chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Facial swelling after booster; Swollen Mouth; Open sores in the mouth after booster; Swollen Throat; Very uncomfortable after booster; Swollen after booster//swollen Head after booster; Itchy after booster; Allergic reaction after booster; Fever 101F after booster; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Facial swelling after booster), MOUTH SWELLING (Swollen Mouth), STOMATITIS (Open sores in the mouth after booster), PHARYNGEAL SWELLING (Swollen Throat) and DISCOMFORT (Very uncomfortable after booster) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 045B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic shock. Concurrent medical conditions included Soy allergy (She thinks that PEG 2000 in the vaccine came from Soy).   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021 at 3:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced SWELLING FACE (Facial swelling after booster), MOUTH SWELLING (Swollen Mouth), STOMATITIS (Open sores in the mouth after booster), PHARYNGEAL SWELLING (Swollen Throat), DISCOMFORT (Very uncomfortable after booster), SWELLING (Swollen after booster//swollen Head after booster), PRURITUS (Itchy after booster), HYPERSENSITIVITY (Allergic reaction after booster) and PYREXIA (Fever 101F after booster). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. On 15-Dec-2021, PYREXIA (Fever 101F after booster) had resolved. At the time of the report, SWELLING FACE (Facial swelling after booster), MOUTH SWELLING (Swollen Mouth), PHARYNGEAL SWELLING (Swollen Throat), SWELLING (Swollen after booster//swollen Head after booster) and PRURITUS (Itchy after booster) had not resolved and STOMATITIS (Open sores in the mouth after booster), DISCOMFORT (Very uncomfortable after booster) and HYPERSENSITIVITY (Allergic reaction after booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Dec-2021, Body temperature: 101 (abnormal) Fever 101F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported.  Patient thinks that PEG 2000 in the vaccine came from Soy and say she did not have anything else at the time that would cause an allergic reaction. Patient also stated  many years ago patient took Tylenol FLU blue liquid and had a anaphylactic reaction to it and had to use EpiPen at the ER
This spontaneous report as received from another healthcare professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of VAQTA (strength, dose, route of administration and lot # were not reported). No adverse effects were reported. On 17-DEC-2014 a telephone call was placed to the medical assistant who stated that she was unfamiliar with the reported incident of incorrect product storage. The reporter transferred the call to another person who was also unfamiliar with the event. This is one of several reports received from the same reporter. Additional information has been requested.
covid test result=Positive; Covid test date=25Aug2021,covid test result=Positive; body aches.; fever, HA/fever last night; Coughing; Feels like " hit by truck"; Felt like she was super tired; Went into work because she thought she just didn't get enough sleep; This is a spontaneous report from a non-contactable nurse. A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248), dose 1 via an Intramuscular route of administration, on 28Jan2021 (age at vaccination: 61), in left arm as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 25Aug2021 the patient experienced covid test result as positive, body aches, fever, HA/fever last night, Coughing, feels like " hit by truck", felt like she was super tired, went into work because she thought she just didn't get enough sleep. Covid prior vaccination reported as unknown and post vaccination reported as yes. On 25Aug2021 the patient underwent lab test and procedure included SARS-CoV-2 test: positive. Treatment received reported as unknown. The patient had a physician office visit. The outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event COVID_19, Drug ineffective and suspect drug BNT162B2 cannot be excluded.
Slight fever beginning at 7 pm, aches, chills, general lethargy. Went to bed around 10:30. Felt fine when I woke at 6:30 Thursday morning.
sudden hearing loss; ear felt like it kept popping; boiling, feverish and terrible; Initial information received on 27-Nov-2019 regarding an unsolicited valid serious case received from a non-healthcare professional.  This case involves a 69 years old female patient who experienced sudden hearing loss (sudden hearing loss), ear felt like it kept popping  (ear discomfort) and boiling, feverish and terrible (pyrexia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Nov-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and expiration date not reported) via intramuscular route in unknown administration site.  On an unknown date, the patient developed boiling, feverish and terrible (pyrexia) (1 day) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  On an unknown date, the patient developed a serious sudden hearing loss (sudden hearing loss) and her ear felt like it kept popping (ear discomfort) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]. This event was assessed as medically significant.  Other relevant tests included no laboratory data reported.  Final diagnosis was sudden hearing loss, ear discomfort and pyrexia.   The patient was treated with intra-otic cortisone (cortisone) injections, CETIRIZINE HYDROCHLORIDE (ZYRTEC) and with mineral dose pack.  The outcome was Unknown for pyrexia and as recovering for all the other events.  Information on the batch number was requested.; Sender's Comments: This case concerns a 69 years old female patient who presented with sudden hearing loss, ear discomfort and pyrexia after vaccination with Fluzone high dose. The time to onset is compatible. However, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
pt recvd Hep B vax & w/in 12 hrs following vax devel flu-like sx; no further details were provided;
On May 7th, I started getting a scratchy throat. When I woke up I still had a scratchy throat and fever of 103.1 so I took a COVID-19 hometest and it was positive. I went to the local urgent care and ask for a prescription of Paxlovid. I picked up the medication on Tuesday. I had a stuffy nose, cough and fever. Once I picked up the Paxlovid on Tuesday, I could feel my chest starting to get heavy so I started the medication on Tuesday. By Wednesday my symptoms were improving. I still had a cough and fever but the fever was going down and my chest no longer felt heavy. By Friday I was almost symptom free. I have completely recovered from all the symptoms
Severe urticarial rash developed 2 days after IZ's. Total duration rash about 3 days.
