chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hospitalized for 7 days with DRESS syndrome; This spontaneous case was reported by a consumer and describes the occurrence of DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (hospitalized for 7 days with DRESS syndrome) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (hospitalized for 7 days with DRESS syndrome) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 7 days due to DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS. At the time of the report, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (hospitalized for 7 days with DRESS syndrome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
The patient called at 8:55pm on 1/15/19 and says that her arm is very sore and that she feels tingling in her fingers. I told her to try taking some ibuprofen and ice the sore area and to call her doctor in the morning. I called the patient at about 6 PM to see how she was. She said that she didn't want to call her doctor. She also said that it hurt to put on her coat. She says that the numbness/tingling in her hands is gone but the arm still hurts when she moves it. Once again I told her to try ice and ibuprofen and to call her doctor.
5/21/18 in the morning patient began to notice redness and a lump at injection site. The redness had spread on 5/22/18 so patient circled red area. On 5/23 the redness had definitely spread beyond previously noted area, patient had a slight fever and felt fatigued. Patient went to Urgent Care and was subsequently prescribed Cephalexin 500mg for a 7 day course.
Skin-small papules scattered on face and body (approx. 2 dozen); some are scabbed. Present for four days; still breaking out.
Pruritic rash - macular raised and nasal congestion within 24 hours after receiving immunizations worsening of symptoms over weekend. Given 25mg Benadryl IM on 12/9/02. To continue 25mg Benadryl po BID x 5d.
Upper arm became very sore and later became red, hard, and hot to the touch, Redness spread to armpit. Had a fever of 100 degrees F for 2 days, Soreness lasted 6 days.
only received the first dose of Engerix-b which was administrated on July 8 2022; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 46-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 08th July 2022, with batch number-n4ga4 and expiry date - 02nd January 2023).   On an unknown date, the patient did not receive the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-Oct-2022 Reporter's comment: The nurse reported that the patient was late for the second dose of Engerix-B.  There was no adverse event reported. The consent to follow-up was granted. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Engerix-B, which led to incomplete course of vaccination.
pain at the injection site; Temperature elevation; fever; fatigue; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 4-day-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   On 05-OCT-2023, the patient received the 1st dose of Arexvy (left arm), Flu vaccine and COVID 19 VACCINE. On 06-OCT-2023, 1 days after receiving Arexvy and Flu vaccine, the patient experienced injection site pain (Verbatim: pain at the injection site), temperature elevation (Verbatim: Temperature elevation), fever (Verbatim: fever) and fatigue (Verbatim: fatigue). The outcome of the injection site pain and fatigue were not reported and the outcome of the temperature elevation and fever were resolved.   It was unknown if the reporter considered the injection site pain, temperature elevation, fever and fatigue to be related to Arexvy and Flu vaccine.     It was unknown if the company considered the injection site pain, temperature elevation, fever and fatigue to be related to Arexvy and Flu vaccine.   Additional Information: GSK Receipt Date: 6-OCT-2023 The reporter stated that the patient received the COVID, RSV and Flu vaccines at the same time and woke up the next morning with pain at the injection site.   Later that day she had a fever and fatigue.
Took 1st Typhoid cap appropriately --> 6 hrs. later had dizziness, light-headed followed by nausea and vomiting assoc. with movement. Hx of 2 episodes vertigo in the past. This episode passed and cleared at 24 degrees - Pt. Dc'd oral Typhoid and was switched to injectable.
My reaction to the vaccine is the same way I felt when I had Covid back in December but with a new symptom. I am experiencing bad head aches, severe body aches, fever, nauseous,. This time with the vaccine I'm having severe spasms on my leg, arms and back  to the point that I can't even touch it . I feel worse than I did when I was going through Covid.  This is my 2nd day and I'm still feeling terrible.
On the 27th and 28th I felt kind of tired and slept a lot. The next week I was fine. Around 6/16, I saw what I thought was a mosquito or spider bite. It was just an itchy red bump, so I didn?t pay much attention to it. By the 6/21, the hives started coming up a little. On 6/26, it got bigger, and it was spreading on my back. I went into the ER thinking it was a spider bite. They took a look and diagnosed me with shingles. I was given gabapentin and an anti-viral. I had a bad reaction to the gabapentin, so I took it once and stopped. The antiviral is done, and the rash has crusted over and came off. I still have pain on my left side that I have ever experienced before. I am following up with my doctor regarding this.
