chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MORE ACID REFLEX; EXHAUSTION WAS A DIFFERENT TYPE OF TIREDNESS AS IF SHE WAS COMING FROM ILLNESS/ EXTREMELY TIRED; STINGING THROUGH THE KIDNEY, MAINLY THE RIGHT SIDE FOR 1-2 MINUTES; LOWER BACK PAIN; BURNING IN LEGS AND FEET (BURNING, HOTNESS, HEAT IN THE BACK OF LEGS IN THE CALF AREA) AND BOTHERED BY THE ACHENES FEELING, LEGS ARE BURNING HOT WHEN SHE TOUCHES HER LEGS, THEY ARE NOT HOT AND NO PAIN, FEELS THAT THEY ARE HOT (HOT SENSATION); DID NOT SLEEP GOOD WHICH LASTED FOR 3-4 NIGHTS; DRIVING HER CRAZY; IT IS JUST HOW SHE FEELS THAT THEY  ARE HOT( HOT SENSATION); This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included: blood clots in the lungs, and concurrent conditions included: hypertension, stomach ulcer, and acid reflex. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced driving her crazy. On AUG-2021, the patient experienced it is just how she feels that they are hot ( hot sensation). On 10-AUG-2021, the patient experienced stinging through the kidney, mainly the right side for 1-2 minutes. On 10-AUG-2021, the patient experienced lower back pain. On 10-AUG-2021, the patient experienced burning in legs and feet (burning, hotness, heat in the back of legs in the calf area) and bothered by the achenes feeling, legs are burning hot when she touches her legs, they are not hot and no pain, feels that they are hot (hot sensation). On 10-AUG-2021, the patient experienced did not sleep good which lasted for 3-4 nights. On 10-AUG-2021, the patient experienced exhaustion was a different type of tiredness as if she was coming from illness/ extremely tired. On an unspecified date, the patient experienced more acid reflex. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not sleep good which lasted for 3-4 nights on 14-AUG-2021, had not recovered from burning in legs and feet (burning, hotness, heat in the back of legs in the calf area) and bothered by the achenes feeling, legs are burning hot when she touches her legs, they are not hot and no pain, feels that they are hot (hot sensation), and the outcome of stinging through the kidney, mainly the right side for 1-2 minutes, lower back pain, exhaustion was a different type of tiredness as if she was coming from illness/ extremely tired, more acid reflex, driving her crazy and it is just how she feels that they are hot( hot sensation) was not reported. This report was non-serious.
asymptomatic COVID-19 leading to hospitalization after 2 doses of Moderna: COVID-19 infection COVID-19 pneumonia Date of onset of symptoms: 1/17/2022 Date of covid positive test and admission to ED: 1/21/2022 Vaccination status: vaccinated Imaging: CXR 1/21 showed patchy bibasilar opacities  Oxygen requirements on admission: 2-3L Current oxygen requirements: 3-L Medical therapy: remdesivir, steroids, rocephin and zithromax discontinued Anticipated special isolation end date: 1/31/2022 Was ready for discharge ; cancelled due to V tach  plans to get booster 2/14/22
redness developed around the injection area with the size of 3 inch diameter. it got worse as days went on. patient visited ER to get the prescription for antibiotic
A medical assistant reported pt received a vaccine and1 week later developed injection site reaction characterized by redness, and soreness.
Information has been received from a nurse practitioner concerning a 16 year old female patient who on 08-DEC-2008 was vaccinated with a first 0.5ml dose of GARDASIL (Lot# not reported), IM Left deltoid, and on 09-NOV-2010 was vaccinated with a second 0.5ml dose of GARDASIL (665768/1377Y, Exp date 29-JUN-2012), IM Left deltoid. Concomitant therapy included intranasal FLUMIST. The nurse stated that on approximately 12-NOV-2010 the patient experienced itching, minor swelling and a raised "bump" at injection site. The nurse also stated that the rash and symptoms lasted for a few weeks (no dates reported). There was no treatment given for the events. At the time of the report the patient had recovered. The patient sought unspecified medical attention. Follow-up information has been received from the Advanced Practice Registered Nurse previously reported as nurse practitioner who reported that the student female patient with no pre-existing allergies was vaccinated with a second dose of GARDASIL (665768/1377Y), IM, Right arm (Left deltoid, previously reported), Unknown time on 09-NOV-2010. Concomitant therapy included a first dose of intranasal FLUMIST (Lot# 501047P), IN, Unknown time on 09-NOV-2010. The Advanced Practice Registered Nurse stated that on 12-NOV-2010, unknown time the patient experienced edema and hyper pigmentation at the injection site, Right deltoid. At the time of the report that patient had recovered from these symptoms. The patient did not seek medical attention. Follow-up information has been received from the Advanced Practice Registered Nurse who reported that the patient with no illness at the time of vaccination. The nurse stated that on 12-NOV-2010, unknown time the patient experienced pruritus, swollen area at the injection site, right deltoid. The patient did not seek medical attention. At the time of the report the patient had recovered. No further information is available.
