chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Grade 3 local reaction - > 10 cm induration at injection site within 12 hours then gradual resolution over several days. Delayed Reaction: 7 days later > 10 cm erythema developed surrounding injection site with minimal induration. Did not appear infected. Photos taken of both events.
STARTING THE NIGHT OF THE VACCINE SHE DEVELOPED SEVERE ARM PAIN THAT RADIATED DOWN TO HER HAND. SHE WAS NOT ABLE TO MOVE HER ARM THE ENITRE NIGHT. SHE HAD CHILLS, FEVER, AND NAUSEA. THERE WAS NO REDNESS OR SWELLING AT THE INJECTION SITE.  MOTRIN MADE THE PAIN "SOMEWHAT BETTER". SHE WAS STILL SORE THE NEXT DAY, BUT WAS ABLE TO MOVE HER ARM.
Numbness on entire left side,  migraine headache for 2 days,  and heavy break thru vaginal bleeding
BEGINNING SUNDAY 10/17/21 PATIENT HAD REDNESS AND SWELLING ON ARM AND DOWN INTO BREAST
no adverse event; vaccine used which were beyond the 30-Day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date) and NO ADVERSE EVENT (no adverse event) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date).    Concomitant products were not reported.  It was reported that patient received monovalent dose that was administered beyond 30 day beyond use date. The use by date of lot 042J21A was reported as 17-Feb-2022.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Significant Live Follow up received narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
05/12 acute diarrhea in morning. Went to urgent care on 5/20/21-Prescribed Imodium - no effect. Went to ER at Hospital on 5/22/21 - Prescribed Diphenoxylate-atropine with no effect. Still watery loose stools. 5/26/21 - Went to urgent care again. Did stool culture. Trying BRAT diet. As of today, 6/1/21 still chronic diarrhea and very weak.
erythema, swelling, pain, warmth at left deltoid injection site, measured 7 x 5 cm today. Pt C/O pain in entire shoulder girdle, unable to lift arm above shoulder until today, today can lift left arm 30 degrees above shoulder.
No adverse event; 11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender 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.    In 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    It was unknown if the patient receives any other vaccine in the 4 weeks prior to Moderna Pink Cap COVID-19 vaccine.  These patients were never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years. Concomitant product use was not provided by the reporter. It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A & Exp. Date: unknown), (Lot number 216K22A & Exp. Date: unknown). Treatment information was not provided.  This case contains information about patient 7th out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:Patient 7 out of 11
Very mild arm soreness; felt dehydrated; mild headache; fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247) via an unspecified route of administration, administered in left arm, on 10Mar2021 at 10:45 (at the age of 35 years old) as 1st dose, single dose, for COVID-19 immunization; ethinylestradiol, etonogestrel (ETONOGESTREL/ETHINYLESTRADIOL MYLAN; batch/lot number and dose were not reported) vaginal ring via unspecified route of administration, from unspecified date, at an unknown dose and frequency, for an unspecified indication. The patient's medical history included exercise induced asthma and chronic bronchitis. Concomitant medications were not reported. The patient previously took aspartame and experienced headaches and nausea; and PERCOTCET and experienced vomiting, nausea and hives. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Mar2021 at 11:15 A.M., it was reported that the patient experienced very mild arm soreness, felt dehydrated starting about 30 minutes after the vaccine dose through the end of the day, very thirsty despite drinking a lot of water, mild headache and fatigue, moderate in the afternoon and more extreme towards the end of the day. The patient did not receive a treatment for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The action taken in response to the events for etonogestrel/ ethinylestradiol was unknown. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Vaccine administered 4.13.21.  ED -- > Hospitalized on 4.14.21.  Septic arthritis vs. reactive arthritis vs. other -  64 y.o. female with a history of Crohn's complicated by multiple small-bowel obstructions requiring bowel resection and lysis of adhesions, chronic hyponatremia, hemochromatosis, iron deficiency anemia. She presented to the emergency department with acute left knee and wrist pain.   # Knee Pain # Wrist Pain Acute, progressive polyarthritis in the setting of recently receiving her 1st COVID vaccine.  Imaging revealed small diffusion in the left knee with concerns for septic arthritis.  Arthrocentesis with WBC count 35,000, no organisms or crystals.  Labs significant for leukocytosis and elevated CRP and ESR. Pain has progressed to involve multiple joints particularly on the left side.  Given polyarticular involvement, reactive arthritis secondary to immunization verses Crohn's disease seems likely, although cannot definitively rule out septic arthritis at this time. Plan: o Monitor off antibiotics for now o Follow blood and fluid cultures o Trend ESR, CRP o Orthopedic surgery following o Pain control with tylenol, oxycodone o Consider GI consult if picture appears consistent with Crohn's related arthropathy   # Acute on Chronic Hypo-osmolar Hyponatremia Sodium 125, baseline appears to be 125-130.  Thought to be SIADH based on past endocrinology evaluation. Plan: o Check serum, urine osm, TSH, cortisol o BMP daily o 2 L fluid restriction o Hold home spironolactone  #  Left knee and wrist pain with swelling.  Likely secondary to reactive arthritis as a side effect of 1st COVID vaccine on 04/13/2021.   White count concerning for septic arthritis of the left knee as well. # leukocytosis with elevated sed rate and CRP, possible reactive arthritis versus septic arthritis -follow-up on cultures from knee arthrocentesis.  So far shows a white blood cell count of 35000, no organisms or crystals -monitor complete blood count -orthopedics following -pain control -trend ESR, CRP -monitor peripheral blood cultures x2 -monitor off antibiotics   ORTHOPAEDIC TRAUMA CONSULT   CC:  Swollen, painful joint    A: 64 y.o. female w/ with acute onset of left pain, swelling after COVID vaccine concerning for septic arthritis vs gout vs pseudogout. Joint was aspirated, and labs are consistent with reactive arthritis. Anterior femoral cortical defect noted on XR. ESR 47, CRP 10.5, WBC 16, afebrile        Recent Labs   04/12/21 1152 04/14/21 0252 WBC 11.32* 16.31*     Recent Labs   04/14/21 0252 CREACTIVEPRO 10.5*     No results for input(s): SEDRATE in the last 72 hours.     P: -CT ordered R/o septic arthritis -Joint arthrocentesis completed in ED               -synovial fluid labs- WBC: 32K, gram stain negative, crystals negative -Plan for admission to medicine vs ED obs to monitor cultures given elevated synovial WBC  -pain control  -ESR/CRP elevated  -WBAT LLE -No abx needed at this time for knee
On November 15, 2022, I had severe stomach pain and lower back pain. I had diarrheas, nausea vomiting and chills, cough, headache, dizziness, restlessness and loss of balance. I visited the doctor at urgent care on 11/22/2022 I was prescribed ondansetron. Emergency room on 11/23/2022 and the I was prescribed dicyclomine. These symptoms began to fade on Friday, 11/25/2022. As of today, I am not 100 percent recovered.
pt states today p/vax pneumonia shot rt arm being to swell down to elbow; red-bluish color; soreness, fever 103 x 3 days & h/a; mild since took flu shot; nauseated;
Received VARIVAX on 3/23/11. On 3/31/11 diagnosed cellulitis at shot site 7 inch diameter red, hard, hot, swollen around site of needle. AUGMENTIN ES started.
papulovesicular eruption RUE reported (not brought to medical attention) p/1st dose;repeated p/2nd dose;
Fatigue Headache Joint Pain Fever  Chills Muscle Pain Injection site swelling Diarrhea
Very rapid heart beat (154). High Blood pressure 175/120. 12.50mg Coreg administered at 11:30 PM. Able to sleep at 1:30 AM next day.
Inability to move arm to full capacity.  Left arm with limited range of motion after first injection and worsened after second injection
This spontaneous report was received from a female consumer of an unknown age referring to herself. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 30-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX) route reported as vaccine (dose, frequency, lot # and expiration date were not reported), for prophylaxis. On approximately 25-OCT-2016 (reported as "eight weeks later"), she got Group B Strep (Beta haemolytic streptococcal infection) and red burning down in private area (Burning sensation) (Localized erythema). The patient sought medical attention and she was prescribed with and unspecified antibiotic which has not worked. The outcome of the mentioned adverse events was unknown. The causality between the aforementioned adverse events and ZOSTAVAX were unknown. No product quality complaint was involved (PQC). Additional information is not expected, as there was no consent to contact.
