic
Clinical narrative: Developed painful, itchy rash on right side of abdomen (across rib cage) approximately 10 days after receiving flu vaccination. Rash became more inflamed, painful, and spread. Sought medical attention within 2 days. Dermatologist confirmed the rash as shingles.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Since 9/23/2017, I have had severe L arm pain which affected upper body dressing and sleep. Today 10/9 pain is significantly less but still present during L arm movement.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Red, swollen arm on left side 10 cm by 7 cm, tender to touch and warm.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient experienced 24 hours of fever spiking to 101 degrees and nausea and vomiting and dizziness.
Age: 35.0
Sex: F
Vaccine: PNC13
Symptoms: Chest pain, Chills, Cough, Fatigue, Headache
Clinical narrative: Patient received the PREVNAR 13 on Friday and began to feel fatigued by that evening. By Saturday she began experiencing chest and nasal congestion, coughing, fever, chills, headache, and nausea with 3 episodes of vomiting. These symptoms have continued through Monday (the present time), although she reports that the fever and chills have abated.
Age: 35.0
Sex: F
Vaccine: PNC13
Symptoms: Nasal congestion, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient received the PREVNAR 13 on Friday and began to feel fatigued by that evening. By Saturday she began experiencing chest and nasal congestion, coughing, fever, chills, headache, and nausea with 3 episodes of vomiting. These symptoms have continued through Monday (the present time), although she reports that the fever and chills have abated.
Age: 65.0
Sex: M
Vaccine: FLUC4
Symptoms: Myalgia
Clinical narrative: SORENESS AND TENDERNESS IN THE MUSCLES.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Anaphylactic reaction, Injection site rash, Pruritus
Clinical narrative: Patient presented to pharmacy with a rash on her left arm around the area of the injection. She was not having any issues breathing or symptoms of anaphylaxis, just an annoying rash. She has taken benadryl without any relief so she will be contacting her doctor for a prescription to help with the itching.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Electrocardiogram normal, Syncope
Clinical narrative: Experienced a syncopal episode about 8 hours after vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Patient describes a red irritated ring approximately 5 inches in diameter radiating from the injection site. Patient applied lavender ointment and was recovering. Patient stated the irritation was subsiding.
Age: 33.0
Sex: M
Vaccine: YF
Symptoms: Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Pt received yellow fever (Stamaril) on 9/27/2017. On 10/4/2017 pt reports symptoms of tiredness, muscle ache and headache. On 10/5/2017 pt reported he woke up sweating profusely. He was seen by his primary care on 10/6/2017. No diagnosis- per pt it was a normal reaction from the vaccine. No medication or labs works done. Symptoms all resolved by Saturday 10/7/2017.
Age: 71.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Syncope
Clinical narrative: The patient received the vaccination, then stated she was feeling light headed. She was given water to drink and then she fainted. 911 was called and she was taken to a local hospital.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Bone pain, Mobility decreased, Pain in extremity
Clinical narrative: Extreme pain from collar bone to finger tips on left side. Very difficult to move.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Erythema, Feeling hot, Flushing, Palpitations
Clinical narrative: Following her injection with the influenza vaccine FLUCELVAX-QUADRIVALENT, with a Lot no. 195220, she described experiencing: Some slight tingling in her tongue and a feeling of hot in her arm region. Thereafter, she got lightheaded and dizzy and felt flushed. She felt like her heart was racing and her whole body was hot, although she did not have a fever. Thereafter her arm got red and swollen, which was about 45 minutes later. Subsequently, she went to urgent care, and they administered BENADRYL, and watched her for some time. She did get better, and went home and fell asleep. Over the weekend, she described being itchy in her skin, which has abated some, but she still has some slight itchiness increased, over normal.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia oral, Peripheral swelling, Pruritus
