chrisvoncsefalvay/vaers-outcomes huggingface dataset:
side effects as muscles soreness; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced muscle soreness and tiredness. On an unknown date, the outcome of the muscle soreness and tiredness were unknown.   It was unknown if the reporter considered the muscle soreness and tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-Feb-2023 Reporter's comment: The patient stated that typically how long do the side effects last after the shot and had muscles soreness and tiredness were main ones. The patient stated that did not want to give out his/her information to random people. The reporter denied to follow-up.
Thawed and refrozen vaccine was administered to patients; Poor quality vaccine administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Thawed and refrozen vaccine was administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Thawed and refrozen vaccine was administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On 06-Oct-2021, PRODUCT STORAGE ERROR (Thawed and refrozen vaccine was administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
large hard knot; Swelling at site of injection; itching in the arm of injection; redness at site of injection; Swelling face; warm at site of injection; Swelling lymph nodes of neck and breast; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING FACE (Swelling face), VACCINATION SITE WARMTH (warm at site of injection), LYMPHADENOPATHY (Swelling lymph nodes of neck and breast), VACCINATION SITE INDURATION (large hard knot) and VACCINATION SITE SWELLING (Swelling at site of injection) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (seasame). Concomitant products included MULTIVITAMINS [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced SWELLING FACE (Swelling face), VACCINATION SITE WARMTH (warm at site of injection), LYMPHADENOPATHY (Swelling lymph nodes of neck and breast) and VACCINATION SITE ERYTHEMA (redness at site of injection). On an unknown date, the patient experienced VACCINATION SITE INDURATION (large hard knot), VACCINATION SITE SWELLING (Swelling at site of injection) and VACCINATION SITE PRURITUS (itching in the arm of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swelling face and Vaccination site swelling, at a dose of 1 dosage form and IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, SWELLING FACE (Swelling face), VACCINATION SITE WARMTH (warm at site of injection), LYMPHADENOPATHY (Swelling lymph nodes of neck and breast), VACCINATION SITE INDURATION (large hard knot), VACCINATION SITE SWELLING (Swelling at site of injection), VACCINATION SITE ERYTHEMA (redness at site of injection) and VACCINATION SITE PRURITUS (itching in the arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-020217 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19-APR-2021 and it contains No new information On 07-May-2021: Follow up received on 07-MAY-2021 and added updated patient's demographics. Patient's medical history and concomitant drugs were added. Events were added large hard knot and itching in the arm of injection.
No additional AE; improperly stored DILUENT that had a not supported TE was used to reconstitute an MMR II vaccine; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, allergies and drug reactions were not provided.  On 13-OCT-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin, (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #U031360, expiration date: 07-OCT-2023, (strength, dose number, route and site of vaccination were not provided) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin, (M-M-R II) was reconstituted with a improperly stored, sterile diluent (STERILE DILUENT) solution for injection/infusion, 0.5 milliliter, administered once, lot #W009116, expiration date: 04-NOV-2023 (strength, route and site of administration were not provided) (product storage error). The suspect therapies underwent the temperature excursion of -23 Celsius (C) degrees for 17 hours. The previous temperature excursion did not occur. No additional adverse event (AE) (no adverse event).
burning in the site of the administration; pain in the site of the administration; This case was reported by a pharmacist via call center representative and described the occurrence of injection site burning in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site burning and injection site pain. On an unknown date, the outcome of the injection site burning and injection site pain were unknown.   It was unknown if the reporter considered the injection site burning and injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-SEP-2022 Reporter's Comments: The pharmacist reported that the patient experienced burning and pain in the site of the Shingrix administration.
Had postponed quarterly steroid shot for inflammatory arthritis and stopped Celebrex 500 mg  BID three days prior to shot to maximize response to vaccine. On fourth day following vaccine, woke to terrible arthritis pain in left shoulder and across back and chest. Pain continues to present but helped some by tramadol 50 mg . Not sure if it was vaccine related or if stopping anti-inflamatory meds allowed arthritis pain to resurface. Have scheduled shoulder replacement.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 07-APR-2015, the patient was vaccinated with improperly stored (Merck) VARIVAX lot# J013728, expiration date 30-OCT-2015 (dose and route were not reported). No adverse symptoms reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information has been requested.