This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (Died of Cardiac arrest) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. 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 CARDIAC ARREST (Died of Cardiac arrest) (seriousness criteria death and medically significant) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age of vaccine administered). The patient died on an unknown date. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. At the time of death, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age of vaccine administered) outcome was unknown. No Concomitant and Treatment Medication was provided by reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This fatal spontaneous case concerns a 15yearold female patient, with no medical history reported, who received the second dose of her COVID19 immunization schedule with mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected event of cardiac arrest. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. No further information regarding the event, death date and cause of death have been provided for medical review. It is unknown whether an autopsy was performed. Product administered to patient of inappropriate age was also considered in the case. The benefit risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up received and does not contain any new information. On 14-May-2021: Follow-up received and does not contain any new information. On 17-May-2021: Follow-up received and does not contain any new information. On 22-Jul-2021: Follow-up received and does not contain any new information. Sender's Comments: This fatal spontaneous case concerns a 15yearold female patient, with no medical history reported, who received the second dose of her COVID19 immunization schedule with mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected event of cardiac arrest. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. No further information regarding the event, death date and cause of death have been provided for medical review. It is unknown whether an autopsy was performed. Product administered to patient of inappropriate age was also considered in the case. The benefit risk relationship of mRNA-1273 is not affected by this report. Reported Cause(s) of Death: Cardiac arrest.
ADMINISYTRATION ERROR:  BOOSTER DOSE ADMINISTERED BEFORE 6 MONTHS PATIENT 1ST DOSE WAS ON: 06/09/2021 PATIENT 2ND DOSE WAS ON: 07/08/2021 BOOSTER DOSE ADMINISTERED BY ERROR ON: 12/02/2021  *PATIENT WAS INFORMED ABOUT THE ERROR.  PATIENT HAS NOT COMPLAINED ABOUT ANY SYMTOMS OR ADVERSE EVENTS AT THIS TIME. *NO FURTHER ACTION REQUIRED AT THIS TIME.   *IT IS NOT RECOMENDED BY CDC TO REPEAT DOSE
2mo infant rec'd DTP/HIBTITER/OPV on 8APR91; then developed fever, irritability & sz; Hospitalized w/meningitis dx as caused by H. Influenza;
Initial response:  fatigue; pain at injection site, shoulder and breast; numbness of nose and mouth. Two days later:  sneezing, coughing  began.  By the third day  I had major flu like systems, congestion; deep coughing, fatigue, body aches, heat waves, bad headache, continuing pain on the arm and shoulder.  It is now my  6th day and the symptoms have not abated.
This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 05-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017, dose, route and site of administration were not reported). The vaccine was exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:01/06/21,Pfizer,Lot#EL3246 2nd dose: 01/27/21,pfizer,Lot#EL9262  Diagnosed covid positive:04/03/21 Exposure:unknown Symptoms:Runny nose,congestion.
patient hospitalized within 6 weeks of receiving COVID vaccine, presented tot ED within 6 weeks.
I felt a very sharp and burning sensation from the area where I received the vaccine. It went to my left breast up to my nipple. The same day my lymph nodes began to swell under my armpits, Left jaw, and neck. My left arm was very heavy. I could not extend it above my head. That lasted for months. To the point where they found a lump under my breast. I ended up having a mammogram in August 2021, which were negative. You could feel the lump but there was nothing to be over concerned for. They prescribed me Toradol. It caused me a lot of anxiety. I am a nurse and I have received many immunizations and this reaction lasted a long time.
approx 5min p/vax 6cm x 6cm area of erythema presented around inj site of MMR lt thigh & vax;2cm x 2cm area of erythema was around PPD site;no facial swelling;no rash;no wheeze;DPH given;
Patient called the evening of 12/3/14 and stated that she had an adverse reaction to the flu vaccine. She stated that her arm had been painful since the vaccine was administered making it difficult to sleep, wash her hair, and dress herself. She stated that she contacted her PCP who gave her some medication to reduce inflammation. She still has not had relief and stated she was going to have xray/CT/MRI later this week. We advised her that we would report the incident to the CDC and encouraged her to continue to follow up with her PCP and keep us informed of her condition.
