chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Red arm), PRURITUS (Itchy arm), INFLUENZA LIKE ILLNESS (Felt like coming down with the flu), NASAL CONGESTION (Most of the time she feels congestion) and COUGH (Cough mostly in the afternoon or when she exercises) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery in October 2021. Concurrent medical conditions included Pollen allergy, Allergy to molds and Blood cholesterol abnormal. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red arm), PRURITUS (Itchy arm), INFLUENZA LIKE ILLNESS (Felt like coming down with the flu), NASAL CONGESTION (Most of the time she feels congestion), COUGH (Cough mostly in the afternoon or when she exercises), SINONASAL OBSTRUCTION (sinus are blocked), HEADACHE (Slight headache) and PAIN IN EXTREMITY (Patient felt her arm sore/Achy arm/sometimes it still hurts). At the time of the report, ERYTHEMA (Red arm), PRURITUS (Itchy arm), INFLUENZA LIKE ILLNESS (Felt like coming down with the flu), NASAL CONGESTION (Most of the time she feels congestion), COUGH (Cough mostly in the afternoon or when she exercises), SINONASAL OBSTRUCTION (sinus are blocked), HEADACHE (Slight headache) and PAIN IN EXTREMITY (Patient felt her arm sore/Achy arm/sometimes it still hurts) had not resolved. Concomitant medication included unspecified medication for her cholesterol. Patient never had COVID positive test or diagnosis. No vaccines were given within 1 month prior to Moderna COVID-19 vaccine. It was stated that symptoms were worse the last 3 days. Patient had not experienced a similar event in the past. No treatment was given for the events.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 22 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; ABILIFY and Adderall XR. Past drug history included: Zyrtec, reaction(s): "Drug Allergy"; Azithromycin, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received anti viral medication Paxlovid from 18Oct2022 to 23Oct2022 to treat COVID-19.
I received my third shot, the booster.  All Moderna and I had mild side effects with all three.  One the first one a swollen gland under my arm pit and a lump at the injection site.  Glad three days later, swollen arm day seven.  For the second, felt flu like symptoms and injection site pain the next day.  For the booster, I had body aches the day after the shot but on day 11, I experiences extreme hives covering my body, extreme skin writing and my joints were swollen.  My dr had to put me Prednisone and I began taking multiple Zyrtec every few hours.  The prednisone reduced the swelling but I am still experiencing hives and extreme skin writing.  I had these already but not even close to what I am experiencing now.  It is also less controlled with antihistamines.
Customer described dizziness, itch and pain at the time of injection.   On day #2 she reported chills, exhaustion, and joint pain not relieved by tylenol.   On day three, she was still not feeling better.   She saw some improvement on days 4 and 5.   On day six she noticed a raised and red rash... inflammed at 1/8 inch height.    On day seven the swelling was down but the rash increased in size to about 2.5 inch diameter around injection site.
Diarrhea arm soreness Narrative: employee states: She is not certain if this is related tothe vaccine or not. She experienced arm soreness after injection for about 2 days. Then she experienced intestinal issues through the weekend that did not subside until Monday or Tuesday of the following week. Her stomach was gurgling and noisy on Thursday afternoon. She had fluid diarrhea Friday, Saturday, and Sunday. It seemed better on Monday/ Tuesday.
Headache and pain behind Rt. eye, developing into a low grade reaver and vomiting. By Tuesday the 11 I developed a rash on my face with pain shooting behind my eye to the back of the head. Tuesday at Emergency room eye was swollen closed, rt. side of face was broke out in scabs and sharp pains through the eye and scalp.
A report has been received from a Physician via Medical Rep concerning a patient of unknown gender, who had been receiving FLUMIST quadrivalent, (intranasal), 0.2 Millilitres. FLUMSIT quadrivalent (intranasal) started on 03-Dec-2015. The patient experienced high temperature and diarrhea which started on 04-Dec-2015 and tested positive for A and B strains of the Flu. The outcome of the event of high temperature diarrhea and tested positive for A and B strains of the Flu is unknown. The report was considered to be non-serious.
