chrisvoncsefalvay/vaers-outcomes huggingface dataset:
02/23/2022 Vaccination 02/26/2022 I woke up and I realized I couldn't hear out of my R ear, with loud buzzing and my head was 'stuffy'. Also, sort of a loss of feeling of balance. I made appt with ENT as it was so alarming.  02/27/2022 Appt with ENT. He thought there may be inflammation in that auditory nerve or a tumor. Sent for MRI of that area of brain. MRI was negative. He decided to treat with series of steroid injections into my R eardrum to calm down the inflammation. That did not change anything.  F/up hearing test; NO PROGRESS. We stopped the injections as they were not helping. We are 'waiting' to see if hearing will return. I have a follow up appt in 6months from now.
Patient called to Pharmacy and said she was dizzy, weak, and light headed.  We advised her to go to ER or Urgent care. Patient was treated for slow shallow breathing, face swelling. Patient was given a steroid shot and a prescription for prednisone.  The pharmacist  called to check on her in the late afternoon. She said she felt better.  Dr advised her not to get a flu vaccine in the future. (Patient was given FLUARIX 0.5ml, lot: 359MH, exp: 6/20/17 in left deltoid).
Severe congestion  2 days Cough  - still present on 3 day after shot  Runny nose 2 days Body aches 3 days Fatigue  3 days  Nausea 1 day Chills  1 day Fever evening of second day  I was feeling great until the night of the shot, then became more fatigued and achy . It felt like the flu.
1st dose moderna 1/30/21, soreness at vaccination site lasted 2 days, 12 days after vaccination itchy/red/swollen spot 2 inches under vaccination site
2 DAYS AFTER VACCINE DEVELOPED LOCAL REACTION, WITH SWELLING AND WARMTH AT SITE, THEN STARTED HAVING HIVES ALL OVER THE BODY OVER THE NEXT 2 DAYS.
Patient received Pfizer COVID vaccines 3/11/21, 4/8/21, and 8/19/21 according to data base. Patient was admitted to hospital 9/9/21 for elective CABG and MVR surgery. When patient was opened in OR pericarditis was found and noted in the patient operative report. Patient did not report any recent viral/infectious illness in the month leading up to surgery.
Pt came into office complaining of cough, headache and papules X 10 to 20 and generalized to upper extremities.
Malaise and headache x 1 day. Redness surrounding injection site x 2 weeks
phantom scents that were rancid smelling; heavy period; extremely bad period cramps; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11May2021 at 13:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergy to cashews. 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-19 vaccination. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and ethinylestradiol, norgestimate (MILI) for birth control from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Apr2021 at 13:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On 28May2021, at 14:00 the patient experienced phantom scents that were rancid smelling and this went on for a few days and stopped; 2 weeks after getting the vaccine patient had heavy period and extremely bad period cramps. The patient was on period for 5 days. The patient reported that she was on birth control because she was not supposed to have period due to how much it hurts and how much blood loss she had. The patient never spotted or started period while on this birth control but after the vaccination she was on period. The patient did not receive any treatment for the events. 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, and emergency room/department or urgent care. The clinical outcome of the events phantom scents that were rancid smelling was recovered on an unknown date in 2021; while that of heavy period and extremely bad period cramps was not recovered at the time of this report.   The lot number for BNT162b2, was not provided and will be requested during follow up.
Dizziness, Headache, NauseaVomiting, Increased fatigue, Migraine, Nausea, Dizzy, increased respiratory rate Narrative:
Redness and swelling across right deltoid with parethesias-Probable cellulitis secondary to vaccination site.
4-6-07 Reports swelling in (R) ankle, (R) wrist, both knees. Pain in arms. Numbness and pain in hands, worse in two middle fingers-this occurs at night and awakes him from sleep. Hands hurt to make a fist. Phone call to client today 4/9/07 reports symptoms are gone. Adds he is a carpenter and had dental work and crown, since received vaccines.
Patient started experiencing severe muscle pain and limited mobility of the left arm the evening after she received the flu vaccine. Patient is still experiencing these symptoms and is receiving steroid injections and physical therapy at this time to help treat symptoms.
