chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt ill after covid vaccination; Cold; Sinus infection; Bruises after injection; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt ill after covid vaccination), NASOPHARYNGITIS (Cold), SINUSITIS (Sinus infection) and VACCINATION SITE BRUISING (Bruises after injection) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MALAISE (Felt ill after covid vaccination), NASOPHARYNGITIS (Cold), SINUSITIS (Sinus infection) and VACCINATION SITE BRUISING (Bruises after injection). At the time of the report, MALAISE (Felt ill after covid vaccination) outcome was unknown and NASOPHARYNGITIS (Cold), SINUSITIS (Sinus infection) and VACCINATION SITE BRUISING (Bruises after injection) was resolving.            No relevant concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.   The reporter's causality for the event(s) of felt ill after COVID vaccination was not provided. The reporter's causality for the event(s) of cold, sinus infection and bruises after injection with HUMIRA(ADALIMUMAB) was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient order influenza (Fluarix) 0.5mL IM x1 but was administered COVID bivalent vaccine.
following HPV injection left deltoid, client c/o dizziness and nausea. Client positioned on the floor, lying on her back and cool compresses applied to forehead for two minutes. Clients stated she was "OK" I assisted her to her chair. Five minutes later, client c/o dizziness, nausea and being hot. Again positioned client on her side on the floor and applied cool compresses.  V.S. B/P 120/70, Pulse 80, Resp. 16, Skin warm and dry. Client stated she was "OK"-not dizzy or nauseous. Positioned client to sitting position for five minutes then to chair. Client's father helped her up. Client returned 1/2 hrs later and stated she felt fine. Client stated "I think it was an anxiety attack. I had one in high school".
Swelling, itching, stinging, heat to touch at injection site. Right posterior upper arm.
Myalgia, Fever, Chills, Injection site pain, Fatigue Narrative:
Received MMR 3-30-12 - broke out in rash all over 4-5-12.
she felt terrible/felt awful; she was exhausted,/she didn't get out of bed for the entire day.; she didn't feel like she had a fever but her whole body was shaky/started to shake but not as badly; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (she didn't feel like she had a fever but her whole body was shaky/started to shake but not as badly), FEELING ABNORMAL (she felt terrible/felt awful) and FATIGUE (she was exhausted,/she didn't get out of bed for the entire day.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 013B20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (she didn't feel like she had a fever but her whole body was shaky/started to shake but not as badly). On 11-Feb-2021, the patient experienced FEELING ABNORMAL (she felt terrible/felt awful) and FATIGUE (she was exhausted,/she didn't get out of bed for the entire day.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 10-Feb-2021 for Tremor, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) on 11-Feb-2021 for Exhaustion, at an unspecified dose and frequency. At the time of the report, TREMOR (she didn't feel like she had a fever but her whole body was shaky/started to shake but not as badly), FEELING ABNORMAL (she felt terrible/felt awful) and FATIGUE (she was exhausted,/she didn't get out of bed for the entire day.) outcome was unknown.            No  Concomitant medications were provided.  Patient had an ultrasound of the brain but still waiting for the neurologist appointment.   This case was linked to MOD-2021-380725 (Patient Link).
This case was reported by a nurse and described the occurrence of vertigo in a 61-year-old male subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis. The subject is a physician and the subject's office administered the vaccination. On an unspecified date in 2004 the subject received the first dose of Twinrix in his right arm. On an unspecified date in 2004, "at some point after the first Twinrix injection," the subject experienced vertigo and inner ear problems and "had to visit the emergency room." The events resolved on an unspecified date on or before 23 June 2005. The vaccination course with Twinrix was discontinued.
This case was reported by a physician via a sales representative and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with Twinrix for prophylaxis. Concurrent medical conditions included HIV positive status. On unspecified dates the subject received three separate doses of Twinrix (1ml for third dose, unreported dosing for first two doses). At an unspecified time after completing the third dose of Twinrix, the subject was found to not have responded to the hepatitis B portion of therapy. No diagnostic tests were reported. The reporter noted that no additional information was known regarding the subject and that the subject  may have been the physician's patient or may have seen the physician via consult. At the time of reporting the outcome of the event was unspecified.
