chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Dysgeusia, Visual impairment
Clinical narrative: This is a serious spontaneous case, initially received from non-health professional (consumer) on 24-Dec-2018, concerning a 73-year-old, elderly male patient. The patient's current conditions included diabetes and high blood pressure (since on unspecified date) (reported as medical history). The patient's concomitant medications included Metformin, Simvastatin, Omeprazole, Amlodipine, Doxazosin and Levothyroxine for unknown indications. On 21-Dec-2018, the patient was administered INN Flu vaccine seasonal [influenza vaccine, influenza virus vaccine polyvalent, route of administration: intramuscular, anatomical location: deltoid, dose, batch number, expiry date, manufacturer and trade name: not reported] for influenza prophylaxis. On the same day, after vaccination, the patient developed metallic taste and vision changes which the patient felt that the areas of letters were missing and he couldn't read at all. The patient treated with natural tears solution. The outcome of the events was not recovered (ongoing). The reporter assessed this case as non-serious.; Reporter's Comments: A 73-year-old, elderly male patient with medical history of diabetes and high blood pressure developed metallic taste and vision changes with reading disorder, on the same day after INN Flu vaccine. Considering the plausible temporal relationship between vaccination and events (metallic taste and vision changes) the company assessed the events as possibly related to suspect vaccine. However, the co-administered metformin should be considered as confounding factor for the event of metallic taste. Despite temporal association between vaccination and event of reading disorder, the clinical course suggests the reported vision changes as a more plausible explanation for the event. Hence, the company assessed the causality as not related to suspect vaccine. The company assessed the event (visual disturbances) as serious (medically significant).
Age: 56.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Mobility decreased, Pain, Pain in extremity, X-ray
Clinical narrative: As soon as I got the shots and was going to put my arm back in sleeve I felt a sharp pain shoot down my arm. Arm was ok but later that evening about 9:00 pm my arm was very painful. By the morning I couldn't move my arm at all. I was in SEVERE pain for 2weeks. I can move it now. The pain is still going on. But tolerable.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Feeling abnormal, Headache
Clinical narrative: During the night (around 3 AM?), I woke in a lot of pain. My joints and my muscles hurt all over and I had a sharp headache on the right side of my head. The injection site hurt and I couldn't lie on that side because of it. The site itself did not appear swollen or red, just tender. My hands were so swollen, I couldn't make a fist. I tried to go back to sleep but only managed to doze on and off.  I felt better after a shower and started my day but found that I started feeling bad again. The swelling in my hands went down. I went to church but couldn't kneel because it hurt too much. I went to the supermarket (I only had a short list) but couldn't carry the bags in the house because I was too tired and achy. TYLENOL (2 extra strength) helped somewhat and I continued to take that during the day (every 4 hrs, total 6 pills). I spent the day laying down and did not have the energy to read or even to watch TV. I was able to sleep that night. I awoke with a migraine (MAXALT generic, needed the second pill 2 hrs after the first) and that resolved after ~5 hrs. The joint and muscle pains were still there but much less, although I continued to be very tired. I continued to improve. Today, I'm still tired and somewhat achy but overall much better. The swelling in my hands resolved.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Middle insomnia, Migraine, Myalgia
Clinical narrative: During the night (around 3 AM?), I woke in a lot of pain. My joints and my muscles hurt all over and I had a sharp headache on the right side of my head. The injection site hurt and I couldn't lie on that side because of it. The site itself did not appear swollen or red, just tender. My hands were so swollen, I couldn't make a fist. I tried to go back to sleep but only managed to doze on and off.  I felt better after a shower and started my day but found that I started feeling bad again. The swelling in my hands went down. I went to church but couldn't kneel because it hurt too much. I went to the supermarket (I only had a short list) but couldn't carry the bags in the house because I was too tired and achy. TYLENOL (2 extra strength) helped somewhat and I continued to take that during the day (every 4 hrs, total 6 pills). I spent the day laying down and did not have the energy to read or even to watch TV. I was able to sleep that night. I awoke with a migraine (MAXALT generic, needed the second pill 2 hrs after the first) and that resolved after ~5 hrs. The joint and muscle pains were still there but much less, although I continued to be very tired. I continued to improve. Today, I'm still tired and somewhat achy but overall much better. The swelling in my hands resolved.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Peripheral swelling
Clinical narrative: During the night (around 3 AM?), I woke in a lot of pain. My joints and my muscles hurt all over and I had a sharp headache on the right side of my head. The injection site hurt and I couldn't lie on that side because of it. The site itself did not appear swollen or red, just tender. My hands were so swollen, I couldn't make a fist. I tried to go back to sleep but only managed to doze on and off.  I felt better after a shower and started my day but found that I started feeling bad again. The swelling in my hands went down. I went to church but couldn't kneel because it hurt too much. I went to the supermarket (I only had a short list) but couldn't carry the bags in the house because I was too tired and achy. TYLENOL (2 extra strength) helped somewhat and I continued to take that during the day (every 4 hrs, total 6 pills). I spent the day laying down and did not have the energy to read or even to watch TV. I was able to sleep that night. I awoke with a migraine (MAXALT generic, needed the second pill 2 hrs after the first) and that resolved after ~5 hrs. The joint and muscle pains were still there but much less, although I continued to be very tired. I continued to improve. Today, I'm still tired and somewhat achy but overall much better. The swelling in my hands resolved.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Joint swelling, Peripheral swelling
