chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and unspecified reporter refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 14-AUG-2018, the patient was vaccinated with improperly stored dose of Oka-Merck PROQUAD, lot # N034561, expiration date: 03-JUN-2019, (dose and route of administration were not provided) for prophylaxis (incorrect product storage). The vaccine was reconstituted with sterile diluent which was properly stored. The vaccine underwent a temperature excursion -14 to -10 degrees Celsius for 3 hours and 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006154: US-009507513-1809USA004439: US-009507513-1809USA004440: US-009507513-1809USA004441: US-009507513-1809USA004442: US-009507513-1809USA004443: US-009507513-1809USA004445: US-009507513-1809USA004446: US-009507513-1809USA004447: US-009507513-1809USA004448: US-009507513-1809USA004449.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and unspecified reporter refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 08-AUG-2018, the patient was vaccinated with improperly stored dose of PROQUAD, lot # N034561, expiration date: 03-JUN-2019, (dose and route of administration were not provided) for prophylaxis (incorrect product storage). The vaccine was reconstituted with sterile diluent which was properly stored. The vaccine underwent a temperature excursion -14 to -10 degrees Celsius for 3 hours and 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA006154: US-009507513-1809USA004439: US-009507513-1809USA004440: US-009507513-1809USA004441: US-009507513-1809USA004442: US-009507513-1809USA004443: US-009507513-1809USA004444: US-009507513-1809USA004445: US-009507513-1809USA004446: US-009507513-1809USA004447: US-009507513-1809USA004448:
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Left upper out arm has large raised welt-like erythematous area with pinpoint center, large 5 inch welt, treatment: CLARITIN or BENADRYL, along with applying ice or heat as tolerated, and follow up by 9/17/18 if symptoms are still present or sooner if symptoms worsen.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Chills, Dyspnoea, Influenza like illness, Pain
Clinical narrative: Patient is reporting shortness of breath, chills, achiness, and fever (flu like symptoms).
Age: 23.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Skin warm, Swelling, Tenderness
Clinical narrative: HE REPORTED TO ME ADVERSE EVENTS OF REDNESS, SWELLING, TENDERNESS AND WARM TO TOUCH. HE STATED THAT IT WAS AN ALLERGIC REACTION.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The patient's L upper arm is red, swollen, warm to the touch, and itchy. Mom has been giving him BENADRYL and Ibuprofen as needed for pain and swelling.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Dehydration, Feeling hot, Head discomfort, Muscle tightness
Clinical narrative: Pt states neck got "really tight" in lower neck, unable to turn neck left to right, prohibited from standing up straight, head feels like a lot of pressure, feels dehydrated, pt feels really hot, possibly feverish. Has taken Ibuprofen, but has not had any relief.
Age: 78.0
Sex: M
Vaccine: FLUA3
Symptoms: Chills, Dyspnoea, Gait inability, Influenza like illness, Myalgia
Clinical narrative: Patient stating after vaccine he experienced inability to walk that lasted a day, shortness of breath, chills, achiness, muscle pains, fever and typical flu like symptoms. He stated he took Tylenol # 3 to help with the all the symptoms he was experiencing.
Age: 78.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain, Pyrexia
Clinical narrative: Patient stating after vaccine he experienced inability to walk that lasted a day, shortness of breath, chills, achiness, muscle pains, fever and typical flu like symptoms. He stated he took Tylenol # 3 to help with the all the symptoms he was experiencing.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient received vaccine on Tuesday evening. She began seeing rash on her leg that she attributes to this vaccine on Friday night. Rash is currently improving as of this morning. No longer itchy.
Age: 25.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Seizure
Clinical narrative: After about 1 minute after the vaccine was administered, he began to feel light-headed and then patient lost consciousness and experienced convulsions for less than a minute. He was guided to the floor and regained consciousness in about 20 seconds after convulsions ceased. EMS was called and then he was taken out of the store. He was given fluids by EMS and taken to the hospital to rule out a seizure and returned back to the store later that day recovered from event.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth at site developed a day after vaccination.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Hypoaesthesia, Laboratory test, Muscular weakness, Paraesthesia, Pyrexia
Clinical narrative: Mom called stating patient had numbness, tingling, fever and muscle weakness. Advised pt to go to emergency room for further evaluation.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: 5 days after vaccine developed red raised area approximately 2" diameter. Reported itching, could feel a bump. Waited 2 days, wanted to be checked. States it is getting better, no longer itching, redness decreasing.
