chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cellulitis on her whole bicep; A spontaneous report was received from a consumer and a healthcare professional concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cellulitis on her whole bicep - left arm/cellulitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21-Jan-2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 via unknown route in the left arm for prophylaxis of COVID-19 infection. On 18-Feb-2021, the patient received second of two planned doses of mRNA-1273 (lot/batch: 013M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, after receiving first dose of mRNA-1273, the patient developed cellulitis on her whole bicep - left arm. The event was assessed as medically significant as per IME list. Treatment details included ice pack, antibiotic and steroid.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of event, cellulitis on her whole bicep - left arm was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
58 y/o F with history of drug allergy (anaphylaxis from penicillin, facial swelling/diarrhea from doxycycline), seasonal allergy, mild intermittent seasonal asthma developed facial angioedema, erythematous, non-pruritic macules on her face/chest, and a "tiny bit" of chest tightness 5 hours after Pfizer vaccine. Responded to benadryl. 24 hours later facial swelling returned. On 3rd day after vaccination, swelling had fully resolved. No history of dermal fillers. No history of miralax use. Has tolerated influenza vaccine. No recent other vaccines. Skin testing to miralax, methylprednisolone and triamcinolone was negative. I advised her to avoid second dose of Pfizer vaccine.
Shortness of breath (used rescue inhaler); chest congestion; tired; slight myalgia.
Pt developed a pinkish-red 3 inches of induration, swelling and itching in 24 hours after the shot was given.
Broke her femur; Fell; This spontaneous case was reported by a consumer and describes the occurrence of FEMUR FRACTURE (Broke her femur) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Clot blood (prior to Moderna vaccinations). Previously administered products included for Clot blood: Enoxaparin (enoxaparin for 6 weeks as a blood clot preventative.). Past adverse reactions to the above products included No adverse event with Enoxaparin.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2022, the patient experienced FEMUR FRACTURE (Broke her femur) (seriousness criterion medically significant) and FALL (Fell). At the time of the report, FEMUR FRACTURE (Broke her femur) and FALL (Fell) outcome was unknown.            No concomitant medication information provided  The reporter stated that the patient had so far received three Moderna COVID-19 doses. The reporter also reported that the patient did not experienced any adverse events after the first three Moderna doses. The patient was scheduled to received the second Moderna booster dose on today 16Jun2022. The patient fell and broke the femur on 30Apr2022 and had to have surgery and rehab. The patient had a history of blood clots (prior to Moderna vaccinations), so the patient was placed on enoxaparin for 6 weeks as a blood clot preventative.   Reporter did not allow further contact
Mother states child received immunizations 7/24/03. When got up this AM she noted swelling and redness in left arm. Redness measures 9" from shoulder to elbow. Swelling at deltoid area 10 1/2" round (right arm measures 9" and is not affected). No fever or other symptoms of adverse side effects.
Immediate pain at injection, stinging sensation. Lasted for another 20 to 30 minutes off and on. Tingling and numbness of right arm for short periods after shot off and on for about first 15-20 minutes. Slight dizziness for first 15 -20 minutes lasting short periods. Nausea, briefly twice in first 20 minutes. Light-headed for the duration of 30 minute wait-and-watch period. This was the most noticeable for me, besides the intense stinging sensation in my arm. After 30 minutes of being watched in common area, I stood up to leave with my adult children and my legs were wobbly. The nurses made me sit and stay a while longer and brought me a snack. I drank my water I had brought with me. Left after an additional 15 minutes.
after getting the vaccine in morning, later that same evening patient felt sluggish, nauseaus, tired. Daughter finally convinced patient to see a doctor. Md prescribed her a cough medication. She still felt bad for another 2-3 weeks, so she finally went to the emergency room where she diagnosed with blood clots in the legs and the lungs. She staying in hospital approx. 4-5 days before being released.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 10-JUN-2015, the patient was vaccinated with a dose of PREVNAR 13 instead of PNEUMOVAX 23 (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The healthcare provider reported that no adverse effects were reported. Additional information has been requested.
Joints in his 2 hands that his bothering him; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Joints in his 2 hands that his bothering him) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Joints in his 2 hands that his bothering him). In 2021, MUSCULOSKELETAL DISCOMFORT (Joints in his 2 hands that his bothering him) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  It was reported that 8 joints in his 2 hands that his bothering him. Patient thought it was bizarre that he had arthritis in the same joint. The side effect started after the 2nd dose, it lasted about a week and it all gone.   This case was linked to MOD-2021-270609 (Patient Link).
