chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  COVID infection following COVID vaccine series 02/25, Pfizer, dose #1 03/18, Pfizer, dose #2 09/17, Pfizer, dose #3 09/01 pt admit to medicine cc: 3-4 weeks watery diarrhea, SOB, generalized weakness, and nasal congestion dx: COVID PNA los: 8 days 09/01 pt cc: fatigue, dyspnea exposure: unknown 09/01 ABG result: i-pH 7.41, i-PC02 35.1, i-P02 53, i-HCO3 22.2 09/01 FIBRINOGEN 515 09/01 TROPONIN I <0.016 09/01 DDIMER 0.25 09/01 FERRITIN 998.7 09/02 FIBRINOGEN: 528 09/02 DDIMER: 0.43 09/02 ESR 60 09/03 FIBRINOGEN: 414 09/03 DDIMER: 0.53 09/03 ESR 39 09/04 FIBRINOGEN: 359 09/04 DDIMER: 0.66 09/04 ESR 31 09/05 FIBRINOGEN: 308 09/05 DDIMER: 0.96 09/05 ESR 21 09/06 FIBRINOGEN: 258 09/06 DDIMER: 25.90 09/06 ESR 27 09/06 DDIMER 0.69 09/07 FIBRINOGEN: 271 09/07 DDIMER: 0.84 09/07 ESR 23 09/07 procalcitonin <0.05 09/08 FIBRINOGEN: 261 09/08 DDIMER: 0.76 09/08 ESR 18 09/09 ESR 16 09/09 DDIMER 0.69 09/13 clinically resolved 09/17 COVID swab, result: detected 09/17 SARS-COV-2 Variant Sequencing result: pending
Approximately 8-9 hours after injection: Extreme fatigue, Headache, Body Aches. Approximately 20 hours after Injection: Extreme Fatigue, Headache, Body Aches, Injection site pain, muscle and bone pain, dizzy/off balance. Approximately 24 hours after injection: Extreme Fatigue, Headache, Body Aches, Injection site pain, muscle and bone pain, dizzy/off balance, and Fever.
Dizziness, constantly tired, nausea,  room spins when I stand up, I have fainted twice, constant migraine (I have had it for 14 days now) , often very weak,
Expired dose/received expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose/received expired doses) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose/received expired doses). On 30-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose/received expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported. The treatment information was  not provided.  Action taken with the drug in response to events was not applicable.
18 y/o F with PMHx of anxiety and panic attacks began to have upper extremity stiffening, wrist extension and absent stare x 20 seconds. She became incontinent and lost postural tone shortly after. She states that she was very anxious about getting the vaccine; states that came into the parking lot of the facility yesterday and "psyched [herself] out" so much that she could not come in to get vaccinated. She was evaluated by EMS and clinical leads. Mother states that she tends to have a lot of panic attacks but has never had a reaction like this. Patient's mother also states that she is seeing a therapist for her anxiety and panic attacks but is not currently on any medications.
On 5/2/00, the pt developed multiple (45) pox marks on the abdomen, chest, back and buttocks.
TEMP103LN,VOMITING,URI.sYMPTOMS STARTED IN THE PM AFTER SHOTS.
Muscle pain relief; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Muscle pain relief) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Muscle pain relief). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Muscle pain relief) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Administered vaccine after 8 hours of refrigeration instead of 6 hours; A spontaneous report was received from a physician concerning a 36-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered vaccine after 8 hours of refrigeration instead of 6 hours.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A, Exp. date: 25 May 2021) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient was administered with a vaccine dose that had been stored in the refrigerator for 8 hours due to a misunderstanding with the instructions. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine after 8 hours of refrigeration instead of 6 hours, was considered resolved on 31 Dec 2020.; Reporter's Comments: This report refers to a case of 36- year-old female patient who experienced non-serious unexpected event of patient was administered vaccine after 8 hours of refrigeration instead of 6 hours.(Expired product administered) for mRNA-1273, lot # 025J20A, Exp. date: 25 -May -021. There were no reported AEs associated with this case of administered vaccine after 8 hours of refrigeration instead of 6 hours.
This spontaneous report as received from a pharmacist refers to currently 61 years old female patient with no pertinent medical history. On unknown date (reported as "more than 10 years ago"), the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. Pharmacist reported that the patient's recent (date unspecified) hepatitis b titer came back negative. No treatment information was reported. It was reported that the patient saw physician. At the time of the report, the patient's outcome was unknown. The relatedness for the patient's event was unknown for RECOMBIVAX HB. Additional information has been requested.
