chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bumps turned into blisters on arms legs, feet, and ankles; severe itching; bumps turned into sores on arms, legs, feet, and ankles; bumps got progressively worse; bumps on body; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (bumps on body), CONDITION AGGRAVATED (bumps got progressively worse), PRURITUS (severe itching), VACCINATION COMPLICATION (bumps turned into sores on arms, legs, feet, and ankles) and BLISTER (bumps turned into blisters on arms legs, feet, and ankles) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced SWELLING (bumps on body). On 08-May-2021, the patient experienced CONDITION AGGRAVATED (bumps got progressively worse). On 12-May-2021, the patient experienced PRURITUS (severe itching), VACCINATION COMPLICATION (bumps turned into sores on arms, legs, feet, and ankles) and BLISTER (bumps turned into blisters on arms legs, feet, and ankles). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, SWELLING (bumps on body), CONDITION AGGRAVATED (bumps got progressively worse), PRURITUS (severe itching), VACCINATION COMPLICATION (bumps turned into sores on arms, legs, feet, and ankles) and BLISTER (bumps turned into blisters on arms legs, feet, and ankles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details were not provided
Numbness in index finger of left hand starting 2 days after injection. Have not sought medical attention yet.
nauseous; dizzy; fuzzy; This is a spontaneous report from a contactable consumer (patient). A 50-Year-old non-pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EM0477, expiry date was not reported) via an unspecified route of administration in left arm on 04Feb2021 at 16:30 (at the age of 50-year-old) as 1st dose, single for COVID-19 immunization. Medical history of the patient included one kidney. Patient have not received any other medications in two weeks and have not received any other vaccine in four weeks. Patient previously received antibiotic (unspecified) on an unspecified date for unspecified indication and experienced allergy. On 04Feb2021, at 17:30, the patient experienced Nauseous, dizzy, fuzzy. Reportedly, patient was tested for COVID post vaccination on an unspecified date, result of test (not reported). On 01Feb2021, patient underwent a lab test of COVID- SARS-CoV-2 test (Nasal swab) and tested negative. Patient did not receive any treatment for the events. Outcome of the event was recovering.  Follow-up attempts completed. No further information expected.
Red rash 10-15 cm in width at its widest point, below site of injection with TRUMENBA and Hepatitis B vaccinations, lasted 3-4 days.
after 3 doses of vax the pt lab tests indicated the pt failed to seroconvert.
Body aches, chills, joint pain, fever between 100.4 and 101.8; headache, fatigue, eye burning/watering; stayed home in bed, hydrating, still not feeling well today; fever down to 99.8
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 13-FEB-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # N015136, expiration date 16-FEB-2019 (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 47 °F to 77 °F (47°F) for 1 hour and 13 minutes, as recorded by a data logger. The vaccines had a previous temperature excursion in the range between 47 °F to 77 °F for 9 hours. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA007492: US-009507513-1802USA007813.
Got the ZOSTAVAX vaccine yesterday and woke up to a rash on the sides of my neck, sides of my forehead as well as the front of my neck have taken BENADRYL throughout the day.
This spontaneous report as received from a physician's assistant via a company representative refers to a 27 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, reported as several years ago, the patient was vaccinated with the series of GARDASIL (dose, lot #, route of administration were not reported). On an unknown date, reported as several weeks ago, the patient received a positive HPV test result from pap smear. Product quality complaint (PQC) was not involved. No treatment was given for the adverse events. The outcome of the event was not reported. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
received 0.5 mL but should be 0.7 mL, with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2022SA426941(CLUSTER).  This case involves a 67 years old female patient who received 0.5 ml but should be 0.7 ml, with no reported adverse event after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct-2022, the patient received 0.5 ml but should be 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE with no reported adverse event (incorrect dose administered) (lot UJ900AA and expiry date: 30-Jun-2023) via unknown route in unknown administration site for Prophylactic vaccination.  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Based on information previously received, the following information has been amended by upgraded the case from non-case to valid Agency with no AE with addition of event "wrong dose administered".
