chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 16-year-old female patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Dec-2010. The patient received the expired FLUMIST on 20-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Fever, nausea, headache, muscle aches (all over), a very sore and red upper arm at the injection site.
DAY 8..1/31/2021 awoke with red, swollen, itchy, hot arm at injection site....
Within 3 hours of the Modern vaccine I was in EXCRUCIATING pain!!! The pain was localized on the left side of my upper body (same side as the shot) and it went to my chest, back, neck and all the way down my arm. It was absolutely unbearable and I was literally on the floor writhing in pain and in tears. I have had two spinal fishing abs this was the WORST pain I have endured in years! I have an extremely high pain tolerance and this was enough to level a horse. It was if my body was attacking itself or my lymph nodes swelled to the point of excruciating pain. Not just a little sore....this was painful!  By the morning, all of that pain had subsided and I was only left with a super sore shoulder at the injection site. Nothing helped....not my heating pad, or ibuprofen or even oxycodone and any normal person would have called an ambulance or gone to the ER. HORRIFIC PAIN!!!!
21Sep - tested positive on antigen test; 21Sep - tested positive on antigen test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient did not have any known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Sep2022, outcome "unknown" and all described as "21Sep - tested positive on antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Sep2022) Positive, notes: Tested positive on antigen test; (27Sep2022) Positive, notes: Faint positive antigen test; (28Sep2022) Negative, notes: Clear negative antigen test; (30Sep2022) Positive, notes: Strong positive antigen test; (22Sep2022) Positive, notes: Tested Positive on PCR test. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 22Sep2022 to 27Sep2022. On 21Sep2022, the patient tested positive on antigen test. On 22Sep2022, the patient tested positive on PCR test. The patient was prescribed Paxlovid and began Paxlovid course. On 26Sep2022, the symptoms had nearly gone with just slight cough remaining. On 27Sep2022, the patient took last Paxlovid dose. On 27Sep2022, the patient had faint positive antigen test, the symptoms were gone. On 28Sep2022, the patient had clear negative antigen test, symptoms were gone. On 29Sep2022, no test was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Received first dose of Anthrax in left arm 1/11/03. He had a little bit of localized pain, that resolved. Had a second injection in the right arm 1/25/03 and within 24 hours has had increased swelling and redness.
Given on 21st September 2019 at approximately 15:30. The arm with the flu shot is experiencing muscle and nerve pain radiating throughout the arm. It is difficult to lift the arm above my head and make a tight fist.   I have observed a darkish blue color on the upper side of hand.
ACHES AND PAINS; VERY TIRED/ FATIGUE; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. 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, batch number: Unknown) dose was not reported, administered on 18-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-OCT-2021, the patient experienced aches and pains. On 18-OCT-2021, the patient experienced very tired/ fatigue. On 18-OCT-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of very tired/ fatigue and aches and pains was not reported. This report was non-serious.
Fatigue for less than 24 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administration date 09Jun2021 (Lot number: EW0168) at the age of 15 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergy" (unspecified if ongoing), notes: Verbatim: Seasonal allergy. Concomitant medication(s) included: ZYRTEC ALLERGY taken for seasonal allergy. Vaccination history included: Bnt162b2 (dose 1, single, Lot number: EW0167, Expiry date: Unknown) administration date: 19May2021, when the patient was 15 years old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset Jun2021, outcome "recovered" (2021), described as "Fatigue for less than 24 hours".  Additional information: Calling about the Covid vaccine. States that his teenage daughter turned 16 last week. She has had both of her Covid vaccines, the 2nd one was on 09Jun2021. She had an appointment scheduled with her doctor yesterday for a flu shot, but instead of a flu shot they gave her a covid shot; it was the one that was just approved for kids under 12. The doctor was supposed to discuss this with Pfizer, but he wanted to call Pfizer as well because he is concerned. Asks what should he be looking for regarding side effects? States that she got the shot between 4:30-5pm  and has had no side effects so far. She did go to school today, but he called the school and told them what happened so if she starts to have any side effects, they will call him to go pick her up. He just wanted to find out if they need to be concerned and need to be looking out for certain things. Caller does not have the complete contact information to provide for his daughter's pediatrician. 3rd dose of Pfizer Covid vaccine received instead of the Flu shot on 17Nov2021. Dose: 0.2ml by injection in right arm, Lot: FK5127, Expiry: Unknown. Concomitant medication: States that she takes over the counter medication for seasonal allergies as needed. He initially provided the name of a medication, but he didn't know how to spell it; only stated that it starts with a Z. Caller then stated that he only gives her that medication when her allergies are severe, she normally takes Zyrtec during allergy season. No further details provided regarding the other medication. Anatomical Location of Administration of Pfizer vaccine considered as suspect: Right. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: None. The patient did not require Emergency Room and Physician Office. No Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) AE(s) following prior vaccinations was None, just normal side effects after 2nd dose of the covid vaccine and that was just fatigue for less than 24 hours. No Relevant Tests  Follow-up attempts are completed. No further information is expected.
