chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart racing for 1 hour chest felt heavy 2 hours hard to swallow 15 minutes labored breathing 15 minutes weakness 2-3 hours severe headache for 3 days  I took extra Metoprolol for heart racing and tightness in chest I took Tylenol and Advil for headaches each day together
spinal injury; vertigo; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "has nasal polyps" (unspecified if ongoing), notes: Caller also has nasal polyps. The patient's concomitant medications were not reported.  The following information was reported: SPINAL CORD INJURY (medically significant), outcome "unknown", described as "spinal injury"; VERTIGO (non-serious), outcome "unknown", described as "vertigo".  Clinical Information : The reporter reported that, the day patient got her booster patient woke up with vertigo. Patient had a spinal injury and one of the things that could happen was vertigo. Patient was advised by her Doctor to receive the booster. Then about a week later someone just tested positive. Patient mentioned that patient had an upcoming surgery and kept distance from people.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had hives on my right arm that started approximately 2 hours after receiving both the flu vaccine and COVID vaccine in that arm. Hives lasted approximately 18 hours and were only located on my right arm where I received both injections.
Patients daughter and caregiver was not informed that her mother, PATIENT, had received her 2nd Moderna vaccine while in a rehab facility on 9/30/2021.  It was also not recorded on her official vaccine card. The patient received a dose of 0.5ml at our location on 11/5/21 under the impression it was the patients 2nd dose. However, it was her 3rd shot. Patient at this point has not had any adverse events. I,  informed patient and caregiver that she may not feel well tomorrow (fever, aches, chills) and to keep an eye on her.
Shortened and lengthened menstrual periods since April 2021. Heavy menstrual flow with extremely large and painful blood clots.
cried for 24hr unable to console;refused food & did not sleep during the 24hr period;no fever;seen @ hosp ER mid morning 3OCT96;given DPH calmed w/in 45min;took small amount of formula;was responding nl w/in 2hr per mom report;
Within one hour allergic wheal was present. Then followed by swelling from shoulder to elbow. Area became red and inflamed. Painful to touch for 3-4 days. Swelling remained for 7-8 days.
Client began to feel dizzy and light headed during post-vaccination observation at our site today. She received her first dose of the Moderna vaccine today aroud 0925am. 10am EMTs called. Daughter called to be present with the client (was elsewhere in the clinic). Per daughter, client did not eat this morning, drank coffee which usually does not agree with the client, and did not take her blood pressure medication. Client's blood pressure is elevated, but per EMTs, patient does not wish to go seek further care and wishes instead to discharge home. Client has hypertension at baseline, did not take medication this morning, reports a predictable elevation in BP with stress, anxiety, coffee consumption and lack of food. EMTs ensured the client was safely brought to her daughter's car. Client exited the premises.
Earache in right ear began on 04/08/21, by 04/11/21 I experienced some loss of muscle control on the right side of my face (eye, cheek, mouth). I was diagnosed with Bells Palsy. Blood test for Lyme Disease was negative
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 03Apr2021 as dose 2, single (Lot number: EP7533), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 28Mar2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient took Paxlovid to treat Covid 19 from 08Mar2023 through 12Mar2023. Symptoms resolved. Tested negative on 14Mar2023 and 15Mar2023. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Mar2023) Negative; (15Mar2023) Negative; (17Mar2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  No follow-up attempts are possible. No further information is expected.
pt presents to hospital with  SOB for last few days; c/o tender left lower extremity swelling and tenderness; imaging shows PE and DVT; antivirals, steroids, ABX given; AKI; poor oral intake; PEG tub placement; pleural effusion, thoracentesis performed; pt's condition worsened, hypotensive, tachycardia, hyperkalemia; transitioned to comfort measures and he expired in the hospital
Patient had a syncopal episode that self resolved. Vital signs taken for 30 minutes and patient discharged home in stable condition.
A little after 2 weeks from receiving my second dose of the coronavirus vaccination injection I began experiencing episodes of dizziness, fatigue, and losses of consciousness. If I stand up too quickly or exert myself too much my heart will start to race, I will become extremely dizzy and disoriented and oftentimes faint or pass out. Being out in the sun exasperates these issues to a greater extent. Prior to getting my second dose of the coronavirus vaccine I did not have any issues like this. My cardiologist is unable to give me very many answers other than a diagnosis of cardiac syncope.
From telephone contact with reporting LPN who reported an adverse reaction to Tripedia for a 5 year old male patient. He received Tripedia vaccination on 8/23/01 in left deltoid IM. The patient was also given IPOL SC in the left deltoid. The next day his deltoid from shoulder to the elbow was swollen, erythematous and warm to touch. He was seen in the office on 8/26/01 and given Benadryl which immediately helped.