Age: 13.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effect. PROQUAD was administered instead of MMR.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Head injury
Clinical narrative: Patient received the vaccine on 9/11/18 and was initially fine. As I was giving her mother the flu shot a few minutes later, the patient got dizzy and hit her head on the ground but was not unconscious. EMTs were called and checked all her vitals and stated she was fine. Her blood sugar may have gotten low. Patient went home with her mother.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Nodule, Pyrexia, Swelling
Clinical narrative: Swelling, redness, fevered at touch, knot.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Generalised erythema, Hypophagia, Irritability, Pruritus, Swelling
Clinical narrative: My daughter was sleeping a lot after the vaccines for the first two days. On the third day she began to very irritable and she had a breakout in hives. Her entire body was red and swollen from head to toe. She was also very itchy behind her ears, in her face at the eyes and nose. She was also eating alot less than usual.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Urticaria
Clinical narrative: My daughter was sleeping a lot after the vaccines for the first two days. On the third day she began to very irritable and she had a breakout in hives. Her entire body was red and swollen from head to toe. She was also very itchy behind her ears, in her face at the eyes and nose. She was also eating alot less than usual.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Chest discomfort, Dyspnoea, Hypersensitivity, Malaise
Clinical narrative: About 4 hours later my lungs started to feel like I had a band around them and they itched. Then I started to lose my voice. Continued and was getting worse with me getting short of breath. Severe malaise after 1 day. Went to doc and she gave me prednisone to take for 5 days - and felt it was an allergic reaction. It is now day 6 (six) since the shot and still feel week/sick and still feel short of breath and still have malaise.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Oxygen saturation, Respiratory tract irritation
Clinical narrative: About 4 hours later my lungs started to feel like I had a band around them and they itched. Then I started to lose my voice. Continued and was getting worse with me getting short of breath. Severe malaise after 1 day. Went to doc and she gave me prednisone to take for 5 days - and felt it was an allergic reaction. It is now day 6 (six) since the shot and still feel week/sick and still feel short of breath and still have malaise.
Age: 1.92
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Child was inadvertently given 0.5 ml of FLUZONE when dose should have been 0.25 ml because of child's age. Mother notified within 30 minutes of administration of error.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions and medical history provided. On 24-AUG-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD recombinant human albumin (rHA), lot # N029673, expiration date 21-APR-2019 (dose, site and route of administration were not reported). The sterile diluent used to reconstitute the vaccine was properly stored. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 1 hour. Digital Data Logger was involved. There were no previous excursions reported.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient was seen 2 weeks after his WWC visit on 8-17-18 for office visit 8-31-18 complaining of increased pain and redness at injection site. On exam he had 1 inch by 2 inch area of swelling, erythema, and tenderness at site. He was treated for cellulitis with cephalexin 500 mg tid x 10d.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Chills, Injection site discolouration, Injection site erythema, Pyrexia
Clinical narrative: PATIENT STATES SHE HAS REDNESS AT THE SITE OF INJECTION, SMALL BLUE SPOT WHERE THE NEEDLE WENT INTO HER ARM, LOW GRADE FEVER/CHILLS. STATES THAT AT THE TIME OF INJECTION SHE DIDN'T FEEL ANYTHING.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site inflammation, Injection site oedema, Injection site pain
Clinical narrative: Left arm with inflammation and edema over area of flu vaccine measuring approximately 12 cm by 8 cm, tender to palpation. Mom instructed to administer Ibuprofen and apply ice to area. Mom advised to monitor area, also advised for patient to receive intranasal flu vaccine as alternative to IM injection due to discomfort.
