chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Became itchy and hot; Became itchy; Develop a rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Became itchy and hot), VACCINATION SITE PRURITUS (Became itchy) and VACCINATION SITE RASH (Develop a rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O29K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (High blood pressure medication) and Thyroid disorder (Thyroid medication).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Became itchy and hot), VACCINATION SITE PRURITUS (Became itchy) and VACCINATION SITE RASH (Develop a rash). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Became itchy and hot), VACCINATION SITE PRURITUS (Became itchy) and VACCINATION SITE RASH (Develop a rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.
pt recvd vax & devel a knot @ the inject site which persisted for several wks; No further details were provided;
Vomiting; Flushed bright red; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushed bright red) and VOMITING (Vomiting) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (Half of thyroid gland being removed surgically) on 28-Oct-2020. Concurrent medical conditions included Blood pressure, Thyroid cancer and Immunocompromised.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FLUSHING (Flushed bright red). On 12-Mar-2021, the patient experienced VOMITING (Vomiting). On 11-Mar-2021, FLUSHING (Flushed bright red) had resolved. At the time of the report, VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure and anticancer drug.  No treatment information was provided.
Taste of metal; left arm got swollen; Lost of strengh on the left arm; headache here and there sporadically, not a continuoing headache; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSGEUSIA (Taste of metal), PERIPHERAL SWELLING (left arm got swollen), MUSCULAR WEAKNESS (Lost of strengh on the left arm) and HEADACHE (headache here and there sporadically, not a continuoing headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Symptoms included body aches, headaches, lost of taste and smell and had neurological side effects until September. She lost strength on the right foot and the left hand completely. She was not able to walk and could not even open a bottle of water, could not hold things; it was called COVID hand and COVID feet, both got swollen and veins popped up). She also had reactions on heart and lungs and was treated by pulmonary doctor, neurologist and cardiologist.) in March 2020 and Back surgery in 2008. Concomitant products included MELOXICAM for Back pain, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DYSGEUSIA (Taste of metal), PERIPHERAL SWELLING (left arm got swollen), MUSCULAR WEAKNESS (Lost of strengh on the left arm) and HEADACHE (headache here and there sporadically, not a continuoing headache). On 11-Mar-2021, HEADACHE (headache here and there sporadically, not a continuoing headache) had resolved. On 12-Mar-2021, PERIPHERAL SWELLING (left arm got swollen) and MUSCULAR WEAKNESS (Lost of strengh on the left arm) had resolved. At the time of the report, DYSGEUSIA (Taste of metal) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-074905 (Patient Link).
This spontaneous report was received from a other registered nurse refers to an approximately 25 year old female patient with hypercholesteremia and mitral valve disorder. The patient's medical history included goitre. On an unknown date in 2005, the patient received dose one of (Oka/Merck) VARIVAX INJ (lot # was not reported) injection for vaccination, and on an unknown date in 2007, the patient received dose two of (Oka/Merck) VARIVAX (lot# 656078/0169U and expiration date was 17-JAN-2009) injection for vaccination. Concomitant medications were not reported. The patient had (Oka/Merck) VARIVAX INJ titers drawn on 19-AUG-2010 and these titers came back negative. On an unknown date in 2013, the patient was then administered a third dose of (Oka/Merck) VARIVAX INJ (lot# H009634 and expiration date was 09-MAY-2014) injection for vaccination and had titers drawn again on 24-SEP-2014 which showed negative results. The outcome of events was reported as not recovered/not resolved. Causality was not provided by the reporter. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Developed severe all over body pain around 14 hours after the shot. Could not sleep. Took two Aleve which had no impact. For the next 24 hours of all over body pain between a 4 and 7. No fever. Then it improved for 48 hours before pain increased under left breast and left back for three to four days before noticing an oozing rash under the left breast on June 25. Went to doctor who diagnosed it as Shingles based on presentation.
Pain in left calf began on April 2 during a long road trip. Pain continued for several days. On April 5, I visited Urgent Care for a suspected muscle strain. They referred me to the Hospital emergency care for an ultrasound. The ultrasound detected deep vein thrombosis (DVT) (blood clot) in the popliteal vein in my left leg, above and below my knee. I am currently taking anticoagulant (Eliquis) medication to treat the DVT.
