chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax & devel erythema 10x10 cm & swelling w/out tenderdness at inject site;
Pt had moderna covid vaccine on 12/16/2021, she was admitted with hemoptysis, alveolar hemorrhage, acute kidney injury and nephrotic syndrome. Creatinine was upto 3.4mg/dl and and previously had very stable renal function with mild ckd and minimal proteinuria in the past. Creatinine level was 1.1 mg/dl in april 2021. p-ANCA, myeloperoxidase antibody was positive and renal biopsy showed Diffuse necrotizing pauci-immune Glomerulonephritis with underlying arteriosclerosis and mild to minimal diabetic glomerulosclerosis. Pt's moderna vaccine dates were 1/28/21, 2/25/21, 12/16/21
Feeling Sick; Pains; Shaking; Vertigo; Dizziness; Sore throat; Aches; Severe headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling Sick), PAIN (Pains), TREMOR (Shaking), VERTIGO (Vertigo) and DIZZINESS (Dizziness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DESVENLAFAXINE SUCCINATE (PRISTIQ) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 09-Mar-2021 at 10:15 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MALAISE (Feeling Sick), PAIN (Pains), TREMOR (Shaking), VERTIGO (Vertigo), DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Aches), HEADACHE (Severe headache) and NAUSEA (Nausea). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and ONDANSETRON at an unspecified dose and frequency. At the time of the report, MALAISE (Feeling Sick), PAIN (Pains), TREMOR (Shaking), VERTIGO (Vertigo), DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat), MYALGIA (Aches), HEADACHE (Severe headache) and NAUSEA (Nausea) outcome was unknown.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's historical drug included VARIVAX (Merck) (vaccinated on 07-APR-2014). On 19-MAY-2015, the patient was accidentally vaccinated with a dose of PROQUAD (Merck) (dose, route, lot # and expiration date were not reported) instead of a dose of M-M-R II. There was no adverse effect reported. Additional information has been requested.
Information has been received from a 69 year old male consumer, concerning himself. The patient had no pertinent medical history and no known drug reactions or allergies. On 07-DEC-2012, the patient was vaccinated with a dose of PNEUMOVAX23 1 injection (route and frequency were not reported) (Lot #: HH009286). Concomitant medications included: Influenza Virus Vaccine (manufacturer unknown), received on 06-DEC-2012. On 08-DEC-2012, 8 hours after receiving PNEUMOVAX23, the patient's right arm swelled up to twice its normal size from the shoulder to the elbow. Consumer also reported that his arm was sore and lasted for a week. Consumer also stated that a lump formed on his lip the size of a marble, and a fever and cough developed a few days after the injection. The patient did not seek medical attention. No treatment was given for the events. No lab diagnostic studies were performed. At the time of the report, the patient was recovering from his arm swelled up to twice is normal size from the shoulder to the elbow, lump on his lip, and cough. The patient's outcome for fever was unknown. The patient had recovered from his arm was sore. The relatedness for his right arm swelled up to twice its normal size from the shoulder to the elbow, cough, fever, a lump formed on his lip the size of a marble and his arm was sore was unknown for PNEUMOVAX23. Additional information has been requested.
Approx 22 hours after receiving 2nd Covid 19 vaccine, I started to experience chills.  Chills went away after 8 hours, but right after the chills started, I experienced an absolute terrible headache and nausea.  Even had diarrhea. Everytime I moved my head, it hurt worse.  I could not function.  I was in severe discomfort.  Symptoms lessened after 24 hours.
This spontaneous report was received from a registered nurse refers to 12 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 13-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M009378, dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/Insurance. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
MD ORDERED HEPATITIS A INSTEAD OF HEPATITIS B - HEPATITIS A WAS GIVEN.
