chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cellulitis; Pink tinge on her arm; Hot/raved/spreading; Like a rash/it got worse; Red; This spontaneous case was reported by an other health care professional and describes the occurrence of CELLULITIS (Cellulitis) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 0018(B)21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACYCLOVIR [ACICLOVIR] and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant), PARAESTHESIA (Pink tinge on her arm), VACCINATION SITE WARMTH (Hot/raved/spreading), RASH (Like a rash/it got worse) and VACCINATION SITE ERYTHEMA (Red). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) for Cellulitis, at an unspecified dose and frequency. At the time of the report, CELLULITIS (Cellulitis), PARAESTHESIA (Pink tinge on her arm), VACCINATION SITE WARMTH (Hot/raved/spreading), RASH (Like a rash/it got worse) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient mentioned that she experienced a pink tinge on her arm, like a rash and it got worse: red and hot and raved and spreading. The rash was 2-3 inches below the injection site. Patient was on supplements.  Company comment -This case concerns a 73 year-old female patient with no reported medical history who experienced the unexpected serious event of cellulitis. The event occurred approximately 2 days after the third dose of mRNA-1273. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-378110 (Patient Link).; Sender's Comments: This case concerns a 73 year-old female patient with no reported medical history who experienced the unexpected serious event of cellulitis. The event occurred approximately 2 days after the third dose of mRNA-1273. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.
HAIR FALLING (HAIR LOSS); This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid with pneumonia, and intensive care unit.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAY-2021, the subject experienced hair falling (hair loss). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hair falling (hair loss). This report was non-serious.
vertigo starting the evening of vaccination; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiry date not reported), via an unspecified route of administration on 15Jan2021 13:00 at single dose for COVID-19 immunization.  Medical history included vertigo from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced vertigo starting the evening of vaccination on 15Jan2021 and continues to persist 6 days later with decreasing intensity. The patient further reported they had vertigo that seems to resolve a couple hours after taking the vaccine and has persisted with positional changes. It was further reported that it was diminishing for the past couple of days but they were pretty intense about vertigo in particular. When they were in a laying down position like the whole room is spinning. It was horrible. The day after vaccine like they were spinning for hours at night and with positional changes from laying down to getting out of bed. When they initially lay down they got like a vertigo. The patient was recovering from the event.
About 10 minutes after pt received vaccine, she said she was feeling dizzy.  Pt was able to walk back into the exam room where NP had her lie down on exam table.  Placed cool paper towel on forehead.  Offered pt bottle of water, so pt sat up.  She drank a few sips and laid back down.  Placed another cool paper towel on forehead and neck.  Moved pt up to about 60 degrees on exam table.  Got pt a mint to suck on.  After about 20 minutes, pt sat up on exam table, stated she was feeling better.  Sat on exam table for 5 minutes then said she was ready to stand up.  Had pt stand up for 2 minutes with NP standing by.  Pt was then able to walk out of the exam room without difficulty.
sore throat; internal chills; headache; feeling lousy; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore throat, internal chills, headache, and feeling lousy.  The patient's medical history was not provided. Concomitant medications reported were beclometasone for drug use for unknown indication.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Not provided) via unknown route for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the events sore throat, internal chills, headache, and feeling lousy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event sore throat, internal chills, headache, and feeling lousy was unknown.
Mother noted intermittent head shaking and head jerking, starting 2 days, post vax. At first occurred multiple times a day, for a few seconds, then gradually became less frequent and occurred about 2 X a day, especially when tired. Resolved after a few months. ? involuntary. Reaction brought to my attention at 2 year visit and it had resolved.
Patient vomited shortly after getting home following her vaccination. It occured 3 times yesterday evening and an additional 4 times overnight and this morning. Her mother, has reached out to the pediatrician and is waiting for a call back. Patient is currently not tolerating any food or water. They have purchased pedialyte.
