chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Received Bivalent Booster as the 2nd Primary dose by mistake; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Bivalent Booster as the 2nd Primary dose by mistake) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Bivalent Booster as the 2nd Primary dose by mistake). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Bivalent Booster as the 2nd Primary dose by mistake) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received Bivalent Booster as the 2nd Primary dose by mistake).    Patient age was about 40-year-old.   First Primary monovalent dose was taken on unknown date, Lot and Expiration Date was unknown.   No concomitant medications was reported.  The patient received Bivalent Moderna COVID-19 booster vaccine, instead of the 2nd Primary shot, on 12-NOV-2022. After the shot was administered, the patient informed them that he only had 1 previous  COVID-19 shot.  No treatment medications was reported.   Reporter did not allow further contact
Initial report received from a patient's husband on 13-Nov-2013. A patient, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE High-Dose (dose, frequency, route unknown) (batch number and expiration date unknown) few weeks ago. On an unspecified date, after receiving vaccine the patient experienced soreness at the injection site fro at least two weeks, and general malaise. At the time of reporting, outcome of the events were recovered. No further relevant information was reported.
Daughter has been diagnosed with Typhoid. She has been hospitalized and is on antibiotics and fluids. Fever of 104.
soreness; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program COVAX US Support.     A 68-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EB5313 and Expiration date was unknown), via an unspecified route of administration, administered in right arm on 05Feb2021, as dose 1, single (at the age of 67-years-old) for COVID-19 immunisation. Medical history included immunocompromised from and unknown date and ongoing, primary immune deficiency disease from 2017 (Spring of 2017) and ongoing, Mycobacterium avium complex infection (has been fighting it for 4 years) from 2017 and ongoing and also diagnosed with something else that was related to her being immunocompromised. Patient previously had the Shingrix vaccines for immunisation and had no problems, but they were kind of painful, but caused no problems, had Prevnar 13 on 24Aug2018 (does not have the lot or expiration date for the product) and Pneumovax vaccine both for immunisation and had no problems with either of them. Patient mom died of cancer. Patient had no prior vaccinations (within 4 weeks), prior to the first administration date of the suspect vaccine. Concomitant medication (s) included immunoglobulin human normal (Cuvitru) taken for immunodeficiency from Jun2017 and ongoing (takes the medication at least 48 hours apart from her vaccines, as she will be on it for life). On an unspecified date of 2021, patient had soreness after the first dose. No relevant tests were performed. Patient had no physician office and emergency room visit. Patient weight was 100-102lbs. The outcome of the event was unknown.
Essential Thrombocytosis; Two strokes; Tingling in fingers and toes; Intermittent swooshing sound in both ears; Vision problems in both eyes; Lightheadedness/Dizziness; Joint pain; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ESSENTIAL THROMBOCYTHAEMIA (Essential Thrombocytosis) and CEREBROVASCULAR ACCIDENT (Two strokes) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included HYDROXYCARBAMIDE (HYDREA), PREDNISONE and APIXABAN (ELIQUIS) for an unknown indication.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 ESSENTIAL THROMBOCYTHAEMIA (Essential Thrombocytosis) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (Two strokes) (seriousness criterion medically significant), PARAESTHESIA (Tingling in fingers and toes), TINNITUS (Intermittent swooshing sound in both ears), VISUAL IMPAIRMENT (Vision problems in both eyes), DIZZINESS (Lightheadedness/Dizziness), ARTHRALGIA (Joint pain) and FATIGUE (Extreme fatigue). At the time of the report, ESSENTIAL THROMBOCYTHAEMIA (Essential Thrombocytosis), CEREBROVASCULAR ACCIDENT (Two strokes), PARAESTHESIA (Tingling in fingers and toes), TINNITUS (Intermittent swooshing sound in both ears), VISUAL IMPAIRMENT (Vision problems in both eyes), DIZZINESS (Lightheadedness/Dizziness), ARTHRALGIA (Joint pain) and FATIGUE (Extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cytokine test: increase (High) Increase. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) Abnormal MRI showed two strokes.. On an unknown date, Platelet count: 1.1 million to 1.8million (High) High.         Concomitant medication mentioned as Cholesterol pill ,Thyroid pill. Treatment information was not provided. On an unknown date the patient Cat Scan, blood work, bone marrow biopsy done , results were not reported.  Patient reported that she had four children with a 50 percent chance of passing on in particular the Essential Thrombocytosis.  The caller was advised not to get the vaccine, by her physician. When her mother tested for ET, Essential Thrombocytosis and said could have triggered this.  Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
12-15-06 small red area (dots) appeared like unconnected rash over the next three days. Closed up to make hard knot. Red area about 3x". This area is 3" below injection site. 12-16-06 patient had fever, stiff neck, unable to get up except as necessary. 12-17-06 was better still but still had fever, weakness and felt really bad.