Clinical narrative: Following her injection with the influenza vaccine FLUCELVAX-QUADRIVALENT, with a Lot no. 195220, she described experiencing: Some slight tingling in her tongue and a feeling of hot in her arm region. Thereafter, she got lightheaded and dizzy and felt flushed. She felt like her heart was racing and her whole body was hot, although she did not have a fever. Thereafter her arm got red and swollen, which was about 45 minutes later. Subsequently, she went to urgent care, and they administered BENADRYL, and watched her for some time. She did get better, and went home and fell asleep. Over the weekend, she described being itchy in her skin, which has abated some, but she still has some slight itchiness increased, over normal.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray abnormal, Pneumonia
Clinical narrative: Patient received the PREVNAR and High Dose Flu shot and they have developed a pneumonia requiring admission to hospital several days following the vaccines. They feel this caused the pneumonia and have demanded reporting to the CDC despite education on the vaccines.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient complaining of redness, itching, increased skin temperature, and swelling about 3 inches around site of injection. Advised patient to try benadryl to counteract the supposed allergic reaction. Also advised patient to seek medical attention if condition does not improve or worsens - patient has a history of cellulitis following allergic reactions.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Received the flu vaccine at work in the left arm. Within 48 hours after vaccine, a rash appeared on the left lower back.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Pain, Tremor
Clinical narrative: Patient experienced shaking, aching and terrible headache. Patient's wife expressed if the medication had mercury in it. The patient went to Doctor and Dr suggested patient to take Tylenol. I spoke to patient and he feels better now.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Immediate pain in left shoulder and continued pain without resolving especially when abducting and backward rotation.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Chills, Feeling abnormal, Feeling cold, Gait disturbance, Headache
Clinical narrative: Patient woke up freezing under her covers and was shaking, she tried to get warmer and realized she must have a fever because she couldn't get warmer. She felt her face with her hands and it was burning up so she knew she had a fever. She got up to take TYLENOL for the fever. When getting out of bed, she was shaking violently from the chills more than she had before and could hardly walk. She got to the TYLENOL and dropped some and after she had taken 2, she headed back to the bed, still wobbly from the chills and eventually went back to sleep. The next morning she woke up with a headache and felt awful and took 2 more doses of TYLENOL and felt okay by the next evening.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Pyrexia, Skin warm, Tremor
Clinical narrative: Patient woke up freezing under her covers and was shaking, she tried to get warmer and realized she must have a fever because she couldn't get warmer. She felt her face with her hands and it was burning up so she knew she had a fever. She got up to take TYLENOL for the fever. When getting out of bed, she was shaking violently from the chills more than she had before and could hardly walk. She got to the TYLENOL and dropped some and after she had taken 2, she headed back to the bed, still wobbly from the chills and eventually went back to sleep. The next morning she woke up with a headache and felt awful and took 2 more doses of TYLENOL and felt okay by the next evening.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema
Clinical narrative: Patient presented to pharmacy with excessive redness of upper arm below the injection site spreading to forearm; interestingly, there was no apparent redness around the injection site.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Breath sounds abnormal, Headache, Rhinorrhoea
Clinical narrative: Night of imz, patient got a runny nose. Then in the morning around 4 AM patient had a headache and took tylenol. The tylenol did help. Symptoms continued to worsen to raspiness in the lungs. Patient went to see the doctor today and was prescribed ProAir inhaler.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Rash, Skin tightness, Skin warm
Clinical narrative: Patient stated rash (softball size) warm and tight. Talked to patient 5 days post administration and she states moved down to elbow and feels like it is "getting better". Counseled patient to ice, use an antihistamine and can use TYLENOL. Patient also states soreness is gone.
