chrisvoncsefalvay/vaers-outcomes huggingface dataset:
22MAY11 Swelling at vaccine site (left deltoid) and tenderness. No fever, chills. Robaxin 500mg tab taken for muscle pain. 23MAY11 Increased swelling and erythema, 7cm diameter noted. Clindamycin 300mg every 6 hours initiated.
No adverse event or outcomes. Child was under age for vaccine received. Incorrect birthdate information given by parent. A 2016 birth year was included on registration information instead of the 2017 actual birth year. Spoke with father this morning (3/03/2022), child had no adverse or unexpected reactions or outcome from receiving the vaccine at an earlier than authorized age. Child is healthy and happy at this time.
(Arm) had a pretty big  bruise (at injection site) for 5 to 6 weeks; Arm was red (at injection site) for 5 to 6 weeks; I decided not to get second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING ((Arm) had a pretty big  bruise (at injection site) for 5 to 6 weeks), VACCINATION SITE ERYTHEMA (Arm was red (at injection site) for 5 to 6 weeks) and PRODUCT DOSE OMISSION ISSUE (I decided not to get second dose) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING ((Arm) had a pretty big  bruise (at injection site) for 5 to 6 weeks), VACCINATION SITE ERYTHEMA (Arm was red (at injection site) for 5 to 6 weeks) and PRODUCT DOSE OMISSION ISSUE (I decided not to get second dose). At the time of the report, VACCINATION SITE BRUISING ((Arm) had a pretty big  bruise (at injection site) for 5 to 6 weeks), VACCINATION SITE ERYTHEMA (Arm was red (at injection site) for 5 to 6 weeks) and PRODUCT DOSE OMISSION ISSUE (I decided not to get second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant history was not reported. The treatment history was not provided.
Head ache and sharp shooting pains in head neck  and jaw  every day since vaccine only on left side of head  comes and goes all day.  No relief from otc pain meds
none, patient was given 0.3 mL of Moderna booster instead of 0.25 mL
I experienced severe Tinnitus approximately two weeks after receiving the 2nd dosage of the vaccine (breaking glass and other noises in my ears) but did not go to the doctor for the symptoms.
Patient developed jerking movements of arms the evening following administration of vaccine and the jerking episodes persisted at least 5 days.  Also with excessive inconsolable crying following immunization > 3 hours.
pt recv vax & noted tenderness in arm 25OCT96;called MD office 5NOV96 stating arm is still sore & it's worse when rase arm;no bump, reddness, no warmth;states soreness worse w/movement;cont to c/o soreness not improved;
ill; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill) and FATIGUE (fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K2A) for COVID-19 vaccination.     No medical history was not provided by reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and COLECALCIFEROL (VITAMIN D3 1000) for an unknown indication.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced ILLNESS (ill) and FATIGUE (fatigue). On 31-Jan-2021, ILLNESS (ill) and FATIGUE (fatigue) had resolved.            Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.; Sender's Comments:  SE-MODERNATX, INC.-MOD-2021-114754:
Behavioral changes the evening of the shot & next day. Very talkative and talking manicly. He became angry easily, hyperactive. Symptoms lasted 24 hrs.
inflammation & pain have been going on for five months now; inflammation & pain have been going on for five months now; I am not able to walk or grasp items with my hands. I cannot care for myself.; I am not able to walk or grasp items with my hands. I cannot care for myself.; I cannot care for myself.; This is a spontaneous report from a Pfizer sponsored program Pfizer via a contactable consumer (patient, self-reported). A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she needed someone to contact her regarding treatment/reversal to her immune systems over reaction to the mRNA from the Covid Vaccine. On an unspecified date, the patient had inflammation and pain have been going on for five months now. She has been to the ER twice now. Her PCP has not been able to help. She was referred to a rheumatologist who has not been able to help her since she did not have RA. She could not take any more steroids because they were damaging her body. She was not able to walk or grasp items with her hands. She could not care for herself. There was no Product quality complaint (PQC) present. Outcome of the event inflammation and pain have been going on for five months now was not recovered and for all other events, it was unknown.
