chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Erythema, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included adverse drug reaction (had a history of reactions with many medications). On 11th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, tiredness, pain, shivering and sleepiness. On 12th July 2018, the patient experienced muscle pain, upset stomach, erythema of extremities, pain in arm and headache. In July 2018, the patient experienced diarrhea. On an unknown date, the outcome of the influenza-like symptoms, muscle pain, tiredness, pain, shivering, upset stomach, erythema of extremities, pain in arm, headache, sleepiness and diarrhea were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, muscle pain, tiredness, pain, shivering, upset stomach, erythema of extremities, pain in arm, headache, sleepiness and diarrhea to be related to SHINGRIX. Additional details reported as follows: The patient received the SHINGRIX vaccine on left arm and the patient reported that she had an intense reaction to the vaccine which included flu like symptoms, muscle pain, extreme fatigue with difficulty staying awake, a terrible headache, shivering, terrible upset stomach, diarrhea, arm pain that was killing her, bizarre redness that looked like she had a dinosaur on her arm and the redness was going in different directions. For two days, the patient did not leave her house because she felt like she had the flu. If someone touched her injection arm, she would scream. The night after she received the SHINGRIX, the patient went under the covers in her bed around 8:00 PM and she felt like she was going to die and she did not leave the house until Thursday 12th July 2018.  On 13th July 2018, the patient felt better by Friday.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Myalgia, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included adverse drug reaction (had a history of reactions with many medications). On 11th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, tiredness, pain, shivering and sleepiness. On 12th July 2018, the patient experienced muscle pain, upset stomach, erythema of extremities, pain in arm and headache. In July 2018, the patient experienced diarrhea. On an unknown date, the outcome of the influenza-like symptoms, muscle pain, tiredness, pain, shivering, upset stomach, erythema of extremities, pain in arm, headache, sleepiness and diarrhea were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, muscle pain, tiredness, pain, shivering, upset stomach, erythema of extremities, pain in arm, headache, sleepiness and diarrhea to be related to SHINGRIX. Additional details reported as follows: The patient received the SHINGRIX vaccine on left arm and the patient reported that she had an intense reaction to the vaccine which included flu like symptoms, muscle pain, extreme fatigue with difficulty staying awake, a terrible headache, shivering, terrible upset stomach, diarrhea, arm pain that was killing her, bizarre redness that looked like she had a dinosaur on her arm and the redness was going in different directions. For two days, the patient did not leave her house because she felt like she had the flu. If someone touched her injection arm, she would scream. The night after she received the SHINGRIX, the patient went under the covers in her bed around 8:00 PM and she felt like she was going to die and she did not leave the house until Thursday 12th July 2018.  On 13th July 2018, the patient felt better by Friday.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included adverse drug reaction (had a history of reactions with many medications). On 11th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, tiredness, pain, shivering and sleepiness. On 12th July 2018, the patient experienced muscle pain, upset stomach, erythema of extremities, pain in arm and headache. In July 2018, the patient experienced diarrhea. On an unknown date, the outcome of the influenza-like symptoms, muscle pain, tiredness, pain, shivering, upset stomach, erythema of extremities, pain in arm, headache, sleepiness and diarrhea were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, muscle pain, tiredness, pain, shivering, upset stomach, erythema of extremities, pain in arm, headache, sleepiness and diarrhea to be related to SHINGRIX. Additional details reported as follows: The patient received the SHINGRIX vaccine on left arm and the patient reported that she had an intense reaction to the vaccine which included flu like symptoms, muscle pain, extreme fatigue with difficulty staying awake, a terrible headache, shivering, terrible upset stomach, diarrhea, arm pain that was killing her, bizarre redness that looked like she had a dinosaur on her arm and the redness was going in different directions. For two days, the patient did not leave her house because she felt like she had the flu. If someone touched her injection arm, she would scream. The night after she received the SHINGRIX, the patient went under the covers in her bed around 8:00 PM and she felt like she was going to die and she did not leave the house until Thursday 12th July 2018.  On 13th July 2018, the patient felt better by Friday.