Fever, chills, body aches, fatigue, sore throat, dizziness, naseua for over 1 week following vaccine
2:35 pm Client presented self w/ c/o feeling a bit lightheaded.  no c/o blurred vision.  Respiration even and reg.  B/P 190/98, HR 94.  Paramedics present.  2:45 pm stated feet better, allowed to leave observation area.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received from a patient's parent, who is also a health care professional, on 23 May 2008.  A 22-year-old female patient with a medical history of kidney stones, had received an intramuscular injection of IMOVAX RABIES, lot number A0484-2, as part of a pre-exposure series.  Two hours later, the patient experienced chills and muscle aches.  24 hours after vaccination, the patient developed behavioral changes described as "crying, angry, anxious".  She also had difficulty swallowing for 48 hours.  The patient was treated with MOTRIN and XANAX and the events resolved within 48 hours.  The patient had no complaints of shortness of breath or facial or throat swelling.  The patient recovered from the events.
Almost 30 minutes after second vaccine noted throat fullness, tongue swelling, lightheadedness and dizziness.  No fever or rash;  no SOB, dyspnea, stridor.  On exam throat, uvula, posterior pharynx and tongue pink, not erythematous and no swelling.  Observed and administered Benadryl 25 mg po with marked improvement over next 60-90 minutes.
Itchy/ itchy arm; Left arm swollen; Left arm painful; Redness increase about 3-4 inch/ Redness all down to her left elbow; Redness at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness increase about 3-4 inch/ Redness all down to her left elbow), VACCINATION SITE PRURITUS (Itchy/ itchy arm), VACCINATION SITE SWELLING (Left arm swollen), VACCINATION SITE PAIN (Left arm painful) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included WARFARIN for an unknown indication.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 23-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). On 24-May-2021, the patient experienced ERYTHEMA (Redness increase about 3-4 inch/ Redness all down to her left elbow). On 25-May-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy/ itchy arm), VACCINATION SITE SWELLING (Left arm swollen) and VACCINATION SITE PAIN (Left arm painful). At the time of the report, ERYTHEMA (Redness increase about 3-4 inch/ Redness all down to her left elbow), VACCINATION SITE PRURITUS (Itchy/ itchy arm), VACCINATION SITE SWELLING (Left arm swollen), VACCINATION SITE PAIN (Left arm painful), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medications were provided.
Pts. Left thigh was swollen with splotch red/pink skin warm to touch and painful. Pt was started on antibiotics for 10 day treatment. Per FNP reaction to DTAP and need to be reported.
lightheadedness; metallic taste in mouth; chest tightness; feeling dizzy; head rush; This is a spontaneous report from a contactable healthcare professional. A 43-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), dose number 1, via unspecified route of administration and anatomical location on 15Mar2021 (at the age of 43-year-old at vaccination) as a single dose for COVID-19 vaccination. Medical history and concomitant medications for the patient were not reported. On 15Mar2021 (during 15 minutes waiting period after injection), the patient experienced light-headedness and "head rush", felt dizzy and had a metallic taste in mouth. The sensation of chest tightness was reported upon her arrival to bay. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. As therapeutic measures patient took levalbuterol (MANUFACTURER UNKNOWN) which helped her chest tightness. Other treatments included antihistamines [unknown], water and snacks. The outcome of the events was recovered on an unknown date. No follow up attempt is needed. No further information is expected.
