chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stroke; did not get second dose when she was supposed to; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and PRODUCT DOSE OMISSION ISSUE (did not get second dose when she was supposed to) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) and PRODUCT DOSE OMISSION ISSUE (did not get second dose when she was supposed to). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not get second dose when she was supposed to) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment medication were reported.  Patient had a stroke. Patient was given her first dose of the vaccine (they went to give it to her) and the second dose was supposed to be on 14 Nov 2021 but they did not go to give it to her.   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Non Significant follow up information received Contact information updated; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with medical history of stroke and vaccine history of receiving first dose of unspecified vaccine, who experienced product dose omission. The patient received her first dose of unspecified vaccine and was supposed to received the second dose of unspecified vaccine but was not able to because the vaccinator did not come. The patient was inquiring why the vaccinator didn't come which resulted to patient missed her appointed schedule. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 66 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EK8982), in left arm, on 09Feb2021 as dose 2, single (Lot number: EM9810), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asmaa undifferentiated connective tissue disease" (unspecified if ongoing), notes: undifferentiated connective tissue disease; "sick sinus syndrome" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; AZELASTINE; FLUTICASONE. Past drug history included: Hydroxychloroquine, reaction(s): "Known allergies: hydroxychloroquine", notes: Known allergies: hydroxychloroquine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Oct2022) Negative, notes: tested negative Days 6 and 8; (28Oct2022) Positive, notes: positive on Day 10; (26Oct2022) Negative, notes: tested negative Days 6 and 8. Therapeutic measures from 19Oct2022 to 24Oct2022 were taken as a result of drug ineffective, covid-19.
This study case was received from the investigator in a trial on 22 February 2012 with additional information received on 28 February 2012. A 29-year-old male subject had received the following vaccinations: On 04 November 2009, an injection of ACAM2000 (lot number not reported). On 03 November 2009, an injection of ANTHRAX (manufacturer and lot number not reported), INFLUENZA, LIVE, INTRANASAL (manufacturer and lot number not reported) and TYPHIM VI, sanofi pasteur SA (lot number not reported). The subject had an abnormal troponin I on 13 November 2009, a normal echocardiogram on 14 November 2009 and an abnormal ECG on 15 November 2009. The subject was diagnosed with chest pain, unspecified on 13 November 2009. The subject had no significant medical history. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
severe headache behind the eyes; Initially extreme fatigue; started to have shortness of breath; muscle aches; cough; second dose on 05Jan2021 08:30; This is a spontaneous report from a contactable physician (patient). A 39-year-old female patient received second dose of BNT162B2 (Lot number: EL3246), intramuscularly on 05Jan2021 08:30 in left arm at single dose for COVID-19 immunization. Medical history included known allergies: latex and asthma. Patient did not have COVID prior vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), drospirenone/ethinylestradiol (YASMIN), melatonin, and ibuprofen (MOTRIN). Patient previously took montelukast sodium (SINGULAIR) and experienced allergy. Patient received first dose of BNT162B2 (Lot number: EK5730), intramuscularly on 18Dec2020 09:00 in left arm at single dose for COVID-19 immunization. Patient experienced initially extreme fatigue, then muscle ached all within 12-24 hours, severe headache behind the eyes. Then when thought was getting better, she started to have shortness of breath, worsening fatigue, and cough; all on 05Jan2021 12:00. These events were resulted in emergency room/department or urgent care. COVID was tested post vaccination. COVID test type post vaccination was nasal swab. COVID test name post vaccination was COVID 19 nasopharyngeal swan. COVID test date was on 08Jan2021. Test result was pending. Treatment received included nebulizer treatment, and steroid course. Patient was not recovered from these events.; Sender's Comments: Based on a compatible temporal relationship and known product safety profile, causality between events severe headache and extreme fatigue and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient received the Abrysvo RSV vaccine 09/13/2023 and the Arexvy 11/02/2023
On return to the clinic for second dose, a small scar area is noted below injection site on L arm.  Appears to be from scratching at previous site however it is lower than injection site.  Mother reports no adverse affects of 1st dose.  Skin is well healed where evidence of scratching/scar is noted.  2nd dose administered, site marked for mother to monitor.  Mother will monitor.
