chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I contracted COVID-19 4/29/22 with symptoms of drainage, congestion, cough, sinus pressure, headache, fatigue, lost sense of smell and taste 5/1/22, and as of 5/3 the congestion is beginning to improve.
body aches; severly tire; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches) and FATIGUE (severly tire) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (body aches) and FATIGUE (severly tire). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (body aches) and FATIGUE (severly tire) outcome was unknown.            No concomitant medications were reported.
Patient had diffuse Urticaria, Shortness of breath, chest tightness.  Occured approx 1 hr after injection.  Treated with epinephrine and claritin.
p/vax pt devel a fever which went as high as 102 & resolved p/3 days;pt also devel 2 episodes of diarrhea, vomited once & devel a macular rash on extremities;rash spread to trunk & head;
No additional adverse effects; four pediatric patients received the adult formulation of VAQTA; This spontaneous report was received from the office manager and refers to an unspecified pediatric patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 03-DEC-2019, the patient was vaccinated with the adult formulation of hepatitis a vaccine, inactivated (VAQTA) 50U/1.0ml, 1 milliliter, once,  lot # S012250 expiration date on 07-JUL-2020 (route and anatomical location were not provided), for prophylaxis. No adverse effects were reported.  This is one of several reports received from the same reporter.    ; Sender's Comments:  US-009507513-1912USA011814: US-009507513-1912USA003828: US-009507513-1912USA011816:
felt achy; could not get to their yardwork; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced pain and impaired work ability. On an unknown date, the outcome of the pain and impaired work ability were unknown.   It was unknown if the reporter considered the pain and impaired work ability to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. Consumer mentioned that his neighbor had a more severe reaction to the second Shingrix injection. He stated that the neighbor reported that they felt achy and could not get to their yardwork. Caller did not wish to provide any additional details (initials DOB, etc.) Did not consent to follow-up.
Nosebleed, high blood pressure. Visit to ER, hospitalized 36 hours, , atrial fibrillation diagnosis; stabilized, nose pack, echocardiagram, medications,  eval by cardiologist, and medical team at Hospital.  Released to home with no activity restrictions. Contact with PCP, Nose pack removed by ENT 2 days later, appointment arranged with Cardiologist.
Two episodes of transient (many hours duration) of encephalopathy,  dysarthria, and dysphagia. MRI brain revealed DWI hyperintensities/ADC hypointensities/FLAIR hyperintensities of the splenium of the corpus callosum and symmetric confluent bilateral white matter territories.
numbness in my right leg the night of the vaccine, a mineral or metallic taste in my mouth for a few hours after receiving the vaccine. Also severe diarrhea started around midnight the night of the vaccine and did not clear up until March13.
malaise; feeling run down; fever; comparable to getting the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Flu years before" (unspecified if ongoing); "Crohns disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling run down"; PYREXIA (non-serious), outcome "unknown", described as "fever"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "comparable to getting the flu". Reporter stated "Common to all the vaccinations (with involves all the booster shots) has been a general malaise, specifically, feeling run down with an accompanying fever. In that sense, it has been comparable to getting the flu."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initially; confusion/difficultly focusing. Secondary: imbalance. Then developed, dizziness (room spinning sensation).
Patient was given GARDASIL on 7/20/09 at 1430 and seconds later patient stated she was not feeling well and asked for water. Patient then turned pale and and began falling backwards. Patient was on exam table and lowered to pillow - No injury from this. Patient lost consciousness for 30 seconds and then regained consciousness. Patient was given juice and re examined by doctor. Her father picked her up and drove her home. Advised patient if she has any SOB, swelling up tongue or throat call 911.
Having chest discomfort on my left side.   The discomfort originally was constant and started to become intermittent returning in mornings and evenings.    It's has progressed to be random.  I have not had this type of complaint prior to the injection.
This case was reported by a other health professional via call center representative and described the occurrence of nausea in a 38-year-old female patient who received BOOSTRIX (batch number B3G4G, expiry date-5th NOVEMBER-2017). On an unknown date, the patient received BOOSTRIX .5ml. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced nausea, headache and vomiting. On an unknown date, the outcome of the nausea, headache and vomiting were unknown. The reporter considered the nausea, headache and vomiting to be related to BOOSTRIX. Additional details were provided as follows: The reporter stated that, the patient experienced adverse events (nausea, headache and vomiting) associated with BOOSTRIX vaccination. It is unknown if the side effects resolved. The reporter would like to be contacted regardless if there were similar reported adverse events associated with this specified lot number or not. The reporter was nervous because she used to buy BOOSTRIX in bulk. This case has been linked with case US2016GSK105719, reported by the same reporter..
It was reported that a 43 year old female pt rec'd a Fluzone SV "00-01" vaccination on 12/5/00. Pt developed flu like symptoms (aches, congested and continuous fever). On 12/7/00 the pt was seen in the physician's office. Physician prescribed antibiotics for a week and the symptoms never resolved. The pt began to vomit frequently,. On 12/19/00 she was admitted to the hospital (St Mary's in St Louis). Pt was hospitalized for 3 wks and is now on dialysis 3 times a week. The pt is the reporter and did not believe that her physician ever reported this event. From follow up correspondence received from 1/8/02 the pt's medical history was provided. No further info is anticipated for this report. This case is closed.
