chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine on 03 Nov 2021, from vial stored in refrigerator on 23 Sep 2021; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Administered vaccine on 03 Nov 2021, from vial stored in refrigerator on 23 Sep 2021) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine on 03 Nov 2021, from vial stored in refrigerator on 23 Sep 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Administered vaccine on 03 Nov 2021, from vial stored in refrigerator on 23 Sep 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. HCP stated that there was a confusion between the expiration date printed in the carton the expiration date when the QR code was scanned.The vial was placed in the refrigerator was on 23 Sep 2021.Vial did not undergone any temperature excursion. No adverse event was reported. No treatment medications were reported.
10/12/2005 approx 12:30pm began having fever of 99.0F, fevers continued ranging from 99 max of 103 on 10/13/2005 at 10:30pm mother alternated Tylenol with Ibuprofen. At no time did Pt have any other symptoms. Pt was seen in office on 10/14/2005 with temp of 101.3.
Headache, muscle/joint ache.  Chills/sweating.  Upset stomach.  Tired!!!!
Pt vaccinated with DTP/OPV four hrs later turned ash white & stopped breathing. After shaking him he started to cry & resumed breathing. Every time he stopped crying he would stop breathing again. He stopped breathing 10-15 times.
Six days after receiving flu vaccine I developed a bad Hives/Rash all over my left arm.  The rash then also covered my right arm.  It lasted for approximately 7 days.
allergic to the product; Initial information received on 09-Nov-2023 regarding an unsolicited valid non-serious case received from a Patient. This is a courtesy case from agency.  This case involves a 83 years old female patient who was allergic to the tetanus toxoid.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date and month in 1962, the patient received a dose of suspect tetanus toxoid produced by unknown manufacturer site (lot number, route, administration , dose, formulation, strength and expiration date: not provided) for Immunisation.  On an unknown date the patient was allergic to the product (allergy to vaccine) (unknown latency) following the administration of tetanus toxoid.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
I began developing symptom on 22-Jun-2022 which began with general malaise and lack of appetite. The symptoms progressed to somnolence, cough, nasal congestion and fever the following day. I tested positive for COVID with a home nasal swab test on 24-Jun-2022. As of 6/30/2022, I was free of symptoms. I had the 2 vaccine series as well as the booster dose.
BLOOD CLOT; SWOLLEN LEGS; This spontaneous report received from a patient concerned a female of unspecified age, and unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown)1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient believed that she had blood clots due to having swollen legs and all the other symptoms of it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and swollen legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211020575-covid-19 vaccine ad26.cov2.s -Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium
Heart pain and palpitations; Tachycardia; blurred vision; confusion; dizziness; vomiting; nausea; weakness; loss of appetite; couldn't form a sentence; Heart pain and palpitations; severe headaches; severe head pressure; severe ear pressure; internal tremors; chest pain; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Ep 2533, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 15Apr2021 (at the age of 43-year-old) as dose 2, single for covid-19 immunization. Medical history included psoriasis from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient had previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: er 2613, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 24Mar2021 (at the age of 43-year-old) as dose 1, single for covid-19 immunization. On 12May2021 the patient experienced heart pain and palpitations, tachycardia, blurred vision, confusion, dizziness, vomiting, nausea, weakness, loss of appetite, couldn't form a sentence, heart pain and palpitations, severe headaches, severe head pressure, severe ear pressure, internal tremors, chest pain. The patient was hospitalized for 2 days. On an unspecified date the patient underwent lab tests and procedures which included blood test: unknown result, computerized tomogram: unknown result, covid-19: unknown result. The patient was received treatment for the resulted events. Ae resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The clinical outcome of events was not recovered.  Information on the Lot/batch number has been requested.
Life threatening circumstances; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a female patient who received DTP (A or W not known) (DTP (A or W not known)) for prophylaxis.   On an unknown date, the patient received the 1st dose of DTP (A or W not known). On an unknown date, unknown after receiving DTP (A or W not known), the patient experienced adverse event (serious criteria life threatening). On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to DTP (A or W not known).  Additional details were provided as follows: The reporter was patient's parent. The age at vaccination was not reported. The patient had life threatening circumstances following her 1st dose of DTP vaccine and her pediatrician said it would become a fatal event if she ever received the "P" part of the vaccine again. This case is 1 of the 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR254860:Same reporter US-GLAXOSMITHKLINE-US2020AMR254861:Same reporter US-GLAXOSMITHKLINE-US2020AMR254863:Same reporter
Patient seen in clinic on 6/15 with sore throat, congestion, sneezing, coughing, and chills and tested positive for COVID-19 by PCR testing. On 6/16 she was seen in the ED for hypoxia and was ultimately admitted to the hospital from 6/16-6/21 with acute on chronic hypoxemic respiratory failure and COVID-19 pneumonia. She has a history of COPD. This meets criteria for vaccine breakthrough case review.
