chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On 28-JAN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # and expiration date were not provided) 2 ml, oral. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Covid Arm - red, swelling, itching - started second day - worse third say, lasted for 5 days
UrticariaPruritus injection site warmth, redness, itchiness, soreness Narrative:
Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist by phone. This case involves Neonate patient (age and gender not reported) who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (batch number: UT626TMA, expiry date: Jun-2019, dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because the vaccine was given to a newborn. It was unknown if any adverse event occurred or not following the vaccination. 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. Documents held by sender: none.
Admitted to medical center 7/28 w/ symptoms fever & chills.  Blood tests, chest x-ray, chest ct, chest ct w/contrast.  Diagnosed low iron anemia, pneumonia (middle lobe, rt lung, and pulmonary embolism.  Discharged 8/3
Tenderness in the arm; sore arm; Weakness; Tiredness; Headache; chills; 24 hours later, I could not walk without assistance; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness in the arm), GAIT DISTURBANCE (24 hours later, I could not walk without assistance), PAIN IN EXTREMITY (sore arm), ASTHENIA (Weakness) and FATIGUE (Tiredness) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seizures since 1991 and Type 2 diabetes mellitus since 1995. Concomitant products included VALPROATE SEMISODIUM (DIVALPROEX) for Seizures, METFORMIN for Type 2 diabetes mellitus, PHENYTOIN (DILANTIN [PHENYTOIN]) and COLECALCIFEROL (VIT D3) for an unknown indication.   On 30-Dec-2020 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021 at 3:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced GAIT DISTURBANCE (24 hours later, I could not walk without assistance) and CHILLS (chills). On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ASTHENIA (Weakness), FATIGUE (Tiredness) and HEADACHE (Headache). On an unknown date, the patient experienced TENDERNESS (Tenderness in the arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Claritin at an unspecified dose and frequency. On 29-Jan-2021, TENDERNESS (Tenderness in the arm), GAIT DISTURBANCE (24 hours later, I could not walk without assistance), PAIN IN EXTREMITY (sore arm), ASTHENIA (Weakness), FATIGUE (Tiredness) and HEADACHE (Headache) had resolved. On 30-Jan-2021, CHILLS (chills) had resolved.            This case was linked to MOD-2021-004598 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Additional information was received and captured reporter details, medical history, patient details, concomitant medications and event.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient woke up feeling dizzy and nausea, did not vomit or faint.
I receive my vaccination at 8 AM at 11 PM I started chilling, I had a temperature of 101, I had a headache and achiness. This lasted until I fell asleep about 7 AM the following morning.
Developed rash on abdomen, lower back and sides of torso on Monday 2/6/17. No treatment needed. Rash R/T PROQUAD (MMRV) Afebrile. No other symptoms.
Information has been received from a physician concerning a female who on 26-JUL-2007 was vaccinated with a 2.0ml dose of Rotateq (No lot number was provided) and the patient spit up the vaccine and contracted rotavirus when doing so. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Peripheral neuropathy reported in pt who recvd flu vax 12NOV91; pt admitted to hosp w/lower extremity weakness; discovered to have adenocarcinoma of lung; MD wonders if lower extremity weakness is part of a neoplastic synd re: CA or ADR vax
numbness in legs, electric shocks in spine, lymph node swelling, fever 103, sl h/a; 11NOV93 only has sl h/a;
Low grade fever, body aches, severe headache, nausea (fever and body aches treatable with ibuprofen) lasting from night of injection until four days after.  Did have confirmed COVID infection in January 2021.
Lump, swelling redness at injection site.  Nausea. Mild headache. Muscle aches exasperated.
