chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT RECEIVED A COVID DOSE AFTER BEYOND USE DATE OF 12/17/2022
Pt states that he started having trouble breathing 2 days ago. He has a history of hypertension, diabetes, CAD, CHF, and wears 4L of oxygen at night. He was admitted for an NSTEMI and found to be COVID positive.
Pt received TDAP on 03/04/2015. On 03/04/2015 in the evening pt developed chills, nausea & myalgias. On 03/05/2015 pt developed vomiting. 03/06/2015 N/V resolved and pt noted increased pain and redness & swelling at inj site. Pt seen in F/U 3/6/15 and tx'd for cellulitis.
7 years and 8 months old was given quadracel with no reported adverse event; Initial information received on 15-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 years and 8 months old female patient who was given quadracel (DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE) 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 MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 12-Aug-2022, the patient received a fifth dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation, strength: unknown) lot C5970AA, expiration date: 02-Feb-2024, via intramuscular route in the left thigh as Immunization.  On 12-AUG-2022 the patient who was 7 years and 8 months old was given quadracel with no reported adverse event (product administered to patient of inappropriate age) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  corrective treatment-None   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 guidelines. 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.
w/in 6 hrs of receiving DTP, pt cried unconsolably for greater than 3 hrs;
I was notified by the store manager that a patient had fainted (within 15 mins of receiving the vaccine) per his dad, they were walking around the store and when the pt mentioned that he didn't feel good and he noticed he was about to pass out then he caught him. when I saw the pt, he was sitting and was alert and oriented. He stated that his head hurt and that he had lost his hearing briefly but he was regaining it, though it wasn't back to normal. 911 was called and paramedics were dispatched dad was made aware that the paramedics were on their way.  However, when paramedics got to the pharmacy, both the dad and pt were no longer in the waiting area. I was made aware by my technician that the dad stopped by later to say pt was seen by the paramedics.
08/29/22 presents to ED for "fall". PMHx of "CKD, dementia, HTN, HLD"
spotting(showing small amounts of menstrual blood); I got my period even though it was only day 10 of my cycle; I bled heavily for 5 days; I am anxious about when my period will happen again; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0164, Expiration date: Unknown) via an unspecified route of administration, administered in left arm on 17Apr2021 17:00 (at the age of 46-years-old) as dose 1, single for COVID-19 immunization in public health clinic/facility. It was reported that, patient had other vaccine on same date. No other vaccine was administered in four weeks. The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination. The patient did not have known allergies. Medical history included premenstrual dysphoric disorder. The patient concomitant medications were not reported. On 18Apr2021, the patient experienced spotting (showing small amounts of menstrual blood), she got her period even though it was only day 10 of her cycle, she bled heavily for 5 days, she was anxious about when her period will happen again. The day after the vaccine, she began spotting (showing small amounts of menstrual blood). The next day, she got her period even though it was only day 10 of her cycle. She tracked her menstrual cycle on the clue app, and she do not have irregular periods. She bled heavily for 5 days. This was extremely unusual for her. She was anxious about when my period will happen again and if it will be triggered by the second dose. No treatment was given for the events. The events were considered as non-serious by the reporter. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
About 15 minutes after receiving the vaccine my arm started itching at the site.  Over the next two hours my arm began to swell.  I called the provider who placed the vaccine and they told me to come back to the office.  THere they told me they had realized that they gave me a Pneumococcal Polysaccharide instead of a PPD as soon as I left, but did not call me.  Instead they waited for me to call back.  I was given 50 ml of Benadryl and a Rx for Naprosyn and Benadryl.  My arm continued to swell and I lost feeling in my hand and arm.  Over the next two days feeling came back, but I still have significant weakness in my left arm and diminished range of motion in my left fingers.
Patient complained of a thick tongue , 20 minutes approx. after injection. (07:49am) Patient was offered Benadryl 25mg orally at 07:52 am and accepted.  Patient stating she is feeling better at 08:00 am continued with observation Patient assisted out to her car  at 08:21 am states she is much better and ready to go home.
This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (dose and route unknown) from lot # M023380 with expiry date of 11-MAY-2018 for prophylaxis. No adverse effects were reported. No product quality complaint was involved. Additional information is not expected, the reporter did not have further data.; Sender's Comments: , MERCK 1609USA006651:Mfr number.
Patient experienced swelling and redness at injection site and after a few minutes of counseling passed out for 10-15 seconds. Patient broke out in cold sweats and reported feeling warm and lightheaded.
Patient contracted adenovirus, hospitalized in ICU x 1 day, then inpatient x 2 weeks to date.  Was seen 1/12 by PMD and diagnosed with Strep throat and given antibiotics.  Eventually diagnosed with adenovirus when hospitalized after 1/12.
Patient came to ED with worsening shortness of breath, cough, and confusion.  Patient was admitted to the hospital with Covid and hypoxia and treated with remdesivir.
Still complaining of pain at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Still complaining of pain at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A and 011F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-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 PAIN (Still complaining of pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Still complaining of pain at the injection site) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment medications are provided.
