chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient started minor bleeding from injection site and quickly developed hematoma. Pressure was applied to stop bleeding and quickly a cold compress was applied for 15 minutes. Patient was told what signs to look for, and when it was necessary to reach out for further medical attention should problem get worse. Patient was provided another cold compress to take while they drove home.
PATIENT CAME IN TO PHARMACY ON 8/14 WITH A VISIBLE REDNESS ON LEFT DELTOID WHERE VACCINE WAS ADMINISTED.  SHE STATED THE ARM HURT THE DAY AFTER THE VACCINE, BUT HAS CONTINUED TO HURT AND THE REDNESS SHOWED.  THE REDNESS ON ARM IS ABOUT AN INCH IN DIAMETER
Treatment of COVID-19; Treatment of COVID-19; Dose 1,2,3,4: Comirnaty; Dose 5: Moderna vaccine; 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 (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 25Apr2021 as dose 2, single (Lot number: EW0171), in left arm, on 06Dec2021 as dose 3 (booster), single (Lot number: FJ8757), in left arm and on 20Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Nov2022 at 15:00 as dose 5 (booster), single (Lot number: 010H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bronchitis chronic" (ongoing); "Known allergies: penicillin" (ongoing); "Known allergies: sumac" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergy: erythromycin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Nov2022 at 15:00, outcome "unknown", described as "Dose 1,2,3,4: Comirnaty; Dose 5: Moderna vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient did not receive any other medication in 2 weeks. Patient was treated with Paxlovid for COVID-19 from 15Aug2023 to 20Aug2023. The patient did not have any Adverse event. No treatment was received for AE.
Numbness in fingers and wrists; painns in shoulder, pectoral and scapula areas.
Sept 18th 2021, approximately 2 weeks after the 2nd dose of moderna was to fully effective, i started my period. It lasted until December 7th 2021. That was very unusual and I cramped almost every day. And had to wear a pad every day. On December 25th 2021, my period started again. As of today. February 11th, 2022, I am still on my period. I have heavy bleeding. And cramp everyday still. I ha e had 5 vaginally infections since my 3nd dose of the Moderna vaccine. And I have sought medical attention 4 times for treatment. The first time I purchased over the counter medication. I went to a obgyn specialist to seek treatment for all these symptoms. My first appointment was December 6th 2021. My doctor suggested getting an iud to help normalize my periods. I got the iud placed on January 22nd 2022. it has not helped yet as of today. These past 5 months have been extremely painful, costly, and emotionally and physically draining. It has effected my physical relationship with my husband, it has made me not be able to do many normal daily activities. And I have spent many hours at doctors offices, money for treatment and travel expenses to get to doctors. This has been very traumatic and overwhelming. These symptoms should have been listed as possible side effects. To this day, I am in great physical pain and can not live my life the same as before my 2nd dose of the Moderna clovid 19 vaccine.
Narrative:  Patient died due to complications of progressing cancer. No suspected that COVID-19 administration played any role in death.
HEART ATTACK;   Information was received from a Consumer/other non-health professional concerning a 67 Year(s) old Male patient, enrolled in the post marketing study who received Suspect product APIXABAN for Product used for unknown indication, lot number: Unknown; Suspect product COVID-19 VACCINE for Product used for unknown indication, lot number: Unknown. On an unknown date, the patient experienced myocardial infarction (heart attack) which was considered serious due to medical significance. The outcome of the event is unknown. The patient stated he had a heart attack due to a COVID-19 vaccine. The status of APIXABAN medication is unknown. The status of COVID-19 VACCINE medication is unknown. Concomitant medications were not reported. The reporter considered event myocardial infarction not related to product APIXABAN. The reporter considered event myocardial infarction related to product COVID-19 VACCINE. Tracking of Changes: 06-Jul-2022: Initial information was received.   Eliquis is under agreement.; Sender's Comments: Comment: This 67-year-old patient had myocardial infarction after apixaban therapy. Elderly age is a significant risk factor for the reported event and is considered not related to apixaban therapy.  A causal association between reported event and BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a physician concerning a female pt with a history of hospitalization, who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. It was noted that the pt went home from the hospital, three weeks later when she was seen in the clinic she was vaccinated again IM with another 0.5ml dose of Pneumococcal 23v polysaccharide vaccine. Recently after the second vaccination, the pt experienced a skin reaction. Unspecified medical attention was sought. The pts outcome was unknown. NO product quality complaint was involved. Additional information has been requested.
Patient had a very fine rash appear between injection site and elbow (right arm). No itching, inflammation or warmth reported.
