chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Just wanted to sleep; Labored breathing; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Just wanted to sleep) and DYSPNOEA (Labored breathing) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Just wanted to sleep) and DYSPNOEA (Labored breathing). At the time of the report, SOMNOLENCE (Just wanted to sleep) and DYSPNOEA (Labored breathing) outcome was unknown.            The concomitant medications were not provided. The Treatment information was not provided.   This case was linked to MOD-2021-182488 (Patient Link).
feelings of sadness; This is a spontaneous report from a non-contactable other healthcare professional (patient).   A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 28Feb2021 16:00 (4:00 PM) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included chronic pelvic pain, depression, Anxiety, Pudendal nerve neuralgia, Endometriosis, factor V leiden all from an unknown date and unknown if ongoing. The patient is not pregnant at the time of vaccination. The patient had no covid prior vaccination and is not covid tested post vaccination. The patient was vaccinated at a School or Health Clinic. There were no other vaccine in four weeks. Concomitant medication included (reported as Other medications in two weeks) lamotrigine (LAMICTAL); venlafaxine hydrochloride (EFFEXOR); ondansetron (ZOFRAN [ONDANSETRON]); topiramate (TOPAMAX); levorphanol (LEVORPHANOL); all taken for an unspecified indication, start and stop date were not reported. The patient previously took prednisone, levoquin and cipro [ciprofloxacin] and experienced drug hypersensitivity. It was reported that the patient experienced feelings of sadness on 01Mar2021 at 01:15 AM. The outcome of the event was not recovered. It was unknown if treatment for the event was initiated.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.  No further information is expected.
Received brief on Smallpox date of vaccination (08/16/2018), 2 days later (08/18/2018) got new tattoo over site, arrived at tattoo place with band aid in place. On 08/21/2018, noticed red bumps within the tattoo artwork. Followed up for 7 day site check on 08/23/2018 with autoinoculation of the smallpox site to right arm. Non adhering bandages with TEGADERM placed over effected area with instructions to follow up daily to ensure site is covered to prevent further spreading. Patient instructed to wash all clothing and linens today with hot water and detergent. No close contacts. Tattoo place notified and aware that the patient was vaccinated against smallpox and to be on guard for potential cross contamination.
suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included lysine.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In FEB-2023, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 The patient was diagnosed with internal shingles in February. The patient did not felt any better until May. The patient had both shingles injections. The physician shrugged his shoulders, only 90 percent effective. The physician asked about the way to knew about the lysine and how much did receive. The patient did not ever wanted to get that again. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
stomach cramps; could barely walk towards the bathroom; Diarrhea; Severe body ache; nausea; headache; fever; body chills; feels too tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), GAIT DISTURBANCE (could barely walk towards the bathroom), DIARRHOEA (Diarrhea), MYALGIA (Severe body ache) and NAUSEA (nausea) in an 18-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 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps), GAIT DISTURBANCE (could barely walk towards the bathroom), DIARRHOEA (Diarrhea), MYALGIA (Severe body ache), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever), CHILLS (body chills) and FATIGUE (feels too tired). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps), GAIT DISTURBANCE (could barely walk towards the bathroom), DIARRHOEA (Diarrhea), MYALGIA (Severe body ache), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever), CHILLS (body chills) and FATIGUE (feels too tired) outcome was unknown.            Concomitant drug was not reported. Treatment medication was not reported.
Experienced nausea (10 days), extreme fatigue (10 days), fatigue (30 days), rapid heartbeat/palpitations (10-14 days), rash on both arms/forearms and torso (14 days), headache (30 days but most severe initial 10 days), mild fever (7 days), anxiety (14 days).  Initially, only reported fatigue, nausea, headache, fever and rash, so we consulted a dermatologist we were already seeing, and she thought the rash was related to isotretinoin he was taking.
I had 2 documented strokes at Hospital.  I now have balance issues, double vision, peripheral vision issues that have moved me from a working and independent person  to not working and relying on others to help me.
The patient reports that approximately 11 hours after receiving the vaccine he experienced chills and felt weak. Then 2 days after receiving the vaccine, he developed a red, itchy rash to his left side approximately 4 inches dixtal to his axilla. The rash is almost completely gone, and chills and weak feeling resolved when the patient woke the next day.
Headache, Sedation, Chest pain, entire arm soreness Narrative:    Other Relevant History:
This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown ages and genders. The patient's medical history or concurrent conditions were not reported. On unknown dates since 01-NOV-2016 (reported as "excursion started on 01-NOV-2016 and vaccinations may have occurred since then"), the patients were vaccinated with unspecified doses in series of improperly stored doses of ROTATEQ (which had the lot # L048854, expiration date 31-AUG-2017) (dose and vaccination site were not informed) orally. Information regarding concomitant medication was not provided. No adverse effects were reported. It was also reported that the temperature was 12.6 C. The time frame was 168 hours. There was not previous temperature excursion. The call was not because of a "data logger". And there was no product quality complaint involved. A list of patients and actual dates of administration was not available. Additional information has been requested.
