chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced ACCIDENTAL UNDERDOSE (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose).    No concomitant medications information was reported.  Vaccination date: between 22-Jul-2022 and 28-Jul-2022. It was unknown if patients experienced any symptoms after getting the vaccine.  No treatment medications were provided.
I have a fever, chills and body aches, exhaustion and cannot get up off of my couch.
Increased swelling and pain in underarm on side of injection. Injection was about at 0800 on 1/9, pain began around 1900 1/9 and woke up with swelling and worsening tenderness on 1/10 at 0800. Swelling and pain continued into 1/11 and has not improved. No palpable lymph nodes
This spontaneous report was received from licensed practical nurse, regarding an unknown number of patients (number, age, and gender were not provided). On an unknown date, unknown number of patients might have received doses of GARDASIL; RECOMBIVAX; and VAQTA, for prophylaxis purposes. (Lot number, expiration date, and route were not provided). The reporter stated that the doses were exposed to consistent temperatures of 33.5 degrees F, every day for 4 months. No adverse effect was reported. Additional information has been requested.
patient was given Fluzone HD last year but it was given in half doses. One partial dose done and a week later the second partial dose was given/No AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA311164 same reporter.  This case involves a patient of an unknown demographics who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site, in two half doses. One partial dose done and a week later the second partial dose was given.  It was a case of actual medication error due to Wrong technique in product usage process.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  Information on the batch number was requested.
PT received COVID #2 vaccine at 0830 to the left deltoid. Several hours after the vaccine he had arm soreness at injection site, body aches, fatigue, malaise, dizziness and lightheadedness. The symptoms persist the following day at which time pt was evaluated in th employee health clinic. Vitals normal. Neurological exam normal.
L arm started to get swollen and sore 3.5 hours after injection.  Redness and swelling progressed over the next few days. Swelling was rom the top of the shoulder extending down to the elbow. Arm was painful and hot to touch.  On 7/18/2019 went to rapid care, nurse practitioner stated that it was not cellulitis. Patient was prescribed Ranitidine, she was unsure why.  By 7/20/2019 the swelling started to subside.  7/29/19 swelling gone, no longer painful, only a little itchy.
2 days of severe chest pain, EKG with ST segment elevation and troponin elevated to 7, consistent with pericarditis.
Sore arm, chills,  temp= 100 On 1/8/2021 temp=100.8, body aches, sore arm Took Tylenol
Patient came in on 6/29/20 and wanted to let me know that after receiving the shot on 6/27/20 he had pain in his shoulder and had a hard time moving his arm. He thinks it is going to be okay. He can move it a little more now.
This is a prospective pregnancy case. This 32-year-old female subject was enrolled in a study to detect and described any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with BOOSTRIX during pregnancy or within 28 days preceding conception. The subject received BOOSTRIX on 6th January 2015. The subject's last menstrual period was on 28th May 2014 and estimated date of delivery ws 4th March 2015. The subject received BOOSTRIX at week 32 of the pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. The subject had 3 previous full term pregnancies.
It started on 10/14 ? night sweats, pjs were wet, sheets, hair were all wet. That happened about every 3 days in October. In November, the night sweats got less, maybe every 2 weeks. In December, they came back again every week. Struggled with first two months - shortness of breath and tiredness during night sweats, 3rd month has been much easier to deal with, but they are still on going. I talked to Dr.. I did write down what I ate that day and what other things could cause this reaction but I couldn?t find any pattern. Haven't had night sweats since my early 50s. Haven't had these at this age before, one time post surgical but they're very different.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unspecified demographics. The pertinent medical history was not reported. The nurse reported that since an unknown date in February 2015, the patients were vaccinated with GARDASIL, intramuscular which underwent a supported temperature excursion. The concomitant medications were not reported. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Ear infection 1 week prior to abnormal labs, cough x 1 week, nasal congestion x 1 week, croup 2 months prior to admission - 3/16 plts 12,000 received IVIG 10 gm x 1 dose. See labs below. 5/26/09-records received for DOS 3/16-3/17/09-presented with low platelet count of 19,000. In ED presented with petechial rash and bruising.  Stool little loose.