Patient was administered Td vaccine on 07/12/07.  On 07/14/07 patient experienced arm swelling, pain, redness.  Patient used cold compresses and Tylenol to relieve the pain.  Reaction took 5-6 days to resolve.
Extreme lightheadedness and dizziness upon waking getting out of bed. I felt as if I were going to fall over/pass out as I was urinating and had to get on my knees. Also, extreme soreness at the shot location.
Rash over your entire body, started on abdomen to extremeties.  Not using any different dtergent
Hard pnk wheal around site of injection.  As day and into next day reaction was from shoulder to elbow.  Inflammation, hardness, fever.
Vaccine was given at 12 noon on 8/24/05.  At 8/25/05 at 4 a.m. client awoke in the night feeling feverish, temp was 100.1.  Morning of 8/25, client complains of headache, fatigue, malaise.
Patient had his first Booster Moderna COVID 19 vaccine on April 7th, 2022 and he presented to clinic to get the 2nd Booster yesterday on June 7th 2022, 3 months after first booster, the health care staff who administered the vaccine thought it was 4Months since the first booster and gave it to patient then reported to the supervisor when realized that it was only 3 months
Severe rash & pain on legs, 3/16 moved to arms as well a small rash on torso.  Legs & feet appear to be worse.  103 rectal Fever & restless.
15min post injection patient got into his car and started experiencing flushing and severe nausea. he started to sweat and felt as if he was going to vomit. He returned to the pharmacy immediately. pharmacist gave patient some water and he started to feel better immediately. he did not report SOB or any swelling. no injection site reaction was observed. patient remained at the pharmacy for additional 30minutes and left at 2:30pm. Pharmacist followed up with the patient at 5pm and pt reported that he is feeling fine and no further issues. This patient has not had a vaccine since teenage years and this was his first flu shot that he can recall. However, he did say he does not remember having any reactions to vaccines.
Patient tested positive for covid 8/12 and treated with antiviral medication.  She came to the ED on 8/20 for worsening fatigue, weakness, and decreased appetite.  Patient was admitted to the hospital to be treated for Covid.
11/9/05 Flu vaccine administered. 11/11/05 Half of thigh swollen, red, warm to touch. Resolved with Benadryl.
From initial information received from the patient, who is a healthcare professional, regarding an adverse event occurring in the USA, it was reported that the 48 year old female patient received a dose of TET TOX Booster USP, lot number unknown, administered intra-muscularly in the left deltoid on 08/05/2004.  The patient was administered the tetanus product because of a needle stick after a blood draw.  Her last tetanus booster was reportedly eight years ago.  The emergency room informed the patient her healthcare provider requires a tetanus booster every 5 years.  One day after receiving the product, the patient developed a large local reaction consisting of redness, vomiting and diarrhea.  The patient self medicated with Motrin and Tylenol.  She had not recovered from these events at the time of this report.  From additional information received on 09/13/2004 from the responsible physician, it was reported that the physician has no knowledge of this reaction except as told by the patient.  She reported that she was not the emergency room medical doctor, but is the patient's primary care physician.  No new medical information was provided at this time.
Child was fine while sitting in room about 4-5 minutes after shot; she wandered away from me while I was making appointment. I heard a loud band and looked over and saw pt laying on the floor on her back, feet towards me, her eyes were open.
Site: Pain at Injection Site-Mild, Systemic: right arm has been sore since first shot see below for more details-Mild, Additional Details: Her right arm has been sore, she can still feel where the needle went into her arm from the first Covid vaccination. This arm waxes and wanes with different severities of pain and the pain,sensations, and uncomfortableness has lasted 21 days. I told patient if the pain continues for another week or if the pain gets worse,  seek medical attention for it.
NUMB TONGUE ON RIGHT SIDE FOR TWO DAYS; RESOLVED ON ITS OWN WITHOUT FURTHER INCIDENT
This spontaneous report was received from a medical assistant, concerning a 4 year old child patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored PROQUAD, lot # N019248 and expiration date 20-DEC-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: US-009507513-1801USA002808: US-009507513-1806USA010177: US-009507513-1806USA010178: US-009507513-1806USA010179: US-009507513-1806USA010171: US-009507513-1806USA010176: US-009507513-1806USA010181: US-009507513-1806USA010174: US-009507513-1806USA010173: US-009507513-1806USA010175.