chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient Receive a dose of Flulaval instead of Fluzone/ no AE; Initial information received on 21-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves a 72-year- old female patient who received dose of INFLUENZA VACCINE INACT SPLIT 3V [ FLULAVAL] instead of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (wrong product administered).   The patient's past medical treatments, vaccinations, concomitant medications and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE INACT SPLIT 3V [FLULAVAL] not produced by Sanofi Pasteur (batch number and expiry date not reported) instead of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED[FLUZONE] suspension for injection (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.   It was a case of actual medication error due to wrong vaccine administered (latency same day).   It was reported "We recently had a 72 year old female patient receive a dose of Flulaval instead of Fluzone. I contacted the Centers for Disease (CDC), who directed me to my State Department of Health to determine whether we should re-dose the patient, and if so- when. The State Department of Health representative confirmed that we should re-dose the individual, but asked that I contact you for guidance on when to re-dose. I would appreciate any information you can provide regarding how soon after administration of a sub-therapeutic dose of influenza vaccine, we should administer a therapeutic dose to this patient".  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  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.  There will be no information on batch number for this case.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The pertinents' medical history and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka-Merck) PROQUAD (lot # M006104, expiration date: 01-AUG-2017 (dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a consumer and refers to an approximately 73 years old male patient reporting on himself. The patient had no medical history, concurrent conditions, drug reactions or allergies. However, he stated that prior to receiving ZOSTAVAX, he was always healthy and rarely sick. On an unknown date in 2016, the patient was vaccinated with one dose of ZOSTAVAX, in his shoulder, (dose, route, lot number and expiration date were not reported), to prevent shingles. The vaccine was diluted with Merck sterile diluent. On an unknown date in 2016, the day after the patient received the ZOSTAVAX, the patient developed shingles on his shins, stomach area, and from his ear lobes down to his Adam's apple. Since the patient developed herpes zoster disseminated, he had been getting "flare ups" of the shingles, primarily on the right side. On an unknown date, the patient visited the physician's office, and underwent an unspecified blood work without results reported. The herpes zoster disseminated was not treated. At the time of reporting, the outcome of herpes zoster disseminated was not recovered. The reporter did not assess the causal relationship between the herpes zoster disseminated and the therapy with ZOSTAVAX or Merck sterile diluent. Upon internal review the event of herpes zoster disseminated was determined to be a medically significant event.
Patient cam to Walgreens with her mother for a Covid 19 shot. We administered the Pfizer shot in the left arm and was asked to stay in the store for 15 to 20 minutes to make sure she di not have an adverse reaction. She walked to the front of the store and and started felling dizzy, therefore, mom had patient sit down on the floor. Our store manager noticed she was on floor and cam over to offer assistance. Pt's mom said she pass out and was not feeling good. I was paged and upon going to front of the store saw the patient on the floor. I came up to and ask how she's feeling and noticed she was flushed and warm. An associate got her some water and a chair. Our store manager offered to call 911 and mom did not want an ambulance called and after 15 to 20 minutes of sitting in the chair drinking water, patient was able to leave the store with no assistance. I called to check on Pt at 5:30pm and she was feeling good with no other issues.
45 year old patient complains of covid vaccine adverse reaction.  States had vaccine on 8/10/21.  Waited 15 min without problems and then noticed roof of mouth started itching.  Then having a numb feeling pop up with burning and itching on tongue within 1 hour of getting shot.  By the time she got home it moved to lips and throat.  On the 12th morning face was mildly swollen.  Took a Benadryl Tuesday night after she got home.  Had an immune response with flu like symptoms Tuesday after getting shot and resolved in 24 hours.  States ears feel full and throat feels raw and tongue feels like it burning but it is not bad.  Taking Zyrtec during day because Benadryl makes her feel too drowsy.  Was able to go to karate last night.  But did noticed when she was more active her throat felt inflamed.
1st dose given 02/11/2002, 2nd dose 02/14.  On 02/15 - noted sever joint  pain all over, significant swelling of hands, face, and feet.  Complaint of headache and general malaise.  Reported to manufacturer.
