chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. On 19-NOV-2014 the patient was vaccinated with RECOMBIVAX HB 2.5 microgram/0.5ml (route and lot unspecified), expiry date: 31-MAY-2014. On 19-NOV-2014, the patient was vaccinated with an expired RECOMBIVAX HB. It was unspecified if it was the patient's first dose. No adverse effect was reported. Additional information has been requested.
bilat mod swollen hands;no loss of arms;afeb;sl change in nl acitivty level pe rmom;, sl lethargic, hard to wake up in AM on 12AUG98;dx common, mild rx;T100.0;
12/27/2022 I started experiencing shortness of breath, coughing. After reaching out to doctor I was diagnosed with Post Covid-19 conditions. I was prescribed Symbicort and Flonase.
I became immobilized, couldn't walk or stand, high fever, night sweats, all joints affected, in wheelchair/ walker for 1.5 months, palpitations. The annual follow-up states that he still has "flat feet" little ankle motion during the morning hours and some night sweats and others.
Black and blue mark, itching under skin not relieved by hydrocortisone cream, swelling and feeling of hardness with the swelling, slight warmth.  At the point of feeling the warmth, took one Benadryl tablet at night.  By the next morning, swelling and hardness had started to dissipate but then a slight rash and redness extending in a circle started to about 3.5 to 4 inches in diameter.  Benadryl cream and/or hydrocortisone (whichever I had available at the time) started to relieve the itching.  Today, 11 days out from the shot, it is still improving.
HERPES ZOSTER DISSEMINATED; STOMACH/ABDOMINAL PAIN; HEADACHE; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chicken pox as a child.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and expiry: unknown) dose was not reported,1 total administered on 06-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 20-APR-2021, the patient experienced headache. On 21-APR-2021,the patient experienced stomach/abdominal pain and it was for two days. On 23-APR-2021, the patient broke out in a rash/shingles/herpes zoster/chickenpox all over legs, inner and outer thighs and in front part of stomach and arms. The patient visited the emergency room was diagnosed with herpes Zoster disseminated. The patient was prescribed with Valaciclovir for the rash and the rash was improving. The patient was waiting for the appointment with the rheumatologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach/abdominal pain, and headache on 22-APR-2021, and was recovering from herpes zoster disseminated. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210454708-covid-19 vaccine ad26.cov2.s-herpes zoster disseminated . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Ear ache March 19, lymph nodes inflamation, low grade fever, pain, spreading, very painful, REGULAR MEDS NO LONGER EFFECTIVE.
Itching; Redness; swollen arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), ERYTHEMA (Redness) and PERIPHERAL SWELLING (swollen arm of injection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, CHLORTHALIDONE and MELOXICAM for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), ERYTHEMA (Redness) and PERIPHERAL SWELLING (swollen arm of injection). At the time of the report, PRURITUS (Itching), ERYTHEMA (Redness) and PERIPHERAL SWELLING (swollen arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On 18-JUN-2014, the patient was vaccinated with first dose of ROTATEQ. No concomitants were reported. On 18-JUN-2014 the patient vomited vaccine as well as last feeding after administration of ROTATEQ. Patient sought medical attention (patient in office). There was no intervention to previous serious criteria. Action taken with respect to ROTATEQ was not applicable. No product quality complaint (PQC) was involved. The outcome event was resolving. Causality was not provided. No further information provided. Additional information has been requested.
Received expired booster dose of the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 037B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment  medications were reported.