Information has been received from a pharmacist concerning a 35 year old pregnant female expecting twins who in 1997 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live. It was unknown if this was a first or second dose of the vaccine. On 11/11/2005 the patient developed a rash or pox at 26 weeks gestation. Medical attention was sought and the patient was hospitalized. The pharmacist noted that the lesions crusted over quickly and that it was a mild case. Subsequently, the patient recovered. Follow up information was received from the pharmacist indication that the patient did not receive the vaccine while she was pregnant. She received it prior to pregnancy, but developed VZV while pregnant. This was reported as failure of vaccine to prevent disease. Additional information is not expected.
pt recv vax 11OCT95&4 days later pt devel hallucinations&paranoid ideation;pt hosp w/resp arrest&required mechanical ventilation;pt is now vegetative state;poss creutzfeldt-Jakob disease;also therapy for depression;
no adverse event; Varivax was administered to a patient after improper storage; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.     The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route, and anatomical location unknown) lot # T017686, expiration date 21-MAY-2022, 1 dosage form, for prophylaxis.     On 06-JAN-2021, it was noticed the patient had been vaccinated with an inappropriately stored varicella virus vaccine live (oka/merck)(VARIVAX) vaccine.  The vaccine was stored at a temperature of -12°C for 11 hours and 10 min. Also, there was a previous temperature excursion of -14°C to 10°C for 2 hours and 30 minutes. The error was noticed due to a data logger. The patient did not have an adverse event.
Severe pain along with numbness in my left arm, weakness in my left arm and hand as well. These symptoms have been going on for almost two weeks. Neck pain and shoulder pain is almost unbearable (exclusivly on the left side). Along with hives every morning starting Oct. 9th, 2014 on chest and left upper arm.
Employee stated she immediately began feeling an "itching sensation" over her scalp, left arm, and trunk.  Employee did not have any respiratory issues/compromise.  Employee was taken to the ED and treated with SoluMedrol, Benadryl, and 1L IVF.  Employee was discharged and back to herself the next day.
Moderna Covid 19 Vaccine EUA.  My left arm was stiff and painful day of. Went to work. Pain was across shoulders. Took Aspirin, Advil, Tylenol at various times. Went to doctor on 03/02/2021. I mentioned I had had Covid shot. Pain required lying flat and lifting arm above head. Was treated for clavicular ridiculous they and given muscle relaxer. A day or so with increased pain called for pain medicine. Mentioned again about Covid shot. Given Tramadol. No pain relief just dizziness and lethargy. Back to doctor on  03-09/2021. Gabapentin ordered and X-ray ordered. Some numbness on lower right leg. Pain down back of left arm in addition to other areas.
This is a serious observational study case initially received on 26-Apr-2019, concerning a 21-year-old adult female, pregnant subject of body weight 170.5 lbs, height 62.8 inches and body mass index (BMI) 30.4, enrolled in study. The subject's obstetrical history noted that the subject had 3 previous pregnancies with 2 full term live births and one pregnancy with spontaneous abortion. No birth defects were reported. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal or paternal history with major congenital malformations. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period (LMP) date was 13-Feb-2018 (as reported). The type of pregnancy was singleton. The pregnancy status of the subject was collected, and no pregnancy complications were noted. The subject's concomitant medications included prenatal vitamins for general health. On 14-Jan-2019, the subject was administered Flu Vaccine Egg Split QIV CSL [batch number: YF41608 (reported as YF1608), dose, route of administration, anatomical location, batch number and expiry date: not reported) for an unknown indication. On 23-Jan-2019, the subject had undergone first trimester screen and maternal screen with nuchal translucency and no major congenital malformations were noted. On 27-Feb-2019, the subject had undergone ultrasound antenatal screen and no major congenital malformations were noted. On an unspecified date in 2019, the subject experienced herpes simplex virus infection. The subject was treated with Valacyclovir [start date: 01-Apr-2019, dose: 1 g, frequency: twice a day (bid), route of administration: oral and stop date: 02-Apr-2019) for herpes simplex virus infection. The outcome of the event herpes simplex virus infection was not recovered (reported as ongoing). The subject's corrected estimated date of delivery (CEDD) was 29-Jul-2019 (as reported). Reporter's Comments: A 21-year-old pregnant subject experienced herpes simplex virus infection, unspecified period of time after receipt of Flu Vaccine Egg Split QIV. Despite the lack of onset latency, the causality of the event herpes simplex virus infection assessed as not related considering the infectious aetiology of the event. The event vaccine exposure during pregnancy assessed as not related considering the intended use of the vaccine. The company assessed the event 'herpes simplex virus infection' as serious (medically significant).
