chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported.
7 days after my shot, I began to have swelling, redness, and heat around my injection site. The skin felt tight and my arm hurt. So far it has been about 48 hours and it is still red. The redness has slowly expanded around my upper arm. I did not have any reactions like this in the first week after the dose.
sleepy; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 3 patients. This is 2nd of three reports. This consumer reported for a (Age: 83; units: Unknown) female patient (mother) that:  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "sleepy".  Additional information: I have heard (withheld) from my mother, she is 83 (age unit was not specified). I went online for her, she lives about 30 miles from me. And I went online and they contacted her and she got an appointment and she also got the Pfizer shot. My mother and I talked to other people they said they had the same response. Let me tell you, I was sleepy for three or four days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021320975 same reporter/drug/event, different patients;US-PFIZER INC-2021321063 same reporter/drug/event, different patients
Can't smell; Can't taste; Chills; Fever; Neck pain; Back pain; Sore throat; Nasal congestion; Runny nose; Cough; A report was received from a physician concerning a 43-year old, female patient and experienced nasal congestion, runny nose, fever, chills, cough, sore throat, back pain, neck pain, can't smell and can't taste.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 21 Dec 2020, approximately 4 days prior to the onset of the events, nasal congestion, runny nose, fever, chills, cough, sore throat, back pain, neck pain, and 5 days prior to the onset of the events, can't smell and can't taste, the patient received their first of two planned doses of mRNA-1273 (BATCH #011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 22 Dec 2020, the patient was exposed to her COVID-19 positive daughter. On 25 Dec 2020, the patient began to experience nasal congestion, runny nose, fever, chills, cough, sore throat, back pain, neck pain. On 26 Dec 2020, the subject reported no longer being able to taste or smell. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, nasal congestion, runny nose, fever, chills, cough, sore throat, back pain, neck pain, can't smell and can't taste, were unknown.   The reporter did not provide an assessment for the events, nasal congestion, runny nose, fever, chills, cough, sore throat, back pain, neck pain, can't smell and can't taste.; Reporter's Comments: This case concerns a 43 year old female who experienced non-serious unexpected events of congestion, runny nose, cough, sore throat, back pain, neck pain, can't smell and can't taste and non-serious expected events of fever and chills. The events occurred 4 days after first dose of mRNA-1273, followed one day later by loss of taste and smell.  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.
Inadvertant autoinnoculation from smallpox vaccination.  Vaccinee had large amount of drainage from vaccination site.  On the wrist of the arm that was vaccianted, she developed a lesion that resembled a vaccination lesion. Size of approximately the tip of a pencil eraser. Lesion went through the vaccination lesion evolution.The lesion was covered  as per vaccination bandaging and resolved to scab
Round pink large bump, the size of my palm 2" below the shot. It is warmer to the touch than the temp of my arm. It showed up immediately after the shot.  I went to the Dr. 6/25/2021
I tested positive for COVID-19 on 6/17/22. I had a fever, headache, sore throat, and body aches. I basically had flu like symptoms. I just traveled to a reunion and some people that were there tested positive. I called my doctor and they prescribed me Paxlovid. Within 8 hours of my first dose of Paxlovid, I started feeling better, but my symptoms lasted for about 5 days.
