chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid-19; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (Covid-19) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 007A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 12-Jan-2021, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were given to the patient. The patient received monoclonal antibodies none days after vaccine administration.   This case was linked to MOD-2021-011079 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: email, address, birth date, product start date and batch number updated; Reporter's Comments: This case concerns a female of unknown age who experienced aa serious unexpected event of COVID-19.  The event occurred 6 days after the first dose of mRNA-1273 and was treated with monoclonal antibody infusion. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
A consumer report has been received. The report concerns a 2 year old, male consumer, who had been receiving FLUMIST (intranasal), 0.2 Millilitres, daily. FLUMIST (intranasal) started on 22-Oct-2014. The patient experienced fever which started on 19-Oct-2014. The outcome of fever is unknown. The report was considered to be non-serious.
A physician reported that a 63 year old female received tetanus toxoid 45 years ago and subsequently developed fever and hallucinations. No further information is available.
Fever 100.9 for 5 days.   Muscle aches, chills, headache.   Arm pain entire left arm.
She developed redness and swelling covering almost her entire left anterior thigh within 6-8 hours of receiving DTaP, IPV, and MMR.  Nurse follow up on 07/13/04 states: "No new information."  Nurse follow up on 08/09/04 states: "cellulitis; fever; vomiting; otitis media; pneumonia."
Patient experienced a rash and pruritus that began on her left side/waist and left arm. She was advised to treat with diphenhydramine and hydrocortisone cream but had no relief. By 4/22/2021 the rash was all over her body and was not responding to either creams. Patient was advised to be seen by her doctor, urgent care or ED.
Information has been received from a mother (a medical assistant) concerning her 22 week old daughter who on 05-DEC-2007 was vaccinated with PedvaxHIB (lot # not reported). Concomitant therapy also given on 05-DEC-2007, included DTAP-IPV (manufacturer unknown), IPOL, Pneumovax (manufacturer unknown), and Rotateq. On 05-DEC-2007, her daughter developed at injection site lump, and injection site redness after being vaccinated with PedvaxHIB. The child was seen by a nurse in the office. She also developed a fever. She was treated with warm compresses. At the time of reporting, the patient had not recovered. Additional information has been requested. 02/18/09 This is in follow-up to report(s) previously submitted on 02/18/2008. Follow-up information was received from the physician's practice. "The patient's parent informed that the vaccine had nothing to do with the report because we don't carry that in our office, regular HIB was given only". No additional information is expected.
Information has been received from a registered nurse concerning a 21 year old female who on an unspecified date was vaccinated with Gardasil (lot # not reported) 0.7 ml IM injection. The physician reported that when she went to administer the vaccine to the patient, the vaccine delivered 0.7ml as opposed to 0.5 ml. Subsequently the patient experienced dizzy spells; work-up was negative. The physician reported that the dizzy spells were not related to Gardasil but to dehydration. No further information was available at the time of reporting. Additional information is not expected.
#Myopericarditis  Patient with significant hx of SOB, presenting with progressive worsening of DOE and new pleuritic chest pain. Low c/f ACS given pt with atypical prolonged chest pain, pt without significant vascular risk factor, and EKG without ischemic changes. Low c/f tamponade given pt without clinical features,  pulsus of 8, and bedside u/s with collapsible IVC. Low c/f HF given normal NTproBNP, no LE swelling, and no c/f volume overload on CT PE. Overall highest suspicion for myopericarditis given pleuritic chest pain, and pericardial effusion. Unclear what precipitated pericarditis but consider viral process vs underlying autoimmune etiology. Ischemic workup unremarkable. CRP elevated to 251.6, ESR 98. Respiratory viral panel was negative. Consulted rheumatology to consider autoimmune physiology, workup was unremarkable. ANA negative, ANCA negative, TSH wnl. SS-A/SS-B, CCP, Syphilis, TspotTB, Cortisol AM wnl. TTE on 2/1/22 showed normal biventricular size and function.  Small pericardial effusion with echocardiographic signs suggestive of effusive constrictive physiology. Cardiac MRI showed findings consistent with pericardial inflammation, without evidence of constrictive physiology. - continue colchicine 0.6mg TID for three months  - continue indomethacin 50mg TID for 2 weeks followed by indomethacin 25mg TID for 2 weeks - continue famotidine 20mg BID
THE PATIENT'S FATHER DESCRIBED THE ADVERSE  EVENT ON 11/18/2020. HE STATED THAT PATIENT STARTED HAVING SEIZURES THE DAY AFTER RECEIVING THE FLU VACCINATION. HE STATED THAT WAS NOT UNUSUAL FOR PATIENT TO HAVE SEIZURES AFTER RECEIVING  A VACCINATION. IT HAD HAPPENED BEFORE WITH OTHER VACCINATIONS. HOWEVER, AFTER RECEIVING THE FLUZONE QUAD PF ON 10/24/2020 SHE HAD A SEIZURE EVENT AND CONTINUED TO HAVE UNCONTROLLABLE SEIZURE FOR THE NEXT SEVERAL DAYS. THE FATHER STATED THE PATIENT WAS HOSPITALIZED DUE TO THE SEIZURES.
