chrisvoncsefalvay/vaers-outcomes huggingface dataset:
For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022; Expired doses of Moderna COVID-19 were administered beyond the beyond use date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date.) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date.) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  It was reported that patient received total 4 doses, Vial did not undergo any temperature excursion.  No treatment medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2022: Follow up received contain Non significant information
Pt hx 4 prev. episodes since age 3rd grade -> pt reports "immune disorder" and consults for rh. arthritis. AFLURIA given 12/16/14 - 12/18. 12/18 ER visit, dx Bell's Palsy - steroidal course - No improvement 1/7/15.
During the evening after the shot (7/2/2018) the patient reported feeling exhausted - The next morning (7/3/2018) the patient stated they had a rash and shingles on the injection side.
Lymph nodes below her chin blew 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 female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "only 'fluey' symptoms". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovering", described as "Lymph nodes below her chin blew up".  Additional information: Lymph nodes went down after a few weeks.  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-202201346192 Same patient and drug; different dose and event;US-PFIZER INC-202201346627 Same patient and drug; different dose and event;
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and PEDVAXHIB (Lot number, expiry date, route and dose were not reported). Certified medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reports. Follow-up received. Certified medical assistant stated other 104 children received GARDASIL and other 18 children received PEDVAXHIB. Follow up information has been received from the certified medical assistant regarding a 12 years old, male patient with no pertinent medical history reported. On 14-NOV-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Other suspect therapies included the first dose of PEDVAXHIB (lot number and expiration date not reported) administered on 14-NOV-2012 (intramuscular on the left arm, dose not reported). Concomitant therapies included the second dose of Hep A vaccine (manufacturer unknown) (intramuscular on the right arm, second dose) on 14-NOV-2012. It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
My wife called the ambulance for me as symptoms I was having mimiced a heart attack. I had sudden and intense tightness in the left chest (felt like I was shot) the developed into pain and then numbness/immobility of the left arm (vaccine was administered in the left shoulder area).  Since this point I have had routine soreness/tightness in the chest and constant shortness of breath/wheezing.
I had a runny nose, cough and started feeling losey. I took a COVID-19 test that morning that was positive. I had flu like symptoms. I don't think I had a fever. I'm lethargic, no appetite, headaches, and having to clear my throat a lot.
14OCT woke up very stiff & sore;fever came on in PRN @ 2PM 101.7 lasted 12hr;today gen body soreness, fever gone, feels weak;states has had flu shot for post 6hr w/o any rxn;
Have severe arm pain when arm is moved in certain ways, usually when reaching for something.  Also pain when I lean heavily on, and mild pain in arm when I run.  Seems to be getting worse.  My 90 year old dad also rec'd the Pfizer, and is telling me he has the exact same symptoms/pains.
VARIVAX vaccine was administered 3 days past it's expiration date; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies, and concomitant medications were not provided.  On 25-OCT-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL (route of administration was not reported) lot# S033540, expiration date 22-OCT-2022, given as prophylaxis (Expired product administered).
Almost immediately after administration of Kinrix, patient developed rash inferior to site about 6 cm almost down to elbow with some induration and hives on his back.  No respiratory involvement.  Patient was examined by the MD and administered PO Benadryl.  Monitored for 20 mins at which time rash resolved and hives mostly resolved.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (strength, dose and route were not reported) (lot # N023828 and expiration date: 25-JUN-2020) for prophylaxis. The vaccine was stored in below 32 degrees Fahrenheit (F)/0 degree Celsius (C) (-0.3 C) for 64 hours. The digital data logger was not involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1806USA012212: US-009507513-1806USA012213: US-009507513-1806USA011719.
Information has been received from the author of a literature. This literature marketed report as received from the authors refers to 46 male patients of unknown age with Human Immunodeficiency Virus HIV infection which was diagnosed in 5 patients before vaccination and in 41 after vaccination. On an unknown date, the patients were vaccinated with a dose of HepB vaccine (recombinant) (manufacturer unknown) (Lot numbers, expiration date, dose and route were not provided). Concomitant medication included combination antiretroviral therapy (cART). On an unspecified date, the patients experienced vaccination failure reported as "vaccine non-responder". The reporter stated that to assess and quantify the effect of HepB vaccine (recombinant) (manufacturer unknown) response on CD4 lymphocytes (CD4) reconstitution after cART initiation, all available CD4 counts for participants from cART initiation to one year post-cART were analyzed. The outcome of vaccination failure was unknown at the time of the report. The reporter considered vaccination failure to be related to HepB vaccine (Recombinant) (manufacturer unknown). This is one of several reports from the same literature. Additional information has been requested.
