chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case previously recorded as MA2009-3772. Combined initial and follow-up case report was received from a physician on 05 NOV 2009 and 06 NOV 2009. An unknown number of children, younger than 4 years, was vaccinated i.m. for the first time with 0.25 ml S-OIV FLUVIRIN (batch no. unknown) on an unknown date. No adverse events were reported. Novartis Pharma reference no. NA09-007617.
On March 27th, I notice a pimple on the site where my covid shot was given..  I was itching,  thats when I realize that I had a pimple there as well..
Prolonged heavy menstrual cycle with excessive blood clot starting on 3/22/21 till present 5/10/21.  Despite intervention by ob/gyn such as performing pelvis ultrasound  and  performing a  uterine biopsy with negative result for cancer as well as treating me with  medroxyprogesterone for a course of 15 days that I completed  as prescribed . After the medroxyprogesterone, I have to be placed 3 days ago on birth control pill, the menstrual bleeding continues . It?s been almost for 50 days. Need help!
I had the 3 of them already and I still got the COVID; I had the 3 of them already and I still got the COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Sulfur, reaction(s): "allergic to Sulfur", notes: I am allergic to Sulfur. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had the 3 of them already and I still got the COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient's doctor prescribed the patient one medication called PAXLOVID.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The evening after the injection the patient suffered symptoms of the following:  Blacking out several times (almost fell down), blurry vision, severe piercing headache, chills, fever, body aches, extreme sweating, sore throat, loss of appetite, loss of taste, arm and shoulder hurt extremely bad.
Vomiting and Hugh cold sore that infected and went to dr for antibiotics.  It was diagnosed as cellulitis.
Sore throat; runny nose; dizziness; diarrhea; face rash; This is a spontaneous report from a contactable consumer or other non hcp. A 32-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 24Feb2021 17:00 (Lot Number: EN6198) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included Sertraline, Vitamin D NOS, cyanocobalamin (VITAMIN B12) for unknown indication. The patient experienced sore throat, runny nose, dizziness, diarrhea and face rash all on 24Feb2021 21:00. Outcome of the events was unknown.
ONE MONTH after 2nd dose dev sudden onset of shaking chills, muscle aches, severe fatigue, joint pain, soaking sweats, headache, skin sensitivity, low grade fever
Pt felt lightheaded, dizzy about 5 minutes after his vaccine, LOC with some stiffness and tremors during brief episode.  Pt was then positioned lying down, monitored for 30 mins, vitals nl,  continued to have lightheadedness, tingling in extremities, intermittent hot/cold.  Pt agreed to be transferred to ER after incomplete recovery after 30 mins.
Hot pain at injection site; fever; fatigue; headache; muscle pain in arm and shoulder; decreased arm range of motion. Still have arm and shoulder pain and fatigue 10 days after injection.
Patient waited in room for 15-20 min. Asymptomatic @ that time mom and patient walked to check out patient became faint. Returned to room for re-eval/monitoring.
Ringing in ears (left ear more pronounced than right).  The left side is also where the shot was administered.  Since the shot was administered I have experienced ringing in ears 4-6x's per day (these ringing "episodes" last 15-30 min).
First 2 days: Deep burning pain at injection site, unable to move my arm. Trembling/shaking all over. Pain in shoulders, back of neck and head. Fever, nausea, very loud intestinal sounds - I actually recorded them - fatigue. Day 3: less severe but stayed home from work - exhaustion, bright red  itchy rash on neck and shoulders, some pain in left shoulder but more of a stinging sensation instead of burning.
I tested positive for COVID-19 on 1/18/23. On 1/14/23 I hosted a large celebration for my son, so that event was stressful and wonderful, but I suspect that is where I contracted COVID. On Jan 18th, I woke up with a sniffley nose and took a COVID-19 rapid at home test and it was positive. Later on that day I started to feel much worse and called my doctor. I was prescribed PAXLOVID and started taking it that same day. That night I had a fever and lots of coughing and congestion. I also experienced some fatigue and brain fog. I never tested my fever at night, it would have been much higher I think, but when I did check I was at 99.8. By the evening of January 19th I felt much better, and today 1/20, I feel even better, except for the PAXLOVID mouth, the metallic bitter taste. It happens within a half hour of the dose and 10 hours later fades. Also, in retrospect, thinking back to the last few months, the vaccination injection site has been painful whenever pressure is applied, even this far out if I lean against it.
