chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe chills; muscle aches all over; rhabdo-like and mild fever; This is a spontaneous report from a contactable physician reported for himself via Pfizer sales representative. A male patient of an unspecified age started to receive bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at SINGLE DOSE second dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of vaccine bnt162b2 on unknown date. On an unspecified date the patient experienced severe chills, muscle aches all over and rhabdo-like and mild fever on an unspecified date all with outcome of recovering. The action taken was not applicable. Therapeutic measures were taken: Advil. .  Information on the Batch/Lot number has been requested.
Diarrhea, headache, fever (101.7), severe lethargy. This lasted for 2 days and then she started experiencing headaches and fever again on 10/05/2012.
pt recv vax 10JUL95 830AM & 530PM felt tired;545PM body ached, felt weaker, a throbbing h/a started, slept;6PM pt awoke feeling hot, feverish, sweaty, went back to sleep 10PM;awoke in chills;joints ached;denied hunger;inj site red & inflam
Information has been received from a nurse concerning a 16 year old patient of unknown gender. On an unknown date the patient was vaccinated with a dose of PROQUAD (Merck) (strength, dose and lot# were unknown). (Drug administered to patient of inappropriate age). No adverse effects reported. Additional information has been requested.
This is a spontaneous report from a contactable nurse. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration on an unknown date in May2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, hashimoto's disease and patient was allergic to sulfa (sulfonamide). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on an unknown date in 2021 at 15:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation.  On 08May2021 at 03:00 the patient experienced fever highest 101.7, vomiting, muscle aches, cramping, headache, weak and tired. On same day the patient underwent body temperature and the result was 101.7 (unspecified unit). The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever highest 101.7, vomiting, muscle aches, cramping, headache, weak and tired were recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
Since the vaccine, bilateral lymph node swelling in the neck and right ear pain (7 months)
High fever of 102°F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever of 102°F) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 01-Dec-2020.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PYREXIA (High fever of 102°F). At the time of the report, PYREXIA (High fever of 102°F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Pyrexia: (High) 102°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
On 1/20/21 at 0900 started to have acute itchiness in right deltoid area.  Viewed right upper arm in mirror and noted redness at previous injection site.  Approximately 1" - 1.5"  directly below the reddened area, there were hives which appeared to be almost in a circle.  The acute itchiness lasted for 2 hours then subsided.  Both areas very red.  Throughout the day there was intermittent itchiness at both locations.  Redness faded somewhat but still visible throughout the day.  Notified Medical Center COVID call line.  Notified primary care provider.  No treatment administered.  Continued to monitor throughout the day.    At 1600, headache present.  Took Tylenol 500 mg 2 tablets by mouth.   At 1645, felt warm.  Took temperature with Infrared thermometer and noted temperature was 98.9 at that time.  In the morning of 1/21/21 as of 0635, redness in right deltoid injection site and area below remains present and fading.  Some  itchiness continues.
Itching started at the injection site - left tricep region then radiated to arm, back, abd, ears, then thighs.  No rash or hives.  Patient sent to ER for further evaluation.
This is an initial report received 02-NOV-2016 via a telephone call from a nurse practitioner. The nurse practitioner reported that an unknown number of patients may have been vaccinated with the following improperly stored vaccines: RECOMBIVAX, lot # M032653, expiration date 31-MAY2018, M-M-R-II, lot# M017346, expiration date 06-APR-2018, GARDASIL lot# K008621, expiration date 04-MAR-2017. It was reported that the storage temperature was 20 degrees C for 120 days (2,880 hours). It was reported the excursion dates were: 01-JUN-2016 through 30-AUG-2016. There was no previous temperature excursion. It was unknown if the vaccines were administered. No adverse events were reported. This telephone call report was because of a data logger. Additional information was requested.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 23-DEC-2016, the patient was inadvertently vaccinated in addition to a scheduled dose of VARIVAX with a dose of PROQUAD, (lot # M007965 with an expiration date in 15-AUG-2017), for prophylaxis. No adverse event was reported and no product quality complaint was involved. Additional information has been requested.
On Saturday, 11/6, approximately 15 hours after the vaccine I developed chills and fever 100-100.9 and a mild headache until I went to sleep. I awoke feeling fine the next day. The following evening, 11/8 I felt 'anxious' and took my pulse. My rate was fine (about 72 bmp) but I noticed the pulse was irregular. The symptoms continued and I  made an appointment with a cardiologist who saw me on 11/11.
The day after the injection, I felt dizzy, chilled, and weak.  I went back to bed for 3 hours, got up and didn't have the energy to do anything else for the remainder of the day.  I felt normal when I got up the following morning.
