chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This employee developed tachycardia about 5 hours after receiving her 2nd dose of Moderna vaccine. Her resting heat rate was in the 130?s per her report. She also reports swelling in her L arm. Her resting heart rate returned to normal by the time she woke up this morning. She reports arm pain/swelling and chest pain this afternoon. She states her breathing is fine. She was directed to see a provider asap.
Patient having low grade temp next day. Two days later, heavy diarrhea and temp. Treating diarrhea.
Patient under age 18 was vaccinated with Moderna, which is a vaccine error.  Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn her away on a Moderna-only day. An ID requirement has been put in place to prevent this situation from occurring in the future.  Follow up to be done by  Physician or delegee will include specific description of next steps for obtaining dose 2.
A 60 yo female was in the observation area following a 1st dose Pfizer (Lot# EW0171, expiration: 08/30/2021) that she received at 1215. At 1248 she flagged the Medic with a complaint of feeling lightheaded and a non-radiating headache rated 1/10 on pain scale. Client denied blurry vision, shortness of breath, nausea, vomiting, or chest pain. Client stated she has an allergy to aspirin and morphine sulfate, denied any past medical history and medications. Client states symptoms started 15 minutes post vaccine. At 1250 the medic took baseline vitals with client sitting:  Blood pressure (BP): 110/80, Respiration rate (RR): 12, Heart rate (HR): 75, client was alert and oriented to time, space, situation and person (CAOx4) and skin was normal for ethnicity, warm and dry, pupils were equal, reactive to light and accommodating (PEARL). Client stated headache increased to 3/10 and continued to deny any other symptoms. Client stated last oral intake was at 0900 and claimed minimal fluid intake. Client was  offered a bottle of water.  At 1301 second set of vitals taken with client standing: BP 112/80, HR 72, RR, 12, CAOx4, negative for orthostatic pressures. Client stated the lightheadedness was gone and headache remained at a 3/10, client attributed headache to lack of fluid intake. At 1315 client released from observation area. Client was able to stand and walk without assistance and left the observation site with a steady gait.
Sun evening developed fever lasting through Tue. Wed developed hives. Treated with Benadryl. Hives returned exactly 6 hrs from initial dose of Benadryl. Administered second dose of Benadryl, contacted PCP, and this is where we are now.
1 hour after injection started to feel dizzy. 6 hours body aches and then fever started.  Within 12 hours my fever went up to 103.4. I was freezing cold for 48 hours and body shakes like I have never experienced. Once my fever broke I began sweating and this lasted for over a week. But by 48 hours after the fever broke I had right sided numbness. Started at my right foot and then by 12 hours had reached my face. My entire right side was numb. I also had been experiencing more than usual heart palpatations and asthma since my first shot back on 8/2. I went to the ER at the Hospital as a potential stroke. All tests came back clear. MRU, Angiogram, echocardiogram and blood work. My follow up with cardiology is putting me on a bio patch heart monitor as a precaution as I still have heart palpatations. The numbness went away for the most part after fluids and a night in the hospital.
NO ADVERSE EVENT. Pt got mono valent Pfizer booster instead of Bivalent Booster
Woke up with pain in right armpit. It is swollen and very sore even just with arm resting normally on side. No treatment as yet. Vaccine was Thursday afternoon, it's Saturday morning. Symptoms immediately following vaccine were soreness and swelling at injection site, next morning for all day, headache, fatigue, muscle aches. Which are normal and occurred after previous 2 shots.
This spontaneous reprot as received from a pharmacist refers to a patient of unknown age and gender. The patient's drug reactions/allergies included unspecified injection site reaction following administration of PNEUMOVAX23 on an unknown date (MARRS# 1507USA001503). On 24-JUN-2015 the patient was vaccinated with ZOSTAVAX lot # L006392, dose 0.65 ml, subcutaneous. On 29-JUN-2015 the patient experienced injection site rash. The patient was seen in the pharmacy. No treatment was given for adverse event. The outcome of injection site rash was reported as not recovered. Causality assessment was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
On and off nauseous after the 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (On and off nauseous after the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (On and off nauseous after the 2nd dose). At the time of the report, NAUSEA (On and off nauseous after the 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported , No treatment medication was report   This case was linked to MOD-2021-169978 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant followup appended
After my second dose, I experienced diarrhea, stomach upset and fatigue. I also experieced fever, chills and body aches, had flu like symptoms. I also had some swelling at the injection site and a right sore arm.
My next period following the vaccine was 5 days late and very heavy. It is not possible I was pregnant during that time period.
Patient felt facial flushing, pounding in chest, burning and hot ears and blood pressure went up. Tingly in right arm and chest and hands. Symptoms resolved, after a few minutes but then returned. Patient sat with nurse during this reaction.
Itching at vaccination site; "swelling" at site (vaccine felt as though it just remained at site rather than absorbing into system). Itching continued (and swelling diminished slightly daily) through 2/25/2010.  On March 5, developed shingles without rash on left front torso (skin painful to touch). Also have unusual fatigue (and prior to pain onset did have more than normal sensitivity to light.) I began a 7-day course of acyclovir (generic) 3x daily-1 gram caplets. Pain continues (day 3 of med), may have modified somewhat, but is still very intense.
