chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; mild cough; Tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), COUGH (mild cough) and SARS-COV-2 TEST POSITIVE (Tested positive for Covid) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (fever), COUGH (mild cough) and SARS-COV-2 TEST POSITIVE (Tested positive for Covid). At the time of the report, PYREXIA (fever), COUGH (mild cough) and SARS-COV-2 TEST POSITIVE (Tested positive for Covid) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
the dose received had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 52-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 15th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an expired dose of Twinrix, which led to expired vaccine used. The reporter did not consent to follow-up. The Vaccine Administration Facility is the same as Primary Reporter.
I had a lot of fatigue, and I had a mild fever with the highest being 100 degrees. I had a very bad sore throat which was very uncomfortable for 3 or 4 days. When I ate or swallowed it hurt worst. On February 25, 2023, I tested I received a positive result on a COVID-19 home test. The doctor called in the prescription for Paxlovid which I began taking on Tuesday evening. I was slowly starting to feel better. I still had a lot of fatigue and disrupted sleep, but the fever had died down. Thru the 7th of March I received positive COVID-19 home test. I was slowly getting better but still testing positive for some time.
huge raised swollen bump on injection site which was hot to touch; also total 3 swollen lymph nodes in armpit and on the collar bone area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (huge raised swollen bump on injection site which was hot to touch) and LYMPHADENOPATHY (also total 3 swollen lymph nodes in armpit and on the collar bone area) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE SWELLING (huge raised swollen bump on injection site which was hot to touch) and LYMPHADENOPATHY (also total 3 swollen lymph nodes in armpit and on the collar bone area). At the time of the report, VACCINATION SITE SWELLING (huge raised swollen bump on injection site which was hot to touch) outcome was unknown and LYMPHADENOPATHY (also total 3 swollen lymph nodes in armpit and on the collar bone area) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She took Heat pack & Ice pack as treatment for the event occurred .
Patient reports right upper quadrant pain and also severe abdominal issues That have been persistent for weeks. Saw MD and had tests done but did not have appendicitis or any other issues per MD.
Pt started running fever 104 R on 24JUN91-3AM; Taken to Hosp to visit brother & started staring, febrile, vomited; Seen in ER; Grandma stated pt may have had diarrhea;
symptoms include nausea and diarrhea w chills and fatigue, low -grade temp. Onset   about  12/31. Tested positive on 1/5/22. Lives with son who is sick with covid.
blotching red itchy urticaric rash, flushed cheeks, puffy, warm ears (w/o other known cause for allergic like response)
MMR given, 1 week later developed fever, coryza, cough, cervical lymphadenitis and rash of trunk, face and extremities, fever 104 - 1:30 a.m. 11/11 then developed rash.
chest cold, h/a, conjunctivitis, sore throat; temp not measured, pt doubts there was fever;
Patient was given her second vaccine 4 weeks before her due date.  She received the first dose on 1/19/21 and the second was given on 2/19/21. This was due to a communication error from both pharmacy colleagues and the patient. Upon investigation, patient did not have any side effects and was informed that the dose is viable although not recommended per the CDC.
ACUTE RESPIRATORY FAILURE 4/6/2022 ENDOMETRIAL THICKENING  ACUTE RESPIRATORY FAILURE 4/6/2022 ENDOMETRIAL CANCER
Patient having nose bleeds but only in the left nostril; Patient having blood in my right ear but looking at the fluid to come out just a little bit; Patient ridiculously forgetful; I was like really knocked out exhausted; Patient was like really knocked out exhausted; Shortness of breath; This is a spontaneous report from a contactable consumer (reported for self). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 21Apr2021 at 08:45 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the consumer reported that the patient having nose bleeds but only in the left nostril and the patient having blood in right ear but looking at the fluid to come out just a little bit and patient been ridiculously forgetful. Patient was like really knocked out exhausted after the first shot and like now patient experiencing shortness of breath. So, the patient wondering should get the second shot. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
At about 12 hours post Covid vaccine #2 I woke up in the middle of the night feeling restless and had chills with a slight headache. I wasnt able to sleep well until about 6am when I took 400mg of ibuprofen and zzzquil. I had a low grade fever all day until about 7pm and then teeth sensitivity developed. It started on my right side in my lower teeth and then it quickly developed into all of my teeth being sensitive even when not eating or drinking. This lasted for approximately 48 hours.
