chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hard red spot on the deltoid near the injection site about the size of a half dollar; hard red spot on the deltoid near the injection site about the size of a half dollar; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard red spot on the deltoid near the injection site about the size of a half dollar) and VACCINATION SITE ERYTHEMA (hard red spot on the deltoid near the injection site about the size of a half dollar) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (hard red spot on the deltoid near the injection site about the size of a half dollar) and VACCINATION SITE ERYTHEMA (hard red spot on the deltoid near the injection site about the size of a half dollar). At the time of the report, VACCINATION SITE INDURATION (hard red spot on the deltoid near the injection site about the size of a half dollar) and VACCINATION SITE ERYTHEMA (hard red spot on the deltoid near the injection site about the size of a half dollar) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  Patient had hard red spot and it was barely raised.
Information has been received from a physician concerning a 41 year old female with a history of spontaneous hives (cause unknown: occurring since high school) and no drug allergies, who on 12-NOV-2007 was vaccinated IM with a 1 mL dose of VAQTA (lot number: 658170/0760U). There were no concomitant medications. The patient experienced urticaria over the anterior portion of the hips and buttocks the same say of vaccination. The patient was administered over the counter BENADRYL for the event. The nurse reported that on 21-NOV-2007 the patient came into the office to receive hepatitis B virus vaccine rHBsAg (yeast) (MSD) and still had the hives so the patient did not receive the vaccine. There were no lab diagnostic studies performed. The patient did not received any further VAQTA. There was no product quality complaint. Additional information has been requested.
Vomiting continuously for three days; joints and muscle aches; joints and muscle aches; Chill; Very severe headache; dizzy spells; Lost of balance when walking/balancing unable to drive; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EV6203), via an unspecified route of administration, in left arm on 08Mar2021 16:15 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took prednisone and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced vomiting continuously for three days, joints and muscle aches, chills, very severe headache continuous for 7 days, dizzy spells and loss of balance when walking on 08Mar2021 19:00. The patient has not been able to go back to work after receiving first dose due to dizzy spells and balancing as she is unable to drive. The events resulted in emergency room visit and physician office visit. Emergency physician & personal doctor recommended the patient not to take the 2nd dose. The patient underwent lab tests and procedures which included blood test for COVID-19: negative  on 12Mar2021, nasal swab for COVID-19: negative on 12Mar2021, head and chest X-ray as a part of treatment. The patient was also prescribed medications for the events. The outcome of the events was recovered with sequalae.; Sender's Comments: Based on a plausible temporal association, all the events (vomiting, joints and muscle aches, chills, headache, dizzy spells and loss of balance when walking) are assessed as related to BNT162B2.   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.
Shortness of breath, heart palpitations, and feeling like passing out. This occurred on 3/13 and again on 3/15.
Injection site arm hurt; Could not lift injection site arm up straight above head; Injection site arm pain got progressively worse; Fatigue; A spontaneous report was received from a female patient concerning herself, a 82-year-old, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site arm hurt (Pain in extremity), not lift injection site arm up straight above head (Hypokinesia), injection site arm pain got progressively worse (pain) and fatigue (fatigue).    The patient's medical history was not provided. Concomitant product included latanoprost.  On an unknown date, the patient received the first of two planned doses of mRNA-1273 (Batch number: 013L20) via intravenous route in her left arm shoulder deltoid for prophylaxis of COVID-19 infection.  On an unspecified date, after vaccination the patient experienced some reactions including injection site arm hurt, not lift injection site arm up straight above head, injection site arm pain got progressively worse and fatigue. Treatment for the event was not provided.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events injection site arm hurt, not lift injection site arm up straight above head, injection site arm pain got progressively worse and fatigue were considered unknown.; Reporter's Comments: This case concerns an 82-year-old female who experienced NS unexpected events of pain in extremity, worsened pain, and hypokinesia, and NS expected fatigue. The events occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
DDD (degenerative disc disease), cervical; Cervical spondylosis with radiculopathy. Procedures: Anterior discectomy and fusion at Cervical 5-Cervical 6, Cervical 6-Cervica l7. Recovery in hospital. Hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report as received from a healthcare worker refers to a 14 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K011562, expiration date 08-APR-2017 (strength, dose and route of administration were not provided). There were no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Chest pains.  Hypertension of 230/118 at 1:45pm 3/3/21. 2 hours after receiving Covid vaccine.  Went to ER.  Evaluation with EKG, chest X-ray, lab work.  Chest pains subsided.  Hypertension continued 212/109.  Medications administered for blood pressure which was lowered after approx 4 hours.
Soreness; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Soreness) and PYREXIA (Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not provided.).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced PAIN (Soreness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at an unspecified dose and frequency. On 30-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, PAIN (Soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Body temperature: 99.4 DF. On an unknown date, SARS-CoV-1 test: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sore arm; Fatigue; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 63 years on 29Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue on 29Jan2021 (not sure if related) and sore arm on 30Jan2021. No treatment was received for the events. The outcome of the event was recovered on an unspecified date.  Information on lot/batch has been requested.