Age: 88.0
Sex: F
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 88-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (on an unspecified date received 1st dose). On 31st May 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 6th June 2018, 6 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were recovered/resolved. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The initial caller was the  pharmacist. The pharmacist was unable to provide lot number for the doses provided. The reporter stated that the patient developed shingles approximately one week after 2nd dose of SHINGRIX. After the initial reporting the call was placed to the patient and patient reported that she developed a rash on 6th June 2018, the rash progressed and then the patient saw her physician on Thursday (7th June 2018), and was diagnosed with shingles and physician given course of medication to take. The patient was unable to provide name of medication. The patient reported that the rash resolved within 3 to 4 days, after starting the medication.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Bone pain, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bone pain in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, 1 day after receiving SHINGRIX, the patient experienced bone pain, stomach discomfort and tiredness. On an unknown date, the outcome of the bone pain, stomach discomfort and tiredness were unknown. It was unknown if the reporter considered the bone pain, stomach discomfort and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the left arm. The reporter was the wife of the patient and the patient got on the phone call as well. The patient had experienced achy bones, feeling tired and sick to the stomach. The reporter would not provide their phone number, pharmacy's phone number or prescriber's phone number, but gave consent to contact those healthcare providers. The reporter provided contact details of the nurse practitioner.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Loss of personal independence in daily activities, Malaise, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 2nd dose of SHINGRIX. On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced fever, myalgia, chills and malaise. On 17th July 2018, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the fever, myalgia, chills, malaise and activities of daily living impaired were not recovered/not resolved. The reporter considered the fever, myalgia and chills to be probably related to SHINGRIX. It was unknown if the reporter considered the malaise and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient (a social acquaintance) notified GlaxoSmithKline physician that, he presented fever, chills, myalgia, malaise (on the day of vaccination) and unable to conduct normal activities on the day of reporting. The vaccine was not discontinued. The patient was not died because of the event. The events were not required any surgical or medical intervention to prevent one of the outcomes described in preceding questions. The events were not result in congenital anomaly, birth defect, life threatening, death, significant disability and hospitalization.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy, Ultrasound scan abnormal, Vaccine positive rechallenge
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a 17-year-old male patient who received BEXSERO (batch number 16D401, expiry date 28th February 2019) for prophylaxis. Previously administered products included BEXSERO with an associated reaction of injection site pain (Refer the case for 1st dose_US2018GSK127345). On 10th May 2018, the patient received the 2nd dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site swelling, injection site pain and enlargement of lymph nodes. The patient was treated with antibiotics nos. Rechallenge with BEXSERO was positive. On an unknown date, the outcome of the injection site swelling, injection site pain and enlargement of lymph nodes were unknown. It was unknown if the reporter considered the injection site swelling, injection site pain and enlargement of lymph nodes to be related to BEXSERO. Additional details were provided as follows: The patient experienced injection site swelling, injection site pain and 2 left infraclavicular node swollen. This is 1 of 2 cases, reported by the same reporter for the same patient. Lab Comments: On an unknown date, the patient underwent for ultrasound scan and found ultrasound measured 1.2x1.6x0.8 centimeters, 1.1x1.4x0.7.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site induration, Injection site pain
Clinical narrative: Very tired, intense headache, body aches everywhere, chills, fever 101.8, swelling at injection site and hard to the touch plus tender. Lasted two or three days. Called my MD and she said to wait it out.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Very tired, intense headache, body aches everywhere, chills, fever 101.8, swelling at injection site and hard to the touch plus tender. Lasted two or three days. Called my MD and she said to wait it out.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash down arm about 4 inches.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dysgeusia, Dyspnoea, Eye pain, Fatigue
Clinical narrative: Myalgias, exhaustion, achey eyes, cough and wheezing. Most of the symptoms went away by the next day, but the cough and wheezing have persisted for 5 weeks, still not abating. There is some slimey thin watery phlegm that tastes bitter and salty, frequently requires spittingit out, and rarely a metallic taste of blood in the early mornings. No fever, no mucus, but sometimes the cough is so severe it makes me gag. I feels like a reactivation of a bronchitis I had for 8 weeks last fall, 6 months previously. But not like a typical bronchitis, more on an interstitial level. I am truly worried about long lasting lung damage. Some shortness of breath.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Productive cough, Retching, Wheezing
