chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea, dizziness, felling of going to pass out, sweaty, fever, chills, body aches, crawling under skin tingling, swelling on lymph nodes especially underarm of injected arm, fatigue, muscles weak, moving slow, everything lasted about 3-5 days
Patient states rash on left arm started 4-5 days post administration of 2nd dose of the Moderna COVID vaccine. Patient went to see primary care physician, was prescribed orals meds, symptoms did not subside and later was referred to an Infectious Disease physician. Patient went to see Infectious Disease physician and was diagnosed with having "Moderna Rash" and "Frozen Shoulder." Infectious Disease physician told patient to call site where she received COVID vaccine and have it reported.
I am running temperature 100.4; muscle soreness; tired; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2020, the patient received the 2nd dose of Shingrix. On 17th November 2020, 1 days after receiving Shingrix, the patient experienced fever, muscle soreness and tiredness. On an unknown date, the outcome of the fever, muscle soreness and tiredness were unknown.   It was unknown if the reporter considered the fever, muscle soreness and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix, fever,muscle soreness and tiredness. The patient had fever of 100.4 degree fahrenheit. The age group was not reported but taken as adult as per vaccine indication. The information regarding consent to follow up was not reported. No further information was available.
This spontaneous report was received from a nurse referring to patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. The nurse reported that an unknown number of doses of ROTATEQ (lot #: L033545; expiration date: 30-MAR-2017) experienced a temperature excursion of >46F - <77F for 6 hours 30 minutes. Data logger was involved. There was no previous temperature excursion. On multiple unspecified dates, unspecified patients were administered these improperly stored doses of vaccines. No adverse effects reported. This report is one of the reports from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009748.
Redness and itching around injection site; minor pain. Condition has persisted and redness seems to be spreading.
On 9/2/00, the pt developed a rash under his left breast, left posterior ribs, and on left buttocks; patches blistery in appearance. No other areas noted at this time.
Post a second shot of Pfizer Vaccine, normal symptoms appeared of tiredness, sore arm, and generally feeling awful started. Went to see a heart doctor as well, thinking something may be wrong, kept getting worse. Persistent pain in the breast and under armpit/shoulder area started to get severe. Had trouble breathing. Eventually ended up at Urgent Care on May 26th - presented with Fluid in Lungs. Went to the hospital via ambulance, where liver enzymes and liver ducts also inflamed. No pneumonia, no positive for COVID, not positive for hepatitis or any other bacteria-related infections. all liver enzymes have returned to normal levels, but one. Still have fluid in the lungs, though it it getting better on its own and we are now back at home.
Dizziness. Vaccine recipient stated  "My feet are heavy, like someone is weighing them down". Onset of symptoms within 15 minutes of vaccine administration.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: patient showed up on Saturday 09/17 with bruised and itchy left arm right starting the spot of injection till the whole left hand.
pt recv vax & became lethargic then t105 x 6hr then improved;seemed self the next day;no sequelae; may have been viral illness;
p/vax pt exp very tender lt arm at inj site; raised red macular rash; low grade temp; malaise; anorexia; tx: benadryl, tylenol, rest x24hr
Patient experienced on second shot (vaccine) left arm hurt got it in t's a little warm and it was red around and itches; Patient experienced on second shot (vaccine) left arm hurt got it in t's a little warm and it was red around and itches; This is a spontaneous report from a contactable consumer. A 73-Year-Old female consumer (patient) received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration in left arm on 18Feb2021, as single dose for covid-19 Immunization. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for covid-19 immunization. Relevant medical history included Diabetic (From: Dec 2005 to: Unspecified), CPAP from an unspecified date to unspecified date, Asthma from an unspecified date to unspecified date and Cholesterol from an unspecified date to unspecified date. The patient concomitant medication included started on unspecified date Dulaglutide(TRULICITY) took for Diabetes, Budesonide (BUDESONIDE) took for Asthma, Metformin (METFORMIN) (500 mg tablet), twice a day took for unspecified indication, Pravastatin (PRAVASTATIN) (40mg) Indication used for Cholesterol, Lisinopril (LISINOPRIL) (5 mg, once a day), Aspirin (ASPIRIN [ACETYLSALICYLIC ACID]) (82 mg, Once a day), Multivitamins, (2 pills, once a day), Aminobenzoic Acid, Calcium Pantothenate, Cyanocobalamin, Nicotinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamine Hydrochloride (B-COMPLEX [AMINOBENZOIC ACID;CALCIUM PANTOTHENATE; CYANOCOBALAMIN; NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]), Vitamin d (VITAMIN D [VITAMIN D NOS]) (200 IU and took 2 (tablet) of those daily), Omega Fish Oil (FISH OIL) (1200 mg, (2 dose) once a day) Ubidecarenone (COQ-10) (100 mg, once a day) stopped if unspecified date. Patient experienced on second shot (vaccine) left arm hurt got it in t's a little warm and it was red around and itches. The outcome of the event was not unknown.
