chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No further adverse event; TE was supported; one dose was administered; This spontaneous report was received from a nurse, regarding to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant therapies, allergies and drug reactions were not reported.  On 19-OCT-2023, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis (lot #X009734 has been confirmed as valid, expiration date was reported and confirmed on 30-SEP-2024, therapy type rHA, vaccination scheme, strength, and route of administration were not provided), that vaccine was involved in a temperature excursion (Product storage error) for a time frame of 3 hours 41 minutes, with a temperature of -14.3 degree Celsius (°C). There were previous temperature excursions from a temperature of -14 °C to -10°C for 3 minutes. Other temperature excursion were reported as follows: 14°C to -10°C(-14.6C) for 2 Hours 12 Minutes 0 Seconds; -14°C to -10°C(-14.6C) for 5 Hours 43 Minutes 0 Seconds; -14°C to -10°C(-14.6C) for 4 Hours 49 Minutes 0 Seconds; -14°C to -10°C(-14.3C) for 6 Hours 3 Minutes 0 Seconds; -14°C to -10°C(-14.2C) for 6 Hours 59 Minutes 0 Seconds; -14°C to -10°C(-14.3C) for 2 Hours 33 Minutes 0 Seconds; -14°C to -10°C(-14.6C) for 0 Hours 45 Minutes 0 Seconds; -14°C to -10°C(-14.6C) for 2 Hours 7 Minutes 0 Seconds; -14°C to -10°C(-14.8C) for 0 Hours 34 Minutes 0 Seconds; -14°C to -10°C(-14.5C) for 1 Hour 25 Minutes 0 Seconds; -14°C to -10°C(-14.8C) for 0 Hours 26 Minutes 0 Seconds; -14°C to -10°C(-14.8C) for 0 Hours 24 Minutes 0 Seconds; -14°C to -10°C(-14.8C) for 0 Hours 15 Minutes 0 Seconds; -14°C to -10°C(-14.5C) for 4 Hours 23 Minutes 0 Seconds; -14°C to -10°C(-14.1C) for 9 Hours 24 Minutes 0 Seconds; -14°C to -10°C(-14.2C) for 8 Hours 10 Minutes 0 Seconds; -14°C to -10°C(-14.2C) for 8 Hours 5 Minutes 0 Seconds; -14°C to -10°C(-14.2C) for 8 Hours 31 Minutes 0 Seconds; -14°C to -10°C(-14.2C) for 6 Hours 37 Minutes 0 Seconds. No further adverse event (AE) (No adverse) details were reported.
Fever, arm swelling, arm tenderness, body aches, and rash on legs lasted 2 days.  Rash on legs is what prompted reporting of symptoms.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6200), in left arm, on 25Mar2021 as dose 2, single (Lot number: ER8732), in left arm, on 29Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: other medical history: High blood pressure; "GERD" (unspecified if ongoing), notes: other medical history: GERD. There were no concomitant medications. Past drug history included: Most antibiotics, reaction(s): "Known Allergies: Most Antibiotics"; Triptans, reaction(s): "Known allergies: Triptans"; Lipitor, reaction(s): "Known allergies: Lipitor"; Pepcid, reaction(s): "Known allergies: Pepcid"; Nifedipine, reaction(s): "Known allergies: Nifedipine"; Ace inhibitors, reaction(s): "Known allergies: ACE inhibitors". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: Other medication in 2weeks: No; Antiviral details: [{Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 07Jul2022, Treatment stop date: 11Jul2022, Indication: Treatment of COVID-19.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) and COVID-19 cannot be ruled out.
numbness and tingling to my lips and the right side of my face; numbness and tingling to my lips and the right side of my face; numbness and tingling to my lips and the right side of my face; numbness and tingling to my lips and the right side of my face; jaw ache to the right side of my jaw; This is a spontaneous report from a contactable nurse, the patient. A 52-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an unspecified route of administration in left arm on 27Mar2021 at 12:00 (age at vaccination was 52 years) as a single dose for COVID-19 immunisation. The patient medical history included history of anaphylaxis. The patient was allergic to latex, bananas and melons. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 27Mar2021 at 12:30, starting 20-30 minutes after injection, the patient began to feel numbness and tingling to her lips and the right side of her face. When she returned home, she took a BENADRYL with some relief. However, since then the face and lip tingling had persisted intermittently and she had a jaw ache to the right side of her jaw. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 30Mar2021, the patient underwent abbott binax nasal swab test for COVID-19 and the report was negative. The clinical outcome of the events numbness and tingling to lips and the right side of face and jaw ache to the right side of jaw was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021; Doses was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was infection control manager.  Concomitant medication of the patient was not reported.  There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-491837 (Patient Link).