Clinical narrative: Myalgias, exhaustion, achey eyes, cough and wheezing. Most of the symptoms went away by the next day, but the cough and wheezing have persisted for 5 weeks, still not abating. There is some slimey thin watery phlegm that tastes bitter and salty, frequently requires spittingit out, and rarely a metallic taste of blood in the early mornings. No fever, no mucus, but sometimes the cough is so severe it makes me gag. I feels like a reactivation of a bronchitis I had for 8 weeks last fall, 6 months previously. But not like a typical bronchitis, more on an interstitial level. I am truly worried about long lasting lung damage. Some shortness of breath.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site erythema, Tenderness, Vaccination site swelling
Clinical narrative: On 23 July she received PPSV23 and this morning noted redness and swelling at vaccinate site as well as two areas of redness on her left upper arm near (but not confluent with) the vaccination site. She also complains of a feeling of tenderness and fullness of her left axilla. She denies fever/chills, generalized cutaneous symptoms, lip/tongue/oral/laryngeal, pulmonary, GI, neurologic, and CV symptoms.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Catatonia, Crying, Diet refusal, Screaming, Staring
Clinical narrative: Patient received vaccinations in late afternoon, went down for a nap around 5:30 PM, woke at 8:30 PM with ear piercing screams, crying inconsolably, shaking, blank stare and otherwise unresponsive (catatonic state, with no fever experienced, would not eat, unable to calm) until 03:30 AM on 08/09/2014.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Tremor, Unresponsive to stimuli, Vaccination complication
Clinical narrative: Patient received vaccinations in late afternoon, went down for a nap around 5:30 PM, woke at 8:30 PM with ear piercing screams, crying inconsolably, shaking, blank stare and otherwise unresponsive (catatonic state, with no fever experienced, would not eat, unable to calm) until 03:30 AM on 08/09/2014.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient seen for four month well child visit on 6-13-2018, discovered adverse event on 7-25-18 when billing office called inquiring why a KINRIX was ordered on a four month old.  Vaccines due were Dtap,Polio,HIB,PCV and Rotovirus. Patient given KINRIX (Dtap/IPV) combo vaccine vs. Dtap vaccine and IPV vaccine. Immediately verified that this was truly given by reviewing MONTHLY IMMUNIZATION LOG where nursing staff signs out any vaccines given. Consulted with PCP as soon as I was made aware of medication error. Contacted MOC, completed all required reports. Emailed RN Clinic Coordinator with all pertaining information.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Exostosis, Influenza like illness, Injection site pain, Pain in extremity
Clinical narrative: Patient states she woke up the morning after vaccine (5/3/18) with flu like symptoms, and her arm was in severe pain, at injection site, shoulder and under the arm. Patient states she was in bed for 2 days, then made an appt with her PCP Dr. about these ailments. Dr. referred her to the orthopedic physician for X-rays. Patient states Dr. found arthritis and a slight bone spur unrelated to the injection. Patient was then referred to physical therapy and is continuing that.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray abnormal
Clinical narrative: Patient states she woke up the morning after vaccine (5/3/18) with flu like symptoms, and her arm was in severe pain, at injection site, shoulder and under the arm. Patient states she was in bed for 2 days, then made an appt with her PCP Dr. about these ailments. Dr. referred her to the orthopedic physician for X-rays. Patient states Dr. found arthritis and a slight bone spur unrelated to the injection. Patient was then referred to physical therapy and is continuing that.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: On 23 July he received his annual Anthrax vaccine booster (dose #6) and over the next 48 hours noted gradual onset of localized swelling, redness, and tenderness affecting his right deltoid and upper arm. He denies chest pain, fever/chills, arthralgias, myalgias, generalized cutaneous symptoms, and systemic symptoms. He reports similar, albeit less marked, swelling and redness affecting the vaccination site with prior Anthrax vaccine doses but denies other adverse vaccine reactions. Mild (3/10) pain at site but has not affected his ability to perform his daily activities.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at shot site. 3.5" X 3.5" surface area.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Nausea
Clinical narrative: Nausea, Headache, Redness of Arm.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Depression, Fatigue, Fibromyalgia
Clinical narrative: Sore arm, area of injection is raised, warm, and red (even after 48 hours); flareup of fibromyalgia symptoms (approximately 36 hours), chills - couldn't get warm but no fever (began about 9 hours after injection and continued approximately 18 hours. Fatigue still lingering, and a sense of depression.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Sore arm, area of injection is raised, warm, and red (even after 48 hours); flareup of fibromyalgia symptoms (approximately 36 hours), chills - couldn't get warm but no fever (began about 9 hours after injection and continued approximately 18 hours. Fatigue still lingering, and a sense of depression.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, aches, chills.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Child with red, warm swollen R thigh at injection site. Area is 11 cm wide and 10 cm long. R thigh is 35.5 cm in circumference and L thigh is 34.5 cm. No swollen glands or other s/s at this time.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Feeling abnormal, Nausea, Pallor, Sensory loss
