chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient received Monovalent booster instead of Bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Monovalent booster instead of Bivalent) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082B22A) for COVID-19 vaccination.     No Medical History information was reported.  On 14-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Monovalent booster instead of Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Monovalent booster instead of Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received Monovalent booster instead of Bivalent).    No concomitant information was reported. No treatment information was provided. The case was reported for elderly patient 2 out of 3.   This case was linked to US-MODERNATX, INC.-MOD-2022-672558, US-MODERNATX, INC.-MOD-2022-672524 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-672558:3rd Elderly patient US-MODERNATX, INC.-MOD-2022-672524:1st Elderly patient
having electric type changes/charges in skull; This case was reported by a consumer via interactive digital media and described the occurrence of electric shock sensation in head 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 electric shock sensation in head. On an unknown date, the outcome of the electric shock sensation in head was not recovered/not resolved.   It was unknown if the reporter considered the electric shock sensation in head to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-SEP-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that he/she had been experiencing electric type changes/charges in his/her skull. Follow-up would not possible, as no contact, details were available. Additional supportive information: Since, it was a case received via interactive digital media and the patient/reporter does not explicitly stated of having received a shingles vaccine and the therefore, shingles vaccine" is coded as the suspect product, conservatively.
13 year old child received the Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old child received the Moderna vaccine) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old child received the Moderna vaccine). On 22-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old child received the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There was no concomitant medication. Treatment information was unknown.   This case was linked to MOD-2021-163351 (E2B Linked Report).; Sender's Comments:  MOD-2021-163351:MOD-2021-163351
Initial inset of the event was extreme flushing of the face, confusion and with no resulting  memory of the almost hour long event.   Extreme confusion and some memory loss continued for almost 24 hours.  He was taken to  Emergency Room because of the fear that it was a TIA or seizure.  All test preformed at  hospital came back normal (CT Scan, Extensive Labs, EEG, Echocardiogram).  He was kept overnight to make sure the event was not a precursor to a stroke.  He was released on 2/9/21 and told to make an appointment with his family physician and seek a neurological consult.
Per pt, My body hurt. Let and right arm. Couldn't crawl I think those symptoms have mollified to exhaustion and a common cold.  Addendum: uncertain if pt. recd Moderna vs. Pfizer.
Varicella zoster-like rash on the chest (not at the site of immunization).
no adverse medical side effect from moderna vaccine patient denied having previous vaccine, however when reporting moderna vaccination to Department of Health it was discovered that patient received COVID-19 Janssen vaccine on 04/05/2021
Pt recv vax on 3/19/99; on 3/20/99 pt exp diarrhea & vomiting x 3-4 days
Patient states he had swelling, warm to the touch on his arm after getting the PNEUMOVAX shot. The swelling didn't go away until 3 days later. He's ok now. He was taking ALEVE to help swelling. No temperature. No systemic anaphylactic effects.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a non health care professional (manager). This case involves a 78 years old male patient who was vaccinated with a dose of ADACEL (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration. No information about any adverse event 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Angioedema to lips and face within 24 hours of receiving the covid Janssen vaccine
left shoulder burned; headache; This spontaneous case was reported by a consumer and describes the occurrence of THERMAL BURN (left shoulder burned) and HEADACHE (headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced THERMAL BURN (left shoulder burned) and HEADACHE (headache). At the time of the report, THERMAL BURN (left shoulder burned) and HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment information provided. After first dose patient had a headache and left shoulder burned.   This case was linked to MOD-2021-338406, MOD-2021-338407 (Patient Link).
Systemic: Tinnitus-Medium, Additional Details: patient says symptoms are moderate during the day, but severe when sleeping. in addition to being diagnosed by audiologist, patient was also seen by a covid doctr.
achalasia extreme fatigue/lethargy brain fog joint pain tinnitus elevation in blood sugar elevation in blood pressue changes in menstrual cycle (twice per month, heavy flow)
Mom reports t104 ax 3hrs p/immunization DPT w/swelling @ site; Mom reports administering APAP q 4hrs as instructed;
Generalized urticarial Initial report received on 23/Jun/2006 from a physician. A 13 year old male patient had received an intramuscular left deltoid first dose injection of Menactra, lot number U2069AA, on 16/Jun/2006. One day later, he experienced a rash all over his body which developed into urticaria. He was examined in an emergency room and treated with Prednisone 20mg for four days. At the time of this report, recovery status was unknown. A corrective variation was created on 14/Jul/2006 with a LRD of 23/Jun/2006 in order to amend the adverse event screen. Follow up information received on 14/Jul/2006 from a physician. The parent that contacted the reporter on 23/Jun/2006 and informed him that the patient had recovered. No diagnostic testing was performed.