Several patients administered vaccine during clinic visit.  Nurse that administered noted an extra vial of drug at the end of the clinic.  One patient of the several patients had diluent only administered.  Patients asked to return in 6 weeks for an add'l vaccine dose.
I was bleedy heavily with clots through my nose, my mouth would fill up with bloody clots during the episodes which lasted for 5 days. The bleeding lasted about 30mins per episode 3 episodes a day.
Presented with SOB, cough and was admitted for COVID-19 viral infection.  He has been coughing with progressive dyspnea and pleuritic chest pain component x1 day with chest wall pain since fall couple weeks ago.  No fevers chills rigors loss of taste or smell nausea vomiting abdominal pain or diarrhea.  No dysuria or hematuria.   He received full dose aspirin, azithromycin, Decadron in the ED.  He was continued on zinc, vitamin D3, decadron, famotidine and monitored overnight with no need for oxygen. He was found safe for discharge with continued supplements and decadron.
Spoke to patient on the phone on 7/20/21.  Patient claims that day of shot, injection site became a red "bullseye" lump/mark.  Over the next few weeks up until today, patient claims a rash has continued to spread over his body that is very itchy.  Also claims that he is now more sensitive to the sun (vision impaired) & can't physically tolerate being in the heat like he could before the vaccine.
Moderna vaccine was administered outside of clinic - reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------ T78.40XA ALLERGIC REACTION, INIT 3/28/2022 DM 2 WO COMPLICATIONS
persistent crying for 5-6hr;no fever-no local rxn or swelling, no vomiting;
reports that 1 day p/vax pt exp pain & stiffness in both arms w/tingling in hands;rt side resolved then lt side became progressively stiffer & sore;neck stiffness & pain cont w/progression to rt side
Severe eczema on topical steroids. Ran out of steroids 1/14/00 & on 1/15/00 developed generalized varicella-like rash w/300 vesicules w/clear fluid, pruritus. Was seen on day #6 of sx's, too dry to scrape/culture. Tx:Keflex.
I experienced chest pain and numbness in bilateral upper and lower extremities on 3/25/2022. I went to the emergency department and was admitted under observation as my troponin levels were rising. I experienced more chest pain and was ultimately transferred to a higher level of care that evening. I was admitted to the hospital, had an angiography, and then was transferred to the cardiovascular ICU. I was diagnosed with a spontaneous coronary artery dissection. I was discharged on 3/ 27/2022.
Vaccine given at 3p US WNI at 7:30p c/o occ. moist productive cough of thich yellow phlegm. Nurse practitioner notified and orders cxr, sputum culture, aerosols and Doxocycline 100 mg bid x 10 dyas Hx of CVA- with hemiparesis rt side. Was going to give vaccine in "good" arm, but she wanted me to put it in her right. "I've never had problems before" 11/15/07 Rt arm swollen and red, warm to touch Bruising by elbow Nurse practitioner notified warm compress qid x 4 days
Whole body burning sensation, chills, headache, nausea, muscle aches and general exhaustion. Improved on second day to only muscle aches, general exhaustion, headache, and nausea. On third day, only mild muscle aches, headache, and nausea. Resolved on fourth day post-vaccine.
vesicles red spot, pustules, went from the injected site to all around the shoulder side area and there for 4 days after week later from the first vaccine and after 2 weeks later started shingles.
Three days following dose #1, I had difficulty achieving and maintaining an erection during intercourse. This was the first time in my life this happened. In the days that followed, my libido was noticeably lower. I usually awoke with an erection 4 or 5 days per week, but over the two weeks following the first dose had zero days arising with an erection. Things began getting back to normal, and about 3 weeks after dose #1 I achieved and maintained an erection during intercourse without any problems. Following dose #2, the same drop in libido and erection difficulties occurred, but four weeks after administration they have not resolved themselves. Prior to dose #1, it was not uncommon for me to wake during the night due to arousal. This has not happened since. I have had no changes in diet or exercise. January was a lower-than-average stress month for me, while February has been more typical.  Second dose administered 02/04/2021, Moderna Lot # 012M20A, Injection in Left Arm
Patient reports tightness in throat, difficulty to swallow and nervousness. Patient reported improved anxiousness . Patient given 25mg Benadryl by mouth, juice BP 128/78 prior to discharge  No sx of shortness of breath or inability to swallow Patient was sent home
SLIGHT HEADACHE, DIZZINESS STARTED THURSDAY MORNING, FRIDAY MORNING AND TODAY LONGER THAN MORNING.
Fever Chills Body ache Dry Cough Nasal Congestion  Lymph nodes inflammation on the side of the injection  Tiredness Injection site pain Left cheek inflamation
Shortness of breath, tightness in chest, severe aches all over body, vomiting, diarrhea, very sore at site of injection, fever. Too much pain for older person.
