chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 12Oct2021 (at the age of 83-year-old) as dose 3 (booster), single for covid-19 immunization; influenza vaccine (FLU VACCINE VII), via an unspecified route of administration administered in the right arm on 12Oct2021 (at the age of 83-year-old) (Batch/Lot number was not reported), at single for immunization. Medical history included Heart Surgery in 2003 (They told him he would only be good for 10 years but its been 18 years now and he was still good), Hernia Repair Surgery (He's an auto mechanic, He's had 4 in total. The last one was about 10 years ago.), Caller states that he needs to get his other glasses to see. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN (E.C.)); metoprolol (METOPROLOL), both taken for an unspecified indication, start and stop date were not reported; simvastatin (SIMVASTATIN) taken for blood cholesterol, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) dose 1 via an unspecified route of administration in the left arm on 10Feb2021 (Lot number: EL9262) (at the age of 83-year-old) as a single dose and dose 2 via an unspecified route of administration in the left arm on 02Mar2021 (Lot number: EN6201) (at the age of 83-year-old) as a single dose for covid-19 immunization. The patient mentioned that he received his third shot on 12Oct2021 at the same time with his flu vaccine. He had concerns. He got the vaccine on Tuesday (12Oct2021), then on Wednesday (13Oct2021) and Thursday (14Oct2021) his stomach was upset. Upset stomach was very very little now, on Wednesday or Thursday it's like he was trying to throw up but nothing would come out, he laid down, and it went away, it is not as bad as before. Now today (15Oct2021) he was dizzy. He was just a little dizzy, when standing up, he feels a little bit off. Dizzy did not start in the morning, actually he went out and did his work, and around 3PM (15.00) today he got up and was woozy dizzy, he was still the same way, he was dizzy but can still walk, everything was not the same. He had a little trouble walking. He was not sure if that's part of what the vaccine was supposed to do. He got both shots of the Pfizer covid vaccine and the Flu shot. He wanted to know if this was a normal wide effect, could he get dizziness a couple days after. Patient asked if there could be delay in onset of symptoms or side effects of the vaccine. The patient had bloodwork done a couple months ago and his liver and kidney looked good. Outcome of the event dizzy was not recovered, upset stomach, trying to throw up but nothing would come out was recovering; other events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Cough; breast was sore; nipple was red and hot; pain in the back; Hip was burning; not sleeping well; right upper thigh was hot and burning; couldn't get out of bed; could hardly walk - had to use cane; legs were hurting; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), BREAST PAIN (breast was sore), NIPPLE INFLAMMATION (nipple was red and hot), BACK PAIN (pain in the back) and BURNING SENSATION (Hip was burning) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Colon cancer (11 years ago), Oral infection in December 2020, Temporomandibular joint disorder in December 2020, Pain (teeth filling sore under tongue, gum aching) in December 2020 and Surgery. Concurrent medical conditions included Diabetes (type 2 diabetes) and Cancer (carcinoid cancer). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), METFORMIN, VITAMIN D3, CYANOCOBALAMIN (B12-VITAMIN) and LINAGLIPTIN (TRAJENTA) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (legs were hurting) and GAIT DISTURBANCE (could hardly walk - had to use cane). On an unknown date, the patient experienced COUGH (Cough), BREAST PAIN (breast was sore), NIPPLE INFLAMMATION (nipple was red and hot), BACK PAIN (pain in the back), BURNING SENSATION (Hip was burning), INSOMNIA (not sleeping well), FEELING HOT (right upper thigh was hot and burning) and ASTHENIA (couldn't get out of bed). The patient was treated with DICLOFENAC SODIUM (VOLTAREN EX) ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Cough), BREAST PAIN (breast was sore), NIPPLE INFLAMMATION (nipple was red and hot), BACK PAIN (pain in the back), BURNING SENSATION (Hip was burning), PAIN IN EXTREMITY (legs were hurting), INSOMNIA (not sleeping well), GAIT DISTURBANCE (could hardly walk - had to use cane), FEELING HOT (right upper thigh was hot and burning) and ASTHENIA (couldn't get out of bed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-038139 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non significant follow-up appended.
The pt had a reaction to pneumococcal vaccine. Left arm got red, hot and swollen for five days.
Swelling, redness on arm of injection. Soreness - severe - limited use of arm (left arm only).
