chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (chills) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, High cholesterol and Pre-diabetes. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, METFORMIN, LOSARTAN, PRAVASTATIN, COLECALCIFEROL (VITAMIN D3) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, 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 experienced PYREXIA (Fever), CHILLS (chills) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever), CHILLS (chills) and HEADACHE (Headache) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2022-455237 (Patient Link).
Early the next morning I woke up with both hands and wrists spawning. The were jerking like I was having muscles spasms. I couldn't control them. The injection site was swollen and hard. Monday the right hand and wrist were not spasming. Tuesday evening the left wrist and hand had stopped spasming. I ran a fever Sunday and Monday. It didn't get over a 100.
Ringing-type of noise in ears seems to be more in right ear. Seems like it is getting worse after second shot.
Breakthrough case admission after 2 vaccines Moderna 3/20/21 Lot# 047A21A;  Moderna 4/17/21 Lot# 040B21A
Patient fell out of his chair to the left side and lost consciousness for about 5 seconds at 12:22pm.  As soon as he started falling out of his chair on his side, three RNs went to his aid and helped him turn on his back and he regained consciousness. Patient was offered to be taken to the Emergency Department but he refused. He was also encouraged to call for someone to come pick him up since he drove on his own, but said he was 'okay.' Patient reported vaguely remembering falling over and slight pain in his left arm where he was given his vaccine. No rash or swelling around the vaccine site. A small abrasion and bruise above his right eyebrow was noted and patient was given an ice pack. Patient was assisted to a seated position and vital signs were taken at 12:25pm BP:118/55 HR: 62 pulse ox: 98% on room air. Patient was assisted to a standing position after he reported feeling 'fine' and was accompanied by a RN to the stretcher where he was monitored until 1:15pm.  Patient was given an orange juice and a granola bar and an ice pack. Patient's vital signs were taken at 12:40pm BP:113/83 HR:61 pulse ox:100% on room air and he reported feeling 'good' and 'much better.' Last vital signs were taken at 12:56pm in a standing position in which patient reported no symptoms; no dizziness, lightheadedness or any other symptoms. BP: 112/64 HR: 58 pulse ox: 100%. Again patient was offered to be escorted to the Emergency Dept. and to also to call someone to pick him up. Patient refused both. Patient was accompanied by a RN to his car outside which he reported no symptoms at this time. We advised patient to wait longer and to come back into the hospital and to call someone if he felt any dizziness or lightheadedness. He verbalized his understanding. Patient discharged.
I felt pain at the injection site soon after being vaccinated, and that day developed a hard lump under the injection site that was painful to touch. Over the next 7 days I also developed a large red rash, about 5 inches in diameter over the deltoid/injection site. The rash is warm, it itches and the my arm feels numb. No treatment has been undertaken.
Person had just received the shot, tolerated well, with no visable anxiety or crying.  She was next to her brother who displayed some anxiety when given his shot.  Upon walking away, she said she was thirsty then fainted, slid down the wall onto cooler.  She was diaphoretic.  Ammonia ampule was applied.  She awoke.  BP: 90/40 P 60.  BP at 4:00 102/80 P 88 PERRL.  Person denied any further dizziness.
Administered Moderna Vaccine that is beyond recommended 12 hour period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna Vaccine that is beyond recommended 12 hour period) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     Concurrent medical conditions included Pain in thumb since 28-Apr-2021.    On 21-Jul-2021 at 4:35 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna Vaccine that is beyond recommended 12 hour period). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Administered Moderna Vaccine that is beyond recommended 12 hour period) 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.   It was reported that Patient was administered with a vial which was opened on 20-JUL-2021 10:46AM. He was realized that he was given expired vaccine after discharged from the clinic. During follow up he was contacted multiple times but no response, messages left on patients voicemail to contact clinic.  No Concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received contains Patient demographic details, Medical History and Vaccine information. On 26-Jul-2021: Follow up received has other patient information linked to this case.
