chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild fatigue; Fever; Chills; Initial information was received on 26-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional under reference number - US-SA-SAC20211029001074.  This case involves 67-years old male patient who experienced mild fatigue (fatigue), fever (pyrexia) and chills, after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history included Vascular occlusion, Kidney stone and Rotator cuff tear.  Past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MELOXICAM (MELOXICAM); BUSPIRONE (BUSPIRONE); IBUPROFEN (IBUPROFEN); and TERAZOSIN (TERAZOSIN).  On 25-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 26-Sep-2021, the patient developed a non-serious mild fatigue (fatigue), fever (pyrexia) and chill one day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory test results included: On 08-Jan-2020 - Antibody test - Positive On 07-Jan-2020 - COVID-19 - Negative  It was reported "Patient treated with antibiotics."  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were additional lab data/results available.  It was not reported if the patient received a corrective treatment for events.  At time of reporting, patient had recovered from events.  There will be no information available on batch number for this case.
Diarrhea 3-4 times daily for 10 + days starting day after vaccine administration.
Tonsils became very swollen 2 days after receiving vaccine. Pain in tonsils was also involved. After pain ceased, I produced a heavy amount of mucus for 4 days. No medication helped.
Information has been received from a registered nurse concerning a 70 year old male with a history of herpes simplex treated with VALTREX and acyclovir in December 2007 who on 22-APR-2009 was vaccinated with ZOSTAVAX (Merck) (Lot#663883/0132Y) (dose and route not reported) in his upper right arm. Concomitant therapy included albuterol. On 24-APR-2009 the patient had a rash on medial side of his right arm. And the rash was bubbly and raised, it is the size of baseball in diameter. The patient has gone to office to seek medical attention. At the time of reporting, the outcome of rash was not recovered. Additional information has been requested.
pt recv vax 15SEP97 & then devel acute polyneuropathy, resp alkalosis, altered mental status;
No Adverse event; 9 individuals that received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) in a 35-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL dose) 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 UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL dose).    Concomitant medications were not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live follow-up received is significant. Batch/lot number was added.
stopped breathing during the night; when it happened he woke himself up; constipation; This is a spontaneous report from a contactable consumer (patient) reported that, A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took magnesium citrate for constipation, miralax for constipation and experienced blocked up. On an unspecified date, the patient experienced stopped breathing during the night; when it happened he woke himself up and constipation. The event stopped breathing during the night was serious (medically significant). Patient was received treatment for event constipation. It was reported that consumer stated that since his first dose of the Pfizer COVID 19 vaccines he has experienced side effects. He states that he stopped breathing during the night. He sleeps alone but when it happened he woke himself up. He states that he called about this previously. He is now experiencing some constipation. He states that he was worried because this medication was so new. He has taken magnesium citrate or Miralax when "blocked up" in the past and those helped but they haven't helped now. He asks what impaction would mean and how it would be done. He would like to know if these are side effects of the Pfizer COVID 19 vaccine. Serious was No. The clinical outcome of event constipation was not recovered; while other event outcome was unknown.  Information about batch/lot number has been requested.
Information was received on 14-JUL-2017 from an office manager regarding multiple unspecified patients (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On multiple unreported dates, the patients were inadvertently administered improperly stored doses of VARIVAX (lot # M032495, exp 06-JUL-2018) and ZOSTAVAX (lot # M035695, exp 07-NOV-2017)(dose, route, and site of administration not reported) for prophylaxis. No side effects reported. The outcome of the events were not reported. Temperature: 15 degrees Fahrenheit to 46 degrees Fahrenheit Time frame: 1 hour Previous temperature excursion?: No Was call because of a data logger?: Yes. No further information was provided. Additional information has been requested.
Patient had the Pfizer booster shot on Monday of last week and within 3 hours of it she was in Afib; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 89-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 89 years for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: ATRIAL FIBRILLATION (hospitalization) with onset 09Oct2023, outcome "unknown", described as "Patient had the Pfizer booster shot on Monday of last week and within 3 hours of it she was in Afib". The patient was hospitalized for atrial fibrillation (start date: 09Oct2023, discharge date: 10Oct2023, hospitalization duration: 2 day(s)). The events "patient had the pfizer booster shot on monday of last week and within 3 hours of it she was in afib" required emergency room visit. Clinical Course: Patient had Pfizer booster shot on Monday of last week and within 3 hours of it she was in Afib. She went to the hospital through ambulance, she was dismissed from the hospital after a day. She had been diagnosed with Afib before, and doctors were treating those as an episode of Afib. She had a doctor's appointment today at 10:15 AM and so, she was calling us to ask if she needed to took a Pfizer Covid vaccine again as this was what happened to her before she goes to her doctor. Advised her that signs of a severe allergic reaction can include a fast heartbeat based on the Patient Information we have for Comirnaty. He advised her to consult further with her doctor/HCP about this as Pfizer does not provide treatment recommendations. Also told her that if indeed that her doctor says this was an allergic reaction to Comirnaty, then if ever there will be a new Pfizer Covid vaccine that would come out next year that was similar to Comirnaty, then Pfizer would not recommend for her to took it as it was going to be life-threatening. She understood and agreed and will be going to her doctor today.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Pfizer administered past the BUD of 04/20/2022. Pfizer contacted and extended BUD to 04/22/2022. Revaccination recommended.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; 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 2023SA057309 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 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 (product storage error) (latency: unknown) and was administered to patient post temperature excursion with no reported adverse event (poor quality product administered (latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunization).   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.