Age: 78.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Contusion
Clinical narrative: Patient experienced a "deep bruise" that was still present 2 weeks after.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Dermatitis, Pain, Rash erythematous
Clinical narrative: Dermatitis. She had a red enlarged rash from her elbow to her shoulder. She came in on Thursday the 5th and still had the rash. Pt said it hurt.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse event, was given DTaP instead of Dtap.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient  went to the urgent care the day following the PNEUMOVAX vaccination at approximately 5pm on 10/3/17. She was experiencing redness, swelling and heat on her upper left arm from the area where the shot was given down to the elbow. Patient stated that she started having pain in the arm the previous evening and had trouble sleeping, but woke up with the redness and swelling. Dr determined that she had cellulitis and put her on Cephalexin 500mg 2 capsules twice daily for 7 days. Spoke with patient on 10/5/17 at about 11am and she stated that she had been fatigued, but the redness was resolving and she was feeling better.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Patient  went to the urgent care the day following the PNEUMOVAX vaccination at approximately 5pm on 10/3/17. She was experiencing redness, swelling and heat on her upper left arm from the area where the shot was given down to the elbow. Patient stated that she started having pain in the arm the previous evening and had trouble sleeping, but woke up with the redness and swelling. Dr determined that she had cellulitis and put her on Cephalexin 500mg 2 capsules twice daily for 7 days. Spoke with patient on 10/5/17 at about 11am and she stated that she had been fatigued, but the redness was resolving and she was feeling better.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Paraesthesia
Clinical narrative: Patient came in today (10/9/17) and complaining of severe pain in the upper right arm where the shot was given. She said she couldn't move the arm. But there is no swelling or redness at the site of the injection. She also complained of tingling in  the lower arm occasionally when she moved her fingers and arm. I advised patient to use TYLENOL and can use ice pack as needed to get relief from pain.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient reports soreness in arm with limited range of motion for over 2 weeks. Also describes feeling of something still in arm. Pain when arm is raised.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Soreness, painful, unable to move or use for the past 3 days.
Age: 1.42
Sex: F
Vaccine: VARCEL
Symptoms: Decreased appetite, Injection site erythema, Injection site rash, Irritability, Lethargy
Clinical narrative: Fever, lethargy, loss of appetite, growing red raised rash at injection site, and increased fussiness.
Age: 1.42
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever, lethargy, loss of appetite, growing red raised rash at injection site, and increased fussiness.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Nausea, Paraesthesia, Syncope
Clinical narrative: Patient experienced lightheadedness, sweating, nausea, blurry vision, fainting, and tingling in hands.  Administered vaccine to patient then going to administer to her husband. She said she felt dizzy, I had her sit down for a few minutes. I administered flu shot to her husband and and they proceeded to leave. She felt dizzy and fainted in the store on the way out, her husband was holding her so she did not injure herself. We laid her on the floor for a few moments the had her sit in a chair for about 20 minutes and gave her some water. She had not eaten much this morning. She tensed up when gave her the vaccine and she said she felt it going in. After the 20 minutes in the chair she said she felt better and  we helped her to the car and they drove home. I recommended they contact the doctor or go to the walk in clinic if she didn't feel better. I contacted the house and spoke to the husband about 3:00pm and he said that she was better.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Patient experienced lightheadedness, sweating, nausea, blurry vision, fainting, and tingling in hands.  Administered vaccine to patient then going to administer to her husband. She said she felt dizzy, I had her sit down for a few minutes. I administered flu shot to her husband and and they proceeded to leave. She felt dizzy and fainted in the store on the way out, her husband was holding her so she did not injure herself. We laid her on the floor for a few moments the had her sit in a chair for about 20 minutes and gave her some water. She had not eaten much this morning. She tensed up when gave her the vaccine and she said she felt it going in. After the 20 minutes in the chair she said she felt better and  we helped her to the car and they drove home. I recommended they contact the doctor or go to the walk in clinic if she didn't feel better. I contacted the house and spoke to the husband about 3:00pm and he said that she was better.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Skin discolouration
Clinical narrative: Patient contacted the pharmacy on 10/09/2017 @ approximately 10:00 AM complaining of dark spots no her knees that she says appeared the day after she received her vaccination on 10/05/2017. The spots themselves are discolorations and not inflamed or giving the appearance of a rash. Patient says that the spots do hurt at night w/ sharp pain. While I do not believe this reaction is stemming from her pneumonia vaccine administration, I am reporting to VAERS system as she is convinced that it is. I recommmended that the patient consults with a physician and especially if the condition worsens.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Nausea, Pain
Clinical narrative: About 12 hours after receiving the flu vaccine I woke up in the middle of the night with chills, body soreness, nausea, and diarrhea. They persisted for about 24 hours.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Reported to me on 10/9 Redness, slight swelling, and low fever.
