chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of neurological problem in a 51-year-old female subject who was vaccinated with Fluarix (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of Fluarix (unknown).  At an unspecified time after vaccination with Fluarix, the subject experienced an unspecified neurological problem.  At the time of reporting the outcome of the event was unspecified.
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via The Agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA277871, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
3/12" x 3/12" x 3" Red, circular rash in area of ecclymosisin center. Mild tenderness, and warmth.
Shot Dec 22 1:30 pm. Tingling in feet, legs at 2pm on Dec 23. Decreased but still tingling by Dec 30, 2009. Also pain in back for 3 days.  2009
Patient said that he had had some chest tightness that happened after the shot as well as increased stomach acid. He did not specify exactly when it had happened but it was not immediately after the shot and was sometime the next day. He said it had since gone away. He was not sure if this was caused by the vaccine or possible anxiety. He was told to seek emergency care with the chest tightness and to notify his doctor. It is not known if he actually went.
Patient said arm was sore, said it felt like it was paralyzed and heavy. She said she experienced rashes all over her body, especially where things were tighter, like her watch. She had a migraine, a quick fever, and fatigue. She said she followed up with her doctor, and she said to just put creams on the rashes. We suggested to maybe get a second opinion. Everything cleared up except the rashes and fatigue.
Rash started on 9/24/2023. Rash covering entire body including palms.  Baby had increased fussiness and feeding intolerance. Had expected fever for 3 days after  vaccination. Fever had resolved as of 9/23/2023. Mom noted that sibling who is now 5 had similar reaction to 1 year old vaccines
Temperature of 102 the next day after first shot, while also taking Motrin and Advil, nausea, intense shaking and body aches, foggy headed, swollen sensitive lymph nodes and body muscle pain on left side and low energy the first round of symptoms lasted about a week.  Then I had severe migraines and throwing up even though I?ve never had migraines before. This lasted about a week. Then I began to develop painful lymph nodes and got shingles, also something that has never happened before. Shingles healing right as I got second shot on March 5th and had same high fever sick reaction as first week of second shot but with diarrhea this time which I did not have the first time.
upper respiratory infection; Heart medication/ Heart disorder; injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection), CARDIAC DISORDER (Heart medication/ Heart disorder) and INJECTION SITE RASH (injection site rash) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa (Moderate to Severe).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection), CARDIAC DISORDER (Heart medication/ Heart disorder) and INJECTION SITE RASH (injection site rash). At the time of the report, UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection) and CARDIAC DISORDER (Heart medication/ Heart disorder) was resolving and INJECTION SITE RASH (injection site rash) had resolved.            No concomitant medications were reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The reporter's causality for the event(s) of injection site rash and upper respiratory infection with Adalimumab Solution for Injection was Reasonable Possibility. The reporter's causality for the event(s) of Heart medication with Adalimumab Solution for Injection was Not Provided.   No treatment medications were reported.
Patient received a Moderna Covid 2nd booster vaccine dose instead of  the Pfizer Covid 2nd booster vaccine dose requested.  Patient reached telephonically and informed of the error. Had no concerns or questions and was provided a Moderna consent for the vaccine she received which she completed and signed.
Breast size increased about a month after first injection. Soreness and pain in joints?elbows, knees and wrists began about once month after first injection. Soreness comes and goes throughout the  day.
I and my wife were out of the country, and was diagnosed with COVID-19 about 3 days after returning home. Called doctor but did not go into office.
Slight itching; A spontaneous report  was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced slight itching/pruritus.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced Slight itching/pruritus.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   on an unknown date the outcome of  slight itching/pruritus was unknown.
Product storage error; No adverse event; Expired dose was administered on 11FEB2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose was administered on 11FEB2023), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 11-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose was administered on 11FEB2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose was administered on 11FEB2023), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired dose was administered on 11FEB2023) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medication information provided. Individual vial size was 2.5 ml.  Date the vial was initially stored in the refrigerator was 24-Jan-2023  The vial did not undergo any temperature excursions. No treatment information provided.
4 hours post vax, the pt complained of feeling tired, left upper arm was red, inflamed, and swollen.
The patient experienced an injection site reaction on her right arm. She first recognized the reaction on 10/20 (the morning after she received the vaccine). Between 10/20/16 and 10/21/16, the size of the reaction area grew significantly. We referred her to the Student Health Center on campus and she was evaluated by a physician. She was prescribed a short course of hydrocortisone for the inflammation and was told to monitor the site. She will follow up with the Health Center if it worsens.
