chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Face and mouth X-ray normal, Hyperaesthesia, Hypoaesthesia, Pain in extremity
Clinical narrative: Severe left leg pain, unable to weight bear, numbness, burning, sensitivity to touch. Went to ER and to PCP. Placed on steroids, pain medication, nerve pain medication, antiviral medication.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ultrasound scan normal, Urine analysis
Clinical narrative: Severe left leg pain, unable to weight bear, numbness, burning, sensitivity to touch. Went to ER and to PCP. Placed on steroids, pain medication, nerve pain medication, antiviral medication.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Gait inability, Hyperaesthesia, Loss of personal independence in daily activities, Neuralgia, Post herpetic neuralgia
Clinical narrative: Severe left leg pain, unable to weight bear, numbness, burning, sensitivity to touch. Went to ER and to PCP. Placed on steroids, pain medication, nerve pain medication, antiviral medication.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Gait inability, Headache, Hyperaesthesia, Intervertebral disc protrusion, Loss of personal independence in daily activities
Clinical narrative: Severe left leg pain, unable to weight bear, numbness, burning, sensitivity to touch. Went to ER and to PCP. Placed on steroids, pain medication, nerve pain medication, antiviral medication.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Neuralgia, Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity, Photophobia, Post herpetic neuralgia
Clinical narrative: Severe left leg pain, unable to weight bear, numbness, burning, sensitivity to touch. Went to ER and to PCP. Placed on steroids, pain medication, nerve pain medication, antiviral medication.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Spinal operation
Clinical narrative: Severe left leg pain, unable to weight bear, numbness, burning, sensitivity to touch. Went to ER and to PCP. Placed on steroids, pain medication, nerve pain medication, antiviral medication.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Myocarditis
Clinical narrative: Seen in ED on 19 April; Dx: Myopericarditis; Transferred to Hospital.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Myocarditis
Clinical narrative: Seen in ED on  21 April; Dx: Atypical chest pain & Myocarditis; Transferred to Hospital. Did also get an Anthrax Vaccine 28 Feb 2018 #4 in series; mfg MIP; lot number 300021A.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient developed redness the size of a fist around the injection area.
Age: 56.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Abdominal pain upper, Axillary mass, Dizziness, Headache, Nausea
Clinical narrative: Fever >101 degrees F x 7 days starting day after injection; lump in lower axillary region of left side (with tenderness) starting 2 days after injection and resolving 4 days after injection; stomach ache with nausea for 6 days starting day after injection; dizziness with headache for several days starting day after injection.
Age: 56.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever >101 degrees F x 7 days starting day after injection; lump in lower axillary region of left side (with tenderness) starting 2 days after injection and resolving 4 days after injection; stomach ache with nausea for 6 days starting day after injection; dizziness with headache for several days starting day after injection.
Age: 27.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP
Symptoms: Blood creatine phosphokinase, C-reactive protein, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: 14 APR ED. 18 APR PCM VISIT FOR ACUTE PERICARDITIS - CARDIOLOGY AND IMMUNIOLOGY CLINIC CONSULTS. 20 APR PRM: SX: SOB AND CP/DISCOMFORT - ACUTE PERICARDITIS. 23 APRIL: FOLLOW-UP WITH CARDIOLOGIST.
Age: 27.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP
Symptoms: Pericarditis, Troponin
Clinical narrative: 14 APR ED. 18 APR PCM VISIT FOR ACUTE PERICARDITIS - CARDIOLOGY AND IMMUNIOLOGY CLINIC CONSULTS. 20 APR PRM: SX: SOB AND CP/DISCOMFORT - ACUTE PERICARDITIS. 23 APRIL: FOLLOW-UP WITH CARDIOLOGIST.
Age: 27.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP
Symptoms: Chest pain, Electrocardiogram change, Myocarditis, Troponin increased
Clinical narrative: 14 APR ED. 18 APR PCM VISIT FOR ACUTE PERICARDITIS - CARDIOLOGY AND IMMUNIOLOGY CLINIC CONSULTS. 20 APR PRM: SX: SOB AND CP/DISCOMFORT - ACUTE PERICARDITIS. 23 APRIL: FOLLOW-UP WITH CARDIOLOGIST.
Age: 27.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP
Symptoms: Chest pain, Coxsackie virus test positive, Electrocardiogram change, Myocarditis, Parvovirus B19 test positive
Clinical narrative: 14 APR ED. 18 APR PCM VISIT FOR ACUTE PERICARDITIS - CARDIOLOGY AND IMMUNIOLOGY CLINIC CONSULTS. 20 APR PRM: SX: SOB AND CP/DISCOMFORT - ACUTE PERICARDITIS. 23 APRIL: FOLLOW-UP WITH CARDIOLOGIST.
