chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temple and right teeth "felt like it was burning"; puffy cheeks; temple sensitive to touch; left side of her mouth had blisters in the upper palate; "felt like she had sinus infection"; left eye was swollen; aches and pain at injection site; chills; fever 100.2°F; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (aches and pain at injection site), CHILLS (chills), PYREXIA (fever 100.2°F), SINUSITIS ("felt like she had sinus infection") and EYE SWELLING (left eye was swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (aches and pain at injection site), CHILLS (chills) and PYREXIA (fever 100.2°F). On 10-Mar-2021, the patient experienced SINUSITIS ("felt like she had sinus infection"), EYE SWELLING (left eye was swollen) and BLISTER (left side of her mouth had blisters in the upper palate). On 12-Mar-2021, the patient experienced TOOTHACHE (temple and right teeth "felt like it was burning"), SWELLING FACE (puffy cheeks) and SENSITIVE SKIN (temple sensitive to touch). At the time of the report, VACCINATION SITE PAIN (aches and pain at injection site), CHILLS (chills), PYREXIA (fever 100.2°F), SINUSITIS ("felt like she had sinus infection"), EYE SWELLING (left eye was swollen), TOOTHACHE (temple and right teeth "felt like it was burning"), SWELLING FACE (puffy cheeks), SENSITIVE SKIN (temple sensitive to touch) and BLISTER (left side of her mouth had blisters in the upper palate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
PATIENT REFERS 4 DAYS AFTER VACCINATION STARTED WITH CHEST OPPRESSION, NECK PAIN AND DIZZINESS. PATIENT IS ADMITTED TO THE HOSPITAL.
8/18- First visit to doctor due to poor eating and loose, frequent, foul smelling bowel movements and black stool. Low grade fever, lethargy, and excessive crying/clingy. 8/25- second visit to doctor due to fever 102-104, intermittent. Lymphadenopathy. Slowed activity/lethargy. Poor eating. Excessive crying/whining. Rash developed on trunk 8/24. Complete CBC ran, showed abnormalties. Test results on file.
Benign Paroxysmal Positional Vertigo lasting over 12 hours until taking meclizine, with occasional milder recurrences in the weeks since it first occurred.
Vasovagal Syncope (belief).   She fainted while out to eat at dinner while seated.  She very quickly recovered conscienceness but was pale and dizzy and reported to be sweaty afterward.  It was somewhat odd that it occurred several hours after the vaccination and when she otherwise had seemed fine following vaccination.   She has had this happen once before when she recieved her HPV shot at age 11, but otherwise has not had the reaction following any other vaccinations include all available previous covid vaccinations.
Red, nonraised rash appeared on right hand,  from thumb to index within 2-3 hours of shot. Rash still present (10 days after). Rash began to get purple, scaley and tender to touch.
No additional AE details; HCP transferred from MVCC agent who stated a patient was believed to have received less than the recommended dosage of GARDASIL 9 due to needle leakage. No additional AE details or PQC.; needle leakage; Poor quality product administered; Product quality issue; This spontaneous report has been received from a nurse and refers to a patient, of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot  number: 1780876, expiration date reported as 09-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided). The patient was believed to have received less than the recommended dosage of he suspect vaccine due to needle leakage (underdose, needle issue, poor quality product administered, and product quality issue). No additional adverse event reported.
3/3 - very sore arm & achyness, 3/4 - sore arm continued, 3/5 - woke up with vertigo that subsided quickly, but dizziness, and headache on right side with brain fog continued, 3/7 - lymph node under right arm swollen and very sore and lasted about 1 week. vertigo in the morning stopped, but dizziness and headache continued, 3/9 - soreness in the arm is back with swelling, redness and itchy.  this only lasted a couple of days 3/17 - dizziness and headache continued.  dizziness is worse in the morning.  developed a back spasm probably unrelated to the vaccine, but started taking meloxican for inflamation of the back.  Coincidentally, it seemed to help with headache and dizziness.  Still taking meloxican and headache and dizziness are minimal, but still present.  Will be getting off the meloxican on Friday, 3/26, and we'll see???  3/ 20 - started with fever blisters and mouth ulcers(probably from shot or stress  all this has brought on my body)
Extreme chills for 24 hours, nausea, fatigue, headache, joint pain, and fever. Symptoms lasting up to 48 hours.
