chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with MMR II injection (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. On an unknown date the patient had titers drawn (details unspecified) which revealed negative for measles. The action taken with therapy with MMR II was unknown. The outcome of the event was unknown. The relatedness of the events to the therapy with MMR II was unknown. There was no product quality issue reported. Additional information has been requested.
Varicella and Dtap administered to R ant. thigh on 6/21/07 developed overlying erythematous, edematous, inflamed patch, itchy and warm.
Slight muscular discomfort; Stomach discomfort / Abdomen discomfort; Stomach pain/ Abdomen pain; This spontaneous case was reported by a physician and describes the occurrence of MUSCLE DISCOMFORT (Slight muscular discomfort), ABDOMINAL DISCOMFORT (Stomach discomfort / Abdomen discomfort) and ABDOMINAL PAIN UPPER (Stomach pain/ Abdomen pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0173NA, 038K20A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Went through a series of cancer treatments).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE DISCOMFORT (Slight muscular discomfort), ABDOMINAL DISCOMFORT (Stomach discomfort / Abdomen discomfort) and ABDOMINAL PAIN UPPER (Stomach pain/ Abdomen pain). At the time of the report, MUSCLE DISCOMFORT (Slight muscular discomfort), ABDOMINAL DISCOMFORT (Stomach discomfort / Abdomen discomfort) and ABDOMINAL PAIN UPPER (Stomach pain/ Abdomen pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient is on a number of different medications (name was unspecified).  No treatment information was provided.  The patient received third dose of vaccine and reports slight muscular discomfort, not severe with stomach and abdomen discomfort and pain. The patient had went through series of cancer treatments and considered as immunocompromised.
Severe pain in R arm at the site of Prevnar-13 administration started in evening of 6/12, patient unable to sleep due to pain. No swelling, redness, fever or discharge.
First vaccine 12/18/2020. Developed tachycardia with palpitations and shortness of breath within a couple days of first vaccine.  Diagnosed with Covid 12/26/2020 (only migraines and lost of taste and smell). Went through cardiac testing, negative at time. Tachycardia and palpitations with shortness of breath have continued to present day. Last seen by a provider on 01/15/2022. Received booster shot earlier that same day. Had palpitations in office and referred for cardiology consult for myocarditis. Elevated lab work includes elevated C reaction protein and elevated ESR.
Patient received Stem Cell Transplant; This spontaneous case was reported by a physician and describes the occurrence of STEM CELL TRANSPLANT (Patient received Stem Cell Transplant) in a 60-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced STEM CELL TRANSPLANT (Patient received Stem Cell Transplant). At the time of the report, STEM CELL TRANSPLANT (Patient received Stem Cell Transplant) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The reporter who was a Doctor was calling on behalf of a 60-year-old patient who received 2 doses of Moderna COVID-19 vaccine on unknown dates. The reporter stated that after the second dose of Moderna COVID-19 vaccine, the patient received Stem cell transplant on 01-APR-2021. According to the reporter, the CDC website recommends repeating both doses of Moderna COVID-19 vaccine after the stem cell transplant and the reporter instructed the patient to go ahead and repeat the doses. The patient two weeks ago, on 17-Nov-2021 went to the pharmacy and the pharmacist gave them a half dose booster instead of repeating the full dose.   This case was linked to MOD-2021-403158 (Patient Link).
dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 102-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 26-Mar-2021, the patient experienced DIZZINESS (dizziness). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at a dose of 2 pills. At the time of the report, DIZZINESS (dizziness) outcome was unknown.            Concomitant medications reported were, high blood pressure medication and others (unspecified) used for unknown indication.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up information contains no significant information.
2/25/2021 7am I got painful cramps in Right Calf that lasted about 10 minutes.  They subsided when I got out of bed and moved leg and walked 2/26/2021  6am I got painful cramps in Left Calf lasted about 10minutes.  They subsided when I got out of bed and moved leg and walked.
pt recv vax & devel an inj site rxn characterized by swelling, tenderness, & warmth;tx w/Depo Medrol & Zyrtec & recovered;
Pt experienced these symptoms 10-11 days post vax. Continued spread of maculopapular rash incl. palms of hands. Worsened wheezing (did respond to Atrovent Neb Tx). Poor oral intake by hx. Fevers now resolving. Mom states pt had anaphylaxis and measles.
Second Covid-19 vaccine caused her big reaction on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Second Covid-19 vaccine caused her big reaction on arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE REACTION (Second Covid-19 vaccine caused her big reaction on arm). At the time of the report, VACCINATION SITE REACTION (Second Covid-19 vaccine caused her big reaction on arm) had resolved.            Concomitant medication was not provided. Treatment medication information was not provided by the reporter. On unknown date, the patient experienced rinvoq not helping like it did in the beginning, COPD/lung issues that have gotten worse since starting rinvoq, second covid-19 vaccine caused big reaction on arm and joints hurt. On unknown dates, after third covid-19 vaccine felt like autoimmune flared and second covid-19 vaccine caused big reaction on arm resolved. In Oct 2021 she stopped Rinvoq at physicians direction. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-620784 (Patient Link).
