chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had a burning pain on left side breast , lymph nodes swollen , plus all over body pain . -pain and lymph node swelling progressed to right side and breast continued to get worse so patient went to the ER where she was diagnoses with acute mastitis. it was determined to be  vaccine related. She was prescribed antibiotics and pain meds with time course unknown
ITCHY RED BUMPS TO LEFT ARM/BACK/CHEST; This spontaneous report received from a consumer concerned a 72 year old male. The patient's weight was 375 pounds, and height was 69 inches. The patient's past medical history included: chronic obstructive pulmonary disease, and atrial fibrillation, and concurrent conditions included: diabetic, and other pre-existing medical conditions included: Patient was on 02 therapy. Patient had no known any allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: 23-AUG-2021) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced itchy red bumps to left arm/back/chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy red bumps to left arm/back/chest. This report was non-serious. This case, from the same reporter is linked to 20210843220.
I have been getting a headache every day for 2 to 3 hours ever since I got the second house
Vertigo; This is a spontaneous report from a contactable other Health care professional (patient). A 43-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL1283) via an unspecified route of administration, in the left arm on 23Jan2021 at 13:00 (at the age of 43-years-old) as dose 1, single for COVID-19 immunization at Public Health Clinic Administration facility. Medical history included seasonal allergy. There were no concomitant medications. The patient previously took Augmentin and experienced drug allergy. Prior to vaccination, patient was not diagnosed with COVID-19 and not received any other vaccines within 4 weeks. Since the vaccination, patient has not been tested for COVID-19.  It was reported that later patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200) via an unspecified route of administration, in the left arm on 25Feb2021 at 14:45 (at the age of 43-years-old) as dose 2, single for COVID-19 immunization. On an unspecified date in Jan2021, after first vaccination, the patient experienced vertigo. The seriousness criteria of event vertigo was reported as persistent/significant disability/incapacity. It was reported that no treatment was received for the event, as the event did not require the initiation of new medication/other treatment/procedure. Went to physician on 12Jul2021 after symptoms of vertigo had already stopped. Vertigo persisted daily for 4 Months. The patient underwent lab tests and procedures which included biopsy breast resulted negative on 06Jan2021. This report may be a duplicate if the reporter also submitted directly to his/her local agency. Reporter consider the Pfizer product had a causal effect to the adverse events. Outcome of event vertigo recovered on 30May2021.  Follow-up attempts are completed. No further information is expected.  Follow-up (12Aug2021): New information received from a contactable other HCP. This other HCP reported in response to HCP letter [sent to other HCP] via follow-up letter which included that: Reporter information updated, Suspect product details (Dose details, date and time, site and route of injection, anatomical site of injection, Lot number), Vaccination facility type, Lab details (relevant test), Adverse event details (onset date, seriousness criteria, outcome, date of recovery) were updated.  No follow up attempts are needed. No further information is expected.
Patient had rash for six days.  No fever.  Less than fifty pox on body.  No complications, no pre-existing conditions.
interchange of vaccine products; expired vaccine used; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) 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.   Concomitant medication were not reported .  Treatment medication were not reported .
woke with distorted vision doctors have no idea why I presented with advanced posterior and anterior uveitis I did not have health insurance and had to wait until july 17 to get my eye checked
pt been on sulfa drugs since 13DEC for ear infect; started w/fine maculo papular rash on 19DEC; low grade temp, vomiting, very fussy; took to MD 20DEC & 21DEC; stopped sulfa drugs gave DPH 21DEC; MD said rash looked like roseola, rash;
Dose #1 of Moderna given 02/14/2021 2nd dose was administered too early on 02/27/2021 with only 13 days between doses.
Pt C/O some soreness at vac site on 1/24/17 PM. Soreness at site continued but pt. wasn't aware of 8 1/2 cm x 8 cm redness surrounding vac site until 1/26/17 AM. Vac site was also warm to touch. Pt. to apply ice and use TYLENOL p.r.n.
