chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ulcerative colitis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 21K-163-4036289-00 (MFR Control No).  A 38 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: COLITIS ULCERATIVE (medically significant), outcome "not recovered", described as "Ulcerative colitis flare up". The action taken for adalimumab was unknown. Clinical course: The reporter's causality for the event (s) of ulcerative colitis flare up/not sure if Humira was working unknown onset with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the event (s) of Ulcerative colitis flare up/not sure if Humira was working unknown onset was not provided/reported. The reporter's causality for the event (s) of ulcerative colitis flare up/not sure if Humira was working unknown onset with Humira (adalimumab) was possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event ulcerative colitis and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Had vacinnation for shjngles on 6/15/2017. On 6/16/2017 I was awaken out of my sleep by severe pains in my left foot. The pain start running up my calf to my thigh, hip and leftnside of my back. The pain was so severe at times It made me limp when walking. After a week I went to urgent care. I explain to them about the vaccinctions I had and the pain on the left side of my body. They did a scan on my leg and found nothing. I explain my pain was a 10. I was given a shot for pain in my hip. The pain was still ther. I was given morphin in an IV, the pain was still severe. I was given a pill for pain before I was sent home with a prescription for muscle relaxers and IBProfin. I dchedule an appointment with my Doctor. By this time I had developed a ras of bumps on my backmand red blotches on my left leg. Once the Doctor looked at the spots and listened to all events that had occured, she realized that the live shingles vaccinnation had attached to the nerves in the left side of jy body mainly in the left leg giving me the shingles.
Throbbing pain (L) arm down to 1st 3 digits T. 97.5 BP 100/56 Given prednisone and Tramadol.
Headache, stomach ache followed by 4 red bumps 2 on face, 2 on arm. Shortly after that, severe cough and cold symptoms. Mother then developed same symptoms on week 3 with unknown red bumps on back of neck, nausea, chest cold, flu like symptoms.
pt recv vax 9OCT95 & 4APR97 pt devel rash all over body;
Pt reports having had Tdap (L) deltoid on 1/12/15. Pt states on 1/13/15, had lymph node swelling (L) neck 1/14/15. Pt reports (L) elbow -> finger numbness and tingling, (L) elbow is inflamed and warm to touch. Pt has limited movement of (L) arm with weak hand grasp (L). Pt referred to ER.
I had typical reactions - right after the vaccine. Recent health event: Starting July 17, sore throat and sinus infection and then into Bronchitis and chest infection. That was it. It was scary because I lost my sense of smell - but not until after a week after I first noticed symptoms.  I went to Urgent Care course of Amoxicillin. It helped with symptoms. My smell loss returned within two days of starting Amoxicillin. I Could still taste sweets and sour - tongue flavors.  But I could not smell my child's dirty diapers.
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Additional Details: Immediately following the first dose of covid vaccine, patient verbally said he was going to faint. It then happened in a fraction of a second, lasted for roughly 5 seconds. Pt recovered after 5 seconds or so. Reported a hx of fainting without any known reasons. No medical history of seizures or neurological conditions. Recommended patient to be seen by a physician.
GBS whole body paralysis after 2 COVID then 2 shingle then another COVID shots 5 all togethet
Vaccine administration error/Expired vaccine given with no reported adverse event; Initial information received on 10-May-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient where diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [pentacel (Vero)] vaccine administration error/expired vaccine given with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On 01-Feb-2023, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (expiration date- 28-Jan-2023) (dose, frequency, strength: not provided) for immunization, Information on the batch number was requested.  On 02-Feb-2023 the vaccine administration error/expired vaccine given with no reported adverse event (expired product administered) (latency- 1 day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine.  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.
It became clear that patient was not going to be able to manage on his own again and family was unable to care for him at home with his current level of needs. Therefore arrangements were made for him to discharge to an assisted living.
I had severe dizziness and fainting for two days after shot, and shortness of breath.
Fully vaccinated with moderna vaccine x2. Tested positive for Covid on 02/17/2022. Admitted to  Medical Center on 02/15/2022. Expired on 02/18/2022 while still hospitalized.
Last year I had a very severe reaction to the flu vaccine site was inflamed and I had high temperature while starting to get delirious. Went to dr and received prednisone illness lasted 3 days. This year we decided to try a half dose first that's when the adverse reaction started again. Site of injection was immediately sore, 1 hour after injection started getting very tired. 12 later woke up to severe chills.  Felt hot I took my temperature it was 103 degrees with body aches. Started drinking lots and lot of water and applying ice packs to forehead and neck area. Laid down and dosed off for 2 hours when I woke up my temperature was at 102 degrees and stared going down to 101 degrees  until 10 hrs later temperature was 99 degrees. Still very ill just like having the flu. I called my dr . to report it  as the symptons started going away gradually after 4 days I am still not up to par. Still sweating and weak.