Age: 72.0
Sex: M
Vaccine: FLUC4
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient called the next day and said there was no reaction at injection site but that arm was warm to the touch with swelling below the elbow. patient was referred to their doctor.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Chest pain, Dizziness, Erythema, Feeling abnormal
Clinical narrative: Within 2 minutes of administering vaccination the patient's face turned bright red, right arm was weak and patient had chest pain/tightness her mother called for us I seen her face and her holding her chest and had my technician call 911 patient was still able to talk and breathe but did not feel good. By the time firefighter and paramedics arrived patient was feeling better just lightheaded, she was checked out by paramedics and given the option if she wanted to go to the hospital or home. She said she was feeling better and did not need to they were going to hook her up to the EKG in the ambulance then let her go.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Muscular weakness
Clinical narrative: Within 2 minutes of administering vaccination the patient's face turned bright red, right arm was weak and patient had chest pain/tightness her mother called for us I seen her face and her holding her chest and had my technician call 911 patient was still able to talk and breathe but did not feel good. By the time firefighter and paramedics arrived patient was feeling better just lightheaded, she was checked out by paramedics and given the option if she wanted to go to the hospital or home. She said she was feeling better and did not need to they were going to hook her up to the EKG in the ambulance then let her go.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Pallor
Clinical narrative: Administered flu shot to patient, patient sat at pharmacy for at least 5 mins while his dad was picking up his prescription. After they walked away from pharmacy, patient fell one time hear produce dept and again at floral dept. Dad was with him the whole time. Patient appeared pale skined, nothing noticeably different prior to and after vaccination. Patient never had a reaction to the flu vaccine in the past.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Shortly after getting the vaccine arm became swollen, hot, red, hard to the touch. Last night and this morning the redness started to spread to the elbow. Redness has spread to elbow and around the arm - biceps and triceps. Redness has spread below the vaccine site. Has not taken any oral medications or taken any other actions to alleviate issue.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin decreased
Clinical narrative: Presented to ED 10/9/17 for fever and rash. Had a simple febrile seizure in the ED. Admitted to the hospital for observation. Treatment was supportive (Tylenol, fluids). Event report submitted upon admission to the hospital (anticipate discharge tomorrow, but TBD depending how the night goes).
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal
Clinical narrative: Presented to ED 10/9/17 for fever and rash. Had a simple febrile seizure in the ED. Admitted to the hospital for observation. Treatment was supportive (Tylenol, fluids). Event report submitted upon admission to the hospital (anticipate discharge tomorrow, but TBD depending how the night goes).
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Blood sodium normal, Blood urea normal, Carbon dioxide normal, Chest X-ray normal, Differential white blood cell count normal
Clinical narrative: Presented to ED 10/9/17 for fever and rash. Had a simple febrile seizure in the ED. Admitted to the hospital for observation. Treatment was supportive (Tylenol, fluids). Event report submitted upon admission to the hospital (anticipate discharge tomorrow, but TBD depending how the night goes).
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Haematocrit normal, Haemoglobin normal, Platelet count normal, Protein total normal
Clinical narrative: Presented to ED 10/9/17 for fever and rash. Had a simple febrile seizure in the ED. Admitted to the hospital for observation. Treatment was supportive (Tylenol, fluids). Event report submitted upon admission to the hospital (anticipate discharge tomorrow, but TBD depending how the night goes).
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Streptococcus test negative, White blood cell count normal
Clinical narrative: Presented to ED 10/9/17 for fever and rash. Had a simple febrile seizure in the ED. Admitted to the hospital for observation. Treatment was supportive (Tylenol, fluids). Event report submitted upon admission to the hospital (anticipate discharge tomorrow, but TBD depending how the night goes).
Age: 77.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth of left upper arm and shoulder.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Pyrexia, Rash, Wheezing
Clinical narrative: Rash that progressively got worse and spread to face, trunk, arms and slightly on both legs. Rash took nearly 3 weeks to go away. Low grade fevers. Wheezing started on 8/31 requiring albuterol breathing treatments.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Swelling
Clinical narrative: Pt had localized swelling from elbow to shoulder and reported nausea and dizziness.