Information has been received from a physician concerning a 19 month old female who on 18-MAY-2009 was vaccinated orally with the first dose of ROTATEQ (lot # 663359/1661X), the second dose on 20-JUL-2009 (lot # 663711/0107Y) and the third dose on 21-SEP-2009 (lot # 663909/0184Y). On 12-NOV-2010 this past Friday, the patient experienced an outbreak of confirmed rotavirus. The patient was not hospitalized. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Follow-up information has been received from a licensed practical nurse via a medical record. It was reported the female child had been given all 3 doses of ROTATEQ vaccines on time. On 12-NOV-2010, the patient was diagnosed with rotavirus. The stool test revealed negative for clostridium difficile toxin assay and positive for rotavirus antigen on 12-NOV-2010. On an unspecified date, the patient recovered. Additional information is not expected.
Patient is a 91 year old male with hx of Afib on chronic warfarin tx, CAD s/p stents, PPM placement, CKD III, and prostate CA s/p suprapubic catheter placement, who presented to the ER due to positive home COVID test 12/29.  Pt states that he had approximately 20 family members visiting from all around the country (some of whom are still at his home).  Two 13yo family members tested positive yesterday during their drive back and were positive.  He reports that his test came back positive, but that 4-5 other household contacts have all tested negative so far.  He reports that all of those gathered that were vaccine-eligible were vaccinated and that the adults had received boosters.  Pt reports that for the last 2 days he has had some mild increase in his baseline cough, SOB, and pinkish blood-tinged sputum, as well as reported low-grade fever ~100.1.  His daughter-in-law, who is a nurse, recommended that he come to the ER.  Pt has not noted any change in his taste or smell or appetite, no HA, or myalgias.  He has not hand nausea/vomiting, loose stools (notes constipation at baseline), or change in urinary habits.  Pt states that his last 2 home INR checks have been elevated (on Tuesday INR>8) and he did not take a dose last night.  He indicates that Prednisone was started a few months ago "for more energy."  Pt's O2 sats were reported as low at home (70's?), 86% on RA ABG in ER.  Discharged on Discharge DX: 1. 2019 novel coronavirus disease (COVID-19), Discharge, 12/30/2021 2. Acute respiratory failure with hypoxemia, Discharge, 12/30/2021 3. Sleep apnea on CPAP, Discharge, 12/30/2021 4. Chronic atrial fibrillation, Discharge, 12/30/2021 5. Chronic anticoagulation, Discharge, 12/30/2021 6. Supratherapeutic INR, Discharge, 12/30/2021 7. Type 2 Diabetes mellitus with hyperglycemia, Discharge, 12/30/2021 8. Peripheral neuropathy, Discharge, 12/30/2021 9. CKD (chronic kidney disease), stage III, Chronic renal insufficiency, stage III (moderate) 10. Anemia, Discharge, 12/30/2021 11. Essential hypertension, Hypertension 12. Sinoatrial node dysfunction s/p PPM, Discharge, 12/30/2021 14. Hypercholesteremia, Discharge, 12/30/2021 15. Chronic diastolic congestive heart failure, Discharge, 12/30/2021 16. Coronary artery disease s/p stents, Discharge, 12/30/2021 17. GERD - Gastro-esophageal reflux disease, Discharge, 12/30/2021  Discharged home with family.
Covid arm-on day 8. 1 large, itchy hive reaction. Lasted about 5 days.
Per Consult Note received COVID vaccine x2 and booster. Inpatient hospitalization, ICU admission. Covid PNA. Transferred from outside facility for futher management.
headache; arm hurt all the way up to neck L; arm hurt all the way up to neck L; dizziness; queasy; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).   A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) in the left arm on 19Mar2021 at 10:30 (at the age of 57-years-old) as a single dose for COVID-19 immunization. Medical history included supraventricular tachycardia (SVT), hypergamagolbulinaemia benign monoclonal, asthma, diverticulosis, fatty liver, clot blood, perimenopause and borderline diabetes. Patient reported allergies to latex allergy, sulfonamide allergy. The patient previously received KEFLEX, verapamil (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medications included acetylsalicylic acid (ASPIRIN) and enalapril maleate, lercanidipine hydrochloride (ZANEXTRA) from unknown date for an unknown indication received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient experienced headache, arm hurt all the way up to neck L, dizziness, queasy on 19Mar2021. Details were as follows: on 19Mar2021, within 10 minutes after the vaccine, the patient experienced headache, left side pain all the way up to neck, queasy and dizziness. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the events. On 03Apr2021, the patient underwent COVID-19 test (nasal swab) and the result was pending. The clinical outcome of experienced headache, arm hurt all the way up to neck L, dizziness, queasy was not recovered.    No follow-up attempts are needed. No further information is expected.