Headache, Fever, Swollen R. deltoid like golf ball, erythema, pain Narrative:
I was feeling okay until I started feeling pain on my left side underneath part of my ribs, the pain continues through the week. A week later I went to urgent care and got Labs done and everything came back okay, I went back to my provided the next day bc the pain was awful. Labs were check my liver and kidney and results were normal. They were not concern at all.
HURTING ALL OVER; SWOLLEN; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, and allergy to penicillin. The patient experienced drug did not work when treated with etanercept, and really bad memory issue when treated with methotrexate.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. Concomitant medications included ascorbic acid, colecalciferol, folic acid/vitamin b12 nos, losartan potassium, nebivolol hydrochloride, and tofacitinib citrate.  On an unspecified date, the patient experienced hurting all over, swollen, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, hurting all over and swollen was not reported. This report was non-serious.
NAUSEA/VOMINTING, INJECTION SITE PAIN/SWELLILNG/REDNESS.
Worst tinnitus I ever had.  And Not by a little.  First began noticing evening of 4/26/2021.  I have always had tinnitus but not anything close to this bad and not point Of seeking medical help.  It?s really annoying.
Pt reported to us that she got Bell's Palsy after receiving dose. She also said she had suffered previously from a stroke on the other side of her brain so they were unsure if it was from the vaccine.
Vaccine dosage error, gave this patient (10 y/o) the 12+ dosage of vaccine.
This case was reported by a nurse via call center representative and described the occurrence of general body pain in a 17-year-old female patient who received BEXSERO (batch number ABX711AA, expiry date 31st December 2019) for prophylaxis. On 10th September 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. In September 2018, less than a week after receiving BEXSERO, the patient experienced general body pain, malaise and fever. On an unknown date, the outcome of the general body pain, malaise and fever were unknown. It was unknown if the reporter considered the general body pain, malaise and fever to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in left deltoid. The reporter was a registered nurse reporting an adverse event on behalf of the patient. The patient's body temperature was 101 degree fahrenheit. The reporter stated that the patient's mother was planning to take the patient to the visit her physician on the day of reporting. This case was linked with the case US2018GSK165851, reported by the same reporter.
This spontaneous report as received from a pharmacy student refers to a male patient of unknown age. On 20-FEB-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The student reported that "recently" on an unspecified date in 2013, the patient experienced severe headaches. The outcome of severe headaches was reported as not recovered/not resolved. Additional information is not expected.
DIARRHEA, HEADACHE, EXTREME PAIN REAR LEFT SHOULDER BLADE, NECK PAIN, RAPID HEART BEAT, FATIGUE LASTING 8 DAYS.
Information has been received from a medical records via of a health professional concerning a 1 day old male who on 27-APR-2008 was vaccinated with the first dose of RECOMBIVAX HB.  On 27-MAY-2008, the patient was vaccinated with a second dose of RECOMBIVAX HB.  Secondary suspect therapy included the first dose of ROTAVIRUS on 27-JUN-2008 and the second dose on 28-AUG-2008, and, the first dose of HIB CONJ vaccine (OMPC) on 27-JUN-2008 and the second dose on 28-AUG-2008.  Concomitant therapy included PNEUMOCOCCAL vaccine (unspecified), POLIOVIRUS vaccine and DIPHTHERIA TOXOID (+) PERTUSSIS vaccine (unspecified) (+) TETANUS TOXOID.  On 30-APR-2008 the baby had a routine exam and the physician reported that the baby had mildly icteric to shoulders (not noted in the hospital) and had gained excellent weight.  On 11-JUN-2008, it was reported that the baby had experienced rash on face for 1 week, red in ears and neck going onto chest.  No fever.  The mother was instructed to call the physician if baby had fever over 101, if child became worse or rash didn't go way in 1-3 weeks.  On 18-SEP-2008, the baby developed ear infections, built of wax in ears, was pulling at ears, congested, didn't sleep well and was fussy.  Wax was removed bilaterally and both tympanic membranes cleared and mobile.  The baby was diagnosed with upper respiratory infection and otalgia.  This is one of two reports from the same source.  Additional information has been requested.
