chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination site pain; TIGHT; injection site was red; itchy rash; red spot; shingles; eczema; psoriasis; itching; FEELS LIKE SHE IS LOSING HER MIND; sensitivity in her arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sensitivity in her arm), RASH PRURITIC (itchy rash), RASH MACULAR (red spot), HERPES ZOSTER (shingles) and ECZEMA (eczema) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Vaccination: Shingles.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (sensitivity in her arm), HERPES ZOSTER (shingles), ECZEMA (eczema), PSORIASIS (psoriasis), PRURITUS (itching) and NERVOUS SYSTEM DISORDER (FEELS LIKE SHE IS LOSING HER MIND). On 26-Jan-2021, the patient experienced RASH PRURITIC (itchy rash), RASH MACULAR (red spot), VACCINATION SITE INDURATION (TIGHT) and INJECTION SITE ERYTHEMA (injection site was red). On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, PAIN IN EXTREMITY (sensitivity in her arm), RASH PRURITIC (itchy rash), RASH MACULAR (red spot), VACCINATION SITE INDURATION (TIGHT) and INJECTION SITE ERYTHEMA (injection site was red) was resolving and HERPES ZOSTER (shingles), ECZEMA (eczema), PSORIASIS (psoriasis), PRURITUS (itching), NERVOUS SYSTEM DISORDER (FEELS LIKE SHE IS LOSING HER MIND) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Added events
This spontaneous report was received from a physician via company representative refers to an 18 year old male patient. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, route of administration, anatomical location and lot# was not reported). Concomitant medications were unspecified by reporter. On an unknown date, after receiving vaccination, the patient collapsed. The physician's office called ambulance and the patient was taken to the hospital. Although, at the time the patient boarded from the ambulance, the doctor said the patient seemed to be fine, the patient was taken to the hospital to check his electrocardiogram (EKG), and blood tests. All tests turned out fine. The next day patient had follow up check up visit with the physician and the patient seems fine. The causal relationship between the event and GARDASIL was not reported. Additional information has been requested.
pt presents to the ED for "cold sweats, fever, headaches and soreness, and eye pain" that began yesterday after receiving the J&J COVID vaccine, has not attempted to take tylenol or motrin for fever and headaches
PATIENT CALLED AND REALIZED SHE RECEIVED 2 FLU VACCINES FOR THIS SEASON. SHE CAME IN FOR A PNEUMONIA SHOT, BUT FILLED OUT A FLU FORM AND THEREFORE RECIEVED A SECOND FLU SHOT.
per mom pt in car seat noted to be cyanotic, staring, appeared to be not breathing; mom stimulated pt; pt started to breath & color returned;
6 pm in the evening on 04/06/2021 started getting severe chills. The next day woke up with a severe migraine (with its usual accompanying symptoms), lack of appetite, and body aches. Body aches particularly acute in areas where I have had past injuries and surgeries...indicating strong inflammatory response. No fever, but essentially felt like an intense case of the flu. Symptoms abated by 5 pm on 04/08/2021 after complete bed rest. Lethargy continued for the next few days, however, that is usual for me after a migraine on the higher end of the pain scale, and may not be a direct result of the vaccine itself.
High Blood Pressure (140+/90) and High Rapid Heart Rate (120 beats per minute) Chills, Fever (reached 101 degrees at high point), Body Aches, Lack of Appetite, Fatigue, Brain Fog, Eye Problems  As of today, 11/19/21, Blood Pressure had returned to normal but still have a Rapid Heart Rate at 91 beats per minute. Body Temperature: 98.8 No chills, lack of appetite, fatigue, brain fog or eye problems
I received my first shot on 7/1. My cycle should?ve started on July 4th.  I had bad cramps (which I never have) but no period until 7/10. I am never late and this period was very heavy and bad cramps.   Im believing this was due to the vaccine as this was the only thing that changed in my life. (I also took a pregnancy test to ensure I wasn?t having a miscarriage, test was negative).   Wanted to report this as  a possible side effect (as I researched and do see some others had changes in their period post vaccine around 1%).
