chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache (1 week), Fever 102.5 (1.5 weeks), rash, nausea (5 weeks), dizziness (5 weeks), extreme fatigue (still experiencing at 7 weeks), swollen face.
arrhythmias; rapid heartbeat; slight nausea; slight headache; light bothered vision for some days; mild chills; A spontaneous report was received from a retired nurse concerning herself who is 90 year old received Moderna COVID-19 vaccine and have experienced arrhythmias, rapid heartbeat, slight nausea, slight headache, some visual problems (light bothered her for some days) and mild chills.  The patient has prior history of irregular heart beat . Her relevant concomitant medications were cholesterol medication, Crestor and medication for irregular heartbeat. No information on allergies.   On 28-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of COVID-19 vaccine intramuscularly for the prophylaxis of COVID-19 infection.  On 30-JAN-2021, 2 days after her vaccination, she developed arrhythmias, rapid heartbeat, slight nausea, slight headache, some visual problems (light bothered her for some days) and mild chills. After one week she felt like no more symptoms ongoing and felt good again. She visited her physician for arrhythmias, and he said, she should keep an eye on it, but no medication yet. She is concerned about her second shot.  Action taken with 2nd dose of Moderna COVID-19 vaccine was not reported.  The outcome of the events, arrhythmias, rapid heartbeat, slight nausea, slight headache, visual problems and chills were resolved at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. However, patient's advanced age and prior history of irregular heart beat are considered risk factors for arrhythmias.
Pain at injection site, swelling at injection site, headache, fatigue, stiff neck and upper back.
Ever since received Vaccine admitted in Hospital at least 4 times because she was having seizures, heart problem; Ever since received Vaccine admitted in Hospital at least 4 times because she was having heart problem; She lost 100 Pounds; she can't swallow; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program.  A female patient of an unknown age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on May2021 at single dose for COVID-19 immunization. The patient was unsure of the day as she when received the first vaccine. Medical history and concomitant drugs were unknown.  Since received Vaccine the patient was admitted in Hospital at least 4 times because she was having seizures, heart problem. Dates when patient was in hospital were unspecified. She lost 100 Pounds on "charade food" (further not clarified) and she could not swallow. The outcome of the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
I fainted while sitting in the chair about 5 minutes or less after the shot.  I felt myself not feeling well immediately after the shot.
I went for hikes 10-12 miles in January February March, the longest hike was 16 miles. After the vaccination I couldn't even go for 1 mile hikes developed chest pain on exertion.
pt recv vax lt arm 17APR95 & on 19APR95 discovered large tender marble sized lump lt axilla; pt is exp intermittent entire lt upper extremity numbness involving all fingers;
Entire head and shoulder pounding headache, awakening in sleep, with tingling/numbness in hands and feet. Treated with OTC medication.
Information has been received from a nurse in office concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not reported). The patient had syncopal events after vaccination. It was unknown if medical attention was sought. The outcome of the patient was not reported. This is one of several reports from the same source. Additional information has been requested.