I received my second covid vaccine on Monday.  For the two days following the vaccine I felt very fatigue with nausea, 1 episode of vomiting, chills, elevated temps,  muscle and joint pain.  I left work early yesterday due to these s/s.  I also had some numbness to my left hand.  I had my vaccine given in my left deltoid.  The numbness in my left hand has resolved today, but now I am having right arm/hand,  heaviness, numbness with limited ROM.  It has progressively worsen throughout the day to the point that my hand is very shaky and I am starting to not have full control.  My handwriting has started to become sloppy and I am having trouble drawing up vaccines.  You can phone follow up, or you can reply via email.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 14-FEB-2017, the patient was vaccinated once with an expired 0.65 ml dose of ZOSTAVAX lot # L039126, expiration date 08-JAN-2017, subcutaneously. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
01/02: dry cough, headache, bodyache, congestion.  Today 01/04 has phelgm and cough.  Staff was due to start work today at 3 pm.  But not feeling right.  Had COVID test last week - negative.
PATIENT HAS STARTED TO BE NAUSEAUS 5 MINUTES AFTER VACCINATION AND THEN STARTED TO EXPERIENCE CHEST TIGHTNESS. MOM DECIDED TO BRING PATIENT TO THE EMERGENCY ROOM. SPOKE TO PATIENT 11/21/2021 AND SAID THAT THE ER SAID SHE HAD EXPERIENCE A VACCINE REACTIOPN AND NOT AN ALLERGIC REACTION.
415 pain in muscle area of injection site. Sharp. 430 noticed swallowing, throat started to feel different. 440 tingling in tongue
This spontaneous report as received from a company representative concerning an 8 month old male child. On an unknown date the patient was vaccinated with PEDVAXHIB. Concomitant therapies included PEDIARIX. On the same date the patient experienced asymptomatic cyst around the injection site after being administered PEDVAXHIB. The patient sought medical attention. The outcome of asymptomatic cyst around the injection site was reported as not recovered/not resolved. Additional information has been requested.
Presented to the emergency room with a complaint of shortness of breath. Patient on BiPAP. Patient reports his first  symptom onset around 7 to 8 days with cough, fatigue, body aches. This morning he got very short of breath and EMS was called. In the emergency room he was found saturating mid to high 80s on NRB. Patient was subsequently placed on BIPAP. Covid test was positive chest x-ray revealed bilateral pulmonary infiltrates suggestive of viral pneumonia. Labs showed potassium 5.5, chloride 112, C02 19, BUN 53, creatinine 1.8, elevated LFTs, increased inflammatory markers, ferritin, LDH. proBNP less than 10. WBC 10.6, hemoglobin 13.7, platelet 161, D-dimer 348, fibrinogen 560, CRP 11.89. Patient  admitted to medical ICU
resident had a hypoglycemic rxn 6hr p/vax;resident is not a diabetic;blood glucose was 17;
PATIENT WAS GIVEN PFIZER FOR HIS SECOND COVID19 IMMUNIZATION INSTEAD OF MODERNA. HE RECEIVED MODERNA FOR HIS FIRST DOSE.
Patient developed fever as high as 101.3 per the ear and had severe fatigue.  Patient continues to have low grade fevers and severe fatigue.
I fully understand that this is outside the side effect window.  However, on Sunday, March 14 I started to experience a fever (100.4), fairly significant fatigue,, tireness, loss of appetite and a slight headache.  The reason I am writing is that in addition to getting the vaccine, at which time I was triple-masked, I only left my home one other time to drop off mail at a post office (again, triple masked).  Neither myself nor my wife (the only other person I live with) left the house (other than she left once to pick up our grocery order, outside).  On Sunday, after the symptoms started, I went to a local clinic and took a PCR Covid test.  The results came back negative six hours later.  The symptoms lessened on Monday (the fever ranging from 99.4-100.4----my usual body temp is 97.6) and by Monday night the fever was gone.  By Tuesday morning not only was the fever gone, but so also were all the symptoms.  Again, I know this is outside the usual timeframe for side effects, other than maybe a skin rash, but I wanted to let you know because I think it is unlikely I contracted another virus because I go virtually nowhere, and am tripled masked whenever I go anywhere.