Fever 100.5; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 10-year-old male patient received bnt162b2 (BNT162B2), administered in left arm (Lot number: 5618) at the age of 10 years as dose 1 (tris), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 27Jan2022 at 06:00, outcome "unknown", described as "Fever 100.5". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Patient was seen in office on 8/30/18 to receive vaccines. He was then taken to Urgent Care facility on 9/1/18 for red swollen area on left thigh that continued to increase in size and became "streaky" according to parent. Upon physical exam it was noted that patient had the following exam: Left thigh, anterior aspect: 3-inch diameter of non-blanching pinkishness with central 1-inch reddish induration. Border of the patch is irregular. No excoriation, vesiculation, or purpuric change. He was diagnosed with cellulitis and placed on cephalexin for 10 days. No further symptoms at this time.
face burn just a little bit; had minor flu like symptoms; Lymph nodes swell up; hot flashes increase in number; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (face burn just a little bit), INFLUENZA LIKE ILLNESS (had minor flu like symptoms), HOT FLUSH (hot flashes increase in number) and LYMPHADENOPATHY (Lymph nodes swell up) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J212A) for COVID-19 prophylaxis.     Patient had no history of COVID positive test or diagnosis. Patient had no history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Patient did not receive any other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Gluten intolerance, Soy allergy, Allergy to nuts (tree nuts), Peanut allergy, Vegetable allergy (tomatoes), Allergy to chemicals (coloring dyes), Egg allergy, Sesame allergy, Shellfish allergy, Drug allergy (Oxycodone) and Postmenopause. Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (MICROGESTIN) and LEVOTHYROXINE SODIUM (TIROSINT) for an unknown indication.    On 28-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (face burn just a little bit), INFLUENZA LIKE ILLNESS (had minor flu like symptoms), HOT FLUSH (hot flashes increase in number) and LYMPHADENOPATHY (Lymph nodes swell up). At the time of the report, BURNING SENSATION (face burn just a little bit) and LYMPHADENOPATHY (Lymph nodes swell up) outcome was unknown and INFLUENZA LIKE ILLNESS (had minor flu like symptoms) and HOT FLUSH (hot flashes increase in number) had resolved.            Patient had received Moderna vaccine 1st dose on 14Apr2021, left arm IM with lot no 040B21A and 2nd dose on 12May2022 left arm IM with lot no 014C21A.  Patient received half dose of 1st booster in left arm (a little higher up in the muscle). Patient had minor flu like symptoms for a day and half. Patient experienced hot flashes increased in number and had severity for 4 months.  No treatment information was provided by the reporter.    This case was linked to MOD-2022-662107, MOD-2022-662027 (Patient Link).
Patient experiencing "frozen shoulder" saw a physician and stated it was from vaccine damaging tendon. Patient unble to lift arm above shoulder level. Was planning to undergo physical therapy to resolve.
Itchy Rash on upper arms, lower back and lower legs.   Other spotty itching spots.  Itching head and hands, but no rash on hands and head.  after two weeks and treatment with prednisone symptoms have subsided.
15 min p injection Rt arm pain, hot/face flush, felt "weird" fatigued, arm very painful. Took a darrocet that night. On 11.7.07 in am awoke arm swollen some warm to touch. area around injection site pink-red. hard/indurated. pain up neck/shoulder, pain into shoulder blade + down waist. took Advil and Benadryl/ which helped.
This spontaneous report was received from a vaccine coordinator and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, concomitant therapies, drug reactions or allergies was provided.   On unknown dates in 2016, between 11-NOV-2016 and 01-DEC-2016, the patients might have vaccinated with improperly stored RECOMBIVAX HB)lot# M026309, expiration date: 11-NOV-2018 (dose, route of administration were not reported). The administered doses of vaccine were stored in the temperature of 1.1 degrees Celsius for 6 hours and 30 minutes. Previously the vaccine was improperly stored in the temperature of 1.3 degrees Celsius for 11 hours 18 minutes, in the temperature of 1.4 degrees Celsius for 5 hours 32 minutes, in the temperature of 1.5 degrees Celsius for 9 hours and 42 minutes and in the temperature of 1.1 degrees Celsius for 6 hours and 30 minutes. Cumulatively the vaccine was stored in the temperature of 1.1 degrees Celsius for 43 hours and 18 minutes. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA009209: US-009507513-1612USA009210:
The morning following vax, he had a large (2-3") hot red circle at injection site. The pt also experienced a fever of 101-102 followed by a seizure. He was taken to a nearby pediatricians office. He had another seizure since and now has autism. The annual follow-up states seizure disorder and autism.
