chrisvoncsefalvay/vaers-outcomes huggingface dataset:
aches and pains in the muscles; aches and pains in the muscles; Fatigue; Chills; soreness at the injection site; hard lump at the injection site; felt sick for two days; bumps in her arm that stayed for about a week; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches and pains in the muscles), MYALGIA (aches and pains in the muscles), FATIGUE (Fatigue), CHILLS (Chills) and VACCINATION SITE PAIN (soreness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (aches and pains in the muscles), MYALGIA (aches and pains in the muscles), FATIGUE (Fatigue), CHILLS (Chills), VACCINATION SITE PAIN (soreness at the injection site), VACCINATION SITE MASS (hard lump at the injection site), ILLNESS (felt sick for two days) and HYPERKERATOSIS (bumps in her arm that stayed for about a week). On 18-Mar-2021, ILLNESS (felt sick for two days) had resolved. On 22-Mar-2021, HYPERKERATOSIS (bumps in her arm that stayed for about a week) had resolved. At the time of the report, PAIN (aches and pains in the muscles), MYALGIA (aches and pains in the muscles), FATIGUE (Fatigue), CHILLS (Chills), VACCINATION SITE PAIN (soreness at the injection site) and VACCINATION SITE MASS (hard lump at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included paracetamol with Codeine.
Bells palsy 2 d after flu shot administration. FLUVIRIN 2011-2012 formula Lot 1101901 Exp 06/2012.
Information had been received on 19-APR-2017 regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was vaccinated with ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 12-MAR-2015 at a Drug store as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. It was reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-NOV-2015, the patient was treated at a health center for a painful rash that was diagnosed as shingles. Again, on or about 04-DEC-2015, the patient was treated at the same facility for a severe outbreak of herpes zoster. While shingles is a chronic and incurable condition, the patient has been prescribed VALTREX to manage her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA009664: US-009507513-1704USA009757: US-009507513-1704USA009812.
She had the vaccine and within 1 minute she had tingling in her tongue and numbness that went away immediately.  She did not have any other symptoms until 8 days later when she had 104 fever, could not walk, had stiffness in all of her muscles and aching, diarrhea.  They went to the doctor office and he did a COVID test that came back negative.  The fever still continued and her husband took her to the hospital on Tuesday 3/16/21.  They ran fluids on her and at the end of the day they said she was okay to go home.  The next day the fever started again and he ended up calling an ambulance to take her to the hospital.  She went to Hospital on 3/16, who took her to another Hospital.  They sent her home about 4 days later and said that her symptoms were from the vaccine.   He called and he filed a report with them.  They sent her home the next day, got another high fever, and her husband took her to the ER at again that evening.  She had high fever, extremes aches and pains and headaches.  They kept her a couple of days and then released her again.  She was home for a couple of days and they were managing her fever as it would spike at night.  She also had 8 other medications to take.  She then woke up yesterday 4/4/21 with severe back pain, cannot walk real well, and her husband called the ambulance again.  Now she has swelling in her heart, swelling around her heat and not breathing very well, and 104 fever and getting progressively worse  They said that she now has pericarditis and pericardial effusion and are going to release the fluid today.  She is still in the hospital.
with in a 10 days of first maderna vaccine I contacted my OBGYN due to swollan/sore  lymph nodes  under my left arm. Dr. referred me to have ultrasound, mammogram and to see breast surgon.  After a couple visits and multipul Ultrasounds  and waiting out to see if the swelling would subside, it was decided to perform bioplsy to rule out any form of cancer.
Shoulder pain that lasted months, eventually diagnosed as frozen shoulder syndrome, still having pain now, doctor recommended physical therapy.
Child received vaccine on 3/5/08, had fever; 3/6/08 R thigh area gradually swelling red, warm, tender, no vesicle, no blister, slight fever 99.  Child walking ok, gait ok.
Fever, chills, vomiting, extreme weakness, muscle aches, sore arm within 12 hours and resolved within 2 days.   Numbness and tingling of face, arms, and legs. onset about 24 hours after the vaccine. Numbness ongoing. Right side of face, right calf, left calf.
Information has been received from a pharmacist concerning a 44 year old female therapist who had had chickenpox 3 times as a child. In approximately 1996, the patient was vaccinated with a dose of measles virus vaccine, live (manufacturer unknown). On an unknown date, 1 week within vaccination the patient got the flu. Patient's outcome was not reported. Relationship between flu and vaccination with measles virus vaccine, live (manufacturer unknown) was not reported. This report is linked to MARRS 1502USA004907 from the same patient. Additional information has been requested.
