chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling; Extreme rigors for 1/1.30 hours; Severe muscle ache; Severe joint ache; Headache; Sharp pain in ears for 4 hours; Extreme thirst; Drenching, heavy perspiration; A spontaneous report was received from a nurse concerning a 75-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) who experienced swelling, extreme rigors for 1/1.30 hours, severe muscle ache, severe joint ache, headache, sharp pain in ears for 4 hours, chills, extreme thirst, drenching, and heavy perspiration.  The patient's medical history, was not provided by the reporter. Concomitant medications were reported included amlodipine 2.5 mg daily, rosuvastatin 10 mg/day, protasemone 225 mg every 12 hours, xarelto and a multivitamin.     On 25 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 057620A) in intramuscular in the right arm for prophylaxis of COVID-19 infection.    On 25 Jan 2021 experienced swelling, extreme rigors for 1/1.30 hours, severe muscle ache, severe joint ache, sharp pain in ears for 4 hours, chills, extreme thirst. On 26 Jan 2021 patient experienced drenching, heavy perspiration.   Treatment included 650 mg Tylenol and 7.5 mg Meloxicam.  No relevant lab data was provided by the reporter.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events, swelling, severe muscle ache, severe joint ache, headache were unknown. On 25 Jan 2021 extreme rigors for 1/1.30 hours was recovered. On 26 Jan 2021 sharp pain in ears for 4 hours, chills, extreme thirst, drenching, heavy perspiration were recovered.; Reporter'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.
Redness, swelling in right arm (about 2.5 inches in diameter), extreme fatigue, muscle aches, joint pain, stomach upset, skin on right side of torso from back bone to midline of the front of torso has become very sensitive to any touch, pressure, and is accompanied by significant pain. Most of the symptoms are subsiding, the pain in the torso has become worse.
It started with a temperature and chills, fatigue, cough, my heart was racing. I went to the ER and they said I had bacterial pneumonia in addition to COVID.
I started with a little sore throat on 05/15/2022, it was a little scratch and a little something there. On the 05/16/2022 I started feeling kind of coughing, I started with a cough with nasal congestion, blowing my nose, sneezing, tired, feeling a little bit winded with activity. No shortness of breath just a little winded. I think I had a low fever at about 98.9. I am glad this was mild. I called my doctor and they called so I could get the monoclonal antibody therapy at 12:00PM ET on 05/18/2022 in my right arm. I'm feeling pretty good, still a bit of runny nose and sneezing, I am pretty active and I was able to walk the dog 3.5 miles yesterday.
13NOV97 pt recv vax 14NOV97 rt deltoid red/swollen 15NOV97 seen in MD office rt deltoid 5cm blanching erythema w/mild swelling no induration centered around puncture site;
GOT SICK; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced got sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20220203920.
Fever, up to 102.9 night of 3/30/2021 (early morning of 3/31/2021). Low grade fever again5:00 p.m. 3/30/2021. Fatigue. Headache. Rash around injection site almost reaching shoulder and just above elbow. No treatment.
Localized reactions swelling; Localized reactions redness; flu like symptoms; then tingling in other arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Localized reactions swelling), VACCINATION SITE ERYTHEMA (Localized reactions redness), INFLUENZA LIKE ILLNESS (flu like symptoms) and PARAESTHESIA (then tingling in other arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) and SIMVASTATIN for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Localized reactions swelling), VACCINATION SITE ERYTHEMA (Localized reactions redness), INFLUENZA LIKE ILLNESS (flu like symptoms) and PARAESTHESIA (then tingling in other arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Localized reactions swelling), VACCINATION SITE ERYTHEMA (Localized reactions redness), INFLUENZA LIKE ILLNESS (flu like symptoms) and PARAESTHESIA (then tingling in other arm) outcome was unknown.            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.   This case was linked to MOD-2021-071114 (Patient Link).
Swelling about 5 inches away from injection site area on under side of arm.  Pain and redness.
