chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a pregnancy case. This 26-year-old female subject was enrolled in an open label study. The subject received the 1st dose of BOOSTRIX on 30th December 2014. The subject's past medical history included renal failure. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed incorrect storage of drug (Non-serious). Additional event(s) included vaccine exposure during pregnancy. The outcome of incorrect storage of drug was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy outcome was unknown. Additional information received: Nurse reports that a 26 yo pregnant female and past medical history of kidney failure was administered BOOSTRIX today after it was stored at 28 degrees C. No additional information is known at this time.
Headache, very stiff, felt sick, hands and feet went numb, then lost the ability to walk on my own.
He experienced redness and soreness on his arm following vaccination; redness and soreness on his arm following vaccination; redness and soreness on his arm following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (redness and soreness on his arm following vaccination), ERYTHEMA (redness and soreness on his arm following vaccination) and PAIN IN EXTREMITY (He experienced redness and soreness on his arm following vaccination) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038k20a) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN (redness and soreness on his arm following vaccination) and ERYTHEMA (redness and soreness on his arm following vaccination). On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (He experienced redness and soreness on his arm following vaccination). At the time of the report, PAIN (redness and soreness on his arm following vaccination), ERYTHEMA (redness and soreness on his arm following vaccination) and PAIN IN EXTREMITY (He experienced redness and soreness on his arm following vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: TCR attached NNI case.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On 19-MAY-2014, the patient was vaccinated with an expired dose of ROTATEQ vial 2 ml oral (lot number and expiration date were not reported). No adverse effects reported. Additional information has been requested.
Chills, arthralgia, myalgia, nasal congest, dry cough, lymph-adenopathy, hepatosplenomegaly, neutropenic, dx thrush; Also back pain, malaise fever to 105, thrombocytopenic, morbilliform rash, ele liver funct, dypnea, resp distress synd;
No additional AEs.; Since the patient did not receive the varicella portion of what would have been PROQU AD received, a missed dose AE is being filed; a different color than normal. It was off in color and reported to be slightly tannish.; Product foaming; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.           The reporter received 20 vials of new measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) and on 12-MAY-2021, when a nurse reconstituted a vial she noticed a different color than normal. It was off in color and slightly tannish. The lyophilized powder appeared as it normally did and the sterile diluent (indication: prophylaxis, dose, strength, route were not reported, lot# T008475, expiration date 19-NOV-2022) was the same as usual. The reporter also reported that there was foam in the vial. The patient did not receive measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) 0.5 ml (lot# U002540, expiration date 24-JUL-2022, dose, route and anatomical location were not reported) for prophylaxis on that day (missed dose) as the reporter did not want to use any of the 20 vials. The patient instead received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The reporter did not have a varicella vaccine on site to give the patient as a complete replacement for the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD). No additional adverse events were reported.
We all went for testing and also tested positive; We all went for testing and also tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "We all went for testing and also tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: our tests are positive. Clinical Information: Reporter stated, My husband and I are in our 70's and my son and daughter in-law and 18-month granddaughter live with us. She is a teacher and tested positive for Covid. We all went for testing and also tested positive. We all had received Pfizer inoculations and boosters and although our tests are positive, we are all functioning very well.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200676409 Same product/reporter/AEs, different patient
Chills, fever, sore arm from injection site, and headache. Took Tylenol and Ibuprofen. All have resolved except for headache.
At 4:00 AM she awoke feeling hot and chilled. She did not take her temp. Her rt. arm was sore & bruised where the injection had been placed. She took Motrin and felt better. On 11/08/20012 she went to the ER and was diagnosed with Right arm cellulitis and given Bactrim DS. On 11/12/2012 she was seen in Orientation and arm was much better.
I had a fever for two days. I had a rash on my arm from where the injection was to my elbow 2 inches in width. It was itchy, red, and bothersome. I took Allegra and after 2-3 days it was better. After two weeks from the shot, I had muscle spasms in my arm 10-12 times a day and it was pretty much gone by July.
My menstruation has now been one or two days longer than before vaccination. Also, the heavier part of my period is also pretty debilitating, as I am now more likely to call into work because of the severity of the pain and discomfort.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 63 year old female of unknown race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, hypertension, high cholesterol, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN)frequency 1 total,  dose was not reported, administered on 26-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 24-JUN-2021, the patient reported that she had Antibody test which came out negative (Confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000184012. The suspected product quality complaint has been confirmed to be not voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210654376-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Had both shots, shingles/suspected vaccination failure; shingles; painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case. The age at vaccination was not reported. The patient had both Shingle shots and had shingles at the time of reporting.  The patient stated they were very painful. The patient reported that shots were only 90 percent effective. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
vaccine was administered outside of our facility - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------- I26.99 ACUTE PULMONARY EMBOLISM 1/19/2022 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, WO BEHAVIORAL DISTURBANCE I82.411 ACUTE DVT OF RIGHT FEMORAL VEIN 1/19/2022 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, WO BEHAVIORAL DISTURBANCE R09.02 HYPOXIA 1/19/2022 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, WO BEHAVIORAL DISTURBANCE
1/30 Received vaccine at 12 noon Reports she developed fever of 102.3, chills, body aches that evening on 1/30, took Tylenol every 6 hours, symptoms lasted less than 36 hours, Monday woke up feeling better but drained, called out sick for Monday.
