chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an office manager and refers to a 12 month old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 14-DEC-2016, the patient was vaccinated with the second improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516.
October 23, 2022 about 2:00AM I went to the hospital. I have sleep apnea, I really couldn't breathe, my heart rate was 140 at resting time the hospital diagnosed me with a heart condition called "Arrhythmia". I was prescribed and Arrhythmia medication amiodarone HCL 100; & also ELIQUIS; to help with symptoms.
Information has been received from a physician concerning a 2-year-old female who was vaccinated when she was 12 months old with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed shingles. The patient sought medical attention via an office visit with her physician. The patient recovered at an unspecified date. A product quality complaint was not involved. Additional information has been requested.
Anaphylactic response, started approx 5 minutes after injection. Developed throat swelling initially, epipen given, then benadryl 50mg IM, then developed lip swelling, additional dose of epi given, 911 called and brought to local emergency department where she is still currently receiving care.
A week or maybe it was 2 weeks after my last Moderna Covid-19 shot, I experienced an episode of my heart fluttering or irregular heartbeat which was definitely not normal. I also was trying to catch my breath which was also not normal. I have never felt this way before. I took a nap after feeling like that because it made me really tired. I woke up feeling ok after an hour of napping. Every now and then I still feel my heart flutter randomly since I had the shot. So I'm a bit concerned. After looking up side effects, I came across news of people having similar heart symptoms after the Moderna shot, so I thought I should report it so it can be documented that it has happened to me too.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 45-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8736), at the age of 45, in left arm, on Apr 24, 2021, at 11:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced axillary pain, breast inflammation (my left armpit and left breast became inflamed) and pain (it has hurt ever since), onset 2021, with outcome of not recovered. No therapeutic measures not taken as a result of axillary pain, breast inflammation and pain. Additional information: Patient did not took any other vaccine in four weeks. Patient do not have COVID-19 infection prior to vaccination. Patient not tested COVID-19 post vaccination. The next day after the vaccination, my left armpit and left breast became inflamed and it has hurt ever since. It deflated a bit but it continues. No follow-up attempts possible. No further information expected.
Pt was given pediatric dose of the Covid-19 booster instead of the full adult dose as requested by provider by one of our RN's. I was notified of the error and notified Dr. The patient was notified and due to the CDC recommendations, Patient has been scheduled to receive the booster shot in 8 weeks to avoid any potential risks to due to his age.
pt became very sleepy immediately after taking the vax.  She got home and was so fatigued and in so much pain she went to bed and slept for almost 2 days.  She says she has severe body aches and pains and is having major  problems with both  hands going numb, tingling, and hurting.  On 4/20/21 she went to her PCP, Dr.  and she was told to take Ibuprofen for her pain.  On 5/6/21 she went to Dr.  He did blood work.  No Arthritis or other problems were found.  CRP was elevated at 14.  She has been to her Chiropractor on 2 different occasions to help with pain.  She has had this pain going on 2 months and will see her PCP again at the end of the May.
"The patient had possible myocarditis in March - a few weeks after having the Covid vaccine. He had chest pain and elevated troponin, with a negative cath. Symptoms resolved with medications.   Can he receive the covid booster? "
Covid arm. My arm started to itch early this morning and I was scratching in my half awake sleep I believe. All day it has been a hot red blobby area.
FLUZONE QIV NP PFS reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no adverse evevnt; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked to cases 2023SA054981 and 2023SA057733.   This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c (clesius) and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine, Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   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 the guidelines. 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.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.; Sender's Comments:  SAD20230216001803: SAD20230220001440:
received second dose of vaccine on day 27 instead of day 28; A spontaneous report was received from a consumer concerning a female patient (demographics not provided) who received the second dose of Moderna vaccine on day 27 instead of day 28.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On unknown date, the patient received their first of two planned doses of mRNA-1273.   On unknown date, the patient received their second dose of mRNA-1273 (route and site of administration were not provided) for prophylaxis of COVID-19 infection.  On an unknown date, the patient was administered the second dose of vaccine before day twenty-eight. Treatment information was not provided.    The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event received second dose of vaccine on day 27 instead of day 28 was resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273 with no associated AEs.