Started feeling shaky in my legs and dizzy like I was going to pass out. I ended up going to the ER. This has been ongoing up until as recent today. I ended up at the ER due to experiencing symptoms.
itching on the injection site; Rash on Injection Site; red injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching on the injection site), VACCINATION SITE RASH (Rash on Injection Site) and INJECTION SITE ERYTHEMA (red injection site) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.  The patient's past medical history included No adverse event (no historical condition was reported).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itching on the injection site), VACCINATION SITE RASH (Rash on Injection Site) and INJECTION SITE ERYTHEMA (red injection site). At the time of the report, INJECTION SITE PRURITUS (itching on the injection site), VACCINATION SITE RASH (Rash on Injection Site) and INJECTION SITE ERYTHEMA (red injection site) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sunday morning at approximate 12:10pm, I sat down to eat lunch and completely lost my appetite. I tried to eat but almost threw up several times. Throughout the day symptoms continued to worsen. Symptoms included complete body muscular pains, joint pains in knees and hips, drowsiness/fatigue, low grade fever (99.6), chills, nausea,  loss of appetite. I could not stand in the shower and had a hard time walking. Due to full body pains, I had a hard time sleeping. I believe this caused issues  forming detailed long term memory during this time period as much of it feels like a blur/hazy. Symptoms persisted through to Monday, May 17th  2021 to approximately 1pm. I took Monday off from work due to symptoms.  For treatment I took ibuprofen over the counter (200mg extra strength), drank approximately 2 gallons of water, and rested.   Outcome. I felt better around Tuesday. There appeared to be no long term effects following the first shot apart from having a hard time concentrating for about a week, frequently forgetting what task I was working on at work.
Haematochezia; Loss of consciousness; Diarrhoea; Nausea; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of HAEMATOCHEZIA (Haematochezia) and LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to antihistamines.) and Diabetes.   On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced HAEMATOCHEZIA (Haematochezia) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea) and NAUSEA (Nausea). At the time of the report, HAEMATOCHEZIA (Haematochezia), LOSS OF CONSCIOUSNESS (Loss of consciousness), DIARRHOEA (Diarrhoea) and NAUSEA (Nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The patient reported blood in her stool.  Concomitant products were not provided.  Treatment medication were not reported.  Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Event terms, onset dates and outcomes captured per Authority reporting.  Events seriousness per IME list; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Event terms, onset dates and outcomes captured per Authority reporting.  Events seriousness per IME list
Loss of appetite; Fatigue; Headache; Low fever; Muscle ache; Soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm), DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (Low fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm). On 10-Jan-2021, the patient experienced DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Low fever) and MYALGIA (Muscle ache). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm), DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Low fever) and MYALGIA (Muscle ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided  Company assessment:Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Pt states she felt light headed, agitated, felt beginning signs of asthma episode, tingling, tight feeling in chest and bronchioles.  Pt self admin inhaler, no improvement.  Treated in ER  Seen in Er for Shortness of Breath, shakey, dizzy. Per follow-up: 2/11/00 - Letter and consent form returned with note that they needed dates of ER Service - Letter rewritten and consent form remailed - dates of ER Service 12/27/1999.
Pt has numbness on left side; This spontaneous case was retrieved on 06-Sep-2022 from Reporting System (reference number: 0900746-1), reported by other healthcare professional and concerned a 67-year-old, female patient.  The patient's concurrent condition included allergy to morphine. The patient's concomitant medications were not reported.  On 04-Dec-2020, the patient was vaccinated with Fluad (TIV) (influenza vaccine inact sag 3v; dose: reported as 'two'; route of administration: intramuscular; anatomical location and indication: not reported). The batch number reported was 279736 (reported batch number was identified by Seqirus to be linked to suspect product Fluad (TIV) instead of reported suspect product Fluad Quadrivalent).   On 05-Dec-2020, one day, after receiving Fluad (TIV), the patient experienced numbness on left side.   On an unspecified date in 2020, the patient went to the emergency room (ER), however no further information was reported.  At the time of initial reporting, the patient had not recovered from the event.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 67-year-old subject was vaccinated with Fluad (TIV). Reportedly, one day after receiving Fluad (TIV), the patient experienced numbness on left side. Considering suggestive chronology and no alternative aetiology provided, causal role of the suspect vaccine is assessed as probably related.; Sender's Comments: A 67-year-old subject was vaccinated with Fluad (TIV). Reportedly, one day after receiving Fluad (TIV), the patient experienced numbness on left side. Considering suggestive chronology and no alternative aetiology provided, causal role of the suspect vaccine is assessed as probably related.