Fever to 106.9 by multiple assessments via home thermometer (temporal scanner) about 30 hours post-vaccination
HOSPITALIZED; BEYOND THE 42 DAY INTERVAL FOR THE 2ND DOSE; This spontaneous case was reported by an other health care professional and describes the occurrence of HOSPITALISATION (HOSPITALIZED) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 HOSPITALISATION (HOSPITALIZED) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (BEYOND THE 42 DAY INTERVAL FOR THE 2ND DOSE). At the time of the report, HOSPITALISATION (HOSPITALIZED) and PRODUCT DOSE OMISSION ISSUE (BEYOND THE 42 DAY INTERVAL FOR THE 2ND DOSE) outcome was unknown.        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 medication was not given.    No laboratory was not given.   No treatment information was not given.; Sender's Comments: Very limited information regarding this event has been provided at this time. Details regarding if AE associated to vaccination was the cause for hospitalization is required for further assessment. This report refers to a case of product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.
Jaw pain, tingling sensation of lips, back muscle tightening. BP 133/91 (pulse 102)' repeat BP 115/76. O2 sat 99%.
Patient received his vaccine on 09/17/2021 at 1507 in his left deltoid. After 15 minutes the patient started to complain of jaw pain that felt like throbbing that transitioned into a dull sharp pain. At 1527 RN took the patient's vitals the patient's BP was 142/90 and O2 was 97%. The patient's symptoms have not gone away and he was advised to go see his primary care physican if the symptoms didn't go away due to his medical history with Stage 4 renal cancer
Fever beginning at 7 pm of 101-102 F, racing heart beat, headache, swollen temples, insomnia due to racing heart beat, chills, fatigue
Hypersensitivity, severe joint pain, all over body rashes/hives, dermatographia
Dizziness, balance problems, unable to walk without assistance.  Nausea, and vomited times 3.  Loud ringing in ears, headache, and chills.  Lasted for approx. 4 hours, then resolved.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old male patient who received vaccine DAPTACEL lot C5171AA, expiry date: 23-MAR-2019 via unknown route in the left thigh (dose not reported) on 01-Oct-2018. instead of Adacel. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENACTRA for Immunisation and Influenza vaccine for immunization. It was an actual medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration. It was reported that 11y male received Daptacel when they were due to receive the first dose of Adacel. No known reported symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
left arm was inflamed and in pain and she was unable to lift it; woke up with pain in my left arm from my shoulder to my wrist; her left arm was inflamed; This is a spontaneous report from a contactable consumer.  A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown), on unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. Medical history was not reported. concomitant medication included Apixban (ELIQUIS) from an unknown date. The patient had taken vaccine in right arm, but she did not have any discomfort in that arm, whereas At 3:00am her left arm was inflamed and in pain and she was unable to lift it, she had to use her right arm to move her left arm. she had taken a blood thinner right before she got her vaccination. The outcome of events was unknown.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Information on the Batch/Lot number has been requested.
This case involves an unknown age and gender patient who experienced have red, itchy welts all over my body (urticaria, erythema and pruritus) while receiving INFLUENZA VACCINE. Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious red, itchy welts all over my body (urticaria, erythema and pruritus) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if patient physician provide consent to be contacted. There were no lab data/results available. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was unknown for all events. There will be no information available on the batch number for this case.
Dizziness, Headache, Myalgia, Fever, "skin hurts"
Patient received 0.5ml 10mcg Energix B instead of adult 1ml 20mcg Energix B
No adverse events. The patient was given the Pfizer Pediatric 0.2ml instead of the Pfizer Adult/Adolescent 0.3ml.
The patient received the Moderna vaccine on 1/27/21, and had some reactions that were exhibited on 2/17/21. He was sent out to the hospital on 2/17/21, and returned the same day.  Summary of reaction: stuttering, DTR 2, hand tremors, diarrhea Outcome: A&O x 3, decreased hand tremors, able to walk slightly in a straight line. given ativan 2 mg PO with relief of symptoms.
I ended up testing positive for COVID-19 on 05/04/2022. I was having stomach aches, headaches, runny nose, congestion, fatigue, and a fever of 102. This lasted for about 4 days.
pt presented w/swelling on rt side of neck & face-level bottom of ear to shoulder firm not red-no fever;saw PMD-told swelling of parotid;
Headache; Nausea; Vomiting; Diarrhea; Drowsiness; Dose 1: 22Mar2021, Dose 2: 05Apr2021; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 13:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included eosinophilic esophagitis. The patient had no known allergies to food, medications or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Mar2021 at 13:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 06Apr2021 at 05:00, the patient experienced headache, nausea, vomiting, diarrhea and drowsiness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, vomiting, diarrhea and drowsiness was resolving at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HIGH BLOOD PRESSURE; SICK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced high blood pressure, and sick. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high blood pressure and sick was not reported. This report was non-serious.
I got a massive headache after the shot and it has not went away as of yet. I also feel extremely tired and very sick to my stomach.
About 5 days the vaccine, developed a red rash about 7x4 cm around the site of injection.
VERY ILL; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced very ill. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very ill was not reported. This report was non-serious. This case is a duplicate of 20230657808. This case, from the same reporter is linked to 20230657800.
Patient received meningococcal vaccine with the wrong saline diluent. Patient parents were notified, Mother stated no signs or symptoms or any reactions from the vaccines and agreed to bring child in 9/15/22 to be vaccinated correctly.