Severe bowel pain; Pain in the shoulder; Nausea; Vomiting; Chills/shakes; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of GASTROINTESTINAL PAIN (Severe bowel pain), ARTHRALGIA (Pain in the shoulder), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills/shakes) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced GASTROINTESTINAL PAIN (Severe bowel pain), ARTHRALGIA (Pain in the shoulder), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills/shakes). On 17-Jan-2021, VOMITING (Vomiting) had resolved. On 18-Jan-2021, GASTROINTESTINAL PAIN (Severe bowel pain), ARTHRALGIA (Pain in the shoulder), NAUSEA (Nausea) and CHILLS (Chills/shakes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided    This case was linked to MOD21-11685 (E2B Linked Report).; Sender's Comments:  MOD21-11685:Crosslinked: Same reporter
2 days p/vax pt exp inflammation of cervical & axillary lymph nodes. Pt tx w/Duricef 500mg po bid for 10 days.
Urticaria. Woke up with itching on Dec 1, 2021. Any area touched by clothes or hands flairs up. Skin on chest and back extremely sensitive. Chest is most rashy. Had J&J shot 4/9/2021. Moderna booster on 11/21/2021.
Chills; fever; explosive diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 43-years-old non pregnant female patient received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 26Feb2021 at 09:00 (at the age of 43-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Patient did not receive any other vaccine in four weeks. On 02Mar2021 at 16:00, patient experienced chills, fever and explosive diarrhea. Therapeutic measures were not taken due to the events. The patient underwent lab tests and procedures which included sars-cov-2 antibody test result of which was pending. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch no cannot be obtained.
His monocyte count last year was 9 (normal value6-12) but this year it is 11.7 (normal value 3-7); His eosinophil count last year is 1.0 (normal value 1-5) and for this year it is 1.0 (normal value 2-4); He states that his hemoglobin and hematocrit levels are also low; He states that his hemoglobin and hematocrit levels are also low; This spontaneous case was reported by a patient and describes the occurrence of MONOCYTE COUNT INCREASED (His monocyte count last year was 9 (normal value6-12) but this year it is 11.7 (normal value 3-7)), EOSINOPHIL COUNT DECREASED (His eosinophil count last year is 1.0 (normal value 1-5) and for this year it is 1.0 (normal value 2-4)), HAEMOGLOBIN DECREASED (He states that his hemoglobin and hematocrit levels are also low) and HAEMATOCRIT DECREASED (He states that his hemoglobin and hematocrit levels are also low) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Monocyte count (last year was 9 (normal value 6-12)) in 2022 and Eosinophil count (last year is 1.0 (normal value 1-5)) in 2022.    On 28-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 02-Nov-2023, the patient experienced MONOCYTE COUNT INCREASED (His monocyte count last year was 9 (normal value6-12) but this year it is 11.7 (normal value 3-7)), EOSINOPHIL COUNT DECREASED (His eosinophil count last year is 1.0 (normal value 1-5) and for this year it is 1.0 (normal value 2-4)), HAEMOGLOBIN DECREASED (He states that his hemoglobin and hematocrit levels are also low) and HAEMATOCRIT DECREASED (He states that his hemoglobin and hematocrit levels are also low). At the time of the report, MONOCYTE COUNT INCREASED (His monocyte count last year was 9 (normal value6-12) but this year it is 11.7 (normal value 3-7)), EOSINOPHIL COUNT DECREASED (His eosinophil count last year is 1.0 (normal value 1-5) and for this year it is 1.0 (normal value 2-4)), HAEMOGLOBIN DECREASED (He states that his hemoglobin and hematocrit levels are also low) and HAEMATOCRIT DECREASED (He states that his hemoglobin and hematocrit levels are also low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Colonoscopy: No polyps seen. In 2023, Eosinophil count (2-4): 1.0, Decreased. In 2023, Haematocrit: Low. In 2023, Haemoglobin: Low. In 2023, Monocyte count (3-7): 11.7, Increased.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Reporter was a semi-retired pharmacist and asked if Spikevax affects the monocyte and eosinophils count. He got the Spikevax vaccine and had his annual checkup on 02Nov2023. He stated that his hemoglobin and hematocrit levels were also low which may mean that he may have cancer as he lost a brother to colon cancer.  Treatment information was not reported.