Severe stomach trouble; Nausea; Constipation; Diarrhea; cramping; Bloating; gassy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2022 17:45 (Lot number: 33025BD) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "Severe stomach trouble"; NAUSEA (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "Nausea"; CONSTIPATION (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "Constipation"; DIARRHOEA (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "Diarrhea"; MUSCLE SPASMS (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "cramping"; ABDOMINAL DISTENSION (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "Bloating"; FLATULENCE (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "gassy". Therapeutic measures were not taken as a result of abdominal discomfort, nausea, constipation, diarrhoea, muscle spasms, abdominal distension, flatulence.  Additional information: The patient did not receive other Vaccine in four weeks. The patient had not covid prior vaccination. The patient has not covid tested post vaccination.    No follow-up attempts are possible. No further information is expected.
On 3/5/ 21, I had a shoulder MRI done on right shoulder for pain over several months. On 2/12, I had my first dose of the Covid 19  vaccine,  Moderna.   When results come back for MRI, I was informed of a single, enlarged  node and told given my breast cancer history, I should pursue further testing.  I just had a clear mammogram in Dec 2020, so it really didn't make sense.  I've been advised by my primary to get a diagnostic mammo and ultrasound.   Not sure this is appropriate.
rash/hives, headaches, neuropathy, brain fog, intense pressure in head, blurred vision, twitching decrease in appetite, burning sensation, irregular menstruation
I was a breastfeeding mother to my 4 month old daughter.  After getting my first dose I slowly starting losing my milk supply and by day 7 I couldn?t even pump a drop of milk out. I went from pumping 40 oz of milk a day to zero by day 7 after getting the Covid vaccination.
Pt' s wife called and reported that pt was having a reaction to the covid vaccine that he received at clinic this am. States that pt can not stop shaking. Reports that he had breakfast this morning and that he also had a snack. Endorses shortness of breath and wheezing. Denies itching of nose, throat, or mouth. Recommend that he immediately take a benadryl. Advised that he should take immediate action and call EMS. Patient's wife states that her son is going to take pt to office. Advised that they should pull over immediately if his condition should change.
Breakthrough case admission after 4 vaccines Pfizer 1/20/21  Lot# El3249;  Pfizer 2/7/21 Lot# EL9265;  Pfizer 9/26/21 Lot# FF8841 ; Pfizer 4/11/22 Lot# FJ9943;
PCV15 vaccine administered in the R thigh; just above R knee(too low). Mother reported patient's inability to move R leg s/p vaccination for approx 12 hours. Also, experienced 2 days of crying in pain and excessive swelling above right knee. Patient continues with red area 2+ months later on 8/28/2023.
Developed mild itching over all skin surface including scalp about 20 minutes post vaccine administration.  No rash.  Administered Benadryl 50mg orally.  Vital signs stable with PO2 @ 99% & Pulse 62-64, regular.  Itching subsided and she was discharged to her husband @ noon.  She was instructed to contact her hematologist to inform of this event.
6 dots on her knees; rash on her hands and knees that itched like crazy; Itching; Hives; Rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (6 dots on her knees), RASH PRURITIC (rash on her hands and knees that itched like crazy), PRURITUS (Itching), URTICARIA (Hives) and RASH (Rash) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism and Seizures. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), VITAMINS NOS, ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMIN D3, CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]) and MAGNESIUM for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced RASH PRURITIC (rash on her hands and knees that itched like crazy), PRURITUS (Itching), URTICARIA (Hives) and RASH (Rash). On an unknown date, the patient experienced ERYTHEMA (6 dots on her knees). The patient was treated with STEROIDS on 09-Mar-2021 for Adverse event, at a dose of 7 days. On 03-Mar-2021, PRURITUS (Itching), URTICARIA (Hives) and RASH (Rash) had resolved. On 04-Mar-2021, RASH PRURITIC (rash on her hands and knees that itched like crazy) had resolved. At the time of the report, ERYTHEMA (6 dots on her knees) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 97.6 degree Celsius normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received her first dose on 16-Feb-2021 in her left arm and reported that ten days later she developed a rash on her hands and knees that itched like crazy and it lasted for six days. She also had six dots on her knees and the redness stayed until the date got closer to her second dose.   She was prescribed prednisone (as treatment) but stopped taking in time before second dose.  The patient reported events to be related to Moderna Vaccine.   This case was linked to MOD-2021-101720 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Updated patient details, suspect product details, concomitant medications, treatment medications and event details.
