chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients).    This case contains information for the 40 of 100 patients described by the reporter  No concomitant medications were reported.  Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, lot numbers unknown to the HCP.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Patient's doctor called and said she was there being seen for redness and swelling at injection site on 10/24/13.
The patient presented to the pharmacy stating they got their flu shot on 10/23/23 at our pharmacy.  Upon going home, the patient consulted with his wife and she stated that he had already received a flu shot approximately 10 days prior to this at another facility.
Over a period of about a month I had 3 superficial blood clots the first being in the left leg and the 2nd 2 in the right leg each about a week apart.
Rapid Heartbeat started about 1-1/2 hours after the shot.  Heartbeat was rapid for several hours and then intermittently for ~30 Hours.  My face was flushed & hot.  I started trying to look up Moderna side effects but could not find anything about rapid heartbeat until after I found the Moderna fact sheet online.  I did not go to the hospital as I had no chest pains or shortness of breath.  But I did take a baby aspirin 3 times over the course of the 30 hour period.  I was also very fatigued during this time.  The rapid heartbeat has subsided by now  but I don't know if i should still get the 2nd shot which is scheduled for April 16.
Very red, very warm, very swollen and very painful; Very red, very warm, very swollen and very painful; Very red, very warm, very swollen and very painful; Very red, very warm, very swollen and very painful; This spontaneous report was received from a pharmacist via Pfizer referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route, lot# and expiration date were not reported).  On an unknown date, the patient experienced erythema, feeling hot, pain and swelling (reported as "very red, very warm, very swollen and very painful"). The outcome of erythema, feeling hot, pain and swelling was unknown.  The causal assessment between all the events and the suspect therapy was not provided.
5 minutes after patient received injection, burning sensation started at left shoulder (site of injection), spread across torso, down both arms and legs, and up head.  Patient became nauseous and light-headed.  While walking to toilet, patient chose to lie down, rather than faint.  While patient was conscious and rational, due to her age, EMTs were called and patient transported to Medical clinic for evaluation.  Patient was slightly disoriented for next 48 hours.
Started feeling a little off a few hours after the vaccine but it was manageable. Around 8 hours after the vaccine my symptoms had gotten worse to the point i couldn?t leave the bed. Extreme chills, headache, fatigue and nausea were the primary symptoms. As of this writing, 27 hours after the vaccine my symptoms have significantly reduced but haven?t gone away.
Arm pain immediately after vaccine given. Pain radiates down arm weakness in arm PT with only partial relief
Patient caregiver reported after the patient left (>15 minutes) patient was diaphoretic, pale, and that the patient reported his 'throat was closing up.' The caregiver however also stated the patient was not having problems breathing. The caregiver stated the patient didn't require any additional treatment after they had being lying down.
I had what I thought was a blockage in my intestines in July. My food was not passing through my stomach. It would just stop. It two two weeks and then it left. I started shaking and did not have good stability. I had lost weight and my cholesterol went up to 65 points. I was in hyper-Cholesterol. It has since sent calcium to my heart valve. The blockage part is coming back every once in a while. I have to be careful not to eat much and not put much on my stomach. I have been bleeding a lot from my gums. I had my teeth cleaned in October and there was blood everywhere. I am not bleeding anymore. I was diagnosed with an inflammation problem. In November, I discovered I may have inflammation syndrome. I have lost almost 40lbs, I was getting worse until the point I could not eat. I taking the same supplements, I feel good I am able to walk, there are certain days when I'm having trouble walking. My Cholesterol is now the issue to regulate it. In December, my COVID antibodies were massive and I did not have COVID but I was exposed. My doctor does not want me to take another shot, cause she feels I do not need it. I am waiting on blood test to tell me about my cholesterol. I have now Inflammation Syndrome.
- as soon as needle came out- burning and itching, arm started swelling and redness covered upper arm  - waited 30 min at clinic to ensure she didnt have anaphylactic shock  - face started getting red and puffy, red splotches all over body, dizziness 30 min later, lasted 30 min   - throat never closed up, breathing was unlabored
Vaccine (Tetanus and Diphtheria Toxoids Adsorbed - Decavac) administered on 06/17/05. Less than 8hrs later, patient states injection site felt very tender, warm to touch, lump noted as well. On 6/20/05, redness and induration is approximately same size of a baseball, very warm to touch and tender. Patient to further observe, to return to clinic in 1-2 days for recheck. If worsens, patient will be given oral antibiotics per PCP.
