chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Armpit redness; Armpit burning irritation; Armpit burning irritation; Arm was sore; Tenderness in lymph gland; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2020, the patient received Shingrix. On 31st August 2020, less than a day after receiving Shingrix, the patient experienced lymph node tenderness. On 1st September 2020, the patient experienced localized erythema, skin irritation and burning sensation skin. In September 2020, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the lymph node tenderness, localized erythema, skin irritation and burning sensation skin were unknown.   It was unknown if the reporter considered the pain in arm, lymph node tenderness, localized erythema, skin irritation and burning sensation skin to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and arm was sore. No redness at injection site. The patient started to feel tenderness in lymph gland under left arm, redness and burning irritation in left armpit.
A report has been received from Health Professional, concerning a female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient had been received nasal FLUMIST QUADRIVALENT on an unknown date. Prescriber took FLUMIST QUADRIVALENT herself and administered it to her daughter and they both got the flu in Dec-2013. This case concerns the daughter. The outcome of the event of flu was unknown. The reporter considered the event to be non-serious.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications. n an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 1 DS Vial 00006411902, lot # M036059 with expiration date of 03-JUN-2019, for prophylaxis (dose and route of administration were not reported). The vaccines were exposed to a temperature excursion of 47-77 degrees Fahrenheit (°F) for 2 hours. The error was not noticed with a data logger. There were not previous excursions. No adverse symptoms were reported. No other information was provided.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA002242: US-009507513-1705USA002243: US-009507513-1705USA002244:
Left upper arm rash for 3 days complains of itching, pain at site, hot to touch area of injection from DTaP red & warm approx. 3" x 3" no induration.
61-year-old female with no significant past medical history presenting for evaluation of altered mental status.  Patient arrives via EMS.  Brought from urgent care due to increased confusion.  Patient's son took her to Urgent Care per EMS.  Urgent Care was concerned as patient had repetitive questioning in the increased.  No known past medical history.  No psychiatric history.  Denies SI/HI.  Denies any hallucinations at this time.  Denies any recent illness. Review of Systems Review of Systems Constitutional: Negative for chills and fever. Respiratory: Negative for shortness of breath.   Cardiovascular: Negative for chest pain. Gastrointestinal: Negative for abdominal pain, nausea and vomiting. Psychiatric/Behavioral: Positive for confusion.  All other systems reviewed and are negative.
Patient passed in chair a couple minutes after receiving pfizer dose number 2. Patient was responsive to rph. Did not have this reaction with first dose. Patient reports not eating or drinking that morning and did not eat dinner the night prior.  Was given water, gatorade, and a couple cookies. 911 was called and she was taken out to ambulance. Had low blood pressure and heart rate (number unknown).
Drug ineffective; 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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 12Oct2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown"; COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 30Apr2023 to 04Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300186522 same patient/product, different dose/event;
experienced sore arm; full dose even though he is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (experienced sore arm) and ACCIDENTAL OVERDOSE (full dose even though he is not immunocompromised) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 002B21A and 027A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included UBIDECARENONE (COQ-10) and COLECALCIFEROL (VITAMIN D3) 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 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (full dose even though he is not immunocompromised). On an unknown date, the patient experienced PAIN IN EXTREMITY (experienced sore arm). On 03-Nov-2021, ACCIDENTAL OVERDOSE (full dose even though he is not immunocompromised) had resolved. At the time of the report, PAIN IN EXTREMITY (experienced sore arm) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-374206, MOD-2021-374377 (Patient Link).
morbilliform rash for 3 weeks: shins, feet, shoulders, upper trunk, arms mixture of triamcinolone 0.1% ointment (night) and cream(day). daily  bleach bath cleared up by the week of 05/18/2021 left with scarring on affected areas
Arm pain; It is hard to raise the arm; This spontaneous case was received on 21-Oct-2021 from a pharmacist via The Regulatory Authority (reference number: SEQW21-04341) and concerned a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.  On 29-Oct-2021, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for Influenza prophylaxis. The batch number was not reported.  On 01-Oct-2021, two days after receiving Afluria Quadrivalent, the patient experienced arm pain.  On an unknown day in Oct-2021, it was hard to patient to raise the arm.  At the time of initial reporting on 21-Oct-2021, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  Company comment: A patient of an unreported age was vaccinated with Afluria Quadrivalent. Two days after receiving Afluria Quadrivalent, the patient experienced arm pain and mobility decreased. Due to biological and chronological plausibility, causality is assessed as possibly related.; Sender's Comments: A patient of an unreported age was vaccinated with Afluria Quadrivalent. Two days after receiving Afluria Quadrivalent, the patient experienced arm pain and mobility decreased. Due to biological and chronological plausibility, causality is assessed as possibly related.
