chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Both eyes itchy, red, swollen, particularly my right eye; Both eyes itchy and red eyes; Both eyes red; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number, Expiration date was not provided) via an unspecified route of administration in the left arm, on 10Mar2021 (age at vaccination 41-years) 10:30 as dose 2, single for covid-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (BNT162B2, Batch/Lot number, Expiration date was not provided), dose 1 (on 16Feb2021 at 12:30 in Left arm as dose 1, single for covid-19 immunization. Patient was not pregnant at the time of vaccination. on 11Mar2021 11:00 the patient experienced both eyes itchy, red, swollen, particularly right eye. The patient did not receive any treatment. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Blood Clots in left leg and Pulmonary Embolism causing 12 day hospitalization placed on blood thinners and blood testing done to check for genetic history.  only factor of 5 that was found was the Lupus Anticoag PL .  Doctors explained since no other factor 5 indicators exist I was not born with this diagnosis.  acquired at some point in the last few years due to no history prior.
ALLERGIC REACTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction was not reported. This report was non-serious.
MODERNA COVID VACCINE #3 GIVEN 01/06/2022, LOT #030H21B; pt passed away at home with COD being:  severe sepsis, post COVID condition, COPD; no record of pt's PCP or when a positive COVID test was done
Left deltoid pain like someone punching her since flu shot. Constant even when not sleeping on the arm.
Had TDaP. Had couple days of muscle pain. Had achy pain in shoulder and elbow with numb feeling in fingers 2 - 4 since injection.
This spontaneous report was received from a Doctor of Pharmacy and refers to a 64 year old female patient with shrimp and chloramphenicol allergy and no pertinent medical history. On 01-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # L015417 (expiration date 01-AUG-2016) (route and dose not reported). There was no concomitant medication. On 02-NOV-2015, the patient reported to the pharmacist that she had developed on the same date a "rash" that was "hard and red and it was three to four inches wide". The patient then applied an ice pack to the area and took an unspecified dose of ibuprofen and BENADRYL (unspecified dose and frequency). Then, on 03-NOV-2015, the patient reported to the pharmacist that unspecified "blisters" appeared around the injection site as well. No laboratory testing were performed. The patient sought medical attention by calling the pharmacist. At the time of the report the patient had not recovered from the "rash that was hard and red" or from the "blisters" that appeared around the injection site as well. There was no product quality complaint (PQC) involved. Additional information has been requested.
This spontaneous report was received from an office manager referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates in January and February 2017, the patients received improperly stored doses of ZOSTAVAX lot # M019646, expiration date: 18-JUL-2017; lot #M035695, expiration date: 07-NOV-2017 (dose and route of administration were not reported) for prophylaxis. The reporter had not been informed of an adverse experience. Administered doses of ZOSTAVAX were exposed to temperature excursions as follows: In January 2017, between 5°F and 14°F for 4640 minutes (806 minutes highest 32°F); in February 2017, between 5°F and 14°F for 5164 minutes (560 minutes highest 36°F). Data logger was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA008835: US-009507513-1703USA009922: US-009507513-1703USA009923: US-009507513-1703USA009924: US-009507513-1703USA009925: US-009507513-1703USA009926: US-009507513-1703USA012105: US-009507513-1704USA001629: US-009507513-1704USA001630.
shingles; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows this case was self-reported by the patient. The age at vaccination was not reported. The patient had shingles vaccine and had light case of shingles. The patient could take second dose at some point.
PAIN AT SITE OF INJECTION.  REDNESS SURROUNDING SITE EVOLVED NEXT DAY, ALONG WITH FLU LIKE SYMPTOMS. THE FOLLOWING DAY AND DAYS SINCE REDNESS SLOWLY TRAVELING DOWN ARM.
a lump came out close to my neck, lymph node type; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EP6955, Expiration date was not reported), via an unspecified route of administration, in left arm on 09Mar2021 10:15 (age at the vaccination 41-years) as first dose single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included potassium citrate taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccine in four weeks. Patient received within 2 weeks of vaccination: Anticoncep, bifllex, wate way. It was reported that 10 days after first dose, a lump came out close to my neck, lymph node type on 19Mar2021 03:00 PM. Patient did not receive treatment for the event. The outcome of the event was unknown.
A report was received from a health care professional on 10/08/01, concerning a 46 year old female healthcare professional who experienced flu like symptoms, approximately 24 hours after she inadvertently administered the Fluvirin to a patient. On 10/03/01, the health care professional experienced flu like symptoms including fatigue and nausea, approximately 24 hours after she, accidentally sprayed her eyes with Fluvirin, during administration. The healthcare professional flushed her eyes with sterile solution immediately after the exposure. She recovered 3 days later on 10/06/01. The reporter has assessed the relationship of study medication to the event as possible.
