chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acute myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute myocarditis) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Acute myocarditis) outcome was unknown. Related      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Acute myocarditis) to be related.    Concomitant and treatment medications information was not provided.  Patient presented with acute chest pain.  Company Comment: This literature non-study case concerns a 22 year old male patient with no medical history reported , who experienced Serious ( hospitalization , medically significant ) , expected event of myocarditis which occurred on an unknown date after vaccination with the 2nd dose of mRNA-1273 vaccine . It was reported that this patient presented with acute chest pain. The details surrounding this event were not reported since the full text of this literature for review is not available.The event outcome was reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. The reviewer has limited information regarding this case as mentioned since the full text was not available at the time of the medical review   This case was linked to MOD-2022-513533, MOD-2022-513580, MOD-2022-513581.; Sender's Comments: This literature non-study case concerns a 22 year old male patient with no medical history reported , who experienced Serious ( hospitalization , medically significant ) , expected event of myocarditis which occurred on an unknown date after vaccination with the 2nd dose of mRNA-1273 vaccine . It was reported that this patient presented with acute chest pain. The details surrounding this event were not reported since the full text of this literature for review is not available.The event outcome was reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. The reviewer has limited information regarding this case as mentioned since the full text was not available at the time of the medical review.
"Covid Arm"- Redness, itchiness, rash, delayed cutaneous hypersensitivity at injection site. Currently the size of a quarter, firm and itchy/hot. Started exactly one week post injection, itchiness lasted one day.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 43-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No concomitant medications was provided. No treatment medications was provided.
2/28/21 Patient presented and was admitted through the emergency department for confusion, weakness, and low grade temperature (100.1 F). On admission, pertinent labs were Hgb of 5.1, WBC 60k which was consistent with autoimmune hemolytic anemia (AIHA).. Patient was diagnosed with chronic lymphocytic leukemia in 2016. The patient has had a prior history of AIHA in 2017.  Per the Agency, hospitalizations are to be reported irrespective of attribution to vaccine.
Received flu shot about 2:00 PM.  At 6:00 PM, I began to shake very hard from head to toe.  I couldn't walk or hold anything in my hands.  My husband was home.  Got in my recliner.  Was really bad.  I knew it had to be the shot.  About 9:00 it slowly started to leave from head to toe.  Then it was gone.  The next day my arm was red, swollen & fevered.  That was ok that evening.  Doctor was out of town.  I spent most of the day - 9/30/09 in my recliner.
07Mar98 pt recv 1 dose vax. 11Mar98 pt devel varicella-like lesions & fever.
Pt presented to health dept 11-9-01 with check out redness in right upper inner arm. Right arm consisted with edema. Pt stated 11-08-01 she had pain, redness and edema in right upper arm radiating into right axilla and elbow. T101. No redness or edema noted in right deltoid on 11-09-01. Pt stated no fever or pain in arm today 11-09-01. Pt reported on 11-07-01 that she had no constrain and ration to Flu or pneumonia shot. On 11-09-01 pt stated that she has had a pneumonia shot at Dr's office and it reacted the same way and MD told her that the shot was probably not effective and for her to get another shot. Received another pneumonia shot 12-01-98.
Itchiness, pain, soreness, redness, fever, chills, development of lump all on left arm.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On 05-AUG-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), at a pharmacy, for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient developed facial and nerve pain accompanied by numbness originating on the right side of his face. On 02-SEP-2016, the patient presented to medical clinic, his primary care physician, and was assessed as suffering from nerve pain and trigeminal neuralgia believed to be a reaction to ZOSTAVAX vaccine. Shortly thereafter, on 05-OCT-2016, the patient underwent a magnetic resonance imaging (MRI) of his brain which indicated worsening of the patient's trigeminal neuralgia. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. The events of Trigeminal neuralgia, nerve pain and persistent strain of herpes zoster were disabling. Additional information has been requested.
ADVERSE EVENT IS ONLY RELATED TO A DELAY IN THE INTERVAL OF ADMINISTRATION. PATIENT RECEIVED DOSE #1 ON 5/7/21. PT CANCELLED MULTIPLE TIMES FOR SECOND INJECTION. DOSE #2 GIVEN 6/30/21 ON DAY 54 POST INJECTION OF DOSE #1. SPOKE WITH MODERNA CUSTOMER CARE PRIOR TO ADMINISTRATION AND DISCUSSED LACK OF DATA SUPPORTING EXTENDED INTERVAL DOSING. DISCUSSED WITH PATIENT AND MOTHER PRIOR TO ADMINISTRATION. PATIENT AND MOTHER VERBALIZED UNDERSTANDING OF INFORMATION AND AGREED TO TODAY'S INJECTION.
