chrisvoncsefalvay/vaers-outcomes huggingface dataset:
placed in the fridge and the beyond use date was 20Jan2022/ There were doses administered; placed in the fridge and the beyond use date was 20Jan2022/ There were doses administered; placed in the fridge and the beyond use date was 20Jan2022/ There were doses administered; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Jan2022 (Lot number: FK5618, Expiration Date: 20Jan2022) as dose number unknown (tris), 0.2 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (medically significant), PRODUCT STORAGE ERROR (medically significant), EXPIRED PRODUCT ADMINISTERED (medically significant) all with onset Jan2022 and all described as "placed in the fridge and the beyond use date was 20Jan2022/ There were doses administered".  Clinical course: Product Details: Lot FK5618, NDC 59267105501. The product is the Pfizer covid vaccine specifically involving the orange cap vials. The Vaccines were administered beyond the 10 weeks, agent explains that it can be stored in the fridge for 10 weeks but it was used beyond that, the beyond use date would have been 20Jan2022. 15 doses in total were administered. The administration took place on 21Jan2022, 24Jan2022, 25Jan2022, 26Jan2022, and 28Jan2022.   Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the information currently available in narrative ,the casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200175416 Same reporter/drug/event, different patient
Based on additional information received on 26 February 2016, this case initially considered as non-serious was upgraded to serious due to seriousness criteria: disability. Initial unsolicited report received from a consumer on 18 January 2016. This case involves 72-year-old female patient who was vaccinated with a dose of Fluzone HD (batch number not reported) intramuscularly in the right deltoid on 18 October 2015. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported and she had no illness at time of vaccination. The patient's concomitant medications were not provided. On 24 October 2015, six days following the vaccination, the patient had experienced numbness, pins and needles feeling, burning type pain in her right leg from the knee to toes and foot drop on the right foot. The patient required ER/doctor visit. Laboratory data was not reported. The patient had received physical therapy as corrective treatment. The outcome of events was reported as not recovered. Follow up information received from a consumer on 26 February 2016 and additional information received on 03 March 2016. Batch number was updated as UI481AA. Pre-existing physician-diagnosed allergies, birth defects, and medical conditions was reported as scleroderma (crest), gastroesophageal reflux disease (GERD), Esophageal Cancer, hypothyroid. The patient did not experience any adverse event prior to vaccination. She did not receive any other vaccinations within 4 weeks prior to date of vaccination. Concomitant medications included Anastrozole 1 mg daily, Calcium 1200 mg daily with "vitamin D", Cyclobenzaprine 5 mg with at bed time, Prolia 60 mg for 6 month "for 6 MO", Furosemide 40 mg daily as needed, Levothyroxine 125 mcg daily, Omeprazole 40 mg daily, Ranitidine 150 mg daily at bed time, Tramadol 5 mg "as needed" pain, Temazepam 15 mg as needed for sleep, sucralfate four times a day. On 29 October 2015, 10 days following the vaccination, the patient had experienced numbness and foot drop. It was reported that, permanent disability resulted on 21 February 2016 and by the time of reporting, patient still had a problem. The patient had a doctor visit on 28 October 2015, she visited a neurologist on 30 Nov 2015, a neurosurgeon on 02 December 2015 and began physiotherapy. Laboratory data included brain MRI (On 02 November 2015), Spine MRI, lower extremity with Doppler, Ultrasound RT. On 10 December 2015, Electromyography was performed. The patient had not recovered from foot drop and numbness. List of documents held by sender: none. Sender's Comments: Foot drop is unlisted with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE whereas numbness, burning leg and tingling is listed. Time to onset seems to be compatible with a role of the vaccination. Complementary information regarding the patient's condition at the time of the events, medical history and investigations exploring alternative etiologies are needed to further assess the case.
2-3 hrs after injection, L check muscle twitching that lasted until bedtime (3 hrs). Next morning, L check was not twitching but felt as though it might. This lasted all day. Within 2 days, there was a nerve sensation that radiated to L eye and L side of mouth. This sensation has persisted but improved now.