This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown dates, the patient were vaccinated with an improperly stored doses of LIQUID PEDVAXHIB (dose and route were not reported, lot # K016965, expiration date 20-JUL-2017). There was no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Patient had arm soreness x 2 days after injection, then resolution of symptom.   On 2/19/21, patient developed annular, erythematous rash at injection site.   TX:  Benadryl and observation.
Breakthrough case admission after 2 vaccines Moderna 1/19/21 Lot# 011L20A;  Moderna 2/16/21 Lot# 011L20A
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 11May2021 16:00 (Lot number: ER8735) at the age of 19 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Specific relevant test for thromboembolic events with thrombocytopenia was none. Reported that 1st dose-sore arm, resolved in 2-3 days, he rarely get sick and have Very strong immune systems.  No follow-up attempts are possible. No further information is expected
9 hours after the shot I felt very nauseous.  After getting out of bed, my legs felt wobbly and I passed out.
Chills . headache. Nausea. Sleepy. Blured vision . arm at site very sore . small lumps developed and still have them .
Admit Date: 8/14/2022  8:33 PM Discharge Date:  8/18/2022  Admitting Physician:  Discharge Physician: M.D.   Discharge Diagnosis: Principal Problem:   Pneumonia due to COVID-19 virus Active Problems:   Pancytopenia   Severe protein-calorie malnutrition   Pacemaker   Mild aortic regurgitation   NSTEMI (non-ST elevated myocardial infarction)   Left ventricular systolic dysfunction   Hypomagnesemia   Essential hypertension   Mixed hyperlipidemia       HPI: "Patient is a 70 y.o. female with a onset of fever 2 days ago brought on by respiratory infection, has had cough and congestion. Nothing noted to make it worse. Not particularly short of breath.  Nausea and vomiting with this. To ED, has tested + for COVID. She is vaccinated. "   Hospital Course:  The patient was admitted to the hospital and was evaluated and treated per below.     * Pneumonia due to COVID-19 virus Description of the Problem/Progression:  Plan:  o Pneumonia due to Covid 19 virus. Improving on current treatment. Completed Remdesivir D 3/3. Nebs and inhalers as ordered. Continue to follow up daily inflammatory markers and d-dimer. Patient remained on room air. Continue nebs and inhalers. Encourage incentive spirometry use and pronating. Continue supportive/symptomatic treatment and supplements as ordered per COVID protocol. Follow up daily lab.  o NSTEMI. Likely type II MI with supply/demand mismatch due to the above. Serum troponin peaked at 0.2. Was seen by cardiology. Echocardiogram was done showing ejection fraction of 40-45%. Cardiac stress test was done showing no ischemia. No further ischemic workup planned per cardiology. Follow-up outpatient. o Elevated d-dimer. Trending down back to normal. CTA of the chest done on admission showed no PE and venous ultrasound of the lower extremity shows no DVT. o Pancytopenia. Recurrent. Etiology is unclear. Gradually improved in the hospital Hematology consulted, follow-up on patient. o Severe protein calorie malnutrition. Chronic. Patient was encouraged by mouth intake. Seen by dietitian, consult appreciated. Started on supplements. Continue to monitor. o Hyperlipidemia. Continue statin therapy. Lipid profile ordered.         Physical Exam on the Date of Discharge: Stable and improved     Consults:   IP CONSULT TO CARDIOLOGY IP CONSULT TO SOCIAL WORK IP CONSULT TO ONCOLOGY/HEMATOLOGY   Significant Diagnostic Studies:    labs, microbiology, radiology, nuclear medicine, and cardiac graphics: per chart.     Disposition:  home   Discharge Condition:  good
Patient reported feeling tingly and itchy shortly after receiving the vaccine.  He did not have any difficulty breathing or hives.  He decline an offer for EpiPen, Benadryl, or calling 911.  He said he took his own Benadryl and was going to go home.  We followed up with him an hour or 2 later and he said the itching and tingling had subsided.
Thrombocytopenia, oral lesions, and bloody nose. Treated with 1 unit of platelets. Outcome pending.
Pt. states that after receiving the 3rd dose of Moderna 12/28/2021, started experiencing symptoms within 30mins of dizziness with continuing into the evening of fatigue, fever, and chills. No noted Primary visit/communications. Pt. still experiencing symptoms.
Extreme fatigue, left side pains, elevating to full body aches when I move, walk or talk.  My while body feels heavy like my left arm,  noticably when I move.  I move around with the hopes of working out the pain, that helps some.  This is day two, I'm expecting this to pass.
Spent several days in bed sick afterwards; Arm hurt like hell for a week; This case was reported by a consumer via social media interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and sickness. On an unknown date, the outcome of the pain in arm and sickness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient received 1st dose of Shingrix and arm hurt really bad and spent several days in bed sick afterwards. The patient stated that it was better than getting shingles. The follow up would not possible as no contact details were available. For 2nd dose, refer case US2021AMR104402, reported for the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104402:2nd dose,same reporter,same AE
This spontaneous report was received from a physician and refers to a multiple unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD, lot number M033209 with expiration date 09-JAN-2018, other suspect therapy included sterile diluent which was properly stored, lot number and expiration was not reported (dose, route and anatomical location were not reported for the above described therapies for prophylaxis. There was no previous temperature excursion. The vaccine was exposed to temperatures between 9 Celsius (C) and 25 Celsius (C) during 7 hours and 56 minutes. Data logger was filled. On unknown dates, the patients reported "injection site redness and swelling". At the time of the report, the outcome of the vaccination site swelling and vaccination site erythema was unknown. The relatedness between the events and therapy with PROQUAD was not reported. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA002218.