Information has been received from a registered pharmacist and female consumer concerning a 76 year old female patient with high cholesterol, hypertension and allergy to CODEINE who on 06-NOV-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 663195/1416X).  Concomitant therapy unspecified medications for cholesterol and blood pressure lowering.  It was noted that the patient was "possibly" given the influenza virus vaccine (unspecified) on 06-NOV-2008.  The pharmacist reported that the patient developed a lump at the injection site.  The patient's daughter also called the pharmacist and feel it that the patient received the dose of ZOSTAVAX (Merck) intramuscularly because of the injection site reaction.  The pharmacist could not confirm that the dose of ZOSTAVAX was given intramuscularly.  The patient sought unspecific medical attention by calling the pharmacy.  Additional information has been requested.
Initial unsolicited report received from nurse on 17-Oct-2017. This case involves 72-year-old female patient, who was vaccinated with a 0.5ml once dose of FLUZONE HIGH-DOSE via intramuscular route in left arm (batch number, expiry date and dose in series were not reported) on 17-Oct-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, patient diagnosed her with Left rotator cuff tendonitis, she did have extensive bruising to her Left deltoid by the end of the day, entire shoulder feels inflamed and bruised, had pain with use of the arm, pain with arm use and gripping and may have administered the vaccine too high she was unable to push the plunger. The entire shoulder feels inflamed and bruised. It was an actual medication error case due to wrong injection technique. Lab data and Corrective treatment were not reported. Event's outcome were not resolved at the time of reporting. 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 sender: none.
patient feel faint and turned whitish color skin is cold and clammy. Patient report feeling cold before sitting on floor to lay flat. EMS was called and patient was assessed. Blood pressure WNL patient was able to walk out after EMS evaluation
Diarrhea, 101 temp; within the week, stomach issues-to see gastroenterologist; chest pains, high blood pressure; nausea Never hospitalized; waiting possible transfer to medical facility; kidney damage, lung damage, partial collapse, heart problems and stomach issues.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose number unknown (booster), single (Lot number: Gh9694) at the age of 65 years 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 included: "Dormant pancreatic cancer" (unspecified if ongoing); "mild diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
At around 6pm on the date of my second Moderna vaccine I had a few alcoholic drinks with my dinner because I was feeling fine after the vaccine shot.  At around 8 the next morning my body started to have a seizure while I was sleeping.  I have never had a seizure before in my life.  I went to the hospital and was discharged at around noon and ended up having another seizure in my sleep around 2 pm.  I had to spend the next day in the hospital.
Know of people vaccinated and got it/Suspected vaccination failure; Got it (shingles); This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-MAR-2023 Reporter's Comment: This case was reported by the consumer via interactive digital media. The reporter reported that terrible and he/she knew of people who were vaccinated against it and got it. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Left leg pain, immobility, high fever. Discharge summary states immunization reaction, crying. msv
Around her left arm (where the shot was administered) it's warm, red, and swollen advise pt to take ibuprofen/acetaminophin for comfort and follow up w/MD if it doesnt' get better in 3 days.
I noticed supraclavicular lymph node swelling the evening after the day I received my first Shingrix vaccine.
NVD, swelling at site and down to elbow. Pt states it was the PPSV23 vaccine.  Pt informed me of this when I was contacting her on 17 DEC 20 regarding the recall of Merck PNEUMOVAX23 prefilled syringes. Product recalled on 16Dec2020 (MMQC-20-1258).
Strep pneumococcal sepsis 10/31/03. hafnia Alvei urinary tract infection 10/31/03. Rocephin IM x 3 days then follow-up Augmentin X 10 days. treated out-patient. The medical record received on 12/10/03 states dehydration, decreased appetite and OM.
Fever, Chills, off and on. Extreme Fatigue, Headache, Dizziness,   I treated myself.
Case number PHEH2014US24321, is an initial spontaneous report from a nurse received on 02 Dec 2014, with a follow up report received from the nurse on 19 Jan 2015. This report refers to a 59 years old male patient. Historical condition and concomitant medication were not reported. His past vaccinations (unspecified) were well tolerated. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscular in left deltoid at a dose of 0.5 ml on 12 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. Patient did not experience any adverse event. No adverse event was reported following this medication error. Follow up report received from the nurse on 19 Jan 2015: Updated vaccination history, recent vaccination site and reporter's statement.