Headache, Fever, chills, lethargy, fatigue Narrative: Dose #2, Day #1 moderate arm soreness where injection was given (lasted one day), fever 100 degrees and chills (lasted 12 hours), migraine (lasted two days, is prone to migraines, post vaccine more severe than normal), lethargy and fatigue that I could barely get out of bed (lasted two days); states Dose #1 Day#1 mild arm soreness.
Myalgia, Fever, Angioedema, site painful and red Narrative:  Other Relevant History:
sore arm; a shooting pain towards her armpit going down her arm; chills; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection), via an unspecified route of administration on 16May2021 (at an age of 41-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, the patient experienced sore arm, a shooting pain towards her armpit going down her arm, chills, diarrhea. Consumer reported that after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine yesterday, 16May2021, she had a sore arm, a shooting pain towards her armpit going down her arm, chills and diarrhea. She said she took Advil for her arm discomfort, but was told by a friend that she should not have taken the medication. She also said she was told that she should have taken Tylenol instead of Advil. She called to seek guidance regarding this. Consumer also said that in all the forms she has, there was no information about taking medications at the same time with taking the vaccine. Therapeutic measures were taken as a result of sore arm, a shooting pain towards her armpit going down her arm. The clinical outcome of the sore arm, a shooting pain towards her armpit going down her arm, chills, diarrhea were unknown.
Headache, neck stiffness and pain, body aches, nausea, fever, chills, dizziness, fainting, fast heart rate, low BP
I experienced fever, severe jaw pain and headaches. I took 600mg of Ibuprofen which did not help resolve my symptoms. The fever has returned to normal, but the other symptoms are continuing. When I went to Urgent Care, they diagnosed me with a UTI.
p/vax pt devel fever to 102; morbiliform rash; (red papular); mild pruritus;
This case was extracted from the VAERS database via a search of QScan on 24 February 2009 (reference number 331690). A 33-year-old female patient received an intramuscular injection of FLUZONE SV 2008-2009 (lot number U2768AA) on 05 November 2008. Approximately five hours post-vaccination, she began experiencing fatigue, body aches and pains, bright red burning eyes, fever and lung tightness. She went to bed and subsequently began experiencing a headache approximately 12 hours post-vaccination. The following morning she had improved; red eyes continued.
my arm was sore for about a day, had a headache for a couple of days and on Sunday i just started itching,
the needle didn't lock with the syringe, so during administration, some of the solution left the syringe with no AE; the needle did not lock with the syringe; Initial information received on 17-Dec-2021 regarding an unsolicited valid non-serious case from a pharmacist via Agency (Reference number-00903456).  This case involves an unknown demographics gender patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and the needle did not lock with the syringe, so during administration, some of the solution left the syringe (underdose and syringe issue).  The patient past medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7356MA and expiry date: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination.  It was reported "Should another dose be given? Unknown amount of vaccine was administered".  It was actual medication error case due to Vaccine underdose and syringe issue.  At the time of report, no adverse event was reported.
This spontaneous report as received via a company representative from a pediatric nurse practitioner (CPNP) refers to a 6-month-old patient of unknown gender. The patient had no concomitant medications, pertinent medical history or known drug reactions and allergies. On 30-APR-2018, the patient was vaccinated with the third dose of ROTATEQ, one unspecified dose, orally (lot # N030364 with the expiration date of 06-MAR-2019) for prophylaxis. Prior to the vaccine administration, the patient received MOTRIN (dose, frequency, strength, formulation, route of administration and indication for use were not reported). The patient also received regularly scheduled unspecified vaccines at the same time as ROTATEQ. On 30-APR-2018, within 1 hour of receiving ROTATEQ, the patient experienced vomiting, was seen by a physician and was treated with unspecified fluids to prevent dehydration. The vomiting continued for about one day and then subsided. The causality assessment between the event and ROTATEQ was not provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1805USA000702.
