chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he felt like he had the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (he felt like he had the flu) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (he felt like he had the flu). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Flu like symptoms, at a dose of 1 dosage form. On 25-Feb-2021, INFLUENZA LIKE ILLNESS (he felt like he had the flu) had resolved.            No concomitant medications were reported.   This case was linked to MOD-2021-396043, MOD-2021-396061 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Nov-2021: Include no new information.
It is unlikely that the adverse effect is from the vaccine but from damage to the tendon from the placement of the shot in the tendon. Have experienced pain for getting close to two months. Pain in right arm especially in shoulder but also elbow lower arm and some in hand and fingers.  Pain has continued since the shot was administered.  Started physical therapy December 8.  Would have started sooner but was out of the country.
Per mom, "after receiving immunizations, started to walk away. She was really pale, like she was going to faint, then she vomited. The nurses had her lay down and they took her BP. She hadn't taken anything that morning and I did give her a dose of Advil before coming. She was fine the rest of the day and night. The next morning at 08:20 AM, she woke up with a blood curdling scream. My husband and I ran into the room. She tried to stand up but said she couldn't move her legs. Her temperature was 102F. Her legs were "limp". We called our doctor, who said to give her Advil and take her to the ER. We did but by the time we got there, she was fine. Her right arm was very swollen, warm to touch and slightly red. The limpness lasted 45 minutes approx. The temperature lasted 24 hours from 101F-102F. Doctor said it could be the shot." Mom states that in 11/00, daughter was dx'd with urinary tract infection and has been on Sulfa drug since then. On 4/16/01, doctor tests for UTI finally were normal.
had pneumonia after having two Pneumonia shots; had pneumonia after having two Pneumonia shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA PNEUMOCOCCAL (medically significant), outcome "unknown" and all described as "had pneumonia after having two Pneumonia shots". The patient reported she had already had pneumonia after having two Pneumonia shots. One of the vaccines the respondent reported receiving was Prevnar 13.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started with bumps on face 8 hours later and also on neck a few hours later and the bumps are itchy. Redness on Rt arm deltoid at injection site.
17 yo student give Heplisav-B- no adverse reaction noted. Error noticed on 8/18/2023 with chart review
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The concurrent condition, medical history and concomitant therapy were not reported. On 08-APR-2016, the patient was vaccinated with improperly stored GARDASIL (confirmed not GARDASIL 9, lot # K016966, Expiration Date 10-MAY-2017, strength, dose and route not provided). The GARDASIL was exposed to 32F for 15 days (360 hours). There was no previous temperature excursion. It was called because of a "data logger". No adverse symptoms reported. Additional information has been requested.
Systemic: Dizziness / Lightheadedness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: She complained to employee of lightheadedness.  By the time I went to see her she had fainted.  She opened her eyes again, but felt fainty . We called 911.  Administered EpiPen. Rescue came and stayed with her for about an hour when her relative came to pick her up.
HCP reporting a patient older than 13 years of age was administered PROQUAD instead of MMR II and VARIVAX; HCP reporting a patient older than 13 years of age was administered PROQUAD instead of MMR II and VARIVAX; This spontaneous report was received from a licensed vocational nurse and refers to a patient older than 13 years of age and of unknown gender. The exact age of the patient was not provided. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 24-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (strength, dose, lot #, expiry date, anatomical site, and route of administration were not provided) for prophylaxis (product administered to patient of inappropriate age). The vaccine was administrated instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II); and varicella virus vaccine live (Oka/Merck) (VARIVAX) (wrong product administered).
pediatric patient received an adult dose; pediatric patient received an adult dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 2-year-old male patient who received HAV (Havrix adult) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st March 2022, the patient received the 2nd dose of Havrix adult 1 ml and Havrix Pre-Filled Syringe Device. On 1st March 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were 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 a pharmacy intern. The reporter stated that the pediatric patient received an adult dose (1 ml) of Havrix, which led to overdose and adult product administered to child. No symptoms were reported. The reporter consented to follow up.