PRESENTING PROBLEM: CHF (congestive heart failure), NYHA class I, acute, combined [I50.41] Acute on chronic congestive heart failure, unspecified heart failure type [I50.9]   HOSPITAL COURSE: Patient is a 85 y.o. male who presents today with SOB. Pt. has a PMH of CHF, seizure disorder, OSA w/ CPAP, DM2, CKD3, A-fib on eliquis, HTN. He presented with 3 week history of dyspnea, edema, and orthopnea.  He presented w/o hypoxia but Chest x-ray shows pulmonary edema. Labs with elevated BNP of 16,000, previously around 3,000.  He was admitted to ED obs but Patient was also found to have COVID though he was fully vaccinated so he was transferred to medicine service. He did well and was euvolemic on room air and discharge was planned however his room mate at his facility was covid negative so he couldn't dc home until there was a private room for him. He discharged on 11/8 without incident and no change in long term medications (antitussives sent).    Consultations - none   Procedures - none   BP 124/71  | Pulse 77  | Temp 36.8 °C (Oral)  | Resp 20  | Ht 1.702 m  | Wt 99.4 kg  | SpO2 98%  | BMI 34.32 kg/m²    Physical Exam  Physical Exam: BP 124/71  | Pulse 77  | Temp 36.8 °C (Oral)  | Resp 20  | Ht 1.702 m  | Wt 99.4 kg  | SpO2 98%  | BMI 34.32 kg/m²  General appearance: alert, cooperative, no distress, appears stated age Head: Normocephalic, without obvious abnormality, atraumatic Throat: Lips, mucosa, and tongue normal. Teeth and gums normal Lungs: clear to auscultation bilaterally Heart: regular rate and rhythm, S1, S2 normal, no murmur, click, rub or gallop Abdomen: soft, non-tender. Bowel sounds normal. No masses,  no organomegaly Extremities: extremities normal, atraumatic, no cyanosis or edema Skin: Skin color, texture, turgor normal. No rashes or lesions     Radiology results reviewed from the following date(s): admission Lab results reviewed from the following date(s): admission
Flulaval given to 4 month old patient; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number L3HK9, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th December 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 28th December 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Physician reported that medical assistant administered a dose of Flulaval at the age of 4 months old patient, which led to inappropriate age at vaccine administration. Consent to follow up was granted by Email or phone number but no contact details available.
Redness at site of vaccine from "shoulder area to almost elbow" per parent. Fever today 100.8 (ax).
Areas of red induration on administered arm. Recommended BENADRYL 50 mg/25. Also, MD wrote rx for KEFLEX 500 Q8x 10d.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient was vaccinated with an improperly stored dose of 0.5 ml LIQUID PEDVAXHIB (lot# unknown) intramuscular on 29-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Kidney stone; A spontaneous report was received from a consumer, concerning a 68-years old female patient, who was administered Moderna's COVID-19 vaccine and developed kidney stones.   The patient's medical history was not provided. The patient was not taking any concomitant medications.  On 20 Jan 2021, approximately 30 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) in the right arm for prophylaxis of COVID-19 infection.   The patient stated that she went to Emergency room (ER) on 18 Feb 2021 for kidney stone. The patient was treated with flomax, tylenol with codeine, motrin 600mg, zofran ODT. The patient wanted to know if she can still take her Flomax and get 2nd dose.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, kidney stone was unknown.; Reporter's Comments: This case concerns a 68-year-old female who experienced serious unexpected event of Nephrolithiasis.   The events occurred 30 days after the first dose of mRNA-1273. Treated with Flomax, Tylenol with Codeine, Motrin, Zofran. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Headache, fogginess, malaise. These have mostly resolved as of  07:31 on 4/13/2021.  Ringing in both ears and slight pressure in ears(pressure was mildly painful 4/11-4/12. Ringing and pressure still present as of  07:31 on 4:/13/2021.
The main thing that I remember is that I experienced an irregular heartbeat. It was racing faster than usual. It could have been into A-Fib, but it was so different from A-Fib and that's why I was concerned. It lasted for 8-10 hours. I called my Cardiologist and he saw me on  02/06/2021. By the time I had my appointment, everything was back to normal. Well, as normal as can be with A-Fib.
