chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator 22-Jun-2023 and was administered on 24-JUL-2023; No adverse event; Dose was given after the beyond used by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after the beyond used by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 22-Jun-2023 and was administered on 24-JUL-2023) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     It was reported that patient medical history was unknown. It was reported that patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 24-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 24-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after the beyond used by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 22-Jun-2023 and was administered on 24-JUL-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after the beyond used by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 22-Jun-2023 and was administered on 24-JUL-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose was given after the beyond used by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 22-Jun-2023 and was administered on 24-JUL-2023).    No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that patient administered on 14-Jan-2021, 2nd dose unknown, 3rd dose unknown 4th dose lot number was 002M21A administered on 09-Apr-2022 5th dose unknown. The 2.5 ml vial was initially stored in the refrigerator 22-Jun-2023.  The BUD date was reported as 22-Jul-2023. The vial did not underwent any temperature excursions. It was reported that one intact carton and remaining vials had been discarded. No treatment medication was reported. This case is reported for patient 1 out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-734896, US-MODERNATX, INC.-MOD-2023-734899, US-MODERNATX, INC.-MOD-2023-734913 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734896:Same Reporter US-MODERNATX, INC.-MOD-2023-734899:Same Reporter US-MODERNATX, INC.-MOD-2023-734913:Same Reporter
Pt. states that after receiving the 2nd dose of Moderna 04/16/2021, started experiencing symptoms 04/17/2021 of Intense Neuropathy in both feet. Emergency Room visit 04/17/2021, Blood Work (Normal-High Hemoglobin) no recommendations.
[BioNTech COVID-19] treatment under Emergency Use Authorization(EUA):BioNTech Pfizer COVID-19 Vaccination. Two vaccinations given. Mild arm tenderness associated with 1st dose. Second dose administered 20 days after 1st dose resulted in adverse effects (AE) approximately 40-43 hours after 2nd dose was administered. AEs involved nausea, malaise, flu-like symptoms, mild fever, chills, body aches, gastritis and diarrhea. AEs lasted approximately 4-5 hours. Fatigue lingered for approx. 12 hours. Patient felt normal upon awakening next morning with no additional or lingering AEs to report since experiencing AEs from 2nd dose of BioNTech vaccine. 650mg acetaminophen was taken during 2nd dose experience with AEs. Acetaminophen did alleviate severity of symptoms slightly. Patient had loss of appetite due to AEs experienced. Patient was able to consume water without complications. No mental effects only tiredness from symptoms were experienced.
Patient's arm became very sore, rock hard and pain radiated down under armpit, up into neck and shoulder, lasted for 4 days.
She tested positive on PCR test. She was already vaccinated with two doses of Pfizer vaccine.; She tested positive on PCR test. She was already vaccinated with two doses of Pfizer vaccine.; This is a spontaneous report from a non-contactable consumer (Patient) via Pfizer Sales Representative. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EL3246; Expiration Date: 30Apr2021), via an unspecified route of administration on 15Jan2021 as single dose and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EL0140; Expiration Date: 30Mar2021) via an unspecified route of administration on 24Dec2020 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient tested positive on pcr test. she was already vaccinated with two doses of pfizer vaccine. On an unspecified date she had mild symptomatology. Event took place after use of product. Many months after application. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient was accompanied by mother. Patient was visibly anxious prior to and during immunization; his mother notified me he has a history of feeling faint after immunizations. I acknowledged this, deposited the syringe in the sharps container, told patient and mother to stay in the store for at least 15 minutes to make sure he felt okay afterwards, and patient was lightheaded. Mom asked if they could stay there a minute, to which I said yes, and I stayed there to assist if he passed out. He experienced a brief loss of consciousness while seated; this was accompanied by loss of bladder control and brief twitching in legs. He was awake shortly after and given water and instant cold packs. Mom and him were given privacy in the room per her request and I told her to come get me if they needed any assistance at all; about 20 minutes later, they exited the room and asked if they could leave if he felt fine. I told them yes but to call us if they ran into any other issues.
