chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got third dose from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Got third dose from an expired vial) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 012M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 13-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 13-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Got third dose from an expired vial). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Got third dose from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-352622, MOD-2021-352613, MOD-2021-352994, MOD-2021-352991 (Patient Link).
Site: Pain at Injection Site-Mild, Systemic: no information-Mild, Additional Details: patient wife called on 10/03/22 at 4 pm to informed on duty pharmacist that her husbund died today. pharmacist asked is it due to vaccine? she replied due to weak heart. she also asked pharmcist to do vaccine events reporting. above section i have to select pain on site due to complete this form however wife did not mention anything over the phone about pain on site.
Received vaccine on 5/26.  Difficulty breathing and talking, possible epiglottis swelling occurred on 5/29.  Seen by PCP on 6/2, prescribed oral Prednisone 50 mg daily x 10 days for continued SOB.
Fever, chills, vomiting, diarrhea, coughing, lethargy
Patient developed blistering of her mouth, behcet's like syndrome afterwards.  it persists for 2 weeks and then again comes back
Muscle pain; Slightly pinkish rash on muscle part of arm; Very little swollen; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), RASH (Slightly pinkish rash on muscle part of arm) and PERIPHERAL SWELLING (Very little swollen) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced MYALGIA (Muscle pain), RASH (Slightly pinkish rash on muscle part of arm) and PERIPHERAL SWELLING (Very little swollen). At the time of the report, MYALGIA (Muscle pain), RASH (Slightly pinkish rash on muscle part of arm) and PERIPHERAL SWELLING (Very little swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Cholesterol meds for an unknown indication. No Treatment products included
Patient was scheduled to receive CoVid-19 Vaccine at along with brother. Immunization certified pharmacy technician gave vaccine in patient's left arm a few minutes after 1400 hours (~1410). Vaccine was Pfizer BioNTech Covid 19 Vaccine Lot # EW0180 with set expiration date of 08/31/2021. Mandatory observation time is approximately 15 minutes. During observation time, patient began to complain of nausea. Staff located a bio hazardous bucket for patient to vomit in, if needed. Staff noticed patient was diaphoretic and nauseous, along with pallor of the face and upper extremities. Patient's upper extremities began to stiffen at which point, staff decided to contact emergency medical services (via 911). Fire Department and Paramedics arrived within 2 minutes of the phone call and the child was released without any medical attention after 10 minutes (~1440 hours)
Patient received Moderna covid-19 vaccine at 9 am on 5/11/21, later in the afternoon patient started to have trouble seeing. Blurred vision: patient stated could no longer read small print and night vision while driving was an issue. Patient came back to pharmacy this week to report issue was referred to  and is still experiencing side effects over a week later. Patient referred to eye doctor as they are still having vision issue
This subject is a 67 year old male who was admitted to the hospital and died while enrolled in a study. The subject received two doses of RSV vaccine or Placebo and Influenza vaccine. The last dose prior to the event was given on 10/23/03. The subject was hospitalized for a stomach mass, date of hospitalization not reported. While in the hospital subject developed a blood clot and died 334 days post immunization on 9/21/04. The subject's death due to a blood clot was reported by the investigator as unknown in relationship to the study vaccine.  Follow up on 10/08/04 states: "There was no autopsy done for this decedent."  Nurse follow up on 10/14/04 states: "pulmonary embolism; deep vein thrombosis."  Nurse follow up on 10/19/04 states: "small bowel mass."  Nurse follow up on 11/11/04 states: "fat necrosis of the mesentery with partial small bowel obstruction."
no vision on right eye; Torn retina; Little tired; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration at the age of 75-years-old, administered in Arm Left on 26Feb2021 16:55 (Lot Number: EN6200) as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included prednisone taken for Ruptured disc from 11Feb2021 to 19Feb2021 and from 07Mar2021 to 17Mar2021. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 04:55 AM (Lot Number: EL9265) as a single dose for COVID-19 immunization and experienced severe back pain and sore arm. The patient reported, "I chose to not fill this auto entirely with help. I had a sore arm after dose 1, little tired after dose 2. I reported I had a torn retina days after dose 2 but did not think it was due to the vaccine. Just wondered it happened 3-10, still can't see, under doctors care. I don't think the prednisone or the eye issue was caused by the vaccine but reported it." The patient experienced torn retina on 12Mar2021 and little tired on 2021. The patient underwent lab tests and procedures which included eye ultrasound: torn retina, no vision in right eye. Still no vision 22Mar2021 (under doctors care) on 12Mar2021, X-ray: hip degeneration on 10Feb2021. The outcome of the events was unknown. The event torn retina was considered as serious (medically significant). Vaccination facility type was Hospital.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided, the reported torn retina is likely an intercurrent medical condition and unrelated to BNT162B2. The patient's advanced age have been assessed as a risk factor that could have contributed to the event.