Shortness of breath; Coughing; Wheezing; This is a spontaneous report from a contactable physician via a sales representative. A female patient in her early thirties received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization. Medical history included ongoing ulcerative colitis from an unknown date. The patient's concomitant medications were not reported. The patient experienced coughing, wheezing and shortness of breath on an unspecified date. The outcome of the event was unknown. The physician has referred the patient to a Pulmonologist  Information on the Batch/lot number has been requested.
Swelling and itchiness  in right eye.  Marks  on skin under the eye appeared.  Eyelid swelled, eye got red, strange blemish formed under eye.  Area around the eye became painful.
Fever of 102-103 for three days.  Chills, fatigue, headache, blurred vision, dizziness, body aches, congestion, and small productive cough for five days.  Fatigue, headache, slight dizziness and improving cough on days six and seven (today).
This is a spontaneous report from a non-contactable consumer. A 76-years-old male patient of an unspecified ethnicity received a single dose of PREVNAR13, via an unspecified route of administration on an unspecified date. The patient's medical history and concomitant medications were not reported. ON an unknown date, the patient experienced feeling kind of wiped out, fatigue The patient reported that he received the vaccine on Saturday and it had been 72 ours; he normally is a very energetic person. The clinical outcome for the event of taken feeling kind of wiped out, fatigue was unknown. No follow up attempts possible. No further information expected.
Patient is a 61 y.o. male who is a patient of DO with significant medical history of HTN, bipolar disorder, cardiomyopathy, GERD, HFrEF, HLD, OSA presented to Hospital with dyspnea and hypotension.   Acute respiratory failure with hypoxia Covid-19 Virus Infection Possible community acquired bacterial pneumonia Date of onset of symptoms: 12/17/22 Symptoms present on admission: malaise, dyspnea, cough Date of covid positive test: 12/17/22 Vaccination status: vaccinated Imaging: CXR with bibasilar infiltrates concerning for bacterial overlay,  Though generally uncommon with covid - will check micro data and include antibiotics Cultures: Blood cultures no growth to date.  Sputum culture, pneumonia urine antigens ordered Oxygen requirements on admission: 4L Current oxygen requirements: None Medical therapy: Decadron, Rocephin, Azithromycin Discharge Rx: Decadron to complete 10 days, Omnicef to complete 7 days, azithromycin to complete 5 days   AKI on CKD Metabolic acidosis BUN 66 / Cr 2.72, Bicarb 16 Baseline Cr ~ 1.5 with some baseline variation With both AKI and acidosis, as well as contraindication to repeated bolus with resp failure Bicarb drip started on admission Nephrology consulted Creatinine improved to 1.65 on 12/25 Bicarbonate improved to 23 on 12/25 Follow-up with patient's primary nephrologist as outpatient  Hypotension, resolved HTN Chronic HTN but reportedly hypotensive at home Told to hold antihypertensives and presents normotensive to mildly hypertensive Coreg, hydralazine, nifedipine resumed Valsartan to be held until follow-up with nephrology   PAF Coreg for rate control Eliquis for stroke prophylaxis S/p pacer   Chronic pancreatitis Continue Welchol and Creon   Elevated troponin Troponin 73, chronically elevated, delta flat In absence of chest pain EKG paced without any convincing evidence of ischemia No further inpatient work-up   DM2 with longterm insulin use A1c 7.1 Lantus and SSI   Mood disorder Continue Depakote, Abilify, Buspar Decrease Nocturnal Ativan with respiratory failure   OSA Nonadherent to CPAP Monitor on continuous pulse ox  Chronic HFrEF With recovered EF at 55% Sept '21 Continue Coreg Hold Lasix initially with AKI
Shakes & Chills,Muscle Aches in legs, 101 Fever Fatigue
2 days after receiving the 2nd dose, he started with difficulty breathing./cannot take deep breath./still has shortness of breath.; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (2 days after receiving the 2nd dose, he started with difficulty breathing./cannot take deep breath./still has shortness of breath.) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 1730L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (2 days after receiving the 2nd dose, he started with difficulty breathing./cannot take deep breath./still has shortness of breath.). At the time of the report, DYSPNOEA (2 days after receiving the 2nd dose, he started with difficulty breathing./cannot take deep breath./still has shortness of breath.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided. Blood pressure medicine reported as concomitant medication.
