chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the arthritis was painful; slept for 12 hours; very very achy; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (the arthritis was painful), SOMNOLENCE (slept for 12 hours) and PAIN (very very achy) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A, 012M20A and 046C21A) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL SUCCINATE, AMLODIPINE, LOSARTAN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ESOMEPRAZOLE for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced ARTHRITIS (the arthritis was painful), SOMNOLENCE (slept for 12 hours) and PAIN (very very achy). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) at a dose of Vicodin 10/325mg took maybe 1/2 to a 1. At the time of the report, ARTHRITIS (the arthritis was painful), SOMNOLENCE (slept for 12 hours) and PAIN (very very achy) was resolving.            This case was linked to MOD-2021-331149 (Patient Link).; Sender's Comments: This case concerns a 73-year-old, male patient with medical history of lung cancer, who experienced the unexpected non-serious adverse event of special interest of arthritis. The event occurred on the same day after the second dose of Spikevax (Moderna COVID-19 vaccine. The rechallenge was negative since the patient recovered from the event and then received the third dose without recurrence. The medical history of lung cancer remains and negative rechallenge remains as a potential confounder. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
During the Covid pandemic I received Pfizer vaccine 12/21/20, 1/11/21 and 9/21/21 as a condition for keeping my job at hospital. I retired May 2022. I got more Pfizer Covid boosters at pharmacy 6/22/22 and 12/14/22. Approximately 12/15/2022 I went to my annual physical. Dr. my hypertension diagnosed about 1-2 years earlier was escalating. I was taking amlodipine and losartan. I was diagnosed with new onset atrial fibrillation, it was confirmed by an in office EKG that day. I started a blood thinner and given a consult to a cardiologist. Dr. Cardiology did an EKG to confirm at my first visit. My drug regimen was changed to amiodarone and continue blood thinner and metoprolol and cardiologist told me I would most likely need a cardio version. I subsequently had an echocardiogram to clear me for the cardio version. On my repeat visit to cardiology my echo was evaluated as benign. Also it was discovered I was in normal sinus rhythm. The cardiologist said no cardio version needed but to continue amiodarone 1 month then we will change it to something more safer for long term use. I suspect the Pfizer vaccine either triggered or contributed or caused my a fib. The cardiologist wanted me to transition from amiodarone to Multaq. Multaq is very expensive so we settled on sotalol instead and stopped amiodarone.
Tenderness, swelling, redness L deltoid 50mg Keflex tid x 7d.
Expired Moderna was administered on 11/19/2021 lot# 046C21A. Patient was called back to the clinic and vital signs were taken and were WNL. Patient showed no s/s of any distress and when asked he states no s/s. Provider was notified and also Moderna manufacture and they will update with guidelines. Patient was release back to security.
EMPLOYEE REPORTED UPSET STOMACH WITH CRAMPING AND TINGLING OF FINGERS AND ROUND LIPS.
sore arm; Strong pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PAIN (Strong pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     Concomitant products included PREDNISOLONE, APIXABAN (ELIQUIS), GABAPENTIN, LEVETIRACETAM, ALLOPURINOL, TOPIRAMATE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), POTASSIUM and MECOBALAMIN (VITAMIN B12 [MECOBALAMIN]) for an unknown indication.   On 22-Jan-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 2 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PAIN (Strong pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 24-Jan-2021, PAIN IN EXTREMITY (sore arm) and PAIN (Strong pain) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-214675 (Patient Link).
4NOV92 no problems until 2nd day arm swollen, hot, used cold compress & APAP; no fever; 3NOV92 seen by MD dx cellulitis given ATB;
(L) shoulder bursitis; shoulder pain 2 weeks. Pt used Advil and ice.
5 X 8cm area of erythema and swelling 2 days after Tdap given. Benadryl PRN.
Itching at injection site for two or three days.  Over the next 3 weeks progressed itching over entire body resulting in hives.  Sought medical attention 9-21-2014.
Positive COVID 19, sore throat, headache, fever, coughing, and runny, stuffy nose.
