chrisvoncsefalvay/vaers-outcomes huggingface dataset:
GUILLAIN-BARRE SYNDROME; FEELING UNWELL/BODY DIDNT FEEL RIGHT; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The patient reported that she started to not feel well shortly after. Her body didn't felt right. She went to the Emergency room and Urgent Care several times throughout the remainder of 2021. The beginning of 2022 started the same way and each time the Doctors said that it was just viral. The patient reported that On 22-MAR-2022 her body became increasingly numb from her neck down. She literally couldn't feel anything and couldn't hold anything in her hands. She lost the ability to stand and collapsed to the floor. She remembered being able to hear her husband talking but she couldn't open her eyes. An Ambulance was called and the patient was taken to the Emergency Room once again. They did a Spinal Tap, and she was admitted into the hospital for the first time. The number of days hospitalised was unspecified. After more testing to rule out Stroke, MS (multiple sclerosis), Lyme Disease she was told she had Guillen Barre Syndrome. She spent nearly two weeks in the hospital before she was moved to rehab for two weeks. She was released from rehab on 12-APR-2022 and continued therapy at home. Four weeks later she started to experience some of the same symptoms as in the beginning. Her husband took her to the doctor and they were asked to go back to the Emergency Room. The patient reported that it was worse this time. Her left arm and hand were completely useless along with both legs. She spent nearly two more weeks in the Hospital before once again being moved into a rehabilitation facility for four weeks. The patient was released on 15-JUN-2022 and was going to continue with home care for physical therapy and occupational therapy. The use of her left hand and arm had come back but not her legs and she was unable to walk. Laboratory data included: Spinal tap, not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from guillain-barre syndrome, and the outcome of feeling unwell/body didnt feel right was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220657124-covid-19 vaccine ad26.cov2.s-guillain-barre syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.
Bruise; Covid antibody test and it came back negative; some bleeding that soaked the bandage; some significant soreness and stated that the injection site is still sore if he presses on it; a very cold sensation at the injection site; felt a chill on his arm; This is a spontaneous report from a contactable Consumer(patient). A 71-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249, Expiry Date: May2021), intramuscularly on 15Jan2021 at 0.3 mL, single, left arm for covid-19 vaccination. Medical history and concomitant medications reported as none. There was some/fair amount of bleeding that soaked/saturated the bandage after the shot and a bruise developed that was 3 inches around and was there for 10 days and he still had the bruise. He said that there was also a cold sensation at the injection site when it was administered and he felt a chill on his arm. He said that he was calling because he wanted to make sure the first dose was effective. He said that his 2nd dose was due next week. The bleeding resolved within the hour and soaked the band aid itself. He said that it was not persistent bleeding it was just immediately after the injection. He also had some significant soreness at the injection site and stated that the injection site was still sore if he presses on it.  He never bothered to look at his arm and stated that he noticed the bruise was there about 8 days later. It might have been there prior to that, but he did not know. He had blood work done on the 25Jan2021 and asked for a Covid antibody test and it came back negative. The patient asked should there be a positive antibody test at this point? The patient asked did this mean he didn't develop immunity? The bruise had diminished but still there. The soreness was still there. The soreness was not sore if pressure was not put on it and was never sore if he laid on it. The patient was asking if Pfizer considered the vaccine to be viable. He was not on a blood thinner. Onset date of events "some bleeding that soaked the bandage" was 15Jan2021, of bruise was unknown, "some significant soreness and stated that the injection site is still sore if he presses on it" was 15Jan2021, "a very cold sensation at the injection site" was 15Jan2021. The outcome of event "some bleeding that soaked the bandage" was recovered on 15Jan2021, of bruise and "some significant soreness and stated that the injection site is still sore if he presses on it" was recovering, of other events was unknown.
Rash on both arms, abdomen, upper thighs, lymphnodes left arm pit swollen
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and allergies were not reported. On 20-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous, (strength and anatomical location were not reported), (lot # K006439 with expiration date: 05-AUG-2015), which was expired. No adverse events were reported. Additional information has been requested.