Chills beginning around 8:30pm the evening of receiving the vaccine, followed by fatigue, insomnia, headache, low grade fever, and muscle aches
Acute stroke CT and MRI. MRI showed acute infarction in left cerebellar and occipital lobe started on aspirin 81 mg and crestor 40 mg for management.
5/08 was just fatigue and a headache but on 5/09 a.m., I woke up with vertigo.  It passed and I felt better until it returned overnight, about 2:30 a.m. on 5/10.   The vertigo was severe, debilitating.   If I moved at all, I was nauseas.   I had to stay in bed all day and have family members bring me water and Gatorade.  On 5/11, I was just tired with a headache but no longer experiencing vertigo.
still has the itching all over again, but no body rash; This is a spontaneous report from a contactable consumer (patient's husband) or other non hcp. A 58-years-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 26Jan2021 (Batch/Lot Number: EN5318) as 2nd dose single for COVID-19 immunization. Reporter mentioned that his wife is having some kind of allergic reaction. Received the 1st dose (as historical vaccine) of the Pfizer-BioNTech COVID-19 Vaccine last 06Jan2021 then her arm became sore for a couple of days. On Day 3/4, mentioned she had to keep clearing her throat, was taken to the doctor and said she had Strep (sore throat, and she had pus bags on the side of her throat in the back). She was given amoxicillin but developed a bad itch all over her body. The Amoxicillin was stopped and replaced with Zyrtec and Benadryl. It was good for a couple of days and we've set an appointment on 10Jan2021 to the ENT. Wife received the second dose on 26Jan2021, and today she still has the itching all over again, but no body rash. Reporter is asking if it is okay to continue taking the antihistamines any other information since other doctors don't seem to know what it was and also states that he now thinks that what his wife is having, has something to do with the shot, because she has had nothing else for a few days. Reporter confirms that his wife had no other vaccines on the same day as the COVID vaccine. Medical history includes blood pressure abnormal from an unknown date and unknown if ongoing. Caller states that his wife does take blood pressure medicine. Concomitant medications included aspirin taken for an unspecified indication, start and stop date were not reported. The patient experienced still has the itching all over again, but no body rash on an unspecified date. The outcome of the event was not recovered.  Follow up (28Jan2021): This is a follow up spontaneous report from a contactable consumer. No information was received upon follow up.  Follow-up attempts are completed. No further information is expected.
Itching about the injection site 03/16/21. Redness and heat over lateral triceps and biceps 03/18/21. Applied .1 triamcinolone: improving
Instead of receiving  0.2ml of the Pfizer Pediatric COVID vaccine, the patient received 0.2ml of the adult Pfizer Pediatric vaccine.  Patient actually did not experience any adverse effects at the time of reporting; filling out this form per protocol.
pt recv vax;lab eval revealed that pt failed to seroconvert; varicella antibody neg;
CUSTOMER FELT VERY HOT AFTER ADMINISTRATION OF VACCINE. IMMIDIATLY MADE HIME LIE DOWN. BLOOD PRESSURE WAS MEASURED WHICH WAS 136/93. HE CONTINUED TO FILL HOT AND UNEASY. LATER STARTED FEELING CLAMY. 911 WAS CALLED . PARAMEDICS. ASSESED HIM AND LITTLE LATER WAS RELEASED. PER CUSTOMER PARAMDICS ASSESED HIM OF ANXIETY EVENT
ADULT OBSTRUCTIVE SLEEP APNEA 11/5/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
C/O LEFT neck sore and swollen day after received Hep.A IM in RIGHT Deltoid muscle.  3 days after Hep A C/O fever 101, lethargy,extremely tired with night swets. Fever subsided and symptoms cleared Sunday day 4 after injection.  Referred to her physician.  Doubt related to Hep A given in opposite arm from complaints of swelling, tenderness.