Moderna COVID-19 vaccine administered after temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered after temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered after temperature excursion). In June 2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered after temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
Patient presented to the ER with nausea, vomiting and diarrhea and a syncopal episode at home.  Patient was admitted to the hospital for management of COVID-19 disease.  He was seen by pulmonology and Infectious Disease.  Patient's symptoms resolved with steroids and antibiotics.  He did not need IV remdesivir, remained on room air and is stable to be discharged home with advice to follow-up with pulmonology on outpatient basis.  He will take azithromycin and probiotics along with vitamin-D on discharge.
SHE HAD A LIGHT-MILD FIBROMYLAGIA, LITTLE FLARE; SLEEPING DISORDER WAS light,controable with medicine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FIBROMYALGIA (SHE HAD A LIGHT-MILD FIBROMYALGIA, LITTLE FLARE) and SLEEP DISORDER (SLEEPING DISORDER WAS light,controllable with medicine) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021 at 10:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FIBROMYALGIA (SHE HAD A LIGHT-MILD FIBROMYALGIA, LITTLE FLARE) and SLEEP DISORDER (SLEEPING DISORDER WAS light,controllable with medicine). At the time of the report, FIBROMYALGIA (SHE HAD A LIGHT-MILD FIBROMYALGIA, LITTLE FLARE) and SLEEP DISORDER (SLEEPING DISORDER WAS light,controllable with medicine) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   The patient had Heart Arrhythmia after the 2nd dose of Moderna Covid Vaccine. When reporter met patient's family, they informed his health issue to him. Currently, He had made regular consultation/ checkup with his primary doctor and he was doing a healthy diet and workout regularly. No Concomitant medications were reported.  Company comment: This is a spontaneous case concerning a 45-year-old male patient with no medical history reported, who experienced the unexpected non serious AESI of fibromyalgia and unexpected non serious event of sleep disorder. The events occurred after the first dose of mRNA1273 vaccine. At the time of this report the outcome for fibromyalgia and sleep disorder was reported as unknown. The patient had Heart Arrhythmia after the 2nd dose of Moderna Covid Vaccine, the event was ongoing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-459811 (E2B Linked Report).; Sender's Comments: This is a spontaneous case concerning a 45-year-old male patient with no medical history reported, who experienced the unexpected non serious AESI of fibromyalgia and unexpected non serious event of sleep disorder. The events occurred after the first dose of mRNA-1273 vaccine. At the time of this report the outcome for fibromyalgia and sleep disorder was reported as unknown. The patient had Heart Arrhythmia after the 2nd dose of Moderna Covid Vaccine, the event was ongoing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-459811:Email case : FW: Follow up Request Moderna COVID-19 vaccine: MOD-2022-459811 - Dose 2
Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a 75-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (Fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.No concomitant medications were reported.No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-060824 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060824:First dose case
Shingles shot 3/19/09 - arm turned red and swollen 3/20 painful to the touch (lasted 30 day) - bruse mark and tender to touch (3 nts) - bruse mark and tender to touch (7 nts) (but I still have tenderness & bruse).
Patient noticed that there was a small red rash around the injection site 2 days after injection and reported that her lymph node near her armpit was swollen and tender.
Moderna 1st dose given 0.25ml instead of 0.5ml, immediately after gave another 0.25ml to equivalate to the full dose on the same arm. Patient was explained what had happened and was in observation for 15 min after.  No physical adverse effect only wrong dose given initially.
Canker sores, red/injection site pain, headaches o 01/24/2021
No additional AE reported; Adinistration of on expired PRODUCT to a patient; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's current condition, pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 25-FEB-2022, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot # not reported and expiration date reported as 29-JAN-2022) 1 dose, for prophylaxis (expired product administered). Vaccine had no prior temperature excursions and had been stored per the recommended storage range until administration. No additional adverse event (AE) reported. No product quality complaint (PQC) reported.