5 days after my friends brother took the vaccine he died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (5 days after my friends brother took the vaccine he died) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Company Comment: This case concerns a male patient (age not provided) with no relevant medical history, who experienced the unexpected event of Death. The event occurred approximately 5 days after a dose of mRNA-1273 (Moderna Covid-19 vaccine); It's unknow if it was the first or second dose. The rechallenge was not applicable. Limited information provided precludes a complete medical or causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-369784 (E2B Linked Report).; Sender's Comments: This case concerns a male patient (age not provided) with no relevant medical history, who experienced the unexpected event of Death. The event occurred approximately 5 days after a dose of mRNA-1273 (Moderna Covid-19 vaccine); It's unknow if it was the first or second dose. The rechallenge was not applicable. Limited information provided precludes a complete medical or causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report. US-MODERNATX, INC.-MOD-2021-369784:MOD21-158695/Same reporter; Reported Cause(s) of Death: brother took the vaccine he died
had a temp starting 7NOV97 until 12DEC97;leg swelled up on 7NOV(7 it was blue & as large as a small apple;could not walk properly for 6wk;pt taken to MD;
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No medical history or concurrent condition were reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose, route were not reported). Other suspect therapies included Tdap (lot number, expiry date, dose, route were not reported). No concomitant medications were reported. On an unknown date (reported as "couple of weeks post administration of vaccine products"), the patient was hospitalized for an unspecified emergency surgical procedure. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review the event was considered to be medically significant. Additional information has been requested.
Patient was administered vaccine and told to wait the 15 minute monitoring period. After about 4 minutes, I heard her say "I'm not feeling right." I went to where she was sitting and asked "are you ok?" and had her take some slow, deep breaths. I then saw her eyes roll back and she lost consciousness. Thankfully, I was there and grabbed her as she toppled from the chair. I told the staff to call 911 and supported her neck and body in the chair. I could tell she was breathing and she was sweating profusely. I held her and spoke to her, and after about 15 seconds, she began to come out of it. After about a minute she was alert and orientated again.  I had her slowly sip a little water. The EMTs arrived in about 5 minutes and the assessed her vitals. She indicated that this was the first time anything like this had happened to her. They advised that since she had fainted, she should go to the hospital for observation, but she declined, stated that she felt fine at that point. Since she was driving, I insisted that she remain another one-half hour before leaving. During that time she drank more water and alternately sat and walked around the pharmacy. She did indicate that she had drank a protein shake that morning, but not eaten. I advised her to in the future, tell her doctor and/or any immunizer about the event. She left, stating that she was feeling fine, and I called her several hours later to make sure that she had indeed gotten home ok. She again said that she felt fine.
Pt. received HIBERIX to R thigh on 1/8/10, that evening had vomiting. Next am large 6 cm area of redness at vaccine site. Redness slowly resolved but area still bruised, and overlying dry, crusty skin. Feels like a calcified hematoma under injection site.
Heart jump to 180s. ?Reduced? to 150-160s for 10-15 minutes.   Doctor thinks it was heart palpitations and supraventricular tachycardia (SVT).
Pt recvd 1st dose of Hep B vax 03OCT89 & later devel bilateral diffuse hand pain,which was worse @ night.P/ 2nd vax 16NOV89 joint pain worsened.Tx w/ ibuprofen & naproxen.
11-10-18 Pt states 2 days after flu immunization and hasn't resolved is a very deep pain that radiates down to his thumb.no swelling, or redness. Neither ibuprofen or heat alleviate the pain. I suggested topical lidocaine and visit doctor for further examination.
mom states pt screamed for least 4 hrs p/vax; states temp OK; took to MD; cold packs in sore leg;
Patient experienced swollen face the night of the day of administration. Patient went to ER and was given BENADRYL and prednisolone.
Injection site red and hard circle the size of a quarter, left upper arm and shoulder all the way to neck painful with pain shooting down to hand at times-- this was day after shot and the next day, greatly improved 3rd day then ok. Used hydorcortisone cream on injection site and ASPERCREAM type product on arm/shoulder. The day after shot had great muscle/joint pain and stiffness, extra fatigue. Improved the next day and back to my normal chronic symptoms after that. Took TYLENOL or ibuprofen one pill once a day since I have trouble with those, took CBD I normally do not use.
15 minutes after injection, a syncopal episode occurred while sitting down. I awoke after a few seconds and I was transported to the nearest emergency room and an ECG was done with no abnormal findings. I was cleared and released.