A patient that received a dose from a vial that had been punctured more than 12 hours; Received dose from vial punctured more than 12 hours before/punctured for more than 12 hours (about 11 hours after the 12 hour period).; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient that received a dose from a vial that had been punctured more than 12 hours) and PRODUCT STORAGE ERROR (Received dose from vial punctured more than 12 hours before/punctured for more than 12 hours (about 11 hours after the 12 hour period).) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient that received a dose from a vial that had been punctured more than 12 hours) and PRODUCT STORAGE ERROR (Received dose from vial punctured more than 12 hours before/punctured for more than 12 hours (about 11 hours after the 12 hour period).). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (A patient that received a dose from a vial that had been punctured more than 12 hours) and PRODUCT STORAGE ERROR (Received dose from vial punctured more than 12 hours before/punctured for more than 12 hours (about 11 hours after the 12 hour period).) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 18-JAN-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
I received my first dose of the Pfizer COVID vaccine last Thursday (4/8) at 9am. I did not have any immediate side effects -- just mild soreness at the injection site in my right arm approximately 8 hours later (I'm left-handed), which subsided by the next morning. However, at approximately 3am on Friday (4/9), I woke up with a fair amount of discomfort in all of the fingers in my left (dominant) hand. It felt like what I would imagine someone suffering from arthritis might feel; I got up to take some ibuprofen and I had difficulty grasping the doorknob, for example. The pain mostly subsided by the time I woke back up, although there was some very minor continued stiffness in my left index finger, which also eventually seemed to go away after a few days.  Fast forward to this morning (4/13) and I woke up around 5am with renewed discomfort and stiffness in my left index finger, requiring ibuprofen. It is now ~3:45pm and the discomfort remains slightly, but has mostly subsided. I should add that I've never experienced this before the vaccine, and I cannot think of anything I did differently in the last week other than receiving the first dose of the Pfizer vaccine.  I reported this event today to my primary care physician, but have not sought additional treatment.
Swelling, itchy, warm to touch rash. Low grade fever, skin felt like it was on fire almost like after a sunburn, joint pain.
Initial report was received from another manufacturer (document number 45221964) who received the report from a health care professional. A female patient (age and date of birth not reported) had received ADACEL (lot number, route, site and date of administration not reported). According to the reporter, "the patient fainted after ADACEL (Sanofi Pasteur) was given and when she had a finger stick blood test drawn the same day". No additional information was provided. Per the reporter, the medical assistant who reported the event to the other manufacturer, and the patient's physician, requested no further contact be made. Documents held by sender: None.
After the second dose I had pain not only at the injection site, but also in a circle around the arm to the underarm/armpit area.  This lasted a few days, went away and has come back intermittently. Also sometimes happens in the other arm but not as painful. This still is occurring.
This spontaneous report as received from a health care worker refers to a patient of unknown age. On 10-SEP-2013, the patient was vaccinated with a first dose of PNEUMOVAX23 (lot # J005011, expiry date was 04-DEC-2014). Approximately on 10-SEP-2013, within a few hours, the patient experienced redness, swelling, warmth and pain at the injection site. Later approximately on an unknown date in September 2013, these symptoms got worsened and spread to the entire upper arm. The reporter mentioned that the injection site reaction was not local anymore but had encompassed the entire arm. Patient sought medical attention for the same (Office visit). The outcome of all the reported events was not recovered/not resolved. This is one of the 3 reports received from the Same Reporter Link (MARRS#1309USA014075 and 1309USA014074). Additional information has been requested.
After eight hours received Moderna vaccine, I had very bad body aches and fiver more that 102 F for two days and three nights. I was covid 19-positive  back to December 24, 2020 and probably already develop antibodies.
Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid-19) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In September 2023, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 1 out of 4.   This case was linked to US-MODERNATX, INC.-MOD-2023-748924, US-MODERNATX, INC.-MOD-2023-748925, US-MODERNATX, INC.-MOD-2023-748928 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748924:Patient 2 out of 4 US-MODERNATX, INC.-MOD-2023-748925:Patient 3 out of 4 US-MODERNATX, INC.-MOD-2023-748928:Patient 4 out of 4
Developed very weak, painful right arm between elbow and wrist on 1/28/21.  Pain in arm woke me up 2x during night, that I went to an Express Care early 1/29, where they thought I had tendinitis.  On 1/30 at 5 AM, right arm pain so excruciating and all fingers in right arm were going numb and very hard to stretch out fingers and pain also went up to my right shoulder. On 1/30, at 6AM went to ER, they were wondering if I had an ulnar nerve compression, then discharged.  Monday night, 2/1/21, I developed blisters filled with white liquid on back of my right wrist, and right arm.  Diagnosed with shingles by Dr. on 2/3/21 in Doctor's office.