Sickest I have ever been for 12-24 hours. Aches, chills, bones and joints hurt. Mild fever, severe headache. Body felt like it was on fire.  Fatigue, lethargy and weakness.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M007960 with expiration date 15-AUG-2017, therapy type rHA; Lot # M015700 with expiration date 26-SEP-2017, therapy type rHA; dose unknown, subcutaneous). It was reported that the vaccine was improperly stored at -13.5 Celsius degree (C) for 2 hours 9 minutes and at -14.7 C for 56 minutes and then was back in range. There was no previous temperature excursion. Data logger was involved. No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
patient presented to hospital 5-12-21 with expressive aphasia,right facial droop, MRI Brain showed acute left frontal/anterior MCA infarct and left M2 thrombus. He underwent successful endovascular thrombectomy.  echocardiogram revealed small patent foramen ovale. Cardiologist did not feel this was the source of thrombus. carotid work up negative and 30 day event monitor negative for Atrial Fibrillation.
5 days post vax pt developed a low fever. Pt was treated with Motrin. Awakened the next day with a low fever and was given more Motrin. At noon that day fever was 102.3 axillary, pt was given another dose of Motrin then had a seizure at approximately 12:30.
Patient came to pick up her medication and her arm was bruised from the flu shot. Patient is a nurse and stated the intern gave the shot too low  and gave it too anterior in the arm and after that it has been burning and has limited mobility and there is a bruise. She has been putting some ice on the arm and taking ibuprofen. Pain is relived and is getting better. She does not see the urge to go to the emergency room. She will contact us if she does not get better
severe dehydration from vomiting; severe dehydration from vomiting; very bad headache; body aches; was going from shivering to over heating; esophagitis; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in the right arm on 29Mar2021 16:00 (Batch/Lot Number: EP6955) as single dose (at the age of 30-years-old) for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient was negative for the nasal swab on 03Mar2021. The patient received the first dose of BNT162B2 intramuscularly on the right arm on 08Mar2021 16:00 (at the age of 30-years-old) for COVID-19 immunization. The patient had no other medication in two weeks and no other vaccine in four weeks. The patient had no COVID prior to vaccination. After about 4 hours of receiving second dose (29Mar2021, 19:00), the patient had a very bad headache, body aches, and was going for shivering to overheating. She began to vomit non-stop, couldn't keep food or liquids down. She ended up going to urgent care on 30Mar2021 and was sent to the ER.  She was admitted to the hospital on that day for severe dehydration from vomiting and was told she had esophagitis. The adverse events resulted in doctor or healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized for three days. The patient received unspecified IV's, medications and had scans (unknown results). The patient was recovering from the events.; Sender's Comments: The events was considered related to suspect vaccine BNT162B2 based on strong temporal association and known safety profile of the drug. however, Relevant medical history and concurrent disease are missing for a medically meaningful assessment.  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 RAs, Ethics Committees, and Investigators, as appropriate
Painful lesion left side of face near mouth x 5 days. Treated with oral antiviral and antibiotics and topical steroids as well as NSAID for lymphadenopathy.
pain under my tongue on the right side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 12Mar2021 (Lot number: EN6202) at the age of 26 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "PCOS" (unspecified if ongoing). Concomitant medication(s) included: JUNEL FE 1/20. The following information was reported: GLOSSODYNIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "pain under my tongue on the right side". Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. The event occurred a few hours after receiving the first dose and resolved on its own a day later.  No follow-up attempts are possible. No further information is expected.
Patient felt dizziness. Onsite EMS was called vitals BP 180/106  98% O2 HR 104. Patient Refused evaluation or care. Released against medical advise.
Depression; anxiety; anger; Feeling of hopelessness; Feeling of worthlessness; Feeling of Despair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jul2021 13:00 (Lot number: EW0196) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DEPRESSION (non-serious) with onset 22Jul2021 15:00, outcome "recovered", described as "Depression"; ANXIETY (non-serious) with onset 22Jul2021 15:00, outcome "recovered", described as "anxiety"; ANGER (non-serious) with onset 22Jul2021 15:00, outcome "recovered", described as "anger"; FEELING ABNORMAL (non-serious) with onset 22Jul2021 15:00, outcome "recovered", described as "Feeling of hopelessness"; FEELINGS OF WORTHLESSNESS (non-serious) with onset 22Jul2021 15:00, outcome "recovered", described as "Feeling of worthlessness"; FEELING OF DESPAIR (non-serious) with onset 22Jul2021 15:00, outcome "recovered", described as "Feeling of Despair". The events "depression", "anxiety", "anger", "feeling of hopelessness", "feeling of worthlessness" and "feeling of despair" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of depression, anxiety, feeling of despair.   Additional information: Depression, anxiety and anger with the first shot. This lasted for two weeks. The feeling of hopelessness, worthlessness and despair. The second shot had only physical side effects. Restless legs, the feeling of sunburnt skin, rash, fever, restlessness, fatigue and a week of headaches. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient doesn't have any allergies and there is no medical history.  No follow-up attempts are possible. No further information is expected.
First DaY immediately after the shot: Strong itching around mouth;  40 minutes later: runny nose; strong sense of back of throat and esophagus  burning; sensation in lungs like...pulsing slight burn--If you can imagines a sparkler (yep, the kind from the 4th of July) being in your lungs that is only a little painful, more like a wiggle, than  a painful sensation, that would describe it. 2nd day: really tired by 4PM, feeling feverish. Very tired . Tired enough that I accidentally  left the house for a job interview wearing one white sock and one black sock. Which isn't normal for me. 3rd day: muscle aches. 4th days feels like a really mild virus.   This is not me but another person from  my former job said she had spontaneous canker sores from the Pfizer shot.