ITCHINESS THROUGHOUT THE BODY AND  ON THE TOP OF FOOT; ITCHY EYES; FLUSHED FACE; SNEEZING; HEADACHE; FATIGUE; SORENESS ON THE SITE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced soreness on the site arm. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced itchy eyes. On 13-MAR-2021, the subject experienced flushed face. On 13-MAR-2021, the subject experienced sneezing. On 14-MAR-2021, the subject experienced itchiness throughout the body and on the top of foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy eyes, and flushed face on 14-MAR-2021, sneezing on 15-MAR-2021, soreness on the site arm on 10-MAR-2021, headache on 11-MAR-2021, and fatigue on 12-MAR-2021, and was recovering from itchiness throughout the body and on the top of foot. This report was non-serious.
I don't know exactly when it started, but my mom got her Covid booster on Thursday afternoon and Friday at 6 PM I arrived at her house to find her on the floor. She slid off the bed but was about 5 feet away from it (not sure how she got there) but she had a scrape on her back so I believe this part of her story to be accurate.  She could not complete a coherent sentence though so I'm not exactly sure what happened.  She could not roll over to her hands and knees to get herself up. I called EMS and she spent one night in the hospital for observation. She was very disoriented, weak, confused. She was much more herself by Saturday and felt fine by Monday so I think it was her reaction to the vaccine.  She's not a terribly healthy person to begin with which is why I encouraged her to get the vaccine. I will not encourage her to get it again though   She had gotten  the flu shot a couple of weeks before this but she doesn't remember when and we don't know which one it was
covid-19; covid-19; Clinical courseThis is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: other medical history: No. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Adverse event Had COVID with symptoms; symptoms lasted for several days. Started feeling better. Then, had what I would call a relapse cough was nonstop, body aches, tired. No fever but a decline in overall.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt developed chills and body aches after receiving flu vaccine. Next day she threw up without warning and has had some chest burning. She also reports feeling clammy and shaky.
Red warm area 5 x 7.5cm around vaccine site - KINRIX given 2 days prior. No other problems mom noticed redness yesterday & brought pt. in for evaluation. Advised warm compresses, MOTRIN/TYLENOL, BENADRYL & return to office if worse, fever, drainage.
hives / red itchy spots; hives / red itchy spots; hives / red itchy spots; This case was reported by a consumer and described the occurrence of hives in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than 5 months after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced hives, pruritus and red rash. On an unknown date, the outcome of the hives, pruritus and red rash were not recovered/not resolved.   It was unknown if the reporter considered the hives, pruritus and red rash to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by patient's husband. Age at vaccination was not reported. The patient received shingles shot in September or October of 2020, along with a flu shot. The reporter did not have lot number.  The patient had hives. They break out with little red itchy spots it was ok during the day but at night he must get up and put gel on the spots to stop the itching.  The patient got a shot for itching but they were still itching.  The patient spots moved to his legs and arms, the patient did not plan on getting the second shot. The reporter did not consent to follow-up. This case was linked with the case US2021025208, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021025208:same reporter
On 2/17/22 patient was administered vaccine that had expired on 2/12/22.
It was reported on 9/20/2023, an employee administered a 19+ influenza vaccine to patient instead of a 65+ influenza vaccine.
booster dose was administered today September 28, 2023. This is being reported as a possible late dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old male patient who received HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 8th September 2022), Twinrix (received 2nd dose on 15th September 2022) and Twinrix (received 3rd dose on 29th September 2022).   On 28-SEP-2023, the patient received the 4th dose of Twinrix. On 28-SEP-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: booster dose was administered today September 28, 2023. This is being reported as a possible late dose).The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-SEP-2023 The reporter stated that patient received the first dose of the Twinrix accelerated dosing schedule last year.  This was being reported as a possible late dose. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The patient received 4th dose of Twnrix later than the recommended schedule, which led to lengthening of vaccination schedule. The case had been linked to US2023133825, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023133825:Same reporter, different patient
Severe itching where it caused inflamed skins from the constant itching. Rash bumps throughout body.
Anxiety, dizziness  HR 115 RR 22 O2 99% BP 100/70
Swollen & indurated, red & pt states that it is warm, fever, neck pain, lt arm pain.
Patient complained of a bruise around the injection site and fever in the hours following administration. She states that she did not feel well enough to return to the pharmacy until today (10/27/2022).
Over a 7 day period: Severe fatigue continual, headaches mild to moderate hourly, body chills continual.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 49-year-old male. Neither medical history nor concomitant medications were reported. On 02-Mar-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form the previous season and 2) product expiring during the peak of the flue season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009: product complaint investigation results.