Age: 27.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP
Symptoms: Troponin increased
Clinical narrative: 14 APR ED. 18 APR PCM VISIT FOR ACUTE PERICARDITIS - CARDIOLOGY AND IMMUNIOLOGY CLINIC CONSULTS. 20 APR PRM: SX: SOB AND CP/DISCOMFORT - ACUTE PERICARDITIS. 23 APRIL: FOLLOW-UP WITH CARDIOLOGIST.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site induration, Injection site mass, Injection site pain, Irritability, Lethargy
Clinical narrative: Soreness and hard lump (approx 2.5cm diameter) at injection site two days after vaccination. Child was unusually fussy and would not sleep well. Treated with infant ibuprofen for pain relief. Third day after vaccination the child became letharhic and developed a 104F fever with head scanning thermometer, followed by a runny nose and very exaggerated muscle twitches (flailing arms, jerking body movements) in her sleep. Treated with ibuprofen as needed, which reduced fever and improved energy levels. Fever was ongoing for 4 days at the time of this report.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Muscle twitching, Poor quality sleep, Pyrexia, Rhinorrhoea
Clinical narrative: Soreness and hard lump (approx 2.5cm diameter) at injection site two days after vaccination. Child was unusually fussy and would not sleep well. Treated with infant ibuprofen for pain relief. Third day after vaccination the child became letharhic and developed a 104F fever with head scanning thermometer, followed by a runny nose and very exaggerated muscle twitches (flailing arms, jerking body movements) in her sleep. Treated with ibuprofen as needed, which reduced fever and improved energy levels. Fever was ongoing for 4 days at the time of this report.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic reaction, Chest X-ray, Electrocardiogram, Full blood count, Metabolic function test
Clinical narrative: Anaphylaxis (face swelling, throat swelling and closure).
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pharyngeal oedema, Swelling face, Throat tightness, Troponin
Clinical narrative: Anaphylaxis (face swelling, throat swelling and closure).
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Dry mouth, Pharyngeal oedema
Clinical narrative: Anaphylaxis (face swelling, throat swelling and closure).
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: Symptoms started a few hours after vaccine was given. Patient experienced fever up to 102 degrees F, joint pain, shivers, chills, fatigue, loss of appetite. Symptoms lasted about 24 hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Mobility decreased
Clinical narrative: Pt start med having symptoms a few hours after the vaccine was administered. She experienced fever up to 102 degrees F, joint pain, shivers, chills, fatigue, loss of appetite. She says she was unable to leave her bed the entire time she had the adverse events. Her symptoms lasted about 24 hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt start med having symptoms a few hours after the vaccine was administered. She experienced fever up to 102 degrees F, joint pain, shivers, chills, fatigue, loss of appetite. She says she was unable to leave her bed the entire time she had the adverse events. Her symptoms lasted about 24 hours.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Condition aggravated, Injection site erythema, Mobility decreased
Clinical narrative: Patient said she woke up on 4/21/18 at around 1 am with arthritic symptoms that seemed to have suddenly become worse and could barely move or walk. She experienced extreme myalgia and severe inflammation of joints. She also had redness at site of injection. She almost went to the emergency room but decided to wait till the morning. She then said as morning came, the symptoms got less severe and she went for some simple shopping to grocery store. The symptoms were significantly less by morning of 4/22/18 and she was better by afternoon of 4/22/18. She wants her experience reported to the makers of the vaccine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Patient said she woke up on 4/21/18 at around 1 am with arthritic symptoms that seemed to have suddenly become worse and could barely move or walk. She experienced extreme myalgia and severe inflammation of joints. She also had redness at site of injection. She almost went to the emergency room but decided to wait till the morning. She then said as morning came, the symptoms got less severe and she went for some simple shopping to grocery store. The symptoms were significantly less by morning of 4/22/18 and she was better by afternoon of 4/22/18. She wants her experience reported to the makers of the vaccine.
Age: 19.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP
Symptoms: Unevaluable event
Clinical narrative: 20 APRIL: ED.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain on site of injection followed by redness. The site then developed a red circle that eventually went around the entire arm. Patient experienced these symptoms for 10 to 14 days. Patient started treating with BENADRYL upon pharmacist's recommendation and then followed with ibuprofen 400 mg daily for two days and intermittent ice on the site.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Insomnia, Nausea, Pyrexia
Clinical narrative: Nausea, fevers, chills, headache, insomnia for 12 hours. Symptoms started approximately 12 hours after the injection.