Information has been received from a nurse practitioner concerning a 22 year old female patient with allergic reactions to bees who on 21-JAN-2008, was vaccinated IM with a first dose of Gardasil.  On approximately 22-JAN-2008, within 24 to 48 hours of being vaccinated, the patient experienced hives on both arms.  Unspecified medical attention was sought.  The nurse practitioner recommended that the patient take BENADRYL.  It was reported, after the patient took the BENADRYL, her symptoms resolved.  No product quality complaint was involved.  Additional information has been requested. Information has been received from a nurse practitioner concerning a 22 year old female patient with allergic reactions to bees and a questionable allergy to "ncodan" who on 21-JAN-2008, was vaccinated IM into the left deltoid with a furst dose of HPV vaccine (lot # 654539/0742U). On approximately 22-JAN-2008, within 24 to 48 hours of being vaccinated, the patient experienced hives on both arms. Unspecified medical attention was sought. No laboratory diagnositc studies were performed. The nurse practitioner recommended that the patient take BENADRYL. It was reported, after the patient took the BENADRYL, her symptoms resolved. No product quality complaint was involved. Additional information is not expected.
Narrative:  72 yo male with a h/o squamous cell carcinoma of the lung, stomach cancer s/p partial gastrectomy, ocular melanoma s/p resection, IgG monoclonal gammopathy, paroxysmal atrial fibrillation, and iron deficiency anemia who presented to the ED on 9/8/21 for progressive weakness and increased sputum production was admitted to internal medicine team, then transferred to MICU. Pt then was transferred MICU to inpatient hospice on 9/11/21 with Acute Hypoxic Respiratory Failure secondary to interstitial pneumonia, not caused by covid infection. Pt then died on 9/12/21 during inpt hospice care. Pt had received covid vaccines on 2/5/21 & 3/9/21. Death not related to covid vaccines.
Information has been received from a registered nurse concerning a child who was vaccinated with a dose of varicella virus vaccine live. The RN reported that the patient subsequently developed a severe case of chicken pox. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. The RN also reported that another patient developed a mild case of chicken pox after being vaccinated with varicella virus vaccine live (WAES0404USA02413). No further information is expected.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6199), on 25Mar2021 as dose 2, single (Lot number: ER2613), on 01Dec2021 as dose 3 (booster), single (Lot number: FH8027) and on 13Apr2022 as dose 4 (booster), single (Lot number: FK9729), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "OSA" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "sulfonamide" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid from 23Oct2022 to 28Oct2022.
Reaction to left thigh up to the knee.  Warm compresses to area for swelling and observe.
p/vax pt exp headache; chills; nausea; pt adrenaline rush & crash caused most of the symptoms pt felt;
sore throat, cough, chills, nasal congestion, post nasal drainage, sneezing. Had hives or bug bites on legs, have since cleared up. starting on 10/10/21
I noted an increase in the number of events of tachycardia I experienced. These events are typically quite short, lasting less than 1-2 minutes. In 2010, I had a single episode of AFib that self-terminated around an hour after I realized I was in an arrhythmia (confirmed on EKG). Since then, I have had occasional paroxysmal runs of tachycardia, typically <10 seconds long. Earlier this year, I started to notice tachycardias with increasing frequency. I now experience them 1-2x/week with a ventricular rate of ~180 for up to a minute or so at a time. My watch confirms these, and my GP referred me to cardiology for a formal workup. On reviewing the strips, my cardiologist believes the episodes to likely be a focal ATach, possibly from a pulmonary vein. He prescribed "pill in the pocket" therapy, where I'll carry medication (Cardizem and Xarelto) for the possibility of a sustained event. An echocardiogram is also scheduled but hasn't been performed yet. I am very aware of the tachycardias, but asymptomatic. I should note that I don't attribute this arrhythmia to my vaccination, nor does my medical team. However, it did seem to ramp up around the time of my vaccinations and so I wanted to report it just in case it turns out to be a more widespread finding.
Patient started with fever to 103F.  Developed rash papular on body that began to resolve without treatment in 48 hours.  No fever after 24hours.