From the bottom of her elbow all the way to her shoulder blade she could not move; ears are hurting; legs were like jelly; fever 101.5; arm is hurting from her shoulder to her elbow; nauseated; getting sick; sore throat; plugged up nose; can't smell anything; light-headed; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (getting sick), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (plugged up nose), ANOSMIA (can't smell anything) and DIZZINESS (light-headed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced ILLNESS (getting sick), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (plugged up nose), ANOSMIA (can't smell anything), DIZZINESS (light-headed), PAIN IN EXTREMITY (arm is hurting from her shoulder to her elbow) and NAUSEA (nauseated). On an unknown date, the patient experienced MOBILITY DECREASED (From the bottom of her elbow all the way to her shoulder blade she could not move), EAR PAIN (ears are hurting), LIMB DISCOMFORT (legs were like jelly) and PYREXIA (fever 101.5). At the time of the report, ILLNESS (getting sick), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (plugged up nose), ANOSMIA (can't smell anything), DIZZINESS (light-headed), MOBILITY DECREASED (From the bottom of her elbow all the way to her shoulder blade she could not move), EAR PAIN (ears are hurting), LIMB DISCOMFORT (legs were like jelly), PAIN IN EXTREMITY (arm is hurting from her shoulder to her elbow), NAUSEA (nauseated) and PYREXIA (fever 101.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 (High) 101.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Symptoms: It was reported that the patient could not take any food and water down, she took a sleeping pill and she fell down and broke her left side toe. Treatment medication was taken but not specified.  No concomitant medications were reported
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Oct2021 as dose number unknown, single (Lot number: FF2593) at the age of 67 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient was not pregnant at time of vaccination. Other medication in 2 weeks reported as no. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I have a rebound of covid. Symptoms started 5 -6 days after finishing paxlovid and testing negative; (23Jun2022) strong positive, notes: Tested again 9 days after finishing paxlovid and tested strong positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that, anti-viral details: product-COVID 19 Treatment, brand-Pfizer, treatment start date was on 10Jun2022 and treatment stop date was on 14Jun2022, Indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events Covid 19 and Drug ineffective and suspect drug BNT162B2 cannot be excluded.
Patient woke  on Saturday morning at 1am after receiving  Moderna coronavirus vaccine on Friday afternoon with the sensation that her tongue was swollen.  She saw that it looked swollen and took Benadryl.  She has continued to need Benadryl for the past 2 days because as the dose wears out of her system, the swelling reoccurs.  She denies SOB, lips/facial swelling, or dysphagia.  Course is stable.
Getting really weak to the point of passing out; Heart palpitations; Heart is fluctuating; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Getting really weak to the point of passing out), PALPITATIONS (Heart palpitations) and HEART RATE ABNORMAL (Heart is fluctuating) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stent insertion NOS (Heart stents) in September 2020. Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ASTHENIA (Getting really weak to the point of passing out), PALPITATIONS (Heart palpitations) and HEART RATE ABNORMAL (Heart is fluctuating). At the time of the report, ASTHENIA (Getting really weak to the point of passing out) outcome was unknown and PALPITATIONS (Heart palpitations) and HEART RATE ABNORMAL (Heart is fluctuating) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was specified.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Outcome of the event updated
MODERNA COVID 19 VACCINE  Moderna vaccine was administered to patient ON 4/13/2021  . Patient is 16 years old- age is not included ( APPROVED FOR 18 YEARS AND ABOVE ).
This spontaneous report as received from a licensed practical nurse refers to a 15 month old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, on 31-DEC-2014, the patient was vaccinated with VARIVAX (Merck) inj that was improperly stored (0.5 ml once, subcutaneously; lot number not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Triggered massive autoimmune response, body aches, fever, extreme tiredness, joint aches.  It would not pass, after 4 weeks, I was required to go on steroids to feel better.
a week of insomnia; This case was reported by a consumer via call center representative and described the occurrence of insomnia in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to plants. Concomitant products included temazepam (Restoril).   On 13th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced insomnia. On an unknown date, the outcome of the insomnia was recovered/resolved.   It was unknown if the reporter considered the insomnia to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced a week of insomnia. The patient was allergic to several plants. The reporter believed that the plant extract contained in the Shingrix vaccine was the source of the insomnia. The patient was on Restoril for treatment of insomnia and that medication being effective in the management of the insomnia for over 7 years.  The patient reported believed that Shingrix reduced or completely overrode the efficacy of the Restoril. The reporter consented to follow up.