Case number PHEH2016US026599, is an initial spontaneous report received from a consumer on 11 Oct 2016. This report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX (unknown whether seasonal or pandemic influenza vaccine, batch number: not reported) at a dose of 0.5 ml, intramuscularly on an unknown date. On an unknown date, the patient stated that, whenever she gets the influenza vaccine, she experienced the influenza like symptoms for a while. Last year when she took the FLUCELVAX vaccination, the symptoms only lasted 02 days. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the event was reported as non serious by the consumer. The causality of the event was not reported. The case was lost to follow up at initial.
fever; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever. Reported that patient experienced a fever for 14 hours. Reporter queried Caller states that she got the Pfizer COvid-19 vaccine and only experienced a fever for 14 hours. Caller declines being transferred to fill out a safety report. The outcome of event was recovered on an unspecified date in 2021.  Information about lot/batch number has been requested.
soreness at injection site, slight fever, headache,  moderate to severe joint pain, slight muscle pain. Symptoms resolved after 24 hours.
Moderna Vaccine mistakenly given to a 16 y/o patient.  No adverse effects, hospital pharmacist called patient and her parent to discuss the off label use of the vaccine.
20 minutes after receiving his first COVID-19 vaccine, the patient began experiencing palpitations, chest tightness, and diffuse paresthesias.  Patient was taken to the ED for monitoring. Workup in the ED was negative and the patient was discharged home.
Vaccine was given at 2pm. At 10pm intense chills. At midnight bodyaches and 102 fever. During the next day headache, dizziness, fatigue, bodyaches. Fever lasted 24 hrs. Second day symptoms improved. Body aches continue.
One week after receiving injection, my left arm became swollen, red, hot and very itchy.
Received 6 shots on 08/09/2006 , I had fever up to 103  on 08/19 and 08/20 with red papular rashes all over the body except legs.  Left arm more than right.  Patient had Varicella at left arm
Report burning sensation of the chest, tachycardia and elevated blood pressure immediately after receiving the vaccine. Symptoms resolved within 10 minutes.
Elevated heart rate; Light headiness; Throat felt scratchy; Throat felt  weird; This is a spontaneous report from a contactable consumer via regulatory authority.  A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), on 01Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19.  The patient's medical history and concomitant medications were not reported. On 01Apr2021, the patient experienced elevated heart rate immediately after vaccination, which resolved 30 mins post vaccination and also the patient had a bit of light headiness and throat felt weird/ scratchy a few hours later which resolved in about 10 minutes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events.  The clinical outcome of elevated heart rate, light headiness, throat felt weird and throat felt scratchy was recovered on 01Apr2021.  No follow-up attempts are needed; information about lot number cannot be obtained.
Pt received the Moderna Covid vaccine 12/29/2020 at work.  She  works at Hospital as a Tech (pt care tech in ICU) She states she had soreness at right arm injection site for 2 days that resolved.  Then, on post-vaccine day #8 (1/6/2021), she developed a rash at the injection site that was itchy. The area was raised, itchy and red. Measured at work = 5 x 5 cm.  Used HCT cream TID and took zyrtec 10 mg at work yesterday. The rash looks a lot better today. Not itchy anymore.  The area is tender but not as red as it was. No discharge/pus.  No numbness or tingling.  T97.6  Pt denies any other sxs except for SOB for about 30 min intervals over the first 2-3 days after the vaccine. Pt checked pulse ox when feeling short of breath and it was 96%. She states she's not sure if it was from anxiety.
Information has been received from an approximately 61 year old female consumer with no allergies/drug reactions and no pertinent medical history who reported that "about 5 years ago" (approximately 2003) she was vaccinated with PNEUMOVAX 23 vaccine (lot # not reported). There was no concomitant medication. "Soon after getting shot" she experienced a raised red welt at injection site to another and down to elbow which went away in a couple of weeks. She also reported having pain in her arm which lasted about one year. Unspecified medical attention was sought. Additional information is not expected.
pt recvd vax & had high pitched scream; low grade fever x 2 mon; difficulty breathing, diarrhea for 2 days & cont soft stools; rattle in lungs sound; not meeting nl milestones;
14 month old male patient received administered expired dose of IPOL vaccine, no AE; Initial information received on 04-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 month old male patient who was vaccinated with an expired dose of IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCIN) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On 04-Dec-2020, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot P1F491M and expiry date: 30-Nov-2020) via an intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  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.