Age: 33.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Pain, Redness and swelling left upper, lateral and anterior arm beginning evening of administration. The area involved is where Tdap administered. MMR given posterior left posterior upper arm, without symptoms. Pain and swelling worsened over course of week. Neck stiffness, mild, beginning 4/4/18. No difficulty swallowing or breathing.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and tenderness at the site of injection for 3 days after the immunization.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient had shingles shot yesterday. She came in today complaining of an injection site reaction. She states that her left arm is sore and hot to touch. She showed me her left arm where the reaction occurred. There was a red circle about the size of an orange and some bruising. Patient denied dizziness, shortness of breath, swelling, difficulty breathing, or any other symptoms. She said it doesn't itch and does not have any rashes or redness on any other area of the body. I provided her a VIS, highlighted the section on injection site reactions, went over it with her and explained that injection site reactions, such as the one she is having, can occur. I introduced her to follow up with her prescriber or seek medical attention if she experiences any dizziness, shortness of breath, swelling, difficulty breathing, signs of anaphylaxis or serious reaction.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Herpes simplex test negative, Lymphocyte count increased, Monocyte count increased, Stomatitis, Urticaria
Clinical narrative: Patient developed sores in his mouth one day after receiving the vaccination and then 2 weeks later he developed more sores in his mouth. He developed hives that cleared overnight after taking BENADRYL 1 week after vaccination. He developed hives over body that cleared again overnight after taking BENADRYL 2 weeks after the vaccination. He developed hives even worse over entire upper body/torso/face on 04/20/2018 and 04/21/2018 to the point he had to be treated in the ER with (DECADRON and ZYRTEC).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt had symptoms of cellulitis (redness, swelling, pain and heat at site of injection) that started the day after the injection. She waited a couple days and then went to the urgent care and got diagnosed with cellulitis. She recieved KEFLEX, BACTRIM and some ibuprofen.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Impaired work ability, Influenza like illness, Influenza virus test negative
Clinical narrative: Patient has mild- flu like symptoms (muscle/joint soreness/ weakness) to first vaccine. Thought he may have had flu, but tested negative. For second dose series, patient had to leave work early the next day, his entire body felt very weak, and barely made it to car. Patient's joints hurt so bad, and he is very active, and was worried he would never be able to go to gym again. The following morning, patient woke up, and was in no pain at all, as if nothing had happened day before.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Patient has mild- flu like symptoms (muscle/joint soreness/ weakness) to first vaccine. Thought he may have had flu, but tested negative. For second dose series, patient had to leave work early the next day, his entire body felt very weak, and barely made it to car. Patient's joints hurt so bad, and he is very active, and was worried he would never be able to go to gym again. The following morning, patient woke up, and was in no pain at all, as if nothing had happened day before.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: An alarming bright red rash appeared across my midriff  -- approximately 4 inches high. There was also a rash where the shot was administered. I saw my doctor on 4/17/18 and she prescribed 50 mg of BENADRYL every 4-6 hours, which I took for 4 full days until the rash began to lessen.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: An alarming bright red rash appeared across my midriff  -- approximately 4 inches high. There was also a rash where the shot was administered. I saw my doctor on 4/17/18 and she prescribed 50 mg of BENADRYL every 4-6 hours, which I took for 4 full days until the rash began to lessen.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: An alarming bright red rash appeared across my midriff  -- approximately 4 inches high. There was also a rash where the shot was administered. I saw my doctor on 4/17/18 and she prescribed 50 mg of BENADRYL every 4-6 hours, which I took for 4 full days until the rash began to lessen.
Age: 12.0
Sex: M
Vaccine: MMRV, TD
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever within a day and rash from head to toe that started several days after vaccine.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: She was picking up her medicine and had a conversation with me and I asked her if she had a shingle vaccine, she said I gave it to her about a month ago. She said she had some rash around her neck and stuff. She said that she had autoimmune disease before and she think it made her sensitive to things when she is sick. She doesn't think anything serious and she said it went away 2 days after. She said she will come back to get the second shot.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Headache, Influenza like illness, Nausea
Clinical narrative: Headache, Body Aches like flu, queasy stomach, hot/cold flashes.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pain, Peripheral swelling, Pyrexia
Clinical narrative: SWOLLEN ARM, SLIGHT FEVER, 4/14 NIGHT THE SWOLLEN AREA MOVED UPWARDS, BUT TEMPERATURE DECREASED BY FRIDAY MORNING. TOOK TYLENOL FOR PAIN AND FEVER. BENADRYL 25MG FOR ALLERGIC REACTION, STARTED ON 4/15. PATIENT WENT TO DR OFFICE ON 4/16 AND RECEIVED CETIRIZINE 10MG RX.