Age: 14.0
Sex: M
Vaccine: HEP, MNQ, TDAP
Symptoms: Muscle contractions involuntary, Muscle spasms
Clinical narrative: Patient had uncontrollable muscle contractions and spasms after vaccination, sent to ER for evaluation.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fatigue, muscle pain, fever.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Anxiety, Blood potassium decreased, Fatigue, Full blood count normal, Headache
Clinical narrative: Anxious feeling, shakiness, headache, fatigue, nausea and fever of 103 F.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Laboratory test normal, Nausea, Pyrexia, Tremor, Urine analysis normal
Clinical narrative: Anxious feeling, shakiness, headache, fatigue, nausea and fever of 103 F.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: White blood cell count decreased
Clinical narrative: Anxious feeling, shakiness, headache, fatigue, nausea and fever of 103 F.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site bruising, Injection site swelling, Lymphadenopathy, Nausea
Clinical narrative: Bruising and swelling at site ..... swelling of lymph nodes and bruising under arm pit... nausea and feverish.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Bruising and swelling at site ..... swelling of lymph nodes and bruising under arm pit... nausea and feverish.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Anaphylactic shock, Dyspnoea, Myalgia, Urticaria
Clinical narrative: Patient was in a anaphylactic shock, SOB, hives, myalgia. Was given a dose of epinephrine and reaction was reversed.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Bursitis, Rotator cuff syndrome
Clinical narrative: Shoulder bursitis or rotator cuff tendonitis.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: Slight dizziness, headache, minor nausea.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Pain
Clinical narrative: Diarrhea started Sunday evening, woke up Monday morning had body aches, chills, diarrhea,  headache, fatigue. I took a 2 hour nap and still went to bed at 8:30 that night and slept until 6:30am the next day.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Fatigue, Hypopnoea, Malaise
Clinical narrative: Yesterday I was administered the flu vaccine at 8:10 AM at Dr.'s office. Around 1:30 PM, I began to experience chills and muscle aches. These symptoms progressed to include shallow breathing and tingling sensations in my bilateral fingertips with general malaise. I began to experience more severe fever and chills and around 3:30 PM, became nauseous and then had about 20 minutes of severe vomiting and dry heaves. Right after that, I was very fatigued and slept for at 2 hours. By 6 PM I felt much better but had little appetite. By 10 PM all symptoms resolved. This morning I feel completely back to baseline after a good night of sleep.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Nausea, Paraesthesia, Pyrexia, Retching
Clinical narrative: Yesterday I was administered the flu vaccine at 8:10 AM at Dr.'s office. Around 1:30 PM, I began to experience chills and muscle aches. These symptoms progressed to include shallow breathing and tingling sensations in my bilateral fingertips with general malaise. I began to experience more severe fever and chills and around 3:30 PM, became nauseous and then had about 20 minutes of severe vomiting and dry heaves. Right after that, I was very fatigued and slept for at 2 hours. By 6 PM I felt much better but had little appetite. By 10 PM all symptoms resolved. This morning I feel completely back to baseline after a good night of sleep.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Yesterday I was administered the flu vaccine at 8:10 AM at Dr.'s office. Around 1:30 PM, I began to experience chills and muscle aches. These symptoms progressed to include shallow breathing and tingling sensations in my bilateral fingertips with general malaise. I began to experience more severe fever and chills and around 3:30 PM, became nauseous and then had about 20 minutes of severe vomiting and dry heaves. Right after that, I was very fatigued and slept for at 2 hours. By 6 PM I felt much better but had little appetite. By 10 PM all symptoms resolved. This morning I feel completely back to baseline after a good night of sleep.
