chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chronic Fatigue Syndrome worsened; Had plenty of side effects; Pain in the back side, that lasted for three weeks; Muscles pain, that lasted for three weeks; Join pain, that lasted for three weeks; Swollen lymph nodes, under the armpit of the injection side; Chills and was round down that night; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC FATIGUE SYNDROME (Chronic Fatigue Syndrome worsened), VACCINATION COMPLICATION (Had plenty of side effects), BACK PAIN (Pain in the back side, that lasted for three weeks), MYALGIA (Muscles pain, that lasted for three weeks) and ARTHRALGIA (Join pain, that lasted for three weeks) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic fatigue syndrome and Epstein-Barr virus infection. Concomitant products included OMEGA-3 [OMEGA-3 NOS] and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION COMPLICATION (Had plenty of side effects), BACK PAIN (Pain in the back side, that lasted for three weeks), MYALGIA (Muscles pain, that lasted for three weeks), ARTHRALGIA (Join pain, that lasted for three weeks), LYMPHADENOPATHY (Swollen lymph nodes, under the armpit of the injection side) and CHILLS (Chills and was round down that night). On an unknown date, the patient experienced CHRONIC FATIGUE SYNDROME (Chronic Fatigue Syndrome worsened). The patient was treated with CELECOXIB (CELEBREX) from 03-Nov-2021 to 04-Nov-2021 at a dose of 1 dosage form and TIZANIDINE on 03-Nov-2021 at a dose of 1 dosage form. At the time of the report, CHRONIC FATIGUE SYNDROME (Chronic Fatigue Syndrome worsened), VACCINATION COMPLICATION (Had plenty of side effects), MYALGIA (Muscles pain, that lasted for three weeks), ARTHRALGIA (Join pain, that lasted for three weeks) and LYMPHADENOPATHY (Swollen lymph nodes, under the armpit of the injection side) outcome was unknown and BACK PAIN (Pain in the back side, that lasted for three weeks) and CHILLS (Chills and was round down that night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that on 02-Nov-2021, she had an appointment with doctor because she was not feeling better with the joint pain, muscle pain and fatigue.   This case was linked to MOD-2021-398450 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Patient demographics, Medical history, Outcome of events Joint pain and Muscle pain, Additional event of Chronic fatigue syndrome, Treatment medications were updated. On 01-Dec-2021: Contains no new information.
prolonged crying >6hr, inconsolable;local cellulitis @ DTP inj site;erythema & induration;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On 17-APR-2018 the patient was vaccinated with an expired dose of VAQTA 50/1.0 U/ml (lot # M018767, 01-FEB-2018) (dosing regimen and frequency unknown) for prophylaxis (expired product administered). No adverse events were reported. There was no product quality compliant reported. This case is linked to case number 1804USA008569 via same reporter link. Sender's Comments: US-009507513-1804USA008569.
Since the day of the vaccine, I have had a change in taste. Whenever I eat meat or anything savory, it tastes like gasoline. Some other things taste funny too. It began with my toothpaste, so I just thought it was a bad tube. After buying a new brand of toothpaste, I discovered that it was my tastebuds that were off. Toothpaste and anything minty or savory I once loved eating now tastes like gasoline smells. Once loved smells from cooking food are also unbearable now.  Most sweet foods still taste the same, though and are good.
Started having new lesion on back with itching. Started changing in spring '23 dx with melanoma
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very sore), PAIN (Has body ache), COUGH (Coughing), VOMITING (Vomiting most of the night) and PYREXIA (100.1 temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PAIN IN EXTREMITY (Arm is very sore), PAIN (Has body ache), COUGH (Coughing) and PYREXIA (100.1 temperature). On 25-Jan-2022, the patient experienced VOMITING (Vomiting most of the night). At the time of the report, PAIN IN EXTREMITY (Arm is very sore), PAIN (Has body ache), COUGH (Coughing), VOMITING (Vomiting most of the night) and PYREXIA (100.1 temperature) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: 100.1 (High) 100.1. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The case was reported by patient's mother. No concomitant medication information was provided. No treatment medications were provided. The reporter wanted to know if the symptoms were related to the vaccine. Reporter did not allow further contact.
