chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a health care professional on 31Aug05. An 11 year old male pt with a medical history of cephalosporin allergy, had received an injection of Decavac, lot number U1211BA, in the left arm and a dose of IPOL, lot number Y0298-2 in the right arm on 29Aug05 at 2:00PM. Twenty hrs later, he developed a facial rash and pruritus. The facial rash gradually spread to include the upper arms to the elbow area bilaterally. The pt also experienced nausea and vomiting. By 31Aug05, two days post immunization, the pt had generalized facial edema with more prominent eye lid edema. His mother also reported a fever of 100.5F. The pt was treated with steroids (40mg) and Allegra was prescribed. At the time of this report the pt had not recovered from these events.
On Feb 10, 2022 I was rushed to the hospital via ambulance and ultimately diagnosed with a stroke. Follow up with Neurologist highlighted I had a previous stroke 3 - 6 months prior to Feb 10 (as shown on my MRIs).  I have had significant testing and follows with doctors and they are unable to find a medical reason why I had the strokes.  I am 51yo.  Hematologist says it could be related to vaccines given time frames and all medical test results.
Pt devel high fever & vomiting 2 days p/vax; sx resolved w/in 48 hrs;
pt recv vax & devel an inj site welt & fever;the reporter felt that this exp was r/t therapy w/varicella vax;
This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site rash and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site rash and injection site itching were unknown. It was unknown if the reporter considered the injection site swelling, injection site rash and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and developed swelling and a rash directly under the injection site. Swelling and rash developed approximately two days after the dose was given. The healthcare professional described rash as itchy. The healthcare professional did not have date of vaccination, lot number and expiration date to provide.
Joint ache/pain. Almost every joint in my body ached/hurt. Each knuckle in my fingers, arms, lets, backbone/vertebrae. I was also extremely tired. I slept most of the day and then all night. I took Tylenol for the pain which seemed to help. I was perfectly fine the following day. Vaccine at 9:15 am. Tiredness noted in later afternoon. Joints hurting by 10pm. Slept most of next day and took Tylenol. Woke up the following day and was fine. Symptoms lasted roughly 24 hours.
Narrative:  He relates having experienced nausea that started while he was driving home from the initial vaccination. When he got home, he took a zofran (already had on-hand) and ate lunch. The nausea lasted for about 30 minutes. He denied other common adverse effects including vomiting, diarrhea, and abdominal cramping. He was able to tolerate lunch w/o any issues.
Received 2nd dose Sunday 3rd. Monday was extremely fatigued with muscle aches, headache, and injection site redness, pain, swelling, and itching developed on arm where vaccine was administered. Tuesday 1/05 fatigue improved however rash started to develop in right arm. Took Zyrtec and rash improved. Last reported a new rash developed improved on right and left thighs that is painful. Medications taken this time were Benadryl.
The ringing in ear enhanced a little bit/it had intensified after receiving the 2nd booster; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (The ringing in ear enhanced a little bit/it had intensified after receiving the 2nd booster) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 017E21A, 013M20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 08-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced TINNITUS (The ringing in ear enhanced a little bit/it had intensified after receiving the 2nd booster). At the time of the report, TINNITUS (The ringing in ear enhanced a little bit/it had intensified after receiving the 2nd booster) had not resolved.            No concomitant medications were reported. Patient did not had COVID positive test or diagnosis. Patient had no other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient told that the tinnitus has continued, in fact gotten worsened.Patient was very sure that the booster dose have some link with tinnitus. No treatment information was provided.   This case was linked to MOD-2022-645094 (Patient Link).