One hour after vaccine, patient had a generalized tonic clonic seizure. Forehead temperature prior to seizure was 100.3F. Patient had received acetaminophen 15 mins prior to seizure and has a history of one previous febrile seizure. Post-ictal for 15 mins and returned to baseline. Patient given ibuprofen and acetaminophen around the clock for 24 hours and was on amoxicillin for otitis media. On 12/8/2022, PCP re-evaluated and said otitis improving, no other source of infection. That evening, patient developed nonspecific rash. On 12/9/2022, patient had developed diffuse papular and macular erythematous rash and evaluated in ED. Given steroids and started Zytrec. Amoxicillin discontinued. Rash progressed to edema and swelling of legs/knees, worsening rash and lesions. Saturday 12/10/2022 rash progressed to ecchymotic abdominal lesions and abdominal distention. Returned to ED and admitted 12/10/2022. Diagnosed with erythema multiforme minor. Given hydroxyzine and topical steroids. Discharged 12/11. Swelling progressed to hands on 12/12/2022. Dermatology follow up on 12/13/2022 concern for acute hemorrhagic edema of infancy. Labs and UA performed; occult stool ordered 12/14/2022 due to anemia. Rash improving and resolving, returning to baseline. Occult stool positive 12/16/2022. Dermatology follow up 12/16/2022 with tentative final diagnosis of acute hemorrhagic edema of infancy.
It was just a few small red blotches; A rash started on my front torso; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (It was just a few small red blotches) and RASH (A rash started on my front torso) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced RASH MACULAR (It was just a few small red blotches) (seriousness criterion medically significant) and RASH (A rash started on my front torso) (seriousness criterion medically significant). At the time of the report, RASH MACULAR (It was just a few small red blotches) and RASH (A rash started on my front torso) outcome was unknown.      Patient received treatment cortisone cream.   No concomitant medication was reported.  Company Comment  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.   This case was linked to MOD-2021-068590 (E2B Linked Report).; Sender's Comments:  MOD-2021-068590:2nd dose of vaccine
Erythema, heat, tenderness right upper thigh. Treated: Keflex 250mg 3/4 tsp PO QID for 7 days. Benadryl 12.5 mg/dl every 6 hours. OTC Ibuprofen as directed, ice.
CHILLS; SORE ARM; MUSCLE ACHES; NAUSEA; This spontaneous report received from a health care professional concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, every 1 total from 06-APR-2021 09:00 to 06-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced chills, sore arm, muscle aches, and nausea. On 07-APR-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, sore arm, muscle aches, and nausea on APR-2021. This report was non-serious.
Fever, cough, aches, chest congestion, runny nose, tiredness, headache
This spontaneous report as received from a consumer refers to herself, a 50 year old female patient. The patient had no pertinent medical history and no history of drug reactions/allergies. On 03-MAR-2014 the patient was vaccinated with ZOSTAVAX single dose, subcutaneously in the left arm. Strength, dose and lot number were not reported. The patient used no concomitant medication. On 04-MAR-2014, the patient developed a 4 inch by 1 inch hardened, itchy welt at the injection site. Also on 04-MAR-2014, the patient developed a muscle spasm of the right side of the neck. The patient tried hot compresses and MOTRIN with no improvement. The patient called the physician's office and was scheduled for an evaluation at the physician's office on 05-MAR-2014. At the time of report, the patient had not recovered. Additional information has been requested.
nausea, abdominal discomfort 24 to 36 hrs resolved on their record;
arm very sore for 2days and nothing else. On day 8, developed large swelling and itching and site of injection. Swelling size of a tennis ball. Day 9 and 10 still swelling and itching but decreased, then eventually went away. Still now on day 18 experience mild itching at site at times.