MS exacerbation; hemiparesis; optic neuritis; intranuclear opthalmoplegia; This is a spontaneous report received from contactable reporter(s) (Other healthcare professional). Other Case identifier(s): LRN4462471.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS. The following information was reported: MULTIPLE SCLEROSIS RELAPSE (medically significant), outcome "unknown", described as "MS exacerbation"; HEMIPARESIS (medically significant), outcome "unknown", described as "hemiparesis"; OPTIC NEURITIS (medically significant), outcome "unknown", described as "optic neuritis"; OPHTHALMOPLEGIA (medically significant), outcome "unknown", described as "intranuclear opthalmoplegia".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received their first dose of BNT162B2 (lot number: EL0140; expiry date unknown), intramuscular on 21Dec2020 at single dose for COVID-19 immunization. Medical history included congestion and dry cough (before vaccination), and not tasting anything from an unknown date. Concomitant medication included vitamins. The patient reported that they just have the concern about the vaccination last Monday that was 21Dec2020, on 25Dec2020, Christmas day they were diagnosed with Covid. They were thinking because the day before their vaccination they already had like some kind of congestion and also some kind of dry cough but they didn't really think that it was Covid but they were still able to get the vaccination on Monday. When they started to feel like they were not tasting anything, that's when they decided to get tested and it turns out to be positive. They were confirmed positive on the 25th but in their mind they were probably having Covid since the day before they got they vaccination. So their worry is, is there any effect where they got the vaccine where they already have the Covid in their body. So that is really their worry right now. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 25Dec2020. The outcome of the events was unknown.; Sender's Comments: The association between the event drug ineffective (COVID-19) with BNT162b2 can not be completely excluded.
Tachycardia, elevated temperature without fever,  dizziness,  generalized weakness, malaise
Red bullseye at injection site.  Half dollar size red circle around injection site.  Expanded pinkish red site beyond the center red circle.  Upper arm at injection site was swollen,warm to touch and itchy.  Called the pharmacist who did the injection. He instructed me to keep an eye on it.  By the end of the day I went to Urgent Care, for a doctor to look at.  The urgent care dr cited the bullseye as a rash and gave me a Cortizone shot to ease symptoms and to use ice for relief.  On 30 April, my arm had something running down it.  So I covered it with gauze.  Noticed when I go to bed at night, my armpit is sore.  1 May 14, injection site is still red spot half dollar size; is improving.
patient came into clinic and despite being only 16 years old received first dose of moderna vaccine , patient is not known to have any prior health issues !
Whenever took any of the covid-19 vaccine, it rattled Crohn's disease; Muscles were sore and could not bend down like used to; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Whenever took any of the covid-19 vaccine, it rattled Crohn's disease) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Crohn's disease.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, 40MG/0.4ML. On an unknown date, the patient experienced CROHN'S DISEASE (Whenever took any of the covid-19 vaccine, it rattled Crohn's disease) (seriousness criterion medically significant) and MYALGIA (Muscles were sore and could not bend down like used to). At the time of the report, CROHN'S DISEASE (Whenever took any of the covid-19 vaccine, it rattled Crohn's disease) had resolved and MYALGIA (Muscles were sore and could not bend down like used to) had not resolved.            No concomitant medication information provided. It was reported that patient had a booster dose. MPID: 4782590 It was unknown if patient was enrolled in COVID-19-Vaccine Trial. No treatment information provided.  Company comment: This spontaneous case concerns an elderly female patient of unknown age with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Crohn's disease an unknown time after the booster dose of mRNA-1273.222. The patient reported that she experienced a Crohn's disease flare up every time she took a COVID-19 vaccine. Crohn's disease can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-675618 (Patient Link).; Sender's Comments: This spontaneous case concerns an elderly female patient of unknown age with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Crohn's disease an unknown time after the booster dose of mRNA-1273.222. The patient reported that she experienced a Crohn's disease flare up every time she took a COVID-19 vaccine. Crohn's disease can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient is a hospital employee who received dose 1 (11/27/2021) and dose 2 (05/28/2022) of Pfizer vaccine at a local pharmacy store.  Presented to hospital emergency room on 6/22/2022 at 10AM.   Sections of medical record copied below from ED physician assistant notes.    Chief complaint "Patient presents with palpitations.  Pt states he woke up at 2am with palpitations (heart racing). He said the started to feel tingling in his L face, L shoulder and hand. He denies chest pain/SOB. The "heart racing" feeling improved but then returned. He states he is vaccinated x3 but does not have his card with him. " History "35-year-old male presents for evaluation of palpitations that began around 2 PM this morning he woke up from sleep because his heart was racing and felt like it was pounding in his chest.  He felt pins and needle sensation in his left shoulder radiating down his left upper extremity and into his neck.  He got up tried to drink some water and felt lightheaded as though he was going to pass out.  He also reports discomfort to his left chest described as a dull ache that does not radiate. " ED Course Wed Jun 22, 2022 "1035AM EKG interpreted by me: sinus rhythm at 75 bpm;no ST/T changes; Qtc 405 (-)Brugada (-)WPW  1132AM CXR as read contemporaneously by me: no acute cardiopulmonary disease no pericardial effusion  1235PM Pt resting comfortably in bed. Complains of continued chest pain and paresthesias. Exam remains non-focal. Additional treatment with toradol 15 mg IV ordered 1320PM Pt counseled that all blood work and imaging studies are unremarkable. Vital signs remain stable and he is in no acute distress. Provided with cardiology f/u and given strict return precautions"
Fever of 102.7 for 2 days; Hives on trunk; Extremely sore breasts/armpits; Extremely sore breasts/armpits; Painful lumps; Painful lumps; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 28Apr2021 at 10:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included diverticulitis, traumatic brain injury (TBI) and allergies which were unspecified. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had received unspecified medication within two weeks of the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 07Apr2021 at 10:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 13:00 the patient experienced a fever of 102.7 (Unspecified units) for two days, hives on trunk which required prednisone prescription, extremely sore breasts/armpits with painful lumps which had continued daily since the second vaccine. On 06Aug2021, the patient underwent nasal swab (COVID-19 virus test) and the result was negative. On an unknown date in 2021, the patient underwent mammogram, ultrasound, and biopsy and the result was unknown. The events resulted in several doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of hives on trunk and included treatment with prednisone (MANUFACTURER UNKNOWN) and as a result of fever, and extremely sore breasts/armpits with painful lumps included treatment with RX (unspecified prescription). The clinical outcome of the events fever of 102.7 was recovered on 30Apr2021, hives on trunk and extremely sore breasts/armpits with painful lumps were not recovered at the time of this report.