Fever; Chills; Headache; My arm has redness, it has swelling and it is very hot; My arm has redness, it has swelling and it is very hot; My arm has redness, it has swelling and it is very hot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever, chills, headache, my arm has redness, it has swelling and it is very hot. Additional Context: Consumer stated, I am calling because I received my second dose of the Covid vaccine on Friday at 3:00 and today, I am having a lot of side effects. On Friday, I got fever, I got chills and headache. On Saturday and Sunday and today was Monday, my arm has redness, it has swelling and it is very hot and I am having a headache. Consumer further stated, is there another person I can talk to, I don't understand you. I will call again. And hung up abruptly. Limited information was available over the call as consumer hung up abruptly. Hence, product details (LOT, expiration date, NDC, UPC), purchase details and other details were unknown. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I had an extremely heavy lost of blood from menstrual cycle, with big blood clothes as big as 4 inches in diameter. Also, very painful cramps and very heavy and long periods. I saw my doctor, they did a biopsy  and ultrasound they diagnosed me with iron deficiency anemia which is adenomyosis.
have been exposed to Covid and are going to go get tested today; This is a spontaneous report from a contactable consumer. This consumer reported similar events for himself and his wife. This report is for reporter's wife. This consumer reported for a female patient (wife) that:  A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 15Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Patient had first dose on the vaccine on 15Jan2021 and were scheduled to get our second dose on 05Feb. The patient medical history and concomitant medications were not reported. Patient had been exposed to Covid on an unspecified date and were going to go get tested today.  Patient was enquiring about to get the second dose if test positive. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021085494 same reporter/drug/event, different patient
Schizophrenia; This is a spontaneous report received from Pfizer sponsored program. A contactable consumer reported that a 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiry date not reported), via an unspecified route of administration on 27Feb2021 as a single dose of COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter questions if patient can still receive the second dose as the patient is with schizophrenia and wanders off and sleeps at different locations. Outcome of the event was unknown.  Information about Lot/Batch number requested.
DIZZINESS AND VERTIGO AND APPEAR TO SEE FLOATERS / HAVE NOT HAD THIS AFFECT SINCE i WAS FIRDT DIAGNOSED WITH TINNITUS AND COMLETE RIGHT EAR HEARING LOSS vestibular disorder in 1985
Headache began at 1200. Began vomiting at 100pm, every hour until 1000pm. Diarrhea  also, chills but no fever.
This spontaneous report as received from a medical assistant, also reported as a health care worker, refers to a female patient of unknown age. On 18-MAY-2013 the patient was vaccinated with dose 1 of GARDASIL. Lot number, expiry date, route of administration, anatomical location and prophylaxis were not reported. On 03-APR-2013 the patient was vaccinated with dose 2 of GARDASIL. Lot number, expiry date, route of administration, anatomical location and prophylaxis were not reported. No adverse event was reported, no PQC was involved. The outcome and treatment information were not reported. Additional information has been requested.
Pt recv vax on 10/19/98; on same day pt exp edema,erythema, fever, tenderness of Lt leg; tx=antibiotic.
bleeding prolifically with gigantic blood clots coming out; bleeding prolifically with gigantic blood clots coming out; had only 2 menstrual cycles (02May2021 and 24Jul2021) since the vaccine and patient was normally regular with her cycles; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL8982, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 05Feb2021 at 17:30 hours as dose 2, single (at the age of 50-year-old) for COVID-19 immunisation. Medical history included penicillin allergy from an unknown date and unknown if ongoing and had no other medical history. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. Patient did not receive concomitant medications within 2 weeks of vaccination. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 16Jan2021 at 09:00 hours as dose 1, single (at the age of 50-year-old) for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had only 2 menstrual cycles since the vaccine and patient was normally regular with her cycles. Patient last cycle ended 16Feb2021, just after her second dose. The first one, patient had since then was at 02May2021 (the beginning of May) and patient bled for over a month. Then she visited her doctor to get an exam. The next cycle patient had begun 24Jul2021 and by 01Aug2021, patient was bleeding prolifically with gigantic blood clots coming out for over 48 hours. Patient went back to her doctor for another exam and blood work and hormones labs in Aug2021. All of which came out normal. Patient had never in her life experienced menstrual cycles such as these 2 and they were the only one patient had since her second dose of the vaccine. Patient had doctor or other healthcare professional office/clinic visit for all the events. The events were reported as non-serious by the reporter. Patient received no treatment for the events. The outcome of all the event was unknown.  Follow-up attempts are completed. No further information is expected.
