chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Irregular Menstrual Cycle since February of 2022, test done that tested me for menopaused and it came back negative. I also developed a lump in my left breast with localized tenderness around spring time of 2022. I did an ultrasound in June of 2022, scan showed benign tissue however I was directed to follow-up in October. I am still having localized tenderness around left breast. My primary care doctor did have me see a breast specialist and to follow-up with a plan of care. My menstrual cycle has completely ceased. I did have to go to a urologist because it felt like I was having bladder spasms and thought that I had a UTI, urgent care and PCP stated that it was negative. I feel like I have to pee all the time. We are unclear of the cause as of now and this has been going on since April of 2021.
Patient arm warm to touch with reddened raised area 70 mm long in length. Patient denies any pain.
pain in shoulder, pain in elbow, pain in muscle all on lt arm;pain & diff lifting up & extending arm & back for 3mo now;no tx;MD stated not nl-might be resistance high already to tetanus & did not need shot
Feeling really achy; Kind of like the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 26Oct2021 10:00 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for Covid-19 immunization; Bnt162b2 (Dose: 02), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 27Oct2021, outcome "recovering", described as "Feeling really achy"; INFLUENZA LIKE ILLNESS (non-serious) with onset 27Oct2021, outcome "recovering", described as "Kind of like the flu". Therapeutic measures were taken as a result of pain, influenza like illness.  Additional information: The patient received the COVID Booster shot yesterday around 10 a.m. and woke up this morning feeling really achy, kind of like the flu. The patient took some Aleve this morning and it was subsiding.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Bilateral hip pain with standing that developed 1.5 days after vaccination and is currently continuing to get worse.  Taking motrin for symptomatic relief
received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. the patient was administered second booster No treatment medications were reported.
Patient weakness unable to diagnosis specific cause . Onsite EMS was called vitals BP 180/108  99% O2 BG 69  HR 68. Patient treated and  released against medical advise.
legs red; legs swollen; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (legs red) and PERIPHERAL SWELLING (legs swollen) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (legs red) and PERIPHERAL SWELLING (legs swollen). At the time of the report, ERYTHEMA (legs red) and PERIPHERAL SWELLING (legs swollen) 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.   Patent's wife reported husband was taking several medicines but could not remember the names.   Treatment of events was not reported.
Client reports dizziness with movement and stiff neck. Denies fever (97.1 at time of call) nor HA. Client alert and oriented x 4, no confusion. Client denies taking any OTC medications to treat symptoms. Client reports hx of low BP, she denies taking any meds for BP. Client reports does not have way to take BP at home.
Initial misuse report received from a healthcare professional on 05 September 2013. It was reported that 2 doses of MENACTRA were administered to a patient within 10 days. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
DIFFICULTY IN BENDING RIGHT KNEES; SEVERE RIGHT KNEE PAIN AND JOINT PAIN; HEART PALPITATIONS; DIZZINESS; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 220 pounds, and height was 5.9 inches. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient had no known allergies and did not had any history of drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A,expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced heart palpitations. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced flu like symptoms. On 24-APR-2021, the subject experienced difficulty in bending right knees. On 24-APR-2021, the subject experienced severe right knee pain and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitations on 07-APR-2021, and dizziness, and flu like symptoms on 24-APR-2021, and had not recovered from difficulty in bending right knees, and severe right knee pain and joint pain. This report was non-serious.
-sore arm at the injection site -shivering/shaking at night time -body aches -neck "felt like on fire" -sweating (12/11/2019 to 12/14/2019)
Approximately 9 days after injection my arm started feeling sore and then a few days later started to itch and a large rash area appx 4"x5" appeared.  As of today I still have it and it continues to itch but I have no other symptoms such as headache or chills.  The rash seems to be fading today.  It was after I went online and saw a picture  I realized this was similar to what I have but my rash is not as severe nor does it have the darker "halo" around it.   The day after my injection I had a mildly sore arm but that went away until the rash and itch started several days later.
Pale, sweating, felt faint, nauseous immediately after receiving vaccine. EMS called.
Received the following text message from the mother of the patient:  Patient was airlifted to the hospital where she is living.  She had the J&J vaccine yesterday and went into anaphylactic shock.   She pretty much always been allergic to everything.   They put her on a high does of steroids but was just wondering if you had heard any reactions like that.   Said it could take up to 6 weeks to settle in her system.  She's fine now.
