chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Lot number: 016522), in left arm, on 26Mar2022 at 17:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 20Apr2022 at 16:45 as dose 4 (booster), single (Lot number: 016522) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "vonWillibrands" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Anchovies" (unspecified if ongoing), notes: Known allergies: Anchovies; "Known allergies: Environmental" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: 01Jan2020; ESCITALOPRAM, start date: 01Jan2022; PIOGLITAZONE, start date: 01Jan2022; METFORMIN, start date: 01Jan2022; JARDIANCE, start date: 01Jan2022; GLYBURIDE, start date: 01Jan2022; ATORVASTATIN, start date: 01Jan2022; MONTELUKAST, start date: 01Jan2022; ENALAPRIL, start date: 01Jan2022. Past drug history included: Compozine, reaction(s): "Known allergies:compozine", notes: compozine. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 07May2022, outcome "not recovered" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive; (May2022) Negative; (23May2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Mother notes that patient started stuttering at the beginning of sentences. He has never done so. Mom notes that it happened several times 11/07, several more times 11/08, and only once or twice today 11/09/09. Patient was otherwise well, did not have any fever, any other s.s, no headaches, weakness, sore throat, trouble swallowing, no gait abnormalities, no tics, nothing, else. Today mother feels he may be getting better, but is concerned for the context of starting so soon after the 2 vaccines.
35 year old immunocompetent patient received shingrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 35-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th May 2022, the patient received Shingrix. On 5th May 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 5-MAY-2022 Reporter's Comment: Healthcare professional reported a 35-year-old immunocompetent patient received Shingrix. The reporter consented to follow up. Additional Supportive Information: A 35-year-old patient received Shingrix, which led to inappropriate age at vaccine administration.
Patient had symptomatic Covid-19 diagnosis; Patient had symptomatic Covid-19 diagnosis; This is a spontaneous report from a non-contactable consumer. This report was received via a sales representative.  A adult female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had symptomatic COVID-19 diagnosis on Feb2021. The patient visited the doctor or other healthcare professional office. It was unknown whether the treatment was received for the events. The outcome of the event Covid-19 was not recovered and unknown for other event.  No follow-up attempts are needed. No further information is expected.
pt given APA p/inject was cranky but no fever til 2AM when awakened burning up-fever 104 called urgent care told to put in tepid bath, t105 then gradually down 103; 2 days later still fever 101 despite APAP;
she has a reaction to Covid vaccination that caused Bells's Pasly.; face was numb; her face was numb was having a hard time saying words.; This is a spontaneous report form a contactable consumer (patient). A 74-month-old female patient received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient she had a reaction to Covid vaccination that caused Bells's Pasly. It was reported that patient was in the hospital and her face was numb was having a hard time saying words. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
COVID-19 Disease and tested Positive post first vaccine; Low Oxygen Levels; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 Disease and tested Positive post first vaccine) and OXYGEN SATURATION DECREASED (Low Oxygen Levels) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 Disease and tested Positive post first vaccine) and OXYGEN SATURATION DECREASED (Low Oxygen Levels). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 Disease and tested Positive post first vaccine) and OXYGEN SATURATION DECREASED (Low Oxygen Levels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Patient provided information regarding history of asthma, previous allergic reations to animal, perfume, dust, pollen. Also, reported anxiety when she see needle or syringe. When staff asked patient whether she is comfortable to complete her vaccination, patient replied that as long as she do not see the procedure she will be fine. After vaccine administration patient reported discomfort in her throat. Dr.  and EMT team were notified. Patient's vital signs were BP 116/72 HR 103 O2 98% RR 18. Patient was monitored for forty minutes, no medications were administered. Patient left in stable condition (vita signs BP 121/70, HR 95, O2 99% RR 18). No hospitalization required.
On 5/21/09 Pt saw Doctor reports received Td Booster at Hospital on 5/19/09. Left arm erythema induration 2 degrees. DX: Local allergic reaction to Tetanus. Rx: Benadryl, Medrol dose pack + warm compresses.
