chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient seen on 7/19/06 - physical for college.  Given Hep B & meningococcal. Returned on 8/9/06 and diagnosed with shingles.  ? Reaction to immunizations
patient receiving a 3rd dose of Menactra / no AE; Initial information received on 04-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 years old male patient who receive 0.5 ml third dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6541AA (Expiry date 31-Mar-2021) via unknown route in unknown administration site on 03-Sep-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) (it was reported as Gaurdacel).   It was an actual medication error case due extra dose administered.  At a time of vaccination No adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Cold symptoms, dry ear canals, lesion legs, arms, stomach, back (15-20 lesions), hot flashes given Benadryl, ear drops.
Patient came in for physical exam on 9/20/12 dr ordered vaccines for patient D-Tap. Hepatitis A & PPD. Nurse gave PENTACEL, Hep A & PPD.
I felt fine up until 4 pm my arm started getting sore and swollen. I just put on some ice. I started getting chills and a  fever at 6 pm. Pretty much what I did was stay at home in bed for 3 days and take a lot of fluids and sleep. I did not go to the doctor and did not take any medicine. On 08/31/2021 I decided to go to the doctor because I still had fatigue since I received the vaccination. They took blood work and I still do not have the results. I have been tested 2-3 times for Covid because I keep thinking I have Covid because I have a lot of fatigue, it always come back negative. One time they did an EKG and it was normal.
Cellulitis per MD. Redness, inflammation/swelling, and pain of the right arm. Patient went to emergency room/urgent care and was given Keflex antibiotic
Patient received her booster dose on 1/28; on 1/29 she realized she was having left sided  facial swelling.  She waiting until 2/1 to present to  PCP. The PCP called to have her directly admitted into the hospital. She is currently being treated with steroids, NSAIDs, and antibiotics.
blood pressure was sky high; couldn't get out of bed; feeling terrible; feeling thirsty; nausea; Headache; feeling weak; dizzy; Vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (blood pressure was sky high), ASTHENIA (feeling weak), DIZZINESS (dizzy), VERTIGO (Vertigo) and HYPOKINESIA (couldn't get out of bed) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history reported.  Concomitant products included LEVOTHYROXINE SODIUM (L-THYROXIN 1A PHARMA) and ASCORBIC ACID, COLECALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (MULTIVITAMIN HP) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced ASTHENIA (feeling weak), DIZZINESS (dizzy), VERTIGO (Vertigo), POLYDIPSIA (feeling thirsty), NAUSEA (nausea) and HEADACHE (Headache). On an unknown date, the patient experienced HYPERTENSION (blood pressure was sky high), HYPOKINESIA (couldn't get out of bed) and FEELING ABNORMAL (feeling terrible). At the time of the report, HYPERTENSION (blood pressure was sky high), ASTHENIA (feeling weak), DIZZINESS (dizzy), VERTIGO (Vertigo), HYPOKINESIA (couldn't get out of bed), FEELING ABNORMAL (feeling terrible), POLYDIPSIA (feeling thirsty), NAUSEA (nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Computerised tomogram: Inconclusive. On 17-Mar-2021, X-ray: Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was in a bad shape and had go to the hospital. Physician recommended not to get the second shot. 9 days Later patient could not get out of bed. Patient experienced a really bad Vertigo and ambulance took to Emergency room and they kept patient for part of day until blood pressure went back to little lower.   Patient have chosen not to get second dose.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow up information received on 08-APR-2021,  Health care professional details are updated. Patient demographic was updated. Additional events are also added On 11-May-2021: Pt stating she is not getting her 2nd vaccine.
It started on 12/30/20 around 10 pm with just a headache, then it progressed to hot flashes and nausea. I ended up throwing up around 4 am on Thursday 12/31/20 at work. Then over the weekend I  felt very lethargic, had body aches, and the hot flashes continued. My left arm hurt as expected, but the soreness went up into the left side of my neck as well. Today (1/3/21) is the first day since I got the vaccine where I no longer have a headache and feel basically back to baseline.