Sex: F
Vaccine: FLU4
Symptoms: Blister, Erythema, Injection site pruritus, Photosensitivity reaction
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of skin red in a adult female patient who received FLULAVAL QUADRIVALENT. Concurrent medical conditions included drug allergy. Concomitant products included Losartan, XYZAL, COQ10, Red Rice Yeast Extract, SYNTHROID and glucosamine. On 12th September 2017, the patient received FLULAVAL QUADRIVALENT. On 12th September 2017, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced skin red, injection site itching, blister and photosensitivity. On 17th September 2017, the outcome of the skin red, injection site itching, blister and photosensitivity were recovered/resolved. The reporter considered the skin red, injection site itching and blister to be related to FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the photosensitivity to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. At the injection site, the patient's skin was itchy. The patient was exposed to the sun on the same day and had photosensitivity. The patient experienced redness on the face, neck and chest. Between the 12th September 2017 and 17th September 2017, when the patient had redness of the skin, she also developed blisters on her ears and neck. The physician gave consent to reach out to her office manager, if she was to be contacted.
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site wheal in a patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site wheal, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site wheal, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site wheal, injection site pain and injection site swelling to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The age at vaccination was not reported. The sales representative believed that the flu vaccine received by the patient was the FLULAVAL QIV Pre Filled Syringe. The patient complained of a 2 inch welt, soreness, and swelling at the injection site. The sales representative had no patient identifies or lot and expiration date of the vaccine. The health care professional could be contacted directly for further information. This was one of the cases, reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site wheal in a patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site wheal, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site wheal, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site wheal, injection site pain and injection site swelling to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The sales representative believed that the flu vaccine received by the patient was the FLULAVEL QIV Pre Filled Syringe. The patient complained of a 2 inch welt, soreness, and swelling at the injection site. The sales representative had no patient identifiers or lot and expiration date of the vaccine. The health care professional could be contacted directly for further information. This was one of the 5 cases, reported by the same reporter.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Patient did not have any pain or discomfort at time of administration. That night patient had pain in injection site. The next day the patient when to primary care doctor about the pain and some numbness in his arm.
Sex: U
Vaccine: FLU4
Symptoms: Local reaction
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of local reaction in an unspecified number of patients who received FLULAVAL Quadrivalent. On an unknown date, the patient received FLULAVAL Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FLULAVAL Quadrivalent, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was unknown. It was unknown if the reporter considered the local reaction to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: The age at vaccination of the patients was not reported. The healthcare professional stated that, several patients had a local reaction to the vaccine. On the reporting date, the healthcare professional reported this information to VAERS as well. However, the field representative was unaware that the information needed to be reported to GSK (GlaxoSmithKline) in addition to what was reported to VAERS. No further information was reported regarding the event.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Blood iron decreased, Blood test, Computerised tomogram head, Electrocardiogram, Feeling hot
Clinical narrative: At 4AM on 10/3/17, pt felt sick to her stomach, passed out, went to Emergency Room, stated iron was low. Next day 10/4/17, went to another ER, feeling hot and increased HR. That day received IVF. Pt was started on iron tablets.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased, Loss of consciousness, Nausea
Clinical narrative: At 4AM on 10/3/17, pt felt sick to her stomach, passed out, went to Emergency Room, stated iron was low. Next day 10/4/17, went to another ER, feeling hot and increased HR. That day received IVF. Pt was started on iron tablets.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Cough, Croup infectious, Febrile convulsion, Neurological examination normal, Speech disorder
Clinical narrative: On 5/29/17 (3 wks after vaccines) infant had apparent febrile seizure, associated with croup. He was seen at ER with stridor and cough noted. Parent concern that his speech is less than older site.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Stridor
