chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10X7 cm, red patchy colored area on left arm at injection site warm to the touch. hive like appearance. Began 2-3 days after IZ administration. symptoms are reducing at this time.
Prolific itchy rash on administration arm. Recommended diphenhydramine. No outcome yet.
The cough started about a week after vaccination(s), sleep problems started at the same time, stomach issues (not tolerating feedings, mucus poop)  The doctor said the cough was allergies, prescribed allergy medication, and breathing treatments.  We did not do the allergy medications and only did breathing treatments for a week.  The cough persisted until the child was 7 months old.
Irregular heart beats. Come and go. Went to ER, all is ok. Wakes me up at night, and can last for hours. Hard to eat, walk, even rest does not always help.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided by the reporter.  No treatment information was provided.
drug ineffective; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4269969-00 (AbbVie).  A 20 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Jul2021 (Batch/Lot number: unknown) at the age of 19 years as dose 1, single and intramuscular, administration date 20Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for psoriatic arthropathy. 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 "unknown" and all described as "COVID-19". The action taken for adalimumab was dosage permanently withdrawn.  Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN), UNKNOWN) The reporter's causality for the event(s) of COVID-19 with PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN), UNKNOWN was no reasonable possibility.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events.
02/14/2023 I started having feeling that I had a sinus infection.  After going to the hospital my pressure was high and was prescribed Prednisone and Doxycycline. Symptoms lasted 3 weeks.
Headache, Fever, chills, fatigue, itchy red, raised rash at injection site Narrative: Headache, fever, chills, fatigue, arm soreness-red rash itchy; tylenol; resolved in 35 hours.
Dizzy and clenching of hands/tightening of body after vaccines. Pt did not remember this after vaccines. Alert and oriented, responding to RN questions right after.
ACUTE RESPIRATORY FAILURE WITH HYPOXIA, COVID-19 Hospitalization and Death
My ear Eustachian tube bulges and I feel pressure in the evening; My ear Eustachian tube bulges and I feel pressure in the evening; fogginess; confusion; Both of our second toe feels numb; headaches in the back of my head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2022 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPOAESTHESIA (non-serious) with onset 01Mar2022, outcome "recovering", described as "Both of our second toe feels numb"; EUSTACHIAN TUBE DISORDER (non-serious), EAR DISCOMFORT (non-serious) all with onset 01Mar2022, outcome "recovering" and all described as "My ear Eustachian tube bulges and I feel pressure in the evening"; CONFUSIONAL STATE (non-serious) with onset 01Mar2022, outcome "recovering", described as "confusion"; FEELING ABNORMAL (non-serious) with onset 01Mar2022, outcome "recovering", described as "fogginess"; HEADACHE (non-serious) with onset 01Mar2022, outcome "recovering", described as "headaches in the back of my head". The events "my ear eustachian tube bulges and i feel pressure in the evening", "fogginess", "confusion", "both of our second toe feels numb" and "headaches in the back of my head" required physician office visit. Therapeutic measures were not taken as a result of eustachian tube disorder, ear discomfort, feeling abnormal, confusional state, hypoaesthesia, headache.  Additional information: Patient didn't received other vaccine in four weeks and other medications in two weeks. My ear Eustachian tube bulges and I feel pressure in the evening , fogginess and confusion, my husband and I have toes that are numb. Both of our second toe feels numb. He also received a Pfizer shot. I also have headaches in the back of my head. No covid prior vaccination. Patient was covid tested post vaccination. No known allergies. Covid test post vaccination: covid test type post vaccination Nasal Swab,covid test result was Positive.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dizziness, fainting, possible seizure, numbness/tingling in right arm, slight numbness/tingling in right side of face
Positive COVID test after two doses of Pfizer vaccine  Vaccine dates -    01/28/2021  and  02/18/2021
Moderna COVID booster given incorrect dose, was give 0.5ml rather than the recommended 0.25ml
"Flu like" feeling and chills started appx. 8:30 AM on 10/16/2008. On 10/17/2008 "hard to pick arm up" did not to work. That evening noticed arm bright red and swollen size of her hand, at PNEUMOVAX injection site.
swollen lymph node; injection site pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph node"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
5x7 cm erythematous, indurated, pruritic area @ inject site-rt buttock;
Kawasaki disease, inflammation, oropharyngeal erythema, conjunctivitis, rash, fever x6 days
Hallucinations, swollen arm pit, fever and headache, muscle weakness, fatigue.