pt recv vax 25JUL96 & p/ a few days pt devel a lump @ the inj site;the event is cont;
rt thigh began swelling 2nd day p/inject w/redness & swelling inc to cover entire upper thigh to knee & around sides of leg; hosp 26MAR93 IV therapy for cellulitis;
pt recvd vax;felt warm;given apap at 4pm;became "starey-eyed",lethargic then had sz about 30-40 secs;called 911;O2 given; to er via ambulance; t 104; remained in er x 5 hrs;
AST was 35; Immunoglobulin is at 1800; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME INCREASED (AST was 35) and IMMUNE SYSTEM DISORDER (Immunoglobulin is at 1800) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. Concurrent medical conditions included Liver cirrhosis since 2021. On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced HEPATIC ENZYME INCREASED (AST was 35) and IMMUNE SYSTEM DISORDER (Immunoglobulin is at 1800). The patient was treated with BUDESONIDE at a dose of 3 mg. At the time of the report, HEPATIC ENZYME INCREASED (AST was 35) and IMMUNE SYSTEM DISORDER (Immunoglobulin is at 1800) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 01-Nov-2021, Aspartate aminotransferase: 35 (High) AST was 35. On 01-Nov-2021, Immunoglobulins: 1800 (High) Immunoglobulin is at 1800. No concomitant medications were reported. This case was linked to MOD-2021-389011 (Patient Link).
Pt received VARIVAX and INFLUENZA vaccines 2 days ago.  Yesterday she noted swelling, redness and pruritus on right deltoid area.  She came today; on exam the area was a round papule, reddened, swollen and hot of 2 inches diameter.  She was treated with BENADRYL and sent to school.
Tested positive for Covid on 12/6/21 and expired on 12/11/21. Patient was admitted to hospice for end stage CHF on 11/24/21.
Bleed a little on arm after injection; Unsure if complete dose received; Vaccine ran down arm of patient; Exposure via skin contact; This case was reported by a nurse via call center representative and described the occurrence of injection site hemorrhage in a 56-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 97S5T, expiry date 30th June 2020) for prophylaxis.   On 22nd October 2019, the patient received FluLaval Tetra 2019-2020 season. On 22nd October 2019, immediately after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site hemorrhage, accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the injection site hemorrhage, accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The registered nurse called in to question that any information or recommendations when Flulaval vaccine ran down arm of patient. The healthcare professional was unsure if complete dose received because a small amount of vaccine seen running down patient's arm after Flulaval administration, which led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. The healthcare professional stated that the patient did bleed a little on arm after injection. The adverse event was collected.  The reporter did not consent to follow-up.
described via phone by grandmother turned white & cold; still breathing but unresponsive; taken to hosp; adm overnoc OK now;
Diarrhea; Feeling more nauseous every day- very mild nausea, started with the first dose, but got worse with the second; Did not take the vaccine from the vial, but had syringes laying on the table already filled up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 15:00 (Lot number: EN6201) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Microscopic colitis" (unspecified if ongoing), notes: Verbatim: Microscopic colitis; "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: FAMOTIDINE taken for gastrooesophageal reflux disease (ongoing). The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 24Feb2021, outcome "unknown", described as "Did not take the vaccine from the vial, but had syringes laying on the table already filled up"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; NAUSEA (non-serious) with onset 25Feb2021, outcome "not recovered", described as "Feeling more nauseous every day- very mild nausea, started with the first dose, but got worse with the second". Relevant laboratory tests and procedures are available in the appropriate section. Additional information- It was reported that patient  received her first does of Pfizer's COVID vaccine on 24Feb2021 and they did not take the vaccine from the vial, but had syringes laying on the table already filled up. She  is concerned with the stability of the vaccine. she stated for her second shot, they took it out of the vial  No follow-up attempts are possible. No further information is expected.
Left arm was sore; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Left arm was sore) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In February 2021, the patient experienced PAIN IN EXTREMITY (Left arm was sore). In February 2021, PAIN IN EXTREMITY (Left arm was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
**PLEASE NOTE VACCINE SITE INFORMATION IS NOT AVAILABLE IN THE EHR**  Patient presented in acute on chronic respiratory failure and found to be COVID+. MICU was consulted for admission 1/18, as the patient required BiPAP and levophed gtt for hypotension. He was placed on dexamethasone, vancomycin, and zosyn upon admission. Ultimately, he was weaned from BiPAP and placed on HFNC, but his O2 requirements continued to increase. He ultimately required intubation on 1/19. Healso had persistent atrial flutter with RVR, ultimately requiring electrical cardioversion on 1/20. Given this, cardiology was consulted and he was placed on a heparin drip. Per cardiology, he was started on dronedarone as HFrEF thought due to tachyarrhythmia with thought rate control would resolve systolic function, as well as metoprolol. He required esmolol drip initiation and was then taken off dronedarone due to systolic failure. He was in periodic episodes of shock, ultimately found to have septic shock 2/2 pseudomonas UTI and pneumonia requiring cefepime. Multiple goals of care discussions were had with NOK and grandson, with ultimate decision to withdraw care due to inability to wean ventilator, continued decompensation and patient's wishes not to live on life support. Hospice was consulted with plan for discharge to hospice, however, grandson chose to withdraw care prior to transfer to hospice with patient peacefully passing at 1601 on 2/1/22.