On 7/23/05 client attended a reception and was cut by an aluminum picnic table on the back of her right leg. Presented to this health dept on 7/25/05 for Td Booster. Client states she had called her doctor's office and nurse told her she should get a Td booster as it had been about 9 years since the last injection of Td. Client stated she told physician's nurse the last time she received Td she had a slight reaction, had experienced a feeling of warmth throughout her body, that went away a short while after the injection. Client stated that physician's nurse told her as long as she did not have a severe reaction to last  Td, she should be okay in getting another booster. Client was instructed to wait 15 to 20 minutes after receiving injection before leaving health dept. Client asked for a drink of water after receiving injection and stated she was experiencing a metallic taste in her mouth. After approx 5 minutes client stated metallic taste was going away. On 7/29/05 client reported on voice mail, reaction she experienced later the evening of 7/25/05. 8/1/05 Phone call to client, who stated, on 7/25/05 around 3:00PM her left arm became very sore and she was unable to raise her arm. She put warm moist heat on injection site and elevated her arm, which relieved discomfort somewhat. On 7/26/05 client reports fever of 102, chills, twitching of eyelids. Fever relieved with Tylenol. Client stated that symptom of eyelid twitching gradually wore off over a period of 4 days. Client reported her symptoms to her physician's office and was told to not have any more Td boosters.
Left eye became red and swollen.  Vision became blurred bilaterally (L>R) He reports that it is too blurry to read newspaper.  Redness and swelling persisted for 3-4 days before improving. He did not seek medical attention at that time. Pt presented one month after vaccination reporting the above complaint.  He reports that vision is improving but still blurry in left eye.  Vision exam revealed right eye:20/20, Left eye 20/25. Conjunctiva and cornea bilaterally normal exam by bed side. Fundoscopic exam on undilated pupil: No papiledema present, normal papila nervi optici bilaterally .
PFIZER-BioNtech COVID-19 Vaccine EUA Experienced first nose bleed in life over night  after receiving vaccine. I have had 8 subsequent nose bleeds since.  I have also had foul malodorous change to my olfactory senses, not loss of smell but change in everything I smell.
Dizziness; Felt bad; Increased heartrate; Felt weak; Face turned blood red; Chills,could not get warm; Felt nauseated; Left arm was swollen with a 3 inch diameter spot on arm; Felt achy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FEELING ABNORMAL (Felt bad), HEART RATE INCREASED (Increased heartrate), ASTHENIA (Felt weak) and ERYTHEMA (Face turned blood red) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (patient had coronavirus in September 2020.) in September 2020.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 07-Feb-2021, the patient experienced DIZZINESS (Dizziness), FEELING ABNORMAL (Felt bad), HEART RATE INCREASED (Increased heartrate), ASTHENIA (Felt weak), ERYTHEMA (Face turned blood red), CHILLS (Chills,could not get warm), NAUSEA (Felt nauseated), VACCINATION SITE SWELLING (Left arm was swollen with a 3 inch diameter spot on arm) and MYALGIA (Felt achy). At the time of the report, DIZZINESS (Dizziness), FEELING ABNORMAL (Felt bad), HEART RATE INCREASED (Increased heartrate), ASTHENIA (Felt weak), ERYTHEMA (Face turned blood red), CHILLS (Chills,could not get warm), NAUSEA (Felt nauseated), VACCINATION SITE SWELLING (Left arm was swollen with a 3 inch diameter spot on arm) and MYALGIA (Felt achy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, SARS-CoV-2 test: positive (Positive) Positive.     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.   Concomitant medication was not provided. Treatment information was not provided.
Patient had headache, nausea, diarrhea, rash on upper torso, numbness of tongue. Mother took child to ER was advised by physician not to get anymore HPV vaccine.
Right thigh swollen "the whole thigh" per mom.  Very red and sore to touch. HIB vaccine.  No reaction with the Prevnar.
no medical records received; pt died at home per death certificate with the causes of death being CHF, COVID 19, Arteriosclerotic and hypertensive cardiovascular disease
RASH ALL OVER BODY, EXTREME SORENESS OF MUSCLES IN BACK OF NECK AND DOWN THE BACK, LOSS OF APPETITE, LETHARGY, LISTLESSNESS, FELT FAINT AFTER A WALK ON 09/14/2014.
Big blotchy rash; Case reference number MOD-2021-008930 is a spontaneous case report sent by a Non-Health Professional on 18-JAN-2021 00:00:00 .  On  24/DEC/2020  the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  days  later,  the patient developed Big blotchy rash.the patient also developed Diagnosed with COVID after 1st vaccine. Relevant laboratory results included   and relevant physical signs were not provided.The patient experienced the following serious criteria:. The eventual diagnosis made on was Rash macular . The Non-Health Professional did not declare any relatedness between Big blotchy rash and Moderna COVID-19 Vaccine.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .    Narrative (for narratives and signal review) Brief 3 line summary of above for ADR listing: Report Source- Non-Health Professional,  Age-  ,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome-  .