Left arm became swollen, red, itchy 10 days from shot. My lymphnodes in my left arm are swollen from a ultra sound. Unclear if from vaccine or from another source doctor would like to wait 3 months to check before a biopsy
body aches; 61 year old patient supposed to receive Flublock and he received FluzoneHD instead; 61 year old patient supposed to receive Flublock and he received FluzoneHD instead; 61 year old patient supposed to receive Flublock and he received FluzoneHD instead; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a 61 years old patient who experienced body aches (pain) while received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.   On 27-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ253AB, Expiration:05/06/2020 via intramuscular route in the left deltoid instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  On an unknown date, the patient experienced Body aches (pain), unknown latency following vaccination with  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE .  It was a case of actual medication error due to Inappropriate age at vaccine administration, overdose and wrong vaccine administered.  No corrective treatment information was reported.  At the time of report outcome of he event was unknown and not applicable for rest of the 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  List of documents held by the sender: none
Patient woke up with 101 degree temp and sore throat on 11/06/2019.
Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date). On 30-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.  Date of refrigeration was 07-May-2021.
Mid-cycle bleeding resembling a full flow full duration (5 day) period on day 14 of my cycle.; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 (at the age of 43-years-old) (Batch/Lot Number: EN531) as single dose for COVID-19 immunisation. Medical history included covid prior vaccination. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccine in four weeks and other medications in two weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 01Feb2021 (at the age of 43-years-old) (Batch/Lot Number: EL3248) for COVID-19 immunisation. Since 06Mar2021 09:00 AM, the patient had mid-cycle bleeding resembling a full flow full duration (5 day) period on day14 of her cycle. The patient did not receive treatment for AE. The patient had not tested covid post vaccination. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Inflammation of left calf: 5/27 pm began experiencing severe muscle pain and inflammation of left calf on the inside of the leg.  Pain in calf, swelling of calf and fluid retention in left ankle has persisted since it began. (now 13 days with no improvement).  Weight bearing is still difficult. Using a calf brace. Formerly healthy leg now damaged. Ultrasound on June 2 for possible DVT was negative. Exam by orthopedic provider on 6/4 surmised inflammation in calf not due to injury but a reaction from the vaccine. Other swelling: 5/28 began experiencing swelling and tenderness in ankle, groin area, and testicles.  Has continued to present. Ultrasounds on 6/8 confirm no clots in leg.  Also confirm fluid retention in leg, groin, and testicles. Cough:  Have experienced persistent slight cough from 5/28 to present.  No sputum or nasal congestion.  Treating with over the counter cold remedies with no change. Chest xray and CT scans on 5/8 reveal no fluid in lungs or heart Night Sweats and fever: Extensive night sweats and low grade fever 5/28,29,30,31.   .Other information: Had COVID February 17- March 5 Received monoclonal antibody therapy on 2/24 ( casirivimab and imdevimab) Had recovered from Covid and was in good physical health exercising daily prior to vaccination.  Had no previous injury in left calf preceding the vaccination.
Headache, Myalgia & Phlebitis Narrative:  Other Relevant History:
Multiple papular crusting lesions for 2 days. Dx with atypical varicella.
Herniated lumbar disc; Back pain; Difficult standing; Difficult walking; A spontaneous report was received from a consumer concerning a 50-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced back pain, difficult standing/ dysstasia, walking/ gait disturbance and herniated lumbar disc/ intervertebral disc protrusion.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 19 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 023M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 1 Mar 2021, the patient experienced back pain, difficult standing, walking and was diagnosed herniated lumbar disc.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The outcome of events, back pain, difficult standing, walking and was diagnosed herniated lumbar disc was not reported.
widely distributed (80% body surface area) of rash that has been very resistant to treatment.  Looks psoriasiform and biopsy suggested psoriasis but treatment resistance is most consistent with pityriasis rubra pilaris although he has no scalp or hand/foot involvement
itching; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and RASH (Rash) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching) and RASH (Rash). At the time of the report, PRURITUS (itching) and RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. Patient took steroid cream as treatment medication.
Swollen arm, redness covering 4 inches x 5 inches, temp of arm 102, pain, tenderness, dizziness, nausea, woke with stiff neck the next day, headache. Pictures if desired from past 2 years with similar reactions
Intense itching neck, face, head; red marks on neck, face; took chewable Benadryl & symptoms resolved (first time I have had an allergic reaction to a flu shot).
1/27/2021 - Freezing cold, shivering, full body muscle aches, shot site pain worse than before. Symptoms continued through the night, requiring multiple blankets, layers of clothing, and figuring how to lay to avoid pain. 1/28/2021 - I had to call off from work. Exhaustion found; remained in bed all morning. Muscle pain worsened, but improved at about 6pm. Continued to be cold, but no shivering; improved at about 2pm. But started having cycles of cold/hot. Headache developed. 1/29/2021 - Returned to work late. Continued weak muscle pains, cold/hot cycles,  and headache. All mild.