A customer that is 33 years old comes in for GARDASIL 9; No additional adverse effects reported; This spontaneous report was received from a pharmacist and refers to a 33-year-old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, lo# and expiry date were not provided) for prophylaxis (product administered to patient of inappropriate age). The patient did not come back for the second dose until 4 months. The reporter wanted to know when should the patient back for the third dose. No additional adverse effects were reported.
FEVER 100 DEGREES FOR 30 HOURS CHILLS BODY ACHES LOSS OF APPETITE RACING HEART WITH RESTING PULSE OF 102 FOR 36 HOURS
Inflammation, redness, warm to touch, induration to left upper arm at site of injection.
The vial was initially placed in the refrigerator on 22-Sep-2021 and dose administed on 30-Nov-2021.; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (The vial was initially placed in the refrigerator on 22-Sep-2021 and dose administed on 30-Nov-2021.) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially placed in the refrigerator on 22-Sep-2021 and dose administed on 30-Nov-2021.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (The vial was initially placed in the refrigerator on 22-Sep-2021 and dose administed on 30-Nov-2021.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No adverse events were reported. The vial did not undergone any temperature excursion issue. The vial was initially placed in the refrigerator on 22-Sep-2021. Many doses were administered from expired lots due to confusion with the expiration date printed in the label.  No treatment information was provided.
severe chills, fever 102,1, felt like someone beat me all over, swollen lymph nodes, bright read rash  at injection site which i still have., headache, nausea
immediately following vaccine, staff reported bad taste in mouth followed by feeling dizzy and nauseous. Staff member was given water, snack and received 25mg PO of Benadryl along with 30 minutes of observation. At the end of 30 minutes, staff member stated that he still felt a little light headed but felt it was better. Staff returned to work. After getting to area of his office another staff member noted that he was looking unsteady and assisted him safely to a chair. Staff member then became increasingly disoriented, hyperventilating,  and unable to answer questions, vital signs were stable, 2 L O2 via nasal canula was started for patient comfort which did provided improvement and he became more responsive. 911 was called to have him transported to a medical facility for further evaluation. He has since recovered.
26FEB awoke w/itchy, blotchy "hive rash on forearms, thighs, armpit, legs; no fever or arthralgia; 27FEB went to ER 3PM; found generalized urticarial rash; no wheezing, lungs clear; ER d/c dx allergic rxn;
Headache, itchy eyes. Dizziness and weakness. Difficulty breathing. Itching and coughing.
61 Y male with h/o GERD, myotonic dystrophy (adult onset muscular dystrophy dx age early 40s, now with bilateral hand and leg weakness, difficulty with balance, fecal incontinence, last neuro note from 1/20/21), ?tachyarrhythmias followed by cardiology (last in 3/2020), right knee OA, who presents with increasing shortness of breath. Pt started having headache, sore throat, cough, myalgias on 8/2. He had a positive covid test on 8/11/21. He was vaccinated with pfizer on 4/12/21, 5/3/21.   The last two days he has been feeling much worse. He has shortness of breath, wheezing, cough, chest congestion, fatigue, more sputum production. He has had chest discomfort across both sides of his chest. He had a VAV today and was referred to ED for evaluation. Per ED Dr  "Pt placed on o2 by nursing as sats were at 90% on ra.  I had him do squats in the room off o2. His oxygen levels initially dropped into the high 80's, but then became very dyspneic/tachypenic and felt like he was going to syncopize.  His o2 levels rebounded quickly with rest and his increased respiratory rate, but pt did not feel comfortable going home."   Regarding his myotonic dystrophy, he reports that his weakness has been steadily worsening monthly. He is still able to eat and swallow normal texture foods. Last night he was able to eat steak and mashed potatoes. No choking episodes. However, sometimes his jaw "catches" and he is unable to chew or speak temporarily. His hands and legs are weak. On ROS, he denies fever, abd pain, nausea, vomiting, dysuria, hematochezia, melena. He has a walker but does not use it. He still drives; his car is in our parking lot. He takes an occasional antiacid for GERD but it is mostly controlled by diet and lifestyle modification. "   1) COVID Pneumonia, Acute hypoxemic Respiratory failure - Symptom onset on 8/2/2021. Patient found to be COVID positive on 8/11/2021.  