HPV # 2 administered in left deltoid. Brief fainting immediately. Rested supine on exam table with feet/lower legs elevated. Given some candy. Left office about table with feet / lower leg's elevated. Given some candy. Left office about 15 minutes later.
itchy all over body; pea sized lesions all over body/lesions under toenails/lesions on 80% of legs/lesions all over arms/lesions all over back/lesions all over chest/some lesions on neck/one lesion on head/a bunch of lesions in mouth; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy all over body) and SKIN LESION (pea sized lesions all over body/lesions under toenails/lesions on 80% of legs/lesions all over arms/lesions all over back/lesions all over chest/some lesions on neck/one lesion on head/a bunch of lesions in mouth) in a male 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 effect. Concomitant products included OLMESARTAN, TESTOSTERONE and PREDNISONE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 03-Mar-2021, the patient experienced SKIN LESION (pea sized lesions all over body/lesions under toenails/lesions on 80% of legs/lesions all over arms/lesions all over back/lesions all over chest/some lesions on neck/one lesion on head/a bunch of lesions in mouth). On 13-Mar-2021, the patient experienced PRURITUS (itchy all over body). At the time of the report, PRURITUS (itchy all over body) and SKIN LESION (pea sized lesions all over body/lesions under toenails/lesions on 80% of legs/lesions all over arms/lesions all over back/lesions all over chest/some lesions on neck/one lesion on head/a bunch of lesions in mouth) outcome was unknown.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: No specific follow-up information recorded. On 16-Mar-2021: No specific follow-up information recorded.
Moderna COVID-19  Nose bleed 1/28/21 at 0140 am Nose bleed 1/28/21 at 0430 am Nose bleed 1/30/21 at 0330 am Nose bleed only on left side of nose
Rt. supraclavicular massive lymphadenitis improved on DURICEF for 3 days.
Sudden onset of extreme pallor; Somnolent, went to sleep for several hours; Vaccine administered to 1 month child; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2393248-1. The original narrative from the sender is the following:  sudden onset of extreme pallor. Somnolent, went to sleep for several hours, awoke appearing normal and back to baseline.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "sudden onset of extreme pallor", "Somnolent, went to sleep for several hours" and "Vaccine administered to 1 month child".  No further information is expected.
Declining blood glucose. Vertigo. Symptoms were relayed by the patient's daughter-in-law.
April 2 -3 felt tired and achey and chills April 8 - 10 tingeling of face, left eye hurt.  April 11 no energy, left eye watering,  lips swelling April 13 more swelling of face - Night of 13 wanted to rip my face off!!! April 14 swelling of eyes, lips, cheeks, hives on face and eyes.  Felt miserable Zoom call with Doctor put on Medrol dose pack, Allegra, AM Zyrtec,PM  Pepcid AC, purchased Epinephrine, Benadryl during day April  April 19 more hives on chest
Seriousness criteria other medically significant (OMIC). Initial information received on 9/1/06 from another company0 no reference number provided. The information was initially reported to The other company by a health care professional. A 40 year old female pt with no relevant medical history received a dose of tetanus toxoid 15 years earlier at a medical facility different from the one where the reported was located. The manufacturer, trade name, lot number, route and site of administration for the tetanus toxoid were not reported. An unspecified amount of time after vaccination, the pt developed transverse myelitis. The pt sought unspecified medical attention. At the time of this report, the pt had residual numbness in her hands and weakness. No other information was provided.
Around 6:30, I started feeling dizziness and got a severe headache. After waking up from a nap that night around 9, I woke up to a 101.4 fever, itchy throat, dizziness, naseau, and a swollen, red circle around my injection site that was hot to the touch. I couldn't sleep due to pain and discomfort from my arm and fever. I woke up around 4:30, vomiting. I took Advil and Hydroxizine around 8 am to sleep, but it still didn't help as I woke up every 30 minutes. I had a fever of 101.3 and these same symptoms the whole day of 4/14. Before going to bed this night, my temperature was down to 100.3. I woke up the next morning (4/15) and my temperature was down to 99.4, so I went to work. I still had the symptoms of itchy throat, dizziness, and weakness. My arm was still swollen and sore too. Another symptom I thought was interesting that I had was waking up drenched in sweat this morning (4/16) and yesterday morning (4/15).  I even woke up through the night to put a fan on me at high speed and took my blankets off, yet still woke up sweating. Tonight, my temperature is back to normal, but I still have an itchy throat, some dizziness, and an itchy injection site.