This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
fever; chills; lethargy; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EP7534), via an unspecified route of administration in left arm on 28Mar2021 at 10:00 (age at vaccination 20-year-old), as a 1st dose, single for covid-19 immunisation at Pharmacy or Drug Store. The patient medical history was not reported. Patient do not have any known allergies. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 20Apr2021 at 12:00, patient experienced fever, chills, and lethargy. The patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included Polymerase chain reaction test (Nasal Swab): negative on 22Apr2021, 25Apr2021 and 26May2021. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Approximately 2/3rds of the arm has swollen up/ mild swelling; her arm is still red, this happened after the second dose/ it was very red and warm and itching/ it was a red area about 5 cm in diameter around the injection site in the upper arm; it was very red and warm and itching; Soreness of the arm/It hurt, it was warm, slightly swollen and raised from rest of the skin; It hurt, it was warm, slightly swollen and raised from rest of the skin. It was initially located in like the back of the arm, right where the shot was given; It hurt, it was warm, slightly swollen and raised from rest of the skin. It was initially located in like the back of the arm, right where the shot was given; This is a spontaneous report from a contactable Physician.  A 76 year old female Physician reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK4176 Expiry date 31Mar2021), at single dose in the left Arm on 14Jan2021 at 2:30PM for COVID-19 immunization. The patient had received the first dose of BNT162B2 (lot E11865, Exp Mar2023) in the left arm on 23Dec2020 . Medical history included asthma and allergy. She had a contrast IV reaction before. She is Allergic to everything, inhalants, weeds, dust, trees, grasses, foods like chickpeas that have her bad asthma and fishes like Halibut. When she did a skin test she reacts to everything. She has been on prednisone. She was admitted to the hospital a year ago in November for an asthma attack. Concomitant drugs included inhalant steroid medication and other medication for Asthma.  The patient reported that on 15Jan2021 after the second dose, approximately 2/3rds of the arm has swollen up, this lasted about 7 days. On the 8th day and it is beginning to go down. She also added that her arm was still red. The mild swelling actually started as itching, within 10-12 hours, when she woke up and looked it was a red area about 5 cm in diameter around the injection site in the upper arm. It hurt, it was warm, slightly swollen and raised from rest of the skin. It was initially located in like the back of the arm, right where the shot was given, like upper back of arm. On 16Jan2021, it was close to half of the upper arm, well not exactly half the arm, but it was very red and warm and itching, on the left Arm.  On 17Jan2021 it was at 2/3rd of the arm, almost 15 cm's in length at that point. Still very red, it wrapped towards the front of the arm, she could see the color without looking in the mirror.  The swelling has ended, the raise part stopped around the 19Jan2021.  The redness as of the 19Jan2021, it was less, the skin is slight pink, pinker than the normal skin, she has put some steroid cream skin lotion on the red area, she did that on 16Jan2021 twice a day. She also took Benadryl for 2 nights on 16Jan2021 and 17Jan2021.  The itching stopped, when the skin was covered it was not that bad, but when the air hits it, it itches. Caller also added that there was soreness on the arm, it was achy, but it was very minimal now, she notices it when lifting things, that was when it hurts.
Chills, night sweats, muscle and joint ache, slight throat pain, lymph node swelling in right arm pit, slight loss of appetite
The night after I got the shot, I woke up enough (around 1am) to feel that my nose felt weird but didn't think much of it. In the morning (around 6:15am) I realized that I had had a bloody nose in the night. There was enough blood that some was dried on my face and my hand as well as in my nose. I called my pharmacy around 6:30am and he said to report the incident just to be sure.
Pt's left arm started itching immediately after receiving vaccine. Had red, raised area - gave 2 tsp. BENADRYL, applied ice to area. Area improved after giving BENADRYL. Pt was discharged.
Immediately after the shot, I was fine.  I was tired a few hours later, but nothing out of the ordinary. The next morning, I had a soreness or rawness in the upper, back part of my mouth, near the nasal area.  It went away by 11am. Sept 13, nine days after my first shot, I noticed what felt like itchiness all over my body, mostly on my back.  There was a noticeable rash from the lower left portion of my neck all the way down the full of my back, to my upper buttox.  The rash went away by Sept 20th, but there is still some slight itchiness on my arms and legs.  It seems to be going away.
Patient received dose 2/2 of Pfizer vaccine on 2/25/2021. She had an IUI procedure done in (country) on 12/14/2020, which was confirmed to be successful at her follow up OB/Gyn visit- then returned to (country) . Patient returned to (country) on Feb 8, 2021 for 10 week US and was found to have no fetal heart tone, missed spontaneous abortion at approximately 7w5d. This timing would draw into question the timing of the vaccine administration.
Pt recvd vax 22FEB94 & had t102 22FEB, 23FEB, 24FEB APAP helped had sz 24FEB94 was admt to hosp x 1 day, saw neuro; mom states neuro said thought sz was from DTP-only to give DT from now on;
Symptoms from vaccine did not start until Day 5. I woke up at 0900 with a sore arm, nausea, headache, generalized aches, chills. By that evening (unsure of time), started with my usual asthma flare-up symptoms. These include, soreness of breath, chest tightness and pain, wheezing. I started treatment at home with q4h DuoNeb breathing treatments and a decreasing prednisone prescription.  This treatment did not work so I followed up with my pulmonologist and his PA-C for a follow-up. They made the decision that this flare up was caused "by my immune response to the covid vaccine."