Sore arm one hour after receiving immunization, around 5:00pm dizziness, tired, nausea. 9:00pm : 101.2 fever, body aches, fever subsided with 600mg Motrin. 4/12: 8am: normal temperature, body aches, tired.
Pt received Pneumovax vaccine on 01/05/05 at 12:30 pt stated arm pain that night around 18:00. Pt called MD office on 01/06/05 at 16:50 c/o arm pain, shoulder area sensitivity, c/o red streaks, blotches deltoid area spreading to back/side. 5AM c/o warmth to area, sent to ER for eval. Shoulder cellulitis, treated with Levaquin 500mg
Syncope followed by muscle aches, cough, sore throat, congestion, fatigue, weakness.
I had low grade fever was advised to take fever reducer for 3 days took Advil did get COVID. I think the adverse events would have been my menstrual didn't experience anything immediately after. I have a follow up appt for my ovarian cyst.
Body aches, chills, temperature of 99.2F, diarrhea, injection site swelling, redness and pain. Symptoms resolved within 48hrs of vaccination
c/o soreness & irritability; mom noted arm had large red patch beneath shot site that went to the elbow; hot to touch;
could not breath; in induced coma; went into cardiac arrest; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COMA (in induced coma), CARDIAC ARREST (went into cardiac arrest) and DYSPNOEA (could not breath) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043021A and 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced COMA (in induced coma) (seriousness criterion hospitalization) and CARDIAC ARREST (went into cardiac arrest) (seriousness criterion hospitalization). On 19-Apr-2021 at 1:00 AM, the patient experienced DYSPNOEA (could not breath) (seriousness criterion hospitalization). The patient was hospitalized on 19-Apr-2020 due to COMA, then on 19-Apr-2021 due to CARDIAC ARREST and DYSPNOEA. The patient was treated with Manual therapy (CPR) for Cardiac arrest and Manual therapy (CPR) for Dyspnoea. At the time of the report, COMA (in induced coma), CARDIAC ARREST (went into cardiac arrest) and DYSPNOEA (could not breath) outcome was unknown.            No concomitant medications were reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Lethargic; Lump below the injection site; Achy; Dizzy when I first get up in the morning; This case was reported by a consumer via sales rep and described the occurrence of lethargy in a 79-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than 3 weeks after receiving Shingrix, the patient experienced lethargy, injection site lump, pain and dizziness. On an unknown date, the outcome of the lethargy, injection site lump, pain and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the lethargy, injection site lump, pain and dizziness to be related to Shingrix.  Additional details were received as follows: The patient received 2nd dose of Shingrix two and half weeks before the date of reporting. The patient experienced lump below the injection site and was lethargic and achy. The patient felt dizzy when first get up in the mornings. The patient was concerned about the dizziness. The patient asked is it uncommon for these effects to be continuing 18 days after the injection. The patient asked are there any treatments to alleviate the symptoms.
Administered expired vaccineHasn't expired from manufacturer expiration but was in fridge over 30 days; Vaccine was in fridge over 30 days; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccineHasn't expired from manufacturer expiration but was in fridge over 30 days), PRODUCT STORAGE ERROR (Vaccine was in fridge over 30 days) 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)) (batch no. 201L228) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccineHasn't expired from manufacturer expiration but was in fridge over 30 days), PRODUCT STORAGE ERROR (Vaccine was in fridge over 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccineHasn't expired from manufacturer expiration but was in fridge over 30 days), PRODUCT STORAGE ERROR (Vaccine was in fridge over 30 days) 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 (Administered expired vaccineHasn't expired from manufacturer expiration but was in fridge over 30 days) and PRODUCT STORAGE ERROR (Vaccine was in fridge over 30 days).    No concomitant information was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-731925 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731925:same