Information was received from the consumer on 06-JAN-2010. A 54 year old female patient received influenza immunization polyvalent (manufacturer unspecified) on ??-Oct-2009. The patient had a medical history of "Strokson" sleep apnea and codeine allergy. On ??-Oct-2009, the same month as the administration of suspect drug, the patient got extremely sick and sought medical attention. She was hospitalized for three (3) days with pneumonia and strep throat. Unspecified blood work had been performed. Patient outcome was unknown. Additional information has been requested. This case was originally reported to Merck & Co., Inc (manufacturer report# 1001USA00180).
Sinus Infection/ Sinus Drainage; Hoarse; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus Infection/ Sinus Drainage) and DYSPHONIA (Hoarse) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sinus infection. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II) for Sinusitis.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced SINUSITIS (Sinus Infection/ Sinus Drainage) and DYSPHONIA (Hoarse). At the time of the report, SINUSITIS (Sinus Infection/ Sinus Drainage) and DYSPHONIA (Hoarse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported.
Pt recieved CV-19 and Shingles immunization same day. Pt reported fever, body aches "feeling terrible" x 3-5 days.
Erythematous rash appeared ~10 days after vaccine administration "a few inches" below the injection site.  Rash lasted ~3 days then disappeared.  Rash did not require treatment.  Patient did not report rash until after symptoms resolved.
FEVER; CHILLS; HEADACHE; UPSET STOMACH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced fever, chills, headache, and upset stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache and upset stomach was not reported. This report was non-serious.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. Medical history was not reported. The nurse practitioner informed that on 28-AUG-2014 the patient was vaccinated with PROQUAD (Merck) injection, 0.5 ml, subcutaneous, which expired on 22-AUG-2014 (lot number were not reported). No adverse effects were reported. The outcome of the event was unknown. Follow up information received with updates on 28-OCT-2014, regarding 4 year old female patient with known demographics. The patient has 3 sibling. It was reported that on 28-AUG-2014 at 3:00pm, the patient was vaccinated with second dose of PROQUAD (Merck) injection, lot#J002306, expire date 22-AUG-2014 to the left arm. No adverse effects were reported. This is one of the several report received from the same reporter. Additional information has been requested.
Sound on her right ear has become unbearable and it never goes away; Productive cough (dark yellow sputum); Making her crazy; Little fever (99 something - her normal temperature is 97); Body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of TINNITUS (Sound on her right ear has become unbearable and it never goes away), PRODUCTIVE COUGH (Productive cough (dark yellow sputum)), FEELING ABNORMAL (Making her crazy), PYREXIA (Little fever (99 something - her normal temperature is 97)) and MYALGIA (Body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included Hay fever, Fibromyalgia, Biliary colic (Gallbladder attack) in 2009 and Pancreatitis (For which she was admitted in the ICU). Concurrent medical conditions included Type 1 diabetes mellitus (at 65 years old) since 2019 and Osteoarthritis. Concomitant products included INSULIN for Type 1 diabetes mellitus.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced TINNITUS (Sound on her right ear has become unbearable and it never goes away), PRODUCTIVE COUGH (Productive cough (dark yellow sputum)), FEELING ABNORMAL (Making her crazy), PYREXIA (Little fever (99 something - her normal temperature is 97)) and MYALGIA (Body aches). At the time of the report, TINNITUS (Sound on her right ear has become unbearable and it never goes away), PRODUCTIVE COUGH (Productive cough (dark yellow sputum)), FEELING ABNORMAL (Making her crazy), PYREXIA (Little fever (99 something - her normal temperature is 97)) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 99 something (High) Her normal temperature is 97. On an unknown date, Blood test: abnormal (abnormal) Pancreas  not producing insulin.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-295816 (Patient Link).
Fever, sore throat, stuffy nose, soreness at  injection site, swollen glands, general ill feeling.
Rec'd vaccines 4/15 - 4/16 awoke with L arm swollen, slightly tender no erythema no fever.