Significant illness 1 day post with nausea and vomiting. Fever Chills.  Also, 1-day post 2nd dose she developed painful axillary lymph node involvement.
Had first Moderna vaccine on January 6,2021 no side effects at that time maybe a little tired, some redness  on vaccine site a little pain,had the second dosis on February 3,2021same time  after 1 PM,did ok until 3 AM next day lots of itching so took a Claritin allergy pill,but at 8 AM could not get out of bed fever,shaking chills ,so after two hours of chills took two tylenols,the chills,shaking stopped but that day unable to eat no apetite ,same on Friday ate a little felt weak,today Saturday still feel weak but ate some soup bread and cereal.Think I will be okay did not report to Dr thought some side effects are expected did sleep a lot first and second day after the second vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High bp" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Naproxen, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2,  manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 31Oct2023 to 04Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367591 Same patient, different drug, different event;
Patient had been diagnosed with mild autism prior to receiving a flu vaccine in November 2005. His autism was mild and he was functioning well. Approximately two weeks following the flu shot he began regressing in skills on a global scale. From November up until February 2006 he gradually lost his ability to speak, eat with utensils, use the toilet, and socialize and interact with others and he also develped severe snesory processing issues. He frequently looked to be in pain but was unable to verbalize if he felt bad. On February 5, 2005 patient began a three month period of no speech or verbal sounds whatsoever. He made no noise at all, not even when he cried. We consulted his neurologist who was at a loss, but ordered an EEG and an MRI, both of which revealed nothing wrong with patient. We then consulted a Developmental Pediatric Specialist who advised us to put patient on a detoxifying gluten free/ casein free diet immediately. We attempted to add in supplements and fish oil to his diet but due to his sensory defensiveness he would not consume this items. One month after starting patient on the detox GF/CF diet he resumed speaking again, almost over night. Patient has made good progress regaining skills, but he still suffers from severe sensory processing disorder and his level of autism is not at a moderate level, whereas before it was extremely mild. For reference, I was not aware that VAERS existed and was never informed by a Dr that I should report this as an adverse reaction, which is why this has not been reported for the past two years. I was only recently made aware of VAERS and encouraged to report what happened.
Chronic Rash that started at the injection site(left deltoid IM) approximately 2 weeks after second Moderna vaccine up to present. Same rash appeared along collarbone bilaterally; 2 golf ball size spots along flanks bilaterally;  high pubic area and along testicles; low back localized in center of spine. The rash could be best described as flat "flaky" surface. Affected areas can be very itchy and uncomfortable when sweaty. Course of treatment to date has been Cortisone cream as needed and Benadyl  prior to bed.
This case was reported in a literature article and described the occurrence of idiopathic thrombocytopenic purpura in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 43 days after receiving Meningococcal ACWY-CRM vaccine, the subject developed idiopathic thrombocytopenic purpura. Serious criteria included GSK medically significant. The outcome of idiopathic thrombocytopenic purpura was unknown. It was unknown if the investigator considered the idiopathic thrombocytopenic purpura to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of idiopathic thrombocytopenic purpura (ITP) in a patient aged between 11-and-21 year of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of a self-controlled postlicensure safety that evaluated the safety profile of quadrivalent meningococcal conjugate vaccine in a large cohort aged 11 to 21 years. The patient belonged to the comparison window. Comparison window was defined as the period from the end of the risk period (1-42 days) up to 1 year after vaccination or to disenrollment, whichever came first. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 30 September 2011 and 30 June 2013, the patient received MENVEO (administration route and site unknown; dosages unknown; batch number not provided) at a participating medical centre. On an unspecified date, between 43-365 days (comparison window), the patient developed ITP. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event of ITP and MENVEO. The authors concluded that "This observational study was not intended to provide conclusive evidence of causality. Rather, it detected potential temporal associations between MenACWY-CRM vaccination and adverse events. With nearly 50 000 individuals vaccinated with MenACWY-CRM included in this study, we observed a temporal association between occurrence of Bell's palsy and receipt of MenACWY-CRM concomitantly with other vaccines. The association needs further investigation because it could be due to chance, concomitant vaccination, or underlying medical history predisposing to Bell's palsy". This is 1 of the 8 valid cases reported in the same literature article.
PAIN IN ARM, PATIENT REPORTED FLUID IN ARM. I ADVISED HER TO GO TO THE MD. MD DIAGNOSED TENDONITIS AND REACTION TO THE VACCINE. PATIENT REPORTED THAT HER ARM FELT BETTER ON 7/19/19 TO ME.