maculopapular erythematous and urticarial rash on upper chest, bilateral UE
body aches, low grad temp, nausea that led to one episode of dry heave vomiting, weakness & fatigue
This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (A little flare up of arthritis) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 024M20A) for COVID-19 vaccination. The patient's past medical history included Autoimmune arthritis (Autoimmune disease Arthritis) and Flare up of arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for an unknown indication. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced ARTHRITIS (A little flare up of arthritis). The patient was treated with CERTOLIZUMAB PEGOL (CIMZIA) for Arthritis, at an unspecified dose and frequency and ETANERCEPT (ENBREL) in July 2021 for Adverse event, at an unspecified dose and frequency. In May 2021, ARTHRITIS (A little flare up of arthritis) had resolved. The patient stated that she has not felt arthritis pain this bad (compared to after vaccination). Company Comment: This case concerns a 56-year-old female patient with relevant medical history of Autoimmune arthritis and Flare up of arthritis (before first dose of mRNA-1273), who experienced the unexpected non-serious adverse event of special interest, Arthritis (A little flare up of arthritis). The event occurred the same day after receiving the second dose of mRNA-1273 Vaccine. The patient was treated with CERTOLIZUMAB PEGOL (CIMZIA) and then with ETANERCEPT (ENBREL). It is reported that the event had resolved 1 month and 12 days after the event. Rechallenge is not applicable since the patient had a flare up before the first dose and it is not reported when it had resolved. The medical history of Autoimmune arthritis and Flare up of arthritis remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. This case was linked to MOD-2021-407194, MOD-2021-407413 (Patient Link).; Sender's Comments: This case concerns a 56-year-old female patient with relevant medical history of Autoimmune arthritis and Flare up of arthritis (before first dose of mRNA-1273), who experienced the unexpected non-serious adverse event of special interest, Arthritis (A little flare up of arthritis). The event occurred the same day after receiving the second dose of mRNA-1273 Vaccine. The patient was treated with CERTOLIZUMAB PEGOL (CIMZIA) and then with ETANERCEPT (ENBREL). It is reported that the event had resolved 1 month and 12 days after the event. Rechallenge is not applicable since the patient had a flare up before the first dose and it is not reported when it had resolved. The medical history of Autoimmune arthritis and Flare up of arthritis remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Shingles to right leg,  4 days after 2nd vaccine, near ankle.  9 days later rash started to spread resembling amoxicillin rash in children ( no recent medication taken except Tylenol, benadryl)
Presented with SOB with known Coviod exposure; Dx Covid PNA; elevated liver enzymes due to Covid; treated with steroids, Vit C, Vit D, Zinc, remdesivir, O2, antibiotics; discharged home on O2
This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 55-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.  Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. Concurrent medical conditions included distal pancreatectomy and splenectomy. On 1st September 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 1st September 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter was the patient. The patient had preoperative care after a distal pancreatectomy and splenectomy in October 2021. The patient received 1st dose Bexsero at the age of 55 years old, which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.
Fatigue, mental confusion, brain fog.  Moderate skin rash lasting 5 days
This case was reported by a healthcare professional (nurse) via a sales representative and described the occurrence of injection site pain in approximately 20 subjects of unspecified age and gender who were vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline). On an unspecified date in 2013 the subjects received a dose of FLUARIX Quadrivalent (unknown details). In 2013, within months of vaccination with FLUARIX Quadrivalent, the subjects experienced injection site pain, injection site redness, swelling at the injection site and nodule at the injection site. The nurse reported from multiple sources that "they have experienced fairly significant local reactions to FLUARIX" Quadrivalent. The nurse reported that one subject was a physician who contacted GlaxoSmithKline. The nurse documented that she "did not have any information on the patients affected but instructed the employees to call GlaxoSmithKline if experiencing any side effects following FLUARIX QIV administration". At the time of reporting the outcome of the events were unspecified. The nurse reported another case with FLUARIX QIV. See case A1043774A for details on the other case. Follow up was received from the nurse on 21 October 2013. The nurse reported that the case had been reported to a regulatory agency; however, the reference number was not provided. No further details were provided.
**I do not know which influenza vaccine I had, I just chose one from the list*** I had a flu shot at work around 11am. I have never before had a flu shot, but didn't expect any issues. By 2pm I was very anxious and felt very itchy. I had on cheap jeans so i just attributed my itchy legs to that and the anxiety was attributed to being at work on a beautiful Friday afternoon. Once i got home from work around 5pm and changed, i noticed i had hives all over my knees. My throat was also a little itchy, but that isn't uncommon for me. foods/drinks/seasonal allergies give me an itchy/swollen throat alot. I went to urgent care and they gave me a steroid shot. The hives were gone within minutes and my throat was also clear again.
I am breastfeeding my 15 month old son and he got a rash on his abdomen and face that has progressed more over past several days. He has had no fever but acts like he doesn?t feel great as he was not eating like his normal self. I don?t know if the rash is related or not but it is during the time of the vaccine.