No adverse event; Moderna Covid-19 vaccine used beyond its use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine used beyond its use by date.) and NO ADVERSE EVENT (No adverse event) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     It was unknown if patient was allergic to medications, food, and other products. It was unknown if the patient had ever been diagnosed with/ tested positive for COVID-19. Acute and chronic illnesses at the time of vaccination were unknown. It was unknown if other vaccines were given to patient within 1 month prior to Moderna COVID-19 vaccine.     On 05-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine used beyond its use by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine used beyond its use by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine used beyond its use by date.).    No concomitant medications information was reported. Patient received the second booster.  It was unknown if the event caused the patient to seek medical care. It was unknown if the patient experienced a similar event in the past.  No treatment medications were provided.
Information has been received from a certified medical assistant concerning a patient who "years ago" was vaccinated with RECOMBIVAX HB (manufacturer unknown) and experienced "severe allergic reaction with hives from head to toe". The patient only received 2 of the 3 recommended vaccinations as a result. Subsequently, years ago, the patient recovered from "severe allergic reaction with hives from head to toe". Additional information has been requested.
This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 24-AUG-2016, the patient was vaccinated with expired dose of ZOSTAVAX 19400 PFU, lot # L0124771/expiration date- 1-JUL-2016. No adverse event was reported. The outcome was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 13-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date- 10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
My head felt heavy; it felt like my head was surrounded by water.  Lots of pressure around my ears. My mind was very foggy; I could not think clearly.  It was hard to concentrate and focus.  It felt like I was extremely groggy but not sleepy.   My think pattern was very slow.   My appetite decreased;  I felt nauseous a couple of times. No fever.  I took 2 Tylenol tablets (regular dose), and laid down to rest for several hours.   The longer the day went, the more severe the symptoms become.  I took another 2 Tylenol tablets at bedtime, and went to bed earlier.  During the day I drank lots of fluids, and ate light food.
immediate allergic reaction; small nodule/swellup at site of injection returns to normal within 5 minutes
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II, lot # reported as L039612, expiration date reported as 07-OCT-2017, lot # L007216, expiration date reported as 03-MAR-2017, lot # reported as L023386, expiration date reported as 25-JUN-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 8.8 degrees Fahrenheit for 7 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports from the same reporter. Additional information has been requested.
Had sore arm with first dose, hurt when sleeping on my left arm/Second shot, the left arm was very sort, hurting to use my arm for 2 days.; Felt a little dizzy/some dizziness.; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 19Mar2021 at 07:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 09Apr2021 at 07:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unspecified date in 2021, after the first dose the patient reported that he had a sore arm that hurt when he slept on his left arm. The patient also felt a little dizzy. On 10Apr2021, after the second shot the patient reported that the "left arm was very sort" and it hurt when he used his arm for 2 days. The patient also experienced some dizziness. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events' sore arm that hurt when he slept on his left arm and felt a little dizzy were resolved on an unspecified date in 2021. The clinical outcomes of the events "left arm was very sort" and some dizziness were resolved on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Information regarding Flumist nasal solution was received from a consumer regarding a 37 year old male patient who experienced a stuffed nose and sore throat. At 37 years of age, the patient received a dose on 12/15/03. The patient has no relevant medical history. Indication for Flumist was immunization. Product was administered on 12/15/03. Dose regimen was 1 dose (IN). Patient was not taking concomitant therapy. The patient experienced stuffed nose and sore throat on 12/16/03. No additional information was available at the date of this report.
This case was reported by a healthcare professional and described the occurrence of red raised welt at injection site in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 September 2014, the subject received unspecified dose of FLULAVAL (.5 ml, unknown route and unknown deltoid). On 20 September 2014, 1 day after vaccination with FLULAVAL, the subject experienced red raised welt at injection site. The subject noticed 1/2 dollar sized big red welt at injection site. At the time of reporting, the event was improved after 3 days. This case is one of the 5 cases reported by the same reporter for the same vaccine.
