chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness at the injection site; Achy for 24 hours; Malaise for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Achy for 24 hours), MALAISE (Malaise for 24 hours) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Behcet's syndrome (Inflammation of the blood vessels), Lymphangioleiomyomatosis and Raynaud's disease. Concomitant products included AZATHIOPRINE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), AMLODIPINE, HYDROXYCHLOROQUINE, COLCHICINE and FOLIC ACID for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN (Achy for 24 hours) and MALAISE (Malaise for 24 hours). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site). On 16-Feb-2021, PAIN (Achy for 24 hours) and MALAISE (Malaise for 24 hours) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-596770 (Patient Link).
This spontaneous report was received from a registered registered nurse and refers to a 12 months patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 30-JUL-2017, the patient was supposed to receive M-M-R II and VARIVAX but BY mistake and not a confusion,  the patient received vaccination for prophylaxis with PROQUAD, 0.5 ml once, subcutaneous, lot number N014948 with expiration date on 11-NOV-2018 (strength, dose number and anatomical location were not reported) and with VARIVAX lot Number N017394 and expiration date on 07-JUN-2019 (strength, dose number, anatomical location and route of administration were not reported). The lot number and expiration date of the sterile diluent used for reconstitution was unknown. There was no adverse effect reported.
Right arm "rash" described as macule with clear demarcated edge, slightly raised reported as oval around injection site. Slightly raised and itching.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment products reported.   This case was linked to MOD-2021-051866 (Patient Link).
breastfeeding 5 months; Red inflammation" with 2 inches wide; Little itchy; Red inflammation" with 2 inches wide; This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding 5 months), VACCINATION SITE INFLAMMATION (Red inflammation" with 2 inches wide), VACCINATION SITE PRURITUS (Little itchy) and VACCINATION SITE ERYTHEMA (Red inflammation" with 2 inches wide) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024JQ0A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE INFLAMMATION (Red inflammation" with 2 inches wide), VACCINATION SITE PRURITUS (Little itchy) and VACCINATION SITE ERYTHEMA (Red inflammation" with 2 inches wide). On 13-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding 5 months). On 12-Jan-2021, VACCINATION SITE INFLAMMATION (Red inflammation" with 2 inches wide), VACCINATION SITE PRURITUS (Little itchy) and VACCINATION SITE ERYTHEMA (Red inflammation" with 2 inches wide) had resolved. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding 5 months) 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.   Reporter did not allow further contact; Sender's Comments: This is a case of product exposure during breastfeeding with associated AEs of vaccination site inflammation, vaccination site erythema, vaccination site pruritus. Patient will continue to be contacted for further monitoring of AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Complained of migraine and stomach ache 3 days duration, body aches and sore arms x 5 days.
Nov90 pt vax w/ MMR; devel fever, cough, conjunctivitis, runny nose, and a truncal rash dx as measles.
BELLS PALSY; This spontaneous report received from a consumer via social media a company representative concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 01 total administered 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 bells palsy. Reporter stated, "My son took the shot and got bells palsy." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221246567-bells palsy. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
patient c/o feels like heart racing, denies shortness of breath, HR regular, skin warm and dry, teeth chattering, patient states they feel cold, monitored for 45 minutes, patient left at 1147 states she is ready to go, states I am ok.
Erythema over posterior upper right arm from deltoid to just below elbow. Warm to touch, no pruritus. Complains of mild malaise for 2 days after vaccine, improved 3rd day. Treated with Benadryl, Neprosyn.
blood pressure shot up to 205/112/blood pressure went down to 136/75; head hurt; couldn't hear that well; pulse 137; a heat wave go through her body up to her head; red rash and hives; red rash and hives; This is a spontaneous report from a contactable other healthcare professional (Patient). A 62-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 21Dec2020 16:00 at single dose for COVID-19 immunization, vaccine location provided as Left arm.  Medical history included Penicillin allergy. The patient's concomitant medications were not reported. After about 10 minutes receiving the vaccine on 21Dec2020 16:15, the patient felt a heat wave go through her body up to her head, couldn't hear that well and head hurt. Her blood pressure shot up to 205/112, pulse 137, red rash and hives. The patient was transported via parametics to the Emergency Room for observation. Her blood pressure went down to 136/75. No treatment was received for all the event. The outcome of the events was recovered on 21Dec2020.  Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the event blood pressure increased cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Information has been received from a nurse practitioner concerning a 24 year old female with no relevant medical history who in May 2007 and in July 2007, was vaccinated with a first and second dose of GARDASIL vaccine (yeast) respectively (lot number, injection site and route not reported). On 06-MAY-2008 the patient was vaccine with the third dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). Concomitant therapy included minocycline HCl (MINOCIN). On 06-MAY-2008 the patient had an abnormal PAP test and was positive for the HPV DNA reflex group which tested the 6 high risk types. The patient was diagnosed with low grade lesions or precancer. Unspecified medical attention was sought. Additional information has been requested.