This case was reported in a literature article and described the occurrence of anaphylaxis in a 15-year-old female subject who received dTpa vaccine. This case refers to patient 30 in the literature article. Co-suspect products included Varicella vaccine. The subject's past medical history included allergic rhinitis. Concurrent medical conditions included shellfish allergy and drug allergy. On an unknown date, several minutes after receiving dTpa vaccine, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included angioedema with serious criteria of GSK medically significant and swollen tongue. The subject was treated with epinephrine, antihistamine and Steroid (Unspecified). The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included angioedema (recovered/resolved) and swollen tongue (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, angioedema and swollen tongue may have been caused by dTpa vaccine and varicella vaccine. Additional information was reported: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 15-year-old female patient who had received an unspecified Tdap vaccine (manufacturer unknown) and an unspecified varicella vaccine (manufacturer unknown). The patient was a female. The subject's medical history included atopic disease with allergic rhinitis and shellfish and methylprednisolone allergies. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified Tdap vaccine and an unspecified varicella vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date, within 30 and less than 60 minutes after the vaccination, the patient developed lips angioedema and tongue swelling. This was classified as anaphylaxis by the family practice provider. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was clinic. The patient was treated by epinephrine, oral antihistamine and oral steroid. At the time of reporting the outcome of the events was recovered. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
About 2 weeks after my booster I started experiencing hives and intense itching.  Still experiencing symptoms 6 months later.
Lightheadedness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 13May2021 (Lot number: ER2613) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Date of first Vaccination: 22Apr2021., Dose 1, Lot No : EW0172), administration date: 22Apr2021, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Lightheadedness".  Additional information: Consumer was asked to probe further questions: Consumer stated, No I have go to work I have just calling to tell that I was not sure how long these symptoms should last. Comment: As consumer was unwilling to share further information. Hence further probing could not be done. Limited information available over the call.  Follow-up attempts completed. No further information expected.
It sure felt like the flu when I was so, so sick after I took one; Initial information received on 11-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (patient) via Media through social media.  This case involves a patient of unknown age who was sure felt like the flu when patient was so, so sick after patient took one (illness), while patient was treated with influenza usp trival a-b subvirion no preservative vaccine [Fluzone].  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient who was sure felt like the flu when patient was so, so sick after patient took one (illness).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 30Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 11Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfites" (unspecified if ongoing), notes: Known allergies: biaxin, sulfites. Concomitant medication(s) included: LEVOTHYROXINE; ESCITALOPRAM. Past drug history included: Biaxin for Known allergies: biaxin, notes: Known allergies: biaxin, sulfites. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient took other medication in 2weeks : Amneal (Levothyroxine), Accord (escitalopram). Took Paxlovid for 5 days because patient tested positive. Tested negative on 7th day. Started feeling sick again in a few days. Tested positive again 6 days after the negative test. Symptoms were worse this time. No treatment and recovering now. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Took Paxlovid for 5 days because I tested positive. Tested positive again 6 days after the negative test; Negative, notes: Tested negative on 7th day. Therapeutic measures were taken as a result of covid-19.
50 y/o male with history of Asthma who presents with itchy, sore throat post vaccination administration. Patient denies SOB, chest pain or difficulty breathing. Patient vitals within normal limits and lungs clear. Benadryl 25 mg PO x1 given and patient observed by the NP and Paramedics. After 20 minutes of observation patient reported that he felt better, no issues with swallowing and was comfortable being discharged home. Patient discharged home in stable condition.-------------------------------END
Onset of symptoms was 24 hrs after vaccine.  First symptoms were fatigue, abdominal discomfort, loss of appetite, mild dizziness, swollen injection site, arm soreness.  Starting 48 hours after the vaccine:  jaundice symptoms, including: itchiness on the feet and palms, large patchy bruises on the legs, clay-colored stools, extreme fatigue, yellowing of the eyes, dark-colored urine.  Later, small, round, skin lesions emerged and spread , starting around March 11, 2021.  By the 23, red, itchy, patches had expanded over the chest, abdomen and groin areas.
Systemic: Fainting / Unresponsive-Mild, Systemic: Tinnitus-Mild, Additional Details: The patient fainted about 3 minutes after receiving second dose of covid vaccine. He came around within 15 seconds then fainted again for a few seconds. An ambulance was called. He was given water and orange juice and let rest. She said his ears were ringing but that subsided quickly. The paramedics came and checked vital signs and all was normal so he did not go to the hospital. He said he was feeling fine and left after resting about 40 minutes.
