chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient was vaccinated subcutaneously in right arm with 0.65ml expired ZOSTAVAX (lot # 671004/0729AA, expiration date 17-AUG-2012) on 07-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested. This is one of the several reports received from the same source.
Immediately after the injection his face went numb, couldnt speak clearly, almost passed out, blood pressure skyrocketed, pupils dilated, and he was dizzy. Now, 6 days later he STILL has migraines, stabbing stomach pains, low blood pressure, nausea, and dizziness, and he can barely stay awake. He has not been able to return to school since the vaccine because of how bad the effects are.
This spontaneous report as received from a nurse refers to a 6-week-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 18-MAR-2016, the patient was in the office and was administered the 1st dose in the series of ROTATEQ orally (dose, lot # and expiration date were not reported). On 18-MAR-2016, the patient projectile vomited after being administered only half of the dose of ROTATEQ. At the time of the report, the patient was still in the office. The outcome of the event was not reported. The relatedness between the event and ROTATEQ was not reported. Additional information has been requested.
Flu vaccine given on 12/08/03 lt deltoid muscle, employee noticed redness, soreness, swelling at injection site on 12/09/03. Symptoms increased by am of 12/10/03, reported to employee health office today.Sent employee to convenient care office, MD instructed her to continue to watch area and report any increase in symptoms.
Fever up to 104F, aches/chills, shortness of breath, increased loss of bladder control
PT HAD SEVERE PAIN IN ARM AND SHE COULD NOT EVEN LIFT HER ARM. SHE WENT TO DOCTOR TO REPORT IT TO HIM. SHE HAD SEVERE PAIN AND IMMOBILITY THAT LASTED FOR DAYS. SHE HAS FLU SHOT EVERY YEAR AND NEVER HAD ANY REACTION UNTIL THIS YEAR.
Pt had taken an MMR vaccine 2 days prior to being administered Yellow Fever. No adverse s/s. Will do Yellow Fever titer in 30 days (one month) when pt returns to clinic.
back pain/ pain across his back in his lower part that fades away after he gets up; Before vaccination he already had back pain, but it got worse after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021244788 (Pfizer).  A 85 year-old male patient received bnt162b2 (BNT162B2), administration date 20Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "had back pain" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, administration date: 30Jan2021, for COVID-19 immunisation. The following information was reported: BACK PAIN (non-serious) with onset 2021, outcome "recovering", described as "back pain/ pain across his back in his lower part that fades away after he gets up"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "Before vaccination he already had back pain, but it got worse after vaccination".  Additional information: He mentioned that reports of back pain associated to the COVID-19 vaccine have been mentioned on TV news. Caller mentions that he called earlier and wanted to know if there were reports about back pain. He says that he got the 2 doses of the Pfizer-BioNTech covid 19 vaccine; the first dose he got it on 30Jan and the second on 20Feb. He has some pain across his back in his lower part that fades away after he gets up. He says that he has back pain before getting the vaccines (the 2 doses of the covid vaccine) and thought it was due to an old mattress he had. Now he has changed his mattress for a new one and says that the pain is in the lower part of his back. Was tried to get an agent but there was 34 calls ahead. caller did not want to wait and give his consent to be contacted, however he wanted to be contacted around 5pm because he has to go. AE duplicate.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
patient came in today to show me his upper right arm, which appears to have a red type rash and scaley dry skin that he has been itching. He stated the itching and redness appeared a couple days after his flu shot in his right arm
After three days all my joints hurt, I could not bench, nor walk, my knees were red; the following week all my toes were red (red like apples). I went to the clinic. They said my body was fighting the vaccine. They sent me home. In 6 months, I went back to the doctor, and they gave me a shot to relax my muscles. I have a very bad arthritis.
2.5 cm nodule at injection site; hard but not fluctuant, minimal redness; tender.
MI, symptoms started 2 hours after immunization; This is a spontaneous report from a contactable physician. A 64-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly, administered in the right arm on 14Apr2021 (Batch/Lot Number: EW0161) as a single dose for COVID-19 immunization. The vaccination facility type was reported. Relevant medical history included obstructive sleep apnea on CPAP; hypogonadism on bioTE; depression; history of (h/o) pneumonia; colon polyps; recurrent sinusitis; erectile dysfunction; MTHFR Mutation C677T Heterozygous; low high density lipoprotein (HDL); dyslipidemia; lumbar disc disease; and sciatica; all from an unknown date and unknown if ongoing. Concomitant medications included bupropion hydrochloride (WELLBUTRIN XL); anastrozole; celecoxib (CELEBREX); levothyroxine, liothyronine (NP THYROID); and escitalopram oxalate (LEXAPRO); all taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM), from which the patient had known allergies. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient experienced myocardial infarction (MI), symptoms started 2 hours after immunization on 14Apr2021. The adverse event (AE) resulted in a doctor or other healthcare professional office/clinic visit and an emergency room/department or urgent care, and hospitalization. The patient was hospitalized for the event "MI, symptoms started 2 hours after immunization" for 3 days. Therapeutic measures were taken as a result of the event, which included cardiac stent. The patient was recovering from the event.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of myocardial infarction.  The reported event likely represent intercurrent medical condition in this patient with history of dyslipidemia.   There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline, counteractive treatment measures and concomitant medications This case will be reassessed upon receipt of follow-up information.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
My injection site is still swollen; My injection site is still red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (My injection site is still swollen) and VACCINATION SITE ERYTHEMA (My injection site is still red) 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 VACCINATION SITE SWELLING (My injection site is still swollen) and VACCINATION SITE ERYTHEMA (My injection site is still red). At the time of the report, VACCINATION SITE SWELLING (My injection site is still swollen) and VACCINATION SITE ERYTHEMA (My injection site is still red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Hi! Ingot my second shot on Friday. My injection site is still swollen and red. Is this normal or should I call my PCP?