The patient called and stated that upon ambulating this morning, his left leg "feels like it's going to give out on me when I stand on it." The patient claims that he has had no changes in his daily regimen, no new medications, and is not taking any medications that he can reasonably attribute to this possible side effect. I advised the patient to complete the CDC V-Safe form provided with his vaccine, and to contact his primary healthcare provider as soon as possible to seek guidance for assessment and treatment. Additionally, we will contact the CDC for further guidance and appropriate parties will reach out to the patient as more information becomes available.
Fever over 104 for 2 days. Fever above 101 for 2 days. Respiratory issues such as asthma started a day after injection. Major erection reported within 6 hours after injection. Same thing happen with the 2 prior injections. Patient is very tired and feels like his mind in in a fog. No loss of smell. Major chills and body akes. As of October 25, 2021 patient is in excellent shape but has not returned to normal activity.
redness around injection site, hives, hot to touch, itchy, swollen, pain when pressure. Benedryl orally, topically. Still within 24 hours of onset of symptoms. ?Covid arm?
swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "not recovered", described as "swollen lymph nodes".  Additional information: It was reported that, the patient still experiencing lymph nodes before getting the second dose. She still feels swollen lymph nodes. Patient wanted to know if she could take the second dose with a lymph node. No unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt had Hep B vax #2 24SEP92 & c/o febrile condition on 27SEP92 which began in PM w/t101 oral;  pt then took ASA which alleviated sx; 28SEP awoke again w/t101 then took Nyquil;
pt called in morning of 18OCT95 reporting onset of sore arm @ site devel evening of 17OCT95; w/down towards waist, to back of lt shoulder; general tenderness w/o swelling or redness x/ @ inj site;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 10:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 10:30 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's age was reported as 72.43 years. No concomitant medications were reported. This vial was moved to fridge on 08-Jan-2021. Product moved to clinic on 12-Jan-2021. Batch number 041L20A was administered on 12-Jan-2021 underwent temperature excursion with temperature of 34 degrees Fahrenheit at 08:00 am and 09:00 am. Beyond use date for the vial was reported as 07-Feb-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Vision changed can not see well with glasses on. If I remove my glasses my vision is better.; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unknown route of administration in the right arm (at the age of 53-year-old), as a single dose on 18Mar2021 at 07:30 for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was allergic to codeine. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 18Mar2021 at 11:00, the patient vision had changed, could not see well with glasses on and the vision was better if glasses removed. The patient cleaned and checked glasses. No therapeutic measures were taken for the event. The clinical outcome of the event was reported as not recovered.   Information about lot number cannot be obtained. No further information is expected.
1:28 Localized itching & mild redness just under vaccine site (left arm only), patient was given 60mg fexofenadine orally, vitals were stable (hr 82, pulse ox 99%, bp 110/60), no other symptoms. By 1:39pm itchiness improved. By 1:45pm redness resolved & itchiness fully resolved. No other symptoms.
A report has been received from a Pharmacist concerning a 54 year old patient of unknown gender, who had been receiving nasal FLUMIST Quadrivalent. The patient's medical history included obstructive sleep apnea. The patient's concurrent disease(s) included hypertension, Hyperlipidemia and Paroxymal atrial fibrillation. Concomitant medications included Atorvastatin, Gemfibrozil, Acetylsalicylic acid,, fish oil, Vit B1 in comb w/Vit B6 and B12, Guaifenesin, Levaquin, Ubidecarenone and Diltiazem. FLUMIST Quadrivalent started on an unknown date. it was reported that 54 year old patient received FLUMIST Quadrivalent. The outcome of the event of 54 year old patient received FLUMIST Quadrivalent is unknown. The report was considered to be non-serious.
3 months after being fully vaccinated came down with Shingles.  I was reading that this was happening, and wanted to make sure that I reported this event.  two weeks of severe pain on right side then 3 patches of shingles rash, Started antivirals and finished a 7 day course and now it is resolved.  no more pain or rash
?Moderna COVID-19 Vaccine EUA? Redness at and around site, swelling of site, pain at site, fatigue in arm, itching and and around site, swollen regional lymph nodes(clavicle).
PAIN IN NECK; RUNNY NOSE; PAIN IN BOTH ARMS; This spontaneous report received from a patient concerned an 81 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non-smoker, penicillin allergy, sulfa allergy, arthritis, incontinence, and cataracts, and other pre-existing medical conditions included patient did not have any drug abuse/illicit drug use. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced pain in neck. On 09-APR-2021, the subject experienced runny nose. On 09-APR-2021, the subject experienced pain in both arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in both arms, pain in neck, and runny nose. This report was non-serious.