Pt. developed a lump and bruising on Right arm at site of one injection 2 weeks post injection.
Two days following vaccination, I started experiencing chest pain, palpitations, pressure which is still continuing. I went to see cardiologist and he believes the inflammation from the vaccine may have exacerbated my mitral valve prolapse resulting in my symptoms, which I have never experienced before the vaccine.
9 x 9 1/2 erythematous rash area thigh (L) itchy increased warm.
fever developed within 24 hours, highest reported temperature 100.8 at 1:00pm 2/19/21. Symptoms resolve by 2/20/21
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 05-NOV-2013, patient received improperly stored VARIVAX dose 2, from lot # H018451 (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Hot/ arm was hot to touch where the injection was; Arm is still red/ a big red patch where the injection was; sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot/ arm was hot to touch where the injection was), VACCINATION SITE ERYTHEMA (Arm is still red/ a big red patch where the injection was) and VACCINATION SITE PAIN (sore) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical history information was reported.  Concomitant products included FISH OIL from 2010 to an unknown date, MULTIVITAMIN [VITAMINS NOS] from 2000 to an unknown date, CHASTE TREE [VITEX AGNUS-CASTUS] from 2019 to an unknown date and MAGNESIUM from 2019 to an unknown date for Supplementation therapy.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot/ arm was hot to touch where the injection was), VACCINATION SITE ERYTHEMA (Arm is still red/ a big red patch where the injection was) and VACCINATION SITE PAIN (sore). At the time of the report, VACCINATION SITE WARMTH (Hot/ arm was hot to touch where the injection was), VACCINATION SITE ERYTHEMA (Arm is still red/ a big red patch where the injection was) and VACCINATION SITE PAIN (sore) had resolved.        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.   Other Concomitant medications include herbal medicines  No treatment medications were reported. Non drug treatment includes cold ice packs every half hour to cool it down   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received on 03 Jun 2021. Patient demographics were added, Concomitant medications were added, Event(vaccination site pain) was added and outcome of events changed from not recovered to recovered
pt recvd vax & devel swelling & tenderness @ the inject site; pt also devel joint pain; MD treated w/Motrin;
Patient was living in a nursing home with positive cases when administered.  His age and chronic condition was such that he did not have time after the vaccination to avoid exposure or develop immunity.
Patient experienced an allergic reaction . Onsite EMS was called vitals BP 176/104  99% O2 room air HR 95. Patient Treated, Transported by the EMS to the hospital.
Outbreak of Eczema on Arms, legs, torso. Although this is not life threatening, it is something that I have not experienced for 40 years.   Not sure if it is side-effect or a coincidence. Thought you would be interested in knowing this  information for your records.
Pt given 2 fluzone vaccines (same lot #) by mistake at 2mo well child check.  Also given rotateq, but other 2mo vaccines were not given after error was realized.  Pt / mom sat for 30 minutes after injections and no reaction observed.  Mom will monitor for any AE and call immediately should anything be observed.
Fatigue, headache, body aches, fever (99.7) Symptoms present upon waking at 6:30 a.m. 04/10 Symptoms persisted off and on all day  Took naproxen sodium to treat symptoms Symptoms were not present the next day, 04/11
FEVER; MUSCLE PAIN; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNWON) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and muscle pain. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures.
Information has been received from a registered nurse concerning a 13-year-old female with no pertinent medical history and an allergy to penicillin and amoxicillin who on 17-AUG-1998 was vaccinated subcutaneously into left arm with a first dose of 0.5 ml of varicella virus vaccine live (Oka/Merck) (Lot# 625047/1574E). There was no concomitant and or prior vaccines reported. There was no illness at the time of vaccination. On 17-MAR-2007 the patient developed an unknown number of varicella lesions. It was reported that the patient's father had shingles at an unknown time, and it was not known if the father had received any varicella containing vaccine. Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. As of 22-Mar-2007 the patient was recovering from chicken pox. No product quality complaint was involved. The outcome was not known at the time of reporting. No additional information is expected.
don't feel very well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (don't feel very well) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (don't feel very well). At the time of the report, MALAISE (don't feel very well) had not resolved.            No concomitant medications were provided.  No treatment medications were provided.  Symptoms onset date will be in JAN 2022.
Breakthrough case admission after 2 vaccines Pfizer 3/19/21 Lot# EP7534;  Pfizer 4/9/21 Lot# ER8734
Fever and rash type of skin reaction with spots of redness, swelling, and discomfort (no itching) described by the patient that developed 1 to 2 days after the injection. All resolved in 5 to 7 days.
The day following immunization administration, the patient developed cellulitis to bilateral thighs at injections sites.