chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via company representative refers to a patient of unknown gender. The age of the patient was reported as in the 80's. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX dose, route, indication and lot # not reported. On an unknown date the patient got shingles. The outcome of adverse event was unknown. The relatedness between adverse event and therapy with ZOSTAVAX was unknown. This case is linked to same reporter's report # 1306USA006218. Additional information has been requested.
Patient presents with a potential reaction to the COVID19 vaccine. The patient presented with dizziness, diaphoresis, nausea. She was placed in supine positions with legs elevated. She was given oral hydration and monitoring was increased.    Returned to baseline and left to home with self-driving.
flu like symptoms; upset stomach; had pressure in her heart; was feeling uncomfortable; fever; body pains; headache; redness injection down to the elbow; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (upset stomach), CARDIAC DISCOMFORT (had pressure in her heart), DISCOMFORT (was feeling uncomfortable) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hyperacidity (Acidy stomach). Concurrent medical conditions included Heart disorder, Latex allergy, Fruit allergy (Apples), Shellfish allergy, Broken heart syndrome, Diabetes, Hypertension, Rheumatoid arthritis, Osteoporosis, Fibromyalgia, Asthma and Diverticulitis. Concomitant products included IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT), ALBUTEROL SULFATE, METFORMIN, EMPAGLIFLOZIN (JARDIANCE), METHOTREXATE, MONTELUKAST, EZETIMIBE, ATORVASTATIN, VITAMIN D2, METOPROLOL, FAMOTIDINE, ASPIRIN [ACETYLSALICYLIC ACID], FOLIC ACID, GABAPENTIN, TRAMADOL, METHYLPREDNISOLONE, AMITRIPTYLINE, LOSARTAN and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (upset stomach), CARDIAC DISCOMFORT (had pressure in her heart), DISCOMFORT (was feeling uncomfortable), PYREXIA (fever), MYALGIA (body pains), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness injection down to the elbow). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL DISCOMFORT (upset stomach), CARDIAC DISCOMFORT (had pressure in her heart), DISCOMFORT (was feeling uncomfortable), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness injection down to the elbow) had resolved and PYREXIA (fever) and MYALGIA (body pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were reported.
Throat swollen and sore; Throat swollen and sore; Feels scratchy and hurts to swallow.; Feels scratchy and hurts to swallow.; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 06Apr2021 at 11:30 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included lupus, fibromyalgia, occasional high blood pressure. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), buspirone hydrochloride (BUSPAR), clonidine (MANUFACTURER UNKNOWN) and quetiapine fumarate (SEROQUEL) and biotin (MANUFACTURER UNKNOWN) from unknown dates for an unknown indication. The patient previously took risperidone (MANUFACTURER UNKNOWN) and experience drug allergy. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 03:00, the patient experienced throat swollen and sore, which occurred approximately 36 hours after the vaccine and also experienced feels scratchy and hurts to swallow. Therapeutic measures were not taken as a result of the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events throat swollen, throat sore, feels scratchy and hurts to swallow was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Received 2nd vaccination on Wednesday, May 19 2021 and symptoms started May 21, 2021 when being discharged from Nursing Home. Could barely get in vehicle and once home, needed to be pushed in wheelchair due to extreme weakness. Could not stand or walk for the next three days. Have since slowly regained some strength, but feels at least 70% of strength was lost and had to start over with physical therapy. Very upset and discouraged.
Today the injection site is swollen, hard and hot. Had Moderna shot on the 28th of February. It had been mildly sore. I started putting Neosporin on the injection site for pain relief. Just checking to see if there is anything else that I should be doing.
PATIENT'S PARTNER HAS TOLD ME PRIOR TO VACCINATION SHE WAS ANXIOUS/SCARRED TO GET THE VACCINATION.   THAT SHE "MAY" PASSOUT.  I SPOKE WITH THE PATIENT AND SHE EXPRESSED BEING NERVOUS, BUT SHE WANTED THE SHOT.  DURING THE SHOT I SPOKE WITH HER AND EVERYTHING WAS GOING OK.  AFTERWARD SHE SAID SHE WAS FINE AND I LET HER SIT IN THE VACCINATION CHAIR FOR ABOUT 5 MINS.  SHE THEN WALKED TO THE FRONT OF THE STORE WITH HER PARTNER TO SIT DOWN.  SHE HAD A COLD LEMONAID BOTTLE.  AFTER ABOUT 10 MINS I HEARD A FALL.  PATIENT HAD FALLEN OUT OF THE CHAIR AND HIT HER LEFT CHEEK ON THE WINDOW SILL.  THERE WAS  A LITTLE BRUISING.  I OFERED TO CALL EMS, BE SHE DECLINED.  I GOT A BAG OF ICE AND RAG FOR HER TO APPLY TO CHECK AND TO HELP COOL HERSELF.  I ALSO BROUGHT A FAN FOR HER USE.  AFTER ABOUT ANOTHER 15-20 MINUTES HER PARTNER ANNOUCED THAT SHE WAS OK AND THEY WERE LEAVING
Admitted on 9/21 with  syncope spell and sense of weakness with 2 day history of nausea and diarrhea. Revealed COVID-19 pneumonia requiring 8L O2 with severe stenosis with regurgitation (not candidate for TAVR). Underwent dialysis with several episodes of hypotension. Initiated CRRT but continued to decline. Patient and family agreed to palliative care but continued to deteriorate and passing on 9/30.