General fatigue and malaise the day after her booster shot. Progressed to cardiac arrest.
I had no response to the first vaccination but I had read enough in the news to know that my response to the second was not uncommon.   After the second vaccination, my arm became very sore during the day.  When I went to bed at 11pm, I was unable to sleep for about 45 minutes because I was shivering and unable to stop.  I added additional clothing and finally managed to stop shivering and sleep.  My sleep was restless all night, with bad dreams, a headache, and neck pains.  My  watch indicated that my sleeping heart rate was higher than average throughout the night.  After showering at 7am and forcing myself to carry on, I felt better later in the morning and all symptoms were gone.
Heartflutterind; Leg pain all the time; Lower legs swelling; Headache; Tired; This is a spontaneous report received from a contactable consumer (patient). A 38-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on an unspecified date (Batch/Lot number was not reported) at vaccination age 38 years as single dose for covid-19 immunisation. Medical history included known allergies: penicillin. Patient was not pregnant. Concomitant medication included lorazepam. Patient experienced Heart flutterind, leg pain all the time, lower legs swelling, Headache, tired, all on 18May2021 07:30 AM. Treatment was received. Lab data included EKG, chest X-ray, multiple blood tests, ultra sound e. Outcome of events were not recovered.  Information about batch/lot number has been requested.
1st evening, tired. Next day, face was swollen, extreme fatigue, some nausea. Swollen face lasted 3 days, tiredness lasted 4 days.  Mostly concerned about swelling in face.
Became very cold and shaking like a bad fever,    Treatment bundled up and went to bed for approximately 9 hours and sweated under blankets. Took 2 500 mg Tylonel tablets after 9 PM. had a fever of 101.2 about 10 am on Sept 29.  Felt much better by 7 PM Sept 29. Cold sweat for approximately  7 to 8  hours after 9 PM on the 28th.  Did not go to doctor felt much better by evening of Sept 29, 2020
daughter recvd vax 25SEP95 & devel chicken pox 15NOV95 (WAES95112035) & 28NOV95 (64 days post daughter's vax & 10 days from the onset of daughter's rash) pt devel a high fever & 29NOV95 devel a rash;no further details were provided;
Wednesday Nov. 2, 2022 vaccinated, Friday Nov. 4, 2022, chest pain, shortness of breath, constant PVCs, thought I was being dramatic or having panic attacks, so I waited. Went to Urgent Care on November 14, 2022 for continued abnormal heartbeats, chest pain, exhaustion. Was referred to Hospital ER after EKG showed multiple PVCs. All labs normal at ER, referred to Heart Center for Holter monitor to track abnormal heart activity, findings showed nothing. Follow up with PCP  where he referred to cardiologist with Clinic. Upon exam pericardial "rub" was evident when listening to heart. Referred to Medicine for echo on 1-6-2023, finding of pericarditis, already waning.  Have had no follow up from this doctor, info I have is from accessing the patient portal. Continuing to have abnormal heart beats. I can feel them throughout chest and am breathless and dizzy to the point of incapacitation. During PCP follow up blood work was ordered, found to have severe iron deficiency.
sore for about a month and a half; shoulder is hurting really bad; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 80-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. He received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) as single dose on unspecified date for COVID-19 Immunization. The patient experienced sore for about a month and a half and shoulder was hurting really bad on an unspecified date. Caller (male, 80 years old) reported getting a second dose of PFIZER-BIONTECH COVID-19 VACCINE almost 3 months ago, stated, it was sore for about a month and a half, now hurting bad upon further clarification the shoulder was hurting bad. Looking for information about it. The outcome for the events was unknown.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2014US016737, is an initial spontaneous report from a physician received on 18 Aug 2014. This report refers to a patient of an unknown demographics. Past medical history and concomitant medications were not reported. The patient received only Men CWY liquid conjugate component of MENVEO (batch number: not reported) without reconstitution with Men A lyophilized component intramuscularly on an unknown date. No adverse event was reported following this medication error.