On 11/03/05 I received the Inactivated Influenza Vaccine at approx. 1:40pm.  I went to sleep around 8:00pm that evening.  Around 10:00pm I woke up freezing, my feet were so cold and hurt that I wanted to cut them off so I bundled up and stayed in bed.  I also took my temperature it was 100.6 so I took 2 Tylenol Sinus.  Around 11:00pm my body was boiling so I took my temperature again and it was 102.5.  I changed into something cooler and put a cold, damp wash cloth on my forehead.  I fell asleep and woke up to my alarm at 6:00am on 11/04/05, feeling better and just a little weak.
ACNE SECRETIONS, SMALL BUMPS ERUPTING AROUND BOTH EYES LIDS, AND LASHES, SECRETING SOMETIMES WHITE, YELLOW, AND BLACK COLOR; This spontaneous report received from a consumer concerned a 93 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced acne secretions, small bumps erupting around both eyes lids, and lashes, secreting sometimes white, yellow, and black color. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acne secretions, small bumps erupting around both eyes lids, and lashes, secreting sometimes white, yellow, and black color. This report was non-serious.
Swelling and pain from shoulder to elbow, chills, advised to treat with MOTRIN, BENADRYL, and cold packs and seek emergency treatment if no relief.
Trouble swallowing: 30 hours after shot, continuing though current time of 70 hours Nausea, vomiting,  dizzy, fainting 65 hours after shot. 2 episodes Fever - 72 hours after shot
48 hours after immunizations, had redness and itching on left thigh with 10" induration. Given Keflex and Zyrtec on 05/20/2005.
Muscle pain at injection site, arm, and shoulder, headache, chills, fatigue, nausea
ADMISSION: 75-year-old male with PMH of hypertension, gout, CAD status post triple bypass surgery presents with 2 day history of diarrhea and progressive lower extremity weakness.  Patient states that his diarrhea started 2 days ago and is brown watery in nature.  No foul odors.  In association to this he is feeling a bit abnormal.  Patient states for the past 6 months he has had progressive lower extremity weakness bilaterally.  He states that he is not able to ambulate well anymore.  Upon investigation parents should states that he is diet of me and vegetables and admits to drinking at least 1 glass of alcohol per night.  Patient denies headache, lightheadedness, dizziness, shortness of breath, chest
Tachycardia (heart rate as high as 182); Fever (as high as 103.2 even on ibuprofen); Body aches; Headache; Injection site pain; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 17-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 11:30 (at the age of 17-year-old) as dose 2, single for COVID-19 immunization. Medical history included, known allergies: Some foods (banana, avocado, almonds, cucumbers, some raw vegetables) from an unknown date and unknown if ongoing and patient did not have other medical history. Concomitant medication(s) included cetirizine hydrochloride (ZYRETIC); pseudoephedrine hydrochloride (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]); levocetirizine dihydrochloride (XYZAL) and diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported (other medications the patient received within 2 weeks of vaccination). Patient was not pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (Lot number: unknown), administered in Left arm on 13Apr2021 11:30 AM (at the age of 17-year-old) for COVID-19 Immunization. Facility where the most recent COVID-19 vaccine was administered: Other. 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. Since the vaccination, the patient had not been tested for COVID-19. On 03May2021 15:00, patient experienced tachycardia (heart rate as high as 182), fever (as high as 103.2 even on ibuprofen), body aches, headache, injection site pain, joint pain. Patient received 400 mg ibuprofen as treatment for adverse events. The events were assessed as non-serious, did not results in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient underwent lab tests and procedures which included Fever: 103.2 on 03May2021 (as high as 103.2), heart rate: 182 on 03May2021 (Tachycardia (heart rate as high as 182)). Therapeutic measures were taken as a result of tachycardia (heart rate as high as 182), fever (as high as 103.2 even on ibuprofen), body aches, headache, injection site pain, joint pain. The outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 17-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N016994, expiration date 29-NOV-2018, for prophylaxis (strength, dose, route and frequency were not reported). The PROQUAD was reconstituted with a properly stored sterile diluent (MERCK) lot # M034763, expiration date 22-APR-2019. The temperature excursion was of 6°F to 14°F, during 120 hours 30 minutes. However, a previous temperature excursion of 47°F to 50°F for 35 minutes was also reported. A digital data logger was involved. No adverse effects were reported. Additional information is not expected. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA003525: US-009507513-1801USA003527: US-009507513-1801USA003526: US-009507513-1801USA003524: US-009507513-1801USA003523: US-009507513-1801USA003522: US-009507513-1801USA003521: US-009507513-1801USA003520: US-009507513-1801USA003612.