Age: 62.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: On 4/19/18 patient received two vaccines in our pharmacy. In his left arm he received SHINGRIX (NDC 58160-0823-11) and his right arm HAVRIX (NDC 58160-0826-43). On 4/22/18 patient came in to show his left arm which was slightly raised, red, swollen and itchy. I told him he can use OTC TYLENOL or ibuprofen and use cold compress on the area. I also told him to follow up with his PCP if the reaction gets any worse. Patient was satisfied with this information.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Eye swelling, Headache, Nausea
Clinical narrative: Severe headache, aches, pains, dizziness, nausea, weakness, swollen eyes, very very sore everywhere. Still having symptoms, but not as bad today.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Severe headache, aches, pains, dizziness, nausea, weakness, swollen eyes, very very sore everywhere. Still having symptoms, but not as bad today.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Blood test normal, Cold sweat, Colonoscopy normal, Constipation, Dyspepsia
Clinical narrative: Unknown feeding problems immediately. Reflux, constipation, digestive issues since 3 weeks old. Cold sweat, twitchy, red face, lots of passsing gas. Lasts 8-10 hours and happens up to once a day every week.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Electrocardiogram normal, Electroencephalogram normal, Endoscopy upper gastrointestinal tract normal, Erythema, Flatulence
Clinical narrative: Unknown feeding problems immediately. Reflux, constipation, digestive issues since 3 weeks old. Cold sweat, twitchy, red face, lots of passsing gas. Lasts 8-10 hours and happens up to once a day every week.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Gastrooesophageal reflux disease, Laboratory test normal, Muscle twitching, Poor feeding infant, Stool analysis normal
Clinical narrative: Unknown feeding problems immediately. Reflux, constipation, digestive issues since 3 weeks old. Cold sweat, twitchy, red face, lots of passsing gas. Lasts 8-10 hours and happens up to once a day every week.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Ultrasound abdomen normal, Ultrasound skull normal, Urine analysis normal, X-ray gastrointestinal tract normal
Clinical narrative: Unknown feeding problems immediately. Reflux, constipation, digestive issues since 3 weeks old. Cold sweat, twitchy, red face, lots of passsing gas. Lasts 8-10 hours and happens up to once a day every week.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness (10 x 10 cm) swelling and pain at injection site which persisted for >4 days. Would liike to attach picture.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: 1 week after receiving the vaccine I developed a lesion on my lower lip that resembled a fever blister. I have been treating it with ABREVA for a week with no improvement.
Age: 1.0
Sex: M
Vaccine: MMRV, PPV, VARCEL
Symptoms: Crying, Ear infection, Fall, Pyrexia
Clinical narrative: Fever starting 1-2 days after no other side affect at time treated with baby ADVIL, few days later single ear infection treated with amoxicillin for 5 days-gone, few days later double ear infection treated amoxicillin and baby ADVIL gone, pulls on ears still months later, falls over hard while sitting had severe crying for no apparent reason from the day after for a few weeks.
Age: 1.17
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Antibody test positive, Rash, Vomiting
Clinical narrative: Patient had rash which increased and worsened in the region of the back, abdomen, arms and the legs. Went to the Hospital for increased rash and multiple episodes of vomiting.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Injection site pain, Pyrexia
Clinical narrative: Injection site  soreness to elbow. Fever, chills and diarrhea around 2:30 am, combined with vomiting until around 10 am. Fever lasted 'till about 6 pm. Completely debilitating. No treatment sought. 95% recovered by 4/22/2018.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Injection site  soreness to elbow. Fever, chills and diarrhea around 2:30 am, combined with vomiting until around 10 am. Fever lasted 'till about 6 pm. Completely debilitating. No treatment sought. 95% recovered by 4/22/2018.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Blood test normal, Gait inability, Nausea, Pain
Clinical narrative: Took first dose at 20:00 on April 18, 2018, as prescribed. Awoke at 1:00 April 19, 2018 with severe abdominal cramping and nausea. I had to go to the ER for pain as I could not walk and barely could talk due to pain. Best way to describe pain is if I were to drink bleach. Pain lasted 3 days.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Speech disorder, Urine analysis normal, White blood cell count normal
Clinical narrative: Took first dose at 20:00 on April 18, 2018, as prescribed. Awoke at 1:00 April 19, 2018 with severe abdominal cramping and nausea. I had to go to the ER for pain as I could not walk and barely could talk due to pain. Best way to describe pain is if I were to drink bleach. Pain lasted 3 days.