Fever of 103.2 rectally. Twitching. Blank stares lasting about 1-2 minutes a piece.  Administered Tylenol at home at 10:45 PM took her to ER when her fever wasn't affected. When rechecked, her fever reduced to 101.0 and the ER staff administered Motrin at about 1:15 AM and discharged with instructions to keep an eye on her temperature and the blank stares and twitching spells.
12/18/2020 scrotal pain. Evening onset of rash 12/19/2020 Rash lower lumber, left butt cheek, scrotum and penis. Took picture and sent to Consult with infectious disease. Doctor deemed rash to be SHINGLES and prescribed Valtrex. By evening, rash had progressed all over and pain associated with shingles.  12/20/2020  Stable but rash is still prominent.  Consult over tele
Right sided focal seizures with tonic clonic movement of right leg, arm, body, face, eye and tongue lasting 10-15 minutes. Right sided weakness post seizure.
This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers to 07 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F. And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event and reporter's comment. Amended narrative accordingly.
Red and fever. Swollen. Shot given on (R) deltoid & posterior (R) upper arm.
Widespread urticaria developed about 5 minutes post vaccine. Patient self-treated with fexofenadine and said he had resolution of symptoms.
Pain in the arm, throat inflammation, earache and inflammation, dizziness, nausea, stomach discomfort, drowsiness, scalp pain.
Prior to vaccinations 1 and 2, I was peri menopausal, having irregular periods. Prior to vax, I experienced 2 lighter and shorter periods in 8 months prior to 1st vaccine. Approximately 2-3 weeks after 2nd vaccine, I had a much heavier and longer period than ever before since starting my menstrual cycle at the age of 12.  Approximately 4 weeks later, I had a 2nd period, not quite as heavy and long as first right after the vax, but somewhat heavier and longer than normal. Approximately 4-5 weeks later, I had a 3rd period that was more similar to my periods prior to beginning stages of menopause. Last day of last period was approx 9/18/2021.
Started with injection site pain and mild swelling.  Proceeded to cause muscle pain in trapezoid, up neck to head.  Painful sinus cavity and up neck to top of head.  Muscle pain became more serious as night went on from trapezoid down throughout entire body.  I became very weak and tired.  The headache and muscle ache continued through the night and then very early in the morning serious shivering and shaking.  Jaw clenching and nerve pain and numbness like carpal tunnel in arms and lower legs.  Adverse event continued for 3 days in which I was bedridden.  No fever or vomiting.  I called pharmacist about pain medication, but tylenol did nothing.  Halfway through day four I felt headache begin to subside as did muscle aching.  It took 5 days to feel like I could do my normal daily routine.  This reaction has been the reason I have delayed and dread getting the second dose.  I am still unsure if I will get it or not.  Horrible!
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) 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.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were not provided No treatment medication information were not provided   This case was linked to MOD21-062631 (E2B Linked Report).; Sender's Comments:  MOD21-062631:crosslinked
Fever 102.7,  chills,  swollen face, feeling unwell,  muscle pain, headache, pain
Day 1: Small twitches throughout both legs.  Cold chills for approximately 2 hours.  Brain experienced a cold feeling sensation focused on the front of the brain once.  Brain felt a "tingly" feeling sensation three times above the left ear that lasted about 20 seconds each time.  Pains coming and going all over legs including thighs, shins, calves, knees, ankle and feet.  Days 2 and 3:  Pains coming and going all over legs including thighs, shins, calves, knees, ankle and feet. Chest pains on both sides that were coming  and going.  Breast and nipple pain.  Shooting pain on forearms that were coming and going.  Arm weakness in both arms.  Stabbing pains all over the sides, stomach, and back that were coming and going.  Ear and jaw pain on both sides coming and going.  