Cellulitis - upper (R) arm red, swollen, painful warm to touch, fevers 102-103, nausea/vomiting. Treatment with KEFLEX 500 three times daily for 7 days
About 3-4 hours after receiving vaccine, developed itchy red rash on both sides of abdomen and neck. Then i began having tingling and numbness on left side of body along with nausea and dizziness. My neck became tingly and then my bottom lip went numb. Lasted several hours, almost thought my throat was going to began closing. Took multiple Benadryl, rash did not get better. Had to call doctor next day to get steroids. Day 6 rash is clearing up. Still have random tingling to left side.
Pt seen in ER on 04/15/2006 at 16:15 with c/o fever of 101.7F within 24 hours; headache, upset stomach, neck pain with extension and increased sleeping. Pt had pain scale of 9/10 X 2-3 days. Pt was treated with normal saline IV, Tylenol, Motrin, Rocephin and Phenergan. CT done on 4/15/06 was normal. Pt was discharged at 21:15. Neurological exam was normal.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient's arm "puffed" up and became warm to the touch about 10-15 minutes after he received it. Patient said he felt fine otherwise and went home.
Arm continued swelling 8 days later; Pain in arm at injection site; Arm red; Arm itchy; Arm puffy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in arm at injection site), VACCINATION SITE ERYTHEMA (Arm red), PRURITUS (Arm itchy), OEDEMA (Arm puffy) and PERIPHERAL SWELLING (Arm continued swelling 8 days later) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history Provided.).    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm at injection site), VACCINATION SITE ERYTHEMA (Arm red), PRURITUS (Arm itchy) and OEDEMA (Arm puffy). On 08-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm continued swelling 8 days later). At the time of the report, VACCINATION SITE PAIN (Pain in arm at injection site), VACCINATION SITE ERYTHEMA (Arm red), PRURITUS (Arm itchy), OEDEMA (Arm puffy) and PERIPHERAL SWELLING (Arm continued swelling 8 days later) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient has taken treatment and applied anti itch cream concomitant medicataion for blood pressure
Redness below the injection site; Swelling below the injection site; tired and fatigued; This spontaneous report was received from a consumer of unknown age and gender reporting on her/himself through customer survey. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis.  On an unknown date, the patient experienced Redness and swelling below the injection site for three days (injection site erythema and injection site swelling). Additionally, the patient experienced fatigue and was tired. She/he enquired if it was normal for pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23).  At the time of the report, the outcome of injection site erythema, fatigue and injection site swelling was not provided.  The reporter did not assess the relatedness between injection site erythema, fatigue and injection site swelling with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23).
1-16: Cant take deep breath, 1-17-18: R hand swollen, painful - Advil, 1-21-23: Extreme pain in L wrist, Swollen. Advil pm, Advil, immobilized with stretchy bandage
Symptoms: Vomiting, extremely lethargic (responsive but unable to keep eyes open), high heart rate/pulse, loss of appetite, fever  Treatment: IV, ibuprofen
Pt received vaccines at approx. 08:50 on 9/28/01. Pt left 10 minutes later, with no reaction noted. Mother called office at approx. 09:30 and had noted welts all over the pt's body. She came back in, 15 minutes later, and was seen again and given Benadryl and referred to ER.
Acute onset severe muscle spasming of right semitendinosis muscles and daily muscle tremors of same muscles to date.
Tinnitus in both ears, Pulsatile Tinnitus in my Left Ear It has been persistent since 3 days after the 2nd Pfizer shot - all the time- so for 4 weeks plus and ongoing Saw an ENT- CT Scan came out clear Will see  TMJ Specialty dentist soon May see a Neurologist for work up over the Pulsatile Tinnitus
I had a cough that was keeping me up at night and I felt achy. I went to the urgent care, and they tested me for COVID-19, and it came back negative. So, they said I had a sinus infection. I went to another urgent care a couple days later and they said I might have RSV.
ITCHING AT INJECTION SITE; HURTING RIGHT ARM; FATIGUE; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 03-MAY-2021, the subject experienced itching at injection site. On 03-MAY-2021, the subject experienced hurting right arm. On 03-MAY-2021, the subject experienced fatigue. On 03-MAY-2021, the subject experienced swelling at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hurting right arm, fatigue, itching at injection site and swelling at injection site was not reported. This report was non-serious.
