chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flank pain; chest discomfort; night sweat; headache; tired; severe back pain; Slight scratchiness; swelling at the very back of the roof of my mouth and the start of my throat within the 15 min; 1/30 back pain/1/31 tired/back pain,headache 2/1 back pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN5318) via an unspecified route of administration in left arm on 28Jan2021 at 11:00 as unknown single dose for COVID-19 immunization at Clinic. Medical history included inflammatory arthritis, migraine headaches, spinal stenosis, sciatica, tinnitus. Patient previously took trazodone and experienced allergies with trazadone. Concomitant medications included acyclovir [aciclovir], amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), aspirin [acetylsalicylic acid], clarithromycin (CLARITIN [CLARITHROMYCIN]), topiramate (TOPAMAX). Patient did not receive any other vaccine in four weeks. Patient was not pregnant at the time of vaccination. Patient was not diagnosed COVID prior vaccination. On 28Jan2021, patient experienced slight scratchiness, swelling at the very back of the roof of my mouth and the start of my throat within the 15min. of administration. On 29Jan2021 (next day) at 03:00 AM, patient experienced headache, tired, severe back pain. On 30Jan2021, patient experienced back pain, chest discomfort, night sweat, no fever. On 31Jan2021, patient experienced tired, back pain, headache. On 01Feb2021, back pain, flank pain. No treatment was received for the adverse events. Patient had not been COVID tested post vaccination. The outcome of the event flank pain was recovered in Feb2021, outcome of the event disease recurrence was unknown and outcome of the other events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in a clinic facility on 09Apr2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 09Apr2021, the patient experienced convulsions. The outcome of the event was unknown.  No follow-up attempts are completed; information about batch/lot cannot be obtained.
Client was given pediatric dose.  Was supposed to get adolescent/adult dose.  Pt tolerated well. No adverse reaction to vaccine.  Parents and client informed.  Discussed repeat dose not indicated and client should get adolescent/adult dose at her 2nd dose appointment.
Intermittent heart palpitations beginning one day after second COVID vaccine. Symptoms on and off since then.
A few hours after receiving the flu shot I experienced facial swelling, lip swelling, elevated blood pressue.
several red/purple flat spots on  the right foot, roughly round shape, 1-1.5 cm  in size. Itching sensation.
covid vaccine breakthrough case  dose 1 1/24/21 Pfizer EL9261 dose 2 2/14/21 Pfizer EM9810
Patient went to Doctors office for seven year well visit. Patient was healthy with no symptons of cold or flu.  Flu shot was offered and given to patient. Patient developed cold and flu like symptons overnight and begin weezing. The following day went back to doctor and he prescribed pulmicort and Xopenex to help with the viral induced asthma. Overnight developed pain in joints.  Went back on third day and treated joint pain with Motrin. Ashtma cleared after two weeks of treatments of pulmicort and Xopenex. Each time patient gets a cold, an asthma attack occurs and breathing treatments are given (pulmicort and xopenex.)  The patient never had asthma or any related symptons prior to the flu shot.
Received H1N1 vaccine on 10/29/09 at 5pm, at 7:30pm developed cramps in left foot, then went to left calf, then cramping into right calf-all symptoms occured by 8pm on 10/29/09-had difficulty walking. Developed increased pain and cramping by 11/1/09. Went to the ER on 11/1/09 labs showed increased CPK . Diagnosed with Rhabdomyolsis. CPK on 11/1/09-21-701, 11/10/09- 674, 11/24/09-143 12/8/2009 MR and DC summary for 11/1-11/5/2009, patient with c/o's BLE weakness, pain and difficulty walking, tx: aggressive IV hydration,  DC DX Acute Rhabdomyolysis
Having problems, 15 years now. I started getting ill after receiving my basic training vaccinations in Nov 1987, not real bad, just enough to feel like I had the flu all the time. I received more vaccinations and it's been down hill from that point.  I continue to struggle daily. I've gone from doctor to doctor and they run tests and still don't know what to make of my problems, which are symptoms ranging from Lupus, Fibromyalgia and Rheumatoid arthritis. I have and will continue to work full time, as long as my health will allow me too, and I'm not concerned with compensation from anyone else that may have caused my health problems, I just want answers and some hope that my health can be fixed, I want my life back. I dont know what vaccinens I was given and was told my medical records were lost when i requested them in 1991.
sore lt arm starting immed p/vax @ inject site & moving down arm; bruising of lt bicep arm has remained w/dull ache >6 days p/vax;
Subsequential PE; Anemia; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Subsequential PE) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis, Hypothyroidism, COPD, Asthma, Drug allergy (Sulfa), Drug allergy (Ceftin) and Drug allergy (Cefuroximine). Concomitant products included ETANERCEPT (ENBREL) for Rheumatoid arthritis, SALBUTAMOL (ALBUTEROL HFA), DILTIAZEM HYDROCHLORIDE (DILTIAZEM CD) and LEVOTHYROXINE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced ANAEMIA (Anemia). On 24-Apr-2021, the patient experienced PULMONARY EMBOLISM (Subsequential PE) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Subsequential PE) and ANAEMIA (Anemia) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-029848 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. On an unknown date in 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), as prescribed and/or administered by a healthcare provider at the physician's office, for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries; including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered as not recovered. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
Patient states she had a circular raised, itchy uncomfortable rash on her right upper leg/buttocks and down to her knee. She went to primary care md and they said it could be from her SHINGRIX shot she got and to have the pharmacy report. No treatment was given.
