chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Four days after vaccination the  injection  site has a round, red, itchy rash. Other side effects experienced day after vaccination include fever, chills, headache, body aches. Day of vaccine four hours after, shoulder pain, arm pain, and tingling/numbness of hand and fingers on vaccine arm.
Covid-19 booster dose given from vial that expired 03/18/2022.
Narrative: COVID infection following COVID vaccine series 014 Pfizer, dose #1 02/11 Pfizer, dose #2 08/11 pt cc: diarrhea, fever, myalgia, nausea exposure: unknown 08/17 COVID swab, result: detected 08/17 SARS-COV-2 Variant Sequencing result: pending 08/22 clinically resolved
ALT and AST went down; ALT and AST went down; ALT went up; AST went up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALANINE AMINOTRANSFERASE INCREASED (ALT went up), ASPARTATE AMINOTRANSFERASE INCREASED (AST went up), ALANINE AMINOTRANSFERASE DECREASED (ALT and AST went down) and ASPARTATE AMINOTRANSFERASE DECREASED (ALT and AST went down) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for Thyroid disorder, AZATHIOPRINE SODIUM (IMURAN [AZATHIOPRINE SODIUM]), SIMVASTATIN, FERROUS SULFATE, VITAMINS NOS (MULTIVITAMINS ) and PROBIOTICS NOS for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ALANINE AMINOTRANSFERASE INCREASED (ALT went up) and ASPARTATE AMINOTRANSFERASE INCREASED (AST went up). On 02-Mar-2021, the patient experienced ALANINE AMINOTRANSFERASE DECREASED (ALT and AST went down) and ASPARTATE AMINOTRANSFERASE DECREASED (ALT and AST went down). At the time of the report, ALANINE AMINOTRANSFERASE INCREASED (ALT went up), ASPARTATE AMINOTRANSFERASE INCREASED (AST went up), ALANINE AMINOTRANSFERASE DECREASED (ALT and AST went down) and ASPARTATE AMINOTRANSFERASE DECREASED (ALT and AST went down) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
Pt given flu vaccine in right deltoid. Pt arm turned red, pt c/o throat tightness and chest tightness. Benadryl 50 mg im gulln. Motrin 600mg PO gulln.
Vaccination site lump; vaccination site warmth; it got bigger and looks worse; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Vaccination site lump), VACCINATION SITE WARMTH (vaccination site warmth), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and VACCINATION SITE SWELLING (it got bigger and looks worse) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 037A21B) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 05-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE MASS (Vaccination site lump), VACCINATION SITE WARMTH (vaccination site warmth) and VACCINATION SITE SWELLING (it got bigger and looks worse). The patient was treated with IBUPROFEN for Vaccination site mass, at an unspecified dose and frequency; NAPROXEN for Vaccination site mass, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site mass, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Vaccination site lump), VACCINATION SITE WARMTH (vaccination site warmth) and VACCINATION SITE SWELLING (it got bigger and looks worse) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            Concomitant medications also include Two medications for anxiety,Medication for reflux, Medication that is not daily for diaphragm spasm, but patient hadn't taken it in a month.  Action taken with mRNA 1273 in response to event was not applicable.
Patient is fully vaccinated. ED visit on 11/27/2021.Patient is COVID + on 11/27/2021. Chief complaint:  shortness of breath and cough.  Patient presents to the ED secondary to cough, congestion. She reports a two-week history of dry nonproductive cough, worsening shortness of breath and chest discomfort. She states that her cough is so severe it causes chest pain and occasional vomiting. Denies any diarrhea. Reports severe fatigue. No fevers or chills.Has attempted over-the-counter medications with no improvement of symptoms.Positive for weakness and headaches. Positvie for tachypnea and tachycardia.Patient underwent an extensive workup otherwise unremarkable - other than leukocytosis, likely reactive secondary to excessive amounts of steroids given by local urgent care. No other evidence of acute bacterial pathology. As far as Covid goes, patient does not require any supplemental therapies. Repeat ambulatory pulse ox normal. Stable for discharge. Given medication for symptom relief. Will follow up as directed. Will present back to the ER if symptoms worsen.