No adverse effects noted; One of the vaccinations given was supposed to be Prevnar, but instead Gardasil or Gardasil 9 was given; One of the vaccinations given was supposed to be Prevnar, but instead Gardasil or Gardasil 9 was given; This spontaneous report was received from a consumer, concerning her 2 month old grandson. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported.       On 29-OCT-2019 at approximately 15:00, the patient received immunizations with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (reported as "Dtap injection", which the reporter believed immunized the patient to polio and hepatitis B); a hib conj vaccine (reported as "HIB injection"), and rotavirus g1 p1 vaccine live (89-12) (ROTARIX) (or possibly rotavirus g1 g2 g3 g4 p1 reassortant vaccine live (human-bovine)(ROTATEQ)) oral vaccination. The patient was also supposed to receive a pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) injection, but instead he received either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), administered in the patient's tight (dose, route of administration, lot number and expiration date were not reported) No adverse effects were noted.
Severe headache later in the day, given TYLENOL, decreased appetite that evening and felt nauseous, symptoms improved in 24 hours but still felt tired.
Both times I received this vaccine I had side effects. Painful body aches, headache, weakness, chills, sore arm at injection site.
rash little tiny spots all over body, blotchy on face only;fever for 4 days;mom had no thermometer, but was pretty hot;fever lasted consistently for 2 days then intermittently for 2 days;mom was cutting jalapeno peppers, handled child w/pep
pt recv vax & became irritable, exp loss of appetite, devel pink urine;taken to ER UA negative for blood;urine discoloration attributed to limited intake of fluids & pt treated w/APAP;
This is a spontaneous report from a contactable other healthcare professional, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration in the left arm on 19Mar2021 at 14:00 (at the age of 50-years-old), as a single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, the day after injection, the patient experienced, soreness in arm, headache and fatigue and one week and one day after injection the patient experienced migraine headache. The adverse events resulted in an emergency room visit or department urgent care visit and treatment was received for the adverse events. The clinical outcomes of soreness in arm, headache, fatigue and migraine were unknown, at this time of report. No follow-up attempts are needed. No further information is expected.
Burning sensation; Swollen tongue; Itching tongue; Cough; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation), SWOLLEN TONGUE (Swollen tongue), TONGUE PRURITUS (Itching tongue) and COUGH (Cough) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No medical history.  The patient's past medical history included No adverse event. Concomitant products included ATENOLOL and AMLODIPINE BESILATE (NORVASC) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation), SWOLLEN TONGUE (Swollen tongue), TONGUE PRURITUS (Itching tongue) and COUGH (Cough). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. On 29-Mar-2021, BURNING SENSATION (Burning sensation), SWOLLEN TONGUE (Swollen tongue) and TONGUE PRURITUS (Itching tongue) had resolved. At the time of the report, COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication include Benadryl
I have a fever (100.2F) the day after getting the shot which I know is normal with on & off headache & my vaccinated arm is swollen and red from shoulder all the way to the elbow from the day after getting the shot till present which I know is not normal anymore. I didnt take any antihistamine yet but is planning to take one tonite.
bleeding heavily (menstrual); the Mirena IUD that I had for about a year and a half, dislodged from my uterus (It fell out.); This is a spontaneous report from a contactable consumer (patient). A 55-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8732) via an unspecified route of administration on 25Mar2021 at 15:00 (at the age of 55-years-old) in left arm as a single dose for covid-19 immunization. Medical history included anaemia, thalassaemia, narcolepsy, and bipolar disorder all from an unknown date and unknown if ongoing. The patient previously took Compazine and experienced allergy. Prior to vaccination, the patient was not diagnosed with covid-19. The patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Concomitant medications received within 2 weeks of vaccination included levonorgestrel (MIRENA IUD); oxcarbazepine (OXCARBAZEPINE); quetiapine (QUETIAPINE) and methylphenidate hydrochloride (CONCERTA) all taken for an unspecified indication, start and stop date were not reported. The patient experienced bleeding heavily (menstrual) around 38 hours after the vaccination on 27Mar2021 at 06:00. She mentioned about 24 hours after that, the Mirena IUD that she had for about a year and a half, dislodged from her uterus (It fell out). Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment medication included Tranexamic acid to control the bleeding. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test (saliva) with pending result on 29Mar2021. The outcome of the events was not resolved.  Follow-up attempts are possible. Further information is requested.