Inappropriate schedule of vaccine; experienced blurred vision; Metallic taste in mouth; Tingling of tongue; This case was reported by a consumer via call center representative and described the occurrence of blurred vision in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, several minutes after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced blurred vision, taste metallic, tingling tongue and incomplete course of vaccination. On an unknown date, the outcome of the blurred vision, taste metallic and tingling tongue were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the blurred vision, taste metallic and tingling tongue to be related to Shingrix.  Additional details were provided as follows: The reporter reported for herself. The patient received 1st dose of Shingrix in left deltoid couple of years ago and within a few minutes of receiving the vaccine, experienced blurred vision, a metallic taste in her mouth and tingling in her tongue. The symptoms lasted about an hour and then resolved. Till the time of reporting, the patient did not receive dose 2 of Shingrix, which led to incomplete course of vaccination. The patient thought her HCP or pharmacist already reported this event. No further information was available. The reporter did not consent to followup.
Pt began c/o redness, swelling, and heat to injection area the day after vaccine administration.  Area was marked and continued to get larger, patient was seen by PCP three days after injection.  Pt was treated with lidocaine patch
I had walking pneumonia a week or 2 later but the real issue started in August of 2023. I went diving in a backyard pool of 10-12 ft deep. I came out of the water and was hanging out later. I went home and I got in the shower and started getting pain in my left hip and up into my chest. I was having trouble breathing. I went to the hospital and my vitals were fine. 24 hours later I was in the car on the way to work and had sudden shortness of breath. I worked the next day and was fine. The next day my heart rate jumped from 80-90bpm to 160bpm and it varied up and down. I took an ambulance to the hospital. My chest was tight and I was concerned. They tested for stroke and heart attack and found nothing wrong. They sent me home. A couple weeks ago in October, it happened again, it jumped up to 159. I had a friend take me to the hospital. EKG is normal. CT scans are normal. Pulmonary test is normal. I am doing an MRI soon. Since then I have heart palpitations off and on. I just feel weird and I get headaches off and on as well. I have never had health issues so this is sudden and random. I get random pains, I get acid reflux a lot now as well.  I am a flight attendant and I see doctors in different places due to my flight schedule. Doctors do think it could be anxiety but I really dont think it is that. It has to be related to the vaccines. I received Covid Janssen on 3/24/2021 and had no issues.
requested pt's medical records, but they were never sent; pt had a positive COVID test on 9/16/21; per death certificate, pt passed away in a nursing home facility with causes of death being Malnutrition, Anorexia, 2019-NCOV Acute Respiratory Distress
No additional AE reported. No PQC reported.; ROTATEQ had been administered to a patient since the excursion occured; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant therapy was not provided.  On an unspecified date in 2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # T039454 has been verified to be a valid lot number, expiration date reported as 14-DEC-2021; strength, dose and route were not reported) for prophylaxis. The vaccine had been stored under 0.3 degree Celsius for 11 hours, 0.4 degree Celsius for 11 hours and 0.6 degree Celsius for 3 hours, recorded by digital data logger. The reporter was told that the vaccine was still viable. There was no previous temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) was reported.
She got her vaccine, was OK, had no symptoms and was fine, went to bed and woke up having chills and hot.  She then got a headache, her teeth are hurting, her back is aching.  The headache continues and so does her teeth.  She has not taken anything for the symptoms.  She was running fever last night, but did not measure it.  She was not able to get up to take her temperature.    She did not have any symptoms from the first two vaccines.
Fever, rash, hypereosinophilic syndrome dx. Follow up states diagnosed also with peripheral neuropathy. 60 day follow up states hypereosinophilic syndrome, peripheral neuropathy. The annual follow up received on 10/01/03 states she has hypereosinophelia syndrome and lower extrem. deficits.
A report was received by a health care professional on 22 October 2003 concerning 80 adult vaccinees who received Fluvirin subcutaneously. A 27 gauge half-inch needle was used. Non of the vaccinees exhibited any adverse symptoms. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
When I received the shot there was a burning sensation. My arm was sore for four days, where the shot was given. Then I noticed that I was unable to do certain movements, like rotate my arm, pull up my pants because there was a shooting pain down towards my arm, this went on for three weeks after I received the shot. If I tried to lift my arm over my head my shoulder was in pain. I now have limited movement in my left arm. I went to see my primary Doctor and he referred me to a shoulder doctor. I then went to see the Shoulder specialist and he gave me a shot, in my shoulder. For  about 4 hours, I was relieved of my pain, however it was short lived, my shoulder went back to limited rotation. I did go back to the doctor and he is sending me to get an MRI. There is no diagnosis at this time but I did not want to wait longer to report this.