Myasthenia gravis; double vision; my left eye was drooping; my left arm could not be raised above horizontal position; This spontaneous case was reported by a consumer and describes the occurrence of MYASTHENIA GRAVIS (Myasthenia gravis) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Double vision. Concomitant products included AMLODIPINE, ATORVASTATIN, BUSPIRONE, FLUOXETINE, MELOXICAM and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYASTHENIA GRAVIS (Myasthenia gravis) (seriousness criterion medically significant), DIPLOPIA (double vision), OCULAR DISCOMFORT (my left eye was drooping) and LIMB DISCOMFORT (my left arm could not be raised above horizontal position). The patient was treated with EPINASTINE at a dose of 1 drop in each eye twice daily; PYRIDOSTIGMINE (oral) at a dose of 60 mg three times a day and MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) (oral) at a dose of 500 mg twice a day. At the time of the report, MYASTHENIA GRAVIS (Myasthenia gravis) outcome was unknown and DIPLOPIA (double vision), OCULAR DISCOMFORT (my left eye was drooping) and LIMB DISCOMFORT (my left arm could not be raised above horizontal position) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company comment: This case concerns a 79-year-old, male patient with a medical history of double vision, who experienced the unexpected events of myasthenia gravis, diplopia, ocular discomfort, and limb discomfort. The events occurred on an unknown date. The rechallenge is not applicable in this case as the relationship of events to dose cannot be determined. The reporter's assessment was not provided. The concomitant use of meloxicam, buspirone and amlodipine remain confounders as these drugs can adversely affect myasthenia gravis. The benefit-risk relationship of the Moderna Covid-19 vaccine is not affected by this report.   This case was linked to MOD-2021-326958 (Patient Link).; Sender's Comments: This case concerns a 79-year-old, male patient with a medical history of double vision, who experienced the unexpected events of myasthenia gravis, diplopia, ocular discomfort, and limb discomfort. The events occurred on an unknown date. The rechallenge is not applicable in this case as the relationship of events to dose cannot be determined. The reporter's assessment was not provided. The concomitant use of meloxicam, buspirone and amlodipine remain confounders as these drugs can adversely affect myasthenia gravis. The benefit-risk relationship of the Moderna Covid-19 vaccine is not affected by this report.
ITCHY EYE; SNEEZING; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855101 expiry: 11-APR-2022) dose was not reported, administered on 30-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced itchy eye, and sneezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchy eye and sneezing was not reported. This report was non-serious.
Patient called next day and said area around shot is filled with pus like material. Doesn't itch Patient iced it.
Temperature 101.0, vomiting after eating, inconsolable screaming 45mins to 1 hour throughout the day off and on.
reddness below site of inject; arm warm to touch arm swollen & hard; pt ran temp of 102;
Arms hurt and  legs ached; Terrible cough; Burning mouth; A little dehydrated; Fever of 100.9 (degrees Fahrenheit); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arms hurt and  legs ached), COUGH (Terrible cough), ORAL DISCOMFORT (Burning mouth), DEHYDRATION (A little dehydrated) and PYREXIA (Fever of 100.9 (degrees Fahrenheit)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Flu in 2020.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arms hurt and  legs ached), COUGH (Terrible cough), ORAL DISCOMFORT (Burning mouth), DEHYDRATION (A little dehydrated) and PYREXIA (Fever of 100.9 (degrees Fahrenheit)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arms hurt and  legs ached), COUGH (Terrible cough), ORAL DISCOMFORT (Burning mouth), DEHYDRATION (A little dehydrated) and PYREXIA (Fever of 100.9 (degrees Fahrenheit)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Nausea, rash behind left ear, muscle pain, weakness, joint pain, lethargy, headache
After receiving anthrax #2 on 12 Nov 07, he reports he developed bilateral elbow and bicep pain that interfered with exercise. He also reports experiencing flu-like sxs that lasted for 4-5 days. This UE pain never resolved. After receiving anthrax #3 on 13 Mar 2008 he reports a worsening of the UE pain that has continued until the present. It occurs only with activity or physical strain such as lifting heavy objects. Reports no increase in UE pain with anthrax #4 on 11 Jun 09. Symptom: Joint Pain, isolated, Muscle Pain.