Moderate arm pain x3 days. Beginning at 0200, experienced severe chills and shivering. No elevated temperature, but shivering continued for one hour before resolving.
pt devel fever, malaise, vomiting on 29JUN93; 30JUN93 fever was 103 R w/APAP; seizured 30JUN93 @ 315PM; seen by MD on 30JUN93 430PM; temp still 103 R: MD found red throat so took a throat cult;
A few days after 3 17-09 injections (not sure which day) noticed decreased mobility of R shoulder and "lightening bolts" down arm to fingertips. Patient was very tense during shot and wondered if he pulled something. He is to f/u w/ urgent care.
Patient reported shivers, nausea, vomiting. Pt had COVID in recent past but was recovered at time of vaccination.
has to rest to be productive; dry throat; soreness in middle back; tired; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (has to rest to be productive), DRY THROAT (dry throat), BACK PAIN (soreness in middle back), FATIGUE (tired) and MYALGIA (muscle pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (has to rest to be productive), DRY THROAT (dry throat), BACK PAIN (soreness in middle back), FATIGUE (tired) and MYALGIA (muscle pain). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (has to rest to be productive), DRY THROAT (dry throat), BACK PAIN (soreness in middle back), FATIGUE (tired) and MYALGIA (muscle pain) outcome was unknown.            No treatment medications were reported.
Painful swelling in left axilla and pectoral muscle. Onset 22 hours from vaccination and ongoing at 54 hours. No treatment.
Pain level 10 headache unmanageable with otc drugs. Fever over 102+ with severe chills.  Iv and morphine at emergency room after 5 days of symptoms. Tramadol and megestrol at home coupled with 2400mg ibuprofen per day. Symptoms not letting up as of day 8.
Redness and hot to touch, swelling of arm (given on 4-6-15).
numbness to right ear and in front of ear. Also right ear feels plugged/underwater sound, Very sore left arm injection site.
My mother-in-law suddenly got vasculitis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VASCULITIS (My mother-in-law suddenly got vasculitis) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.  No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VASCULITIS (My mother-in-law suddenly got vasculitis). At the time of the report, VASCULITIS (My mother-in-law suddenly got vasculitis) outcome was unknown.     Concomitant medication not reported. Treatment medication not reported.  Reporter did not allow further contact
Information has been received from a health professional concerning a female who in 2007 was vaccinated with the first dose of GARDASIL. Per the reporter, the patient fainted after receiving the first dose of GARDASIL. The patient sought unspecified medical attention. Subsequently, the patient recovered from having fainted. No further informtion was provided. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  TRANSIENT CEREBRAL ISCHEMIA  11/4/2022 --  RECURRENCE OF SAME SYMPTOMS
This case was reported by a healthcare professional (nurse) and described the occurrence of intramuscular formulation administered by other route in an adult subject between 48 and 52 years of age of unknown gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 October 2013 at 14:30 the subject received a dose of FLULAVAL (.1 dose, intradermal, unknown arm) and experienced intramuscular formulation administered by other route, wrong vaccine administered, and underdose. The FLULAVAL is indicated as a 0.5ml dose to be administered intramuscularly; however this subject received 0.1 dose (underdose) "in the forearm". The nurse reported that "she accidentally gave" "a 0.1 dose of FLULAVAL as a PPD in the forearm, instead of intramuscularly." The nurse refused to provide any additional details. The nurse reported 2 other cases with FLULAVAL. See cases A1045209A and A1045210A for details on the other cases. Follow up received from nurse on 1 November 2013. The nurse reported that this case had been reported to Regulatory agency; however, a reference number was not provided. The nurse documented that on 7 October 2013 at 14:00 (previously 14:30), a female subject between 60-69 years old (previously an adult between 48 and 52 years of age of unknown gender) received a primary dose of FLULAVAL and experienced "marked pruritis for 10 minutes" and injection site redness (not previously reported). The nurse did not consider the events serious. The events were not life threatening, did not involve severe or permanent disability, did not involve hospitalization, did not involve congenital defect, and did not jeopardize the subject or required intervention. The subject was evaluated by a physician within 15 minutes of the vaccination. On 10 October 2013, the nursing report documented that there were no adverse reactions at that date; however, the specific date of resolution was not reported. The nurse also provided follow up for the other 2 cases of A1045210A and A1045209A.
