chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The HCP administered an expired Moderna Vaccine to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 016B21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.   Date the vial was initially stored in the refrigerator on 08-Sep-2021 o
Pt recieved pneumovax on 4/12/06 and was feeling fine at the time. Also had lab testing routinely done that day-CMP,Lipid, TSH, T4,CBC. Labs and vaccine ordered. Pt. returned on 4/13 complaining of shortness of breath, chest pain, fatigue and fever overnight-evaluated by me. Vital signs were normal and exam unremarkable that day and was reassured- EKG normal. Given durabac samples for pain and told to rest and drink fluids. also had labs from day before checked and had lft elevation but otherwise OK and told to hold lipitor. Patient returned and saw doctor on 4/14 and had increasing chest pain and weakness-CXR normal. Vital Signs normal and was given a prednisone taper and a shot of Decadron and Torradol. By that evening patient was unable to get out of bed and lethargic. She went by EMS to hospital. Labs showed hyponatremia at 130 and decreased TSH (both had been normal 4/12 prior to vaccination) and incresed osmalality and was felt to be dehydrated. Was treated by doctor with IVF and got some better and sent home. Saw doctor 4/17 and still was weak an with chest pain but was recovering. The ER doc had told her to hold tegretol but doctor started it back on 4/17. Seen by me on 4/20 and was doing better. Weakness almost resolved and chest pain significantly diminished. Labs-CMP, TSH, T4 pending from 4/20.
Lightheadedness, flushing, blurry vision, rash ( red blotching on face, neck, chest), and nausea 10 minutes after 2nd vaccination, followed by headache, fatigue, myalgias, and afebrile chills. Developed vertigo, status migrainosus, and diarrhea one week after. Now more than one month out with severe daily headache requiring multiple medication therapies, including injections, and specialist care.
DEATH; STROKE; MASSIVE ORGAN FAILURE; This spontaneous report received from a consumer via a company representative via social media concerned a two elderly patients of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. Both patients were healthy and had full physical before taking vaccination. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. The reporter reported that, know of two over 65 folks who died two weeks after Johnson and Johnson shot. Stroke and massive organ failure. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients died of unknown cause on an unspecified date and the outcome of stroke and massive organ failure was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210955453-Covid-19 vaccine ad26.cov2.s- Death, Stroke, Massive organ failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
received half the vaccine; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced incorrect dose administered.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020 around 13:30, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 28 Dec 2020, during vaccine administration, the patient experienced incorrect dose administered. The pharmacist stated that the patient did not receive the full dose. The pharmacist estimated that the patient received half of the vaccine and the rest leaked out. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The event, incorrect dose administered, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a female patient who received the first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered without any associated adverse events.
6 days after vaccination, patient noted widespread pimples on chest and upper back. No itching or pain. No lesions elsewhere. No fever, resp, cardiac, or systemic symptoms. He has a hx of acne and tried acne face wash on back and chest, with no real change in "pimples". [PHOTOS available] Contacted on 20 Aug 2018 and most lesions resolved, but a few remaining on his left shoulder. Smallpox vaccination site now forming a scab.
Significant redness, induration, itching, tender-worsening-enlarging thru day-size 4 cm, treated with Septra DS bid x 10 days (given 10/15/11).
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date the patient had already received the first dose of GARDASIL (injection, 0.5 ml, lot# and route were not provided). But the patient was unable to receive the second "0.5ml dose" of GARDASIL during a scheduled appointment on an unspecified date because the vial was supplied empty (product quality complaint (PQC) filed). No adverse effect was reported. Additional information is not expected because no consent to contact physician.
Patient received first dose of Pfizer vaccine in right deltoid muscle while seated in the front passenger side of the vehicle. Patient immediately had a suspected vagal response, fell back and passed out. Patient was unconscious for approximately 10 seconds. Patient was pale and clammy.  911 was activated by clinic staff. Patient was immediately reclined and put in the supine supine position. Ice packs were applied to post occipital/neck region, as well as left and right axilla. Patient regained consciousness after ice packs and complained of nausea/headache. Non productive emesis. Initial vitals: P47, R10, Unable to get BP, SPo2-94%. Patient was placed in semi fowlers position for emesis as EMS arrived on scene. Patient was answering questions and AAOx3 on EMS arrival. EMS vitals: BP-110/60, P-55, RR-12 SPO2-96, blood sugar 102. After EMS assessment, Patient was able to ambulate under own power around the vehicle. Patient refused further  treatment by EMS. Patient stayed for 30 minute observation without further incident.
R arm pain, fatigue after 1st shot. After second shot  sinus pressure, started 1 hr after shot. Following day, r arm sore, fatigue sinus pressure continued. After second day, no more fatigue, sinus pressure but developed vertigo with nausea, vomiting and diarrhea.
Rash near injection site that appears approximately one week after injection. First day rash appeared with small bumps, then following days transitioned to look like a weld approximately 4 inches long and 2 inches wide around the injection site. No iching or pain.   Rash barely visible 4 days later.