Clinical narrative: After receiving the Tdap injection in the left deltoid he became pale & said that he couldn't feel his arm. He stated that he was going to throw up. Ice pack applied to the back of the neck & he was moved to a cot with his legs elevated. He was holding appropriate conversation continuously, stating I feel bad. Pupils PERRLA. Client rested on the cot with legs elevated for 10 minutes. He continued to be able to hold conversation & recalled events about his health history, including a recent diagnosis of ACM, "grade 6". This was not noted on the consent form & grandmother stated that she didn't think [she] needed to say anything because I didn't expect him to have a spell with this today. Two more shots were given while he was lying on the cot: MCV4 & HPV, at 11:35 am.  Client remained stable & was moved to a seated position on the side of the cot for 10 minutes.  He left in the care of his grandmother/guardian.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Influenza like illness, Myalgia
Clinical narrative: About 12 hours after the shot, I became very fatigued. About three hours later, I had some discomfort in my decending colon. The fatigue lasted for about 24 hours. At one point I had very mild flu like symptoms of ache in my muscles but this only lasted for several hours. About 36 hours after the shot, I am 100% normal energy level with no other symptoms.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 8cm (W) x11cm (L) left upper arm with local erythema, tender to the touch with swelling.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Tenderness
Clinical narrative: 7 cm x 8 cm large bruise left arm. Tender to the touch no swelling, fever or chills.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Hyperaesthesia, Post herpetic neuralgia
Clinical narrative: Post hermetic neuralgia involving T-8 - T10 dermatomes on right in paraspinour region. No redness, vesiculation, rash, or other findings. Skin is very sensitive to touch and demonstrates burning sensation.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT REPORTED A RAISED, FIRM BUMP AT THE SITE OF THE INJECTION. THE SIZE OF THE BUMP WAS ABOUT THE DIAMETER OF A QUARTER AND FELT ITCHY. PATIENT DID NOT HAVE ANY OTHER SYMPTOMS.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient expecrienced pain in arm for 36 hours after injection. It recurred one week later.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: For about 24 hours I had headache, muscle pain, tiredness and fever of 99.5, and mildly painful swelling at the injection site. All symptoms cleared by the second morning following the vaccination.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: For about 24 hours I had headache, muscle pain, tiredness and fever of 99.5, and mildly painful swelling at the injection site. All symptoms cleared by the second morning following the vaccination.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: PT described pain after receiving 1st vaccine on 4-22-18. She came in 7-25-18 to let us know that after receiving her 2nd shot on 7-19-18 the next day her arm had a red swollen spot which hurt. She said she also experienced shivering. She is feeling better but wanted us to report her adverse event. Her arm on 7-25-18 still showed some redness where she received the vaccine but she's feeling much better.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Chills, fever, shivering, body ache, headache, nausea.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient came by the Pharmacy today (7/25/18) complaining of a sore arm with redness and itching. She stated that the soreness had been pretty constant since receiving the vaccination, but the redness and itching started on tuesday morning (7/24) as far as she can remember. All symptoms are isolated to the injection site. I advised the patient to followup with her PCP as soon as possible. She reported no signs of a systemic reaction.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Chills, Gait disturbance, Headache
Clinical narrative: Less than an hour after the injection, (and I put ice pack on the injection site for 20 minutes every 2 hours) I became feverish, had severe bone, joint and soft tissue pain, could hardly walk. Finally took temp at 10 PM, and it was 102.5. I already knew the injection site would be painful for 2 weeks, but with 1st shot, I did not have these debilitating symptoms. I shivered all night and it all continues today! Have taken 2 ALEVE x2 in 24 hours, but if I had something stronger would have taken it, as body pain is 8/10. Severe headache, all of which caused me to stay in bed all day...and still feel the same. And of course, cannot even lay on right arm, as pain is 8/10.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Less than an hour after the injection, (and I put ice pack on the injection site for 20 minutes every 2 hours) I became feverish, had severe bone, joint and soft tissue pain, could hardly walk. Finally took temp at 10 PM, and it was 102.5. I already knew the injection site would be painful for 2 weeks, but with 1st shot, I did not have these debilitating symptoms. I shivered all night and it all continues today! Have taken 2 ALEVE x2 in 24 hours, but if I had something stronger would have taken it, as body pain is 8/10. Severe headache, all of which caused me to stay in bed all day...and still feel the same. And of course, cannot even lay on right arm, as pain is 8/10.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Blistery rash on right abdominal area near a scar appeared 7/21/2018.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash erythematous, Rash vesicular
Clinical narrative: Blistery rash on right abdominal area near a scar appeared 7/21/2018.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever of 102.2, chills, fatigue, and redness and swelling at the site of the injection.