"blurry" blisters in her mouth; This spontaneous case was reported by a health care professional and describes the occurrence of ORAL MUCOSAL BLISTERING ("blurry" blisters in her mouth) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A2A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ), VITAMIN D3, LORATADINE, METFORMIN and WARFARIN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ORAL MUCOSAL BLISTERING ("blurry" blisters in her mouth). At the time of the report, ORAL MUCOSAL BLISTERING ("blurry" blisters in her mouth) 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.   Treatment information included hot water and salt.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: No new information was provided.
Anaphylaxis at half hour after second shot ,  had allergic symptoms on following Thursday  3/18 and Thurs 3/25
chills, very achy around the injection site but also in my legs, hips, nausea
Report 20010207481 described lymphadenopathy in a vaccinee of unspecified age and gender who received hep B vaccine recombinant. The vaccinee's allergies, medical history, and concomitant medications were not specified. On an unspecified date, the vaccinee received a dose of Engerix-B; it was not known whether the vaccinee had received previous doses of Engerix-B. subsequently, the vaccinee experienced lymphadenopathy. As of 08/24/2001, the outcome of the adverse event was unknown.
nausea; chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she does have a lot of allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/ Lot number not reported), for COVID-19 immunization, reaction(s): "high blood pressure/ after the first shot it went up to 159/85", "heart palpitations", "PVCs". The following information was reported: NAUSEA (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever".  Additional Information: The patient who is a female almost 72 years of age reported for herself that she has had 5 previous shots of the Pfizer COVID vaccines. She is calling about the new one that was just released but nowhere has it yet. She had a different reaction to each vaccine but would like to stick with Pfizer because that is what her body is used to. She does have a lot of allergies. The first shot she had a very severe reaction to. She developed high blood pressure, and she had always had low pressure. Her blood pressure was usually 100/60 and after the first shot it went up to 159/85, she thinks. It was like that for quite a while, until right before she had to get the second shot and it got better. She called the Pfizer reaction line, and they told her that it happening to people but its temporary and if you already deal with that issue the shot could make it worse, but she never had that issue before. So, she went to the heart hospital to go get checked out. She was having heart palpitations and PVCs bad. She could feel them. She always gets them but doesn't feel them. But she didn't have that strong of reaction again like she did to the first dose of the Pfizer COVID vaccine. When she went to see the doctor and told her about it, the doctor, who is thin like her, said she got the Moderna COVID vaccine, and she also was having heart palpitations. The subsequent doses it was always the nausea and the chills and things like that , fever.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300299983 Same patient/ reporter, product, Different dose/ events;US-PFIZER INC-202300300612 Same patient/ reporter, product, Different dose/ events;US-PFIZER INC-202300300610 Same patient/ reporter, product, Different dose/ events;US-PFIZER INC-202300300611 Same patient/ reporter, product, Different dose/ events;
pt recv vax AUG95 & 20MAY96 pt exp a rash w/100-150 lesions which was dx as chicken pox;
PANIC ATTACKS; DIZZINESS; SPIKING BLOOD PRESSURES FOR A WHILE; AFFECTING MENTAL HEALTH; RINGING OF THE EARS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have spiking blood pressure, dizziness and panic attacks in her life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for covid-19 prophylaxis. No concomitant medications were reported. On APR-2021, the patient experienced affecting mental health, and ringing of the ears. On an unspecified date, the patient experienced panic attacks, dizziness, and spiking blood pressures for a while. Laboratory data (dates unspecified) included: Blood pressure spiking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spiking blood pressures for a while, and ringing of the ears on JUN-2022, and the outcome of dizziness, panic attacks and affecting mental health was not reported. This report was non-serious. This case, from the same reporter is linked to 20220827357.
Tightness and tingling in throat, Itching  on shoulders, arms, abd and lower extremities,  hive on left ear lobe.  15 min after vaccine administered 25mg Benadryl given PO, continued to observe.  30 min later 25mg Benadryl given PO and observation continued.  1 hour later pt. discharged to friend, VS stable, No resp. distress, responds appropriately.     Contacted pt. several days later and she had a HA, nausea and sore throat, no itching or resp. distress.  Informed pt. of emergency protocol.
Case previously recorded as MA2009-4290. Initial case report received from a registered nurse via agency, on 04 NOV 2009. A 6 month-old female patient was accidentally vaccinated with S-OIV FLUVIRIN (batch no. 100813) i.m. on 04 NOV 2009. No adverse effect was reported. Agency reference no.:NA09-007607.