Adverse effects have made running so painful I can't do it anymore: Column 1 is the Date: 2 is location: 3 is distance in miles: 4 avg. time @ mile 3/1 Neighborhood           3.5            9:58 3/3 Neighborhood           6.43 11:01 3/5 1st Pfizer Vaccination   3/6 Neighborhood            3.4 11:27 3/8                                     8.02 11:35 3/11 Some neck pain   3/13 Run-Treadmil                     6.26   12:19 3/19 Neighborhood            7.23  10:49 3/26 2nd Pfizer Vaccination   4/2 Neighborhood             3.5 10:06 4/6 Neighborhood             6.44 11:14 4/8 Run-Treadmil                      3.19  11:23 4/12 Neighborhood             8          12:27 4/16 First Serious Symptoms   4/16 Run-Treadmil                      6.28   11:20 4/20 Run-Treadmil                      2.7   11.38 4/23 Run-Treadmil                      5   11:53 4/26 Aborted Run Abdominal and Neck Pain   5/7 Doctor 5/14 CT Scan / X-Ray   5/25 Aborted Treadmil Jog
1) Chest pressure (he did not get evaluated at the time of symptoms) 2) RIGHT hand tremor (opposite side of vaccine)
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 16-SEP-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 24-SEP-2015, the patient was treated at a medical clinic for a blistering vesicular outbreak which was then diagnosed as shingles. She was prescribed prednisone for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Information has been received from a nurse concerning a 16 year old female who on 15-MAY-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 660387/19687U). There was no concomitant medication. On 16-MAY-2008 the patient developed widespread hives. The patient's mother sought medical attention on 27-MAY-2008 and the doctor recommended BENADRYL. The patient's outcome was not reported. Additional information has been requested.
Developed swelling of face, hands and feet the following morning, along with hives all over the body. Was taken to the emergency room and given a prescription for 5 days of prednisone and Benadryl to use as needed for swelling.
Grave's disease, which got confirmed/diagnosed in August 2020. It has started with a significant weight loss, swelling in ankles, changes in mental abilities - panic attacks, liver numbers by blood test weren't ok.  I started to see a psycho therapist. I had to change the physician. The second doctor finally knew what is happening with me. I also develop Eye Grave disease, which has not been treated yet but it will have to. The therapy with Tapezza costs a lot of money. Should that be denied I can expect a surgery. I don't need to write that the immune disease changed my life upside down and causes a lot of stress and pain.
pt informed mom that she was not feeling well.  nurse in observation lane witness seizure.  pt was unconscious for 5-10 seconds.  pt vomited as well.  bp was 104/54 at 1154a, 107/52 at 11:52a, rest of vitals WNL.  Md assessed, observed for additional 30 minutes.  pt stated she was feeling well and was driven home by her mom
Fever , chills, sore throat, stuffy nose, difficulty breathing, which last for one month . I had to take two different antibiotics to get well.
Severe joint pain all over the body/ continue to have joint pain after the 2nd dose as well; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Sep2021 15:00 (Lot number: FE3592) at the age of 54 years as dose 2, single and administered in arm left, administration date 02Sep2021 16:00 (Lot number: FD8448) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cashew nuts" (unspecified if ongoing), notes: Known allergies: Cashew nuts; "Penicillin allergy" (unspecified if ongoing); "Shortness of breath", start date: Jul2020 (ongoing), notes: shortness of breath since having covid Ju2020; "COVID-19", start date: Jul2020 (unspecified if ongoing), notes: who had COVID infection a year ago. Concomitant medication(s) included: NEXIUM; CRESTOR. The following information was reported: ARTHRALGIA (non-serious) with onset 03Sep2021 08:00, outcome "not recovered", described as "Severe joint pain all over the body/ continue to have joint pain after the 2nd dose as well". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of arthralgia.  Additional Information: Prior vaccination within 4 weeks was reported as none. Prior to vaccination, patient was diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Device Date: 06Oct2021 Severe joint pain all over the body that lasted for 3 weeks to the point it was difficult to get in and out of a car. I continue to have joint pain after the 2nd dose as well.  Follow-up attempts are completed. No further information is expected.
HIVES, ITCHINESS, SEVERE RASH. INFLAMED ARMS, REDNESS. STARTED FROM INJECTION SITE AND SPREAD TO ARMS, LEGS, AND TRUNK.
Dose error - 0.25 ML was administered instead of 05 ML - no adverse effects noted. Second dose of 0.25ML was administered the same day per CDC recommendations.
dry mouth; fever reaching 102.8; nausea; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization; Bnt162b2 (2nd dose), for Covid-19 immunization. The following information was reported: DRY MOUTH (non-serious), outcome "unknown", described as "dry mouth"; PYREXIA (non-serious), outcome "unknown", described as "fever reaching 102.8"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; CHILLS (non-serious), outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Higher Fever did not start until 24 hrs after dose. This was despite every 6 hr use of 1g Tylenol  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm painful aa per usual after getting yearly flu shot. Pain has been getting progressively worse and now radiating down my arm.