Dose administered after exposure to room temperature >24 hours; Administration of a dose after 12 hours the vial was first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of a dose after 12 hours the vial was first puncture) and PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature >24 hours) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Morphine and Codeine).    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of a dose after 12 hours the vial was first puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature >24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of a dose after 12 hours the vial was first puncture) and PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature >24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown if the patient was on concomitant/ regular medication and if experienced any symptoms.  Treatment details was not reported by the reporter.
Patient called on 04/07/2018 mentioning that the day after she recieved the vaccine when she came back from work the area that she got the SHINGRIX vaccine was hot, red and had a hard lump. On Wednesday 04/04/2018 went to her doctor and according to the doctor she was infected with the vaccine and prescribed her cephalexine 500 mg four times a day for seven days. Pt had had no complain, but wanted to just let us know abouT the situation. Also said. according to the physician the vaccine was injected too low.
Chills & fever, exhausted - slept from 11pm - 1pm next day (14hrs). Felt much better upon waking.
I received second vaccine Friday 7/30/21 at 1600.  Approximately  24 hours after, I was experiencing SOB.  Intense tightening of chest muscles/ rib cage down to lower back. This continued/worsening. Sunday am  reached out to  primary Md. I was advised to go to ER. Worked up to R/O PE as well as MI. Also COVID neg.  DC on Robaxin  and ibuprofen.  SOB continues. Can not catch my breath.
Terrible headache; I got body aches; Chills; I have absolutely no energy; At one point today my ears hurt as well; Very lethargic no energy; Low grade fever; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 16:45 (Lot number: FH8030) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Family history included: "diabetes" (unspecified if ongoing); "heart disease" (unspecified if ongoing). Concomitant medication(s) included: TELMISARTAN (ongoing); AMLODIPINE BESILATE; LIPITOR; FAMOTIDINE; NORETHINDRONE ACETATE. Vaccination history included: Bnt162b2 (Dose:1, Date: 01Mar2021, Time: 11:00, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: EL3247), administration date: 01Mar2021, when the patient was 52 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, Date: 01Apr2021, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: EP6955), administration date: 01Apr2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021 16:45, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset 24Nov2021, outcome "unknown", described as "Terrible headache"; PAIN (non-serious) with onset 24Nov2021, outcome "unknown", described as "I got body aches"; CHILLS (non-serious) with onset 24Nov2021, outcome "unknown", described as "Chills"; ASTHENIA (non-serious) with onset 24Nov2021, outcome "unknown", described as "I have absolutely no energy"; EAR PAIN (non-serious) with onset 24Nov2021, outcome "unknown", described as "At one point today my ears hurt as well"; LETHARGY (non-serious) with onset 24Nov2021, outcome "unknown", described as "Very lethargic no energy"; PYREXIA (non-serious) with onset 24Nov2021, outcome "unknown", described as "Low grade fever". Therapeutic measures were taken as a result of headache, pain, chills, asthenia, ear pain, lethargy.  No follow-up attempts are possible. No further information is expected.
Patient developed full varicella infection with fever beginning 6 days after vaccination and continued for 4 days a/w vesicular eruption that continued in wave for 4 days; oral lesions noted as well
Rash 4x2 cm R arm, 4 x 2.5 cm on right side of face, 0.6 x 0.5 lateral to right eyebrow, red, raised, with papules.
Shoulder joint pain in arm that was vaccinated. Large area of pain around the injection site. Reddening of the skin 5-6cms around the injection site. 1st sign persisted for a week and half.  The second two signs persisted for 4 days.
sore underarm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: EW0177) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Nightmares" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing), notes: Caller states that because of that the doctor put her on the Clonazepam for anxiety in 2016. Concomitant medication(s) included: CLONAZEPAM taken for anxiety, start date: 2016 (ongoing); AMLODIPINE BESYLATE taken for blood pressure measurement (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9262, Anatomical location: Left arm.), administration date: 23Jan2021, when the patient was 79-year-old, for COVID-19 immunization, reaction(s): "sore underarm"; BNT162b2 (DOSE 2, SINGLE; Lot number: EL9266, Anatomical location: Left arm.), administration date: 13Feb2021, when the patient was 79-year-old, for COVID-19 immunization, reaction(s): "sore underarm". The following information was reported: AXILLARY PAIN (non-serious) with onset 14Oct2021, outcome "recovering", described as "sore underarm". Relevant laboratory tests and procedures are available in the appropriate section.