elevated heart rate and heart palpitations; elevated heart rate and heart palpitations; This is a spontaneous report from a contactable healthcare professional (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included Covid-19 and recovered. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced elevated heart rate and heart palpitations. It was reported that the patient received his 1st dose about 3 weeks ago shortly after he recovered from Covid-19. Patient was asking if he should receive second dose right away or if there was any data on possible exacerbated side effects with patients who recently recovered from COVID-19 before the vaccine. Outcome of events was unknown.  Information on the Lot/Batch number has been requested.
This spontaneous report as received from a physician via a company representative refers to a 1 year old patient of unknown gender. Information regarding concurrent conditions and pertinent medical history was not provided. On 03-OCT-2014 the patient was vaccinated with a dose of (Merck) VARIVAX (injection, lot # K003423, expiry date 06-MAR-2016, 1 shot in the left thigh, route unspecified). Concomitant therapies included VAQTA, which was vaccinated at the same time. On an unspecified date, in approximately October 2014, the patient developed a varicella-like blister at injection site after receiving (Merck) VARIVAX. The reaction was reported to the office on 15-OCT-2014. No treatment was given for the adverse event. No lab diagnostics study was performed. The outcome of the event was reported as recovered on an unspecified date of 2014. Additional information has been requested.
C/O chills and shaking approx. 3:00 pm 02/13/08 and feeling cold during the night/ took Tylenol ES one tab. Developed H/A and facial swelling this morning.  Temp 104.3, HR 120, BP 110/60, lungs clear, pulse SA 02 97%. Tylenol 325 mg 2 tabs and Benadryl 25mg one tablet given 10:00am today.
salivating a lot and her mouth is running a lot and doesn't stop; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 5-year-old female patient received bnt162b2 (BNT162B2), administration date 08Jan2022 (Batch/Lot number: unknown) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "heart condition" (unspecified if ongoing), notes: Verbatim: heart condition. There were no concomitant medications. The following information was reported: SALIVARY HYPERSECRETION (non-serious) with onset 09Jan2022, outcome "not recovered", described as "salivating a lot and her mouth is running a lot and doesn't stop".  Follow-up attempts completed. No further information is expected.
Large swelling at injection site and left armpit, slight fever, joint ache, weakness, headache
Red swelling on the arm right below where the shot was given starting the day after the vaccine was given.
tears came into her eyes because of the pain.; Pain goes down the collar bone; hard to get dressed; it really hurt when the person gave her the second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (it really hurt when the person gave her the second shot), PAIN (tears came into her eyes because of the pain.), PAIN (Pain goes down the collar bone) and LIMB DISCOMFORT (hard to get dressed) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 36B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (it really hurt when the person gave her the second shot). On an unknown date, the patient experienced PAIN (tears came into her eyes because of the pain.), PAIN (Pain goes down the collar bone) and LIMB DISCOMFORT (hard to get dressed). At the time of the report, VACCINATION SITE PAIN (it really hurt when the person gave her the second shot), PAIN (tears came into her eyes because of the pain.), PAIN (Pain goes down the collar bone) and LIMB DISCOMFORT (hard to get dressed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Nausea after 2nd shot resolved. Intermittent nausea after 3rd shot for 6m-12m. Parent just reported this to us on 9/19/2015.
Information has been received from a physician concerning a 24 year old female who on 10-SEP-2008 was vaccinated with a dose of GARDASIL vaccine (yeast) 0.5 ml IM. On 10-SEP-2008, the patient was at the doctors office and after receiving the dose of GARDASIL vaccine (yeast), she had blood drawn and fainted. The patient reported to the physician that she felt tingling "down her side" after fainting. An EKG was performed in the office, which showed and irregular heart rate. The patient was evaluated in an emergency room, and then she recovered and was discharged to home. Additional information has been requested.
Initial misuse report received from a nurse on 01 October 2013. The patient had received two doses of FLUZONE HD 10 minutes apart. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/11/21 2nd dose02/08/21 Diagnosed covid positive:08/3021 Symptom onset:08/28/21 Exposure: Symptoms:muscle aches, sore throat,diarrhea,runny nose
received / first dose / in 2020 / 7 months later in 2021 / received /second dose; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was the patient. In 2021, 7 months after 1st dose, the patient received 2nd dose, late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up. This case was linked with case US2021158164, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021158164:same reporter - reporter´s husband case
Upset stomach, mild nausea for about 36hrs, extreme fatigue for about 72hrs- rest and eating start by foods were only treatments (self care)
Skin rash covering my chest, and neck.  with spots on both arms and my back. The rash is flat, slightly raised in some spots, and itchy.  Saw the Dr. and was told to take antihistamines and to let them know if it gets worse.    Previous symptoms that have subsided were full-body aches, headache, fever, and chills that lasted 24 hours.