No adverse effects were reported; The patient was inadvertently administered an expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist referring to a 63 year old patient of an unknown gender. No information was provided regarding the patient's medical history, current conditions, concomitant medication, drug reactions and allergies.  On 10-JUN-2019, the patient was inadvertently administered an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscular with lot number N027624  and expiration date on 11-MAY-2019, for prophylaxis (dose, dose number, frequency and anatomical injection site were not reported). No adverse event were reported.
I received a call from client's friend/co-worker today stating client has been hospitalized since April 10th. Diagnosed with aseptic meningitis. Infection control doctor (Dr.) thought it may be caused the yellow fever vaccine, along with ibuprofen. Client is still hospitalized as of April 12th.
Client's father called 8/10/2017 states son developed a raised hive like rash under arms and on the back of both legs from knee folds to buttock folds. States that son C/O itching in the middle of the night the same day shots were administered. No other symptoms. Rash remains present with BENADRYL and hydrocortisone creams. There has been no improvement or advancement. Denies cashew exposure or changes in soaps, foods or laundry detergent. Father is concerned if child should receive further vaccines in future.
Felt achy; Back was achy; Left arm was achy like when you get a flu shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt achy), BACK PAIN (Back was achy) and PAIN IN EXTREMITY (Left arm was achy like when you get a flu shot) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21N) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-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 PAIN (Felt achy), BACK PAIN (Back was achy) and PAIN IN EXTREMITY (Left arm was achy like when you get a flu shot). At the time of the report, PAIN (Felt achy), BACK PAIN (Back was achy) and PAIN IN EXTREMITY (Left arm was achy like when you get a flu shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment information was not provided.  Patient stated that she did not feel sick or bad just achy.
None, we called patient the same afternoon and 24 hours later. No adverse events. Patient reports he was feeling fine and back to normal activities.
While giving vaccination to patient, the needle stick inside her left hand middle finger first knuckle middle piercing in and out. Vaccinator had long nails approximately 1 inch long.
Starting on the day of the vaccine, I went to bed and at 3 am woke up with chills. The next day, I had a headache and  fever 100.4-101 for 2 days.  I did take Tylenol.  The following day (2 days post vaccine), I noticed a grape size lump on my left arm. It felt hard and round and located on my forearm. The area around the lump was also swollen.  It was tender to the touch.  The injection site also had swelling and very red in color, which took 1 week to resolve.  The lump seem to be getting larger and getting worse. I saw my doctor 1 month post vaccine on 6/4/2021.  I was recommended to go see an orthopedist.  I am still waiting my appt.
This spontaneous case reported by an other healthcare professional, describes the occurrence of product dose omission issue (patient got the first dose of the Moderna vaccine on Mar 3, 2021 and has not received the second one yet) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 036A21A) for COVID-19 immunization. No medical history reported. On Mar 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced product dose omission issue (patient got the first dose of the Moderna vaccine on Mar 3, 2021 and has not received the second one yet). At the time of the report, product dose omission issue (patient got the first dose of the Moderna vaccine on Mar 3, 2021 and has not received the second one yet): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular): unknown. Concomitant medications included systemic steroids. The reporter did not provide any causality assessments or treatment information.
Syncope at 1033 am, recovered while lying down, cool compress, water. Observed with vitals for 30 mins. Discharged asymtomatic at 1103
didn't receive the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd dose) 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.    In April 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 PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd dose) had resolved.            The patient stated that she received 1st dose of the Moderna COVID19 vaccine on April 2021 and didn't receive the 2nd dose as she "had to had surgery" that was due to a private cause unrelated to the vaccine.  No concomitant medications reported.  No treatment information was provided.
screaming, head banging, poop smearing, regression with verbal skills, regression with fine motor skills, anxiety, fear, fever, sleep issues, decreased pain sensitivity, obsessive tendencies, oppositional  tylenol for initial treatment  still same issues after years of ABA, OT, SLP, and meds
Narrative:  Patient 93 year old home bound - received 4th dose on 7/22/22. Had very swollen arm after injection, ws admitted to hospital 3 days later with vomitting due to colitis exacerbation
Pt was approved for pediatric dosage of Pfizer Vaccine. Accidently MA gave 0.3ml dosage instead of required 0.2ml dosage. As soon as mistake received, provider was notified, mother of child was notified and mother stated child is well.