Pt experience injection site soreness, redness and inflammation. Pt also devel swelling around the injection site all the way to the elbow.
Redness, rash, itching, swelling at injection site. Area is 6" around injection site. Left upper arm. Better after 3rd day after applying cortisone cream. Lasted for 2 weeks.
Muscle pain severe, extreme fatigue, left arm pain, swelling, left breast pain., joint aches
Increased swelling, redness, itching. Treatment: Antibiotic and Steroid pills.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (for tolerance to the 1st dose refer case US2018177049). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The second shot was administered a few weeks ago and he had some soreness again but not as bad. It also resolved within a couple of days.
Worst Headache ever For 2 days, Achy, Fatigue (but better than Covid).
SEVERE CHILLS - TYLENOL EFFECTIVE (STARTED 8 HOURS AFTER) LOW GRADE FEVER - TYLENOL EFFECTIVE (STARTED 8 HOURS AFTER) NAUSEA - NO TREATMENT BETTER (STARTED 8 HOURS AFTER AND LASTED 12 HOURS) PAIN IN ARM AND BELOW LEFT RIB CAGE - TYLENOL EFFECTIVE (STARTED 8 HOURS AFTER) RED RASH AT INJECTION SITE - NO TREATMENT BUT NO PAIN (STARTED NEXT DAYS 4/10/21 STILL GOING AS OF 4/12/21 11:00AM CST) COLD SWEATS - NO TREATMENT (STARTED NEXT DAY 4/10/21 STILL GOING AS OF 4/12/21 11:00 AM CST) STIFFNESS IN NECK AND SHOULDERS - NO TREATMENT (STARTED NEXT DAY 4/10/21 AND ENDED 4/11/21 IN THE EVENING)
Systemic: Tingling/Numbness/Right side of face (injection given on right side); symptoms lasted 1 day
Patient was experiencing convulsions the evening/night of the vaccine administration. She also experienced shivers and had back pain. However, it was reported the patient is prone to back pain. Post convulsion, the patient was experiencing  extreme sweating.
flu like symptoms: tired, had muscle pain, a headache, shivering, fever, stomach pain, or nausea.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative through social media concerned a 48 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included he was healthy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose, start therapy date were not reported, with frequency time 01 total, administered in MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter stated that, he had read a story about a healthy man who got vaccine in MAR-2021. On an unspecified date, patient died from Covid-19 (suspected covid-19 infection) and suspected clinical vaccination failure. It was unknown if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of suspected covid-19 infection on an unspecified date, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000197778; Sender's Comments: V0: 20211031836-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS V0: 20211031836-Covid-19 vaccine ad26.cov2.s-Suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COVID-19
A report has been received from a Health Professional concerning a 2 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 1-Dec-2012. The reporter stated that they administered expired FLUMIST to a patient on 11-Dec-2012. RN reports the patient has not reported any side effects. The outcome of the event of ADMINISTERED EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
14 days after vaccine, injection site red, size of half dollar bill. No fever, no itch, no pain,  Next day redness the size of 2 dollar bills. covered most of the front of the forearm. No fever, no itch, no pain.  My Dr. felt under my arm, no swollen lymph nodes. Prescribed Triamcinolone Acetonide Cream USP 0.1 %. I used it for 2 days. Redness gone.
Lymph nodes under left arm left breast inflammation/ sore, chest pain, abdominal cramping, nausea, headache,  right leg cramping, difficulty breathing
Patient experiences 24 hours of intermittent nausea and weakness with two episodes of vomiting.  Patient experienced no fever.