Severe hives all over the body, itching, and headache. Fever was there for 5 days straight after the jab
Chills began about 9 pm the evening of the vaccine, serious chills. During the sleeping hours chills continued and then a fever began to occur. My left  enter deltoid from origin to insertion was exquisitely painful. The next  morning my deltoid was reddened from inflammation and very painful. My temp was 101. All of the joints in my entire body ached down to the very small joints in toes and fingers.  That state remained for 2 entire days. The inflammation in my upper arm remained for about 10 days. At least with the 2nd shot I did not get the blisters around the injection site that I did with the 1st shot in the series. I did take diphenhydramine and Tylenol  and had lots of rest time.
I had a very sore arm for about a day after receiving the vaccine. I had a racing heart when I would lay down and I just didn't feel well. I contacted my doctor, and I am being referred to a cardiologist. I am now taking two different medications Metoprolol and Xarelto.
This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A 60-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8730), at the age of 59, in left arm, on Apr 29, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER2613), in left arm, on Apr 7, 2021, for COVID-19 immunisation. The patient experienced  myalgia (muscle pain) and oropharyngeal pain (sore throat), with outcome of unknown. Additional information: The patient experienced muscle pain and sore throat after they wake up every morning. She wondered if that's to be expected with the COVID-19 vaccine, and if it will go away or anything. This LRN W2021394316 crosslinked with LRN W2021394310. Follow-up attempts completed. No further information expected.
pt received pediarix on 7/19/07 at 1400, had some desaturations  prior to vaccines, at 1500 pt had desats and around 1800, apneas.  Desats reported as low as 30's.  Pt required support- eventually entubated.  Weaned  to Cpap overnight but  re-entubated in morning.  Did septic workup and started antibiotics.  Checked cultures, cbc, crp.  08/27/2007 Clinical Summary received from attending MD. 78 day old NICU baby had multiple episodes of apnea and bradycardia with desaturation prior to vaccinations, treated with nasal O2.  Pediarix given 7/19/07  and infant had more episodes of bradycardia with desaturations requiring intubation 4 hours s/p vax.
Pt was inadvertently given pfizer covid monovalent for 6m-4year. Patient parent was notified.
Information has been received from a mother concerning her 6-month- old who on 27-Nov-2006 was vaccinated PO with the second 2.0 mL dose of Rotateq (human bovine) after receiving the first 2.0 mL dose in July 2006 at 2 months of age. It was unknown if medical attention was sought. The patient did not experience and adverse event. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2007. Follow-up information was received from a registered nurse (RN) concerning a 7-month-old male who on 28-DEC-2006, at 1000, was vaccinated PO with the third 2.0 mL dose of ROTATEQ (Lot #655866/1110F). There was no illness at the time of vaccination. Medical attention was not sought and no adverse events occurred. Additional information is not expected.
Patient became diaphoretic, dizzy, pale, and weak after first dose. Went to ED. Discharged in stable condition. Advised to eat prior to receiving second dose.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 24-AUG-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M015698, expiration date: 26-SEP-2017, dose was not provided), subcutaneously. No adverse effect was reported. Product quality complaint was not involved. Additional information has been requested.
Swelling, erythema, induration, pain, right upper arm 3/6 circumferential within a few hours.
Increase in pain. Cold sweats, lightheaded, decreased appetite, increased erythema anterior radiating to axilla.
Information has been received from a physician concerning a 12 yr old female who on 22Aug95 was vaccinated with a dose of varicella virus vaccine live (lot608677/0426B). There was no concomitant medication. On 31Jan06 the pt presented with shingles characterized by painful left upper arm and itchy red bumps. Unspecified medical attention was sought. The pt was treated with a five day course of acyclovir. There was no product quality complaint involved. Additional information is not expected.
One day post vax, the pt developed hives on arms, legs, face trunk. Still has them one week later.
A few hours after vaccine, palms and feet became painfully red and itchy; Next day, started breaking out in severe hives; Took antihistamines to help relieve it, but they keep coming back; Spoke with my doctor and we're waiting to see if it goes away on its own.
Extreme redness and inflammation originating at the site of injection. Area is hot to touch and slightly painful.