Clinical narrative: During the night (around 3 AM?), I woke in a lot of pain. My joints and my muscles hurt all over and I had a sharp headache on the right side of my head. The injection site hurt and I couldn't lie on that side because of it. The site itself did not appear swollen or red, just tender. My hands were so swollen, I couldn't make a fist. I tried to go back to sleep but only managed to doze on and off.  I felt better after a shower and started my day but found that I started feeling bad again. The swelling in my hands went down. I went to church but couldn't kneel because it hurt too much. I went to the supermarket (I only had a short list) but couldn't carry the bags in the house because I was too tired and achy. TYLENOL (2 extra strength) helped somewhat and I continued to take that during the day (every 4 hrs, total 6 pills). I spent the day laying down and did not have the energy to read or even to watch TV. I was able to sleep that night. I awoke with a migraine (MAXALT generic, needed the second pill 2 hrs after the first) and that resolved after ~5 hrs. The joint and muscle pains were still there but much less, although I continued to be very tired. I continued to improve. Today, I'm still tired and somewhat achy but overall much better. The swelling in my hands resolved.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: During the night (around 3 AM?), I woke in a lot of pain. My joints and my muscles hurt all over and I had a sharp headache on the right side of my head. The injection site hurt and I couldn't lie on that side because of it. The site itself did not appear swollen or red, just tender. My hands were so swollen, I couldn't make a fist. I tried to go back to sleep but only managed to doze on and off.  I felt better after a shower and started my day but found that I started feeling bad again. The swelling in my hands went down. I went to church but couldn't kneel because it hurt too much. I went to the supermarket (I only had a short list) but couldn't carry the bags in the house because I was too tired and achy. TYLENOL (2 extra strength) helped somewhat and I continued to take that during the day (every 4 hrs, total 6 pills). I spent the day laying down and did not have the energy to read or even to watch TV. I was able to sleep that night. I awoke with a migraine (MAXALT generic, needed the second pill 2 hrs after the first) and that resolved after ~5 hrs. The joint and muscle pains were still there but much less, although I continued to be very tired. I continued to improve. Today, I'm still tired and somewhat achy but overall much better. The swelling in my hands resolved.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Feeling abnormal, Headache
Clinical narrative: Patient complained of severe headache, fatigue, chills, fever and swollen joints in hands. Patient states that her hands were so swollen she was unable to make a fist. Patient reports that symptoms subsided after a day of rest and sleep. Patient also stated that she had worked on this product during development an stated that she experienced "level 3 side effects" and requested that we report this incident to help update the post marketing data.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Middle insomnia, Migraine, Myalgia
Clinical narrative: Patient complained of severe headache, fatigue, chills, fever and swollen joints in hands. Patient states that her hands were so swollen she was unable to make a fist. Patient reports that symptoms subsided after a day of rest and sleep. Patient also stated that she had worked on this product during development an stated that she experienced "level 3 side effects" and requested that we report this incident to help update the post marketing data.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Peripheral swelling
Clinical narrative: Patient complained of severe headache, fatigue, chills, fever and swollen joints in hands. Patient states that her hands were so swollen she was unable to make a fist. Patient reports that symptoms subsided after a day of rest and sleep. Patient also stated that she had worked on this product during development an stated that she experienced "level 3 side effects" and requested that we report this incident to help update the post marketing data.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Joint swelling, Peripheral swelling
Clinical narrative: Patient complained of severe headache, fatigue, chills, fever and swollen joints in hands. Patient states that her hands were so swollen she was unable to make a fist. Patient reports that symptoms subsided after a day of rest and sleep. Patient also stated that she had worked on this product during development an stated that she experienced "level 3 side effects" and requested that we report this incident to help update the post marketing data.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient complained of severe headache, fatigue, chills, fever and swollen joints in hands. Patient states that her hands were so swollen she was unable to make a fist. Patient reports that symptoms subsided after a day of rest and sleep. Patient also stated that she had worked on this product during development an stated that she experienced "level 3 side effects" and requested that we report this incident to help update the post marketing data.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Aches, chills, probably mild fever.