Head pain and pressure that would come and go in different spots, main spots behind/around ears, at the base of the skull, and behind eyes. Ringing in ears.  Day 4:  Neck and shoulder pain.  Arm soreness and pain coming and going.   Head pain, pressure, and discomfort.  Hip pain that felt like a pinching sensation.  Shortness of breath.  Chest pains. Leg twitches and quivers through both legs.  Breast pain on one breast.  Arm pain on both arms.  Hard time using a mouse and writing.  Extremely tired.  Leg numbness on the L side that was coming and going.  Ringing in ears.  Day 4:  Evening Episode: Around 7pm my heart started beating hard and fast.  I felt dizzy and nauseous.   My breathing was fast and shallow.   I had to lay down immediately.  I was unable to move or speak for approximately 15-20 minutes.  My body felt off and my L leg was partially numb feeling for this period of time.  I felt like I was going to pass out but remained conscious.   Days 5-8:  Head pain and pressure every day.  Mainly on the back of the head and around the ears.  Arm pain coming and going, both sides.  Neck and shoulder pain coming and going.  Sharp pains all over the back coming and going.  Leg pain coming and going in different spots.  Light chest pain coming and going.  Ringing in ears.  Days 9-11:  Light arm pain on both arms.  Daily head pain and pressure, less painful.  A little leg pain that comes and goes in different spots.  Ears ringing.  Days 12-13 (Day 13 is today, the day that this reaction is submitted): Head pain and pressure only 1-2 times a day.  Light arm pain.  Twitches/quivers occasionally on legs.  There is a bruise with a very small lump on the upper R thigh on top of a spider vein.   I almost went to the ER on day 4 after the scary episode that I experienced but decided not to because of the financial burden since I do not have health insurance.   I have an appointment to be seen at a low-cost clinic to speak with a doctor over the reaction and the lump on my thigh.
Patient was suppose to receive a Prevnar vaccine and received a Men B Truemenba. Patient mother was informed right away that patient received wrong vaccine. Mother was informed about symptoms to watch for and notify her pediactric doctor or take child to ER. Mother verbalized understanding.  Mother was notified on 2/1/2022 to follow up on child. Mother reports child is fine and is not have any adverse reactions. Child is doing fine and eating and drinking.
Fever 1/16/06 and spots, itchy also sore throat 1/17/06, 1/19/06 multiple papules some with pustule substance=50 on temples, forehead, chest arms and down legs.  Atypical VZV (varicella zoster virus)
PAIN ALL THE TIME; FEEL A DIFFERENCE IN BODY; MUSCLES STIFF 24-7; CONSTANTLY COLD; MUSCLES ARE ALWAYS SORE 24-7; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had flu and never got cold never wore a jersey or jacket. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced pain all the time, feel a difference in body, muscles stiff 24-7, constantly cold, and muscles are always sore 24-7. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscles are always sore 24-7, muscles stiff 24-7, pain all the time, and constantly cold, and the outcome of feel a difference in body was not reported. This report was non-serious.
Throat & chest tightening, tongue tingling, coughing, trouble breathing - immediately after receiving vaccine. Pt has extensive medical hx and hx of severe allergic reactions, carries epi pen with her. Epi (given asap after start of symptoms) and Benadryl given here prior to transfer to ED- Medical Emergency Team immediately called at onset of symptoms and transferred to ER with them.
REDNESS AND PAIN AT INJECTION SITE 24 HOURS AFTER INJECTION.
12 year old female patient reports feeling dizzy after being immunized paramedic takes vitals at 4:58 pm BP 90/70, pulse 110, DXT 112 and respirations 12 pm. Doctor indicates additional 30 minutes of observation. Liquid (juice) is administered. After completing the waiting time the patient stands little by little but refers to feeling the same symptoms. Patient reports being on menstrual cycle since yesterday with heavy bleeding in addition, she reports taking second dose of HPV which was administered 14 days ago
Pt recieved Moderna for 1st 2 doses of vaccine. Pfizer was administered and upon examination of pt card, She had recieved Moderna for first 2 doses.
