chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 2:25 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:49 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced 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). 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 58.64 for dose administered on 13-Feb-2021 and 58.74 for dose administered on 20-Mar-2021. No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021. Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 37 degree Fahrenheit at 10:00 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-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 Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
Patient received the vaccine at her home. She was straight cathed by a home health nurse and there was a blood clot and a large amount of blood noted to her urine. She was monitored over the weekend, but her urine remained clear. She has been in her usual state of health and has had no other symptoms since then
It started with a scratchy throat on Monday. On Tuesday morning, I did a COVID-19 test and tested negative. The symptoms got much worse. I was stuffy and had nasal congestion. That afternoon, I went in for a COVID-19 PCR test and tested positive. On Wednesday morning, I had a virtual visit with my doctor. Wednesday afternoon, I went for my first remdesivir treatment and started to feel a little better. I had my second treatment yesterday. Today, I have some symptoms but it's significantly better. I go for my third treatment this afternoon.
PT WAS GIVEN THE TYPHIM VACCINE ON 4-10-08.  ON THE AFTERNOON OF 4-11-08 PT STARTED TO HAVE SWOLLEN GLANDS IN THE BACK OF HER HEAD AND NECK.  THIS CONTINUED ON AND SHE STILL HAS THEM TODAY.  ON THE MORNING OF THE 14TH THE PATIENT WOKE UP AND BROKE OUT IN HIVES.  THESE RESOLVED WITHIN 2 DAYS.  ON THE AFTERNOON OF THE 16TH PT STARTED TO HAVE JOINT PAIN AND SWELLING IN HER WRISTS, ELBOWS, HANDS, AND ANKLES.
tested COVID positive a few weeks after receiving his first vaccine; tested COVID positive a few weeks after receiving his first vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 48-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an intramuscular route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for Covid-19 immunisation. Other vaccine in four weeks was unknown. The patient medical history and concomitant medications were not reported. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. On an unspecified date, the patient had tested covid positive a few weeks after receiving his first vaccine (adverse event was tested COVID positive a few weeks after receiving his first vaccine). Once all virus symptoms were gone, he was advised by the clinic in, to go ahead and get his second shot (approx 1 week after virus symptoms cleared). The patient was diagnosed with COVID-19, prior vaccination. The patient has been tested for COVID-19, since the vaccination was unknown. The vaccine second dose was given on 20May and within several days, On 23May2021, the patient had extremely lethargic and experienced chest pains. During a visit to local urgent care he was told he had a heart attack. Following an echocardiogram, he ended up having a triple bypass to clear the blockage found. He does have some family history of heart disease but was unaware of any issues with his own health and had not experienced any symptoms prior to this incident). The event resulted in doctor or other healthcare professional, office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on an unspecified date. The outcome of events was recovered on an unspecified date.   Information on Lot/Batch number has been requested.
SOB, vomiting/dry heaving for 1-2 hours. - 12 hours from shot Redness & edema - 9cm x 14cm. @ site of injection painful injection site.
This is a spontaneous report received from a contactable pharmacist. A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0187, expiration date: Sep 13, 2021), on Sep 16, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient administered expired product (expired beyond recommended storage and handling), onset Sep 16, 2021, with outcome of unknown. No follow-up attempts possible. No further information expected.
Started feeling a bit tired after receiving the varicella shot on Monday, September 12th. Took an hour nap and after waking up sweaty, tired, feverish and too weak to get out of bed, I decided to sleep more. Slept until 12:30pm the next day (Tuesday). Took Tylenol to bring down my fever. Had some broth and toast and slept some more. Had taken 2 days off of work.
I received the Moderna bivalent at 1100. On the same day at 2030, I had the chills and severe pain in the suprapublic area. It felt like I needed to urinate even though I just had 1 hour previously. I urinated and temporarily had relief, but then the pain returned. This repeated itself for several hours. This morning, 24 hours after the injection, the pain in the suprapubic area is gone as is the urge to urinate.
Patient came into the pharmacy on 1/24/18 and said her arm was extremely sore on Monday evening after the administration of the vaccine. She said she couldn't sleep at all on Monday night because she was in so much pain. Today she said she cannot move her arm forward or up and cannot do daily activities like showering or changing. She is going to the doctor's office tomorrow.
Received  vaccine at 6:30 pm.  By 10:30 pm, I was having very bad  chills, body shakes, and chattering teeth.  I took a warm shower to warm up, and started  coughing a lot, then vomiting  for the rest of the e evening.   I also had a terrible  headache.