I got really sick after receiving the vaccine with nausea and unable to stand up straight for a couple of days. In 03/2023, I had a doctor's appointment regarding a hernia. The test they gave me was the incorrect one and they found I have severe fatty liver.  Now I am on a diet to try to reverse this diagnose.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's medical history included that the patient had received an unspecified "flu vaccine" each year since the administration of PNEUMOVAX23 and did not have a reaction to the "flu vaccine". On an unknown date in several years ago the patient was vaccinated with PNEUMOVAX23 (lot number, dose and injection site were not reported) intramuscularly as routine. On an unknown date in several years ago the patient experienced bad skin reaction. The action taken was not reported. The outcome of bad skin reaction was reported as recovered on an unspecified date. The adverse event did not reappear after reintroduction. It was unspecified if the patient sought any medical attention. Additional information has been requested.
1-2hr p/shot eyes itchy, tightness in chest, coughing, hives on chest;DPH about 5-6oclock d/t coughing, SOB;next day throat & flu-like sx;
Headache, disorientation, brain fog, exhaustion, nausea, body aches on left side
Pt recv vax on 5/12/98; on 5/13/98 pt exp localized rx.
Red hard hot itchy area around injection site; Extreme fatigue; body aches; joint pain; nausea; headache; Red hard hot itchy area around injection site; Red hard hot itchy area around injection site; This is a spontaneous report received from a  non- contactable consumer (patient). A 52-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 12:45 (at 52 years old, not pregnant) (Batch/Lot Number: ER8736) as 2nd dose, single for covid-19 immunisation. Medical history included Hashimoto Thyroiditis from an unknown date. The patient had her first dose of bnt162b2 (lot number -EL9263)  vaccine on 05Apr2021 11:00, on left arm for covid-19 immunisation. Concomitant medications included levothyroxine sodium (SYNTHROID); vitamin b complex (VITAMIN B); vitamin d [vitamin d nos]; magnesium.  After dose 2, patient experienced on 27Apr2021 08:00, Extreme fatigue, body aches, joint pain, nausea, headache, no treatments for these events. Red hard hot itchy area around injection site that she took Benadryl for. Patient had no reaction to dose 1. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow up possible. Follow up information can not be obtained
About 4-5 minutes after getting the vaccine, I coughed and then could not breathe. I was sitting down and quickly stood up gasping for air. I was in the library at the time.  Several people ran to my side and sat me down on the floor. My O2 sat was 86, pulse 120. I was able to start breathing without epi. O2 went up to 100. Was taken to the ED and given Benadryl and Prednisone. I waited quite a long time. The ED was packed. I ended up leaving, as I felt fine. I am fine today and at work. This was my second vaccine.  No adverse event after the 1st dose.
Less than a month after receiving the Varicella Zoster Virus or chickenpox vaccine, I presented with a high fever and vaginal ulcers which was later diagnosed as the onset of Behcet's disease. This diagnosis came from a doctor.8/15/2008 MR received for DOS 12/20/2000 with DX:  Behcet's Disease.  On Oct 26, 1998 pt developed high fever with development of genital ulcers. Chills, sore throat, neck pain and stiffness, enlarged cervical lymph nodes, R hip pain, and hypersensitivity to touch accompanied this. Fever and ulcers resolved but returned in 2/1999 with a 4 week outbreak. 2/2000 developed blood blisters in the ear with vertigo.  8&11/2000 fever and genital ulcers tx with prednisone and abx with good result. Ophth consult WNL.  1/25/2010 I will always have Behcet's disease which I know was triggered by this vaccine, sadly.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 10Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (Sep2023) and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 13Sep2023 to 18Sep2023.  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-202300306836 same patient and reporter, different drug and event;
a minute or so after I vaccinated patient, I asked her to stay in store 15 minutes,   she came back to the window stating she didn't feel well.  I brought her back into the room  and monitored her. She complained of pain moving up chest,  "ball" in throat, then tongue swelling, severe pain in head and then tingling in the arms.  She never had any difficulty breathing or speaking . EMS was called and came and patient refused treatment and left on her on with her parents