Headache, left sided neck/shoulder pain, heaviness left arm, swelling at injection site, lump, redness, arm pain.
numbness of left arm; This case was reported by a pharmacist and described the occurrence of numbness of upper extremities in a 51-year-old male patient who received HBV (Engerix B adult) (batch number BG92Z, expiry date 4th July 2022) for prophylaxis.   On 3rd February 2020, the patient received Engerix B adult (intramuscular). On 3rd February 2020, 1 hr after receiving Engerix B adult, the patient experienced numbness of upper extremities. On an unknown date, the outcome of the numbness of upper extremities was recovering/resolving.   It was unknown if the reporter considered the numbness of upper extremities to be related to Engerix B adult.  Additional information was provided as follows: The patient received Engerix B vaccine in the left deltoid. About 1 hour later, the patient reported numbness of the injected arm all the way from the shoulder to the hand. At the time of reporting, the patient was improving. The reporter consented to follow up.
Sterile abscess, left thigh at Pediarix injection site.  No history of fever or elevated temperature on date of vaccination or of today's visit for the nodule in the left thigh.  No redness, warmth, or tenderness at site of sterile abscess.  Parents noted the abscess incidentally yesterday.
feels a bean size lymph node near her neck; right shoulder feels like it's tearing and pulling; super arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (super arm soreness), ARTHRALGIA (right shoulder feels like it's tearing and pulling) and LYMPHADENOPATHY (feels a bean size lymph node near her neck) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (super arm soreness). On 18-Mar-2021, the patient experienced ARTHRALGIA (right shoulder feels like it's tearing and pulling). On an unknown date, the patient experienced LYMPHADENOPATHY (feels a bean size lymph node near her neck). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 12-Mar-2021, PAIN IN EXTREMITY (super arm soreness) had resolved. At the time of the report, ARTHRALGIA (right shoulder feels like it's tearing and pulling) had not resolved and LYMPHADENOPATHY (feels a bean size lymph node near her neck) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Swollen lymph node in right armpit starting the day after 1st dose was administered and lasting through 4/8/2021.  Rash and swelling on upper right arm at injection area beginning on 4/5/2021 and still present as of the date of this report.  Rash started as a small patch and has grown to the size of a large orange.  Visited Primary Care physician on 4/7/2021 PM and was prescribed Medrol and Famotidine for adverse effects, as well as Zyrtec and Flonase for seasonal allergies.  Began medication on 4/8 in AM, swollen lymph node has subsided, upper arm is no longer swollen however rash remains with some redness and other discoloration. Medrol prescription is for 5 days and Famotidine is 2x daily for 10 days.
chills were so bad that she couldn't hold anything because her hands were shaking so bad; chills were so bad that she couldn't hold anything because her hands were shaking so bad; fever of 101.8; bad headache; felt nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills were so bad that she couldn't hold anything because her hands were shaking so bad), TREMOR (chills were so bad that she couldn't hold anything because her hands were shaking so bad), PYREXIA (fever of 101.8), HEADACHE (bad headache) and NAUSEA (felt nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, the patient experienced CHILLS (chills were so bad that she couldn't hold anything because her hands were shaking so bad), TREMOR (chills were so bad that she couldn't hold anything because her hands were shaking so bad), PYREXIA (fever of 101.8), HEADACHE (bad headache) and NAUSEA (felt nausea). On 26-Jul-2021, CHILLS (chills were so bad that she couldn't hold anything because her hands were shaking so bad), TREMOR (chills were so bad that she couldn't hold anything because her hands were shaking so bad), HEADACHE (bad headache) and NAUSEA (felt nausea) had resolved and PYREXIA (fever of 101.8) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jul-2021, Pyrexia: 101.8 (High) 101.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. Upon in internal review on 04-Aug-2021, the age was corrected to 69 years
At 2:11pm Patient went into syncope episode for few seconds after vaccinated for 5 minutes. Nurse practitioner assessed patient. No EMS was called. BP: 98/50. HR: 47 but increased to 78 after 5 minutes. Patient is allergic to penicillin and has a hx of anaphylaxis 7 years ago. Patient was recovered.
allergic reaction; itching on his arm starting at the elbow; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (allergic reaction) and PRURITUS (itching on his arm starting at the elbow) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced HYPERSENSITIVITY (allergic reaction) and PRURITUS (itching on his arm starting at the elbow). At the time of the report, HYPERSENSITIVITY (allergic reaction) and PRURITUS (itching on his arm starting at the elbow) 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.   This case was linked to MOD-2021-101641 (Patient Link).
Patient had two seizures, one at 9:30 AM and another at 5:55 PM.  Patient has known seizures, and Mom states that the seizures were different.
This case was reported by a healthcare professional and described the occurrence of malaise in a 52-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included CLEOCIN, DIFFERIN, DIFLUCAN, Multivitamins and LUMIGAN. On an unspecified date, the subject received a dose of FLULAVAL at 0.5 ml in the left arm. On 06 September 2010, the subject experienced malaise, fatigue and sore throat. The events were reported to be improved by 20 September 2010. The events were reported to be unrelated to treatment with FLULAVAL.