Age: 66.0
Sex: F
Vaccine: CHOL
Symptoms: Labelled drug-food interaction medication error
Clinical narrative: This spontaneous case report was received from a consumer (PVX2018-2956) on 11-Oct-2018. The report describes a female consumer who "had a protein drink before and after the administration of VAXCHORA". The consumer was receiving VAXCHORA for cholera vaccine. It was reported that the consumer took VAXCHORA on 10-Oct-2018 but she had a protein drink 30 minutes before and 5 or 10 minutes after the dose. The action taken with VIVOTIF with respect to the event "had a protein drink before and after the administration of VAXCHORA" was not applicable. The clinical outcome of the event "had a protein drink before and after the administration of VAXCHORA" was unknown. Company's Comment: The causality of the event "had a protein drink before and after the administration of VAXCHORA" was considered as not applicable.
Age: 38.0
Sex: F
Vaccine: CHOL
Symptoms: Oral administration complication, Product preparation issue
Clinical narrative: This spontaneous case report was received from a pharmacist (PVX2018-3285) on 27-Nov-2018. The report describes a 38-year-old adult female consumer who "took the vaccine without the buffer component". The consumer was receiving VAXCHORA for an unknown indication. It was reported that the consumer took VAXCHORA but forgot to put the buffer component into the water, and drank only the active component. The action taken with VAXCHORA with respect to the event "took the vaccine without the buffer component" was not applicable. The clinical outcome of the event "took the vaccine without the buffer component" was unknown. Company's Comment: The causality of the event "took the vaccine without the buffer component" was considered as not applicable.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of an unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant medication included sterile diluent. On 24-DEC-2018, the patient was vaccinated with an improperly stored dose of PROQUAD injection, therapy type: rHA, lot# R018779 (expiration date: 29-DEC-2019) for prophylaxis (anatomical location, route and dosage details were not reported). The vaccine was reconstituted using properly stored sterile diluent (lot and expiration date were not reported). The vaccine underwent a temperature excursion of 15 degree Fahrenheit (F) to 46 degree F for 44 minutes of time frame. The patient did not experience any adverse effects. The call was because of a "data logger". No previous temperature excursion was reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant medication included DILUENT MRK INJ. On 11-DEC-2018, the patient was vaccinated with an improperly stored dose of varicella VARIVAX injection, lot# N035937 (expiration date: 18-DEC-2019) for prophylaxis (anatomical location, route and dosage details were not reported) (product storage error). The vaccine was reconstituted using properly stored DILUENT MRK INJ, lot# R002209 (expiration date: 03-JAN-2020). Between 10-DEC-2018 to 21-DEC-2018, the vaccine underwent multiple temperature excursions from -14 degree Celsius (C) to -10 degree C for 90 minutes of time frame. The patient did not experience any adverse effects. The call was because of a "data logger". No previous temperature excursion was reported. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in July 2018, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (dose, lot # and expiration date were not provided) for prophylaxis. On an unknown date in November 2018, the patient received her second dose of GARDASIL 9. No adverse effects were reported.
Age: 12.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site rash in a 12-year-old female patient who received MENVEO for prophylaxis. Co-suspect products included BOOSTRIX for prophylaxis and FLULAVAL QUADRIVALENT (2018-2019 season) for prophylaxis. On 21st December 2018 16:15, the patient received MENVEO, BOOSTRIX and FLULAVAL QUADRIVALENT 2018-2019 season. In December 2018, 15 hrs 15 min after receiving MENVEO, BOOSTRIX and FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site rash, injection site hives, injection site itching, injection site pain and injection site erythema. The patient was treated with ZYRTEC and BENADRYL. On an unknown date, the outcome of the injection site rash, injection site hives, injection site itching and injection site pain were unknown and the outcome of the injection site erythema was recovering/resolving. It was unknown if the reporter considered the injection site rash, injection site hives, injection site itching, injection site pain and injection site erythema to be related to MENVEO, BOOSTRIX and FLULAVAL QUADRIVALENT 2018-2019 season. Additional information was provided as follows: The patient received 3 shots at her 12yr annual exam on 21st December 2018 at 4:15pm. She received two shots in her left arm and on shot in her right arm. There were no issues during the 15-minute wait and no issues through the night. In December 2018, 15 hrs 15 min after the patient experienced injection site rash, injection site hives, injection site itching, injection site pain and injection site erythema. The patient received MENVEO,BOOSTRIX and FLULAVAL QUADRIVALENT. The records are unclear as to which vaccine was placed in each arm and on her left arm had a rash the size of two silver dollars and two hives at the site where she received the two shots. The area was itchy and painful. The patient called the Dr. who recommended ZYRTEC or BENADRYL. The patient administered one pill of ZYRTEC 10mg at about 9:00 am on 22nd December 2018. The redness seemed to be clearing.The patient would continue to monitor.