ON 4-3-09 PATIENT WAS ADMINISTERED THE SMALLPOX VACCINE AS A REQUIRED PROPHYLACTIC BEFORE DEPLOYMENT WITH HIS UNIT. ON 4-27-09 PATIENT PRESENTED TO HEALTH CLINIC WITH MULTIPLE AREAS OF ERYTHEMATIC SORES ON HIS BACK, FRONT TORSO, UNDERARMS, GROIN, BILATERAL LEGS, AND BILATERAL ARMS. THESE SORES WERE RED, RING LIKE, RAISED ON THE OUTSIDE WITH PUSTULES. ORIGINAL SITE OF THE INOCULATION WAS STILL IN AN EARLY STAGE MEANING MOIST AND SEEPING WITH NO EVIDENT SCAB. PATIENT STATES THAT THE SORES STARTED TO DEVELOP APPROXIMATELY 1 WEEK AGO ON 4-20-09 AND PROGRESSED IN MULTIPLE STAGES DUE TO THE ITCHING AND HIM SCRATCHING AT THEM THINKING THEY WERE BUG BITES. NONE OF THE SORES SEEM TO HAVE ANY TYPE OF BACTERIAL INFECTION AND PATIENT WAS TREATED WITH ANTIHISTAMINES TO ALEVE THE ITCHING TO TRY AND FURTHER PREVENT SPREADING. PT WAS ISOLATED TO HIS ROOM FOR THE DURATION OF HIS UNIT'S DEPLOYMENT AND HAS BEEN INSTRUCTED TO COME INTO THE CLINIC ONCE A DAY FOR OBSERVATION AND FURTHER TREATMENT IF NEEDED. PATIENT WAS INSTRUCTED TO USE BABY POWDER AND CORN STARCH ON SORES TO HELP WITH DRYING AND HOUSING STAFF HAVE BEEN INSTRUCTED NOT TO CLEAN HIS ROOM OR CHANGE HIS SHEETS DURING HIS STAY. WHEN PATIENT CHECKS OUT OF HIS ROOM FOR HIS RETURN HOME ON 1MAY09,  MEDICAL PERSONNEL WHO HAVE BEEN INOCULATED WILL MEET HIM AT HIS ROOM AND CLEAN IT USING CAVICIDE AND BLEACH WATER. ALL BEDDING AND TOWELS WILL BE HANDLED AS MEDICAL WASTE AND BE DISPOSED OF AS HAZARDOUS BIOMEDICAL WASTE.
Ulcerative lesions scattered on the body and in the mouth, sore throat, dizziness and headaches.
It started at 3am uncontrollably violent chills, high fever of 104 degrees, extreme head aching, and hives.
Cellulitis upper limb (left), redness, swelling, very hot to touch. On Septra 200mg/5ml (1 1/2 tsp Bid X 10 days). Benadryl Syrup PRN. (Probably reaction to DTAP).
Day after injections patient described itching and tingling at injection site. Red and warm to touch. Dx. cellulitis-treated with KEFLEX 500 tid.
Child received Proquad and Varivax vaccines at same visit inadvertently. This resulted in child getting a double dose of Varicella vaccine  today.  Varivax and MMR were ordered. I called Merck and requested info on possible adverse events. Our office informed family of error.
Date and time adverse event started: fever first 101.6 on 2/18, chills on 2/19; 1800 282 3171 number provided  take apap 2 500mg or 3 325 mg. q 4 hours while high fever but not more than 4 000mg in 24 hour period.
One day later, his arm was swollen around about 4 inches where he received the vaccine. 2 days later it turned red with small bumps all over, he complained it was itchy.
Patient got second vaccine dose at 10 days.  did not report any adverse even.  Pharmacist discovered vaccine given early while reviewing system.
1st Shingrix shot in November 2022. 2nd Shingrix shot 2/18/23 at 3:30pm. Starting at 6:30am on 2/19/23 the following symptoms began: nausea, diarrhea, heartburn, dizziness/vertigo, headache, congestion, sneezing, severe exhaustion, malaise, muscle aches, severe/unrelenting chills, rash at the injection site, plus severe pain, redness, and swelling at the injection site. After 48 hours most of the above listed symptoms improved except for pain at the injection site. Then, on 2/22/23, the following symptoms started: severe chills returned, plus congestion, sore throat, sneezing,  several cold sores, and also the exhaustion returned. As of 02/23/23, 5 days after the 2nd dose, these symptoms are ongoing  plus continuing injection site pain. The pharmacy text told me NOTHING about these potential side effects.
Dtap left thigh 1:00 pm Act Hib left thigh. Returned 3-17-04 at 3pm- thigh swollen-general. Benadryl. Cool compresses. No streaking and no warmth. Returned 3-18-04 2pm edema down, no erythema, improved, no pint tenderness.