I started having sniffles, coughing, sneezing on the plane trip back from vacation. It felt more like a summer cold. Once I arrived home I took a home COVID 19 test that came back positive. I called my doctor and he referred me to the COVID 19 provider. Doctor and I spoke about my symptoms and conditions, he prescribed Paxlovid that I started taking that night. Five days later I felt much better.
8x10 cm red , warm, swelling of right deltoid where DTaP was given two days prior.
Patient states that he received his first dose of the Moderna vaccination on October 10.  The next day he began having myalgias, chills, and headache.  2 days later, he developed chest pain and shortness of breath.  He had a fever to 103 deg F at home.  Chest pain is described as tightness, located in the midsternal region with some radiation to the neck.  He reports this is worse with bending forward.  The pain has been constant.   He feels as though he is unable to take a deep breath.  He had COVID in 1/2021 - with positive COVID-19 test on 1/18/2021. He presented to the ED and was noted to have elevated WBC and cardiac troponin.  CTA chest was negative for pulmonary embolism.  He was diagnosed with acute myocarditis. There was improvement in the chest discomfort, albeit still present, at the time of discharge.  Symptomatic treatment recommended.
pt recvd vax 12JUN95 & during the last wk of NOV95 pt broke out w/chicken pox;
Pt recv vax on 8/25/98; on 8/27/98 pt exp shortness of breath, chest tightness.
INSOMNIA; PAIN IN HIP JOINT; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 198 pounds, and height was 63 inches. The patient's concurrent conditions included epilepsy, non-smoker, non-alcohol user, depression, and seizure, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, expiry: 18-JUN-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. Concomitant medications included escitalopram oxalate for depression, and phenytoin for seizure. On 06-JUN-2021, the subject experienced insomnia. On 06-JUN-2021, the subject experienced pain in hip joint. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in hip joint, and had not recovered from insomnia. This report was non-serious.
pt recvd vax; fever 101 ax;sz x 1 6:30am;mom said pt doing well 29dec94, says complications due to vax;1st sz pt has ever had;
SWELLING AND ERYTHEMA OF 2 CM DIAMETER ON RIGHT DELTOID.
pt exp extremely dizzy, room spinning, nauseated, felt like could vomit-went to ER could not find anything wrong other than elevated BP;
Bivalent vaccines have undergone several temperature excursions and have been administered to patient; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 50-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19.     On 23-Sep-2022 at 3:55 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    No concomitant medicine were reported.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.   Reportedly, the nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.   It was reported that no adverse reactions were reported to their knowledge for any patients.  No treatment medicine were reported.
03/19/2023 tested positive for COVID-19. I had very mild symptoms; mild sore throat, nasal congestion, chills, malaise, body aches and fatigue. I reached out to the Telehealth service and was not a candidate for Paxlovid, Symptoms lasted 4 days.
Given the CWY component without A portion; Given the CWY component without A portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 20-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 22nd August 2022, the patient received Menveo. On 22nd August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-AUG-2022.  Reporter's Comments: The pharmacist reported that a patient was given just the Menveo CWY component only without combining it with the menA portion. The reporter declined to provide lot no/expiry date. The reporter declined to store her contact information in our database but consented to follow-up. The reported contact info emailed. Additional Supportive Information: The patient received only Menveo CWY component only without combining with the menA portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
A report has been received from a Health Professional concerning a 50 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced a male patient of 50 years old received FLUMIST QUADRIVALENT. The outcome of the event of a male patient of 50 years old received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
One week after I had chest pain I went to the doctor because it did not go away. They did KA  & eco and nothing was found. They gave me pills for the pain. I scheduled to see a heart specialist on Nov 4.  My blood pressure went up too and I am taking pills for that.
Information has been received from a physician concerning a now approximately five years old male patient who had an anaphylactic reaction to VARIVAX in the past (date unknown). It's unknown if the patient has sought any medical attention. The patient subsequently experienced anaphylactic reaction while on therapy with MMR II (MSD, WAES0907USA01222). Additional information has been requested.
diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment medications was provided.