Red rash to chest area with no pain noted per patient. Swelling around injection site, per client tender & red.
stated that he is on crutches; stated that he cannot walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WALKING AID USER (non-serious), outcome "unknown", described as "stated that he is on crutches"; GAIT INABILITY (non-serious), outcome "unknown", described as "stated that he cannot walk".  No follow-up attempts are possible. No further information is expected.
" Presents to the ED via EMS from NH for evaluation of L sided weakness .  Treated with steroids, antibiotics, supplemental O2; S Patient had findings suggestive of septic shock. She was given aggressive IV hydration. Suspicion was pneumonia. Her condition has been on a slow decline. Patient with multiple hospitalizations and does not seem to be getting significantly better. family has decided to proceed with hospice care.
Headache, Myalgia, Fever, NauseaVomiting, chills, pain in arm on injection site Narrative:
Red, hard, warm to the touch at injection site, warm compresses and ice packs, also BENADRYL for and itching that may occur.
After taking Comvax at 13 months, pt developed pneumonia.  Pt has history of haemophilus b vaccine and hep b at 2 months and at 4 months haemophilus b.  Pt was also give haemophilus b and hep b at 12 months. Information has been receicved from a physician concrerning an otherwise healthy 13-month-old female patient with no history of recurrent infection who was vaccinated with COMVAX. Subsequently the patient experienced severe pneumonis and was hospitalized. Blood cultures were positive for Haemohilus flu type b. No pinal tap was performed. Vaccination history includes COMVAX at age 2-months-old and heamophilus B conjugate vaccine at age 4-months-old. It was noted that since the patient had a birth dose of HEV, the health department gave haemophilus B conjugate vaccine at 4 months and then gave COMVAX at 12-months. It was also reported that the patient did not receive a booster dose and that the patient received two appropriate doses of "OMP" in infancy. An ELISA titer of 1.92 mcg/ml was reported at day 14 of the patient's infection. Follow-up information reported that the patient has recovered from the pneumonia and has been discharged to home. Additional information has been requested.
red bumps on tip of nose for first 30 minutes; on day 8 sore throat and dry skin for 1 week Narrative:
Patient developed high fever 104F at day 7-10 and rash on torso, back, face and legs. Treated with over the counter fever reducer Tylenol, Motrin.
This spontaneous report was received from a male patient of unknown age. The patient's medical history included prior heart attack (dates unspecified). Patient stated that he also previously had an allergic reaction to an unspecified medication, but he did not recall the details  of the reaction or what medication had caused it or what was the manufacturer. On an unknown date (reported as "5 or more years ago") the patient was vaccinated with ZOSTAVAX ("one shot", therapy route "injection", lot number unspecified by the reporter). Concomitant medications included: many unspecified medications, including unspecified pain medicine (manufacturers unspecified). Patient reported that, beginning "about 6 or 7 months after" having received ZOSTAVAX, he has had recurring shingles-like spots which have been in the region of his "back and rear" and "mostly on his left side". He has gotten one or two spots in this area of his body "every 3 or 4 weeks" ever since the first onset. He currently has a spot. Patient sought medical attention and his physician diagnosed these spots as "shingles". An unspecified salve was given to the patient as a treatment for the adverse event. The patient reported also having difficulty remembering things. None lab tests were performed. The outcomes of having difficulty remembering things were unknown and not recovered from shingles. The relationship between the ZOSTAVAX and the events was not provided. Additional information has been requested.
Patient started having symptoms on 9/23/14 at 11pm. First symptom was chills at 11 pm then shortness of breath at 2 am, then patient passed out and woke up at 6 am and had no other problems.
Patient immediately experienced dizziness that did not resolve and evolved into vertigo that she sought medical attention for on 08/26/2021. MD told her to call us to report ADR. Taking Lorazapam and Meclizine.
Pain in head, body, eyes and arm. Fever, chills and large painful swelling at injection site.
Sore throat began 1 hour after vaccination. It became severe and lasted 72 hours. There was a large accumulation of clear mucus in the throat beginning at 48 hours. After 72 hours, marked improvement. No fever.
This spontaneous report was received from a nurse practitioner via a company representative, referring to a female patient of an unknown age. Information about her historical conditions, drug reactions or allergies and concomitant medications were not provided. On an unspecified date in 2019 (reported as early February), the patient was vaccinated with GARDASIL 9 for prophylaxis (anatomical location, route of administration, lot number and expiration date were not provided). On an unknown date, the patient experienced hives (urticaria). By the time of the report, the outcome of the event was not provided. The causality assessment between GARDASIL 9 and urticaria was not provided.