Chronic Myeloid Leukemia; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC MYELOID LEUKAEMIA (Chronic Myeloid Leukemia) and PAIN IN EXTREMITY (Sore arm) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included FLUOXETINE, LISINOPRIL, GLIPIZIDE, METFORMIN, AMITRIPTYLINE, PANTOPRAZOLE, ASPIRIN [ACETYLSALICYLIC ACID], PIOGLITAZONE, FAMOTIDINE, SEMAGLUTIDE (OZEMPIC) and ALLOPURINOL for an unknown indication.    On 25-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 CHRONIC MYELOID LEUKAEMIA (Chronic Myeloid Leukemia) (seriousness criteria hospitalization and medically significant) and PAIN IN EXTREMITY (Sore arm) (seriousness criterion hospitalization). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency. At the time of the report, CHRONIC MYELOID LEUKAEMIA (Chronic Myeloid Leukemia) outcome was unknown and PAIN IN EXTREMITY (Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: high (High) High.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       The patients latest blood work was better.  Company comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Received notification from county director that patient is currently hospitalized beginning two days after Moderna vaccination, spoke to patient today 2/26/2021. Patient received vaccine Monday morning 2/22/2021 around 9:07am, by 9pm Monday evening patient reports weakness, fatigue, sore arm, fever, chills, and no appetite. Patient states symptoms persisted all day Tuesday 2/23/2021. On Wednesday 2/24/2021 at 11:30am patient was eating a peanut butter sandwich and felt something inside mouth. Upon looking in mouth patient noticed "black sores." Patient then called husband and was taken to ER and was then transferred to Hospital. Patient states she has been diagnosed with ITP idiopathic thrombocytopenic purpura.
He developed cough; Fatigue; Headache; body ache; Fever; Lack of drug ineffective; tested positive for COVID 19; Rhinitis; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (tested positive for COVID 19), RHINITIS (Rhinitis), COUGH (He developed cough), FATIGUE (Fatigue) and HEADACHE (Headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced COVID-19 (tested positive for COVID 19), RHINITIS (Rhinitis), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (body ache), PYREXIA (Fever) and DRUG INEFFECTIVE (Lack of drug ineffective). On an unknown date, the patient experienced COUGH (He developed cough). In August 2021, COVID-19 (tested positive for COVID 19), RHINITIS (Rhinitis), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (body ache) and PYREXIA (Fever) had resolved. At the time of the report, COUGH (He developed cough) had not resolved and DRUG INEFFECTIVE (Lack of drug ineffective) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, COVID-19: positive (Positive) COVID-19 positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided by reporter. The patient was treated by his doctor
Developed allergy like symptoms that got progressively worse. Swollen throat caused problems eating/breathing to the point that had to go to ER in April. The specialist mentioned that the problems were caused by allergic rxn. Still have soreness/achiness at site of injection. Received 3rd Td dose in series on 7/27/05.
unbelievable pain on her right knee/Severe Pain/ Extreme Pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (unbelievable pain on her right knee/Severe Pain/ Extreme Pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient never had COVID positive test. The patent had no allergies. No medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.     On 14-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced ARTHRALGIA (unbelievable pain on her right knee/Severe Pain/ Extreme Pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. In April 2022, ARTHRALGIA (unbelievable pain on her right knee/Severe Pain/ Extreme Pain) had resolved. Not Provided  No Concomitant product use was reported. AE caused patient to seek medical care. The patient  went to see the primary doctor and an orthopedic surgeon who ran tests on patient, but had no explanation on what was going on.
Product problem. Required intervention to prevent permanent impairment/damage (Devices). See additional page(s) for complete text.
Tested COVID-19 positive, resulted in hospital admission and pneumonia and ARDS. Symptoms included cough and shortness of breath.
Sudden dizziness and nausea, feeling faint about 3 hours after vaccine. Lasted about an hour. Better after lying down.
I can't text. It is brutally painful./ It feels like all the vaccine is stuck in one place; My arm is sooo painful/ Hurts so bad; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I can't text. It is brutally painful./ It feels like all the vaccine is stuck in one place) and MYALGIA (My arm is sooo painful/ Hurts so bad) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced VACCINATION COMPLICATION (I can't text. It is brutally painful./ It feels like all the vaccine is stuck in one place) and MYALGIA (My arm is sooo painful/ Hurts so bad). At the time of the report, VACCINATION COMPLICATION (I can't text. It is brutally painful./ It feels like all the vaccine is stuck in one place) and MYALGIA (My arm is sooo painful/ Hurts so bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  No treatment medication was provided
Myocarditis; fever; chills; body aches; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.       No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). At the time of the report, MYOCARDITIS (Myocarditis), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (Myocarditis), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) to be possibly related.    No concomitant medication was reported.  No treatment details were provided.  Company comment: This is a literature non-study case concerning a 24-year-old, male patient with no reported medical history, who experienced the serious (due to medically significant) unexpected AESI of Myocarditis. The event occurred approximately 4 days after the second dose of mRNA-1273 vaccine. The patient's electrocardiogram demonstrated a sinus rhythm without ischemic changes. Laboratory studies revealed: elevated troponin I (18.94ng/mL, normal 0.01- 0.04), elevated Creatine Kinase (704 U/L, normal 49-348), elevated C Reactive Protein (26.4 mg/L, normal. A transthoracic echocardiogram 4 days post vaccination was within normal limits, the left ventricular ejection fraction (LVEF) was 65%. No focal wall motion abnormality was seen. Computed tomographic angiography of the coronary arterial system 5 days post vaccination demonstrated a calcium score of 0 without coronary artery stenosis and small bilateral pleural effusions. Cardiac MRI with gadolinium 5 days post-vaccination demonstrated normal LV size and EF (58%), patchy mid-myocardial and epicardial delayed gadolinium enhancement (Fig. 1), with superimposed edema, fulfilling the Lake Louise Criteria for myocarditis. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-223812 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Upon internal review on 02-Aug-2023, significant correction was performed to upgrade the event Myocarditis to serious medically significant. On 28-Jun-2021: Follow up received by safety 30-Jun-2021 included a no newinformation. On 29-Jun-2021: Follow up received by safety 30-Jun-2021 included a full text article received.