Had second covid shot on February 18th. On February 20th while exercising on the treadmill I noticed my stamina was not the same. Felt like I just started an exercise program. I have been waling on treadmill for 20 years waling 4-6 miles at a time. Felt like I could hardly walk due to getting tired easily and very early in routine. Afterwards I am experiencing shortness of breath, smothering feeling, hard to take a deep breath, lightheadedness and palpatations. Have not been able to keep my normal exercise routine due to symptoms. Contacted my doctor about symptoms and he ordered a treadmill test. Did the treadmill test on March 16 and awaiting the results.
pt recvd 1st dose of vax on 26MAY92 & exp extreme pain in the injected arm, numbness & tingling @ inject site as well as in the hand & fingers of rt hand was unable to lift arm, exp arthralgia & nausea; seen in ER;
pt recv vax, immun site, was warm to touch, redness & swelling about 4";
This spontaneous case was reported by a consumer and describes the occurrence of PULSE ABNORMAL (feeling her pulse through out her body), HEART RATE INCREASED (Heart rate spikes ranging between 50 to 116 bpm recorded with apple watch), NAUSEA (Nausea) and FATIGUE (Generalized fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. HRS011A21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PULSE ABNORMAL (feeling her pulse through out her body) and HEART RATE INCREASED (Heart rate spikes ranging between 50 to 116 bpm recorded with apple watch). On 06-Mar-2021, the patient experienced NAUSEA (Nausea) and FATIGUE (Generalized fatigue). On 05-Mar-2021, PULSE ABNORMAL (feeling her pulse through out her body) and HEART RATE INCREASED (Heart rate spikes ranging between 50 to 116 bpm recorded with apple watch) had resolved. At the time of the report, NAUSEA (Nausea) and FATIGUE (Generalized fatigue) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Heart rate: variable (abnormal) baseline:72 bpm variable reading ranging from 50 bpm as high as 116 bpm. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient did not use any concomitant medications. Patient did not use any treatment medicines for the symptoms.
TREMORS IN HAND; JOINT STIFFNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced tremors in hand, and joint stiffness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tremors in hand and joint stiffness was not reported. This report was non-serious.
First few hours I felt fine. After 24 hours I had arm soreness in left arm and chills and body aches all over, moderate to severe with exhaustion. Then the next day I felt fine in terms of flu symptoms were gone, but I started to develop swelling in lips and a rash on my arm near the injection site. This morning (3 days later ) I have extreme hives all over my face and moderate hives all over my body. They itch.
Breakthrough case admission after 2 vaccines Moderna 2/15/21 lot# 038K20A;  Moderna 9/25/21 lot# 017E21A;
Reports child woke up the morning after receiving the shots with swelling noted to right upper arm, shoulder and upper back on the right side down to the elbow. Mother reports the swelling worsened during the day. Mother further reports that the child is continuing to use his arm and fingers as normal. Child reports that arm is hurting. Child was taken to the emergency room last night. Child waited 6 hours, family left without being seen due to large number of patients waiting to be seen. Ice pack was applied, child went to sleep. Mother reports that swelling to the right arm is unchanged today. States child is participating in normal activities today.
pt recvd vax 11:30am; cried since 3pm; leg was red, swollen at 3:30pm; improved now 5:15pm; less swelling, less redness & pt can be comforted; apap given at 1pm & 5:30pm;
The vaccine was administered high on the left arm. A nerve or bone may have been hit. Pt had very sore arm, very painful when trying to raise arm for removing clothes, driving etc.
varicella rash on 03/24/2006, documentation in chart from previously having the varivax vaccine on 08/30/2000.
if patient receives second injection further apart than 42 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (if patient receives second injection further apart than 42 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (if patient receives second injection further apart than 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (if patient receives second injection further apart than 42 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Non-Significant Follow up- Email Address updated
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received FLUARIX QUADRIVALENT (batch number 92XR5, expiry date 30th June 2019) for prophylaxis. On 17th October 2018, the patient received the 2nd dose of FLUARIX QUADRIVALENT (subcutaneous) .5 ml. On 17th October 2018, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site erythema, pain, injection site swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, pain and injection site swelling were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema, pain and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT in the right arm subcutaneously, which led to incorrect route of vaccination. The patient presented with redness at injection site, swelling at injection site and right side of body hurt.