Respiratory failure with flash pulmonary edema and cardiogenic shock, Symptoms started 12 hours after the booster (3rd) dose. Healthy at baseline with no symptoms reported before the vaccine was given.  Respiratory failure progressed over 48 hours requiring ED visit, admission and mechanical ventilation with refractory hypoxemia, cardiogenic shock and acute kidney injury.  Echocardiogram showed severe acute mitral valve regurg with myxomatous mitral valve leaflets and chordal rupture involving the anterior leaflet.  Patient underwent emergency mitral valve replacement.
Narrative: COVID infection following COVID vaccine series 03/05 Janssen, dose #1 08/30 COVID swab, result: detected 08/30 SARS-COV--2 Variant Sequencing results: pending 08/28 pt cc: cough and fatigue exposure: unknown
Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included IBUPROFEN (ADVIL 12 HOUR) for Headache.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder). At the time of the report, ARTHRALGIA (Sore shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications was reported. Ibuprofen was taken 2 hours prior to vaccination.
2.5 inch diameter swelling, heat, redness, significant pain and soreness. Site is very hard to the touch. Edematous, erythematous, circular.
Headache everyday; Nauseated; Sore throat; Tired; Dizzy; This is a spontaneous report from a non-contactable consumer, the patient. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the left arm on 09Sep2021 at 12:15 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Sep2021 at 19:00, the patient experienced headache everyday, nauseated, sore throat, tired and dizzy. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache everyday, nauseated, sore throat, tired and dizzy were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
On Day 5 (February 21st) after receiving her 2nd COVID vaccine injection, the patient suffered a massive stroke. She was rushed to an ED, arriving within 45 minutes, immediately received TPA treatment and thrombectomy from the right side of her brain. She continues to receive acute treatment inpatient.
Headache, NauseaVomiting, redness, pain/discomfort at site Narrative:  Employee called with symptoms above, and stated she was leaving work
Per patient-began feeling bad about 1:15/1:20pm-blacked out, came too vomiting, felt SOB, went to the ER. Other tests run to rule out other causes-ER came to conclusion it was a vaccine reaction. Pt feeling well today.
Ten minutes after the injection I had a burning feeling. My arm was physically hotter from shoulder to elbow for several hours after injection. This was also confirmed by the tech that administered the vaccine. Headache started 2 hours after injection and turned into a migraine 5 hours after injection. Blood and bruising at injection site.  24 hours later - severe pain in left arm, cannot raise over head. Migraine and nausea persisting  even after OTC meds. Moderate fatigue and dizziness.
Two or three days prior to this date both my feet started to hurt and on this date my hands and feet went numb and I had an overall feeling of uncoordination.  Went to emergency room the next day due to worsened condition, hospitalized for 78 days for Guillain Barre Syndrome.
pt called the pharmacy at 1140am today to ask if pt could be having allergic reaction to the pfizer vaccine given today at 940am.  pt wife stated that pt was dizzy shortly after getting the vaccine but was walking around the store (not in observation area). at approximately 1120am pt started having generalized itching (eyes, inside ears, nose, chest, arms and legs).  patients wife was looking for benadryl to give the patient when the call ended.
Pt recv vax on 7/28/98; on same day pt exp irritability, crying, not eating, fever (102.9), yellow drainage from right eye
Pt administered Pfizer covid vaccine at 4:12pm.  Pt complained of feeling flushed and "felt funny".  Diphenhydramine 12.5mg liquid administered orally.  Within less than 5 minutes pt complains of "throat feels tight, can't talk and chest is tight".  I had staff call 911 and administered 0.3 mg per Epi Pen into left thigh.  Ambulance on site with in 5 minutes.  Pt stated feels "some relief but still felt throat tight and chest still tight"  Pt was then taken to the ER.
-Shivering -fever -upset stomach -diarrhea FYI I was exposed to chicken pox as a child (9-10yrs) but did not get it.
CANCER; LUPUS; This spontaneous report received from a patient via a social media and by a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, dose 1, 1 in total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date following dose 1 vaccination with covid-19 vaccine ad26.cov2.s, the patient was diagnosed with cancer and lupus. It was reported that "Hey guess what Cancer diagnosis. Lupus diagnosis. Fully vaccinated". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cancer and lupus was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220759796.; Sender's Comments: V0: 20220759828- covid-19 vaccine ad26.cov2.s-Cancer. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: NATURE OF EVENT. Therefore, this event(s) is considered not related.  20220759828- -covid-19 vaccine ad26.cov2.s- Lupus. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.