chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Batch/Lot number: unknown), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 13Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The patient did not receive any other medications/products within 2 weeks of starting COVID-19 treatment. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19 with Paxlovid from 20May2022 to 24May2022. The patient experienced rebound COVID on 28May2022 at 04:00 PM after a full course of Paxlovid. The patient started testing negative one day after completing the five-day course. Two days later, he had fully recovered with no symptoms. 2-3 days after. He started to become Sick again and tested three times positive for COVID. The tests were immediately very positive (more so than any test he took during Paxlovid treatment). The patient was symptomatic and isolating again. While the symptoms were not as severe as the first round, he was quite sick.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient woke up crying early am.  Next day, right (where DTaP and HIB were mixed), whole thigh red (bright) warm to touch, "itchy".  2 days later was white where injection was given then 3in circle was red.  Left thigh 2in red-raised area.  Temperature 99.8, local reaction lasted x 3 days on this date, still looks "sherry or like it was burned." "Peeling."
Poly Myalgia Rheumatica; This is a spontaneous report from a contactable consumer (patient herself).   A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, administered in right arm on 09Feb2021 14:00 (age at vaccination:72 years) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient's medical history was not reported. Concomitant medication included prednisone. The patient was allergic to demerol. The vaccine was administered in hospital. On 12Feb2021 08:00, the patient experienced polymyalgia rheumatica. The patient received prednisone as treatment for the event. The event required emergency room visit. The event of myalgia was considered to be medically significant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for covid-19. The device date was 12Jun2021. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
This spontaneous report as received from a female patient of unknown age, regarding herself. No medical history and current conditions were reported. On an unknown date in 2011 (reported as 3 to 4 years ago) the patient was vaccinated with ZOSTAVAX (dose, lot number was unknown). No concomitant medications were reported. It was reported that on an unknown date the patient was in physician office for a schedule visit and the physician noticed a rash on her leg and diagnosed the rash as shingles. The outcome of the event shingles was reported as not recovered. The reporter causality was not provided. No further adverse event information was provided. Additional information has been requested.
exhaustion/tiredness (consistently all day), mild nausea (on and off all day), headache (mild, all day) Resulted in sleeping for most of the day, eating simple foods. Symptoms were completely gone by the following morning (April 28)
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 55 years for COVID-19 immunization; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Chronic allergic rhinitis" (unspecified if ongoing), notes: Chronic allergic rhinitis. Concomitant medication(s) included: SINGULAIR; LOSARTAN; FLOVENT. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  Clinical course: Patient started Paxlovid (Lot number: GF4424)treatment on 12Aug2022 and stopped on 16Aug2022 via oral route for COVID-19. Patient received other medications in 2 weeks. No known allergies were reported.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
16Mar-inc T,sleeping-T not taken by parent.Sat midnight-higher T-APAP/baths given. 17Mar 7am-Fontanel rigid-discomfort when moved,dad rushed to ER-Home @ 11am.18Mar-still running T -reported taken
Horrible stomach pains; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Horrible stomach pains) and DIARRHOEA (Diarrhea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Horrible stomach pains) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (Horrible stomach pains) and DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Pt stated at her visit for 3rd injection, that after her 2nd injection she "lost her vision x 30 seconds. Blinked a few times and it came back"
Severe pain in arm at location of flu shot, a bit woozy as patient left store. Pain lasted through the next day.
Patient felt dizzy and nauseous.  Patient's Pulse, Oxygen level and Blood pressure were checked.  Patient Blood pressure was 208/119.  Patient was transported to Emergency Room, where her high blood pressure was treated and brought under control. Patient was then discharged from the ER to home on 4/2/2021.
A non-serious spontaneous report of inadvertent administration of expired H1N1 LAIV received from a registered nurse/health professional concerning a five-year-old female out of eight patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine was expired on 15-Jan-2010. On 25-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
in the bed for two weeks; Pain; This case was reported by a consumer via )interactive digital media and described the occurrence of bedridden in a 50-year-old 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 bedridden and pain. On an unknown date, the outcome of the bedridden was recovered/resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the bedridden and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The patient got that shingles shot when the patient turned 50 years as the birthday gift.  The patient got the shingles shot and landed back to the doctor then in the bed for two weeks. The patient stated that never been in so much pain and literally been hit by a bus. The patient was pray to don't get the shingles, as it was two shots now. The patient contact details were not reported so follow up not possible
Given at day 6 of  refrigeration as approved by Pfizer excursion temperature of 7 days, but not Walgreens.
woke up to a lump in her arm and a red line and very itchy. She put Neosporin on it and a cold compress.
