chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient on Warfarin (coumadin) and has autoimmune disorders. Has been taking warfarin for 26 years after she had a massive stroke. Never had anything about 3.2 INR (a test for the clotting factor). INR has always been around 2.5-3. She has always been on 7.5 mg of Warfarin/day. 2nd dose of Moderna  on 04.08.2021. Her INR on 04.10.2021 was 4.6. Double what she usually is. She then skipped 2 Warfarin tablets. On 04.12.2021 it was 1.4. Usually tests once a month so she doesn?t know if her INR was high after her first shot. Patient reports feeling fine. She has talked to her PCP regarding this and about managing her Warfarin depending on what level her INR is.
Information has been received from a nurse concerning a 15 year old female with a history of syncope who on approximately 19-JAN-2010, "about 2 months ago" was vaccinated with the first dose of GARDASIL (0.5 ml). Within 20 minutes the patient experienced syncope. The patient recovered soon after. No further information is available.
Patient call pharmacy to report redness and "lump" that is 5" long and 2" wide at injection site. No other sx or complaints.
Soar throat. Body ache. Eye rash. Made appointment with a dermatologist for the eye rash.
This spontaneous report as received from a physician's assistant refers to a teenage male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route and lot # not reported). Concomitant therapies included MENACTRA. The physician's assistant reported that on an unknown date during his office visit, the patient fainted (syncope) after receiving GARDASIL, MENACTRA and underwent a blood draw. The outcome of syncope was unknown. The patient did not receive treatment for the adverse event. Additional information is not expected. There is no permission to contact the physician.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 24th October 2018, the patient received the 1st dose of SHINGRIX .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced injection site muscle pain. On 29th October 2018, the patient experienced injection site warmth, injection site itching, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site muscle pain was recovered/resolved and the outcome of the injection site warmth, injection site itching, injection site erythema and injection site swelling were recovering/resolving. It was unknown if the reporter considered the injection site muscle pain, injection site warmth, injection site itching, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that one of her patients experienced muscle soreness and pain at injection site on an unknown date. However, the side effects went away after 3 days. Five days after receiving SHINGRIX (a day before reporting, at night), the patient started to get new symptoms at the injection site such as, hot to the touch, itching, redness and swelling. She did not had fever.
At about four hours later began to have redness and tingling in both arms and ears. Felt very hot. Developed rash on back, trunk, arms. Itching became generalized.
Runny nose; Have no taste; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) and AGEUSIA (Have no taste) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose) and AGEUSIA (Have no taste). At the time of the report, RHINORRHOEA (Runny nose) and AGEUSIA (Have no taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Received 2 of 2 rabies vaccines for PEP.  After first one, I developed generalized arthralgias and myalgias which I was told was normal. After the second dose, approximately 4 hours later, I started to have tingling sensations in face (mainly nose and lips) as well as bilateral arms/hands; very light headed, and some blurred vision.
Patient states they starting seeing flashing lights and went to see optometrist and was diagnoses with vitreous detachment
Fever of 101.1, nausea, vomiting, severe body aches, cough, chest pain, chills, shaking, fatigue, swelling and redness at injection site  Majority of symptoms lasted for about 50 hours, nausea is still present at 60 hours  Took Tylenol every 4-6 hours
On day 2 after second dose, that arm had a large red swollen itchy area near injection site. After about 8 hours of applying ice, some of the swelling has gone down. Area is still very red, itchy and sore.
Pt exp chickenpox & fever. "Was covered head to toe." It was also noted the pt sibling had similar exp. (WAES9801257).
This spontaneous report was received from a 71 years old consumer reporting on herself with asthma, no drug reactions or allergies and a history of irregular heart beat, who on 04-APR-2012, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number not reported). No other co-suspects were reported. Concomitant medications included metoprolol and simvastatin (manufacturer unknown). The consumer reported that on 06-APR-2012. she had small blisters. By Sunday, 08-APR-2012, she had a full blown case of shingles. She had a rash on the side of her heck around to her ear. She was told to use warm compresses and then ice on the area to ease her discomfort, acetaminophen, VICODIN and gabapentin were also given as a treatment for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered as she was still in pain. The relatedness for patient had a full blown case of shingles/she had the rash on the side of her neck around to her ears was unknown for ZOSTAVAX. Additional information has been requested.
Temp to 103, swelling & redness of R/arm at injection site to 25 x 15 cm with extreme tenderness. This lasted 8 days before starting to subside.
Pt had rash on both arms, upper torso and neck approx 6 hours post vaccination (#3). Rash resolved during night leaving approx 2-3 inches erythema around injection site.
Patients states that once in a while he gets muscle twitching at the injection site and that it shock like pain.  The pain comes and goes.
Stomach pain, watery diarrhea, nausea, drowsiness, hives all over body. Prescribed with  Ioperamid 2MG capsule 4 times a day  and diphenhydrAMINE 25MG capsule every 6 hours.  Symptoms were relieved the same day after taking the pills.
