chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; chills; body aches; This case was reported by a consumer via interactive digital media and described the occurrence of fever 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 fever, chills and general body pain. On an unknown date, the outcome of the fever, chills and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, chills and general body pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. Post vaccination the patient had a week of fever, chills and body aches. The patient's provider said that because of the events, the patient might not want to get the second shot and asked about GlaxoSmithKline's advice.
Heart palpitations, dizziness, heavy breathing, fell off of chair, unconscious for about 5 seconds.
Moderna 2nd dose was given 6 days early. 2nd dose due on 12-21-21 and it was given on 12/14/21. Pt is scheduled to return on 12-21-21 to repeat the 2nd dose.
pt recvd vax;to er w/ t 101.3;hx of sz at home;discharged 2;presented again 7:45pm w/ another sz at home & t 103 R;not breathing;post ictal;rep sl labored;crying appropriate;resp rate=60;spinal tap & x-ray done;
Child had fever 102 and convulsion following DTP/OPV/HIB CONNAUGHT Immunization
Raynauds phenomena 1/1/2019 onset Dx 1/21/2019 Hashimoto Thyroiditis Dx 1/31/2019
pt recvd vax;arm very itchy & swollen; OK by 18jan; advised to consult MD before getting 3rd dose;
Taken to the ER for waking in the middle of the night with chest pain, pounding heartbeat and shortly thereafter, vomiting.  This started approximately 36hrs after her 2nd dose of the Covid vaccination. She  also had a 101F fever, chills and headache, however that had subsided already when the chest pains began.
administered covid vaccine Pfizer during 15 min wait period after administiation, pt stated light headed, nausea & upon getting up he fainted. Called 911 pt better & left on his own
Severe headache, chills, fever  SEVERE SPASMS IN URETHRA AND VAGINA. Spotting next day. (Menopausal, no period in 3 years before this)
About 6 hours after receiving the vaccine, I started getting body aches. Then after about 3 hours I was feeling super cold, I felt as if I could not get warm 8 was shivering for 2 hours. Then I could barely move because of my body aches, started getting a fever in the middle of the night. I was taking Tylenol and Advil all night to help with the fever and body aches. My lymph nodes in my inner thigh were so sore, it felt like someone had punched me there. I was basically in a fetal position for next 12 hours after coming home.
Dose #4 given inadvertenly,  Vaccine record was not correct at the time of administration. The Hepatitis doses had been left off the transfer of the Mother's copy to our clinic copy by the front desk office staff
I got the Covid vaccine being 5 weeks pregnant and I went home and felt fine. On 7/23 the next day I experience a very high fever . But I felt fine otherwise . On 7/24, I began to have bleeding while I was urinating .  I went to the ER that same day and I ended up having a miscarriage. I want to believe that the Covid vaccine was so strong on my body and I was so early in my pregnancy that my body was not able to hold out .
DEATH; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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: Unknown, expiry date: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 28-MAR-2021, the patient received vaccine shot and she died on the same day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death and Other Medically Important Condition).; Sender's Comments: 20210356482 - Covid-19 Vaccine Ad26.Cov2.S - Death. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
HA, joint/muscle aches(generalized), Stomach upset, vomiting(mild/once), Left arm(vaccine site)ache, fatigue. In general all symptoms were mild.
Erythema and swelling to right upper arm at site of vaccination concerning for cellulitis versus localized skin infection.  Onset of symptoms 8 days after receiving COVID vaccine.
I experienced fever, cough, congestion, body aches, headaches, fatigue. I did at home COVID test on 10/18/2022 which I tested positive.   I am still congestion and some fatigue today.
After receiving the vaccines patient turn pale, weak, dizzy, with nausea and needed help to stand. This happened about 5-10 minutes after the vaccine administration. The patient was taken to Hospital, where they determine upon arrival that the patient has low blood pressure so they administer 9 NSS (1000ml) draining a full drip.
Moderna 10 PM, started to shiver, head ache freezing, fever, went to sleep, had night mares, took Tylenol, sleep till 3:30 PM, went back to sleep at 6Pm and woke up 6am.
Per wife, the pt had a seizure at home. Unable to give a time as to how long pt had what was a seizure at home. She called 911 and husband transported to ER. Arrived at ER-CT done-discharged at 4:30pm husband has had a seizure last year 9 days after flu vaccine given.
C/O HA starting above L eye spreading to R eye then back of head. C/O feeling hot. Nausea and dizziness 15 mins after LAIV. Mother gave 600 mg ADVIL. Transported via EMS-hospital.