Patient fainted around 5 minutes after receiving Pfizer vaccine. She regained consciousness shortly thereafter and returned to normal after around 15 minutes.
Pt recieved yellow fever vaccination 05 Feb09. After recieving the injection, pt experienced dizziness, confusion, nausea, and blurred vision x 4 days.  Pt is still experiencing symptoms but they are starting to resolve.  4/7/09 MR received for ER visit 2/7/09 with dx: Nausea w/o vomiting, lightheadedness. Pt initially presented 2/6/09 with c/o dizziness, nausea and syncopal episode with fall.  Returned to ER next day with continued lightheadedness, nausea, H/A and intermittent blurry vision. W/u (-) and d/c. Returned for f/u 2/9/09 with visual disturbance improved but still with balance issues. PE WNL. DX: Blurry vision.  Adverse Effects of Vaccines, most likely YF.  Sx resolved by 2/17/09.
Patient had the shot twice in life and got a severe flu; Patient was so sick; Initial information regarding this unsolicited valid non-serious social media case was received from a consumer (patient) and transmitted to Sanofi on 10-Dec-2020.  This case involved a patient who had the shot twice in life and got a severe flu (influenza) and was so sick (illness), after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  The patient's past vaccination(s) included INFLUENZA.  On an unknown date, the patient received a dose 2 of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had the shot twice in life and got a severe flu (influenza) and was so sick (illness), unknown latency following the administration of INFLUENZA VACCINE.  It was reported that the second one while patient was working in a Doctors office. Doctor insisted it was only a myth and it was not a live virus. 2 days later doctor sent him home. Best told so ever.  It should be a personal decision for flu and COVID-19 (coronavirus disease) shots. Neither decision should be judged  Relevant laboratory test was not reported.  Final diagnosis were influenza and illness.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the both reported events.  There would be no information available on batch number for this case.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K021484 and expiry date on 03-NOV-2016; dose and route of administration were not reported). No adverse effects were reported.  Follow-up information was received on 03-AUG-2015 and 05-AUG-2015 from a certified medical assistant, who reported that she would have to research for the request made for the patient identifiers, lot number and expiration date and the dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 15 months-old patient of unknown gender. On 13-JUL-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # was confirmed as K021484 and expiry date was 03-NOV-2016). This is one of several reports received from the same source. Additional information has been requested. Patient's details, product, event and narrative were updated.
I had vaccination on 09/12/2022. On 11/18/2022 I went to the emergency room for severe stomach pain. I had a lot of tests done. The blood panel was abnormal and I was diagnosed with Pancreatitis. I was not given a course of treatment and it resolved itself within 3 days. My vertigo was triggered during the stress of this and started having more episodes. I can barely open my eyes. I have had 6 episodes since then. I have also had an episode of A fibrillation since then. I do have an upcoming appointment with cardiology in 12/2022.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 11-NOV-2013 the patient received a dose of VARIVAX (Merck) (lot number, dose, route and site of administration were not reported) and a dose of PROQUAD (Merck) (lot number, does, route and site of administration were not reported) during the same visit. No symptoms were reported. Additional information has been requested.
Syncopal episode, pt states he "feels out of it", weakness, pale skin, nausea x 5 minutes. Pt recovered in supine position. (HR 54 / B/P 102/58 / SAO2 97% RA).
experiencing a feeling that his arm is asleep since the administration of AVA # 1 on 9 Jul 08. Stated he received AVA # 2 on 28 Jul again in his right arm. Stated numbness radiates down to his hand and at times he has problems with weakness in his arm. Denies any previous or current injuries and other than slight discomfort in his right elbow he denies any other problems. He did report that his right upper arm was swollen and red with a knot after his vaccination but the swelling did not extend below the elbow. Reported that the swelling only lasted a couple of days; Symptoms: Paresthesia, Weakness, Edema at injection site 30-50mm, Erythema.
Slight fever, 99.2, with chills and muscle aches. Event occurred about 2:00 am on 01/26/2021. I took a Tylenol went back to bed. No fever upon waking. Minor muscle aches and mild soreness at injection site.
Dose given at pharmacy 3/13/2018. Prev. ZOSTAVAX 9/14/10. Shingles left flank  - pain 3/19/2018, rash 3/21/2018.