Age: 53.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Hypoaesthesia, Pain, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Patient stated that she experienced fever and vomiting an hour after the vaccines were given. It lasted 5-6 days. Her whole body was numb and in pain. Her arm was swollen.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Pt reported to me initially on 7/24/18 during a well visit that with the 2nd dose of HPV given above he had a large localized reaction. He reports that the left upper arm was very erythematous, swollen, and warm without streaking or increasing in size. Estimated reported size per mother was about 5-6 cm long and 3-4 cm wide. It lasted more than 1 week but less than 1 month. They could not fully recall. It later resolved and the date of next visit it was completely resolved.
Age: 0.75
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Inability to crawl, Injection site bruising, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: At approximately 7:30pm patient spiked a temperature of 103.3. Sure was writhing in pain and screamed when touched. Her right thigh had a 1/4" red lump at the injection site that was hot to the touch. The fever was reduced through essential oil adminstration to the soles of her feet. The fever returned after approximately 6 hours and continued for 48 hours, but stayed below 102. The red lump in the right thigh got as large as a quarter in size, before falling into a large bruise after 72 hours. While the lump was large patient reacted very strongly to get leg being touched or bumped. She refused to crawl or to roll into her stomach putting pressure on that thigh.
Age: 0.75
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Pain, Pyrexia, Screaming, Tenderness
Clinical narrative: At approximately 7:30pm patient spiked a temperature of 103.3. Sure was writhing in pain and screamed when touched. Her right thigh had a 1/4" red lump at the injection site that was hot to the touch. The fever was reduced through essential oil adminstration to the soles of her feet. The fever returned after approximately 6 hours and continued for 48 hours, but stayed below 102. The red lump in the right thigh got as large as a quarter in size, before falling into a large bruise after 72 hours. While the lump was large patient reacted very strongly to get leg being touched or bumped. She refused to crawl or to roll into her stomach putting pressure on that thigh.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Nodule, Oropharyngeal pain, Pain, Purulent discharge, Pyrexia
Clinical narrative: This is spontaneous case, reported by healthcare professional (non-other) to VAERS and initially retrieved on 03-Feb-2018 by Seqirus from VAERS (VAERS ID: 724391), concerns a 48-year-old, adult female patient. The patient's historical condition included spinal post-concussion (motion and light sensitivity). The patient's current condition was not reported. The patient's concomitant medications included loratadine, progesterone, Estradiol, multivitamin, Gamma-aminobutyric acid, 5HTP, flaxseed oil, vitamin D, vitamin B, reservatrol and Curcumin for an unknown indication. On 03-Oct-2017, the patient was administered with influenza vaccine (route of administration: injection, anatomical location: left arm, dose, manufacturer, trade name, batch number and expiry date: not reported). On 04-Oct-2017, after 1 day of vaccination, that patient had whole body pain and mild fever. The patient had sore throat and pus nodules were visible in her throat. It was reported that, the patient never experienced fever and pus nodules in throat with previous vaccination. It was reported that, patient had not consulted the physician. No lab test was done. At the time of this report, the patient had not yet recovered from the events. The reporter assessed this case as non-serious. Non-significant case correction received with IRD 03-Feb-2018: The statement in the narrative was corrected from 'in throat before in previous vaccination' to 'in throat with previous vaccination'. The narrative was amended accordingly.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Paraesthesia
Clinical narrative: Patient received Hepatitis A vaccine at approx. 5:00 p.m. on 7/23/18. Great-grandmother called office the next day stating patient was having shortness of breath, and tingling in her hands and face. Great grandmother was advised to take pt. to the E.R. She stated she reacted to one of her vaccines like this last yr. she did not take pt. to ER. She gave her BENADRYL and VENTOLIN inhaler 2 puffs. Patient is fine.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Patient called the pharmacy about 2pm today and states she has a fever 101 degree Fahrenheit, nausea, vomiting, body aches, headache, chills. Says she took TYLENOL to help.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient called the pharmacy about 2pm today and states she has a fever 101 degree Fahrenheit, nausea, vomiting, body aches, headache, chills. Says she took TYLENOL to help.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Insomnia, Pyrexia, Seizure, Streptococcus test negative, Vomiting
Clinical narrative: 102 F last night not able to sleep, rotating ibuprofen and TYLENOL, started vomiting this morning and fever 103 F, spiked to 104.8, fever down this early afternoon 98T, had a little seizure lasting about 10-15 seconds.
