chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a male patient of unknown age with heart disease. On 25-OCT-2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous). There was none drug reactions. Concomitant drug included aspirin. The pharmacist reported that the patient was administered ZOSTAVAX on 25-OCT-2013 and on an unspecified date a few years ago the patient developed pain and weakness from the elbow to the shoulder on the arm of the ZOSTAVAX injection. The patient called the pharmacist for medical attention and none treatment was given and none diagnostics studies were performed. The outcome of the adverse events was not reported. Additional information has been requested.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient (gravida 5) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included EKG (Have to get EKG done every 4 weeks) since an unknown date. Concurrent medical conditions included Sulfonamide allergy, Diabetes and High risk pregnancy. Concomitant products included INSULIN for Diabetes.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 09-Jun-2021. On 15-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 15-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Heart rate: increased (High) Accelerated heart rate, 99 resting and above 150beats per min.     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 treatment medication details was reported.; Sender's Comments: This is a case of product exposure during pregnancy with the event of Increased Heart Rate. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
This report is from a physician referring to a 49 year old male. No known drug allergies. The vaccinee has type II diabetes and takes Glucophage, Sinemet, Serzone and Univasc. On 2/18/00, the pt received his 1st IM, left deltoid dose of Havrix. 90 minutes later, on 2/18/00, the pt experienced a rash. Outcome: ongoing. 2-3 days, post vax, the pt experienced a sore throat. Outcome: ongoing. A doctor visit was required and the vaccinee was treated with Benadryl and steroids (NOS). The most recent information, received on 2/24/00, reports the condition of the vaccinee as ongoing.
Patient received booster dose instead of full dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received booster dose instead of full dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stem cell transplant in November 2021.    On 11-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Feb-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received booster dose instead of full dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received booster dose instead of full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Pharmacy Intern stated that a patient who had a stem cell transplant in Nov 2021 completed her primary doses in Aug 2021. The doctor recommended that the patient should get revaccinated but instead, the patient received the booster dose 0.25 mL on11FEB2022. She confirmed that the stem cell transplant was not related to the patient getting the primary doses. No treatment medications were provided.   This case was linked to MOD-2022-510100 (Patient Link).
Extensive local reaction to Td booster 3mm bruising with 7 x 6cm area of redness/induration/warmth with pt report of tenderness and burning sensation.
Patient and his entire family came to our pharmacy and requested a seasonal flu vaccine and the Pfizer bivalent booster. He was mistakenly given 2 seasonal flu vaccines. He received 2 flucelvax vaccines (one on each arm) and then a pfizer bivalent booster in his left arm.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent. On 08-FEB-2018 the patient was vaccinated with VARIVAX (dose, frequency and route were not reported) (lot # N012619 and expiry date: 21-APR-2019) for prophylaxis. The nurse reported that, first patient was administered a dose of improperly stored VARIVAX on 08-FEB-2018. The vaccines were stored in temperature 6 degree Fahrenheit (F) to 14 F (7.3F) for 25 Minutes. There was a previous temperature excursion of 6 F to 14 F for 206 minutes. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. The outcome of events was unknown. The relationship between events and VARIVAX was not provided.
3hrs p/vax pt c/o lt arm joint pain that radiated to neck; pain possibly involved subacromial bursa; also exp nausea; lymerix was discontinued. Case reference number 1999012419-1 is a spontanous report from a nurse practitioner referring to a 40 year old female. At the time of the event, the patient was taking EFFEXOR. On 20-May-1999, the patient received her first treatment with LYMERIX at an unspecified dose for prophylaxis. Approximately 3 hours later, the patient returned to the clinic with complaints of left arm joint pain that radiated to her neck. The pain possibly involved the subacromial burs below the left deltoid. Also, the patient experienced nausea. LYMERIX was discontinued. The recent information received on 20-May-1999 reports the symptoms are ongoing. The most recent information, received on 05-Oct-99 reports the condition of the patient is unknown.