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a month after receiving SHINGRIX, the patient experienced chills, general body pain and headache. On an unknown date, the outcome of the chills, general body pain and headache were unknown. It was unknown if the reporter considered the chills, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, it's been 9 days since he received the shingles shot and have chills, body aches and off and on headaches. The patient asked if this was normal.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Lethargy, Melaena
Clinical narrative: Tdap shot, tar stool, cramps in stomach, lethargic.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Malaise, Muscle twitching
Clinical narrative: Client presented to clinic on 11/19/2018 for a seasonal flu shot. Vaccine administered and client observed for 15 minutes before leaving clinic. Client reports on 12/21/2018 that he felt "sick" for a few days after the vaccine was given and noticed a week later some twitching and numbness in hand and feet. Went to see his PCP and was referred to a neurologist. Client went to neurologist and was diagnosed with Guillain-Barre. Has been instructed by his PCP to not receive any more seasonal flu vaccines.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: The following morning my right deltoid was swollen, hard, very sore, and hot to touch. Within two hours later I began running a fever and the pain began to radiate up my neck and to my ear. In the early afternoon, my vision was somewhat blurred and I began to have nausea, fever/chills, and headache. "Bruised" feeling muscle pain, hard, swollen, and hot to touch right deltoid continued until 01/01/2019.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Neck pain, Pain, Pyrexia
Clinical narrative: The following morning my right deltoid was swollen, hard, very sore, and hot to touch. Within two hours later I began running a fever and the pain began to radiate up my neck and to my ear. In the early afternoon, my vision was somewhat blurred and I began to have nausea, fever/chills, and headache. "Bruised" feeling muscle pain, hard, swollen, and hot to touch right deltoid continued until 01/01/2019.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: The following morning my right deltoid was swollen, hard, very sore, and hot to touch. Within two hours later I began running a fever and the pain began to radiate up my neck and to my ear. In the early afternoon, my vision was somewhat blurred and I began to have nausea, fever/chills, and headache. "Bruised" feeling muscle pain, hard, swollen, and hot to touch right deltoid continued until 01/01/2019.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Alanine aminotransferase normal, Albumin globulin ratio normal, Anion gap, Aspartate aminotransferase normal
Clinical narrative: Vomiting started the day after the vaccine. Patient had decreased appetite. Last stool was the morning after the vaccine was given. Went to the ER 3 days after the vaccine. Was treated with ZOFRAN and released. Oral rehydration protocol was reviewed by my staff and started Monday around noon. The patient tolerated the protocol but was less active, more sleepy and less responsive. Patient returned to the ER. I evaluated him there. We gave him 2 fluid boluses. Repeated his abd x-ray. He had large amounts of dark blood, currant colored on rectal. He was transferred to hospital. His exam was positive for intussusception. He had a barium enema to reduce the telescoping bowel but had a complication of perforation during the procedure. The surgeons then proceeded with laparotomy for reduction of the intussusception, resection of sessile mass in terminal ileum with ileocolic resection with ileostomy creation.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Barium enema abnormal, Basophil percentage decreased, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin normal
Clinical narrative: Vomiting started the day after the vaccine. Patient had decreased appetite. Last stool was the morning after the vaccine was given. Went to the ER 3 days after the vaccine. Was treated with ZOFRAN and released. Oral rehydration protocol was reviewed by my staff and started Monday around noon. The patient tolerated the protocol but was less active, more sleepy and less responsive. Patient returned to the ER. I evaluated him there. We gave him 2 fluid boluses. Repeated his abd x-ray. He had large amounts of dark blood, currant colored on rectal. He was transferred to hospital. His exam was positive for intussusception. He had a barium enema to reduce the telescoping bowel but had a complication of perforation during the procedure. The surgeons then proceeded with laparotomy for reduction of the intussusception, resection of sessile mass in terminal ileum with ileocolic resection with ileostomy creation.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood culture, Blood glucose normal