Patient reported red spots, that contained a clear fluid on hands, chest & back, that itch. No fever. No difficulty breathing, no swollen tongue/throat. Patient taking Benadryl and topical 1% Hydrocortisone Cr. Went to family MP. Triamcinolone 0.5% Cr. Ordered 10/25/08.
Left arm swelling and felt hot to touch day of vax. Started to turn red and swelling got bigger x 1 day. Redness increased. Parents notified office. MD examined area. 9 cm x 10 cm red area noted on left deltoid region of PT advised mother to give Benadryl and to contact office if Sx's worsen.
Bruise at injection site, especially when received ADACEL shot on left arm. As for right arm, received Pneumovax 23 and had swelling/inflammation along with pain where she could not lift her arm; area is below the injection site. Patient was informed to use TYLENOL (APAP) or NAPROSYN she has at home and seek medical help or contact PCP if needed or if pain still persists and bothersome.
Arm sore for a day - and that was it. A month later, April 10, 2021. Heart Attack - they put in a stent (two stents) - two of my coronary arteries had collapsed.
Myalgia, Fever, NauseaVomiting, CHIKLLS, SEWATS, HEAVY ARMS Narrative:  STAYED HOME FROM WORK
Patient did not have any adverse events. We discovered after I administered the Moderna vaccine that she had already had the Moderna booster 0.25 mL on  10/22/21. Lot# 091D21A, Exp. 12/12/21. She said she was due for #3.
I just could not stay out of the bathroom for long, I just kept coming in and cleaning out my gut; My tummy started to feel a little bit strange, queasy and all that; My tummy started to feel a little bit strange, queasy and all that; This is a spontaneous report from a contactable consumer reported for self. This 59 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Jan2021 at single dose (Lot: EJ1685, Expiration Date: Mar2021) for covid-19 immunisation. Medical history included High Blood Pressure, Severe Asthma. The patient stated weighed a little less before the holidays. The patient 169 pounds and now it is 10 pounds more than weighed before the holidays (general statement). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 for covid-19 immunisation. Concomitant drug included amlodipine for high blood pressure, losartan at 100 mg for high blood pressure, milrinone (PRIMACOR) and montelukast sodium (SINGULAIR) for asthma. The patient stated, "I got the second vaccine this Saturday and then yesterday, Sunday (10Jan2021), my tummy started to feel a little bit strange, queasy and all that and then tonight, last night (11Jan2021), when I went to work, I just could not stay out of the bathroom for long, I just kept coming in and cleaning out my gut and I did not really eat that much yesterday, so, I don't think it was anything I ate. I just wanted to report that I had stomach issue and that was a result to the vaccine." The patient had some Imodium but was wondering if should take it. Outcome of the events was unknown.
Patient called pharmacy on 3/8 to report that the arm she received vaccine in was red, hot and swollen and that she though she had COVID arm. Advised her to use cold compress, oral antihistamine, and topical steroid and call primary care doctor.
Headache; Fever; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), CHILLS (chills) and FATIGUE (fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with CHLORPHENAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE (ADVIL ALLERGY AND CONGESTION RELIEF) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), PYREXIA (Fever), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
28MAY 10AM DTP recvd by 11AM feverish, h/a, emesis x 1; temp to 106 despite antipyretics; no other sx; 29MAY 0200 hrs visit to ER;
ACUTE RESPIRATORY FAILURE; ENDOTRACHEAL INTUBATION; INTENSIVE CARE; SARS-COV-2 TEST POSITIVE; COVID-19; PULMONARY EMBOLISM; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 2055433) on 04-FEB-2022 and concerned an 83 year old male of unspecified race and ethnicity. The patient's height and weight were not reported. The patient's concurrent conditions included: anxiety, Benign prostatic hyperplasia (BPH) with obstruction, depression, dysphagia, hypertension, Gastrooesophageal reflux disease (GERD) and paroxysmal atrial fibrillation no anticoagulation. The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: unknown) dose was not reported, 1 total administered on left arm on 11-MAR-2021 for unspecified indication. Drug start period was 307 days. Concomitant medications included acetylsalicylic acid, clonazepam, duloxetine, finasteride, guaifenesin, mecobalamin, metoprolol, mirtazapine, olanzapine, pantoprazole, paracetamol, sennoside a+b, tamsulosin, tramadol, and trazodone. On 12-JAN-2022, the patient tested positive for COVID (sars-cov-2 test positive) and was hospitalized (date unspecified). The patient was admitted to inpatient (intensive care) intubated (endotracheal intubation) with acute hypoxemic respiratory failure due to COVID-19 and pulmonary embolism. The patient was hospitalized for 9 days. As of 21-JAN-2022, the patient was still in hospital.