received doses and they hurt a lot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: received doses and they hurt a lot). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient already took Shingles vaccine dose and they hurt a lot. The follow-up could not be possible as no contact details were available.
Family members experienced a rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Family members experienced a rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Family members experienced a rash). At the time of the report, RASH (Family members experienced a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Severe tiredness after 2nd shot for 3 days, but became less run down feeling over time. 3 weeks after second shot, noticed extreme fatigue during cardiovascular activity. Reported to Primary Healthcare Provider during routine physical on 06/11/21. Bloodwork (taken 6/15/21) showed symptoms of myodysplastic syndrome. Referred to hematologist for treatment.  Awaiting further testing including bone tap and appointment. Patient had none of these symptoms prior to second COViD vaccination and assumed symptoms would disappear over time. He is still symptomatic as of this date.
Had a sore shoulder for a few days; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ARTHRALGIA (shoulder soreness). At the time of the report, ARTHRALGIA (shoulder soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Elevated, resting heart rate of over 100 bpm. Normally 70-75. Heart beating stronger than normal. Started about 22 hours after vaccine and has lasted since. No increased blood pressure.
Approx 1 day after AFLURIA and PNEUMOVAX dose, pt c/o swelling, redness, pain on injection site. Redirected pt to MD if not resolved in 3-5 days. Pt went to ER on 1/21 (3 days later) and was diagnosed cellulitis.
Covid-19 positive on 09-17-2021. Hospitalized 09-17-2021 Flown to another state 09-22-2021 Died of Covid-19 10-02-2021
5x6cm red, warm area around Prevnar site c/w cellulitis. 2.5cm diameter warm, red, firm area around Hep A site c/w cellulitis. Augmentin and Loratadine prescribed.
65 y/o male received TDAP vaccine and reported tingling feeling all over approximately 2-3 hours after vaccine. Has > 5 allergies to other medications- similar reactions reported. Diphenhydramien 25 mg other.
this patient's family arrived at the Respiratory Clinic for their annual flu shot and they decided to also get the Moderna vaccine added on for all three family members.  While this patient's age showed she was eligible for the vaccine, we learned _after_ giving the vaccine that they had previously received doses of the Pfizer vaccine for their age group on 09/08/22, 11/03/22 and 04/20/23.  It was after injecting this patient with the Moderna monovalent, database informed us that this patient was not eligible to receive the Moderna vaccine based on the fact that they previously had been caught up with the Pfizer dose.  Patient's mother was instructed to wait 15 minutes for observation and nothing out of the norm occurred. I wanted to let you know that this happened in the event that your team would like to do any follow up.  PCP, Dr. has been notified of this incident. I am also filing a Data and VAERS report regarding this incident.