Severe worsening of her Neuropathy. She has a lot of numbness and tingling in her feet and hands. Severe fatigue. She had a fever and aches for a few days. Vision in right eye became bad. Her eyelids had started to droop. Got dizziness for weeks .
I started reporting symptoms like achiness and fatigue. Then I started getting headaches. I called them killing headaches. They started getting worse. I saw my doctor in May and again in July. I asked if this could be because of the vaccine and she said she has not read anything like that. She thought this was just a sinus infections so she gave me antibiotics. It did not take care of it. The headaches are so bad. It gets to the point were you cannot hold your head up when they are worse. I still get the headaches, not every day, but at least 4-5 times a week.
Patient was here on 4/22/21 around 4:00 pm to receive her second dose of Pfizer Covid-19 vaccine. She reports chills, numbness in her feet/leg , and palpitation within 5 minutes after her vaccine. She said due to the palpitation she had shortness of breath. She sat and rest with heater next to her, with some water to drink. Her heartrate was a little high at 96 beats/min at first, then went down to 94 then 92. Her Blood pressure was 123/75, then 116/80. She had mostly recovered with rest of about 30mins to an hour. We suggested her to follow up with urgent care doctor, since she does not have PCP. She had friends/family there to assist her with taking her to the doctor. Her friend was a physical therapist and took a copy of the notes with her symptoms and readings.
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 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 57 years for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. 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), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 14Jun2023 to 18Jun2023. Patient experienced Rebound COVID.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 05-MAR-2019, the patient was vaccinated with a partial dose of PROQUAD (lot # R015739, expiry date 02-DEC-2019) along with a sterile diluent (# N035969, expiry date 18-APR-2020) for prophylaxis (dose, strength, vaccination site, route unspecified). No adverse events were reported. Product quality complaint (PQC) was not involved.
Patient presented 5 days after vaccination to the emergency department with a 3 day history of fever 38.5 C, myalgia, nausea, vomiting, diarrhea and shortness of breath. Physical examination revealed  a maculopapular rash in the cheeks, painless cervical lymphadenopathy, glossitis and diffuse erythema of the oral mucosa, and jaundice.  Echocardiogram showed generalized left ventricular hypokinesis with systolic dysfunction EF 41%. Patient was diagnosed with Multisystem Inflammatory Syndrome (MIS-A) and fulfilled the Brighton Collaboration Network definition of vaccine induced MIS-A. The patient responded well to intravenous immunoglobulin (IVIG), hydrocortisone and methylprednisolone therapy.
This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fatigue and myalgia. On an unknown date, the outcome of the fatigue and myalgia were unknown. It was unknown if the reporter considered the fatigue and myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional did not wish to provide date of birth, lot, expiry date of vaccine from 1st dose. After the 1st dose, the patient did not have any problems other than fatigue and myalgia.
Pregnant (received vaccine); This spontaneous prospective pregnancy case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant (received vaccine)) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use from 2008 to 08-Aug-2020. Previously administered products included for Pregnancy: Folic acid from June 2020 to August 2020. Concurrent medical conditions included Seasonal allergy since 1998 and Constipation since December 2020. Concomitant products included MACROGOL 3350 (MIRALAX) for Constipation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, CETIRIZINE for Seasonal allergy.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 28-Jul-2020 and the estimated date of delivery was 04-May-2021. On 11-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant (received vaccine)). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 11-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant (received vaccine)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2020, Pregnancy test: positive (Positive) positive. On 06-Oct-2020, Ultrasound abdomen: normal (normal) normal. On 15-Dec-2020, Ultrasound abdomen: normal (normal) normal. On an unknown date, Cytogenetic abnormality: normal (normal) Negative (normal).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
After the first Pfizer shot, I had a headache and was unable to sleep. Administered in left arm.  After the second Pfizer shot on 4/29/21, I was unable sleep. 24 hours after the shot was administered into my right arm, the area of my right underarm area near the lymph node tripled in size. The shot was administered in the right arm. To date, five days later, my right underarm is still slightly swollen by about 20%, but it feels better.
pt was found blue & not breathing @ 07:45;EMS & medical examiner called to scene (pt's home);pt father states baby had been acting fine prior to this AM-last saw baby 0130 & hadn't noticed any problems
Noticed to have 2 enlarged lymph nodes in right groin area; MMR vaccine was given in that leg.