While on vacation in a 14 passenger van with non compliant older male passengers who were coughing and not wearing masks, even though I had on a KN95 mask, I was unfortunately exposed to COVID-19. A few days later, I developed an earache and a mild sore throat. I did not attribute it to COVID-19 though so I flew home and upon returning, I took two at home COVID-19 tests and the results were positive. The next morning, I called my doctor's office who advised that I monitor my symptoms and get back in touch if they got worse. For 4 days I had a low grade fever, mild to moderate headache, and fatigue. I also had a herpes outbreak although I was unaware that I had any form of herpes. I had to go to the doctor for the HSV-1 break out and was prescribed VALTREX. I quarantined for 10 days and continued to test positive for COVID-19 until the 10th day. By the 10th day, my symptoms had improved with the exception of a mild cough that lingered for 10 days and mild nasal congestion that lasted 16-18 days.
VACCINE WAS GIVEN BEYOND THE BEST USE BY DATE OF 2/27/2023.  UPON REPORT TO AND INVESTIGATION BY PFIZER, VACCINE WAS BEYOND EXCURSION AND CONSIDERED EXPIRED.  THEY DEFERRED TO THE PRIMARY CARE PROVIDER TO DETERMINE NEED FOR REDOSING. PCP DR. DETERMINED REDOSING IS NEEDED AND PATIENT IS SCHEDULED THIS WEEK TO REPEAT DOSE 1.
Large red circle at injection site. Sore to the touch and warm. Slightly itchy.
Ischemic stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 2, single (Lot number: EN6203) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure", start date: 2020 (unspecified if ongoing), notes: Losartan keeps in check since stroke Baby; "High Cholesterol", start date: 2020 (unspecified if ongoing), notes: Atorvastatin, then Profluent after stroke. The patient's family history included: "Stroke" (unspecified if ongoing), notes: Mother had stroke after taking celebrex years ago. The patient's concomitant medications were not reported. Vaccination history included: pfizer/biontech coviD-19 vaccine (DOSE 1, SINGLE, Time: AM, Site and route of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL9264), administration date: 03Feb2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: ISCHAEMIC STROKE (hospitalization, life threatening) with onset 11Mar2021 at 12:00, outcome "recovered" (12Mar2021 at 12:00), described as "Ischemic stroke". The patient was hospitalized for ischaemic stroke (start date: 11Mar2021, discharge date: 12Mar2021, hospitalization duration: 1 day(s)). The event "ischemic stroke" required emergency room visit. The patient underwent the following laboratory tests and procedures: Battery of tests: (11Mar2021) Ischemic Stroke; Magnetic resonance imaging: (unspecified date) Unknown result; Urine analysis: (unspecified date) Unknown result. Therapeutic measures were taken as a result of ischaemic stroke (Lisinopril, Losartan, Atorvastatin). The clinical course was reported as follows:  had ischemic stroke 16 days after second COVID vaccination. At the time I asked view of Withheld doctors if they were reporting to you. They said no, since it wasn't a known side effect.
Patient called to speak to the pharmacist on duty and described having a hives reaction on  her forearm that appeared 2 weeks after vaccine. He relayed the information to another staff member who filled out this VAERS. Patient was counseled to follow up with her Primary Care Physician and seek immediate medical attention if condition worsened or persisted.
per staff at a residential facility "2 hours after vaccine administration he was lethargic, pin point pupils, etc.  We called 911 as he suffered a TIA"
Joint and muscular pain throughout whole body, low-grade fever, chills, starting around 4 am the following day. Then around 11 am nausea, headache, cough are added to previous symptoms.
This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 10-OCT-2013 was vaccinated with a dose of ZOSTAVAX {strength, dose and route not reported, lot # H021459, expiration date: 30-APR-2013 (also reported as 03-APR-2014}, that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Soreness for one week after booster (shot 3), bruise the size of a silver dollar lasting two weeks.
Information has been received from a RN concerning a 55 year old female with a reliable history of natural chickenpox who on 30Jul2002 was vaccinated with one dose SC of varicella virus vaccine live. Concomitant therapy that day included a first adult dose of hepatitis B virus vaccine rHBsAg (yeast) (MSD). It was noted that on 22Jul2002, prevaccination, the pt has a chickenpox titer of 0.81. On 08Apr2003 the pt had a titer of 0.79. It was also noted that there were no untoward effects at any time. Additional information has been requested.
VACCINE ADMINISTERED IN A 16 YEAR OLD; This spontaneous report received from a pharmacist concerned a 16 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the patient experienced vaccine administered in a 16 year old. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered in a 16 year old was not reported. This report was non-serious.