Pt fainted, hit head on floor, near fainting x 2 15 minutes inbetween/ tingling in legs and arms.  Pt was feeling well enough to leave after ~55 minutes of vaccine being administered.  Pt declined need for paramedics but was referred to physician for f/u.  Patient did seek care at urgent care facility.  Per phone encounter, pt  is feeling better, saw physician and checked out ok, per MD, pt just had a fainting episode.
Td vaccine given 10/6/03 in left arm on morning of 10/8/03. Site noted to be red/warm and swollen. No induration. Symptoms did not start until at least 36-40 hours after vaccine given. Tx'd with ice and Benadryl.
Initial misuse report received from a healthcare professional on 29 May 2013. It was reported that ACTHIB component from PENTACEL was reconstituted with sterile water and administered to a patient (no information was provided regarding the patient) without the DTAP/IPV component. No adverse event was reported. Documents held by sender: none.
2 hrs p/vax given was taking nap mom checked on pt removed blanket felt warm appeared to be awake blank stare did not respond to verbal command, legs & arms kicking like was dreaming lasting 2-3mins; t103 oral;
Patient developed pain, swelling, and increased redness below site of injection that lasted greater than 72 hrs.
Patient developed red, swollen, raised rash on Tuesday 12/28/21, 2 weeks after her Varicella vaccine. Parent's presented to the Clinic for concerns. Patient is well appearing and has no other symptoms. Rash does not seem to bother patient. Doctor educated parents that "1-3 percent of patients who receive varicella vaccine develop a localized rash consisting of two to five lesions at the injection site, and another 3-5 percent develop a generalized varicella-like rash within one month of immunization. Most of the vesticular rashes that occur within the first two weeks after varicella immunization are caused by wild-type VZV. People with rash should refrain from physical contact with people who are susceptible.
12/24 I felt stuffy with runny nose and chest congestion. Attributed this to my usual allergies at first but by 12/26 it felt much worse. Got a Covid test PCR and was found positive. 12/27 Called to confirm if my medicines were sufficient for Covid. Was advised to quarantine for 10 days and plenty of rest and liquids. Did not go see a doc or get any other medical test or labs done. Feeling ok as of 01/18/2022.
Sore throat inside and out 12/22-1/1/22 Fatigue 12/23-1/5/22
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient waited at pharmacy for 15 minutes after vaccination, then left to go get coffee with her mother. At coffee shop, patient complained of feeling hot then passed out and her head hit the floor. She immediately regained consciousness. We elevated her feet and stayed with her and monitored her until paramedics came. Paramedics assessed and stated that all vitals were good. After sitting for a bit, patient left to go home with her mother. Per patient's mother she had not eaten today.
p/vax pt immediately fainted 30 sec; tonic clonic movement; then nausea; neg moro; resolution & episode not consistent w/ vasovagal episode
This is a spontaneous report from a non-contactable pharmacist. This pharmacist reported for 8 patients (students). Only 4 experienced an adverse event. This case refers to patient 4. A male patient of an unspecified age received TRUMENBA at single dose and BEXSERO, both via an unspecified route of administration on unknown date. The patient medical history and concomitant medications were not reported. The patient experienced severe myalgia so that he can't move his arm on an unspecified date with outcome of unknown. No follow-up attempt possible. No further information expected.
Approximately 15 min after received varicella vaccine, developed facial urticaria and generalized itching, anxiety sneezing, cough & wheezing. Received epinephrine IM BENADRYL and albuterol nebulizer resolved in 45 minutes.
Fever,  body aches,  chills starting 8 hours after 2nd dose resolved in 24 hours.   epigastric pain and spasms >24 hours after 2nd dose.  Resolved within 2 hours.
Flu shot resulted in severe elbow and shoulder pain. Now entire area is sore with poor range of motion. I have trouble lifting because of weakness. Bending my elbow causes jolts of pain.
PATIENT WAS GIVEN UNDILUTED DOSE (0.2 ML) OF PFIZER PEDIATRIC COVID 19 VACCINE.  PARENTS WERE CONTACTED AND NOTIFIED.  NO ADVERSE REACTIONS WERE NOTED AT THE TIME.  PARENTS WILL REPORT ANY PROBLEMS.