HAD STRONG REACTIONS; This spontaneous report received from a patient concerned multiple patients. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced had strong reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had strong reactions was not reported. This report was non-serious.
Patient called to report nausea, ache, and fever (does not know temperature but knows when she has a fever)
The day after the vaccination had symptoms that effected my work.  The symptoms were fever, body/muscle aches, and  headache.
Severe systemic arthritic reaction to all joints. Severity lasted 8 weeks, and although lessened, is still strong. Most effects in both shoulders, left elbow, left hand, both hips, both knees.
Patient developed chest pain approximately 6 days after receiving first dose of Pfizer vaccine. He presented to the ER on 7/23/21 (11 days after vaccine) and was found to have a pulmonary embolism and deep venous thrombosis in his inferior vena cava (IVC).
Fever inc to 100.6 R, bulging fontanel this AM 4DEC91 dry coughing x 1 day, diarrhea off & on x 1 wk; poss bacteria meningitis;
Dry and then wet cough that has lasted 2 months. Break out of eczema on feet, hands and arms that has yet to resole after 2 month. In 2 days of vaccine, a flare of microscopic colitis that has yet to resole. Was in remission prior to vaccine. Fatigue and brain fog.
I have a prior history of occasional minor tinnitus.  A few weeks after the 2nd Moderna vaccine, the tinnitus has become louder and now it is constant.  I don't know if it's related to the vaccine, but it's gotten much worse over the past two weeks.
Hot; Itchy; It went from bright red to pink; Sore; A pink rash, t grew and grew, about day 6-7-8-9 it was a; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot), PRURITUS (Itchy), SKIN DISCOLOURATION (It went from bright red to pink), RASH (A pink rash, t grew and grew, about day 6-7-8-9 it was a) and PAIN IN EXTREMITY (Sore) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE and LISINOPRIL for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced RASH (A pink rash, t grew and grew, about day 6-7-8-9 it was a). On 10-Feb-2021, the patient experienced FEELING HOT (Hot), PRURITUS (Itchy), SKIN DISCOLOURATION (It went from bright red to pink) and PAIN IN EXTREMITY (Sore). At the time of the report, FEELING HOT (Hot), PRURITUS (Itchy), SKIN DISCOLOURATION (It went from bright red to pink) and PAIN IN EXTREMITY (Sore) outcome was unknown and RASH (A pink rash, t grew and grew, about day 6-7-8-9 it was a) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Menorrhagia,  worse starting early October.  In November saw Dr. Hgb was 7.6, was irritated, dizzy, syncope,   Now taking iron pills 3 times daily, had pelvic ultrasound that showed no changes since 2008.  Bleeding slowed and stopped, after 3-4 weeks. No history of severe anemia, no history of abnormal bleeding.
Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with FAMCICLOVIR (FAMVIR [FAMCICLOVIR]) on 29-Jan-2021 for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported
This spontaneous report as received from a registered nurse refers to unknown number of patients (unknown age and gender). The nurse reported that improperly stored oral ROTATEQ might have been administered to an unknown number of patients on unspecified dates. Lot # and administration information were not provided. No adverse effects reported. This is one of two reports received from the same reporter. Additional information is not expected.
This spontaneous report as received from a registered nurse refers to a male physician of unknown age with diabetes and Parkinson's disease who on 30-AUG-2012, was vaccinated SQ with a dose of ZOSTAVAX (dose and lot # not reported). It was reported that the physician developed numbness of his left hand and arm on 31-AUG-2012 on awakening. The numbness had continued and the physician had difficulty holding things with his left hand. The physician was currently seeing patients and planned to contact his unspecified primary care physician. The physician did not seek medical attention and did not receive any treatment. At the time of the report, the physician had not recovered. The relatedness for numbness of his left hand and arm and difficulty holding things with the left hand was unknown for ZOSTAVAX. Additional information has been requested.