Pt developed urticaria, swelling, three days after vaccine.  Unclear that related to vaccine. Etiology unclear.
Extremely sore arm night of and next day. Hard lump and itching started 2-3 days later. Lump turned red, painful, and really itchy 6 days later. Today is day 8 and redness is getting larger
He is very nervous; Whole arm went numb (dead) for 5 min to the armpit; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Whole arm went numb (dead) for 5 min to the armpit) and NERVOUSNESS (He is very nervous) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced HYPOAESTHESIA (Whole arm went numb (dead) for 5 min to the armpit). On an unknown date, the patient experienced NERVOUSNESS (He is very nervous). On 09-Feb-2021, HYPOAESTHESIA (Whole arm went numb (dead) for 5 min to the armpit) had resolved. At the time of the report, NERVOUSNESS (He is very nervous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Event were updated to RESLOVED
Within minutes after receiving vaccines, patient experienced a spell of whole-body stiffening, which lasted a few seconds and he banged his head on a window. After 30 minutes sat/stood w/o dizziness.
DISCHARGE DIAGNOSES: Acute hypoxic respiratory failure, Covid-19 pneumonia, GPC blood cultures, Metabolic encephalopathy, Underlying Alzheimer's dementia, Diastolic heart failure, not in exacerbation, H/O PE, Subtherapeutic INR, Schizoaffective disorder, HLD, GERD. HOSPITAL COURSE: Briefly, this is a 62 y.o., female, with a PMH of Alzheimer's dementia, CKD, COPD on2 L O2, PE on Coumadin, and schizoaffective disorder who presented with nausea/vomiting, fevers and chills. Found to be Covid-19 positive. For more detail, including PMH, PSH, PFH, Social HX and further info please see admissions. Hospital course dictated by problem: Acute hypoxic respiratory failure, Covid-19 pneumonia, Treating with Decadron, Already anticoagulated with Coumadin, O2 needs seem to have improved to baseline. Discharging home: GPC blood cultures- Both bottles growing GPC identified as Staph hominis. She was started on IV Vancomycin overnight. Obtained repeat blood cultures on 2/10 which were negative. Per guidelines, she will complete ABX coverage with Keflex x 3 more days. Metabolic encephalopathy, Underlying Alzheimer's dementia, Encephalopathy likely resolved and patient is perhaps now at baseline- Continue with donepezil. Diastolic heart failure, not in exacerbation- Continue with torsemide, spironolactone, and potassium supplements. H/O PE- Subtherapeutic INR- Coumadin dosed by pharmacy- Daily INRs. Schizoaffective disorder- Continue PTA meds of prazosin, mirtazapine, hydroxyzine, gabapentin, Cymbalta, and clozapine- Defer ordering PTA Klonopin PRN at this time. HLD- Continue atorvastatin. GERD- Continue pantoprazole.
PAIN IN INJECTION AREA,REDNESS,INCHING AND BURNING FOR 3 DAYS.
pt recv vax 13OCT94 & 28OCT94 devel ecchymotic spots over extremities & body;exam nl;platelet count 16,000;tx IV gamma globulin;1NOV94 fever;dx ITP poss secondary to the vax;
Received his first dose of the vaccine and later developed pneumonia.; A spontaneous report was received from a health care professional concerning a male who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced received his first dose of the vaccine and later developed pneumonia  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, the patient developed pneumonia after receiving his first dose. No treatment was reported.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome for the event, received his first dose of the vaccine and later developed pneumonia was unknown.; Reporter's Comments: The event of pneumonia was more consistent with infectious process in pandemic set up.Very limited information regarding this event has been provided at this time.  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.
Other than slightly sore arm at injection site no immediate adverse reactions. I have been living with tinnitus for 10 years or so and I have noteced since around mid July that the symptoms are more prevalent and annoying. I have no formal treatment for the issue.
expired dose of pentacel was administered with no reported adverse event; Initial information received on 01-Mar-2023 regarding an unsolicited valid non-serious case received via health professional. number: 01512650.  This case involves 3 months old male patient who received expired dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine (HEPATITIS B) for Immunization; Rotavirus Vaccine Live Oral 1V (Rotarix) for Immunization; and Pneumococcal Vaccine CONJ 13V (CRM197) (Prevnar 13) for Immunization.  On 27-Feb-2023, the patient received expired dose of suspect Pentacel (VERO) Vaccine at dose 0.5ml once (lot: UJ623AA, expiry date: 25-Feb-2023) via intramuscular route in the right thigh for Immunization with no reported adverse event (expired product administered) at same day latency.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the 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.