On an unknown date, the patient developed redness around injection site. Later that evening the patient also reported that she had headache and had become dizzy. The patient took TYLENOL for headache and she reported that the symptoms had improved but were not completely resolved. The outcome of headache, dizzy and redness around injection site was reported as recovering. Additional information has been requested.
dizziness; nausea; tingling down left arm where she gother shot.; frequent throat clearing; vomiting (nausea); muscle aches (left arm); headaches; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 (Lot number: EN6205) at the age of 51 years as 2nd dose, single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose : 1ST DOSE, SINGLE DOSE), when the patient was 51 years old, for COVID-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "dizziness"; NAUSEA (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "nausea"; VACCINATION SITE PARAESTHESIA (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "tingling down left arm where she gother shot."; THROAT CLEARING (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "frequent throat clearing"; VOMITING (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "vomiting (nausea)"; MYALGIA (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "muscle aches (left arm)"; HEADACHE (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "headaches". Therapeutic measures were taken as a result of dizziness, nausea, vaccination site paraesthesia, throat clearing, vomiting, myalgia, headache. Additional information: The patient was stable and responded good to the treatment provided and was discharged asking for follow up with general physician.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Age for Historical Vaccine added. Vaccination Facility Country added  No follow-up attempts are needed. No further information is expected.
weakness but going inch by inch down her arm; Area warm to the touch; Woke up in middle of the nigh; Swelling at injection site; Pain at injection site; Arm hurts/ proceeded to get worse/ throbbing started/ muscle pain/ but going inch by inch down her arm; pain moving down her arm/elbow area; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness but going inch by inch down her arm), FEELING HOT (Area warm to the touch), INSOMNIA (Woke up in middle of the nigh), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema, Accident in 1979, Wrist injury (Broke left wrist near the palm) and Hip injury. Concurrent medical conditions included Polycystic ovarian syndrome, Thyroid disorder, Sjogren's syndrome, Lupus syndrome and Asthma. Concomitant products included LEVOTHYROXINE and SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness but going inch by inch down her arm), FEELING HOT (Area warm to the touch), INSOMNIA (Woke up in middle of the nigh), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (Pain at injection site), MYALGIA (Arm hurts/ proceeded to get worse/ throbbing started/ muscle pain/ but going inch by inch down her arm) and ARTHRALGIA (pain moving down her arm/elbow area). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness but going inch by inch down her arm), FEELING HOT (Area warm to the touch), INSOMNIA (Woke up in middle of the nigh), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (Pain at injection site), MYALGIA (Arm hurts/ proceeded to get worse/ throbbing started/ muscle pain/ but going inch by inch down her arm) and ARTHRALGIA (pain moving down her arm/elbow area) outcome was unknown.        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.   Patient was born with DES (diethylstilbestrol) exposure. Patient had issues when she was born. Patient never got period when teenager and also never able to get pregnant.   This case was linked to MOD-2021-177941 (Patient Link).
This spontaneous case reported by a pharmacist, describes the occurrence of accidental underdose (given 0.25mL dose instead of the 0.5mL for the first full dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 017B22A) for COVID-19 immunization. No medical history reported. On Jul 1, 2022, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; .25 milliliter. On Jul 1, 2022, patient experienced accidental underdose (given 0.25mL dose instead of the 0.5mL for the first full dose). At the time of the report, accidental underdose (given 0.25mL dose instead of the 0.5mL for the first full dose) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter would like to know if he should restart the first dose, or start the second dose.
day p/vax pt felt feverish, eyes sting & burn, diffuse myalgias/arthralgias, nausea, diarrhea.
Patient received Covid vaccine ?around 3:45?. Patient?s initial complaint was feeling ?alittle bit itchy? and her ?nose was closing up?. Vitals taken at 3:48- 129/75 BP, 98 HR, 98% O2. Continuing complaint of ?itching?. 1 mL of Benadryl (Lot #080010, Exp 08/22) given at 3:52. Vitals taken again at 3:54- 150/84 BP, 92 HR, 97% O2. Patient sipped water and speaking with responding nurses at 3:55. At 4:00, reported ?throat itching? and had hoarseness, coughing, and congestion. 4:01, 0.3 mg Epi given via autoinjector (Lot #0GM147, Exp 11/21). 4:06 patient reported her tongue was less ?itchy? and decreased congestion. 4:14 vitals were 123/72 BP, 106 HR, 98% O2 & patient reported no improvement of symptoms. 4:15, Dr. was called at which time recommended to call EMS. 4:16, RN called EMS. 4:18 patient reports ?someone is pushing on my throat?. 4:20 a 0.3 mg Epi given via autoinjector (Lot #0GM147, Exp 11/21). 4:22 vitals were 126/81 BP, 107 HR, 96% O2. 4:26 EMS arrived at clinic and left via stretcher. EMS provided with medications given to patient.