4 episodes of nausea/vomiting/diarrhea, then found by spouse with altered mental status and nonresponsive/snoring. Taken to Emergency department for stroke evaluation. Ruled out for stroke, intubated for airway protection and cerebral edema with meningeal enhancement observed on CTA. Admitted to ICU.
Chills, fatigue, myalgias, headache, pain at injection site. Starting 4 hours after injection and resolved within 24 hours following injection.
45-year-old female presents the emergency room for evaluation of headache, chest discomfort, nausea, hot flash sensation while at work today.  States she felt well yesterday.  Has not measured a temperature.  Has not had any recent Covid testing or no known ill exposures but does work in as a medical assistant in a medical office.  Headache is dull in nature frontal, gradual and not of sudden onset.  No associated vision/speech change, neck pain or stiffness, focal extremity numbness or weakness.  Chest is discomfort with some shortness of breath and congestion but no productive cough or purulent phlegm.  No associated palpitations or lightheadedness and no history of heart disease, DVT/PE.  Did have nausea but no abdominal pain and did not vomit.  No unusual recent foods.  Normal bowel movements without constipation, diarrhea, melena.  Normal urination.  No new leg pain or swelling.  Symptoms mostly improved at this time but still has some head discomfort.
No adverse effects were reported; a 38 year old female patient received a dose of PROQUAD; This report was received from a medical assistant (also an office manager), referring to a 38 years old female patient. The patient's medical history and concomitant medication were nor provided.   On 14-MAY-2019, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (lot # R013575 (recombinant Human albumin (rHA)) with expiration date 10-NOV-2019) subcutaneously for prophylaxis (product administered to patient of inappropriate age).  No adverse effects were reported in the patient.
Information has been received on 13-APR-2018 from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, by a physician in a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated at a physician's office for a vesicular outbreak, which was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
He was given Moderna instead of Pfizer. His first dose was given 1/14/2021 of Pfizer Lot EL3249. He had left his card at home and documentation was not available at time of administration.
Had soreness in my arm and some tiredness the next day. I had shooting back from my buttocks down to my legs (description of the back pain).
started 4-6 weeks after 2nd vaccine dose. Large oval discolored area rt lower leg on calf. Now with same type lesions on abdomen. Was diagnosed with Morphea by skin biopsy.
Seen on 07/31/2003, day after receiving immunization, painful right leg, refused to weight bear; warm to touch, swollen right thigh (DTaP given there).
Information has been received from a physician concerning a 31 year old male with no relevant medical history or allergies who on 07/29/04 was vaccinated with a dose of Hepatitis A virus vaccine inactivated. There was no concomitant medication. The next morning, on 07/30/04, the pt developed urticaria/hives, a generalized rash on torso, and swelling of lips, hands and feet. The pt continued to have hives beyond 6 weeks post vaccination.  The pt was treated with aggressive medication therapy including prednisone, ranitidine HC1 (Zantac) 150mg twice daily, cetirizine 10mg twice daily, fexofenadine (Allegra) 180mg twice daily and montelukast sodium 10mg. The pt's urticaria waxed and waned depending on his medications. The pt was seen on 09/17/04 and was recovering, having been hive free and symptom free for 5 days. Therapy with montelukast sodium was discontinued. Therapy with the other medications was continued. The goal was to slowly taper the pt off the treatment medications to see if the pt remained symptom free. At the time of this report, the physician considered the pt as recovering. The pt's hives, rash, and swelling of the face, hands, and feet were considered other medical events (OMIC). Additional information has been requested. Follow up 03/03/05: Patient's recovery status is unknown.
Almost 30 minutes after my second shot of the modern a vaccine, I was experiencing haziness. From 12pm-5pm the day of the shot, I had horrible pain in my left arm and I couldn?t lift my arm above my head. I was also very tired and had a headache. From 5pm-10pm the day of the shot I was experiencing a fever of 102 degrees Fahrenheit. I was experiencing chills and muscle aches all over my body. From 10pm the day of the shot to 4am the next morning I would wake up every 2 hours and nausea and vomit while still experiencing the shivers and fever.