musculoskeletal discomfort - achiness- and fatigue-resolved after 48hrs. Began 2/12/20 Injection given on 2/11/20
Pt is COVID + from 10 days prior. Continues with fatigue, shortness of breath, weakness, decreased appetite, diarrhea,
Ovarian Vein Thrombosis; Colitis; Vomiting; Diarrhea; Fatigue/ tired/ felt exhausted; Brain Fog; Insomnia; Panic Attacks; Anxiety; Depression; high rheumatoid factor; high inflammatory markers; high cytokines; Fear; 14% weight loss/lost about 7% of my body weight; nausea/nauseous; body aches all over/Body Aches/Pain; felt unwell; arm soreness; dizzy; loss of appetite; Chills; stomach ache; sleep is very poor; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0162), via an unspecified route of administration, in right arm on 20Apr2021 16:00 (at the age of 35-years-old) as dose 1, single for COVID-19 immunization. Medical history included chronic sinusitis, indoor allergies, appendectomy, septra allergy, intolerance to Augmentin, sulfa allergy and other allergies. Concomitant medications included citalopram, cetirizine hydrochloride (ZYRTEC), melatonin, beclometasone dipropionate (QNASL), celecoxib (CELEXA), ipratropium bromide (ATROVENT) and ipratropium. The patient experienced nausea, body aches all over, body aches, pain, 14% weight loss/lost about 7% of my body weight, arm soreness, felt unwell, dizzy, loss of appetite, chills, stomach ache and poor quality sleep on 20Apr2021 17:00 and ovarian vein thrombosis, colitis, vomiting, diarrhea, fatigue, tired, felt exhausted, brain fog, insomnia, panic attacks, anxiety, depression, high rheumatoid factor, high inflammatory markers, high cytokines and fear on 20Apr2021 20:00. The patient was hospitalized for the events for 7 days. The patient underwent lab tests and procedures which included antibody test: negative in Aug2021, colonoscopy: unknown result and computerised tomogram: unknown result on an unspecified date, cytokine test: high, rheumatoid factor: high and inflammatory marker test: high on 20Apr2021, nucleic acid test: negative on 28Apr2021 Nasal Swab, sars-cov-2 test: negative in Apr2021 Blood test, sars-cov-2 test: negative on 28Apr2021 Nasal Swab. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.
Dizzy; hard to chew and talk; hard to chew and talk; Pain; Tiredness; difficult to breathe; Weakness; throat closing up; This is a spontaneous report received from contactable consumer (patient himself). A 34-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 13Apr2021 (age at vaccination: 34-years), as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 via unspecified route, in left arm, on 08Mar2021 (age at vaccination: 34-years) as dose 1, single for covid-19 immunisation. Patients medical history included HIV since 2015, unknown if ongoing. Concomitant medications were not reported. Patient took the vaccine on Tuesday morning, 13Apr2021, and he felt sick after it. He felt pain, was weak, and tiredness yesterday 14Apr2021. Today the caller was feeling dizzy, his throat was kind of closing up, it was hard to chew and talk, he felt he needs more air, and was very tired. Patient was at work today and when stands up he feels tired, weak and it was difficult to breathe. The outcome of events for difficult to breathe, weakness and throat closing up was not recovered, and rest was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt saw PCP on 2/4/09 for GYN/PAP and received #1 GARDASIL that day. Urine HCG on 2/4/09 was negative. Pt subsequently had (+) pg test 2/16/09. Pt had onset of vaginal bleeding 3/25/09 - presented to ER and was found to have a sub chorionic hemorrhage with viable fetus - pt- had episodes of vag. bldg 3/26/09, 3/28/09, 4/1/09, 4/8/09, 4/27/09 and was noted to have a "fleshy" cervical polyp on exam 5/11/09. Patient returned to our office for continued bleeding and cramping and was sent for dx. U/S at ER -> dx of 17 wk fetal demise with subsequent delivery of infant. On 5-11-09 developed retained placenta with hemorrhaging requiring D&C for manual removal of placenta.
Patients mother complains of swollen reddened area from both injection sites and a temperature of 100.8 Fahrenheit persistent over 48 hours.
Very Itchy, slightly burning spots started on my back and progressed around my whole torso.   Nothing was noticed on my extremities. The itching was the worst and the burning was still very uncomfortable. No Redness or splotching was visible. The symptoms lated 5 weeks and then slowly disappeared over the next 2 weeks. No treatment was used except scratching.
Severe unilateral posterior and anterior neck pain on the left side started around 4 PM on 2/5/2021, along with pain with swallowing.  Any movement of the neck in the lateral or side bending positions led to severe pain.  All swallowing was also painful requiring me to brace myself every time I swallowed.  This pain got increasingly worse for a period of 24 hours and then plateaued.  I started taking 400 to 600 mg of Ibuprofen and 500 mg of Tylenol in order to reduce the pain to a tolerable level.  I finally wen to the Emergency Room at my local hospital on 2/7/2021 after consulting with my local COVID hotline and my PCP.
Malaise beginning 12 hours after vaccine, fever beginning  at 17 hours, lethargy and multiple episodes of vomiting beginning at ~20 hours and lasting 12 hours. I am reporting so we can track side effect profiles for kids who receive one smaller dose and one adult dose. Patient received smaller dose for first COVID vaccine (Pfizer FK5618 on 11/9/21) and turned 12 between first and second dose. She received adult dose for #2 and had much more pronounced side effects than I've seen in most kids who've received two of the same dosage.