I woke up with swollen lymphnodes the next day and the area is still swollen and tender to the touch.
Body aches, nausea,  headache   I took ibuprofen and it helped the body aches and headache but the nausea is still lingering.
Symptoms consistent with COVID-19 infection: sweats/chills/fever up to 101, cough, nausea/vomiting/diarrhea, body aches, congestion/runny nose
Fatigue, nausea, muscle soreness, stuffy nose, dizziness, achy
Erythema extended to elbow.  Warm to touch on 11/09/2021 not on 11/10/2021.  Patient reports erythema improving since noticed on 11/09/2021
Extreme fatigue. By 11:00 PM extreme pain, very sore to the touch, blotchy red and swollen. 11/09/10 the same fatigue and pain. 11/10/10 pain getting better but still very fatigued.
Patient returned to pharmacy reporting redness, tenderness, and inflammation at site of injection.  Patient indicated some pain when sleeping on the site of injection.  Advised to use a warm cloth to reduce tenderness.
Injection site and whole upper arm area was very sore, hurt when moving arm.  It got progressively worse during the evening. However, it felt much better by Sunday.
VARIVAX was administered following temperature excursion.; No adverse effects or symptoms following administration; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided by the reporter.  On 15-MAY-2022, the vaccine underwent a temperature excursion of 6 Fahrenheit (F) for 7 minutes. There was no previous temperature excursion. Following the temperature excursion, on 26-MAY-2022, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL, lot# U020244 with expiration date 28-JUN-2023 (strength and route of administration was not reported), administered for prophylaxis. No adverse effects or symptoms following administration.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA001561: US-009507513-2206USA001549: US-009507513-2206USA001318: US-009507513-2206USA001331: US-009507513-2206USA001347: US-009507513-2206USA001555:
The night of the injection, I got nauseous and I woke up the next morning around 3am with a severe migraine that lasted all day. My nausea got worse as the day went on and I had severe muscle aches also. They were better the next day but still there. I was better on the third day and was able to return back to work.
Pt had 2 restless nights, Mon & tuesday, developed a hard lump & redness at site. Improved today, slept well last night & redness gone. Hard lump remains
stimulate immune-mediated autoantibody formation; Statin-Induced Necrotizing Autoimmune Myopathy; This is a literature report for the following literature source(s). Other Case identifier(s): US-MLMSERVICE-20221226-4002044-1, NZ-Adis-3743469-322644, US-MYLANLABS-2022M1140938. Introduction: Statins have become the most prescribed medications. We examine the case of a woman who developed statin induced necrotizing myopathy after receiving the Pfizer COVID-19 vaccine after 15 years of statin use. Case: A 67-year-old woman with history of hypothyroidism, hyperlipidemia, and a remote history of breast cancer, treated with surgical excision, presented with a two-month history of progressive proximal muscle weakness in all four extremities. During this time, she noticed unusual difficulty in her habitual exercise routine, culminating in being suddenly unable to walk or lift her arms. Prior to the onset of her symptoms, she reported that she had received the Pfizer COVID-19 booster vaccine. She had been adherent to her daily medications for over fifteen years (atorvastatin 20mg and levothyroxine 75mcg). Labs revealed creatine phosphokinase of 10,354. Muscle biopsy of the thigh was indicative of necrotizing myopathy. 3-hydroxy-3-methylglutaryl coenzyme A reductase antibodies were elevated at over 200 units, suggesting an immune-mediated myopathy. She was treated with intravenous immune globulin and placed on a prednisone taper. Her strength improved, and she was discharged home with physical therapy. Discussion: Statin-induced necrotizing autoimmune myopathy (SNAM) is a rare manifestation of autoimmune myositis. In the anti-HMG-CoA reductase subtype, the immune system is sensitized to HMG-CoA reductase resulting in immune-mediate cellular injury. The duration of exposure to statins prior to development of SNAM varies from 2 months to 10 years, with an average of 3 years. The authors' patient had previously been on statin therapy for 15 years without issue and subsequently developed SNAM after receiving a COVID-19 booster. This highlights the possibility that ribonucleotide vaccines, in particular COVID-19, may stimulate immune-mediated autoantibody formation and lead to increased risk for SNAM in patients on statin therapy. These patients would benefit from alternative lipid lowering therapies, such as Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) inhibitors.