Patient was on nasal Cannula at 2Lpm and now on RA.  Goal SpO2 >92%. Consider ICU evaluation if requiring >40LPM and 60% FiO2 for SpO2 >/= 90% - Self-proning as tolerated for O2 req >3L - Decadron 6mg IV or PO qday for up to 10 days (started 8/14/2021) or until no longer hypoxic. - Remdesivir 200mg IV x1, followed by 100mg IV daily until clinical improvement or 5 days (started 8/14/2021), last dose 8/18/21. - Daily LFTs. Hold Remdesivir if ALT >10xULN or CrCl<30 - Pecid for GI prophylaxis - trend inflammatory markers - Lovenox 40mg SQ daily and hold for Plt <25k, Fibrinogen <100, active bleeding - continue isolation in hospital per Regional/Local ID guidance. -Plan to increase activity levels in room and check 02 sats on RA tomorrow.   Modified IMPROVE VTE SCORE (for discharge) Age more than 60 years. - 1 POINTS Total Points: 1 o Consider anticoagulation if IMPROVE VTE score greater or equal to 4 OR IMPROVE VTE score is 2 or more, and the D-dimer is greater than 2x ULN on discharge.  o Anticoagulate with Rivaroxaban 10mg orally daily for 30 days total post-discharge or Enoxaparin 40mg SC q24 hours
Constant, roaring, and very loud tinnitus-mostly in right ear, but definitely in both ears Headaches and facial pressure on right side, same side as loudest tinnitus Sparks of quickly arriving and quickly leaving severe chest pain slightly left of center
Site: Pain at Injection Site-Medium, Additional Details: body felt heavy, decreased arm extension, md visit on 7/20/21, when lift arm, feels like it locks
For Five Day Body Pain,  severe headache, chills and fever, arm pit soreness, soreness down arm to wrist, nausea, redness on shoulder under injection spot that has grown larger and is hot.
ran temp @ noc <102;no fever during day-began noc p/vax;reported achiness & blotchy face;family reports resolved on 26MAR97;family reports tests revealed pt had mononucleosis;
This spontaneous report as received from a consumer refers to her 13-year-old son with asthma, nut allergy and weakened immune system. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot#, dose, route and site of administration were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced havoc and lost year of life. The outcome of impaired quality of life was reported as recovered/resolved on an unspecified date. The reporter considered impaired quality of life to be related to GARDASIL. Additional information has been requested.
Pt developed fever >101F within 12 hrs of receiving vaccine. Edema and severe pain at site of injection. Began after 2hrs of injection which included shoulder area and restricted right arm movement. Symptoms persisted for three days. Pain not relieved by APAP. Disturbed sleep.
Light headed. Fainted. Shaking uncontrollably. Extreme fatigue and body aching. Extreme sweating. After 24 hours, all muscles very sore.
PRESENTS 4/26 TO HOSPITAL EMERGENCY DEPARTMENT (ED) 5 DAYS POST VACCINATION WITH TONGUE SWELLING , SOB  WHILE IN ED HAD CARDIAC ARREST, WAS RESUSCITATED, INTUBATED AND TRANFERRED TO ICU. IS CURRENTLY ON VENTILATOR AND VASOPRESSOR SUPPORT.
This spontaneous report was received from the patient's mother refers to a 17 year old female patient. The patient had allergy to penicillin. On 07-JUL-2011 the patient was vaccinated with the first dose of GARDASIL; on 15-AUG-2011 the patient was vaccinated with the second dose of GARDASIL; and on 09-APR-2012 the patient was vaccinated with the third dose of GARDASIL. On 01-DEC-2014 the patient went to a physician visit for a routine sports physical examination and was vaccinated with GARDASIL, one injection, intramuscular in the arm, (strength, lot number and expiration date were not reported). Concomitant therapies included unspecified flu shot in the other arm on the same day GARDASIL was administered. The reporter stated that the patient was given a 4th dose of GARDASIL in error, because the patient already completed the three dose series of GARDASIL and this should had been in her medical records. On 01-DEC-2014, after being administered the fourth dose of GARDASIL, the patient "fainted", hit her head, and was unconscious for about one minute near the front desk. The patient was immediately rushed to the Emergency Room for further testing and observation. The patient showed signs of low blood pressure and she vomited. Electrocardiogram (EKG), labwork and computerised tomogram (CAT) scan were performed, results were not provided. The patient was treated with fluids. No further information was provided. The outcome of fainted, hit her head, unconscious for about one minute, signs of low blood pressure and vomited were unknown. Upon internal review the event unconscious was considered serious due to medically significant. Additional information is not expected, because contact information was not provided.