Information has been received from a physician concerning a 72 year old female with allergies to penicillin, sulfa, tetracycline, and prochlorperazine maleate (COMPAZINE) and no other medical history who on 16-OCT-2006 was vaccinated SC in the right arm with a dose of ZOSTAVAX (lot #652936/0981F). Concomitant therapy included raloxifene hydrochloride (EVISTA). On 17-OCT-2006 the patient developed a welt at the site of injection. The site of injection was swollen, red, and itchy. The physician stated that the patient had an appointment to be examined on 18-OCT-2006. The patient was currently taking topical hydrocortisone cream and would be advised to take diphenhydramine. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
I developed cough and fever (to 101 degrees) 46 hrs after the injection. I had fever for 4 nights and productive cough, headache, and sore throat. I was short of breath with walking and peak flow dropped by 30%. Symptoms lasted 1 week. Left arm swollen and red. Swelling lasted 2 wks.
Employee received Flu vaccine 0n 10/26/23. On 10/28/23 he noted one hive around the injection site.  On 10-31-23 he noted 4-5 hives around injection site and contacted Employee Health where he got the vaccine.  RN talked with the Chief Medical Officer who is over Employee Health.  Employee took Benadryl at home after work and on 11/3/23 he stated the hives disappeared after the Benadryl.
dizziness some days after the first shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness some days after the first shot) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness some days after the first shot). At the time of the report, DIZZINESS (dizziness some days after the first shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment or concomitant information was provided   This case was linked to US-MODERNATX, INC.-MOD-2021-073835 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073835:Patient's case
bright red and warm to touch spot with hard bump under the skin that expanded over the course of 4 days.
Body aches headache pain stomach pain was admitted into the hospital due to reaction. Oxygen cut off to my colon. 2 week stay in hospital.  GI and pain doctors. Icemic colitis due to reaction.
pt reports immediate itching & hives 10NOV92 severe allergic reaction displaced rt arm lateral to inner aspect; vax given rt deltoid; 8" x 5" area immediately below (2") visualized site of inject-reddened, pt reports terrible itching;
Have had increasingly significant pain in left shoulder. It is not at the injection site. It feels as though it is in the joint. I do not have a history of arthritis at the location. Has become increasingly worse to the point that I cannot lift the arm without severe pain in the shoulder joint area. Tylenol and ibuprofen do not seem to help.
(L) arm, deltoid & neck cellulitis within 18 hrs of administration 100.4 temp.
On the same day as the employee received the vaccine at 10:00pm she began having itching all over her body difficulty sleeping and muscle aches in upper extremities/back areas. No rash at the time nor shortness of breath. The next day she noted that her whole body seemed swollen arms, legs, face and then she noted blotches of red all over body - not raised, they were flat. She did take a ZYrtec  which seemed to help a little. She saw her provider on 4/9/18 who suggested she take Benadryl 25 mg. which helped a lot. She reported this to Employee Health on 4/10/18 and her sore muscles and blotchy rash and swelling had gone. She is still slightly itchy but no rash.  She is concerned about getting additional Hepatitis B vaccination IF she needs it.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history concurrent conditions, drug reactions and allergies were not reported. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT) Lot # N013297 and expiration date 25-SEP-2019. On 01-MAY-2018, the patient was vaccinated with an expired dose of VARIVAX for prophylaxis, lot #M005972 and expiration date  02-FEB-2018 (strength, dose, frequency and route of administration were not reported). No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1805USA002676: US-009507513-1805USA001997:
Upon getting my second shot of Maderna for COVID, my blood sugars, which are under control in normal situations for a diabetic (A1C in the low 6s) spiked for 2 weeks.  They only just this past Monday returned to normal and I am now in normal ranges.  I am not sure this is a symptem or not but it is peculiar because I kept exercising and dieting the same as before the shot.
Moderna COVID-19 Vaccine EUA. Approximately one week after receiving the first vaccine, I began experiencing pain in my left elbow and now it has also moved down to my knuckles on my left hand. It continues to this day and is sometimes severe.
Pfizer 3/20/21 and 4/10/21. Positive on 1/13/22
Pt felt sick to her stomach, vomited, and developed a fever 2 hours after getting vaccine. She had flu like symptoms for 36 hours following vaccine
Infant received vaccine on 9/23/20 after a well child exam.  Infant returned to clinic on 9/28/20 with a low grade fever and enlarged lymph node on left side of neck. Infant was sent to ER on 9/28/20 for evaluation and treatment of symptoms and was discharged home on oral antibiotics,  Infant was seen in office on 9/30/20 for continuation of low grade fever and rash that developed over entire body.  Infant was sent back to ER for further evaluation of evaluation and treatment of symptoms. Infant was admitted to hospital from 9/30/20 to 10/4/20 for treatment of Kawasaki like illness. Infant was followed by cardiology and infectious disease during hospital stay.  The overall impression of  infectious disease MD was that Kawasaki like illness occurred secondary to hep b vaccination and recommended reporting vaccine in VAERS.