Presents to the ED as a code blue. Per EMS patient tested positive for COVID-19 1 week ago. EMS performed 4 rounds of CPR with epinephrine, but patient remained in asystole. He also had a king airway placed by EMS. EMS report they initially received the call due to patient being unresponsive.
Vaccine given in right arm. Pain started just after leaving doctor's office. Pain extended from right shoulder and shoulder blade down arm to fingers. This pain was strong and lasted about one week. Pain also radiated into front chest shoulder area and into back. Pain lasted like this for at least 4 months, then has continued since then if arm lifted to certain degree or if over used.
29y old female complained of pain, swelling to left arm. Received Anthrax shot 19APR04. Positive for edema, erythema, induration of approx. 6.5x5.5 " to left arm. Cellulitis. Meds: Keflex, Motrin
Immediate burning pain in left arm at injection site.  Throbbing pain in left arm continues 5 months later. Weakness in left arm and pain when lifting arm in certain positions.  Unable to sleep on left side.
diarrhea & h/a w/in 24hr;h/a lasted over 1wk;
Patient came in yesterday 7/21/21 at around 3pm to get the second Pfizer shot. During the consultation, patient was asked about side effects she had experienced after the first shot. Patient claims that approximately a day after the vaccine was administered, her chest started hurting, she experienced shortness of breath, difficulty breathing, fever at 100 and sore arm. We advised patient to seek a physician to evaluate whether patient should be getting the second CV19 Pfizer shot.
High fever 8hrs after flu shot. Fever lasted 9-10hrs. Had bad headache and stomach aching the next day. Also having body weakness. Able to eat light breakfast but it's not sitting well.
Patients receive an invalid COVID Bi-valent booster vaccine, expiration date exceeded 10 week thaw expiration Per Pfizer and the CDC this is a storage handling error (temp excursion) and a repeat dose is recommended immediately no minimum interval. The CDC also recommends waiting 8 weeks for an additional immunization due to increased risk of myocarditis in certain age groups.
Dizziness; Chest pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 18-Mar-2021.    This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness) and CHEST PAIN (Chest pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (trees and grass) and Food allergy (fruits, lemons, melons, certain spices such as coriander, thyme, and pepper). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DIZZINESS (Dizziness) and CHEST PAIN (Chest pain). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Dizziness and Chest pain, at a dose of 1 dosage form. On 22-Feb-2021, DIZZINESS (Dizziness) and CHEST PAIN (Chest pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient was administered vaccine that was improperly stored (in freezer for too long and considered expired by manufacturer at date of administration due to lack of study data). Patient acknowledged recommendation and plans on scheduling revaccination at the end of June.
Swelling, redness,itchy rash. Very hard swelling at the site of the injection.  Has been taking oral benedry and applying ice to the site. Today,01,21,2021, the redness is spreading
Patient felt dizzy and experienced syncope. Left leg felt weaker than normal. Lactated ringers and meclizine 25 mg PO once provided in the emergency department. Patient was discharged from the emergency department.
Mid back soreness, tingling right arm and hand, tingling both feet, mental and physical fatigue. Passed out while at the jewelry counter in store. Fell back and struck head on tile floor. Unconscious less than 15 seconds with blank stare. Woke up did not know what happened. Then complained of headache and neck pain.
Patient had a fever to 101.3 and headache following vaccine. The following morning, he reported to his mother that he had had chest pain during the night. The patient reported chest tightness, and a rapid heartbeat when he awoke from sleep.
Rash behind knee; This spontaneous case was reported by an other caregiver and describes the occurrence of RASH (Rash behind knee) 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 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash behind knee). At the time of the report, RASH (Rash behind knee) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-138739 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-138739:
Fever and chills, with body aches and fatigue. Lasted for 24 hours. At time of adverse event was 14 weeks pregnant. Due soon.