Local mild allergic reaction with immediate induration and redness near injection site; not typical local injection site reaction because of robust induration.  No other symptoms; no shortness of breath, chest pain, etc at that time.  Later on Sept 29, the patient presented with chest pain that reportedly got worse since having the vaccination; however, workup was completely negative (BNP and Troponin within normal limits).
the injection went too low on his deltoid; got a bruise, a fairly good size of bruise; A spontaneous report was received from a healthcare professional concerning a 65-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fairly good size of bruise.  The medical history was not provided. Concomitant product use was not provided.  On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection.  On 07 Jan 2021, the injection went too low on his deltoid, and he suspected that it did not hit the deltoid muscle but the muscle below that, and that was why he got a bruise. He got a fairly good size of bruise. He also stated that he didn't have a lot of muscle mass.  On 04 Feb 2021, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection and he had no issue.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event vaccine administered at inappropriate site was considered resolved on 07 Jan 2021. The outcome of the event fairly good size of bruise was unknown.; Reporter's Comments: This report refers to a case of vaccine administered at inappropriate site for mRNA-1273 (lot # unknown) with reported non-serious unlisted event of contusion. Based on the current available information and temporal association between the use of the product and the start date of the event of contusion, a causal relationship cannot be excluded
No reported adverse event. Logistical error occurred Patient was given Moderna on 3-31-21. I was under the impression based on paper work that patient was going to receive Pfizer?s  2nd dose. Checked with nurse verbally. Administered  Pfizer. When I went to fill out vaccination card I noticed patient had gotten Moderna on 3-31-21 lot number 021b12A. Observed for 30min with no complaint or incident.
I am a 62 year old male. On April 20, 2021 I received my first Moderna Vaccine shot. The basic reason for this was so I didn't have to wear a mask at work as mandated because I am Asthmatic. Soon after my first shot I noticed unusual bruising all over my body, however I dismissed it. In retrospect I wish I would have checked it out.   Then I received my second shot on May 21, 2021 as follow up. I soon became very tired at work and started having breathing problems. On June 19, 2021 I decided to go to the Emergency Room because I was having a problem breathing and Flu-like symptoms. Several hours later the Doctor entered my room and told me my Spleen was enlarged and I had Acute Myeloid Leukemia. I was transferred to another hospital because they had better equipment to deal with the Leukemia. When I arrived they also determined I had Pneumonia as well ?Coincidence? No I truly believe that the Moderna Vaccine caused these health issues. I will be sending this letter to Senators  and Moderna. I am very upset at this time and I will be pursuing this further? Moreover, I will be an advocate for the people not accepting these shots. I also plan to make known my plight to the Thank you.
First vaccine administered August 10,  August 20th around 530 PM a half inch red line showed up under my left arm along with fever to the touch. By Saturday morning Aug 21st I developed a severe rash, blisters, redness all over my arm from 2 inches above elbow up to about an inch above the injection site. Swollen, red and very itchy. Blisters and terrible, painful rash. The redness and puffiness spread all over the top of my arm to both sides. The sleeve of my shirt hurt to touch it. Extreme sensitivity. I called my doctor on Monday Aug 23 and they wanted to see me on Tuesday Aug 24th. Dr stated that this was COVID Arm and she said there could potentially be a secondary infection at the injection site due to how how severe my arm was. I was prescribed antibiotics to take for one week as well as a steroid topical ointment. I do recall while at Walgreens the staff member took the needle cap off and then dropped the vaccine on her work station table needle side down then administered.