Patient reports presenting with flushing and itchiness/rash within several hours of receiving the vaccination. Patient denies angioedema, trouble breathing, nausea/vomiting.
Numbness, tingling of right arm. Facial drooping on right side. Right upper lip numb. Severe headache.
Erythematous 2 cm border. Decodrox 1/2 mg, fever
Dizziness,  light-headed about 12 hours after 2nd shot. Ongoing at this time.
WEAKNESS IN THE LEGS; CHILLS; FEVER; LOWER BACK PAIN; SHORTNESS OF BREATH; NAUSEA; SORENESS OF THE ARM; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced soreness of the arm. On 07-MAR-2021, the subject experienced fatigue. On 08-MAR-2021, the subject experienced lower back pain. On 08-MAR-2021, the subject experienced shortness of breath. On 08-MAR-2021, the subject experienced weakness in the legs. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, chills, fever, fatigue, and nausea on 08-MAR-2021, was recovering from weakness in the legs, and soreness of the arm, and had not recovered from lower back pain. This report was non-serious.
About 4-5 hours after COVID booster (flu shot at 11 AM, COVID at 2:30) - nausea and dizziness started.  Vomited multiple times with severe dizziness and nausea.  No fever or below 99.5.  Dizziness and vomiting continued through night from Oct 15 into mid-morning Oct 16.  Symptoms alleviated on Sat Oct 16 afternoon through Sun afternoon.   Then on Sunday evening (Oct 17th) dizziness returned and nausea and vomiting.  These symptoms continued throughout night and into early morning of Oct 18.  Symptoms alleviated at this time and now have mostly disappeared.  Some slight nausea still felt as of Oct 19.  Dull headache now and some fatigue.
Pt presented to clinic 2 days after administration of Tdap.  Pt complains of redness in Left arm, swelling and pain. Patiens arm has visible erythema with edema, and is warm to touch.  Pt is afebrile and has no  complaints of respiratory difficulty. Ice pack given to arm and patient advised to take Motrin and report back to clinic on Monday for follow up. Pt advised to go to ER if reaction progresses and symptoms worsen.
Information has been received from a registered nurse concerning a 23 year old female who was vaccinated with her first dose of Gardasil. There was no concomitant medication. Subsequently the patient experienced weakness and nausea after receiving the vaccination. Unspecified medical attention was sought. Subsequently, the patient recovered from the symptoms. No product quality complaint was involved. Additional information has been requested.
PAtient noticed on the day of it was red, next day it was swollen, red was spreading and continuing to spread as of now, burning, itchy, warm, painful (pain scale 2)
I started with the COVID-19 infection symptoms on 11/11/2022. I tested positive on 11/23/2022 and I was still sick. I was starting to feel better by that time. I got the hearing loss and that started on 11/17/2022 and I was seen for it on 11/22/2022 with a virtual visit. I had my hearing tested on 11/23/2022. That's when I thought I had this sudden neurosensory hearing loss which can be triggered by any respiratory infection. I went to the ER on 11/19/2022 and requested for steroids which I started the on 11/20/2022 and hearing improved by the 11/22/2022. My hearing improved with the 10 day course of prednisone. But it didn't improve all the way so I had 3 injections of dexamethasone into my ear drum. I believe my hearing is all the way back, but I have not had that tested yet. I was out of work for 3 weeks because of my COVID-19 infection, but I was well enough to go back to work on 11/28/2022. The cough had lasted about another week or so, which lasted until about 12/10/2022, then it resolved after that. On 12/26/2022, I had been having some left sided lower back pain for a couple of weeks, but that day I woke up with excruciating pain down my leg along with numbness and weakness. I went to the doctor that same day. I had an appointment that day and they had me take NSAIDs around the clock and was taking those until 12/29/2022 until I was in so much pain I couldn't take it. At that time, I talked to a doctor on the phone and she prescribed prednisone for that as well. The prednisone worked and over the next few days, it resolved. I had an MRI on 01/02/2023 for both conditions. The MRI for the hearing was normal. I haven't gotten the results back for my lower back yet, but my suspicion is that the COVID-19 infection may have kicked off a hyper immune response. Hearing has been recovered, and lower back not quite recovered.