Information has been received on 05-JAN-2018 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 14-OCT-2012, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-DEC-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. The patient was prescribed valacyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
the injection site is irritated; the injection site is itchy; the injection site is painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (the injection site is irritated), VACCINATION SITE PRURITUS (the injection site is itchy) and VACCINATION SITE PAIN (the injection site is painful) in a 77-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced VACCINATION SITE IRRITATION (the injection site is irritated), VACCINATION SITE PRURITUS (the injection site is itchy) and VACCINATION SITE PAIN (the injection site is painful). At the time of the report, VACCINATION SITE IRRITATION (the injection site is irritated), VACCINATION SITE PRURITUS (the injection site is itchy) and VACCINATION SITE PAIN (the injection site is painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported . Treatment details was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant follow up received included reporter address, patient date of birth, suspect route of administration and event onset date.
tiredness; headache; Fever of 100.5f approx; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EN5318), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 09:45 as DOSE 2, SINGLE for covid-19 immunisation (Age at vaccination 48 years). Medical history included food allergy (red meat allergy (alpha-gal). The patient's concomitant medications were not reported. Historical vaccine includes dose 1 bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number not reported) on 27Jan2021. No covid prior vaccination. No covid tested post vaccination. On 16Feb2021 16:00 (6 hours after vaccination) patient experienced tiredness, headache, fever of 100.5f approx. persists 24 hours after vaccination. The patient underwent lab tests and procedures which included body temperature: 100.5 fahrenheit on 16Feb2021. No treatment was received as result of event. Could you kindly confirm the first awareness date of adverse events since discrepant information provided? It was filled that AE start date is 16Feb2021, while PRD was 17Feb2021. Response: Date confirmed. Complete recovery as of 19Feb2021. The outcome of all event was recovering.  Follow-up (24Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding awareness date. The response included:  Follow-up (03Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding awareness date of adverse events. The response included:  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Diagnosed with reactive arthritis; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS REACTIVE (Diagnosed with reactive arthritis) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced ARTHRITIS REACTIVE (Diagnosed with reactive arthritis) (seriousness criterion medically significant). At the time of the report, ARTHRITIS REACTIVE (Diagnosed with reactive arthritis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated he suffered from severe swelling and pain in both right and left thigh, knee, leg, foot and ankle. Patient visited ER twice, and was later diagnosed with reactive arthritis and was under the care of a rheumatologist.  Concomitant medications were not reported. Treatment information in response to events was not provided.  This case concerns a  62 year old male patient with no relevant medical history, who experienced the unexpected event of arthritis reactive. The event approximately 36 days after the second dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The event is considered related to the product per the reporter's assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a  62 year old male patient with no relevant medical history, who experienced the unexpected event of arthritis reactive. The event approximately 36 days after the second dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The event is considered related to the product per the reporter's assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of the Moderna COVID-19 vacinne is not affected by this report.
Got COVID shot on 1/18/2021 tested positive for COVID on 1/27/2021
BLOOD CLOT IN LEFT ELBOW; SUICIDAL ATTEMPT; LEGS AND ARMS SWELLING; LEG AND ARM CRAMPS; SHORTNESS OF BREATH; PAIN; CHEST PAINS; STOMACH CRAMPS; HEADACHES; TIREDNESS; This spontaneous legal report received from a patient via a company representative concerned a male of unspecified age, race and ethnicity. 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, expiry: unknown) dose was not reported, 1 total, administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, shortly after the administration of vaccine, he developed symptoms of leg and arm swelling, leg and arm cramps, stomach cramps, pain, headaches, chest pains, shortness of breath, tiredness, loss of energy, loss of sleep and loss of focus and concentration. Later he found an clot on his left elbow and for months he was refused examination for his illness. On NOV-2021, the physician later thought blood clot to be an cyst and performed an surgical procedure cutting into his left elbow with only blood streaming out and no cystic matter found.  On DEC-2021, later physician diagnosed it as a blood clot and prescribed a steroid injection. On JAN-2022, same physician again performed a second surgical procedure with only blood streaming out and no cystic matter found after a second surgery. This prescribed steroid injection was then administered in or around the end of FEB or early MAR of 2022 eliminating the blood clot and illness. The patient reported that he would possibly die after finding about his blood clots for which he suffered emotionally and psychologically of depression, anxiety, feelings of hopelessness, helplessness, suicidal thoughts and attempts caused by the defendants conduct, negligence, medical malpractice, injection of toxic waste (steroid injection), infliction of physical, psychological and emotional pain, suffering, injuries and risk of death making all of them liable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain, headaches, chest pains, tiredness, blood clot in left elbow, stomach cramps, suicidal attempt, legs and arms swelling, leg and arm cramps and shortness of breath was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230122135.; Sender's Comments: V0: Medical Assessment comment not required as per standard operating procedure for legal case.
slight ringing in my right ear increasing to constant, loud ringing after a few months.  I have had hearing loss requiring me to wear hearing aids.
?Covid arm? - itchy oval shaped rash at injection site, slightly raised and hot to the touch, slightly painful to the touch
severe joint paint, feels like she can?t walk. Low grade fever, chills, fatigue.
Patient states left arm is still sore 5 weeks after receiving her influenza vaccination. She states she has to prop her arm up at night; cannot lift her arm up during the day; and injection site was hard for 1 week after injection and reports that there is still a lump in the area. It was suggested that patient follow up with her Primary Care Prescriber ASAP. She made an appointment for today 11/30/17.