Developed pain; numbness; tingling in my left foot which spread to left leg; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Feb2021 (Lot number: EIV5318) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "celiac disease" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; CYMBALTA; LEXAPRO; LIVALO; OMEPRAZOLE. Past drug history included: Bactria, reaction(s): "Drug allergy", notes: known allergies: Bactria. Niacin. Lipitor. Crestor; Niacin, reaction(s): "Drug allergy", notes: known allergies: Bactria. Niacin. Lipitor. Crestor; Lipitor, reaction(s): "Drug allergy", notes: known allergies: Bactria. Niacin. Lipitor. Crestor; Crestor, reaction(s): "Drug allergy", notes: known allergies: Bactria. Niacin. Lipitor. Crestor. Vaccination history included: Bnt162b2 (Dose 1, Single, lot number: FJ1611, vaccine location: Left arm), administration date: 11Jan2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 18Feb2021, outcome "not recovered", described as "Developed pain"; HYPOAESTHESIA (non-serious) with onset 18Feb2021, outcome "not recovered", described as "numbness"; PARAESTHESIA (non-serious) with onset 18Feb2021, outcome "not recovered", described as "tingling in my left foot which spread to left leg". The events "developed pain", "numbness" and "tingling in my left foot which spread to left leg" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, hypoaesthesia, paraesthesia.  Additional information: The patient had no other vaccine in four weeks and adverse event: Developed pain, numbness, tingling in my left foot which spread to left leg. This resolved after about 4 months but recently started up again with last booster shot 27Jan2022. treatment medication included Gabapentin and prednisone. The patient had covid prior vaccination, and tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Within 12 hours: chills, fever, fatigue, nausea, headache Within 24 hours: rash at injection site, pain in arm, light sensitivity Within 36 hours: swollen lymph nodes, facial swelling, mood swings Within 48 hours: severe migraine, more nausea, trouble concentrating Within 72 hours: sudden faintness, mood swings, tight chest, diziness  Within 96 hours: ringing in ears, left side weakness
Information has been received from a Nurse Practitioner referring to 5 unspecified patients of unknown age and gender. Information about the patients' concurrent condition, medical history, drug reactions/allergies and concomitant medication was unknown. On unknown dates, the patients were each vaccinated with a dose of improperly stored ROTATEQ (dose unknown, lot # M002254 with expiration date 15-NOV-2017) orally. No adverse effect was reported. The vaccines had been exposed under temperature 48.9 Fahrenheit for 1 hour. There was no previous excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt complains of itchiness and occurring shortly after flu shot on 12-2-13 and its spread mostly on her chest area.
patient came in stating that he started having  "severe arm pain" and a bump under the skin as well as the skin being hot and inflamed. stated that the pain was an 8 or 9 out of 10. told the patient to see his doctor but in the meantime he could ice it and take tylenol.
I have contracted conjunctivitis. My eye is red and tearing and I have not had any contact with my eyes. I am going to use eye drops to help allievate the symptoms.
flu like symptoms; headache; shaking; weakness; fever; unbelievable fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), TREMOR (shaking), ASTHENIA (weakness) and PYREXIA (fever) in a 79-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.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), TREMOR (shaking), ASTHENIA (weakness), PYREXIA (fever), FATIGUE (unbelievable fatigue) and PAIN IN EXTREMITY (sore arm). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), TREMOR (shaking), ASTHENIA (weakness), PYREXIA (fever), FATIGUE (unbelievable fatigue) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided          No treatment medications provided No Concomitant medications provided   This case was linked to MOD-2021-316889 (Patient Link).
Felt an allergic rxn began wheezing; took inhaler but wheezying continued; took other meds & was okay;  Had another attack 30NOV;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Alopecia" (unspecified if ongoing); "connective tissue disorder" (unspecified if ongoing); "eczema" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received treatment with Paxlovid for Covid-19. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
VOMITING; CHILLS; This spontaneous report received from a parent concerned a 19 year old female. 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 not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, and chills. This report was non-serious.
I received my 2nd dose of the Pfizer vaccine on 2/21/21 and on 3/9/21 I first noticed a metallic taste when eating certain foods. The taste is more prominent in peanut butter cups, diet coke, and many other foods. It has caused me to stop eating/drinking some things and overall has changed my eating experience. It has been 11 weeks since I first noticed this change and it has been consistent the whole time.