Patient called at 9:10 AM on 11/4/19 to report she had an adverse reaction to pneumovax-23 she received on 11/2/19.  She stated within 1 hour she had a raised red area with hives at injection site which has now gone down.  She had swelling under her arm and currently reports swelling and soreness at elbow area.  She did not seek medical treatment.  She has no fever.  She did report over the phone that she received Fluzone HD at pharmacy on 9/27/19 and experienced a similar reaction.
Throat sore felt like lump in throat-3pm. About 1hr later yes blood shot with pus (white). Hives were noted next AM upon waking on right side of stomach- red strip with few off to side. Called MD and was told to take Claridan 10mg as directed. 11/15 hives fading, not itchy.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient received an improperly stored dose of (Oka/Merck) VARIVAX from lot # N022977 with expiration date 23-AUG-2019 or Lot # N023958 with expiration date 01-SEP-2019, for prophylaxis, (strength, dose, frequency and route of administration were unknown); which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). The storage temperature was reported as 6 to 14 degrees F for a time frame of 180 minutes. There was a previous temperature excursion of 6 to 14 degrees F for 222 minutes. Digital data logger was involved. No adverse effects were reported. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1802USA004551: US-009507513-1802USA004550: US-009507513-1802USA004552.
This literature marketed report was received from the authors in a published literature abstract title concerning to 50 year old male with a history of Chronic obstructive pulmonary disease (COPD) and prior splenectomy following traumatic splenic rupture who presented with fever, altered mental status, and sonmolence. He was subsequently intubated and transferred to the Intensive care Unit (ICU), at which time his wife was able to report that since splenectomy he had experienced two episodes of pneumococcal meningitis in the past few years. Following the second bout of meningitis he had undergone proper vaccination with both PREVNAR 13 and vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (dose, route, lot# and the expiration date were not reported) one year prior to his presentation. On an unknown date, on exam, he was noted to had a temperature of 103.7, heart rate of 126, and Blood Pressure (BP) of 109/63. He was initially noted to had retiform purpura diffusely spread over his body with a dark, dusky appearance of the nose, ears, eyelids, bilateral hands and feet, and tip of the penis. These areas eventually became pulseless and developed necrosis. His labs were remarkable for a White Blood Cells (WBC) of 47,000, platelets of 34,000, Prothrombin time (PT) of 16.1, International normalised ratio (INR) of 1.5, Partial thromboplastin time (PTT) of 58.7,and fibrinogen of 185. Schistocytes were noted on peripheral blood smear. Two sets of blood cultures were positive for pneumococcus. The diagnosis of purpura fulminans from Pneumococcus was made. Despite being on appropriate antibiotics and maximal supportive care, the patient developed multisystem organ dysfunction and was eventually transitioned to a comfort care approach and passed away shortly after. This case was interesting in the fact that this patient developed invasive pneumococcal disease despite being properly vaccinated with pneumococcal vaccine, polyvalent  (23-valent)(manufacturer unknown) and PREVNAR 13 and having no other immunodeficiencies. At the time of reporting, the  outcome of vaccination failure was not provided. The reporter considered vaccination failure to be related to PNEUMOVAX23 and PREVNAR 13.  Additional information has been requested.
Spotting/vaginal bleeding; This is a spontaneous report from a non-contactable consumer. A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0164, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 12May2021 (age at vaccination 37 years) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took celebrex and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0173, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 20Apr2021as dose 1, single for covid-19 immunisation. The patient experienced spotting/vaginal bleeding on 27May2021. Patient visited Doctor or other healthcare professional office. The patient underwent lab tests and procedures which included Nasal Swab was negative on 01Jun2021. The patient did not receive any treatment for occurred events. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Febrile seizures x 2 in 2ys. Sx Rx.
Given to pt who is 16 years old. No adverse side effects noted. Pt received counseling from RN and Pharmacist.
1530 Heart racing and nausea with heaves no emesis BP 165/108 , HR 161, sats 98%, Resp 20.EKG 4 lead done. Reports Hx of anxiety denies any other medical Hx. 1532 BP 160/105, HR 136-159 , RESP 18, sats 98 denies chest pain. AAOx4. Family members are at his side.  1535 BP 165/103, HR 140, Resp 19, Sats 97%. Nausea relieved.remains on continuous monitoring denies SOB refused oxygen. 1547 Rescue arrives Client refused to be transported. family members present are in agreement with the client decision. BP 163/110,HR 132.Client educated on symptoms to call 911or go to ER. 1553Rescue Left Refused offer of W/C to car. 1600 signed AMA Waiver. Left ambulating accompanied by his family