4 hours after injection developed red raised hive like rash on neck, under arms, groin area.  24 hours after injection became shaky, hot disoriented-fell forward at desk.  Did not lose consciousness.  Another episode about 4 hours later and third episode while at ER.  Says episodes now less frequent.  Had one this AM.  On Benadryl.
The 1st shot was administered to my left arm on  3/29/21 at 4:00PM . On 3/3021 3:00  I started to experience pain in my left and forearm . The same symptoms  followed to my right arm 2days later.  The symptoms gradually subsided but lasted until lasted until 3/16/21.
did not feel well; Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well), CHILLS (Chills) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced MALAISE (did not feel well), CHILLS (Chills) and PYREXIA (fever). At the time of the report, MALAISE (did not feel well) and PYREXIA (fever) outcome was unknown and CHILLS (Chills) had not resolved.            No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-027691 (Patient Link).
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jan2021 (Lot number: FL3247) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "little ball/lump/mass in collar bone area" (ongoing), notes: at least 2-3 years before, but it never hurt. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient was concomitantly taking unspecified birth control medications.  No follow-up attempts are possible. No further information is expected.
expired dose of ROTATEQ (2nd dose in the regimen) was administered to a baby; plagiocephaly; torticollis; This spontaneous report was received from a physician and refers to a 4 month old female patient. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.  On an unknown date in 2021, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, for prophylaxis (exact dose, lot number and expiration date were not provided).  On 06-OCT-2021, the patient was vaccinated with an expired dose, second dose in dosage regimen of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, for prophylaxis lot number: 1684166, expiration date: 27-JUN-2021 (exact dose was not provided) (expired product administered).  On an unknown date in 2021, the patient had two diagnosed minor conditions plagiocephaly and torticollis. It was unknown when these two additional diagnoses were made in relation to the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administration. There was no side effects thus far reported by the doctor. The baby was fine and was an otherwise healthy baby. No treatment was given. The patient did not seek for medical attention. The physician stated that it sounded like he should repeat the dose in 4 weeks given the questionable efficacy of an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  The outcome of the events was unknown.The causality assessment was not provided.
Moderna monovalent booster dose (0.25ml of 100mcg/0.5ml) given on 8/31/22 when it was declared not to use monovalent for boosters anymore. Doses given prior to learning of this guidance. 4 total given, an additional was a full dose given to a patient that had Janssen and moderna half dose that was immunocompromised. This patient received a full dose.
Moderna COVID-19 Vaccine EUA  reddness at injection site - noticed 10 days past injection; no itching or pain
Almost immediately I felt a burning feeling in my arm and chest area. I complained to the nurse who later released me after 10 minutes. I went home and passed out. I found myself to be out of breath and did an EKG and said I was in AFIB. I was referred to Cardiologist to treat the AFIB.  I also developed Sleep Apnea. I can't run anymore and now I can hardly walk down the road.
Severe frontal sinus headache that started around 5 pm. No relief with Extra Str. Tylenol. Pain so severe, I could not sleep all night. Had telehealth visit on 1/12/2021 and APN recommended I take 1000 mg. Tylenol and 600 mg  Ibuprofen at the same time and to rest and to repeat these medications in 6 hours. Headache resolved after 2nd dose of medications. Since that episode, I continue to have intermittent frontal sinus headaches, not as severe as the first one.
warm to touch on the injection site; Soreness at the injection site; Redness that is spreading; joint and bone pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch on the injection site), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE ERYTHEMA (Redness that is spreading) and ARTHRALGIA (joint and bone pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (Controlled by medicines) since 2008, Cholesterol (Controlled by medicines) since 2008 and Acid reflux (oesophageal) (Controlled by medicines) since 2008. Concomitant products included FLUOXETINE HYDROCHLORIDE, PANTOPRAZOLE, ATORVASTATIN, METOPROLOL and VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for an unknown indication.    On 03-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ARTHRALGIA (joint and bone pain). On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to touch on the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE ERYTHEMA (Redness that is spreading). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 06-Mar-2021, ARTHRALGIA (joint and bone pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm to touch on the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE ERYTHEMA (Redness that is spreading) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient has undergone blood workup as a normal checkup and everything look good including calcium and vitamin D. He took a Bone density scan which shows significant osteoporosis. Patient was referred to Osteoporosis clinic, where he was recommended Reclast infusion which he took.   This case was linked to MOD-2021-263858 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant Follow-up:- medical history, second dose info and concomitants are updated. On 22-Jul-2021: NNI- No New Information
Temperature per pt. Redness, swelling, pain at injection site. Symptoms better day 2. Tx TYLENOL/MOTRIN for fever & discomfort, warm compress to area.
