chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Atrial fibrillation; Water rentention; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant) and FLUID RETENTION (Water rentention). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) and FLUID RETENTION (Water rentention) outcome was unknown.            The concomitant medications were not reported. The treatment information was not provided.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
I was fine after the shot. One week later I developed a rash at the vaccination site.  The site was itchy and red with raised bumps and I could  feel little bumps. It has only been one day since I noticed this.
On 19 MAR 2008 we received via a physician the following information: A 5-year-old male child with known asthma (subject 1-07-06206), born on 22 FEB 2002, was vaccinated i.m. into the deltoid with Fluvirin (batch no. 80686) on 20 NOV 2007.  He presented on 20 DEC 2007 with fever, abdominal pain and wheezing.  He responded to bronchodilators and was admitted to hospital for rehydration and treatment of pneumonia (i.v.antibiotics).  The patient was discharged improved on 21 DEC 2007.  The subject participated in a field trial.  Fluvirin was used in that trial as a control, and Novartis Vaccine & Diagnostics (NVD) has donated the Fluvirin, but other than that has not been involved.  The investigator did not see any causal relationship with the vaccination and Fluvirin.  Concomitant medication included Flonase and albuterol.  Seriousness criterion: hospitalisation.  Causality: not related, due to improbable time interval.  Pneumonia was most likely caused by bacterial infection as the patient improved under antibiotics.  Expectedness assessment according to EU SPC/US label: The reported symptoms are not expected after vaccination with Fluvirin.  No change in benefit-risk ratio.  No measures necessary.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-395985 (Patient Link).
1-Fever, 100.0 F, 8hrs after shot. 2-ER visit 18hrs after shot. Fever 104F with Acetaminophen and Ibuprofen being given. 3-Office visit for follow-up 26 hrs. after vaccine. 4-Phone call from parents w/questions about possible febrile seizure activity and persistent fever 103 to 104 F continuing 4 days post vaccine. 5-Office follow up scheduled 7 days post vaccine. Afebrile 6 days post vaccine.
Chronic urticaria/daily hives since 11/13/2021. Uncontrollable itching, lump in throat feeling, red, hot skin.
Extreme soreness and swelling at injection site lasting about four days. For two days after injection, mild nausea and extreme lethargy.
Received vaccines on 9/7/16, leg started to swell immediately. They elevated, iced. Swelling did go down with elevation. Swelling and redness on left middle thigh, swelling going down to knee, red, some pain, hot to touch, red and streaky.
Stomach really hurts; Severe migraine; Vomiting /She wants to throw up; Body aches; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach really hurts), MIGRAINE (Severe migraine), PYREXIA (Fever), VOMITING (Vomiting /She wants to throw up) and MYALGIA (Body aches) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body aches) and HEADACHE (Headache). On 19-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach really hurts), MIGRAINE (Severe migraine) and VOMITING (Vomiting /She wants to throw up). At the time of the report, ABDOMINAL PAIN UPPER (Stomach really hurts), MIGRAINE (Severe migraine), PYREXIA (Fever), VOMITING (Vomiting /She wants to throw up), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: 102.2 (High) Unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
First 2 doses were fine. After my 3rd (booster) I started losing weight very rapidly. I was 141 lbs, and now, 6 months later, I am 105 lbs. Cancer & other things all ruled out. The ONLY thing different was the booster. I have since spoken to 23 other people who had the exact same thing happen...so there must be more of us. I am a walking stick with skin hanging off and the doctor is stumped.
911 called and ER visit for severe weakness, near fainting, blood pressure rising x several days, the 200/100
Patient was given incorrectly diluted COVID vaccination.  Was given a pediatric dose diluted as if an adult dose. Patient has not been able to be contacted for repeat vaccination after multiple attempts
Pt complained of temporary increase in heart rate, nausea, and trouble breathing. Pt stated this occurred late into the evening ~8 to 12 hours after receipt of vaccine. Pt currently reports no ADRs and does not report any need for emergency services
A breastfeeding patient received the first dose of Moderna vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (A breastfeeding patient received the first dose of Moderna vaccine.) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (A breastfeeding patient received the first dose of Moderna vaccine.). At the time of the report, EXPOSURE VIA BREAST MILK (A breastfeeding patient received the first dose of Moderna vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
patient came in on 2/15/22 and wanted us to file this info that she was incapacitated for 3 full days starting 2 hours after receiving her 3rd Moderna booster dose (0.25mls) Not able to move because of lack of enregy. no appetite, mild fever, chills and aches.