Itchy skin; Hot skin; painful skin on my face ears torso and arms; This case was reported by a consumer via call center representative and described the occurrence of itchy skin in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th April 2019, the patient received the 1st dose of Shingrix. In April 2019, 1 day after receiving Shingrix, the patient experienced itchy skin, feeling hot and pain of skin. On an unknown date, the outcome of the itchy skin, feeling hot and pain of skin were recovered/resolved.   It was unknown if the reporter considered the itchy skin, feeling hot and pain of skin to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had itchy, hot and painful skin on face ears torso and arms for the last six weeks. In the 24 hours following the 1st vaccine, the patient had all of the adverse effects listed. The reporter asked could this be an adverse effect.  The reporter scheduled to have the 2nd dose on the day after reporting, and did not know if the patient should have it.
I experienced fatigue, headache, and a slight cough. I tested positive for COVID-19 on 03/08/2023. I had a telehealth visit. They did not prescribe any medications because it would conflict with the medication I was already taking. So they said to call or go to the emergency room only if the symptoms got worse or I had trouble breathing. The symptoms lasted and declined in about 5 days and in about 7 days I was better.
I fainted and my heart rate was 144 which is extremely high; I fainted and my heart rate was 144 which is extremely high; I had woken up in a sweat, had 103.6 fever.; I had woken up in a sweat, had 103.6 fever.; After fainting I threw up and continue to not feel good; After fainting I threw up and continue to not feel good; I also had a bad headache; This is a spontaneous report from a contactable consumer (patient).   A 23-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient stated that, "The 24th, the day after my shot. I had woken up in a sweat, had 103.6 fever. I fainted and my heart rate was 144 which is extremely high. After fainting I threw up and continue to not feel good. I also had a bad headache and continue to have one." The adverse event result in Doctor or other healthcare professional office/clinic visit. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was not resolved.   No follow-up attempts are needed. No further information is expected; information about lot/batch number cannot be obtained.
FATIGUE, PAIN IN LEFT SHOLDER, LOSS OF MOVEMENTS AND 50% OF MUSCLE MASS ON LEFT SIDE
"SWOLLEN, TENDER AXILLARY, R SUPRACLAVICULAR, AND R ANTERIOR CERVICAL LYMPH NODES GREATER THAN 5 DAYS. IMPROVING WITH MOTRIN 800 mg TID AND WARM COMPRESS"
Developed Bells Palsy after 4 days it eventually resolved and patient came back for second dose
Patient was given a Daptacel (Dtap/Hib/Polio) vaccine in addition to a Vaxelis vaccine (Dtap/Hib/Polio/Hep B) on the same day, 7/24/2023. This resulted in a duplication of the Dtap/HIB/Polio components of the vaccine. Patient's mother was notified. Report child had no ill effects or additional symptoms after vaccination beyond normal fussiness.
Hives starting on eyelids and forehead, all over face, and back of ears. I got these symptoms almost exactly 6 days after each vaccine dose. I treated the hives with hydrocortisone and oral anti histamine medication, it took about 5 days to clear up after the first dose, just starting to see symptoms with the second dose.
Pt presented to current MD office on 06/02/05 with Varicella disease despite having vaccine.
An 18-year-old female patient, with no reported medical history, received an intramuscular right deltoid injection of MENACTRA (lot number U2919AA) on 30 July 2009. Three weeks post-vaccination, while undergoing a routine eye exam, she was noted to have a swollen optic nerve. Outcome was unknown. No additional information was reported. Follow-up information was received 24 September 2009 from a health care professional. The patient had no illness at the time of vaccination. She was seen by a neurologist who R/O MENACTRA being the cause of symptoms (specific symptoms not reported). According to the reporter, the patient recovered from the event. The date 11 August 2009 was entered in the seriousness criteria box of the VAERS form; however, it was not specified what this date represents. No additional information was provided at the time of the report. Follow-up information received 19 October 2009 from a health care professional. According to the reporter, the patient did not have any symptoms, but did have papilledema on ophthalmoscopic exam. The etiology was determined to be birth control pills. DIAMOX was prescribed as corrective treatment and birth control pills were stopped. At the time of the report, the patient had not recovered (previously reported as recovered). Follow-up information received 30 November 2009 from a health care professional. The reporter clarified that the patient had a doctor's visit on 11 August 2009. No additional information was provided. Follow-up information received 07 December 2009 from a health care professional. The patient continued to asymptomatic, though she had mild optic nerve papilledema. The reporter indicated there is no additional information at this time. Follow-up information received on 21 December 2009 from a health care professional. Per the reporter, the patient was taking birth control pills at the time of the vaccination on 30 July 2009; and that she still has optic nerve swelling. No further information is expected.