Broke out in hives and large patchy spots over her body with sever itching.  She was take to the hospital where they gave her a eppy pin injection and benedryl.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: Sulfur" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: anti viral details: product: COVID 19 Treatment brand: Paxlovid Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of suspected covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a RN concerning a female with allergy to some preservatives who in approx 2005 (recently) was vaccinated with hep A virus vaccine inactivated. The nurse reported that the pt was having an allergic reaction to something. The nurse was not sure if the hep A virus vaccine inactivated was the cause. She said the pt was going to undergo allergy testing. The outcome was reported as not recovered. Additional information is not expected.
Patient called this morning complaining that injection site had become swollen, red, and very itchy. The adverse reaction started after injection and lasted several days. Patient reports that the reaction is improving and going away.
Swollen, red and warm to the touch. Warm compresses. Triamcinolone acetonide 0/1% cream apply 2-3x's 8d.
Approximately 11 days after the vaccination, I began to break out with a skin problem, which became quite pronounced.  After visiting a dermatology office, I learned that I had psoriais.  I had previously phoned  the County  COVID hot line number to ask if the vaccination could cause a skin problem as it takes hold several days after the injection.  They were unaware of any history of this type.  Likewise the dermatologist was unaware of any such history, but said that it was a possibility.  In fact, it could simply be a coincidence in timing.  However, I wanted to bring it to someone's attention.  (Note: I currently intend to proceed with the 2nd shot in a couple weeks unless advised otherwise.)  I do so simply because I read on the web this morning that high activation of the immune system can cause psoriasis.
crying, high pitched 3-3 1/2 hrs duration began 30 mins p/; fever 102-30 mins p/inject, down w/APAP, poor sleep (only a few mins @ a time)- 1 noc p/shot;
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ADULT OBSTRUCTIVE SLEEP APNEA ACUTE NON ST ELEVATION MI CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Initial information received on 27-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 years old female patient who received a 0.5 mL dose of suspect vaccine FLUBLOK QIV lot QFAA1818, expiry date- 30-Jun-2019 via unknown route in the left deltoid on 20-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications. It was a case of actual medication error due to Inappropriate age at vaccine administration. No side effects or reaction reported. 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.
Unknown called at 1104am for anaphylaxis, patient came for flu vaccine and Pfizer covid vaccine 3rd dose, patient c/o throat closing, coughing, and agitation.  V/S BP-176/95, HR- 90, O2 sat -99% RA,RR-30, patient sitting up on a gurney, patient given Epinephrine 0.3mg IM injection on left lateral thigh, for anaphylaxis, observed patient closely,  V/S at 1107am: BP-135/82, HR-77, O2sat-99%RA, RR-25, continued to monitor patient closely, patient tolerated IM injection well, 1110am  V/S: BP-124/72, HR-86, O2sat-98%RA, 1112am: paramedics came, IV insertion done by paramedics, 1121am, Benadryl 50mg IV given by paramedics, patient talking, patient denies medication and food allergies, translation completed by RN, patient able to open her eyes and talking in full sentences, no signs and symptoms of ARDS, 1125 paramedics picked up pt on the way to Hospital ED.   IN ED: No sob, no fevers, no cp, no itchiness, no swelling, no abd pain or n/v.  Per ED MD note, pt likely had an episode of bronchospasm.  Pt stable and released from ED.
COVID BREAKTHROUGH CASE. On May 3rd I developed sore throat and fever and I was told that I had been exposes to COVID a few days prior. I did a rapid it was negative. Symptoms persisted fever and cough took another test on the 5th it was positive called my dr. she prescribed Paxlovid. Took for 5 days as prescribed symptoms subsided. Tested negative Sunday May 8th. I completed the medication on 9. On the 13 of May I had a fever sore throat took a rapid and it was positive. Called my dr. and she felt I rebounded from the medication.
No Adverse event; Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine).    No concomitant medication was reported.    They reported that 15 patients received 0.5ml of the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657506, US-MODERNATX, INC.-MOD-2022-657547, US-MODERNATX, INC.-MOD-2022-657560 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657506:Master case (Crosslink case with same reporter) US-MODERNATX, INC.-MOD-2022-657560:Same reporter US-MODERNATX, INC.-MOD-2022-657547:
Pfizer bivalent booster given 12/01/2022 instead of second Pfizer (5-11) dose due to age change between first and second dose. Client is due on or after 01/26/2023 to complete primary series.
ITCHING & SOME SWELLING OF BOTH HANDS & ARMS, NOW TAKING BENADRYL TO RELEIVE THE ITCHING.