3/20/03 Immunized with Anthrax #3 right deltoid. Next day with joint pain right hand progressed to involve all joints. No fever or myalgia. Ibuprofen taken for pain.
Patient was given a third dose of Pediatric Pfizer vaccine on 01/04/2021
On 2/6/2021 in the morning I had numbness & tingling on my left hand. My arm was very sore & it was painful. I also had fever 99.2. My arm numbness and tingling is still going on that hasn't resolved and I've been seeing a doctor for it.
3 hrs after taking the vaccine he started getting skin sensitivity on his face. He look in the mirror and started see little red bumps on his face. He took Benadryl a it got better a little. When he woke up the next day the bumps spreaded from his face to down his neck.
Pt exp burning sensation from neck to shoulder, nausea, fever & swelling @ inject site; treated w/Phenergan & events subsided p/treatment;
Pain at injection site, chest pain, dizzy, headache, cough, high blood pressure, sore throat, chills, body aches, weakness. Is going to see PCP. Current symptoms include sore throat, cough, chills, and body aches. Not taking any medications at this time.
Initial unsolicited report received from a non-healthcare professional on 8 September 2015. This case involves a 17 years old male patient who was vaccinated with a third intramuscular dose of MENACTRA (batch number U5186AA, dose was not reported) in right deltoid on 31 August 2015. The patient did not have illness at time of vaccination and had no known allergy. The patient previously received two doses of MENACTRA "10 September 2011". Concomitant medications were not reported. On 3 September 2015, three days following the vaccination, the patient experienced swelling of legs, arms and welts on entire body. The patient required emergency room and physician visit. Lab data and corrective treatments were not reported. The patient was recovered from the events on an unspecified date. List of documents held by sender: none.
This is a spontaneous report from a contactable nurse via a Pfizer Sales Representative. A female patient of unspecified age and ethnicity received a single dose of TRUMENBA on an unknown date. Medical history and concomitant medications were not provided. After vaccination, on an unknown date, the patient experienced sore arm. Event outcome was unknown. Follow-up (02Dec2015): New information reported from a contactable nurse includes: confirmation of reporter's occupation (nurse). Follow-up (06-JAN-2016): Follow-up attempts are completed. No further information is expected.
pt recv vax & w/in 48hr devel a severe site rxn which was described as cellulitis;tx w/IV ATB;
Left upper arm/deltoid erythematous and swollen. MOTRIN and BENADRYL (dose per age/wt) given x 24 hours. Erythema and swelling improved with decreased pain and increased ROM. Will continue MOTRIN and BENADRYL x 48 hrs.
PT felt dizzy after vaccination and complaining of loosing vision. She complained of being nauseated.  Patient was accompanied by her mom. She was holding her hand and I asked patient to relax and take deep breath.  She felt better after few minutes.   I advised patient to keep sitting for 15 minutes before leaving. Patient and MOM both left once she felt better. I advised patient to call us if there is any more question or reaction.
Had the vaccine and had no problems other than fatigue, went to sleep and woke up with nausea, dizziness, shakiness, muscle and joint pain.  The arm where she received the vaccine in is sore, and the pain goes up her arm, up her neck and into her jaw, thought she was having a heart attack.   She also had a fever of 99.8.  She took Tylenol for these symptoms.   Was not able to go to work due to feeling poorly.
Some pain in right arm; Some tenderness in right arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Some pain in right arm) and TENDERNESS (Some tenderness in right arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced MYALGIA (Some pain in right arm) and TENDERNESS (Some tenderness in right arm). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, MYALGIA (Some pain in right arm) and TENDERNESS (Some tenderness in right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment medications was not given.
Patient came into clinic for Triage 6/26/2023  due to possible allergic reaction for vaccine TDap given 06/19/2023. Nurse observed site. Site was red, swollen and warm to touch. Nurse notified provider, visit was then escalated to a provider visit.