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 30Mar2021 as dose 2, single (Lot number: EP7533), in left arm and on 07Dec2021 as dose 3 (booster), single (Lot number: 330308D), in left arm for covid-19 immunisation. The patient's relevant medical history included: "TTP" (unspecified if ongoing), notes: Other medical history: TTP. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive. Therapeutic measures were taken as a result of covid-19 included Paxlovid, treatment start date: 07May2022, treatment stop date: 11May2022.  Clinical course: No reaction to Booster. Took Paxlovid after testing postive for Covid. I tested negative after 4th day and then 6 days after that experienced symptoms and tested positive again.  No follow-up attempts are needed. No further information is expected
Within 30 minutes I had a headache, fatigue that lasted 2 days. I had small hives on my face starting day 2 lasting 2 days. I had a lump behind left ear that lasted 5 days. I have had ringing in my ears, louder in the left ear, since the injection, for 2 weeks now. It is quite loud and annoying. I have recovered from all side effects except the ear ringing.
Diagnosed with Bell's Palsy 2 wks after vaccination.  But I must also admit to having a cold sore about a week before the vaccination. I feel it is necessary to report both factors for accuracy.
Patient states my lip feels like it is swelling, patient lower lip with swelling noted. Patient assisted to Emergency Dept via W/C 02 sat 99%, B/P 150/88, HR 99
Hot and cold sweats all night, severe joint and muscle pain, very fatigued, did not get up all day except to urinate. It was like the worst flu ever! 4/15/21: extreme fatigue and dizziness upon getting up to walk or moving my head. Unable to concentrate on computer screen to work. but, pain and hot/cold sweats gone.
pt exp flu-like sx w/fever which lasted 3 days p/receiving Typhoid vax;
Swelling and large rash like ring around injection site that is red and irritated. No pain, just the ring, redness, swelling, and irritation. Appeared at least a week after injection.
Client received NS instead of COVID -19 vaccination.  Client was notified  and recommended to return for a correct vaccination. Client returned on 04/20/2021 and received correctly mixed Pfizer vaccination. Lot number EP7533, Intramuscular in left deltoid.
Initial misuse report received from healthcare professional on 29 July 2014. A '5-year-old' patient (no other information was provided regarding patient) had received a dose of TENIVAC and a dose of DT vaccine on an unspecified date. I.E. inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.
PATIENT STATES FEELS LIGHTHEADED AND HEART FLUTTERING. VITALS ARE BP 185/90, HR 103, RESP 20 AND O2 SAT 0F100%.  MONITOR STRIP DONE WITHA HR OF 112 AND REGULAR.  PATIENT MONITORED ANOTHER 15 MINS WITH HR OF 90 AND REGULAR. PATIENT ISTRUCTED TO GOTO EMERGENCY CLINIC IF SYMPTOMS RETURN.
no additional AE; improperly stored administered vaccines; This spontaneous report was received from a nurse and refers a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-NOV-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), dose: 0.5 milliliter, lot# S021326, expiry date: 05-JAN-2021 (dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -10.8 degrees Celsius for 1 hour 30 minutes. There were previous excursions related: -12.3 degrees Celsius for 1 hour and -10.3 degrees Celsius for 10 hours and 30 minutes. Data logger was involved. No adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA003626: US-009507513-2012USA003635: US-009507513-2012USA003631: US-009507513-2012USA003632: US-009507513-2012USA003633: US-009507513-2012USA003634: US-009507513-2012USA003618: US-009507513-2012USA003617: US-009507513-2012USA003627:
quite significant pain in the right arm/arm throbbing; redness from wrist to elbow; rash from elbow to wrist; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (quite significant pain in the right arm/arm throbbing), ERYTHEMA (redness from wrist to elbow) and RASH (rash from elbow to wrist) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Arthritis. Concomitant products included FUROSEMIDE for Blood pressure high, POTASSIUM and VITAMINS NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (quite significant pain in the right arm/arm throbbing), ERYTHEMA (redness from wrist to elbow) and RASH (rash from elbow to wrist). The patient was treated with CORTISONE for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (quite significant pain in the right arm/arm throbbing), ERYTHEMA (redness from wrist to elbow) and RASH (rash from elbow to wrist) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I was prepping for a colonoscopy at the hospital, I had ketoacidosis. In the process of being there, my chest began to hurt. They did a chest x-ray and it showed I had pneumonia. I did not know I had pneumonia. I was in the hospital from 06-28-2021 till 07-01-2021.  I was surprised I had pneumonia. They did a Covid test and I was negative.  I will have a follow up with my doctor. I still have a cold and some breathing difficulty.