Clinical narrative: On 5/29/17 (3 wks after vaccines) infant had apparent febrile seizure, associated with croup. He was seen at ER with stridor and cough noted. Parent concern that his speech is less than older site.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Aphasia, Autism spectrum disorder, Cyanosis, Malaise
Clinical narrative: On 5/29/17 (3 wks after vaccines) infant had apparent febrile seizure, associated with croup. He was seen at ER with stridor and cough noted. Parent concern that his speech is less than older site.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Respiratory arrest, Seizure, Speech disorder, Toe walking, Tonsillar hypertrophy
Clinical narrative: On 5/29/17 (3 wks after vaccines) infant had apparent febrile seizure, associated with croup. He was seen at ER with stridor and cough noted. Parent concern that his speech is less than older site.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Vaccination complication
Clinical narrative: On 5/29/17 (3 wks after vaccines) infant had apparent febrile seizure, associated with croup. He was seen at ER with stridor and cough noted. Parent concern that his speech is less than older site.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Body temperature increased, Febrile convulsion, Tongue ulceration
Clinical narrative: Pt had generalized febrile seizure on 7/13/17, one day after Hep A vaccine. Temp 101.1 degree in ER. Small cut on tongue noted. Tube in (L) TM. Saw neurology on 9/14/17, developing normally.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Cyanosis, Pyrexia, Respiratory arrest, Seizure
Clinical narrative: Pt had generalized febrile seizure on 7/13/17, one day after Hep A vaccine. Temp 101.1 degree in ER. Small cut on tongue noted. Tube in (L) TM. Saw neurology on 9/14/17, developing normally.
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site wheal in a patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site wheal, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site wheal, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site wheal, injection site pain and injection site swelling to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The sales representative believed that the flu vaccine received by the patient was the FLULAVAL QIV Pre Filled Syringe. The patient complained of a 2 inch welt, soreness, and swelling at the injection site. The sales representative had no patient identifiers or lot and expiration date of the vaccine. The health care professional could be contacted directly for further information. This was one of the 5 cases, reported by the same reporter.
Sex: M
Vaccine: MENB
Symptoms: Feeling abnormal, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced fever, pain and feeling bad. On an unknown date, the outcome of the fever, pain and feeling bad were unknown. It was unknown if the reporter considered the fever, pain and feeling bad to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient had aches and generally felt bad. The healthcare professional did not have any patient information. No further information was provided. This case was linked with the case US2017GSK151115, reported by the same reporter.
Age: 16.0
Sex: M
Vaccine: HPV4, MENB, MNQ
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 16-year-old male patient who received BEXSERO (batch number 16B101, expiry date unknown). Concomitant products included GARDASIL and MENACTRA. On 15th August 2017, the patient received the 1st dose of BEXSERO. On 16th August 2017, 1 days after receiving BEXSERO, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to BEXSERO. Additional details were reported as follows: This case was reported by a medical assistant. On 15th August 2017, the patient received 2nd doses of GARDASIL (batch number: N012043) and MENACTRA (batch number: U5823AB). The patient was not new to these vaccines and did not had a reaction to them. After about 24 hours of vaccination, the patient experienced a 6 by 8 cm erythema at the site of injection. The erythema was not hot to touch. The event lasted a few days. The reporter was transferred to medical information for questions on whether the patient could receive another dose of BEXSERO.
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a adult female patient who received FLUARIX Quadrivalent. Co-suspect products included FLUARIX Quadrivalent. The patient's past medical history included Meniere's disease. On an unknown date, the patient received FLUARIX Quadrivalent 2016-2017 at an unknown dose and FLUARIX Quadrivalent 2017-2018. On an unknown date, less than a year after receiving FLUARIX Quadrivalent 2016-2017 and not applicable after receiving FLUARIX Quadrivalent 2017-2018, the patient experienced dizziness and dizziness. On an unknown date, the outcome of the dizziness was recovered/resolved and the outcome of the dizziness was unknown. It was unknown if the reporter considered the dizziness to be related to FLUARIX Quadrivalent 2016-2017. It was unknown if the reporter considered the dizziness to be related to FLUARIX Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that she experienced dizziness after receiving the FLUARIX vaccine this year and last year. The patient did have a history of Meniere's disease but she did not believe that was responsible for the dizziness she had experienced after the vaccinations. The patient did not want to provided any details of her experience and she refuse to provide demographic information. The patient denied permission to contact her physician.
