chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of eosinophilic myocarditis in a 12-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject had no history of vaccine reaction, drug allergy and was healthy. No concomitant medication. Previous vaccination included ENGERIX B (GlaxoSmithKline, unknown route) given on an unspecified date. On an unspecified date, the subject received 2nd dose of ENGERIX B (unknown route, lot number not provided). 1 day after vaccination with ENGERIX B, the subject experienced fever, weakness and chills. The following day, she experienced vomiting, dark colored urine and oliguria. 3 days after vaccination the subject received ADVIL. Laboratory tests were performed and showed: Body temperature: 38.7 deg C; Heart rate: 120/min; Blood pressure: 84/50 mmHg; Respiratory rate: 22/min; Oxygen saturation: 100%. At Clinical examination: No murmurs, rub, or gallop rhythm were detected. Her chest was clear on auscultation. Hepatosplenomegaly was found and erythematous maculopapular rash. Echocardiography showed moderately diminished biventricular function (ejection fraction of 30%), consistent with a diagnosis of myocarditis. Histopathology examination of a myocardial biopsy showed eosinophilic infiltration in the presence of myocyte necrosis. Histologic examination of a skin biopsy specimen revealed perivascular lymphocytic infiltrates, coupled with the myocardial biopsy findings, this supported a diagnosis of hypersensitivity vasculitis. Hepatitis B core antibody: negative; Stool culture: negative; Throat culture: negative: serology for Mycoplasma: negative; Epstein-Barr virus: negative; Adenovirus: negative; Influenza test: negative; Blood culture: negative; Urine culture: negative; The subject was admitted to the intensive care unit on hospital on day 7 after immunization, with renal failure and shock. The subject was treated with milrinone, ceftriaxone, methylprednisolone, prednisone, and dobutamine. No further antibiotics were given as her fever abated promptly, cultures were negative, and her findings were consistent with a hypersensitivity reaction. At the time of reporting the events were improved. Clinical improvement was observed by day 7 of corticosteroid therapy with gradual normalization of cardiac function in the ensuing 8 weeks. The author considered the events were related to vaccination with ENGERIX B. No additional information expected therefore the case has been closed.
Within 5-10 minutes of receiving vaccine, patient c/o red hands, itchy skin, ears/face red, hives on arm and leg. No wheezing, no swelling of throat, cough without SOB.
Could not blink left eye, numbness in left side of face particularly cheek. Progressed overnight to 10/28/2010 to near total paralysis of left side, including eyelids, eyebrows, forehead on left, left cheek, left half of lips, and left half of tongue.
Patient complained of tingling and numbness of lips after receiving vaccine. Patient stated this occurred with dose #1 and was instructed to take 12.5 mg of Benadryl 30 minutes prior to arrival for this dose, which she did. She was given 25 mg liquid Benadryl now and had swelling of bottom lip. She was monitored for an additional 30 minutes and had no further complaints of numbness/tingling and states that her symptoms had disappeared. She left with her family at that point.
Became immunocompromised; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNODEFICIENCY (Became immunocompromised) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (Became immunocompromised) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (Became immunocompromised) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  The reporter was inquiring about a patient who became immunocompromised and was confused whether the patient was eligible for fourth dose. Reporter was unsure if it was diagnosed before or after receiving the Moderna COVID-19 vaccination. The patient got two doses and the booster. HCP was concerned about the vaccination regarding the out of order (booster before 3rd dose).  Company comment: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected events of immunodeficiency. The event occurred after second or third dose of mRNA-1273. As reported, the patient became immunocompromised but it was unclear if it was diagnosed before or after receiving the Moderna COVID-19 vaccination. The patient got two doses and the booster, as reported. No information regarding any diagnostic findings was provided. Reportedly,  HCP was concerned about the vaccination which was out of order (booster before 3rd dose). The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected events of immunodeficiency. The event occurred after second or third dose of mRNA-1273. As reported, the patient became immunocompromised but it was unclear if it was diagnosed before or after receiving the Moderna COVID-19 vaccination. The patient got two doses and the booster, as reported. No information regarding any diagnostic findings was provided. Reportedly,  HCP was concerned about the vaccination which was out of order (booster before 3rd dose). The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a physician concerning a 46 month old female who was vaccinated with varicella virus vaccine live. There was no concomitant medication. On 02/15/2002 the pt experienced "> 100 lesions VZV." The lesions were described as puss filled and green. It was noted that she received symptomatic treatment, but no prescription drug treatment. No hospitalization was required. The pt's experience is still being treated. Additional info has been requested.
Area was the size of my fist 3 by 3 inches red hot tight area on skin. I told patient to mark the margins and if got worse to make appointment with MD---that to take BENADRYL and put ice pack on her arm 15 minutes at a time to help with redness, itching. She felt physically sick and was leaving work because of it.