Herpes zoster oticus/Ramsay-Hunt syndrome; Information has been received regarding a case in litigation from a lawyer and consumer, to a patient of unknown age and gender. Information about concurrent condition, historical condition and concomitant medication was unknown.   On or about 24-SEP-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency and route unknown) for the long-term prevention of shingles and/or zoster-related conditions, by the pharmacist at a pharmacy.   On an unknown date, the patient was treated for herpes zoster oticus and Ramsay Hunt Syndrome. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster oticus and Ramsay Hunt Syndrome was considered as not recovered/not resolved. The herpes zoster oticus was considered to be related to zoster vaccine live (ZOSTAVAX).     Upon internal review, herpes zoster oticus and Ramsay Hunt Syndrome was considered to be medically significant.
Information has been received from a vaccine coordinator concerning a 17 year old female with no pertinent medical history, who on 21-JAN-2008 was vaccinated with Gardasil and fainted.  It was noted that the patient has a history of fainting when given a shot.  The physician's assistant said that it did not meet the symptoms of a seizure.  Unspecified medical attention was sought.  Subsequently, the patient recovered from faint.  No further information was provided.  Additional information has been requested.
24 hrs post vax pt reported nausea w/vomiting x 3-4 days, inject site is very painful & erythemic 8-10cm around site;
fever, screaming, vomiting started 30SEP92 about 2PM APAP given but fever cont; 8PM, t104 @ 915PM t105; eyes rolled back in head; seen in ER; poss infect; limp or lt side numb-lt eye closed dragged lt foot;
Dizziness nausea and ears ringing for 2 days with out relief from medication.
Pt remained with what appeared to be PVS after completion of a complete course of antibiotic therapy as well as multiple rounds of HD to clear any potential intoxicants. He remained relatively stable otherwise and was on TCT and progressing, with possible hope of transfer near family or to have family come to pt. for pt to enter hospice. 5/30, early AM, overnight team paged due to difficulty obtaining O2 sat. Pt was found to be in cardiac arrest and despite resuscitative efforts, expired. Family was contacted by overnight team. Time of death 0212 on 5/30/2023.
Acute anaphylactic - IV Benadryl and Salumedrol per mouth Zyrtec. Symptoms resolved.  Nurse follow up on 06/18/04 states: "Flushed, itching, puffy eyes, anxiety, Tachypneic."
Patient is asking if it's safe to take antibiotics for her infection; This is a spontaneous report from a contactable consumer (patient) via a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as 1st dose single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the Pfizer vaccine on 27Apr2021 and the second dose was scheduled on 18May2021 (correct dosing schedule). The patient was asking if it's safe to take antibiotics for her infection. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Redness and sore arm appeared unexpectantly on the 9th day after receiving my 1st injection of Covid-19 vaccine. Still red and sore today.
Date above is estimated.  Child began to develop a stuffiness in her nose.  Became more difficult to breath out of nostril.  Went to PCP.  Was referred to ENT.  Had polyp in nose.  Mother concerned that polyp developed due to nasal H1N1 given in the fall.
-  increased heart palpitations for 2 months; resolved. negative workup with cardiology - increased menstrual flow ( heavier periods ) x 3 months. new ovarian cyst - simple cyst - Supraclavicular lymph node swelling. Ultrasound x 2 with dx as reactive lymph node. no biopsy.
I experienced rashes by my torso area and they took about a week to fade away they were not painful nor itchy.