No adverse effects; patient was administered an improperly stored VARIVAX; Information has been received from an office manager who was in charge of vaccine storage, referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug/allergies reactions were not provided.  On 25-JUN-2019 the patient was administered an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S000132, expiration date 02-JAN-2021; strength, dose number and route were not reported) for prophylaxis (product storage error). No adverse effects.   Temperature and Time frame: 6 degrees Fahrenheit to 14 degree Fahrenheit (8.2 F) for 1 hour and 25 minutes; 15 degrees Fahrenheit to 46 degrees Fahrenheit (16 F) for 5 minutes. No data logger.
My son took the Oral Rotavirus vaccine on September 6th, 2022 at 2:15 PM and the three in one vaccine (Dtap,HepB,IPV). He was fine after on that day (09/06/2022) and the following days 09/07/2022-09/08/2022. On September 9th, 2022 at 12:15 he had made a bowel movement. Two hours later he made another bowel movement and i noticed blood in it. At 4:30 he made another bowel movement and there was no blood in it. I gave him a bottle and then 30 mins after the bottle he made another bowel movement and there was blood in that. an hour after he made another bowel movement with blood in it. Over the course of the day September 9th, he had over 5 blood, mucusy, bowel movements. All throughout the night he had severe diarrhea. Me being a first time mom i was terrified. At around 4:30 AM i took him to Hospital to get looked at. I explained to the pediatrician there what has been going on. He explained that the rotavirus vaccine can create bloody stools and that he isn't showing signs of intussusception and that there isn't anything they can do about it other then letting it run its course and we were discharged. My son has had severe diarrhea since Friday 09/06 12;15 pm and also has a extremely bad rash around his bottom area due to the diarrhea. I will be taking him to his pediatrician 09/13/2022.
Patient received casirivimab instead of intended COVID vaccine.  48-hr follow up didn't identify AEs. Patient received COVID vaccine on December 31
Pt found unresponsive in bed at end of a nap, unable to resuscitate, went to ER and death pronounced.  4/6/07 Received Autopsy Report which reveals COD as Undetermined.  Had flu like symptoms for few days prior to death.  Found face down on mattress on floor of nursery in home.
Patient says body aches and chills started the evening of the 17th. On the 19th she coughed up blood. Patient is trying to get in to see her MD.
blurred vision, dizzeness, passed out  went to hospital by ambilance heart rate was 40
This spontaneous report was received from a registered nurse referring to a 13 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was inadvertently vaccinated with a dose of PROQUAD and a dose of VARIVAX (dose, route, lot numbers and expiration dates for both therapies were not provided) reconstituted with sterile diluent, for prophylaxis. There were no adverse effects reported. Additional information has been requested.
Pt developed a runny nose with a nose bleed a few hours after receiving FLUZONE HD vaccine. Event only occurred once and there ws no other events reported.
MONOVALENT VACCINE WAS ADMINISTERED IN ERROR FOR A BIVALENT BOOSTER DOSE. ADVISED FACILITY CDC RECOMMENDS DO NOT HAVE TO REPEAT DOSE BUT MAY ADMINISTER BIVALENT VACCINE IN 2 MONTHS.