Itching, like bugs crawling on her, all the time; Felt zapping Electrical shots on her legs, arms, and face; A faint tingling in the legs; Off label use; Interchange of vaccine products; Neuropathy reaction; This is a spontaneous report from a non-contactable consumer (patient). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), at dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced neuropathy reaction, itching, like bugs crawling on her, all the time, felt zapping electrical shots on her legs, arms, and face, a faint tingling in the legs on an unspecified date; off label use and interchange of vaccine products on an unspecified date. The course of the events is as follows: Caller stated that she had a reaction to Pfizer's first dose. Three days after vaccination she started having symptoms which she describes as a neuropathy reaction that lasted for five months. She had itching, like bugs crawling on her, all the time. She also felt zapping like electrical shots on her legs, arms, and face. Now, she still has a faint tingling in the legs. Because of this, she did not  get the second dose of the vaccine. She was tested for antibodies and she had none. Her doctor referred her to an immunologist who told her that he could dilute the Moderna vaccine and distribute it that way. He would mix the vaccine with saline and apply it as a six doses series. The patient underwent laboratory tests and procedures which included antibodies: none on an unspecified date. The outcome of event neuropathy reaction was recovered on an unspecified date; outcome of events  itching, like bugs crawling on her, all the time, felt zapping electrical shots on her legs, arms, and face was unknown; outcome of event a faint tingling in the legs was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
DETACHED POSTERIOR MEMBRANE IN EYE; KIDNEY FUNCTION WENT FROM NORMAL TO STAGE 3; ARTHRITIS FLARE; EYE ACHE; ACUTE BACTERIAL BRONCHITIS /MUCUS IN LUNGS; HEADACHE; This solicited report received from a patient via Agency: concerned a 60 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included arthropathic psoriasis. The patient was treated with product Stelara (ustekinumab) (solution for injection in pre-filled syringe, subcutaneous, batch number: Unknown and expiry: Unknown) 90 mg, frequency was not reported, from AUG-2001 for arthropathic psoriasis.  The patient received the covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 04-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Z-pak (azithromycin) for drug used for unknown indication.  On 05-OCT-2021, the patient experienced detached posterior membrane in eye, headache and eye ache, then mucus in lungs, the had arthritis flare and returned to urgent care acute bacterial bronchitis. The patient's kidney function went from normal to stage 3. Further waited for more blood work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ustekinumab was not reported. The patient was recovering from arthritis flare, eye ache, acute bacterial bronchitis /mucus in lungs, detached posterior membrane in eye, kidney function went from normal to stage 3, and headache. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and detached posterior membrane in eye, kidney function went from normal to stage 3, acute bacterial bronchitis /mucus in lungs, arthritis flare, eye ache, and headache was related; and between ustekinumab, and detached posterior membrane in eye, kidney function went from normal to stage 3, arthritis flare, eye ache, acute bacterial bronchitis /mucus in lungs, and headache was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211131851-covid-19 vaccine ad26.cov2.s-detached posterior membrane in eye, kidney function went from normal to stage 3. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211131851-stellera-detached posterior membrane in eye, kidney function went from normal to stage 3. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
I can't sleep it feels like something is under my skin or like I am having chills, the Tylenol is not touching it; Chills; it is just like something is crawling under my skin or something, but it is irritates me I can't sleep at all; it is just like something is crawling under my skin or something, but it is irritates me I can't sleep at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 01Oct2021 (Lot number: 30135BA) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; AMLODIPINE. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunization; Bnt162b2 (Second dose), for Covid-19 immunization. The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "I can't sleep it feels like something is under my skin or like I am having chills, the Tylenol is not touching it"; CHILLS (non-serious), outcome "unknown", described as "Chills"; FORMICATION (non-serious), SKIN IRRITATION (non-serious), outcome "unknown" and all described as "it is just like something is crawling under my skin or something, but it is irritates me I can't sleep at all". Therapeutic measures were taken as a result of insomnia, chills.  Follow-Up (28Oct2021): Follow-up attempts are completed. No further information is expected.
This information has been received from a billing coordinator concerning an unspecified patient of unknown age and gender. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date in June 2017 (reported as since 07-JUN-2017), the patient was vaccinated with an expired dose of PROQUAD with lot number M044720 and expiration date 07-MAY-2017 (dose, strength, dose number, route of administration and anatomical location were not provided), for prophylaxis. The reporter could not provide the lot number and the expiration date for the properly stored sterile diluent used to reconstitute the dose of PROQUAD. No adverse effects reported.
BURNING UPON INJECTION, KNOT AT INJECTION SITE, SWELLING 2IN BLUISH/PURPLISH RASH, AND ITCHING.