Fever, headache, dizziness, nausea, sore arm for 4 days and counting, sore throat, vertigo, and muscle pains throughout my body
The Moderna vile that we used was taken out of the freezer and thawed out on 9/10/21 at 7am.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (The Moderna vile that we used was taken out of the freezer and thawed out on 9/10/21 at 7am.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The Moderna vile that we used was taken out of the freezer and thawed out on 9/10/21 at 7am.). On 30-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (The Moderna vile that we used was taken out of the freezer and thawed out on 9/10/21 at 7am.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No treatment medications were reported.  The reporter had question regarding product re-administration.   Reporter did not allow further contact
reactions to shots other than sore arm; Rebound COVID; COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL3302), on 01Mar2021 as dose 2, single (Lot number: EN5318), on 09Oct2021 as dose 3 (booster), single (Lot number: 301308A) and on 09May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Patient's Medical History (including any illness at time of, vaccination)? None; "Covid", start date: 2018 (unspecified if ongoing), notes: only for 24 hours. Shingles Shot; Shingrix; 2 shots before COVID so, 2018 Vaccination Date: long time ago. Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; CALCIUM; IRON; D3; MULTIPLE VITAMINS. Vaccination history included: Shingles (only for 24 hours.Shingles Shot; Shingrix; 2 shots before COVID so, 2018 Vaccination Date: long time ago), for immunization, reaction(s): "feverish"; Shingles (Shingles Shot; Shingrix; 2 shots before COVID so, 2018 Vaccination Date: long time ago), for immunization, reaction(s): "fever". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovered" (Aug2022) and all described as "COVID-19 treatment"; DISEASE RECURRENCE (medically significant) with onset 18Aug2022, outcome "unknown", described as "Rebound COVID"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as " reactions to shots other than sore arm ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Additional information: No other conditions was reported.No investigation was reported. Paxlovid treatment was given from 8Aug2022 to 13Aug2022. Paxlovid for Covid-19 and she had Covid rebound and her doctor told her she needed to call in and report. The rebound Covid started 18Aug2022. She hopes the rebound Covid is not ongoing and states she doesn't have any symptoms. She doesn't have the packaging anymore but has the paper work that the pharmacist attaches. She sees, Quantity 30 and manufacturer packaging; 150x2-100mg. She took for 5 days.No additional vaccines administered on same date of the pfizer suspect if applicable, list all vaccines administered on same date with the pfizer vaccine considered as suspect.No emergency room visit was reportd. No prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was reported. patient medical history (including any illness at time of vaccination) was reported as none. Relevant tests was reported as none.
About 45 to 50 minutes after vaccine was administered body and face felt warm and face was itching for the rest of the afternoon.  02/23/2021 itching of face and genitals. 02/24/2021 mild rash appeared on hands and face and continues to itch. Advised to take Benadryl or Claritin to help the itch.
Pt C/O tightness in center of chest, nausea, pain in L arm. Chest tightness and nausea occurred within minutes of receiving vaccine, resolved after 2-3 minutes. L arm pain began after chest tightness and nausea subsided, lasted 10-15 minutes. Pt had vitals checked, initially BP elevated at 152/87, rechecked after 7 minutes down to 124/78. All other vitals normal (84 BPM, 98.2 degrees, 14 RPM, 99% O2). ECG performed and reported "Normal ECG". Pt noted symptoms resolved before leaving office.
On 6/20/09 per parent, client got out of bed at 9:00 Am, without eating or drinking went to use bathroom. Client felt dizzy (told this to Dad), then passed out "for a few seconds" Hit her mouth on bathroom counter. Went to ER for stitches and had EKG (results neg). On menstrual period.
21 yo f w/stated hx of factor V leiden deficiency c/o new acute atraumatic onset of diffuse ha w/mild nausea w/o vomiting x3hrs, states concern for blood clot etiology given recent J&J vaccine w/i past week; Pt states sensitivity to noise during this time; Pt states paternal hx of 'blood clot that shredded my dad's arteries and veins' in the brain but denies this as stroke; Pt denies any fevers/ns/chills, other hearing changes, nasal congestion, sore throat, recent illness, hx of sig head inj/trauma/surg/procedure
Sore arm at injection site. Moved across chest and shoulders with pain, tightness and soreness. Moved into right arm with soreness and pain. Moved down into back and lower back with pain and soreness. Lasted for 3 days.