Vomiting, diarrhea ? 4 days  Hot flashes and sweating - continuous, still occurring Feeling like I have a fever but no fever ? continuous, still occurring Severe pain radiating down right arm ? comes and goes  Dizziness ? continuous, still occurring  Dehydration  Nausea ? continuous, still occurring  Loss of function in right side of face (eye and eyebrow), weakness in right arm ? lasted about 8 hours and occurred day 5 after vaccine
2 days later developed severe deactivation of my gout/polyarticular attack every 3-4 weeks; 2 days later developed severe deactivation of my gout with significant knee effusion; Did not receive second shot; This spontaneous case was reported by a physician and describes the occurrence of GOUT (2 days later developed severe deactivation of my gout/polyarticular attack every 3-4 weeks), JOINT EFFUSION (2 days later developed severe deactivation of my gout with significant knee effusion) and PRODUCT DOSE OMISSION ISSUE (Did not receive second shot) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 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 GOUT (2 days later developed severe deactivation of my gout/polyarticular attack every 3-4 weeks), JOINT EFFUSION (2 days later developed severe deactivation of my gout with significant knee effusion) and PRODUCT DOSE OMISSION ISSUE (Did not receive second shot). At the time of the report, GOUT (2 days later developed severe deactivation of my gout/polyarticular attack every 3-4 weeks) and JOINT EFFUSION (2 days later developed severe deactivation of my gout with significant knee effusion) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported by reporter  2 days later developed severe deactivation of my gout with significant knee effusion that required needle aspiration twice along with polyarticular attack every 3-4 weeks  that was still ongoing despite traditional gout treatments.  Treatment information was not provided by reporter.      Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Follow up done and does not contain any significant information
I first got a really sore throat, coughing, chest congestion, little headache, really awful post nasal drip. Then a really bad cough developed a day after and I was coughing so hard I was throwing up. A lot of nausea and body aches, with a nonsignificant fever. My skin was sensitive. I was told to take SUDAFED and given anti-nausea medication. I still have some congestion and sinus stuff.
This spontaneous report as received from a pharmacy technician concerning a currently 59 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 11-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J003700; expiration date: 27-MAR-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Diffuse maculopapular rash, pruritic, worse on face, with a fever up to 102F that lasted 2-3 days. Treated with Motrin and Benadryl.
Patient stated that within a minute after taking the vaccination he become real cold and his skin tuned real pale and ghostly white. Patient stated it felt like he was loosing his eye sight. Patient also stated that he started sweating in his hands uncontrollably.
arm is swollen really bad to the point she can almost not lift it; arm is swollen really bad to the point she can almost not lift it; A spontaneous report was received from a consumer who is an adult female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe arm is swelling and inability to lift/move the vaccinated arm.    The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date in 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date in 2020, after the vaccine administration, the patient experienced severe arm is swelling and inability to lift/move the vaccinated arm. There was no treatment information provided.  There were no relevant laboratory tests provided.  Action taken with mRNA-1273 in response to the event of arm is swollen really bad to the point she can almost not lift it was not reported.   The outcome for the events, severe arm is swelling and inability to lift/move the vaccinated arm, was unknown at the time of this report.  Causality was not provided for the events, severe arm is swelling and inability to lift/move the vaccinated arm.; 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.
Pt vaccinated w/DTP/OPV developed hives over face, arms & legs. Nurse reported child played in bushes day of vaccination. MD believes rash not due to vaccine. Pt fully recovered 2 days after vaccine given. Treated w/Benadryl & Aveeno Oat.
Symptoms of medical shock about 16 hours after vaccine dose--cold sweat and ashen complexion, dizziness, fainted, intense nausea. All symptoms except nausea and thirst subsided with bed rest and electrolyte fluids.