1) 3rd dose (booster) Moderna administered (See VAERS ID: 1463411) a) within 6-8 hours of the 2nd vaccine: i) Dizziness. ii) Slight nausea. iii) Moderate soreness at injection site iv) Muscle aches v) Weakness, difficult to lift injected arm vi) mental confusion, difficult to concentrate. b0 After 8 hours post 3rd vaccine / overnight: i) Chills / moderate but uncontrollable shaking / teeth chattering. iii) Extreme Thirst. iii) Moderate headache. iv) Tinnitus c) 11/21/21: Three weeks post booster: i) Skin tags are emerging in "sweat" areas and along Lymph lines on neck, chest & upper arms. 11) Continue to experience mild memory loss and confusion
Had normal sore arm, sl. swollen 1-3 days p/TD vax; On 26NOV90, pt's arm became very swollen, hard, reddened(esp a red circle around swollen area), & hot to touch. Also was very itchy. Referred to MD.
Shot felt weird when injected and felt dizzy. Two days after vaccine I had low blood pressure and very tired. That lasted 2 days. Then my blood pressure became high. I have had dizziness, heart palpitations, confusion and fatigue since then. ER visit with blood pressure of 165/92. Still no answer. Waiting to see cardiologist
Headache, stiff neck, weak body, fuzzy thinking, shaky, unstable walking, metal taste in mouth.
Same day post vax, this pt experienced arm swelling and arm pain. It was also noted that the pt's arm was red and warm to the touch.
Received Covid vaccine on 8/19/2021.  I started having vaginal bleeding on 8/21/2021.  My normal menstrual cycle was supposed to being on or around 8/27/2021.  I experienced vaginal bleeding for 21 days from 8/21/2021 until 9/10/2021.  My normal cycle is 7 days.  I've never experienced any bleeding past 7 days in my life.  I am hesitant to take any hormone medication, due to my sister having a blood clot to her eye when she took hormone medication in the past.  I saw my OB doctor on 9/2/2021.  I opted to not take any medication at that visit, and let my body quit bleeding on it's own, due to this being very unusual for me and my family history of blood clots.  I continued having vaginal bleeding, and had to see my OB doctor again on 9/9/2021.  At that time I was prescribed Microgestin 1/20 PO TID for 7 days.  Then after 7 days Microgestin 1/20 PO QD.  I began taking the medication on 9/9/2021.  I finally quit having vaginal bleeding on 9/10/2021.  However, I am still taking the medication.  I did experience some very minor spotting  with dark drown blood with wiping on 9/11/2021 & 9/12/2021, but not bleeding like I was.  I also got my 2nd COVID vaccine on 9/9/2021.
This spontaneous report was received from a nursing assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot# K004204, expiration date 31-JAN-2017 (dose and route of administration were not reported). No adverse effects were reported.
I am reporting  the following reaction, as I was unable to enter it on V-safe due to the site not functioning properly.  Twelve hours post vaccination: onset of shaking chills, temperature 101 F, severe headache, nausea, myalgia, arthralgia and fatigue Twenty four hours post vaccination: severe headache and moderate nausea, myalgia, arthralgia and fatigue, temperature 98.8F Forty eight hours post vaccination: moderate headache, mild nausea and fatigue Seventy two hours post vaccination: slight headache, nausea and fatigue Ninety six hours post vaccination: symptoms resolved
This information was reported to this writer. The patient received the vaccination without incident. He went to the post vaccination area and sat for the recommended 15 minutes. When he stood up he complained of blurry vision. No LOC; did not fall. Patient stated that this has happened in the past as well. EMS was notified. Patient drank juice. EMS assessed patient. Patient cleared to go home by EMS. Left facility with his father.