Pt called, reported: May 4 Pneumococcal vaccine left arm - developed one hive near injection site. Within one hr dev chest, throat and nasal congestion. Did not seek medical attention as he stated it was not life threatening. Sx persisted for a couple of hrs. That pm he developed a migraine with pain behind eyes and base of skull. No n/v, + photosensitivity. Pain eased in morning but worsened throughout the day. No medical attention for headaches. He took VICODIN that he had left over from his surgery. He reported a generalized worsening of his allergy sx. He used his albuterol inhaler but noticed no results. Headaches subsided within one week.
pretty bad side effects; chest was hurting so bad; complete body aches; just hurting; in bed could barely walk; This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE REACTION (pretty bad side effects), CHEST PAIN (chest was hurting so bad), MYALGIA (complete body aches), PAIN (just hurting) and GAIT DISTURBANCE (in bed could barely walk) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced ADVERSE REACTION (pretty bad side effects), CHEST PAIN (chest was hurting so bad), MYALGIA (complete body aches), PAIN (just hurting) and GAIT DISTURBANCE (in bed could barely walk). At the time of the report, ADVERSE REACTION (pretty bad side effects), CHEST PAIN (chest was hurting so bad), MYALGIA (complete body aches), PAIN (just hurting) and GAIT DISTURBANCE (in bed could barely walk) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications listed.
Some general malaise expected after vaccine, but is a runner and began to notice floaters before his eyes, lights when running, and within 2 days of vaccine developed a very uncomfortable, pain in the whole pelvic region. Went to PMD who did U/A C/S and subscribed 2 subsequent rounds of Bactrim DS, as the first (and the second had no effect.) Eventually sent to urologist who prescribed PT and the pain finally disappeared 6 months later. However, in this time he also noted abdominal swelling, weight gain of 25 #, SOB he attributed to anxiety, fatigue, and decrease in ability to run. Toward December he developed lung congestion with pink frothy sputum, was diagnosed with pneumonia, placed on Augmentin which did not help, and was brought to ED on Jan. 1, 2022 and eventually diagnosed with pulmonary edema and heart failure with a pleural effusion of 1 liter. (No pneumonia).
Fever 104 degrees. Rash- Flat red dots on back and chest this AM 6-7 raised bumps on back red with white center 5 legs red and swollen. Fussy. Won't walk but can walk.
Information has been received from a consumer concerning her 22 year old daughter, with no known drug reaction/allergies and no pertinent medical history, who on 26-AUG-2008, was vaccinated with the first of GARDASIL and on unspecified dates, was vaccinated with the second dose and third dose of GARDASIL.  There was no concomitant medication.  The reporter stated that her daughter started having side effects after getting the second dose of the GARDASIL vaccine.  On 19-FEB-2009, the patient experienced nausea, rash at the injection site, abdominal pain, vomiting, muscle pain, weakness and complained of she felt sick all the time.  The consumer stated that "she did seek medical attention and they keep telling it is a stomach virus".  At the time of the report, the patient had not recovered.  Additional information has been requested.  3/23/09 Received vaccine & PCP medical records of 12/4/08-2/24/2009. FINAL DX: none provided Records reveal patient experienced cold s/s of cough, fatigue, fever, nasal congestion, sore throat & wheezing on 12/4 & had sick family member. Dx w/acute nasopharyngitis & cerumen impaction.  RTC 2/19/09 for routine GYN exam & HPV #2.  RTC 2/20 w/colicky abdominal pain x 1 day.  Exam revealed lower abdominal/pelvic pain thought to be premenstrual as due for depoprovera following wk.  RTC 2/24 w/continued abdominal pain.  No further records available.  3/23/09 Link w/342211.
Redness, hardness, warmth, itching at shot site in left arm. Tender to the touch.  All occurred a week after vaccine.
Local soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Local soreness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Hypothyroidism and Drug allergy ((Percutaneous nephrostomy)PCN- pain medication). Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) from 02-Jan-2012 to an unknown date for Depression, THYROID for Hypothyroidism.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PAIN (Local soreness). At the time of the report, VACCINATION SITE PAIN (Local soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medications was not reported.   This case was linked to MOD-2021-363399, MOD-2021-305281 (Patient Link).
Tiredness (2 days), shivering (1 night), fever (101.6 for one day), stomach pain (2 days), nausea (2 days), cellulitus below the injection site (ongoing).