Age: 27.0
Sex: F
Vaccine: TTOX
Symptoms: Headache, Injection site rash, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Nausea, Fever, Headache, Severe swelling in injection site, Rash on injection site.
Age: 0.58
Sex: M
Vaccine: RV1
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: ROTARIX given instead of ROTATEQ no adverse effects reported.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Aspiration, Breath sounds abnormal, Chest X-ray, Decreased appetite, Dysphagia
Clinical narrative: On the date of 4/15/18 resident had been eating all meals and supplements per his baseline, resident was brought to his PM meal and was noted to hold food/fluids in his mouth and made no efforts to swallow. Staff removed food from resident's mouth and provided oral care. Resident was monitored following episode for aspiration. Following episode resident is noted to have adventitious lung sounds, poor appetite, and lack of baseline response to stimuli. Diet was changed by speech therapy to pureed and honey thick liquids, resident's plan of care has been noted to be comfort cares by POA prior to event.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyporesponsive to stimuli, Swallow study
Clinical narrative: On the date of 4/15/18 resident had been eating all meals and supplements per his baseline, resident was brought to his PM meal and was noted to hold food/fluids in his mouth and made no efforts to swallow. Staff removed food from resident's mouth and provided oral care. Resident was monitored following episode for aspiration. Following episode resident is noted to have adventitious lung sounds, poor appetite, and lack of baseline response to stimuli. Diet was changed by speech therapy to pureed and honey thick liquids, resident's plan of care has been noted to be comfort cares by POA prior to event.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: HPV9 was given to early no adverse effects reported.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Dehydration, Diarrhoea, Hypokalaemia
Clinical narrative: Pt presented to UCC w/ c/o diarrhea on 4/17 that had been occurring since 1 hr after the SHINGRIX vaccine was given then progressed to 4-5 stools hourly. No bloody or dark stools. No nausea or vomiting but no appetite. Everything goes right through me. Denies eating any foods that tasted spoiled or bad. Small meals on wt loss diet. Pt was found to be dehydrated with hypokalemia, requiring IV fluids and repletion of potassium. Potassium chloride 20 MEQ once, sodium chloride ML once, Loperamide 4 mg once.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Back of left upper are swollen and red around the site where PROQUAD was given. Mother of child stated she noticed the arm along with fever on 4/21/18. Mother states that the arm does look better today 4/23/18, than it did on 4/21. Swelling and redness has decreased per mom. She came to clinic to ask if she should be concerned. Mother was told to apply cold compresses to arm and follow up with pediatrician. She was counseled to signs and symptoms of infection. The child has a well child visit with his pediatrician today and mother stated she would have the doctor look at child's arm at that time.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: Whole body rash noted (hands and feet excluded) on 4/17/2018.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Haematoma, Metabolic function test, Pain, Red blood cell sedimentation rate normal
Clinical narrative: Redness, pain, swelling, hematoma. He is giving her cefdinir 300mg and heat every 4 hours and will see her again on Friday April 27th 2018.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Redness, pain, swelling, hematoma. He is giving her cefdinir 300mg and heat every 4 hours and will see her again on Friday April 27th 2018.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Injection site pain
Clinical narrative: "By Friday evening I had a bad headache and hardly slept at all Friday evening. Chills, slight fever, aching and just feeling bad was what I experienced all Friday evening into mid-morning on Saturday. Saturday I was exhausted and fatigued and just layed around all day (very much unlike me.) Sunday was better but the shot site was still very sore. I was not able to sleep on my left side for at least 3 nights."
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pyrexia
Clinical narrative: "By Friday evening I had a bad headache and hardly slept at all Friday evening. Chills, slight fever, aching and just feeling bad was what I experienced all Friday evening into mid-morning on Saturday. Saturday I was exhausted and fatigued and just layed around all day (very much unlike me.) Sunday was better but the shot site was still very sore. I was not able to sleep on my left side for at least 3 nights."