10/9 Presented with large area bruised swollen and discolored - pt states painful. Rph recommended MD visit. Pt made appt and was seen. MD advised symptom care, time, no further attn unless continues to worsen.
Narrative:  COVID infection following COVID vaccine series 04/12, Moderna , dose #2 11/17 pt admit medicine cc: confusion dx: LOS: 11/17 CXR impression: Stable small right pleural effusion with increased right basilar opacity which may represent associated atelectasis or pneumonia. 11/17 pt cc: exposure: unknown 11/17 COVID swab, result: detected 11/18 COVID swab, result: NOT detected 11/18 CTA PE impression: No pulmonary embolus. Small right pleural effusion with right basilar consolidation, likely compressive atelectasis. Left adrenal gland 3 cm nodule of indeterminate density. Consider comparison to prior outside imaging if available. Alternatively, recommend non urgent CT adrenal protocol. 11/19 FIBRINOGEN: 529 11/19 DDIMER: 1.34 11/19 ESR: 80 11/19 US DOPPLER impression: Bilateral lower extremity: patency and compressibility of the visualized portion of the deep venous system without evidence for thrombosis. Spectral waveform analysis: normal phasic flow and appropriate response to augmentation. Venous structures identified and cleared: Common femoral vein, femoral vein, and popliteal vein. No popliteal fossa cysts identified.Bland
Developed sun allergy for the first and so far only time in my life. Lasted about 3 weeks and would respond to sun exposure. Strongest reaction on arms and neck area, which had been repeatedly exposed to sun the weeks before without issues. Also developed extreme jaw/tooth pain, entire upper and lower jaw, which lasted a few days and could only be coped with a lot of ibuprofen. About 4 months later I developed an abscess and needed a root anal and the specialist estimated that the nerve had already died a few months before, which coincides with the extreme jaw pain phase that started within hours after the second vaccine dose.
The patient believes that Moderna Covid-19 vaccines work to stop her seasonal allergies; sore deltoid muscle; localized swelling with redness at the injection site; localized swelling with redness at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (The patient believes that Moderna Covid-19 vaccines work to stop her seasonal allergies), MYALGIA (sore deltoid muscle), INJECTION SITE SWELLING (localized swelling with redness at the injection site) and INJECTION SITE ERYTHEMA (localized swelling with redness at the injection site) in a 60-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030536) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Exercise induced asthma (mild) and Chronic myeloid leukemia (which is in remission for 20 years.). Concomitant products included DASATINIB MONOHYDRATE (SPRYCEL) for Leukemia, CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) from August 2023 to 08-Oct-2023 for Seasonal allergy, FUROSEMIDE and POTASSIUM for an unknown indication.   On 03-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In October 2023, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (The patient believes that Moderna Covid-19 vaccines work to stop her seasonal allergies), MYALGIA (sore deltoid muscle), INJECTION SITE SWELLING (localized swelling with redness at the injection site) and INJECTION SITE ERYTHEMA (localized swelling with redness at the injection site). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (The patient believes that Moderna Covid-19 vaccines work to stop her seasonal allergies) outcome was unknown and MYALGIA (sore deltoid muscle), INJECTION SITE SWELLING (localized swelling with redness at the injection site) and INJECTION SITE ERYTHEMA (localized swelling with redness at the injection site) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Reported that starting 12 months after her fourth vaccine the allergies came back and resolved 5 days after her 5th dose. The patient started her Claritin at the end of August and found that 5 days after her 5th Spikevax vaccine she could stop taking her Claritin because all of her seasonal allergies were resolved.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-746358 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746358:Same patient, Monovalent Dose
Father requested Pfizer booster for pt. VAR form was completed by patient's father; he wrote down DOB and the age of 16 yeas old. When counseling prior to administration, Rph noted the age of 16 years written on VAR form and proceeded with vaccination; Rph realized that pt was only 15 years old during batching of the record. Pt is not experiencing any adverse reactions. Family is not upset. Report submitted since Pfizer booster is currently only authorized for ages 16 years and up.