Day after injection: bump under skin at injection sight, soreness, tenderness and warm to touch   These lasted for 2-3 days  Over a week after injection: itching at injection sight, large rash on upper arm, warm to the touch. Rash is red around edges and white in the center.  Rash has not gone away yet.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 55-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; 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 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: TERIPARATIDE, start date: 06Jul2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid from 12Sep2023 to 17Sep2023, for the treatment of covid-19. No known allergies.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between  bnt162b2  and the reported events covid 19, drug ineffective cannot be excluded.
Information has been received from a 75 year old female with allergic to sulfa who was vaccinated with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot # not reported) for prevention of shingles about 4 days ago, on approximately 29-DEC-2008. Concomitant therapy included LIPITOR. On 02-JAN-2009 the patient experienced pain at injection site and had an upset stomach. "Routine labs" were performed. The patient was not recovered. Additional information has been requested.
Erythema and induration developing 1 day after varicella vaccine. Rx ibuprofen & diphenhydramine.
On that Friday, I had a fever and started shaking. I took my temperature the next morning, it was 100.7 and my normal temp is 97.7. I felt bad all day. I took some Tylenol, my temperature came down, I started feeling better and haven't had a temp since. Didn't seek treatment because I had already been warned about the side effects.
ACHY; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included asthma, and concurrent conditions included sulfonamide allergy, isocyanide allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. the patient had allergies of muscle and horseradish. The patient experienced drug allergy when treated with doxycycline.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-MAY-2021 12:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-MAY-2021, the subject experienced achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy. This report was non-serious.
t100.7ax, swollen rt thith won't bear weight;mild tenderness & 2-3cm lump beneath the prev inj site;poss abscess rt leg d/t vax;rt leg pain;pain @ inj site;t101, leg pain refused to walk on it
Got the two vaccines and broke out\ Suspected vaccination failure; Broke out worse than ever, terrible; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with melatonin. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported for reporter's husband. The age at vaccination was not reported. The reporter stated he got the two vaccines for shingles and has broken out worse than ever. The reporter stated that been said everyone was different, but he just had an absolutely terrible breakout last week of reporting date. The reporter went to the health food store and they told 5 mg melatonin and it has almost all healed up, worth a try and the patient was sleeping like a rock. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Erythema and induration surrounding site of administration. Cephalexin started 10/22 with minimal improvement. BACTRIM started 10/24 and by 10/26, nearly resolved. No fevers or systemic symptoms. Cellulitis.
nausea; lack of energy; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Apr2021 (Lot number: EW0161) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "PTSD" (ongoing), notes: On medications to manage PTSD, Onset date: 10 + years; "Anxiety" (ongoing), notes: Onset date: 10 + years. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, Time: 09:50, Anatomical site of Injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: ER8732), administration date: 04Apr2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "recovered", described as "nausea"; ASTHENIA (non-serious), outcome "recovered", described as "lack of energy"; PAIN (non-serious), outcome "recovered", described as "body aches".  Additional information: Vaccination facility type: Pharmacy or Drug Store. No vaccine administration at military facility. No Prior vaccinations within 4 weeks. No Relevant test done.   No follow-up attempts are possible. No further information is expected.
Patient came to the office the next day after getting her BEXSERO shot. She said her arm hurt, was warm to touch and she was aching all over. She also c/o dizziness, headache and itching.
first Shingrix injection on 13 SEP 2020 / second Shingrix injection on 12 OCT 2020; tired; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 93FR9, expiry date 29th April 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 12th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 12th October 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. In October 2020, the patient experienced tiredness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the tiredness and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were reported as follows: On 12th October 2020, the patient received the 2nd dose of Shingrix vaccine, shorter than the recommended schedule, which led to shorting of vaccination schedule. The pharmacist stated that the patient was tired. The reporter consented to follow up. For tolerance of 1st dose refer cases US2020AMR206754.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR206754:Same reporter
A report has been received from a Health Professional (Registered nurse) concerning a 22 year old, Female subject, who had been receiving Nasal FLUMIST (intranasal). The patient history included Pregnancy. FLUMIST (intranasal) started on 16-Sep-2013. Registered nurse reported that they gave inadvertently FLUMIST to a pregnant woman which started on 16-Sep-2013. Patient has not reported any symptoms. The outcome of the event of gave FLUMIST to a pregnant woman is unknown. The report was considered to be non-serious by the reporter.
Information has been received from a certified medical assistant referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On 10-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # L012036, expiry date: 07-APR-2017) (dose, strength and route were not reported). There was no concomitant medication reported. At the time of the report, no adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Employee states when she received the vaccination she knew something wasn't right.  Stating when shot went in, she immediately felt it go around her shoulder, the next couple of days the pain kept getting worse not better.  By the weekend she was unable to raise her arm up a few inches, arm movement since the day of shot has not improved.  Range of motion is very limited, continued pain radiating down her arm, feels like it locks up and the releases to allow arm to move.