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case, a possible causal association between the reported events Autoantibody response , Immune-mediated necrotizing myopathy and the suspect drug cannot be excluded.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Client received her first dose of Pfizer vaccine and during the post-vaccination wait period, she reporting itching on her arms and upper chest. On examination, she did not have any hives, redness or swelling of the skin. Vital signs: BP=173/116, Pulse=98, regular respiration ? not labored. Client stated that she has high blood pressure, but had taken her medication in the afternoon. She was asked to wait for an additional 15 minute to see if her symptoms would improve, but it remained the same. She did not want the EMT to be called but stated that she preferred a friend to pick her up, after she was advised that it was prudent to be evaluated at the hospital. ?911? was called and Medic arrived, evaluated her and transported her away at 16:45 hours.
Initial case received from a pharmacist on 10 April 2014. A female patient, whose medical history was unknown, received a dose of YF-Vax (lot number not reported) and an oral dose of VIVOTIF (other manufacturer, lot number not reported) on 07 April 2014. Two days post-vaccination, on 09 April 2014, she experienced a relapse of herpes. Outcome was not reported. Documents held by sender: None.
9JAN seen by MD no known chronic med problems-devel acute onset of weakness in all 4 extremities depressed reflexes @ biceps, absent reflexes of the proximal leg weakness & difficulty getting up; poss category of inflam poly radiculopathy;
2-11-21 Blood pressure was elevated at 150/87. Appointment made at Dr. office. Seen on 2-12-21 Instructed to monitor Blood pressure and call if remains elevated. On 2-13-21 at 7:55am I woke up with a bad headache, dizziness, and slurred speech. EMS called, Blood pressure dangerously high. I was taken to Medical Center with a Thrombolytic Stroke. I had a CT, 2 MRIs, and clot retrieval preformed. Thankfully I can still function pretty normally. The only adverse effects are slight brain damage.
This spontaneous report as received from a patient's mother refers to an approximately 18 year old female patient. The patient's pertinent medical history included Graves' disease, blood disorder (not specified) and low ferritin levels. The patient had a history thyroid ablation (reported as ablated thyroid). The reporter stated each time after the patient received dose one, two, and three in the series with GARDASIL intramuscular (strength, dose not reported) for prevention of Human papilloma virus (HPV), she experienced tenderness at the injection site. Concomitant therapies included SYNTHROID, elimmental iron supplement (unspecified), spironolactone and JUNEL. The reporter also stated that the patient received each dose about three months apart (estimated dates of vaccinations: June 2013 for first dose of GARDAIL intramuscular (strength, dose not reported) for prevention of HPV, September 2013 for second dose and 19-DEC-2013 for third dose. No treatment was given for the events. The reporter stated the patient's physician called and told the patient that her third dose of GARDASIL which was about a week ago (approximately on 19-DEC-2013) was, from a recently recalled lot. The reporter could not confirm the lot number, but stated that it was the lot of GARDASIL that was just recalled. The reporter stated that other than tenderness at the injection site, (the patient) did not experience any other side effects. The patient did not seek medical attention. The outcome of events was reported as recovering. The relatedness between events and GARDASIL was not reported. Additional information has been requested.
Headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headaches) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
About 16 hours after my shot, I started getting body aches, headache, and weakness. A little while later, my headaches, and body aches got worst. I have a fever. I was warm to the touch. I lost my aplite. I was nauseous. I had chills even though I was warm to the touch. I started having discomfort on my chest, left side. I have had a very acute pain in my neck into my back. I talked to my doctor.