Arm was sore immediately following shot.  In the evening on 10-28, upper arm became red, hot, inflamed, swollen, itchy, and painful from shoulder to elbow.  Treated with recommended Benadryl and Motrin every 6 hours and iced frequently.  Morning of 10-29 swelling and redness had decreased.  By the evening of 10-29 swelling, redness, hotness, and itch came back worse than the morning.  Went to Urgent care and was prescribed steroids and antibiotic for allergic reaction and possible infection.
pt devel rash (itchy) rt thigh then spread all over body to arms/legs/abd & back;no other sx;rash resolving still prominent rt thigh;no other sx;
This spontaneous report was received from a registered nurse and refers to 3 unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 02-JUN-2017, the patients were vaccinated with doses of improperly stored VARIVAX lot # M027344 with expiration date on 01-JUN-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 13 degrees Fahrenheit for 9 hours. Digital data logger was used to record the excursion. The vaccine underwent previous temperature excursion of 7 degrees Fahrenheit for 17 hours and 30 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002688:
Received PREVNAR 13 at 11:29am on 9/28/17. Patient reports she began feeling fever, chills, and "sensation of something stuck in her chest" along with redness, swelling, warmth, and itchiness of injection site. States feeling in chest resolved around 1am on 9/29/17 after drinking cold water but the local reaction continued (with some improvement) until today. Denies any chest pain, pain of site, or SOB. Left deltoid area has reddish urticarial area and is slightly warm to touch, no tenderness or fluctuance, no axillary adenopathy, no evidence of cellulitis or abscess. Treatment includes ice pack 4 times a day, diphenhydramine 25mg tab q 8 hrs as needed and ibuprofen 600mg tab three times a day.
Developed urticarial rash over face, trunk & legs w/in 4 hrs of receiving immun; Developed diarrhea w/in 8-10 hrs, fever of 101 on 6MAR91;
sick; Initial information received on 15-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a 18 years old patient of unknown gender who was sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency, route, administration site, lot number and expiry date was unknown) for prophylactic vaccination.  On an unknown date the patient developed a non-serious  event "sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"Last time I was sick was after I got a flu shot. I was 18 and now over 50."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Unknown for the event sick.
Stiffness in joints and muscle of arms and shoulders. Increasing pain in following days continuing to today.
Sever tingling and numbness all over my body, face, arms, fingers, legs, feet etc, Chills, Tiredness, headache, muscle pain, nausea, tenderness in the arm, swelling,  Swelling hands and feet, dizzy
Patient called on 8/21/2019 to claim she is experiencing painful rashes on the back of her right leg. She also complained of rash on back/right side of her head. She claims the rash rash has gotten worse since. She claims that the rash gets painful when she gets out in the heat.
Around 5:00 pm he became very tired and irritable and refused to eat.  I thought he was just upset from the day's events so I put him to bed. Around 9 the next morning he woke up & seemed confused & was very irritable. By 9:30 am he started throwing up & complaining of a headache. He would not eat or drink and his fever was 101. Over the course of the next 4 hours he threw up 6x. He was extremely upset and screaming in pain. His body was occasionally jerking almost like mild seizures.
The patient came to the pharmacy on 12/2/19 and reported that she was having muscle pain and some shoulder pain that started after she received the flu vaccination. She stated that the symptoms started after receiving the vaccine on 9/17/19, and have not resolved. She had not received any treatment for the pain, at this time but was counseled to contact her doctor and schedule an appointment. She said she has an appointment next month, but was told to contact her doctor as soon as possible to describe her current symptoms.
Approximately 10 minutes after the shot, patient reports not feeling well, rapid heart beat, shakiness, and has difficulty breathing (feels like her throating is closing up).  Gave one dose of 0.3 mg Epi-Pen 15 minutes after the vaccine.  Called paramedics and arrived at 5:35 pm when patient was taken to the hospital.  Patient was alert when she was picked up by the paramedics.
Coughing, feels like throat is getting tighter, itchy throat, evaluated by EMS-refused transport
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Severe
Herpes Zoster (Ocular) with a fever of 104. Treatment is antivirals until his appointment with Ophthalmologist on Tuesday  6/1/2021. Currently still  symptomatic. Outcome in eye is uncertain.
It was reported the patient had NAFLD; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001481 (Novavax).  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "underlying liver condition" (ongoing); "acute liver injury" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (booster), administration date: 2022, for COVID-19 immunisation, reaction(s): "jump in liver enzymes"; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: NON-ALCOHOLIC FATTY LIVER (non-serious), outcome "unknown", described as "It was reported the patient had NAFLD". The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300392929 Same patient, different dose, different event;US-PFIZER INC-202300392929 Same patient, different dose, different event;
TOOK FIRST DOSE AFTER EATING MEAL; This spontaneous case (PVX2019-1075) was received from consumer on 01-May-2019. It describes a 48-year-old female consumer who "took first dose after eating meal". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif 1-1.5 hours after a meal on 29-Apr-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took first dose after eating meal" was unknown.  Company's Comment: The causality of the event "took first dose after eating meal" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took first dose after eating meal" was considered as not applicable.