Patient was administered YF-VAX intramuscularly rather than subcutaneously with no reported adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered YELLOW FEVER VACCINE [YF-VAX] intramuscularly rather than subcutaneously with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect YELLOW FEVER VACCINE (strength, formulation, route, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of was administered yf-vax intramuscularly rather than subcutaneously with no reported adverse event (incorrect route of product administration) (latency: unknown).  Action taken: not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Dizziness; weakness; Fever 101.5 F; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (weakness), PYREXIA (Fever 101.5 F), CHILLS (Chills) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (weakness), PYREXIA (Fever 101.5 F), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 18-Feb-2021, DIZZINESS (Dizziness), ASTHENIA (weakness), PYREXIA (Fever 101.5 F), CHILLS (Chills) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Body temperature: 101.5f 101.5F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   This case was linked to MOD-2021-243218 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Non-Significant follow up appended to AER
Presented with increasing dyspnea over 2-3 weeks; CXR with mod pleural effusion and/or infiltrate/atelectasis; Labs: D-dimer 3.14; CRP 4.89; Ferritin 195; Tx: Maxipime, vit C, Decadron, Zithromax, Vit D3, Lovenox, Zinc; Minimal supplemental O2 via NC; back to room air by d/c; pt with thoracentesis on 1/19; pleural fluid was exudative; sent for cytology; CT chest with pulm nodules, right sided pleural based masses, bulky mediastinal lymphadenopaty and multiple liver lesions all concerning for metastatic disease.
Occlusive Dural venous sinus thrombosis involving the right sigmoid sinus and visualized right internal jugular vein with non occlusive dural sinus  thrombosis of the right transverse sinus
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I'm worried that the vaccine was out of refrigerator when administered) and PRODUCT STORAGE ERROR (doses were out in the open and not in a refrigerator) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (I'm worried that the vaccine was out of refrigerator when administered) and PRODUCT STORAGE ERROR (doses were out in the open and not in a refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I'm worried that the vaccine was out of refrigerator when administered) and PRODUCT STORAGE ERROR (doses were out in the open and not in a refrigerator) 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.
Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients; This non-serious spontaneous safety report, with reference number 02268180/ Interaction# 02268162 was received on 17-OCT-2022, from a non-health Professional.   Due to the nature of the event, the causality between the event "Unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients" and Vaxelis was not applicable.  Further information is expected.  For reference purposes this case is linked to MCM-004173, MCM-004202 and MCM-004203.
PATIENT DECEASED ON    5-23-22  AND TESTED + AT MEDICAL CENTER 5-23-22 .
Father reports pt developed diffuse, slightly raised rash. The night pt received vaccines. Father states infant was rubbing self against sheets. No fever. Rash had resolved when pt came to clinic about 24 hours after immunizations.
Red swollen area around injection site and below injection site.  Area hot to the touch and mild fever.  Pain due to swelling that lasted three to four days.
Patient was admitted with COVID-related Pneumonia 7/24/2021, discharged on 7/26/2021.  Received both doses of Pfizer vaccine (dose #1 on 12/31/2020 and does #2 on 1/21/2021).
8pm teeth chattering chills By Sunday morning 9am 100.9 fever and swollen underarm lymph nodes  Sunday 3pm no fever (with ibuprofen) Exhaustion (lasted 3 days) Inability to regulate body temperature (no fever) 2 additional days (hot/cold and sweats) Swollen lymph nodes lasted 5 days
Initial headache 30 min post vaccination and lasted for 1 hour. On 12/25/2020 tenderness noted in left armpit (lt injection arm). Tenderness persisted and worsened through 1/4/2021. On 1/4/2021 a lump was noted inferior lateral left neck. Ultrasound proved multiple enlarged lymph nodes in left axilla and left neck.
Inconsolable crying with head twitching - lasted for about 30 minutes - low grade fever 1st 24 after shots.