TEMPERATURE EXCURSION BETWEEN 49.82  TO 51.26 DEGREES FOR 48 HOURS; ADMINISTRATION OF VACCINE STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1822809 expiry: 07-MAR-2022) dose was not reported, administered on 16-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-NOV-2021, the patient experienced temperature excursion between 49.82 to 51.26 degrees for 48 hours. On 16-NOV-2021, the patient experienced administration of vaccine stored outside of the recommended storage condition. On 16-NOV-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion between 49.82 to 51.26 degrees for 48 hours, administration of vaccine stored outside of the recommended storage condition and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20211139517.
Patient had a golf size red spot to left arm. Not warm or swollen just redness to the area where shot was delivered. Patient works in hospital and advise if site gets work to seek medical attention. Patient verbalized understanding
States about 3 hours after administration she felt nauseous, dizzy, cold, clammy, blurry vision, ringing ears, near syncope, visited ED.
Patient urinated and passed a small blood clot. Happened once ten days after vaccination and then resolved. Patient had another episode 4/9/2021, passed small blood clot with urination, and again, resolved
Neurology consult on 2/20/02 states the pt apparently awoke with a scream this morning while her grandparents were caring for her. She drew up with all 4 extremities, then became limp and unresponsive. They immediately brought her to ER. She remained unresponsive during that trip, though over a 30 minute period, began to arouse. She was initially drowsy, then returned to baseline. She then proceeded to have 2 more spells of similar nature while in ER and a 4th while on the pediatric ward, each of a similar nature though according to the family, they seemed to get less prolonged each time. The last spell, she was also noted to have some diffuse tremulousness associated with the drawing up of all 4 extremities. That episode apparently lasted less than a minute and she recovered over a 20 minute period. There are no local symptoms of her extremities though the nurse had noted some deviation of her eyes to the right with the 4th spell. Mother noted some cyanosis during the tonic phase on the previous episode. She has no previous history of seizures. She did have croup approx. 4 weeks ago though had fully recovered by 2 weeks ago. She did receive DTAP, Hib and Prevnar yesterday evening and appeared to tolerate those IZs, ate well last evening and slept well through the night. She has had no apparent fever though did have a low-grade 99.7F temperature since on the ward. There has been no history of trauma. The clinical dx is recurrent seizures treated with Phenobarbital and Tegretol.
Headache, NauseaVomiting, lightheadedness, chills 30 min post injection  Narrative:
HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included lyme's disease, and concurrent conditions included fibromyalgia, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headache on 13-APR-2021. This report was non-serious.
Day after vaccination patient developed stroke.  No treatment given and symptoms resolved.  Unclear if related in some way to vaccine since occurred day after administration of Shingrix.
First even I had I did not  think twice about I went to Emergency room because I woke up with Vertigo so I rode in an ambulance there On May 17. I was ok for a while and then on June 14th I had symptoms of stroke on June 14th I had numbness on left side of my body and cloudy vision, I rode in the ambulance went to another er and I was admitted for an overnight stay. They said it was a TIA. On June 18th I had exactly the same symptoms except for vision, I called 911 and they insisted that I go to the ER again, I rode in the ambulance to er and they said I had a probable TIA. On August 26th at 9 am and I was driving in car I noticed I had patchy vision and that went on all day, next I still had it and  a friend drove me to the ER. They admitted me. On that MRI it showed changes that I had occurred and the area of brain was consistent with vision problems and that one they diagnosed it as a small stroke. Now I am on blood thinners and when I finish I will start a aspirin regimen.
Dx of COVID, SOB that was worsening over 1 week. x-ray showed cardiomegaly with congestion. Treatment:  remdesivir and Lovenox, antibiotics.
extreme burning mouth; tongue syndrome; This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 at 15:00 as dose 1, single (batch/lot number: EN6202) at the age of 75 years, in left arm for covid-19 immunization. The vaccine was administered in a public health clinic/veterans administration facility. The patient's relevant medical history was not reported. Concomitant medications included: LOVASTATIN. The following information was reported: ORAL DISCOMFORT (disability), outcome "not recovered", described as "extreme burning mouth"; TONGUE DISORDER (disability), outcome "not recovered", described as "tongue syndrome". The patient informed that the events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. The patient underwent the following laboratory tests and procedures: I Health Covid-19 antigen rapid test: (12Apr2023) negative, notes: nasal swab. Therapeutic measures were taken as a result of oral discomfort, tongue disorder which included gabapentin 300 mg, 3 times a day.; Sender's Comments: Based on the available information and the known product safety profile, a causal relationship between the reported events oral discomfort, tongue disorder and BNT162B2 is considered possible. 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.
This spontaneous report as received from a physician via an unspecified reporter through a company representative, refers to patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 06-MAY-2015, the patient was vaccinated with VAQTA "25U/.5ML 10x1(ped), lot # J000985 with expiration date 20-AUG-2015 (route of administration unknown), which was stored at 9 Celsius Degrees for 72 hours, at 1 Celsius Degrees for 48 hours and at -1 Celsius Degrees for 8 hours. The storage criteria and the type of excursion was refrigerator (R) and the vaccine status was reported as "in excursion". There were no concomitant therapies and adverse effects reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Patient was given Flublok instead of Flucelvax. Per patients mother only a local reaction was noticed. However, mother states this happens with all vaccines that she receives. No other symptoms or signs noted. Patient is well and not experiencing any trouble.