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The office contacted the patient 09/12/2018 per the parent there were no reactions to the vaccine. Asked if there was swelling,redness, fever, rash or any other symptoms after receiving the vaccine. Per the parent there were none.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Barium enema abnormal, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Developed intussusception approximately 10 days after vaccine.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: No adverse advent.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Blood calcium, Blood chloride, Blood cortisol, Blood creatinine
Clinical narrative: Immediately after shot tingling and numbness sensation in neck and jaw on left side of body. As day progressed symptoms didn't go away. Went to urgent care, had me take BENADRYL, symptoms progressed to tingling in left arm and top of hand. Went to general doctor, said to keep taking BENADRYL. Symptoms progressed so went to ER on Thursday evening, vitals were good still couldn't figure out what it was. Friday symptoms went from tingling to burning, all through intestines and vaginal region as well as face and arm. Dr. ran additional tests and blood work came back ok. He put me on ALLEGRA, went to the OBGYN to check on burning sensations and all tests were clear there. Sensations moved from just left arm and face to all over and throughout legs. Seems to be a nerve sensor issue. Each day is different, have some pain in back of head through back, but all feels nerve related. Going on three weeks and still having issues. Had I known this was as possible side effect I would never have taken the shot. Going to the doctor again this week to see if there is anything else I can do.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Blood folate, Blood glucose, Blood magnesium, Blood potassium, Blood sodium
Clinical narrative: Immediately after shot tingling and numbness sensation in neck and jaw on left side of body. As day progressed symptoms didn't go away. Went to urgent care, had me take BENADRYL, symptoms progressed to tingling in left arm and top of hand. Went to general doctor, said to keep taking BENADRYL. Symptoms progressed so went to ER on Thursday evening, vitals were good still couldn't figure out what it was. Friday symptoms went from tingling to burning, all through intestines and vaginal region as well as face and arm. Dr. ran additional tests and blood work came back ok. He put me on ALLEGRA, went to the OBGYN to check on burning sensations and all tests were clear there. Sensations moved from just left arm and face to all over and throughout legs. Seems to be a nerve sensor issue. Each day is different, have some pain in back of head through back, but all feels nerve related. Going on three weeks and still having issues. Had I known this was as possible side effect I would never have taken the shot. Going to the doctor again this week to see if there is anything else I can do.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Blood urea, Burning sensation, Carbon dioxide, Computerised tomogram
Clinical narrative: Immediately after shot tingling and numbness sensation in neck and jaw on left side of body. As day progressed symptoms didn't go away. Went to urgent care, had me take BENADRYL, symptoms progressed to tingling in left arm and top of hand. Went to general doctor, said to keep taking BENADRYL. Symptoms progressed so went to ER on Thursday evening, vitals were good still couldn't figure out what it was. Friday symptoms went from tingling to burning, all through intestines and vaginal region as well as face and arm. Dr. ran additional tests and blood work came back ok. He put me on ALLEGRA, went to the OBGYN to check on burning sensations and all tests were clear there. Sensations moved from just left arm and face to all over and throughout legs. Seems to be a nerve sensor issue. Each day is different, have some pain in back of head through back, but all feels nerve related. Going on three weeks and still having issues. Had I known this was as possible side effect I would never have taken the shot. Going to the doctor again this week to see if there is anything else I can do.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Differential white blood cell count, Epstein-Barr virus antibody, Full blood count, Gastrointestinal pain, Headache
Clinical narrative: Immediately after shot tingling and numbness sensation in neck and jaw on left side of body. As day progressed symptoms didn't go away. Went to urgent care, had me take BENADRYL, symptoms progressed to tingling in left arm and top of hand. Went to general doctor, said to keep taking BENADRYL. Symptoms progressed so went to ER on Thursday evening, vitals were good still couldn't figure out what it was. Friday symptoms went from tingling to burning, all through intestines and vaginal region as well as face and arm. Dr. ran additional tests and blood work came back ok. He put me on ALLEGRA, went to the OBGYN to check on burning sensations and all tests were clear there. Sensations moved from just left arm and face to all over and throughout legs. Seems to be a nerve sensor issue. Each day is different, have some pain in back of head through back, but all feels nerve related. Going on three weeks and still having issues. Had I known this was as possible side effect I would never have taken the shot. Going to the doctor again this week to see if there is anything else I can do.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Helicobacter test, Hypoaesthesia, Immediate post-injection reaction, International normalised ratio, Paraesthesia
Clinical narrative: Immediately after shot tingling and numbness sensation in neck and jaw on left side of body. As day progressed symptoms didn't go away. Went to urgent care, had me take BENADRYL, symptoms progressed to tingling in left arm and top of hand. Went to general doctor, said to keep taking BENADRYL. Symptoms progressed so went to ER on Thursday evening, vitals were good still couldn't figure out what it was. Friday symptoms went from tingling to burning, all through intestines and vaginal region as well as face and arm. Dr. ran additional tests and blood work came back ok. He put me on ALLEGRA, went to the OBGYN to check on burning sensations and all tests were clear there. Sensations moved from just left arm and face to all over and throughout legs. Seems to be a nerve sensor issue. Each day is different, have some pain in back of head through back, but all feels nerve related. Going on three weeks and still having issues. Had I known this was as possible side effect I would never have taken the shot. Going to the doctor again this week to see if there is anything else I can do.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Prothrombin time, Troponin I, Urine analysis, Vitamin B12, Vulvovaginal burning sensation
Clinical narrative: Immediately after shot tingling and numbness sensation in neck and jaw on left side of body. As day progressed symptoms didn't go away. Went to urgent care, had me take BENADRYL, symptoms progressed to tingling in left arm and top of hand. Went to general doctor, said to keep taking BENADRYL. Symptoms progressed so went to ER on Thursday evening, vitals were good still couldn't figure out what it was. Friday symptoms went from tingling to burning, all through intestines and vaginal region as well as face and arm. Dr. ran additional tests and blood work came back ok. He put me on ALLEGRA, went to the OBGYN to check on burning sensations and all tests were clear there. Sensations moved from just left arm and face to all over and throughout legs. Seems to be a nerve sensor issue. Each day is different, have some pain in back of head through back, but all feels nerve related. Going on three weeks and still having issues. Had I known this was as possible side effect I would never have taken the shot. Going to the doctor again this week to see if there is anything else I can do.