Two weeks after vaccination patient states he started having numbness and tingling in his left deltoid and both hands that has not resolved after two months.
No adverse effects were reported; the patient was inadvertently administered one dose of expired VAQTA; This spontaneous report was received from an office manager and refers to a patient of unknown age, race and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 18-APR-2019, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, inactivated (VAQTA)lot number reported as M037245 with expiration date on 21-FEB-2019 (frequency and route of administration was not reported) for prophylaxis. No adverse effects were reported. At the moment of this report the outcome of expired vaccine used was unknown.  Lot number M037245 is an invalid lot number for Hepatitis A Vaccine, inactivated.; Sender's Comments:  US-009507513-1906USA002588:
Patient stated she felt she had tachycardia- pulse was 130's for approximately 2 minutes - resolved spontaneously. Patient asked for assistance due to history of SVT's
Light menstrual bleeding day after vaccine. Day 12 of my menstrual cycle. Menstrual cycle is not expected for approx 16 days.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 21-JUL-2017 the patient was vaccinated with RECOMBIVAX HB dose 3 for prophylaxis. On 21-JUL-2017, 3 months 16 days after onset of therapy the patient experienced inappropriate schedule of drug administration. No adverse event reported. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to RECOMBIVAX HB. This report is linked to case #1707USA010213, due to same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1707USA010213.
FATIGUE; This spontaneous report received from a patient via a company representative concerned a 78 year old female. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue. This report was non-serious.
Patient had chicken pox as a child and shingles in her 20's.  Received Shingrix vaccination on 8/15 and had normal side effects, such as sore arm and headache for first 48 hours.  After 48 hours, developed deep nerve pain in left side of head and neck in and beneath the skin, earache, muscle pain followed by raised red, lumpy, painful rash on neck, under hair on left side of scalp, around and inside ear canal.  Essentially, reactivation of shingles within 48 hours of vaccination.  Rash continues to spread at 6 days post vaccination, but has not developed typical shingles blisters.  No part of the rash extends past the midline.  I will see my primary physician tomorrow.  This possible side-effect was not discussed in any literature, was not disclosed by primary physician, was not disclosed by pharmacist.   Shingrix 50 mcg/0.5 ml Inj; 58169-0823-11 I hope one of these numbers is the "lot number."  Primary physician's office said pharmacist should report unusual adverse reaction; pharmacist said primary physican would report.  So I, the patient, have reported to the best of my ability.
HAVING COVID AGAIN TWO DAYS AFTER VACCINATION; ARM SORENESS TO THE TOUCH JUST AROUND THE INJECTION SPOT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On AUG-2021, the patient experienced having covid again two days after vaccination. On AUG-2021, the patient experienced arm soreness to the touch just around the injection spot. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from arm soreness to the touch just around the injection spot, and the outcome of having covid again two days after vaccination was not reported. This report was non-serious.
Hives on body began in evening after vaccine given in the afternoon. Hives persist as of 1/7/08.
stiffness from her earlobe to her neck to her shoulder and to the right side of her chest; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness from her earlobe to her neck to her shoulder and to the right side of her chest) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness from her earlobe to her neck to her shoulder and to the right side of her chest). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness from her earlobe to her neck to her shoulder and to the right side of her chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Raised, swollen, warm area at sight of injection. Told to see primary care physician.
Severe aching throughout body and feeling I could not move.  Pain lasted for weeks.  (On night of the 3 vaccines I had to call 911 due to waves of nausea and shakes.)  In early Sept. '09 I had flu shot: caused body aches, etc. even MORE SEVERE than after the pneumovax!!!!