Itching throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Itching throat) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to molds.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (Itching throat). At the time of the report, THROAT IRRITATION (Itching throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.
Initial report was received on 10 October 2011 from a health care professional. A male patient (name, age and date of birth not reported) had received FLUZONE (lot number, route, site and date of administration not reported) and an unspecified amount of time later, experienced a high fever and was hospitalized. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Patient was "fussy" per mother and did not want to take his naps during the day.  Fussiness resolved by 3/27/10 completely.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients from 5 patients of unknown age and gender. On an unknown date in 2013 over the last six months, the patient was vaccinated with ZOSTAVAX vial with lot # J008528 and expiry date 19-OCT-2014 (dose number, dose unit unknown) subcutaneously for vaccination. On an unknown date of 2013 over the last six months, unspecified number of patients from 5 patients developed injection site reactions after receipt of the ZOSTAVAX. The injection site reactions were described as being swollen, itchy, painful and warm. On an unknown date, injection site reaction described as swollen, itchy, painful and warm was recovered. Pharmacist stated that lot numbers she has used in the last six months was J006830 (expiry date 14-SEP-2014) and J008528 (expiry date 19-OCT-2014). The outcome of injection site warm, injection site reaction, injection site swollen, injection site itchy and injection site painful was reported as recovered/resolved. This case # 1402USA004725 is linked to case # 1402USA002955 via same reporter link. Additional information has been requested.
3 miscarriages in one year - March 2022 - pregnant when received booster  D&C -March 2022  Diagnosed with PCOS May 2023  Rupture ovarian cysts -May 2022  Missed ovulation  Irregular period-heavy bleeding  Severe pelvic pain  No know cysts or reproductive issues/pain prior to vaccine .
Narrative: Patient is 92 year old with multiple medical comordbidities (see below) PROBLEM LIST: *Urinary incontinenceSeen by Regulatory Authority  Parkinson's disease Allergic rhinitis Insomnia Complete faecal  incontinence Disorder of nail Dermatitis Contracture of knee joint Acquired iron Mild cognitive impairment Seen by palliative care service Chronic fatigue syndrome Skin cancer History of cataract extraction Thumb injury Stented coronary artery Aneurysm of popliteal artery Claudication Peripheral vascular disease Essential hypertension High chloesterol Hypothyroidism Osteporosis Chronic systolic heart failure Coronary arteriosclerosis Obstructive sleep apnea syndrome Vitamin D deficiency Atrial fibrillation H/O: vertebral fracture History of repair of musculotendinous cuff of shoulder Infection of phalanx of finger or thumb Malignant melamoma of skin of nose History of myocardial infarction  Disorder of prostate Gastroesophageal reflux disease Allergic arthritis History of hypotension Adjustment disorder with depressed mood Patient received COVID vaccine on 06/10/2021 and patient died on 03/11/2022 (cause unknown). Likely death is not related to vaccine due to patient's advanced age and comorbidities
Inconsolable crying for about 5 hrs that started three hours after shots (5). L thigh was hard and red.