Clinical narrative: Vomiting started the day after the vaccine. Patient had decreased appetite. Last stool was the morning after the vaccine was given. Went to the ER 3 days after the vaccine. Was treated with ZOFRAN and released. Oral rehydration protocol was reviewed by my staff and started Monday around noon. The patient tolerated the protocol but was less active, more sleepy and less responsive. Patient returned to the ER. I evaluated him there. We gave him 2 fluid boluses. Repeated his abd x-ray. He had large amounts of dark blood, currant colored on rectal. He was transferred to hospital. His exam was positive for intussusception. He had a barium enema to reduce the telescoping bowel but had a complication of perforation during the procedure. The surgeons then proceeded with laparotomy for reduction of the intussusception, resection of sessile mass in terminal ileum with ileocolic resection with ileostomy creation.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein increased, Carbon dioxide normal
Clinical narrative: Vomiting started the day after the vaccine. Patient had decreased appetite. Last stool was the morning after the vaccine was given. Went to the ER 3 days after the vaccine. Was treated with ZOFRAN and released. Oral rehydration protocol was reviewed by my staff and started Monday around noon. The patient tolerated the protocol but was less active, more sleepy and less responsive. Patient returned to the ER. I evaluated him there. We gave him 2 fluid boluses. Repeated his abd x-ray. He had large amounts of dark blood, currant colored on rectal. He was transferred to hospital. His exam was positive for intussusception. He had a barium enema to reduce the telescoping bowel but had a complication of perforation during the procedure. The surgeons then proceeded with laparotomy for reduction of the intussusception, resection of sessile mass in terminal ileum with ileocolic resection with ileostomy creation.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased activity, Decreased appetite, Enema administration, Eosinophil count decreased, Eosinophil percentage decreased
Clinical narrative: Vomiting started the day after the vaccine. Patient had decreased appetite. Last stool was the morning after the vaccine was given. Went to the ER 3 days after the vaccine. Was treated with ZOFRAN and released. Oral rehydration protocol was reviewed by my staff and started Monday around noon. The patient tolerated the protocol but was less active, more sleepy and less responsive. Patient returned to the ER. I evaluated him there. We gave him 2 fluid boluses. Repeated his abd x-ray. He had large amounts of dark blood, currant colored on rectal. He was transferred to hospital. His exam was positive for intussusception. He had a barium enema to reduce the telescoping bowel but had a complication of perforation during the procedure. The surgeons then proceeded with laparotomy for reduction of the intussusception, resection of sessile mass in terminal ileum with ileocolic resection with ileostomy creation.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Glomerular filtration rate, Haematochezia, Haematocrit normal, Haemoglobin normal, Hyporesponsive to stimuli
Clinical narrative: Vomiting started the day after the vaccine. Patient had decreased appetite. Last stool was the morning after the vaccine was given. Went to the ER 3 days after the vaccine. Was treated with ZOFRAN and released. Oral rehydration protocol was reviewed by my staff and started Monday around noon. The patient tolerated the protocol but was less active, more sleepy and less responsive. Patient returned to the ER. I evaluated him there. We gave him 2 fluid boluses. Repeated his abd x-ray. He had large amounts of dark blood, currant colored on rectal. He was transferred to hospital. His exam was positive for intussusception. He had a barium enema to reduce the telescoping bowel but had a complication of perforation during the procedure. The surgeons then proceeded with laparotomy for reduction of the intussusception, resection of sessile mass in terminal ileum with ileocolic resection with ileostomy creation.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Ileectomy, Ileostomy, Intestinal perforation, Intussusception, Laparotomy
Clinical narrative: Vomiting started the day after the vaccine. Patient had decreased appetite. Last stool was the morning after the vaccine was given. Went to the ER 3 days after the vaccine. Was treated with ZOFRAN and released. Oral rehydration protocol was reviewed by my staff and started Monday around noon. The patient tolerated the protocol but was less active, more sleepy and less responsive. Patient returned to the ER. I evaluated him there. We gave him 2 fluid boluses. Repeated his abd x-ray. He had large amounts of dark blood, currant colored on rectal. He was transferred to hospital. His exam was positive for intussusception. He had a barium enema to reduce the telescoping bowel but had a complication of perforation during the procedure. The surgeons then proceeded with laparotomy for reduction of the intussusception, resection of sessile mass in terminal ileum with ileocolic resection with ileostomy creation.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lymphocyte count increased, Lymphocyte percentage increased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume decreased