15 month old baby was administered boostrix; 15 month old baby was administered boostrix; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number MY515, expiry date 31st January 2023) for prophylaxis.   On 11th August 2022, the patient received Boostrix. On 11th August 2022, unknown after receiving Boostrix, the patient experienced underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the underdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comment: The reporter reported that, a 15 months old baby was administered Boostrix. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, a 15 months old baby was administered Boostrix, which led to underdose and inappropriate age at vaccine administration.
Sore arm after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after the 2nd dose) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 07-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm after the 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm after the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient reports no concomitant medication use.
Vitiligo; This spontaneous case was reported by a patient and describes the occurrence of VITILIGO (Vitiligo) in a 48-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     The patient had never been tested positive for COVID-19. The patient no acute illness at the time of vaccination or up to one month before. The patient no chronic illness.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (First Dose LOT: 04A21A) on 12-Mar-2021, Moderna Covid-19 Vaccine (Second dose LOT:036B21A) on 09-Apr-2021 and Moderna Covid-19 Vaccine (Third Dose LOT:065FC21A) on 20-Nov-2021. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, Moderna Covid-19 Vaccine and Moderna Covid-19 Vaccine. Concurrent medical conditions included Drug allergy (sulfa drugs).    On 03-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced VITILIGO (Vitiligo). At the time of the report, VITILIGO (Vitiligo) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered VITILIGO (Vitiligo) to have an unknown relationship.    It was reported that the patient always wore masks. The patient had not experienced similar events in the past. No concomitant medication was reported.  Due to the event the patient visited the dermatologist on 01-Nov-2022. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Oct-2023: Significant follow-up received. Reporter details updated. Patient details updated. Current condition added. Previous doses batch number updated. Suspect administration date was updated. Reporter causality updated.
Cellulitis at injection site (L) arm. Cephalexin Rx 500 mg PO TID.
patient c/o sore arm and requested rn care to check temp taken 98 ice pack applied to right arm, patient stated she felt relief
Patient experienced syncope the morning following administration of the Shingrix and Pneumovax 23 vaccines. The patient experienced a contusion to the head and was taken to the ED for assessment where he was later admitted. He is currently being further assessed to determine other potential causes for the syncope.
Vaxelis and Engerix-B administered on the same day.; This case was retrieved during the Reporting System monitoring on 12-JAN-2023 with the following. The original narrative from the sender is the following:  Vaxelis and Engerix-B administered on the same day; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 6-month-old male patient who received HBV (Engerix B) (batch number YY2R3, expiry date 12th May 2024) for prophylaxis. Co-suspect products included VAXELIS for prophylaxis. Previously administered products included Engerix-B (The first dose was received on an unknown date). On 24th October 2022, the patient received the 2nd dose of Engerix-B (The first dose was received on an unknown date). On 24th October 2022, unknown after receiving Engerix B, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown. Additional Information: GSK Receipt Date: 28-OCT-2022. Reporter's Comments: The medical assistant had reported that a child patient was given Vaxelis (manufacture-Sanofi) and a 2nd dose of Engerix-B on the same day 24th October 2022. The vaccine administration facility was the same as the primary reporter. The reporter had consented to follow-up. Additional supportive information: The patient had received the second dose of Engerix-B and Vaxelis on the same day, which had led to overdose of hepatitis B component.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event, "Overdose".  No further information is expected.