Pt got fever, T: 99 - 101 degree F from the evening to next day, then started having cough - o/e: Chest: some wheezes and crackles (rales) on base of lung (+) they treated with AZITHROMYCIN and and cough expectorant - acetaminophen
throat had a tickle in it, felt funny; A spontaneous report was received from a healthcare professional (Pharmacist) concerning a female patient who was in her late 30's, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tickle in her throat(felt funny).  The patient's medical history, as provided by the reporter, included exercise-induced asthma, but does not take any medications for it (hadn't had to use a rescue inhaler for almost a year).  On 15 Jan 2021, approximately five to ten minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On observing the event she was given  two puffs of albuterol inhaler and felt better. After 15 minutes her throat was doing it again. They gave her oral Benadryl 25mg. The staff took her to the emergency room and gave low dose oral prednisone for three days and a single oral dose of famotidine.  Action taken with mRNA-1273 in response to the events was not reported.    The events, tickling in throat were considered resolved after two days.   The reporter considered it as a anxiety-type reaction as she came to the vaccination site alone.
8CM ERYTHEMA ON RIGHT THIGH. HOT TO TOUCH. IF INCREASES GREATER THAN 1/2 INCH, START AUGMENTIN.
A report was received from a health care professional on 12/17/03 concerning an 8 year old female vaccinee who inadvertently received a sub-optimal dose of Fluvirin on 12/15/03. On 12/15/03, a vaccinee inadvertently received a dose of 0.25ml of Fluvirin. No adverse events had occurred as a result at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee did not experience any adverse reaction. The vaccinee did not contract influenza and she will later receive the full dosage of Fluvirin in mid January. No follow up pending. All information received.
I had two shots on the same day. Since then both my arms are sore, overly dry mouth that caused me to get up in the middle of the night 3 times to get a drink of water so I can didn't feel like I wasn't going to get any saliva in my mouth. Taste buds were overly active so things I use to like doesn't taste good at all. I tasted very strongly any flavor that was in the food or drink. I has a headache more often than from my tooth extraction. While brushing my teeh the toothpaste stung my gums.
Rashes came out after 7 days of booster dose. Rashes came out too after my second dose (Moderna)
Seizure. Looked up in space. Was shaking and trembling. On medication for seizure now.
pt recvd 3 doses of Engerix-B; titer test indicated did not respond;
28 Y/O female. 5 Minutes after second dose of Moderna vaccine. In observation started complaining of itching.   Physical Exam-  Skin- Hives upper torso, Bilateral upper extremity  A&Ox3  Respiratory rate even and not in labor Patient in no acute distress.
Started with a headache 2/8/21 and on 2/9/21 Temp of 101.7, chills, body aches, nausea
Mother was called about her daughter who while in day care was nauseated, vomiting. Fever of 102 degree, achy. No redness or swelling at site of inject. Child appeared lethargic. Advised to treat Sx with fluids and TYLENOL or Ibuprofen as need. Seek med care if symptoms get worse or breathing problems.
I went to visit my grandson and he wasn't well. The day I drove back home on the 30th is when I noticed I was feeling bad. He tested positive of COVID. The next day I had a stuffy nose and sore throat and weird heart palpitation and congested. I felt sick but not overwhelmed. I went to the Emergency Room and got a Covid test and it was positive. I felt sick and bad for 3-4 days and then felt fine. I was tired and felt like I had a really bad cold but without breathing or chest issues.
This spontaneous report as received from a physician refers to a 8 months old patient. The patient was vaccinated with VAQTA (lot# is unknown) on 13-JUL-2012. No adverse effect was reported, it's unknown if the patient sought medical attention. Additional information has been requested.