Pt reported severe left leg pain.  She also had point tenderness in left thigh that worsened with sitting.  This occurred the night she received the vaccine but self resolved.  She had pain with her second injection the following month, but it was not as bad
This spontaneous case was reported by a consumer and describes the occurrence of EAR HAEMORRHAGE (bleeding from her right ear) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 19-MAR-2021 00:00) for an unknown indication.     The patient's past medical history included No adverse event. Concomitant products included WARFARIN SODIUM (COUMADIN).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced EAR HAEMORRHAGE (bleeding from her right ear). On 20-Mar-2021, EAR HAEMORRHAGE (bleeding from her right ear) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
received vaccine while pregnant after IUI; arm was very sore; felt feverish; Normal reaction; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (received vaccine while pregnant after IUI) and VACCINATION SITE REACTION (Normal reaction) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol abuse. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 18-Dec-2020 and the estimated date of delivery was 24-Sep-2021. On 19-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (received vaccine while pregnant after IUI) and VACCINATION SITE REACTION (Normal reaction). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (received vaccine while pregnant after IUI) and VACCINATION SITE REACTION (Normal reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Ultrasound foetal: 7-8 week ultrasound was good. It confirmed everything was measuring on track..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications Prenatal vitamins. Treatment details were not provided.
TACHYCARDIA; DIZZINESS; VOMITING; DIARRHEA; NUMBNESS IN HAND; ARM PAIN; HEADACHE; FEVER; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the subject experienced tachycardia. On 05-APR-2021, the subject experienced dizziness. On 05-APR-2021, the subject experienced vomiting. On 05-APR-2021, the subject experienced diarrhea. On 05-APR-2021, the subject experienced numbness in hand. On 05-APR-2021, the subject experienced arm pain. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, dizziness, vomiting, diarrhea, numbness in hand, and fever on 06-APR-2021, and had not recovered from arm pain, headache, and nausea. This report was non-serious.
pt recv vax 31OCT97 & 3NOV97 pt exp upper rt arm rxn consisting of redness, swelling & pain upon movement of the arm;also exp fever & was seen by MD;abscess;
found to be COVID positive but without any obvious symptoms. She was given a single dose of iv remdesivir on 3/9. She remained afebrile with normal vitals and her leukocytosis resolved quickly. She was feeling much better and was tolerating oral diet. No signs of infection at her previous surgical incision sites. She was transitioned to oral augmentin to complete a 10 day course after discharge. Her prelim blood cultures were negative.
Suspected Vaccination failure; got shingles on the bottom of my feet / suffer for a long time with it being on my feet; nerve damage in both feet; my left foot is numb I suffer every day; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve damage and numbness in feet. The patient was treated with vicks vaporub nos (Vicks Salve (Nos)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving and the outcome of the nerve damage and numbness in feet were not recovered/not resolved.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. It was unknown if the reporter considered the nerve damage and numbness in feet to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles shot, the patient got shingles on the bottom of his/her feet. The patient suffered for a long time with it being on his/her feet. Both feet it took a long time to heal. The patient's friend asked, what happened to his/her feet and he/she told her, he/she did not know. She said, go and get some Vicks salve and the patient did and they started healing pretty fast.  The patient's doctor put him/her on everything tried to heal but nothing worked. And after all of it, no one told the patient it was from the shot, but he/she knew it was. Later, the patient went back to his/her doctor and said he/she had the shingles and he took at him/she and said yes you were right. At the time of reporting, the patient was suffered with nerve damage in both feet do to this, his/her left foot was numb, and he/she suffered every day. The patient suggested to be careful about taking shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Redness at injection site, swelling, warm. eventually progressed to some blistering at site, noted after band-aids removed.
Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Oct-2022, 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 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question).    Concomitant medications details were not reported.  Reportedly, the pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The patient received vaccine from a vial that underwent a temperature excursion in the freezer.  The patient received the booster dose.  All the vaccines were found to be viable.  Treatment details was not reported.