TIREDNESS, HEADACHE (MIGRAINE),, MUSCLE PAIN, CHILLS - SEVERE, JOINT PAIN, NAUSEA, FEELING UNWELL, SWOLLEN LYMPH NODES (LEFT ARM ONLY)
Thrombus of right middle cerebral artery at bifurcation of M1 and M2 causing stroke
Short of breath, needing to use her inhaler and has been experiencing heart palpitations.  She verbalized that her symptoms have been resolving over time.
Sore arm where shot given.  Some weeping also.  Cream used 12/22. Follow-up information received 1/26/10. Manufacturer for vaccine and lot number are unknown.
Approximately 14 hr after pt received vaccine she awoke with difficulty breathing and swelling to face and lips. Symptoms subsided throughout the day, although swelling to face and lips continued until late afternoon. Pt notified by phone MD office. Instruct to take OTC Benadryl.
Information has been received from a nurse concerning a 9 year old female who on 22-OCT-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot number: 658287/1173U). Concomitant therapy that day included Fluzone (manufacturer unknown), Gardasil and hepatitis A vaccine (inactive) (MSD). "The patient experienced 2 centimeters of irregular erythema on her left arm after receiving the vaccination." No further information was given. The outcome was reported as recovered on 26-OCT-2007. There was no product quality complaint. Additional information has been requested.
not to the vaccine, but patient was hospitalized for VOCID-19 on 3/17. Tested positive for COVID-19 on 3/11/21.
Localized Edema left thigh. Sites of DTAP and IPV and Varicella
Very sore arm for several days after shot.  On day 9 I started to get a low grade fever, body aches, headache,  upset stomach and extreme fatigue. Day 10 I was having severe memory issues. I struggled with putting words together and forgetting things like passwords and even how to turn off my computer. My husband was very alarmed and thought I was having a stroke.  He took me to the ER.
Patient c/o nausea, dizziness, loopy, faintness, Nurse evaluated and gave her some snacks and fluids due to patient stated she had not eaten that morning.  no other signs came up and she had stated she was feeling better and was released to go home.  Patient's boss called and stated patient was not doing well since she went home, called patient- and she stated that she is unable to walk straight and had all the same symptoms she had in the clinic, informed  provider and she asked to have patient go to the nearest hospital and be evaluated for possible allergic reaction. she was evaluated and deemed no allergic reaction to covid vaccine and was given ok to receive 2nd dose was seen at 1705 1-14-2022
Patient reported to ED with 24 to 48 hour history of sudden onset chest pain and shortness of breath. On arrival patient was pale, diaphoretic, and hypoxic with O2 sats 60s-70s. Patient was placed on 15L HFNC. CT with contrast was obtained which revealed 'near occlusive filling defect in distal right main pulmonary artery, concerning for PE...clot burden extends into the RUL, RML, and RLL arteries.' Heparin infusion was initiated and patient was transferred to PICU for higher level of care.
SKIN PEELING/SKIN FLUFFING; SEVERE RED RAISED LARGE PAPULAR RASH ON UPPER TORSO AND UPPER ARM; RASH ON BILATERAL INNER THIGHS; EAR LOBES SWELLED UP; UPPER NECK SWELLED UP; NECK DOWN RED; ITCHY SKIN; This spontaneous report received from a consumer concerned a 66 year old male. 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: 20A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced ear lobes swelled up. On MAY-2021, the subject experienced upper neck swelled up. On MAY-2021, the subject experienced neck down red. On MAY-2021, the subject experienced itchy skin. On 08-MAY-2021, the subject experienced severe red raised large papular rash on upper torso and upper arm. On 08-MAY-2021, the subject experienced rash on bilateral inner thighs. On 09-MAY-2021, treatment medications included: diphenhydramine hydrochloride. On 10-MAY-2021, the subject experienced skin peeling/skin fluffing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe red raised large papular rash on upper torso and upper arm, upper neck swelled up, itchy skin, and rash on bilateral inner thighs on MAY-2021, and skin peeling/skin fluffing on 12-MAY-2021, and was recovering from ear lobes swelled up, and neck down red. This report was non-serious.