12/13/21 presents to ED for "chest tightness/SOB". PMHx of "HTN, CVA, COPD, Afib on Eliquis, NPH s/p VP shunt"
pt received 3 doses; w/in 1-2 days of dose 3 exp fever and malaise; resolved w/in 24-36 hr
pt devel lt arm weakness & pain x 1wk or more;when using lt arm cont to feel uncomfortable;has seen neuro states must have hit a nerve;
SARS-CoV+SARS-CoV-2 (COVID-19) Ag [Presence] in Respiratory specimen by Rapid immunoassay~SARS-CoV+SARS-CoV-2 (COVID-19) Ag [Presence] in Respiratory specimen by Rapid immunoassay test on 7/6/21 and was positive. Case investigation interview with patient has not been performed at the time of this note.
Site became reddened and hot to touch, swollen, and hard knot where shot was given.
My nose began burning and started with a migraine which then turned into constant fatigue and awful body aches. This is day 5 and I have no energy, my breathing is not the best. It feels like I have COVID all over again.
At time of injection, there was a drip of blood when needle removed.  Bleeding stopped with single cotton ball and bandaid.  Patient states the area began to bruise later and it has taken weeks to fully resolve.  States it has remained slightly tender to touch.  No loss of ability to use arm fully as usual reported by patient.
A few hours after receiving vaccine the patient experienced edema around elbow. Patient reported adverse effect to me 3 days later and I counseled him on the options. Patient decided to go to emergency room and was given antihistamines for the reaction. Shortly after, patient's adverse effect resolved.
This spontaneous report was received from a registered pharmacist via a company representative concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient developed redness, soreness and swelling around injection site. It was unspecified if the patient sought medical attention. It was unspecified if any treatment was provided or if any lab tests were performed. The outcome of redness, soreness and swelling around injection site was unknown. The relatedness for redness, soreness and swelling around injection site was unknown for ZOSTAVAX. Additional information was been requested.
Chills; Sweats; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and HYPERHIDROSIS (Sweats) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced CHILLS (Chills) and HYPERHIDROSIS (Sweats). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and HYPERHIDROSIS (Sweats) 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 became dizzy and nauseous 5 minutes after administering vaccine. vitals taken, noted elevated blood pressure that was beyond her normal per patient. Laid patient down on bed. Gave pt water and candy. Vitals rechecked within 5 minutes, blood pressure still elevated with her having same symptoms.  Benedryl given by mouth.  Pt continued to have elevated BP with worsening BP with every check. Pt still having the nausea and dizziness but it is not getting worse per patient. She starts to have flushing of the face. EMS called to evaluate patient. Patient taken to hospital. This all took place in one hour after administration of the vaccine.
Soreness in the arm on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness in the arm on the injection site) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-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 INJECTION SITE PAIN (Soreness in the arm on the injection site). At the time of the report, INJECTION SITE PAIN (Soreness in the arm on the injection site) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received and contains non significant information
This is a spontaneous report received from a contactable reporter (consumer). A male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "type 1 diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 06Dec2021, outcome "unknown", described as "Seizure"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "blood sugar was in the 300's". The patient underwent the following laboratory tests and procedures: blood glucose: 300's. Additional information: The caller was talking to the (company name withheld) guy about his son who is a type 1 diabetic and had a seizure. The patient's blood glucose was in the 300's. The patient also had the Pfizer Covid vaccine. The lot number for BNT162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200494170 same reporter/drug, similar events, different patients.