After 4th dose, the ringing in her ears lasted for about 4 months and it was very loud/With the first 4 doses, the ringing was only in one ear; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (After 4th dose, the ringing in her ears lasted for about 4 months and it was very loud/With the first 4 doses, the ringing was only in one ear) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Cholesterol, Macular degeneration (status such as improvement or worsening was reported as Stable.) since 2019, Drug allergy (allergy to Meloxicam) and Fruit allergy (allergy to Blueberries). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, BEVACIZUMAB for Macular degeneration, LEVOTHYROXINE SODIUM (SYNTHROID) and TRETINOIN for an unknown indication.    On 11-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (After 4th dose, the ringing in her ears lasted for about 4 months and it was very loud/With the first 4 doses, the ringing was only in one ear). At the time of the report, TINNITUS (After 4th dose, the ringing in her ears lasted for about 4 months and it was very loud/With the first 4 doses, the ringing was only in one ear) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: blood pressure was normal at 118/75.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received five doses of the Moderna COVID-19 vaccine and it included Moderna COVID-19 bivalent booster. After each shot Patient experienced ringing in ear. With the first 4 doses Patient experienced the event of ringing in ear, and it was only in one ear. Patient read that dehydration could be a cause of ear ringing. However, the Patient consumed a lot drinking water. Hence Patient concluded that dehydration was not cause. Also, Patient has normal blood pressure hence Patient ruled out that it was also not cause for ringing in ear. As patient read online that ringing in ear could be caused due to high blood pressure  Patient did not experience a similar event in the past. Patient went to hearing doctor for the symptoms.  Symptoms improved over time between each shot for patient and it came back whenever Patient had another Moderna shot.  Patient never had COVID-19 or Patient never test or diagnosis with COVID-19.  No treatment medication was reported.   This case was linked to MOD-2022-661330, MOD-2022-661339 (Patient Link).
Swollen/painful arm on Day1. On Day2, two large red areas appeared around injection site. The red patches had small blisters like a 2nd degree  sunburn and was painful like a sunburn. Arm was still mildly swollen/muscle painful. On  Day 3 the blisters began to dry and crack open. Skin became less red, but itchy and started to peel. As of today, May 1, 2021, the redness is gone, but still peeling and itchy. Whatever this was is mostly gone.  Other Day 1 side effects were typical... slight fever and extreme tiredness, but this was over by the end of Day 2.
Second dose was given outside window - given  15 days following 1st dose rather than 28 days 3/26/2021 - Blood sugar swings dramatic highs and lows. Stabilized within about 24 hours
Fever associated, generalized tonic/clonic seizure. Seen at ER and put on Zithromax due to mildly abnormal chest X-ray. No recurrence.
about 1 hr after vaccines patient returned to office with significant urticarial rash to body, including surrounding lips. No tongue swelling. Prescribed prednisolone x 2 days (initial dose given in office), and Ranitidine x 1 day. Also benadryl given in office and as needed. Rash/bruising mostly cleared after a couple of days. Rash/bruising lasted longest on Right thigh, it finally cleared up on friday afternoon.
Patient reports red area with firm center that is a little larger than a quarter to injection site. Area is painful with palpation.
48 hours post vaccine I started having sore throat, cough, fever for the next three days. Later I got tested positive. 5 days after vaccine I was experiencing SOB but all symptoms were gone after 10 days post injection. Not sure if I was exposed to people with covid prior to receiving the vaccine. I also do work with covid patients at work
Started feeling weak next day after shot.  As days went by I became increasingly short of breath.  This continued for over 2 weeks and then started having chest pain.  Went to ER and admitted with pericarditis.  2 days later I went into Atrial fib.  The next day I had a cardioversion.  Home the following day.  One week at home not feeling well, I was readmitted with increased chest pain and shortness of breath.  Pulse very low and needed a pacemaker which was inserted Easter Sunday.  Home now and still not feeling well.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Fatigue, Chills, and Difficulty Sleeping Narrative:
This spontaneous report as received from a nurse practitioner via company representative refers to a 26 year old female patient. Medical history included other unspecified medical problems. The patient was not pregnant. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (Lot number, expiry date, route and dose were not reported). On an unknown date, the patient developed muscle pain, fever, joint pain and neck pain. The patient sought medical attention for the same (saw the doctor). The outcome of developed muscle pain, fever, joint pain and neck pain was reported as recovering/resolving. Additional information has been requested.
Information has been received from a 58 year old female occupational therapy student with no pertinent medical history reported and no known drug allergies who in "late 1960's" as a teenager was vaccinated with a dose of MERUVAX (dose, route and lot number not reported). There was no concomitant medication. The patient reported that an antibody titer in June 2010 revealed a negative titer to rubella. It was not specified if the patient sought medical attention. Additional information is not expected.