24 hrs p/immun mom noticed big, raised welts around both arms, abdo, back, both legs; feet swollen, hands swollen, face puffy (individual rasied bumps) lasted 3 days until Monday nite;
11/17/21 presents "as transfer from a HCF for retroperitoneal hematoma, Afib w/ RVR". PMHx "of Paroxysmal afib (on warfarin) and schizophrenia"
Right arm became hard and tender with pain radiating into upper back-Seen by on-call MD 16 days later (for different problem) (R) deltoid hard mild tender areas 4x3cm.
Severe headache. Nausea.  Vomiting.   Tired.  Difficulty concentrating.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062G20A and 031C20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included TRAMADOL, ESTRADIOL, PANTOPRAZOLE, LEVOCETIRIZINE, MONTELUKAST, POTASSIUM, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HYDROCHLOROTHIAZIDE) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-039239 (Patient Link).
I have previously had sleep apnea symptoms, but after receiving the fourth dose of Moderna, I started to experience the symptoms again. I would wake up not being able to breathe. I also experience moderate fatigue, memory loss, brain fog and not being able to focus or concentrate. I went to a sleep clinic and was scheduled for a sleep study. During the sleep study, I did not meet the diagnostic sleep criteria, so I was not diagnosed with sleep apnea. I was told that I have severe periodic limb movement, which is a neurological condition. I was put on MIRAPEX, but I couldn't handle the side effects that it caused. I have a follow up appointment with them in a couple of weeks and I will decide if I want to take any medication.
Initial report received from a health care professional on 23 June 2010. A 14-year-old adolescent male patient, with a remote history of hydrocephalus, received an injection (site and route not provided) on 22 June 2010 of MENACTRA, lot number U3090AA, and an injection (different site but not specific) of BOOSTRIX (reported as "BOOSTERIX"), GlaxoSmithKline Biologicals lot not provided, and on the morning of 23 June 2010 developed a high fever, headache, shortness of breath, nausea, and muscle pains. He had received on 23 June 2010 a meningitis work up with negative results as of 2:28 pm on 23 June 2010. The patient's cultures were pending. He was admitted to the hospital (date not provided). The patient's two other siblings received the same two vaccines with the same lot numbers and did fine. The outcome was not reported. Documents held by sender: None.
TOOK ALL DOSES OF EXPIRED VIVOTIF; This spontaneous case (PVX2019-1505) was received from a pharmacist on 11-Jun-2019. It describes a female consumer who "took all doses of expired Vivotif". The consumer was receiving Vivotif (expiry date: Apr 2019) for an unknown indication.  Case report: The consumer took all the expired doses of Vivotif. The doses were expired on Apr 2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took all doses of expired Vivotif" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took all doses of expired Vivotif" was considered as not applicable.
pancreatitis; Fever102; felt lousy; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:15 as UNKNOWN, SINGLE DOSE for covid-19 immunisation. Medical history included High blood pressure, hypothyroid, osteoporosis, and allergies: Bactrium, kelflex. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); valsartan (DIOVAN).  On 18Mar2021 16:00, the patient experienced Fever102 felt lousy, 10 days later had pancreatitis and spent 4 days in hospital. She had never had pancreatitis before. All scans showed no gallbladder cause, she did not drink. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab: negative on 05May2021. Treatment received for the adverse event included Iv fluids pain meds. The outcome was recovered with sequel. This case was reported as serious, life threatening, caused/prolonged hospitalization.  Information on the lot/batch number has been requested.
RespDepression, Tachycardia,  desaturation 82% on RA 120s tachycardia  Narrative: To Benadryl q 6 hours x 24 Zyrtec q 24 for 3 days  Metoprolol 75 xl PCP ordered CBC CNIP d-dimer and chest film  all normal
Severe lower bottom left of the abdomen on March 26 at around 7am. Difficulty in walking.  Pain around hip and middle and upper back.
Patient described "redness & soreness" after shot. Saw physician for worsening discomfort, and was diagnosed with "cellulitis". Received antibiotic.
This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 83-year-old female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 82 or 83 years old. The patient was diagnosed with shingles. No batch number or expiry date for SHINGRIX was provided.
I had a sore shoulder for a day but that was it.  On 09/21/2022, I had a sore throat, congestion, brain was fuzzy and a cough. On 09/22/2022, I tested positive for COVID-19 with a home test. I contacted my doctor and was given a prescription for Paxlovid. It really helped to shorten the duration of the virus. As of today, I continue to have a cough.
Client presented to clinic with mother on 6/20/23 for COVID-19 Moderna Bivalent vaccine. Client at the time was 5y and 11mo. Counseling, education and VIS was offered to MOC. This RN vaccinated the child with a COVID-19 Moderna Bivalent vaccine. Due to EHR auto-populating 0.5mL dosage, unknown if 0.25ml or 0.5ml dose was given. This RN left a message for the MOC on 7/31/23 when the error was noted. MOC returned call on 7/31/23, RN explained the situation and provided further counseling/education. MOC expressed understanding and stated child did not have any adverse reaction after vaccination, only reported injection site tenderness that was a similar reaction to his first COVID-19 vaccine. At this time, a repeat dose is not required as per CDC recommendations.