Could not eat; Feeling really sick; Dizzy; Bad Rash; Headache; Nauseous; Throwing up; Redness; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the arm right on 16Apr2021 at 11:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, arthritis, diverticulosis, gastric issues, anxiety, depression, post-traumatic stress disorder (PTSD) and iodine allergy. The patient previously took Bactrim, carbamazepine, propranolol, Tessalon Perles and ketorolac and experienced allergy to the medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received vaccines within four weeks prior to the vaccination. Concomitant medications included amitriptyline hydrochloride (ELAVIL), salbutamol sulfate (PROAIR HFA) budesonide; formoterol fumarate (SYMBICORT) all for an unknown indication from unknown dates and medroxyprogesterone acetate (DEPO-PROVERA) on14Apr2021 for an unknown indication. On 16Apr2021 at 11:30, the patient experienced bad rash, headache, nauseous, throwing up and dizzy. The patient woke up the next day on 17Apr2021 and still had rash and redness and also experienced feeling really sick and could not eat. Therapeutic measures were taken as a result of events and included treatment with Benadryl and Zofran and they called emergency medical technician (emt). The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events, bad rash, headache, nauseous, throwing up, dizzy, redness, feeling really sick and could not eat was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Treatment of COVID-19; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 09Feb2022 at 16:00 as dose 3 (booster initial pfizer dose), single at the age of 38 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Jan2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 09Feb2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset Jun2022, outcome "unknown", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical information: Patient did not received other medication in 2weeks. Patient received Paxlovid Indication (Treatment of Covid-19)treatment start date was 07Jun2022 and stop date was11Jun2022. Patient has no known allergies.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Developed a burn like area on left wrist area. 12 hours later began to develop blisters on right hand and right wrist. This was followed by blisters on the left hand and a blister over the reddened area on the left wrist. Also developed a reddened area on the top of the right thigh that developed a blister. All of this happened within 24 hours.  5 days after the onset of blisters the small blisters have dried up and now present as dark red spots on my skin. Still have a large blister present on the right ring finger. Right wrist blister was inadvertently hit and it busted. That blister was large like blister on right finger. Hands have become heat sensitive - warm shower water is very hot on hands. Hands feel like they are on fire at times.
chills that were uncontrollable (sister said they were almost like seizures); Chills; fever; cough; sore throat; Chest Pain; joint pain; shook so hard; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm right on 06Aug2021 11:00 (Batch/Lot Number: FC3180) (at age 77-years-old) as dose 2, single for covid-19 immunisation. The first dose was received on 14Jul2021 10:30 (lot number EW0185) (at age 77 years-old) on the right arm. Medical history included open heart surgery and cochlear implant. Concomitant medication(s) included thyroid (THYROID); atorvastatin calcium (LIPITOR); acetylsalicylic acid (BABY ASPIRIN); and trazodone; all taken for an unspecified indication, start and stop date were not reported. There were no other vaccine within 4 weeks. The patient previously took codeine and experienced allergy. The patient experienced chills that were uncontrollable (sister said they were almost like seizures), fever, cough, sore throat, chest pain, joint pain on 06Aug2021 23:00. It was also reported that going to bathroom challenge because patient shook so hard could hardly make it. Patient was 2 days sick. There were no treatment given for the events. Outcome of the events was recovering. Patient was not diagnosed with covid 19 prior to vaccination and has not been tested post-vaccination.
Patient received SHINGRIX vaccine, came in 3 days later, said he felt fine but his insulin requirement had doubled.
received Rotarix, patient is eight months old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-month-old patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Concomitant products included ROTAVIRUS VACCINE (ROTATEQ) and ROTAVIRUS VACCINE (ROTATEQ).   On an unknown date, the patient received Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that, the patient might have received a dose of Rotarix after starting the series with two doses of Rotateq. The patient received dose of Rotarix at the age of 8 months old, which led to inappropriate age at vaccine administration. It was unknown whether this occurred a few months ago. The reporter did not consent to follow up.
Fever up to 102.6, vomit, fatigue, light headed, chest heavy, cough, diarrhea
Elevated temperature 104-105 F. Mother notified Health Department of above symptoms at 6 month IZ appointment - per physician. DTAP not given - physician will provide pediatric DT.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 17-SEP-2014, the patient was vaccinated with M-M-R II (dose number was not reported) lot # H017027, expiration date 14-SEP-2014, 0.5 ml, subcutaneous. Medical assistant reported that an expired dose of M-M-R II was administered to a patient on 17-SEP-2014. No adverse effects reported. Additional information has been requested.