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reported considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine at local community pharmacy. The reported did not have SHINGRIX exact start date and batch number. The patient came to clinic with very sore arm and stated that it hurt to move arm. The reporter said event did not require intervention or hospitalization. The reporter was agreed to receive follow up from GlaxoSmithKline.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Calcinosis, Mobility decreased, Musculoskeletal pain, X-ray limb abnormal
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of calcium in a 76-year-old male patient who received SHINGRIX (batch number YS53Y, expiry date unknown) and (batch number 52G7X, expiry date unknown). On 2nd February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced calcium deposits, shoulder pain and mobility decreased. On an unknown date, the outcome of the calcium deposits was unknown and the outcome of the shoulder pain and mobility decreased were recovered/resolved. It was unknown if the reporter considered the calcium deposits, shoulder pain and mobility decreased to be related to SHINGRIX. Additional information was reported as follows: Within a few days after vaccination the patient developed pain and then difficulty with movement. The pain lasted about 3 weeks and the difficulty with movement lasted another 3 weeks. An X-ray of the shoulder was taken at some point and showed calcification. The batch number for SHINGRIX was updated from YS534 to YS53Y as per sales data sheet.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site warmth, Serum sickness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of serum reaction in a 4-year-old male patient who received KINRIX (batch number 2439H, expiry date 25th April 2020). Concomitant products included Measles Mumps Rubella and VARIVAX. On 6th February 2018, the patient received KINRIX. On 7th February 2018, 1 days after receiving KINRIX, the patient experienced serum reaction, extensive swelling of vaccinated limb, injection site erythema and injection site warmth. On an unknown date, the outcome of the serum reaction, extensive swelling of vaccinated limb, injection site erythema and injection site warmth were recovered/resolved. It was unknown if the reporter considered the serum reaction to be related to KINRIX. The reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site warmth to be almost certainly related to KINRIX. Additional information was received as follows: The registered nurse called to the call center representative regarding adverse event. The reporter stated that the patient received a dose of KINRIX in his left deltoid on 6th February 2018 and on the same day he also received MMR and VARIVAX which was manufactured by Merck. The reporter stated that symptoms began the day after vaccination and the patient had a follow-up physician's visit on 6th February 2018. The reporter stated that the patient experienced redness, swelling, and warmth which was extended to the elbow and spread to back of shoulder of left arm. The reporter was not aware of any other medical intervention taken and stated that symptoms are now resolved. The reporter stated that the physician diagnosed this as other serum reaction due to vaccination and stated that there were no signs of infection. The reporter stated that she was not aware of any other medication or medical history of patient.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old male patient who received SHINGRIX. Concurrent medical conditions included rash. Concomitant products included Atorvastatin, Losartan and Metformin. On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 4th April 2018, 5 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the shingles was unknown and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The patient noticed a rash prior to receiving SHINGRIX. The patient received SHINGRIX in an unknown deltoid at the patient's doctor's office. On 4th April 2018, the patient went to his dermatologist because rash was not resolving and the patient diagnosed with shingles at that time.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain
Clinical narrative: Resident sustained an episode of chest pain for which he refused medication intervention or emergency treatment following his vaccination. Chest pain resolved its self in an unknown amount of time with no interventions.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Asthenia, Fatigue, Mucosal discolouration, Pallor, Yawning
Clinical narrative: Approximately 5 minutes post vaccines child became very pale especially in her mucous membranes, weak, and appeared as she was tired with yawning and not answering questions. Child was put in supine position, did not lose consciousness and vital signs were monitored which were within normal  limits. Child remained pale and weak for approximately 10 minutes. Child was slowly advanced to sitting and walking over a 30-4- minute period before leaving clinic.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Bruxism, Dyskinesia, Dyspnoea, Fluid intake reduced