This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 10-SEP-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J001700 and expiry date 08-MAY-2014. Dose and route were unspecified. The reporter informed that one shipment of improperly stored ZOSTAVAX vials (lot number J001700 and expiry date 08-MAY-2014) received on 27-JUN-2013 were exposed to 5 degrees centigrade for possibly 105 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 1 of several reports from same reporter. Additional information has been requested.
Itchiness; Vaccine injected Subcutaneously; Redness at the injection site; Injection site bruise; Injection site unsual lump; A spontaneous report was received from a 67-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and vaccine received subcutaneously and experienced redness at the injection site, bruise, injection site unusual lump and itchiness.   The patient's medical history was not provided. concomitant medications were metoprolol, clonixin lysinate, pargeverine hydrochloride, levothyroxine sodium, magnesium malate, zinc glycinate and vitamin d [vitamin d nos].   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) "subcutaneously" in her right arm for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient stated that the vaccine was applied on the lower part of the deltoid muscle. Her health care professional checked that it was done subcutaneously. She experienced redness at the injection site, bruise and an unusual lump.   On 13 Jan 2021, the patient began to experience itchiness, which was treated with diphenhydramine hydrochloride.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, Redness at the injection site, bruise and injection site unusual, were considered ongoing.   The outcome of event, vaccine injected subcutaneously, was resolved 06 Jan 2021.   The outcome of the event, Itchiness, was resolved on 15 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 and concerns a 67 year-old, female patient, who experienced the events of redness at the injection site, bruise, injection site unusual lump and itchiness. The events of redness at the injection site, bruise, injection site unusual lump occurred the same day after the first and only dose of mRNA-1273 vaccine administration. The event of itchiness occurred approximately 7 days after the first and only dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Patient developed shortness of breath and leg swelling as well as on and off episodes of palpitations after receiving 2nd dose of Moderna vaccine. Also developed fever and chills and a worsening cough (fever and chills had since resolved).
extreme dizziness, spinning room for approximately 30 seconds then nauseous for rest of day. Vertigo?
Patient developed redness and swelling 3cm x 4cm on left thigh at the site of MMRV injection Tx: Cool compresses to left thigh Benadryl gel topically for itching  TID topically to (L) thigh Ibuprofen for children 100mg/5ml  7ml PO q6h PRN
On 01/14/2022 I started to have all over body aches. I had chills and the sense of a fever but I was not running a temp. I was fatigue. On 01/16/2022 I did a rapid test from work and it came back positive. I started to have a sore throat and I was coughing. I was also experiencing major hip and leg pain. My headaches felt like it was a sinus headache. I took Tylenol and ibuprofen. I don't feel like the Tylenol helped much, but the ibuprofen helped the headaches and leg/hip pain. I tested again on 1/21/2022 and it was still positive. On 01/22/2022 I did go to urgent care and was prescribed an antibiotic. I tested again on 01/26/2022 and finally tested negative. I still experience a cough that randomly occurs if I exert myself or laugh. My doctor has listened to my lungs and states they still sound good. He will monitor it and if it doesn't get better we will do a chest x-ray after April.
Reddened hard\lumpy area approx 4 inches below injection site; painful to palpation; achiness with all ROM; intermitten itch; burning hot sensation; intermitten sharp stabbing sensation; moderate swelling  Started at approx 4pm on 1/21 with same symptoms persisting to current time--- area increasing in size
Patient got Shortness of breath, leg cramps, lost control on his body and seizures 2 hours after getting the vaccine and stayed for about 5 minutes. No medication or treatment was given. reported by his sister
12/21/21 presented to EC ED for "fatigue and muscle pain". PMHx of "asthma, HTN, and recent COVID pneumonia".
pt recv vax & devel breakthrough chickenpox;the reporting MD noted pt child mom look like chickenpox blisters over areas w/clear fluid;
On 2/8/03 pt had severe headache only, on 2/9/03 muscle aches all over body, on 2/12/03 re raised rash to torso, and on 2/13/03 rash spread to neck and scalp.
Fainting, 5-10 minutes post injection, weakness, paleness, dizziness, fatigue. No appetite. Received 3 vaccine on 8-10-10 at 4:45 pm. cont's with symptom at 1:00pm 8-11-10.