BRAIN FOG; CONGESTION; MUSCLE AND BONE ACHES (BACK/RIBS/ARMS); HEADACHE; FATIGUE; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (pfizer) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 (The patient was diagnosed with covid-19 infection before vaccination.), and concurrent conditions included: unspecified drug allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. Since the vaccination, the patient had not been tested positive for covid-19. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total, administered to left arm on 01-APR-2021 12:00 for covid-19 prophylaxis. No concomitant medications were reported.   It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received non-company suspect moderna covid-19 vaccine (elasomeran) (dose number in series 2) (intramuscular, form of admin was not reported, batch number: 017F21A, expiry: UNKNOWN) dose was not reported, administered to left arm on 29-OCT-2021 12:00 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination moderna covid-19 vaccine (elasomeran) (dose number in series 2). The patient additionally received non-company suspect pfizer (tozinameran) (dose number in series 3) (intramuscular, form of admin was not reported, batch number: HF9275, expiry: UNKNOWN) dose was not reported, administered to left arm on 09-OCT-2023 11:30 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 3).  The patient also received influenza vaccine (form of admin, route of admin, and batch number were not reported) dose was not reported, administered to left arm on 09-OCT-2023 for prophylactic vaccination On 09-OCT-2023 20:00, the patient experienced brain fog, congestion, muscle and bone aches (back/ribs/arms), headache, and fatigue (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, tozinameran, and influenza vaccine was not applicable. The patient recovered from brain fog, congestion, muscle and bone aches (back/ribs/arms), headache, and fatigue, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
low grade temp; multiple hive-like rashes on thigh around inj site & distal thigh
Bloody stools about 3-4 weeks after vaccine. Stool sample taken and submitted for testing. Tested positive for rotavirus.
Numbness on left side of body, starting with the foot and going up; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN6202 and expiry date was not provided), via an unspecified route of administration in the left arm on 25Feb2021 at 16:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Patient did not have any known allergies. Patient's medical history was not reported. Concomitant medication included pravastatin. Patient had previously received first dose of BNT162B2 (Lot Number: EN5318) in left arm, on 02Feb2021 at 16:00 (at age of 58-years-old) for COVID-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 05Mar2021 at 08:00, patient experienced numbness on left side of body, starting with the foot and going up. This started 7 days after vaccine. Comes and goes every day still. Adverse events result in visit to Doctor or other healthcare professional office/ clinic. No treatment was received. The outcome of events was not recovered.  Information on Lot/ Batch number was available. Follow up letter has been generated for further information.
After 5 weeks, my arm is still numb and if I move it a  certain way, it feels like a bee sting or jabbing a needle in my arm pain.
Pt was given MMR and Varicella in thigh on 8/8/14. 8/10/14 pt had a fever T-101 @ 7:30AM and febrile seizure @ 11:30 am. 8/10 pt developed a vesicular, clustered shingle like rash on thighs-resolved after 2 days.
Heat; Facial swelling; Redness; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING HOT (Heat), SWELLING FACE (Facial swelling) and ERYTHEMA (Redness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Endometrial carcinoma. Concomitant products included LENVATINIB MESILATE (LENVIMA) and PEMBROLIZUMAB (KEYTRUDA) from 11-Feb-2021 to an unknown date for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced FEELING HOT (Heat), SWELLING FACE (Facial swelling) and ERYTHEMA (Redness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 19-Feb-2021, SWELLING FACE (Facial swelling) and ERYTHEMA (Redness) had resolved. At the time of the report, FEELING HOT (Heat) outcome was unknown.        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.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Regulatory Authority
Night of vaccines pt had 105.1 temp down to 102 x 2 days.