Vaccinated a 13 year-old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccinated a 13 year-old) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024021A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccinated a 13 year-old). On 10-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccinated a 13 year-old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment medications were reported.  It was reported that the pharmacist heard the information on the news that children between 12 to 16 years of age were eligible for vaccination but after the administration of the vaccine the pharmacist realized the information was about Pfizer vaccine and not Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Patient age updated.
Extreme headache, lethargy, and fatigue morning after vaccine. Pale clammy skin, cold-sweats, diarrhea, nausea, vertigo, dizziness, fainting, lightheadedness, muffled hearing, and blurred vision, later that afternoon. Pale, clammy skin, cold-sweats, vertigo, fainting, lightheadedness, muffled hearing, and blurred vision spells 1-2x/day since vaccine 1 week ago.
a rash all over my body with yellowish raised skin/bumps; a rash all over my body with yellowish raised skin/bumps; Severe shivering and chills; 5 different fevers; Body aches; Headache; Loss of appetite; Fatigue; This is a spontaneous report from a contactable other HCP reporting for himself.  A 28-years-old male patient received the second dose of bnt162b2 (BNT162B2; Lot # EK9231) vaccine , via an unspecified route of administration in the left arm on 05Jan2021 at single dose for covid-19 immunisation .  Medical history included , type 2 diabetes mellitus , sinus arrhythmia, gout.  Concomitant medication included atenolol (ATENOLOL).  The patient previously took lisinopril and experienced drug hypersensitivity, on 15Dec2020 the patient received the first dose of bnt162b2 for covid-19 immunisation and complained from headache, and hyperhidrosis.  The patient experienced severe shivering and chills  on 05Jan2021 23:30 with outcome of recovering ,  fevers on 05Jan2021 23:30 with outcome of recovering , body aches  on 05Jan2021 23:30 with outcome of recovering , headache  on 05Jan2021 23:30 with outcome of recovering , loss of appetite on 05Jan2021 23:30 with outcome of recovering , fatigue  on 05Jan2021 23:30 with outcome of recovering , a rash all over my body with yellowish raised skin/bumps  on 21Jan2021 with outcome of recovering.   The patient received Prednisone and Benadryl as treatment.  No follow-up attempts are possible. No further information is expected.
High increase in Blood Pressure; Pale; Rash; Severe Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High increase in Blood Pressure), PALLOR (Pale), RASH (Rash) and HEADACHE (Severe Headache) in a 68-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (High increase in Blood Pressure), PALLOR (Pale), RASH (Rash) and HEADACHE (Severe Headache). The patient was treated with SODIUM LACTATE (INTRAVENOUS SODIUM LACTATE) at an unspecified dose and frequency. At the time of the report, HYPERTENSION (High increase in Blood Pressure), PALLOR (Pale), RASH (Rash) and HEADACHE (Severe Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Consumer is taking Paxlovid; Consumer is taking Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Consumer is taking Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: PQC not present. Consumer was taking Paxlovid and she's getting a foaming affect in her stomach and it's causing acid reflux. She developed a huge hematoma on her right arm after getting the Pfizer COVID vaccine. She got a rash on her thigh after the 2nd dose. Now, after starting Paxlovid she had a painful bump and bruising on her arm. The pain feels like it's in the bone. She states she did not feel well.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Right arm pain Fever 102 Aches in legs, back, and neck Headache Increased blood pressure 150/120 Nausea Severe Fatigue
he is really sore and he's having a hard time moving his body because he's sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 9 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 07Nov2023, outcome "unknown", described as "he is really sore and he's having a hard time moving his body because he's sore". Therapeutic measures were taken as a result of pain.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
A report has been received from a Health Professional concerning a 21 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. The reporter stated that the patient experienced expired FLUMIST quadrivalent administered. The outcome of the event of expired FLUMIST quadrivalent administered is unknown. The report was considered to be non-serious.
After patient had ADACEL (Tdap) vaccination, she had injection site pain, swelling, erythema (within 2-3 hours) she went to MD office and MD prescribed antibiotic.
Irregular menstrual cycles and heavy periods since ive received the covid-19 vaccine. Cycles have an 8.4 day variance and I bleed through many pads on the first two days of my period. The amount of bloating and nausea has increased during menstrual bleeding since I've received the Pfizer COVID 19 vaccine doses.
Child turned 12years old, 2 days before the school covid 19 vaccine clinic for 5-11 year olds. Child received the Pfizer 5-11 year old dose