Symptoms appeared after leaving vaccination clinic, on the 3 hour drive home. Headache, shortness of breath, and severely bloodshot eyes, with eye pain. Fever spiked at 102.7 with body aches, nausea, diarrhea. Severely bloodshot eyes and eye pain did not resolve. I presented 4/11/2021 at a Urgent Care. Diagnosed with sinus and bilateral eye infections. Prescriptions  for antibiotic, 10 day course and Cipro0.3% eye drops. Completed a 10 day course of both, but the eye symptoms and headache did not resolve. Wednesday, April 21  seen in-person by eye specialist Dr. Diagnosed with eye inflammation, and prescribed prednisone 1% eye drops. After two doses the eye pain and headache began to resolve. On April 22, I hand an in-person appointment with my endocrinologist. He told me I had had an unusual allergic reaction to the vaccination. After 1st vaccination, I also had mild bloodshot and painful  eye symptoms which resolved on their own after 3 days.  Eyes are now back to normal. I am concerned about the possibility of another adverse reaction if I were to receive a COVID-19 booster shot.   No contact lenses or glasses.
On 8-10-2022, I started having a sore throat, feeling of fever but did not check temp, chills, headache, general malaise, body aches and oral gum pain as well. I also had a hypersensitive bladder. The following day, 8-11-2022, I took a home COVID-19 test with positive results. I called my primary care doctor for a telehealth visit and he prescribed Paxlovid. I started taking the Paxlovid on the same day. I am still having fatigue and feeling "spacey". I am reporting a breakthrough case of COVID-19.
Pain and swelling around injection site. The swelling seems to be moving down the arm as days pass, not being swollen at the injection site now (day 5), instead being swollen further down.
Tightness, heaviness in chest, worst when lying down. Could not take deep breaths, felt like I would stop breathing if fell asleep.
Large red bump at injection site; Large red bump at injection site; Bump keeps getting larger, hard, and hot; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non hcp). The reporter is the patient.  A 19-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 at 18:00 (Lot number: unknown) at the age of 19 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None", notes: other medical history: no; known allergies: no. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Anatomical site: left arm; Route of administration: unspecified; Administration time: 10:00), administration date: 13Apr2021, when the patient was 19 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown; Anatomical site: left arm; Route of administration: unspecified; Administration time: 08:15), administration date: 04May2021, when the patient was 19 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 at 18:00, outcome "unknown", described as "Dose received: 3"; VACCINATION SITE MASS (non-serious) and VACCINATION SITE ERYTHEMA (non-serious), all with onset 08Dec2021 at 07:00, outcome "not recovered", all described as "Large red bump at injection site"; VACCINATION SITE WARMTH (non-serious) with onset 08Dec2021 at 07:00, outcome "not recovered", described as "Bump keeps getting larger, hard, and hot". The events "Large red bump at injection site" and "Bump keeps getting larger, hard, and hot" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site mass, vaccination site erythema and vaccination site warmth.  Additional information: The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Along with normal side effects, bump keeps getting larger, hard, and hot. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient is a 21yo male with no significant past medical history. Patient reported to ED on 19 Jul 2018 concerned for sores on his face. Patient reports that 4-5 days ago he noticed 'pimples' on his face, which progressed to the current state. The sites are painless, and mildly pruritic. Patient denies any other localized or systemic symptoms, such as fever, fatigue, myalgias, chest pain, etc. The patient has two lesions on the right side of his face: lesion number 1 is approximately 0.5 inches below the lateral angle of his eye (malar area), and lesion number 2 is approximately 1.5 inches above the center of his eyebrow. The two lesions appear to be in different stages: lesion number 1 is flat, round, with partial crusting and an even, erythematous border, resembling a normal vaccine take after approximately 14 days. Lesion number 2 is slightly raised, round, with a pink center and even orders, has the appearance of a plaque. Neither lesion has any vesicles, pustules, or discharge. He denies any eye symptoms, no burning, redness, pain, or discharge. He denies lesions to GU area. He reports sm lesions to ankles. Appears to be a vaccinia contact transmission: patient believes he was exposed d/t handling all weapons for his job.