01/22/2021 @ 04:00 AM: Joint pain, fatigue, disorientated, headache, nerve pain, abdominal pain for two days. Continues with fatigue and not fully recovered.
3-7-07 Mother phoned and reported her daughter began running a low temp. on 3-6-07. Reports temp. 100.6. Stated she has a small red rash on both forearms.
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 25-AUG-2014 the patient was vaccinated with PNEUMOVAX23 (dose strength, route not reported) lot # J0069212 that expired on 09-AUG-2014. The reporter also stated that the patient has not experienced an adverse effect. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
itchy rash at her lower legs; small patches at the bottom of both of her legs round her ankles; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash at her lower legs) and RASH (small patches at the bottom of both of her legs round her ankles) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) and CALAMINE for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced RASH PRURITIC (itchy rash at her lower legs) and RASH (small patches at the bottom of both of her legs round her ankles). At the time of the report, RASH PRURITIC (itchy rash at her lower legs) and RASH (small patches at the bottom of both of her legs round her ankles) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient took Benadryl 2(diphenhydramine) 5mg, calamine topical to alleviate the symptoms.
HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's; This spontaneous safety report, with reference number 02299086 (Interaction # 02299043) was received by the partner on 19-DEC-2022 and forwarded on 21-DEC-2022, from a health professional.   Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis was not applicable.   Further information is expected.  For reference purposes, this case is linked to MCM-004406, MCM-004408, MCM-004409 and MCM-004410 (same reporter).  SIGNIFICANT FOLLOW UP INFORMATION was received on 03-JAN-2023 from the health care professional.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis remains not applicable.  No further information is expected.
Initial information received on 27-Aug-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a three years old male patient who received a 0.5 mL dose of IFLUZONE QUADRIVALENT (lot number U6260AA) in the left thigh on 27-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage of vaccine. It was reported that FLUZONE QUAD was delivered in the morning after it was shipped on 22-Aug-2018 and was exposed to warm temperatures for too long. It was not reported if the patient experienced any adverse event or not. 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 and Module VI of the 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. Documents held by sender: none.
Severe headache, muscle aches around the shoulder/neck area, could not sleep all night.
Redness & swelling around site of inject, red rash, from below inject site to above knee; discomfort w/ambulation, t100 orally; Given meds;
17 y.o. female registered online for a Pfizer booster dose but upon arrival on site changed vaccine choice to Moderna. Pt was given Moderna clipboard and sat at Moderna booster station. Vaccinator gave the 17 y.o. pt a Moderna booster shot. When attempting to chart the dose in COLOR software, vaccinator realized  the pt should have received  Pfizer booster shot as per CDC guidelines. Pt and pt's mother made aware of medication error. Pt speaking in clear sentences. A&O x 5. Denied any sx of difficulty respiration, SOB, dizziness. Pt and pt's mother encouraged to contact Health dept with any future questions or concerns.
Systemic: "Guillan-Barre-like" but not assessed by professional-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: Patient describes "Guillan-Barre-like", later stated she did not ever seek medical attention for her concerns. Reports mostly back to normal now. Pharmacist advised to follow-up with PCP (and that she should have as soon as she had effects)
could hardly move her right arm yesterday because it was kind of sore; right arm pain at the injection site, described as pain right where it was picked and a kind of; . This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (could hardly move her right arm yesterday because it was kind of sore) and VACCINATION SITE PAIN (right arm pain at the injection site, described as pain right where it was picked and a kind of) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 016B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DOCUSATE SODIUM (COLACE CLEAR) for Constipation, ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (right arm pain at the injection site, described as pain right where it was picked and a kind of). On 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (could hardly move her right arm yesterday because it was kind of sore). At the time of the report, PAIN IN EXTREMITY (could hardly move her right arm yesterday because it was kind of sore) and VACCINATION SITE PAIN (right arm pain at the injection site, described as pain right where it was picked and a kind of) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient said she did not want to do a form but she is OK  no problems   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: TCR: AE outcome