No additional AEs reported.; Nurse reports the administration of VARIVAX via intramuscularly versus subcutaneously. No additional AEs reported. No PQCs reported. No further details provided.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 03-AUG-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection 0.5 ml, lot # W011625 confirmed to be valid with expiration date: 06-APR-2024,  intramuscularly instead of subcutaneously (incorrect route of product administration), for prophylaxis. There was no additional adverse event reported.
Pt. was diagnosed with influenza at UC. Vomiting, diarrhea, fever up to 106.
back ache; felt like I had the flu; felt like I was going to pass out; weird feeling; out of body experience; hands feel weird as if they did not belong to me; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (back ache), FEELING ABNORMAL (felt like I had the flu), PRESYNCOPE (felt like I was going to pass out), FEELING ABNORMAL (weird feeling) and AUTOSCOPY (out of body experience) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M-20A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced BACK PAIN (back ache), FEELING ABNORMAL (felt like I had the flu), PRESYNCOPE (felt like I was going to pass out), FEELING ABNORMAL (weird feeling), AUTOSCOPY (out of body experience) and HAND DEFORMITY (hands feel weird as if they did not belong to me). At the time of the report, BACK PAIN (back ache), FEELING ABNORMAL (felt like I had the flu), PRESYNCOPE (felt like I was going to pass out), FEELING ABNORMAL (weird feeling), AUTOSCOPY (out of body experience) and HAND DEFORMITY (hands feel weird as if they did not belong to me) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant and treatment details were not provided.   This case was linked to MOD-2021-034856 (Patient Link).
Large hives on left arm below  injection area, low grade fever 99.4, mild body aches, tiredness
I can't straighten my arm; my elbow hurts a lot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (I can't straighten my arm) and ARTHRALGIA (my elbow hurts a lot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOVEMENT DISORDER (I can't straighten my arm) and ARTHRALGIA (my elbow hurts a lot). At the time of the report, MOVEMENT DISORDER (I can't straighten my arm) and ARTHRALGIA (my elbow hurts a lot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided No treatment medication provided   This case was linked to MOD-2021-303250 (Patient Link).
Two days after my first shot I began to experience heavy bleeding. My period completed the Thursday before, so this was a 4 day gap (with no bleeding). I am a healthy mother of 3 with very regular periods, so this was extremely unusual. I also experienced cramping, fatigue and a taste of iron in my mouth.
Diffuse bilat arthralgias in extremities, beginning in wrists, fingers and eventually involving ankles and knees. Also c/o subjectively of swelling in joints.   Symptoms began within 7-10 days of first Anthrax vaccination and worsened significantly within 2-3 days of second vaccination of Anthrax.  Now that patient is 3 months after his second anthrax, symptoms are gradually improving.
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 30-APR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
13 year old female received#2 Pfizer vaccine and within 5-10 minutes after her vaccine she was sitting in post observation with her father when one of our employees called over to me that she was fainting. I ran over to the girl and she had passed out-she was sitting in the chair and did not fall. She was breathing with a pulse of 77- her color was pasty and she was not responding verbally. She was very limp and did not awake after multiple attempts with  ammonia inhalant, calling her name and rubbing her chest. 911 was called immediately and female was transported to  Hospital within in 20 minutes of incident.  I spoke with her stepmom and she informed me that she was sleeping now and is doing ok.   They did blood work at the hospital and did not find any issues. Step mom states it took 1 1/2 hours for her color to return. She did tell me that stepdaughter has had syncope issues before and is on antidepressant med that may have caused this. We were not aware of this during time of vaccination.
Information has been received from a physician concerning a 13 year old female patient with no pertinent medical history or allergies, who on 18-JUN-2010 was vaccinated with the first dose of GARDASIL (Lot # unknown, route and dose not reported). There was no concomitant medication. The physician stated that the patient's father reported that the next day after receiving the vaccine, on 18-JUN-2010, she developed headache, nausea and dizziness. No fever, rash or swelling were seen. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Follow up information was received from a physician who indicated that the patient with no illness at the time of vaccination and no pre-existing allergies or medical conditions on 17-JUN-2010 at 11:00 a.m. was vaccinated with a first dose of GARDASIL (lot# 663453/0249Y) in her right deltoid. On 18-JUN-2010 the patient experienced nausea and dizziness for a few days. On 21-JUN-2010 the patient recovered. No laboratory or diagnostic tests were performed. Additional information is not expected.