12/27/2022 in the evening Fever peaking at 100, body aches, and a severe headache.  12/28 symptoms continued into the day.  Tested positive with an At Home COVID-19 Test.  Televisit with Doctor.  Prescribed Paxlovid and treat symptomatically.   12/29 fever broke, symptoms improved, but developed a productive cough and felt fatigued.  Night of 12/29 pulse ox levels 80-83%.  Consulted Doctor 12/30 who recommended going to ER.  I went to ER that day.  Tests reviled no blood clot.  Once participant got up and about Blood Oxygen level went into the low 90?s%.  EKG, blood work and Chest CT scan also performed in ER, revealing all normal findings.  Released from ER after a few hours.  Blood Oxygen level returned to normal range.  Symptoms improved over the next few days.  Fatigue lingers with strenuous activity.   Still coughing.
soreness in the crease between left arm and back, soreness is about quarter inch/really hurts; injection site pain; aches; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (soreness in the crease between left arm and back, soreness is about quarter inch/really hurts), VACCINATION SITE PAIN (injection site pain), MYALGIA (aches) and VACCINATION SITE ERYTHEMA (red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION COMPLICATION (soreness in the crease between left arm and back, soreness is about quarter inch/really hurts), VACCINATION SITE PAIN (injection site pain), MYALGIA (aches) and VACCINATION SITE ERYTHEMA (red). On 27-Jan-2021, VACCINATION SITE PAIN (injection site pain) and MYALGIA (aches) had resolved. At the time of the report, VACCINATION COMPLICATION (soreness in the crease between left arm and back, soreness is about quarter inch/really hurts) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  The treatment information was unknown.
Patient started having trouble breathing.  She went to the ER at   She was there about 3 1/2 hours while they gave her diphenhydramine and performed a chest x-ray.  Chest x-ray was normal.  Diphenhydramine helped patient and was able to go home. Her husband was able to call us the next day and said she was just fine.
Extreme vertigo (dizziness, unsteady when standing, floating when laying), weakness, confusion (fuzzy brain), un-well feeling, constipation, shortened temper, for 7 days after injection. After 12 days; occasional dizziness and no energy.
Pt received vaccines for Hepatitis A and Menactra, approx. four minutes after administration the patient felt dizzy and was helped to the floor by her mother.  After laying on the floor patient lost consciousness twice briefley and had a period of fine tremors in face and upper limbs lasting 5-10 seconds with no loss of bowel/bladder control noted.  Pt. pulse dipped down to 40 bpm and pt. became diaphoretic.  Within 10 minutes of becoming conscious, pt. stated she was feeling better.
Approximately 5 minutes after injection, pt began complaining of "feeling warm." He was provided with water by a staff member. The patient then fell to the floor from a seated position in a chair in the observation area. The EMT and Paramedic immediately responded to the patient. They assessed the patient and brought him into a wheelchair once he was feeling well enough to do so. The patient never lost consciousness. Initial vitals: BP 96/60, O2 95% on room air, RR 24, HR 64. The Paramedic took a 12-lead EKG, result was Sinus rhythm with apparent ST elevation. Subsequent EKG was sinus brady with apparent ST elevation. The patient was free of contusions or scrapes from his fall from the chair. PT initially refused transportation to the emergency department. After some convincing, the patient was agreeable to seek elevated medical treatment and was transported by ambulance.
Shortly after receiving Imms PENTACEL, PREVNAR & ROTATEQ developed bloody diarrhea.
Information has been received from an emergency medical technician concerning a 15 year old female patient with no drug reactions or allergies who on approximately 20-MAY-2009 had a yeast infection.  On 21-MAY-2009 she received a dose of GARDASIL (lot # not reported) intramuscularly.  Concomitant therapy included SERTRALINE HC1.  On 21-MAY-2009 the patient developed nausea, headache and vomiting.  The patient also complained of soreness at site of injection.  At the time of the report on 27-MAY-2009 the patient had not recovered.  The patient sought medical attention called the office.  There were no laboratories diagnostics performed.  Additional information has been requested. 6/22/09 Medical records received DOS 5/12/09 to 6/3/09. Patient presents with soreness at injection site, headaches, nausea and vomiting. At time of immunization was being treated with Diflucan for candidiasis of vulva and vagina.
This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not provided.