Clinical narrative: Vomiting started the day after the vaccine. Patient had decreased appetite. Last stool was the morning after the vaccine was given. Went to the ER 3 days after the vaccine. Was treated with ZOFRAN and released. Oral rehydration protocol was reviewed by my staff and started Monday around noon. The patient tolerated the protocol but was less active, more sleepy and less responsive. Patient returned to the ER. I evaluated him there. We gave him 2 fluid boluses. Repeated his abd x-ray. He had large amounts of dark blood, currant colored on rectal. He was transferred to hospital. His exam was positive for intussusception. He had a barium enema to reduce the telescoping bowel but had a complication of perforation during the procedure. The surgeons then proceeded with laparotomy for reduction of the intussusception, resection of sessile mass in terminal ileum with ileocolic resection with ileostomy creation.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Mean platelet volume normal, Metabolic function test, Monocyte count increased, Monocyte percentage increased, Neutrophil count normal
Clinical narrative: Vomiting started the day after the vaccine. Patient had decreased appetite. Last stool was the morning after the vaccine was given. Went to the ER 3 days after the vaccine. Was treated with ZOFRAN and released. Oral rehydration protocol was reviewed by my staff and started Monday around noon. The patient tolerated the protocol but was less active, more sleepy and less responsive. Patient returned to the ER. I evaluated him there. We gave him 2 fluid boluses. Repeated his abd x-ray. He had large amounts of dark blood, currant colored on rectal. He was transferred to hospital. His exam was positive for intussusception. He had a barium enema to reduce the telescoping bowel but had a complication of perforation during the procedure. The surgeons then proceeded with laparotomy for reduction of the intussusception, resection of sessile mass in terminal ileum with ileocolic resection with ileostomy creation.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Neutrophil percentage decreased, Platelet count normal, Procedural intestinal perforation, Protein total increased, Red blood cell count normal
Clinical narrative: Vomiting started the day after the vaccine. Patient had decreased appetite. Last stool was the morning after the vaccine was given. Went to the ER 3 days after the vaccine. Was treated with ZOFRAN and released. Oral rehydration protocol was reviewed by my staff and started Monday around noon. The patient tolerated the protocol but was less active, more sleepy and less responsive. Patient returned to the ER. I evaluated him there. We gave him 2 fluid boluses. Repeated his abd x-ray. He had large amounts of dark blood, currant colored on rectal. He was transferred to hospital. His exam was positive for intussusception. He had a barium enema to reduce the telescoping bowel but had a complication of perforation during the procedure. The surgeons then proceeded with laparotomy for reduction of the intussusception, resection of sessile mass in terminal ileum with ileocolic resection with ileostomy creation.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Red cell distribution width normal, Somnolence, Vomiting, White blood cell count normal, X-ray abnormal
Clinical narrative: Vomiting started the day after the vaccine. Patient had decreased appetite. Last stool was the morning after the vaccine was given. Went to the ER 3 days after the vaccine. Was treated with ZOFRAN and released. Oral rehydration protocol was reviewed by my staff and started Monday around noon. The patient tolerated the protocol but was less active, more sleepy and less responsive. Patient returned to the ER. I evaluated him there. We gave him 2 fluid boluses. Repeated his abd x-ray. He had large amounts of dark blood, currant colored on rectal. He was transferred to hospital. His exam was positive for intussusception. He had a barium enema to reduce the telescoping bowel but had a complication of perforation during the procedure. The surgeons then proceeded with laparotomy for reduction of the intussusception, resection of sessile mass in terminal ileum with ileocolic resection with ileostomy creation.
Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Fatigue, Immediate post-injection reaction, Influenza, Insomnia, Mucosal discolouration
Clinical narrative: Noticed immediate fatigue and soreness in arm, followed next day by slow deterioration and worsening of sinus congestion, fever, muscle aches, insomnia, followed by third day of quite severe cold and flu symptoms, body ache and mucus turning from mostly clear to a greenish color.
Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Myalgia, Nasopharyngitis, Pain, Pain in extremity, Pyrexia
Clinical narrative: Noticed immediate fatigue and soreness in arm, followed next day by slow deterioration and worsening of sinus congestion, fever, muscle aches, insomnia, followed by third day of quite severe cold and flu symptoms, body ache and mucus turning from mostly clear to a greenish color.
Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Sinus congestion
Clinical narrative: Noticed immediate fatigue and soreness in arm, followed next day by slow deterioration and worsening of sinus congestion, fever, muscle aches, insomnia, followed by third day of quite severe cold and flu symptoms, body ache and mucus turning from mostly clear to a greenish color.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram normal, Hallucination, visual, Visual impairment
Clinical narrative: 15 min after administration pt had visual disturbance seeing white vertical lines and white spiders dropping from the ceiling.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Myalgia, Pain, Rash vesicular
Clinical narrative: Receive second dose of SHINGRIX on 12/28/18. Next day I got pain, swelling, headache, muscle pain, belly pain and rash look like shingles.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Receive second dose of SHINGRIX on 12/28/18. Next day I got pain, swelling, headache, muscle pain, belly pain and rash look like shingles.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase normal, Fluid retention, Injection site pain, Lymphadenopathy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient presented to the emergency department with pain at the site of a tetanus shot 5 days ago. Exam is very benign. She has no cellulitis, crepitus, edema. Does have some mild axillary adenopathy. She had an MRI that showed some nonspecific fluid around her deltoid. The radiologist had commented that this could be cellulitis versus myositis. However, provider did not think patient has either of these conditions. She has no fever, no elevation of her CK, no elevation of her WBC, no erythema, no warmth, no redness. Her fluid collection may be a nonspecific reaction to her vaccine. It could also be a small amount of blood. Patient reported she felt much better after a dose of IV TORADOL. Patient was discharged and instructed to follow up with PCP or the emergency department if condition didn't improve.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: White blood cell count normal
Clinical narrative: Patient presented to the emergency department with pain at the site of a tetanus shot 5 days ago. Exam is very benign. She has no cellulitis, crepitus, edema. Does have some mild axillary adenopathy. She had an MRI that showed some nonspecific fluid around her deltoid. The radiologist had commented that this could be cellulitis versus myositis. However, provider did not think patient has either of these conditions. She has no fever, no elevation of her CK, no elevation of her WBC, no erythema, no warmth, no redness. Her fluid collection may be a nonspecific reaction to her vaccine. It could also be a small amount of blood. Patient reported she felt much better after a dose of IV TORADOL. Patient was discharged and instructed to follow up with PCP or the emergency department if condition didn't improve.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain
Clinical narrative: Received SHINGRIX vaccine (first dose) and the next day had sharp stabbing pain in left eye only. Right eye was unaffected. No injury or infection or other issue except the vaccine. Placed Vaseline lubricant made for eyes in the left eye to keep it well moisturized and took pain medications and symptoms resolved in next 24 hours.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Body temperature increased, Myalgia, Rash erythematous
Clinical narrative: Patient had SHINGRIX and Pneumococcal-23 vaccine on same day and developed temperature of 102, myalgias, and red rash.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Extreme swelling around injection site of SHINGRIX.
Sex: F
Vaccine: CHOL, HEP, HEPA, TYP
Symptoms: Labelled drug-food interaction medication error, Syncope, Vomiting
Clinical narrative: This spontaneous case report was received from an other healthcare professional (PVX2018-3387) on 07-Dec-2018. The report describes a 20-year-old adult female consumer who fainted and vomited following the intake of VAXCHORA (company suspect) (lot no: 7000009 and expiry date: 28-Feb-2019). The consumer also "took an apple juice after taking VAXCHORA". The consumer also took Hepatitis A vaccine, Hepatitis B vaccine, and TYPHIM, (non-company suspect) for an unknown indication. It was reported that the consumer received several vaccines on 07-Dec-2018 (Hepatitis A, Hepatitis B, TYPHIM, and VAXCHORA). VAXCHORA was the last vaccine to be taken. She fainted about 45 minutes after the first vaccine was taken, or about 30 minutes after VAXCHORA was taken. As treatment, the nurse gave her water and apple juice and she also shared that, about an hour after administration of VAXCHORA, consumer had vomited. Furthermore, the nurse stated that the consumer had vasovagal response in the past with blood draws, but not with vaccines. The action taken with VAXCHORA, Hepatitis A vaccine, Hepatitis B vaccine, and TYPHIM with respect to the events fainted and vomited was unknown, while with respect to the event "took an apple juice after taking VAXCHORA" was not applicable. The clinical outcome of the events fainted and vomited was resolved, while with respect to the event "took an apple juice after taking VAXCHORA" was unknown. Company's Comment: In this case, it was reported that a 20-year-old female consumer fainted and vomited following the intake of VAXCHORA, Hepatitis A vaccine, Hepatitis B vaccine, and TYPHIM vaccines. There seems to be temporal association between the intake of VAXCHORA vaccine and the events. However, fainting episodes/ syncope are common adverse event after the intake of Hepatitis B vaccine, and TYPHIM vaccines. Also, fainting episodes could cause abdominal distress and can lead to nausea and vomiting as seen in this case. Hence, the causality of the events syncope and vomiting is assessed unlikely with VAXCHORA vaccine. The causality of the event " took an apple juice after taking VAXCHORA"was considered as not applicable.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, referring to a 4-year-old patient of unknown gender. There was no information reported regarding the patient's medical history, concurrent conditions or concomitant medication. On 21-DEC-2018, the patient was administered an improperly stored dose of PROQUAD (strength, route and dose not provided) lot # R017628 and expiration date 18-DEC-2019, for prophylaxis. The dose was reconstituted with a properly stored sterile water diluent (MERCK) (lot # and expiration date not provided). No adverse effects reported. It was reported that the storage temperature of the vaccines was 6 to 14 Fahrenheit degrees and the time frame was 18 minutes. There was no previous temperature excursion and the call was because of a "data logger". This case is one of two from the same reporter (Information captured in MARRS # 1812USA011839). Sender's Comments: US-009507513-1812USA011839.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dysphonia, Fatigue, Malaise, Mucous membrane disorder