Presented to the ED with complaints of left hip and left leg pain status post syncope and fall 1 day ago.  States that she got up to use the bathroom and while getting up from the toilet blacked out and fainted.  Reports some dizziness prior to blacking out but denies any chest pain, palpitations, shortness of breath.  States that when she awoke she was diaphoretic.  States that she also fell 1 day prior.  Dependent on a cane or walker for ambulation after stroke and residual left-sided weakness as well as diabetic neuropathy.  Denies any recent illness, fever, chills, chest pain, changes in urinary habits, changes in bowel habits.  Pt had left hip cephalomedullary rod fixation.  POD 5 noted to have cough and chills Pt discharge plan was for inpatient rehab - upon testing for placement patient tested Positive for COVID 19 on 1/26/22.  Patient had previously been vaccinated with Pfizer 3/4/21 and 8/16/21. Patient discharged from hospital 2/10/22
This case was reported in a literature article and described the occurrence of unknown cause of death in an adult subject of unspecified gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified 2011-2012 season (administration site and route unknown, batch number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified 2011-2012, the subject was hospitalised. The subject died from cause undetermined. It was unknown whether an autopsy was performed. Summary of the literature article: Annual influenza vaccine has been recommended for adults at high risk for influenza complications since 1960; universal vaccination has been recommended since 2010. Two recent reviews both reported that there is little evidence to support vaccine effectiveness against serious influenza complications for adults. Clinical trials have been too small to evaluate influenza complications, and most observational studies have not used laboratory-confirmed influenza as an outcome. The case-positive, control-negative study design is an efficient method to determine vaccine effectiveness that assures appropriate classification of cases and identifies controls with risk factors for both acute respiratory illness and propensity to seek medical care similar to those of influenza-positive patients. During the 2011-2012 influenza season, the authors enrolled hospitalized adults with acute respiratory illness and tested each for influenza using reverse transcription polymerase chain reaction. Influenza vaccination was verified in 35% (6/17) of adults with influenza-associated hospitalizations compared to 64% (97/152) of test-negative controls; adjusted vaccine effectiveness was 71.4% (95% confidence interval, 17.1% - 94.9%). Although the authors enrolled subjects with fairly broad eligibility criteria, discharge diagnoses were not associated with either influenza diagnosis or vaccination status. These data are among the first estimates of vaccine effectiveness for the 2011-2012 influenza season. More important, this study adds to the evidence indicating that inactivated influenza vaccine can prevent more than half of all influenza-associated hospitalizations in older adults. Influenza causes an average of 294 128 hospitalizations annually; most are in adults aged. 50 years. The authors's conclusion stated that given current vaccination rates and a vaccine effectiveness of 60%, more than one-third of these hospitalizations could be prevented by increasing vaccination uptake in this population.
She is a 14 yo girl who has been seeing  Cardiology for chronic idiopathic pericarditis, referred to ID to investigate potential causes, including if there might be a link to the COVID vaccine that she received. The infectious disease testing was overall unremarkable, except that her COVID IgG was negative (sent because she had a history of presumed COVID), and a sendout for COVID Spike protein IgG was positive (likely showing response to the vaccine).   timeline of events:  July 2020 ? patient with presumed COVID-19, symptomatic with a viral illness and multiple family members with similar symptoms tested + for COVID-19 September 2020 ? began experiencing intermittent episodes of chest pain ? seen by PCP only at several visits with normal EKG (9/9/2020, 1/27/21), estimated 5-6 episodes total  5/15/21 ? 1st dose of Pfizer COVID-19 vaccine Week of 5/25/21 ? started to have more significant symptoms of chest pain that lasted for longer than previously, seen by PCP 6/3/21, 6/14/21, 6/17/21 and started on naproxen 6/5/21 ? 2nd dose of Pfizer COVID-19 vaccine 6/21/21 ? first seen by Cardiology, had elevated inflammatory markers and trivial pericardial effusion, diagnosed with likely recurrent pericarditis 6/22/21 ? seen by Rheum, added colchicine 7/13/21 ? f/u with Cards, symptoms improved, echo normal 8/23 ? f/u with Cards, symptoms resolved, normalized inflammatory markers, stopped naproxen 8/31 ? f/u with Rheum, symptoms remain resolved 9/9 ? cardiac MRI done, some delayed enhancement noted in the pericardium but no thickening or effusion 9/17/21 ? seen by ID, symptoms remain resolved
A nurse reported that a female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Ultrafined (Wyeth) on 03/09/00. She subsequently developed an injection site reaction characterized by a "baseball" size area of swelling, redness, and tenderness. Follow up info received from the physician on 10/06/00, indicated that the patient was a 48 year old female who experienced the adverse event on 03/11/00. The patient recovered.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills, swollen lymphnodes Narrative:  Other Relevant History: