chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Member previously received Jansen as first dose. Member requested and Received Moderna booster at 1206. Immediately after vaccination, member complains of being very tired and weak. RN was called to station. Patient says she cannot get up and she needed to just sit there. Suddenly she went limp and was held up by the RN. Member always remained conscious and oriented, just weak.   Nurse assessed function and strength of each limp before wheelchair was brought over. Patient was able to pivot to wheelchair.   Member was then able to transfer from wheelchair to gurney.    1210  Vitals 143/93 (77) BP 120 HR sat 99  Member's husband was called to the bedside and stated that she has not eaten anything that day. Pt drank 8oz juice and a few pieces of graham crackers.  Upon reassessment of limbs, starting with toes, patients started having decreased movement in left toes, feet, and arm. Right side had full strength.   1213 MD Stat (Hospital Urgent Response team consisting of RNs, MD, and Security) 1216 MD stat arrived and conducted a full assessment.   Dr. Recommended patient go to the the ER because the members left sided weakness. 2L o2 started for high BP  1217 ED called  1230  RN started PIV   1232 EMS called   Member transferred out at 1240
upset stomach a couple doses back; after injection he was running a fever; Psoriasis flare; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare), ABDOMINAL DISCOMFORT (upset stomach a couple doses back) and PYREXIA (after injection he was running a fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 06-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach a couple doses back) and PYREXIA (after injection he was running a fever). In March 2021, the patient experienced PSORIASIS (Psoriasis flare). At the time of the report, PSORIASIS (Psoriasis flare), ABDOMINAL DISCOMFORT (upset stomach a couple doses back) and PYREXIA (after injection he was running a fever) was resolving.            Concomitant medications were not reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Patient had never experienced any symptoms or flares prior to the Covid vaccine. A few days after his first dose he broke out in a major flare. Physician advised him that he was either a carrier or he wasn't.  No treatment information was provided by the reporter.
NAUSEA; DIARRHEA; LEG CRAMPS; TINGLING TO THE HANDS, FEET AND THROUGHOUT THE WHOLE BODY; NUMBNESS TO THE FINGERS AND TOES; BLURRED VISION; INTERMITTENT HEADACHE; PAIN INSIDE THE RIGHT THIGH; FATIGUE; SORE RIGHT ARM; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, hypothyroidism, milk allergy, tomato allergy, wheat allergy, allergic to weeds, allergic to cat and dog dander, sulfonamide allergy, and tetracycline allergy. The patient experienced drug allergy when treated with epinephrine, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sore right arm. On 06-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced tingling to the hands, feet and throughout the whole body. On 12-APR-2021, the subject experienced numbness to the fingers and toes. On 12-APR-2021, the subject experienced blurred vision. On 12-APR-2021, the subject experienced leg cramps. On 12-APR-2021, the subject experienced pain inside the right thigh. On 12-APR-2021, the subject experienced intermittent headache. On 14-APR-2021, the subject experienced diarrhea. On 18-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore right arm, and fatigue on 09-APR-2021, and had not recovered from tingling to the hands, feet and throughout the whole body, numbness to the fingers and toes, intermittent headache, blurred vision, diarrhea, nausea, leg cramps, and pain inside the right thigh. This report was non-serious.
On 11/26/2022 started having headache, body aches, fatigue and cough.
Pt recv vax on 11/1/98; on 11/2/98 pt exp pain, swelling, red hardening of vax site; swollen fingers &thumb;tx=Medrol
Day of vax temp went to 102.4 R; temp down w/APAP & Pediaprofen but would keep returning to 102.4 R when due for antipyretic, inc irritability @ times, this continued x 5 days;
PATIENT REICIEVED THE VACCINE IN THE LEFT DELTOID ON MONDAY MORNING. PATIENT STARTED TO DEVELOPE A RASH ON HER ARMS, CHIN, AND NECK THAT STARTED TUESDAY EVENING. PATIENT TOOK BENADRYL AND CALLED THE PHARMACY WHEN WE INFORMED HER TO CONTACT HER DOCTOR IF THE REACTION CONTINUES OR WORSENS OVER THE NEXT COUPLE OF DAYS.
On Day two of the shot I had a sore arm and began to feel symptoms in which on day three I began to feel symptomatic on day 4 I took a home COVID-19 test which was positive. I contacted my Primary Care Provider who told me due to difficulty breathing to call an ambulance which transported me to the hospital, the hospital discharged me four hours later. I digressed again my wife was home then and took me back to the same hospital which prescribed Paxlovid for me and gave ne breathing treatments.
Chest pain; Blood pressure fluctuating; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), BLOOD PRESSURE FLUCTUATION (Blood pressure fluctuating) and DYSPNOEA (shortness of breath) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Foot surgery (2 weeks before vaccination). Concurrent medical conditions included Allergy NOS.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced CHEST PAIN (Chest pain), BLOOD PRESSURE FLUCTUATION (Blood pressure fluctuating) and DYSPNOEA (shortness of breath). At the time of the report, CHEST PAIN (Chest pain), BLOOD PRESSURE FLUCTUATION (Blood pressure fluctuating) and DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.   Reporter did not allow further contact
acute pancreatitis; Pneumonia; edema; fever; fatigue; nausea; bloating; Major bowel movement; loss of appetite; muscle pain; A spontaneous report was received from a unknown years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue (Fatigue), fever (Pyrexia), bloating (Abdominal distension), major bowel movement (Bowel movement irregularity), pneumonia (Pneumonia), loss of appetite (Decreased appetite), acute pancreatitis (Pancreatitic acute), edema (Oedema), muscle pain (Myalgia) and nausea (Nausea).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin calcium, ramipril, metoprolol succinate, acetylsalicyclic acid and fish oil.  On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number: 12L20A) through intramuscularly route of administration in the right upper arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, approximately eight days after the vaccine, patient started experiencing muscle pain, major bowel movements, loss of appetite, bloating and nausea. On 26 Jan 2021,t he patient was hospitalized due to fatigue, fever and some GI issues. Patient was diagnosed with acute pancreatitis, pneumonia, and some edema. Patient said he was tested for COVID-19 multiple time at the hospital and all came back negative. Patient was given some antibiotics and Eliquis for treatment.  On 08 Feb 2021, the patient received their second of two planned doses of mRNA (Lot number:013L20A) intramuscularly for prophylaxis of COVID-19 infection. He did not report any symptom on his second dose.  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 events were unknown.; Reporter's Comments: The events were consistent with increased risk associated with pancreatitis which was consistent with pancreatic inflammation with unknown etiology. Company assessed the events to be unlikely related to company product.
Loss of taste  Chills  Headache  Dizziness/ lightheaded  Nausea  Difficulty breathing  Chest pain Extreme exhaustion
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 23-JAN-2013, 27-JUN-2013 and 28-AUG-2013 the patient was vaccinated with the first, second and third 0.5 ml doses of GARDASIL (lot# not reported) IM separately. No adverse effects reported. Additional information has been requested.
I have had pain in my left arm by the site of administration since the exact day it was administered. It was initially extremely painful but by day two subsided. Now it constantly hurts and has gotten no better or no worse. It hurts to lift or rotate and even extend my arm. Even taking off my jacket or moving my arm above my head while I sleep sets off excruciating pain.
1) Itchiness on chest and back within 10 minutes of shot. Dissipated after a couple of hours. 2) Feverish, chills and flu-like symptoms, on and off for 2 days. Came in waves. 3) General weakness for 2 days, on and off.
This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. The patient received AFLURIA on unknown dates, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 16-Oct-2015, 8 hours after starting treatment with AFLURIA the patient experienced fatigue, nausea, and rash on torso. Event treatment: The patient did not treat the events. Reporter's assessment: The reporter considered the events non serious.
ACT-HIB vaccine was given post expiration with no reported adverse event;Initial information received on 22-Sep-2021 regarding an unsolicited valid non-serious case received from another health care professional and consumer non health care professional via Medical Information number: 00780823.  This case involves a Four months old female patient who who was administered an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID VACCINE [DTAP] and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 30-Aug-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE batch number: UJ351AAB and expiry date: 09-AUG-2021 via intramuscular route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "that Medical assistant transferred. Obtained report details from medical assistant. Medical assistant asking if there are any studies regarding expired ACTHIB being administered. Medical assistant asking if the ACTHIB needs to be revaccinated. Medical assistant also asking why Merck would have different information for PedvaxHIB. Note: Contact Name and Contact Details obtained. Obtained and verified email address from medical assistant".  At time of reporting, the patient outcome was Unknown for the event.  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 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.
Chills, low-grade fever (100), headache, muscle/body aches, nausea.  It lasted through the day and evening of February 5.  By 6 am February 6, the symptoms had resolved.    Treated with Tylenol. I reported this to my doctor who said this was not unusual, especially since I had had Covid in November.
Jan 18:  noticed soreness in arm and twinges of pain when moving arm.   (Arm already compromised by rotator cuff surgery in 2012) Jan 20:  Noticed rash and redness about 4 cm in diameter at site of needle penetration.
3 days after the vaccine my left knee joint and area of achilles tendon started to hurt, inflammation and burning. Difficulty walking.
SORE AT TIME OF INJECTION, SWELLING AND REDNESS AROUND INJECTION SITE NOTED ON 02/01/11, LOCAL CARE ADMINISTERED, ADVIL FOR PAIN
Mother came in to have PPD read. While at clinic, she mentions a reaction to injection site. Child has felt malaise for since injection day. Denies fever. Reaction occurred next day. Reddened welted area approx. 6cm in diameter to R deltoid (Kinrix injection site). Ice pack is applied after inspection.
Severe injection area soreness, mild-moderate fever (100.3 - 101.9), achiness, fatigue, mild headache (later in day)
pass out; Vasovagal syncope; passed out again; This is a spontaneous report from a contactable consumer (Patient). A 53-year-old female patient (Non-pregnant) received second dose of BNT162B2 (Pfizer Covid-19 vaccine, Lot number ER8729 expiry date: unknown) via an unspecified route of administration at right arm as a single dose on 09Apr2021 03:00 PM, for Covid-19 immunization. Medical history included Hypothyroid, She had known allergies to Anti-Inflammatory, aspirin, penicillin, codein, ginger and horse radish. Concomitant medications were not reported. The patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, Lot number: EP7534 expiry date: unknown) via an unspecified route of administration at right arm as a single dose on 19Mar2021 04:00 PM, for Covid-19 immunization. On 10Apr2021 at 03:00 am, she woke to go to the bathroom feeling fine, after getting up from the toilet she saw stars and felt and had a Vasovagal syncope. When she woke up, she tried to get and pass out again. She woke up and was able to walk to my bed and passed out again when she reached the bed. She did not receive treatment for the events. She did not have any other vaccine in four weeks prior to suspect. She did not have Covid prior vaccination nor was she tested for Covid post vaccination. The patient had recovered from the events of pass out, vasovagal syncope and passed out again. No further information was available.
diarrhoea; stomach cramps; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 06Apr2021 at 03:45 (at the age of 46-years-old) as dose 2, single for COVID-19 immunisation. Medical history included rheumatoid arthritis, latex allergy, sulfa allergy and allergy to erythromycin and tetracycline. Concomitant medications included levothyroxine sodium (SYNTHROID), simponi aria (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO) for unknown indication on an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 04Mar2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 13:30 hours, the patient experienced diarrhoea, stomach cramps and fatigue. 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 adverse events. The clinical outcome of the event diarrhoea, stomach cramp and fatigue was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Amendment of past drug event, relevant medical history and Concomitant drug information.
Left axillary swelling; tachycardia; shortness of breath; fever; chills; muscle aches; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 10Jan2021 18:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 20Dec2020 (04:00 PM) for Covid-19 immunization. Medical history included known allergies to latex, cinnamon, and nickel. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced left axillary swelling, tachycardia, shortness of breath, fever, chills, muscle aches, and joint pain on 10Jan2021 (19:00). The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 post vaccination.
Grandma was tested positive 11 days after the first dose; Grandma was tested positive 11 days after the first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient (reporter's grandmother) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was tested positive 11 days after the first dose. Grandmother had an appointment for 2nd dose on 30Jan2021 and tested positive after 1st dose. He said his grandmother had a test again on an unknown date but this time she's negative for Covid-19. The outcome of the events was recovered on an unknown date. Information on the lot/batch number has been requested.
Myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 25-year-old male patient 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 MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: 55% (normal) left ventricular ejection fraction -55%. On an unknown date, Troponin I: 20.4 (ng/ml) (abnormal) 20.4 (ng/mL).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    Concomitant medications were not reported. Therapy for the event was not reported. It was reported that all patients recovered within 6 days of their presentation with complications. This analysis shows that myocarditis related to COVID-19 vaccine has an overall fast recovery with no short-term complications.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-317975, MOD-2021-317976, MOD-2021-317977, MOD-2021-317978 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version; Knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Knows about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version".  Clinical information: Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), 12 years - 15/15 mcg per dos Lot Number Unknown Reason: Complainant does not have the product with them at the time of call. During the call she (reporter) stated that she knew about 4 or 5 patients who got COVID 2-3 weeks after receiving a dose of the COVID-19 vaccine bivalent version, she believed that this vaccine might not be matching the current COVID variant "that is out there". Caller declined to make a safety report since she did not want to report something on behalf of other patients.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201300085 Similar report from same reporter;US-PFIZER INC-202201300194 similar report from same reporter;