arm soreness; community acquired pneumonia; COPD; shortness of breath; chest congestion; weakness; fatigue; Muscle aches and pains; she became ill; This is a spontaneous report from a contactable nurse from a Pfizer-sponsored program Pfizer First Connect. A 68-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on 06Jan2021 at single dose on right deltoid for covid-19 immunisation. Medical history included blood pressure high and seasonal allergies. There were no concomitant medications. The patient previously received first dose of bnt162b2 (Lot: EJ1685) on 16Dec2020 for COVID-19 immunization. The patient experienced community acquired pneumonia, shortness of breath, chest congestion, weakness, fatigue, COPD, muscle aches and pains, she became ill, all on12Jan2021; arm soreness on an unspecified date. Events required Emergency Room visit. Clinical course reported as: she got the second dose of the pfizer covid vaccine on 06Jan2021 and on 12Jan2021 she experienced shortness of breath, chest congestion, weakness and fatigue. Nurse stated ER doctor thought she had COPD or community acquired pneumonia. Nurse further stated she had the second COVID-19 vaccine on 06Jan2021. A week later on 12Jan2021, she became ill. She had all the symptoms of COVID. She was short of breath, very fatigued. She couldn't get any air, she was at work. She had muscle aches and pains. The shortness of breath, fatigue and weakness lasted several days. She also had severe chest congestion. She confirmed she got better. It actually took 4 or 5 days. By that Sunday (17Jan2021) she was better. She wanted it noted she had no reaction right after the shot. She stated she only had arm soreness, it was just a little sore, not even worth mentioning. It was only when she moved her arm a certain way. This was with either vaccine (first or second vaccine). She went to the doctor and somebody thought it might be a reaction, but the nurse thought it was too late for a reaction. The ER doctor thought it was COPD and community acquired pneumonia. Her primary doctor thought it was COPD. The patient underwent lab tests and procedures which included COVID-19 test: negative on 12Jan2021. Outcome of arm soreness was unknown, others was recovering.; Sender's Comments: Based on the drug-event time interval and the vaccine's safety profile, the  community acquired pneumonia is possibly intercurrent condition, unrelated to vaccine BNT162B2 administration, which is not the disease that the vaccine BNT162B2 can prevent from. While the COPD is more likely underlying condition, unrelated to vaccine BNT162 injection.   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.
Extreme mucus from nose. Constant. Constant clearing out of air passages by coughing.
Right arm mildly swollen. Seen yesterday measure 33cm diameter. Left arm 32 cm Menactra given and in the same arm DTaP. aware d/emor stole let know.
Lethargic - no energy for multiple days. Arm sore for full week (felt like someone had punched my arm). Very little appetite. Mild fever (between 99.8 and 100.3) day after. I had similar reaction after dose 1 (only lasted at most 36 hours), but nothing like this after dose 2. Dose 3 knocked me for at least 5 days with arm hurting longer.
Fever up to 105, red swollen arm & shoulder; APAP & Pediaproprosen given;
Restless night with chills, some body aches. By noon (12/04/2016), severe chills, rigors, fatigue, temp just below 103 F. Swelling at injection site. Large red welts several inches long. By 12/4/16, fever persisting of 103 F. By morning of 12/05/2016, fever had broken. still fatigued. Welts and swelling still present at vaccine site. Otherwise, doing better.
Swollen right supraclavicular lymph nodes, pain at injection site, 30mm induration, no erythema.
Moderna booster. Weeks later, I developed a rash on the arm I received the shot.
Stomach cramps; severe abdominal pains. Headaches and body aches. Stomach cramps were in the morning, and they did not resolve. The headaches and body aches didn't really resolve either before the second vaccine. Loss of appetite and loss of weight which continued through the second vaccine too.
Left upper arm red, swollen, warm to touch, stated had 'flu-like symptoms', headache on 9/6 + 9/7; MD appt. on 9/8.
Flushing/sweating, throat "on fire"/itchy within 5 minutes of vaccination
Suspected Vaccination failure; Shingles; Rash on back; Skin discoloration; This case was reported by a pharmacist via sales rep and described the occurrence of Suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and skin discoloration. On an unknown date, the outcome of the vaccination failure, shingles, rash and skin discoloration were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and skin discoloration to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient had rash on his back after getting both doses. The patient never experienced pain or symptoms but his PCP saw it last week and the discoloration and location was indicative that it was a shingles rash. The reporter agreed to follow-up from GlaxoSmithKline. This case was considered as suspected vaccination failure as details regarding time to onset for target disease was unknown at the time of reporting.
COMIRNATY COVID 23-24 (12Y  UP) PFS was ok for the first 8 hours, then felt achy and went to bed. Woke up with chills, burning hot, bright red patches all over my body, facial swelling, hands and feet swelling. Pain in arm. Hives and welts all over face, hands, arms, legs, back and feet.