Age: 77.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Bacterial infection, Blood culture positive, Culture urine positive, Gait inability, Musculoskeletal pain
Clinical narrative: Pain in the legs and shoulders that affected the muscles and patient states that she could not walk. Patient had also been to the gym the day before. She did not receive anything at the urgent care to treat the pain. Fever with a temperature of about 101 degrees Fahrenheit.
Age: 77.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia, White blood cell count increased
Clinical narrative: Pain in the legs and shoulders that affected the muscles and patient states that she could not walk. Patient had also been to the gym the day before. She did not receive anything at the urgent care to treat the pain. Fever with a temperature of about 101 degrees Fahrenheit.
Age: 1.17
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMRV
Symptoms: Body temperature increased, Tremor
Clinical narrative: Full body shaking for 2 minutes with temperature to 100, resolved.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Pt mom called on 9/11 and stated the son woke up with the injection site severally swollen to where you could see where the needle was stuck at. The child had been scratching the area alot but said it did not hurt.  It was swollen almost to his elbow. I asked if he was having any breathing difficulties she stated no. I told her to place an ice pack on it for about 15 minutes and also to give him to ibuprofen every 6 hours for the next 24 hours. I told her if the swelling continued to progress down his arm or his breathing became affected to take him to the ER. She stated ok.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaemia, Antinuclear antibody positive, Arthralgia, Chest pain, Chills
Clinical narrative: Within 24 hours developed fever, chills, joint pain, arm pain and raised wheel around injection site. I continued to feel poorly for several weeks, exhausted, with sores in my mouth and flu-like symptoms. On 6/16/18 I started experiencing chest pain which worsened in intensity, I was seen in the Emergency Dept on 6/18/18 and diagnosed with "likely pericarditis." I was treated with high dose Ibuprofen which was not effective. I was seen by PCP on 6/25/18 and was not feeling any better. She had stat blood work drawn which showed elevated inflammatory markers. Even with treatment, I continued to get worse. I was admitted to the hospital on 6/28/18 and diagnosed with pericarditis. Lab work done in the hospital revealed positive ANA and anti dsDNA. I was diagnosed with systemic lupus erythematosis.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Double stranded DNA antibody positive, Echocardiogram abnormal, Fatigue, Feeling abnormal, Full blood count abnormal
Clinical narrative: Within 24 hours developed fever, chills, joint pain, arm pain and raised wheel around injection site. I continued to feel poorly for several weeks, exhausted, with sores in my mouth and flu-like symptoms. On 6/16/18 I started experiencing chest pain which worsened in intensity, I was seen in the Emergency Dept on 6/18/18 and diagnosed with "likely pericarditis." I was treated with high dose Ibuprofen which was not effective. I was seen by PCP on 6/25/18 and was not feeling any better. She had stat blood work drawn which showed elevated inflammatory markers. Even with treatment, I continued to get worse. I was admitted to the hospital on 6/28/18 and diagnosed with pericarditis. Lab work done in the hospital revealed positive ANA and anti dsDNA. I was diagnosed with systemic lupus erythematosis.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammatory marker increased, Influenza like illness, Injection site urticaria, Pain in extremity, Pericardial effusion
Clinical narrative: Within 24 hours developed fever, chills, joint pain, arm pain and raised wheel around injection site. I continued to feel poorly for several weeks, exhausted, with sores in my mouth and flu-like symptoms. On 6/16/18 I started experiencing chest pain which worsened in intensity, I was seen in the Emergency Dept on 6/18/18 and diagnosed with "likely pericarditis." I was treated with high dose Ibuprofen which was not effective. I was seen by PCP on 6/25/18 and was not feeling any better. She had stat blood work drawn which showed elevated inflammatory markers. Even with treatment, I continued to get worse. I was admitted to the hospital on 6/28/18 and diagnosed with pericarditis. Lab work done in the hospital revealed positive ANA and anti dsDNA. I was diagnosed with systemic lupus erythematosis.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pericarditis, Pyrexia, Stomatitis, Systemic lupus erythematosus