Pt was given SHINGRIX on 3/15/18 and later that night, pt c/o feeling very hot, clammy and eventually fainted in her bathroom (fell slowly- no resulting injury). Pt called pharmacy to report incident-- sx's resolved, but today 3/16/18 feeling very fatigued. Writer explained to pt that this is a normal reaction and that her body is responding to the vaccine, and encouraged pt to come back for her second dose- ADE should resolve in about 48 hours.
RAPID PULSE, DIZZY AND BLOTCHY RED SKIN (STUDENT CAME IN WITH BLOTCHY RED SKIN). AFTER VACCINE STUDENT RETURNED TO CLASS.
OV by dad with 4 children, 3 for imm. Patient given his vaccines, did well. About 5 minutes after imm given, I heard thump. Child on floor face down. Care given. Sent to ER. Liquid diet still restricted activity.
Patient complained of swelling to the pectoral area that spread towards the arm pit.  No pain or redness.   Patient is using ice packs and Ibuprofen to treat.
trouble falling asleep; This spontaneous case was reported by a consumer and describes the occurrence of INITIAL INSOMNIA (trouble falling asleep) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced INITIAL INSOMNIA (trouble falling asleep). On 09-Apr-2021, INITIAL INSOMNIA (trouble falling asleep) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-127517 (Patient Link).
Itchy Hands and neck with redness and hives. Taken to hospital by ambulance as a precaution.
The side effects include seizures that started drastically on previously stated date. no other symptoms were noticed or recorded from the five month time period between the short and the symptoms.
patient received a pfizer bioNtech booster shot at mobile vaccine clinic. Patient did not have vaccine card on him and there was no access on site. His original series was Moderna. Patient was asked prior to receive the booster and he mentioned he took pfizer.
t105;2 R, lethargy, vomiting; treated w/APAP, clear liquids;
Redness at injection site; Pain at injection site; Arm started to hurt; Small bump at injection site; Itchy at injection site; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm started to hurt), INJECTION SITE SWELLING (Small bump at injection site), INJECTION SITE PRURITUS (Itchy at injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE PAIN (Pain at injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm started to hurt), INJECTION SITE SWELLING (Small bump at injection site) and INJECTION SITE PRURITUS (Itchy at injection site). On 08-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE PAIN (Pain at injection site). At the time of the report, PAIN IN EXTREMITY (Arm started to hurt), INJECTION SITE SWELLING (Small bump at injection site), INJECTION SITE PRURITUS (Itchy at injection site), INJECTION SITE ERYTHEMA (Redness at injection site) and INJECTION SITE PAIN (Pain at injection site) outcome was unknown.        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.   No treatment information was provided.  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's Comments: 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.
given after bud date. date on box was written as 7/31/23 but was incorrect and should have been 1/18/23 10 weeks after receiving on 11/10/22. no adverse reaqction
Very sick; A spontaneous report was received from a consumer concerning a patient (age and gender unknown), who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hospitalization for being very sick and with some underlying sickness.  The patient's medical history was not reported. Concomitant medications were not mentioned.   On an unmentioned date, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the reporter stated that after receiving second dose of the vaccine the patient was in hospital and very sick.  Treatment for the events was not mentioned.   Action taken with mRNA-1273 in response to the events is not applicable as both doses of the vaccine have been taken.   The outcome of the events, very sick with underlying sickness, was considered unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
On the 27th at night I got chills and fever. A big headache didn?t let me sleep. Then on the 28th I was feeling unwell. Bodyaches and fever. I got an Ibuprofen and this got rid of the Headache and body aches. I took 2 ibuprofen in total and by the end of the day I was feeling much better
Developed rash on various locations on my upper body. The largest areas being the right flank, covering about 50% of the area. The rash on the other areas of the upper body were diffuse in small patches, including the left flank and upper back, shoulders, and upper extremity.
This spontaneous report was received from a pharmacist referred to a patient of unknown age and gender. The reporting pharmacist reported that on 14-AUG-2014 patient was inadvertently administered an expired dose of PNEUMOVAX23 (lot # J006921, expired on 09-AUG-2014) (dose, route and frequency unspecified). No adverse effect reported. Additional information has been requested.
Saw Cardiologist after receiving second dose Pfizer Covid Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE., Manufacturer unknown), for COVID-19 Immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Saw Cardiologist after receiving second dose Pfizer Covid Vaccine". The event "saw cardiologist after receiving second dose pfizer covid vaccine" was evaluated at the physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She had a lymph tissue lumps fever chills muscle aches headache. She said she felt about 50% better the following day. She eventually succumbed and passed away.
has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, about 1 year ago of reporting date).   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 details were provided as follows: The age at vaccination was not applicable for this report. The patient missed to receive the second dose of Shingrix at appropriate time and had not received it till the time of reporting, which led to incomplete course of vaccination. No vaccine data was provided. The reporter consented to follow up. The VAERS details were reported for 1st dose of Shingrix.