LT DELTOID MUSCLE IS VISIBLY DAMAGED, WITH A DENT.  THE MUSCLE APPEARS TO BE GONE.
pt recv vax; serum sickness rxn; fever, chills, body aches, HA; & local rxn at site of inject; red & swelling;
Patient with chest tightness, chest burning sensation and SOB experienced approximately 1 hour after vaccine administration.  Patient self medicated with Benadryl 50 mg PO and EPI PEN prior to  calling 911.  Emergency room evaluation and workup for chest pain complaint including IV placement, labs (CBC, Chem 7, Troponin and repeat Troponin), observation period s/p EPI PEN administration until 1845 on 12/30/2020.
I started experiencing spasms in the right side of my face. I had a weird feeling in my veins that went up and down my arms and by Saturday it was up in my head. this lasted for 4 hours. I had a bright white light in my right eye that was like a burst of light every time I blink. I went to the eye doctor on 2/5 and they gave me an eye dilation drop and he said that when the lining of the eyeball pulls away from the eyeball it catches the light coming into the eye and reflects down into the eye very bright. I started swelling and had a red rash on my neck, back of my neck, jaw, arms and kegs and belly. it started itching and had raised dots. about 12 dots on each limb/surface. I took Claritin and Famotidine. I woke up with more itching and a cold wave over my body. I took more Claritin and famotidine. My arms, legs, belly, and back started itching again. I had chills. The skin on my arm was hard in spots. I took half a Benadryl on Monday the 8th at 5 am. at 8am I was still itching. it died down but then flared up again and I took Zyrtec at 8pm. Tuesday the 9th I woke at 5am with more itching. I ate food and had more itching. Wednesday I had pain in my jam and my tmj flared up and I had pain in my molar but the Dentist said there was nothing wrong with my tooth. On 2/9 I had a blood draw and everything was normal. the only thing not normal was the carbon dioxide in my system. On 2/16 I was still feeling weird.
trouble taking a deep breath (not exactly short of breath--just feel need to try to get deep breath frequently).  Best best describe it as; sore right arm; This is a spontaneous report from a contactable consumer (Patient herself). A 66-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration, administered in Arm Right on 09Mar2021 11:15 as single dose for COVID-19 immunization. Medical history included autoimmune thyroiditis, coagulopathy, osteoporosis from an unknown date and unknown if ongoing. Patient had not any known allergies. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included apixaban (ELIQUIS) and thyroid (ARMOUR THYROID) taken for an unspecified indication. It was reported that, on 09Mar2021 she had expected sore right arm; however, since last evening, she was having trouble in taking a deep breath (not exactly short of breath-just felt need to try to get deep breath frequently). Best described it as need to take deep yawn. The patient had not received any treatment for adverse event. The patient was not diagnosed prior and since the vaccination with COVID-19. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt. states that after receiving the 3rd Booster dose of Moderna 09/10/2021, started experiencing symptoms that evening of body aches, extreme fatigue, severe headache, low appetite, and swelling under the left arm. 09/12/2021 presented with 2 new Cold sores. Symptoms have subsided besides the 2 cold sores. No noted Primary visit.
Patient reported feeling "very itchy" after receiving her second Pfizer vaccine Lot #EW 0170 while waiting in 15 minute waiting area.  Patient taken to the med bay and vital signs at 12:10 p.m. 150/109, 88 HR, 99% O2.  Patient stated that she was feeling "very itchy and hot."  Benedryl 25 mg administered to patient.  Vital signs retaken at 12:17 p.m. 145/89, 88 hr, 98% O2. Patient stated she was feeling "a bit better" at 12:25 pm.  PHN advised patient to call 911 or go to ER if symptoms worsen.  Patient's husband picked up patient and drove her home.
Initial and follow-up information has been received from a medical assistant concerning a 6 month old male (previously reported as 12 month old female) who on 21-AUG-2006 was inadvertently vaccinated with a dose of Prevnar. At the time of report, no symptoms had been reported. The medical assistant also reported that the Risk Management Department of her organization, which includes 30 clinics, was working on an company-wide program to develop a standardized protocol for vaccine administration. Some of the issues it was addressing included identifying the correct patient and rechecking the vaccine with another person. She noted that it was to protect both the patient and the health care professional who was administering the vaccine. Her office also sent a letter to the parents of the children who had received the Prevnar. No product quality complaint was involved. Follow up information from the medical assistant indicated that, on unspecified dates, the patient was also concomitantly administered a third dose of hepatitis B vaccine, recomb (MSD) (lot# 651736/0672R), IM in the right thigh, a third dose of Tripedia, IM in the right thigh and a third dose of ACTHIB, IM in the left thigh. The medical assistant reported that there was no illness at the time of vaccination and no adverse event reported. No further information is expected.