APPROX 1 MINUTE AFTER VACCINATION THE PATIENT FAINTED FOR A DURATION OF ABOUT 20-30 SECONDS. PATIENT WAS SEATED AND MOTHER OF PATIENT WAS PRESENT AND WAS HOLDING AND SUPPORTIN HIM DURING THAT TIME. AFTER THE PATIENT CAME TO THEY BEGAN FEELING BETTER AND HAD NO FURTHER ISSUES.
AFTER RECEIVING VACCINE PATIENT STATED THAT SHE FELT HOT AND I PROVIDED WATER TO HER. THEN SHE SAID SHE WAS HAVING TROUBLE SEEING AND THEN SHE PASSED OUT IN MY ARMS. PATIENT WAS IN THE SEATED POSITION AND DID NOT HIT THE FLOOR. I HELD PATIENT IN A BEAR HUG AND SHE WAS UNCONSCIOUS FOR 3 TO 4 MINUTES. AFTER REGAINING CONSCIOUSNESS, THE PATIENT STATED THAT SHE HAS A TENDENCY TO FAINT WHEN GIVING BLOOD ETC. PATIENT WAS ESCORTED FROM WALMART BY HER MOTHER AND DECLINED PARAMEDIC TRANSPORT.
tachycardia; started feeling pressure in her ears that went down to her throat; Decided not to get the second dose; symptoms of an allergic reaction/anaphylaxis; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia), EAR DISCOMFORT (started feeling pressure in her ears that went down to her throat), INTENTIONAL DOSE OMISSION (Decided not to get the second dose) and HYPERSENSITIVITY (symptoms of an allergic reaction/anaphylaxis) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0NCZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Aspirin).    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced TACHYCARDIA (tachycardia), EAR DISCOMFORT (started feeling pressure in her ears that went down to her throat), INTENTIONAL DOSE OMISSION (Decided not to get the second dose) and HYPERSENSITIVITY (symptoms of an allergic reaction/anaphylaxis). The patient was treated with Benadryl for Adverse event, at an unspecified dose and frequency. On 29-May-2021, TACHYCARDIA (tachycardia), EAR DISCOMFORT (started feeling pressure in her ears that went down to her throat), INTENTIONAL DOSE OMISSION (Decided not to get the second dose) and HYPERSENSITIVITY (symptoms of an allergic reaction/anaphylaxis) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Patient does not have an history of COVID-19 and myopericarditis .
Routine physical in July of 2021 discovered that my platelets were very high and had been going up incrementally.  I was diagnosed in September of 2021 with Essential Thrombocythemia a condition that I did not have before the Covid 19 vaccination.   I am being treated with Hydrea and will most likely have to stay on this treatment long-term.   I am reporting this as the Janssen vaccine has been associated with abnormal platelets.
Day 2 diarrhea, fever and upset stomach Day 2 broke out all over my chest and stomach and just don't feel good
Increased unquenchable thirst, increased urination, severe diaper rashes unable to be cured by anything other than athletes foot fungus creams, brittle nails, more lethargic, occassional fruity breath, all classic symptoms of type 1 diabetes - taking patient to doctors on 12/4/15 for testing. Did not have these issues prior to this last set of vaccinations.