Vaccine received at 5:00 pm on 1/12/21. Around 2:00 am on 1/13/21 I experienced chills and profuse sweating which lasted for about 3 hours. Thereafter I have fatigue and generalized aching.
sever sweloning  hands  @ arms  legs and foot      heartburn   I was put on a  water pill  and A  heartburn  med.
01/05/23 presents to ED for "SOB" "cough". PMHx of "atrial fibrillation (not on AC d/t GIB), CHF, NICM, CAD, emphysema, CKD, HTN, HLD, GIB, and obesity"
inconsolable crying for 6 hours. Bilateral thigh swelling, right knee swelling and erythema.
Runny nose started first with 100 degree fever, over next two days developed lots of congestion and coughing and overall fussiness.
Moderna COVID-19 Vaccine IT all started around 11:00pm I got cold for bit and then I got a little light headed and dizzy, then fell asleep for around an hour and got stomach aches all morning and dizzy ness which also led to exhaustion.
Soreness a little bit; Her eyes started watering; Her eyes started itching really bad; Her face started swelling; All red, her ears bright red; Reallly itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness a little bit), LACRIMATION INCREASED (Her eyes started watering), EYE PRURITUS (Her eyes started itching really bad), SWELLING FACE (Her face started swelling) and ERYTHEMA (All red, her ears bright red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN (Soreness a little bit), LACRIMATION INCREASED (Her eyes started watering), EYE PRURITUS (Her eyes started itching really bad), SWELLING FACE (Her face started swelling), ERYTHEMA (All red, her ears bright red) and PRURITUS (Reallly itchy). On 20-Feb-2021, PAIN (Soreness a little bit), LACRIMATION INCREASED (Her eyes started watering), EYE PRURITUS (Her eyes started itching really bad), SWELLING FACE (Her face started swelling), ERYTHEMA (All red, her ears bright red) and PRURITUS (Reallly itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sore, red, itchy area around injection site. Extends from top of shoulder to mid-bicep.
Report of pain and soreness of left arm where injection was given. Treatment: Tylenol with no improvement. Outcome: Does not interfere ADLs
Body rash that is coming and going; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Body rash that is coming and going) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Body rash that is coming and going). At the time of the report, RASH (Body rash that is coming and going) outcome was unknown. Not Provided          No concomitant medications reported. No treatment information reported.
may i take my second shot 40 days after the first?; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (may i take my second shot 40 days after the first?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (may i take my second shot 40 days after the first?). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (may i take my second shot 40 days after the first?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient declined for follow up. No concomitant medication were reported. No treatment medications were reported. No lab data has been provided by the reporter.
Headache, chills, body aches, vomiting for 12 hours then hands (and feet) turned red + numb. Red rash up to mid-shen
Patient received Pfizer COVID vaccine on 2/27/21, 3/19/21, 8/31/21, and 3/23/22. On 10/2/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure and sepsis secondary to COVID infection and bacterial PNA (during hospitalization, blood culture was positive for strep pneumo). Patient was discharged home on 10/5/22.
1st shot: 4/16: immediate unconfortable, itchy, got home and arms and neck had welts / hives. looked like chicken pocks in my throact and nose. vacination area did not heal for over a month.  I still have scar.  Cloudy feeling, unable to concentrate. Never have felt the same.   2nd shot: 5/14; still  not healed, immediate uncomforable again, redness itcheness, medics made me stay for 20 minutes. Arrived home and a huge hive appeared on my neck are only.  Itchy still. Cloudy effect, never have felt the same. just a weird over all feeling.   aske d husband to move beds, suicial thoughs anda plan. I had anappointmentfor doctor and she asked to speak with him and  made me go to ER.
Metalic taste in mouth; Rash in arm; Numbness; Strong tingling feeling in left nostril and left side of mouth; Strong tingling feeling in left nostril and left side of mouth; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0161) via an unspecified route of administration in the left arm on 12Apr2021 at 14:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa drugs (sulfonamide allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other vaccines within two weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 12Apr2021 at 16:00, the patient experienced metallic taste in mouth, rash in arm, numbness and strong tingling feeling in left nostril and left side of mouth. The patient reported that it had been two weeks and she still feel the metal taste and tingling sensation in nose and mouth (strongly). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events metallic taste in mouth, rash in arm, numbness and strong tingling feeling in left nostril and left side of mouth were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Rash on left shoulder blade near injection site, pain, severe headache itching, pain, oozing fluid.
