chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unexpected death on 12/4/01, while sleeping. No symptoms. Doubt related to Lymerix vaccine but wife wanted it reported. See autopsy report. COD as per autopsy report -- cardiomegaly with left ventricular hypertrophy
after second dose the shortness of breath and difficulty breathing began to get worse; challenging for him to walk around as he normally could; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration (at the age of 65-year-old) on 02Mar2021 (Lot number: unknown) as single dose for COVID-19 immunisation. Medical history included allergic to fish oil. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration (at the age of 65-year-old) on 09Feb2021 as single dose for COVID-19 immunisation and experienced shortness of breath and difficulty breathing. The patient previously took simvastatin (ZOCOR) and experienced allergic. Patient reports that he received both dose of vaccine. First dose on 09Feb2021, second dose 02Mar2021. Patient had an x-ray (negative for any findings per patient) and was prescribed prednisone. Patient reports that the symptoms got better but never went away. Patient states after second dose the shortness of breath and difficulty breathing began to get worse again. Patient also mentions is challenging for him to walk around as he normally could. Patient states he was fine until he took the shot and he needs to know what he was supposed to do. Caller reports that he cannot afford to got to hospital. Patient would like to know how long his symptoms will last, if his lungs are good then what can it be. Patient got the 2 doses of Pfizer covid-19 vaccine, he stated that he was experiencing difficulty of breathing (DOB) and he wants to talk to a pharmacist to know what was the cause why he had that on an unspecified date in Mar2021. The patient underwent lab tests and procedures which included x-ray: negative on Feb2021 negative for any findings per patient. Therapeutic measures were taken as a result of after second dose the shortness of breath and difficulty breathing began to get worse. The outcome of the event dyspnoea was not recovered and other event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a nurse referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 11-NOV-2015 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # L030589, expiration date 10-FEB-2017; dose and route not reported). No adverse effect was reported. Additional information has been requested.
Pt got 2nd shingrix dose approximately around 2:30pm  on 12/4, today around 6pm she was cooking and woke up on the floor. She believes she fainted and she was also vomiting earlier in the day.  I urged the patient to go to the ER
Fever, headaches, body aches, hard to breath for two day.  Took Tylenol.
Initial unsolicited report received from a Nurse on 16 September 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of MENACTRA (batch number U5185BA, Expiration date 11 March 2017, dose, route, dose series and site of administration was not reported) on 17 August 2015. The patient medical history and concomitant medications were not reported. On an unspecified date following the vaccination, the patient experienced numbness all over her body, felt tired and weak, could not pick her backpack and could not concentrate or focus. It was also reported that her parents took her to urgent care. On 21 August 2015, the patient was sent to hospital. Lab data and corrective treatment was not reported. The outcome of events was not reported. List of documents held by sender: none.
Hypomagnesemia and Severe sepsis with acute ATN, Rhabdo, hypoxic respiratory failure. Was started on diuretics. Remained hypoxemic in spite of 40 pound diuresis. Pulmonary consulted.   Developed large volume watery diarrhea subsequently tested positive for C. difficile.  Started on fidaxomicin 200 mg twice daily to complete 10-day course. For her pancreatic cyst, she was seen by GI and she underwent EGD/EUS 12/23, initial findings concerning for chronic pancreatitis. Treated for all hospital problems and discharged home. Hospital admission within 6 weeks of receiving the COVID vaccine.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  Date of refrigeration of vial was 7 May 2021.   This case was linked to MOD-2021-363032, MOD-2021-363245, MOD-2021-363226 (Patient Link).
PATIENT WAS GIVEN THE BOOSTER SHOT TOO SOON. PATIENT REMAINED AT SITE FOR 15 MINUTES WITH NO SYMPTOMS REPORTED BY THE PATIENT.
06Sep90 pt vax;  15Sep90 pt complained of achiness.  17Sep90 devel fever & diffuse red, raised papular eruption of trunk, face, & proximal extremities.  Rash resolved.