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MENB
Symptoms: Urticaria
Clinical narrative: Patient has 1 day of urticaria rash (5 days after vaccines given), no other symptoms. No respiratory issues. No new exposures, seen in ED on 7/23, given BENADRYL and prednisone, worsening rash on 7/24 and seen in office. Directed to continue BENADRYL and prednisone.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Muscle spasms, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Shingrix (received 1st dose on unknown date. Refer case US2018GSK131453). On 25th May 2018, the patient received the 2nd dose of SHINGRIX(intramuscular) .5 ml. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, fatigue, nerve pain, general body pain and burning sensation. On an unknown date, the outcome of the influenza-like symptoms, fatigue, general body pain and burning sensation were recovered/resolved and the outcome of the nerve pain was not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, fatigue, nerve pain, general body pain and burning sensation to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. The patient experienced flu-like symptoms that included body aches and fatigue. Patient states that the symptoms started approximately 48 hours after receiving the injections. Patient states that approximately 2 weeks after receiving the second injection, she experienced nerve pain that is a burning sensation similar to a bee sting that she feels on her left shoulder blade and occasionally under her left arm. The patient stated that the nerve pain had subsided some; however, she does still felt it intermittently. The patient stated that the symptoms lasted for a few days and then resolved. This case has been linked with case US2018GSK131453, reported by the same reporter for 1st dose.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Fatigue, Influenza like illness, Neuralgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Shingrix (received 1st dose on unknown date. Refer case US2018GSK131453). On 25th May 2018, the patient received the 2nd dose of SHINGRIX(intramuscular) .5 ml. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, fatigue, nerve pain, general body pain and burning sensation. On an unknown date, the outcome of the influenza-like symptoms, fatigue, general body pain and burning sensation were recovered/resolved and the outcome of the nerve pain was not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, fatigue, nerve pain, general body pain and burning sensation to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. The patient experienced flu-like symptoms that included body aches and fatigue. Patient states that the symptoms started approximately 48 hours after receiving the injections. Patient states that approximately 2 weeks after receiving the second injection, she experienced nerve pain that is a burning sensation similar to a bee sting that she feels on her left shoulder blade and occasionally under her left arm. The patient stated that the nerve pain had subsided some; however, she does still felt it intermittently. The patient stated that the symptoms lasted for a few days and then resolved. This case has been linked with case US2018GSK131453, reported by the same reporter for 1st dose.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Chest pain, Dizziness, Heart rate decreased, Hypoaesthesia, Hypotension
Clinical narrative: Dizzy spell. Patient was observed and problem resolved. Complain of numbness of both lower legs the day after the vaccination lasting for five minutes. Complain of numbness in both legs two days after vaccination. This lasted for five minutes and resolved. Complain of problems breathing on 07/16/2018 this resolved in ten minutes by itself. Patient was examined on 07/16/2018, and 07/24/2018 in my office by me. His examination was completely normal.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Palpitations
Clinical narrative: Dizzy spell. Patient was observed and problem resolved. Complain of numbness of both lower legs the day after the vaccination lasting for five minutes. Complain of numbness in both legs two days after vaccination. This lasted for five minutes and resolved. Complain of problems breathing on 07/16/2018 this resolved in ten minutes by itself. Patient was examined on 07/16/2018, and 07/24/2018 in my office by me. His examination was completely normal.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: C-reactive protein, Dizziness, Dyspnoea, Full blood count, Hypoaesthesia
Clinical narrative: Dizzy spell. Patient was observed and problem resolved. Complain of numbness of both lower legs the day after the vaccination lasting for five minutes. Complain of numbness in both legs two days after vaccination. This lasted for five minutes and resolved. Complain of problems breathing on 07/16/2018 this resolved in ten minutes by itself. Patient was examined on 07/16/2018, and 07/24/2018 in my office by me. His examination was completely normal.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Metabolic function test, Red blood cell sedimentation rate