Chills; Insomnia; soreness at injection site; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 09Jan2021 12:15 in left arm at single dose for COVID-19 immunization. Medical history included chronic sinusitis from an unknown date and unknown if ongoing. There were no concomitant medications. On 09Jan2021 12:45, the patient experienced chills, insomnia and soreness at injection site. No treatment was given to the patient for the events. The outcome of the events was recovering. The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
pt recvd vax 530PM, same day, severe vomiting, chills, fever;lasted thru the noc; was OK the next day;
Local reaction with cellulitis. Required urgent care visit 9/8/18 and antibiotic treatment for 10 days.
On 07/08/2022 I had sore throat and symptoms like a sinus or pollen allergy symptom or infection and the next morning the pain was worse than before and tested positive with a at home test. I developed a headache. I did have a fever until the end of the day that went from 102 to 108. I went to urgent care and had a PCR COVID-19 test that was positive. I was told to take zinc, vitamin C and MUCINEX twice a day. On today 07/22/2022, day 14 I have tested negative. I am now fatigue more in the evening falling asleep more than normal. I developed a slight productive cough that is not often but occurs.
Child was given Flu shot and then 3 hours later developed rash on face and back. Reaction happened at 11:55. Mom notified by phone 12pm. BENADRYL liquid given by mouth at 12pm BP 90/70 P 102 R 24 all at 12:09.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) and NO ADVERSE EVENT (no adverse event) in an 8-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064A22A and 064A22A) for COVID-19 vaccination.     Concurrent medical conditions included ADHD and Asthma. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT HFA), CLONIDINE, METHYLPHENIDATE HYDROCHLORIDE (RITALINA) and METHYLPHENIDATE HYDROCHLORIDE for an unknown indication.   On 03-Nov-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Dec-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Dec-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.       No treatment information provided.
patient didn't respond to series; This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a 34-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B and the 1st dose of Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional deatils were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient did not respond to1st series of Engerix B vaccine, which led to therapy non-responder. This case was linked with case US2022021691, for the 2nd series of Engerix B vaccine with same patient and same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022021691:Same patient, different series
My lips have swollen about 6 different times (1 time per side upper left, upper right side, lower right side,lower left side) all at different. Also my finger, toe, and side have all swollen at different times. I have also had rashes on my legs, hands, arms, stomach.
48 hours following injection, i experienced dizziness, left arm numbness. left facial numbness. 72 hours after vaccine , i had heart rate 160's, dizziness, and short period of backing out. recovery was slow, felt everything was 'off' felt slow moving .
Extreme muscle weakness/fatigue which worsened and finally abated on 11/3. Nausea which peaked on 11/2 and abated by afternoon on 11/3.
Weakness in hands; Left arm pain,Forearm pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in hands) and PAIN IN EXTREMITY (Left arm pain,Forearm pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 048A21A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included CHLORPHENAMINE MALEATE (CHLORTAB [CHLORPHENAMINE MALEATE]) for Allergy, IBUPROFEN for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced MUSCULAR WEAKNESS (Weakness in hands) and PAIN IN EXTREMITY (Left arm pain,Forearm pain). At the time of the report, MUSCULAR WEAKNESS (Weakness in hands) outcome was unknown and PAIN IN EXTREMITY (Left arm pain,Forearm pain) had not resolved.            Other concomitants included arthritis medicine but patient was not taking. Patient had left arm pain but it was not constant Patient has no allergies. Patient not had COVID positive. Not took other vaccines. And patient was not an immunocompromised Treatment medication were not reported
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown ages and genders. The nurse reported that on unknown dates, unknown number of patients might have been vaccinated with doses of PNEUMOVAX 23 (dose, lot number, expiration date and route of administration not reported) that had multiple excursions. No adverse effects were reported. Follow up information has been received from another registered nurse who stated that she did not had any additional information regarding PNEUMOVAX 23. She was not in the office when the temperature excursion occurred. This is one of several reports received from the same source. Additional information has been requested.