Flu-like symptoms; Fatigue; Aches; Nausea; feeling "icky and blah; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, fatigue, pain, nausea and feeling abnormal. On an unknown date, the outcome of the influenza-like symptoms was unknown and the outcome of the fatigue, pain, nausea and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fatigue, pain, nausea and feeling abnormal to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The age group was captured as adult as per Shingrix indication.  The reporter reported that a number of patients (exact number unknown) had reported flu-like symptoms after having Shingrix.  The side effects include fatigue (feeling "icky and blah"), aches, and nausea that usually resolve about 48 hours after receiving the vaccine. The reporter gave permission to follow up.
ACUTE NON ST ELEVATION MI 4/6/2021 HYPERLIPIDEMIA  ACUTE NON ST ELEVATION MI 4/6/2021 ATHEROSCLEROSIS OF AORTA
9/5/22 pt brought to hospital with CP; found to have severe two-vessel CAD; recommended surgical revascularization; taken to cath lab; developed hypoxia; O2 supplementation; respiratory status worsened; pt developed fever; 9/10/22 found to be positive for COVID; ICU; intubated; suffered PEA arrest; ECG showed possible distal apical septal free wall rupture; taken to OR; became bradycardic; asystole; ACLS with success
itching; nausea; bad chills; back pain; fever; aching; joint pain; fatigue; vomiting; body temperature 102.4F; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain), FATIGUE (fatigue), VOMITING (vomiting), PYREXIA (body temperature 102.4F) and CHILLS (bad chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Factor V deficiency, Diabetes and Hemophilia (1977 the patient was diagnose with hemophilia) in 1977. Concomitant products included WARFARIN for Factor V deficiency.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced ARTHRALGIA (joint pain), FATIGUE (fatigue), VOMITING (vomiting), PYREXIA (body temperature 102.4F), BACK PAIN (back pain), PYREXIA (fever) and PAIN IN EXTREMITY (aching). On 22-Jan-2021, the patient experienced CHILLS (bad chills). On an unknown date, the patient experienced PRURITUS (itching) and NAUSEA (nausea). On 23-Jan-2021, CHILLS (bad chills) had resolved. At the time of the report, ARTHRALGIA (joint pain), FATIGUE (fatigue), BACK PAIN (back pain), PYREXIA (fever), PAIN IN EXTREMITY (aching), PRURITUS (itching) and NAUSEA (nausea) outcome was unknown and VOMITING (vomiting) and PYREXIA (body temperature 102.4F) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
A week later I started with a very bad headache and both arms were in pain and I was given steroids' on both arms, I would get super cold and it was a cold that I had never experience in my life and that lasted two weeks, The headaches were unbelievable, I was very weak and no energy at all. It was something hard to describe, My left arm was extremely sore. I now have joint pain and I went to Cancer Specialists. I got done a lot of labs that I don't remember the names, and I was also seen by Clinic and I had to get HIV test, and more special labs, results came back negative. white cells came back elevated. I still have headaches and a lot of joint pain on both arms.
Within 12 hours of receiving the 2nd COVID-19 dose, Patient lost color in his face, extreme lethargy and malaise,  headache, fever of 99.6 degrees, nausea, and eventual vomiting.  Symptoms lasted 24 hours and caused him to remain home from school.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age,. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck), lot # L005299, expiry date 17-FEB-2016. Temperature 0.2 degree centigrade for 5.5 hours and there was no previous excursion and it was administered. This is one of the 4 reports received from the same reporter. Additional information has been requested.
SWOLLEN GLANDS IN JAW; HEADACHE WAS AFFECTING BOTH SIDES OF THE HEAD; FATIGUE; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: E04AZ1A,  expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced swollen glands in jaw. On 18-MAY-2021, the subject experienced headache was affecting both sides of the head. On 18-MAY-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache was affecting both sides of the head, fatigue, and swollen glands in jaw. This report was non-serious.
I had them even I had a shot/Suspected vaccination failure; I had them, not so good; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, he/she had the shingles even though he/she had a shingles shot already. The reporter stated that, it was not so good. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Received varicella vaccine done #1 on 8/10/04. Developed fever, headache, pox rash (chicken pox disease) 8/29/04.
Adacel injection that had been frozen in a prior temperature excursion reached 27 fahrenheit making the doses not suitable for use which was administered to a female patient /No AE; Initial information received on 15-May-2019 regarding an unsolicited valid non-serious case received from a consumer.   This case is linked to case 2019SA135518 (male patient).   This case involves a 37 years old female patient who was injection a 0.5ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot C5602AA via unknown route in the left deltoid on 10-May-2019 that had been frozen in a prior temperature excursion reached 27 Fahrenheit making the doses not suitable for use.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to product storage error.  No side effects reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.