Very tired; nauseous; a little achy around the area; trouble with sinuses; diarrhea; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Very tired), NAUSEA (nauseous), VACCINATION SITE PAIN (a little achy around the area), SINUS DISORDER (trouble with sinuses) and DIARRHOEA (diarrhea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergies to dust/seasonal allergies). Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for ADHD, GLUCOSAMINE for Arthritic pains, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), VITAMIN D NOS, CINNAMOMUM CASSIA (CINNAMON [CINNAMOMUM CASSIA]), PROBIOTIC COMPLEX and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2020, the patient experienced DIARRHOEA (diarrhea). On 27-Jan-2021, the patient experienced SINUS DISORDER (trouble with sinuses). On 29-Jan-2021, the patient experienced FATIGUE (Very tired), NAUSEA (nauseous) and VACCINATION SITE PAIN (a little achy around the area). At the time of the report, FATIGUE (Very tired), NAUSEA (nauseous), VACCINATION SITE PAIN (a little achy around the area), SINUS DISORDER (trouble with sinuses) and DIARRHOEA (diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.
Hives after receiving H1N1 nasal vaccine BENADRYL given by parents no SOB.
08/22/2021 2nd Vaccination- Lymph nodes were swollen. A couple weeks later, experiencing tailbone Hurt during sports and the inflammation and pain is not going away like it should. It is questionable if it is autoimmune which is preventing it from healing properly. *scheduled for injection / they didn't say what kind; ganglion. Local hospital won't administer, looking into possibly of another location. *Fingers swelling up every time she goes out into the cold, even if just for a few minutes.
arm has just been sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm has just been sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00076190) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm has just been sore). At the time of the report, PAIN IN EXTREMITY (arm has just been sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.  Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Pt noted to have febrile sz x 2 min < 24 hr after vaccine admin.
Appx 8 hours after vaccination, pt had chest pain, back pain, Headache, Fatigue, chills. Lasted for appx 36 hours.
PSA INCREASED/CHEMICAL REOCCURRENCE; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: prostatectomy (in 2005). On 31-AUG-2020, Laboratory data included: PSA (prostate-specific antigen) test which resulted 06.  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 09-NOV-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date (after J and J Vaccine), the patient had prostate-specific antigen test which went to 0.29 and has risen ever since (Dose number in series 2). The patient underwent hormone therapy and radiation therapy at this time for chemical reoccurrence. Patient would like to inquire if there is any relationship between the vaccine and PSA which was risen (after 17 years). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from PSA (prostate-specific antigen) increased. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20221156381- PSA increased/ Chemical reoccurrence. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.
pt c/o mild, persistant h/a x 7-8 days & round, quarter size yellow spot @ inject site; sx noted approx 1 wk p/inject;
second dose of GARDASIL 9 past the 12 month recommendation in the PI.; No additional AE information available.; This spontaneous report was received from nurse prescriber and refers to an adolescent patient (exact age not reported) of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-MAY-2021, at the age of 11-year-old, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #T007024, expiration date: 23-APR-2022 (dose, route of administration and exact location were not provided) for prophylaxis.  The patient missed his 6 month follow-up. Next visit to receive a second dose was scheduled on 10-MAY-2022.This would be 1 year and 6 days from his first dose (Inappropriate schedule of product administration). No additional adverse event information (No adverse event).
Information has been received from a consumer concerning her son, a 12 year old male with allergies to penicillin and KEFLEX and with no medical history, who on 17-MAR-2009 was vaccinated with the second dose of VARIVAX (Merck), SQ, 0.5ml. There was no concomitant medication. On 18-MAR-2009 the patient developed a swelling "about the size of a dime". On 19-MAR-2009 the patient had a rash on his hand and the swelling was "the size of a golf ball." The reporter brought him to see the doctor and was told that it was just his body reacting to the vaccine. On 20-MAR-2009 the swelling "is about the size of the palm of my hand" and he still had the rash. The patient had no lab diagnostics study performed. At the time of the report the patient was not recovered. Additional information has been requested.
PT CALLED INTO THE OFFICE REPORTING THAT HER ARM IS RED, HOT, RAISED, FIFTY CENT PIECE IN SIZE, DENIES RED STREAKS OR FEVER, ADVISED TO TREAT WITH OTC MEDICATIONS , IF S/S CONTINUE TO SEE MEDICAL ATTENTION WITH HER PCP, AWARE, VERBALIZED UNDERSTANDING
Appoximately 25 minutes after patient recieved Rabavert, she stated her ears (bilaterally) felt hot, and that radiated to her jaws and cheeks.  When she swallowed she felt like something was in her throat.  She looked down and noted a rash on her right arm (this was the one the vaccine was given in).  These symptoms resolved within 30-45 minutes after they started without intervention.