Felt faint, stated feeling sweaty then wanted water, pulse was regular, skin warm; within 3-5 minutes was observed with rigidity and seizure-like activity. Laid on floor and unresponsive for about 15 seconds, then recovered and became alert spontaneously within 10 minutes. Observed for additional 30-40 minutes.
On first injection (3 months ago) I only experienced extreme soreness in the arm. With this injections, I developed a fever of over 101, chills, headache, nausea and stomach pain within 12 hours of receiving the vaccine at 9:30 am.  The fever and other symptoms had diminished by 8 am the following morning with acetaminophen.  All symptoms, without additional medication, appear to have been within 48 hours.
This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Die from the vax) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 2021 The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication provided. No treatment information mentioned. Reporter mentioned 2 friends in their 40s who died after the vaccine. Both were healthy, one was forced to take it or would lose their job. Company comment: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced unexpected, medically significant Death, which occurred at an unknown time with regards to vaccination with mRNA-1273. No further information was provided. The cause of death is unknown, and no autopsy result was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced unexpected, medically significant Death, which occurred at an unknown time with regards to vaccination with mRNA-1273. No further information was provided. The cause of death is unknown, and no autopsy result was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reported Cause(s) of Death: Unknown cause of death.
Urine Smelled Bad; Initial Report Received on 04-May-2021  A pharmacy intern reported that a 73 year-old female (race and ethnicity not provided) was administered HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and her urine smelled bad 4 days after receiving the first dose of HEPLISAV-B.  No other medical history was reported.  No relevant concomitant medications were reported.    On 28-Apr-2021, the patient received the first dose of HEPLISAV-B (Lot # 934259, expiration date 28-Sep-2021 and NDC number 43528-003-05) to the right deltoid at a doctor's office.   On 03-May-2021, four days after receiving the first dose of HEPLISAV-B, the patient reported that her urine smelled bad. No other information was provided about this event and no other adverse reactions were reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Moderna Dose 4 & 5; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EL9269), on 02Mar2021 as dose 2, single (Lot number: EN6202) and on 25Sep2021 as dose 3 (booster), single (Lot number: 301307A) at the age of 37 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18May2022 as dose 4 (booster), single (Lot number: 059M21A) for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 27Sep2022 as dose 5 (booster), single (Lot number: 055F22B) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Migraines" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE, start date: Feb2022. Past drug history included: Minocycline, reaction(s): "Known allergies: Minocycline". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Sep2022, outcome "unknown", described as "Moderna Dose 4 & 5". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Dec2022) Negative, notes: two negative home tests on the evening of 05Dec2022; (07Dec2022) Negative, notes: two negative home tests on the evening of 05Dec2022 and morning of 07Dec2022; (10Dec2022) Positive, notes: on the morning of 10Dec2022 tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The patient also received other medication venlafaxine (Feb2022) in 2 weeks. The patient had known allergy with minocycline and also had other medical history of asthma, migraines.
Fever x 1.5 days. T max 102 - fever went down with anti-fever meds.