Ten days after vaccination - severe reddness/induration/cellulitis and drainage. Positive bacterial infection treated with Cipro 500 mg po BID x 10 days.
Hospitalized (not for COVID, but for diverticulitis and C. diff - 11.17.21) within 7 days of receiving vaccination.   Admission Date: 11/17/2021 Discharge Date: Nov 21, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute diverticulitis Acute on chronic colitis Ulcerative colitis with complication, unspecified location HOSPITAL COURSE: 79 year old female with a history of ulcerative colitis who presented with 12 days of worsening diarrhea and left lower quadrant abdominal discomfort.  Symptoms began after taking Keflex for a skin biopsy.  In the emergency department she had CT imaging of her abdomen and pelvis showing colitis beginning in the transverse colon and into the sigmoid colon and also some component of diverticulitis in the sigmoid colon.  Stool for C difficile toxin was positive. She was treated with oral vancomycin 125 mg q.i.d., Rocephin, and IV Flagyl for the diverticulitis.  She had excellent improvement in her abdominal pain although she still had some diarrhea by discharge. Medications at discharge: 1. For diverticulitis take Keflex 500 mg 4 times daily and Flagyl 500 mg 3 times daily for 7 days to complete treatment. 2. For Clostridium difficile colitis take vancomycin liquid 125 mg 4 times daily for 10 days.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a pharmacist concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported, expiry: unknown) dose was not reported, dose number in series was 1, 01 in total was administered on FEB-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 31-DEC-2021, the patient contracted coronavirus disease (COVID-19) (suspected COVID-19 infection) breakthrough infection roughly 2 weeks ago (end of December beginning of January) which resulted in suspected clinical vaccination failure (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable The outcome of the suspected COVID-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The case was associated with regulatory authority.; Sender's Comments: V0 20220126472-COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
hard to breathe.  I am allergic to cats; the outcome when I'm around cats has always been difficulty breathing.  Consequently, I make it a point to stay away from cats.  Post the Moderna COVID vaccine dose #1, my breathing is labored, and my lungs feel congested and heavy with wetness.  6 days ago, I came into contact with a cat, which sent me into a hyper state of difficulty breathing 5 days ago, which lasted for a full 24 hours.  Post that episode, my breathing continues to be labored, and my lungs continue to feel congested and heavy with wetness.  I can go about my day, but I'm not at 100%, like I was before I took dose 1 of the vaccine.
Vaccinated with J&J on 11/12/21. Presented to ER on 1/3/22. COVID positive on 12/29/21. who presented to ED with increasing work of breathing.  Reports nausea with vomiting and diarrhea for several days. Patient denies fevers, chills, body aches, headaches, loss in sense of taste or smell.  She had tested +ive for COVID 19 on December 29 stating symptom onset was three days prior to positive test.  She received the Johnson and Johnson vaccine approx 4 months ago.  CXR demonstrated bilateral pulmonary opacities.  A CTA chest is ordered.  Labs are all in process.  She is to be admitted at this time for further management. Received ceftriaxone, azithromycin, dexamethasone, and remdesivir. Discharged on 1/12/22
After the vaccination patient sat down in waiting room next to the pharmacy.  He passed out in his chair and appeared to have a seizure.   He was pale in color and had sweat dripping off is forehead.  Blood pressure was 150/90 and pulse 80 bpm.  He was given a cold compress and two bottles of water to drink.  After 45 minutes patient felt fine and was able to leave on his own.