Case previously recorded as MA2009-4802. Initial case report received from a nurse via MeCom on 18 NOV 2009. A 3-years-old male patient was vaccinated with S-OIV FLUVIRIN (batch no. 10127601, 1013265P) 0.5mL i.m on 15 NOV 2009. No adverse effect was reported. MedCom reference no.: NA09-008489.
multiple bilateral DVTs; pulmonary embolus; This is a spontaneous report from a contactable Physician (Patient). A 66-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN6200, Expiration date was not reported), via an unspecified route of administration, in Arm Left on 23Feb2021 13:15 as single dose, the first dose via an unspecified route of administration, a in Arm Left on 02Feb2021 13:15 as single dose for covid-19 immunization. Medical history included Subarachnoid hemorrhage (SAH), hypertension (htn), degenerative discs, malignant melanoma and prostatectomy (2 years 3 months). Concomitant medications included atorvastatin calcium and lisinopril taken for an unspecified indication, start and stop date were not reported. The patient previously took cephalosporin for allergies. After receiving the second dose patient experienced pulmonary embolus on an unspecified date in 2021 and multiple bilateral DVTs diagnosed on 11Mar2021. As per the reporter seriousness criteria reported as emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Patient did not receive any other vaccine in four weeks. Patient did not have Covid prior vaccination. Patient was not tested Covid post vaccination. Therapeutic measures were taken as a result of pulmonary embolus multiple bilateral dvts. The outcome of the events was not recovered.; Sender's Comments: Based on the temporal relationship, A possible contributory role of the suspect product to the development of Pulmonary Embolus and Deep Vein Thrombosis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt received 2 doses of Moderna COVID-19 vaccine on 3/6 & 4/3. Around 12/26 she developed some waxing mentation, which persisted and worsened until being brought to the hospital by family on 12/29/21. In ED, she tested positive for COVID-19.
PT REQUESTED AND RECEIVED MODERNA BOOSTER 2 AND IT WAS DISCOVERED IN RECORDS THAT PATIENT HAD 2ND BOOSTER 4/13/22- NO C/O OCCURRED AFTER VACCINE.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-JUN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml)(lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer)(R/F) for each time were 440, 33 and R; 80, 34 and R. The storage criteria was refrigerator R. This is one of several reports received from the same source. Additional information has been requested.
NO ADVERSE EVENT OCCURED,  PATIENT WAS UNDER AGE, HOWEVER PARENT CONSENT WAS OBTAINED
(L) deltoid red, bruised and swollen non-tender good ROM, (+) warm-ice, BENADRYL, NSAID or TYLENOL prn.
Chills, fever pain at injection site, arthralgia, headache Narrative:  symptoms lasted 18 hrs  Other Relevant History:
BODY ACHES; MIGRAINE; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 62876897/180529, and batch number: 62876897/180529 expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced migraine. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and chills, and had not recovered from headache, migraine, and body aches. This report was non-serious.
3 days post vaccination Pt reported red, hot itchy rash developed on left abdomen, still present post vaccination day 5 redness almost gone but itchiness still present.
Reports sore arm and fatigue today, that does not interfere with ability to work.; Reports sore arm and fatigue today, that does not interfere with ability to work.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05Apr2022 (Batch/Lot number: unknown) as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Booster dose number unknown, manufacturer unknown), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 06Apr2022, outcome "unknown" and all described as "Reports sore arm and fatigue today, that does not interfere with ability to work.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial report received on 13 November 2009 and 16 November 2009 from a nurse, who is also the patient. A 49-year-old female patient received a first intramuscular left deltoid injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP009AA) on 19 October 2009. On 11 November 2009, 23 days post-vaccination, the patient experienced pain in her entire left arm. Her left index finger was described as having linear red bumps, which was diagnosed by an emergency room physician as shingles. The patient had a history of catamenial pneumothorax and allergies to penicillin and COMPAZINE, and was taking SINGULAIR, ACTIVELLA, ALLEGRA, Vitamin D, and LUPRON concomitantly. AT the time of the report, the event was still ongoing. Documents held by sender: None.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Oct2021 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: "Asthma" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 02Sep2022 at 12:00, outcome "unknown", described as "Rebound symptoms and positive test 2 days after completing dose pack". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Sep2022) Positive, notes: at 12:00 PM. Rebound symptoms and positive test 2 days after completing dose pack. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course: Patient was treated for covid-19 with antivirals from 25Aug2022 to 30Aug2022. Patient experienced terrible taste, there was rebound symptoms and positive test 2 days after completing dose pack. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and COVID-19 cannot be ruled out.
10-15 scabbed over lesions: 2 on forehead, 3-4 on back, 2 on inguinal region & 1-2 on legs;no fever;+ pruritus;