Clinical narrative: Within 24 hours developed fever, chills, joint pain, arm pain and raised wheel around injection site. I continued to feel poorly for several weeks, exhausted, with sores in my mouth and flu-like symptoms. On 6/16/18 I started experiencing chest pain which worsened in intensity, I was seen in the Emergency Dept on 6/18/18 and diagnosed with "likely pericarditis." I was treated with high dose Ibuprofen which was not effective. I was seen by PCP on 6/25/18 and was not feeling any better. She had stat blood work drawn which showed elevated inflammatory markers. Even with treatment, I continued to get worse. I was admitted to the hospital on 6/28/18 and diagnosed with pericarditis. Lab work done in the hospital revealed positive ANA and anti dsDNA. I was diagnosed with systemic lupus erythematosis.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse prescriber and efers to a 2-year-old male patient. There was no information about the patient's concurrent conditions and medical history provided. On 14-AUG-2018, the patient was vaccinated with one dose of improperly stored VAQTA 25/0.5 (units not provided), lot # R002086, expiration date: 22-APR-2019 (site and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 1o minutes. Digital Data Logger was involved. There was previous excursions reported.; Sender's Comments: US-009507513-1809USA004659:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 20-AUG-2018, the patient may have received an improperly stored dose of PNEUMOVAX 23 lot# N029303, expiration date: 21-APR-2019 via intramuscular route (exact dose, site of administration were not reported) for prophylaxis. The vaccine was exposed to temperature in the range between 47 to 77 degrees Fahrenheit for 30 minutes. Temperature excursion was detected by a data logger. There was no previous temperature excursion. No adverse events were reported.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse prescriber and refers to a 8-year-old male patient. There was no information about the patient's concurrent conditions and medical history provided. On 15-AUG-2018, the patient was vaccinated with one dose of improperly stored VAQTA 25/0.5 (units not provided), lot # R002086, expiration date: 22-APR-2019 (site and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 1o minutes. Digital Data Logger was involved. There was previous excursions reported. Sender's Comments: US-009507513-1808USA009736.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included multiple myeloma. On 6th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th April 2018, 7 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The patient stated that a week after receiving SHINGRIX, she experienced a mild case of shingles. The patient had not received the second shot of the SHINGRIX vaccine till the time of reporting. No further details were provided by the patient. Due to time constraint the patient disconnected the call.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Hyperhidrosis, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX for prophylaxis.  On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, sweating, tremor, dizziness and upset stomach. On an unknown date, the outcome of the injection site erythema, injection site swelling, sweating, tremor, dizziness and upset stomach were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, sweating, tremor, dizziness and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The caller was cousin of the patient who received both doses of SHINGRIX. The age at vaccination was not reported. The caller reported that the patient received a dose of SHINGRIX and experienced injection site reaction including swelling and redness, was dizzy, upset stomach, shakes and sweating that lased for 24 hours and then resolved. The lot number, pharmacy information and physician information were not available. The patient had denied permission to contact their physician. The patient received 2nd dose of SHINGRIX for tolerance effect see case US2018GSK163683.