Before I received my dose, I pre-medicated myself with Benadryl and famotidine because I had an allergic reaction to the Moderna vaccination. After I was vaccinated the pharmacist watched me for my first 15 minutes and then went home. I initially didn't experience anything major during my initial 4-6 hours except for some arm pain. By hour 6, my arm had started to swell as well as my underarm pit and left breast. So I took some more and famotidine. and that helped a little. I also started to feel the chills and so I created a big bottle and took all of my vitamins and pills mentioned above, and went to bed. I woke up several hours later with chills, severe muscle pain, and weakness to the point where I could barely walk to the bathroom. The main muscles that hurt the most were my arms, legs, stomach and neck (way worse than my worse period cramps type of pain.) My Chest was also hurting and my arm was now extremely swollen along with my underarm pit and left breast. All are noticeably bigger than the right side. I then went through one of the worse sicknesses of my life for the next 48 hours and now I feel fine except for the severely swollen arm/underarm pit and left swollen breast.
A small oval itch and swollen, My arm was achy. This decreases over the next week. By June 17, it was just a small amber swatch across my arm. It was about ½ in x 1 ½. On June 18, it started getting swollen red and itchy again. ON June 19, it got really huge. It was like 8 inches wide, 4 in wide. It swelled about ¼ in. It was like a plateau on my arm. On June 20, the swelling went down and looked like a tick bite like a bullseye. By the 22, I noticed my lymph nodes were swollen under my armpit and near my breast. I contacted my doctor and saw her on June 25th at 9:30AM. The patch was not as big at the appointment, but it was still visible. She told me to put hydrocortisone on it which I did not do. It has gotten less red. My lymph nodes were still present and began getting less tender until present day. The secondary reaction still shows a faint outline of where it was. The injection area is also a little dark. At no point did I feel fevered, chills, body aches or anything. It was very localized to my arms and lymph nodes.
Reaction:  The evening after receiving an influenza vaccine in clinic, patient developed rash/swelling at injection site, progressive weakness, dysuria, nausea, and 10/10 back pain.  Management:  Patient evaluated in clinic 2 days after the vaccine was administered and sent to the ED for further workup. In ED neurology decided to admit the patient. In hospital, reported weakness was not demonstrated on exam (strength 5/5 at all sites) and reflexes were all intact. The patient's home dose of gabapentin was increased to 600 mg TID to help with the patient's back pain. Patient was discharged to home with physical therapy the next day.
in the middle of the night my toes turned beat red/purplish color and numb and cold started to form blisters took almost a week to get over it still have rough spots where the blisters were. Went to the dr. took my blood pressure and it was high. went for several test at the Cardiologist  my blood pressure was still high and i was also having some discomfort and chest pain
Muscle pain on injected arm started the next day of vaccination, got worse as the go by.
itched; Arm swelled up quite a lot into a 4" across area; burned; It was a little red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itched), VACCINATION SITE ERYTHEMA (It was a little red), VACCINATION SITE SWELLING (Arm swelled up quite a lot into a 4" across area) and VACCINATION SITE PAIN (burned) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (It was a little red). On 14-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itched), VACCINATION SITE SWELLING (Arm swelled up quite a lot into a 4" across area) and VACCINATION SITE PAIN (burned). On 16-Apr-2021, VACCINATION SITE PRURITUS (itched), VACCINATION SITE ERYTHEMA (It was a little red), VACCINATION SITE SWELLING (Arm swelled up quite a lot into a 4" across area) and VACCINATION SITE PAIN (burned) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   This case was linked to MOD-2021-114410 (Patient Link).
pt recvd vax; exp swelling of the plantar aspect of foot & around big toe & punctate black vesicular rash on forehead,body & plantar aspect of foot;md suspected poss serum sickness;
Severe allergy reaction. Started itching 1 day after immunization & broke out into hives 2 days after shot & was admitted in ER.
Received varicella vaccine 2/5/01. Developed large number of vesicles all over body. To MD to confirm varicella.
sore throat.......no other symptoms.........Dr office phone call said it is most likely side affect of the booster.  It's annoying and constant but has not deterred my daily routine
Symptoms of tiredness and head sinus pressure came on throughout the day monday 3-29-21. Symptoms were unchanged tues morning 3-30-21. She died Tuesday 3-30-21 between 10:34 am and 12:00 pm. She was found unresponsive at 12:07 pm when husband returned home for lunch. Autopsy results still pending.
I developed Shingles shortly after receiving my second Pfizer vaccination.  I had received a vaccination AGINST getting shingles about 6 years ago and thought myself protected.  These events could be unrelated but the quick onset of shingles so soon after being vaccinated, makes me consider the possibility that the vaccine triggered this event somehow and needs to be looked into.  I still have shingles
pt rcvd vax; pt devel injection, respiratory, upper; congestion, respiratory; cough; fever; asthenia/fatigue; dysuria; WBC inc; nausea; vomiting; pain, abdominal; eosinophils decreased; injection, urinary tract; sinus disorder, chronic;
Red spots that appeared around left ear on 3/23/18 and have since spread to face neck abdomen and back, spots itch.
2/3/22 pt had a positive COVID test; was admitted to hospital with COVID pneumonia; took 2 days of Remdesivir, then stopped due to spike in LFT; given dexamethasone; dc'd to home on 2/11/22 with O2 via NC; 2/17/22 pt to ED for worsening SOB and AMS; positive for COVID still; O2 saturation 50%; placed on BiPAP; sent to PCU; worsening condition; worsening renal function; family transitioned pt to comfort care; he passed away in the hospital