This spontaneous report as received from a registered nurse refers to at least 3 patients of unknown age and gender. On 20-AUG-2014 and 21-AUG-2014, at least 3 patients were vaccinated with expired doses of M-M-R II lot # H014978, expiry date 09-AUG-2014, subcutaneous (dose not reported). No known adverse effects were reported. Additional information has been requested.
CHILD'S DOB WRITTEN INCORRECTLY  AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS MOTHER. CHILD IDENTIFIED IN DATABASE WITH A DIFFERENT DOB. CHILD TOO YOUNG FOR VACCINE IN 5/2021. VAERS TO FOLLOW FOR SECOND DOSE RECEIVED ON 6/16/2021.
Initial misuse report received from a healthcare professional on 29 July 2013. It was reported that, while administering DAPTACEL to a patient much of the vaccine ran down the arm as the needle might not have been on properly. No information was provided regarding the patients. No adverse event was reported. Documents held by sender: none.
Severe body aches beginning approx 18 hours after vaccine and lasting about 36 hours, fever for approx 48 hours (ranging from 99 to 102 after taking several doses of Acetaminophen), severe fatigue
Became lightheaded and clammy after Tdap vaccine administration.  Assisted to supine position with legs elevated x 45 minutes.  Assisted to sitting position.  Color pink, skin warm/dry.  Orange juice given after feeling better/sitting.  BP 108/50 HR 72 at time of discharge to home with parent.  States returned to feeling "normal" when leaving vaccine area.
I developed a headache, cough, fever, body aches, loss of sense of smell and taste. I did a COVID-19 test and it was positive. I called my doctor, and they prescribed me Paxlovid. I felt better after a couple of days of taking it. The cough lasted a couple of weeks along with my loss of sense and smell. The COVID-19 seemed to suppress the efficacy of my antidepressant medication like my body was reacting as if I stopped taking it.  I have no lingering side effects.
APPETITE LOST; SORE THROAT; ACHING JOINTS; MUSCLE PAIN; HEADACHE; INJECTION SITE PAIN; UNABLE TO SLEEP; ITCHY RASH; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-APR-2021 03:24 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced unable to sleep. On 09-APR-2021, the subject experienced itchy rash.  On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced fatigue. Laboratory data included: Fever (NR: not provided) 100 increase body temperature (units unspecified). On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced aching joints. On 10-APR-2021, the subject experienced muscle pain. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced injection site pain. On an unspecified date, the subject experienced appetite lost. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat, itchy rash, and fever, was recovering from muscle pain, headache, and injection site pain, had not recovered from fatigue, and the outcome of appetite lost, aching joints and unable to sleep was not reported. This report was non-serious.
Patient marked on her consent form she had not previously received a COVID vaccine. Her sister, who was present, remembered she already received a dose of Johnson & Johnson (Janssen) COVID vaccine; after she had already been vaccinated with Pfizer COVID vaccine. Patient received the J&J (Janssen) COVID vaccine at a detention center on 4/10/2021.
Pt was administered a COVID vaccine that had been drawn up for 7 hours. No adverse reaction noted. Mother was notified of mistake and encouraged to bring pt back to the office for repeat dose.
Pt. received 2 doses infant influenza vac. and 1 adult dose influenza vaccine at the same visit, in error. No known adverse reaction at this time.
Noticed a week later. At injection site and surrounding area round red raised/bump size of quarter hive looking , painful, warm - whole arm painful as well and underneath armpit . Otherwise no other on my body . ER doctor treating it for cellulitis prescribed antibiotics and Tylenol and discharge
Immediately after given GARDASIL, patient became pale, lightheaded, C/O dizziness, blurred vision, she was given water, laid down on exam table - BP 90/60. After 5 min. her color returned, felt nauseous. BP 100/70, she was observed another 20 minutes. No problems. I contacted Mom the next day - 4/18/17. She called office back on 4/19/17 - doing well on 4/19/17. Patient had a headache 4/18/17.
Initial report received from a consumer on 21 January 2014. A 61-year-old female patient had received an intradermal dose of FLUZONE ID, batch number and dose number were not reported) in the left arm on 16 January 2014. Patient is allergic to mycins, penicillin and has arthritis in her hands. Patient had no illness at the time of vaccination. On 17 January 2014, at 08:00 PM the patient developed a 4 inch long, 3 inch wide, oval, red rash, hot to touch, and a little itchy area on her left arm at the vaccination site. It was reported that the area had become lighter in color and had reduced in size.   Corrective treatments were not reported. Laboratory investigations were not done. The patient had not recovered from the events. Documents held by sender: none
pt had sore arm that limited use of arm for nearly a wk; this is being reported because 3 pts w/severe local reactions all from same bottle of DTP;