Clinical narrative: Dizzy spell. Patient was observed and problem resolved. Complain of numbness of both lower legs the day after the vaccination lasting for five minutes. Complain of numbness in both legs two days after vaccination. This lasted for five minutes and resolved. Complain of problems breathing on 07/16/2018 this resolved in ten minutes by itself. Patient was examined on 07/16/2018, and 07/24/2018 in my office by me. His examination was completely normal.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Lymphadenopathy, Mobility decreased, Myalgia, Oedema
Clinical narrative: Muscle pain and edema after a few hours. Fever (over 101) after 18 hours. Fever lasted more than 12 hours. Joint and muscle pain increased with fever and lasted about 2 days. Day two: lymph nodes swollen in shoulder and underarm area. Difficulty lifting arm. Edema lasted about 3 days. I received the second shot in the series 48 hours ago. I began running a fever about 12 hours later. Fever reached 101.5. I slept 12 hours. joint and muscle pain is decreasing. I have edema in my arm muscle. Shoulder lymph node is swollen. Reaction after 2nd shot is not as bad as first, but was still significant.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Muscle pain and edema after a few hours. Fever (over 101) after 18 hours. Fever lasted more than 12 hours. Joint and muscle pain increased with fever and lasted about 2 days. Day two: lymph nodes swollen in shoulder and underarm area. Difficulty lifting arm. Edema lasted about 3 days. I received the second shot in the series 48 hours ago. I began running a fever about 12 hours later. Fever reached 101.5. I slept 12 hours. joint and muscle pain is decreasing. I have edema in my arm muscle. Shoulder lymph node is swollen. Reaction after 2nd shot is not as bad as first, but was still significant.
Age: 54.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Pt complain of mild pain of the arm and fever (described as warm head). Advised pt to take TYLENOL 1000mg every 4 to 6 hours if needed. max 4gm/day.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Breath holding, Chills, Dizziness, Loss of consciousness, Muscle contractions involuntary
Clinical narrative: Patient received the MCV4 and a PPD Test today. He first received the MCV4 and had no symptoms that he was going to faint. After the PPD Test, the mom stated that she was surprised that he did not faint because he had just fainted a few weeks before because of pain. I was giving him a paper towel for the blood on his PPD test when he stated that he felt like he was going to faint. His mother and I reached him right as he fainted. While he was experiencing this episode, which lasted around a minute or two, his whole body tensed up causing his legs to stiffen, arms to draw in, his back to arch and he was holding his breath. A few seconds after his back arched it relaxed and his head was hanging down. Around 5 seconds after this he took a breath. He also urinated on himself while he was not conscious. When he regained consciousness, he started to throw up. I gave him a wet paper towel, some water and offered a sucker. After a few minutes he stated that he felt like he was going to faint again, so with the assistance of his mother we moved him to the bed. I went to get RN after he was on the bed and stated that he did not feel like he was going to faint again. After she was in the room with him, I went to get Dr. to see him.----He was pallorous, yawning and shivering, but alert. He related a recent hx of a similar episode triggered by a sudden, sharp pain upon turning his neck in a movie theater. His mother had taken him to the emergency room after that event. He was kept supine in clinic for approximately 40 minutes, after which he was able to sit and drink a bottle of water the Dr. gave him. After a few minutes more the Dr. ambulated him in the hallway without difficulty and he experienced no symptoms. He was well enough to be dismissed. Precautions with dehydration risk, possible future risk with venipuncture or injections, and provided them with a printout on vasovagal syncope from the Clinic website. All questions were answered to their satisfaction.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Musculoskeletal stiffness, Opisthotonus, Pallor, Syncope, Tension