Mild shaking; Feeling malaise; By Thursday evening I had a headache; I was so weak and lightheaded; I required assistance to walk; Was having difficulty articulating herself; I became nauseated, but did not vomit/ Nausea; The exhaustion continued to worsen; my pulse was 48 just a few hours later; I had some chills; Intermittent pain on left side; I was so weak and lightheaded/ I started getting weak; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7533), via an unspecified route of administration in left arm on 06Apr2021 at 13:00 (at the age of 50-year-old) at single dose for COVID-19 immunisation. Medical history included adrenal Insufficiency, lupus, Crohn's, celiac, vitiligo (reported as Vitaligo), Raynauds-1, MTHFR mutation, migraines, gastroesophageal reflux disease (GERD), renal cysts, mild myopathy, mild neuropathy, patient had known allergies to penicillin, antihistamine, sulfa, gluten and contrast. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included belimumab (BENLYSTA), modafinil (PROVIGIL), levothyroxine sodium (SYNTHROID), hydrocortisone and R. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously took diazepam (VALIUM), codeine, tramadol, trazodone (reported as trazadone), risedronate sodium (ATELVIA) and all had known allergies. On 06Apr2021, within 4 minutes, the patient started getting weak. After 30 minutes at 13:30 on 06Apr2021, patient was so weak and lightheaded and required assistance to walk and had difficulty articulating herself. Patient became nauseated but did not vomit, and exhaustion continued to worsen and her pulse was 48 just a few hours later on 06Apr2021. The patient had some chills and intermittent pain on her left side on 06Apr2021. On 08Apr2021, by Thursday evening, patient had a headache that lasted almost 20 hours after 3 doses of paracetamol (TYLENOL). Nausea, mild shaking and felt malaise began Friday afternoon on 09Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of headache included paracetamol (TYLENOL). No treatment was received for the other events. The clinical outcome of headache was recovered on 09Apr2021; outcome of the other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Mixed series: patient received #1 dose of Moderna on 4/14/21; Given  #2 dose as Pfizer on 5/12/21.
felt temporary black out; loss of memory; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt temporary black out and temporary loss of memory.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, it was reported that the patient experienced a possible adverse event after the first dose of the vaccine.   It was reported that on the night of receiving the vaccine the patient felt temporary blackout and temporary loss of memory. She mentioned that "she wake up fine the next morning". No treatment information provided.    The outcome of the events felt temporary black out and temporary loss of memory were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.
Intense pain with malaise, nausea and chills. Pain worsened and is not allieviated with ibuprofen. I am beginning an antibiotic today.
Patient states history of fibromyalgia. The day after getting the vaccine, she experienced increasing joint pain. Within a couple days, the joint/body pain increased to the point she was not able to walk and was using a wheelchair. She has been evaluated by her PCP who then referred to an orthopedic specialist for further evaluation and treatment. Now two weeks after the vaccine, her mobility and joint pain have improved to the point she is only needing a walker to move around. However, she states she is still not back to her pre-vaccine mobility/pain status. There may be another VAERS report from her PCP
Contracted covid; Contracted covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, in Jan2023 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown) and in Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Sep2023, outcome "not recovered" and all described as "Contracted covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Sep2023) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: No any other vaccine was given in four weeks. No covid prior vaccination: No. Known allergies: No.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event; All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In April 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation).    Dosage text for suspect product was reported as unknown.  No concomitant medications were provided. Doses were administered from 24-Apr-2023 to 28-Apr-2023.  It was reported that the patients were of age between 6m-5y and reported no symptoms. No treatment medication was provided. This case contains information for the 4th of 12 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-722123 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722123:(patient 1)
No additional AE/PQCs reported; administration of improperly stored PROQUAD.; This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 12-OCT-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status rHA (lot number T015598 was confirmed to be valid, expiration date: 02-NOV-2021) (dose, route of administration, vaccination site were not specified) for prophylaxis. The vaccine underwent a temperature excursion between 20.5 degrees Fahrenheit (F) for 1 hour 54 minutes. There was a previous temperature excursion between 6F to 14F (12.3F) for 23 hours. Digital data logger was involved. No additional adverse effect was reported.
Patient has a brown mark where vaccines Hib and PREVNAR were administered. This was on 2/4/16 - and baby still has mark on thigh.