Rash sensation, nothing visible on skin; This case was reported by a consumer via interactive digital media and described the occurrence of rash 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 rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK receipt date: 12-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient recently got the shingles vaccine and now he/she had what felt like a rash sensation for the last week with nothing visible on the surface of my skin yet. Additional supportive information: The follow-up could not be possible as no contact details were available.
Patient developed intestinal intussusception on 5/26/23 after vaccination on 5/19/23.   Of note, he also had the new onset of  upper respiratory symptoms the day prior to the event (5/25) but viral testing was not done.   I am not certain if the time frame fits the vaccination but I do know that there can be an association between the rotavirus vaccine and this condition which is why I am reporting it.
Patient returned from the restroom and reported feelings of dizziness and nausea. During 15 minutes of observation, patient was in a seated position and was provided water. Syncope reaction was observed.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Flu Seasonal TIV Dresden (Influenza vaccine unspecified 2012-13 season) for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of injection site pain (patient had gotten the flu vaccine every year for the past nine years). On an unknown date, the patient received Influenza vaccine unspecified 2012-13 season. On an unknown date, less than a year after receiving Influenza vaccine unspecified 2012-13 season, the patient experienced injection site pain. Rechallenge with Influenza vaccine unspecified 2012-13 season was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine unspecified 2012-13 season. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported that she has gotten the flu vaccine every year for the past nine years and it usually hurts a little at the injection site, but resolved after a couple days. This was 6 of the 9 cases reported by the same reporter for the same patient.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE ST ELEVATION MI, INFERIOR WALL ACUTE ST ELEVATION MI, UNSPECIFIED ACUTE NON ST ELEVATION MI 1/13/2023 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
1. Whole body became weak while showering. Was losing ability to stand. Hobbled to bed and put pajamas back on.  Went to home office. Sat down at desk and became completely paralyzed, unable to move ANYTHING. Couldn't even hold head up (chin dropped to chest) and COULDN'T SPEAK. 2. EXTREME sweating began--whole face dripping. 3. Husband arrived home from grocery store and got me back into bed, 4. Husband took my blood pressure, which was down to 103/?? 5.  Paralysis lifted within a few minutes.
pt recv vax 5NOV96 & 7NOV96 pt exp fatigue & flu sx (low grade fever, myalgia, lower back pain);pt has not yet recovered;
had a large bump @ site-turned into several bumps;then had fever & rash;bumps did not blister & scab over;
I got a case of shingles rash , all over my left arm (same arm as shot), starting exactly 1 week after my vaccine. I am in good health otherwise.
This spontaneous report as received from a nurse refers multiple unspecified patients of unknown age and gender. The patient's concurrent conditions, historical conditions, concomitant medications and drug allergies/reactions were not reported. On an unknown date approximately in February 2018 (reported as on or after 02-FEB-2018) the patients were vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number N019838, expiry date 16-FEB-2019) (dosing regimen and frequency unknown) or (OMPC) PEDVAXHIB (unknown lot number and expiry date) (dosing regimen and frequency unknown) for prophylaxis (Product storage error). It was reported that the vaccines experienced a temperature excursion of 1 degrees Centigrade for 10 hours. It was reported that there no previous temperature excursion (details unspecified). No adverse effects were reported. It was reported that this case was reported due to a digital data logger. There was no product quality complaint reported.
pt recv vax; approx 4 cm erythema macule rt thigh at inject site; d;
8/13/21 pt inadvertantly received  a 3rd dose of Moderna vaccine which was NOT indicated.   8/14/21 pt complains of tiredness, lethargy, headache, maliase, chills, n/v.    8/15/21 pt complains of upset stomach and mild heache/aches
Came to ED on 5/19 with hypoxia, O2 sat 72%. Diagnosed with pneumonia on 5/9 and had taken levaquin. Admitted and placed on broad spectrum anitbiotics.  Cardiology consulted due to drop in EF to 15%. Given amiodarone and metoprolol. Had espisodes of confusion. On 5/29 HR, respirations and WBC increased. Restarted antibiotics. 5/30 tested + for COVID 19. Placed on steroids with confusion increasing. Signs of worsening renal failure. Extended family met on 6/7 and decided on comfort care.