Roughly 14 hours after receiving her second vaccine, my daughter had a 100.3 temperature, vomited once, and said her head hurt.  She also had chills with her fever.  Tylenol was given and that helped.  This morning I gave her another dose of Tylenol and she has started to eat a little.  She says her head still hurts and we are pushing the fluids.  I haven't taken her temperature this morning but she feels cooler and is feeling better, although her energy comes & goes.
I received and tolerated the booster with no adverse effects. I started getting very tired and had a cough on 12/27/2022. I tested positive COVID-19 on 12/29/2022. I contacted my doctor and was given the prescription PAXLOVID. I took one dose and had to stop as it made me sick. I was really sick for eight days. I lost my sense of taste and smell. I also tested positive for COVID-19 on 01/09/2022. As of today, I will have a coughing spell for a day or two. I now use FLONASE daily.
first shot hurt; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix a few months ago and experienced pain. For the tolerence of 2nd dose refer case US2020AMR041761, reported by same reporter for the same patient.
Patient was not eligible for 4th dose of COVID vaccine. Patient is not immunocompromised. 1st dose- 5/14/21 2nd dose- 6/4/21 3rd dose- 1/7/22
Information has been received from a registered nurse concerning a 51 year old male patient with no past medical history and no known drug allergies, who on Oct 09, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 3639394/0416L). It was noted the patient had been vaccinated with a dose of influenza vaccine the day before (Oct 08, 2002). On the night of Oct 09, 2002 the patient's arm became "extremely painful, swollen, and hard", although there was no redness around the injection site. The patient developed difficulty in raising his arm. It was noted the patient did not know whether he had ever received the pneumococcal vaccine 23 polyvalent in the past. Unspecified medical attention was sought. Additional information has been requested.
Patient enrolled in the Janssen study received study medication (Janssen ad26.CoV2.vaccine) on 10/17/2022. Of note, the patient was recently admitted 12/2/2022 -12/8/2022 with worsening fatigue and weakness, poor appetite, weight loss, Acute kidney injury and found to have CMV viremia was initiated on Valcyte. improved to 3.5 with IV fluids. Myfortic was held and prednisone increased. Discharged from hospital on 12/8/2022 prescribed home health care to follow up with kidney transplant nephrology. Unfortunately, patient required direct admission to the hospital on12/27/22 with reports of continued weight loss (10 kg over 1 month) and was unable to eat due to pressure in abdomen. He reported ongoing diarrhea and significant weakness, extreme difficulty even getting out of a chair. Creatinine was 2.4; IVF were started. CMV was negative and BK urine and blood were undetected. Urine culture was negative. GI was consulted and EGD and flex sigmoidoscopy were done. EGD showed esophageal plaques consistent w/ candidiasis. Fluconazole was started 12/29 with plan to continue through 1/18/2023. Colonic mucosa was grossly normal. He did have perianal hemorrhoids and non-bleeding external and internal hemorrhoids. Biopsies in colon, stomach and duodenum were negative for CMV. The flex sigmoidoscopy report suggested the sigmoid colon had focal features suggestive for mild graft-versus-host disease and focal nonspecific acute colitis. GI enteric pathogen panel was negative. GI pathogen panel was positive for norovirus and the patient was started on nitazoxanide 500mg BID x3 days. His diarrhea resolved. Case reviewed with both GI and hem/oncology who felt this finding in the sigmoid colon was due to norovirus rather than GVHD therefore no further treatment was pursued. Due to two negative CMV PCR, Valcyte was discontinued 12/30 and we will continue to monitor with weekly CMV DNA PCR. During admission, he had anemia requiring blood transfusion and Aranesp. Nutrition team was consulted, and thiamine was initiated for refeeding syndrome (multivitamin continued). He initially required phosphorous repletion, now only potassium supplementation and has been provided a prescription upon discharge. Physical therapy recommends home health PT. He has all needed equipment at home. By 1/4/2023, diarrhea has resolved, appetite improved, and Creatinine improved overall. Patient discharged with low dose Lasix due to edema. Patient discharged on 1/4/2023 condition stable. Discharge diagnosis: candidiasis and norovirus. Principal Investigator assessed causality as not study related.
metal taste in mouth with all foods the 1st day, but now metal taste in mouth only with proteins, meat, chicken, eggs,  and cannot eat them, very little with fish, none with shellfish,