She received a Flu shot at my office on 9/7/2023  She then went to pharmacy to receive her RSV in opposite arm on 9/7/2023.  The following day she developed a fever.  A couple days later, on 10th about 11 pm, she developed blisters all around her mouth  The blisters were persistently active for 4 days and filled with bloody material   On 9/15/2023, She  has had them starting to heal and they are scabbed over    Multiple blisters on bilateral mouth   Painful   She has had fatigue and malaise since the fever started  She came into medical facility on 9/15/2023 for a well exam and told Dr about the incident.  at that time photos were taken of her lips and top of mouth    The lips had multiple scabbed areas in the region of the vermilion border but she also had dry blood streaked on her tongue as well as mucosal blood in the roof of her mouth.  No petechia.   She was not feverish but she was feeling fatigued.   Dr called her on 17th to clarify history elements and learned that she is still feeling poorly  She will return to the office on Monday for labs
COVID positive on 9/13/21 despite being fully vaccinated. Now with acute respiratory failure due to covid pneumonia requiring ICU admission and BIPAP. Still in process of being treated. Receiving decadron (requiring increased ARDS dosing due to progressively worsening respriatory status) and remdesivir. Received dose of tocilizumab 800 mg IV today.
15 (09:50) minutes post vaccination, pt approached healthcare staff and indicated eye itchiness and thickening in throat.   Per pt, facial swelling was not present.  Pt was observed closedly x 3 minutes, during which time pt indicated throat swelling was progressing.  Diphenhydramine, 25 mg PO administered at 09:55.  At 10:10 pt stated eye itchiness was worstening, and he was unable to swallow, could breathe comfortably thru his nose.  At this time RN and MD decided to call for emergency support, and they arrived at approx 10:15.  After initial assessment they determined the best course of action was to transfer to ER should airway management be needed  Pt and EMS left facility at 10:25.
Patient got anxious and nauseated instantly. Was questioned regarding medication. Is taking blood pressure and anti-anxiety - Did not take them this day.
Sciatica, back and legs, used walker for 3 months; Side effects were awful/ he is not the same; Used walker 3 months; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sciatica in a 78-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sciatica (Verbatim: Sciatica, back and legs, used walker for 3 months), feels awful (Verbatim: Side effects were awful/ he is not the same) and walker user (Verbatim: Used walker 3 months).  The outcome of the sciatica and feels awful were recovering/resolving and the outcome of the walker user was recovered/resolved.   It was unknown if the reporter considered the sciatica, feels awful and walker user to be related to Shingles vaccine.     It was unknown if the company considered the sciatica, feels awful and walker user to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by the patient's friend via interactive digital media. The reporter reported that, his/her friend (patient) got Shingles vaccine part 2 and the side effects were awful patient said.  The patient never had sciatica, back and legs, but now he had it.  The patient used walker 3 months, and said it was better, but the patient was not the same. The follow-up could not be possible as no contact details were available. The case had been linked with US2023AMR038451, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR038451:Same reporter
Generalized malaise weakness the day after vaccination. Reactive arthritis, roaming from ankles, knees, wrists, individual fingers, foot arches with no previous injury to any of affected joints. Affected joint generally painful for several days even with MOTRIN 800mg TID, then another set of joints affected.
One week from the day of receiving series one of the moderna vaccine I noticed my arm was itchy before going to bed. It also felt more dense in the area where I received the shot in my left arm. The next day, today, I did not experience itching throughout the day but noticed in the evening there was a 2 inch red welt around the injection site, The area feels more dense than my other arm and I have a burning sensation and it feels somewhat  tender.
It started 8 minutes after, numbness nd tingling in lower lip and spread to tongue and to scalp and then to neck and arms. I started feeling my tongue was tingling. I notified them and they brought me to EMT and he checked my O2 stats - 88 - When I took a deep breath they dropped to 86. My blood pressure was raised. Hives on chest. They gave me Benadryl  - I think it was 25 mg and Oxygen and kept monitoring me. They decided to transfer me ER at.  - I had three doses of Benadryl before I got to the hospital - one dose in the ambulance. The Benadryl was IM and IV. I was transported to the local hospital that has an ER. It took about three days for the itching to stop. It got better with the 60 total that first night but for it to totally stop it took three days.
This spontaneous report was received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated intramuscularly with the second dose of 0.5 ml of GARDASIL (Lot #: 665768/1377Y, expiry date 29-JUN-2012) on 09-AUG-2012. The first dose of GARDASIL (dose, route, lot # unknown) was on 24-MAY-2012. No adverse effect reported. Additional information is not available.
About 2 weeks after 2 nd shot i started having skin itching and bumps on my skin no pain just itching. I have not seen my doctor because it doesn?t hurt just itching left shoulder right arm a few spots in my left side of face and head and back of my left leg. And general all over itching at times it kept me up at night. It?s getting better
fatigue,vomiting,low grade fever (100) & red spots over abd;spots lasted 2 1/2 days while other sx disappeared p/one day;took 2 advil
/P DTP slept 1 hr-then woke up crying inconsolably 10-15 min. Then slept 10 hrs not getting up to eat. Irritable X 4 days. Gets up crying every 15 min.
Approx 1 inch below injection site the patients arm became red & inflamed approximately the size of a baseball. The inflammation subsided after 48 hours.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild
tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.Treatment medication was not provided.
Chest pains, tightness in chest, light headed/dizzy/ fatigue, heart palpitations
Headache, Myalgia, Arthralgia,  fatigue; Narrative:  Other Relevant History:
WOKE UP SNEEZING, RUNNY NOSE, TEETH HURT; SAT/SUNDAY. MONDAY CALLED PCP. PHONE VISIT WITH DR, BROUGHT IN FOR TESTING.
This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 50-year-old female patient who received SHINGRIX for prophylaxis. On 20th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 30 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received both doses of SHINGRIX. Approximately 1 month after 1st dose the patient had a shingles outbreak. This was diagnosed at emergency room. This was the 4th episode of shingles the patient had experienced in her lifetime. She received her 2nd of SHINGRIX in September.
Swelling of lymph nodes for two months, First time treated with Predisone and Naproxin to combat severe pain in back and knee.  Recently within the last month Ultrasound performed and I experienced full body pain and weakness.  Treated with Augmenton and narco.
Pt to clinic today & reported rx to vaccine on 8/5/11. GARDASIL admin. to pt on 8/5/11 in the am. Pt awoke on 8/6/11 with swollen lips. Denies other sx. Pt states she took BENADRYL p.o. & swelling resolved. Pt did not see a doctor for her symptoms.
Fever, body pain, joints, chills, arm pain, bodily discomfort and irritated. The effect of these symptoms lasted approximately 24 hours. I got the vaccine at 3:00 pm and the symptoms started that day at 10:00 pm and ended until the next day 10:00 pm (symptoms lasted approximately 24 hours). I took NEO MELUBRINA and paracetamol every 6 hours
Moderna covid-19 vaccine EUA  Developed tender and enlarged lymph nodes in the left supraclavicular area 6 days post vaccine. Also with significant fatigue persistent which developed about 36 hours after vaccine. Went to urgent care and was tested for mono which was negative . Awaiting PCP visit for blood work and further work up.
Per mom, evening of vaccine, soreness to arm. Approximately 30 hours later, notable heat, redness and swelling. To ER; instructed to see PCP.
under her injection arm about two weeks after her first dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (under her injection arm about two weeks after her first dose) 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 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE SWELLING (under her injection arm about two weeks after her first dose). At the time of the report, VACCINATION SITE SWELLING (under her injection arm about two weeks after her first dose) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Admission Diagnosis: CHF (congestive heart failure), NYHA class I, acute on chronic, combined (CMS/HCC) [I50.43]     Hospital Principal Problem (Discharge Diagnoses): CHF (congestive heart failure), NYHA class I, acute on chronic, combined (CMS/HCC)
7/24/2021 (day after second dose) presented with painful, warm red lump at injection site, that grew in size. 7/25/2021 presented with much larger hot red rash 7/26/2021 the rash has spread in circle shape; currently itchy and experiencing radiating pain in the right shoulder, arm and neck
Full body rash with target lesions, no mucosal involvement.  Diagnosed with erythema multiforme that started 7 days after vaccines.  He had temp of 100.2 after getting vaccines, but no other sx and was not given tylenol or any other medication.  Rash progressed over 3 days at time of visit on 5/31/12.  No difficulty breathing or life threatening illness.