Guillain-Barr syndrome. IVIG, plasma phresis. The 60 day follow up received on 9/3/03 states, still suffering with Guillain-Barre syndrome. Breathing difficulty continues. Can not walk due to weakness and arthritis problems. Has improved some, but at a very slow rate. Lot # for pneumonia vaccine is unknown-no record at Dr. office. 12/20/05 Reviewed medical records. Add accident with injuries.
arm is sore, red, swelling almost to elbow and under arm, fever, chills, sick to stomach and migranes
This is a 69y.o. female with past medical history of polymyalgia rheumatica, hx of breast cancer in remission, CKD, HTN, chronic hep b?, DM presents with covid pneumonia. She states that she went to bed Monday and hasnt been able to get out of bed since because she has felt so fatigued. She has muscle aches/cramps, diarrhea, vomiting, cough and shortness of breath.she has been trying to drink fluids but has significant decrease in appetite. She is a former smoker 10 pack year history and quit 30 years ago, she does not use any inhalers. She was on methotrexate for her polymyalgia rheumatica and was on 10mg prednisone daily but was recently taken off of methotrexate 2/2 it not working and was increased to 20mg qd prednisone.  She currently admits to shortness of breath, fatigue, and headache but denies any pleuritic chest pain or cardiac chest pain
Sore left arm for 1 week. 2 days after getting my vaccine my left breast had pain and my ribs underneath my left breast had pain as well and today 10/30/2021 still has pain on my breast and ribs.
Fainted, vomited, paleness, sweating and cold. Got better after 15-20 mins.
gradual decline in her abilities both mental and physical; gradual decline in her abilities both mental and physical; tremors; could no longer walk; lost use of right arm; hallucinating; fallen and could not get up; A spontaneous report was received from a consumer concerning a 88-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced a fall, a gradual decline in her abilities both mental and physical, hallucinating, having tremors, could no longer walk and has lost the use of her right arm.   The patient's medical history was not provided by the reporter. Concomitant medicines were not reported.  On 19-Feb-2021, approximately one day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 30M20A)  in the right arm for prophylaxis of COVID-19 infection.  On Saturday 20-Feb-21, it was reported that the patient had fallen and could not get up.  On Sunday 21-Feb-21, per report, the patient had a noted decline in her mental and physical abilities, was hallucinating, having tremors, difficulty walking and had lost the use of her right arm. The patient was transported to the hospital via ambulance and admitted. The computed tomography scan was negative.  Testing for urinary tract infection was negative as well.      The patient received both scheduled dose of mRNA-1273, therefore, action taken with the drug in response to the events was not applicable.   The outcomes of the events, a fall, a gradual decline in her abilities both mental and physical, hallucinating, having tremors, could no longer walk and has lost the use of her right arm, were considered unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Really bad body aches; Fever of 100.3; really bad headache; Chills; Vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Really bad body aches), PYREXIA (Fever of 100.3), HEADACHE (really bad headache), CHILLS (Chills) and VOMITING (Vomiting) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 06-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced MYALGIA (Really bad body aches), PYREXIA (Fever of 100.3), HEADACHE (really bad headache), CHILLS (Chills), VOMITING (Vomiting) and NAUSEA (Nausea). At the time of the report, MYALGIA (Really bad body aches), PYREXIA (Fever of 100.3), HEADACHE (really bad headache), CHILLS (Chills), VOMITING (Vomiting) and NAUSEA (Nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature increased: 100.3f (High) 100.3f.
Severe pain of the eyes, eyesight began to degrade , good Visio turned to unable to see without glasses
Increased blood sugar; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Increased blood sugar) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus since August 2020. Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) for Diabetes mellitus, FLUOXETINE and OXCARBAZEPINE for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (Increased blood sugar). At the time of the report, BLOOD GLUCOSE INCREASED (Increased blood sugar) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Blood glucose: (High) fluctuating between 170 mg/dL to low 200 mg/dL daily.         Treatment of the events were not reported.Action taken with mRNA-1273 in response to the events was not applicable.
Extreme migraine, excruciating body pains, chest pain, palpitations, shortness of breath, chills
Sore arm at injection site, lasting about 1-1/2 days. Mild body aches starting 16 hours after vaccination and lasting 6 hours. Mile night sweats 2nd night after vaccination.
Patient was seen by Dr. 11/7/19 and stated that her left arm still painful since injection of flu vaccine 10/14/19. Level of pain 6/10 on this date. Follow up appointment scheduled 11/20/19 with Dr.
Grandmother called states child arm has swollen, hard red area size of 50 cent piece.  Child reported it to grandmother on 01/11/2023.  Grandmother called agency to report on 01/13/2023.   Grandmother provided information to follow up with Primary Care Provider if/as needed.  Grandmother verbalized understanding.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 29-DEC-2015 the patient was vaccinated with VARIVAX (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which improperly stored (Temperature: 9.5 F, time frame: 2 hours). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Dizzy, scratchy tight throat, cough. ER visit 9/20/13.
pt recv vax 30JUN97 & 1wk p/vax pt devel induration @ the inj site;this progressed to sx of fever, myalgias & 1cm red plaques & papules )non-scaling) @ about 1 & 1/2 wk p/vax;fever persists @ temp up to 102;induration area @ inj site;
Information has been received from a lawyer regarding a case in litigation concerning a 62 year old female patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster related conditions. On or about 01-SEP-2014, the patient was administered ZOSTAVAX by a physician (lot# and route unknown). On or about 15-SEP-2014, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome of the event was unknown. Additional information has been requested.
Patient received flu vaccine in rt deltoid per her report. States she noticed swelling and pain under rt arm pit which radiated to her neck and down her left arm.