Clinical narrative: I had the FLUZONE shot quad 2018-19 .5ml and became sick. First day I was very tired with severe muscle pain and the second day developed harsh voice, sore throat which continued to get worse with chest congestion, coughing and discolored mucous.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: I had the FLUZONE shot quad 2018-19 .5ml and became sick. First day I was very tired with severe muscle pain and the second day developed harsh voice, sore throat which continued to get worse with chest congestion, coughing and discolored mucous.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: THIS DOES NOT APPLY TO A SPECIFIC PATIENT. Several patients reported back to the administering pharmacist that they experienced more severe adverse reactions from their SHINGRIX vaccine. These symptoms included severe redness (cellulitis in one case), and severe flu like symptoms (chills, muscle aches, runny nose, headache, congestion/runny nose). When reviewing the cases, it appeared that the patients that had reported the most severe symptoms had received the same lot of the vaccine manufactured by GSK: A5X5B.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Influenza like illness, Nerve injury, Pruritus
Clinical narrative: Within a couple of days of the second SHINGRIX vaccination I experienced flu-like symptoms. Subsequent to that I experienced a burning sensation in my arm below the injection site. I am still experiencing burning and itching below the injection site (inside of left arm above the elbow). Feels like nerve damage. No rash. My doctor recommended I report this.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Person given adult Hep A vaccine but should have received child dose.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Erythema, Eye swelling, Fatigue, Generalised erythema
Clinical narrative: Patient received MMR #2. Within 15 minutes of getting the vaccine, her face was red, around her eyes were swollen. She was not acting herself, more tired. Her whole body then turned red. She was brought back to the office immediately. She was given BENADRYL and observed in the office.  She had no difficulty breathing. No swelling of lips. Prior to leaving the office, she was slightly more interactive and the rash was not worsening. At home, mom observed some tic-like movements, no seizures, that resolved. She was brought back into the office and was noted to have hives all over her body. These resolved that day. No symptoms since.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Tic, Urticaria
Clinical narrative: Patient received MMR #2. Within 15 minutes of getting the vaccine, her face was red, around her eyes were swollen. She was not acting herself, more tired. Her whole body then turned red. She was brought back to the office immediately. She was given BENADRYL and observed in the office.  She had no difficulty breathing. No swelling of lips. Prior to leaving the office, she was slightly more interactive and the rash was not worsening. At home, mom observed some tic-like movements, no seizures, that resolved. She was brought back into the office and was noted to have hives all over her body. These resolved that day. No symptoms since.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Hypersomnia
Clinical narrative: I developed alternating chills and sweats and slept for hours.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Headache, Nausea, Pruritus, Pyrexia
Clinical narrative: Swelling, nausea, headache, itch, fever, hoarse throat.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swelling, nausea, headache, itch, fever, hoarse throat.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Condition aggravated, Fatigue, Musculoskeletal pain, Myasthenia gravis
Clinical narrative: Sore shoulder for two days, Exacerbation of Myasthenia Gravis for two weeks, occurrence of weakness and fatigue caused increase in Mestinon dose.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Asthenia, Blood culture, Blood glucose, Coordination abnormal, Febrile convulsion
Clinical narrative: Simple Febrile Seizure at home, lasting no more than 5 minutes on 7/27/18, family concerns for decreased muscle strength and coordination following seizure. Fevers of 101-103. Second ED visit around 11:45pm 7/27/18 due to fever not responding to MOTRIN and TYLENOL- patient was under-dosed, fever control discussed in length. Complex febrile seizure in ED on 7/28/18, did not last past 5 minutes- neither had focality, neurology contacted and no further work up recommended. Rash started once fever broke and seizures stopped. Family history of febrile Seizures.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Full blood count, Metabolic function test, Pyrexia, Rash, Red blood cell count normal
Clinical narrative: Simple Febrile Seizure at home, lasting no more than 5 minutes on 7/27/18, family concerns for decreased muscle strength and coordination following seizure. Fevers of 101-103. Second ED visit around 11:45pm 7/27/18 due to fever not responding to MOTRIN and TYLENOL- patient was under-dosed, fever control discussed in length. Complex febrile seizure in ED on 7/28/18, did not last past 5 minutes- neither had focality, neurology contacted and no further work up recommended. Rash started once fever broke and seizures stopped. Family history of febrile Seizures.