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site wheal in a patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site wheal, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site wheal, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site wheal, injection site pain and injection site swelling to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The sales representative believed that the flu vaccine received by the patient was the FLULAVAL QIV Pre Filled Syringe. The patient complained on a 2 inch welt, soreness, and swelling at the injection site. The sales representative had no patient identifiers or lot and expiration date of the vaccine. The health care professional could be contacted directly for further information. This was one of the 5 cases, reported by the same reporter.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Rash, redness and swelling at injection site. Began day after and persists 1 week later.
Sex: U
Vaccine: FLU4
Symptoms: Local reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of local reaction in a patient who received FLUARIX TETRA. On an unknown date, the patient received FLUARIX TETRA at an unknown dose. On an unknown date, unknown after receiving FLUARIX TETRA, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was unknown. It was unknown if the reporter considered the local reaction to be related to FLUARIX TETRA. Additional details were provided as follows: This case was reported from a survey that was submitted. The age at vaccination was not reported. The healthcare professional reported minor and major local reactions from administration of GSK pre-filled syringes of FLUARIX. The customer commented on inability to explain why air was in pre-filled syringes by a pharmacist was pretty bleak. The consumer was sent a document that said it was okay to leave air in or remove air was sadly counterproductive causing minor to major local reactions and therefore claims and troubled practitioners because if the poor indecisive responses in verbal and written form.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Anaphylactic reaction, Chest discomfort, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: 5 minutes after flu shot, patient reported dizziness, increased heart rate, shortness of breath, chest tightness, urticaria on chest-pt self injected with EPIPEN, then taken to hospital by EMT for anaphylaxis.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: 5 minutes after flu shot, patient reported dizziness, increased heart rate, shortness of breath, chest tightness, urticaria on chest-pt self injected with EPIPEN, then taken to hospital by EMT for anaphylaxis.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Chills, Cold sweat, Headache, Hyperhidrosis
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 16-year-old female patient who received BEXSERO. On 19th September 2017, the patient received BEXSERO. On 19th September 2017 10:30, 4 hrs after receiving BEXSERO, the patient experienced fever, chills, nausea, headache, pain, knee pain, sweating and clamminess. The patient was treated with ibuprofen. In September 2017, the outcome of the fever, chills, nausea, headache, pain, knee pain, sweating and clamminess were recovered/resolved. It was unknown if the reporter considered the fever, chills, nausea, headache, pain, knee pain, sweating and clamminess to be related to BEXSERO. Additional details were provided as follows: The patient experienced knees hurt. The healthcare professional stated, the patient's mother gave her an ibuprofen and it took all those symptoms away. The HCP reported that, the patient's symptoms were completely gone the next day as well. No further information was provided.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 16-year-old female patient who received BEXSERO. On 19th September 2017, the patient received BEXSERO. On 19th September 2017 10:30, 4 hrs after receiving BEXSERO, the patient experienced fever, chills, nausea, headache, pain, knee pain, sweating and clamminess. The patient was treated with ibuprofen. In September 2017, the outcome of the fever, chills, nausea, headache, pain, knee pain, sweating and clamminess were recovered/resolved. It was unknown if the reporter considered the fever, chills, nausea, headache, pain, knee pain, sweating and clamminess to be related to BEXSERO. Additional details were provided as follows: The patient experienced knees hurt. The healthcare professional stated, the patient's mother gave her an ibuprofen and it took all those symptoms away. The HCP reported that, the patient's symptoms were completely gone the next day as well. No further information was provided.
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence at injection site wheal in a patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, unknown after receiving FLULAVAL QUADRILVANT, the patient experienced injection site wheal, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site wheal, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site wheal, injection site pain and injection site swelling to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The sales representative believed that the flu vaccine received by the patient was the FLULAVAL QIV Pre Filled Syringe. The patient complained of a 2 inch welt, soreness, and swelling at the injection site. The sales representative had no patient identifiers or lot and expiration date of the vaccine. The health care professional could be contacted directly for further information. This was one of the 5 cases, reported by the same reporter.