Information has been received from a pharmacist concerning a 73 year old male who on 11-JUN-2009 was vaccinated with a first dose of ZOSTAVAX (Merck) (lot number 664223/0365Y) subcutaneously. There were no history of drug reactions and allergies. On approximately 13-JUN-2009, the patient "all weekend was tired, having headache and feeling kind of sick". The patient had sought medical attention by phone call. No lab diagnostics study was performed. At the time of the report, the patient did not recover. Follow-up information received the pharmacist and company representative stated that the patient developed an allergic reaction to ZOSTAVAX (Merck) in the form of a rash. Due to the rash, the patient was given cortisone (manufacturer unknown) shot 10 days after vaccination. Now the patient had hand tremors, agitation and insomnia. At the time of report, the patient did not recover. The reporter felt that an allergic reaction in form of a rash were related to therapy with ZOSTAVAX (Merck). Additional information has been requested.
expired dose of ACTHIB was inadvertently administered/ no AE; Initial information was received on 20-Jul-2021 regarding an unsolicited valid non-serious case received from an Other healthcare professional via Regulatory authority (Reference number- 00689723) and transmitted to Sanofi on 20-Jul-2021.  This case involves a four-year-old female patient who inadvertently administered expired HIB (PRP/T) VACCINE [ACT-HIB] vaccine (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) for prophylactic vaccination and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination.  On 19-Jul-2021, the patient received 0.5 ml (total) dose of suspect HIB (PRP/T) VACCINE [lot UJ264AA expiry date 04-Jun-2021] via intramuscular route in right thigh for prophylactic vaccination.  It was reported that, "Caller with question on whether dose needs repeating".  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I started running a fever and aching very bad Saturday morning. By Saturday afternoon my fever was up to 103.5.  I did not want to go to the hospital, but I came very close to calling. I decided to try ice packs on my forehead, neck and chest. I have never had a fever this high, or ached this bad. I don't know how long it took for my fever to come down, but finally came down to 102.5, where it stayed throughout the rest of the day and into Sunday.  I continued to use the ice packs throughout Sunday. I drank a lot of water and took Tylenol for fever and pain. I had a fever for three days. Today, Tuesday, 3/17/2021, I am very light headed.  I was diagnosed with covid-19 on Dec 29th 2020.
patient presented with parent back to office approximately 20 minutes after leaving office- she was given a trumenba vaccine and tubersol PPD implanted.  Pt. was visibly shaking and tachycardic -BP- 118/76 Pulse 126 Oxygen 98% denies heart palpitations, SOB, throat swelling or difficultly swallowing. pt. administered 10ml of Benadryl in office.  pt. was monitored by this provider and Pulse went down to 108 - pt. appeared less anxious and less trembling. Parent defers to take patient home and will monitor - parent to take pt. to ER or call EMS if pt.s pulse elevates over 120 (parent states he knows how to take a pulse) or any further baseline changes. Parent is agreeable to plan. Provider to make a VAERS report.
L. deltoid inflamed indurated and warm to touch. Area approx. 10 cm. @ injection site. Low-grade temp, slight nausea. Dx: cellulitis and abscess tx: KEFLEX 500MG.
In early August of 2022, I woke up and was lethargic, I was wheezing in my chest, achy, and I had just never felt like that before. I also felt like I had a low fever. I felt like I had no energy to move at all. I laid in bed and tested myself for COVID-19, it was positive. Eventually, I called the doctor. He prescribed an antibiotic and SYMBICORT. I was still sick with the same symptoms toward the end of August. Finally, around the second week in September, I could breathe again, and the wheezing went away.
Pfizer monovalent vaccine administered as a booster dose instead of pfizer bivalent vaccine. No adverse events.
Swollen lymph node under right arm almost immediately following injection, pain and soreness. Four days post vaccine, lymph node under am is still very swollen, pain and soreness down arm still present.
Severe eye swelling ( left eye still blurry )  Ear ringing in left ear , head pressure  Blurry eyes , itching , high pulse , severe anxiety. Feeling like adrenaline/ pulse of fast .  Feelings of. Fluid retention    Major concerns is my left eye / eyes being mild  blurry  like a sinus infection. Left eye  gets feelings of being stuck