FIRST DOSE ALL OK  A BIT OF A FEVER. SECOND DOSE HIT ME VERY HARD FEVER TO HALUCINATIONS ALL NIGHT, BOTH LEGS CRAMPING FOR MORE THAN 5 DAYS LEFT ANKLE SWOLLEN, MY DOCTOR DID  AN ULTRASOUND  FROM LEFT LEG TO LOOK FOR CLOT, XRAYS LEFT LEG TOO, BLOOD TEST URINE TEST. I HAD SHEDULED MY YEARLY MAMOGRAM WAS DENIED TO PERFORM IT BECAUSE IT HAD ONLY BEEN TWO WEEKS OF THE SECOND DOSE AND I WAS STILL FEELING TERRIBLE. THEY SAID RESULTS COME OUT ALTERED AFTER THE VACCINE TO WAIT AT LEAST 1 MONTH.  TO THIS DAY I AM STILL SICK I KNOW PRESENTED A HEAVY COLD WITH FEVERS MY DOCTOR JUST GAVE ME TYLENOL AND REST I AM TOTALLY UNDER THE WEATHER. 3.5 WEEKS AFTER 2ND VACCINE.  TODAY IS MAY 2ND 2021
I had mild itching and soreness at the injection site. Then, I got light-headed and passed out. I went to the ER on April 14th. They did an EKG, normal result. They also did blood work, normal results.
Patient states she got a headache within an hour of leaving clinic. Had extreme muscle weakness, collapsed in home. Crawled around for 6 days. Called ambulance and was admitted to the Hospital. Patient states she was there for 16 days, dx with Rhabdomyolysis. Patient ended conversation stating she had an overwhelming craving for soft serve ice cream when she was discharged from hospital.
Tight, heavy, dull pain in left side of chest starting about 6.5 hours after the vaccination. Aches in arm. Cold-like symptoms. Immediate feelings of discomfort at time of vaccination (in back of throat, sinuses, left shoulder where shot was administered).
hurt her leg; This is a spontaneous report from a Pfizer-sponsored program COVAX Support. A contactable (Age: 79; unit: unknown) female consumer reported for herself that:  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported.  Patient had first dose on 24Feb2021 and scheduled to get second dose last 17March2021. However, she hurt her leg that's why was not able to attend the second dose. Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: No. The clinical outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient stated she started to feel a burning sensation in her chest about 7 minutes after receiving injection. Lasted about 5 minutes, then left.
I started getting nausea, it is throwing up; I had fever; Chills; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on 10Apr2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated, I have a question. I had the vaccine on 10Apr2021 and day before yesterday I started getting nausea. It is throwing up and I had fever on an unspecified date and chills and Apr2021, I am wondering, can you get side effects from the vaccine as late as that was 12 or 13 days after I got the shot and about 12 days later I started getting side effects of nausea and chills and fever, that was the first shot. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unkown date in March 2015 (also reported as "the last month"), the patient was vaccinated with an improperly stored dose of ROTATEQ, lot # K01022, expiration date 12-MAY-2016 (dose and dose number were unspecified). No concomitant therapies were reported. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information is not expected because reporter refused additional contact.
This spontaneous case reported by a consumer, describes the occurrence of myalgia (arm pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 040B21A) for COVID-19 immunization. No medical history provided. Concomitant products included iron for an unknown indication. On May 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 1, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 1, 2021, patient experienced myalgia (arm pain). Patient treated with oral Tylenol (paracetamol); 1 dosage form. On May 2, 2021, myalgia (arm pain) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments or concomitant medications. Treatment included: Tylenol by mouth one time.