This spontaneous report as received from a certified medical assistant refers to a female patient of unknown age. On 02-OCT-2009, the patient was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # not reported) IM and on 22-MAY-2013, the patient received the second 0.5 ml dose of GARDASIL (Lot # not reported) IM. No adverse effect was reported. Additional information has been requested.
Pt. passed out, color turned grey, c/o seeing everything in blue color, nausea, burping, cold clammy alt w/ sweating, feverish alt w/ chills. Pt lost consciousness several times over next 2 hours. C/o stomach pain, burping, vomited x1.
Lightheadedness, nausea, headache, chills, dry mouth, bad taste in mouth, excessive urination, feeling drugged/altered.
Information has been received from a pharmacist referring to a 45 year old patient of unknown age. No pertinent or historical conditions were reported. On an unknown date, the patient was inadvertently administered a dose of ZOSTAVAX (strength, dose and route unknown) instead of (Merck) VARIVAX. No adverse effects were reported. Additional information is not expected since the reporter refused to be contacted.
Bell?s palsy.  Numbness in front part of tongue started the afternoon of 2/12/2021.  Morning of 2/13/2021 half of face was unresponsive and droopy.  Talked to my doctor on call and she recommended I be seen at urgent care immediately for evaluation.  Was seen at Urgent Care on 2/13/2021 and it was determined I had Bell?s palsy as a side effect of the COVID-19 vaccine.  They still recommended to get my second vaccine as scheduled on 2/17/2021.
Pt experienced numbness in left arm with some burning sensation two weeks after getting the ADACEL vaccination, but it is getting better now. Pt advised to follow up with doctor.
On  12/25 I was driving home and my left arm got numb, tingly and weak to the the point where I thought I was suffering from a stroke.  I  rushed to my moms and had her to drive me to the hospital where they did a neuro check to include a CT scan which ruled out the stroke but the symptoms lasted about 4 days which came and went with the pain and intensity varying each time which ended around 12/29.  I suffered from body aches and night chills one night.  Around the 12/29 I began to have pressure around the back of my head which felt as if I was laying on bricks when I laid down.  It got to the point to where I couldnt sleep which caused me to go back to the ER on  1/1 where I was given  toradol, decadron and sudafed which allowed me to sleep. I was released from the ER with Motrin 800 and contined to take that and Tylenol until the headaches ceased  which was about 3 or 4 days later. The headache went away but the pressure still remained.  My lymph glands were swollen so I was also given a prescription for amoloxicillin.
Patient had headache; very tender and painful at injection site; site around injection site was warm to the touch and red; pt said no issues on day of injection or day after, however she woke up with her arm hurting and with a headache.
Severe skin rash; itching on both arms and upper thigh; This is a spontaneous report from a contactable consumer. A 72-Years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, in Arm Left, on 12Jan2021, 10:00 AM (age at the time of vaccination 72-Years-old) as a single dose for COVID-19 immunisation. Patient medical history included Hypothyroidism but it was under control and had allergic to dust. Patient did not receive other vaccine in four weeks of vaccination. Patient concomitant medication included levothyroxine sodium (SYNTHROID) 25 mgs, PO daily in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that patient had experienced severe skin rash and itching on both arms and upper thigh areas on 13Jan2021, 08:00 PM and it required medical treatment and patient took other medications as Prednisone 10 mgs PO, Famotidine 20mgs PO, Banophen 25 mgs PO for the events. Outcome of the events were reported as recovered on an unknown date in 2021.
About 7 days after I received my first dose of the Moderna vaccine I began to have a delayed reaction. It started with an itch near the injection site that was red and looked like a hive. It itched and the rash increased in size over the next couple of days. As it healed, the itch decreased and the rash started to resemble the look of ring worm around the injection site. After about 72 hours it was almost completely gone. After about 4 days my arm was completely back to normal. I was never in pain from this, just a little bit of discomfort from the itching. I applied Cortisone cream which helped with that. It freaked me out more than anything. However after discussing it with a couple of healthcare professionals I was able to calm down.
soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3247), via an unspecified route of administration on 24Feb2021 at 08:15 (at the age of 50-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included high blood pressure from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications included nebivolol hydrochloride (BYSTOLIC), hydrochlorothiazide (MANUFACTURER UNKNOWN) and birth control all from an unknown date. The patient preciously received ACE inhibitors and potentially experienced allergic reaction. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 24Feb2021 at 17:00, the patient experienced soreness at the injection site. Therapeutic measures were not given for the events. The clinical outcome of the event vaccination site pain was recovering.