This spontaneous report was received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In May 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L044475, expiration date on 30-May-2017, lot # M004116, expiration date on 25-OCT-2017 and lot # M003659, expiration date on 20-SEP-2017 (dose was not reported). No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 48 degrees Fahrenheit for 50 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Patient has a large red area on upper arm 6 inches above and below injection site that has been increasing in size. The area itches and is painful. She saw her physician in the hospital on 11/7/19 where the doctor determined she has cellulitis in the upper arm. She was given Bactrim DS taking 1 tab twice daily for 10 days.
I took the vaccine on Friday mourning and started having a headache and small fever ~3:30pm and took an ibuprofen and felt fine up until Saturday mourning around ~8:00am I started feeling a mild chest pain. I don't usually eat breakfast so It was just a bit odd and felt about a 2/10 on the pain scale. It gradually got worse and worse throughout the day and I took two tums at 1:00pm until around 3:00pm it was hurting about a 6/10  (I took two tum's again at this time) and around 5:00 it got to about an 8/10 on the pain scale to the point I was grabbing my chest constantly and crying from the pain and was thinking about going to the ER. I decided to take two Advil at that point and around 6:00pm or 7:00pm the pain had subsided down to about a 2/10 scale again. The pain was completely gone the next day and have had no issues since.
Huge amount of swelling .  Big  red patch and knot in thigh at injection site, constant cramping and muscle spasms in back, hips, buttock, thighs and calfs, High fever, Severe headache,  retching and .  Almost as painful as when I had C-Diff.  If they're just going to get more painful each time, I'm out.
Information has been received from a licensed visiting nurse concerning a 4 year old female who on 23-OCT-2008 was vaccinated with (lot # not reported), and second dose of MMR II (manufacturer unspecified). Concomitant therapy included FLUMIST given on 11-OCT-2008. The patient's parents contacted the physician last night, 23-OCT-2008, because the patient stated she "didn't feel good". No fever, nausea or vomiting noted. The patient is recovering. Additional information has been requested.
patient is age 17 , guardian reported client having a slight headache day after immunization which resolved itself, then no other side effects were encountered.
Dysfunctional uterine bleeding, exceptionally heavy period, early period (20 days), extreme cramps resulting in near-fainting or fainting, sudden fall in blood pressure
Tinnitus in right ear. Loss of hearing in right ear. Was put on flonase. Just treated.
Began having seizures ~ 3 month old per mom. She didn't know what they were so didn't say anything re: them until his 9 month visit.
9 cm x 10 cm erythematous plaque, hot raised, at injection site, mild pruritis. Pt noted began after injection, enlarging qd
My reaction was not bad enough to require medical attention but I am reporting it to add to the data base. A few hours following the vaccination, my eyes burned like crazy.  The day after my second dose of the vaccine, I became excessively fatigued.  My arm hurt, I had a very slight fever (99.2 and my normal temp in 97.6) and felt a general malaise.  I went to bed and after 10 hours of sleep felt much better the following day, although still fatigued.  However, the next day, my arm hurt to move it and I discovered swelling under my arm and my lymph node was enlarged.  The swelling went down after a couple of days and all of my symptoms were gone in about five days.
diagnosed with cancer at the end of March; has had chemotherapy and no longer has the antibodies from the vaccines; This is spontaneous report from a Pfizer-sponsored program, COVAX US Support. A contactable consumer (patient) reported that a 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 65-year-old in left arm on 24Feb2021 (Lot Number: EN6200) as single dose for covid-19 immunisation. Medical history included HIV for over 20 years. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at the age of 65-year-old in left arm on 05Feb2021 (Lot Number: EL9269) as single dose for covid-19 immunisation. He was diagnosed with cancer at the end of March (Mar2021) and had chemotherapy and no longer had the antibodies from the vaccines(SARS-CoV-2 Antibody test: Negative) in 2021. The outcome of the events was unknown.
One week after vaccine, the vaccine site became red, hot, and itchy and felt like there was a knot under the skin the size of a golf or ping pong ball. Symptoms lasted approximately 48 hours and went away.