Subsequent to receiving varicella virus vaccine live on 1/95, the pt developed a mild case of chickenpox with approximately 30 - 40 vesicular lesions spread throughout his body with no fever on 4/95. These lesions cleared within 4 days. Three years following his case of chickenpox in April 1999, the pt developed herpes zoster in the distribution of the left inguinal nerve which involve his left hip around to the back to the mid line. He had approximately 100 vesicular lesions that were not painful and lasted about 7 - 10 days. During this period of time he also had one pock mark in the middle of his forehead. The pt's father feels that the herpes zoster was probably due to the wild type varicella zoster virus because the pt had had breakthrough chickenpox about 3 years ago. The pt's brother had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested.
Patient complained of muscle pain/soreness. Patient said it felt like she had been hit by a baseball and couldn't put any pressure on arm without it hurting (slept on opposite side).
Patient developed red swollen (L) thigh 1 1/2 days after vaccines. No fever, no other symptoms except for pain. She improved in 2-3 days.
Patient reported lightheadedness following vaccination. Patient reported not eating before vaccination and fasting the days prior. Gave apple juice and granola bars. Patient vitals remained within normal limits throughout observation period. Patient monitored for total of 45 minutes following vaccination. Patient reported improvement by end of observation period. No other severe reaction noted.
Phantosmia - since the 2nd shot I have smelled smoke all of the time; This is a spontaneous report from a non-contactable nurse, the patient. A 49-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 14Sep2021 at 18:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known drug allergies. Concomitant medications taken within two weeks of vaccination included celecoxib (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on an unknown date in Aug2021 at 18:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 15Sep2021 at 06:00, the patient experienced phantosmia. Since the second shot she had smelled smoke all of the time. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event phantosmia; since the second shot she had smelled smoke all of the time was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Got Booster Moderna Monday 12-13-21,  Tuesday 12-14-21 felt body aches Headache all day until I went to go to bed at 11:30 pm Tue.  My husband found me passed out on bathroom floor. He couldn't get me to respond or wakeup.  He had to drag me into our bed room and i still did not wakeup until Wednessday 12-15-21 about 9:00 am and i felt fine.  Thurs. I went to the urgent care to have a Covid test but it was Negative.  They took my Blood pressure, it was normal, no fever, examined me for a possible stroke and that was normal. No labs were done and no meds.
Vomiting, chest pressure, breathing shallow, trouble swallowing, tingling hands/feet, muscle twitching, muscle spasms, weakness, fatigue, woke up gasping for breath, chills, mental fog, shaky hands.
Patient received Pfizer COVID-19 vaccine (second in series) at 12:34pm by RN in left Deltoid, came to sit in observation area. At about 12:50pm she began to feel flushed and dizzy. Vital signs taken, 136/78 bp, HR 106 regular, normal SpO2. Noted to be mildly diaphoretic with left arm injection site warm to touch, no visible skin changes. No report or evidence on evaluation of respiratory distress. Normal mental status and orientation throughout. Benadryl 25 mg oral tab administered. She also drank apple juice and ate part of a sandwich. After about 15 minutes, bp normalized to the patient's baseline systolic ~110 and slower heart rate, dizziness and flushing resolved.
Sore arm; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 1, single, for Covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included unspecified supplements, taken 4 days after 1st dose. The patient experienced sore arm on an unspecified date. Outcome of the event was unknown. The patient will receive 2nd dose this Friday, and he would like to know if any herbal products/vitamins/supplements can interact with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10/25/2021, 3 days post vaccine- developed a rash, itchy, oval shaped, and started to bruise. It was just below the injection site. It continued for 2 days. The bruise lasted about a week.
A non-serious spontaneous report of H1N1 LAIV administered to patient nine days before age of two years was received from a registered nurse/health professional concerning a 23-month-old male. The patient had no medical history and he was not taking any concomitant medication. On 04-Dec-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 29-Dec-2009 and incorporated into the narrative: Medical history and concomitant medication.
Patient came in for 2nd dose Pfizer covid vaccine and was administered on day 16 instead of the earliest indicated day 17.   Pt informed of error, side effects reviewed and questions answered and pt verbalized understanding of teaching.
Around the 30th  my mother's left breast was a little bit swollen, we didn't think nothing of it. It is has gotten worse and starting to hurt her.