chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with Covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Diagnosed with Covid-19) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   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)) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2023, the patient experienced COVID-19 (Diagnosed with Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (Diagnosed with Covid-19) outcome was unknown.            The patient was fully vaccinated, got primary series, boosters and, got Covid-19. It was reported that the patient was taking some meds but were told to stop taking one while on Paxlovid. It was reported that the patient felt like they got everything, got really sick. Was sicker than a dog.   This case was linked to US-MODERNATX, INC.-MOD-2023-718731 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718731:Wife case
Information has been received from a registered nurse concerning a 16 week old infant who was vaccinated on 12-Oct-2006 with and oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
8 days after the 1st injection a warm red rash showed up 3-4 inches and slight swelling.
Patient's mother, on Friday May 13, 2011 called Customer Service Department to report that her son developed leg weakness after receiving vaccines in December. Mother states her son could no longer walk independently after the vaccinations in December. Mother states she watched him "for a little while" waiting for improvement and when there was no improvement, she took patient to a specialist (unknown). Mother states she did not report this issue to the pediatrician because she waiting until after the specialist report was completed. Patient has been diagnosed with PDD through the early intervention program. Mother would like to know if other children had similar outcomes after receiving the same vaccinations.
pt had a positive COVID test on 1/3/22 taken to Hospital; 1/15/22 pt presents to hospital from facility with SOB; O2 sats in 70s on RA; pt has a UTI; given ABX; sent to ICU; another positive COVID test on 1/15/22; pt died in the hospital; DC and med records sent per VAERS request
The morning after my shot, when I woke up from my bed, I felt very dizzy. Somehow walked to the bathroom. I walked to my bed still slightly dizzy but with more of headache. After about 10 minutes of lying down, I had to rush to the bathroom to throw up. Left me totally fatigued and weak. After that first episode, I have had 30 such episodes to date. I get them every 7-10 days & it follows the same pattern. A dizzy spell, like a prick to my brain that lasts a few minutes, followed by about 5-6 minutes of a dull headache and then followed by nemises. This happens every single time. It is very debilitatating, leaves me totally exhausted and too weak to function normally. I have to sleep it off for a few hours. Sometime
4-5-03 Client went to the ER at the hospital she worked at with fever 100 degrees for 1 week, vomiting and diarrhea for 3 days.  Doctor in the ER examined her and noticed her scar.  He said he needed to do an ECG since she had been vaccinated.  ECG was abnormal.  He told her she needed to follow up with her PCP.  She went back to work.  She went for preop labs and ECG and was told she had had a Ventricular MI at sometime.  Last normal ECG was May 2002.
About 2-3 min after shot, patient experienced tingling and numbness in left, then right foot. About 5-7 min later, felt tingling in lips and sought out the nurse. The nurse gave patient 50mg of Benadryl and patient felt better in about 5-7 minutes. Vital signs were monitored the entire time and BP was mildly elevated at first, but returned to normal within 5 min of Benadryl. Patient denied all other symptoms including shortness of breath, rash, swelling. Patient had family member pick her up and drive her home since she had taken Benadryl. The office NP called patient at 5pm and patient states she was feeling well and experiencing no side effects. Patient advised to call PCP if any new mild symptoms occur and call 911 if any significant symptoms occur. Patient also instructed to call Moderna adverse reaction reporting phone #.
Flu; Initial information received on 09-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-heath care professional.   This case involves an unknown age and unknown gender patient who experienced flu (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease, or risk factor.  The patient medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got my flu shot in Dec 1999, spent the entire month of Jan 2000 with the flu. I never got a flu shot since and I haven't gotten the flu either".   It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/event.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event flu.  There will be no information available on the batch number for this case.