Swelling, egg sized red lump. very tender. Shortness of breath, but no other signs of anaphylaxis.  Note: Injection was not in the deltoid, but in the subcutaneous adipose tissue below the deltoid.
Patient had a syncope episode aprox. 30 minutes after administration. She passed out while in observation. Paramedics on scene responded and gathered information. She passed out again and at that point she was put on the stretcher and brought to a nearby hospital.
The patient was inadvertently administered an expired dose of PNEUMOVAX 23; This spontaneous report has been received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 03-SEP-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, vaccine scheme and anatomical location were not provided; lot number R024025 has been verified to be a valid lot number, expiration date was on 02-SEP-2020); as prophylaxis.
My right ankle started tingling and mildly swelling. Went away after a few hours, and elevating my foot was enough to keep the swelling down in the meantime. I take amlodipine and used to have a problem with ankle swelling when I was on a much higher dose of it, so I was thinking the drugs may be interacting. I did not accidentally take a second dose of amlodipine or anything yesterday, just my usual 5mg that has never caused ankle swelling before.
Pt does not have known case of Varicella and had Varicella Vaccine on 1/4/02.  On 3/22, developed back pain on R, then erupted in violaceous patches of vesicles along R T1.  Seen by 3 physicians-all confirming shingles.  Responded to acyclovir.
Patient stated she started having high fevers around 0200 (10May2016). Also stated chills, body aches and soreness on left arm.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 29-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree.  The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Hives developed over L  arm, neck few minutes after vaccination, patient  also felt tightness throat A/O  x3. vital sign WNL Benadryl given  12.5mg  at 11:15am
Moderna Arm; she got a rash; it is itchy on her hand; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Moderna Arm), RASH (she got a rash) and VACCINATION SITE PRURITUS (it is itchy on her hand) 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 February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Moderna Arm), RASH (she got a rash) and VACCINATION SITE PRURITUS (it is itchy on her hand). At the time of the report, VACCINATION COMPLICATION (Moderna Arm), RASH (she got a rash) and VACCINATION SITE PRURITUS (it is itchy on her hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported   No treatment information was provided   Reporter did not allow further contact
I started to feel nauseous about 10m after getting the shot. After the 15m I had convinced myself I was just low on energy and needed to get food, I got up to head to get bread and my vision started to black out... I eventually lost vision completely so I turned around and called for help. I was helped back to my chair and when sitting I was able to see again. An ex-doctor nearby told me my blood pressure dropped and the pharmacist said my eyes rolled back into my head during the time I said I couldn't see. I was covered in sweat that wasn't there before. I was given water and drank a bunch.. After waiting in the chair for about 30m I started to feel better so I went to get food and recovered completely after eating and resting.
PATIENT FELT DIZZY AND LOSS CONSCIOUSNESS FOR A SECOND THEN REGAIN CONSCIOUSNESS.
Patient had reaction to COVID-19 vaccine. Patient was monitored after COVID-19 vaccine as recommended per guidelines.   The following reaction signs/symptoms were observed: difficulty swallowing, wheezing, stridor and other tongue swelling   Emergency response notified:  EMS (911)   EpiPen administered by Nurse  Required reporting completed?: Yes   Report given to EMS (911)   Pt received second Moderna Covid vaccine today. At 1319 EMT and Nurses responded to call from parking lot that pt "feels like cheeks are swelling on the inside". Responders took pt's vitals: BP 130/90, HR 60, SpO2 98%. Responders kept monitoring pt. At 1350 pt stated that his tongue was swelling, responders noted thick speech, wheezes bilaterally upon auscultation of his lungs, striderous squeaks to throat, and pt stated he couldn't swallow. Nurse administered epi pen per order and protocol in pt's L thigh and called EMS immediately. Responders took pt's vitals as follows: HR 68, SpO2 98% and stayed with pt while waiting for EMS. EMS arrived and pt report was given to EMS at 1356, noted that pt's speech was improving at 1402, EMS stabilized pt and drove away with pt at 1410.
I started having low grade fever and my body was achy, just very tired and probably low grade headache. By the next morning I had low grade fever of 100.5F, by the third day I was perfectly fine.
Presented w c/o toe pain. Admitted for tx of sepsis d/t cellulitis; tested COVID positive on pre-procedural testing but asymptomatic
Pt got flu shot on 10/3/16 came on 10/6/16 with about a 4x4" welt which it seemed like blood had leached under the skin. It had started to clear from injection site down but patient was concerned.
Febrile Seizure. Fever 103F. Had to call ambulance and go to ER. Treated for fever with Tylenol.