Neck pain, Fever of 102F, sore throat, hands hurt, headache, dizziness, noise sensitivity.
Had a metallic taste that lasted about a hour; Had a metallic taste that lasted about a hour, and the smell of it for about 10 mins; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 11Jan2022 at 11:15 (Lot number: FL3198) at the age of 45 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Cold allergy" (unspecified if ongoing), notes: Known allergies: the cold and "Allergy to plants" (unspecified if ongoing), notes: Known allergies: evergreens. Concomitant medication included: PERCOCET.  The following information was reported: DYSGEUSIA (non-serious) with onset 11Jan2022 at 11:15, outcome "recovered" (11Jan2022), described as "Had a metallic taste that lasted about a hour"; PAROSMIA (non-serious) with onset 11Jan2022 at 11:15, outcome "recovered" (11Jan2022), described as "Had a metallic taste that lasted about a hour, and the smell of it for about 10 mins". Therapeutic measures were not taken as a result of dysgeusia and parosmia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 treatment clinic.
Shortness of Breath and Cough (Productive cough green sputum times 3 days. Covid positive 5/24/2022)
muscle spasms on left side of body ; arm, leg, and shin; swollen arm; chills, shivers; headache; redness on swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle spasms on left side of body ; arm, leg, and shin), PERIPHERAL SWELLING (swollen arm), CHILLS (chills, shivers), HEADACHE (headache) and ERYTHEMA (redness on swollen arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced MUSCLE SPASMS (muscle spasms on left side of body ; arm, leg, and shin), PERIPHERAL SWELLING (swollen arm), CHILLS (chills, shivers), HEADACHE (headache) and ERYTHEMA (redness on swollen arm). At the time of the report, MUSCLE SPASMS (muscle spasms on left side of body ; arm, leg, and shin), PERIPHERAL SWELLING (swollen arm), CHILLS (chills, shivers), HEADACHE (headache) and ERYTHEMA (redness on swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient received Pfizer COVID-19 vaccines on 4/1/2021, and on 4/22/2021.   57YO female presents on 4/30 with chief complaint of chest tightness and throat swelling sensation. Patient has a history of allergic reactions. She developed a mild reaction after her first Covid vaccine (4/1). More severe reaction after her second vaccine which was one week prior (4/22). She was doing better after an ER visit and 2 days of prednisone. On 4/30  she began developing the same symptoms specifically tightness in the chest difficulty breathing raspy voice and a feeling of swelling in her throat. No difficulty swallowing.
Itching is relentless; Skin is all scratched up; Creating scars; Rash all over back, neck, down to butt; This is a spontaneous report from a contactable consumer or other Non Health Care Professional.    A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 08Apr2021, as DOSE 2, SINGLE for covid-19 immunisation. The patient had received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date, as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced Creating scars, Skin is all scratched up and Itching is relentless. On 08Apr2021, the patient experienced rash all over back, neck, down to butt (rash). At the time of reporting, the outcome of the events were unknown.   No follow-up attempts are needed. No further information is expected.
Lymph node swelling of armpit and supraclavicular nodes, fever of 100.9 on 02/24/21 (resolved 02/25/21)
Painful, itchy rash over dorsal aspects of hand/fingers. Worse with heat. Some vasculitis/intraepithelial bleeding
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 05-SEP-2013, the patient was vaccinated with an expired dose of VARIVAX(Merck) (lot # 1380AA expiry: 25-AUG-2013). No adverse effects were reported. Additional information has been requested.
Left upper arm from clavicle to 1 inch below elbow with erythema, 2-3 and non pitting edema, tender to palpitation. Patient was evaluated 3 days after DTaP/HIB immunization given in that extremity.
Feeling abnormal; Hard time eating, getting up; Hard time eating, getting up; Loss of apetite; Severe diarrhea; COVID-19 symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of apetite), DIARRHOEA (Severe diarrhea), FEELING ABNORMAL (Feeling abnormal), EATING DISORDER (Hard time eating, getting up) and MOBILITY DECREASED (Hard time eating, getting up) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020. Concurrent medical conditions included Kidney failure since June 2020, Dialysis, Diabetes and Hypertension.   On 23-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced SUSPECTED COVID-19 (COVID-19 symptoms). On 28-Mar-2021, the patient experienced DECREASED APPETITE (Loss of apetite) and DIARRHOEA (Severe diarrhea). On an unknown date, the patient experienced FEELING ABNORMAL (Feeling abnormal), EATING DISORDER (Hard time eating, getting up) and MOBILITY DECREASED (Hard time eating, getting up). At the time of the report, DECREASED APPETITE (Loss of apetite), DIARRHOEA (Severe diarrhea), FEELING ABNORMAL (Feeling abnormal), EATING DISORDER (Hard time eating, getting up), MOBILITY DECREASED (Hard time eating, getting up) and SUSPECTED COVID-19 (COVID-19 symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Significant Follow-up was received on 15-JULY-2021 and  outcome added.