Both arms became red, swollen and hot to touch after receiving vaccines. Dx with cellulitis. Tx with Omnicef 600mg q day x 7 days.
PER PATIENT CAREGIVER : S WELL AND REDDENING OF THE LEFT ARM THE DAY AFTER VACCINATION.  PROGRESSED DOWN TO THE ELBOW.   RECOMMENDED SHE CONTACT HER DOCTOR
Stomach cramps, headache, fatigue. Today, two days, later I developed an itchy rash on both arms and legs.
Patient got vaccine at 8:17am and started feeling nauseous and lightheaded at 8:32am. 8:33 BP was 100/50 and HR of 80. At 8:51 BP was 110/80 and HR 80. At that time, she had some crackers and water. She reported having issues in the past with fainting when seeing needles. We elevated patients legs and put ice packs on head. She started feeling less nauseaous after a while of laying down but was still anxious. Patient has a history of anxiety and takes medications for it. Patients husband came in to help patient leave. Told patient we could bring her to the ER to get evaluated and she declined. When walking outside the room and walking around more, she started to not feel nauseous anymore and just felt anxious. Told patient if any other symptoms occur please go to ER. She stated she understood.
Severe left shoulder pain (arm of injection). Range of motion limited due to pain. Last 4 weeks. Only improved after 7 day oral steroid treatment.
pt recv vax 27FEB98 & appetite dec, slept for a lot (more day by day)-inc thirst, urination was heavy, wasn't activity;on Wednesday sent to ICU d/c w/new onset diabetes mellitus;
Narrative:  Pt is a 92 YO male who was admitted to the hospital for pulling out his foley catheter. Pt had a PMH of Dementia, CKD stage IIIb, persistent afib without RVR, HTN, T2DM on insulin, CAD, hypothyroidism, anemia, hx of folate and vitamin D deficiency, urothelial carcinoma of bladder s/p TUR of bladder tumor in 2019, and recent hospitalization for UTI. Pt continued to receive treatment for UTI and bacteremia. Pt became lethargic and began having decreased O2 requirements; subsequently, family agreed to transfer to hospice. Pt passed away.
Received TDAP vaccine in right arm on 7 JUN 2008 and experienced the following adverse events: squirting blood from injection site which lasted 2-3 minutes in duration, dizziness, and rapid heart beat; followed by joint pain and stiffness that is still present as of 2 Aug 2008.
Patient received Pneumovax but should have received Prevnar.  It has not been 5 years since Pneumovax was given.
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This non-serious spontaneous safety report, with reference number 02244297, was received from a Health Professional on 17-OCT-2022.   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.  No further information is expected.  For reference purposes this case is linked to MCM-004036, MCM-004174, MCM-004175, MCM-004176, MCM-004177, MCM-004178, MCM-004179, MCM-004180, MCM-004181, MCM-004183, MCM-004184, MCM-004185, MCM-004186, MCM-004187, MCM-004188, MCM-004189, MCM-004190, MCM-004191, MCM-004192, MCM-004193, MCM-004194, MCM-004195, MCM-004196, MCM-004197, MCM-004198, MCM-004199, MCM-004200, MCM-004201, due to same reporter and same event.
Around 1 pm the day after my daughter received the vaccine, her leg was swollen about twice it's normal size. It was red and warm to the touch. I sent a picture to her doctor's phone. She instructed me to give her BENADRYL every 4 hours and to keep her informed of any symptoms she may have. The swelling lasted roughly 48 hours. She complained of her leg feeling like it was burning inside.
Light Headed, Dizziness for 5 days - No treatment, went away day later
Patient described having itchy eyes, achy head, dry mouth, nausea, fever, sweating, and swollen tongue.  She reported taking a Zyrtec which helped. Says tongue is still feeling slightly thick today and has whiteness on tongue she couldn't get off with a toothbrush.  She said symptoms started a few hours after the shot and lasted a day.