Postural orthostatic tachycardia syndrome; Pain in arm; Joint pain; This is a solicited report from a contactable consumer (patient), via a non-Pfizer marketing program.  A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on an unspecified date as single dose for COVID-19 immunization and adalimumab (HUMIRA), subcutaneously from an unspecified date at unspecified dose for moderate to severe adult crohn's disease. Medical history included hemorrhage of colon from 2018 and moderate to severe adult crohn's disease. The patient's concomitant medications were not reported. On an unspecified date, patient experienced postural orthostatic tachycardia syndrome, pain in arm and joint pain. The events were reported as serious, medically significant. The action taken in response to the events for adalimumab was unknown. Outcome of event pain in arm was unknown while for all other events was recovered on an unspecified date. Causality assessment for the drug Humira and the events Postural orthostatic tachycardia syndrome and Joint pain was reported as No reasonable possibility by the reporter and manufacturer while for the event Pain in arm was not reported by the reporter and No reasonable possibility by the manufacturer. Causality assessment for the drug BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and the events postural orthostatic tachycardia syndrome, pain in arm and joint pain was not reported by the reporter.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of the vaccine BNT162B2 to reported events cannot be fully excluded based on the presumed temporal relationship and since it is part of the product safety profile. Underlying hemorrhage of colon and moderate to severe adult Crohn's disease may be contributory to the event orthostatic tachycardia syndrome. Case will be  reassessed if additional information is received  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Failure To Thrive      coming from facility. per Superior ems, pt recovering from covid and returned to her facility yesterday. pt has not eaten or drank in approx 3 days and has lost a significant amount of weight     HPI   Patient is a 93-year-old female with history of hypertension and hypothyroidism who presents with a chief complaint of failure to thrive. Patient is alert but oriented ×0 and is unable to provide history. History is provided by patient's son. Patient has a long-standing history of cachexia and failure to thrive. She was recently admitted to a facility about 3 weeks ago. After 1 week of being at the falcity, she was diagnosed with COVID and then was sent to a second facility to isolate. She was asymptomatic at that time for COVID. Patient's son was unable to visit her during this time and when he visited her at the first ECF in which she return to, patient appeared to be malnourished and was acting abnormally. She is normally able to converse and now she is moaning and is hard to understand. Patient's son does not believe that patient has eaten in at least 3 days and possibly up to 10 days because she did not have her dentures at the second facility. She also does not appear to want to eat any food. Denies history of dementia but there is some concern that she may be developing it. Patient is vaccinated for COVID
Dizziness, Myalgia, Fever, NauseaVomiting,  Fatigue Narrative:
This initial spontaneous report was received from a registered medical assistant referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (lot # K010535 with expiration date 27-AUG-2016; dose and route were not provided). No adverse effect was reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
19mins post vaccination, pt had a syncopal episode after seeing the pt's brother also have a syncopal episode.  Pt hit his head on the floor but was awake and alert within seconds of the episode.  Mother states that this happens to pt often.  Positioned on cot w/ feet elevated. Vitals: 18:21 86/44, 65, 99% -- > 18:31 89/54, 72, 100% -- > 18:35 94/64. 86 Pt states that he is feeling better.  Pt placed sitting upright and given juice.  RN instructed mother to take pt to urgent care d/t hitting head.  Pt stable and released from the vaccination site.  No s/sx of distress. VSS.
septic shock with myopericarditis; septic shock with myopericarditis; rigors; fever; diffuse maculopapular rash; tachycardic; tachypneic; blood lactic acid increased; electrocardiogram abnormal; lactic acidosis; troponin increased; This is a spontaneous report from a non-contactable consumer or other non hcp.  A 18-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via intramuscular route of administration, administered on 06Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via unspecified route of administration, administered on unspecified date as single dose for COVID-19 immunisation. It was reported that medications at time of Vaccination was none. No known allergies. The patient experienced septic shock with myopericarditis, rigors, fever, diffuse maculopapular rash, tachycardic, tachypneic, blood lactic acid increased, electrocardiogram abnormal, lactic acidosis, troponin increased on 06Jun2021. Symptoms started out with rigors and a fever. This progressed to a diffuse maculopapular rash that resolved within 24 hours. It was reported that event were Serious, Life Threatening Hospitalized and patient visited emergency room. It was reported that Permanent Disability and Congenital Anomaly / Birth Defect was no. Following day, he was tachycardic and tachypneic when he presented to the emergency department. Ultimately he was found to be in septic shock with myopericarditis. He required pressors. He was currently still in the hospital. It was reported that Prolonged Hospitalization Existence was no and days in hospital was unknown. The patient underwent lab tests and procedures which included blood lactic acid: increased, electrocardiogram: pericarditis positive on 06Jun2021 (pericarditis Positive), lactic acidosis: 5.5 on 06Jun2021(peaking at 5.5), troponin: increased on 06Jun2021 (peaking at 2.9 approximately. The outcome of event septic shock with myopericarditis , tachycardic, tachypneic, blood lactic acid increased, electrocardiogram abnormal, lactic acidosis and troponin increased was not recovered and for rest event outcome was recovered on 07Jun2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client received oral typhoid, MCV4, and Yellow Fever. client took the first pill that same day (10/23/2014), then on Sat (10/25), Monday (10/27), and Wednesday (10/29). On Thursday night, after the first pill, client started feeling a stomach ache, which she describes as "horrible" and "burning" and "kind of like heartburn but lower." She states she feels "like I need to vomit" but has not had any vomiting episodes. She denies diarrhea or loose stools. Pain has been fluctuating since 10/23 until today 11/01. At its worst, pain was 6/0-10. Pain goes away then increases in a cyclical manner. She also experienced flu-like symptoms on starting Friday (10/24/14) and subsiding on Sunday (10/26/14).