3 patient died; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (3 patient died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            It was reported that an oncologist informed to the reporter that few of her patient died out of 100-200 fully vaccinated probably caught COVID. And 3 patient died. They ran unspecified test on them had no protection from vaccine. No antibody found. No concomitant medications were reported. No treatment medications were reported.  Company comment: This spontaneous case report concerns a subject of unknown age and gender that experienced the serious unexpected AESI event of Death after an unknown period of Moderna COVID-19 vaccine administration. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report; Sender's Comments: This spontaneous case report concerns a subject of unknown age and gender that experienced the serious unexpected AESI event of Death after an unknown period of Moderna COVID-19 vaccine administration. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report; Reported Cause(s) of Death: Unknown cause of death
A little after noon on Monday, October 4, 2021, I received my Pfizer Covid booster (3rd shot). Given that I had had an adverse reaction to the March 26 2nd shot, I was prepared for another adverse reaction to the booster. Within 12 hours of my shot and close to midnight, I began having the expected adverse reaction. It started with tingling in my feet, face, legs and arms, and worsened throughout the night to the point that every part of my body from head to toe ached. It was difficult to move any part of my body without experiencing pain or significant discomfort, and that discomfort disrupted my sleep overnight into Tuesday, October 5. It ached to walk, sit and lie prone. I developed a headache during the middle of the night, and took Advil 400 mg to relieve the headache. I did not feel nauseated, did not have a fever and just let the aches subside until I could physically function again about 30 hours after my booster shot. I drank water and coffee (which helped my headache), and ate saltines and cheese throughout the day on October 5. On Wednesday, October 6 I was back to normal.
No adverse event. 1st dose COVID 19 vaccine 1/11/21. Pt scheduled for 2nd vaccine on 2./5/21, 25 days after her 1st dose. CDC recommends 28 days with 4 day window before and after the 28 day mark. Pt 2nd dose rescheduled for 2/2/21 which was 22 days after 1st dose. Pt recieved 2nd dose outside the CDC recommendation time frame.
She's also been having chest pain; Having a rash from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (She's also been having chest pain) and RASH (Having a rash from the vaccine) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (She's also been having chest pain) and RASH (Having a rash from the vaccine). At the time of the report, CHEST PAIN (She's also been having chest pain) and RASH (Having a rash from the vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  The reporter stated that they were having a rash from the vaccine and also been having chest pain.  No treatment information was provided.   This case was linked to MOD-2021-404393 (Link).
The injection was given in the Left upper arm and the arm started to get sore on the evening of 11/13/2010.  The morning of 11/14/10, the Left upper arem was very itchy and sore with some swelling.
Patient came to the pharmacy today and states she received her 2nd dose on 04/28 and after 72h started to feel a lump on left side of neck and and swelling. I explained lymphadenopathy was a rare side effect of vaccine occurring in less than 0.3% o f the population.
Pt recvd vax & devel fever 8hrs post vax; persisting 12 hrs w/no sx; rx APAP;
I have a circular red rash on my arm at the injection site, about 2 inches in diameter. I noticed a little itching at first, but now the rash is just there and it doesn't itch anymore.
Lymphadenopathy and fatigue; Lymphadenopathy and fatigue; First dose of BNT162B2 administered on 17Dec2020 and second dose on 04Jan2021 (18 days apart); This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 04Jan2021 at 10:00 (second dose) on the right arm, and on 17Dec2020 at 15:00 (first dose) on the left arm; both via unspecified routes of administration at a single dose for immunization. Medical history included hypertension and liver disease. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), ibuprofen, paracetamol (TYLENOL), propanol, and sennoside a+b (SENOKOT). The patient experienced lymphadenopathy and fatigue on 05Jan2021 at 05:00. The patient did not receive treatment for the adverse events. Outcome of the events was not recovered.
Varicella Vaccine breakthrough. Rash started 7/15/06, on torso, legs, palate. No fever. Seen in our office 7/17/06 and diagnosed with varicella. Had 100-200 lesions, vesicles with some scabbed.
Slept 37 hours straight after shots. Mother work during that time to feed infant. After 37 hours of sleep, back to normal behavior including colic which he had both before and after shots. After that, no pertussis vaccine was given. Beginning age 5 or 6, had tics, trouble sleeping, learning disabilities, possible ADHD, difficulty processing verbal information. Seen by multiple MDs, therapists, diagnosis still undermined.
Redness/swelling size of grapefruit at site of injection 24 hours after varicella vaccine.