Pt states has had a dull pain for 3 days and noticed the rash this am 2/11/07
Initial and follow up information  has been received from a physician concerning a 61 yr old female nurse who on approx 02Nov04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650084/0605P). Subsequently the pt developed cellulitis at the injection site that was self limited and resolved in 5-7 days and severe induration. The physician reported that the pt had no illness at the time of vaccination. The pt recovered on an unspecified date. There was no product quality complaint involved. Additional information is not expected.
Immediate swelling and burning at injection site. 3 hours later a slight headache started and body aches, around 7pm chills started, 10pm i had a fever spike of 99.9 and chills that made my teeth chatter. Sweating and body aches as well. Fever broke around 6am and chills and body aches mostly subsided. Took tylenol for the residual headache and am feeling mostly normal minus a little soreness at injection site at 8am.
Mixing error occurred, patient may have received only diluent. Patient consulting MD to decide about revaccination.
48 hours after vaccination entire legs (bilaterally), red, swollen, hot from thighs to ankles. Brought to doctor 4 days after vaccine because of streaking on right leg near vaccine site. Both sites with firm masses under skin.
Very sore and inflamed joints in particular my knees and the knuckles on each hand.  The knee soreness has definitely gotten better but it took at least 6 months before there was relief.  My finger knuckles still hurt a decent amount until about 3-4 weeks ago when I started taking aspirin each day (adult dose, 1 time daily).
Immunizations given at 10:30 AM, 5/24/04. Tolerated well; Tylenol offered, mother refused. Per mom, baby felt hot 1-2 hours later; Tylenol given. At approximately 4:00 AM, 5/25/04, baby seemed less responsive, breathing rapidly. ER Visit at 5:00 AM, temp 98.4, pulse 160, respiratory rate 24, vomited twice, pale, nonresponsive, tachypnea 45-60. Admitted to hospital; treated for febrile episode, dehydration. Baby responded well; discharged 5/26/04. Medical Record received on 12/15/2004 states pt experienced an adverse vaccine reaction.
Hallucinating; Urinary tract infection; A spontaneous report was received on 22 Feb 2021 from a consumer concerning a 90-year-old female patient who received Moderna's COVID-19 vaccine and developed a medically important event of hallucinations, and in addition urinary tract infection.  The patient medical history was not provided. Relevant concomitant medications provided included acetylsalicylic acid, vitamin d3, unspecified vitamin b12 , donepezil hydrochloride, levothyroxine, melatonin, omeprazole, permethrin and hydrocortisone.  The patient received their first of two planned doses of Moderna's mRNA-1273(BATCH/LOT # 032L20A) on 22 Jan 2021 for the prophylaxis of COVID-19 infection.  On 12 Feb 2021, patient received their second of two planned doses of Moderna's mRNA-1273(BATCH/LOT # 013M20A) in the left arm for the prophylaxis of COVID-19 infection.  On 20 Feb 2021, in 9 days of receiving vaccine, patient started hallucinating, and has urinary tract infection manifested by an odor and painful urination. Treatment for events were not provided.  Patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.  The outcome of the events, hallucinations, urinary tract infection, were not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Started with a scratchy throat and a lot of sneezing this was Tues afternoon. Monday am I took the home COVID-19 test and it was positive. Mon - thursday I was very cold, chills, stuffy, little fever. But it never got worse than that. On the 5th day I felt a little better and by the 8th day it was as if I wasn't even sick. It was a fast event. I didn't take an antivirals.