DOUBLE VISION; BLOOD SHOT EYES; DROOPY EYES; BAD MUSCLE ACHES; BAD CHILLS; FATIGUE; SWOLLEN LYMPH NODES; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight was 100 pounds, and height was 62 inches. The patient's concurrent conditions included: hypertension, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any drug abuse/illicit drug use. Patient had taken multivitamin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included biotin for drug used for unknown indication, and hydrochlorothiazide for hypertension. On 01-OCT-2021, the patient experienced bad chills. On 01-OCT-2021, the patient experienced fatigue. On 01-OCT-2021, the patient experienced swollen lymph nodes. On 05-OCT-2021, the patient experienced blood shot eyes. On 05-OCT-2021, the patient experienced droopy eyes. On 05-OCT-2021, the patient experienced bad muscle aches. On 06-OCT-2021, the patient experienced double vision. Laboratory data (dates unspecified) included: SARS-CoV-2 PCR test (NR: not provided) Unknown, and SARS-CoV-2 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from double vision on 06-OCT-2021, and swollen lymph nodes on 03-OCT-2021, and had not recovered from bad chills, fatigue, bad muscle aches, blood shot eyes, and droopy eyes. This report was non-serious. This case, from the same reporter is linked to 20211011585.
Upper arm pain began shortly after seasonal flu shot. Initially concentrated at site of shot, which broadened to upper arm and shoulder area with decreasing range of motion and intensifying pain with movement. Dr. indicated he had never seen such a reaction to a seasonal flu shot and ordered an X-Ray, which showed no abnormality. He referred me to orthopedic shoulder specialist, who gave me a cortisone shot in the shoulder and ordered an MRI. The MRI showed a bruised and inflamed bursa and rotator cuff and he felt I had a frozen shoulder. Dr. also recommended physical therapy, and after 9 PT sessions, and also 6 chiropractic therapy sessions I have had little improvement.
The Pharmacist accidentally used a bottle of Moderna that was punctured over 24 hours ago. While assisting the drive-thru, I was asked by my colleague which vial was which, I pointed to the differences, Monavalent which was capped, and the bivalent which should be in a black holder, but is located in a blue one. From there, I turned to finish with my covid appt. The bivalent was then handed to the staff pharmacist, then administered as a booster. After the administering of the vaccine, the staff pharmacist then approached my colleague and I to ask what dose number was this taken from the vial, because it was open and had no dose sticker wrapped around it. Thats when I let her know that she is the first one since I clocked in at 2 to use the vial. And if it was open, then it was the vial from the day prior which obviously was not strong packed. She should have asked that before administering. I was
Initial report received on 13 November 2006, from a physician, who contacted the company with request for medical information and to report an adverse event.  A 42 year old female patient, received Fluzone (lot number U2243AA) (multidose vial, site, side and dose not reported) on 02 November 2006, at the physician's office.  Two days later, on 04 November 2006, the patient experienced tender pretibial nodules on the right side.  On 09 November 2006, she was diagnosed with erythema nodosum.  No corrective treatment was reported.  At the time of the report (13 November 20060, the patient had not recovered.  Information on concomitant vaccines, prior exposure to Fluzone, illnesses at the time of the vaccination and medical history was not reported.  The patient took no prescription and had no over the counter medication recently.  Blood work was pending.  Follow-up information received on 15 December 2006.  The patient received 0.5cc Fluzone intramuscularly in the left deltoid.  It was unknown if the patient received Fluzone before.  She did not have any illness at the time of vaccination.  The reporter had a verbal follow-up with the patient on 07 December 2006, there was "no change".  The patient had negative blood work for C3, Compl. total, CRP, ASO.