Red and Itchy cheeks; Red and Itchy cheeks; Left arm ache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red and Itchy cheeks), PRURITUS (Red and Itchy cheeks) and PAIN IN EXTREMITY (Left arm ache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy, Drug allergy (Cephalosporin), Dust allergy, Iodine allergy, Allergy to molds, Asthma since 1976 and COPD since 1985. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, ALBUTEROL SULFATE for Asthma, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for COPD, OMEPRAZOLE from 03-Jan-2021 to an unknown date for GERD, TERAZOSIN HYDROCHLORIDE (HYTRIN) for Heart disorder, ROSUVASTATIN CALCIUM (LITORVAS) for Hypercholesterolaemia, COLECALCIFEROL (VITAMIN D3 1000) for Osteopenia.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PRURITUS (Red and Itchy cheeks) and PAIN IN EXTREMITY (Left arm ache). On 05-Mar-2021, the patient experienced ERYTHEMA (Red and Itchy cheeks). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Erythema and Pruritus, at a dose of 50 milligram twice a day. On 08-Mar-2021, PRURITUS (Red and Itchy cheeks) had resolved with sequelae, PAIN IN EXTREMITY (Left arm ache) had resolved. At the time of the report, ERYTHEMA (Red and Itchy cheeks) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Treatment also included cold compresses.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07-May-2021 contains no new information. On 10-May-2021: additional information document received on 10-may-2021 contains Allergies added, medication history added. Updated concomitant and treatment medications. On 17-Jul-2021: Follow up received on 17-jul-2021 contains No new information was received.
Lymphadenopathy  - large lymph nodes posterior cervical and tenderness down her neck.  This was more than what we have seen associated with these reactions.  We contacted Infectious Disease and followed his advice to ice, watch and report to VAERS.  We also got a CBC.
01-12-03@1120am: T.C. from parent.  Reports she had to take child to clinic yesterday, Sunday January 11, 2004 for c/o "redness approx 3" diameter in RT thigh with warmth and swelling at sight" initially identified, per parent report on evening of 01-09-04 following administration of vaccinations given on a.m. of 01-09-04 at health department.  Mother states child has remained afebrile throughout weekend.  Mother was encouraged by provider to notify health department of local adverse reaction.  Mother states ATB: Zithromax was administered and she was encouraged to administer PO Benadryl and apply cool cloths to the sight.  Parent states today that symptoms "not better, and not worse."  Encouraged to continue monitering RT thigh area and to comply with Rx regimen and interventions.  Voiced understanding of need to follow-up with PCP for worsening of symptoms and to report such findings to health department, if occurs.  Questions encouraged.  Will follow-up with parent within 1 week to ensure sympotoms not worsening.  Compliance enforced.
This patient contacted us two days after receiving her ZOSTAVAX reporting a raised rash that increased from 3" to 3"x6" and was hot to touch. She also had chills. The next day the rash spread to her elbow and she reported a slight headache.
Pt experienced nausea, numbness, tingling and gradual ascending muscle weakness of LE.
Severe arm soreness; Fever; Headache; Shivers; Body aches; Dizziness; Confusion; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), CONFUSIONAL STATE (Confusion), VACCINATION SITE PAIN (Severe arm soreness), PYREXIA (Fever) and HEADACHE (Headache) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced DIZZINESS (Dizziness), CONFUSIONAL STATE (Confusion), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Shivers) and MYALGIA (Body aches). On an unknown date, the patient experienced VACCINATION SITE PAIN (Severe arm soreness). The patient was treated with PARACETAMOL (TYLENOL) for Headache, Vaccination site pain, Fever, Shivers and Myalgia, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), CONFUSIONAL STATE (Confusion), VACCINATION SITE PAIN (Severe arm soreness), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Shivers) and MYALGIA (Body aches) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided.
Approximately 5 hours after the injection, I had the following symptoms:  Migraine Chills/shaking Muscle aches Fever Nausea   Also, approximately one month following the injection, the injection site is sore when my arm moves certain ways. This is still ongoing.
02/26/2021, the day after the vaccination, I had considerable soreness in my left shoulder, at the point of injection. I had some fatigue and a little bit of a headache, and my energy level kept up and down for the day. The soreness in the area near the injection site got worse for the next several of days. After approximately 5 days, I called the doctor because  I could not move my arm at that point, it was like I had a torn rotator cuff. They told me to monitor it and it eventually started to abate after 10 to 14 days.
Fever 104 x 5 days; lethargic & limp for 3-4 days;
pt recvd vax & exp flu-like symptoms; pt not feeling well, slightly nauseated & vague feeling of discomfort; pt exp also vomiting, severe muscle cramping & pain of legs, thighs,back,abdo & shoulders;pt BP dropped to 78/46; dx systemic rx;