Myalgia, Fever, FATIGUED Narrative:  Other Relevant History:
a low platelet count; This is a spontaneous report from a contactable consumer reporting for her mother.  A female patient of an unspecified age received the first dose of  bnt162b2 (BNT162B2) vaccine, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced a low platelet count on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included platelet count: low.  The reporter is wondering if it is safe for the patient to receive the second shot.  Information about lot and batch number was requested
Starting at 7 PM had fever and chills.  I also wake up several time that night.  I lost about 15 lbs. for no reason within month of the vaccine.  I went to the doctor about this.  They did blood work.  The doctor is under sure what is causing the weight loss.  I have another appointment next week.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer). The reporter is the patient.  A 31-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 30 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0162), on 06May2021 as dose 2, single (Batch/Lot number: unknown) and on 02Dec2021 as dose 3 (booster), single (Lot number: FJ8757) for covid-19 immunisation. The patient's relevant medical history included: "undifferentiated connective tissue disease (that's why I take plaquenil)" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE] taken for undifferentiated connective tissue disease, start date: 01Jan2022, stop date: 04Apr2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Apr2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests: Body temperature: (13Apr2023) 99.9; SARS-CoV-2 test: (04Apr2023) Positive, notes: Initial positive test: April 4 in the morning; (10Apr2023) Negative, notes: morning of 10Apr and morning of 11Apr; (11Apr2023) Negative, notes: morning of 10Apr and morning of 11Apr; (13Apr2023) Positive, notes: Positive test (rebound). Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID rebound. Initial positive test: 04Apr2023 in the morning. Paxlovid: 04Apr2023 evening until morning of 09Apr2023 (lot number: GG4908). During this time, patient did not take his normal Plaquenil, per guidance from his PCP. He restarted Plaquenil a few days after finishing his Paxlovid course. Negative tests: morning of 10Apr2023 and morning of 11Apr2023. Positive test (rebound): evening of 13Apr2023. Symptoms: very running nose (gross), exhaustion (he got really tired grating a carrot. The carrot was not that good), slightly elevated temp (99.9).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
approx. 10 min post vaccine pt started to have elevated heart rate, dizziness, tingling in hands and feeling like her throat was "tight" and more difficult to swallow
Expired dose given to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Additional information include no new information.
vomiting; lost her sense of taste; pain; swelling in arm; chills; fever of 103.8 degree Fahrenheit,fever of 101.1 degree Fahrenheit; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost her sense of taste), PAIN (pain), SWELLING (swelling in arm), CHILLS (chills) and PYREXIA (fever of 103.8 degree Fahrenheit,fever of 101.1 degree Fahrenheit) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020. Concurrent medical conditions included Down's syndrome. Concomitant products included TOPIRAMATE, LEVOTHYROXINE and BIOTIN for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced AGEUSIA (lost her sense of taste), PAIN (pain), SWELLING (swelling in arm), CHILLS (chills), PYREXIA (fever of 103.8 degree Fahrenheit,fever of 101.1 degree Fahrenheit), HEADACHE (headache) and NAUSEA (nausea ). On an unknown date, the patient experienced VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Mar-2021, CHILLS (chills) and NAUSEA (nausea ) had resolved. On 24-Mar-2021, VOMITING (vomiting) had resolved. At the time of the report, AGEUSIA (lost her sense of taste), PAIN (pain), SWELLING (swelling in arm), PYREXIA (fever of 103.8 degree Fahrenheit,fever of 101.1 degree Fahrenheit) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, SARS-CoV-2 antibody test: positive (Positive) Positive. On 13-Mar-2021, Body temperature: 103.8 (High) 103.8 degree Fahrenheit. On 15-Mar-2021, Body temperature: 101.1 (High) 101.1 degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Very sore red eyes, and puffiness and soreness around eyes.  Soreness around upper teeth.  Low grade fever of 99.8.
Received vaccine Thursday 4pm. By Friday 9am started to get chills. A few hours later fever of 101.9. Overnight chills and fever for worse raising to 102.7. Sweats, nausea and waking up to blood pressure dropping where I had passed out twice.  Today, 9/6 still feeling lightheaded, headache and dizziness.
Immediately after, area of injection became swollen, red, warm to the touch, and itchy. Later on that evening, I experienced chills, fever of 100.0F, headache, dizziness, light head, headache, and body aches. The next day, chills went away, but fever, body ache, dizziness, lightheaded, and body aches still remain. In addition, warmth, swelling, itchiness, and redness still remain at site of injection.  The third day, headache, light headed continued with redness, swelling, itchy, and warmth. In the evening, Hea he is gone. All else continues.
Covid19 Pfizer Gray Top was dilute with 1.8 ml of diluent in error. Patient received diluted dose.
Approx. 1 wk post injection,  pt. noticed a symmetrical, quarter-sized white ring around injection site. "like someone took the cap to a plastic water bottle and drew a circle around it with white marker." No other localized or generalized systemic reactions noticed immediately post injection or presently.    On 11/24,  about 1 month post injection pt. went to OB/GYN for Depo Shot and asked to have it placed in other/ LA she usually gets it placed.. due to odd reaction to influenza vaccine "which has never occurred before."   OB looked at it and mentioned it "felt warmer than the other arm" and advised she should probably report it to the Center where vaccine was given (administerer of injection), her PCP, Employee Health and see a dermatologist.  She is in the process of getting an appointment with her dermatologist.