Nurse reported the patient received 3 doses of "HPV vaccine" on an altered dosing schedule; no adverse effects; This spontaneous report as received from a nurse refers to a 14-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 09-AUG-2010, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis(lot number, expiration date, strength, dose, frequency, route of administration were not reported). The patient received additional doses of the suspect vaccine on 01-FEB-2011 and 07-APR-2011 (also reported as the patient received 3 doses of "HPV vaccine" on an altered dosing schedule). No adverse effects were reported.
COUGH; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cough. This report was non-serious. This case, from the same reporter is linked to 20211133950.
patient recieved Fluzone Quadrivalent High Dose that was too-long in transit and was not suitable for use, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a Nurse.  This case is linked to case 2020SA268090, 2020SA268091, 2020SA268092, 2020SA268089 and 2020SA268093 (same reporter).  This case involves a 65 years old female patient who was vaccinated with 0.7 ml once dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringes, lot number UJ498AA and expiration date:30-Jun-2021) via unknown route in the left deltoid for prophylactic vaccination on 28-Sep-2020. The vaccine was too-long in transit and was not suitable for use (PT: product storage error). It was reported that the boxes were cold, but the ice packs were not hard frozen.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported.   It was an actual medication error case due to incorrect product storage. As the vaccines that were not suitable for use were administered to the patients.  No adverse event reported at the time of reporting.  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.
Sore/throbs and loss range of motion due to pain - still as of today 1/14/14. Saw Dr > 1 month after - given hot/cold packs. Have an Rx ointment 7 wks after inj. Now acupuncture treatments and arnica.
Administered Tdap 5-21-14 / "knot appeared 5-23-14" "got fever in it 5-27-14" went to hospital due to being diabetic. Was told it was from shot. Was given clindamycin at hospital with script for BACTRIM and metformin (due to increased blood sugar). If increased or not decreased will "drain".
FRONTAL HEADACHE AFTER 15 MINUTES. FELT BETTER WITH SUPINE.
diagnosed with Covid-19 after receiving a total of 4 Pfizer vaccines each; diagnosed with Covid-19 after receiving a total of 4 Pfizer vaccines each; This is a spontaneous report received from contactable reporter(s) (Physician).  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with Covid-19 after receiving a total of 4 Pfizer vaccines each". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Their internist, who prescribed Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202200722831 same reporter/drug/event, different patient
Gray dot remains 4 + months after shots administered in thighs. Can not discern which shot (vaccine) it was. She has had 4 dots at a time. Present since beginning vaccinations.
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (lot number, dose, frequency and route unspecified) (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
super  ill; was that awful; This case was reported by a consumer via interactive digital media and described the occurrence of illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced illness and feeling bad. On an unknown date, the outcome of the illness and feeling bad were recovered/resolved.   It was unknown if the reporter considered the illness and feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient reported that vaccine made him/her super ill. The patient did not want to take the second shot but the nurse convinced him/her to take the shot. The patient said he/she would never had taken the shots if his/her body would react, it was awful. For tolerance of 2nd dose, refer case US2021AMR176100.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176100:Same reporter
I started my menstrual cycle approx. 2 weeks early and it lasted twice as long.  First week was light spotting and the second week was my "normal" period.
a sore arm; general body aches; pain in his chest; pain in his back; chills; low grade fever 101; very tired; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore arm), MYALGIA (general body aches), CHEST PAIN (pain in his chest), BACK PAIN (pain in his back) and CHILLS (chills) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALLOPURINOL for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (a sore arm), MYALGIA (general body aches), CHEST PAIN (pain in his chest), BACK PAIN (pain in his back), CHILLS (chills), PYREXIA (low grade fever 101), FATIGUE (very tired) and ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (a sore arm), MYALGIA (general body aches), CHEST PAIN (pain in his chest), BACK PAIN (pain in his back), CHILLS (chills), PYREXIA (low grade fever 101), FATIGUE (very tired) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Body temperature: 101 (High) 101F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included angiotensin-converting enzyme(ACE) inhibitors.
Had shot at 11:00 AM. By 3:30 PM, was wiped out & disoriented. Asked wife to drive last leg of trip. Felt weak. Slept for well over an hour when we got home. Chills started around 9:00 PM (weather was 70+ deg F) and continued off/on until 1 AM. Slept under pile of blankets. Muscle and joint aches on both sides of body. Was better by mid-morning of the next day. Injection site was sore for over 24 hours.