Blood pressure was a little up; Diarrhea; Weak; 99.1 F body temperature; Very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure was a little up), DIARRHOEA (Diarrhea), ASTHENIA (Weak), PYREXIA (99.1 F body temperature) and HEADACHE (Very bad headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 106M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included SIMVASTATIN, METFORMIN, LISINOPRIL, OMEPRAZOLE and PIOGLITAZONE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure was a little up), DIARRHOEA (Diarrhea), ASTHENIA (Weak), PYREXIA (99.1 F body temperature) and HEADACHE (Very bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure was a little up), DIARRHOEA (Diarrhea), ASTHENIA (Weak), PYREXIA (99.1 F body temperature) and HEADACHE (Very bad headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 99.1 f (High) Other.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-099195 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Event outcomes updated. Patient stated he was doing fine now
This is a spontaneous report received from contactable other HCP, for a Pfizer sponsored program (141003). A 57-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had influenza-like illness (flu-like symptoms), and arthralgia (increased joint pain), with outcome of unknown. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Patient came in to counseling window and informed me she experienced an adverse reaction (possible allergic reaction) to the Fluzone HD immunization staff administered on 11/1/2019.    She states she experienced lip tingling when she left the store when she got in her car. She then states it gotten worse over the next couple of days and had lip and face swelling. I asked if she went to the emergency room or see a physician about it and she said she did not.   I gave her the VIS sheet for Influenza and informed her to call VAERS to report her reaction. I also advised her to let her physician know about what happened. She also stated that she took pictures of the event. She looked well today and only complains about lip dryness. I recommended an OTC lip balm. She took down my name and staff name and left.
rash neck, arms, & chest;swelling of both arms;was determined to have bronchitis as well;hx asthma;
Spasm in my left eyelid since vaccine.  Warm compresses with no change in spasms.
Pt with fever to 104+ Saturday 11/3 PM. Had several episodes of vomiting and feeling like whole body hurt. Seen in office Sun 11/4, abd exam reassuring and did give ZOFRAN for nausea. PR on Monday 11/5 is that pt remains afebrile and doing better. Not sure if related to vaccine since reaction within hours or unrelated viral process.
The second vaccine shot put my heart into AFIB.  My heart beat was normal for 7 years and within 5 days after the second shot I noticed I was in AFIB.
Soreness at injected site did not subside. Tingling became progressively worse and resulted in numbness in the hand and fingers.
Received flu shot in right deltoid and PNEUMOVAX in left deltoid. Approx. 5 min. after receiving vaccines, she developed severe right arm pain, radiated then to chest and then down whole right side. Pain resolved within 5-10 minutes. Sent to E.D. via ambulance for further evaluation.
In the orevious 4 covid shots/boosters (1-3 Phizer, 4th Moderna), only symptoms were sore arm and enlarged larm pit llymph nodes for 2-3 days.   This 5th booster (Moderan  2023-2024, 12+, SYR): has prodiced nausea, diarrheaz headache, joint and  muscle pain, HIGH fever (102.7) extreme fatigue and general malise. Today , 1 day post shot (Saturday  10/14/23) 9pm and fever still 102.7.   Not sure why such adverse reactions when none  from any previous covid shots but wanted to report.  I have participated in the VAERS reporting throughout all Covid   I also particpate in the study and have tested negative consistently for N protein (any (previous COVID infection) .
After my first shot, my period, which is very predictable, came on time, but extremely heavy with lots of clotting. I soaked through pads and the heaviness lasted longer than a typical period for me.  After my second shot, my period didn't come on time, but instead I had cramping and period symptoms, as well as watery discharge for over  a week. Then, it came about two weeks late and lasted for two weeks (though light bleeding this time). I also had sore breast and night sweats. I am likely in perimenopause, but was regular up to this point.