Patient was otherwise healthy, had one small cold in over a year. Vaccine was at 3:30pm on 5/6/08. By that night, patient's vaccine site was swollen, warm and painful. Patient had 100mg. of Ibuprofen and ice on site. When patient woke in morning of 5/7/08 at 5:45am, he complained that he was unusually tired. He seemed a bit spaced out. He went to school. Not recognizing he was not well, he said his legs were really tired through the day, and at Gym class (9:30am)he realized that he kept losing grip of a baseball bat. He ate lunch at 10:30am and still felt a bit tired. By 2:00pm it seems he lost conciousness in the classroom. He said everything turned white and he fainted. At this point he might have hit his head, had symptoms of a concusion. He blacked out a few times in a wheel chair to and at the health office at school. I arrived at the school by 2:30pm. I witnessed his confusion and dazed behavior. He was shaking and had the chills. His temperature was 99, he had a stiff appearence. The most startling event that I witnessed and the EMT said was not typical of a concusion was that his face seemed almost paralyzed. His face was green/greyish and lack of color. He had no muscle tone in his face. One eye was somewhat lower than the other. The EMT checked for signs of a stroke, it was negative. They took him to the Emergency room. He was given glucose and orange juice and by 5:00pm he was more like himself, including color and muscle-tone in his face. His arms and legs were still weak and still had a low fever for another 2 days. The injection site was swollen for another few days. The Doctors denied that this might have been an adverse reaction to the Menactra vaccine. I think it's just too much of a coincidence for it not to be related. Thankfuly he recovered.
A pharmacist reported that "8 out of 10" patients developed injection site reactions following receipt of Flu Shield from two specific lots. The reactions following receipt of Flu Shield from two specific lots. The reactions were characterized by stinging and redness. MANFACTURER'S Comment: The reporter indicated that 8 patients experienced these events; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Narrative: HA, nausea, vomiting. Progressed to respiratory depression day 3-5 after vaccine Went to ER x 2 and was admitted second time
Face swelled almost double in size.  Severe headache very fast heart rate nausea diarrhea about 3-4 minutes after leaving the vaccine site. Symptoms begin to decrease then stop within 5 minutes. Face remained somewhat swollen for about an hour. Headache remained for about 6 hours then arm hurt for about 6 hours.  Diarrhea remained for 24 hours
Began with swollen face, jaw pain, numbness in lips and left side of face. Received steroids and anti-viral meds. Then it progressed to severe headaches, jaw and ear pain, neck and upper back pain, numbness of left arm and leg (lack of mobility), chest pains and shoulder pain. No movement of face muscles and hard to swallow on left side. Lips were numb and tongue numb and tingling.
Vaccination given at 8:52. Patient indicated he had an itchy throat when he had completed his 30 minute observation time. Pulse Oxygenation was at 99% at 9:22am. No difficulty breathing or swallowing.  Diphenhydramine HCL 25mg given to patient and applied a cold pack. Pulse Oxygenation remained at 99%. Assessment done by MD on site and indicated to give a second dose Diphenhydramine HCL 25mg and instructed patient need to go to ER for observation. Patient refused EMS friend contacted and drove him to nearest ER.
This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified date, the patient was vaccinated with an improperly stored dose of PROQUAD "rHA" injection (dose, frequency and route were not reported) lot # M044021 with expiration date of 01-MAY-2018, for prophylaxis. The sterile diluent (lot # and expiration date were not reported) used to reconstitute the PROQUAD was properly stored. The temperature excursion of the PROQUAD was between -9 °C and 8 °C for a time frame of 1 hour and 10 minutes. No previous temperature excursion was reported. No adverse effects were reported. Data logger was involved. Additional information has been requested. Sender's Comments: US-009507513-1706USA005163: US-009507513-1706USA005175: US-009507513-1706USA005176: US-009507513-1706USA005177: US-009507513-1706USA005178: US-009507513-1706USA005179.
Information has been received from a physician concerning a 13 year old female patient who fainted after receiving a dose of GARDASIL intramuscularly. The patient wanted to leave the office but the office staff had the patient return to the office while they monitored her blood pressure and other vitals. The Physician indicated that the patient bumped her head when she fainted in their lobby. The patient told the physician that she was not hurt from bumping her head. The physician also reported that this patient had a history of fainting with prior immunization but the physician did not know this information at the time. The patient sought unspecified medical attention. On an unspecified date the patient recovered. Follow up information was received from a physician reporting that the 13 year old female student with no medical history or concurrent condition was vaccinated in the left deltoid with the first dose of GARDASIL (lot# 662300/0100Y) on 02-SEP-2009. There were no illnesses at the time of vaccination. Subsequently the patient experienced syncopal episode. The patient denied hitting her head-fell onto buttocks. Her vitals were stable. The patient recovered on 02-SEP-2009. No relevant diagnostic tests or laboratory data was collected. No further information is available.
I did not have an adverse reaction to the vaccine. In the 07/2022 I was diagnosed with atrial fibrillation.
Intense pain from injection site, high fever (103.6) intense headache, entire left side in pain neck stiffness on side of injection. Lasted over a week.