This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID infection) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049121A) for COVID-19 vaccination. Concurrent medical conditions included High cholesterol and Allergy NOS (Allergic reaction with an unknown drug). Concomitant products included ROSUVASTATIN from 21-May-2022 to an unknown date for High cholesterol. On 02-May-2022 at 3:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2022 at 12:00 PM, the patient experienced COVID-19 (COVID  infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 29-May-2022 for COVID-19 prophylaxis, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID  infection) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Race of the patient was reported as Caucasian. DOB for the patient is Apr-1961. The patient was taking any other medications or products within 2 weeks of starting COVID-19 treatment. The patient was on (Rosuvastatin, did not took during Paxlovid treatment days). Company comment: This spontaneous case concerns a 61-year-old, male patient with medical history of High cholesterol, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 32 days after administration of fourth dose of mRNA-1273. There was no information provided regarding the initial three doses. Patient was started on Paxlovid treatment regimen on May 24-29, 2022, 5 days later the symptoms runny nose and nasal congestion recurred. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. It was reported that Covid rebound- mild symptoms returned at 10 days after beginning of Paxlovid treatment, including runny nose, congestion, no fever. Rebound symptoms somewhat milder. Device Date was reported as 03 Jun 2022. Sender's Comments: This spontaneous case concerns a 61-year-old, male patient with medical history of High cholesterol, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 32 days after administration of fourth dose of mRNA-1273. There was no information provided regarding the initial three doses. Patient was started on Paxlovid treatment regimen on May 24-29, 2022, 5 days later the symptoms runny nose and nasal congestion recurred. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Rash size of a quarter 24 hours after injection, size of fist within 48 hours. Swelling, itching, muscle pain.
injection sight was  slightly sore; had temperature of 100.5; body aches; Chills / shivering / slight chills; received the adjuvant of the Shingrix vaccine without the antigen; received the adjuvant of the Shingrix vaccine without the antigen; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on Novemebr 2020,refer case US2021055855).   On 4th February 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 4th February 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, fever, general body pain, chills, inappropriate reconstitution technique and inappropriate dose of vaccine administered. Rechallenge with Shingrix was positive. On 5th February 2021, the outcome of the injection site pain, fever, general body pain and chills were recovered/resolved. On an unknown date, the outcome of the inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain, fever, general body pain and chills to be related to Shingrix.  Additional details provided were as follows: Lot number not available for both the vaccines. Patient received 2nd dose of shingrix in right deltoid and felt injection sight was slightly sore. Later in the day at bedtime he had temperature of 100.5 degree F, chills, body aches, and shivering and next day morning he was still not well with slight chills and the day after that he was fine. Customer had received a call from his doctor's office on 22nd February 2021 and stated that they think the customer only received the adjuvant of the Shingrix vaccine without the antigen, which led to Inappropriate reconstitution technique and Inappropriate dose of vaccine administered. Reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021055855:same reporter
two days after vaccine, i got extreme muscle and joint pain. walking jarred my joints and muscles and was very painful. I went to chiropractor and he was pretty sure it was vaccine and would pain would disappear in a few days. it did after about 4 days. the dispenser was terrible. she couldn't give a good shot and caused extreme pain to my arm. It has been 22 days since my shot and i still have a large bruise.
severe bout of stomach upset today / severe stomach upset after shot; This case was reported by a consumer via  call center representative and described the occurrence of upset stomach in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2021, the patient received Shingrix. On 11th June 2021, 2 days after receiving Shingrix, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was unknown.   It was unknown if the reporter considered the upset stomach to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingrix shot 2 days ago of reporting date to prevent shingles and experienced severe reaction. The patient had a severe bout of stomach upset. The follow up would not be possible as no contact details were available.
GAVE PATIENT 3 AND UP FLU INSTEAD OF 3 AND UNDER FLU. NO SYMPTOMS OR ADVERSE REACTION NOTED.
pt became limp approx 2mins p/vax displayed circumoral cyanosis,very pale,perspiration noted on forehead;whining die respond to verbal commands & spoke throughout ordeal;
blood in stool; headache; This is a spontaneous report from a contactable consumer (patient's wife) from Pfizer sponsored program Pfizer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Apr2021 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. Patient received vaccine yesterday (unspecified) and now had blood in stool and headache. The event outcome for events was unknown.  Information about Lot/Batch number has been requested.
Mild chest paint exclusively around my heart. Pain developed the morning following my vaccination and has persisted since.