PATIENT BEGAN SLOUCHING IN CHAIR AND BECAME UNRESPONSIVE TO VERBAL COMMANDS BEGINNING ABOUT 5 MINUTES AFTER VACCINE ADMINISTRATION. EPINEPHRINE 0.3MG WAS IMMEDIATELY ADMINISTERED INTRAMUSCULARLY INTO THE RIGHT THIGH VIA AUTO-INJECTOR. WITHIN ABOUT 1 MINUTE, THE PATIENT WAS ABLE TO RESPOND VERBALLY TO QUESTIONS; AT THAT POINT, A DIPHENHYDRAMINE 25MG TABLET WAS ADMINISTERED ORALLY TO THE PATIENT. EMS ARRIVED WITHIN 10 MINUTES OF BEING CONTACTED, AND THE PATIENT WAS CAPABLE OF WALKING TO THE AMBULANCE AFTER ASSESSMENT.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Mild, Systemic: heart palipatations-Medium, Systemic: Tachycardia-Medium, Additional Details: Experienced no reaction to doses one or two.  Patient visited primary physician upon onset of heart palipatations.  Patient has follow-up appointment with a cardiologist to investigate heart palipations.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Joint Pain-Medium, Additional Details: Long streaking rash from injection site several inches above and below. Baseball sized swekking that occurred 2 days post vaccination.
R thigh with large 1.5 inch area (approx) of induration, swollen and warm to touch. R thigh, just distal to above, smaller area of induration 3-5 mm. Multiple papular lesions on legs, arms, trunk, face.
Anaphylaxis reaction; Broke out in hives; Itching; Cough on and off/still has a cough; Tightness in her neck; Broke out with rash; This spontaneous case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis reaction), URTICARIA (Broke out in hives), PRURITUS (Itching), COUGH (Cough on and off/still has a cough), MUSCLE TIGHTNESS (Tightness in her neck) and RASH (Broke out with rash) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Allergy. Concomitant products included EPINEPHRINE (EPIPEN) for Allergy.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis reaction) (seriousness criteria medically significant and life threatening), URTICARIA (Broke out in hives) (seriousness criterion life threatening), PRURITUS (Itching) (seriousness criterion life threatening), COUGH (Cough on and off/still has a cough) (seriousness criterion life threatening), MUSCLE TIGHTNESS (Tightness in her neck) (seriousness criterion life threatening) and RASH (Broke out with rash) (seriousness criterion life threatening). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 25 milligram. At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis reaction), URTICARIA (Broke out in hives), PRURITUS (Itching), COUGH (Cough on and off/still has a cough), MUSCLE TIGHTNESS (Tightness in her neck) and RASH (Broke out with rash) outcome was unknown.        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.   Concomitant included some unknown medications for blood pressure. Treatment medication was not reported.  Company Comment : 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. However, patient's medical history of allergies treated with EpiPen remains a contributory factor. Though symptoms were reported separately, they could all be subsumed under the anaphylactic reaction experienced by this patient.; Sender'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. However, patient's medical history of allergies treated with EpiPen remains a contributory factor. Though symptoms were reported separately, they could all be subsumed under the anaphylactic reaction experienced by this patient.
I received my 2 Moderna shot on 4/29/21. About 2 weeks later I began to experience mild tingling in my left hand. On 10/21/21 I received my Moderna booster. On 11/6/21 I began to notice tingling in the right hand. One week later, I began to experience numbness in both feet. Saw my neurologist on 11/21/21 and lab work and EMG was ordered.
A nurse reported that a 28 month old male received an injection of Acel-Imune and subsequently, developed an injection site reaction characterized by an area of redness, swelling and warmth "the size of a half-dollar". On 3/18/00, the pt was seen by the physician, who advised treatment with cool compresses. The pt recovered. This is 1 of 2 reports from this facility of injection site reactions following receipt of 2 different lots of Acel-Imune.
Took him 5 years of getting the flu after getting his first and only flu shot; Initial information received on 22-Nov-2020 regarding an unsolicited valid non-serious case from a non-healthcare professional (patient's wife) via social media.  This case involves an adult male patient with an unknown age who experienced 5 years of getting the flu after getting his first and only flu shot (influenza), while he received Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) reporter stated that so glad her mother never did this to her as a child. Nobody in her house gets one. Nobody gets the flu. Husband learned the hard way. Took him 5 years of getting the flu after getting his first and only flu shot (influenza), following the administration of Influenza Vaccine.  Details of laboratory data were not reported.  Action taken was not applicable.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.