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    Patient was of over 18 years of age. No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 06 Jul 2023, 6 doses were administered at administration site 2. No treatment medication reported.   This case was for the 45th patient out of 47 reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case (Patient 1)
within one hour began vomitting while trying to drive home, slept 5-8pm and woke with terrible headache, very tired and continued vomiting every 3-4 hours until the next evening at 9pm when it finally stopped... continued to have lingering headache, extremely tired, weakness and dizzy for 8 days ... slept 10-12 hours every night when normally i sleep 6-7 hours ... on day 9 i woke and my head felt clear and i could think clearly ... on day 10 i started to physically feel much better like it was finally over ... i'm so extremely scared to get the 2nd dose .... i'm not sure i can make myself .... i can't go through this again
Initial report was received 03 November 2010 from a health care professional. A male infant (age not reported) had received PENTACEL, lot number C3784AB (lot number, route, site and date of administration not reported and an unspecified amount of time later, he experienced seizures. Outcome was not reported. No additional information was provided at the time of the report. Documents held by sender: None.
high fever; A spontaneous report was received from a consumer concerning a male patient  of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a  heavy reaction/adverse reaction and high fever/pyrexia.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot# unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient reported having a "heavy reaction" to the vaccine, including a high fever.   No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, adverse reaction and pyrexia were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of pyrexia, a causal relationship cannot be excluded.
Vaccine given at outreach center. Pt became faint after the vaccine was given. Assessed by MD at site. (3 min after fainting; BP 116/74 and 5 min BP: 130/82). 30 minutes later, pt released to go home by MD.
pt recvd vax & devel pain @ the inject site which lasted about 7 to 8 mins a/resolving; pt also c/o sore & heavy arm all day;
Pain in upper left arm; This is a spontaneous report from a contactable consumer (patient).  An 80-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number EL1284) , via an unspecified route of administration on 18Jan2021 14:00 at single dose on left arm for covid-19 immunisation.  There were no medical history and concomitant medications. The patient experienced pain in upper left arm on 24Jan2021 16:00. She received her first injection as initially on 18Jan2021 14:00. It has been about ten days now and she was now feeling pain in her upper left arm. Yesterday and today the pain was intense. She had felt good all week. She has even taken two Tylenol and it has not calmed down the intense pain. Therapeutic measures were taken as a result of pain in upper left arm (pain in extremity). The outcome of the event was not recovered.
Shot was given high up near shoulder joint and within 45 minutes of the shot  - his shoulder felt "frozen". Today he can lift his arm about 2" with much discomfort and weakness.
erythema & edema extending from above the shoulder to the elbow of the lt arm developing 24hr p/vax;tx w/cool compresses & DPH;sx resolved w/in 72hr;
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. On 09-OCT-2018, there was an storage temperature excursion and on 17-OCT-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N035958 with expiration date on 18-DEC-2019 (strength, dose, anatomical location or route of administration were not provided), for prophylaxis; which was administered concomitantly with a sterile diluent (MERCK) that was not reported as improperly stored. The storage temperature of the vaccine was reported as 47 to 77 degrees Fahrenheit (°F) (58.5 °F) for a time frame of 13 hours and 20 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were being reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA012810.
Mom called on 8/28/13 and reported client had little red pimples about 20 of them that have burst open and now dried- reports also had fever of 101 degrees up until last night - reported these symptoms started 3 days post vaccines.
headache; nausea; 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 HEADACHE (headache) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No medical history reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported.
Flu shot was given to the patient. Patient was sitting down when the shot was given. While the patient was waiting in line to checkout, he fainted and fell to the floor. There was loss of consciousness. Patient regained consciousness quickly. 911 was called. Patient stated that he had not had anything to eat since 0600 that day.
Cerebral venous sinus thrombosis Symptoms - daily headache that started around 7/11/21 which is about 10 days after first dose of the vaccination
Moderna COVID-19 Vaccine: Fever (101.5), tenderness at injection site, headache, nausea, body aches, fatigue
I got graston. My  knee and hamstring was fine until after the next vaccine. got sort of adhesions in my hamstring. saw the chiropractor. got fever for about a day
p/vax pt had seizure; transported to ER; examined by MD; T103 before leaving home non-responsive; no fever in ER; no hx of prior seizures