On 10/10/2013 Pt c/o generally not feeling well. On 10/11/2013 Pt. states couln't get out of bed, c/o neck pain, can't turn neck, pain radiating from neck to head.  Pt. states she had to support neck and head by using hands for support.  Denies fever, cough.  Denies any synptoms at site of injection.  Pt. did see her private MD and was prescribed an antiinflamatory medication x4 days.  Pt. states she is feeling much better, symptoms have lessened, but have not gone away 100%.
Area where shot administered had bright red, itchy rash about 3 inches long and 2 inches wide.  Also sore and tender to touch.
Had mild pain and headache after 1st vaccine on 3-1-2021. Symptoms were even milder after 2nd vaccine on 3-29-2021. BUT scheduled a cortisone injection for knee pain on 4-19-2021, 3 weeks after last vaccine dose. About 10 minutes after the shot while leaving the building, I had a severe reaction which included chest pain, shortness of breath, dizziness, and a bright red flushing all over. Returned to orthopedic office where I was monitored until an ambulance arrived and transported to the hospital. After monitoring, blood tests, EKG was allowed to go home and requested to do a follow up with a cardiologist and primary care physician. Most symptoms had resolved prior to transfer to hospital. Still running a low grade fever this evening. I was concerned that the combination of my MS, MS medication, COVID vaccine and cortisone injection may have caused this extreme reaction.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022; No adverse event; The patient administered the vaccine after the 30 days by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022).    No concomitant product use was reported. The patient received half dose. The vial had not undergone any temperature excursions. No treatment information was provided.
Pt received DTaP in left thigh on 3/21/03. Came in on 3/24/03 with c/o swollen L thigh where had vaccine. Tender to touch; red.
felt horrible; This case was reported by a consumer via  interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose and experienced felts awful, refer case US2021AMR241338).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had reported for him/herself. The patient received Shingles vaccine after his/her sister had them. After receiving Shingles vaccine, the patient felt horrible and stated that, it was better than getting shingles. This case had been linked with case US2021AMR241338, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241338:same patient - 1st dose
My left arm has a red, raised circular swelling around the vaccination site that is about 3 inches in diameter and very warm. It has persisted for more than 2 days and I have taken Benadryl to treat it.
later in evening knot size of grapefruit appeared on leg-diff walking would not play no temp noted; seen by MD recvd Augmentin x 10d;
Notes: Pt had adverse vaccine reaction about 1-2 minutes after injections of menactra and Tdap (in separate arms). Per mother, she blew her nose, then asked mom to "hold" her. When mother was giving hug, patient went "limp" in her arms, then leaned back with "convulsions" and "eyes rolled back." This lasted 5-6 seconds as mother laid her on table then called for help. Pt recalls asking mother to hold her, then the room going dark, then hearing mother call out of room. No loss of bowel or bladder control. She may have hit head slightly against mirror as she was being placed in reclining position. Patient observed to be very shaky and sweaty after event but was coherent and responding to questions appropriately.  She was observed in office for >30 minutes after immunization reaction with BP, pulse checked and remained stable.
Patient was given second dose of Moderna vaccine at 17. Patient tolerated well, no adverse reaction.
FEET SWELLING UP; EDEMA IN LEGS; PRESSURE ON CHEST; WATER RETENTION; This spontaneous report received from a patient via a company representative concerned a 51 year old female. 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: Unknown, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced water retention. On 18-MAR-2021, the subject experienced feet swelling up. On 18-MAR-2021, the subject experienced edema in legs. On 18-MAR-2021, the subject experienced pressure on chest. Treatment medications (dates unspecified) included: furosemide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pressure on chest, feet swelling up, and edema in legs, and the outcome of water retention was not reported. This report was non-serious.
Client reported burning sensation starting in arm vaccine given on 1/8/22. By 1/9/22 she developed some redness on her Lt deltoid. By 1/10/22 the redness increased and she presented to clinic to have it evaluated. RN observed erythematous area across upper lt deltoid measuring 120x150mm with lacy edges. Not warm to touch. No induration noted. Client did not apply any cold or take any medication to alleve symptoms.
pt recvd vax for prophylaxis; 3 days later exp flu-like synd; arthritis, myalgia, & a generalized rash; tx w/ anti-histamines & steroids; asymptomatic p/ 1 wk;
See initial office note, attached (10/17/2014). Progressive neurologic sx also including paresthesia and head bobbing/tremor. EE presents for evaluation of reaction to influenza vaccination. EE received IIV at 0800 on Wednesday 10/15/2014. Since receiving the vaccine EE has developed pain in her large joints (knees, hips, shoulders), some generalized swelling, fluid retention, and difficulty breathing/SOB with some increased wheezing. EE is well know to this author from another matter. EE is highly sensitive to sulphites and other sulfur compounds. EE has no swelling of the lips, tongue or throat at this time. EE's sx have been slowly progressive since receiving the vaccine.