Nausea and dizziness within 5 minutes of administration, continued for 2 hours, transferred by private to ED for continued monitoring.
On 02/08/18, 22 yo M presented to clinic for immunizations. During this visit, pt was ordered dose #1 of HPV vaccine 9-valent IM (GARDASIL 9). CMA prepared dose and injected it into pt's left deltoid. ~2-3 minutes after injection, the pt requested water, then "passed out" for ~2 minutes. RN and MD called into room. Vitals assessed with no abnormalities noted, heart and lungs were normal and pt had good bilateral pulses. Pt was provided with crackers and juice and rested in supine position for 20 minutes. After MD reassessment, pt was cleared for discharge. Non-preventable event listed in product labeling.
Patient has had issues with blood in her urine/kidneys bleeding since having the shot. She has seen two doctors and they were unable to determine cause and related it to the COVID vaccine.
pt recv vax & exp vomit, diarrhea, dehydration & lower back pain 7NOV96 w/in 48hr of vax;pt went to ER & needed to have IV rehydration;pt med hx is remarkable for HTN, upper back pain & severe scoliosis;
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant medications was reported. On an unspecified date (reported as when the patient was a little kid), the patient got a series of VARIVAX subcutaneous injection (dose, lot# and expiration date were not reported) and a series of M-M-R II subcutaneous injection (dose, lot# and expiration date were not reported). On an unspecified date, the reporter stated that the patient showed absolutely no titers for either vaccine. In approximately October (reported as about a month ago), the patient received a 1 dose of VARIVAX and 1 dose of M-M-R II. On 30-OCT-2017 (reported as this past Monday), the patient received a second dose of VARIVAX. The outcome of the adverse events was not reported. Causality assessment was not provided.
Moderna use for COVID-19 under Emergency Use Authorization (EUA): Lot number 047B21A was administered after the expiration date of 10-09-21. There was some confusion pertaining to the expiry extension pending for this lot from public health guidance call, no clarifying statement received at the time of this report. No adverse effects noted post administration.
Initial typical arm soreness and redness though redness sounded excessive and within 1-2 days developed splotchy itchy rash all over body.   Lab testing revealed newly dx autoimmune and +RNP abs
About 15 min after injection my heart started racing and I got lightheaded. Heart rate was 95+ and BP was 190/90 something. My resting HR is 56 and BP is usually around 120/80.  Began to drop after about another 15 minutes. Followed by migraine for the rest of the day.    Felt okay when I woke up, but had one episode during the day today in which my heart rate shot up again and was a little short of breath even though I was not exerting myself. Lasted about 10 minutes.  Injection site hurts to the touch, but otherwise is painful.   Throat hurts a little and a little congested, but probably unrelated.
Within 5-10 mins had burning in my chest/throat and awful taste in my mouth.  Stiff arm & neck within an hour, hives all over.  Heart racing. Severe headache.  After calling 811 of concerns of the burning in my chest/throat not going away they advised calling an ambulance.