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX for prophylaxis.  On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, sweating, tremor, dizziness and upset stomach. On an unknown date, the outcome of the injection site erythema, injection site swelling, sweating, tremor, dizziness and upset stomach were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, sweating, tremor, dizziness and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The caller was cousin of the patient who received both doses of SHINGRIX. The age at vaccination was not reported. The caller reported that the patient received a dose of SHINGRIX and experienced injection site reaction including swelling and redness, was dizzy, upset stomach, shakes and sweating that lased for 24 hours and then resolved. The lot number, pharmacy information and physician information were not available. The patient had denied permission to contact their physician. The patient received 2nd dose of SHINGRIX for tolerance effect see case US2018GSK163683.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin red in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 20th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced skin red and influenza-like symptoms. On an unknown date, the outcome of the skin red and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the skin red and influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: This case was previously reported to doctor. The reporter was the patient's husband. The patient received SHINGRIX on the left arm. In 2018, the patient had a red patch and flu like symptoms but all resolved within a week.
Age: 53.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Autoimmune haemolytic anaemia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of autoimmune hemolytic anemia in a 53-year-old female patient who received BOOSTRIX (batch number 4HY3T, expiry date unknown) for prophylaxis. Co-suspect products included FLAURIX QUADRIVALENT 2018-2019 season) (batch number 55E34, expiry date unknown) for prophylaxis. On 23rd August 2018, the patient received BOOSTRIX .5 ml and FLUARIX QUADRIVALENT 2018-2019 season .5 ml. On 26th August 2018, 3 days after receiving BOOSTRIX and FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced autoimmune hemolytic anemia (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the autoimmune hemolytic anemia was unknown.  The reporter considered the autoimmune hemolytic anemia to be possibly related to BOOSTRIX and FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The reporting healthcare professional (HCP) was in patient pharmacist at the local medical center. The HCP stated that the patient presented to the emergency room (ER) at the medical center on 26th August 2018 and had been diagnosed with autoimmune hemolytic anemia. The HCP stated that the patient was still hospitalized and that the relationship between the vaccines and the patient's diagnosis was unclear but they at the time of reporting were listing the patient as 'allergic to BOOSTRIX as an abundance of caution'. The HCP did not have the vaccine details or expiration date for this adverse event. The HCP stated that the only thing that the medical staff had found might have possibly caused this medical condition for this patient was the recent vaccinations.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Nausea, Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 13th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In August 2018, less than a week after receiving SHINGRIX, the patient experienced headache, weakness, nausea and rash. The patient was treated with ibuprofen (Motrin) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the headache, weakness, nausea and rash were recovered/resolved. The reporter considered the headache, weakness, nausea and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX which was asymptomatic. The patient came back to office on 15th August 2018, the patient complained of headache, weakness, nausea and scattered rash on both of her arms. The physician related these adverse events to SHINGRIX. The patient treated with Motrin and Benadryl and physician said that symptoms were resolved. The reporter agreed to be contacted for the follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Ophthalmic herpes zoster, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a female patient who received SHINGRIX for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a day after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), herpes dermatitis, tingling and headache. On an unknown date, the outcome of the ophthalmic herpes zoster, herpes dermatitis, tingling and headache were unknown. It was unknown if the reporter considered the ophthalmic herpes zoster, herpes dermatitis, tingling and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles on the right side of her face, eye, forehead, with pain in her head also. Approximately 12 to 14 hours after the vaccination, the patient began having the same pain, tingling that had back then. On the date of reporting, the patient still had the tingling. The patient was aksing whether this was normal.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the erythema of extremities was not recovered/not resolved. It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient just had a quick question, she reported that she received first SHINGRIX shot on Thursday morning on 31st August 2018. The pain in her left arm started to get a wee bit better by Saturday, 1st September 2018, it was still sore at time of reporting, but she knew it would get better, however the redness which her doctor told about was her question. It was the size of a baseball or softball, and she questioned if this was normal to be such a large red area. That was all the patient wanted to know.