I had a number of strokes between April and May. As many as 9 of them. Memorial Day, 31st, I went to the hospital ER at 9:00PM. I had a PFO, which is something like Patent Forman Ovale, heart condition, hole in atrium of heart that causes the blood to go from heart to brain. Blood clots to the brain, venous blood gets into the arterial blood. The clots could have formed everywhere but they go straight up the brain. They went through an artery and put a mesh screen over my heart opening and eventually it will help that. It was done through an artery, 15 minute process. I left the hospital the following Saturday. This week (two days ago) I have really bad tinnitus starting in both ears. My hearing is quite disrupted. I don't know how serious it is right now. I am being treated with an anti-cholesterol drug (Lipitor) and aspirin. I still have a little bit of cognitive impairment and physical fatigue. My coordination is messed up. Physical therapy starts the 15th and Speech therapy on the 23rd. I had just gotten a job two weeks before the strokes.
This spontaneous report has been received from a licensed practical nurse referring to an 18 year old female patient. Information regarding the patients medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 01-FEB-2018, the patient was vaccinated with M-M-R II lot # N020926, subcutaneous for prophylaxis. The M-M-R II was exposed to a temperature range between 47°F to 77°F, during a time frame of 216 hours. No previous temperature excursions were reported. No adverse events reported.
This spontaneous report was received from a nurse practitioner regarding a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, dose number, unit, route, anatomical location, lot # and expiration date was not reported) for prophylaxis. On an unknown date, the patient experienced drug allergies to pneumococcal vaccines (also reported as rash) (drug hypersensitivity). The outcome of drug hypersensitivity was unknown. The reporter considered drug hypersensitivity to be related to PNEUMOVAX 23. Sender's Comments: US-PFIZER INC-2019024236: WWID #.
She had a redness and soreness at the site of vaccine.  Also,  about 2 inches below the vaccine site, she started having   about 2- inch diameter rash on 10/7/19. It is very red and itchy.  I told her to use Cortaid cream and take Benadryl.
Pt returned to clinic with localized pain and swelling in left arm. Measurement 10.5x11cm. Pt c/o left arm feels numb, itching, burning at site. Pt stated symptoms started on 19 Oct. 05. Progressively getting worse. Pt came in today seeking care. Pt to see MD. asap.
fever 105, shaking, pain lt arm;  would not use lt arm; headache; threw up;
6 hours after injection developed swelling of lymph nodes in neck and throat.  saliva glad became swollen and ruptured.  Symptoms resolved within two hours
My symptoms began on Sunday morning with a scratchy throat when I woke, and I was tired. Then I had a mild headache. I tested positive for COVID-19 that day, January 28, 2023. The headache went away but I had some mild body aches. I had a runny nose and cough. I took DAYQUIL/NYQUIL. When I spoke with the doctor, I was advised not to take an antiviral. My symptoms were gone after day five.
Patient states he had sweating, pain, swollen arm at injection site, and dizziness/weakness, and was bedridden for most of the day.
Closed fracture of multiple ribs. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID-19 vaccine.
Patient developed increasing pain, redness, and swelling around injection site. Transported to emergency room the following day, 10/23/21. Continued to worsen, went into cardiac arrest and pronounced deceased in the emergency room.