VACCINE WAS ADMINISTERED 7 HOURS AFTER VIAL WAS INITIALLY PUNCTURED
Throat felt tight; Tingling along the right side of the body; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 16:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient had known allergies (unspecified). The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 06:00 (the next day after the vaccine), the patient experienced throat felt tight and tingling along the right side of the body.  The patient reported this lasted for most of the next day after the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events throat felt tight and tingling along the right side of the body was resolved on an unknown date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
headache; Inflammation; flare of Rheumatoid arthritis; MARKETING PROGRAM NAME NOT AVAILBALE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4341426-00.  A 43 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date May2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Route: Intramuscular), administration date: Apr2021, when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2022, outcome "recovering", described as "flare of Rheumatoid arthritis"; INFLAMMATION (non-serious) with onset Feb2022, outcome "recovering", described as "Inflammation"; HEADACHE (non-serious), outcome "unknown", described as "headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. The action taken for adalimumab was dosage permanently withdrawn. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of inflammation and flare rheumatoid arthritis with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event of headache was not provided.  Causality for Pfizer BioNTech COVID-19 vaccine (Tozinameran): The reporter's causality for the events of Inflammation, Rheumatoid arthritis flare up and Headache with Pfizer BioNTech COVID-19 vaccine was possible.  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 information provided there is a reasonable possibility of causal association between the events with the suspect product bnt162b2.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Information has been received from a medical assistant concerning a 17 year old female patient with no medical history, no drug reactions/allergies, who on 22-JUN-2007 was vaccinated intramuscularly in the left deltoid with the first dose 0.5 ml of GARDASIL (Lot # 661952/1129X exp date unknown) and on 20-JUL-2010 with the second dose 0.5 of GARDASIL (Lot # and expiration date unknown). There was no concomitant medication. The medical assistant reported that the mother of the child called the doctor office the other day stating that the child was lethargic, tired and her lips were swelling. At the time of the report, the patient had not recovered. There were not laboratories performed. The patient sought unspecified medical attention. Follow up information has been received from a physician concerning the 17 year old female patient with no pre-existing allergies who on 22-JUN-2007 and 20-JUL-2010 was vaccinated IM in the left deltoid with the first and second doses of GARDASIL (Lot number 661952/1129X). On 20-JUL-2010 the patient developed lip swelling, fatigue, myalgia and flu like illness. Subsequent myalgias and fatigue were persistent and noted on follow-up visit on 11-AUG-2010. Additional information is not expected.
This spontaneous report has been received from a nurse concerning an unspecified patient of unknown age and gender. Medical history and current condition of the patient were not reported. On 07-JAN-2015 the patient was vaccinated with a dose of improperly stored M-M-R II (lot# reported as J000200, expiry date: 09-JAN-2015) (dose, route unspecified). Concomitant therapy was not reported. No adverse effects were noted. No product quality complaint (PQC) involved. This is one of several reports received from same source. Additional information has been requested.
The day of the second dose patient comment that he had a type of chill or tingling in the legs that began about one week ago. It is a type of muscular pain that lasts about 10 minutes and the goes.
Patient experiencing hives (localized at injection sight and systemic [legs, feet]) MD prescribed hydroxyzine and triamcinolone four days later.
I woke up that morning and felt like my arm was really sore at the injection site. I had pain that radiated into my neck and going down my spine. I had intensified allergies/cold feeling-- felt lethargic and exhausted. I could barely do normal tasks and couldn't breathe normal or well days later. I started having asthma attacks and was trying to use my rescue inhaler. I called my doctor when I noticed my oxygen blood concentration level were low. I waited a week until I went to the hospital because my O2 levels dropped to 92%. At the hospital, they gave me medicine that wasn't really helping. They tested me for COVID-19, RSV, strep throat, did lung x-ray, and a full respiratory panel including pneumonia. Almost 2 weeks, they gave me steroids, a new medicinal inhaler, and breathing treatments and antibiotics afterwards to treat the pneumonia my PCP diagnosed me with. One month after my shot, I just began to feel slightly normal and better. I could breathe without the special assistance of the breathing treatment, rescue inhaler, and steroid medication; my O2 level finally picked up to normal 98%.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 18Sep2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
INJECTION SITE PAIN; PINS AND NEEDLES BOTH LEGS; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced pins and needles both legs. On 14-MAY-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine was not applicable. The patient recovered from injection site pain on MAY-2021, and had not recovered from pins and needles both legs. This report was non-serious.