Sex: U
Vaccine: MENB
Symptoms: Infection
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of TRUMENBA, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunisation. Medical history included complement deficiency. The patient's concomitant medications were not reported. On an unspecified date, it was reported that the patient lapsed 2nd dose of a 3 dose series. The patient needed to be vaccinated prior to starting SOLIRIS. Within one month after receiving first dose, patient developed an infection which delayed second dose of product and unable to start on SOLIRIS at this time. The outcome of infection was unknown. Information on the batch number has been requested.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Tremor
Clinical narrative: This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A 21-year-old female patient received TRUMENBA (Lot Number: T52805, Expiry Date: Aug2019), via an unspecified route of administration on 06Sep2018 12:00 at a single dose for immunization at the university health clinic. The patient's medical history and concomitant medications were not reported. On 06Sep2018, 45 minutes after meningococcal group b rlp2086 was administered, the patient experienced temperature of 101.6 degrees and was shaking uncontrollably. The patient's vitals signs were taken; was given ibuprofen and was currently resting. Outcome of the events temperature of 101.6 degrees and shaking uncontrollably was unknown. The events did not require a visit to emergency room.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: Pt came back on 9/12/18 to show me her arms. Her PREVNAR shot was read and swollen about 2 inches out around the injection site. It was warm to the touch. She said that she was not able to lift her arm. I told her that typically that shot can cause the arm to be very sore the next couple of days. She said the area is slightly tender to touch. Her right arm where the flu shot was given was also swollen but not was much. It was not near as read and it was slightly warm to the touch as well. She stated that it was not as sore as the PREVNAR shot. I told patient to take ibuprofen and to place ice packs on both areas for 15 minutes. She said that she has a doctors appointment tomorrow and is going to have her MD take a look at it tomorrow as well.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: PT HERE FOR PPSV23, BECAUSE SHE CARES FOR HER ELDERLY MOTHER AND IS HIGH RISK FOR CONTRACTING DISEASE. AT INJECTION SITE AND BELOW, A 5INCH X 3INCH CIRCULAR/OVAL AREA OF REDNESS, WARMTH AND EDEMA WAS PRESENT WHEN PATIENT CAME BACK INTO CLINIC. PT STATED IT WAS MUCH MORE EDEMATOUS YESTERDAY BUT SHE TOOK A BENADRYL AND SWELLING WENT DOWN SOME. PT INSTRUCTED TO USE ICE PACK OFF AND ON, AND TAKE IBUPROFEN UNTIL SYMPTOMS RESOLVE.
Age: 1.08
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Diarrhoea, Irritability, Rash generalised
Clinical narrative: RASH TO BODY, LOW GRADE TEMP, LOOSE STOOL AND VERY FUSSY PER MOM.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Gait inability, Mental disorder, Muscular weakness
Clinical narrative: Patient received his 4 year immunizations on 08/07/2018, on 08/30/2018 he developed weakness on his legs and was seen at Hospital ER and admitted, was discharged with diagnosis of a "mental problem". Patient returned to center on 9/5/2018 as a follow-up and he continued with lower extremities weakness and refusing to walk. Patient referred to Hospital, he was admitted and worked up, the Neurologist there thinks he may have Acute Cerebellar Ataxia.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Cold sweat, Dizziness, Pallor, Vision blurred
Clinical narrative: Five hours 5:30 pm after vaccination patient complained of being lightheaded, became clammy with a cold sweat and skin was cold and clammy to touch. He was pale, BP 90/66. Last night he had blurred vision. He has had blurred vision at times prior to vaccination. So blurred vision may be related to a medication he takes routinely. Pt laid down at 6 pm for about 2 1/2 to 3 hours and then felt better. After 9 pm pt had blurred vision when viewing computer screen. He is doing fine today. Treatment: rest, cold pack to back of neck, lying down, some nourishment.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Child inadvertently given VARIVAX instead of PROQUAD. No adverse reactions noted from parent/child.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Redness and swelling at the injection site and down her arm. Hot to the touch. Saw her chemotherapy physician today and she gave her a prescription for BACTRIM DS.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Redness and swelling at the injection site and down her arm. Hot to the touch. Saw her chemotherapy physician today and she gave her a prescription for BACTRIM DS.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Chill, shivering, aches, headache, fatigue.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site rash, Injection site swelling
Clinical narrative: Swollen area at injection site. Rash on injection site and above it towards my neck. Low grade fever. Chills. Severe headache. Fatigue. Received shot on Monday and still suffering from listed reaction today Wednesday.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Swollen area at injection site. Rash on injection site and above it towards my neck. Low grade fever. Chills. Severe headache. Fatigue. Received shot on Monday and still suffering from listed reaction today Wednesday.