Clinical narrative: Note Text: Assessed res per NAR request. Res presenting with jerking tremors, irregular, in bil UE. Mouth tensed, jaw locked and teeth clenched. Eyes shut. Able to easily lift eyelids and check pupils-PEARRLA. VS 99.1-92-24-149/85-82% RA. RR 24, labored, shallow with 02 82%-88% RA while laying flat. Elevated HOB greater than 60 degrees, O2 91-94% RA. O2 85% upon lowering HOB. Continued poor food and fluid intake, increased body temperature. Upon AM cares res presented with blanchable erythema to R shoulder that measured about 10x10 cm. Res c/o pain with light touch, guarding R shoulder with mouth clenched. Area swollen. Cold compress applied. Upon later assessment with res tremoring, R shoulder erythema decreased, about 6x6 cm, irregular borders and slightly elevated. Erythema presenting light pink. Reapplied cold compress.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypopnoea, Injection site erythema, Injection site pain, Injection site swelling, Muscle tightness
Clinical narrative: Note Text: Assessed res per NAR request. Res presenting with jerking tremors, irregular, in bil UE. Mouth tensed, jaw locked and teeth clenched. Eyes shut. Able to easily lift eyelids and check pupils-PEARRLA. VS 99.1-92-24-149/85-82% RA. RR 24, labored, shallow with 02 82%-88% RA while laying flat. Elevated HOB greater than 60 degrees, O2 91-94% RA. O2 85% upon lowering HOB. Continued poor food and fluid intake, increased body temperature. Upon AM cares res presented with blanchable erythema to R shoulder that measured about 10x10 cm. Res c/o pain with light touch, guarding R shoulder with mouth clenched. Area swollen. Cold compress applied. Upon later assessment with res tremoring, R shoulder erythema decreased, about 6x6 cm, irregular borders and slightly elevated. Erythema presenting light pink. Reapplied cold compress.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pallor, Tremor, Trismus
Clinical narrative: Note Text: Assessed res per NAR request. Res presenting with jerking tremors, irregular, in bil UE. Mouth tensed, jaw locked and teeth clenched. Eyes shut. Able to easily lift eyelids and check pupils-PEARRLA. VS 99.1-92-24-149/85-82% RA. RR 24, labored, shallow with 02 82%-88% RA while laying flat. Elevated HOB greater than 60 degrees, O2 91-94% RA. O2 85% upon lowering HOB. Continued poor food and fluid intake, increased body temperature. Upon AM cares res presented with blanchable erythema to R shoulder that measured about 10x10 cm. Res c/o pain with light touch, guarding R shoulder with mouth clenched. Area swollen. Cold compress applied. Upon later assessment with res tremoring, R shoulder erythema decreased, about 6x6 cm, irregular borders and slightly elevated. Erythema presenting light pink. Reapplied cold compress.
Age: 19.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea, Muscle spasms, Pain
Clinical narrative: Awakened on 04/21/2018 with stomach pain and cramps. Pain is episodic. No vomiting. One stool was a little loose. Pain was "really bad last night". Rates it at a 4/10 today. Able to tolerate food and fluids. Did not take her second dose on 4/22/18. Non tender abdomen today on exam.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Loss of control of legs, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Following vaccination resident had noted increased apin/body aches. Resident sustained a near fall on 4/13/18 in which her knees gave out from under her and she was lowered to the floor.  Following event resident had noted pain to her neck, back and shoulder.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Arm slightly swollen at injection site, slight fever, nausea, loss of appetite.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Left deltoid redness, swelling, and itching next day after HPV vaccination.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint range of motion decreased, Muscle twitching, Muscular weakness, Pain in extremity
Clinical narrative: 4/16/18 resident's knees became weak with ambulation and she was lowered to the floor-immediate complaints of right knee pain. She is noted to have twitching of the left upper extremity (same site of injection) and increased pain with limited range of motion to the right lower extremity.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary tract infection, X-ray
Clinical narrative: 4/16/18 resident's knees became weak with ambulation and she was lowered to the floor-immediate complaints of right knee pain. She is noted to have twitching of the left upper extremity (same site of injection) and increased pain with limited range of motion to the right lower extremity.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: Client received flu vaccine 12/2/2017, her 4 yo child got the flu and her OB/Gyn prescribed TAMIFLU 2/15/2018 and she took 5 days of the TAMIFLU, at her next OB appointment on 3/6/2018 US showed the fetus had died. Client is not sure if the TAMIFLU had something to do with the miscarriage.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: PT NOTICED RED PIMPLE LIKE RASH ON UPPER RIGHT ARM, SHOULDER, SHOULDER BLADE AND RIGHT BREAST.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Pain in extremity
Clinical narrative: Swelling around site, sore, redness, down to forearm.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Father called 2 days after vaccine stating child had a rash on the arm where vaccine was given. No swelling. Rash hot to touch.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Erythema, Limb mass, Pain in extremity, Peripheral swelling
Clinical narrative: Pain, swelling, lump in arm and redness spread to elbow. She has taken TYLENOL and ALEVE. She has felt weak. Cold compresses to arm. She plans to take BENADRYL.