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: Moderna, dose 5/ Pfizer, dose 4; Pfizer, dose 4; Vaccine brand other: Moderna, Vaccine dose number: 5; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 77 years, in left arm for COVID-19 immunization; elasomeran (COVID-19 VACCINE MODERNA), on 14Sep2022 as dose 5 (booster), single (Lot number: AS7143C), in left arm for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "rheumatoid" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Diovan, reaction: "known allergies: Diovan"; Lisinopril, reaction: "known allergies: Lisinopril"; Oxycontin, reaction: "known allergies: Oxycontin". The following information was reported: IMMUNISATION (medically significant) with onset 14Sep2022, outcome "unknown", described as "Pfizer, dose 4"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna, Vaccine dose number: 5"; OFF LABEL USE (medically significant) with onset 14Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna, dose 5/ Pfizer, dose 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2022) Positive; (10Oct2022) Positive; (12Oct2022) Positive; (14Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Seriousness reported as not serious. Patient will test again on 16Oct2022. AE resulted in: None of the above.
No additional AE reported; VARIVAX that had undergone temperature excursion was administered to patient; This spontaneous report was received from an other health care professional referring to 14-month-old male patient.  On 16-FEB-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) injection (VARIVAX) (lot #W006412, expiration date 23-FEB-2024) (dose not reported) intramuscularly in right thigh.  On 20-JAN-2023, the administered dose had temperature excursion range of -14 degree Celsius to -10 degree Celsius for 1 hour (Product storage error). No additional adverse event reported.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2304USA007822: US-009507513-2304USA007836: US-009507513-2304USA007837: US-009507513-2304USA007843: US-009507513-2304USA007869: US-009507513-2304USA007889: US-009507513-2304USA007931:
was in bed almost 2 weeks, almost died; sick; Initial information was received on 06-Oct-2021 regarding an unsolicited valid Social Media serious case from a consumer/non-health care professional.  This case involves a patient (demographics unknown) who was in bed almost 2 weeks, almost died (bedridden) and sick (illness) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor  Medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient was in bed almost 2 weeks, almost died (bedridden) and sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. These events were leading to disability.  Aspirin, Vitamin C, and some good Chicken Soup is all that patient needed  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome of events was unknown.  Information on batch number was requested for this case.; Sender's Comments: This case concerns a patient (age unspecified) had illness and was bedridden after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
PT DECEASED ON 10/06/2021-HAD VACCINE ON 3/10/21.  PT DIAGNOSED WITH BILATERAL COVID PNEUMONIA-WAS DEPENDENT ON BIPAP.  WAS MADE DNR, AND COMFORT MEASURES
very weak; feeling so bad; Initial information received on 23-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves a patient of unknown age and gender who reported very weak and feeling so bad after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient had received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for influenza.   On an unknown date, the patient developed events very weak (asthenia) and feeling so bad (feeling abnormal) (latency: unknown) following the administration of influenza vaccine.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the events.   At time of reporting, the outcome was Unknown for the events.
Unresponsive episode about 4 hours after immunizations lasted about 1 minute. Spontaneous recovery.
Inject (L) shoulder - (L) facial then R facial swelly. No oral involvement.
MILD PAIN IN RIGHT ARM EVENING 5/16/11.  WENT TO WORK 6/17/11 NOTICED PAIN AND FEVER.  PAIN IN RIGHT LATERAL BREAST, NECK, SHOULDER, UPPER ARM.  VOMITED X 2 EVENING.  AREAS NOW TENDER TO TOUCH. NO REDNESS, SWELLING, WARMTH AT INJECTION SITE.  NO RIGHT AXILLA NODE SWELLING. ABLE TO MOVE ARM. HURTS TO LIFT ARM. REFERRED TO ER/URGENT CARE/MD. IF NO IMPROVEMENT OR INCREASED PAIN.
mom reports pt awakened fr nap 315-4 hr p/vax screaming, cont for 1 1/2hr then turned to crying & fussiness which cont the rest of the noc & throughout next 1 1/2 days;fever of 102.2 @ 8:00 on 28JUN;also seen by MD 4PM on 28JUN
Case number PHEH2014US017244 is an initial spontaneous report received from the pharmacist on 26 Aug 2014. This report refers to 59 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: X11046) intramuscularly on 22 Aug 2014. It was reported that she was vaccinated with expired MENVEO vaccine. No adverse events reported after the maladministration.