after the vaccine I've had two miscarriages.  unable to stay pregnant; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 27-year-old female patient (not pregnant) 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: Covid-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 Immunization.  The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "after the vaccine I've had two miscarriages.  unable to stay pregnant". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: unknown.  Clinical course:  She had three kids. Now all of a sudden after the vaccine she had two miscarriages. unable to stay pregnant. Covid-19 was not prior to vaccination and covid-19 was tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported event abortion and the suspect product BNT162B2 cannot be ruled out.  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.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was  refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State  for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
arm started turning red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm started turning red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERYTHEMA (arm started turning red). At the time of the report, ERYTHEMA (arm started turning red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 13-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (product name reported as "HPV; SDV;10-pack"; lot # J009243, expiration date of 23-APR-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion six times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and type of excursion (R/F) for each time were 112, 34 and R; 784, 33 and R; 488, 32 and R; 64, 31 and R; 72, 28 and R; 40, unknown and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (PFIZER COVID-19 VACCINE), as dose number unknown, single (Lot number: FH8030), as dose number unknown, single (Lot number: EW0171) and as dose number unknown, single (Lot number: EP6955) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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. Conclusion: The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FH8030, fill lot FH4343, and the formulated drug product lot FA9187. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Conclusion: The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0171, fill lot EP8702, and formulated drug product lot EP8604. A complaint sample was not returned. No related quality issues were identified during the investigation that had potential to impact product quality. All release testing performed prior to the release of the reported batch was within specifications. No root cause were identified. The controls in place were determined to be sufficient in order to prevent complaints of this nature. Conclusion: The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Hearing faded in both ears. Like ears stuffed up and ringing in both. Next day seen by doctor and said they showed no infection. Today feels better but still has ringing but volume coming back. Irritated by noise.
Client c/of nausea and dizziness.  states that she hand's had anything to eat since am.  client started having symptom after getting out of car to walk her dog.  Pt voice that she suffers from panic disorder and was having an episode.  Pt assessed, vital signs are as follows:  BP 130/84, HR 80, O2 97%.  Client cleared to go home after stating she felt better.
Petechiae - Rash to body - Platelet count 39 (7/5/11) down from 453 6/17/11.
Patient 9 y/o received wrong dose of Pfizer vaccine; patient received six months to four years old Pfizer vaccine.
accidentally cut themselves with a kitchen knife and lost 1.5 pints of blood; normal aching at the site where it was administered; slowly spread though their body and has stayed with them since the first shot; constipated; nauseous; having occasional fever and chills; having occasional fever and chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (slowly spread though their body and has stayed with them since the first shot), CONSTIPATION (constipated), SKIN LACERATION (accidentally cut themselves with a kitchen knife and lost 1.5 pints of blood), VACCINATION SITE PAIN (normal aching at the site where it was administered) and NAUSEA (nauseous) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced CONSTIPATION (constipated), NAUSEA (nauseous), PYREXIA (having occasional fever and chills) and CHILLS (having occasional fever and chills). On 17-Nov-2021, the patient experienced PAIN (slowly spread though their body and has stayed with them since the first shot) and VACCINATION SITE PAIN (normal aching at the site where it was administered). On an unknown date, the patient experienced SKIN LACERATION (accidentally cut themselves with a kitchen knife and lost 1.5 pints of blood). At the time of the report, PAIN (slowly spread though their body and has stayed with them since the first shot), CONSTIPATION (constipated), VACCINATION SITE PAIN (normal aching at the site where it was administered), NAUSEA (nauseous), PYREXIA (having occasional fever and chills) and CHILLS (having occasional fever and chills) was resolving and SKIN LACERATION (accidentally cut themselves with a kitchen knife and lost 1.5 pints of blood) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  It was reported that, 1-2 weeks later the patient started feeling nauseous, constipated, and had occasional fever and chills. The fever never registered as a temperature, but it felt like they were burning up. This continued and gradually built up until 2 weeks before receiving the second dose of the vaccine when he accidentally cut themselves with a kitchen knife and lost 1.5 pints of blood.   The patient was treated with unspecified supplements and pain killers.   This case was linked to MOD-2022-553156.
Lymphadenopathy axillary; supra clavicular lymphadenopathy; edema of chest wall and axilla.