rosesa; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ROSACEA (non-serious), outcome "unknown", described as "rosesa".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, Arthralgia, Fever, FATIGUE, SORE THROAT Narrative:
COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220752153( 0.0 ) (Janssen).  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160291) at citrate free, subcutaneous for rheumatoid arthritis, uveitis. The patient's relevant medical history included: "Non-infectious intermediate posterior and panuveitis" (ongoing); "Moderate to severe rheumatoid arthritis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered" (Jul2022) and all described as "COVID-19 virus test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive. The action taken for adalimumab was unknown.  Clinical course: The patient previously received COVID-19 vaccine ad26.cov2.s (those number in series 1) (suspension for injection intramuscular, batch number was not reported) dose, start therapy date were not reported, one total for COVID-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of COVID-19 vaccine (dose number in series 1). It was unknown if patient was enrolled in a COVID-19 vaccine trial. Causality for COVID-19 virus test positive was possible as per reporter with Janssen COVID-19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Gave Td IM on Friday 04/29/05, No reaction until 6 days later 05/04/05 with hard knot (size of marble) and pain.
pt recvd vax; t >102; pain; erythema at inject site; devel rash; general malaise;
25JAN99 pt devel coarse tremor & horizontal nystagmus;this progressed to truncal ataxia, w/pt unable to stand or sit unassisted;vertical nystagmus onset 3 days p/adm;T102.4, 7 days p/adm w/vomiting & diarrhea;given med;Annual follow-up received on 1/11/01 states the pt has recovered.
After my third shot, my whole face turned red; my eyes were swelled; insanely itchy all the time; I am in a constant flare with eczema all over my body ever since I got the third dosage of the vaccine.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: Ff2589) at the age of 23 years for covid-19 immunisation. The patient's relevant medical history included: "eczema as a child." (unspecified if ongoing); "Known allergies: Eggs" (unspecified if ongoing), notes: Known allergies: Eggs, hazelnuts; "Known allergies: hazelnuts" (unspecified if ongoing), notes: Known allergies: Eggs, hazelnuts; "Ibs" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6202), administration date: 02Mar2021, for Covid-19 immunization, reaction(s): "After my second dose, a red patch started showing up under my left eye"; BNT162b2 (Dose Number: 1, Batch/Lot No: EM9810), administration date: 09Feb2021, for Covid-19 immunization. The following information was reported: ERYTHEMA (non-serious) with onset 19Oct2021, outcome "not recovered", described as "After my third shot, my whole face turned red"; ECZEMA (non-serious) with onset 19Oct2021, outcome "not recovered", described as "I am in a constant flare with eczema all over my body ever since I got the third dosage of the vaccine."; PRURITUS (non-serious) with onset 19Oct2021, outcome "not recovered", described as "insanely itchy all the time"; EYE SWELLING (non-serious) with onset 19Oct2021, outcome "not recovered", described as "my eyes were swelled". The events "after my third shot, my whole face turned red", "my eyes were swelled", "insanely itchy all the time" and "i am in a constant flare with eczema all over my body ever since i got the third dosage of the vaccine." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of erythema, eye swelling, pruritus, eczema.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201033392 Same patient and drug, different event separated in time;
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted after vaccine-we asked if she wanted us to call EMS she said yes-EMS came to evaluate her and she was ok walked out of pharmacy no issues
Hives on chest and swelling and redness on left arm. Present about 6 hrs after administration. Pt self treated with Benadryl.
I had a delayed injection site reaction that began on day 8 distal to injection site, with redness, induration and mild itching.  It did not bother me so I paid little attention it.  But on day 13 I looked down on my arm and it was a lot larger, more erythema, more indurated, raised, warm- still not painful, only mildly pruritic.  The area measures approximately (irregular shape) 16.5 cm at the largest diameter.  Mow much improved after taking antihistamines.  I'm reporting because of the extent.  Not sure if there's any recommendation as far as premedication prior to second dose.
After 2 Pfizer vac. with mild hives on 2 vac. 08/05/21,+1 Pfizer booster 09/30/21, tested pos. 04/07/22, then developed severe all-over body hives for 2.5-3 mo., itching caused further speading. Around 09/10/22 developed mild hives & continuing; triggered dormant plaque psoriasis. Had been taking Allegra-switched to Zyrtec; applying Iodine to hive area, seems to prevent spreading.
Full body urticaria, >24 hours, expected to resolve in a week with oral steroids and antihistamines, hydrocortisone cream application.
Arrhythmia; headache; hypersexuality; worsened muscle/join pain; fatigue; chills; vomiting; worsened muscle/join pain; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration, administered in left arm on 22Apr2021, at 14:45 (Lot Number: ER8736) as SINGLE DOSE for covid-19 immunization. Medical history included bipolar I disorder from an unknown date, allergy to cilantro, pollen, and lactose from an unknown date. Concomitant medication included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks 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. On 22Apr2021 at 16:00, the patient experienced arrhythmia, headache, hypersexuality, worsened muscle/join pain, fatigue, chills and vomiting. No corrective measures were taken by the patient for the reported events. The outcome was reported as not recovered for the reported events at the time of reporting.
Patient vaccinated for Covid with booster and came to ED for weakness and body aches and admitted for Covid.
was hospitalized 1FEV94 w/asthma, pneumonia, apnea, focal sz;