Injection site - swollen, sore  getting better after 2 full days; Shivering only on first night, extremely cold, required extra blankets; Fever-first night 101.5, second night 100.5, normal morning of third day Tylenol for fever and aching; Excedrine for fever; Third day mostly better with slight arm soreness and slight aching.
Pt developed red, blistery rash; some crusted at time of office visit. Treated with calamine lotion and Benadryl.
Patient complained of dizziness following vaccination. Patient was placed in a supine position and legs elevated. Patient blood pressure was checked a couple times and reported at 137/83 initially and 132/87 finally. Ox/pulse 98/75.Patient report having a white coat effect usually when blood pressure is checked. Patient reported feeling fine after about 10 minutes. Patient was observed for about 15 more minutes then released to her husband. Patient came in following day a report feeling fine and report no additional adverse events.
Dizziness and trembling following shot.  Slight sinus inflammation.  Steroids prescribed.  Dizziness and head disorientation continued after prescription over.  Took blood.  Everything including thyroid and electrolytes were normal.  Dizziness and unsteadiness left after 19 days.
Patient with syncopal episode that occurred after vaccine.  Patient improved with rest and oral intake.  Discharged to home.
Vaccines given about 2-3 mins. after vaccine (MMR) arm became very red, inflamed; itchy area 12x3 ins. small hives at neck and dizzy.
5 hours after had mild stroke like effects to include blurred vision followed by headache. 5 days after had muscle and joint aches in the night which are continuing.
Caller says the patient last got 2 moderna doses back on 2021; Expiration on the vial itself shows Sep2022/administration date: 13Jun2023; it was first punctured yesterday at 4pm but was still given today at 3:20PM; it was first punctured yesterday at 4pm but was still given today at 3:20PM; Creatinine: 10.2; CO2: 22; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID: ().  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jun2023 at 15:20 as dose 3 (booster), 0.3 ml single (Lot number: GL2042, Expiration Date: Sep2022) at the age of 54 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AZOR [AMLODIPINE BESILATE;OLMESARTAN MEDOXOMIL]; XIGDUO XR; METFORMIN [METFORMIN HYDROCHLORIDE]; PRILOSEC [OMEPRAZOLE]; CRESTOR OD. Vaccination history included: Moderna covid vaccine (Dose 1), administration date: 2021, for COVID-19 immunization; Moderna covid vaccine (Dose 2), administration date: 2021, for COVID-19 immunization. The following information was reported: CARBON DIOXIDE DECREASED (non-serious) with onset 13Jun2023, outcome "unknown", described as "CO2: 22"; BLOOD CREATININE INCREASED (non-serious) with onset 13Jun2023, outcome "unknown", described as "Creatinine: 10.2"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 13Jun2023 at 15:20, outcome "unknown", described as "Caller says the patient last got 2 moderna doses back on 2021"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 13Jun2023 at 15:20, outcome "unknown", described as "Expiration on the vial itself shows Sep2022/administration date: 13Jun2023"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 13Jun2023 at 15:20, outcome "unknown" and all described as "it was first punctured yesterday at 4pm but was still given today at 3:20PM". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the "vials were first punctured yesterday at 4 PM but were still given today at 3:20 PM to a patient". The reporter stated that prior to this, the patient just had 2 Moderna doses back in 2021. Further, the expiration date of the vial shows Sep2022. Lab work was done on 13Jun2023 and included albumin: 4.6, ALK phosphate: 72, ALT: 27, AST: 19, BUN: 13, Calcium: 9.9, Chloride: 106, CO2: 22, creatinine: 1.3, globulin: 3.4, glucose: 227, potassium: 4.3, sodium: 140, total bili: 0.6, protein: 8.0, and creatinine: 10.2 . The patient had no prior vaccinations (4 week)
fever, vomiting, pale, weak, lethargy, elevated WBC ct., elevated heart rate, lasted 9-10 hours. Required hospitalization.  Treated with antipyretics which did not work, IV fluids, IV antibiotics.