On the fourth day I began feeling a headache and weakness. On 5th day my symptoms increased to nausea , vomiting,  headache,  dizziness,  weakness,  fatigue,  diarrhea,  trouble breathing,  rapid heart beat. These symptoms persisted for a few days. Then came on again on March 21, 2021. I have visited urgent care center and have tested negative for covid. I have been prescribed pain for headaches and nausea. My symptoms continue and persist as of now. I have missed work due to reactions.
injection site was hot; Firm to palpation; Injection site was swollen; Injection site skin is red; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE INDURATION (Firm to palpation), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site skin is red) 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.    On an unknown date, 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 WARMTH (injection site was hot), VACCINATION SITE INDURATION (Firm to palpation), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site skin is red). At the time of the report, VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE INDURATION (Firm to palpation), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site skin is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication included Diphenhydramine.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Day 2 diahrea and vomited for 1 hr. (thought food poisoning)  on day 8 right arm swelled up size approximately 2" x 3".   On day 9, 2/3 of right arm swollen, firm and  warm to touch.   Showed 2 physicians, advised to apply topical benadryl and oral benadryl taken.
has the following symptoms:  mild dyspnea;myalgia;headache;anosmia/dysgeusia Date of symptom onset: 05/08/21
Redness and itching.  Redness started small and spread to a circle of 2" diameter after about 10 days from vaccination.  The itching started once the redness appeared.  My physician prescribed Triamcinolone Acetonide Cream  and Benedryl.  I have been using the cream for 2 days and the redness is fading away.  The itching has stopped.  Seems to be improving.  Scheduled to get 2nd dose on  March 2 at 11:30 AM at the same location.
Bloody speckled green loose stool x 1 approx 12 hrs after 1st shots and Rotateq no fever soft abdomen
A physician reported the occurrence of sleep apnea in an approximately 4 month old female who was vaccinated with Infanrix for prophylaxis.  This report was received from manufacturer, who was notified of the event during their phase IV study of Daptacel. The subject's medical history, concurrent conditions, and concurrent medications were not specified. Family history was significant for coronary heart disease and no history of sudden death. The subject received injections of Infanrix on 7/22/02 and 9/25/02, respectively. On 9/25/02, she also received injections of IPOL, ActHIB, hep B and Prevnar. Two days post-immunization, on 9/27/02, the subject was seen in the ER "for parental concern due to facial pallor and gray face." The subject was admitted to the hospital for observation with a diagnosis of "acute life-threatening event." In the hospital, an electrocardiogram showed normal sinus rhythm with a rate of 135 beats/minute,  normal corrected QT interval, and "possible" left ventricular hypertrophy. There were no further recurrences and the subject was discharged from the hospital after an unspecified period of time. The subject was examined by the physician in November 2002. The diagnosis of the event was recorded as "apnea during sleep with no recurrence." At this visit, the electrocardiogram was interpreted as normal. The reporting physician stated that the event was life-threatening, and "unrelated/unlikely" related to Infanrix administration.
Child, age 12, presented to a school clinic with parent for 2nd dose of Pfizer COVID vaccine.  He was given Pfizer Pediatric version instead of Pfizer.  When it was realized, nurse called the mother and explained what happened and advised that the child receive a Pfizer (12 and older) version, with no waiting period between shots.  Parent brought child back to school clinic and child was administered the correct version of Pfizer for his age.
Sarcoidosis to flare up; Arthritis; This spontaneous case was reported by a consumer and describes the occurrence of SARCOIDOSIS (Sarcoidosis to flare up) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced SARCOIDOSIS (Sarcoidosis to flare up) (seriousness criterion medically significant) and ARTHRITIS (Arthritis). At the time of the report, SARCOIDOSIS (Sarcoidosis to flare up) and ARTHRITIS (Arthritis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant and treatment medication was reported.  Company comment: This is a spontaneous case concerning a elderly female patient with no reported medical history. Patient has reported co-suspect medication of Adalimumab (Humira) for unknown indication. Patient experienced the unexpected serious (medically significant) event of Sarcoidosis (Sarcoidosis to flare up), and the unexpected non-serious AESI event arthritis. The events occurrence was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. No other information surrounding the events was reported. The outcome of the events was reported as unknown. The co-suspect medication of Adalimumab (Humira) remain confounder for the event Sarcoidosis (Sarcoidosis to flare up). The patient being elderly and the unspecified indication of the co-suspect medication Adalimumab (Humira) may remain confounders for the event arthritis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a elderly female patient with no reported medical history. Patient has reported co-suspect medication of Adalimumab (Humira) for unknown indication. Patient experienced the unexpected serious (medically significant) event of Sarcoidosis (Sarcoidosis to flare up), and the unexpected non-serious AESI event arthritis. The events occurrence was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. No other information surrounding the events was reported. The outcome of the events was reported as unknown. The co-suspect medication of Adalimumab (Humira) remain confounder for the event Sarcoidosis (Sarcoidosis to flare up). The patient being elderly and the unspecified indication of the co-suspect medication Adalimumab (Humira) may remain confounders for the event arthritis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.