Age: 1.5
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Urticaria
Clinical narrative: Developed whole body urticaria 5 days after injection.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: No symptoms for 11 hours, then fever of 102 F, swelling, redness (2-in. diameter), and soreness at injection site. Two ibuprofen and a night's sleep reduced the fever. Swelling, redness and soreness continued for 5 days.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: The patient reported her symptoms the next day on 4/21/18, but told me they started the evening after the vaccine. I have not personally seen the swelling and redness. She reported that she had swelling in her arm down to her elbow with redness and it was hot to the touch. I told her to apply ice packs. She called back on 4/22/18 and said the swelling had not gone down any. I advised her to take diphenhydramine and ibuprofen to help with the swelling and pain. Her report on 4/23/18 states that the swelling has gone down considerably and is no longer red.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Injected limb mobility decreased, Injection site pain, Middle insomnia
Clinical narrative: Around 5-6PM shoulder at injection site became very sore and a little bit of feeling faint off and on.  About 9:pm shoulder still very sore and hard to move arm without pain. around midnight woke up with chills and shaking. Got warm and about an hour later woke up in a deep sweat and felt like I was going to vomit. Sat up in a chair and in about 30 minutes felt better but still pain in shoulder. Woke about 6AM and felt dizzy, pain in shoulder and faint. Stayed in bed all day on 4/18 until about 1:30 and had a fever of 99.8. About 4:30 PM. Was able to get up and move around a bit, ate then back to bed. Felt better the next morning 4/19/18 but still pain in the shoulder injection site.  Took some Tylenol for the pain. On 4/21 the shoulder pain began to subside and only tender on 2/22.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Night sweats, Pyrexia, Tremor
Clinical narrative: Around 5-6PM shoulder at injection site became very sore and a little bit of feeling faint off and on.  About 9:pm shoulder still very sore and hard to move arm without pain. around midnight woke up with chills and shaking. Got warm and about an hour later woke up in a deep sweat and felt like I was going to vomit. Sat up in a chair and in about 30 minutes felt better but still pain in shoulder. Woke about 6AM and felt dizzy, pain in shoulder and faint. Stayed in bed all day on 4/18 until about 1:30 and had a fever of 99.8. About 4:30 PM. Was able to get up and move around a bit, ate then back to bed. Felt better the next morning 4/19/18 but still pain in the shoulder injection site.  Took some Tylenol for the pain. On 4/21 the shoulder pain began to subside and only tender on 2/22.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Head discomfort, Injection site erythema, Injection site pain
Clinical narrative: Day after shot pain and redness at injection site, tiredness and shivering, head felt funny. It was gone the next day.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown. The reporter considered the injection site pain and in arm to be related to SHINGRIX. Additional details were provided as follows: The case was reported to the physician. The age at vaccination was not applicable. The reporter indicated that approximately 12 SHINGRIX vaccinations have been administered at his pharmacy. At least 80% of the consumers that received the vaccine have reported experiencing pain during the administration of the vaccination. Also these patients report experiencing a sore arm for and extended period of time (at least 4-5 days) after receiving the injection. The reporter was unable to provided patient specific information.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Dyspnoea, Fatigue, Feeling cold, Haemoptysis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of respiratory tract congestion in a 77-year-old male patient who received SHINGRIX. Concurrent medical conditions included blood pressure high, cardiac arrhythmia and allergy (had drainage from allergies). Concomitant products included NORVASC and PRADAXA. On 10th April 2018, the patient received the 1st dose of SHINGRIX. On 10th April 2018, several hours after receiving SHINGRIX, the patient experienced respiratory tract congestion and cough. In April 2018, the patient experienced coughing blood, moaning, feeling cold, labored respiration and fatigue. On 11th April 2018, the outcome of the moaning and labored respiration were recovered/resolved. On an unknown date, the outcome of the respiratory tract congestion, coughing blood, feeling cold and cough were unknown and the outcome of the fatigue was not recovered/not resolved. The reporter considered the respiratory tract congestion, coughing blood, feeling cold, cough and fatigue to be possibly related to SHINGRIX. It was unknown if the reporter considered the moaning and labored respiration to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. Prior to the vaccination, the patient had some drainage from allergies. At 16:00, the patient received SHINGRIX on an unknown arm. During the night, the patient started coughing and several times had to get up and spit up the congestion. The next day, in the morning, when the patient spit up the congestion, there were blood traces in it. The caller also noted that, instead of the patient's usual snoring, he was moaning in his sleep. Around at 6 AM (14 hours after vaccination), he felt very cold, but when the caller checked patient's temperature at 7 AM, he did not have fever. The patient felt very fatigued and did not want to get up in the morning, which was very unusual for him. He was asleep at the time of the call, so the reporter did not know how the symptoms were progressed, but she did note that, the patient had stopped heavier breathing and moaning he had earlier in the morning.