Patient is a 56 y.o. female with a history of passing out in March this year. Was seen in ED, workup benign, not admitted. Has had a couple episodes since. Has had echo which was benign. Also of note, had COVID a couple weeks ago, had fever, short of breath, she is over this. Weak episode last night brought on by low BP. Nothing makes this better or worse. No fever, no vomiting. Chest pain at times. Urinary sx but culture recently was negative. To ED, BP low here and improved with IVF. Recent increase in cozaar dose?"   Hospital Course:   Patient presented with weakness. She was found to have near syncope related to orthostatic hypotension. She was seen by cardiology and workup was done including echocardiogram and stress test. No cardiac etiology was identified. Cardiology recommended to stop losartan and continue metoprolol. She had no further episodes of near-syncope so wanted to go home. She was recommended follow-up with PCP and cardiology as an outpatient.  Urinary tract infection was ruled out. Patient was started on iron supplementation at discharge.     Unresolved issues requiring follow up (w/ labs or studies): None         Consults:   IP CONSULT TO CARDIOLOGY   Significant Diagnostic Studies:    Iron deficiency   Operations:  Low-risk stress test   Wound care recs: None    Disposition:  home   Discharge Condition:  good
On 9/18/00, pt had abdominal pain, cramping, vomiting and diarrhea. Had a similar episode after Hep-B #2 on 8/16/99.
10-11 hours after vaccine started with headache, body aches, fatigue.  22 hours after vaccine woke up to severe joint pain, body aches fatigue 36 hours after, mild joint pain and fatigue 48 hours after vaccine fatigue
p/vax pt devel an inj site rxn characterized by redness, tenderness & swelling extending tot he mid-arm;
Patient received vaccination on 7/11/18 and came to pharmacy 7/18/18 to report event. He said after receiving immunization his arm became painful and red at injection site and hot to touch. He said the next morning there was a hard nodule present at injection site. He went to doctor on 7/18/18 and was given antibiotic and steroid to help with reaction. He said pain is getting better but his arm is still red. BENADRYL and OTC pain relievers were also recommended to the patient.
Hives developed on 5/15/01, rapidly spread over head, trunk and limbs. Had chills X 2 hours on 5/15/01. No other symptoms and no dyspnea. He had little clinical response to Benadryl (50mg every 4 hours X 1 day), but improved rapidly with added Rx of prednisone (20mg tid).
REAL SICK; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients of unspecified age, sex, race and ethnicity. No past medical history or concurrent conditions were reported. The patients were previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. It was unspecified whether patients had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patients received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients got real sick (dose number in series 2). It was reported that "every one I know that have got the booster have also got real sick after getting it". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of real sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20220234001.
12 mo shots administered on 9/28. On 10/06 parents noticed a body covering rash while giving night time bath and called on-call provider at clinic.
I felt dizzy, tired and had chills.  I rested overnight and feel fine now.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. No excursion occurred. The Moderna vials were taken out of the freezer, thawed and administered as instructed. No delays occurred in administration of Moderna vaccine. On 01Nov2021, all vaccines were administered within 4-5 hours.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up received includes updated Second reporter Information.
Arm was sore; Little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and FATIGUE (Little tired) in a 71-year-old female patient who received mRNA-1273 (batch no. 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism and Lyme disease.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore) and FATIGUE (Little tired). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and FATIGUE (Little tired) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       The concomitant medication include Hypothyroid medication.  No treatment information was provided.   Reporter did not allow further contact
Information has been received from a nurse practitioner via a company representative referring to a 14 year old patient of unknown gender. On 04-MAY-2015 the patient was inadvertently vaccinated with a dose of GARDASIL (0.5 ml, once, lot# was not reported) in the left hip subcutaneously or intramuscularly (Vaccine administered at inappropriate site). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Pt was given DTaP in left upper arm IM and IPV Subc on Tues 7-31-07 - PM; Wed. morning 8-1-07 arm red and sore; Thursday 8-2-07 entire upper arm red and swollen from shoulder to elbow, no fever. Dr placed on Keflex PO.