Clinical narrative: Patient received the MCV4 and a PPD Test today. He first received the MCV4 and had no symptoms that he was going to faint. After the PPD Test, the mom stated that she was surprised that he did not faint because he had just fainted a few weeks before because of pain. I was giving him a paper towel for the blood on his PPD test when he stated that he felt like he was going to faint. His mother and I reached him right as he fainted. While he was experiencing this episode, which lasted around a minute or two, his whole body tensed up causing his legs to stiffen, arms to draw in, his back to arch and he was holding his breath. A few seconds after his back arched it relaxed and his head was hanging down. Around 5 seconds after this he took a breath. He also urinated on himself while he was not conscious. When he regained consciousness, he started to throw up. I gave him a wet paper towel, some water and offered a sucker. After a few minutes he stated that he felt like he was going to faint again, so with the assistance of his mother we moved him to the bed. I went to get RN after he was on the bed and stated that he did not feel like he was going to faint again. After she was in the room with him, I went to get Dr. to see him.----He was pallorous, yawning and shivering, but alert. He related a recent hx of a similar episode triggered by a sudden, sharp pain upon turning his neck in a movie theater. His mother had taken him to the emergency room after that event. He was kept supine in clinic for approximately 40 minutes, after which he was able to sit and drink a bottle of water the Dr. gave him. After a few minutes more the Dr. ambulated him in the hallway without difficulty and he experienced no symptoms. He was well enough to be dismissed. Precautions with dehydration risk, possible future risk with venipuncture or injections, and provided them with a printout on vasovagal syncope from the Clinic website. All questions were answered to their satisfaction.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Urinary incontinence, Vomiting, Yawning
Clinical narrative: Patient received the MCV4 and a PPD Test today. He first received the MCV4 and had no symptoms that he was going to faint. After the PPD Test, the mom stated that she was surprised that he did not faint because he had just fainted a few weeks before because of pain. I was giving him a paper towel for the blood on his PPD test when he stated that he felt like he was going to faint. His mother and I reached him right as he fainted. While he was experiencing this episode, which lasted around a minute or two, his whole body tensed up causing his legs to stiffen, arms to draw in, his back to arch and he was holding his breath. A few seconds after his back arched it relaxed and his head was hanging down. Around 5 seconds after this he took a breath. He also urinated on himself while he was not conscious. When he regained consciousness, he started to throw up. I gave him a wet paper towel, some water and offered a sucker. After a few minutes he stated that he felt like he was going to faint again, so with the assistance of his mother we moved him to the bed. I went to get RN after he was on the bed and stated that he did not feel like he was going to faint again. After she was in the room with him, I went to get Dr. to see him.----He was pallorous, yawning and shivering, but alert. He related a recent hx of a similar episode triggered by a sudden, sharp pain upon turning his neck in a movie theater. His mother had taken him to the emergency room after that event. He was kept supine in clinic for approximately 40 minutes, after which he was able to sit and drink a bottle of water the Dr. gave him. After a few minutes more the Dr. ambulated him in the hallway without difficulty and he experienced no symptoms. He was well enough to be dismissed. Precautions with dehydration risk, possible future risk with venipuncture or injections, and provided them with a printout on vasovagal syncope from the Clinic website. All questions were answered to their satisfaction.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Body aches, headache, fever 102 degrees.
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: My daughter was given Rotavirus as a shot in her leg, which makes it ineffective. It's supposed to be given orally.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a nurse practitioner referring to an unspecified patient. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 10-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, lot# and expiration date unknown) for prophylaxis. On 30-SEP-2017, the patient vaccinated with the second dose of GARDASIL 9. On 28-DEC-2017, the patient vaccinated with the third dose of GARDASIL 9 (Inappropriate schedule of drug administration). No adverse effects were reported. Follow up information has been received from the nurse practitioner (NP) on 11-JUL-2018. The NP reported the patient received the third dose of GARDASIL 9 eleven days too early. The GARDASIL 9 also reported she planned to revaccinate the patient with a fourth dose of GARDASIL 9. No adverse effects were reported. No additional information provided.
Age: 17.0
Sex: U
Vaccine: MNQ, PPV
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old patient. On 16-JUL-2018, the patient received a dose of PNEUMOVAX 23 lot # N019837, expiration date 21-FEB-2018 because it was accidentally used as the diluent for MENVEO lot number A17057, expiration date March 2019. No adverse effects were reported.