01/30/22 presents to ED for "Shortness of Breath". PMHx of "anemia, CHF, DM type II, CAD, hypertension, CKD on dialysis"
Injection site pain; myalgia; arthralgia; congestion; neck pain; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old male patient received first dose of bnt162b2 (lot number EK5730), via an unspecified route of administration in arm left on 16Dec2020 07:15 at single dose for immunization.  Medical history included hypertension and CAD (coronary artery disease). Patient had no allergy history to medications, food, or other products. Concomitant medication included ticagrelor (BRILINTA), lisinopril, acetylsalicylic acid (ASA), ergocalciferol (VIT D) and magnesium (MAGNESIUM). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced injection site pain, myalgia, arthralgia, congestion, neck pain, fatigue all on 16Dec2020 20:00. Treatment paracetamol (TYLENOL) were taken as a result of reported events. The outcome of the events was recovering.
Localized erythema about 13 cm ? localized cellulitis with induration, warm, red tender
Sore upper arm, chills, cold & clammy, upset stomach, achy, very sore neck.
This spontaneous report as received from a certified medical assistant refers to unspecified a patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown date in 2015 (reported as "since March 2015"), the patients were vaccinated with an improperly stored ROTATEQ (expiration date, dose and route were not reported) route default as oral. Secondary suspects and concomitant therapies were not reported. No adverse effects were noted. There was no treatment given for adverse event. Additional information has been requested. This is one of several reports received from the same reporter.
throat, tongue, palate numb, chest neck red color;DPH give w/relief; P78 R16 BP 135/90 lying flat;states fingers tingling 12:15 neck & ears burning 12:30 upright 132/80 76-18, advised to see allergist
Monovalent Moderna given.   Moderna bivalent should have been given.  Phone call to client and told he could return  to clinic in two months from last Moderna and receive Moderna bivalent that covers Covid variants.  Client voiced understanding and will return.
Patient was vaccinated at around 11:50 am on 11/08/2018. Patient went downstairs with parent after about 15 minutes to make appointment. Patient vomited in waiting area and was brought up by wheelchair to second floor to be reevaluated by medical unit. Patient left wheelchair to walk into unit, fainted and hit side of her head. Patient was reevaluated by provider and released due to patient being in stable condition.
Malaise; pain, swelling, erythema of finger joints both hands, "traveling from joint to joint for several weeks until settling into 2 permanantly." eventual dx Rheumatoid Arthritis. Note: initial flulike illness 24 hr post administration lasted 72 hr, including severe malaise, body aches, fever, anorexia and fatigue.
BLOODY STOOL; INFLAMED BURSA OF LEFT HIP, RADIATING TOWARDS SPINE; ARTHRALGIA; MYALGIA; SLIGHTLY LOW KIDNEY FUNCTION; FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism. The patient had no known allergies. The patient was previously treated with cortisone in shoulder joint.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 on right arm for prophylactic vaccination. Concomitant medications included ascorbic acid, calcium, chondroitin sulfate/glucosamine hydrochloride, colecalciferol, levothyroxine sodium, and magnesium.  In the morning of 17-MAR-2021, the patient felt some fatigue, stayed in bed until noon and fatigue disappeared in the afternoon. On 07-APR-2021, the patient started experiencing pain and soreness in hamstring, behind knees and in hips. The pain and soreness gradually progressed upwards towards spine. The symptoms were worse in the morning and evening, with the period between noon and 8 PM saw some improvement. Since pain and soreness started, the patient had been taking painkillers like candy, Tylenol (paracetamol), Advil (ibuprofen) and Aleve (naproxen sodium) and had no effect on symptoms. On 21-APR-2021, the patient had some bloody stool and saw primary care physician that week. The blood tests, bone density and thyroid function were done. Only finding of note was slightly low kidney function and diagnosis of myalgia and arthralgia. The patient was told to discontinue painkiller use. On 12-JUN-2021, the patient saw orthopedist, was diagnosed with inflamed bursa on the left hip, radiating towards spine and was prescribed a 5 days tapering course of prednisone. The symptoms disappeared starting on the second day of prednisone. The symptoms reappeared with same severity 2 days after stopping prednisone (19-JUN-2021).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bloody stool on 21-APR-2021, and fatigue on 17-MAR-2021, had not recovered from inflamed bursa of left hip, radiating towards spine, myalgia, and arthralgia, and the outcome of slightly low kidney function was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210660357-covid-19 vaccine ad26.cov2.s- bloody stool, slightly low kidney function. This event(s) is considered unassessable. 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).
Pt. reported via arabic phone interpreter of having nausea, dizziness and abdominal pain
2 days following shot, I had a sore throat, lethargy and general aches and pains. That subsided within 1 day and by 10-3-12, I had soreness/swelling and stiffness present in both hands. The pain is moderate (scale 3 out of 10). The joint pain is mostly present in my hands but will be transient in my left knee and all my toes bilaterally. The pain in my hands has subsided a bit but comes and goes throughout the day. I have persistent feeling of swollen hands and residual weakness, more prominent in my left hand.