After getting the Flucelvax vaccine patient reported worsening pain starting at the site but moving down her entire arm.  She is now having trouble using this arm.
BODY ACHES; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 13:30 vaccinated at left deltoid  for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, headache, and fatigue. This report was non-serious.
Approximately eight hours after injection, sweeping to severe fatigue began to onset along with severe headache and moderate to severe chills, along with other "flu-like" symptoms, including symptoms of fever but no recorded fever.  Lasted through the night and hindered sleep without the help of OTC sleep medication.  After 8 hours of overnight sleep, woke up next day feeling better, but still had a terrible headache and a great deal of fatigue.  Considered visiting a walk-in clinic or the ER at least four times throughout this timeframe.  Symptoms lessened with time with a bad headache and lingering fatigue being the most consistent 24 to 36 hours after the initial injection time.  Now May 3 at 1:00pm, several days after, most symptoms have subsided except for some lingering fatigue which still is present.
Red patches on right leg. From the sole of feet up to butt cheek. The discoloration patches spread and darkened over a few months period. Also mood swings.
I received the Pfizer vaccine on 12/21/20 without adverse events other than soreness in deltoid. On 12/31/20 I began to notice pain, redness and swelling in second toe on R foot from base of toe to base of nail. I initially thought it was gout and self medicated with ibuprofen 400 mg BID x 1 day on 01/01/21 with some improvement. I did not take anything on 01/02/21 and woke up on 01/03/21 with return of swelling, redness and pain. I took another 400 mg of ibuprofen and it felt better but after examining the toe, I questioned whether I had developed pernio (COVID toe).
Normal nauseous, achy joints and muscles and headache, sore arm started two hours after injection. Sore arm at injection site went away three days after injection.  Fatigue and achy joints and muscles as well as occasional headaches has continued for two weeks after first dose and has worsened since 4/29/2020.
Moderna COVID-19 Vaccine  Left arm swelled to double normal volume as compared to right arm - swelling went away after a week Imtermitant radiating pain on left side of body from arm to lower leg - stopped after 24 hours
Low fever, severe fatigue, weakness, muscle pain everywhere -- fatigue and weakness lasted one week; rash developed about 2 weeks after first dose on forehead and after second dose became worse on forehead and spread to cheeks, chest and neck. Still have light rash on areas but it appears to be going away slowly.
one of two pts who exp intractable vomiting w/in 12 hrs p/DTAP immun; tx w/Phenergan; pt recovered; pt is not in day care or on ATB; No illness in household;
Vaccines administered 12-3-14. KINRIX (right arm), MMRV (Lt arm). Parent called 12-4-14 - complaint right arm itch with some swelling. 12-5-14 - seen in urgent care for increased swelling, redness, itching from rt deltoid, redness posterior right shoulder and 1/3 down right humerus, 2 hives on face. 12-8-14 - seen by PCP - itchy red rash, swelling resolved.
lightheaded, anxiety for which pt was history with, BP 100/60, HR 78, placed on cot, given juice crackers
Tingling of hands and feet that would come and go and lasted 5 days. I also had a headache and fatigue. I went to my PCP on the 8th. She sent me to a neurologist to rule out any serious problems such as Guillain-Barre. The symptoms subsided on their own by the 10th.