Patient reported arm pain ever since the date of the injection (it has lasted for one and a half months now). He will make an appointment to see his doctor in the coming weeks.
11/29/21 pt to ED from Hospice with worsening dyspnea; EMS transported pt; in ED found to be hypoxic with O2 sats in 70s, positive for COVID, hypertensive, acute on chronic kidney injury, pulmonary edema, pleural effusion, emphysema, extensive atherosclerotic disease; pt intubated and transferred to MICU; given dexamethasone; found to have brachial DVT, started on Heparin; pt has had several hospitalizations in pas for pulmonary edema and renal failure; family decided to have pt extubated and DNR/DNI with comfort measures; moved to PCU where he expired
First dose was on 17April2021 and haven't received the second dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose was on 17April2021 and haven't received the second dose yet) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 3001658) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose was on 17April2021 and haven't received the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose was on 17April2021 and haven't received the second dose yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
vaccines with temperature excursions were administered; No additional AE/PQC reported; This spontaneous report was received from a nurse practitioner referrimg to a 2 month old patient of unknown gemder. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with a first dose of an improper stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # 1707585 with an expiration date on 21-FEB-2022) for prophylaxis (strength, dose, anatomical location and route of administration were not reported) (product storage error).  The dose administered experienced a temperatura excursión of 36°F and 46°F (2°C to 8°C): above 46°F (46.73°F) for 46 hours and 5 minutes and 0 seconds recorded by a data logger.  There was no previous temperature excursión.  No additional adverse events or product quality complaint were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA002066: US-009507513-2104USA002064:
Information has been received from a consumer concerning her aunt who was vaccinated with ZOSTAVAX. Subsequently, it was reported that after the patient received the ZOSTAVAX she developed stiffness in her neck and periods where her hearing goes in and out. It was not reported if the patient sought medical attention. A product quality complaint was not reported. The reporter declined to give any further information. Additional information is not expected.
Information has been received from a physician concerning a patient who was vaccinated PO with a second dose of Rotateq.  Subsequently the patient experienced vomiting.  Very little information was provided regarding this adverse experience.  The outcome was reported as recovered.  There was no product quality complaint.  This is one report of several from the same source.  Additional information has been requested.
2-15-13 Nurse reported that client presented to health dept on 2-14-13 and complained about pain in right arm that reportedly is caused by a flu and pneumonia shot she got in 10-18-12. Pt. left her phone number so supervisor can call her. I called pt. on 2-15-13 11:10am and spoke to her husband about the incident. When questioning pt. about the start of adverse signs/symptoms. She could not recall the time or day her symptoms started. She could not recall the day she visited the primary doctor, but only reports she was having much pain in right arm which had her to make a clinic visit. She reports getting a steroid injection in rt. arm. Pt. reports she may have possible nerve damage or muscle damage.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2023) Negative; (10Apr2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid from 04Apr2023 to 09Apr2023 for COVID-19 treatment. The patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
6 days after my booster shot, I had a severe headache, I had a high blood sugar of over 700 - I went to the Emergency Room and was diagnosed Type 1 Diabetes (DKA) and was prescribed with Insulin.  ( I have no history of diabetes, so this was a very unusual occurrence).
Fever 100-102 > 48 hours, chills, body aches, headache, left arm bright red, swollen, hard, hot (shoulder to elbow).
Pt. experienced left sided abdominal pain and was taken to ER. Was hospitalized and underwent splenectomy for hemorrhagic shock due to splenic hemorrhage. Patient received 5 units packed RBC while hospitalized for low hemoglobin.
A report was received from a health care professional on 6OCT2003 concerning a 39 year old female vaccinee who inadvertently received expired Fluvirin vaccine on 30SEPT2003. On 30SEPT2003, the vaccinee inadvertently received 2002-2003 Fluvirin vaccine. No adverse effect was reported. There was insufficient information to determine the reporter's causality assessment. Cross reference with PJP200300759.
Patient presented to office on 7/16/2017 after vomiting several times  on 7/15/2017; patient with history of GERD. Parent reports patient with  temperature of 100.4 on the morning of 7/16/2017, parent administered tylenol. No fever in office. Cath Urine was preformed in office to rule out UTI. Results were negative. Patient prescribed Zantac and advised to follow up on 7/17/2017. Patient in for follow up on 7/17/2017; symptoms improving.