have Covid disease after 5 Pfizer immunization shots; have Covid disease after 5 Pfizer immunization shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and on 17Nov2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications.No other vaccine in four weeks or other medications in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Feb2023 at 12:00, outcome "recovering" and all described as "have Covid disease after 5 Pfizer immunization shots". The event "have covid disease after 5 pfizer immunization shots" required physician office visit. Physician medical provider prescribed Paxlovid.The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300070780 Same reporter /drug/event ,different patient;
Dizziness, pain in right arm at immunization sight, pain in right groin, all in pain, swelling at inj. site, fatigue, mild fever, chills.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot#L026602, expiration date 19-OCT-2017; lot#M024261, expiration date 30-JUL-2018; lot#M033583, expiration date 14-APR-2019; lot#N000326, expiration date 14-OCT-2019) (dosage and route were not reported) for prophylaxis. No adverse effect was reported. The vaccine was stored at a temperature excursion of 9 Celsius to 25 Celsius for 1 hour 18 minutes and 0 Celsius to 1 Celsius for 75 hours. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA008381: US-009507513-1709USA003596: US-009507513-1709USA003594.
COVID 19; 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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2021 as dose 2, single (Lot number: EN6207, EW0161) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sufla meds"; "Known allergies: latex". The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with nirmatrelvir;ritonavir (PAXLOVID).  No follow-up attempts are possible. No further information is expected.
sweats; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats) 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 17-Feb-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 an unknown date, the patient experienced HYPERHIDROSIS (sweats). At the time of the report, HYPERHIDROSIS (sweats) outcome was unknown.            The patient reported that she had temperature and sweats following her first dose of vaccine. Concomitant and treatment details were not reported.   This case was linked to MOD-2021-034865, MOD-2021-034850 (Patient Link).
I have had many shots and am familiar with "sore arm" sometimes afterwards. This was a total surprise. About 4 hrs. after the shot my arm was extremely sore and by 6pm I had only about 10% range of  motion (front, back, side). The pain was significant if I moved my arm at all, interfered with sleep that night. Saw MD next day and was prescribed MOBIC. Symptoms gradually resolved after 3 days and were gone by 6 days. My arm was not hot or swollen. I have NEVER experienced pain like this from any kind of shot in my arm. It was very unusual thought you should know.
has a hx of Rheumatoid Arthritis and takes gabapentin and Relafan. She states she is immunocompromised. She received her second dose of COVID-19 vaccine on 1/7/2021 without adverse events. on 3/23/21 she developed signs and symptoms of COVID-19 and tested positive for the virus on 3/26/21; she reported the following symptoms: headache, chills, nausea, diarrhea, congestion, SOB, myalgia, and malaise. She was treated with Bamlanivimab infusion on 3/29/21.
subsequently had rash, fever, polyuria, vocal hoarseness beginning day after Shingrix
Flu-like symptoms; 2 lumps in the cheeks; Fever; This spontaneous case was reported by a non-health professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), SKIN MASS (2 lumps in the cheeks) and PYREXIA (Fever) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Restyalne Lyft (Patient received Restyalne Lyft on 17-Nov-2020 evenly distributed over cheek areas) on 17-Nov-2020. Concurrent medical conditions included Thyroid disorder. Concomitant products included SPIRONOLACTONE and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and SKIN MASS (2 lumps in the cheeks). February 2021, the patient experienced PYREXIA (Fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PYREXIA (Fever) had resolved and SKIN MASS (2 lumps in the cheeks) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     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.   Concomitant medications also included thyroid medications.   Treatment information was not provided.
No adverse symptoms; the patient was vaccinated with expired PNEUMOVAX 23; This spontaneous report as received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-OCT-2019, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R012713, expiration date: 03-AUG-2019 (dose and route of administration were not provided) for prophylaxis. No adverse symptoms were reported.
Information has been received from a register nurse concerning a 6 year old male who on 20 June 2002, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot # 638498/1906K). On 31 January 2006, the patient developed a rash formulation like chickenpox, but he never developed a blister. The patient had a mild case of less than 20 lesions. Symptoms were treated. Unspecified medical attention was sought. No additional information was provided. There was no product quality complaint. Additional information has been requested.