She was experiencing chills and shaking; She was experiencing chills and shaking; This spontaneous case was received on 10-Dec-2021 from other healhtcare professional via regulatory authority (reference number: SEQW21-05991) and concerned a female patient, of unreported age.  The patient's medical history was not reported. The patient's current condition included diabetes and high blood pressure. The patient's concomitant medications included Metformin (metformin hydrochloride) for unreported indication.   On 10-Dec-2021, the patient was vaccinated with Afluria Quadrivalent (Flu Vaccine Egg Split QIV; dose: 0.5 ml; route of administration: intramuscular (IM); anatomical location: deltoid) for influenza prophylaxis. The batch number was reported P100357921 expiry date 25-Jun-2022.  On the same day, one hour after vaccination the patient called the Healthcare Professional (HCP) saying that she was experiencing chills and shaking. Her blood pressure was ok and her blood sugar level was good. The patient received the same vaccine last year and had no adverse reactions.  The outcome of the events was unknown.  The case was assessed as non-serious.  Company comment: A female patient of unreported age experienced chills and tremor on the same day after vaccination with Afluria Quadrivalent. Based on plausible temporal relationship and information provided, causality for the reported events is assessed as possibly related.; Sender's Comments: A female patient of unreported age experienced chills and tremor on the same day after vaccination with Afluria Quadrivalent. Based on plausible temporal relationship and information provided, causality for the reported events is assessed as possibly related.
Pt developed hives 6 days /p receiving Influenza Virus vaccine. As of January 22, 1990, it was reported that he had recovered
Expired dose given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-364913 (Patient Link).
night of vaccination: Headache, chills, body aches, nausea. Day 1: Headache, body ache, nausea, rash  Day 2: nausea, Headache, threw up at work, rash Day 3: headache rash day 4:  chsst tightness, tingling left arm, rash, tunnel vision, shortness of breath, sweating.
Information has been received from a registered nurse (R.N.), for VARIVAX (Merck), a Pregnancy Registry product, concerning a female patient in her late 30's who in October 2005 "five years ago", was vaccinated with her first dose of VARIVAX (Merck) (lot number unknown) and then was given her a booster dose on approximately November 2005 "approximately one month later". The nurse stated that a recent titer was drawn because the patient was pregnant, and the patient's titer showed she failed to seroconvert. No adverse effects were reported. The patient sought unspecified medical attention. Last menstrual period and estimated delivery date were not reported. Additional information has been requested.
The symptoms I gad were a sinus head cold that dropped into my bronchial tube area. The x-ray I had didn't show anything in my lungs. I had a heavy chest and a lot of coughing.  I took Sudafed and Mucinex. The doctor prescribed albuterol inhaler and Benzoate. The treated the symptoms not what I had exactly.
Mother states upper arm began swelling the evening after 8:45/am injection. Pt complained of pain at sight. Called MD 12/11/04 AM with complaints of redness and swelling of upper arm. Doctor ordered cold compresses and prednisone 15mg/5cc. Sig 1.75 tsp Laicy x 5 days. 12/12/04: mother took child to Er. No Prescription. 12/13/04: decreased swelling and redness.
Tingling to arm down to fingers.  Numbness to forehead and side of face.  Later had a headache
This spontaneous report as received from a certified medical assistant refers to numerous unspecified patients. The medical assistant reported that numerous unspecified patients received doses of PEDVAXHIB (dose, route and lot # not reported) that went through an unsupported temperature excursion. No adverse effects were reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information is not expected.
Patient did not have reaction, he received and adult dose of Hep instead of the pediatric dose.
Pt reports hives appearing 13 days after shot.  The hives did not improve, which necessitated a trip to the ER, PCP, and allergist.
Nose bleed on left side, busted blood vessel in left eye the next day. Eye has still not cleared up fully but it is looking better.
Coughing a few days after, legs started swelling on 12/14 then went to urgent care and was referred to Dr in urgent care. Dr believed she was in congestive heart failure. Then squad came and transferred her to ER. Seen air in chest and was sent to another ER and was home in 24 hours. Performed echo and barium swallow. Next day went back to ER b/c could not breathe again.