-Chest pressure and pains, difficulty breathing, left side tingles in arm and leg -Inflammation -Severe migraine -Indigestion -Began inside 2 weeks of receiving vaccine.  -This is after the initial flu-like symptoms I experienced from day 1 to day 6.
Post-COVID-19 Vaccine Associated Myopericarditis; This is a literature report.  A 17-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: MYOPERICARDITIS (hospitalization, medically significant), 36 hrs after the suspect product(s) administration, outcome "recovered", described as "Post-COVID-19 Vaccine Associated Myopericarditis". Symptoms at admission: Fever, chills, fatigue, myalgias, pericarditic substernal chest pain. The patient underwent the following laboratory tests and procedures: Ejection fraction: 61 %, notes: at Admission; 57 %, notes: at Follow-Up; 59 %, notes: at Admission; 53 %, notes: at Follow-Up; Magnetic resonance imaging: No edema. Focal midmyocardial and epicardial, notes: delayed enhancement. No pericardial changes.  (at Admission); no edema; mild improvement in enhancement; notes: hyperintense pericardial signal and thickened pericardium; trivial pericardial effusion (4 months). Symptoms at follow-up (4 month): asymptomatic.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Post-COVID-19 Vaccine Associated Myopericarditis and the use of suspect product  BNT162b2 cannot be fully excluded.The case will be reassessed once further information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200057449 Same article/drug/event and different patient.;
This spontaneous report as received from a Registered Nurse refers to a patient ranging in age from 25 to 84 years old of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On unspecified dates between 19-APR-2017 and 01-MAY-2017, the patients received an intramuscular dose of PNEUMOVAX23 (lot: N003997; expiration date: 20-OCT-2018) to prevent pneumococcal infection (dose was not provided). On an unspecified date in 2017, within 24 hours of receiving the dose of PNEUMOVAX23, the patient developed a red, swollen, warm, sore area at the site of injection. The patient called the nurse for medical attention. No laboratories were performed. At the time of the reporting the patient was not recovered from the events. The relatedness of the events with PNEUMOVAX23 was not reported. This is one of several reports from same source. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA001719: US-009507513-1705USA005377:
stroke; face is swollen; shortness of breath; Difficulty in speaking; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), SWELLING FACE (face is swollen), DYSPNOEA (shortness of breath) and DYSARTHRIA (Difficulty in speaking). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), SWELLING FACE (face is swollen), DYSPNOEA (shortness of breath) and DYSARTHRIA (Difficulty in speaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Erythema, edema, increasing over 24 hours, initially no pain, increased discomfort and irritation, soreness for 30 hours. Resolved in 72 hours-96 hours slowly. Required Benadryl and topical steroids.
Patient was under the age the vaccine is indicated for at the time of the injection. Patient, her mother, and her physician already discussed the risk associated with the off-label use of the vaccine. The mother consented the vaccination.
Bud date 04/07/2022 consulted Pfizer who could not provide stability data beyond 04/09/2022 and recommended revaccination. Another booster provided on 05/11/2022
Left thigh red, swollen, and hot (approx 14 x 7cm) fever 101 x 24 hours inj given 7/15/04. Symptoms started 7/16/04. 7/21/04 all redness cleared.
I contracted COVID-19. My symptoms included pain whenever I inhaled and exhaled. I was coughing, felt tired, slightly achy, and had nasal congestion. I took a home COVID-19 test and it turned out negative. But I went to the doctor the next day on 02/8/2023 and took another test. The result was positive. I was prescribed PAXLOVID but I took some over the counter cough syrup. So eventually, the coughing went away and it took awhile for the other symptoms to go away. I pretty much recovered in that 7 day period.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. No information on patients concurrent conditions, medical history and concomitant medications was provided. On 19-MAY-2017, the patients were vaccinated with improperly stored ROTATEQ orally, lot # M040271, expiry date: 30-APR-2018 (dose was not provided). The product was stored in 0 Celsius degrees for 6 hours. The digital data logger was involved. There was no previous temperature excursions. Product quality issue was not involved. No adverse effects were reported. Additional information has been requested.