Died of clots in brain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRAIN STEM THROMBOSIS (Died of clots in brain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medically reported history).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced BRAIN STEM THROMBOSIS (Died of clots in brain) (seriousness criteria death and medically significant). The patient died on 30-Jan-2021. The reported cause of death was Brain stem thrombosis. It is unknown if an autopsy was performed.            This is a 76 year-old, who received mRNA-1273 Vaccine) and died 8 days after receiving first dose of vaccine and subsequently experienced brain stem thrombosis. No medical hx or conmeds were provided.  The reported cause of death was brain stem thrombosis. Very limited information has been reported at this time. Further information is expected.   This case was linked to MOD21-075103, US-MODERNATX, INC.-MOD-2021-075124 (Linked Report).; Sender's Comments: This is a 76 year-old, who received mRNA-1273 Vaccine) and died 8 days after receiving first dose of vaccine and subsequently experienced brain stem thrombosis. No medical hx or conmeds were provided.  The reported cause of death was brain stem thrombosis. Very limited information has been reported at this time. Further information is expected. MOD21-075103: US-MODERNATX, INC.-MOD-2021-075124:Patient's brother in law case; Reported Cause(s) of Death: brain stem thrombosis
Cellulitis/ ER diagnosis; Itching/ marks because of the itching; Redness; Swelling; Warm; Allergic reaction/ ER diagnosis; marks because of the itching; This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), pruritus, erythema, swelling, feeling of warmth, allergic reaction and skin scarring. The patient was treated with cefalexin (Keflex) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the cellulitis, pruritus, erythema, swelling, feeling of warmth, allergic reaction and skin scarring were unknown.   It was unknown if the reporter considered the cellulitis, pruritus, erythema, swelling, feeling of warmth, allergic reaction and skin scarring to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's Comments: The pharmacist reported that patient received Shingrix first dose and had itching, mark because of the itching, redness, swelling and warm. The patient went to the ER (Emergency room) and the diagnosis was cellulitis- allergic reaction.  The patient's doctor did not agree with this diagnosis.  The patient was given Keflex and Benadryl in the ER (Emergency room). The reporter consent to follow up by email.
Patient being seen in office for follow up visit. Provider ordered Pneumovax 23 injection. Patient had received Prevnar 13 20 days prior. Nurse giving injection did not question provider order, and administered injection. Within 10 minutes, patient's face turned red, and he began to feel lightheaded/dizzy. Associate called myself (triage RN), and patient was taken to triage room. BG checked per provider recommendation, and patient was given ice and water. Vital signs within normal limits. Patient given instructions to go home and rest for the remainder of the day.
Raise blood sugar; This spontaneous case was reported by a nurse and describes the occurrence of BLOOD GLUCOSE INCREASED (Raise blood sugar) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Raise blood sugar). At the time of the report, BLOOD GLUCOSE INCREASED (Raise blood sugar) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
FEVER CHILLS ACHES "FELT LIKE I WAS RUN OVER BY A TRUCK"
The pt became faint, then sank to the floor and was unresponsive for about 15-30 seconds, the eyes turned upward for approximately 5 seconds with facial twitching experienced as well. The pt was fully recovered within 5-10 minutes.
1. flu-like symptoms for 24 hours which kept me in bed--body aches, headache, lethargy, loss of apetite 2. soreness at injection site
black bruise at the injection site; concerned that vaccine was not administered intramuscularly; A spontaneous report was received from a patient concerning a 73-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  and developed a big black bruise the size of a silver dollar around 3x3 inches at the injection site and was concerned maybe the vaccine was not intramuscularly administered.   The patient's medical history was not provided.    Concomitant medications reported included blood pressure medication and cholesterol medication, however, no product information was provided.  On 27-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 004M20A) in the left arm for prophylaxis of COVID-19 infection.   Patient reported that approximately 1-2 days following vaccine administration, she developed a big black bruise about the size of a silver dollar at the injection site. Additionally, she reported that she was concerned that the vaccine may not have been administered intramuscularly.    No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, developed a big black bruise the size of a silver dollar around 3x3 inches at the injection site, was considered recovering/resolving.  The event, concerned maybe the vaccine was not intramuscularly administered, was considered recovered/resolved.; Reporter's Comments: This case concerns a 73-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot 004M20A) reporting Incorrect route of product administration and Vaccination site bruising. Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.