Information has been received from a registered nurse concerning a 6-year-old male with no pertinent medical history and no drug reactions/allergies who on 30-OCT-2006 was vaccinated SC with a 0.5mL dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 653465/0465F).  Concomitant therapy included ZYRTEC.  It was noted that the patient was vaccinated with Varivax (MSD) on 03-APR-2002 (lot number not reported).  The patient developed a skin rash on the lower extremity on 02-AUG-2007 which spread to the entire body.  The rash presented as dew drops on rose petals consistent with varicella.  On 03-AUG-2007 the patient was diagnosed with chickenpox by the physician.  No other details were provided.  There were no lab diagnostic studies performed.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Patient received first dose of Pfizer vaccine on March 10 and was suppose to get her second dose on march 31st but was instead given Johnson and Johnson. Patient appears to be ok. States she was feeling lethargic the days following injection, along with a sore arm, but she felt good the Saturday after the injection.  Patient was notified of error.
Got vaccine on 1/16/2021 at 8:03 am only had left arm pain site of vaccine given later in the day started having  Headache, Body aches, Fever, Fatigue. Sunday 1/17/2021 left arm pain where vaccine given, headache, fatigue,  minor body aches.  Monday 1/18/2021 only headache, fatigue, minor left arm pain where vaccine given.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 15-year old male patient, with no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the right arm, route not reported), on 29-JAN-2014 at 3:00 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Patient was going to consult with physician. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Systemic: Fainting / Unresponsive-Medium, Systemic: Weakness-Mild, Additional Details: patient feell week and loss counciusness. I place it on the floor on the side and she started feeling better and recovering counciusness. I adviced to continue breathing and she follow my comands and instantly started to recover.
Case number PHEH2016US012414 is an initial spontaneous case received from consumer on 16 May 2016. This report refers to a 57 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515001, expiry date: May 2016) on left arm on an unknown date. On an unspecified date, the patient was suffering from pain in the entire left arm since vaccination. It was unknown if customer want to pursue a claim for this incident. The outcome of event was not reported. The seriousness and causality of event were not reported. Follow up information received from consumer on 26 Jul 2016: Added physician details.
I got both my Covid shots in my right arm, and about two weeks after the second shot, in late March, my right ear began hissing, chirping, and ringing and hasn't stopped since.  I've been trying every type of treatment I can think of, seeing my doctor and his assistant numerous times, hoping it was due to an ongoing ear infection I had at the time that affected my ear  drum, but it's becoming more clear that it is from the shots, and seems to be permanent nerve damage.
Shortness of breath; Chest pain; Tongue swelled up; I started to lose my voice; my tongue swelled up and it was 'paining' very bad; Nausea; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: FF2587, patient was 39-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 03Sep2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included asthma, bronchitis. The patient's concomitant medications were not reported. Historical vaccines included Flu shot and Pneumonia shot for immunization and experienced allergic with that. No prior vaccination within 4 weeks of COVID Vaccine, no family history for the same adverse event. On 03Sep2021, the patient experienced shortness of breath, chest pain, tongue swelled up, i started to lose my voice, my tongue swelled up and it was 'paining' very bad, on an unspecified date in 2021, the patient experienced nausea. AE resulted in to visit emergency for reported events. Therapeutic measures were taken for all events with Albuterol, I got Benadryl twice, and then they gave me Pepcid, they also gave me Methylprednisolone. It was reported that patient got the Pfizer Vaccine yesterday and told to wait for like 30 minutes and I waited for like '15' minutes and I feel like I was okay, so I pull it up and as I started driving, and experienced events, so I went to the emergency room, I was treated there, they gave me 2 doses Benadryl. I took my EpiPen (treatment) that I have in the car. They gave me steroid, and they gave me something else 'Pepcid'." Reported that same day patient came back from the emergency room. The outcome of event (Nausea) was not recovered, and outcomes of rest all reported events were recovering.  Follow-up attempts are completed. No further information is expected.
Vaccine stored under refrigeration beyond 30 days. Moderna Case. lot number 056M21A maintained the activity necessary to protect against the SARSCoV-2 (COVID-19) virus at time of administration. Did not contact patient per no action required.
Light fever, tired. When I woke up the next morning went to the doctor because both eyes was swollen. Dr. suggested Benadryl. Went away about the 5th day.
received the first dose of the Moderna COVID-19 Vaccine in June and wanted to know what would be the best time to get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna COVID-19 Vaccine in June and wanted to know what would be the best time to get the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna COVID-19 Vaccine in June and wanted to know what would be the best time to get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna COVID-19 Vaccine in June and wanted to know what would be the best time to get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concurrent and treatment medication was reported by patient
Flare of muscle and joint pain (particularly impacting bilateral forearms and lower legs). Joints involved: knees, elbows, shoulders and hips.
pt recv vax & lab eval 3MAY95 indicated a low positive titer, & recently titer were considered negative by quantitative test;