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the acute respiratory failure, endotracheal intubation, intensive care, pulmonary embolism, sars-cov-2 test positive and covid-19 was not reported. This report was serious (Hospitalization Caused / Prolonged).  This report was associated with product quality complaint: 90000216455. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 11-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.This updated information does not alter the causality of previously reported events. 20220213293- covid-19 vaccine ad26.cov2.s- acute respiratory failure,pulmonary embolism, endotracheal intubation, intensive care,  sars-cov-2 test positive and covid-19. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient developed a few petechiae 6 weeks after 1st COVID vaccine. These resolved but then 2 weeks after second vaccine he was found to have thrombocytopenia on cbc and then went on to develop worsening thrombocytopenia with extensive petechiae and was diagnosed with ITP
Phone call from mom on 4/17/20 stating local reaction. Advised to give symptomatic car. Called on 4/18/20 and spoke with physician on call. Area had grown about 4" around and was red and warm to touch. Parent advised to continue symptomatic care. Mom reported to use topical Benadryl during day and oral Benadryl at night. Never fever or systemic symptoms. Redness, warmth resolved by 4/21/20.
Patient started to feel light headed/dizzy right after vaccine, then about 15 minutes later lips started to feel tingly. no closing of airway or throat. Benadryl oral was given 50 mg and she began to feel better 15-20 minutes
There is NO adverse reaction as of this reporting. The HPV vaccine was  given in error today.
Aches; COVID arm/ A huge swollen rash at the injection site that is 6 inches wide and 6 inches long; it is red and hot; Fever; Chills; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), VACCINATION SITE RASH (COVID arm/ A huge swollen rash at the injection site that is 6 inches wide and 6 inches long; it is red and hot), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 012M20A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced PAIN (Aches), VACCINATION SITE RASH (COVID arm/ A huge swollen rash at the injection site that is 6 inches wide and 6 inches long; it is red and hot), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint pain). The patient was treated with CETIRIZINE for Adverse event, at a dose of 10 milligram and IBUPROFEN for Adverse event, at a dose of 200 milligram. At the time of the report, PAIN (Aches), VACCINATION SITE RASH (COVID arm/ A huge swollen rash at the injection site that is 6 inches wide and 6 inches long; it is red and hot), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint pain) outcome was unknown.            No concomitant medication was reported by the reporter.  Patient had side effect after receiving the Moderna COVID 19 vaccine. 24 hours after receiving the booster, patient had fever, chills, joint pain, aches and a huge swollen rash at the injection site that is 6 inches wide and 6 inches long- it was red and hot. Patient looked online and it was called the COVID arm. Patient had taken antihistamine generic Kroger brand- Cetirizine 10 mg and pain reliever Ibuprofen 200 mg.  Patient had consulted physician through email and was told to take pain reliever, antihistamine and cortisone.   This case was linked to MOD-2021-393302, MOD-2021-393289 (Patient Link).
dose of MMRV given on 07/25/2023, vaccine expired on 07/24/2023
shaking chills, chest tightness, tachycardia, vomiting, body aches;
My estradiol levels are extremely high - to the point of being dangerous.    My estradiol was tested before the vaccine and it was normal.   After the vaccine, it began to increase.  I immediately noticed a change in my menstrual cycle.  It comes early and is very heavy, despite being on birth control pills.  In addition, I am experiencing daily dizziness, weight gain, and swollen/tender breasts.
Pt developed more welts on face. Some redness was present prior to immunization administration. Immunizations were given at approx 10:15. Motrin was given about 5 min prior to injections. Mother and child left exam room to receive copies of THS and at this time more redness was detected. Mother and child then left clinic and returned no longer than 5 min later. Child had welts all over face and was given 1/2 tsp of diphenhydramine. Recovery noted within 10 min after tx.