This spontaneous report was received from a nurse and refers to a 1 year old patient of unknown gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 09-SEP-2016, the patient was vaccinated with 0.5 ml dose of PROQUAD (lot # L019997, expiration date: 02-DEC-2016) that was improperly stored (temperature: 44F, time frame: 5427 hours). No adverse effects were reported. Additional information has been requested.
Tenderness and 3.5 to 4 cm round moderate erythema with pain present.  Looks indicative a localized hypersensitivity reaction that has last for 11 days.  Shortness of breath and Headache is also reported and still persist 11 days after vaccine administration.
big red spot; swollen; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (big red spot), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PRURITUS (itchy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (big red spot), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE ERYTHEMA (big red spot), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PRURITUS (itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment included triamcinolone acetonide cream   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: TCR received
On 11/04/2022 Patient was administered a booster dose that had a BUD of 11/02/2022.  Patient had no reports of adverse events.  Moderna was notified and stated the dose administered maintained the activity necessary to provide protection.
Received pneumo vaccine from medical clinic, lot 0885 F, Exp 11/18/08 called office with complain of left deltoid pain. Seen in office.
face felt flushed, achy body, and mild discharge from the nose 1 day after vaccination
Information has been received from a physician concerning a few patients who were vaccinated with Gardasil and fainted. The patients had received other vaccines (unspecified) that day. There were no other problems after they fainted, no hospitalizations. Since the label updated to wait 15 minutes after administration they have been waiting 15-20 minutes. Additional information has been requested.
Swelling, redness, pain, tenderness, warm to the touch for 2 weeks
This spontaneous report as received from a medical assistant refers to two patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date GARDASIL (lot # K007264, expiration date: 03-FEB-2017) was improperly exposed to 8.3 Celsius for 9 days. Then, on an unspecified date, the patients were vaccinated with a dose of GARDASIL (lot # K007264, expiration date: 03-FEB-2017) (dose, frequency and route were not reported). No known adverse effects were reported. No concomitant therapies were reported. Additional information has been requested.
Body hurts; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 19th October 2022, the patient received the 2nd dose of Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient just got his/her second shot yesterday (on the day before reporting) and the only side effects he/she had body hurts. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Lupus flare up; Lupus flare up.; Nauseous; Pain on the right arm / muscular pain and it could be for the injection site; Swelling; This spontaneous case was reported by a patient and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lupus-like syndrome. Concomitant products included RANITIDINE HYDROCHLORIDE (ZANTAC).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced SWELLING (Swelling) and VACCINATION SITE PAIN (Pain on the right arm / muscular pain and it could be for the injection site). On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) (seriousness criterion medically significant), CONDITION AGGRAVATED (Lupus flare up.) and NAUSEA (Nauseous). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up), CONDITION AGGRAVATED (Lupus flare up.), SWELLING (Swelling), NAUSEA (Nauseous) and VACCINATION SITE PAIN (Pain on the right arm / muscular pain and it could be for the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Serious Event added; Sender'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.
almost had COVID; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE (almost had COVID) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYMPTOM RECURRENCE (almost had COVID). At the time of the report, SYMPTOM RECURRENCE (almost had COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.   Reporter did not allow further contact
Extreme fatigue, fever of 101.3 (on and off for two days,) mild diarrhea, huge  red bullseye at injection site (4in. diameter) malaise, overly hungry.
Initial and follow up information has been received from a healthcare professional (HCP), concerning a female patient (age not specified), who was vaccinated on an unknown date with a dose of Gardasil.  As the vaccine administrator gave the injection, the "prefilled Gardasil syringe misfired when the spring malfunctioned, leaking the Gardasil fluid."  The reporter felt that the patient may have received an incomplete dose of the vaccine.  Follow up information from the HCP indicated that the patient's mother had called the doctor's office to report that her daughter "had bleeding from the injection site for the entire day of vaccination."  The HCP stated that the staff was not aware of any bleeding when the patient left the office on the day of vaccination, and did not feel it was related to the prefilled syringe.  The patient sought unspecified medical attention.  This report involved a product quality complaint (SR 1-980720378).  Additional information has been requested.