BENIGN SPOT ON BACK; KNOT ON ARM AFTER VACCINE INJECTION SITE; 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 concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (Janssen series-1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis.  No concomitant medications were reported. It was unknown if patient was enrolled in a Covid-19 vaccine trial. On an unspecified date, the patient had benign spot on back and also knot on the arm that was injection site after taking the vaccination. On an unspecified date, the patient had spot on back which was removed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from benign spot on back, and knot on arm after vaccine injection site. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211215901-COVID-19 VACCINE AD26.COV2.S-Benign spot on back . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
rash on neck; shoulder pain; felt bad for couple of hours; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad for couple of hours), RASH (rash on neck) and ARTHRALGIA (shoulder pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included EVOLOCUMAB (REPATHA), CEPHALEXIN [CEFALEXIN], ASPIRIN [ACETYLSALICYLIC ACID] and RANOLAZINE (RANOLAZINE EXTENDED RELEASE) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING ABNORMAL (felt bad for couple of hours) and ARTHRALGIA (shoulder pain). On 04-Mar-2021, the patient experienced RASH (rash on neck). At the time of the report, FEELING ABNORMAL (felt bad for couple of hours), RASH (rash on neck) and ARTHRALGIA (shoulder pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported. .No lab data was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Event outcome updated
School nurse reports child has chicken pox. 3 children in kindergarten out with chicken pox that have immune records showing varicella immunization. Report sent per request.
Initial information received on 01-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 63 years old male patient who received 0.5 mL dose vaccine FLUZONE HIGH DOSE lot UJ004AP, exp date: 30-Mar-2019 via unknown route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was reported that FLUZONE HD was given to a 63-year-old male and the wrong box was pulled inadvertently. It was unknown if any adverse event was occurred. 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. Follow up information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. No new information received. Documents held by sender: none.
Arm hard like a tennis ball; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Arm hard like a tennis ball) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INDURATION (Arm hard like a tennis ball). At the time of the report, INDURATION (Arm hard like a tennis ball) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
weird taste in my mouth like metal; This is a spontaneous report from a contactable other hcp (patient herself). A 45-year-old-female patient (non-pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EM9810, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 03Feb2021 15:45 (at the age of 45-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included food allergy (Soup), allergy to arthropod sting (wasps), drug hypersensitivity (medication). Concomitant medications were not reported. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Feb2021 06:00 PM the patient experienced, having a weird taste in my mouth like metal. The outcome of the event was reported as unknown.   Follow-up attempts are completed. No further information is expected.
First dose of GARDASIL was received on 12/22/09. No known side effects. Second dose received on 02/26/10. On 03/17/10, my daughter stated she was very tired after eating dinner. She went to the couch to take a nap. Approximately 20 minutes later, she was found on the floor with severe trauma to her face. Urine was on the couch, but more was on the floor where she was found. Although nobody witnessed the event, we all believe she had a seizure. There is no family history of seizures. She has suffered severe injuries to her left eye, large knot over her left eye, and bruising over her entire face, under her chin and behind her ears. She was immediately taken to the ER by ambulance. While in the ER, she complained of her legs spasming. Numerous tests were done, all of which-blood work, EKG, CT scan-came back fine. Today, 3 days after this event, my daughter is still very tired. My daughter is a perfectly healthy, active child who has never had any medical problems until now. After reading numerous reports from other parents who had their child receive GARDASIL, I am convinced this must be the culprit. Nothing else has changed in her life besides receiving this shot.
No evident adverse events at this time. Patient received Moderna COVID19 vaccination on 07/08/2021, and the Pfizer COVID19 vaccine was mistakenly administered as her second dose.
patient felt lightheaded then fainted for a few seconds. ice packs used and drank water, came back to consciousness.
had been well;found unresponsive w/o spontaneous resp in crib,approx an hr p/ being fed; dx SIDS; no autopsy performed;
This spontaneous report as received from a registered nurse refers to 8 unspecified patients of unknown age. The 8 unspecified patients received doses of GARDASIL (lot number, dose, route and indication were not reported) on unspecified dates, that were exposed to temperatures outside of the proper storage range. No adverse effect reported. The outcome and action taken were not provided. It was not specified if the patients sought any medical attention. Additional information has been requested.
This 77 year old female received the Covid shot on  4/1/21    and went to the ED on 4/11/21 and admitted on  4/12/21 and again to the ED on 4/24/21 with the below listed diagnoses and died on 5/9/21. J18.9 - Pneumonia, unspecified organism
The patient developed left sided neck and trapezoid tightness and pain after receiving the moderna covid vaccine in her left shoulder. The injection site is non tender and does not show any erythema or tenderness. The tenderness is over the left trapezius and left lateral neck area. It also feel tight like a muscle spasm.