Shortly after COVID vaccine #1 patient developed right sided tinnitus that progressed to bilateral.  Later that evening she developed right facial tingling.  The next day she developed right arm, leg and scalp tingling with mild. No change in mental status. 1 week later all symptoms resolved except bilateral tinnitus persists.
Fever, chills, lack of appetite, fatigue (beginning ~24 hours after vaccine 1, 9 hours after vaccine 2- took ibuprofen and rested on both occasions) as well as  gum swelling, moderate gum pain (2-3days after vaccine 1, and getting worse until I could not chew without pain, I drank soups instead of eating and put cold compress on my gums for relief. Symptoms diminished starting 6 days in and symptoms ended on day 8 after the vaccine. Felt gum pain again 2-3 days after vaccine 2, experienced much milder gum swelling and pain, no need for a cold compress but I did avoid hard foods for a few days until symptoms disappeared around day 5-6)
Called 2/9/17 to report nausea, body and joint/muscle aches, feverish and irritability.  Sent to ER on 2/14 still c/o symptoms + shortness of breath and chest discomfort.  In ER given IV fluids and Toredol for pain, blood work (all WNL) and was discharged home on rest ^fluids.  Appt,3/16 scheduled to see ID MD.  Pt did not show - states symptoms resolved.
Within two hours had decreased level of consciousness and fever, then got a rash. Eyes glazed over and rolled back in head. Would not eat, sit up, crawl or focus with eyes for 7 days. Regressed back to infant stage. Would only drink some milk. Not interested in playing.
No treatment for the adverse effects as they dont appear to be too severe, so I have not been to see a healtcare professional.
4-6 hours after injection (L) deltoid red, swollen; scratching arm at bedtime; next morning awoke with (L) upper arm red and swollen with scratch marks from itching.
Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The vial was initially stored in the refrigerator on 14 Mar 2022. The vial did not undergo any temperature excursions. Treatment information was unknown.
I am 53, very healthy and had a small ischemic stroke 4 days later.
12 post vaccine - fever , chills , nausea , headache, body aches, fatigue 24 hours post vaccine red , raised area at injection site, warm to touch, fever  48 hours post vaccine - red , raised area at injection site , warm to touch - doubled in size from 24 hours post , fever  72 hours post vaccine - red , raised area at injection site , warm to touch , cellulitis at area , size of a grapefruit , notified physician
3/26/21 11:00 a.m. - 3/28/21 9:00 a.m.:  soreness and tenderness at the injection site - RESOLVED 3/30/21  queasiness 3/31/21  3:30 p.m. - 7:30 p.m.  severe headache over right eye (ameliorated with tylenol) 3/31/21 to present:  moderate to mild nausea 4/1/21  8:30 a.m. to present:  intermittent diarrhea
He seen his lung specialist and they are putting him on Prednisone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021376985 (Pfizer).  A male patient received bnt162b2 (BNT162B2) (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: LUNG DISORDER (non-serious), outcome "unknown", described as "He seen his lung specialist and they are putting him on Prednisone". Therapeutic measures were taken as a result of lung disorder.  Additional information: Patient got his 1st dose last week and today he seen his lung specialist and they are putting him on Prednisone. He wants to know if that would be an issue with the Covid vaccine. Again stated he was prescribed prednisone 20mg to take for 5 days. He wants to know if this will interact with the first dose or the upcoming second dose of Pfizer COVID-19 vaccine. Patient stated that he did tell his doctor he had received the first dose of the vaccine during his appointment. Patient stated he was going to call his doctor to find out whether or taking the prednisone was necessary right now because he did not want it to interfere with the Pfizer COVID-19 vaccine. He states, "I don't want to take this prednisone and mess up the vaccine, I want it to work."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a 24 years old female consumer refers to herself who was not pregnant with no pertinent medical history. The patient was vaccinated intramuscularly with first, second and third doses of 0.5 ml GARDASIL (lot number not reported) respectively on 19-SEP-2007, month 2 (approximately in November 2007) and month 6 (approximately in March 2008). Concomitant medications included ORTHO TRI-CYCLEN. The patient fainted within 5 minutes with the fist and second dose of GARDASIL. The patient was told to lie down and had a cold compress applied for treatment. The patient had sought unspecified medical attention. The outcome was unknown. Additional information is not expected.