This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID 19 infection), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and VACCINATION FAILURE (Vaccination failure) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033h21a and 076c21a) for Prophylactic vaccination. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination. No Medical History information was reported. On 07-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022, the patient experienced COVID-19 (COVID 19 infection). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and VACCINATION FAILURE (Vaccination failure). At the time of the report, COVID-19 (COVID 19 infection), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and VACCINATION FAILURE (Vaccination failure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2022, SARS-CoV-2 test: positive (Positive) Positive and positive (Positive) Positive. The concomitant medication was not reported by reporter. On 19-May-2022, the patient tested positive for Covid-19 and had runny nose at same time (dose number in series 2). This led to suspected clinical vaccination failure (dose number in series 1). The report was associated with product quality complaint. Janssen assessed the event of suspected COVID-19 infection to be possible. The treatment medication was not reported by reporter. Company comment: This case concerns a 46-year-old female patient with medical history of interchange of vaccine products, who experienced the adverse event of special interest of COVID-19 4 months after the third dose of mRNA-1273. Additionally, vaccination failure was also reported. Prior vaccination with JANSSEN COVID-19 vaccine is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case concerns a 46-year-old female patient with medical history of interchange of vaccine products, who experienced the adverse event of special interest of COVID-19 4 months after the third dose of mRNA-1273. Additionally, vaccination failure was also reported. Prior vaccination with JANSSEN COVID-19 vaccine is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Unbeknownst to the Pharmacist, patient had already received a Fluarix shot on August 27, 2023. Patient and caregivers did not inform Pharmacist until after the Fluarix was already given. As such, patient received two Fluarix shots in the same season. One on 8.27.2023 and another on 10.02.2023
After administering the third vaccine which was Prevnar on to her right thigh, the infant had cried to a point where she started turning blue and seemed to have stopped breathing. Infant taken from parent and rubbed on chest and infant started crying though she was sweaty and appeared bluish pale. Per parent, while recovering infant, her energy level is back to baseline. Called Dr. and left message for callback. Infant assessed by Dr., MD on site and spoke to parents regarding infant reaction to vaccinations.
I had chest pains that felt like tightness of my chest.  Friends and family said it sounded like a heart attack (despite being only 25 years old).  It hurt to sit up or maneuver my chest/rib cage in any manner, for example, a sit up caused extreme pain.  The pain was consistent throughout the day.  After it began to dissipate, it was only reproducible when my chest/rib cage was moved or had pressure put onto it. Went to the doctor, diagnosed me with costochondritis.  Received an anti-inflammatory shot.  Reduced the pain.  From initial pain to full recovery was about 3 days (if memory serves correctly, VSafe should have the correct dates as I responded accurately there).  A slight discomfort in my chest did occur after my second shot, but nowhere near the same amount of discomfort.
FULL BODY CHILLS; 102 DEG FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced full body chills, and 102 deg fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the full body chills and 102 deg fever was not reported. This report was non-serious.
Patient presented 11 days post immunization with an Id like reaction to R anterior thigh. Rash initially appeared to be insect bites on R lateral aspect but quickly turned into papulovesicular lesions covering R anterior thigh.
Patient received MENACTRA vaccine on 12-16-11 in right deltoid muscle. Mother noticed swelling of right arm from shoulder to elbow, redness & warm to touch and numbness at times in right arm. Presented at MD office on 12/19/11 with the same above symptoms. MD ordered MOTRIN 200mg one TID, cold compresses. 12/20/11 the right arm was slightly red, swelling markedly decreased and no further numbness. Patient went to school on 12/20/11.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Additional Details: Pt did not disclose that she has localized skin reactions to needles (general allergy to metal) prior to vaccination. Pt reports in the past she will develop localized edema and erythema related to the metal of the needle. Pt did not disclose this til after the vaccine to the RN. Pt did not have any immediate reaction while waiting in waiting area after vaccination and left clinic ambulating independently. Pt does not have an anaphylactic reaction to metal. Pt did not need to return to FU.