4 adult patients received Monovalent vaccine 9 day after MFG expiration date; no adverse event; 4 adult patients received Monovalent vaccine 9 day after MFG expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date), PRODUCT STORAGE ERROR (4 adult patients received Monovalent vaccine 9 day after MFG expiration date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (4 adult patients received Monovalent vaccine 9 day after MFG expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date), PRODUCT STORAGE ERROR (4 adult patients received Monovalent vaccine 9 day after MFG expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 9 day after MFG expiration date) and PRODUCT STORAGE ERROR (4 adult patients received Monovalent vaccine 9 day after MFG expiration date).    No concomitant medications were reported.  Pharmacist was calling to report that 8 adult patients received Moderna COVID-19 vaccine Beyond manufacture Expiration Date.  MFG Expiration date was 20 May 2022 (MI agent checked, it has not been extended).  It was unbroken cartons.  Vial size was reported as 5.5 ml.  The vial was initially stored in the refrigerator on 20-MAY-2022 and 28-MAY-2022  4 adult patients on 21-MAY-2022 and 4 more adult patients on 29-MAY-2022  The vial did not undergo any temperature excursions.  This case contains information for the 8th of 8 adult patients described by the reporter.  No treatment medications were reported.
Severe leg strain, muscles tight, muscle weakness. Progressive and worsening. Onset 48 hours, post vax, to present. Leg stiffness, feeling of sprained tendons and ligaments, muscle tightness, muscles in legs hardened and visible. Fevers to 101F and lymph nodes. Follow up report states " Took 4 years for patient to recover. Apathy among physicians,staff & hospital. Pt now experiences stumbling spells that probably are not related but will be examined."
muscles are hurting; joints are aching/shoulders ache/Knee cap and shoulders ache; Very uncomfortable; This is a spontaneous report from a contactable consumer or non HCP (patient) via Pfizer. A male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported, expiry date was not reported), dose 2 via an unspecified route of administration on 15Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (Comirnaty, Solution for injection, Lot number was not reported, Expiry date was not reported) via an unspecified route of administration on an unspecified date of 2021, as dose 1, single for covid-19 immunisation. On an unspecified date of 2021 the patient experienced muscles are hurting, joints are aching, knee cap and shoulders ache, very uncomfortable. and the patient wants to know if this was normal. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
woke up with a bad headache.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (woke up with a bad headache.) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (woke up with a bad headache.). At the time of the report, HEADACHE (woke up with a bad headache.) outcome was unknown.            No concomitant medications and treatment information were reported.
This case was reported by a healthcare professional and described the occurrence of fever in a 2-month-old female subject who was vaccinated with Pediarix for prophylaxis.  Concurrent vaccination included HIB given on 9 August 2007.  On 9 August 2007 the subject received 1st dose of Pediarix at 0.5 ml in the left thigh.  An unspecified amount of time after vaccination with Pediarix, the subject developed a fever.  The fever lasted for two days and then resolved.  On the third day following vaccination with Pediarix, the subject developed a rash starting on the face and chest then spreading to the torso and legs.  The rash was described as spotty, flat and red.  The nurse felt that the events could possibly be related to heat.  The child had no problem with feedings and was not having any respiratory problems.  At the time of reporting the rash was worse.
Blood clotting resulting in blockage of LAD artery, precipitating an Myocardial Infarction.
I started to feel my adverse event about 12 hours later. I didn't panic about it; on the 6th, I was warned about the temporary adverse events. I woke up sweating profusely and I still didn't have a fever. Every joint in my body was pulsating, I was extremely tired but I was unable to sleep. This lasted about 36 hours. My equilibrium was off, I was unable to walk and I had to hold on to walls. I felt nauseated, I probably didn't eat around that time. I tried to eat fruit or apple. I didn't vomit, and I was very nauseated. I was extra sensitive. I tried to take some Z-Quill, I had these symptoms again in August and in September. It was on September 28th that I finally went to doctor. She wasn't blaming the vaccine, due to no proof. Starting August 23, I had a throbbing joint pain and the sweating issue. I was once again experiencing the off equilibrium feeling. I was getting these arm pains and I never experiencing anything like this. I work in IT but the pain was different. My pointer finger and thumb starting throbbing. They started me in October 21st for physical therapy, once a week or twice a week since I started. If this doesn't get resolved, I was offered to be sent to a neurologist.
Delayed swelling, redness, hot to touch, itchy area (4-5?) around injection site, all appeared 8 days after receiving injection. Otherwise, no symptoms during first week after injection. Ibuprofen has helped reduce symptoms.