Fever (101.5F), headache, muscle aches, cramps, chills, joint swelling. Onset of symptoms was about 17 hours from the vaccine and the worst of it lasted aprox 36 hours then slowly tapered over the next two days.  3 days of not feeling well.
kidney failure; not feeling well; shaking; pale; weak; headache; 101.5F fever; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (kidney failure) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Kidney failure on 14-Apr-2021.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 14-Apr-2021, the patient experienced RENAL FAILURE (kidney failure) (seriousness criterion medically significant), MALAISE (not feeling well), TREMOR (shaking), PALLOR (pale), ASTHENIA (weak), HEADACHE (headache) and PYREXIA (101.5F fever). At the time of the report, RENAL FAILURE (kidney failure), MALAISE (not feeling well), TREMOR (shaking), PALLOR (pale), ASTHENIA (weak), HEADACHE (headache) and PYREXIA (101.5F fever) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5f (High) 101.5F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   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.   Reporter did not allow further contact
Patient was given an expired vaccine. Vaccine Expiration date was 9/19/2021 and vaccine given on 11/6/2021.  No adverse reaction noted.
pt recv vax 29NOV97 & evening of 30NOV97 pt devel a mild fever, bone aches, weakness & diff walking which lasted approx 12hr;
Increased blood pressure; Get tired after Meals; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Increased blood pressure) and FATIGUE (Get tired after Meals) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (Increased blood pressure) and FATIGUE (Get tired after Meals). At the time of the report, BLOOD PRESSURE INCREASED (Increased blood pressure) and FATIGUE (Get tired after Meals) outcome was unknown.            The patient received their first dose of vaccine on 20-Jan-2021 and second dose on 18-Feb-2021. The patient did not have any side effects after both doses of the vaccine but during conversation, the patient reported possible adverse events and stated that the patient began to experience increased blood pressure and get tired after meals and these possible adverse events started on 26-Mar-2021.   Reportedly, the patient had a past history of acid reflux and was taking medication for it. On 30-Mar-2021, the patient would be going to urgent care to get evaluated.  Concomitant medication included medication for acid reflux.  No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
patient received second dose in primary series 21 days after 1st dose, no adverse events noted
Soreness, swelling at injection site & (L) clavicle, felt run down, injection site red & hot to touch, painful, right side tongue ? swollen.
presented to ED with complaints of shortness of breath x 2 days.  Associated with subjective fever, chills, and nonproductive cough. Denies known sick contacts.  Reports adherence to mask wearing in public.  Smokes 1ppd. Drinks 6 beers every Friday.  Received 1st COVID vaccine dose on 3/26.
102 temperature, severe body aches, muscle tenderness, fatigue, uncontrollable crying, severe headache, "burning" eyes.
Left arm pain; fever (103); Body ache; Neck pain; Chills; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Left arm pain), PYREXIA (fever (103)), MYALGIA (Body ache), NECK PAIN (Neck pain) and CHILLS (Chills) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Left arm pain), PYREXIA (fever (103)), MYALGIA (Body ache), NECK PAIN (Neck pain) and CHILLS (Chills). At the time of the report, VACCINATION SITE PAIN (Left arm pain), MYALGIA (Body ache), NECK PAIN (Neck pain) and CHILLS (Chills) had resolved and PYREXIA (fever (103)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Patient fainted when sitting in waiting room after getting the vaccine. She had been sitting in tripod stance looking at her phone and thinks she fainted and rolled to the ground from the chair.  She was sitting on the floor when my assistant walked by after hearing her phone drop. We helped her to the exam table where she lay with head elevated, talking normally and oriented x4. Drank water and ate a granola bar since she said she had not eaten yet today. About 30 min after receiving the shot she felt like she could leave and felt normal. No head injury noted and no bleeding noted. She did say she may feel a little tender on upper right forehead and hairline.
Two days after I received the COVID vaccine I had a distortion in my smell and taste. It was not gone; everything just smells and tastes bad. The best way I can describe it is that it smells like infection.  It has been three weeks since the vaccine and these symptoms still have not gone away. I need help in trying to figure out how to fix this.
Anaphylactic reaction, with tachycardia, hypertension, throat swelling/dyspnea, facial swelling, and diffuse hives.
Approximately, 5 minutes after the injection, became dizzy with fullness in her head, a tight feeling in her neck. Stated that she felt like she was going to pass out. Nausea without vomiting and need to have a bowel movement. Was taken to the Emergency Department. Temp 38.5, given Ativan, Benadryl and IV fluids
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 03-JUN-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reproted) (lot # J011828 and expiry date: 26-DEC-2014, reported as 16-DEC-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Patient complains of fatigue; sore left injection site arm; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Patient complains of fatigue) and VACCINATION SITE PAIN (sore left injection site arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced FATIGUE (Patient complains of fatigue) and VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, FATIGUE (Patient complains of fatigue) and VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.      It was reported that patient was not immunocompromised. No treatment details were reported.   This case was linked to MOD-2022-570986, MOD-2022-571008, MOD-2022-570966, MOD-2022-570982, MOD-2022-570996 (Patient Link).