Chills; Diarrheas; Vomiting; Fever; Headache; Sore throat; Cough; gets really tired easy; Short of breath; vomited again yesterday, comes back for a couple of days every week (diarrhea); This is a spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer (mother) or other non hcp. A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8736 and expiry date: unknown), dose 2 via intramuscular, administered in Arm Right on 23Apr2021 as 2nd dose, single dose for covid-19 immunisation. The patient previously took the dose 1 of the vaccine on 02Apr2021 (Lot Number / Expiry Date: ER8734, No expiry date, Route, Anatomical Location: Left arm) for covid-19 immunisation. He had no issues after the first dose of the vaccine. The patient medical history and concomitant medications were not reported. The patient's family history was none (Diabetes, thyroid issues, and anemia were in distant relatives, but not in immediate family). No vaccinations were given within four weeks prior to first administration of the vaccine. Adverse events following prior vaccinations were none. Additional vaccines administered on the same date were none. The patient experienced chills, fever, headache, diarrheas, vomiting on 24Apr2021, sore throat on Apr2021, cough, tired, short of breath and vomited again yesterday, comes back for a couple of days every week on 2021. After receiving the vaccine, the patient got sick; had chills, diarrheas, with vomiting twice. Did have a sore throat for a little but that has gone away. They had seen their HCP and have had Blood, urine, thyroid testing done and all came back negative; they took a stool sample also. They were being referred to the hospital and was waiting to hear back from the infectious disease doctor. His blood pressure was normal and had not gotten better since he had gotten the second vaccine. Arms don't hurt. The patient was not lethargic but he did feel himself, he got short of breath when he tried skate boarding and he got really tired easily. His diarrhea started initially 24Apr2021 through 27Apr2021 then went away for a couple of weeks, but came back for a couple of day every week. He had it then for 5 days in a row that time. It was usually 2-3 days before. The patient underwent lab tests and procedures which included blood pressure measurement: normal, blood test: normal on 20May2021 came back negative, pyrexia: 102.7, pyrexia: 99.3 to 102, pyrexia: 99.7 on 04Jun2021, stool analysis: unknown on 04Jun2021, thyroid function test: normal on 29May2021 came back negative, urine analysis: normal on 20May2021 came back negative. Outcome of the events Chills, Diarrheas, Fever and Headache was not recovered, Vomiting, Cough, Tired, Short of breath and vomited again yesterday, comes back for a couple of days every week (diarrhea) was unknown, Sore throat was recovered in Apr2021.
This spontaneous report as received from a medical assistant refers to a 7 month old patient, of unknown gender. Concurrent or medical conditions were not reported. On 21-OCT-2015, the patient inadvertently was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscular in the deltoid, lot # reported as K020800, expiration date 05-JUN-2016. Concomitant therapies included ROTATEQ, hepatitis b vaccine (recombinant) (manufacturer unknown), hib conj vaccine (unspecified carrier) and poliovirus vaccine inactivated. The patient was younger that indicated age for PNEUMOVAX23. Presently no adverse effects being reported. Additional information has been requested.
pt recvd vax;devel gen rash;seen by diff ped who felt rash related to heat;10aug95 seen by dermatologist who felt marks looked liked chicken pox;spots were clearing at time of rpt;
positive for COVID-19; sore arm; threw up; fever 102°F; no taste at all; achy; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (achy), AGEUSIA (no taste at all), COVID-19 (positive for COVID-19) and CHILLS (chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included VENLAFAXINE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN (achy) and CHILLS (chills). On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), AGEUSIA (no taste at all), VOMITING (threw up) and PYREXIA (fever 102°F). On 10-Mar-2021, the patient experienced COVID-19 (positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (achy), AGEUSIA (no taste at all), COVID-19 (positive for COVID-19), CHILLS (chills), VOMITING (threw up) and PYREXIA (fever 102°F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
At 4:49 PM patient's mom called pharmacy to inform us that patient had welts all over her body that had started roughly 2 hours after immunization. I informed patient to take Benadryl and inform doctor of reaction.
Information has been received from a Medical Assistant concerning a 17 weeks old male patient who was vaccinated with the first, second and third dose of RECOMBIVAX HB, on 21-NOV-2010, 21-DEC-2010 and 18-MAR-2011 respectively (routes and lot #s were not specified). Secondary suspect therapy included a dose of an unknown Hib vaccine (manufacturer unknown) (dose, route and lot# not specified). Concomitant therapy included DTaP, PREVNAR and poliovirus vaccine. It was reported that an unknown Hib vaccine (manufacturer unknown), DTaP, PREVNAR and poliovirus vaccine; were administered to the patient on 18-MAR-2011, "the same office visit as the 3rd vaccination with RECOMBIVAX HB. The Medical assistant reported that on 18-MAR-2011, after the third dose of RECOMIBAX HB, the patient developed a fever and cough. It was reported that on an unspecified date, the patient recovered from fever, but the cough continues. The patient sought medical attention by calling the physician's office. Additional information has been requested.