swelling at injection site; swollen lymph nodes at under arm; Dizziness/Then felt like going to faint; Nausea; I became pale, diaphoretic, and tachycardia (100s).; I became pale, diaphoretic, and tachycardia (100s).; I became pale, diaphoretic, and tachycardia (100s).; Headache; Severe pain at injection site; Fatigue; Muscle weakness; For about 12 hours or so I had on and off fever and chills; For about 12 hours or so I had on and off fever and chills; This is a spontaneous report from a contactable Nurse (patient). A 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration on 13Jan2021 19:00 at single dose in Left arm for COVID-19 immunization.  Medical history included allergies to Sulfa drugs, attention deficit hyperactivity disorder (ADHD), seasonal allergic rhinitis. Concomitant medication included ibuprofen (ADVIL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), fluticasone propionate (FLONASE), clarithromycin (CLARITIN). Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 23Dec2020 18:00 at single dose which was administered at Left Arm for COVID-19 immunization. There were no other vaccines received in four weeks. The patient did not have covid-19 prior to vaccination and covid-19 not tested post vaccination. The patient started with dizziness and nausea on 14Jan2021 12:30. Then felt like she was going to faint on 14Jan2021 12:30. The patient became pale, diaphoretic, and tachycardia (100s) on 14Jan2021 12:30. Also had a headache and severe pain at injection site as well as fatigue and muscle weakness on 14Jan2021 12:30. For about 12 hours or so the patient had on and off fever and chills as well the rest of the symptoms listed above which started from 14Jan2021 12:30. Today (40+ hours later) on 15Jan2021, the patient developed swelling at injection site and swollen lymph nodes at under arm. No treatment received for the reported events. The outcome of the events was recovered in Jan2021.
left arm swollen hot all the way into the arm pit and down the left ar the elbow. EVERY JOINT IN MY BODY HURTS TO MOVE. FEEL LIKE NO ENERGY  AND SOME OF MY MUSCLES FEEL LIKE THEY ARE ON FIRE. ITS BEEN 3 DAYS ALREADY ITS GETTING WORSE NOT BETTER
Redness / at the injection site/ redness grew to the size of a palm; Itching at the injection site; This case was reported by a pharmacist and described the occurrence of injection site erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number FY5H2, expiry date 25th May 2022) for prophylaxis.   On 12th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th October 2020, 3 days after receiving Shingrix, the patient experienced injection site erythema and injection site itching. On 19th October 2020, the outcome of the injection site erythema was recovered/resolved. On an unknown date, the outcome of the injection site itching was recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.  Additional details were reported as follows: The patient reported redness and itching at the injection site which presented 3 days after the vaccination of Shingrix. The rednesss grew to the size of a palm and lasted for 4 days. The itching lasted for a week. The information regarding consent to follow up was not reported but consent to follow up given.
8/28/21:  8:12 am - received vaccine / booster #3 8/29/21:  7:00am - noted chest pain, shortness of breath - particularly with exertion 8/30/21:  continued chest pain / SOB noted - hypoxia at 83% on room air observed with walking up 2 flights of stairs (typically completed repeatedly during the day with no observed shortness of breath),  heart rate increased - 129 bpm (usual 70's) - saturation level returned to 92% on room air after 5-7 min while seated 8/30/21:  continued chest pain / shortness of breath noted with light ambulation (10 ft) - > called PCP whom directed me to ED 8/30/21:   ED visit at hospital in which I work - increased Ddimer (868),  neg CT for PE, abnormal ECG - anteroseptal infarct, age indeterminate > released from ED 8/31/21:  returned to work in hospital - assistance needed for lifting / mobilizing patients due to chest pain / SOB 9/1/21:  visit to PCP > referral to cardiologist 9/1/21:  contact with Dr.
Stayed in bed much of the day after 2nd shot; Fever 99.7F after 2nd shot; Fatigue after 2nd shot; This spontaneous case was reported by a patient and describes the occurrence of BEDRIDDEN (Stayed in bed much of the day after 2nd shot), PYREXIA (Fever 99.7F after 2nd shot) and FATIGUE (Fatigue after 2nd shot) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation, GERD and Graves' disease. Concomitant products included METOPROLOL SUCCINATE, METHIMAZOLE and FAMOTIDINE for an unknown indication.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced BEDRIDDEN (Stayed in bed much of the day after 2nd shot), PYREXIA (Fever 99.7F after 2nd shot) and FATIGUE (Fatigue after 2nd shot). On 29-Mar-2021, BEDRIDDEN (Stayed in bed much of the day after 2nd shot), PYREXIA (Fever 99.7F after 2nd shot) and FATIGUE (Fatigue after 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Body temperature: 99.7f (High) 99.7F, her baseline temperature is 98F or a little below.         Patient reported of taking unknown supplements and declined for its name. Patient was back to base line on 29 Mar 2021. No treatment medication was reported.   This case was linked to MOD-2022-573655, MOD-2022-573657, MOD-2022-573658 (Patient Link).