Soreness in the arm. Immediately I was very tired. I laid down and slept a lot. I slept through the night and when I woke up I had a dull headache and continued to sleep through the day. I still have muscle and joint pain. I had severe diarrhea all day 9/17. 9/18 still have fatigue and some muscle and joint pain.
Information has been received from a nurse practitioner concerning a female who on 28-APR-2008 was vaccinated with her third dose of GARDASIL vaccine (yeast) (lot# not reported). On 12-MAY-2008 the patient experienced a headache. Subsequently, the patient recovered from the headache. The patient sought unspecified medical attention with a phone call on an unspecified date.  Additional information has been requested.
patient received MMR, VAR and HAV on 4/22/22.  Patient had rash / lesion on right lateral upper thigh at injection site for VARIVAX- noted 5/1/22.  Fever to 103 noted 5/1/22 after the rash / lesion started.  Patient with significant fussiness during this.  Lesion was darker in redness, almost purple with 2 non vesicular papules on either side of the injection site.  Patient continued with fever to 101 x 36 hours and defervesced.  Injection site lesion improving 5/4/22 at office visit.  5/4/22 evaluation with mild pink, flat blanching 2.5 x 1.5 cm lesion on upper lateral right thigh.  No tenderness, no vesicles or papules. No subcutaneous tissue changes.  No streaking or warmth.  No other skin rashes or change.
PATIENT CAME BACK TO THE PHARMACY 6 DAYS AFTER RECEIVING THE VACCINE WITH THE INJECTION SITE REACTION. IT WAS GREENISH IN THE AREA IN AND AROUND THE INJECTION SITE.  THEN SHE REPORTED AN EXTRA REDNESS AROUND OTHER AREAS CLOSEBY WHICH WERE PREVIOUSLY UNAFFECTED.
Headache,  nausea, fever, chills, and body aches 2 days for fever and chills. This is the third for headache
Diarrhoea; cold /Freezing; Severe stomach cramps; Feeling given very high on the arm; Tired /  feels that she is not 100%.; Muscle pain; Shoulder pain; Pain on to the bottom of the neck line; Awful pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain on to the bottom of the neck line), DIARRHOEA (Diarrhoea), NASOPHARYNGITIS (cold /Freezing), ABDOMINAL PAIN UPPER (Severe stomach cramps) and LIMB DISCOMFORT (Feeling given very high on the arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history.  The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (COZAAR) and METFORMIN for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (Awful pain). On 13-Mar-2021, the patient experienced NECK PAIN (Pain on to the bottom of the neck line), FATIGUE (Tired /  feels that she is not 100%.), MYALGIA (Muscle pain) and ARTHRALGIA (Shoulder pain). On 14-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), NASOPHARYNGITIS (cold /Freezing), ABDOMINAL PAIN UPPER (Severe stomach cramps) and LIMB DISCOMFORT (Feeling given very high on the arm). At the time of the report, NECK PAIN (Pain on to the bottom of the neck line), DIARRHOEA (Diarrhoea), NASOPHARYNGITIS (cold /Freezing), ABDOMINAL PAIN UPPER (Severe stomach cramps), LIMB DISCOMFORT (Feeling given very high on the arm), PAIN (Awful pain), FATIGUE (Tired /  feels that she is not 100%.), MYALGIA (Muscle pain) and ARTHRALGIA (Shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received from a physician via a company representative referring to two female patients in their seventies. The patients' medical history, concurrent condition and concomitant therapy were unknown. On unknown dates, the patients received PNEUMOVAX 23 injection (lot#, expiration date, dose and route were unknown). On unknown dates, both patients experienced injection site swelling as well as pain and erythema. The patients did not seek any medical attention. No treatment was given for the events. The events lasted for 4 days and the outcome was reported as fine. The causality assessment between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.