I have been experienced increased blood pressure since the day after the vaccine and never have I had such before the vaccine. On 3/2/2022 at the doctor blood work was done and talked about this event. 04/07/2022 Will be doing more blood test. Was prescribed losartan 50mg to start.
Immediately after injection (seconds after the band aid was placed on shot area), I started to see spots and felt faint, then I progressively felt like it was  getting harder and harder to breath, I felt like my throat was slowly closing in, the EMT gave me oxygen which helped, then I started to feel a numbing sensation start in my hands, work down my spine and then to my feet. My hands continued to get stiffer until they formed claw like shapes and completely stiffened, the EMT had a monitor on my finger to gauge my pulse and they said it was a shooting up and down. My body was sweating profusely. After 20 minutes I felt my hands loosen and my body started to return to normal. The ambulance checked me on site and offered me to go to hospital, but since I was feeling better by that point, so I declined. Once I was feeling better, they tried to take my sugar level, but could not draw any blood when pricking my finger (they assumed this was because all my blood rushed to my vital organs, so blood would be hard to draw/they said this was probably also why my limbs went numb). They told me that I  could possibly be allergic to the vaccine based on the reaction. I was driven home 30-40 minutes later, I felt a bit light headed in the car, but slept for the rest of the day. The following day I just felt very tired, which is probably to be expected after the first shot.
Presented to ER on 1/11/22. who is complaining of worsening shortness of breath and cough with fever in  the beginning going on for almost 2 weeks now.  Lately, she was having some  lower abdominal pain and since her breathing got worse she came to emergency  room where she was found to have a pO2 of only 68.  Currently, however, she is  saturating 93% on 3 L nasal cannula. Found to COVID19. Admitted for Acute on chronic hypoxemic respiratory failure secondary to COVID-19  infection with possible pneumonia.  Admit the patient as an inpatient.   Continue her oxygen.  Start on Decadron as well.  Will give her some vitamin C  and vitamin D. Give ceftriaxone and azithromycin. Discharged on 1/14/22
Patient states developed local swelling around injection site after vaccination. The next day, he had a rash all down his left arm and in his groin area. It was extremely itchy. It continued to spread to his forehead. He came to the pharmacy Monday and explained what happened. It was reported to Glaxo. Patient was also advised to seek medical attention. He went to a walk in clinic this morning  and was told he had an allergic reaction down his arm and that he had shingles in his groin area. He was given steroids and anti viral medications
20 hours after receiving this vaccine, I had a low grade fever, vomiting, diarrhea, nausea, dizziness. These symptoms lasted 48 hours and required me to stay home from work.
While waiting the 15 minutes after vaccination patient attempted to get up to go to the restroom fainted, and fell. Patient get up and seat again looking pale, sweating and skin was cold. While seated she started to heve some involuntary movements in her left arm and leg (possible seizure) for a few seconds.
Sore are and violent digestive cramping, violent vomiting (9 bouts), explosive diarrhea, for 12 hours.  The diarrhea continies through now 4 days later and nausea.   I had zero side effect from J&J so this is horrible shingrix almoat sent me to the ER.    Tbd if go yet
This spontaneous report was received from a registered pharmacist concerning a six patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX, subcutaneously (lot # M035147 with expiration date of 25-OCT-2017; strength, dose and anatomical location were not provided), for prophylaxis, which were administered with sterile diluent (manufacturer unknown). It was also reported that the administered doses experienced a temperature excursion during 3 hours at a temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit on an unspecified date. No previous temperature excursion was reported. A data logger issue was involved. No adverse effects were reported. Additional information has been requested.
second shot was scheduled for 11 Sep 2021 and he did not receive it because he had COVID-19 (Missed the second shot (46 days post first vaccine); Tired; Bilateral Pneumonia; COVID-19 disease; Cough; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Bilateral Pneumonia) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced PNEUMONIA (Bilateral Pneumonia) (seriousness criterion medically significant), COVID-19 (COVID-19 disease), COUGH (Cough) and FATIGUE (Tired). On 11-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (second shot was scheduled for 11 Sep 2021 and he did not receive it because he had COVID-19 (Missed the second shot (46 days post first vaccine)). On 11-Sep-2021, PRODUCT DOSE OMISSION ISSUE (second shot was scheduled for 11 Sep 2021 and he did not receive it because he had COVID-19 (Missed the second shot (46 days post first vaccine)) had resolved. On 24-Sep-2021, PNEUMONIA (Bilateral Pneumonia) and COVID-19 (COVID-19 disease) had resolved. At the time of the report, COUGH (Cough) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.  Company comment This is a  case of Product Dose Omission Issue in a 59-year-old male patient no relevant medical history, who experienced the serious unexpected event of Pneumonia and COVID 19. The event occurred 28 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This is a  case of Product Dose Omission Issue in a 59-year-old male patient no relevant medical history, who experienced the serious unexpected event of Pneumonia and COVID 19. The event occurred 28 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.