No additional adverse events reported; administration of expired GARDISIL 9; This non-valid spontaneous report was received from a physician via office manager and refers to a patient of an unknown age and gender.  On 03-JUN-2021, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 ml, lot # R026716 was valid for formulation vial, expiration date 30-MAY-2021 (route of administration and anatomical location were not provided) for prophylaxis. The reporter inquired viability of administered dose. No additional adverse events reported.  This case is non-valid due to lack of patient's identifiers.  Follow up information was received form an unspecified source at the physician office on 15-JUN-2021.  The reporter stated if they could get more information regrading the patient. However, more information was not able to be provided as it was not available.
13:50/Vaccine administered. Moderna 0.25 mL red top dose was administered to the 11 y/o pt. Attempted to reach out to parents phone at 1400 with no answer, voicemail box was not accepting messages. Attempted to reach out to parents again at 16:45, but no answer again. A voicemail was left for the pt's mother at that time requesting to call back.  Awaiting call back.
Low grade fever (100.4F), runny nose, fussy, viral rash, fatigue, fever persisted for 2-3 days
1/16 Vaccination 1/17 9am  I had temp 100.3. Tylenol. Muscle aches. Lethargic. In bed most of the day. Malaise. Symptoms lasted for 12hours. Didn't completely go away for 24 hours.
Patient was administered Dose #4 pfizer bivalent booster @ 4pm. Patient went to monitoring area then @ 4:30pm sad she has redness on both arms and in chest area. Patient denied any SO(shortness of breath) and redness on both arms began to lighten. Patient had no hives, no itchiness and was advised to apply cool compresses and monitor.  Patient to contact PCP /Doctor with changes or concerns
patient developed nausea, vomiting, headache, fatigue and chills approximately 12 hours after receiving Tdap
Flu Vaccine-Flulaval given at 1:45 today, once patient returned home after shot developed aches but began to have a fever which is currently 7pm 101.6
I received the first dose on March 6.  On March 14 I developed a weal on my upper right arm.  It started about the size of a quarter, but very quickly move to 2-3" in diameter, raised, and Itchy.  It initially was treated with Doxycycline. I received the second dose on 3/27.  about 2 weeks after that, the weal returned.  This time it moved the length of my arm over the time of a week.  This time it was treated with antihistamines.  The weals continued around my body on and off, including the bottom of my feet..  I was able to get into a Dermatologist on June 9, who took a  biopsy of my lower right arm.  The results came back 2 weeks later that it was Chronic Urticaria.  On July 3 I suddenly developed Angioedema of the lips, and ended up in ER.  I was treated with intravenous Benadryl, famotidine, and prednisone, and put on famotadine and predisone for the next 2 weeks.  While things went away for a while, the series of Hives started again, and 2 days after my feet swelled, I developed the Angioedema again and was back in ER.  This has continued  throughout the summer, and continues to the current day.  I have had one more ER Visit on 8/28.  I am currently on Zyrtec, Famotidine, montelkast, and Allegra to treat the hives.
Menstruation disruption, a little heavier bleeding during periods  and spotting once or twice in between periods. This has been going on for about 3 months after receiving 2nd dose of Moderna  on 07/17/2021. I never use to spot between periods and now when I received the moderna vaccine, I have been. Also, after receiving my 2nd dose- the first month I had 2 periods and that has never happened in the past. It has been a little over 3 months & I continue to spot randomly in between periods & it just happens randomly that I?ll start bleeding.
Received flu shot 10/26/16 4 PM had pain immediately got MOTRIN within a few hours had redness on arm, swelling, pain, and itching. Maximum swelling on 10/28/16. 10/29/16 less redness, no pain, less swelling.
Was fine for ~8 hours then started to feel ?off? after completing an upper body workout. I then felt nauseous and threw up, and my body began to ache. 12 hours post vaccination I began to develop a fever of 99.8 with the use of acetaminophen and had severe chills / muscle aches.  The fever progresses to 101.1 about 36hours post vaccine and declined to 100.8 48 hours post vaccine. By 72 hours the fever was gone as well as all symptoms excluding fatigue and a slight headache.