Tested positive on 6/17/22, and started Paxlovid that day.  Experienced a "rebound" on 6/28/22 and the rebound symptoms were noticeably worse than the original covid symptoms.  Fortunately, I felt well enough to get out of bed on 6/29/22.  (Note:  I was vaccinated twice and boosted twice, all four shots were Pfizer.)
100.2 fever nausea reaction to shot area: inflamed arm, red, the size of the top of a can
Received Below immunizations - left arm developed mild redness the evening, post injection at injection site; next day with increased erythema.
reports before Engerix his CAT scan showed a perfect liver and a recent MRI shows fatty liver; reports blurry vision; This case was reported by a consumer via call center representative and described the occurrence of fatty liver in a 53-year-old male patient who received HBV (Engerix B adult) (batch number 4795H, expiry date unknown) for prophylaxis.   On 8th October 2018, the patient received Engerix B adult. On an unknown date, less than 2 years after receiving Engerix B adult, the patient experienced fatty liver and blurred vision. On an unknown date, the outcome of the fatty liver and blurred vision were unknown.   It was unknown if the reporter considered the fatty liver and blurred vision to be related to Engerix B adult.  Additional details were provided as follows: The patient was received Engerix B adult on below the belt on the right side of leg. The reporter reported that before Engerix B adult the patients Computerised tomogram scan showed a perfect liver and a recent Magnetic resonance imaging shows fatty liver. The patient experienced blurry vision after the Engerix B adult vaccine. Consent to follow up was denied.      Lab Comments: On an unknown date lab test were performed.
Case number PHEH2013US020531 is an initial spontaneous report received from a nurse on 30 SEP 2013 with a follow up information received from a nurse on 04 FEB 2014. This report refers to a 25-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml intramuscular dose of FLUVIRIN 2013/2014 (batch number: 1308401, expiry date: MAR 2014) in the deltoid on 27 SEP 2013. It was reported that the nurse was not there when the shipment arrived and it was placed on desk and hence the vaccine is shipping container was placed in room temperature for 72 hours. No adverse event was reported following the medication error.  Follow up medication received from a nurse on 04 FEB 2014: Vaccination date and site of vaccination updated.
Patient complained she experienced itching and "hives" of her arms and trunk 2-3 hours after vaccine administered.  Reported this to health department on 01-16-13, self medicating with OTC Benadryl.
Patient came in for evaluation and got tested for COVID; Inpatient; Vitamin C; Tylenol; Zinc
Heart palpitations - it felt like my heart was jerking and skipping beats. They would happen randomly throughout the day - but when I was resting in the evening and at night -  flutters in my heart - They continued and I wasn't stress or anxious. Doctor visit  - primary care dr - did labs - saw Doctor in  May, the beginning of May  and through June- I could see the beats on my Apple Watch - They referred me to cardiology and I saw Cardiologist in May and June - They could see that I do have quite a few PVC's or PACs - less than one percent of my normal beats. No treatment. I experience a little bit of lightheadedness sometimes when my heart does skip a beat - it's not enough that I have to sit down but I do feel it.
Pain, swelling, redness  at the injection site, headache, weakness , flu -like symptoms were reported on 05/18/19.  On 05/19/19 patient felt better but pain, redness, swelling at the site of the injection were not resolved   yet.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 67-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The expiry date was reported as 07-Apr-2022.  Date the vial was initially stored in the refrigerator was unknown.  The vial did not undergo any temperature excursions.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up documents received includes non significant information.
Unknown which DTaP patient received. She has induration and erythema of her entire lateral LUE to her elbow. Warmth, some pain, induration. Started 3 days after she received the tdap shot in the arm. Since yesterday, daughter said the erythema has doubled in size. Denies fever, chills.
Injected Pediatric dose instead of Bivalent Adult dose and the patient did not get any adverse effect.  The Moderna vial  and box did not indicate any writing stating that it was a pediatric vial.
PATIENT DEVELOPED A BLISTER NEXT TO VACCINATION SITE ON LEFT ARM. PATIENT APPLIED WARM COMPRESS TO SITE, NO PAIN . I TOLD PATIENT TO SEE DERMATOLOGIST. PATIENT MAKING APPT. AND WILL ADVISE AS TO OUTCOME.