vial used outside of labeled information vial was at room temp >12hours but <24 hours post first puncture No adverse effects known Patient does not need to be revaccinated as data is on file support
PRODUCT WAS THE ONE THAT'S GOING TO TAKE HER LIFE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and no alcohol use, and other pre-existing medical conditions included: The patient was a teacher for more than 30 years. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced product was the one that's going to take her life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of product was the one that's going to take her life was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
A report was received of asthma coincident to FluMist therapy. A seven year old with a history of one episode of croup at the age of five and multiple episodes of bronchitis in the past 12 months, received FluMist on 10/10/06. On 11/1/06, the pt was admitted to the hospital with an acute asthma event and remained hospitalized for three days. The pt had no previous diagnosis of asthma. Information regarding hospitalization, treatment, and event outcome were not provided. The reporter did not provide a statement of causality to FluMist. DOS 11/01-11/03/2006 DC DX: Status Asthmaticus, resolved. Hypoxia, resolved and Bronchitis. Presented to PCP with first asthmas attck on 11/1/06. Responded to nebulizer treatment with Xopenex. Sent home, subsequently developed more wheezing and difficulty breathing , sent to facility. On admission significantly dyspeneic. Required oxygen to keep satus above 95%, quite winded with wheezing and subcostal retraction. Started on Xopenex and Atrovent. Pulmicort nebs. Gradually weaned off oxygen. Continue nebulizer treatments at home. Per annual follow up report: Reporter indicated that the patient had finally recovered from the event, 07-Mar-2008.
pt recv vax 15JUN98 & 2 days post vax pt devel redness, swelling & severe pain from the inj site to the elbow;pt seen by MD d cellulitis & prescribed an ATB;
red big knot bigger than a 50 cent coin; affecting her nervous system; affecting her immune system; real itchy; red bumps on her arm (where she got the shot) and her legs; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (red big knot bigger than a 50 cent coin), NERVOUS SYSTEM DISORDER (affecting her nervous system), IMMUNE SYSTEM DISORDER (affecting her immune system), VACCINATION SITE PRURITUS (real itchy) and VACCINATION SITE RASH (red bumps on her arm (where she got the shot) and her legs) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 VACCINATION SITE MASS (red big knot bigger than a 50 cent coin), NERVOUS SYSTEM DISORDER (affecting her nervous system), IMMUNE SYSTEM DISORDER (affecting her immune system), VACCINATION SITE PRURITUS (real itchy) and VACCINATION SITE RASH (red bumps on her arm (where she got the shot) and her legs). At the time of the report, VACCINATION SITE MASS (red big knot bigger than a 50 cent coin), NERVOUS SYSTEM DISORDER (affecting her nervous system), IMMUNE SYSTEM DISORDER (affecting her immune system) and VACCINATION SITE PRURITUS (real itchy) outcome was unknown and VACCINATION SITE RASH (red bumps on her arm (where she got the shot) and her legs) had not resolved.            No concomitant medications were reported. No treatment information was reported. No other information were provided as the consumer was very upset.   Reporter did not allow further contact
Information has been received from a  registered nurse concerning a 3-year-old male who on 11-AUG-2004 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy that day included a dose of Hib conj vaccine (manufacturer unknown) and a dose of measles-mumps-rubella vaccine. On 20-FEB-2006, the patient developed shingles. The patient had blisters on the left thigh and buttocks. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
No additional AE reported; temperature excursion over the weekend were administered to a patient.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reaction/allergies were not reported.  On 13-FEB-2023, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot #W021182, expiration date: 27-FEB-2025); and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #W026135, expiration date: 31-JAN-2024) for prophylaxis (strength, anatomical site of administration and route of administration were not provided) which temperature excursion over the weekend, temperature above 9 degree Celsius for 2 hours 32 minutes and 0 seconds (product storage error). There's no previous temperature excursion. No additional adverse event (AE) reported (no AE).
Fever 102, gave Tylenol got cold symtoms after 5/3/16 then on 5/7/2016 broke out in a rash all over body.
5TH NOSEBLEED IN A WEEK; 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, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced 5th nosebleed in a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 5th nosebleed in a week was not reported. This report was non-serious.
Taken to ER by parents on 05/29/2003 for difficulty breathing, cyanotic skin changes and irritability after receiving immunizations