Took shot 1/20 and asked the RN if I should take it because I explained I just got over covid, I told her I wasn?t sure how long it was  on Dec 19 I was raking leaves and I thought I should do this because I started having runny nose. I didn?t feel well that afternoon sneezing because I thought it was nothing. As the week went on I started sneezing and coughing and stopped up nose. I always end up with sinus infection when I get a cold Dec 28 I went to the doctor at doctors care and they did a covid test before the doctor would see I tested positive.  I went home and rested, no energy, felt like I was hit by a train, couldn?t breathe, sneezed a lot and hardly coughed.  January 1, I called ambulance and went to hospital, I was sick the first week of January.  I didn?t know that you should wait 90 days to get the vaccine after you?ve had Covid.  After I got the vaccination the adverse reaction, I woke up during the night with my arm hurting bad and throbbing and a very large red circle appeared on my arm 2? in diameter. The next 3 days I felt like I had covid all over again, the 4th day I woke up and felt a little better and got out of bed and started making progress each day. Now I?m not good, but I?m ok.
5 hours post injection on 02/06/07, the patient experienced acute onset of fever, malaise, inability to move, shortness of breath, and difficulty speaking. 911 was called, but the patient did not go to the hospital. Follow up received 02/22/07: The patient was seen at the doctor's office on 02/09/07. The patient said her symptom resolved 2-3 hours after they began on 02/06/07, and they have not occurred.
Information has been received from a physician reporting himself. The physician vaccinated with PNEUMOVAX 23 instead of flu vaccine in error on an unspecified date. The physician experienced injection site reaction for past 2 days, swollen 3 by 2 inch area on his left arm and cellulitis like reaction around his axilla. The physician received a dose of PNEUMOVAX 23 vaccine 2 years ago without a problem. At the time of the report, the physician's outcome was not recovered. No further information is available.
Headache, Sedation, Arthralgia, Fever, fatigue, and tiredness Narrative:
10 minutes after injection had tachycardia, anxiety, dizziness that lasted for about 15 minutes before resolving with some residual left cheek numbness.  Had swollen area around injection site for next four days with intense itching, as well as pain ar injection site.  On day 11 post vaccination, developed a rash on injection site covering the area that was previously swollen, approximately 3 inches in diameter as well as tender lymph nodes in left armpit.
injection site pain; chills; fever; didn't use their arm for 3 days; bexsero at an age younger than recommended; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 9-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Concurrent medical conditions included asplenia.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, less than a year after receiving Bexsero, the patient experienced injection site pain, chills, fever, injected limb mobility decreased and inappropriate age at vaccine administration. On an unknown date, the outcome of the injection site pain, chills, fever, injected limb mobility decreased and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the injection site pain, chills, fever and injected limb mobility decreased to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered a dose of Bexsero at an age younger than recommended which led to inappropriate age at vaccine administration. The patient was recommended to receive Bexsero due to them having no spleen. The patient experienced injection site pain, chills, and fever and didn't use the arm for 3 days. The reporter did not consent to follow up.
Hospitalized (10.21.21);  COVID-19 positive (10.21.21);  Fully vaccinated  Admission Date: 10/21/2021 Discharge Date: 10/24/2021 DETAILS OF HOSPITAL STAY: HOSPITAL COURSE: 83 y.o. male who presented with worsening cough, shortness of breath  found to be COVID 19 positive on date 10/21 with pulmonary embolism. He was treated with decadron, 4 day course of remdesivir as well as home inhalers. He initially required 2L NC but was weaned to room air. He improved both clinically and in lab findings. He was discharged home in stable condition to complete decadron course.  CT as above regarding PE. Patient initially started on heparin for PE for suspicion of failed anticoagulation with Xarelto. Home xarelto had been held for upcoming biopsy prior to admission, indicating PE not due to treatment failure. Patient transitioned to loading dose of Xarelto. Echo limited in quality but did not show clear evidence of right heart strain.
Developed rash and paresthesia of arm/upper chest, lasted for almost 3 weeks.