I developed swollen glands on the right side of my face, in front of my ear and  TMJ. I also developed swollen glands under my right ear and neck area. This occurred about 2  1/2 hours after my injection .   I used hot compresses and took Benadryl tablet.  The swelling went down  thru the evening. In the  morning ,   When I awoke, my glands were swollen again.   In the afternoon, I went  Urgent Care, The   Nurse Practitioner to.d me it was a side effect and that there was nothing  to do.   Today,  my  glands are tender to the touch, but not swollen.
Approx 24 hr after IM injection of H1N1 vaccine clients mother called to report child woke up from nap, was crying and vomited x1. Denied any other symptoms.
Numbness and weakness in bilateral upper and lower extremities. Loss of control in half of face. Symptoms started morning of 11/6/10 and became progressively worse. Diagnosed with Guillain Barre Syndrome. Required IVIG during hospital stay.
Received 0.50mL instead of 0.25 mL from Moderna Covid 19 Bivalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.50mL instead of 0.25 mL from Moderna Covid 19 Bivalent) and NO ADVERSE EVENT (No adverse event) in a 6-year-old patient of an unknown gender 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 an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Received 0.50mL instead of 0.25 mL from Moderna Covid 19 Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Received 0.50mL instead of 0.25 mL from Moderna Covid 19 Bivalent) 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 ACCIDENTAL OVERDOSE (Received 0.50mL instead of 0.25 mL from Moderna Covid 19 Bivalent).    No concomitant medications was reported. No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-659990.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659990:Patient 1 case
Swelling, very painful , 100degree fever, lasted 2 -3 days, nausea, shakes, site continues to be very sore like a deep bruise to the bone.
SHORTNESS OF BREATH, PRESSURE ON MY HEART , CHRONIC FATIGUE AND HEADACHES.  SIGNS AND SYMPTOMS LASTED 30 DAYS UNTIL I SAW MY PCP.
This spontaneous report was received from a pharmacist via a company representative referring to a 65 year old female patient. Information about medical history, concurrent conditions and concomitant therapies was unknown. On 22-OCT-2018, the patient received a dose of PNEUMOVAX 23 (dose detail, route, lot # and expiration date were not reported) and a dose of FLUAD (dose detail, route, lot # and expiration date were not reported) for prophylaxis. On an unspecified date in 2018, the patient experienced cellulitis with arm swelling, therefore she went to see her primary care physician and was prescribed steroids with antibiotics (dosage and formulation were unknown). The outcome of cellulitis with swollen arm was unknown at the time of report. The causality assessment were not reported. Upon internal review, cellulitis was determined to be medically significant.
sick as a dog; This case was reported by a other health professional via call center representative and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were reported as follows: The patient was a medical assistant. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received a dose of Shingrix and was sick as a dog afterward. On 31st December 2020, the patient received 2nd  dose of shingrix and did not had any symptoms afterwards. The patient was angry throughout call and declined to provide any contact details, wishing to remain anonymous. No further information provided. The reporter did not consent to follow-up.
Chest pain,  heart rate 200 bpm, sweating, vomiting.  He said he felt like he was having a heart attack and couldn?t catch his breath.  This began two days after his first covid vaccine.   This first episode lasted about an hour.  He had a second episode the next day and that?s when my husband brought him to our local emergency room.
had runny nose when given vax; that noc swelling, redness @ site; 2 days later exploded into horrible sickness; fever, runny nose, watery eyes, sneezying coughing; 12 days later t103 x 36hrs; unable to break fever required 2 trips to MD
This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 21 year old pregnant female patient with bipolar disorder and gastric sleeve. On 21-FEB-2018, the patient was vaccinated for prophylaxis with the first dose of GARDASIL 9 lot # N017832, expiration date 16-NOV-2019, intramuscularly. Concomitant therapies included escitalopram, venlafaxine, naltrexone hydrochloride (VIVITROL) and albuterol sulfate (VENTOLIN). The patient's last menstrual period was on 25-DEC-2017. Conception date was estimated as 08-JAN-2018 and estimated delivery date was 01-OCT-2018. The pregnancy outcome was pending. The patient had an office visit. No treatment was given.