poison sumac; Sore arm at the injection site; Little fatigue; >35 days between doses; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DERMATITIS CONTACT (poison sumac), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days between doses), VACCINATION SITE PAIN (Sore arm at the injection site) and FATIGUE (Little fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes (Improvement A1C down to 6.0) since 04-Sep-2019. Concomitant products included METFORMIN HCL from 04-Sep-2019 to an unknown date, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN + HIDROCLOROTIAZIDA), ATORVASTATIN, MELOXICAM and CETIRIZINE for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days between doses). On an unknown date, the patient experienced DERMATITIS CONTACT (poison sumac), VACCINATION SITE PAIN (Sore arm at the injection site) and FATIGUE (Little fatigue). At the time of the report, DERMATITIS CONTACT (poison sumac), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days between doses) and FATIGUE (Little fatigue) outcome was unknown. Not Provided          This case was linked to MOD-2021-085973 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: significant follow up is added On 24-May-2021: Initial Addiitonal-1: VAERS, medical history, conc meds, AE details and outcome
Patient presented hyperventilating, tachycardic and eventually became apneic and required intubation; had COVID in the past; was COVID IgG positive; troponin normal; ECG sinus tachycardia; all other labs normal on 5/22 and 5/23
I tested positive only my fourth or fifth day of COVID and I have taken Pfizer Vaccines and Booster (Pfizer COVID-19 Vaccine); I tested positive only my fourth or fifth day of COVID and I have taken Pfizer Vaccines and Booster (Pfizer COVID-19 Vaccine); This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I tested positive only my fourth or fifth day of COVID and I have taken Pfizer Vaccines and Booster (Pfizer COVID-19 Vaccine)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive only my fourth or fifth day of COVID. Therapeutic measures were taken as a result of drug ineffective, COVID-19 including  PF-07321332/ritonavir (PAXLOVID).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Smallpox vaccine administered 02/04/04; red on day 7 major reaction with mild erythema, day 9 complained of increased swelling, redness, streaking, malaise (+) lymphed.  Prescribed Z-pack #1 on day 9.  Re-eval on 12/16/04 (day 12), decreased swelling, erythema faint, slight streaking still visible, no LA, no fever.
12 yo received 5-11 yo dosage of vaccine.  Patient is doing well.
Patient stated that she started to feel dizzy and ever since she had the shot her blood pressure has risen. Before receiving the vaccine she had her blood pressure under control.
patient was administered expired Tenivac vaccine with no adverse event; Initial information regarding an unsolicited valid non-serious case received from the other healthcare professional via phone at call center as a Global Medication Inquiry (GMI) and transmitted to Sanofi on 24-Nov-2020.  This case involved a 68-year old male patient who was administered with 0.5 ml of an expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] vaccine (lot number: U6091AA, expiry date: 12-Oct-2020, single dose vial) via unknown route in the left deltoid for prophylactic vaccination on 23-Nov-2020 (Expired product administered).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was administered concomitantly.  It was an actual medication error due to expired vaccine used.  At the time of reporting, the patient did not experience any adverse event.  Reported wanted to know when to vaccinate patient and overall procedure.  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.
pt recvd vax & w//in 24hrs post vax exp SOB,& rash;pt was seen in ER: sx resolved;
vaccination site was red; swollen; warm; itchy; a little lump formed; arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (vaccination site was red), VACCINATION SITE SWELLING (swollen), INJECTION SITE WARMTH (warm), INJECTION SITE PRURITUS (itchy) and VACCINATION SITE MASS (a little lump formed) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical reported history).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was sore). On 26-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itchy) and VACCINATION SITE MASS (a little lump formed). On 27-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (vaccination site was red), VACCINATION SITE SWELLING (swollen) and INJECTION SITE WARMTH (warm). At the time of the report, INJECTION SITE ERYTHEMA (vaccination site was red), VACCINATION SITE SWELLING (swollen), INJECTION SITE WARMTH (warm), INJECTION SITE PRURITUS (itchy), VACCINATION SITE MASS (a little lump formed) and VACCINATION SITE PAIN (arm was sore) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient have given antihistamine but unknown no concomitant medication provided
This spontaneous report was received from a physician via a company representative refers to a 17-year-old female patient. The patient was vaccinated with dose 1, 0.5 milliliter (ml) GARDASIL (lot # not reported) intramuscularly (IM) on 10-AUG-2012. Other suspect therapies included VAQTA (lot # not reported) dose and route not reported. No concomitant medications were reported. Physician informed the representative that the patient fainted after receiving their first dose of GARDASIL. As she was fainting she fell and hit her head. The patient was sent to the Emergency Room (ER) (hospital name/location unspecified) and she received stitches at the ER and did not need to be admitted to the hospital. According to the representative the patient said that they were not going to continue with the GARDASIL dosing series so therapy had been discontinued. Treatment was received for the event. The patient sought medical attention for the event. The events were resolving at the time of this report. No other adverse event (AE) information was given. This is one of the several reports due to the sibling link and from the same reporter. Additional information has been requested.
No additional AE/PQC.; HBP called to report inadvertent administration of a pediatric dose of VAQTA to an adult patient. The adult patient received a pediatric dose of 0.5ml instead of the adult dose of 1 ml on 09/06/2023. HBP did not know any patient demographics or any a; HBP called to report inadvertent administration of a pediatric dose of VAQTA to an adult patient. The adult patient received a; This spontaneous report was received from Other and refers to an adult patient of unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5ml/once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 06-SEP-2023, HBP called to report inadvertent administration of a pediatric dose of VAQTA to an adult patient. The adult patient received a pediatric dose of 0.5ml instead of the adult dose of 1 ml on 09/06/2023. HBP did not know any patient demographics or any additional details. No additional AE/PQC.