Patient developed fever of approximately 102.7f  and began to seize. Taken to Medical Center by ambulance. Parent gave Tylenol for fever.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "High cholesterol" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "green pepper allergy" (unspecified if ongoing); "melons allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid on 19Apr2023 to 24Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency; however, a contributory role of BNT162B2 to the events COVID-19 and drug ineffective cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300175757 same reporter/patient, different drug/event;
administered the Liquid component only; administered the Liquid component only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA756A, expiry date 30th April 2024) for prophylaxis.   On 28th September 2022, the patient received Menveo. On 28th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-Sept-2022 Reporter's comment: The licensed practical nurse called to inquired that any adverse effects to look for. The reporter did not consent to follow-up. Additional supportive information: The patient was inadvertently administered the Menveo liquid component only without the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
My third shot (booster) of all Pfizer series.  No symptoms occurred until day 2.  Sharp, stabbing pain in left axilla with swelling from undersides of elbow, down arm, axilla, breast and to bottom of breastbone, all on left side.  Enough pain to interfere with daily activities for few days and sleep interference for two days.  Visible and palpable edema.  No lumps felt.  (Worrisome for breast cancer symptoms) Heat didn't relieve pain much.  Was unsure if medication would interact, but took Aleve two days after shot, which helped. Total duration of pain about 4-5 days, decreasing after day 3.  Swelling took a bit longer to subside but did resolve on its own.
Pt was monitored after vaccine administration, after 20  minutes no adverse events were noted. Pt came in for TDap and mistakenly was given covid vaccine. I personally handled this patient at several instances, including adminsitering the vaccine. At both instances when addressing the fact that this was a  pfizer booster the pt acknowledged as though she understood. This vaccine was administered upon the form I was presented to give the vaccine as it was a covid vaccine form. I also checked database before administering the vaccine and it currently only shows the first 2 vaccines with the patient being eligible for the third. It was not till she left that she returned and mentioned she actually wanted the TDap vaccination. Pt was then given the correct shot. Pt had already recieved her booster, her most  recent dose was given on 09/02/21. There was no true adverse event here but there was an administration error.
Increased tiredness and soreness at injection (relative to first shot) followed by splitting headache and being mildly feverish. Problems fixed with acetaminophen (650 mg, PO, ADMINISTERED ONCE).  After the first shot (Lot# ER8732), there was immediate soreness at injection site and hives/itchiness (localized in left shoulder (injection site), left armpit and on right side of rib cage) that started 12 days after injection. Diphenhydramine (50 mg, PO q 4 h for 2 days) resulted in no itchiness.
Pt felt flushed and light-headed after receiving vaccine.  Received Benadryl and Zantac form pharmacist.  Remained in vaccination booth with wife for monitoring. After 30 minutes pt felt fine and went home. Instructed to seek medical attention if needed.  This PharmD called pt at home 1 hr later to check on him. Pt stated he felt fine and did not need immediate medical attention.
About an hour after receiving the vaccine, I started to feel warm and started having trouble swallowing. Thirty minutes after that I started feeling flush. I was having more difficulty swallowing. Below my nose to my chin started to tingle and it felt numb. We drove to the ER. I called my PCP before entering, my doctor told me to go in to the ER if the feeling continued. I went into the ER and they saw me immediately. I was triaged very quickly and maybe 30-45 minutes later, I felt normal again. My condition was referred to as a mild adverse reaction to receiving the vaccine.
Woke up what 4am with restlessness, severe headache, myalgias, arthralgias. Not as bad as last booster.   Still present.
Patient received Moderna booster shot, when only Pfizer booster is currently authorized for 16 y/o.
increase of a liver enzyme, ALT, from eighteen to sixty-four; This spontaneous case was reported by a pharmacist and describes the occurrence of HEPATIC ENZYME INCREASED (increase of a liver enzyme, ALT, from eighteen to sixty-four) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HEPATIC ENZYME INCREASED (increase of a liver enzyme, ALT, from eighteen to sixty-four). At the time of the report, HEPATIC ENZYME INCREASED (increase of a liver enzyme, ALT, from eighteen to sixty-four) 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.