He tested positive for Covid on 30Mar2021; bad cough; severe fatigue; lost his sense of taste; loss of appetite; everything tasted like metal; Lost 15 pounds in 2 weeks; feeling sick; inflammation; This is a spontaneous report from contactable consumer (patient's mother) via Pfizer sponsored program.  A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE (age at vaccination 41 years), Solution for injection) via unknown route of administration, in the left arm on 23Mar2021 at single dose for COVID-19 immunization. Medical history included asthma, the reported stated that it was quite scary. Concomitant medications were not reported. On 24Mar2021, the patient had bad cough couldn't stop coughing for 2 weeks, it was awful and the patient was a nonsmoker and he sounded like someone who had been smoking for 70 years. It was a deep horrible cough. He was afraid to get the second shot, and she doesn't want him to be afraid if the symptoms weren't from a reaction and the patient went to the emergency room and they sent him back. She almost lost the patient as an infant with aspiration pneumonia and had severe fatigue which had gone better just in the last day or 2. The reporter had minor symptoms, but her son's symptoms progressed to the point where they told him he had to get a COVID test. The patient was not feeling right beyond 48 hours and was still thinking it was a reaction from the shot. On 30Mar2021, the patient tested positive for COVID. On an unknown date in 2021, the patient started loss of appetite almost right away a couple days after he got the vaccine. He must have had COVID at the same time. Patient was gaining his appetite back. Patient had lost his sense of taste too. Patient had also lost her sense of taste and her sense of smell. He just said that everything tasted like metal. Nothing tastes normal it was the same for her as well. His appetite was coming back, and his cough was subsiding. The patient had inflammation, which was treated with steroids and inhaler and the patient was little overweight and lost 15 pounds in 2 weeks, feeling sick. The reporter asked 4 different doctors and got 4 different answers. Her son was exposed to COVID through his children from school. They had closed the classroom because the teacher had COVID. No one else in the house was positive. On 08Apr2021, (Yesterday), the patient felt a little better which was a blessing. She thinks he was getting better due to the medicine from the pulmonologist. He got a pulmonologist to have a virtual visit and they gave him steroids and an inhaler which has helped and just starting to get a little better. The patient was due for his second dose of the vaccine on 13Apr2021, but she doesn't know if it was okay for him to get it now. The patient had chest X-ray was negative and the patient did not have pneumonia. The outcome of the event cough, fatigue, ageusia, decreased appetite, dysgeusia, was recovering and the other events COVID-19, weight decreased, malaise was unknown.    No follow-up attempts are possible. Information about batch/lot number could not be requested
Itchy and irritated at the injection site; Rash that is pinkish and not red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchy and irritated at the injection site) and RASH (Rash that is pinkish and not red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (Itchy and irritated at the injection site) and RASH (Rash that is pinkish and not red). At the time of the report, INJECTION SITE PRURITUS (Itchy and irritated at the injection site) and RASH (Rash that is pinkish and not red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
14NOV93 evening, pt devel fever of 102 accompanied by sz lasting about 40 mins, finally abating p/receiving rectal & IV Valium in the ER; t103.5 in ER:
pt recv vax 28SEP95 & later the same day pt reported that was exp very sore ax & breast, & that had devel swelling on arm @ the inj site;also had a fever of over 101;tx w/APAP & recovered 30SEP95;
Pt recv vax on 10/19/98; on 10/20/98 pt exp Rt arm swollen & red, fever x 1-2 day; tx=Tylenol
The administration of Merck Pneumovax Vaccine (for adults) to a 29 week infant instead of the intended Wyeth Lederle Pediatric Vaccine- Prevnar.  The caller indicated a Pharmacy Technician selected the vaccine and sent it to the hospital floor and where an RN administered the product to the child. The technician was inexperienced and thought the two "pneumococcal" vaccine products were the same. This field is being used for a Product Confusion Event. Probable cause of problems: Human Error.  Corrective Actions Taken: Pneumovax has pink/purple colored vial caps and stripe on the vial labels and cartons. Prevnar  has blue colored vial caps and blue accent color on carton. The Wyeth Prevnar Vaccine carton, vial and package insert have the verbiage "FOR PEDIATRIC USE ONLY" This wording  was implemented more than a year ago to prevent the Prevnar pediatric vaccine from being confused with pneumococcal vaccines intended for adults. The hospital representative reported she opened an investigation aimed at preventing future events. This has been reported to Merck. No futhere action is anticipated at this time.