On 1/6/01, pt complained of soreness, pruritus and erythema the size of 50 cents at 10:00 AM, Saturday, left deltoid area. On 1/8/01, Monday, mother noted bruise on left deltoid 1"-2" in diameter and still complaining of pruritus. Pt complained of discomfort for 1 1/2 weeks. No treatment or medicines given. On 1/18/01, area of left deltoid, remains slightly bruised and discolored.
This spontaneous report was received from a physician's assistant regarding to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On 27-JUN-2018, the patient was vaccinated with first dose of GARDASIL 9 (dose, frequency, lot# and indication were unknown) via intramuscular route for prophylaxis and subsequently the patient received GARDASIL 9 second dose on 29-AUG-2018, third dose on 06-FEB-2019 and fourth dose (extra dose administered) on 18-APR-2019. No known adverse effects (no adverse event) were reported. No product quality complaint involved.
Patient received a flu shot & pneumonia shot. The arm where the pneumonia shot was administered was red & swollen. Patient said it was very uncomfortable.
Experienced chills and a temperature; Experienced chills and a temperature; This is a spontaneous report from a contactable consumer.  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unknown date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: unknown), dose 1 via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that on an unspecified date, she took the second dose of the Pfizer BioNTech COVID-19 vaccine yesterday and last night experienced chills and a temperature. She inquired and would like to know if there are any other people who took the second dose of the Pfizer BioNTech COVID-19 vaccine and reported a fever afterwards. Therapeutic measures were taken as a result of events and patient already took two Tylenol. The outcome of events was unknown.  Information about lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Within 2 minutes of vaccination, child felt ill, was hot to touch, and needed to sit, was hot to the touch; he turned pale, then he turned rigid, his eyes rolled back in head and he became nonresponsive, and he stopped breathing and was red and unconscious. His rigid body was placed on the floor and b/c he was not breathing on his own, rescue breathing was administered.  The child came back with a gasp and opened his eyes on about the third rescue breath.  He was taken by ambulance to the ER and observed.  The parent was told that this was syncope/fainting, which the parent disagreed with.  The doctor asked why and the parent explained that the child had once in his life fainted and was limp and breathing, but that this was a seizure because of the eyes, rigidity (including jaws), and lack of breathing. Rather than accept that this was a post- flu vaccine seizure as has been documented with other children, the doctor said that syncope can mimic a seizure.  A check of the CDC website confirmed 4 reported cases last year of post- flu vaccine seizures, most which were a quick recovery within 2 minutes.
SORE ARM,  BIG RED SPOT SOUGHT CARE FROM DERMOTOLIOGIST
After the first and second dose I was exhausted for a week straight each time.  Felt fluish and general malaise. The month after receiving the second dose I started coughing wet/dry.  It would not stop.  I felt very run down and had a hard time taking a full inhale of breath.  My oxygen levels were normal though.  I saw a pulmonologist who after sending me to get a Chest XRAy, PET scan that my lungs were peppered with fibroids.  My lymph nodes were entirely active in all parts of my body.  I have been feeling generally sick and very weak over all for months.  Lots of pain in my back and front where my lungs are located.    I've had a hard time working or standing for any long period of time.  My last xray at the beginning of 2020 and was completely clear.  My doctor recently put me on Hydroxychloroquine.  My doctors seem to be at a loss.  I think there is a distinct probability that I have been having adverse reactions.
After 10 days or so, "Covid-Arm, swelling, hot, and sore arm to touch.  Arm ached.  Heart fluttered, heart pounded.  Right Leg went numb for several minutes.  Right hip joint hurt so badly, I limped for 2 days.  Happened over 24 hour period.  Recovered as far as I know at the present moment.