received his first / shot in March of 2020 and never got the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose (0.5 ml) received on 31st March 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional detals were provided as follows: The reporter was the patient's wife. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up. This case was linked with case US2021168378, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168378:Same reporter
Information has been received from a health professional concerning an 18 year old female with no illness at the time of vaccination who on 16-MAR-2007 was vaccinated with a first dose of Gardasil (lot number unknown) with no pertinent medical history or drug/reactions/allergies. On 16-MAR-2007 the patient felt dizzy after the administration of Gardasil. On 17-MAY-2007 the patient was administered the second dose of Gardasil (6566051/0244U) IM in the left deltoid expiry date 27-SEP-2009 at 10:15 AM. Concomitant therapy included fluoxetine HCL (PROZAC), minocycline HCl (MINOCIN) and ethinyl estradiol/norgestimate (TRINESSA). Due to the incident with the first dose the healthcare professional sat the patient down, she had water, a candy bar and sat for 15 minutes. At 10:35 AM at the front desk the patient started to feel dizzy, lowered to the wheelchair and fainted for approximately 30 seconds. The patient was taken to the room, her legs were elevated. Her blood pressure measurement was 90/60 and her total heart was 60. The patient stayed for 45 minutes felt okay and left. The patient recovered on 17-MAY-2007. Further information is not available.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2022 at 6:04 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Jan-2022 at 6:04 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  No treatment information was provided.
Localized swelling at injection sites,swelling of hands and feet, swelling of face and posterior pharynx
No additional AE; Medical assistant called to report that an expired dose of ROTATEQ was administered.; This spontaneous report was received from a medical assistant, referring to a 6-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 24-JAN-2022, the patient was vaccinated with expired dose (expired product administered) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally, lot #: U007860, expiration date: 14-JAN-2022 (exact dose and strength were not provided) for prophylaxis. No additional adverse event was reported.
No additional AE's/PQC's reported; Improperly Stored; Administered; This spontaneous report was received from a registered nurse (also reported as a certified medical assistant) and refers to a 12-month-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 13-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) one dose, lot # U002394 was confirmed to be valid, expiration date 22-JAN-2023, for prophylaxis (dose, route and site of administration were not reported). The administered dose was exposed to the temperature from -10 degrees Celsius (C) to 8 C (4 C) for 20 minutes on 07-SEP-2021 and from -10 C to 8 C (4 C) for 20 minutes 09-SEP-2021 (both during transport). There was also previous temperature excursion reported as from -10 C to 8 C for 7 hours and 30 minutes. No additional adverse event was reported; Sender's Comments:  US-009507513-2109USA005628:
swollen feet occurred approximately 3 days after vaccine and have continued to stay swollen since. It's been 1 week since my dose 1 COVID vacination.
Information has been received from a nurse practitioner concerning a 54 year old male patient with moderate to persistent asthma and allergy to penicillin, aspirin, sulfa and NAPROSYN who on 11-JUN-2009 was vaccinated with a first 0.5 ml IM dose of PNEUMOVAX 23 (Lot # 665300/1314Y) and on 18-DEC-2009 was vaccinated with PNEUMOVAX 23 (Lot # not reported). Concomitant therapy included XOLAIR, NASACORT, ZYFLO CR and SYMBICORT. On 18-DEC-2009 the patient experienced body aches after the second dose of PNEUMOVAX. The patient sought unspecified medical attention. On 21-DEC-2009 the patient recovered. No laboratory or diagnostic studies were performed. Additional information has been requested.
Reports hives five days after vaccination, redness on arm six days after vaccination, not hardened but soft, applied hydrocortisone cream to reddened affected area., followed by red "halo" around injection site the following day. She believes it to be a localized reaction, states concerns with timing of next COVID vaccine. Referred to contact physician.
Started with shoulder pain, the shoulder the shot was given in. Fatigue was present at the same time. Then I had numbness and tingling in the lower arm and hand of the same side. The symptoms then presented in both arms/shoulder, then knees, ankles, feet, then I had swelling of the hands, feet and knees. The intial symptoms started in mid November and progressed quickly into December with worsening in January. I started seeing a doctor in early December, then a Neurologist late that month and then finally a Rheumatologist in February, who then diagnosed me with Rheumatoid Arthritis.
pt recvd vax; 4" diam area of edema & erythema, non tender;
According to patient he received his second anthrax vaccine on the 19th of March 2019 and the next day 20th March said he had Baseball sized area of swelling that was red warm and itchy. He came to our clinic late on the 21st his arm from the L deltoid down to the Antecubital space was Red/Warm/Swollen/and Itchy.
Td given right deltoid IM on 7/1/03. Returned to clinic on 7/3 with erythema over deltoid, increased warmth and minor swelling. Tender over muscle. Provider note says cellulitis vs myositis vs allergy. Treated with Diphorhydramine 25 mg po every 6 hours and Cephalexin 500 mg tid for 10 days.