Narrative:  COVID infection following COVID vaccine series 05/06 Janssen, dose #1 09/11 pt cc: myalgias, nausea, stomach cramps, cough, diarrhea, fatigue exposure: unknown 09/26 PT/INR: 14.4/1.29 09/26 COVID swab, result: detected 09/26 ESR: 116 09/26 LACTIC ACID: 1.20 09/28 COVID swab, result: NOT Detected 09/21 clinically resolved
Day of shot (April 1): Immediately after shot, left arm was sore. Developed fatigue at 2pm. A few hours later, I had a 101 fever, chills, stronger fatigue, strong headache, muscle aches. Around 6pm, I began vomiting continuously. I spoke with an advice nurse and she told me to go to the emergency room. I continued to vomit until about 11:30pm, I was weak and felt like passing out a few times. Later in the evening, I took a Tylenol and finally went to sleep. On April 2nd (day after shot), I woke up with fatigue and headache, but fever was gone and I no longer vomited. I took another Tylenol and headache went away.
Tested positive for COVID after exposure by son.  Months after vaccination.   Symptoms were considered mild: achy, fever, exhaustion/fatigue, nasal drainage, cough
Got very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got very sick) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got very sick). At the time of the report, ILLNESS (Got very sick) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information was unknown.
I have experienced dizziness and fatigue, and heart palipatations and blackouts. Difficulty of breathing and loss of strength in limbs and loss of appetite. I get flushed and over heated when the attacks happen. I feel like a burning sensation in my chest along with the dizziness and potential blackouts. I have gone to my primary physician and they tried cefner to no affect, and then sent me to a cardiologist. The attacks can take any where between a minute and longer. Some last thirty minutes and I have experienced several in a twenty four hour period. I am still currently experiencing them.
This spontaneous case reported by a consumer, describes the occurrence of abnormal heart rate (since getting the booster on Friday, heart rate high 90 low 100 and usually resting heart rate is 60) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient had an abnormal heart rate (since getting the booster on Friday, heart rate high 90 low 100 and usually resting heart rate is 60). At the time of the report, abnormal heart rate (since getting the booster on Friday, heart rate high 90 low 100 and usually resting heart rate is 60) outcome: unknown. Diagnostic results: On an unknown date, heart rate: high 90 low 100 and resting heart rate 60 (normal). No concomitant medication or treatment information reported. Reporter did not allow further contact.
Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 61 years old female patient and reported that the consumer was supposed to get a PNEUMOVAX instead of a Flu shot and inappropriate age at vaccine administration, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 14-Nov-2018, the patient received a 2nd dose of 0.5 ml suspect Influenza USP Trival A-B High Dose Subvirion Vaccine (lot number: UJ047AA) Suspension for injection in pre-filled syringe (expiry date: 28 May 2019, route and site of administration was not reported). The patient received the first dose of FLUZONE HD on 04 Oct 2018. It was a case of actual medication error due to wrong vaccine administered, overdose, extra dose administered and inappropriate age at vaccine administration. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Swollen watery eyes, runny nose, chest congestion, fever 102.2 Sleeplessness, Crying uncontrollably for short periods of time. My child had the vaccines on a Tue. and was very sick by Thursday evening. Today is Sat. and my child is feeling somewhat better without fever but continues to be congested.
His response to Pneumovax was poor/ Repeated pneumococcal vaccines both Pneumovax and Prevnar were required to maintain his protective antibodies; Literature report.  This literature marketed report was received from the authors as stated above, concerning a 66-year-old male patient with history adult-onset asthma and bilateral orbital masses that showed IgG4 lymphoproliferative disease on biopsy. Systemic review was positive for fatigue, easy bruising and bleeding, cough, shortness of air, wheezing, hypertension, joint pain, red dry eyes, and postnasal drip. He did not smoke, denied recurrent infection other than rhinitis, and had no pertinent family history.  On an unknown date, the patient was vaccinated with his first dose pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis. After vaccination, tree of 14 pneumococcal antibody titers were at a protective level (higher than 1.3 mcg/ml) and his response to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was poor (vaccination failure). Pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) booster and one pneumococcal vaccine conj 7v (crm197)(PREVNAR) booster dose were administered while the patient was off immunosuppression.An additional pneumococcal vaccine conj 7v (crm197)(PREVNAR) booster was given while he was on low-dose prednisone to maintain his protective antibodies, and overall, he had a much weaker than expected polysaccharide response, only increasing from 3 to 4 protective antibodies after vaccination.  The outcome of vaccination failure was unknown.  A copy of the published article is attached as further documentation of the patient's experience.
The patient had a low grade fever and discomfort in the vaccinated arm the evening of the vaccine. She knew this was to be expected but as the next few days progressed she continued to have pain her arm and chest. After three days she went to the hospital for evaluation.