8/ headache, fever up to 103.1 resolved 8/30/06 treated with Ibuprofen
Pt recvd 3rd dose of vax & exp severe stomach cramps, severe shaking, chilling, joint pains & feeling of exhaustion.  Stomach cramps persisted for several days but were milder p/1st wk sx;
7 hrs p/vax pt recv vax pt had sudden nausea & abd cramps-no vomiting, no diarrhea, no rash, no SOB, no tightness in throat; p/24 hrs pt very tired; p/36 hrs nl;
Unexplained numbness/parasthesias along with pain of the lower left extremity x 3 weeks. Fatigue. Denies any rash.  Also reported swollen and painful area on anterior/lateral aspect of the left ankle without reported injury to the extremity. Symptoms onset was sudden and gradually improved after three weeks.
Severe pain in her left wrist and it's difficult to open it; This is a spontaneous report from a contactable consumer (patient's child).  An 84 years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown), via an unspecified route of administration on 30Apr2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On 01May2021, the patient experienced severe pain in her left wrist, and it was difficult to open it. The reporter stated that his 84-year-old mother (consumer) received the Pfizer vaccine on Friday approximately at 11:30 am. She just called him today, she reported starting an about 24 hours afterwards she was developing severe pain in her left wrist, and it was difficult to open it. The reporter asked whether it was a normal vaccine side effect or not. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Woke up in the morning and had difficulty standing. Went to facility around 10:00 AM. Was referred to another facility. Arrived there at 3:00 PM and was unable to walk at all. Used a wheelchair to get into facility  Was admitted with a diagnosis of Guillain Barre Syndrome. Remained at facility for 6 days and received IV/IG treatment for 6 days. Was then transferred to hospital and remain there today 11/20/2015. Receiving IV/IG treatment twice weekly and getting physical therapy. Still cannot stand or walk.
Five hours after injections (8:30 PM), started feeling fatigue and muscle and joint soreness.  Two hours later (10:30 PM) while in bed, experienced sever chills and fever of 101 F.   Took Nyquil at 3:00 AM, measured temperature at 6:00 AM, was 98 F.  Fatigue and minor chills continued for the remainder of the morning.  No breathing or GI issues noted during event.
Starting at 8:00pm on 11/27- Hypotension BP 80/30, tachycardia heart rate 150?s, dizziness, nausea, uncontrollable shaking, chills and sweating at the same time, unable to think clearly. An ambulance was called and triaged in the home. Hydrated and monitored vital signs until improved about 1 hour later. EMS advised if taken to the hospital, there would not be anything else that could be done. Upon awakening the next day, my arm , at injection site was red with a large area of induration, edema, itchy. They area of induration grew larger over the next 24 hours and itching worsened. Saw PCP and it was suggested that due to my autoimmune disorder that I had had an immune response to the vaccine after antibodies had started to build up in my body.  I was given a prescription for and epi pen, prednisone and told to use topical Benadryl on the injection site to calm down inflammation.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021 at 3:26 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 3:26 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 65.37 for dose administered on 21-Mar-2021   No concomitant medications were reported.  Batch number 003B21A underwent temperature excursion on 21-Mar-2021 with temperature 34 degrees Fahrenheit at 09:00 AM, 32 degrees Fahrenheit at 10:00 AM and 34 degrees Fahrenheit at 11:00 AM. This vial was moved to fridge on 16-Mar-2021 and beyond use date for the vial was reported as 15-Apr-2021. Product moved to clinic on 21-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
4/34 aSOTRs experienced breakthrough infection between 3-6 months post D3; 4/34 aSOTRs experienced breakthrough infection between 3-6 months post D3; This is a literature report.  An adolescent patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Adolescent Solid Organ Transplant Recipients" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "4/34 aSOTRs experienced breakthrough infection between 3-6 months post D3". The patient underwent the following laboratory tests and procedures: Antibody test: Positive; Positive, notes: 6 months following D3, indicating antibody durability among aSOTRs; SARS-CoV-2 antibody test: Unknown results.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded. ,Linked Report(s) : US-PFIZER INC-PV202300180965 Same article/ drug/event and different patient;US-PFIZER INC-PV202300180965 Same article/ drug/event and different patient;