WEAKNESS; NO TASTE; NAUSEOUS; FATIGUE; BODY ACHES; NUMB LIPS; SWOLLEN FACE RIGHT SIDE; BLURRED VISION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: 1802068 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced weakness. On 06-MAR-2021, the subject experienced no taste. On 06-MAR-2021, the subject experienced nauseous. On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject experienced body aches. On 06-MAR-2021, the subject experienced numb lips. On 06-MAR-2021, the subject experienced swollen face right side. On 06-MAR-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, no taste, body aches, numb lips, nauseous, fatigue, swollen face right side, and blurred vision. This report was non-serious.
Swelling has been increasing; This case was reported by a consumer via interactive digital media and described the occurrence of swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2022, the patient received Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced swelling. On an unknown date, the outcome of the swelling was not recovered/not resolved.   It was unknown if the reporter considered the swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-NOV-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that he / she had received vaccine 48 hours ago.  The patient's area of swelling had been increasing. Additional supportive information: Follow-up would not possible as no contact details were available.
No problem for 24 hours. Next day, almost exactly 24 hours later I had great difficulty walking, uncoordinated, and muscular weakness.  For instance my husband had to push me into bed that night.  When I woke up the next morning, 11/05  I was back to normal. I also had these symptoms after a GI flu in 2020, and also passed out during 2 respiratory flus , 2019 and possibly 2017.
Pt recd vax (deltoid) as a booster dose on 27JUN91 & developed events; Pt put an ice pack on the area; arm looked red deltoid to wrist; tingling in left deltoid & below;
Information has been received from a medical assistant concerning unspecified patients. The patients' concomitant medications, pertinent medical history and concurrent conditions were not provided. On 10-NOV-2016, 3 doses of improperly stored M-M-R II (dose and frequency unknown) (lot # L040960, expiration date 16-OCT-2017, subcutaneous) were inadvertently administered to the patients. The M-M-R II was exposed to temperature excursion of 8.6 Fahrenheit degree (F) for 5 hours. Data logger was involved but there was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 21-JAN-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 22-JAN-2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient experienced site pain for 3 days, night or vaccination, patient had bad chills for a couple of hours, headache, and slight fever
patient received a dose of Flublok instead of Fluzone with no adverse event; 8 year old patient received a dose of Flublok with no adverse event; the packaging for Flublok and Fluzone is very similar which creates confusion with no adverse event; Initial information regarding this unsolicited valid non-serious case received from a pharmacist and transmitted to Sanofi on 12-Oct-2020. This case is linked to case 2020SA284931.  This case involved an 8-year-old patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- QFAA2027, expiration date unknown) instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]  (Lot number and expiration date unknown) via unknown route in unknown administration site (Product administered to patient of inappropriate age) and (Wrong product administered) for prophylactic vaccination on an unknown date. The reporter also reported that the packaging for Flublok and Fluzone was very similar and believed this caused confusion to nurse (Product packaging confusion).  The patient's medical history, medical treatments, vaccinations and family history were not provided. No concomitant drug was reported.  This was a case of actual medication error as Inappropriate age at vaccine administration and Wrong vaccine administered due to Look alike packaging (Latency: Same day).  At the time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient stated recieved Gardasil vaccine 9/11/19. On Saturday 10/5/19 it began getting red, now warm to touch, firm in area. Patient has felt chilled like since Saturday. Patient reports chills (since Saturday) but reports no fatigue and no fever. Skin:: left upper arm at area of tatoo and giardisil injection with swelling and tenderness. She reports no dyspnea / shortness of breath. She reports no abdominal pain, no nausea, no vomiting, and no diarrhea. She reports no urinary difficulties.  Cellulitis of upper arm - 10/7/19 - doxycycline 100 mg po bid x 7d; heating pad; ibuprofen as needed allergic to penicillin L03.119: Cellulitis of unspecified part of limb doxycycline hyclate 100 mg tablet - Take 1 tablet(s) twice a day by oral route for 7 days.     Qty: 14 tablet(s)
Could not move left arm.  Pain shooting through left shoulder with any slight movement (sitting up, turning, trying to get comfortable), swelling at insertion site, jaw tightening, pain at the following joint sites of left arm:  shoulder, elbow and wrist.  Fatigue with activities of daily living.