Hives with fast pulse that would leave and then return in a few days for 1 month.
Small pink spot developed below injection site and over the course of 2-3 days the spot grew bigger and was warm to the touch. By Sunday, 3/21, it had started to bruise and turn purple in color. It was a little sore to the touch and was not a raised bump like a hive or welt, and it did not itch. It was flat, round, pinkish in color and grew  about 2' in diameter and was warm to the touch. By Sunday and today it was not as sore, but was still the same size and bruised.
Moderna COVID-19 Vaccine EUA Itching, red area approxximately 2-3 inches in diameter, knot/bump about the size of a dime.  Itching lasted less than 24 hours, red area got smaller, lasted approximately 48 hours, knot/bump size went down in approximately 48 hours.
The patient reported a sore arm and malaise at 8pm following the vaccination.  At 10:30pm, she awoke to use the restroom and felt weak and was stumbling to the toilet.  She then crawled back to bed.  She stated that she felt like she had a fever, very sore arm, headache and was nauseous.  The following day her symptoms improved but she reported a headache and nausea at 5pm on 10/25/23.
Injection site is warm; Injection site is welted; Injection site is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is warm), VACCINATION SITE URTICARIA (Injection site is welted) and VACCINATION SITE ERYTHEMA (Injection site is red) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is warm), VACCINATION SITE URTICARIA (Injection site is welted) and VACCINATION SITE ERYTHEMA (Injection site is red). At the time of the report, VACCINATION SITE WARMTH (Injection site is warm), VACCINATION SITE URTICARIA (Injection site is welted) and VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  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.; Sender'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.
Several minutes after IM injection with Gardasil vacc -patient felt nauseated and tingley. Fainted. Legs were elevated, BP taken, apple juice given. 10-15 minutes after later-felt better. Evaluated by doctor and was able to leave the office
The day after the second shot, fever of 100.8 and chills/ feeling cold. Sore arm.
some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes; 11 doses were administered after the excursion happened; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes), POOR QUALITY PRODUCT ADMINISTERED (11 doses were administered after the excursion happened) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     Relevant medical history/conditions, allergy, concomitant diseases and risk factor were unknown.     On an unknown date, 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 an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes), POOR QUALITY PRODUCT ADMINISTERED (11 doses were administered after the excursion happened) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes), POOR QUALITY PRODUCT ADMINISTERED (11 doses were administered after the excursion happened) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (some frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04AUG2023 during 2 hours and 50 minutes) and POOR QUALITY PRODUCT ADMINISTERED (11 doses were administered after the excursion happened).    Concomitant medication not reported.   It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Maximum temperature reached was 21.4°F. This was the first and only excursion.  This patient did not experience any adverse events.  This case contains information for 5th patient out of 11 patients.  Treatment medication not reported.
No additional AE's/PQC's were reported; reporting a temperature excursion for VARIVAX/ have been administered to several patients since the escursion; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 06-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose or frequency 1 (units not provided) (route of administration, vaccine scheme, anatomical site of vaccination were not reported; lot number T041685 has been verified to be valid, expiration date reported and established as 10-DEC-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 11.3 Fahrenheit degrees (°F) during a time frame of 15 minutes. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006576:
Generalized aches and pains. Vomiting, headache, fever, swelling. Injection site itching and induration approximately 3 inches. Follow up on 10/07/05: Doctor told the patient to stop taking all of the medication she regularly took and when she saw the patient again, there was still a little bit of induration at inj. site, but all other symptoms completely gone. Patient recovered.
I felt really bad chills; like I was having a fever. After two days, I felt shortness of breath. I had a hard time breathing. I rushed myself to ER  and they checked me to see if I had COVID - negative. I still had shortness of breath. Two days later, I still had shortness of breath - they checked me and they said it was possible pneumonia -Dose was: 5 days/ two days a day. After taking the antibiotic, I felt better. Shortness of breath was better - that was gone but I still felt weak though. I continued to feel weak for a week after that.