This spontaneous report as received from a nurse refers to a female nurse, age unknown. On 17-NOV-2014 the nurse was withdrawing ZOSTAVAX lot # K008882 from syringe and depressed the plunger which sprayed the ZOSTAVAX into her face and eye. Some of the spray landed on her face and hand and she had an initial burning sensation in her eye. The nurse took her contacts out and used a continuous irrigation in her eye. The patient who was to receive the vaccine did not receive it from that syringe and there was no reported issues with the patient. The outcome of sprayed the ZOSTAVAX product into her eye, with some spray landing on her face and hand and initial burning sensation in her eye is unknown. Additional information has been requested.
It was around 12 hours after vaccine started to spike fever, chills (felt as if the chills were coming up my bones). I had Tylenol around 6am my temperature started to go down. The remainder of the day I felt like bad, fever did not return still feeling wiped out. Then couple of days my back started hurting, legs and joint pain from the waist down. I contacted my doctor about my symptoms a month around May.
This spontaneous report was received from a Licensed Practical Nurse concerning a 2 year old male patient, with no drug reactions or allergies and no pertinent medical history. On 17-OCT-2013, the patient was vaccinated with a dose of ROTATEQ (lot # H020559; expiration date 17-APR-2014), 2 ml, oral. No other co-suspect therapy was reported. There was no concomitant medication. It was reported that a dose of ROTATEQ was administered to the patient and the patient immediately vomited out most of the ROTATEQ. The nurse reported that the patient was recovered and the thought he vomited because he had eaten and was crying excessively before administration of the ROTATEQ. No treatment was given to the patient. No laboratory tests were performed. The patient sought medical attention at physician's office when the adverse event occurred. Additional information has been requested.
Symptoms started within a couple hours of receiving vaccine. Hives started on legs during the day and by evening on first day, legs were covered in bumps and slightly less on the arms, neck and face. By 8am the next day, the hives turned red and puffier, chest and stomach were mottled with spots. No fever. Returned to Dr at 4:30pm on the day after the vax and was instructed to give BENADRYL. Gave him one dose at 6:30pm with no real improvement. Morning of 2nd day after the vax and hives are slightly less red on thighs and still the same on lower legs.
The evening of 11/16/01, the child vomited X 1 and no other symptoms were present. The child died in her sleep that night. Cause of Death as per autopsy report was SIDS with focal epiglotitis.
Patient got flu and pneumonia shots on 10/15/13. On 10/16/13 he developed tremors. Patient has let doctor know.
Within 12 hours, I felt tiredness, fatigue, body was weak. I had loss of appetite. Ran a low grade fever. The cough started 2 days after the vaccine was given. With each day, I felt worse, finally on 5/28/2021, I went to the walk in clinic. They took my vitals and wheeled me to the ER. I had a fever of 101.38, elevated heart rate, high BP. nausea with an upset stomach. Several test were run on me at this time. The ER Dr. said I would feel bad for a week or so, and was put off work for 1 week and a half. My cough got worse each day and I kept that cough for about 4 weeks. The ER Dr. said I should follow up with my regular Dr. I seen Dr. 2 different times during the next few weeks.
Patient had symptoms start within two weeks of her shots. I took her to the ER & they sent her home symptoms grew worse and more presented so she was sent to hospital. Fever, lesions, back pain, stomach pain, stiff neck, loss of vision & use of legs.
lost hearing in right ear suddenly (within about 30 minutes) damaged nerves inner, outer and middle ear.  nerves in both legs damaged experience neorapathy in both legs as a result of nerve damage have been to vestibular therapy for inbalance and dizzyness5/21-7/21. still bering treated by Neurology for inbalance and neuropathy
pt states that after taking her 2nd dose of the covid vax she developed chills that day.  Next day she became very fatigued and could barely move.  She stated her every muscle in her body hurt so bad that even the sheets on the bed hurt to touch her skin.  She had a slight temp and started vomiting. She went to bed and slept for hours.  Today 3/5/2021 she states her muscles are getting less sore and she is less shaky.  Pt states she called her pharmacist but has not called her PCP since she is feeling some better today.
I started getting symptoms of runny nose. I tested because I had a friend to test positive 3 days prior. I took 2 at home COVID-19 test that was positive. My symptoms progressed to a sore throat and a cough. I called my doctor and was prescribed PAXLOVID for 5 days. My symptoms lasted for approximately 6-9 days.